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Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER THE SECURITIES ACT OF 1933

~~THE SECURITIES ACT OF 1933~~

BRAINSTORM CELL THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

Delaware	2836	20-8133057
(State or other jurisdiction of	(Primary Standard Industrial	(I.R.S. Employer
incorporation or organization)	Classification Code Number)	Identification Number)

605 Third Avenue, 34th Floor


Delaware	2834	20-7273918
(State or other jurisdiction of incorporation or organization)	(Primary Standard Industrial Classification Code Number)	(I.R.S. Employer Identification Number)

~~New York, NY 10158~~

~~(646) 666-3188~~1325 Avenue of Americas, 28th Floor

New York, New York 10019

Phone: (201) 488-0460

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

~~Liat Sossover~~

~~Chief~~Chaim ~~Financial Officer~~Lebovits

~~c/o~~Chief ~~Brainstorm~~Executive ~~Cell Therapeutics Inc.~~Officer

~~605~~Brainstorm ~~Third~~Cell ~~Avenue, 34th Floor~~Therapeutics Inc.

~~New~~1325 ~~York~~Avenue of Americas, NY28th ~~10158~~Floor

~~(646) 666-3188~~New York, New York 10019

Phone: (201) 488-0460

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

~~Thomas~~Faith BL. ~~Rosedale~~Charles, Esq. ~~BRL Law Group LLC 425 Boylston Street, 3rd Floor Boston, MA 02116 (617) 399-6931 (telephone number) (617) 399-6930 (facsimile number)~~

~~Approximate~~Thompson ~~date~~Hine ~~of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.~~LLP

If300 ~~any~~Madison ofAvenue, ~~the~~27th ~~securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: þ~~Floor

IfNew ~~this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act~~York, ~~please~~New ~~check~~York ~~the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨~~10017-6232

IfPhone: ~~this Form is a post-effective amendment filed pursuant to Rule 462~~(c212) ~~under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨~~344-5680

IfFax: ~~this Form is a post-effective amendment filed pursuant to Rule 462~~(d212) ~~under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨~~344-6101

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

~~Large~~Approximate ~~accelerated~~date ~~filer~~of ¨commencement ~~Accelerated~~of ~~filer~~proposed ¨sale ~~Non-accelerated~~to ~~filer~~the ¨public: ~~Smaller~~From ~~reporting~~time ~~company~~to þtime after the effective date of this registration statement.

~~(Do~~If any of the securities being registered on this Form ~~not check if~~ are to be offered on a delayed or continuous basis pursuant to Rule ~~smaller reporting company)~~415 under the Securities Act of 1933 check the following box. ☒

~~CALCULATION OF~~If ~~REGISTRATION~~this ~~FEE~~Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Title of Each Class of Securities to be Registered		Amount to be Registered				Proposed Maximum Offering Price Per Share				Proposed Maximum Aggregate Offering Price				Amount of Registration Fee
Common Stock, $.00005 par value per Share(1)			84,000,000			$	0.36	(2)		$	30,240,000			$	3,895

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

~~(1)~~If ~~Pursuant~~this toForm is ~~Rule~~a ~~416~~post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, ~~this~~check ~~registration~~the ~~statement~~following ~~also~~box ~~covers~~and ~~such~~list ~~indeterminate number of additional shares of Common Stock as may be issuable with respect to~~ the ~~shares~~Securities ~~being~~Act ~~registered~~registration ~~hereunder~~statement asnumber ~~a result~~ of ~~any~~the ~~stock~~earlier ~~splits,~~effective ~~stock~~registration ~~dividends~~statement orfor ~~similar~~the ~~transactions~~same offering. ☐

~~(2)~~Indicate ~~Estimated~~by ~~solely~~check ~~for~~mark whether the ~~purpose~~registrant ofis ~~calculating~~a ~~the~~large ~~registration~~accelerated ~~fee~~filer, ~~and~~an ~~based~~accelerated onfiler, ~~the~~a ~~average~~non-accelerated offiler, ~~the~~smaller ~~high~~reporting ~~and~~company, ~~low~~or ~~prices~~an ofemerging ~~the~~growth ~~Common~~company. ~~Stock~~See onthe ~~July~~definitions 3,of ~~2014~~“large asaccelerated ~~reported~~filer,” on“accelerated ~~the~~filer,” ~~Over-the-Counter~~“smaller ~~Bulletin~~reporting ~~Board~~company” ~~operated~~and by“emerging ~~the~~growth ~~National~~company” ~~Association of Securities Dealers Inc.~~ in ~~accordance with~~ Rule 12b-2 ~~457(c)~~of ~~under~~ the ~~Securities~~Exchange Act ~~of 1933~~.

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

~~Subject~~Large toaccelerated ~~Completion,~~filer ~~Dated July~~☐ ~~10,~~Accelerated ~~2014~~filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐

The information in this prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this prospectus is not complete and may be changed. The selling stockholders named in this prospectus may not sell these securities until the registration statement becomes effective. This prospectus is not an offer to sell these securities, and the selling securityholders named in this prospectus are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

Table of Contents

SUBJECT TO COMPLETION, DATED May 20, 2026

PROSPECTUS

BRAINSTORM CELL THERAPEUTICS INC.

84Up to 1,~~000~~310,~~000~~528 Shares of Common Stock

~~This~~Up ~~prospectus relates~~ to ~~the~~2,233,334 ~~following offerings~~Shares ~~by certain~~ of ~~our~~Common ~~stockholders~~Stock ~~and~~Issuable ~~warrantholders,~~Upon ~~which~~Exercise weof ~~refer~~Pre-Funded ~~to as “Selling Securityholders”:~~Warrants

·Up ~~the resale of up~~ to 424,~~000~~252,~~000~~634 ~~shares~~Shares of ~~common~~Common ~~stock~~Stock ~~purchased~~Issuable inUpon aExercise ~~private~~of ~~placement;~~Common ~~and~~Stock Purchase Warrants

·Offered ~~the~~by ~~resale of up to 42,000,000 shares of common stock that are issuable on exercise of~~ the ~~warrants~~Selling ~~that~~Securityholders ~~were~~Named ~~acquired in a private placement.~~Herein

~~Holders~~This ofprospectus relates to the ~~warrants~~resale ~~may~~by ~~currently purchase~~the ~~one~~selling ~~share~~securityholders named in this prospectus or their permitted transferees (the “Selling Securityholders”) of (i) up to 1,310,528 shares (the “Shares”) of the Company’s common stock, ~~for~~par ~~each~~value ~~warrant exercised~~$0.00005 ~~The~~per share (the “Common Stock”), (ii) up to 2,233,334 shares (the “Pre-Funded Warrant Shares”) of Common Stock, issuable upon exercise ~~price~~of pre-funded warrants (the “Pre-Funded Warrants”) and ~~number~~(iii) up ofto 4,252,634 shares of ~~common~~Common ~~stock~~Stock (the “Common Warrant Shares,” and together with the Pre-Funded Warrant Shares, the “Warrant Shares”) issuable upon exercise of ~~the~~common stock purchase warrants is(the ~~subject~~“Common toStock ~~further~~Purchase ~~adjustment~~Warrants,” and together with the Pre-Funded Warrants, the “Warrants”). The Shares and Warrants were issued, or will be issued in future closings, to the selling securityholders pursuant to (i) that certain ~~circumstances~~Securities Purchase Agreement, dated February 9, 2026, by and among the Company and the investor signatory thereto (the “February 9, 2026 Securities Purchase Agreement”); (ii) that certain Securities Purchase Agreement, dated February 24, 2026, by and among the Company and the investor signatory thereto (the “February 24, 2026 Securities Purchase Agreement”); (iii) the two Security Purchase Agreements, each dated May 11, 2026, by and among the Company and the investor signatories thereto (the “May 11, 2026 Security Purchase Agreements”); and (iv) that certain Securities Purchase Agreement, dated May 19, 2026, by and among the Company and the investor signatory thereto (the “May 19, 2026 Securities Purchase Agreement,” and together with the February 9, 2026 Securities Purchase Agreement, the February 24, 2026 Purchase Agreement and the May 11, 2026 Securities Purchase Agreements, the “Securities Purchase Agreements”).

The securities that may be sold by the Selling Securityholders are referred to in this prospectus as the “Offered Securities.” We will not receive any of the proceeds from the sale by the Selling Securityholders of ~~these~~the ~~securities,~~Offered ~~although~~Securities; however, we will receive the exercise price ~~for~~of the Warrants upon any ~~warrants~~exercise ~~that~~of ~~are~~the ~~exercised~~Warrants by payment of cash. WeThe ~~are~~Pre-Funded ~~registering securities~~Warrants ~~for~~have ~~resale~~an byexercise price of $0.0005, 3,791,667 of the ~~Selling~~Common ~~Securityholders~~Stock Purchase Warrants have an exercise price of $1.00 and 4,21,055 ~~but~~of ~~that~~the ~~does~~Comon ~~not~~Stock ~~necessarily~~Purchase ~~mean~~Warrants ~~that~~have ~~they~~an exercise price of $1.45 per share. The Securities Purchase Agreements have multiple closings, to the extent closings remain with respect to the Securities Purchase Agreements, we will ~~sell~~receive ~~any~~additional proceeds from such closings. We will bear all costs, expenses and fees in connection with the registration of the ~~securities. Any~~Offered Securities, including with regard to compliance with state securities ~~sold~~or by“blue ~~the~~sky” laws. The Selling Securityholders will bebear ~~offered~~all atcommissions ~~market~~and ordiscounts, ~~privately~~if ~~negotiated~~any, ~~prices~~attributable to their sale of the Offered Securities, except as otherwise expressly set forth under “Plan of Distribution” beginning on page 95 of this prospectus.

~~The warrants are exercisable at $0.348 per warrant at any time on or before the third anniversary of the date of issuance.~~

Investing in our common stock involves a high degree of risk. You should review carefully the risks and uncertainties described under the heading “Risk Factors” beginning on page 8 of this prospectus, and under similar headings in any amendments or supplements to this prospectus.

~~Neither~~Table ~~the Securities and Exchange Commission nor any state securities commission has approved or disapproved~~ of ~~these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.~~Contents

~~The~~This ~~date~~prospectus ofdescribes the general manner in which the Offered Securities may be offered and sold. If necessary, the specific manner in which the Offered Securities may be offered and sold will be described in one or more supplements to this prospectus. isAny ~~_______________~~prospectus supplement may add, ~~2014~~ update or change information contained in this prospectus. You should carefully read this prospectus, and any applicable prospectus supplement, as well as the documents incorporated by reference herein or therein before you invest in any of our securities.

The Selling Securityholders may offer, sell or distribute Offered Securities publicly or through private transactions. If the Selling Securityholders use underwriters, dealers or agents to sell Offered Securities, we will name them and describe their compensation in a prospectus supplement. The price to the public of those securities and the net proceeds the Selling Securityholders expect to receive from that sale will also be set forth in a prospectus supplement.

Our Common Stock is quoted on the OTCQB market tier operated by OTC Markets Group Inc. (“OTCQB”) under the symbol “BCLI”. On May 15, 2026, the last reported sale price of our Common Stock on the OTCQB was $0.716 per share.

We are a “smaller reporting company” as such term is defined under federal securities laws, and, as such, have elected to take advantage of certain reduced public company reporting requirements.

Investment in our Common Stock involves risk. See “Risk Factors” beginning on page 3 of this prospectus, in any applicable prospectus supplement and in the documents which are incorporated by reference herein. You should carefully read this prospectus, any applicable prospectus supplement, together with the documents we incorporate by reference, before you invest in our Common Stock.

Neither the Securities and Exchange Commission (the “SEC”) nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of the prospectus is , 2026.

Table of Contents

TABLE OF CONTENTS

		Page
PROSPECTUS SUMMARY	1
PROSPECTUS SUMMARY		1
ABOUT THIS OFFERING	2
RISK FACTORS	3	8
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS		25
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS	35
EXCHANGE RATE INFORMATION		26
USE OF PROCEEDS	36
USE OF PROCEEDS		26
MARKET INFORMATION FOR COMMON STOCK AND DIVIDEND POLICY	36
DIVIDEND POLICY		26

DILUTION		27
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	37
PLAN OF DISTRIBUTION		28

DESCRIPTION OF CAPITAL STOCK		30
BUSINESS	44
OUR BUSINESS		32

PROPERTIES		54
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	74
LEGAL PROCEEDINGS		56

MARKET FOR OUR COMMON EQUITY		57
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE	88
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		58

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE		64
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	90
MANAGEMENT		65

EXECUTIVE COMPENSATION		71
SELLING SECURITYHOLDERS	92
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT		78
PLAN OF DISTRIBUTION	95
RELATED PARTY TRANSACTIONS		79
DESCRIPTION OF SECURITIES TO BE REGISTERED	98
SELLING SECURITYHOLDERS		84
LEGAL MATTERS	101
LEGAL MATTERS		85
EXPERTS	101
EXPERTS		85
WHERE YOU CAN FIND ADDITIONAL INFORMATION	101
WHERE YOU CAN FIND MORE INFORMATION		85

~~ABOUT THIS PROSPECTUS~~

You should rely only on the information contained in this ~~document~~prospectus or a supplement to ~~which~~this weprospectus, ~~have~~including ~~referred~~the ~~you~~information incorporated herein by reference. WeNeither ~~have~~we ~~not~~nor the Selling Securityholders have authorized anyone to provide you with ~~information~~ ~~that is~~ different information. This ~~document~~prospectus ~~may~~is ~~only~~not bean ~~used~~offer ~~where~~to sell securities, and it is ~~legal~~not tosoliciting ~~sell~~an ~~these~~offer to buy securities, in any jurisdiction where the offer or sale is not permitted. ~~The~~You should not assume that the information contained in this ~~document~~prospectus ~~may~~or ~~only~~any besupplement to this prospectus, whether or not incorporated herein by reference, is accurate onas of any date other than the date ofindicated ~~this~~in ~~document~~those documents.

AsFor ~~used~~investors ~~herein,~~outside “of the United States: Neither we,” ~~“us,”~~nor ~~“our”~~ any of the Selling Securityholders have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the ~~“Company”~~United ~~refers~~States. You are required to ~~Brainstorm~~inform ~~Cell~~yourselves ~~Therapeutics~~about ~~Inc.~~and to observe any restrictions relating to this offering and ~~all~~the distribution of ~~its~~this ~~consolidated subsidiaries~~prospectus.

As used in this prospectus, the terms “Brainstorm,” “we,” “us,” and “our” mean Brainstorm Cell Therapeutics Inc. and our wholly-owned subsidiaries, unless otherwise indicated.

Table of Contents

PROSPECTUS SUMMARY

This summary ~~provides~~only anhighlights ~~overview~~the ofmore ~~selected~~detailed information ~~contained~~ appearing elsewhere in this prospectus. ~~and~~As this is a summary, it does not contain all of the information that you should consider ~~before~~in ~~investing~~making inan ~~our securities~~investment decision. You should ~~carefully~~ read this ~~prospectus~~entire ~~and the registration statement of which this~~ prospectus iscarefully, aas ~~part~~well inas ~~their entirety~~any ~~before~~information ~~investing~~incorporated inherein ~~our~~by ~~securities~~reference, including the information ~~discussed~~ under “Risk Factors” ~~beginning on page 8~~ and our financial statements and ~~notes~~the ~~thereto~~related ~~that~~notes, ~~appear~~before ~~elsewhere in this prospectus~~investing.

~~Company~~This ~~Overview~~prospectus describes the general manner in which the Selling Securityholders identified in this prospectus, or any of their transferees, may offer from time to time (i) up to 1,310,528 Shares, (ii) up to 2,233,334 Pre-Funded Warrant Shares issuance upon exercise of the Pre-Funded Warrants, and (iii) up to 4,252,634 Common Warrant Shares issuable upon exercise of the Common Stock Purchase Warrants.

WeIf ~~are~~necessary, athe ~~biotechnology~~specific ~~company~~manner ~~developing~~in ~~novel~~which ~~adult~~the ~~stem~~Offered ~~cell therapies~~Securities ~~for~~may ~~debilitating~~be ~~neurodegenerative~~offered ~~disorders~~and ~~such~~sold aswill ~~Amyotrophic~~be ~~Lateral~~described ~~Sclerosis~~in ~~(ALS~~a supplement to this prospectus, which supplement may also ~~known~~add, asupdate ~~Lou~~or ~~Gehrig's~~change ~~disease), Multiple~~any ~~Sclerosis~~of ~~(MS),~~the ~~and~~information ~~Parkinson’s~~contained ~~disease~~in ~~(PD)~~this prospectus. ~~These~~To ~~diseases~~the ~~have~~extent ~~limited~~there ~~treatment~~is ~~options~~a conflict between the information contained in this prospectus and asany ~~such~~applicable ~~represent unmet~~prospectus ~~medical~~supplement, ~~needs~~you should rely on the information in the prospectus supplement, provided that if any statement in one of these documents is inconsistent with a statement in another document having a later date—for example, a document incorporated by reference in this prospectus or any prospectus supplement—the statement in the document having the later date modifies or supersedes the earlier statement.

WeOur believe that NurOwn, our proprietary process for the propagation of Mesenchymal Stem Cells (MSC) and their differentiation into NeuroTrophic factor-(NTF) secreting cells (MSC-NTF), and their transplantation at, or near, the site of damage, offers the hope of effectively treating neurodegenerative diseases.Company

~~Our~~Brainstorm ~~approach~~Cell Therapeutics Inc. is ~~considered~~a ~~safe~~leading ~~based~~biotechnology oncompany ~~our~~committed ~~use~~to ofthe ~~autologous cells,~~development ~~which~~and ~~are~~commercialization ~~considered~~of tobest-in-class beautologous ~~free~~cellular oftherapies for the ~~risk~~treatment of ~~rejection.~~neurodegenerative ~~Furthermore~~diseases, ~~MSC~~including ~~are~~amyotrophic ~~known~~lateral sclerosis, commonly referred to beas ~~safe~~Lou ~~with~~Gehrig’s nodisease ~~risk~~(“ALS”), ofprogressive ~~tumor~~multiple ~~formation~~sclerosis (“PMS”), Alzheimer’s disease (“AD”), and other neurodegenerative conditions. ~~The~~ ~~use~~Our ofproprietary ~~adult~~cell therapy platform, NurOwn®, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells isto ~~also~~secrete ~~free~~high levels of ~~the~~neurotrophic ~~controversy~~factors ~~associated~~(“NTFs”), ~~with~~modulate ~~the~~neuroinflammatory ~~use~~and ofneurodegenerative ~~embryonic~~disease ~~stem~~processes, ~~cells~~promote inneuronal ~~some~~survival, ~~countries~~and improve neurological function.

~~Our~~NurOwn® ~~core~~has ~~technology~~a ~~was~~strong ~~developed~~and incomprehensive ~~collaboration~~intellectual ~~with~~property ~~prominent neurologist~~portfolio ~~Prof.~~and ~~Eldad~~has ~~Melamed,~~been ~~former~~granted ~~head~~Fast ofTrack ~~Neurology~~designation ofby the ~~Rabin~~U.S. ~~Medical~~Food ~~Center~~and Drug Administration (“FDA”) and ~~member~~Orphan ofDrug status by both the ~~Scientific~~FDA ~~Committee~~and of the ~~Michael~~European JMedicines Agency for ALS. ~~Fox~~The ~~Foundation~~Company ~~for~~has ~~Parkinson's~~completed ~~Research,~~Phase 3 ALS and ~~expert~~Phase ~~cell~~2 ~~biologist~~PMS ~~Prof.~~clinical ~~Daniel~~trials ~~Offen~~for NurOwn® and has received FDA agreement under a Special Protocol Assessment on the design of a planned Phase 3b registrational trial in ALS. Our wholly owned Israeli subsidiary, Brainstorm Cell Therapeutics Ltd., holds exclusive rights to commercialize NurOwn® technology through a licensing agreement with Ramot, the ~~Felsenstein~~technology ~~Medical Research~~transfer ~~Center~~company of Tel Aviv University, Israel.

~~Our~~The ~~wholly-owned~~Company ~~Israeli~~employs ~~subsidiary,~~20 ~~Brainstorm~~employees ~~Cell~~in ~~Therapeutics Ltd. (~~the ~~Israeli~~United ~~Subsidiary),~~States ~~holds~~and ~~rights to commercialize the technology~~Israel, ~~through~~with asenior ~~licensing~~management ~~agreement~~based ~~with~~primarily ~~Ramot~~in atthe ~~Tel~~United ~~Aviv University~~States ~~Ltd.~~and ~~(Ramot),~~ the ~~technology~~research ~~licensing~~and ~~company~~development ofcenter ~~Tel~~located ~~Aviv~~in ~~University,~~Petach Tikva, Israel.

OnCorporate February 8, 2010, our Israeli Subsidiary entered into an agreement with Hadasit Medical Research Services and Development Ltd., a subsidiary of the Hadassah Medical Organization (Hadassah), pursuant to which Hadassah provides the Israeli Subsidiary with lab services.Information

OnThe ~~February~~mailing ~~17,~~address ~~2010,~~of our ~~Israeli~~principal ~~Subsidiary~~executive ~~entered~~office ~~into~~is ~~an agreement~~1325 ~~with~~Avenue ~~Hadassah~~of ~~and Professor Dimitrios Karussis (~~the ~~Clinical~~Americas, ~~Trial~~28th ~~Agreement).~~floor, ~~Under~~New ~~the~~York, ~~Clinical~~New ~~Trial~~York ~~Agreement,~~10019 ~~Hadassah~~ and our ~~personnel~~telephone ~~agreed~~number tois ~~conduct~~(201) a488-0460. ~~clinical~~Our ~~trial~~website toaddress ~~evaluate~~is ~~the~~www. ~~safety~~brainstorm-cell.com. ~~and~~The ~~tolerability~~information offound ~~our~~on ~~NurOwn~~the ~~cells~~website inis ~~patients~~not ~~with ALS~~part of, inand ~~accordance~~is ~~with~~not aincorporated ~~protocol~~into, ~~developed~~this ~~jointly by us and Professor Karussis~~prospectus.

~~In February 2011, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to NurOwn for the treatment of ALS.~~

In June 2011, we initiated a Phase I/II clinical trial for the treatment of ALS with NurOwn at the Hadassah University Medical Center in Jerusalem (HUMC) with Principal Investigator Professor Dimitrios Karussis, after receiving approval from the Israeli Ministry of Health (MoH).

In July 2011, we entered into a Memorandum of Understanding with Massachusetts General Hospital (MGH) and the University of Massachusetts Medical School (UMass) in anticipation of applying for FDA approval to begin ALS human clinical trials in the United States. In March 2014, we entered into a definitive agreement with MGH in order to launch a Phase II clinical trial in the second quarter of 2014, and we expect to enter into a definitive agreement with UMass for the same.

In July 2012, together with Professor Karussis, we submitted an interim safety evaluation report to the Israeli MoH for the first 12 of 24 patients in the Phase I/II clinical trial. The report confirmed that our NurOwn therapy is safe, did not cause any adverse side effects, and some of the patients showed promising indications of clinical improvement.

InTable January 2013, the Israeli MoH approved a Phase IIa combined (intramuscular and intrathecal) treatment, dose-escalating trial, which we are currently conducting at HUMC. According to the protocol for this safety and preliminary efficacy trial, 12 early-stage ALS patients received both intramuscular and intrathecal injections of NurOwn cells in three cohorts with increasing doses between February and August 2013. The patients were followed for six months after transplantation. Due to medical and technical considerations, two additional patients were enrolled in the trial in late 2013, in order to preserve the originally planned protocol design. These two patients were treated at the beginning of the second quarter of 2014. The complete and final statistical analysis of the Phase IIa data is expected to be available after 6 months of follow up with the patients.Contents

InABOUT ~~January~~THIS 2013, we also announced that we had successfully completed a 12-week repeat dose toxicity study with our NurOwn cells in mice. These repeat doses were prepared from frozen cells, using a proprietary method recently developed by the Company. We believe that our cryopreservation, or freezing, method will enable long-term storage, and production of repeat patient doses of NurOwn without the need for additional bone marrow aspirations. We believe that the positive data from the toxicity study in mice will support our efforts to obtain approval for a future repeat dose clinical study in ALS patients. The study was conducted at Harlan Israel’s laboratories, according to Good Laboratory Practice (GLP) standards. The study protocol was approved by Israel’s National Council for Animal Experimentation.OFFERING

InThe ~~March~~Selling ~~2013,~~Securityholders ~~Principal~~identified ~~Investigator~~in ~~Professor~~this ~~Dimitrios~~prospectus ~~Karussis of~~are ~~Hadassah~~offering ~~presented~~on ~~some~~a ofresale ~~the~~basis ~~data~~a ~~from~~total ~~the Phase I/II trial at the American Academy~~ of ~~Neurology~~(i) up ~~Annual~~to ~~Meeting.~~1,310,528 ~~The~~Shares, ~~trial results~~(ii) up ~~analyzed~~ to ~~date~~2,233,334 ~~confirmed~~Pre-Funded ~~the~~Warrant ~~safety~~Shares ofissuable ~~the~~upon ~~NurOwn~~exercise ~~Treatment and also demonstrated initial signs~~ of ~~possible~~the ~~efficacy. There~~Pre-Funded ~~was a slower decline in overall clinical and respiratory function~~Warrants, ~~as measured by the ALS Functional Rating Score (ALSFRS-R)~~ and ~~Forced Vital Capacity~~ (~~FVC~~iii) up ~~score~~to ~~respectively~~4,252,634 inCommon ~~the~~Warrant ~~six~~Shares ~~patients~~issuable ~~that~~upon ~~received~~exercise ~~an intrathecal injection~~ of the ~~cells,~~Common ~~in the~~Stock ~~six~~Purchase ~~months following treatment as compared to the three months preceding treatment~~Warrants.

On March 14, 2013, we entered into a Memorandum of Understanding with the Mayo Clinic (Mayo) in Rochester, Minnesota, to participate as an additional clinical site in the multi-center Phase II ALS clinical trial in the USA. The team there will be led by Professor Anthony J. Windebank, Head of the Regenerative Neurobiology Laboratory in the Department of Neurology. In January 2014, we announced that we had entered into a definitive agreement with Mayo to conduct the trial and manufacture NurOwn cells in their cell processing cleanroom facility.


Common Stock offered by the Selling Securityholders		Up to 7,796,496 shares of Common Stock consisting of: (i) 1,310,528 Shares; (ii) 2,233,334 Pre-Funded Warrant Shares; and (iii) 4,252,634 Common Warrant Shares.

Risk factors		Before investing in our securities, you should carefully read and consider the information set forth in “Risk Factors” on page 3.

Use of proceeds		We will not receive any proceeds from the offering of the Offered Securities by the Selling Securityholders, except for the Warrants’ exercise price paid for the Common Stock offered hereby and issuable upon the exercise of the Warrants for an exercise price of $0.0005, $1.00, and $1.45 per share for (i) the Pre-Funded Warrants; (ii) the Common Stock Purchase Warrants issued pursuant to the February 9, 2026 Securities Purchase Agreement and February 24, 2026 Securities Purchase Agreement; and (iii) the Common Stock Purchase Warrants issued pursuant to the May 11, 2026 Securities Purchase Agreement and the May 19, 2026 Securities Purchase Agreement, respectively. See “Use of Proceeds” on page 36.

Trading market and symbol		Our Common Stock is quoted on the OTCQB market tier operated by OTC Markets Group Inc. (“OTCQB”) under the symbol “BCLI”.

Effective April 3, 2013, our Israeli Subsidiary entered into a manufacturing agreement with Dana-Farber Cancer Institute (Dana-Farber) under which Dana-Farber’s Connell and O’Reilly Cell Manipulation Core Facility will produce NurOwn in its cGMP-compliant clean rooms for the MGH and UMass clinical sites during our upcoming Phase II ALS clinical trial in the United States.

On May 21, 2013, we submitted a safety report to the hospital Helsinki Committee (IRB) for the first group of (four) patients in our ongoing Phase IIa ALS clinical trial at the Hadassah Medical Center in Jerusalem, Israel.

In June 2013, we entered into a Memorandum of Understanding (MOU) with PRC Clinical, a Contract Research Organization (CRO) based in the San Francisco Bay Area, in anticipation of our planned Phase II multi-center ALS clinical trial in the United States.

~~On July 17, 2013, we received Orphan Medicinal Product Designation for NurOwn for the treatment of ALS from the European Commission.~~

On August 1, 2013, we announced that we submitted a favorable safety report to the hospital Helsinki Committee (IRB) for the second group of (four) patients in our ongoing Phase IIa ALS clinical trial at the Hadassah Medical Center in Jerusalem, Israel. We announced that the treatment was well tolerated and no serious adverse events were observed, except for one SAE (Serious Adverse Event, death due to cardiopulmonary arrest) that was reported as non-treatment related.

InTable ~~September 2013, we announced that we had completed treatment~~ of ~~the 12 patients in our ALS Phase IIa NurOwn dose-escalating clinical trial. We have been informed that one patient in the study expired due to a medical condition unrelated to the Clinical Trial.~~Contents

InRISK October 2013, we launched our activities in the US in preparation of our Phase II multi-center clinical trial, with the initiation of the NurOwn technology transfer process to the Dana Farber Cancer Institute (DFCI). This process was completed on March 31, 2014.FACTORS

OnAn ~~December~~investment ~~10,~~in ~~2013,~~our wesecurities ~~announced~~carries ~~that~~a ~~Prof.~~significant ~~Karussis~~degree ~~had presented some~~ of ~~his~~risk. ~~preliminary~~You ~~findings~~should ~~from~~carefully ~~our~~consider ~~ALS~~before ~~Phase~~you ~~IIa~~decide ~~NurOwn~~to ~~dose-escalating~~purchase ~~clinical~~our ~~trial~~securities at the ~~24th International Symposium~~risks, onuncertainties ~~ALS/MND~~and inassumptions ~~Milan,~~discussed ~~Italy.~~below ~~According~~Any toone ~~Prof.~~of ~~Karussis,~~these ~~the~~risks ~~safety~~and ~~data~~uncertainties ~~are~~has ~~"impressively~~the ~~positive,"~~potential ~~with only~~to ~~minimal~~cause ~~and~~material ~~transient~~adverse ~~(procedure~~effects ~~related)~~on ~~adverse~~our ~~events~~business, ~~even~~prospects, ~~though~~financial ~~the~~condition ~~patients~~and inoperating ~~this~~results, ~~study~~which ~~were~~could ~~injected~~cause ~~both~~actual ~~intrathecally and~~results ~~intramuscularly with up~~ to ~~double~~differ ~~the~~materially ~~dose~~from ofany ~~NurOwn~~forward-looking ~~cells~~statements ~~given~~expressed inby ~~the~~us ~~Phase~~and Ia ~~trial.~~significant Indecrease ~~addition,~~in athe ~~number~~value of ~~patients~~our ~~showed some~~securities. ~~initial~~Refer ~~indications~~to of“Cautionary ~~clinical~~Statement ~~improvement~~Regarding Forward-Looking Statements.”

InWe ~~December~~may ~~2013~~not be successful in preventing the material adverse effects that any of these risks and uncertainties may cause. These potential risks and uncertainties may not be a complete list of the risks and uncertainties facing us. There may be additional risks and uncertainties that we are presently unaware of, or presently consider immaterial, that may become material in the ~~Company~~future ~~submitted~~and anhave ~~Investigational~~a ~~New Drug~~material ~~(IND)~~adverse ~~application~~effect on us. You could lose all or a significant portion of your investment due to ~~the~~any ~~FDA~~of these risks and uncertainties.

OnRisks ~~December~~Related ~~4, 2013, a Notice of Intention~~ to ~~Grant~~our ~~from~~Financial ~~the~~Condition ~~European Patent Office (EPO) was issued for the Company's patent application entitled "Isolated Cells~~ and ~~Populations~~Capital Comprising Same for the Treatment of CNS Diseases" (European serial number EP06766101.7). This patent relates to the production method for the Company's proprietary stem cells induced to secrete large quantities of neurotrophic factors for the treatment of neurodegenerative diseases.Requirements

OnWe ~~February~~need ~~11,~~to ~~2014,~~raise aadditional ~~Notice~~capital. ofIf ~~Allowance~~we ~~was~~are ~~issued~~unable ~~from the~~to ~~U.S.~~raise ~~Patent~~additional ~~Office~~capital ~~for~~in ~~the~~favorable ~~same~~terms ~~patent~~and ~~application~~a astimely ~~above~~manner, ~~U.S.~~we ~~serial~~will ~~number~~not ~~11/727,583~~be able to execute our business plan and we could be forced to restrict or cease our operations.

OnWe ~~March~~will ~~24,~~need ~~2014,~~to ~~the~~raise ~~Israeli~~additional ~~Subsidiary~~funds ~~entered~~to ~~into~~meet aour ~~clinical trial~~anticipated ~~agreement~~expenses ~~with~~so ~~The~~that ~~General~~we ~~Hospital~~can ~~Corporation~~execute ~~d/b/a~~our ~~Massachusetts~~business ~~General~~plan. ~~Hospital~~We ~~(MGH),~~expect to ~~conduct~~incur asubstantial ~~Phase~~and IIincreasing ~~clinical trial~~net oflosses for the ~~Company’s~~foreseeable ~~NurOwn~~future inas ~~ALS,~~we ~~pending~~increase ~~FDA~~our ~~and~~spending ~~Institutional~~to ~~Review~~execute ~~Board~~our ~~(IRB)~~development ~~approvals~~and commercial programs.

InThe ~~March~~amount ~~2014~~of financing required will depend on many factors including our financial requirements to fund any additional research and clinical trials, ~~the~~our ~~U.S.~~ability ~~Patent~~to secure partnerships and ~~Trademark~~achieve ~~Office~~partnership ~~granted the~~milestones ~~Company~~and aour ~~key~~ability ~~patent~~to establish manufacturing and delivery processes for ~~its~~our ~~autologous~~NurOwn® stem cell ~~technology~~therapy as well as to fund other working capital requirements. ~~The~~ ~~patent~~Our ~~covers~~ability ~~the~~to ~~Company's~~access ~~stem~~the ~~cells~~capital ~~induced~~markets or to ~~secrete elevated~~enlist ~~levels~~partners ofis ~~neurotrophic~~mainly ~~factors~~dependent ~~for~~on the ~~treatment~~progress of ~~neurodegenerative~~our ~~diseases~~research and development and regulatory approval of our products.

OnTo ~~April 10~~date, ~~2014,~~ the Company ~~announced~~has ~~that~~not ~~the~~generated ~~U.S.~~revenues ~~Patent and~~from ~~Trademark~~its ~~Office~~activities ~~granted~~and ~~the~~has ~~Company~~incurred ansubstantial ~~additional~~operating ~~patent~~losses. ~~for~~Management ~~its~~expects ~~autologous~~the ~~stem~~Company ~~cell~~to ~~technology.~~continue ~~The~~to ~~patent~~generate ~~covers~~substantial ~~the~~operating ~~production method~~losses ofand ~~the~~to ~~Company's~~continue ~~proprietary~~to ~~stem~~fund ~~cells~~its ~~induced~~operations toprimarily ~~secrete~~through ~~significantly~~utilization ~~elevated~~of ~~levels~~its ofcurrent ~~neurotrophic~~financial ~~factors~~resources ~~for~~and ~~the treatment~~through ofadditional ~~neurodegenerative~~raises ~~diseases~~of capital.

OnManagement’s ~~April~~plan 8,includes ~~2014,~~raising ~~the~~funds ~~FDA~~from ~~approved~~outside ~~commencement~~potential ofinvestors. ~~its~~However, ~~Phase II~~there ~~clinical~~is ~~trial~~no ~~with~~assurance ~~NurOwn~~such infunding ~~patients~~will ~~with~~be ~~ALS.~~available Onto ~~June 6, 2014,~~ the Company ~~issued~~or athat ~~press~~it ~~release~~will ~~announcing~~be ~~that~~obtained ~~its~~on ~~Phase II~~terms ~~ALS~~favorable ~~clinical~~to ~~trial~~the ~~has~~Company ~~now~~or ~~commenced~~will ~~with~~provide the ~~enrollment~~Company ofwith ~~the~~sufficient ~~first~~funds ~~patient~~to atmeet ~~MGH~~its inobjectives. ~~Boston,~~Should ~~Massachusetts.~~we ~~The~~raise ~~Company’s Phase~~additional IIfunds ~~trial~~through isthe aissuance ~~randomized,~~of ~~double-blind~~equity, ~~placebo controlled multi~~equity-~~center~~related ~~study~~or ~~designed~~debt tosecurities, ~~evaluate~~these ~~the~~securities ~~safety~~may ~~and~~have ~~efficacy of~~rights, ~~transplantation~~preferences ofor ~~Autologous~~privileges ~~Mesenchymal Stem Cells Secreting Neurotrophic Factors~~ (~~MSC-NTF~~including orregistrations ~~NurOwn~~rights) insenior 48to ~~ALS~~those ~~patients. The~~of ~~trial is also being conducted at~~ the ~~UMass~~rights ~~Memorial~~of ~~Hospital~~our inCommon ~~Worcester,~~Stock ~~Massachusetts~~ and ~~the~~our ~~Mayo~~stockholders ~~Clinic~~will inexperience ~~Rochester, Minnesota~~additional dilution.

We have a history of losses and we expect to incur losses for the foreseeable future.

As a development stage pre-revenue company, we are in the early stages of executing our business plan. We had no operational revenues for the fiscal years ended December 31, 2022, December 31, 2023, December 31, 2024, or December 31, 2025. We are currently in the process of introducing the Company to strategic partners. In 2026 and the upcoming years, the Company will focus on initiating and completing a Phase 3b trial and commercialization of NurOwn® for ALS, if approved. We are unable, at this time, to foresee when we will generate operational revenues from strategic partnerships. If NurOwn® is approved by the FDA for ALS, we hope to commercialize and start generating revenues shortly thereafter. We expect to incur substantial and increasing operating losses for the next several years as we increase our spending to execute our development programs and commercialization efforts. These losses are expected to have an adverse impact on our working capital, total assets and stockholders’ equity.

We may not be able to continue as a going concern if we do not execute our business plan or obtain additional financing in the future if necessary.

Our independent accountant’s audit report included on this Registration Statement on Form S-1 states that there is substantial doubt about our ability to continue as a going concern. We have incurred only losses since our inception, raising substantial doubt about our ability to continue as a going concern. Therefore, our ability to continue as a going concern is highly dependent upon us executing our business plan in the planned amount of time allotted and obtaining additional financing for our planned operations, if necessary.

On June 1, 2014, the interim results from our Phase IIa ALS trial conducted at Hadassah Medical Center in Jerusalem, Israel were presented at the Joint Congress of European Neurology by Principal Investigator Professor Dimitrios Karussis. The positive safety and preliminary efficacy results observed in this study are consistent with results observed in the Company's previous Phase I/II trial. Between these two studies, a total of 26 patients have been treated with NurOwn, the Company’s stem cell therapy candidate for ALS. In all 26 patients who received NurOwn™ in the two trials, no treatment-related serious adverse events were observed. In the three month pre-treatment “run-in” period, 71% of the patients showed progression of disease with decline in neurological function. In contrast, in the three months post-transplantation with NurOwn, 63% of the patients who received intrathecal (IT), or combined IT and intramuscular (IM) administration, showed stabilization or improvement in neurological function, as measured by their revised ALS functional rating score (ALSFRS-R). Additionally, as Prof. Karussis discussed during his presentation, in both phases of the trial, 63% of the patients treated with NurOwn via IT or combined IT and IM administration were defined as “responders” (slower progression of disability or improvement in their neurological function) at 3 months post-treatment, based on both their ALSFRS-R score and Forced Vital Capacity (FVC), an indication of respiratory function. The six patients treated with NurOwn in the earlier Phase I/II trial via IM administration only, primarily exhibited a localized positive effect. Similarly, in the same Phase I/II trial, the IT transplanted patients also showed indications of neurotrophic and regenerative effects, as evidenced by an increase in Compound Muscle Action Potential (CMAP).

OnTable ~~June~~of ~~6, 2014, the Company announced that the first patient had been enrolled in its Phase II ALS trial at MGH in Boston.~~Contents

OnThere ~~June~~can 6be no assurance that we will be able to raise any additional funds, ~~2014~~or if we are able to raise additional funds, ~~the~~that ~~Company~~such ~~appointed Uri~~funds ~~Yablonka~~will asbe ~~its~~in ~~Chief~~the ~~Operating~~amounts ~~Officer~~required ~~and~~or ~~director~~on terms favorable to us.

OnWe ~~June~~are 9,exposed ~~2014,~~to ~~the~~fluctuations ~~Company~~in ~~appointed Dr.~~currency ~~Anthony~~exchange ~~(Tony) Fiorino as its Chief Executive Officer~~rates.

OnA ~~June~~significant ~~10,~~portion ~~2014,~~of ~~the~~our ~~Company~~business, ~~announced~~particularly ~~that~~our itresearch ~~has~~and ~~initiated a~~development, ~~study~~is inconducted aoutside ~~mouse~~the ~~model~~United ofStates. ~~autism~~Therefore, atwe ~~the~~are ~~Felsenstein~~exposed ~~Medical~~to ~~Research~~currency ~~Center,~~exchange ~~Sackler~~fluctuations ~~Faculty~~in ofother ~~Medicine,~~currencies ~~Tel~~such ~~Aviv~~as ~~University, under~~ the ~~direction~~New ofIsraeli ~~Professor~~Shekels ~~Daniel~~(“NIS”) ~~Offen~~and the Euro. ~~The~~Moreover, ~~study~~a ~~will~~portion ~~explore~~of ~~the~~our ~~effects~~expenses ofin ~~the~~Israel ~~Company's~~and ~~MSC-NTF~~Europe ~~cells~~are onpaid ~~mouse~~in ~~behavior. The~~NIS ~~study~~and Euros, respectively, which ~~will~~subjects beus ~~conducted~~to ~~using~~ the ~~BTBR~~risks ~~mouse~~of ~~model~~foreign ~~for~~currency ~~autism,~~fluctuations. ~~will~~Our ~~investigate~~primary ~~repetitive~~expenses ~~behavior,~~paid ~~increased~~in ~~cognitive flexibility~~NIS ~~and~~are ~~improved~~employee ~~sociability~~salaries, infees ~~mice~~for ~~after~~consultants ~~administration~~and ofsubcontractors aand ~~single~~lease ~~intracerebroventricular~~payments ~~injection~~on ofour ~~the~~Israeli ~~cells~~facilities.

OnThe ~~June~~dollar ~~27,~~cost ~~2014,~~of ~~the~~our ~~Company~~operations ~~announced~~in ~~that~~Israel ~~its~~will ~~technology collaboration~~increase ~~with~~to ~~Octane~~the ~~Biotech,~~extent ~~Inc.~~increases ~~reached~~in ~~an important milestone with~~ the ~~construction~~rate of aninflation ~~Alpha~~in ~~prototype~~Israel ofare anot ~~customized bioreactor~~offset ~~for~~by ~~NurOwn~~a ~~production.~~devaluation ~~The~~of ~~proprietary~~the ~~bioreactor~~NIS ~~under~~in ~~development~~relation ~~will,~~to ~~if successful, provide~~ the ~~Company with large-scale manufacturing capabilities~~dollar, ~~enabling~~which itwould toharm ~~achieve~~our ~~economies~~results of ~~scale in the manufacture of NurOwn~~operations.

~~Our~~Since ~~Proprietary~~a ~~Technology~~considerable portion of our expenses such as employees’ salaries are linked to an extent to the rate of inflation in Israel, the dollar cost of our operations is influenced by the extent to which any increase in the rate of inflation in Israel is or is not offset by the devaluation of the NIS in relation to the dollar. As a result, we are exposed to the risk that the NIS, after adjustment for inflation in Israel, will appreciate in relation to the dollar. In that event, the dollar cost of our operations in Israel will increase and our dollar-measured results of operations will be adversely affected. During the past few years inflation-adjusted NIS appreciated against the dollar, which raised the dollar cost of our Israeli operations. We cannot predict whether the NIS will appreciate against the dollar or vice versa in the future. Any increase in the rate of inflation in Israel, unless the increase is offset on a timely basis by a devaluation of the NIS in relation to the dollar, will increase labor and other costs, which will increase the dollar cost of our operations in Israel and harm our results of operations.

~~Our~~We ~~NurOwn~~are technology is based on a novel differentiation protocol which induces differentiation of the bone marrow-derived mesenchymal stem cells into neuron-supporting cells, MSC-NTF cells, capable of releasing several neurotrophic factors, including Glial-derived neurotrophic factor (GDNF) and ~~Brain-derived~~ ~~neurotrophic~~could ~~factor~~be ~~(BDNF),~~further ~~Vascular~~subject ~~endothelial~~to ~~growth~~securities ~~factor~~class ~~(VEGF)~~action ~~and~~litigation ~~Hepatocyte growth factor (HGF) which are critical for the growth, survival~~ and ~~differentiation~~other oftypes ~~developing neurons. GDNF is one~~ of ~~the~~stockholder ~~most potent survival factors known for peripheral neurons~~litigation. ~~VEGF and HGF have been reported to have important neuro-protective effects in ALS.~~

~~Our~~The ~~approach~~stock market in general has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to ~~treatment~~the operating performance of ~~neurodegenerative~~these ~~diseases~~companies. ~~with autologous~~Securities ~~adult~~class ~~stem~~action ~~cells~~litigation ~~includes~~has aoften ~~multi-step~~been ~~process~~instituted ~~beginning~~against ~~with~~companies ~~harvesting~~following periods of ~~undifferentiated~~volatility ~~stem~~in ~~cells~~the ~~from~~market ~~the~~price ~~patient'~~of a company’s ~~own~~ ~~bone~~securities. ~~marrow~~For example, ~~and~~in ~~concluding~~November 2023, ~~with~~a ~~transplantation~~purported stockholder filed a lawsuit against us and certain of ~~differentiated~~our officers captioned Sporn v. Brainstorm Cell Therapeutics, Inc. ~~neurotrophic~~et ~~factor-secreting~~al. ~~mesenchymal~~in ~~stem~~the ~~cells~~U.S. ~~(MSC-NTF) into~~District Court for the ~~same~~Southern ~~patient~~District –of ~~intrathecally~~New York, and~~/or~~ ~~intramuscularly.~~in ~~Intrathecal~~February 2024, ~~(injection~~March 2024, ~~into~~and April 2024, four derivative actions were filed in the ~~cerebrospinal~~same ~~fluid)~~court, ~~transplantation consists~~consolidated ofand ~~injection~~captioned ~~with~~In aRe ~~standard~~Brainstorm ~~lumbar~~Cell ~~puncture;~~Therapeutics, Inc. ~~there~~Derivative isLitigation no(see ~~need~~“Item 3. Legal Proceedings” for a ~~laminectomy~~more –detailed andescription ~~invasive,~~of ~~orthopedic~~these ~~spine operation~~matters). toWe ~~remove~~could aalso ~~portion~~be ofsubject ~~the~~to ~~vertebral~~other ~~bone~~types of litigation, aswhich ~~required~~may involve claims of breach of fiduciary duties by ~~other~~our ~~technologies~~directors or officers for misuse/mismanagement of company assets/resources or conflicts of interest. ~~Intramuscular~~Any ~~(injection~~such ~~directly~~litigation, ~~into muscle)~~if ~~transplantation~~instituted, iscould ~~performed~~result ~~via~~in substantial costs and a ~~standard~~diversion ~~injection~~of ~~procedure~~management’s asattention ~~well~~and resources, which would harm our business, operating results, or financial condition.

Risks Related to our Cell Therapy Product Development Efforts

If our NurOwn® stem cell therapy does not demonstrate safety and efficacy sufficient to obtain regulatory approval, it may not receive regulatory approval and we will be unable to market it.

The therapeutic treatment development and regulatory approval process is expensive, uncertain and time-consuming. As part of the regulatory process, we conduct clinical trials, for our NurOwn® stem cell therapy to demonstrate safety and efficacy in humans to meet the requirements of the FDA and regulatory authorities in other countries. We have completed our Phase 3 ALS trial and announced on February 2021 that the FDA concluded from their initial review that the current level of clinical data does not provide the threshold of substantial evidence that FDA is seeking to support a BLA. On November 10, 2022, we announced that we had received a RTF letter from the FDA regarding our BLA. The FDA indicated that we could request a Type A meeting to discuss the content of the RTF letter, and the Type A meeting was held on January 11, 2023. We notified the FDA on February 6, 2023 of our decision to request the FDA to file the NurOwn® BLA for ALS over Protest. We submitted an amendment to our BLA on March 7, 2023, in which we responded to the majority of the items included in the RTF letter. Written notification was received on March 22, 2023 from the FDA project manager associated with the BLA confirming the FDA’s decision to grant an ADCOM for the NurOwn® BLA for ALS. On September 27, 2023, we announced that the Advisory Committee voted, with 17 voting no, one voting yes, and one abstention, that NurOwn® did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS. On October 18, 2023, we announced that the FDA invited the Company to request an expedited face-to-face meeting to discuss the path forward for NurOwn® as a treatment for ALS. BrainStorm remains committed to the ALS Community and is actively exploring the next steps in support of

Our proprietary, production process for induction of differentiation of human bone marrow derived mesenchymal stem cells into differentiated cells that produce NTF (MSC-NTF) for clinical use is conducted in full compliance with current Good Manufacturing Practice (cGMP).

~~Our~~Table ~~proprietary~~of ~~technology is licensed to and developed by our Israeli Subsidiary.~~Contents

NurOwn®, including publication of emerging clinical data and development of a protocol for an additional clinical study. On October 18, 2023 Brainstorm announced that the BLA for NurOwn® would be withdrawn. The BLA was withdrawn on November 3, 2023. The decision to withdraw the BLA was coordinated with the FDA and is viewed by the FDA as a withdrawal without prejudice. On November 20, 2023, we announced that the FDA granted the company a meeting to discuss the regulatory path forward for NurOwn® ~~Transplantation~~in ~~Process~~ALS. The meeting took place on December 6, 2023. On December 7, 2023, we announced the completion of a productive meeting with the FDA to discuss NurOwn®. The primary objective of the meeting was to discuss plans for a SPA with the FDA on the overall protocol design for a planned Phase 3b registrational trial for NurOwn®. As an outcome of the meeting, BrainStorm will submit relevant documentation as outlined by the FDA to support the SPA. The ultimate goal of the SPA is to secure the FDA’s agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application. On February 23, 2024, we announced that we submitted the SPA request to the FDA for the planned Phase 3b clinical trial of NurOwn® for the treatment of ALS. On April 9, 2024, the Company announced that it received written agreement from the FDA, under a SPA, on the design for a Phase 3b trial of NurOwn (R) in ALS. The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating the Company’s adequacy in addressing objectives that support a future BLA in ALS. On June 26, 2024, the Company announced that it has reached alignment with FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm’s Phase 3b clinical trial for NurOwn (R), its investigational therapy for ALS.

·If ~~Bone~~we ~~marrow~~fail ~~aspiration~~to ~~from~~obtain ~~patient;~~regulatory approval for our NurOwn® stem cell therapy, we will be unable to market and sell it and we may never be profitable.

·A ~~Isolation~~failure ~~and~~of ~~expansion~~one or more of our clinical trials can occur at any stage of testing. Results of later stage clinical trials may fail to show the ~~mesenchymal~~desired ~~stem~~safety ~~cells;~~and efficacy despite acceptable results in earlier clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that have believed their product candidates performed satisfactorily in preclinical and clinical trials have nonetheless failed to obtain marketing approval of their treatments.

·Specifically, ~~Differentiation~~we are currently comparing NurOwn® stem cell therapy against placebo. Comparisons of outcomes of other reported clinical trials may provide some insight into the ~~expanded~~efficacy of NurOwn® stem ~~cells~~cell ~~into~~therapy, ~~neurotrophic-factor~~however, ~~secreting~~these ~~(MSC-NTF)~~studies ~~cells;~~may ~~and~~be of limited comparative value due to the many factors that affect the outcome of clinical trials, some of which are not apparent in published reports.

·Additionally, ~~Autologous~~several ~~transplantation~~of ~~into~~our past, planned and ongoing clinical trials utilize an “open-label” trial design. An “open-label” clinical trial is one where both the patient’s ~~spinal~~and ~~cord~~investigator know whether the patient is receiving the investigational product candidate or ~~muscle~~either ~~tissue~~an existing approved drug or placebo. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The results from an open-label trial may not be predictive of future clinical trial results with any of our product candidates for which we include an open-label clinical trial when studied in a controlled environment with a placebo or active control.

Differentiation before Transplantation

The ability to induce differentiation of autologous adult mesenchymal stem cells into MSC-NTF cells before transplantation is unique to NurOwn, making it the first-of-its-kind for treating neurodegenerative diseases.

The specialized cells secrete neurotrophic factors for:

· Protection of existing motor neurons;

· Promotion of motor neuron growth; and

· Re-establishment of nerve-muscle interaction.

Autologous (Self-transplantation)

The NurOwn approach is autologous, or self-transplanted, using the patient’s own stem cells. In autologous transplantation there is no risk of rejection and no need for treatment with immunosuppressive agents, which can cause severe and/or long-term side effects. In addition, the use of adult stem cells is free of controversy associated with the use of embryonic stem cells in some countries.

Transplantation site and method

Clinical Indication I: ALS (current) – Based on the approval of the Israeli MoH, we are currently conducting a Phase IIa dose-escalating trial to evaluate safety and preliminary efficacy of NurOwn in ALS patients. Following approval of our IND application by the FDA, we have launched a Phase II clinical trial in the USA.

Future Clinical Development. Future development of NurOwn in ALS will require additional clinical trials, including the administration of repeated doses to ALS patients enrolled in those trials. The design and timing of subsequent clinical trials in ALS is currently under review by the Company. In addition, the Company is reviewing the potential clinical development of NurOwn in other neurodegenerative disorders.

Corporate Information

We are incorporated under the laws of the State of Delaware. Our principal executive offices are located at 605 Third Avenue, 34th Floor, New York, New York 10158, and our telephone number is (646) 666-3188. We maintain an Internet website at http://www.brainstorm-cell.com. The information on our website is not incorporated into this prospectus.

The Private Placement

On June 13, 2014, we entered into a securities purchase agreement (the Securities Purchase Agreement) with a group of investors, including several healthcare-focused funds (the Investors) to effect a private placement (the Private Placement) of the Company’s common stock, $0.00005 par value per share (Common Stock), and warrants to purchase Common Stock. On June 19, 2014, upon the closing of the Private Placement, we received gross proceeds of $10.5 million, resulting from the issuance and sale of 42,000,000 shares of Common Stock (the Shares) at a price per share of $0.25, a 15% discount to the 30 day volume-weighted average price of $0.294. The Investors also received warrants to purchase up to 42,000,000 shares of Common Stock at an exercise price of $0.348 per share (the Warrants). The Warrants were exercisable immediately upon closing of the Private Placement and have a term of three (3) years.

In connection with the Private Placement, we entered into a Registration Rights Agreement (the Registration Rights Agreement) at closing pursuant to which we will file a resale registration statement for the Shares and Common Stock underlying the Warrants within 30 days of the closing date (the Filing Deadline) and have it declared effective at the earlier of (i) the 90th calendar day after the closing date and (ii) the fifth business day after the date the Company is notified by the SEC that such Registration Statement will not be reviewed or will not be subject to further review (the Effectiveness Deadline). The Registration Rights Agreement contains penalties for failure to comply with the terms of the agreement, including monthly liquidated damages in an amount equal to 1.5% of the aggregate subscription amount for failure to meet the Effectiveness Deadline, up to a maximum of 12% of the aggregate subscription amount.

If at any time all of the Shares or shares of Common Stock underlying the Warrants are not covered by the initial Registration Statement, the Company agrees to file with the SEC one or more additional Registration Statements so as to cover all of the Shares and shares of Common Stock underlying the Warrants not covered by such initial Registration Statement, in each case, as soon as practicable, but in no event later than the applicable filing deadline for such additional Registration Statements as provided in the Registration Rights Agreement.

We are registering the shares of Common Stock covered by this prospectus in order to fulfill our contractual obligations to the Investors contained in the Registration Rights Agreement. Registration of the shares of Common Stock covered by this prospectus does not necessarily mean that all or any portion of such shares will be offered for sale by the Selling Securityholders.

Offering by Selling Securityholders

We are registering the following securities issued in connection with the Private Placement as described above under “The Private Placement”:

· For resale by the Selling Securityholders, 42,000,000 shares of Common Stock purchased in the Private Placement; and

· For resale by the Selling Securityholders, 42,000,000 shares of Common Stock issuable upon exercise of the Warrants that were acquired in the Private Placement.

As of the date of this prospectus, each Warrant is exercisable to purchase one share of Common Stock. The exercise price and number of shares of Common Stock issuable upon exercise of the Warrants are subject to further adjustment in certain circumstances.

The exercise price of each Warrant is $0.348 per share. The Warrants are currently exercisable and expire on June 19, 2017. There is a possibility that the Warrants will never be exercised when in-the-money or otherwise, and that Warrant holders will never receive shares or payment of cash in settlement of the Warrants.

Common stock outstanding:		224,834,618 shares as of June 20, 2014.
Use of proceeds:		We will not receive any of the proceeds from the sale of the securities being registered on behalf of the Selling Securityholders hereunder. We will receive the exercise price upon the exercise of any Warrant. To the extent we receive cash upon any exercise of the Warrants, we expect to use that cash for general corporate and working capital purposes.
Market Symbol:		Our Common Stock is quoted on the OTCQB Marketplace under the symbol “BCLI”.
Risk Factors:		Investing in our securities involves substantial risks. You should carefully review and consider the “Risk Factors” section of this prospectus beginning on page 8 for a discussion of factors to consider before deciding to invest in our securities.

We will bear the expenses of registering these securities. The Selling Securityholders will pay the cost of any brokerage commissions and discounts, and all expenses incurred by them in connection with the resale of the securities. See “Plan of Distribution.”

We had 224,834,618 shares of Common Stock outstanding as of June 20, 2014, which excludes:

· 11,688,331 shares of Common Stock issuable upon exercise of outstanding stock options, at a weighted average exercise price of $0.23215 per share, under our equity incentive plans;

· 2,808,437 additional shares of Common Stock reserved for future issuance under our equity incentive plans; and

· 94,011,256 shares of Common Stock issuable upon exercise of outstanding warrants with exercise prices ranging from $0.00005 per share to $1.50 per share.

Except as otherwise indicated herein, all information in this prospectus assumes or gives effect to no exercise of the Warrants.

RISK FACTORS

You should carefully consider and evaluate all of the information in this prospectus, including the risk factors listed below. Risks and uncertainties in addition to those we describe below, that may not be presently known to us, or that we currently believe are immaterial, may also harm our business and operations. If any of these risks occur, our business, results of operations and financial condition could be harmed, the price of our Common Stock could decline, and future events and circumstances could differ significantly from those anticipated in the forward-looking statements contained in this prospectus.

Risks related to our business

We need to raise additional capital. If we are unable to raise additional capital on favorable terms and in a timely manner, we will not be able to execute our business plan and we could be forced to restrict or cease our operations.

We will need to raise additional funds to meet our anticipated expenses so that we can execute our business plan. We expect to incur substantial and increasing net losses for the foreseeable future as we increase our spending to execute our development programs. Our auditors have expressed in their audit report that there is substantial doubt regarding our ability to continue as a going concern.

The amount of financing required will depend on many factors including our financial requirements to fund our research and clinical trials, and our ability to secure partnerships and achieve partnership milestones as well as to fund other working capital requirements. Our ability to access the capital markets or to enlist partners is mainly dependent on the progress of our research and development and regulatory approval of our products.

We expect that the net proceeds of the Private Placement will be sufficient to meet our obligations in the upcoming 12 months as we run a Phase II clinical trial in the United States. However, additional capital may be required or the Company will need to reduce its operating costs in order to finance the Company’s operations beyond the current plans or if there are unanticipated significant increases in costs over the next 12 months.

Should we raise additional funds through the issuance of equity, equity-related or debt securities, these securities may have rights, preferences or privileges (including registrations rights) senior to those of the rights of our Common Stock and our stockholders will experience additional dilution.

Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.

As described in Note 1 of our accompanying financial statements, our auditors in their audit opinion have expressed concern with respect to our ability to continue as a going concern, as well as referred to Note 1 of our financial statements in this regard. Our financial statements do not include any adjustments that may result from the outcome of this uncertainty. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in us. If our NurOwn treatment candidate does not demonstrate safety and efficacy sufficient to obtain regulatory approval, it will not receive regulatory approval and we will be unable to market it. The therapeutic treatment development and regulatory approval process is expensive, uncertain and time-consuming. The timing of any future regulatory approval, if any, for our NurOwn treatment candidate cannot be accurately predicted. We do not expect to receive regulatory approval for any of our product candidates until at least 2015, if ever. If we fail to obtain regulatory approval for our NurOwn treatment candidate, we will be unable to market and sell it and we may never be profitable.

As part of the regulatory process, we must conduct clinical trials, including Phase 2 and Phase 3 clinical trials, for our NurOwn treatment candidate to demonstrate safety and efficacy in humans to the satisfaction of the FDA and regulatory authorities in other countries.

A failure of one or more of our clinical trials can occur at any stage of testing. Previous results obtained in uncontrolled clinical trials may not be predictive of future results obtained in controlled clinical trials. Interim results obtained in clinical trials may not be confirmed upon full analysis of the results of a clinical trial. Results of later stage clinical trials may fail to show the desired safety and efficacy despite acceptable results in earlier clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that have believed their product candidates performed satisfactorily in preclinical and clinical trials have nonetheless failed to obtain marketing approval of their treatments.

Specifically, we have not yet compared our NurOwn treatment candidate against placebo or any other active therapy control group. While comparisons of outcomes to results from other reported clinical trials can provide some insight into the efficacy of our NurOwn treatment candidate, there are many factors that affect the outcome of clinical trials, some of which are not apparent in published reports, and results from two different trials cannot always be reliably compared.

Our business in the foreseeable future will be based on technology licensed from Ramot and if this license were to be terminated upon failure to make required royalty payments in the future, we would need to change our business strategy and we may be forced to cease our operations.

Agreements we and our Israeli Subsidiary have with Ramot impose on us royalty payment obligations. If we fail to comply with these obligations, Ramot may have the right to terminate the license under certain circumstances. If Ramot elects to terminate our license, we would need to change our business strategy and we may be forced to cease our operations. We currently do not owe Ramot any overdue payments. Royalties are due upon commencement of revenues by the Company.

Our Company has a history of losses and we expect to incur losses for the foreseeable future.

As a development stage company, we are in the early stages of executing our business plan. We had no revenues for the fiscal years ended December 31, 2013 or December 31, 2012. Our ability to operate successfully is materially uncertain and our operations are subject to significant risks inherent in a developing business enterprise. We are currently in the process of introducing the Company to strategic partners. In the upcoming three years, the Company will focus on clinical trials. We are unable at this time to foresee when we will generate revenues from strategic partnerships or otherwise. Furthermore, we expect to incur substantial and increasing operating losses for the next several years as we increase our spending to execute our development programs. These losses are expected to have an adverse impact on our working capital, total assets and stockholders’ equity, and we may never achieve profitability.

Our product development programs are based on novel technologies and are inherently risky.

We are subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our stem cell therapy creates significant challenges with regard to product development and optimization, manufacturing, government regulations, and market acceptance. For example, the FDA has relatively limited experience with stem cell therapies. None have been approved by them for commercial sale, and the pathway to regulatory approval for our cell therapy product candidates may accordingly be more complex and lengthy. As a result, the development and commercialization pathway for our therapies may be subject to increased uncertainty, as compared to the pathway for new conventional drugs.

9The novel nature of our autologous stem cell therapy creates significant challenges with regard to product development and optimization, manufacturing, government regulations, and market acceptance. For example, although cell therapy has been available in oncology, the FDA’s experience with mesenchymal stem cell therapies is limited. None have been approved by the FDA for commercial sale in the US, and the pathway to regulatory approval for our stem cell therapies may accordingly be more complex and lengthy. As a result, the development and commercialization pathway for our therapies may be subject to increased uncertainty, as compared to the pathway for new conventional drugs.

WeIf serious or unexpected adverse side effects are ~~faced~~identified ~~with~~during ~~uncertainties~~the ~~related~~development toof our ~~research~~NurOwn® stem cell therapy, we may need to abandon or limit its development.

Our research programs are based on scientific hypotheses and experimental approaches that may not lead to desired results. In addition, the timeframe for obtaining proof of principle and other results may be considerably longer than originally anticipated, or may not be possible given time, resource, financial, strategic and collaborator scientific constraints. Success in one stage of testing is not necessarily an indication that the particular program will succeed in later stages of testing and development. It is not possible to predict, based upon studies in in-vitro models and in animals, whether any of the therapies designed for these programs will prove to be safe, effective, and suitable for human use. Each therapy will require additional research and development, scale-up, formulation and extensive clinical testing in humans. Unsatisfactory results obtained from a particular study relating to a program may cause the Company to abandon its commitment to that program or to the lead therapy or product candidate being tested. The discovery of unexpected toxicities, lack of sufficient efficacy, unacceptable pharmacology, inability to increase scale of manufacture, market attractiveness, regulatory hurdles, competition, as well as other factors, may make our targets, lead therapies or product candidates unattractive or unsuitable for human use, and we may abandon our commitment to that program, target, lead therapy or product candidate. In addition, preliminary results seen in animal and/or limited human testing may not be substantiated in larger controlled clinical trials.5

~~If serious or unexpected adverse side effects are identified during the development of our NurOwn treatment candidate, we may need to abandon or limit its development.~~

IfTable ~~patients~~of treated with our NurOwn treatment candidate suffer serious or unexpected adverse effects, we may need to abandon its development or limit development to certain uses or subpopulations in which these effects are less prevalent, less severe or more acceptable from a risk-benefit perspective.Contents

Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by NurOwn® could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities. The ~~field~~drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. If patients treated with our NurOwn® stem cell therapy issuffer ~~relatively~~serious ~~new~~or ~~and~~unexpected ~~our development~~adverse ~~efforts~~effects, we may ~~not~~need ~~yield~~to anabandon ~~effective~~its ~~treatment~~development or limit development to certain uses or subpopulations in which these effects are less prevalent, less severe or more acceptable from a risk-benefit perspective. Any of ~~human~~these ~~diseases~~occurrences may harm our business, financial condition and prospects significantly.

~~Our~~Despite ~~intended~~our ~~cell~~experience ~~therapeutic treatment methods for ALS involve a new approach that has not yet been proven to work in humans. We are currently~~ conducting ~~Phase~~and ~~IIa~~managing clinical trials ~~for ALS~~, ~~which, together~~we ~~with other stem cell therapies,~~ may ~~ultimately~~not ~~prove~~be ~~ineffective~~able into ~~treatment~~conduct ofand ~~human~~manage ~~diseases.~~future Iftrials ~~we cannot~~ successfully ~~implement~~ ~~our~~and ~~NurOwn~~have ~~stem~~limited ~~cell~~experience ~~therapy~~ in ~~human~~the ~~testing,~~application weprocess ~~would~~necessary ~~need~~ to ~~change~~obtain ~~our~~regulatory ~~business strategy and we may be forced to change our operations~~approvals.

~~Our~~Despite ~~NurOwn~~our ~~treatment~~prior ~~candidate~~experience isin ~~based~~conducting onand amanaging ~~novel~~clinical ~~technology~~trials, ~~which~~ we may ~~raise~~not ~~development~~be ~~issues~~able ~~that~~to weconduct ~~may~~and ~~not~~manage befuture ~~able~~trials successfully. We have limited experience in the application process to ~~resolve,~~obtain regulatory ~~issues~~approvals. ~~that~~If ~~could~~our ~~delay~~clinical ortrials ~~prevent~~are ~~approval~~unsuccessful, or ~~personnel~~ ~~issues~~if ~~that~~we do not complete our clinical trials, we may ~~keep~~not usreceive ~~from~~regulatory ~~being~~approval for or be able to ~~develop~~commercialize our ~~treatments~~stem cell therapies.

~~Regulatory~~If ~~approval~~we ofdo ~~treatment~~not ~~candidates~~succeed ~~that~~in ~~utilize~~conducting ~~novel technology such as ours can be more expensive~~ and ~~take~~managing ~~longer~~our ~~than~~preclinical ~~for~~development ~~other~~activities ~~treatments that are based on more well-known~~ or more extensively studied technology, due to our and the regulatory agencies’ lack of experience with them. This may lengthen the regulatory review process, require us to perform additional studies, including clinical trials, ~~increase~~or ~~our development costs, lead to changes~~ in obtaining regulatory ~~positions and interpretations~~approvals, ~~delay~~we ormight ~~prevent~~not ~~approval~~be ~~and~~able ~~commercialization of these treatment candidates or lead~~ to ~~significant~~commercialize ~~post-approval~~our ~~limitations~~stem ~~or restrictions. For example, the differentiated~~ cell ~~component of our NurOwn treatment candidate is a complex biologic product that is manufactured from the patient’s own bone marrow that must be appropriately harvested~~therapies, isolated, expanded and differentiated so that its identity, strength, quality, purity and potency may be characterized prior to release for treatment. No differentiated cell treatment for ALS has yet been approved for marketing by the FDA or ~~any~~might ~~other regulatory agency. The tests that we use to make identity, strength, quality, purity and potency determinations on our NurOwn treatment candidate may not~~ be ~~sufficient~~significantly todelayed ~~satisfy~~in ~~the~~doing ~~FDA’s expectations regarding the criteria required for release of products for patient treatment and the regulatory agency may require us to employ additional testing measures for this purpose~~so, which ~~could~~will ~~require~~materially usharm toour ~~undertake additional testing and/or additional clinical trials~~business.

~~The~~Our ~~novel~~ability ~~nature~~to generate revenues from any of our ~~NurOwn~~stem ~~treatment~~cell ~~candidate~~therapies ~~also~~will ~~means that~~depend ~~fewer~~on ~~people~~a ~~are~~number ~~trained~~of infactors, orincluding ~~experienced~~our ~~with~~ability ~~treatments~~to ofsuccessfully ~~this~~complete ~~type~~clinical trials, ~~which~~obtain ~~may~~necessary ~~make~~regulatory itapprovals ~~difficult~~and toimplement ~~recruit,~~our ~~hire~~commercialization strategy. We may, and ~~retain~~ ~~capable~~anticipate ~~personnel~~that ~~for~~we ~~the~~will ~~research~~need to, ~~development~~transition ~~and~~from ~~manufacturing~~a ~~positions~~company ~~that~~with ~~will~~a beresearch ~~required~~and development focus to ~~continue~~a ~~our~~company ~~development~~ capable of supporting commercial activities and ~~commercialization~~we ~~efforts~~may not succeed in such a transition.

A significant global market for our services has yet to emerge.

Very few companies have been successful in their efforts to develop and commercialize a stem cell product. Some stem cell products in general may be susceptible to various risks, including undesirable and unintended side effects, unintended immune system responses, inadequate therapeutic efficacy, or other characteristics that may prevent or limit their approval or commercial use. The demand for stem cell processing and the number of people who may use cell or tissue-based therapies is difficult to forecast. Physicians, patients, formularies, third party payers or the medical community in general may not accept or utilize any products that the Company or its collaborative partners may develop. Our success is dependent on the establishment of a large global market for our products and services and our ability to capture a share of this market.

We have limited experience in conducting and managing clinical trials and the application process necessary to obtain regulatory approvals.

Our limited experience in conducting and managing clinical trials and the application process necessary to obtain regulatory approvals might prevent us from successfully designing or implementing a preclinical study or clinical trial. Cell-based therapy products, in general, may be susceptible to various risks, including undesirable and unintended side effects, unintended immune system responses, inadequate therapeutic efficacy or other characteristics that may prevent or limit their approval by regulators or commercial use. Many companies in the industry have suffered significant setbacks in advanced clinical trials, despite promising results in earlier trials. If our clinical trials are unsuccessful, or if we do not complete our clinical trials, we may not receive regulatory approval for or be able to commercialize our product candidates.

If we do not succeed in conducting and managing our preclinical development activities or clinical trials, or in obtaining regulatory approvals, we might not be able to commercialize our product candidates, or might be significantly delayed in doing so, which will materially harm our business.

Our ability to generate revenues from any of our product candidates will depend on a number of factors, including our ability to successfully complete clinical trials, obtain necessary regulatory approvals and implement our commercialization strategy. We may, and anticipate that we will need to, transition from a company with a research and development focus to a company capable of supporting commercial activities and we may not succeed in such a transition.

We may not be able to secure and maintain research institutions to conduct our clinical trials.

We rely on research institutions to conduct our clinical trials. Our reliance upon research institutions, including hospitals and clinics, provides us with less control over the timing and cost of clinical trials and the ability to recruit subjects. If we are unable to reach agreements with suitable research institutions on acceptable terms, or if any resulting agreement is terminated, we may be unable to quickly replace the research institution with another qualified institution on acceptable terms. Furthermore, we may not be able to secure and maintain suitable research institutions to conduct our clinical trials.

WeRisks ~~are~~Related ~~subject~~ to aOur ~~strict~~Business ~~regulatory~~Operations ~~environment. If we fail to obtain~~ and ~~maintain~~Commercialization ~~required~~of ~~regulatory~~Stem ~~approvals~~Cell ~~for our potential cell therapy products, our ability to commercialize our potential cell therapy products will be severely limited.~~Therapies

~~None~~The field of ~~our~~stem ~~product~~cell ~~candidates~~therapy ~~have~~is ~~received~~relatively ~~regulatory~~new ~~approval for~~and ~~commercial~~our ~~sale.~~development Weefforts domay not ~~expect~~yield toan ~~receive~~effective ~~regulatory~~treatment ~~approval for any~~ of ~~our~~human ~~product candidates until at least 2015, if ever~~diseases.

~~Numerous~~Our ~~statutes~~intended ~~and~~cell ~~regulations~~therapeutic ~~govern~~treatment ~~human~~NurOwn® ~~testing~~for ~~and~~ALS ~~the manufacture~~involves ~~and~~a ~~sale~~new ofapproach ~~human~~using ~~therapeutic~~stem ~~products~~cells into ~~the~~treat ~~United~~ALS. ~~States~~Cell ~~and~~therapy ~~other~~is ~~countries~~still ~~where~~a wedeveloping ~~intend~~area toof ~~market~~research, ~~our~~with ~~products. Such~~few ~~legislation~~cell ~~and~~therapy ~~regulation~~products ~~bears~~approved ~~upon,~~for ~~among~~clinical ~~other~~use. ~~things,~~Many of the ~~approval~~existing ofcellular ~~protocols~~therapy ~~and~~candidates ~~human~~are ~~testing,~~based ~~the~~on ~~approval~~novel ofcell ~~manufacturing facilities,~~technologies ~~testing~~that ~~procedures~~are inherently risky and ~~controlled~~may ~~research,~~not ~~review~~be ~~and~~understood ~~approval~~or ofaccepted ~~manufacturing,~~by ~~preclinical~~the ~~and~~marketplace. ~~clinical~~The ~~data~~novel ~~prior to~~nature ~~marketing~~of ~~approval~~our ~~including~~cell ~~adherence~~therapy totechnology ~~GMP~~creates ~~during~~significant ~~production~~challenges ~~and~~with ~~storage~~respect asto ~~well~~product asdevelopment ~~regulation~~and ofoptimization, ~~marketing~~manufacturing, ~~activities~~government ~~including advertising~~regulation and ~~labeling~~approval, third-party reimbursement.

11Our NurOwn® stem cell therapy, even if approved, may not be accepted in the marketplace; therefore, we may not be able to generate significant revenue, if any.

~~The~~Even ~~completion~~if ofour ~~the~~NurOwn® ~~clinical~~stem ~~testing~~cell oftherapy ~~our~~is ~~product~~approved ~~candidates~~ for sale, physicians and the ~~obtaining~~medical ofcommunity ~~required~~may ~~approvals~~not ~~are~~ultimately ~~expected~~use toit ~~take~~or ~~several~~may ~~years~~use ~~and~~it ~~require~~only ~~the~~in ~~expenditure~~applications ofmore ~~substantial~~restricted ~~resources~~than we anticipate. We ~~may~~Our ~~experience~~NurOwn® ~~numerous~~stem ~~unforeseen~~cell ~~events~~therapy, ~~during~~if successfully developed, orwill ascompete with a ~~result~~number of traditional products manufactured and marketed by major pharmaceutical and biotechnology companies. Our NurOwn® stem cell therapy may also compete with new products currently under development by such companies and others. Physicians will prescribe a treatment only if they determine, ~~the~~based on experience, clinical ~~trial~~data, ~~process~~side effect profiles and other factors, that ~~could~~it ~~delay~~is orbeneficial ~~prevent regulatory~~as ~~approval~~compared to other products currently available and~~/or~~ ~~commercialization~~in ofuse. ~~our~~Physicians also will prescribe a product ~~candidates~~based on their traditional preferences. Many other factors influence the adoption of new products, including patient perceptions and preferences, marketing and distribution restrictions, adverse publicity, product pricing, views of thought leaders in the ~~following:~~medical community and

· The FDA or similar foreign regulatory authorities may find that our product candidates are not sufficiently safe or effective or may find our processes or facilities unsatisfactory; · Officials at the Israeli MoH, the FDA or similar foreign regulatory authorities may interpret data from preclinical studies and clinical trials differently than we do; · Our clinical trials may produce negative or inconclusive results or may not meet the level of statistical significance required by the Israeli MoH, the FDA or other regulatory authorities, and we may decide, or regulators may require us, to conduct additional preclinical studies and/or clinical trials or to abandon one or more of our development programs; · The Israeli MoH, the FDA or similar foreign regulatory authorities may change their approval policies or adopt new regulations; · There may be delays or failure in obtaining approval of our clinical trial protocols from the Israeli MoH, the FDA or other regulatory authorities or obtaining institutional review board approvals or government approvals to conduct clinical trials at prospective sites; · We, or regulators, may suspend or terminate our clinical trials because the participating patients are being exposed to unacceptable health risks or undesirable side effects; · We may experience difficulties in managing multiple clinical sites; · Enrollment in our clinical trials for our product candidates may occur more slowly than we anticipate, or we may experience high drop-out rates of subjects in our clinical trials, resulting in significant delays; and · We may be unable to manufacture or obtain from third party manufacturers sufficient quantities of our product candidates for use in clinical trials.6

Investors should be aware of the risks, problems, delays, expenses and difficulties which may be encountered by us in light of the extensive regulatory environment in which our business operates. In particular, our development costs will increase if we have material delays in our clinical trials, or if we are required to modify, suspend, terminate or repeat a clinical trial. If we are unable to conduct our clinical trials properly and on schedule, marketing approval may be delayed or denied by the Israeli MoH or the FDA.

~~Even~~Table if a product candidate is approved by the Israeli MoH, the FDA or any other regulatory authority, we may not obtain approval for an indication whose market is large enough to recoup our investment in that product candidate. We may never obtain the required regulatory approvals for any of our product candidates. Later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions on the product or manufacturer, including a withdrawal of the product from the market.Contents

12reimbursement by government and private payors. Any of these factors could have a material adverse effect on our business, financial condition, and results of operations.

~~Even~~Adoption ifof ~~regulatory~~our ~~approvals~~NurOwn® ~~are~~stem ~~obtained~~cell therapy for ~~our~~the ~~product candidates~~treatment of patients with ALS, wePMS, ~~will~~AD beor ~~subject~~other toneurodegenerative ~~ongoing~~diseases, ~~government~~even ~~regulation.~~if Ifapproved, wemay orbe ~~one~~slow or ~~more~~limited. ofIf our ~~partners~~NurOwn® orstem ~~collaborators~~cell ~~fail~~therapy ~~to comply~~does ~~with~~not ~~applicable~~achieve ~~current~~broad ~~and~~acceptance ~~future~~as ~~laws~~a ~~and~~treatment ~~government~~option ~~regulations~~for ALS, PMS, AD or other neurodegenerative diseases, our business ~~and~~would ~~financial~~be ~~results~~negatively ~~could~~impact beour ~~adversely affected~~revenue forecast.

~~The~~If ~~healthcare~~approved, ~~industry~~the israte ~~one~~of adoption of ~~the~~our ~~most~~NurOwn® ~~highly~~stem ~~regulated industries~~cell intherapy ~~the~~as ~~United~~a ~~States.~~treatment ~~The~~for ~~federal~~ALS, ~~government~~PMS, ~~individual~~AD ~~state~~or ~~and~~other ~~local~~neurodegenerative ~~governments~~diseases, and ~~private~~the ~~accreditation~~ultimate ~~organizations all~~sales ~~oversee~~volume ~~and~~for ~~monitor~~our ~~the~~treatment, ~~activities~~will ofdepend ~~individuals~~on ~~and~~several ~~businesses~~factors, ~~engaged~~including ineducating ~~the~~treating ~~delivery~~physicians ofon ~~health~~how ~~care~~to ~~products~~use ~~and~~our ~~services~~NurOwn® stem cell therapy. ~~Even~~ ifOur ~~regulatory~~NurOwn® ~~authorities~~stem ~~approve~~cell ~~any~~therapy utilizes individualized stem cell therapy, which is significantly different from the pharmacological approach currently used to treat neurodegenerative diseases. Acceptance of our ~~human~~NurOwn® ~~therapeutic~~stem ~~product~~cell ~~candidates,~~therapy ~~current~~by ~~laws,~~physicians ~~rules~~may ~~and~~require ~~regulations~~us ~~that could~~to ~~directly~~provide orthem ~~indirectly~~with ~~affect~~extensive education regarding the mechanism of action of our ~~ability~~treatment, the method of delivery of the treatment, expected side effects and the ~~ability~~method of ~~our~~monitoring ~~strategic~~patients ~~partners~~for efficacy and ~~customers~~follow-up. toIn ~~operate~~addition, ~~each~~the ofmanufacturing and delivery processes associated with our treatment will require physicians to adjust their ~~businesses~~ ~~could~~current ~~include~~treatment of patients, ~~without~~which ~~limitation~~may delay or prevent market adoption of our NurOwn® stem cell therapy as a preferred therapy, ~~the~~even ~~following:~~if approved.

· State and local licensing, registration and regulation of laboratories, the collection, processing and storage of human cells and tissue, and the development and manufacture of pharmaceuticals and biologics; · The federal Clinical Laboratory Improvement Act and amendments of 1988; · Laws and regulations administered by the FDA, including the Federal Food Drug and Cosmetic Act and related laws and regulations; · The Public Health Service Act and related laws and regulations; · Laws and regulations administered by the United States Department of Health and Human Services, including the Office for Human Research Protections; · State laws and regulations governing human subject research; · Occupational Safety and Health requirements; and · State and local laws and regulations dealing with the handling and disposal of medical waste.

Compliance with such regulation may be expensive and consume substantial financial and management resources. If we, or any future marketing collaborators or contract manufacturers, fail to comply with applicable regulatory requirements, we may be subject to sanctions including fines, product recalls or seizures, injunctions, total or partial suspension of production, civil penalties, withdrawal of regulatory approvals and criminal prosecution. Any of these sanctions could delay or prevent the promotion, marketing or sale of our products.

Our NurOwn treatment candidate, even if approved, may not be accepted in the marketplace; therefore, we may not be able to generate significant revenue, if any.

Even if our NurOwn treatment candidate is approved for sale, physicians and the medical community may not ultimately use it or may use it only in applications more restricted than we anticipate. Our NurOwn treatment candidate, if successfully developed, will compete with a number of traditional products manufactured and marketed by major pharmaceutical and biotechnology companies. Our NurOwn treatment candidate may also compete with new products currently under development by such companies and others. Physicians will prescribe a treatment only if they determine, based on experience, clinical data, side effect profiles and other factors, that it is beneficial as compared to other products currently available and in use. Physicians also will prescribe a product based on their traditional preferences. Many other factors influence the adoption of new products, including patient perceptions and preferences, marketing and distribution restrictions, adverse publicity, product pricing, views of thought leaders in the medical community and reimbursement by government and private payers. Any of these factors could have a material adverse effect on our business, financial condition, and results of operations.

Adoption of our NurOwn treatment candidate for the treatment of patients with ALS, or other neurodegenerative diseases, even if approved, may be slow or limited. If our NurOwn treatment candidate does not achieve broad acceptance as a treatment option for ALS, or other neurodegenerative diseases, our business would be harmed.

If approved, the rate of adoption of our NurOwn treatment candidate as a treatment for ALS, or other neurodegenerative diseases, and the ultimate sales volume for our treatment, will depend on several factors, including educating treating physicians on how to use our NurOwn treatment candidate. Our NurOwn treatment candidate utilizes individualized stem cell therapy, which is significantly different from the pharmacological approach currently used to treat neurodegenerative diseases. Acceptance of our NurOwn treatment candidate by treating physicians may require us to provide them with extensive education regarding the mechanism of action of our treatment, the method of delivery of the treatment, expected side effects and the method of monitoring patients for efficacy and follow-up. In addition, the manufacturing and delivery processes associated with our treatment will require treating physicians to adjust their current treatment of patients, which may delay or prevent market adoption of our NurOwn treatment candidate as a preferred therapy, even if approved.

We are subject to environmental, health and safety laws.

We are subject to various laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals and humans, emissions and wastewater discharges, and the use and disposal of hazardous or potentially hazardous substances used in connection with our research. We also cannot accurately predict the extent of regulations that might result from any future legislative or administrative action. Any of these laws or regulations could cause us to incur additional expense or restrict our operations.

Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development or production efforts.

Our success will depend in part on establishing and maintaining effective strategic partnerships and collaborations, which may impose restrictions on our business and subject us to additional regulation.

A key aspect of our business strategy is to establish strategic relationships ~~in order,~~ to expand or complement our research and development or commercialization capabilities, and to reduce the cost of ~~research~~such ~~and development~~activities. There can be no assurance that we will enter into such relationships, that the arrangements will be on favorable terms or that such relationships will be successful. If we are ultimately successful in executing our strategy of securing collaborations with companies that would undertake advanced clinical development and commercialization of our products, we may not have day-to-day control over their activities. ~~Any such collaborator may adhere to criteria for determining whether to proceed with a clinical development program under circumstances where we might have continued such a program.~~ Potential collaborators may have significant discretion in determining the efforts and amount of resources that they dedicate to our collaborations or may be unwilling or unable to fulfill their obligations to us, including their development and commercialization. Potential collaborators may underfund or not commit sufficient resources to the testing, marketing, distribution or other development of our products. They may also not properly maintain or defend our intellectual property rights or they may utilize our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability. Potential collaboration partners may have the right to terminate the collaboration on relatively short notice and if they do so or if they fail to perform or satisfy their obligations to us, the development or commercialization of products ~~would~~may be delayed and our ability to realize any potential milestone payments and royalty revenue would be adversely affected.

We will need to develop or acquire additional capabilities in order to commercialize our NurOwn® ~~treatment~~stem ~~candidate~~cell therapy, if approved for sale, and we may encounter unexpected costs or difficulties in doing so.

We will need to acquire additional capabilities and effectively manage our operations and facilities to successfully pursue and complete future research, development and, if our NurOwn® ~~treatment candidate~~stem cell therapy receives regulatory approval, commercialization efforts. Currently, we have no experience in ~~preparing applications for marketing approval,~~ commercial-scale manufacturing, managing of large-scale information technology systems or managing a large-scale distribution system. We will need to add personnel and expand our capabilities, which may strain our existing managerial, operational, regulatory compliance, financial and other resources. To do this effectively, we must:

·● train, manage and motivate a growing employee base;

14● accurately forecast demand for our treatment; and

·● ~~accurately~~expand ~~forecast~~existing ~~demand~~operational, ~~for~~financial ~~our~~and ~~treatment;~~management ~~and~~information systems.

· expand existing operational, financial and management information systems.

We will need to increase our manufacturing capacity prior to seeking approval for the sale of our products. If we are not successful in establishing a regulatory compliant manufacturing process, we may not obtain approval of products or our ability to obtain regulatory approval for sale could be delayed, which would further delay the period of time when we would be able to generate revenues from the sale of such products, if we are even able to generate revenues at all.

We expect to expand our development, regulatory, manufacturing and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

We expect to experience ~~significant~~ growth in the number of our employees, which could be significant in nature as we near regulatory approval, and the scope of our operations, particularly in the areas of product development, regulatory affairs, manufacturing and sales and marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

We have never manufactured our NurOwn treatment candidate at commercial scale and there can be no assurance that it can be manufactured in compliance with regulations at a cost or in quantities necessary to make it commercially viable.7

We have no experience in commercial-scale manufacturing, the management of large-scale information technology systems or the management of a large-scale distribution system. We may develop our manufacturing capacity in part by expanding our current facilities and/or by setting up additional facilities in other regions of the country. These activities would require substantial additional funds and we would need to hire and train significant numbers of qualified employees to staff these facilities. We may not be able to develop commercial-scale facilities that are sufficient to produce the treatment candidates or their components for later-stage clinical trials or commercial use.

~~Furthermore,~~Table ~~we must supply all necessary documentation, including product characterization and process validation, to regulatory authorities in support~~ of our BLA on a timely basis and must adhere to cGMP regulations and current Good Tissue Practices (GTP) enforced by the regulatory authority through its facilities inspection program. We have not fully characterized our NurOwn treatment candidate and have not validated our manufacturing process. If the FDA determines that the products used in our clinical trials are not sufficiently characterized, we may be required to repeat all or a portion of our clinical trials. If our facilities cannot pass a pre-approval plant inspection, the regulatory approval of the treatment candidates will not be granted.Contents

15resources and our limited experience in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

We ~~are~~have ~~subject~~never tomanufactured ~~significant~~our ~~regulation~~NurOwn® stem cell therapy at commercial scale and there can be no assurance that it can be manufactured in compliance with ~~respect to~~regulations ~~manufacturing~~at ofa ~~our~~cost ~~NurOwn~~or ~~treatment~~in ~~candidate~~quantities necessary to make it commercially viable.

~~All~~Although, ~~entities~~several ~~involved~~members ~~in the preparation~~ of aour ~~therapeutic biological~~management ~~for~~team ~~clinical~~have ~~trials~~experience orin commercial ~~sale~~scale ~~are~~cell ~~subject~~therapy tomanufacturing, ~~extensive~~we ~~regulation.~~have ~~Our~~no ~~NurOwn~~experience ~~treatment candidate must be manufactured~~ in ~~accordance~~commercial-scale ~~with~~stem ~~cGMP~~cell ~~and~~therapy ~~GTP~~manufacturing. ~~before~~We itmay ~~can~~develop ~~be used in~~ our ~~clinical trials or approved for commercial sale. These regulations govern~~ manufacturing ~~processes~~capacity ~~and~~in ~~procedures~~part ~~and~~by ~~the~~expanding ~~implementation~~our ~~and~~current operation of quality systems to control and assure the quality of investigational treatment candidates and treatments, including treatment component characterization and process validation, approved for sale. Our facilities and/or ~~quality~~by ~~systems~~setting ~~and~~up ~~the~~additional facilities ~~and~~in ~~quality systems~~other ofregions ~~some or all~~ of ~~our third party suppliers must pass a pre-approval inspection for compliance with~~ the ~~applicable regulations as a condition of regulatory approval of our NurOwn treatment candidate~~country. IfThese ~~any~~activities ~~inspection~~would or audit of our manufacturing facilities identifies a failure to comply with applicable regulations, or if a violation of applicable regulations occurs independent of an inspection or audit, we or the relevant regulatory authority may require ~~remedial measures~~substantial ~~that~~additional ~~may~~funds ~~be costly~~ and~~/or~~ ~~time~~we ~~consuming~~would ~~for~~need ~~us or a third party~~ to ~~implement~~hire and ~~that~~train ~~may~~significant ~~include~~numbers ~~the temporary or permanent suspension~~ of aqualified ~~clinical~~employees ~~trial~~to orstaff ~~commercial~~these ~~sales or the temporary or permanent closure of a facility~~facilities. ~~Any such remedial measures imposed on us or third parties with whom we contract could materially harm our business.~~

If any contract manufacturing organization (“CMO”) with whom we contract fails to perform its obligations, we may be forced to manufacture the materials ourselves, for which we may not have the capabilities or resources, or enter into an agreement with a different CMO, which we may not be able to do on reasonable terms, if at all. In either scenario, our clinical trials supply could be delayed significantly as we establish alternative supply sources. In some cases, the technical skills required to manufacture our products or product candidates may be unique or proprietary to the original CMO and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all. In addition, if we are required to change CMOs for any reason, we will be required to verify that the new CMO maintains facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce our product candidate according to the specifications previously submitted to the FDA or another regulatory authority. The delays associated with the verification of a new CMO could negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget. Furthermore, a CMO may possess technology related to the manufacture of our product candidate that such CMO owns independently. This would increase our reliance on such CMO or require us to obtain a license from such CMO in order to have another CMO manufacture our product candidates. In addition, changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials.

Furthermore, we must supply all necessary documentation, including product characterization and process validation, to regulatory authorities in support of our BLA on a timely basis and must adhere to cGMP and cGTP regulations enforced by the regulatory authority through its facilities inspection program. If the FDA determines that the products used in our clinical trials are not sufficiently characterized, we may be required to repeat all or a portion of our clinical trials. If our facilities cannot pass a pre-approval plant inspection, the regulatory approval of the stem cell therapies will not be granted.

Lack of coordination internally among our employees and externally with physicians, hospitals and third-party suppliers and carriers, could cause manufacturing difficulties, disruptions or delays and cause us to not meet our expected clinical trial requirements or potential commercial requirements.

Manufacturing our NurOwn® ~~treatment~~stem ~~candidate~~cell therapy requires coordination internally among our employees and externally with physicians, hospitals and third-party suppliers and carriers. For example, a patient’s physician or clinical site will need to coordinate with us for the shipping of a patient’s bone marrow to our manufacturing facility, and we will need to coordinate with them for the shipping of the treatment components to them. Such coordination involves a number of risks that may lead to failures or delays in manufacturing our NurOwn® ~~treatment~~stem ~~candidate~~cell therapy, including:

·● failure to obtain a sufficient supply of key raw materials of suitable quality;

·● difficulties in manufacturing our ~~treatment~~stem ~~candidates~~cell therapies for multiple patients simultaneously;

·● difficulties in obtaining adequate patient-specific material, such as bone marrow samples, from physicians;

·● difficulties in completing the development and validation of the harvested cells required to ensure the consistency of our NurOwn® ~~treatment~~stem ~~candidate~~cell therapy;

~~· failure to ensure adequate quality control and assurances in the manufacturing process as we increase production quantities;~~8

· difficulties in the timely shipping of patient-specific materials to us or in the shipping of the treatment candidates to the treating physicians due to errors by third-party carriers, transportation restrictions or other reasons;

·Table ~~loss or destruction~~ of, ~~or damage to, patient-specific materials or our NurOwn treatment candidate during the shipping process due to improper handling by third-party carriers, hospitals, physicians or us;~~Contents

·● ~~loss~~failure orto ~~destruction~~ensure ~~of,~~adequate orquality ~~damage~~control ~~to,~~and ~~patient-specific~~assurances ~~materials~~in orthe ~~our~~manufacturing ~~NurOwn~~process ~~treatment~~as ~~candidate~~we ~~during~~increase ~~storage~~production ~~at our facilities~~quantities; ~~and~~

·● ~~loss~~difficulties orin ~~destruction~~the ~~of,~~timely orshipping ~~damage~~of ~~to,~~ patient-specific materials to us or ~~our~~in ~~NurOwn~~the ~~treatment~~shipping ~~candidate~~of ~~stored~~the atstem ~~clinical~~cell ~~and~~therapies ~~future~~to ~~commercial~~the ~~sites~~treating physicians due to ~~improper~~errors ~~handling or holding~~ by ~~clinicians~~third-party carriers, ~~hospitals~~transportation restrictions or ~~physicians.~~other reasons;

If● weloss ~~are~~or ~~unable~~destruction ~~to coordinate appropriately~~of, ~~we may encounter delays~~ or ~~additional~~damage ~~costs~~to, inpatient-specific ~~achieving~~materials or our ~~clinical~~NurOwn® ~~and~~stem ~~commercialization~~cell ~~objectives,~~therapy ~~including~~during inthe ~~obtaining~~shipping ~~regulatory~~process ~~approvals of~~due ~~our~~to ~~treatment~~improper ~~candidates~~handling ~~and~~by ~~supplying~~third-party ~~products~~carriers, ~~which~~hospitals, ~~could~~physicians ~~materially~~or ~~damage our business and financial position.~~us;

●

loss or destruction of, or damage to, patient-specific materials or our NurOwn® stem cell therapy during storage at our facilities; and

●

loss or destruction of, or damage to, patient-specific materials or our NurOwn® stem cell therapy stored at clinical and future commercial sites due to improper handling or holding by clinicians, hospitals or physicians.

If we are unable to coordinate appropriately, we may encounter delays or additional costs in achieving our clinical and commercialization objectives, including in obtaining regulatory approvals of our stem cell therapies and supplying products, which could materially damage our business and financial position.

We face competition in our efforts to develop cell therapies for ALS and other neurodegenerative diseases.

We face competition in our efforts to develop cell therapies and other treatment or procedures to cure or slow the effects of ALS and other neurodegenerative diseases. Among our competitors are companies that are involved in the fetal-derived cell ~~transplant~~transplants or embryonic stem cell derived cell therapy and companies developing adult stem cells. Other companies are developing traditional chemical compounds, new biological drugs, cloned human proteins and other treatments, which are likely to impact the markets that we intend to target. Some of our competitors possess longer operating histories and greater financial, managerial, scientific and technical resources than we do, and some possess greater name recognition and established customer bases. Some also have significantly more experience in preclinical testing, human clinical trials, product manufacturing, the regulatory approval process and marketing and distribution than we do.

The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us.

There is a trend towards consolidation in the pharmaceutical and biotechnology industries. This consolidation trend may result in the remaining companies having greater financial resources and discovery technological capabilities, thus intensifying competition in these industries. This trend may also result in fewer potential collaborators or licensees for our ~~therapeutic~~stem ~~product~~cell ~~candidates~~therapies. Also, if a consolidating company is already doing business with our competitors, we may lose existing licensees or collaborators as a result of such consolidation.

There is a scarcity of experienced professionals in the field of cell therapy and we may not be able to retain key personnel or hire new key personnel needed to implement our business strategy and develop our products and businesses. If we are unable to retain or hire key personnel, we may be unable to continue to grow our business or to implement our business strategy, and our business may be materially and adversely affected.

Given the specialized nature of cell therapy and the fact that it is a young field, there is an inherent scarcity of experienced personnel in the field. Our success depends on a significant extent to the continued services of certain highly qualified scientific and management personnel. We face competition for qualified personnel from numerous industry sources, and there can be no assurance that we will be able to attract and retain qualified personnel on acceptable terms. The loss of service of any of our key personnel could have a material adverse effect on our operations or financial condition. In the event of the loss of services of such personnel, no assurance can be given that we will be able to obtain the services of adequate replacement personnel. ~~We do not have key person life insurance on all of our key personnel.~~ The future success of the Company also depends upon our ability to attract and retain additional qualified personnel (including medical, scientific, technical, commercial, business and administrative personnel) necessary to support our anticipated growth, develop our business, and maintain appropriate licensure, on acceptable terms. There can be no assurance that we will be successful in attracting or retaining personnel required by us to continue and grow our operations. The loss of a key employee, the failure of a key employee to perform in his or her current position or our inability to attract and retain skilled employees, as needed, could result in our inability to continue to grow our business or to implement our business strategy, or may have a material adverse effect on our business, financial condition and results of operations.

Table of Contents

Technological and medical developments or improvements in conventional therapies could render the use of stem cells and our services and planned products obsolete.

The pharmaceutical industry is characterized by rapidly changing markets, technology, emerging industry standards and frequent introduction of new products. The introduction of new products embodying new technologies, including new manufacturing processes, and the emergence of new industry standards may render our technologies obsolete, less competitive or less marketable. Advances in other treatment methods or in disease prevention techniques could significantly reduce or entirely eliminate the need for our stem cell services, planned products and therapeutic efforts. Additionally, technological or medical developments may materially alter the commercial viability of our technology or services, and require us to incur significant costs to replace or modify equipment in which we have a substantial investment. In either event, we may experience a material adverse effect on our business, results of operations and financial condition. To date, approved conventional therapies have not shown significant clinical benefit as disease modifying therapies in the indications that we are currently working on.

17We may expend our limited resources to pursue our NurOwn® stem cell therapy or a specific indication for its use and fail to capitalize on stem cell therapies or indications that may be more profitable or for which there is a greater likelihood of success.

WeBecause ~~may~~we ~~expend~~have ~~our~~ limited financial and managerial resources, towe ~~pursue~~have focused development of our NurOwn ~~treatment~~® ~~candidate~~stem orcell atherapy ~~specific~~for ~~indication~~use ~~for~~in ~~its~~patients ~~use~~with ALS, PMS and ~~fail~~AD. toAs ~~capitalize~~a onresult, ~~treatment~~we ~~candidates~~may forego or delay pursuit of opportunities with other stem cell therapies or for other indications that later prove to have greater commercial potential. Our resource allocation decisions also may be ~~more~~cause ~~profitable~~us orto ~~for~~fail ~~which~~to ~~there~~capitalize ison a ~~greater~~viable ~~likelihood~~commercial oftreatment, ~~success~~a more viable indication or profitable market opportunities.

~~Because~~We we have ~~limited~~based ~~financial~~our research and ~~managerial resources, we have focused~~ development ofefforts on our NurOwn® ~~treatment~~stem ~~candidate~~cell ~~for~~therapy. ~~use~~Notwithstanding inour ~~patients~~large ~~with~~investment ~~ALS.~~to Asdate aand ~~result,~~anticipated wefuture ~~may~~expenditures ~~forego~~in orour ~~delay pursuit~~NurOwn® ofstem ~~opportunities~~cell ~~with~~therapy, ~~other~~we ~~treatment~~have ~~candidates~~not oryet ~~for~~developed, ~~other~~and ~~indications~~may ~~that~~never ~~later~~successfully ~~prove~~develop, toany ~~have~~marketed ~~greater~~treatments ~~commercial~~using ~~potential~~this approach. ~~Our~~ ~~spending~~As ona ~~current~~result ~~and~~of ~~future~~pursuing ~~research~~the ~~and~~ development ~~efforts~~of on our NurOwn® ~~treatment~~stem ~~candidate~~cell ~~for~~therapy, ~~this~~we ~~indication~~ may ~~not yield~~fail ato ~~commercially~~develop ~~viable~~stem ~~treatment.~~cell ~~Our~~therapies ~~resource~~or ~~allocation~~address ~~decisions~~indications ~~also~~based ~~may~~on ~~cause~~other usscientific toapproaches ~~fail~~that tomay ~~capitalize~~offer ongreater acommercial ~~viable~~potential ~~commercial treatment,~~or afor ~~more~~which ~~viableindication~~there oris ~~profitable~~a ~~market~~greater ~~opportunities~~likelihood of success.

WeOur ~~have~~NurOwn® ~~based~~stem ~~our~~cell ~~research~~therapy ~~and~~is ~~development~~based ~~efforts~~ on ~~our~~a ~~NurOwn treatment~~novel ~~candidate.~~technology, ~~Notwithstanding~~which ~~our~~may ~~large~~raise ~~investment~~development toissues ~~date~~that ~~and anticipated future expenditures in our NurOwn treatment candidate,~~ we ~~have~~may not ~~yet~~be ~~developed,~~able ~~and~~to ~~may never successfully develop~~resolve, ~~any~~regulatory ~~marketed~~issues ~~treatments~~that ~~using~~could ~~this~~delay ~~approach.~~or Asprevent aapproval ~~result of pursuing the development of our NurOwn treatment candidate, we may fail to develop treatment candidates~~ or ~~address~~personnel ~~indications~~issues ~~based on other scientific approaches~~ that may ~~offer~~keep ~~greater~~us ~~commercial~~from ~~potential~~being orable ~~for~~to ~~which~~develop ~~there~~our ~~is a greater likelihood of success~~treatments.

~~Our~~Regulatory ~~long-term~~approval ~~business~~of ~~plan~~stem iscell totherapies ~~develop~~that ~~our~~utilize ~~NurOwn~~novel ~~treatment candidate~~technology such as ours can be more expensive and take longer than for ~~the~~other ~~treatment~~treatments ofthat ~~neurodegenerative~~are ~~diseases,~~based ~~such~~on asmore ~~ALS,~~well-known MSor ~~and~~more PDextensively studied technology. ~~Even~~This ifmay welengthen ~~successfully~~the ~~develop~~regulatory review process, require us to perform additional studies, including clinical trials, increase our ~~NurOwn~~development ~~treatment candidate~~costs, ~~for~~lead ~~use~~to changes in ~~one~~regulatory ~~indication~~positions and interpretations, wedelay ~~may~~or ~~not~~prevent beapproval ~~successful~~and incommercialization ~~our~~of ~~efforts~~these tostem ~~identify~~cell therapies or ~~discover~~lead ~~additional~~to ~~indications~~significant ~~for it~~post-approval limitations or restrictions. ~~Clinical~~For ~~programs~~example, tothe ~~develop~~differentiated ~~new~~cell ~~indications~~component ~~for~~of our NurOwn® ~~treatment~~stem ~~candidate~~cell ~~will~~therapy ~~require~~is ~~substantial~~a ~~technical~~complex biologic product that is manufactured from the patient’s own bone marrow that must be appropriately harvested, ~~financial~~ isolated, expanded and ~~human~~differentiated ~~resources.~~so ~~These~~that ~~development~~its ~~programs~~identity, strength, quality, purity and potency may ~~initially~~be ~~show~~characterized ~~promise~~prior into ~~identifying~~release ~~potential~~for treatment. ~~indications,~~No ~~yet fail~~differentiated tocell ~~obtain~~treatment ~~regulatory~~for ~~approval~~ALS has yet been approved for ~~commercial~~marketing ~~sale~~by the FDA or any other regulatory agency.

IfThe wenovel donature ~~not~~of ~~accurately~~our ~~evaluate~~NurOwn® ~~the~~stem ~~commercial~~cell ~~potential~~therapy also means that fewer people are trained in or ~~target~~ ~~market~~experienced ~~for~~with ~~our~~treatments ~~NurOwn~~of ~~treatment~~this ~~candidate~~type, wewhich may ~~relinquish~~make ~~valuable~~it ~~rights~~difficult to ~~that treatment through collaboration~~recruit, ~~licensing or~~hire ~~other~~and ~~royalty~~retain ~~arrangements~~capable inpersonnel ~~cases~~for inthe ~~which~~research, itdevelopment ~~would~~and ~~have~~manufacturing ~~been~~positions ~~more~~that ~~advantageous~~will ~~for~~be usrequired to ~~retain~~continue ~~sole~~our development and commercialization ~~rights~~ efforts.

IfWe ~~Ramot~~may isbe ~~unable~~subject, directly or indirectly, to ~~obtain~~federal ~~patents~~and onstate ~~the~~healthcare ~~patent~~fraud ~~applications~~ and ~~technology~~abuse ~~licensed~~laws, tofalse ~~our~~claims ~~Israeli~~laws ~~Subsidiary~~health orinformation ifand ~~patents~~other ~~are~~health ~~obtained~~care ~~but~~laws doand ~~not~~regulations. ~~provide~~If ~~meaningful~~we ~~protection~~are unable to comply, weor ~~may~~have not be ~~able~~fully tocomplied, ~~successfully~~with ~~market~~such ~~our~~laws, ~~proposed~~we ~~products~~could face substantial penalties.

WeIf ~~rely~~we ~~upon~~obtain ~~the~~FDA ~~patent~~approval ~~applications~~for ~~filed~~any ~~by Ramot, the technology licensing company~~ of ~~Tel~~our ~~Aviv~~product ~~University,~~candidates and ~~the~~begin ~~license~~commercializing ~~granted~~those toproducts ~~us by Ramot, all~~ in ~~accordance with~~ the ~~Second~~United ~~Ramot Agreement dated as of July 26~~States, 2007. We further agreed under the Second Ramot Agreement that Ramot, in consultation with us, is responsible for obtaining patent protection for technology owned by Ramot and licensed to us. No assurance can be given that any of our ~~pending or~~operations ~~future patent applications~~ will be ~~approved~~directly, ~~that the scope of any patent protection granted will exclude competitors~~ or ~~provide us~~indirectly ~~with~~through ~~competitive~~our ~~advantages~~prescribers, ~~that~~customers ~~any~~and ~~of the patents that may be issued to us will be held valid if subsequently challenged~~purchasers, or ~~that~~subject ~~other parties will not claim rights~~ to orvarious ~~ownership~~federal ofand ~~our~~state ~~patents~~fraud orand ~~other~~abuse ~~proprietary~~laws ~~rights~~and ~~that~~regulations, weincluding, ~~hold~~without ~~license to. Furthermore~~limitation, ~~there~~the ~~can~~federal beHealth noCare ~~assurance~~Program ~~that~~Anti-Kickback ~~others have not developed or will not develop similar products~~Statute, ~~duplicate~~the ~~any~~federal ofcivil ~~our technology~~and orcriminal ~~products~~False orClaims ~~design~~Act ~~around~~and ~~any~~Physician ~~patents~~Payments ~~that~~Sunshine ~~have~~Act ~~been~~and ~~or may be issued to us or any future licensors~~regulations. ~~Since~~These ~~patent applications~~laws inwill ~~the~~impact, ~~United~~among ~~States~~other ~~and in Europe are not disclosed until applications are published~~things, ~~there can be no assurance that others did not first file applications for products covered by~~ our ~~pending~~proposed ~~patent applications~~sales, ~~nor~~marketing ~~can~~and weeducational beprograms. ~~certain~~In ~~that~~addition, we ~~will not infringe any patents that~~ may be ~~issued~~subject to ~~others.~~patient ~~Also,~~privacy welaws ~~have~~by ~~abandoned~~both ~~our~~the ~~rights~~federal togovernment ~~certain~~and ~~patents~~the ofstates ~~Ramot~~ in ~~certain countries~~which inwe ~~connection~~conduct ~~with~~our ~~the~~business. ~~Letter~~For ~~Agreement~~more ~~by and between us and Ramot dated December 24~~information, ~~2009,~~see ~~which~~“Business – ~~may~~Other ~~limit~~Healthcare ~~our~~Laws ~~ability to~~and ~~fully~~Compliance ~~market our proposed products~~Requirements.

We also rely upon unpatented proprietary technology, know-how and trade secrets and seek to protect them through confidentiality agreements with employees, consultants and advisors. If these confidentiality agreements are breached, we may not have adequate remedies for the breach. In addition, others may independently develop or otherwise acquire substantially the same proprietary technology as our technology and trade secrets.10

WeTable ~~may~~of ~~be unable to protect our intellectual property from infringement by third parties.~~Contents

~~Despite~~Additionally, ~~our~~we ~~efforts~~are subject to ~~protect~~state ~~our~~and ~~intellectual~~foreign ~~property,~~equivalents ~~third parties~~of ~~may~~each ~~infringe~~of orthe ~~misappropriate~~healthcare ~~our~~laws ~~intellectual~~and ~~property.~~regulations ~~Our~~described ~~competitors~~above, ~~may~~among ~~also~~others, ~~independently~~some ~~develop~~of ~~similar~~which ~~technology, duplicate~~may ~~our~~be ~~processes~~broader orin ~~services~~scope orand ~~design~~may ~~around~~apply ~~our~~regardless ~~intellectual~~of ~~property~~the ~~rights~~payor. WeMany ~~may~~U.S. states have toadopted ~~litigate~~laws similar to ~~enforce~~the federal Anti-Kickback Statute and ~~protect our~~False ~~intellectual~~Claims ~~property~~Act, ~~rights~~and may apply to ~~determine~~our ~~their~~business ~~scope~~practices, ~~validity~~including, but not limited to, research, distribution, sales or ~~enforceability.~~marketing ~~Intellectual~~arrangements ~~property~~and ~~litigation~~claims isinvolving ~~costly, time~~healthcare items or services reimbursed by non-~~consuming~~governmental payors, ~~diverts~~including private insurers. In addition, some states have passed laws that require pharmaceutical companies to comply with the ~~attention~~April 2003 Office of ~~management~~Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and/or ~~technical~~the ~~personnel~~Pharmaceutical Research and ~~could~~Manufacturers ~~result~~of inAmerica’s ~~substantial~~Code ~~uncertainty~~on ~~regarding our~~Interactions ~~future~~with ~~viability~~Healthcare Professionals. ~~The~~Several ~~loss~~states ofalso ~~intellectual~~impose ~~property~~other ~~protection~~marketing restrictions or ~~the~~require ~~inability~~pharmaceutical companies to ~~secure~~make marketing or ~~enforce~~price ~~intellectual~~disclosures ~~property protection~~to ~~would~~the ~~limit~~state ~~our~~and ~~ability~~require tothe ~~develop~~registration orof ~~market~~pharmaceutical ~~our~~sales ~~services~~representatives. inState ~~the~~and ~~future.~~foreign ~~This~~laws, ~~would~~including ~~also~~for ~~likely~~example ~~have~~the anGDPR ~~adverse~~in ~~effect on~~the EEA, also govern the ~~revenues~~privacy ~~generated~~and bysecurity ~~any~~of ~~sale~~health orinformation ~~license~~in some circumstances, many of ~~such~~which ~~intellectual~~differ ~~property.~~from ~~Furthermore~~each other in significant ways and often are not preempted by HIPAA, ~~any~~thus ~~public~~complicating ~~announcements~~compliance ~~related~~efforts. There are ambiguities as to ~~such~~ ~~litigation~~what oris ~~regulatory~~required ~~proceedings~~to comply with these state requirements and if we fail to comply with an applicable state law requirement we could ~~adversely~~be ~~affect~~subject to penalties. Finally, there are state and foreign laws governing the ~~price~~privacy and security of ~~our~~health ~~Common~~information, ~~Stock~~many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

~~Third~~Because ~~parties~~of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge and may ~~claim~~not comply under one or more of such laws, regulations, and guidance. Law enforcement authorities are increasingly focused on enforcing fraud and abuse laws, and it is possible that some of our practices may be challenged under these laws. Efforts to ensure that our current and future business arrangements with third parties, and our business generally, will comply with applicable healthcare laws and regulations will involve substantial costs. If our operations, including our arrangements with physicians and other healthcare providers, some of whom receive share options as compensation for services provided, are found to be in violation of any of such laws or any other governmental regulations that apply to us, we ~~infringe~~may onbe ~~their~~subject ~~intellectual property~~to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs (such as Medicare and Medicaid), and imprisonment, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our financial results.

WeIf ~~may~~we beare ~~subject~~found ~~to costly litigation~~ in ~~the~~violation ~~event our technology is claimed to infringe upon the proprietary rights~~ of ~~others.~~privacy ~~Third~~and ~~parties~~data ~~may~~protection ~~have~~laws, orwe may ~~eventually~~ be ~~issued,~~required ~~patents that would be infringed by our technology. Any of these third parties could make a claim of infringement against us with respect~~ to ~~our~~ ~~technology.~~pay Wepenalties, ~~may also~~ be ~~subject~~subjected to ~~claims~~scrutiny by ~~third~~regulators ~~parties~~or ~~for~~governmental ~~breach of copyright~~entities, ~~trademark~~ or ~~license~~be ~~usage~~suspended rights. Litigation and patent interference proceedings could result in substantial expense to us and significant diversion of efforts by our technical and management personnel. An adverse determination in any such proceeding or in patent litigation could subject us to significant liabilities to third parties or require us to seek licenses from ~~third~~participation ~~parties. Such licenses may not be available on acceptable terms or at all. Adverse determinations~~ in agovernment ~~judicial~~healthcare ~~or administrative proceeding or failure to obtain necessary licenses could prevent us from commercializing our products~~programs, which ~~would~~may ~~have~~adversely aaffect ~~material adverse effect on~~ our business, ~~results~~financial ofcondition ~~operations~~ and ~~financial~~results ~~condition~~of operations.

AsAt athe ~~result~~federal level, failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of ~~our~~Section 5(a) of ~~reliance~~the onFederal ~~consultants~~Trade Commission Act (the FTCA), we15 ~~may~~U.S.C ~~not~~ § 45(a). The FTC expects a company’s data security measures to be ~~able~~reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business and the cost of available tools to ~~protect~~improve security and reduce vulnerabilities. Regulators and legislators in the ~~confidentiality~~U.S. are also increasingly scrutinizing and restricting certain personal data transfers and transactions involving foreign countries. For example, the Biden Administration’s executive order “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of ~~our~~Concern” ~~technology~~as implemented by Department of Justice regulations issued in December 2024, ~~which~~prohibits data brokerage transactions involving certain sensitive personal data categories, ifincluding ~~disseminated~~health data, ~~could~~genetic ~~negatively~~data, ~~impact~~and ~~our~~biospecimens, ~~plan~~to countries of ~~operations~~concern, including China. The regulations also restrict certain investment agreements, employment agreements and vendor agreements involving such data and countries of concern, absent specified cybersecurity controls. Actual or alleged violations of these regulations may be punishable by criminal and/or civil sanctions, and may result in exclusion from participation in federal and state programs.

WeMany ~~currently~~states ~~have~~in ~~relationships~~the ~~with~~United ~~two~~States ~~academic~~have ~~consultants who~~also ~~are~~enacted ~~not~~laws ~~employed~~that byregulate ~~us,~~the privacy and/or wesecurity ~~may~~of ~~enter~~certain ~~into~~types ~~additional~~of ~~relationships~~personal ofinformation. ~~such~~For ~~nature~~example, in California, the ~~future.~~California WeConsumer ~~have~~Privacy ~~limited~~Act ~~control over~~ (the ~~activities~~“CCPA”), ofcreated ~~these~~a ~~consultants~~comprehensive ~~and~~privacy ~~can~~framework ~~expect~~for ~~only~~covered ~~limited~~businesses ~~amounts~~by creating an expanded definition of ~~their~~personal ~~time~~information, toestablished benew ~~dedicated~~data toprivacy ~~our~~rights ~~activities.~~for ~~These persons~~consumers ~~may~~in ~~have~~the ~~consulting~~State of California, ~~employment~~imposed orspecial ~~advisory~~rules on ~~arrangements~~the ~~with~~collection ~~other~~of ~~entities~~consumer ~~that~~data ~~may~~from ~~conflict~~minors, ~~with~~and orcreated ~~compete~~a ~~with~~new ~~their obligations~~and topotentially ~~us.~~severe ~~Our~~statutory ~~consultants~~damages ~~typically~~framework ~~sign~~for ~~agreements~~violations ~~that~~of ~~provide~~the CCPA and for ~~confidentiality~~businesses ofthat ~~our~~fail ~~proprietary~~to ~~information~~implement reasonable security procedures and ~~results~~ ofpractices ~~studies~~to prevent data breaches. ~~However~~In addition, inas ~~connection~~of ~~with~~January 1, ~~every relationship~~2023, weamendments ~~may~~introduced ~~not~~by bethe ~~able~~California toPrivacy ~~maintain~~Rights Act (the ~~confidentiality~~“CPRA”) ofhave ~~our~~imposed ~~technology,~~ additional obligations on companies covered by the ~~dissemination~~CCPA. ofThe ~~which~~CPRA ~~could~~significantly ~~hurt~~modified ~~our~~the ~~competitive~~CCPA, ~~position~~including ~~and~~by ~~results~~expanding ofconsumers’ ~~operations.~~rights Towith ~~the~~respect ~~extent~~to ~~that~~sensitive ~~our~~personal ~~scientific~~information ~~consultants develop~~and ~~inventions~~created ora ~~processes~~new ~~independently~~state agency that ~~may~~is bevested ~~applicable~~with authority to ~~our~~implement ~~proposed~~and ~~products,~~enforce ~~disputes~~the ~~may~~CCPA. ~~arise~~Although asclinical totrial ~~the~~data ~~ownership of~~and ~~the~~protected ~~proprietary~~health ~~rights~~information subject to ~~such~~HIPAA ~~information~~are currently exempt from CCPA, we may ~~expend~~be ~~significant~~subject ~~resources~~to inthe ~~such~~CCPA ~~disputes~~with ~~and~~respect weto ~~may~~other ~~not~~personal ~~win~~information ~~those~~regarding ~~disputes~~California residents.

It is uncertain to what extent the government, private health insurers and third-party payers will approve coverage or provide reimbursement for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by an increasing uninsured population and reductions in Medicare and Medicaid funding in the United States.11

Our ability to successfully commercialize our human therapeutic products will depend significantly on our ability to obtain acceptable prices and the availability of reimbursement to the patient from third-party payers, such as government and private insurance plans. While we have not commenced discussions with any such parties, these third-party payers frequently require companies to provide predetermined discounts from list prices, and they are increasingly challenging the prices charged for pharmaceuticals and other medical products. Our human therapeutic products may not be considered cost-effective, and reimbursement to the patient may not be available or sufficient to allow us to sell our products on a competitive basis. Further, as cost containment pressures are increasing in the health care industry, government and private payers adopt strategies designed to limit the amount of reimbursement paid to health care providers. Such cost containment measures may include:

·Table ~~Reducing~~of ~~reimbursement rates;~~Contents

·The ~~Challenging~~CCPA marks the ~~prices~~beginning ~~charged~~of a trend toward more stringent privacy legislation in the U.S., which could increase our potential liability and adversely affect our business. Similar laws have been passed in numerous other states. Such laws are substantially similar in scope and contain many of the same requirements and exceptions as the CCPA, including a general exemption for ~~medical~~clinical ~~products~~trial data and ~~services;~~limited obligations for entities regulated by HIPAA. These comprehensive consumer privacy laws will, among other things, impact how regulated businesses collect and process personal sensitive data, conduct data protection assessments, transfer personal data to affiliates, and respond to consumer rights requests. A number of other states have also proposed new privacy laws, some of which are similar to the above discussed recently passed laws. Such proposed legislation, if enacted, may add additional complexity, variation in requirements, restrictions and potential legal risk, require additional investment of resources in compliance programs, impact strategies and the availability of previously useful data and could result in increased compliance costs and/or changes in business practices and policies. The existence of comprehensive privacy laws in different states in the country would make our compliance obligations more complex and costly and may increase the likelihood that we may be subject to enforcement actions or otherwise incur liability for noncompliance.

19There are also states that are specifically regulating health information. For example, Washington state recently passed a consumer health privacy law that, effective March 31, 2024, regulates the collection and sharing of health information. This law also has a private right of action, which further increases the relevant compliance risk. Connecticut and Nevada have also passed similar laws regulating consumer health data. In addition, other states have proposed and/or passed legislation that regulates the privacy and/or security of certain specific types of information. For example, a small number of states have passed laws that regulate biometric data specifically. These various privacy and security laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products. State laws are changing rapidly and there is discussion in the U.S. Congress of new comprehensive federal data privacy laws to which we could become subject, if enacted.

·The ~~Limiting~~evolving ~~services~~compliance ~~covered;~~and operational requirements related to these various state data privacy and security laws impose significant costs, such as costs related to organizational changes, implementing additional protection technologies, training employees and engaging consultants and legal advisors, which are likely to increase over time. In addition, such requirements may require us to modify our data processing practices and policies, utilize management’s time and/or divert resources from other initiatives and projects. Any failure or perceived failure by us to comply with any applicable federal, state or foreign laws and regulations relating to data privacy and security could result in damage to our reputation, as well as proceedings or litigation by governmental agencies or other third parties, including class action privacy litigation in certain jurisdictions, which would subject us to significant fines, sanctions, awards, injunctions, penalties or judgments. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

·Our ~~Decreasing~~use ~~utilization~~ of ~~services;~~new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.

·We ~~Negotiating~~may ~~prospective~~use and integrate artificial intelligence into our business processes. Use of this technology presents risks and challenges that could affect our business. If we enable or ~~discounted~~use ~~contract~~solutions ~~pricing;~~that draw controversy due to perceived or actual negative societal impact, we may experience brand or reputational harm, competitive harm or legal liability.

·A ~~Adopting~~growing ~~capitation~~number ~~strategies;~~of legislators and regulators are adopting laws and regulations and have focused enforcement efforts on the adoption of artificial intelligence, and use of such technologies in compliance with ethical standards and societal expectations. These developments may increase our compliance burden and costs in connection with use of artificial intelligence and lead to legal liability if we fail to meet evolving legal standards or if use of such technologies results in harms or other causes of action we did not predict. For example, the EU’s Artificial Intelligence Act (“AI Act”) entered into force on August 1, 2024, with most provisions becoming effective on August 2, 2026. This legislation imposes significant obligations on providers and deployers of artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems. The scope of requirements depends on legal and risk determinations that rely on novel legal provisions that have not yet been interpreted by courts or regulators, and non-compliance can lead to significant fines.

·Likewise, ~~Seeking~~in ~~competitive~~the ~~bids~~U.S., several states, including Colorado and California, passed laws that will take effect in 2026, to regulate various uses of artificial intelligence, including to make consequential decisions. In addition, various federal regulators have issued guidance and focused enforcement efforts on the use of AI in regulated sectors. If we develop or use AI systems governed by these laws or regulations, we will need to meet higher standards of data quality, transparency, monitoring and human oversight, and we would need to adhere to specific and potentially burdensome and costly ethical, accountability, and administrative requirements, with the potential for significant enforcement or litigation in the event of any perceived non-compliance.

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The rapid evolution of artificial intelligence will require the application of significant resources to design, develop, test and maintain such systems to help ensure that artificial intelligence is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts. The use of certain artificial intelligence technologies can also give rise to intellectual property risks, including by disclosing or otherwise compromising our confidential or proprietary intellectual property, or by undermining our ability to assert or defend ownership rights in intellectual property created with the assistance of artificial intelligence tools.

Our vendors may in turn incorporate artificial intelligence tools into their offerings, and the providers of these artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security. Further, bad actors around the world use increasingly sophisticated methods, including the use of artificial intelligence, to engage in illegal activities involving the theft and misuse of personal information, confidential information and intellectual property. Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, and adversely impact our business.

It is uncertain to what extent the government, private health insurers and third-party payors will approve coverage or provide reimbursement for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by an increasing uninsured population and reductions in Medicare and Medicaid funding in the United States.

In the United States and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Our ability to successfully commercialize our human therapeutic products will depend significantly on our ability to obtain acceptable prices and the availability of reimbursement to the patient from third-party payors, such as government and private insurance plans. Although we have commenced initial discussions with such parties, pricing for our product, if approved, is yet to determined. Sales of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be covered and paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other payors. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. If reimbursement is not available, or is available only at limited levels, we may not be able to successfully commercialize our product candidates, if approved. The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the reimbursement rate that the payor will pay for the product. Payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved products for a particular indication. A decision by a payor not to cover our gene therapies could reduce physician utilization of our products once approved, and have a material adverse effect on our sales, results of operations and financial condition. For more information, see “Business – Third Party Payor Coverage and Reimbursement.”

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, the principal decisions about coverage and reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, or HHS, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private payors tend to follow the CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to reimbursement for fundamentally novel products such as ours, as there is no body of established practices and precedents for these new products.

These third-party payors frequently require companies to provide predetermined discounts from list prices, and they are increasingly challenging the prices charged for pharmaceuticals and other medical products. Our human therapeutic products may not be considered cost-effective, and reimbursement to the patient may not be available or sufficient to allow us to sell our products on a competitive basis.

Further, as cost containment pressures are increasing in the health care industry, government and private payors adopt strategies designed to limit the amount of reimbursement paid to health care providers. Such cost containment measures may include:

●

Reducing reimbursement rates;

●

Challenging the prices charged for medical products and services;

●

Limiting services covered;

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●

Decreasing utilization of services;

●

Negotiating prospective or discounted contract pricing;

●

Adopting capitation strategies; and

●

Seeking competitive bids.

Similarly, the trend toward managed health care and bundled pricing for health care services in the United States could significantly influence the purchase of healthcare services and products, resulting in lower prices and reduced demand for our therapies.

We may not be able to negotiate favorable reimbursement rates for our human therapeutic products. If we fail to obtain acceptable prices or an adequate level of reimbursement for our products, the sales of our products would be adversely affected or there may be no commercially viable market for our products.

Unintended consequences of recently adopted health reform legislation in the U.S. may adversely affect our business.

The healthcare industry is undergoing fundamental changes resulting from political, economic and regulatory influences. In the U.S., comprehensive programs are under consideration that seek to, among other things, increase access to healthcare for the uninsured and control the escalation of healthcare expenditures within the economy. ~~On March 23~~Payors, ~~2010,~~whether ~~health~~domestic ~~reform~~or ~~legislation~~foreign, ~~was~~or ~~approved~~governmental byor ~~Congress~~private, ~~and~~are ~~has~~developing ~~been~~increasingly ~~signed~~sophisticated ~~into~~methods ~~law.~~of ~~While~~controlling wehealthcare docosts ~~not~~and ~~believe this~~those ~~legislation~~methods ~~will~~are ~~have~~not aalways ~~direct~~specifically ~~impact~~adapted onfor ~~our~~new ~~business,~~technologies ~~the~~such ~~legislation~~as ~~has~~gene ~~only~~therapy ~~recently been enacted~~ and ~~requires~~therapies ~~the~~addressing ~~adoption of~~rare ~~implementing~~diseases ~~regulations,~~such ~~which~~as ~~may~~those ~~have~~we ~~unintended~~are ~~consequences or indirectly impact our business~~developing. ~~For~~In ~~instance,~~both the ~~scope and~~United ~~implications~~States ~~of the recent amendments pursuant to the Fraud Enforcement~~ and ~~Recovery~~certain ~~Act~~foreign ofjurisdictions, ~~2009~~there have ~~yet~~been toa benumber ~~fully~~of ~~determined or~~legislative ~~adjudicated~~ and asregulatory achanges ~~result it is difficult~~ to ~~predict~~the ~~how~~health ~~future~~care ~~enforcement~~system ~~initiatives~~that ~~may~~could impact our ~~business.~~ability ~~Also, in some instances our clients may be health insurers that will be subject~~ to ~~limitations~~sell ~~on their administrative expenses and new federal review of “unreasonable” rate increases which could impact the prices they pay for~~ our ~~services~~products profitably. IfFor ~~the~~more ~~legislation causes such unintended consequences or indirect impact~~information, itsee ~~could~~“Business - ~~have~~Healthcare ~~a material adverse effect on our business, financial condition and results of operations~~reform.”

We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

●

the demand for our product candidates, if we obtain regulatory approval;

●

our ability to set a price that we believe is fair for our products;

●

our ability to generate revenue and achieve or maintain profitability;

●

the level of taxes that we are required to pay; and

●

the availability of capital.

Any reduction in reimbursement from Medicare or other government programs may result in a similar denial or reduction in payments from private payors, which may adversely affect our future profitability.

We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. Federal Government will pay for healthcare drugs and services, which could result in reduced demand for our drug candidates or additional pricing pressures.

Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

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Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain drug access and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, financial condition, results of operations and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our drugs or put pressure on our drug pricing, which could negatively affect our business, financial condition, results of operations and prospects.

Ethical and other concerns surrounding the use of stem cell therapy may negatively impact the public perception of our stem cell services, thereby suppressing demand for our services.

Although our stem cell business pertains to adult stem cells only, and does not involve the more controversial use of embryonic stem cells, the use of adult human stem cells for therapy could give rise to similar ethical, legal and social issues as those associated with embryonic stem cells, which could adversely affect its acceptance by consumers and medical practitioners. Additionally, it is possible that our business could be negatively impacted by any stigma associated with the use of embryonic stem cells if the public fails to appreciate the distinction between adult and embryonic stem cells. Delays in achieving public acceptance may materially and adversely affect the results of our operations and profitability.

We are exposed to fluctuations in currency exchange rates.

A significant portion of our business, particularly our research and development, is conducted outside the United States. Therefore, we are exposed to currency exchange fluctuations in other currencies such as the New Israeli Shekels (NIS) and the Euro. Moreover, a portion of our expenses in Israel and Europe are paid in NIS and Euros, respectively, which subjects us to the risks of foreign currency fluctuations. Our primary expenses paid in NIS are employee salaries, fees for consultants and subcontractors and lease payments on our Israeli facilities.

The dollar cost of our operations in Israel will increase to the extent increases in the rate of inflation in Israel are not offset by a devaluation of the NIS in relation to the dollar, which would harm our results of operations.

Since a considerable portion of our expenses such as employees' salaries are linked to an extent to the rate of inflation in Israel, the dollar cost of our operations is influenced by the extent to which any increase in the rate of inflation in Israel is or is not offset by the devaluation of the NIS in relation to the dollar. As a result, we are exposed to the risk that the NIS, after adjustment for inflation in Israel, will appreciate in relation to the dollar. In that event, the dollar cost of our operations in Israel will increase and our dollar-measured results of operations will be adversely affected. During the past few years inflation-adjusted NIS appreciated against the dollar, which raised the dollar cost of our Israeli operations. We cannot predict whether the NIS will appreciate against the dollar or vice versa in the future. Any increase in the rate of inflation in Israel, unless the increase is offset on a timely basis by a devaluation of the NIS in relation to the dollar, will increase labor and other costs, which will increase the dollar cost of our operations in Israel and harm our results of operations.

We may be subject to significant product liability claims and litigation which could adversely affect our future earnings and financial condition.

Our business exposes us to potential product liability risks inherent in the testing, processing and marketing of stem cell therapy products. Specifically, the conduct of clinical trials in humans involves the potential risk that the use of our stem cell therapy products will result in adverse effects. Such liability claims may be expensive to defend and result in large judgments against us. We currently maintain liability insurance for our clinical trials; however, such liability insurance may not be adequate to fully cover any liabilities that arise from clinical trials of our stem cell therapy products. We also maintain errors and omissions, directors and officers, workers’ compensation and other insurance appropriate to our business activities. If we were to be subject to a claim in excess of this coverage or to a claim not covered by our insurance and the claim succeeded, we would be required to pay the claim from our own limited resources, which could have a material adverse effect on our financial condition, results of operations and business. Additionally, liability or alleged liability could harm our business by diverting the attention and resources of our management and damaging our reputation and that of our subsidiaries.

Political, economic and military instability in Israel may impede our ability to execute our plan of operations.

Our principal operations and the research and development facilities of the scientific team funded by us under the Second Ramot Agreement are located in Israel. Accordingly, political, economic and military conditions in Israel may affect our business and operations are directly affected by economic, political, geopolitical and military conditions in Israel. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its ~~Arab~~neighboring ~~neighbors~~countries and terrorist organizations active in the region. Acts of random terrorism periodically occur which could affect our operations or personnel. The conflicts have involved missile strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel. Ongoing or revived hostilities or other factors related to Israel could harm our operations and research and development process and could impede our ability to execute our plan of operations.

In ~~addition~~October 2023, ~~Israeli-based~~Hamas ~~companies~~terrorists ~~and~~infiltrated ~~companies doing business with~~ Israel’s ~~have~~southern ~~been~~border from the ~~subject~~Gaza ofStrip anand ~~economic~~conducted ~~boycott~~a byseries ~~members~~ of ~~the~~attacks ~~Arab~~on ~~League~~civilian and ~~certain~~military ~~other~~targets. ~~predominantly~~Hamas ~~Muslim~~also ~~countries since~~launched ~~Israel's~~extensive ~~establishment.~~rocket ~~Although~~attacks ~~Israel~~on ~~has~~Israeli ~~entered~~population ~~into~~and ~~various~~industrial ~~agreements~~centers ~~with~~located ~~certain~~along ~~Arab~~Israel’s ~~countries~~border ~~and~~with the ~~Palestinian Authority,~~Gaza Strip and ~~various~~in ~~declarations~~other ~~have~~areas ~~been~~within ~~signed~~the inState ~~connection~~of ~~with~~Israel. ~~efforts~~These toattacks ~~resolve~~resulted ~~some~~in ofextensive ~~the~~deaths, ~~economic~~injuries and ~~political~~kidnapping ~~problems in~~of ~~the~~civilians ~~Middle~~and ~~East,~~soldiers. weFollowing ~~cannot~~the ~~predict~~attack, ~~whether~~Israel’s orsecurity incabinet ~~what~~declared ~~manner~~war ~~these~~against ~~problems~~Hamas ~~will~~and bea ~~resolved.~~military ~~Wars~~campaign ~~and~~against ~~acts~~these ofterrorist ~~terrorism~~organizations ~~have resulted~~commenced in ~~damage~~parallel to their continued rocket and terror attacks. Moreover, the ~~Israeli~~clash ~~economy~~between Israel and Hezbollah in Lebanon, ~~including~~may ~~reducing~~escalate in the ~~level~~future ofinto ~~foreign~~a ~~and~~greater ~~local~~regional ~~investment~~conflict.

~~Furthermore,~~Although ~~certain~~we ofcurrently ~~our~~do ~~officers~~not ~~and~~expect ~~employees~~the ~~may~~ongoing beconflict ~~obligated~~ to ~~perform~~affect ~~annual~~our ~~reserve~~customers, ~~duty~~manufacturing, inresearch ~~the Israel Defense Forces~~ and ~~are~~development, ~~subject~~supply tochain, ~~being~~commercialization ~~called~~activities upand ~~for~~current ~~active~~clinical ~~military~~studies, ~~duty~~there atcan ~~any time. Israeli citizens who have served in the army may~~ be ~~subject~~no toassurances anthat ~~obligation~~further tounforeseen ~~perform~~events ~~reserve~~will ~~duty~~not ~~until~~have ~~they~~a ~~are~~material ~~between 40~~adverse ~~and~~effect 49on ~~years~~us ~~old,~~or ~~depending~~our ~~upon~~operations in the ~~nature of their military service~~future.

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The Israel Defense Force (the “IDF”), the national military of Israel, is a conscripted military service, subject to certain exceptions. Since October 7, 2023, the IDF has called up more than 350,000 of its reserve forces to serve. It is possible that there will be further military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party outsourcing, for example, may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows.

It is currently not possible to predict the duration or severity of the ongoing conflict or its efforts on ours business, operations and financial conditions. The ongoing conflict is rapidly evolving and developing, and could disrupt our business and operations, interrupt our sources and availability of supply and hamper our ability to raise additional funds or sell our securities, among others.

In addition, Israeli-based companies and companies doing business with Israel have been the subject of an economic boycott by members of the Arab League and certain other predominantly Muslim countries since Israel’s establishment. Although Israel has entered into various agreements with certain Arab countries and the Palestinian Authority, and various declarations have been signed in connection with efforts to resolve some of the economic and political problems in the Middle East, we cannot predict whether or in what manner these problems will be resolved. Wars and acts of terrorism have resulted in damage to the Israeli economy, including reducing the level of foreign and local investment.

The Israeli government is currently pursuing extensive reforms to Israel’s judicial system. In response to the foregoing developments, many individuals, organizations and institutions, both within and outside of Israel, have voiced concerns that the proposed reforms may negatively impact the business environment in Israel including due to increased currency fluctuations, downgrades in credit rating, increased interest rates, increased volatility in securities markets, and other changes in macroeconomic conditions. To the extent that any of these negative developments do occur, they may have an adverse effect on our business, our results of operations and our ability to raise additional funds, if deemed necessary by our management and board of directors.

If our or our vendors’ security measures are breached or unauthorized access to individually identifiable health information or other personally identifiable information is otherwise obtained, our reputation may be harmed, and we may incur significant liabilities.

Unauthorized access to, or cybersecurity incidents relating to, our or our vendors’ systems and databases could result in unauthorized access to data and information loss, compromise, or corruption of such data and information. Cybersecurity incidents have been increasing in sophistication and frequency and can include third parties gaining access to employee or customer data using stolen or inferred credentials, computer malware, viruses, spamming, phishing attacks, ransomware, social engineering, and other deliberate attacks and attempts to gain unauthorized access. Because the techniques used by threat actors who may attempt to penetrate and sabotage our network security or our website change frequently and may not be recognized until launched against a target, we may be unable to anticipate these techniques.

In the event of a cybersecurity incident, we could suffer loss of business, severe reputational damage adversely affecting investor confidence, regulatory investigations and orders, litigation, indemnity obligations, damages for contract breach, penalties for violation of applicable laws or regulations, significant costs for remediation and other liabilities. For example, the loss of preclinical study or clinical trial data from completed or future preclinical studies or clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or cybersecurity incident were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed.

We have incurred and expect to incur significant expenses to try to prevent cybersecurity incidents, including costs related to deploying additional personnel and protection technologies, training employees, and engaging third-party solution providers and consultants. Although we expend resources in an effort to protect our customer data against potential theft and cybersecurity incidents, we have been subject to attempted cyber-attacks in the past, and such measures cannot provide absolute security. Moreover, as we outsource more of our information systems to vendors and rely more on cloud-based information systems, the related security risks will increase, and we will need to expend additional resources to protect our technology and information systems.

Despite our efforts, we remain at risk for cybersecurity incidents, including, without limitation, incidents that may occur as a result of third-party action, or employee, vendor or contractor error or malfeasance and other causes. If, in the future, we experience a material cybersecurity incident, we would likely experience harm to our reputation, financial performance, and customer and vendor relationships, and the possibility of litigation or regulatory investigations or actions by state and federal governmental authorities and

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non-U.S. authorities. Additionally, actual, potential, perceived or anticipated attacks may cause us to incur increasing costs, including costs to deploy additional personnel and protection technologies, train employees, and engage third-party experts and consultants.

Changes in Tax Law may Adversely Affect our Business and Financial Condition

The laws and rules dealing with U.S. federal, state and local income taxation are routinely being reviewed and modified by governmental bodies, officials and regulatory agencies, including the Internal Revenue Service and the U.S. Treasury Department. Since inception, many such changes have been made and changes are likely to continue to occur in the future. It cannot be predicted whether, when, in what form, or with what effective dates, tax laws, regulations and rulings may be enacted, promulgated or issued, that could result in an increase in our or our stockholders’ tax liability.

Our business may be impacted by macroeconomic conditions, including fears concerning inflation, rising interest rates and volatile market conditions, including as a result of recently announced tariffs or other policy changes by the current U.S. administration, and other uncertainties beyond our control.

Our ability to effectively run our business could be adversely affected by general conditions in the global economy and in the financial services industry. Various macroeconomic factors could adversely affect our business, including fears concerning the banking sector, changes in inflation, interest rates and overall economic conditions and uncertainties, including as a result of recently announced tariffs or other policy changes by the current U.S. administration. Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. A severe or prolonged economic downturn could result in a variety of risks, including our ability to raise additional funding on a timely basis or on acceptable terms. A weak or declining economy could also impact third parties upon whom we depend to run our business. Although we assess our banking relationships as we believe necessary or appropriate, our access to funding sources in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect us, the financial institutions with which we have arrangements directly, or the financial services industry or economy in general. Moreover, significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations. Changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations and lead to uncertainty regarding our business prospects. For example, in April 2025, the U.S. imposed substantial tariffs on most countries throughout the world. Historically, tariffs have led to increased political and trade tensions. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions, including U.S. trade policies, or any resulting uncertainty, could have a material adverse effect on our financial condition or results of operations.

We have identified a material weakness in our system of internal controls pursuant to Section 404 of the Sarbanes-Oxley Act of 2002. If we fail to fully remediate this material weakness, or if we experience additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or results of operations.

Our management identified a material weakness in our internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control, such that there is a reasonable possibility that a material misstatement in our annual or interim financial statements will not be prevented or detected and corrected on a timely basis. Our management has concluded that, because of this material weakness, our internal control over financial reporting was not effective as of December 31, 2025. These operational deficiencies related to the Company’s reviews and approvals of the execution of certain short term loan agreements. As a result of the material weakness, the Company’s management, under the supervision of the Audit Committee and with the participation of the Company’s Chief Executive Officer and interim Chief Financial Officer, concluded that the Company’s internal control over financial reporting was not effective as of December 31, 2025.

The Company has developed and adopted a remediation plan to address the identified material weakness, and as part of the remediation plan, has adopted a short-term loan approval policy. Any actions we have taken or may take to remediate the identified material weakness are subject to continued management review supported by testing, as well as oversight by the Audit Committee. We cannot assure you that the measures we have taken to date, and are continuing to implement, will be sufficient to remediate the material weaknesses we have identified or avoid potential future material weaknesses. If the steps we take do not correct the material weaknesses

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in a timely manner, the accuracy and timing of our financial reporting could be materially adversely affected and we will be unable to conclude that we maintain effective internal control over financial reporting. For more information relating to the Company’s internal control over financial reporting, the material weakness that existed as of December 31, 2025 and the remediation activities undertaken by us.

Risks Related to Government Regulation

We are subject to a strict regulatory environment. If we fail to obtain and maintain required regulatory approvals for our potential cell therapy products, our ability to commercialize our potential cell therapy products will be severely limited.

None of our stem cell therapies have received regulatory approval for commercial sale.

Numerous statutes and regulations govern human testing and the manufacture and sale of human therapeutic products in the United States and other countries where we intend to market our products. Such legislation and regulation bears upon, among other things, the approval of protocols and human testing, the approval of manufacturing facilities, testing procedures and controlled research, review and approval of manufacturing, preclinical and clinical data prior to marketing approval including adherence to cGMP during production and storage as well as regulation of marketing activities including advertising and labeling.

The completion of the clinical testing of our stem cell therapies and the obtaining of required approvals are expected to require the expenditure of substantial resources. We may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent regulatory approval and/or commercialization of our stem cell therapies, including the following:

●

The FDA or similar foreign regulatory authorities may find that our stem cell therapies are not sufficiently safe or effective or may find our processes or facilities unsatisfactory;

●

Officials at the Israeli MoH, the FDA or similar foreign regulatory authorities may interpret data from preclinical studies and clinical trials differently than we do;

●

Our clinical trials may produce negative or inconclusive results or may not meet the level of statistical significance required by the Israeli MoH, the FDA or other regulatory authorities, and we may decide, or regulators may require us, to conduct additional preclinical studies and/or clinical trials or to abandon one or more of our development programs;

●

The Israeli MoH, the FDA or similar foreign regulatory authorities may change their approval policies or adopt new regulations;

●

There may be delays or failure in obtaining approval of our clinical trial protocols from the Israeli MoH, the FDA or other regulatory authorities or obtaining institutional review board approvals or government approvals to conduct clinical trials at prospective sites;

●

We, or regulators, may suspend or terminate our clinical trials because the participating patients are being exposed to unacceptable health risks or undesirable side effects; and

●

Enrollment in our clinical trials for our stem cell therapies may occur more slowly than we anticipate, or we may experience high drop-out rates of subjects in our clinical trials, resulting in significant delays.

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On August 15, 2022, we announced our decision to submit a BLA to the FDA for NurOwn® for the treatment of ALS. The BLA was filed on September 9, 2022. On November 10, 2022, we announced that we had received a RTF letter from the FDA regarding our BLA for NurOwn® for the treatment of ALS. The FDA informed us that the BLA is not sufficiently complete to enable a substantive review and that the FDA would therefore not file the BLA. The RTF letter contained a list of topics the FDA provided to BrainStorm as rationale for the BLA file being not sufficiently complete to enable a substantive review. According to the FDA, these reasons included one item related to the trial not meeting the standard for substantial evidence of effectiveness and CMC related items. The FDA indicated that we may request a Type A meeting to discuss the content of the RTF letter. On December 12, 2022, we announced the submission of a Type A meeting request with the FDA to discuss the contents of the RTF letter previously issued by the FDA regarding our BLA for NurOwn® for the treatment of ALS. On December 27, 2022, we announced that the FDA granted a Type A meeting to discuss the contents of the RTF letter previously issued regarding our BLA for NurOwn® for the treatment of ALS. The Type A Meeting was held on January 11, 2023.

The perspective shared by the FDA review team reflected what was in the previously issued RTF letter. Conversations on the best pathway to resolve the outstanding questions that continued following the Type A meeting. During these discussions, we were presented with multiple options to return the BLA to regulatory review, which included the regulatory procedure to File over Protest. These discussions resulted in our requesting the FDA to file our BLA over Protest, as this was the regulatory procedure that would allow us to reach an ADCOM in the shortest amount of time. We notified the FDA on February 6, 2023 of our decision to request the FDA to file the NurOwn® BLA for ALS over protest.

We received the FDA Type A meeting minutes on February 9, 2023. We submitted an amendment to our BLA on March 7, 2023, in which we responded to the majority of the items included in the RTF letter. Written feedback was received on March 22, 2023 from the FDA project manager associated with the BLA confirming the FDA’s decision to grant an ADCOM for the NurOwn® BLA for ALS.

The approval process is lengthy and difficult and the FDA, Israeli MoH, or other regulatory authorities may refuse to approve a BLA or equivalent marketing application if the applicable regulatory criteria are not satisfied. Generally, the FDA does not favor the File over Protest procedure. There are also certain consequences of filing an application over Protest. For example, such an application would not be eligible for certain FDA communications over the course of the review cycle. When an application is filed with the FDA over Protest, the FDA generally will not review amendments to the application during any review cycle and will not issue information requests to the applicant during the agency’s review. When an application is Filed over Protest, the performance goals implemented by the FDA under PDUFA do not apply to any resubmission of the application following an FDA complete response action, and any such resubmission is reviewed as available resources permit.

If convened, an advisory committee may recommend against approval of a BLA or may recommend that the FDA require, as a condition of approval, additional preclinical studies, clinical trials or investigations, limitations on approved labeling or distribution and use restrictions. Even if an advisory committee makes a favorable recommendation, the FDA may still not approve the product candidate.

On March 27, 2023, we announced that the FDA will hold an ADCOM to discuss the company’s BLA for NurOwn® for the treatment of ALS. On June 6, 2023, we announced that the advisory committee meeting has been scheduled for September 27, 2023. On September 27, 2023, we announced that the Advisory Committee voted, with 17 voting no, one voting yes, and one abstention, that NurOwn® did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS. On November 20, 2023, we announced that the FDA granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting took place on December 6, 2023. On December 7, 2023, we announced the completion of a productive meeting with the FDA to discuss NurOwn®. The primary objective of the meeting was to discuss plans for a Special Protocol Assessment (SPA) with FDA on the overall protocol design for a planned Phase 3b registrational trial for NurOwn®. The ultimate goal of the SPA is to secure the FDA’s agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application. On February 23, 2024, we announced that we submitted the SPA request to the FDA for the planned Phase 3b clinical trial of NurOwn® for the treatment of ALS. On April 9, 2024, the Company announced that it received written agreement from the FDA, under a SPA, on the design for a Phase 3b trial of NurOwn (R) in ALS. The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating the Company’s adequacy in addressing objectives that support a future BLA in ALS. On June 26, 2024, the Company announced that it has reached alignment with FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm’s Phase 3b clinical trial for NurOwn (R), its investigational therapy for ALS. Even if a stem cell therapy is approved by the Israeli MoH, the FDA or any other regulatory authority, we may not obtain approval for an indication whose market is large enough to recoup our investment in that stem cell therapy. We may never obtain the required regulatory approvals for any of our stem cell therapies. Later discovery of previously

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unknown problems with a product, manufacturer or facility may result in restrictions on the product or manufacturer, including a withdrawal of the product from the market.

Additional time may be required to obtain regulatory approval for our product candidates because they are combination products.

NurOwn® is being developed, and future product candidates may be developed, as combination products that require coordination within the FDA and similar foreign regulatory agencies for review of their device and drug/biologic components. Medical products containing a combination of new drugs, biological products or medical devices may be regulated as “combination products.” In the United States, a combination product generally is defined as a product comprised of components from two or more regulatory categories (e.g., drug/device, device/biologic, drug/biologic). Each component of a combination product is subject to the requirements established by the FDA for that type of component, whether a new drug, biologic or device. In order to facilitate premarket review of combination products, the FDA designates one of its centers to have primary jurisdiction for the premarket review and regulation of the overall product based upon a determination by the FDA of the primary mode of action of the combination product. Where approval of the drug or biologic and device is sought under a single application, there could be delays in the approval process due to the increased complexity of the review process.

The FDA’s agreement to any Special Protocol Assessment with respect to the study design of our planned Phase 3b clinical trial of NurOwn® for the treatment of ALS does not guarantee any particular outcome from regulatory review, including ultimate approval, and may not lead to a successful review or approval process.

We have submitted a SPA request to the FDA for a Phase 3b clinical trial of NurOwn® for the treatment of ALS. The FDA’s SPA process is designed to facilitate the FDA’s review and approval of drugs and biologics by allowing the FDA to evaluate the proposed design and size of certain clinical or animal studies, including clinical trials that are intended to form the primary basis for determining a product candidate’s efficacy. Upon specific request by a clinical trial sponsor, the FDA will evaluate the protocol and respond to a sponsor’s questions regarding protocol design and scientific and regulatory requirements. The FDA aims to complete SPA reviews within 45 days of receipt of the request. The FDA ultimately assesses whether specific elements of the protocol design of the trial, such as entry criteria, dose selection, endpoints and/or planned analyses, are acceptable to support regulatory approval of the product with respect to the effectiveness of the indication studied. All exchanges between the FDA and the sponsor regarding an SPA must be clearly documented in an SPA letter or the minutes of a meeting between the sponsor and the FDA.

Although the FDA may agree to an SPA, an SPA agreement does not guarantee approval of a product. Even if the FDA agrees to the design, execution, and analysis proposed in protocols reviewed under the SPA process, the FDA may revoke or alter its agreement in certain circumstances. In particular, an SPA agreement is not binding on the FDA if public health concerns emerge that were unrecognized at the time of the SPA agreement, other new scientific concerns regarding product safety or efficacy arise, the sponsor company fails to comply with the agreed upon trial protocols, or the relevant data, assumptions or information provided by the sponsor in a request for the SPA change or are found to be false or omit relevant facts.

In addition, even after an SPA agreement is finalized, the SPA agreement may be modified, and such modification will be deemed binding on the FDA review division, except under the circumstances described above, if the FDA and the sponsor agree in writing to modify the protocol. Generally, such modification is intended to improve the study. The FDA retains significant latitude and discretion in interpreting the terms of the SPA agreement and the data and results from any study that is the subject of the SPA agreement.

Moreover, if the FDA revokes or alters any agreement reached under a SPA, or interprets the data collected from the clinical trial differently than we do, the FDA may not deem the data sufficient to support an application for regulatory approval of NurOwn® for the treatment of ALS.

Even though we have obtained Fast Track designation for NurOwn® for the treatment of ALS in the United States, Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.

If a biologic is intended for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address unmet medical needs for this condition, the sponsor may apply for FDA Fast Track designation for a particular indication. The FDA has granted Fast Track designation for NurOwn® for the treatment of ALS and we may seek Fast Track designation for certain other of our current or future product candidates, but there is no assurance that the FDA will grant this status to any of our proposed product candidates. If granted, Fast Track designation makes a product eligible for more frequent interactions with the FDA to discuss the development plan and clinical trial design, as well as rolling review of the application, which means that the company can submit

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completed sections of its marketing application for review prior to completion of the entire submission. Marketing applications of products candidates with Fast Track designation may qualify for priority review under the policies and procedures offered by the FDA, but the Fast Track designation does not assure any such qualification or ultimate marketing approval by the FDA. The FDA has broad discretion whether or not to grant Fast Track designation, so even if we believe a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if we do receive Fast Track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures, and receiving a Fast Track designation does not provide any assurance of ultimate FDA approval. In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program. In addition, the FDA may withdraw any Fast Track designation at any time.

Even though we have obtained Orphan Drug Designation for NurOwn® for the treatment of ALS in the United States and EU, and we may apply for Orphan Drug Designation for other product candidates, we may not be able to obtain such designations or maintain the benefits associated with orphan drug status, including orphan drug marketing exclusivity.

Regulatory authorities in some jurisdictions, including the United States and EU, may designate drugs or biologics for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population of 200,000 or more in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In order to obtain Orphan Drug Designation, the request must be made before submitting a BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

If a product that has Orphan Drug Designation subsequently receives the first FDA approval of that particular product for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, to market the biologic for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. As a result, even if one of our product candidates receives orphan exclusivity, the FDA can still approve other biologics for use in treating the same indication or disease or the same biologic for a different indication or disease during the exclusivity period. Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture sufficient supply of our product or orphan drug exclusivity can be overcome if a subsequent applicant demonstrates clinical superiority over our product.

In the EU, the Committee for Orphan Medicinal Products of the EMA grants orphan designation to promote the development of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition, which either affects not more than five in 10,000 persons in the EU, or products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition when, without incentives, it is unlikely that the medicine would generate sufficient return to justify the necessary investment in its development. In each case, there must be no satisfactory method of diagnosis, prevention, or treatment which is authorized for marketing in the EU, or, if a method exists, the product would be of significant benefit to those affected by the condition.

We have obtained from the FDA and EMA Orphan Drug Designations for NurOwn® for the treatment of ALS. We may seek Orphan Drug Designation for other product candidates. Even if we obtain Orphan Drug Designation, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective, if we are unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition, or if a subsequent applicant demonstrates clinical superiority over our products. In addition, although we may seek Orphan Drug Designation for other product candidates, we may never receive such designations. Any failure to obtain, maintain or otherwise recognize the benefits of orphan drug designation for our products or product candidates could have a material adverse effect on our prospects.

On August 3, 2017, Congress passed the FDA Reauthorization Act of 2017 (“FDARA”). FDARA, among other things, codified the FDA’s pre-existing regulatory interpretation to require that a sponsor demonstrate the clinical superiority of an orphan drug that is otherwise the same as a previously approved drug for the same rare disease in order to receive orphan drug exclusivity. The legislation reverses prior precedent holding that the Orphan Drug Act unambiguously requires that the FDA recognize the orphan exclusivity period

~~Risks related to our Common Stock~~

~~The~~Table ~~price~~ of ~~our stock is expected to be volatile.~~Contents

~~The~~regardless ~~market price~~ of ~~our~~a ~~Common~~showing ~~Stock~~of ~~has~~clinical ~~fluctuated~~superiority. ~~significantly, and~~The isFDA ~~likely~~may tofurther ~~continue~~reevaluate ~~to be highly volatile. To date,~~ the ~~trading~~Orphan ~~volume~~Drug inAct ~~our~~and ~~stock~~its ~~has~~regulations ~~been relatively low~~ and ~~significant price~~policies. ~~fluctuations~~We ~~can~~do ~~occur~~not asknow aif, ~~result.~~when, Anor ~~active~~how ~~public~~the ~~market~~FDA ~~for our Common Stock~~ may ~~not~~change ~~continue~~the toorphan ~~develop~~drug orregulations beand ~~sustained. If~~policies in the ~~low~~future, ~~trading~~and ~~volumes~~it ~~experienced~~is touncertain ~~date~~how ~~continue,~~any ~~such~~changes ~~price~~might ~~fluctuations~~affect ~~could~~our ~~occur~~business. inDepending ~~the~~on ~~future~~what ~~and~~changes the ~~sale~~FDA ~~price~~may ~~of our~~make ~~Common~~to ~~Stock~~its ~~could~~orphan ~~decline~~drug ~~significantly.~~regulations ~~Investors~~and ~~may~~policies, ~~therefore~~our ~~have~~business ~~difficulty~~could ~~selling~~be ~~their~~adversely ~~shares~~impacted.

~~Your~~Inadequate ~~percentage~~funding ~~ownership~~for ~~will~~the beNIH, ~~diluted~~CMS, byFDA, ~~future~~the ~~issuances~~ SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, including significant leadership, personnel, or policy changes, could prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our ~~securities~~business may rely, which could negatively impact our business.

InCurrently, ~~order~~federal agencies in the U.S. are operating under the FY2026 Consolidated Appropriations Act which is set to ~~meet~~expire on September 30, 2026. Without the appropriation of additional funding to federal agencies, our ~~financing~~business ~~needs~~operations related to our product development activities for the U.S. market could be impacted. The ability of the FDA to review and approve new products, weNIH’s ~~may~~and ~~issue~~other ~~additional significant~~agencies’ ~~amounts~~ability to conduct and partner with industry on important research, and CMS’s ability to operate efficiently can be affected by a variety of ~~our~~factors, ~~Common~~including ~~Stock~~government budget and ~~warrants~~funding levels, the ability to ~~purchase~~hire ~~shares~~and retain key personnel and accept the payment of ~~our~~user ~~Common~~fees, ~~Stock~~and statutory, regulatory and policy changes. ~~The~~Average ~~precise~~review ~~terms~~times at the agency have fluctuated in recent years as a result. In addition, government funding of ~~any~~the ~~future~~SEC ~~financings will~~and beother ~~determined~~government byagencies uson which our operations may rely, including those that fund research and ~~potential~~development ~~investors~~activities, is subject to the political process, which is inherently fluid and unpredictable. Disruptions at these agencies, including, for example, as a result of the freeze on federal funding announced in January 2025 and other restrictions, such ~~future~~as ~~financings~~personnel reductions at agencies such as the FDA, may also ~~significantly~~slow ~~dilute~~the ~~your~~time ~~percentage~~necessary ~~ownership in~~for ~~the~~new ~~Company~~product candidates to be reviewed and/or approved by necessary government agencies or may slow or stall planned or ongoing research, which would adversely affect our business.

~~ACCBT~~Disruptions ~~Corp~~at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. ~~holds~~If ~~equity~~a ~~participation~~prolonged ~~rights~~government shutdown occurs or a widespread freeze on federal funding occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, NIH to conduct research or provide grants, or other ~~rights~~ ~~that~~agencies to slow their work, which could ~~affect~~have a material adverse effect on our business. Further, future government shutdowns could impact our ability to ~~raise~~access ~~funds~~the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

~~Pursuant~~Even toif ~~the~~regulatory ~~subscription~~approvals ~~agreement~~are ~~with~~obtained ~~ACCBT~~for ~~Corp., a company under the control of Mr. Chaim Lebovits,~~ our ~~President,~~stem wecell ~~granted ACCBT Corp. the right to acquire additional shares of our Common Stock whenever we issue additional shares of Common Stock or other securities of the Company~~therapies, or options or rights to purchase shares of the Company or other securities directly or indirectly convertible into or exercisable for shares of the Company (including shares of any newly created class or series). This participation right could limit our ability to enter into equity financings and to raise funds from third parties. ACCBT Corp. is entitled to purchase its pro rata share of any additional securities we ~~offer, so that its percentage ownership of the Company remains the same after any such issuance of additional securities. Such additional securities~~ will be ~~offered~~subject to ~~ACCBT~~ongoing ~~Corp.~~government ~~at the same price and on the same terms as the other investors in the transaction~~regulation. ~~ACCBT Corp.~~If ~~will~~we ~~have~~or 30one ~~days~~or ~~from~~more ~~the date~~ of our ~~notice~~partners to ACCBT Corp. of any intended transaction, to decide whether it wishes to exercise its participation rights in the transaction. We also are prohibited from taking certain corporate actions without the consent of ACCBT Corp., including issuing shares, acquiring or ~~divesting~~collaborators ~~assets~~fail ~~and making payment of cash compensation over $60,000 per year. Further, ACCBT Corp. also has the right~~ to ~~appoint~~comply ~~a majority of our Board of Directors. In connection~~ with ~~the~~applicable ~~subscription agreement,~~current we entered into a registration rights agreement with ACCBT Corp. pursuant to which we granted piggyback registration rights to ACCBT Corp. In addition, we issued ACCBT warrants to purchase up to 30,250,000 shares of Common Stock, of which 30,250,000 warrants are presently outstanding. The outstanding warrants contain cashless exercise provisions, which permit the cashless exercise of up to 50% of the underlying shares of Common Stock, and ~~10,083,333~~future oflaws ~~such warrants have an exercise price of $0.20~~ and ~~the remainder~~government ~~have an exercise price of $0.29. ACCBT has waived its participation rights~~regulations, ~~registration~~our ~~rights~~business and ~~anti-dilution~~financial ~~rights with~~results ~~respect~~could tobe ~~issuances~~adversely ~~that were made prior to the date hereof~~affected. In March 2014 we entered an agreement with ACCBT Corp. according to which ACCBT waived certain anti-dilution rights. On May 25, 2014, the Company entered into a Warrant Amendment Agreement with ACCBT, pursuant to which the expiration date of each Warrant held by ACCBT was extended until November 5, 2017, in consideration of ACCBT having provided a series of waivers of their rights, including the anti-dilution rights waiver.

~~You~~Even ~~may~~if ~~experience~~we ~~difficulties~~obtain inregulatory ~~attempting~~approval for a product candidate, it would be subject to ~~enforce liabilities~~ongoing ~~based~~requirements ~~upon~~by Uthe FDA and comparable foreign regulatory authorities governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, adverse event reporting, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-marketing information.S. ~~federal~~These ~~securities~~requirements ~~laws~~include ~~against~~submissions of safety and other post-marketing information and reports, establishment registration and product listing, as well as continued compliance by us and/or ~~our~~any ~~non~~future CMOs CROs for any post-Uapproval clinical trials that we conduct.S. ~~resident~~The ~~directors~~safety profile of any product will continue to be closely monitored by the FDA and ~~officers~~comparable foreign regulatory authorities after approval. If the FDA or comparable foreign regulatory authorities become aware of new safety information after approval of any of our product candidates, they may require labeling changes or establishment of a REMS, impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.

Our principal operations are located through our subsidiary in Israel and our principal assets are located outside the U.S. Our Chief Executive Officer, Chief Financial Officer, and some of our directors are foreign citizens and do not reside in the U.S. It may be difficult for courts in the U.S. to obtain jurisdiction over our foreign assets or these persons and as a result, it may be difficult or impossible for you to enforce judgments rendered against us or our directors or executive officers in U.S. courts. Thus, should any situation arise in the future in which you have a cause of action against these persons or entities, you are at greater risk in investing in our Company rather than a domestic company because of greater potential difficulties in bringing lawsuits or, if successful, collecting judgments against these persons or entities as opposed to domestic persons or entities.

~~The trading price of our Common Stock entails additional regulatory requirements, which may negatively affect such trading price.~~

~~Our~~Table ~~Common Stock is listed on the OTCQB Marketplace, an over-the-counter electronic quotation service. Because the trading price~~ of our Common Stock is below $5.00 per share, trading in our Common Stock is subject to the requirements of certain “penny stock” rules promulgated under the Securities Exchange Act of 1934, as amended. These rules require additional disclosure by broker-dealers in connection with any trades generally involving any equity security not listed on either a securities exchange or NASDAQ that has a market price of less than $5.00 per share, subject to certain exceptions. Such rules require the delivery, before any penny stock transaction, of a disclosure schedule explaining the penny stock market and the risks associated therewith, and impose various sales practice requirements on broker-dealers who sell penny stocks to persons other than established customers and accredited investors (generally institutions). For these types of transactions, the broker-dealer must determine the suitability of the penny stock for the purchaser and receive the purchaser's written consent to the transaction before sale. The additional burdens imposed upon broker-dealers by such requirements may discourage broker-dealers from effecting transactions in our Common Stock. As a consequence, the market liquidity of our Common Stock could be severely affected or limited by these regulatory requirements.Contents

IfIn weaddition, ~~fail~~manufacturers of cell therapies and their facilities are subject to ~~implement~~initial and ~~maintain~~continual anreview ~~effective~~and ~~system~~ periodic inspections by the FDA and other regulatory authorities for compliance with cGMP, GCP, cGTP, and other regulations. For certain commercial prescription and biologic products, manufacturers and other parties involved in the supply chain must also meet chain of ~~internal~~distribution ~~controls~~requirements and build electronic, interoperable systems for product tracking and tracing and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or other products that are otherwise unfit for distribution in the United States. If we ~~may~~or bea ~~unable~~regulatory toagency ~~accurately~~discover ~~report~~previously ~~our~~unknown ~~results~~problems with a product, such as adverse events of ~~operations~~unanticipated severity or ~~prevent~~frequency, ~~fraud~~or problems with the facility where the product is manufactured, ~~and~~a ~~investor~~regulatory ~~confidence and~~agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market ~~price~~or suspension of manufacturing. If we, our ~~Common~~product ~~Stock~~candidates ~~may~~or bethe ~~materially~~manufacturing ~~and~~facilities ~~adversely~~for ~~affected.~~our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:

As● aissue ~~public~~warning ~~company~~letters ~~in the United States, we are subject to the reporting obligations under the U.S. securities laws. The Securities and Exchange Commission,~~ or ~~the~~untitled SEC, as required under Section 404 of the Sarbanes-Oxley Act of 2002, has adopted rules requiring every public company to include a report of management on the effectiveness of such company’s internal control over financial reporting in its annual report. In prior years, management has identified material weaknesses in our internal control over financial reporting. If any of our prior material weaknesses recurs, or if we identify additional weaknesses or fail to timely and successfully implement new or improved controls, our ability to assure timely and accurate financial reporting may be adversely affected, and we could suffer a loss of investor confidence in the reliability of our financial statements, which in turn could negatively impact the trading price of our shares of Common Stock, result in lawsuits being filed against us by our shareholders, or otherwise harm our reputation. If material weaknesses are identified in the future, it could be costly to remediate such material weaknesses, which may adversely affect our results of operations. In addition, our auditor is not required to attest to the effectiveness of our internal controls over financial reporting due to our status of qualifying as a smaller reporting company. As a result, current and potential investors could lose confidence in our financial reporting, which could harm our business and have an adverse effect on our share price.letters;

~~Delaware~~● ~~law~~mandate ~~could~~modifications ~~discourage~~to apromotional ~~change~~materials ~~in control,~~ or an ~~acquisition~~require of us byto aprovide ~~third~~corrective ~~party,~~information ~~even~~to ifhealthcare ~~the~~practitioners, ~~acquisition~~or ~~would~~require beother ~~favorable~~restrictions toon ~~you,~~the ~~and~~labeling ~~thereby~~or ~~adversely~~marketing ~~affect~~of ~~existing stockholders.~~such products;

~~The~~● ~~Delaware~~require ~~General~~us ~~Corporation Law contain provisions that may have the effect of making more difficult or delaying attempts by others~~ to ~~obtain~~enter ~~control~~into ofa ~~our~~consent ~~Company~~decree, ~~even~~which ~~when~~can ~~these~~include ~~attempts may~~imposition ~~be in the best interests~~ of ~~stockholders.~~various ~~Delaware~~fines, ~~law~~reimbursements ~~imposes~~for ~~conditions~~inspection oncosts, ~~certain~~required ~~business~~due ~~combination~~dates ~~transactions~~for ~~with “interested~~specific ~~stockholders.”~~actions ~~These provisions~~ and ~~others~~penalties that could be adopted in the future could deter unsolicited takeovers or delay or prevent changes in our control or management, including transactions in which stockholders might otherwise receive a premium for ~~their shares over then current market prices. These provisions may also limit the ability of stockholders to approve transactions that they may deem to be in their best interests.~~noncompliance;

●

seek an injunction or impose civil or criminal penalties or monetary fines;

●

suspend, withdraw or modify regulatory approval;

●

suspend or modify any ongoing clinical trials;

●

refuse to approve pending applications or supplements to applications filed by us;

●

suspend or impose restrictions on operations, including costly new manufacturing requirements; or

●

seize or detain products, refuse to permit the import or export of products, or require us to initiate a product recall.

The occurrence of any event or penalty described above may inhibit our ability to successfully commercialize our products.

Advertising and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by the FDA, the U.S. Federal Trade Commission, the Department of Justice (“DOJ”), the Office of Inspector General (“OIG”) of the HHS, state attorneys general, members of the U.S. Congress and the public. Additionally, advertising and promotion of any product candidate that obtains approval outside of the United States will be heavily scrutinized by comparable foreign entities and stakeholders. Violations, including actual or alleged promotion of our products for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal sanctions by the FDA or comparable foreign bodies. Any actual or alleged failure to comply with labeling and promotion requirements may result in fines, warning letters, mandates to corrective information to healthcare practitioners, injunctions, or civil or criminal penalties.

The FDA and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of any current or future product candidate. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or to the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained. Non-compliance by us or any future collaborator with regulatory requirements, including safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population can also result in significant financial penalties.

We are subject to environmental, health and safety laws.

~~We do not expect to pay dividends in the foreseeable future, and accordingly you must rely on stock appreciation for any return on your investment.~~

WeTable ~~have paid no cash dividends on our Common Stock to date, and we currently intend to retain our future earnings, if any, to fund the continued development and growth~~ of our business. As a result, we do not expect to pay any cash dividends in the foreseeable future. Further, any payment of cash dividends will also depend on our financial condition, results of operations, capital requirements and other factors, including contractual restrictions to which we may be subject, and will be at the discretion of our Board of Directors.Contents

from any future legislative or administrative action. Any of these laws or regulations could cause us to incur additional expense or restrict our operations.

Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development or production efforts.

We are subject to significant regulation with respect to manufacturing of our NurOwn® stem cell therapy.

All entities involved in the preparation of a therapeutic biological for clinical trials or commercial sale are subject to extensive regulation. Our NurOwn® stem cell therapy must be manufactured in accordance with cGMP and cGTP before it can be used in our clinical trials or approved for commercial sale. These regulations govern manufacturing processes and procedures and the implementation and operation of quality systems to control and assure the quality of investigational stem cell therapies and treatments, including treatment component characterization and process validation, approved for sale. Our facilities and quality systems and the facilities and quality systems of some or all of our third party suppliers must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of our NurOwn® stem cell therapy. If any inspection or audit of our manufacturing facilities identifies a failure to comply with applicable regulations, or if a violation of applicable regulations occurs independent of an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time consuming for us or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed on us or third parties with whom we contract could materially harm our business.

For certain commercial prescription biologic products, manufacturers and other parties involved in the supply chain must also meet chain of distribution requirements and build electronic, interoperable systems for product tracking and tracing and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or other products that are otherwise unfit for distribution in the United States.

Our long-term business plan is to develop our NurOwn® stem cell therapy for the treatment of neurodegenerative diseases, such as ALS, PMS and AD. Even if we successfully develop our NurOwn® stem cell therapy for use in one indication, we may not be successful in our efforts to identify or discover additional indications for it. Clinical programs to develop new indications for our NurOwn® stem cell therapy will require substantial technical, financial and human resources. These development programs may initially show promise in identifying potential treatment indications, yet fail to obtain regulatory approval for commercial sale.

If we do not accurately evaluate the commercial potential or target market for our NurOwn® stem cell therapy, we may relinquish valuable rights to that treatment through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain patent protection for any products we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to commercialize any product candidates we may develop, and our technology may be adversely affected.

Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to our product candidates, their respective components, formulations, combination therapies, methods used to manufacture them and methods of treatment and development that are important to our business. If we do not adequately protect our intellectual property rights, competitors may be able to erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability. To protect our proprietary position, we file patent applications in the United States and abroad related to our novel product candidates that are important to our business; we may in the future also license or purchase patent applications filed by others. If we are unable to secure or maintain patent protection with respect to our technology and any proprietary products and technology we develop, our business, financial condition, results of operations, and prospects could be materially harmed.

If the scope of the patent protection we or our potential licensors obtain is not sufficiently broad, we may not be able to prevent others from developing and commercializing technology and products similar or identical to ours. The degree of patent protection we require to successfully compete in the marketplace may be unavailable or severely limited in some cases and may not adequately protect our rights or permit us to gain or keep any competitive advantage. We cannot provide any assurances that any of our patents have, or

~~DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS~~

~~This~~Table ~~prospectus contains forward-looking statements within the meaning~~ of the federal securities laws. These forward-looking statements are based on management’s beliefs and assumptions. In addition, other written or oral statements that constitute forward-looking statements are based on current expectations, estimates and projections about the industry and markets in which we operate and statements may be made by or on our behalf. Words such as “should,” “could,” “may,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements.Contents

~~Forward~~that ~~looking~~any ~~statements~~of our pending patent applications that mature into issued patents will include, ~~but~~claims ~~are~~with a scope sufficient to protect our current and future product candidates or otherwise provide any competitive advantage. In addition, to the extent that we license intellectual property in the future, we cannot assure you that those licenses will remain in force. In addition, the laws of foreign countries may not ~~limited~~protect our rights to the same extent as the laws of the United States. Furthermore, ~~statements~~ ~~about:~~patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed (21 years if first filed as a provisional application). Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

·Even ~~Statements~~if asthey are unchallenged, our patents and pending patent applications, if issued, may not provide us with any meaningful protection or prevent competitors from designing around our patent claims to circumvent our patents by developing similar or alternative technologies or therapeutics in a non-infringing manner. For example, a third party may develop a competitive therapy that provides benefits similar to one or more of our product candidates but that uses a formulation and/or a device that falls outside the ~~anticipated~~scope ~~timing~~of our patent protection. If the patent protection provided by the patents and patent applications we hold or pursue with respect to our product candidates is not sufficiently broad to impede such competition, our ability to successfully commercialize our product candidates could be negatively affected, which would harm our business. We currently own or have exclusively in-licensed all of ~~clinical~~our ~~studies~~patents or patent applications. Similar risks would apply to any patents or patent applications that we may own and those which we may license in the future. In many cases, in-licensed intellectual property is at greater risk, as we may not have access to all information or to prosecution and other ~~business~~aspects ~~developments;~~of the acquisition, maintenance and enforcement of the in-licensed intellectual property.

·Patent ~~Statements~~positions asof tolife sciences companies can be uncertain and involve complex factual and legal questions. No consistent policy governing the ~~development~~scope of ~~new~~claims ~~products~~allowable in the fields of antibodies and radiopharmaceuticals has emerged in the United States. The scope of patent protection in jurisdictions outside of the United States is also uncertain. Changes in either the patent laws or their interpretation in any jurisdiction that we seek patent protection may diminish our ability to protect our inventions, maintain and enforce our intellectual property rights; and, more generally, may affect the value of our intellectual property, including the narrowing of the scope of our patents and any that we may license.

·The ~~Our~~patent ~~expectations~~prosecution ~~regarding~~process ~~federal~~is complex, ~~state~~expensive, time-consuming and ~~foreign~~inconsistent ~~regulatory~~across ~~requirements;~~jurisdictions. We may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patent rights at a commercially reasonable cost or in a timely manner. In addition, we may not pursue or obtain patent protection in all relevant markets. It is possible that we will fail to identify important patentable aspects of our research and development efforts in time to obtain appropriate or any patent protection. While we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development efforts, including for example, our employees, corporate collaborators, external academic scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby endangering our ability to seek patent protection. In addition, publications of discoveries in the scientific and scholarly literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not until issuance as a patent. Consequently, we cannot be certain that we were the first to file for patent protection on the inventions claimed in our patents or pending patent applications.

·The ~~Our~~issuance, ~~expectations~~scope, ~~regarding~~validity, ~~grants~~enforceability and commercial value of our patent rights are highly uncertain. Further, the scope of the invention claimed in a patent application can be significantly reduced before the patent is issued, and this scope can be reinterpreted after issuance. Even where patent applications we currently own, license, or that we may license in the future issue as patents, they may not issue in a form that will provide us with adequate protection to prevent competitors or other third parties from ~~federal~~competing ~~resources;~~with us, or otherwise provide us with a competitive advantage. Any patents that eventually issue may be challenged, narrowed or invalidated by third parties. Consequently, we do not know whether any of our product candidates will be protectable or remain protected by valid and enforceable patent rights. Our competitors or other third parties may be able to evade our patent rights by developing alternative technologies or products in a non-infringing manner.

·The ~~Statements~~issuance ~~regarding~~or ~~growth~~grant ~~strategies,~~of ~~financial~~a ~~results,~~patent ~~product~~is ~~development~~not irrefutable as to its inventorship, ~~competitive~~scope, ~~strengths~~validity or enforceability, ~~intellectual~~and ~~property~~our ~~rights~~patents may be challenged in the courts or patent offices in the United States and abroad. There may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim. There also may be prior art of which we are aware, ~~litigation~~but which we do not believe affects the validity or enforceability of a claim, ~~mergers~~which ~~and~~may, ~~acquisitions~~nonetheless, ~~market~~ultimately ~~acceptance~~be found to affect the validity or ~~continued~~enforceability ~~acceptance~~of a claim. We may in the future, become subject to a third-party pre-issuance submission of ~~our~~prior ~~products~~art or opposition, ~~accounting~~derivation, ~~estimates~~revocation, ~~financing~~re-examination, ~~activities~~post-grant and ~~ongoing~~inter ~~contractual~~partes ~~obligations~~review, or interference proceeding and other similar proceedings challenging our patent rights or the patent rights of others in the USPTO or other foreign patent office. An unfavorable determination in any such submission,

These statements reflect our views with respect to future events as of the date of this prospectus and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this prospectus and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this prospectus. We anticipate that subsequent events and developments will cause our views to change. You should read this prospectus and the documents referenced in this prospectus and filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

~~EXCHANGE RATE INFORMATION~~

InTable this prospectus, references to “$” are to U.S. dollars, and references to “NIS” are to New Israeli Shekels. The exchange rate between the NIS and the U.S. dollar used in this prospectus varies depending on the date and context of ~~the information contained herein.~~Contents

~~The~~proceeding ~~following~~or ~~table~~litigation ~~sets~~could ~~forth~~reduce ~~for each period indicated: (1)~~ the ~~low~~scope ~~and~~of, ~~high~~or ~~exchange~~invalidate, ~~rates~~our ~~during~~patent ~~such~~rights, ~~period;~~allow ~~(2)~~third ~~the~~parties ~~exchange~~to ~~rates~~commercialize inour ~~effect~~technology ator ~~the~~products ~~end of the period;~~ and ~~(3)~~compete ~~the~~directly ~~average exchange~~with ~~rates for such period~~us, ~~for~~without ~~one~~payment ~~U.S.~~to ~~dollar~~us, ~~expressed~~or inextinguish ~~NIS,~~our asability ~~quoted~~to bymanufacture ~~the~~or ~~Bank~~commercialize ofproducts ~~Israel.~~without ~~The~~infringing ~~average~~third-party ~~exchange~~patent ~~rate is calculated on the last business day of each month for the applicable period~~rights.

									Quarter Ended
	Year ended December 31,								March 31,		June 30,
	2010		2011		2012		2013		2014		2014
Low		3.549		3.363		3.700		3.471		3.459		3.432
High		3.894		3.821		4.084		3.791		3.549		3.493
Period End		3.549		3.821		3.733		3.471		3.487		3.438
Average		3.733		3.578		3.858		3.609		3.497		3.465

In addition, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Moreover, some of our owned and in-licensed patents and patent applications are, and may in the future be, co-owned with third parties. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we or our licensors may need the cooperation of any such co-owners of our owned and in-licensed patents in order to enforce such patents against third parties, and such cooperation may not be provided to us or our licensors. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

~~As of~~Part ~~July~~of 9,our ~~2014,~~business in the ~~daily~~foreseeable ~~representative~~future ~~rate~~will ~~of exchange~~be ~~between~~based ~~the~~on ~~NIS~~technology licensed from Ramot and ~~the~~if ~~U.S. dollar~~this aslicense ~~published~~were byto be terminated upon failure to make required royalty payments in the ~~Bank~~future, ofwe ~~Israel~~would ~~was~~need ~~NIS~~to ~~3.436~~change our business strategy and we may be forced to $1cease our operations.~~00.~~

~~USE~~Agreements OFwe ~~PROCEEDS~~and our Israeli Subsidiary have with Ramot impose on us royalty payment obligations. If we fail to comply with these obligations, Ramot may have the right to terminate the license under certain circumstances. If Ramot elects to terminate our license, we would need to change our business strategy and we may be forced to cease our operations. We currently do not owe Ramot any overdue payments. Royalties are due upon commencement of revenues by the Company.

WeThese ~~may~~existing ~~receive~~licenses ~~gross~~impose ~~proceeds of~~various updiligence, tomilestone ~~$14~~payment,~~616~~ royalty,~~000~~ ~~from~~insurance ~~the~~and ~~exercise~~other ofobligations ~~the~~on ~~Warrants~~us. WeIf ~~will~~we ~~retain~~fail ~~discretion~~to ~~over~~comply ~~the~~with ~~use~~these ofobligations, the ~~net~~licensors ~~proceeds~~may wehave ~~may~~the ~~receive from~~right ~~this~~to ~~offering~~terminate the licenses, ~~but~~in which event we ~~currently~~would ~~intend~~not tobe ~~use~~able ~~such~~to ~~proceeds,~~develop ifor ~~any,~~market ~~for~~the ~~general~~products ~~corporate~~covered ~~and~~by ~~for~~such ~~working~~licensed ~~capital~~intellectual ~~purposes~~property.

~~DIVIDEND~~These ~~POLICY~~agreements impose numerous obligations, such as diligence and payment obligations. Any termination of these licenses could result in the loss of significant rights and could harm our ability to commercialize our product candidates. These licenses do and future licenses may include provisions that impose obligations and restrictions on us. This could delay or otherwise negatively impact a transaction that we may wish to enter into.

WeDisputes ~~have~~may ~~never~~also ~~declared~~arise orbetween ~~paid~~us ~~any cash dividends on our Common Stock. We currently intend to retain any future earnings to finance the growth~~ and ~~development of~~ our ~~business.~~licensors ~~Therefore,~~regarding ~~we do~~intellectual ~~not~~property ~~anticipate~~subject ~~that we will declare or pay any cash dividends on our Common Stock in the foreseeable future. Any future determination~~ to ~~pay~~a ~~cash~~license ~~dividends will be at the discretion of our Board of Directors and will be dependent upon our financial condition~~agreement, ~~results~~ ofincluding ~~operations,~~disputes ~~capital requirements, restrictions under any existing indebtedness and other factors the Board of Directors deems relevant.~~ concerning:

●

the scope of rights granted under the license agreement and other interpretation-related issues;

●

whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

●

our right to sublicense patent and other rights to third parties under collaborative development relationships;

●

our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations; and

●

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners.

If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates. We are generally also subject to all of the same risks with respect to protection of intellectual property that we license, as we are for intellectual property that we own, which are described below. If we or our licensors fail to adequately protect this intellectual property, our ability to commercialize products could suffer.

~~DILUTION~~

~~Dilution~~Table ~~represents the difference between the offering price~~ of the Shares and the net tangible book value per share of our Common Stock immediately after completion of the Private Placement, assuming no value is attributed to the Warrants. Net tangible book value is the amount that results from subtracting total liabilities and intangible assets from total assets. Contents

AtIf ~~March~~Ramot ~~31,~~is ~~2014,~~unable ~~the~~to ~~net~~obtain ~~tangible~~patents ~~book~~on ~~value of our shares of Common Stock was $860,000 or approximately $0.005 per share. After giving effect to~~ the ~~Private~~patent ~~Placement~~applications and ~~attributing~~technology ~~no value~~licensed to ~~the Warrants, and after deducting expenses payable by us,~~ our asIsraeli ~~adjusted~~Subsidiary ~~net~~or ~~tangible~~if ~~book~~patents ~~value~~are asobtained ofbut ~~March~~do ~~31,~~not ~~2014 would~~provide ~~have~~meaningful ~~been approximately $10~~protection,~~604,000,~~ orwe ~~approximately~~may ~~$0.048~~not ~~per~~be ~~share~~able ~~of Common Stock. This represents an immediate increase in net tangible book value of approximately $0.043 per share~~ to ~~existing~~successfully ~~stockholders~~market ~~and~~our anproposed ~~immediate dilution of approximately $0~~products.~~208 per share to new investors. The following table illustrates this per share dilution:~~

Private Placement price per Share			$	0.25
Net tangible book value per share as of March 31, 2014	$	0.005
Increase per share attributable to new investors		0.043
As adjusted net tangible book value per share after the Private Placement				0.048
Dilution per share to new investors			$	0.202

We rely upon the patent applications filed by Ramot, the technology licensing company of Tel Aviv University, and the license granted to us by Ramot, all in accordance with the Second Ramot Agreement dated as of July 26, 2007. We further agreed under the Second Ramot Agreement that Ramot, in consultation with us, is responsible for obtaining patent protection for technology owned by Ramot and licensed to us. No assurance can be given that the scope of any patent protection granted will exclude competitors or provide us with competitive advantages, that any of the patents that may be issued to us will be held valid if subsequently challenged, or that other parties will not claim rights to or ownership of our patents or other proprietary rights that we hold license to. Furthermore, there can be no assurance that others have not developed or will not develop similar products, duplicate any of our technology or products or design around any patents that have been or may be issued to us or any future licensors. Since patent applications in the United States and in Europe are not disclosed until applications are published, there can be no assurance that others did not first file applications for products covered by our pending patent applications, nor can we be certain that we will not infringe any patents that may be issued to others. Also, we have abandoned our rights to certain patents of Ramot in certain countries in connection with the Letter Agreement by and between us and Ramot dated December 24, 2009, which may limit our ability to fully market our proposed products. All granted patents related to NurOwn® (MSC-NTF cells) manufacturing process are fully assigned to or owned by BrainStorm Cell Therapeutics Ltd.

~~Investors~~We ~~that~~also ~~acquire~~rely ~~additional~~upon ~~shares~~unpatented ofproprietary ~~Common~~technology, ~~Stock~~know-how and trade secrets and seek to protect them through ~~the~~ ~~exercise~~confidentiality ofagreements ~~the~~with ~~Warrants~~employees, consultants and advisors. If these confidentiality agreements are breached, we may ~~experience~~not ~~additional~~have ~~dilution~~adequate ~~depending~~remedies onfor ~~our~~the ~~net~~breach. ~~tangible~~In ~~book~~addition, ~~value~~others atmay independently develop or otherwise acquire substantially the ~~time~~same ofproprietary ~~exercise~~technology as our technology and trade secrets.

~~The~~We ~~information~~may inbe ~~the~~unable ~~table~~to ~~above~~protect ~~is based on 176,803,587 shares of~~ our ~~Common~~intellectual ~~Stock~~property ~~outstanding~~from asinfringement ofby ~~March~~third ~~31, 2014 and excludes as of that date:~~parties.

·Despite 51our efforts to protect our intellectual property,~~191~~ third parties may infringe or misappropriate our intellectual property. Our competitors may also independently develop similar technology,~~451~~ ~~shares~~duplicate our processes or services or design around our intellectual property rights. We may have to litigate to enforce and protect our intellectual property rights to determine their scope, validity or enforceability. Intellectual property litigation is costly, time-consuming, diverts the attention of ~~Common~~management ~~Stock~~and ~~reserved~~technical ~~for~~personnel and could result in substantial uncertainty regarding our future ~~issuance~~viability. ~~under~~The loss of intellectual property protection or the inability to secure or enforce intellectual property protection would limit our ~~equity~~ability ~~incentive~~to ~~plans;~~develop or market our services in the future. This would also likely have an adverse effect on the revenues generated by any sale or license of such intellectual property. Furthermore, any public announcements related to such litigation or regulatory proceedings could adversely affect the price of our Common Stock.

·We ~~8,310,937~~may ~~options~~be ~~outstanding~~subject ~~under~~to ~~our~~claims ~~equity~~challenging ~~incentive~~the ~~plans~~inventorship ~~with~~or aownership ~~weighted~~of ~~average~~our ~~exercise~~patents ~~price~~and ofother ~~$0.1705~~intellectual ~~per share;~~property.

·We 68generally enter into confidentiality and intellectual property assignment agreements with our employees,~~871~~ consultants,~~843~~ ~~shares~~and contractors. These agreements generally provide that inventions conceived by the party in the course of ~~Common~~rendering ~~Stock~~services ~~issuable~~to ~~upon~~us ~~exercise~~will be our exclusive property. However, those agreements may not be honored and may not effectively assign intellectual property rights to us. Moreover, there may be some circumstances, where we are unable to negotiate for such ownership rights. Disputes regarding ownership or inventorship of ~~outstanding~~intellectual ~~warrants~~property ~~with~~can ~~exercise~~also ~~prices~~arise ~~ranging~~in ~~from~~other $0contexts, such as collaborations and sponsored research.~~00005~~ ~~per~~If ~~share~~we are subject to $1a dispute challenging our rights in or to patents or other intellectual property, such a dispute could be expensive and time-consuming.50 ~~per~~If ~~share;~~we were unsuccessful, we could lose valuable rights in intellectual property that we regard as our own. The intellectual property landscape around our product candidates is crowded, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating, or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

·Third-party ~~shares~~claims of ~~Common~~intellectual ~~Stock~~property ~~issuable~~infringement ~~upon~~may ~~exercise~~prevent ofor ~~the~~delay ~~Warrants~~our product discovery and development efforts.

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving the infringement of patents and other intellectual property rights in the biotechnology and pharmaceutical industries. We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights and who allege that our product candidates, uses and/or other proprietary technologies infringe their intellectual property rights. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing our product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk that our product candidates may give rise to claims of infringement of the patent rights of others

~~PLAN OF DISTRIBUTION~~

~~Each~~Table ~~Selling Securityholder~~ of the securities and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered hereby on the principal Trading Market or any other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. A Selling Securityholder may use any one or more of the following methods when selling securities:Contents

·increases. ~~ordinary~~Moreover, ~~brokerage~~it ~~transactions~~is not always clear to industry participants, including us, which patents exist which may be found to cover various types of drugs, products or their methods of use or manufacture. Thus, because of the large number of patents issued and ~~transactions~~patent applications currently pending in our fields, there may be a risk that third parties may allege they have patent rights which ~~the~~are ~~broker-dealer~~infringed ~~solicits~~by ~~purchasers;~~our product candidates, technologies or methods.

·If ~~block~~a ~~trades~~third inparty ~~which~~alleges ~~the~~that ~~broker-dealer~~we ~~will~~infringe ~~attempt~~its tointellectual ~~sell~~property ~~the~~rights, ~~securities~~we ~~as agent but~~ may ~~position~~face ~~and resell~~ a ~~portion~~number of ~~the~~issues, ~~block~~including, asbut ~~principal~~not tolimited ~~facilitate the transaction;~~to:

·● ~~purchases~~infringement byand aother ~~broker~~intellectual property misappropriation which, regardless of merit, may be expensive and time-~~dealer~~consuming asto ~~principal~~litigate and ~~resale~~may bydivert ~~the~~our ~~broker-dealer~~management’s ~~for~~attention ~~its~~from ~~account~~our core business;

·● ansubstantial ~~exchange~~damages ~~distribution~~for ininfringement ~~accordance~~or ~~with~~misappropriation, which we may have to pay if a court decides that the ~~rules~~product ofcandidate or technology at issue infringes on or violates the ~~applicable~~third-party’s ~~exchange~~rights, and, if the court finds we have willfully infringed intellectual property rights, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees;

·● ~~privately~~an ~~negotiated~~injunction ~~transactions~~prohibiting us from manufacturing, marketing or selling our product candidates, or from using our proprietary technologies, unless the third party agrees to license its patent rights to us;

·● ~~settlement~~even ofif ~~short~~a ~~sales~~license is available from a third party, we may have to pay substantial royalties, upfront fees and other amounts, and/or grant cross-licenses to intellectual property rights protecting our products; and

·● inwe ~~transactions~~may ~~through~~be ~~broker-dealers~~forced ~~that~~to ~~agree~~try ~~with~~to ~~the~~redesign ~~Selling~~our ~~Securityholders~~product tocandidates ~~sell~~or aprocesses ~~specified~~so ~~number~~they ofdo ~~such~~not ~~securities~~infringe atthird-party aintellectual ~~stipulated~~property ~~price~~rights, ~~per~~an ~~security;~~undertaking which may not be possible or which may require substantial monetary expenditures and time.

·Some ~~through~~of ~~the~~our ~~writing~~competitors ormay ~~settlement~~be able to sustain the costs of ~~options~~complex orpatent ~~other~~litigation ~~hedging~~more ~~transactions~~effectively than we can because they have substantially greater resources. In addition, ~~whether~~any ~~through~~uncertainties anresulting ~~options~~from ~~exchange~~the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations or could otherwise; have a material adverse effect on our business, results of operations, financial condition and prospects.

·Third parties may assert that we are employing their proprietary technology without authorization. Generally, conducting preclinical and clinical trials and other development activities in the United States is not considered an act of infringement. If any of our product candidates are approved by the FDA, a ~~combination~~third party may then seek to enforce its patent by filing a patent infringement lawsuit against us. While we may believe that patent claims or other intellectual property rights of a third party would not have a materially adverse effect on the commercialization of our product candidates, we may be incorrect in this belief, or we may not be able to prove it in litigation. In this regard, patents issued in the United States by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and convincing,” a heightened standard of proof. There may be issued third-party patents of which we are currently unaware with claims to compositions, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Patent applications can take many years to issue. There may be currently pending patent applications which may later result in issued patents that may be infringed by our product candidates. Moreover, we may fail to identify relevant patents or incorrectly conclude that a patent is invalid, not enforceable, exhausted, or not infringed by our activities. If any third-party patents, held now or obtained in the future by a third party, were found by a court of competent jurisdiction to cover the manufacturing process of our product candidates, constructs or molecules used in or formed during the manufacturing process, or any final product or methods use of the product, the holders of any such patents may be able to block our ability to commercialize the product candidate unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover any aspect of our formulations, any combination therapies or patient selection methods, the holders of ~~sale;~~any such patent may be able to block our ability to develop and commercialize the product candidate unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our product candidates may be impaired or delayed, which could in turn significantly harm our business. Even if we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

·Parties ~~any~~making claims against us may seek and obtain injunctive or other ~~method~~equitable ~~permitted~~relief, ~~pursuant~~which could effectively block our ability to ~~applicable~~further ~~law~~develop and commercialize our product candidates. Defense of these claims, regardless of their merit, could involve

The Selling Securityholders may also sell securities under Rule 144 under the Securities Act, if available, rather than under this prospectus.

Broker-dealers engaged by the Selling Securityholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Securityholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440.

In connection with the sale of the securities or interests therein, the Selling Securityholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The Selling Securityholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The Selling Securityholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

The Selling Securityholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each Selling Securityholder has informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.

~~The~~Table ~~Company is required to pay certain fees and expenses incurred by the Company incident to the registration~~ of ~~the securities. The Company has agreed to indemnify the Selling Securityholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.~~Contents

~~Because~~substantial ~~Selling~~litigation ~~Securityholders may~~expense and would be ~~deemed~~a tosubstantial bediversion ~~“underwriters”~~of ~~within~~employee resources from our business. In the ~~meaning~~event of ~~the~~a ~~Securities~~successful ~~Act,~~claim ~~they~~of ~~will~~infringement beagainst ~~subject~~us, we may have to ~~the~~pay ~~prospectus delivery~~substantial ~~requirements~~damages, ofincluding ~~the~~treble ~~Securities~~damages ~~Act~~and ~~including~~attorneys’ ~~Rule~~fees ~~172~~for ~~thereunder.~~willful Ininfringement, ~~addition~~obtain one or more licenses from third parties, ~~any~~pay ~~securities~~royalties ~~covered~~or byredesign ~~this~~our ~~prospectus~~ infringing products, which ~~qualify~~may ~~for~~be ~~sale~~impossible ~~pursuant~~or torequire ~~Rule~~substantial ~~144~~time ~~under~~and ~~the~~monetary ~~Securities~~expenditure. ~~Act~~We ~~may~~cannot predict whether any such license would be ~~sold~~available ~~under~~at ~~Rule~~all ~~144~~or ~~rather~~whether ~~than~~it ~~under~~would ~~this~~be ~~prospectus~~available on commercially reasonable terms. ~~The~~ ~~Selling~~Furthermore, ~~Securityholders~~even ~~have~~in ~~advised~~the usabsence ~~that~~of ~~there~~litigation, iswe nomay ~~underwriter~~need or ~~coordinating~~may ~~broker~~choose ~~acting~~to inobtain ~~connection~~licenses ~~with~~from ~~the~~third ~~proposed sale~~parties to advance our research or allow commercialization of ~~the~~our ~~resale~~product ~~securities~~candidates. byWe ~~the~~may ~~Selling~~fail ~~Securityholders~~to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize our product candidates, which could harm our business significantly.

We ~~agreed to keep this prospectus effective until the earlier of (i) the date on which the securities~~ may be ~~resold~~involved byin ~~the~~lawsuits ~~Selling Securityholders without registration and without regard~~ to ~~any~~protect ~~volume~~ or ~~manner-of-sale~~enforce ~~limitations~~our bypatents ~~reason of Rule 144, without the requirement for the Company to be in compliance with the current public information under Rule 144 under the Securities Act~~ or ~~any other rule of similar effect or (ii) all of~~ the ~~securities~~patents ~~have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule~~ of ~~similar~~our ~~effect.~~licensors, ~~The~~which ~~resale~~could ~~securities will~~ be ~~sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition~~expensive, intime-consuming certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and ~~is complied with~~unsuccessful.

~~Under~~Competitors ~~applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities~~ may ~~not~~infringe ~~simultaneously engage~~our inpatents ~~market~~or ~~making activities with respect to~~ the ~~Common~~patents ~~Stock for the applicable restricted period, as defined in Regulation M, prior to the commencement~~ of ~~the~~our ~~distribution~~licensors. InTo ~~addition,~~counter ~~the~~infringement ~~Selling~~or ~~Securityholders~~unauthorized ~~will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder~~use, ~~including~~we ~~Regulation M, which~~ may ~~limit~~be ~~the~~required ~~timing of purchases and sales of securities of the Common Stock by the Selling Securityholders or any other person. We will make copies of this prospectus available~~ to ~~the~~take ~~Selling~~legal ~~Securityholders~~action ~~and have informed them of the need~~ to ~~deliver~~enforce aour ~~copy~~patents ~~of this prospectus to each purchaser at~~ or ~~prior~~our tolicensors’ ~~the~~patents ~~time~~against ofsuch ~~the~~infringing ~~sale~~activity. ~~(including~~Such byenforcement ~~compliance~~proceedings ~~with~~against ~~Rule~~infringers ~~172~~can ~~under~~be ~~the~~expensive ~~Securities~~and ~~Act)~~time-consuming.

In addition, in an infringement proceeding, a court may decide that one or more of our patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the compositions or activities in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put our patent applications at risk of not issuing. Defense against these assertions, non-infringement, invalidity or unenforceability regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.

Post-grant proceedings provoked by third parties or brought by the USPTO may be brought to determine the validity or priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could result in a loss of our current patent rights and could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation or post-grant proceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as those within the United States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

Issued patents covering our products and product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate, as applicable, is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are various grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, inter partes review, post grant review and equivalent proceedings in foreign jurisdictions (such as opposition proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, or if we are otherwise unable to adequately protect our rights, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize or license our technology and product candidates.

~~DESCRIPTION OF CAPITAL STOCK~~

~~The~~Table ~~following is a summary~~ of all material characteristics of our capital stock as set forth in our certificate of incorporation and bylaws. The summary does not purport to be complete and is qualified in its entirety by reference to our certificate of incorporation and bylaws, and, to the extent applicable, to the provisions of the Delaware General Corporation Law.Contents

~~Common~~Obtaining ~~stock~~and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Some of our pending patent applications may not be allowed in the future. We ~~are~~cannot ~~authorized~~be certain that an allowed patent application will become an issued patent. There may be events that cause withdrawal of the allowance of a patent application. For example, after a patent application has been allowed, but prior to ~~issue~~being ~~800~~issued,~~000~~ material that could be relevant to patentability may be identified. In such circumstances,~~000~~ ~~shares~~the applicant may pull the application from allowance in order for the USPTO to review the application in view of ~~Common~~the ~~Stock, $0~~new material.~~00005~~ ~~par~~We ~~value~~cannot be certain that the USPTO will issue the application in view of the new material. As Further, periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign countries may require the payment of ~~June~~maintenance 20fees or patent annuities during the lifetime of a patent application and/or any subsequent patent that issues from the application. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, ~~2014~~ documentary, fee payment and other similar provisions during the patent application process and following the issuance of a patent. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there ~~were~~are ~~224~~situations in which noncompliance can result in abandonment or lapse of the patent or patent application. Such noncompliance can result in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include,~~834~~ but are not limited to,~~618~~ ~~shares~~failure to respond to official actions within prescribed time limits, non-payment of ~~our~~fees ~~Common~~and ~~Stock~~failure ~~issued~~to properly legalize and ~~outstanding, held~~submit byformal ~~approximately~~documents. 64Such ~~record~~an event could have a material adverse effect on our business.

~~holders~~Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

~~The~~As ~~holders~~is ofthe ~~Common~~case ~~Stock~~with ~~are~~other ~~entitled~~drug toand ~~one~~biopharmaceutical ~~vote~~companies, ~~per~~our ~~share~~ success is heavily dependent on ~~all~~intellectual ~~matters~~property, toparticularly bepatents. ~~voted~~Obtaining ~~upon~~and byenforcing ~~stockholders~~patents in the drug and biopharmaceutical industry involves both technological and legal complexity, ~~including~~and is therefore costly, time-consuming and inherently uncertain. In addition, the ~~election~~United ofStates ~~directors~~has passed wide-ranging patent reform legislation under the AIA. ~~The~~ ~~holders~~Moreover, ofrecent ~~Common~~U.S. ~~Stock~~Supreme ~~do not~~Court rulings have ~~any~~narrowed ~~cumulative~~the ~~voting,~~scope ~~conversion,~~of ~~redemption~~patent orprotection ~~preemptive~~available in certain circumstances and weakened the rights of patent owners in certain situations. ~~The~~ ~~holders~~In ofaddition ~~Common~~to ~~Stock~~increasing ~~are~~uncertainty ~~entitled~~ with regard to ~~receive~~our ~~ratably~~ability ~~dividends~~to asobtain ~~may~~patents bein ~~declared~~the ~~from~~future, ~~time~~this combination of events has created uncertainty with respect to ~~time~~the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ~~Board~~ability ofto ~~Directors~~obtain ~~out~~new ofpatents ~~funds~~or ~~legally~~to ~~available~~enforce ~~for~~ our existing patents and patents that ~~purpose~~we might obtain in the future. In We cannot predict how future decisions by the ~~event~~courts, Congress or the USPTO may impact the value of our ~~liquidation,~~patents. ~~dissolution~~Similarly, orany ~~winding~~adverse ~~up,~~changes in the ~~holders~~patent laws of ~~Common~~other ~~Stock~~jurisdictions ~~are~~could ~~entitled to~~have ~~share~~a ~~ratably~~material inadverse effect on our ~~assets~~business ~~available~~and ~~for~~financial ~~distribution~~condition. toChanges ~~such~~in ~~holders. All~~the ~~issued~~laws and ~~outstanding~~regulations ~~shares~~governing ofpatents ~~Common Stock~~in ~~are~~other ~~fully~~jurisdictions ~~paid~~could similarly have an adverse effect on our ability to obtain and ~~non-assessable~~effectively enforce our patent rights.

~~Anti~~Our European patents and patent applications are subject to challenge in the Unified Patent Court (UPC) for the European Union. We may decide to opt out our European patents and patent applications from the UPC. However, if certain formalities and requirements are not met, our European patents and patent applications could be challenged for non-~~Takeover~~compliance ~~Provisions~~and brought under the jurisdiction of ~~Delaware~~the ~~Law~~UPC. We cannot be certain that our European patents and patent applications will avoid falling under the jurisdiction of the UPC, if we decide to opt out of the UPC. Under the UPC, a granted European patent would be valid and enforceable in numerous European countries. A successful invalidity challenge to a European patent under the UPC would result in loss of patent protection in those European countries. Accordingly, a single proceeding under the UPC could result in the partial or complete loss of patent protection in numerous European countries, rather than in each validated European country separately as such patents always have been adjudicated. Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize our technology and product candidates and, resultantly, on our business, financial condition, prospects and results of operations.

We ~~are~~have ~~subject~~limited toforeign ~~Section~~intellectual ~~203~~property ofrights ~~the~~and ~~Delaware~~may ~~General~~not ~~Corporation Law,~~be ~~which~~able ~~prohibits~~to aprotect ~~publicly-held~~our ~~Delaware~~intellectual ~~corporation~~property ~~from~~rights ~~engaging~~throughout ~~in a “business combination,” except under certain circumstances, with an “interested stockholder” for a period of three years following~~ the ~~date such person became an “interested stockholder” unless:~~world.

·Certain ~~before~~of ~~such~~our ~~person~~key ~~became~~patent anfamilies ~~interested~~have ~~stockholder~~been filed in the United States; however, we have less robust intellectual property rights outside the ~~board~~United States, and, in particular, we may not be able to pursue patent coverage of ~~directors~~our product candidates in certain countries outside of the ~~corporation~~United ~~approved~~States. ~~either~~Filing, prosecuting and defending patents on product candidates in all countries throughout the ~~business~~world ~~combination~~would orbe prohibitively expensive, and our intellectual property rights in some countries outside the ~~transaction~~United ~~that~~States ~~resulted~~may be less extensive than those in the ~~interested~~United ~~stockholder~~States. ~~becoming~~In anaddition, ~~interested~~the ~~stockholder;~~laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. The breadth and strength of our patents issued in foreign jurisdictions or regions may not

· upon the consummation of the transaction that resulted in the interested stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding shares held by directors who also are officers of the corporation and shares held by employee stock plans; or

· at or following the time such person became an interested stockholder, the business combination is approved by the board of directors of the corporation and authorized at a meeting of stockholders by the affirmative vote of the holders of 66 2/3% of the outstanding voting stock of the corporation which is not owned by the interested stockholder.

The term “interested stockholder” generally is defined as a person who, together with affiliates and associates, owns, or, within the three years prior to the determination of interested stockholder status, owned, 15% or more of a corporation’s outstanding voting stock. The term “business combination” includes mergers, asset or stock sales and other similar transactions resulting in a financial benefit to an interested stockholder. Section 203 makes it more difficult for an “interested stockholder” to effect various business combinations with a corporation for a three-year period. The existence of this provision would be expected to have an anti-takeover effect with respect to transactions not approved in advance by our Board of Directors, including discouraging attempts that might result in a premium over the market price for the shares of Common Stock held by stockholders.

Registration Rights Agreement Pursuant to the Registration Rights Agreement, we are required to file a resale registration statement for the Shares and Common Stock underlying the Warrants within 30 days of the closing date (the Filing Deadline) and have it declared effective at the earlier of (i) the 90th calendar day after the closing date and (ii) the fifth business day after the date the Company is notified by the SEC that such Registration Statement will not be reviewed or will not be subject to further review (the Effectiveness Deadline). The Registration Rights Agreement contains penalties for failure to comply with the terms of the agreement, including monthly liquidated damages in an amount equal to 1.5% of the aggregate subscription amount for failure to meet the Effectiveness Deadline, up to a maximum of 12% of the aggregate subscription amount. If at any time all of the shares of Common Stock or shares of Common Stock underlying the Warrants are not covered by the initial Registration Statement, the Company agrees to file with the SEC one or more additional Registration Statements so as to cover all of the shares of Common Stock and shares of Common Stock underlying the Warrants not covered by such initial Registration Statement, in each case, as soon as practicable, but in no event later than the applicable filing deadline for such additional Registration Statements as provided in the Registration Rights Agreement. The Company shall keep the Registration Statement effective until the earlier of (i) the date on which the securities may be resold by the Selling Securityholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. Description of Warrants After the closing of the Private Placement, there were Warrants to purchase up to 42,000,000 shares of Common Stock at an exercise price of $0.348 per share outstanding. The Warrants were exercisable immediately upon closing of the Private Placement and have a term of three (3) years. The Warrants, at the option of the holder, may be exercised by cash payment of the exercise price to the Company. The Warrants may be exercised on a cashless basis commencing at the earlier of (i) one year after issuance or (ii) the completion of the then-applicable holding period required by Rule 144, if no registration statement registering the shares underlying the Warrants is then in effect. The exercise price and number of shares of Common Stock issuable on exercise of the Warrants may be adjusted in certain circumstances including stock dividends, recapitalizations, reorganizations, mergers or consolidations. No fractional shares will be issued upon exercise of the Warrants. If, upon exercise of the Warrants, a holder would be entitled to receive a fractional interest in a share, we will, upon exercise, at our election, either pay a cash adjustment or round up to the nearest whole number, the number of shares of Common Stock to be issued to the Warrant holder.

~~Transfer~~Table ~~Agent~~of ~~and Registrar~~Contents

~~The~~be ~~transfer~~the ~~agent~~same as the corresponding patents issued in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and ~~registrar~~into ~~for~~the United States or other jurisdictions. Competitors may use our ~~Common~~technologies ~~Stock~~in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to certain territories where we have patent protection, but enforcement is ~~American Stock~~not ~~Transfer~~as &strong ~~Trust~~as ~~Company~~that ~~LLC~~in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Most of our patent portfolio is at the very early stage. We will need to decide whether and in which jurisdictions to pursue protection for the various inventions in our portfolio prior to applicable deadlines.

~~OTCQB~~Many ~~Marketplace~~companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protections, particularly those relating to drug and biopharmaceutical products. This difficulty with enforcing patents could make it difficult for us to stop the infringement of our patents or marketing of competing products otherwise generally in violation of our proprietary rights. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, put our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

~~Our~~As ~~Common~~a ~~Stock~~result isof ~~traded~~our reliance on ~~the~~consultants, ~~OTCQB~~we ~~Marketplace~~may ~~operated by~~not ~~OTC~~be ~~Markets~~able ~~Group~~to ~~under~~protect the ~~trading~~confidentiality ~~symbol~~of ~~“BCLI~~our technology, which, if disseminated, could negatively impact our plan of operations.”

We currently have relationships with academic and industry consultants and subcontractors who are not directly employed by us, and we may enter into additional relationships of such nature in the future. We have limited control over the activities of these consultants and can expect only limited amounts of their time to be dedicated to our activities. These persons may have consulting, employment or advisory arrangements with other entities that may conflict with or compete with their obligations to us. Our consultants typically sign agreements that provide for confidentiality of our proprietary information and results of studies. However, in connection with every relationship, we may not be able to maintain the confidentiality of our technology, the dissemination of which could hurt our competitive position and results of operations. To the extent that our scientific consultants develop inventions or processes independently that may be applicable to our proposed products, disputes may arise as to the ownership of the proprietary rights to such information, we may expend significant resources in such disputes and we may not win those disputes.

We received grants from the Israel Innovation Authority, or IIA, we are subject to on-going restrictions.

We have received royalty-bearing grants from the IIA, for research and development programs that meet specified criteria. The terms of the IIA’s grants may limit various technology transfer know-how developed under an approved research and development program outside of Israel.

We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.

Many of our employees were previously employed at other biotechnology companies, including our competitors or potential competitors, in some cases until recently. We may be subject to claims that we or our employees have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of these former employers or competitors. In addition, we may in the future be subject to claims that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and could be a distraction to management. If our defense to those claims fails, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Any litigation or the threat thereof may adversely affect our ability to hire employees. A loss of key personnel or their work product could hamper or prevent our ability to commercialize product candidates, which could have an adverse effect on our business, financial condition and results of operations.

~~OUR BUSINESS~~

~~Company~~Table ~~Overview~~of Contents

WeIf ~~are~~we ado ~~biotechnology~~not ~~company~~obtain ~~developing~~patent ~~novel~~term ~~adult~~extension ~~stem~~and ~~cell therapies~~data exclusivity for ~~debilitating~~any ~~neurodegenerative~~of ~~disorders~~our ~~such~~current asor ~~ALS,~~future MSproduct ~~and~~candidates, ~~PD.~~our ~~These~~business ~~diseases~~may ~~have~~be ~~limited~~materially ~~treatment options and as such represent unmet medical needs~~harmed.

WeDepending ~~believe~~upon ~~that~~the ~~NurOwn~~timing, duration and specifics of any FDA marketing approval of any of our ~~proprietary~~current ~~process~~or future product candidates, one or more of our U.S. patents may be eligible for limited patent term extension under the ~~propagation~~ Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term of ~~MSC~~up ~~and~~to ~~their~~five years ~~differentiation~~as ~~into~~compensation ~~NTF~~for ~~secreting~~patent ~~cells~~term ~~(MSC-NTF)~~lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and ~~their~~only ~~transplantation~~those atclaims covering the approved drug, a method for using it, or ~~near~~a method for manufacturing it may be extended. However, we may not be granted an extension because of, for example, failing to exercise due diligence during the ~~site~~testing phase or regulatory review process, failing to apply for a patent extension within applicable deadlines, failing to apply prior to expiration of ~~damage~~relevant patents, ~~offers~~ or otherwise failing to satisfy applicable requirements. Moreover, the ~~hope~~applicable time period or the scope of ~~effectively~~patent ~~treating~~protection ~~neurodegenerative~~afforded ~~diseases~~could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we believe we are entitled to, our competitors may obtain approval of competing products sooner than we would expect, and our business, financial condition, results of operations, and prospects could be materially harmed.

~~Our~~Risks ~~approach~~related isto ~~considered safe based on~~ our ~~use~~Common of autologous cells, which are considered to be free of the risk of rejection. Furthermore, MSC are known to be safe with no risk of tumor formation. The use of adult stem cells is also free of the controversy associated with the use of embryonic stem cells in some countries.Stock

~~Our~~We ~~core~~transferred ~~technology~~trading ~~was~~of ~~developed~~our inCommon ~~collaboration~~Stock ~~with~~from ~~prominent neurologist~~The ~~Prof.~~Nasdaq ~~Eldad~~Stock ~~Melamed,~~Market ~~former~~to ~~head~~the ofOTCQB ~~Neurology~~Venture ofMarket ~~the~~after ~~Rabin~~our ~~Medical~~Common ~~Center~~Stock ~~and~~was ~~member~~delisted offrom ~~the~~The ~~Scientific~~Nasdaq. ~~Committee~~Because ~~of the~~our ~~Michael~~Common J.Stock ~~Fox~~is ~~Foundation~~quoted ~~for~~on ~~Parkinson's~~the ~~Research,~~OTCQB ~~and~~Venture ~~expert~~Market, ~~cell~~your ~~biologist~~ability ~~Prof.~~to ~~Daniel~~sell ~~Offen~~your ofshares in the ~~Felsenstein~~secondary ~~Medical Research~~trading ~~Center~~market ofmay ~~Tel~~be ~~Aviv University~~limited.

~~Our~~On ~~Israeli~~July 17, ~~Subsidiary~~2025, ~~holds~~the ~~rights~~Company toannounced ~~commercialize~~that it has received a delisting notification from Nasdaq, informing the ~~technology~~company that its Common Stock will be delisted from The Nasdaq Capital Market. Trading of our Common Stock on Nasdaq was suspended at the open of trading on July 18, ~~through~~ 2025. The delisting is a ~~licensing~~result ~~agreement~~of our non-compliance with ~~Ramot~~Nasdaq Listing Rule 5550(b)(1), pertaining to its minimum shareholder equity requirement. The Company’s shares started trading on the ~~technology~~OTCQB ~~licensing~~Venture ~~company~~Market, a U.S. trading platform operated by OTC Markets Group, under the same symbol, “BCLI”, beginning at the open of ~~Tel~~trading ~~Aviv~~on ~~University~~July 18, ~~Israel~~2025.

OnAs ~~February~~a 8,result ~~2010~~of the transfer of the our Common Stock from Nasdaq to the OTCQB Venture Market, we anticipate that our ~~Israeli~~stockholders ~~Subsidiary~~could ~~entered~~experience ~~into~~negative ~~an agreement~~consequences ~~with~~related ~~Hadassah~~to our securities, ~~pursuant~~including but not limited to: ~~which~~limited ~~Hadassah~~availability ~~provides~~of market quotations for our securities; a reduced level of trading activity in the ~~Israeli~~secondary ~~Subsidiary~~trading ~~with~~market ~~lab~~for ~~services~~shares of our Common Stock; a limited amount of analyst coverage; and decreased ability to issue additional securities or obtain additional financing in the future.

OnBecause ~~February~~our ~~17,~~Common ~~2010~~Stock is quoted on the OTCQB Venture Market, ~~our~~your ~~Israeli~~ability ~~Subsidiary~~to ~~entered~~sell ~~into~~your shares in the ~~Clinical~~ ~~Trial~~secondary ~~Agreement~~trading market may be limited. ~~Under~~Since July 18, 2025, the ~~Clinical~~OTCQB ~~Trial~~Venture ~~Agreement,~~Market ~~Hadassah~~is ~~and~~the only liquidity platform for our ~~personnel~~Common ~~agreed~~Stock. We cannot assure our stockholders that our Common Stock will continue to ~~conduct~~trade aon ~~clinical~~this ~~trial~~liquidity platform, whether broker-dealers will continue to ~~evaluate~~ ~~the~~provide ~~safety~~public ~~and~~quotes ~~tolerability~~of our Common Stock on this liquidity platform, whether the trading volume of our ~~NurOwn~~Common ~~cells~~Stock inwill ~~patients~~be ~~with~~sufficient ~~ALS~~to provide for respective efficient liquidity platforms or whether quotes for our Common Stock will continue on this liquidity platform in the future, which could result in ~~accordance~~significantly ~~with~~lower trading volumes and reduced liquidity for investors seeking to buy or sell our Common Stock. As a ~~protocol~~result, ~~developed~~prices ~~jointly by~~for usshares ~~and~~of ~~Professor~~our ~~Karussis~~Common Stock may be lower than might otherwise prevail if our Common Stock was listed on a national securities exchange.

InThe ~~February~~National ~~2011~~Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the Ustates from regulating the sale of certain securities, which are referred to as “covered securities.S” Shares of our Common Stock were considered to be covered securities because they were listed on Nasdaq. ~~FDA~~Because ~~granted~~our ~~Orphan~~Common ~~Drug~~Stock ~~designation~~ is no longer listed on Nasdaq, our Common Stock is not deemed covered securities, and we are subject to ~~NurOwn~~regulation ~~for~~in ~~the~~each ~~treatment~~state ofin ~~ALS~~which we offer our securities.

InThe ~~June~~price ~~2011,~~and wetrading ~~initiated~~volume ~~a Phase I/II clinical trial for the treatment~~ of ~~ALS~~our ~~with~~stock ~~NurOwn~~is atexpected ~~the~~to ~~HUMC~~be ~~with Principal Investigator Professor Dimitrios Karussis, after receiving approval from the Israeli MoH~~volatile.

InThe ~~July~~market ~~2011,~~price weand ~~entered~~trading ~~into~~volume ~~a Memorandum~~ of ~~Understanding with~~our ~~MGH~~Common ~~and~~Stock ~~UMass~~has influctuated ~~anticipation~~significantly ofover ~~applying~~time, ~~for~~and ~~FDA~~is ~~approval~~likely to ~~begin~~continue ~~ALS~~to ~~human~~be ~~clinical~~highly ~~trials~~volatile. inTo date, the ~~United~~trading ~~States.~~volume Inand ~~March 2014,~~price weof ~~entered~~our ~~into~~stock ahas ~~definitive~~seen ~~agreement~~significant ~~with~~fluctuations. ~~MGH~~We ~~and~~expect ~~launched~~such afluctuations ~~Phase~~could IIoccur ~~clinical trial~~ in the ~~second~~future. ~~quarter~~Investors ofshould ~~2014,~~be ~~and we~~aware ~~expect~~of tothe ~~enter~~risks ~~into~~of atrading ~~definitive~~in ~~agreement~~our ~~with~~Common ~~UMass~~Stock ~~for~~due ~~the~~to ~~same~~such volatility.

In January 2013, the Israeli MoH approved a Phase IIa combined (intramuscular and intrathecal) treatment, dose-escalating trial, which we are currently conducting at HUMC. According to the protocol for this safety and preliminary efficacy trial, 12 early-stage ALS patients received both intramuscular and intrathecal injections of NurOwn cells in three cohorts with increasing doses between February and August 2013. The patients were followed for six months after transplantation. Due to medical and technical considerations, two additional patients were enrolled in the trial in late 2013, in order to preserve the originally planned protocol design. These two patients were treated at the beginning of the second quarter of 2014. The complete and final statistical analysis of the Phase IIa data is expected to be available after 6 months of follow up with the patients.

In January 2013, we also announced that we had successfully completed a 12-week repeat dose toxicity study with our NurOwn cells in mice. These repeat doses were prepared from frozen cells, using a proprietary method recently developed by the Company. We believe that our cryopreservation, or freezing, method will enable long-term storage, and production of repeat patient doses of NurOwn without the need for additional bone marrow aspirations. We believe that the positive data from the toxicity study in mice will support our efforts to obtain approval for a future repeat dose clinical study in ALS patients. The study was conducted at Harlan Israel’s laboratories, according to GLP standards. The study protocol was approved by Israel’s National Council for Animal Experimentation.

InTable ~~March 2013, Principal Investigator Professor Dimitrios Karussis~~ of Hadassah presented some of the data from the Phase I/II trial at the American Academy of Neurology Annual Meeting. The trial results analyzed to date confirmed the safety of the NurOwn Treatment and also demonstrated initial signs of possible efficacy. There was a slower decline in overall clinical and respiratory function, as measured by the ALSFRS-R and FVC score respectively, in the six patients that received an intrathecal injection of the cells, in the six months following treatment as compared to the three months preceding treatment.Contents

OnYour percentage ~~March~~ownership 14, 2013, we entered into a Memorandum of Understanding with Mayo in Rochester, Minnesota, to participate as an additional clinical site in the multi-center Phase II ALS clinical trial in the USA. The team there will be ~~led~~diluted by ~~Professor~~future ~~Anthony~~issuances ~~J. Windebank, Head~~ of ~~the~~our ~~Regenerative Neurobiology Laboratory in the Department of Neurology~~securities. ~~In January 2014, we announced that we had entered into a definitive agreement with Mayo to conduct the trial and manufacture NurOwn cells in their cell processing cleanroom facility.~~

~~Effective~~In ~~April~~order 3,to ~~2013,~~meet our ~~Israeli~~financing ~~Subsidiary~~needs, ~~entered~~we ~~into a~~may ~~manufacturing~~issue ~~agreement~~additional ~~with~~significant ~~Dana-Farber~~amounts ~~under~~of ~~which~~our ~~Dana-Farber’s~~Common ~~Connell~~Stock and ~~O’Reilly~~warrants ~~Cell~~to ~~Manipulation~~purchase ~~Core~~shares ~~Facility will~~of ~~produce~~our ~~NurOwn~~Common inStock. ~~its~~The ~~cGMP-compliant~~precise ~~clean~~terms ~~rooms~~of ~~for~~any ~~the~~future ~~MGH~~financings will be determined by us and ~~UMass~~potential ~~clinical~~investors ~~sites~~and ~~during~~such ~~our~~future ~~upcoming~~financings ~~Phase~~may IIalso ~~ALS~~significantly ~~clinical trial~~dilute your percentage ownership in the ~~United States~~Company.

OnACCBT ~~May~~holds ~~21,~~equity ~~2013,~~participation werights ~~submitted a safety~~and ~~report~~other torights ~~the~~that ~~hospital~~could ~~Helsinki~~affect ~~Committee (IRB) for the first group of (four) patients in~~ our ~~ongoing~~ability ~~Phase~~to ~~IIa~~raise ~~ALS clinical trial at the Hadassah Medical Center in Jerusalem, Israel~~funds.

Pursuant to the Subscription Agreement with ACCBT Corp. (“ACCBT”), a company under the control of Mr. Chaim Lebovits, our President and Chief Executive Officer, we granted ACCBT the right to acquire additional shares of our Common Stock whenever we issue additional shares of Common Stock or other securities of the Company, or options or rights to purchase shares of the Company or other securities directly or indirectly convertible into or exercisable for shares of the Company (including shares of any newly created class or series). This participation right could limit our ability to enter into equity financings and to raise funds from third parties. ACCBT is entitled to purchase its pro rata share of any additional securities we offer, so that its percentage ownership of the Company remains the same after any such issuance of additional securities. Such additional securities will be offered to ACCBT at the same price and on the same terms as the other investors in the transaction. ACCBT will have 30 days from the date of our notice to ACCBT of any intended transaction, to decide whether it wishes to exercise its participation rights in the transaction. We also are prohibited from taking certain corporate actions without the consent of ACCBT, including entering into transactions greater than $500,000. Further, ACCBT also has the right to appoint 30% of our Board. In ~~June~~connection ~~2013~~with the Subscription Agreement, we entered into a ~~MOU~~registration rights agreement with ~~PRC~~ACCBT ~~Clinical~~pursuant to which we granted piggyback registration rights to ACCBT. In addition, awe ~~CRO based~~issued inACCBT warrants to purchase up to 134,444 shares of Common Stock, of which 134,444 warrants are presently outstanding. The outstanding warrants contain cashless exercise provisions, which permit the ~~San~~cashless ~~Francisco~~exercise ~~Bay~~of ~~Area~~up to 50% of the underlying shares of Common Stock. 44,815 inof ~~anticipation~~such warrants have an exercise price of ~~our~~$45.00 ~~planned~~and ~~Phase~~the IIremainder ~~multi~~have an exercise price of $65.25. We registered 128,031 shares of Common Stock and 134,444 shares of Common Stock underlying the ACCBT Warrants on registration statement No. 333-~~center~~201705 ~~ALS~~dated ~~clinical~~January 26, ~~trial~~2015 inpursuant to ACCBT’s registration rights. ACCBT has waived its participation rights and anti-dilution rights with respect to issuances that were made on or prior to November 2, 2017. In March 2014, we entered into an agreement with ACCBT according to which ACCBT waived certain anti-dilution rights. On November 2, 2017, the ~~United~~Company ~~States~~entered into a Warrant Amendment Agreement with ACCBT, pursuant to which the expiration date of each Warrant held by ACCBT was extended until November 5, 2022, in consideration of ACCBT having provided a series of waivers of their rights and reduction of rights.

OnYou ~~July~~may ~~17,~~experience ~~2013,~~difficulties wein ~~received~~attempting ~~Orphan~~to ~~Medicinal~~enforce ~~Product~~liabilities ~~Designation for~~based ~~NurOwn~~upon ~~for~~U.S. ~~the~~federal ~~treatment~~securities oflaws ~~ALS~~against ~~from~~us ~~the~~and ~~European~~our ~~Commission~~non-U.S. resident directors and officers.

OnOur ~~August~~principal 1,operations ~~2013,~~are welocated ~~announced that~~through weour ~~submitted~~subsidiary ain ~~favorable~~Israel ~~safety~~and ~~report~~our toprincipal assets are located outside the ~~hospital~~U.S. ~~Helsinki~~Our ~~Committee~~Chief ~~(IRB)~~Executive ~~for~~Officer ~~the~~and ~~second~~Chief ~~group~~Business ofOfficer ~~(four)~~and ~~patients~~some in of our ~~ongoing~~directors ~~Phase~~are ~~IIa~~foreign ~~ALS~~citizens ~~clinical~~and ~~trial~~do atnot reside in the ~~Hadassah~~U.S. ~~Medical~~It ~~Center~~may be difficult for courts in ~~Jerusalem~~the U.S. to obtain jurisdiction over our foreign assets or these persons and as a result, ~~Israel~~it may be difficult or impossible for you to enforce judgments rendered against us or our directors or executive officers in U. WeS. ~~announced~~courts. ~~that~~Thus, should any situation arise in the ~~treatment~~future ~~was~~in ~~well~~which ~~tolerated~~you ~~and~~have noa ~~serious~~cause ~~adverse~~of ~~events~~action ~~were~~against ~~observed~~these persons or entities, ~~except~~you ~~for~~are ~~one~~at ~~SAE~~greater ~~(death~~risk ~~due~~in ~~to cardiopulmonary~~investing ~~arrest)~~in ~~that~~our ~~was~~company ~~reported~~rather than a domestic company because of greater potential difficulties in bringing lawsuits or, if successful, collecting judgments against these persons or entities as ~~non-treatment~~opposed ~~related~~to domestic persons or entities.

InIf ~~September~~we ~~2013,~~fail weto ~~announced~~implement ~~that~~and wemaintain ~~had~~an ~~completed~~effective ~~treatment~~ system of ~~the~~internal 12controls, ~~patients~~we inmay ~~our~~be ~~ALS~~unable ~~Phase~~to ~~IIa~~accurately ~~NurOwn~~report ~~dose-escalating~~our ~~clinical~~results ~~trial.~~of Weoperations ~~have~~or ~~been~~prevent ~~informed~~fraud, ~~that~~and ~~one~~investor ~~patient~~confidence inand the ~~study expired~~market ~~due~~price toof aour ~~medical~~Common ~~condition~~Stock ~~unrelated~~may tobe ~~the~~materially ~~Clinical~~and ~~Trial~~adversely affected.

As a public company in the United States, we are subject to the reporting obligations under the U.S. securities laws. The SEC, as required under Section 404 of the Sarbanes-Oxley Act of 2002, has adopted rules requiring every public company to include a report of management on the effectiveness of such company’s internal control over financial reporting in its annual report. In ~~October~~prior years, ~~2013~~management has identified material weaknesses in our internal control over financial reporting. If any of our prior material weaknesses recurs, or if we ~~launched~~identify additional weaknesses or fail to timely and successfully implement new or improved controls, our ~~activities~~ability to assure timely and accurate financial reporting may be adversely affected, and we could suffer a loss of investor confidence in the USreliability of our financial statements, which in ~~preparation~~ turn could negatively impact the trading price of our ~~Phase~~shares IIof ~~multi-center~~Common ~~clinical~~Stock, ~~trial~~result in lawsuits being filed against us by our stockholders, ~~with~~or otherwise harm our reputation. If material weaknesses are identified in the ~~initiation~~future, it could be costly to remediate such material weaknesses, which may adversely affect our results of ~~the~~operations. ~~NurOwn~~In ~~technology~~addition, ~~transfer~~our ~~process~~auditor is not required to attest to the ~~DFCI.~~effectiveness ~~This~~of ~~process was~~our ~~completed~~internal oncontrols ~~March~~over ~~31,~~financial ~~2014.~~reporting due to our status of qualifying as a smaller

On December 10, 2013, we announced that Prof. Karussis had presented some of his preliminary findings from our ALS Phase IIa NurOwn dose-escalating clinical trial at the 24th International Symposium on ALS/MND in Milan, Italy. According to Prof. Karussis, the safety data are "impressively positive," with only minimal and transient (procedure related) adverse events, even though the patients in this study were injected both intrathecally and intramuscularly with up to double the dose of NurOwn cells given in the Phase I trial. In addition, a number of patients showed some initial indications of clinical improvement.

In December 2013, the Company submitted an IND application to the FDA.

On December 4, 2013, a Notice of Intention to Grant from the EPO was issued for the Company's patent application entitled "Isolated Cells and Populations Comprising Same for the Treatment of CNS Diseases" (European serial number EP06766101.7). This patent relates to the production method for the Company's proprietary stem cells induced to secrete large quantities of neurotrophic factors for the treatment of neurodegenerative diseases.

OnTable ~~February 11, 2014, a Notice~~ of ~~Allowance was issued from the U.S. Patent Office for the same patent application as above, U.S. serial number 11/727,583.~~Contents

Onreporting ~~March~~company. ~~24,~~As ~~2014~~a result, ~~the~~current ~~Israeli~~and ~~Subsidiary~~potential ~~entered~~investors ~~into~~could alose ~~clinical trial~~confidence ~~agreement~~in ~~with~~our ~~The~~financial ~~General Hospital Corporation d/b/a MGH~~reporting, towhich ~~conduct~~could aharm ~~Phase~~our IIbusiness ~~clinical~~and ~~trial~~have ofan ~~the~~adverse ~~Company’s~~effect ~~NurOwn in~~on ~~ALS,~~our ~~pending~~share ~~FDA and IRB approvals~~price.

InDelaware ~~March~~law ~~2014,~~could ~~the~~discourage ~~U.S.~~a ~~Patent~~change ~~and~~in ~~Trademark~~control, ~~Office~~or ~~granted the~~an ~~Company~~acquisition aof ~~key~~us ~~patent~~by ~~for~~a ~~its~~third ~~autologous~~party, ~~stem~~even ~~cell~~if ~~technology. The patent covers~~ the ~~Company's~~acquisition ~~stem~~would ~~cells~~be ~~induced~~favorable to ~~secrete elevated~~you, ~~levels~~and ofthereby ~~neurotrophic~~adversely ~~factors~~affect ~~for~~existing ~~the treatment of neurodegenerative diseases~~stockholders.

OnThe ~~April~~Delaware ~~10,~~General ~~2014,~~Corporation ~~the~~Law ~~Company~~contain ~~announced~~provisions that may have the ~~U.S.~~effect ~~Patent and~~of ~~Trademark~~making ~~Office~~more ~~granted~~difficult ~~the~~or ~~Company~~delaying anattempts ~~additional~~by ~~patent~~others ~~for~~to ~~its~~obtain ~~autologous~~control ~~stem~~of ~~cell~~our ~~technology.~~company, ~~The~~even ~~patent~~when ~~covers~~these attempts may be in the ~~production method~~best interests of stockholders. Delaware law imposes conditions on certain business combination transactions with “interested stockholders.” These provisions and others that could be adopted in the ~~Company's~~future ~~proprietary~~could ~~stem~~deter ~~cells~~unsolicited ~~induced~~takeovers toor ~~secrete~~delay ~~significantly~~or ~~elevated~~prevent ~~levels~~changes ofin ~~neurotrophic~~our ~~factors~~control or management, including transactions in which stockholders might otherwise receive a premium for their shares over then current market prices. These provisions may also limit the ~~treatment~~ ability of ~~neurodegenerative~~stockholders ~~diseases~~to approve transactions that they may deem to be in their best interests.

OnWe ~~April~~do 8,not ~~2014,~~expect ~~the~~to ~~FDA~~pay ~~approved~~dividends ~~commencement of its Phase II clinical trial with NurOwn~~ in ~~patients with ALS. On June 6, 2014,~~ the ~~Company~~foreseeable ~~issued a press release announcing that its Phase II ALS clinical trial has now commenced with the enrollment of the first patient at MGH in Boston~~future, ~~Massachusetts. The Company’s Phase II trial is a randomized, double-blind, placebo controlled multi-center study designed to evaluate the safety~~ and ~~efficacy of~~accordingly ~~transplantation~~you ofmust ~~Autologous~~rely ~~Mesenchymal~~on ~~Stem~~stock ~~Cells~~appreciation ~~Secreting~~for ~~Neurotrophic~~any ~~Factors~~return ~~(MSC-NTF~~on oryour ~~NurOwn) in 48 ALS patients~~investment. ~~The trial is also being conducted at the UMass Memorial Hospital in Worcester, Massachusetts and the Mayo Clinic in Rochester, Minnesota.~~

OnWe ~~June~~have 1,paid ~~2014,~~no ~~the~~cash ~~interim~~dividends ~~results~~on ~~from~~ our ~~Phase~~Common ~~IIa~~Stock ~~ALS~~to ~~trial conducted at Hadassah Medical Center in Jerusalem~~date, ~~Israel~~and ~~were~~we ~~presented~~currently atintend ~~the~~to ~~Joint~~retain ~~Congress~~our offuture ~~European Neurology~~earnings, byif ~~Principal~~any, ~~Investigator~~to ~~Professor~~fund ~~Dimitrios~~the ~~Karussis.~~continued ~~The~~development ~~positive safety~~ and ~~preliminary~~growth ~~efficacy~~of ~~results~~our ~~observed in this study are consistent with results observed in the Company's previous Phase I/II trial~~business. ~~Between~~As ~~these two studies,~~ a ~~total of 26 patients have been treated with NurOwn~~result, ~~the~~we ~~Company’s~~do ~~stem~~not ~~cell~~expect ~~therapy~~to ~~candidate~~pay ~~for~~any ~~ALS.~~cash Individends ~~all 26 patients who received NurOwn~~ in the ~~two~~foreseeable ~~trials, no treatment-related serious adverse events were observed~~future. ~~In the three month pre-treatment “run-in” period~~Further, ~~71%~~any ofpayment ~~the patients showed progression~~ of ~~disease~~cash ~~with~~dividends ~~decline~~will inalso ~~neurological~~depend ~~function.~~on Inour ~~contrast,~~financial ~~in the three months post-transplantation with NurOwn~~condition, ~~63%~~results of ~~the patients who received intrathecal (IT)~~operations, orcapital ~~combined~~requirements IT and ~~intramuscular~~other ~~(IM) administration~~factors, ~~showed~~ ~~stabilization~~including orcontractual ~~improvement~~restrictions into ~~neurological~~which ~~function,~~we asmay ~~measured~~be ~~by their revised ALS functional rating score (ALSFRS-R). Additionally~~subject, ~~as Prof. Karussis discussed during his presentation, in both phases of the trial, 63% of the patients treated with NurOwn via IT or combined IT~~ and IMwill ~~administration~~be ~~were defined as “responders” (slower progression of disability or improvement in their neurological function)~~ at ~~3 months post-treatment, based on both their ALSFRS-R score and Forced Vital Capacity (FVC), an indication of respiratory function. The six patients treated with NurOwn in~~ the ~~earlier~~discretion ~~Phase I/II trial via IM administration only, primarily exhibited a localized positive effect. Similarly, in the same Phase I/II trial, the IT transplanted patients also showed indications~~ of ~~neurotrophic~~our ~~and regenerative effects, as evidenced by an increase in Compound Muscle Action Potential (CMAP)~~Board.

~~On June 6, 2014, the Company announced that the first patient had been enrolled in its Phase II ALS trial at MGH in Boston.~~

On June 6, 2014, the Company appointed Uri Yablonka as its Chief Operating Officer and director.

On June 9, 2014, the Company appointed Dr. Anthony (Tony) Fiorino as its Chief Executive Officer.

On June 10, 2014, the Company announced that it has initiated a study in a mouse model of autism at the Felsenstein Medical Research Center, Sackler Faculty of Medicine, Tel Aviv University, under the direction of Professor Daniel Offen. The study will explore the effects of the Company's MSC-NTF cells on mouse behavior. The study, which will be conducted using the BTBR mouse model for autism, will investigate repetitive behavior, increased cognitive flexibility and improved sociability in mice after administration of a single intracerebroventricular injection of the cells.

OnTable ~~June 27, 2014, the Company announced that its technology collaboration with Octane Biotech, Inc. reached an important milestone with the construction~~ of an Alpha prototype of a customized bioreactor for NurOwn production. The proprietary bioreactor under development will, if successful, provide the Company with large-scale manufacturing capabilities, enabling it to achieve economies of scale in the manufacture of NurOwn.Contents

~~Our~~CAUTIONARY ~~Proprietary~~STATEMENT ~~Technology~~REGARDING FORWARD-LOOKING STATEMENTS

~~Our~~The ~~NurOwn~~statements ~~technology~~contained isin ~~based~~this onprospectus aand ~~novel~~the ~~differentiation~~documents ~~protocol which~~we ~~induces~~incorporate ~~differentiation~~by ofreference ~~the~~herein ~~bone~~or ~~marrow-derived~~therein ~~mesenchymal~~that ~~stem~~are ~~cells~~not ~~into~~historical ~~neuron-supporting~~facts ~~cells,~~are ~~MSC~~“forward-~~NTF~~looking ~~cells,~~statements” ~~capable~~ within the meaning of ~~releasing~~the ~~several~~Private ~~neurotrophic~~Securities ~~factors,~~Litigation ~~including~~Reform ~~GDNF~~Act of 1995 and ~~BDNF,~~other ~~VEGF~~federal ~~and~~securities ~~HGF~~laws. ~~which~~Such ~~are~~forward-looking ~~critical~~statements ~~for~~may ~~the~~be ~~growth~~identified by, ~~survival~~among ~~and differentiation~~other things, the use of ~~developing~~forward-looking ~~neurons.~~terminology ~~GDNF~~such isas ~~one~~“believes,” of“intends,” “plans,” “expects,” “may,” “will,” “should,” “estimates,” or “anticipates” or the ~~most~~negative ~~potent~~thereof ~~survival~~or ~~factors~~other ~~known~~variations ~~for~~thereon ~~peripheral~~or ~~neurons.~~comparable ~~VEGF~~terminology, and ~~HGF have~~similar ~~been~~expressions ~~reported~~are intended to ~~have~~identify ~~important neuro~~forward-~~protective~~looking ~~effects in ALS~~statements.

~~Our~~We ~~approach~~remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements, or industry results, to be materially different from any future results, performance, levels of activity, achievements or industry results, expressed or implied by such forward-looking statements. Such uncertainties and other factors include, but are not limited to the potential consequences of our delisting from The Nasdaq Stock Market and move to over the OTCQB which could limit the liquidity and price of our Common Stock; the outcomes of the putative securities class action and derivative lawsuits filed by five of our shareholders; the potential for more derivative lawsuits to be brought; our need to raise additional capital; our ability to continue as a going concern; regulatory approval of our NurOwn® treatment candidate; the success of ~~neurodegenerative~~our ~~diseases~~product ~~with autologous~~development ~~adult~~programs ~~stem~~and ~~cells~~research; ~~includes~~regulatory and personnel issues; development of a ~~multi-step~~global ~~process~~market ~~beginning~~for ~~with~~our ~~harvesting~~services; the ability to secure and maintain research institutions to conduct our clinical trials; the ability to generate significant revenue, the ability of ~~undifferentiated~~our ~~stem~~NurOwn® ~~cells~~treatment candidate to achieve broader acceptance as a treatment option for ALS, PMS,AD or other neurodegenerative diseases, our ability to manufacture and commercialize our NurOwn® treatment candidate; obtaining patents that provide meaningful protection; competition and market developments; our ability to protect our intellectual property from infringement by third parties; health reform legislation; demand for our services; currency exchange rates and product liability claims and litigation; adverse developments affecting the ~~patient's own~~financial ~~bone~~services ~~marrow~~industry; political instability; unrest and wars, such as the conflicts involving Ukraine and ~~concluding~~Russia, Iran, ~~with~~and ~~transplantation~~Israel ofand ~~differentiated~~its surrounding regions; our clinical development activities; our ability to improve our internal control over financial reporting, ~~neurotrophic~~including ~~factor-secreting~~our ~~mesenchymal~~inability ~~stem~~to ~~cells~~remediate ~~(MSC~~the identified material weakness, as well as the costs and the time associated with such efforts, and other factors described under “Risk Factors” in Registration Statement on Form S-~~NTF) into~~1. These “forward-looking statements” are based on certain assumptions that we have made as of the ~~same~~date ~~patient~~hereof. –To ~~intrathecally~~the extent these assumptions are not valid, the associated “forward-looking statements” and~~/or~~ ~~intramuscularly~~projections will not be correct. ~~Intrathecal~~Although ~~(injection~~we ~~into~~believe that the ~~cerebrospinal~~expectations ~~fluid)~~reflected ~~transplantation consists~~in ofthese ~~injection~~“forward-looking ~~with~~statements” aare ~~standard~~reasonable, ~~lumbar~~we ~~puncture;~~cannot ~~there~~guarantee isany nofuture ~~need~~results, levels of activity, performance, or achievements. It is routine for aour ~~laminectomy~~internal –projections anand ~~invasive~~expectations to change as the year or each quarter in the year progresses, ~~orthopedic~~and ~~spine operation~~therefore toit ~~remove~~should abe ~~portion~~clearly understood that the internal projections and beliefs upon which we base our expectations may change prior to the end of each quarter or the year. ~~vertebral~~Although ~~bone~~these expectations may change, we may not inform you if they do and we undertake no obligation to do so, except as required by ~~other~~applicable ~~technologies~~securities laws and regulations. ~~Intramuscular~~We ~~(injection~~caution ~~directly~~investors ~~into muscle)~~that ~~transplantation~~our isbusiness ~~performed~~and ~~via~~financial aperformance ~~standard~~are ~~injection~~subject ~~procedure~~to assubstantial ~~well~~risks and uncertainties. In evaluating our business, prospective investors should carefully consider the information set forth under the caption “Risk Factors” in this Registration Statement on Form S-1.

Our proprietary technology is licensed to and developed by our Israeli Subsidiary.

The NurOwn Transplantation Process

· Bone marrow aspiration from patient;

· Isolation and expansion of the mesenchymal stem cells;

· Differentiation of the expanded stem cells into neurotrophic-factor secreting (MSC-NTF) cells; and

· Autologous transplantation into the patient’s spinal cord or muscle tissue.

Differentiation before Transplantation

The specialized cells secrete neurotrophic factors for:

· Protection of existing motor neurons;

· Promotion of motor neuron growth; and

· Re-establishment of nerve-muscle interaction.

Autologous (Self-transplantation)

~~Transplantation site and method~~

~~Clinical~~Table ~~Indication I: ALS (current) – Based on the approval~~ of the Israeli MoH, we are currently conducting a Phase IIa dose-escalating trial to evaluate safety and preliminary efficacy of NurOwn in ALS patients. Following approval of our IND application by the FDA, we have launched our Phase II clinical trial in the USA. We are considering whether to conduct further Phase II/III repeat dose clinical trials of NurOwn.Contents

~~Future~~USE ~~Clinical~~OF Development. Future development of NurOwn in ALS will require additional clinical trials, including the administration of repeated doses to ALS patients enrolled in those trials. The design and timing of subsequent clinical trials in ALS is currently under review by the Company. In addition, the Company is reviewing the potential clinical development of NurOwn in other neurodegenerative disorders.PROCEEDS

~~History~~All of the Offered Securities offered by the Selling Securityholders pursuant to this prospectus will be sold by the Selling Securityholders for their account. We will not receive any of the proceeds from these sales except with respect to amounts received by us upon the exercise of the Warrants for cash. Upon exercise of such Warrants, we will receive the applicable cash exercise price paid by the holders of the Warrants, and will use the net proceed for working capital purposes.

The Company was incorporated under the laws of the State of Washington on September 22, 2000, under the name Wizbang Technologies, Inc. and acquired the right to market and sell a digital data recorder product line in certain states in the U.S. Subsequently, the Company changed its name to Golden Hand Resources Inc. On July 12, 2004, the Company entered into a research and license agreement with Ramot to acquire certain stem cell technology and decided to discontinue all activities related to the sales of the digital data recorder product. In November 2004, the Company changed its name from Golden Hand Resources Inc. to Brainstorm Cell Therapeutics Inc. to better reflect its new line of business in development of novel cell therapies for neurodegenerative diseases. In October 2004, the Company formed its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd. in Israel. On December 18, 2006, the stockholders of the Company approved a proposal to change the state of incorporation of the Company from the State of Washington to the State of Delaware. The reincorporation was completed on December 21, 2006 through the merger of the Company into a newly formed, wholly-owned Delaware subsidiary of Brainstorm, also named Brainstorm Cell Therapeutics Inc. On February 19, 2013, the Israeli Subsidiary formed its wholly-owned subsidiary, Brainstorm Cell Therapeutics UK Ltd. in the United Kingdom (the UK Subsidiary).

~~Other~~MARKET ~~Recent~~INFORMATION ~~Developments~~FOR COMMON STOCK AND DIVIDEND POLICY

~~Public~~Market ~~Offerings~~Information

OnOur ~~August 16, 2013, the Company closed a public offering of an aggregate of 23,529,411 units at a public offering price of $0.17 per unit, with each unit consisting of one share of our~~ Common ~~Stock,~~ ~~and 0.75 of a warrant to purchase one share of our Common~~ Stock atis ancurrently ~~exercise~~quoted ~~price~~on ofthe ~~$0.25~~OTCQB ~~per~~Venture ~~whole~~Market ~~share~~under ~~of Common Stock (~~the ~~2013~~symbol ~~Public Offering)~~“BCLI”. The ~~warrants~~sales ~~were~~prices ~~immediately~~on ~~exercisable and will expire three years from~~ the ~~issuance~~OTCQB ~~date. No~~reflect ~~units~~inter-dealer ~~were issued~~prices, ~~however,~~without ~~and~~retail ~~purchasers~~mark-up, ~~received~~mark-down ~~only~~or ~~shares~~commission ~~of Common Stock~~ and ~~warrants. The Common Stock and the warrants~~ may ~~be transferred separately immediately upon issuances. We do~~ not ~~intend~~necessarily torepresent ~~list~~actual ~~the warrants on any securities exchange or other trading market and we do not expect that a public trading market will develop for the warrants~~transactions. The net proceeds to the Company were approximately $3.3 million, assuming no exercise of the warrants and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us associated with the 2013 Public Offering.

OnRecord July 17, 2012, we raised approximately $5.7 million through a public offering (the 2012 Public Offering) of our Common Stock. We issued a total of 19,818,968 shares of our Common Stock at $0.29 per share and 14,864,228 warrants to purchase shares of Common Stock for every share purchased in the 2012 Public Offering, at an exercise price of $0.29 per share. The warrants are exercisable until the 30 month anniversary of the date of issuance. After deducting closing costs and fees, we received net proceeds of approximately $5 million.Holders

As of May 15, 2026, there were approximately 47 holders of record of our Common Stock.

Dividends

We have not paid or declared any cash or other dividends on our Common Stock within the last two fiscal years. Any future determination as to the payment of dividends will depend upon our results of operations, and on our capital requirements, financial condition and other factors relevant at the time.

~~Governmental Grants~~

InTable ~~September 2011, we received notice from the Israeli Office~~ of ~~the Chief Scientist (OCS) of its commitment to grant the Company approximately $1.1 million in accordance with OCS guidelines and the relevant plan approved by the OCS (the Approved Plan).~~Contents

InMANAGEMENT’S ~~2012,~~DISCUSSION weAND ~~received~~ANALYSIS ~~notices~~OF ~~from~~FINANCIAL ~~the~~CONDITION ~~OCS~~AND ofRESULTS ~~its~~OF ~~commitment to grant the Company approximately $1,086,000 for the year ending June 30, 2013.~~OPERATIONS

InThe ~~December~~following ~~2013,~~discussion weand ~~were~~analysis ~~awarded~~should anbe ~~$800,000~~read ~~non~~in conjunction with our audited consolidated financial statements and the related notes that appear elsewhere in this Registration Statement on Form S-~~dilutive~~1. ~~grant~~ This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. Actual results may differ materially from ~~Israel’s~~those ~~Office~~discussed in these forward-looking statements due to a number of factors, including those set forth in the ~~OCS~~section ~~for~~entitled “Risk Factors” and elsewhere in Registration Statement on Form S-1. For further information regarding forward-looking statements, please refer to the ~~year~~section ~~2014~~“Cautionary Note Statement Regarding Forward-Looking Statements” in this Registration Statement on Form S-1.

InCompany ~~February 2014, we were awarded an additional $600,000 non-dilutive grant from the OCS for 2014.~~Overview

~~With~~We ~~regards~~are toa ~~any~~leading ~~funding~~biotechnology ~~received~~company ~~from~~engaged in the ~~OCS,~~development weof ~~are~~best-in-class ~~obligated to~~autologous ~~pay~~cellular ~~royalties~~therapies toderived ~~the~~from ~~OCS,~~a ~~amounting~~patient’s toown 3%bone tomarrow ~~3.5%~~cells offor ~~revenues~~the ~~(subject~~treatment toof ~~the~~neurodegenerative ~~relevant~~diseases. ~~regulations,~~We ashold ~~amended~~the ~~from~~rights ~~time~~ to ~~time)~~ ~~derived~~clinical ~~from~~development ~~sales~~and commercialization of the ~~products~~NurOwn® ~~funded~~technology ~~with~~platform ~~the~~through ~~OCS~~an ~~grant~~exclusive, ~~depending~~worldwide onlicensing ~~the~~agreement ~~origin~~(see ofdetails ~~the products’ production~~herein). ~~Such~~ ~~royalty~~NurOwn® ~~payments~~has ~~shall~~received beFast upTrack todesignation anfrom ~~amount~~the ~~equal~~FDA toin ~~100%~~ALS ofand ~~the~~has ~~grant~~additionally ~~received.~~been ~~The~~granted ~~grant~~Orphan isDrug ~~linked~~Status toby the ~~exchange~~FDA ~~rate~~and of the UEMA.~~S. dollar and bears interest of Libor per annum.~~

~~Any~~We ~~plan~~are ~~approved~~committed byto ~~the~~bring ~~OCS~~innovative ~~research~~central ~~committee~~nervous ~~for~~system ~~grant~~(“CNS”) ~~funding is~~adult ~~subject~~stem cell therapies to ~~Israel’s~~the ~~Encouragement~~market to improve the lives of ~~Industrial~~patients ~~Research~~with ~~and~~debilitating ~~Development~~neurodegenerative ~~Law,~~diseases. ~~5744~~As –a ~~1984~~leader ~~(R&D~~in ~~Law)~~CNS regenerative cellular medicines, ~~which~~we are leveraging NurOwn®, ~~among~~ ~~others~~its proprietary autologous mesenchymal stem cell platform technology, ~~restricts~~a ~~the~~strong ~~transfer~~and ofexpanded ~~any~~intellectual ~~know-how~~property (portfolio, as ~~further~~well ~~defined~~as ~~therein)~~manufacturing and ~~the~~commercialization ~~transfer~~capabilities, ofto ~~the~~address ~~manufacture~~growing ofunmet ~~the~~medical ~~outcome product~~needs across a broad range of neurodegenerative disorders, such ~~Approved~~as ~~Plan~~ALS, ~~outside~~PMS, AD and other neurodegenerative diseases. NurOwn® uses proprietary cell culture conditions to induce MSCs to secrete high levels of ~~Israel~~multiple neurotrophic factors to modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival and improve neurological function.

~~The~~Results ~~research committee may, in special cases, approve the transfer abroad~~ of know-how or any right thereof, derived from research and development conducted under the Approved Plan in Israel, in exchange for receiving know-how from the party abroad; provided, however, that such exchange is towards joint and new research and development.Operations

~~The~~For ~~research~~the ~~committee~~period ~~may,~~from ~~in special~~inception ~~cases~~(September ~~and~~22, on2000) ~~grounds~~until toMarch be31, ~~recorded~~2026, ~~approve~~we adid ~~request~~not togenerate ~~transfer~~any ~~outside~~revenues offrom ~~Israel,~~operations. ~~the~~In ~~manufacturing~~addition, orwe ~~the~~incurred ~~rights~~operating ~~to manufacture~~costs aand ~~product~~expenses ~~developed within the framework~~ of ~~the~~approximately ~~Approved Plan; provided~~$2, ~~however~~046,000 ~~that~~during inthe ~~exchange~~quarter ~~for~~ended ~~such~~March ~~approval~~31, ~~the~~ ~~OCS~~2026.In ~~shall~~addition, bewe ~~entitled~~incurred ~~to,~~operating ~~inter~~costs ~~alia,~~and ~~payment~~expenses of ~~increased~~approximately ~~royalties~~$10,307,000 ~~due~~during to the ~~transfer~~year ofended ~~such~~December ~~manufacturing~~31, ~~rights~~2025.

~~Collaboration~~Research ~~with~~and ~~Octane~~Development, ~~Biotech~~net

OnOur ~~December~~business ~~10,~~model ~~2012,~~calls wefor ~~signed~~significant ainvestments ~~development~~in ~~agreement~~research ~~(the Octane~~and ~~Agreement)~~development. ~~with~~Our ~~Octane~~research ~~Biotech~~and ~~Inc.~~development ~~of Kingston~~expenditures, ~~Ontario~~net ~~(Octane),~~in tothe year ~~jointly~~ended ~~collaborate~~December 31, ~~towards~~2025 ~~developing~~were ~~proprietary bioreactor~~$4,175,000, ~~for~~a ~~scale~~decrease ~~up production~~ of ~~our~~$476,000 ~~NurOwn~~compared ~~treatment. The customized bioreactor (the NurOwn Bioreactor) will enable us~~ to ~~enhance~~ ~~the efficiency of our NurOwn production process~~$4,651,000 ~~significantly increasing our production capabilities by using a single clean room~~ for ~~multiple~~the year ~~patients~~ended December 31, ~~reducing costs and time~~2024.

~~According~~This decrease is due to: ~~the~~(i) a ~~Octane~~decrease ~~Agreement~~of $401,000 infor ~~the~~costs ~~event~~related ~~that~~to ~~the~~clinical ~~parties successfully~~activities ~~complete~~suppliers; ~~the~~(ii) a ~~development~~decrease of ~~the~~$196,000 ~~NurOwn~~in ~~Bioreactor,~~connection ~~the~~with ~~parties~~materials ~~reserve~~and ~~the~~clean ~~right~~room tofacilities; ~~enter~~(iii) a ~~into~~decrease anof ~~agreement~~$38,000 for ~~the supply~~costs related to payroll expenses and (iv) a decrease of ~~clinical~~$132,000 ~~products~~in connection with depreciation and~~/or~~ ~~provisions~~travel costs. This decrease was partially offset by an increase of ~~services~~$291,000 in stock-based compensation expenses, patents, rent and other costs.

~~The~~Our ~~Octane~~research ~~Agreement~~and ~~further~~development ~~dictates~~expenditures, ~~that~~net ~~Octane~~in ~~shall~~the bequarter ~~prohibited from~~ended ~~selling~~March ~~and/or~~31, ~~transferring~~2026 ~~the~~were ~~NurOwn~~$762,000, ~~Bioreactor~~a decrease of $542,000 compared to ~~any~~$1,304,000 ~~third~~for ~~party~~the ~~without~~quarter ~~our~~ended ~~prior~~March ~~written~~31, ~~consent~~2025.

~~The~~This ~~3-year~~decrease ~~collaborative~~is ~~project~~due ~~with~~to: (i) a ~~total~~decrease ~~budget~~ of 1$279,~~365,~~000 ~~Canadian~~ ~~dollars~~for iscosts ~~being~~related ~~supported~~to bypayroll ~~the~~expenses ~~Canada~~and stock-~~Israel~~based ~~Industrial~~compensation ~~Research~~expenses, and ~~Development~~(ii) ~~Foundation~~a ~~which~~decrease ~~collaborates~~of ~~with the~~$311,000 ~~Israeli~~in ~~OCS.~~connection ~~The~~with ~~Israeli OCS has confirmed its participation~~materials, ~~in such project~~depreciation, ofpatents ~~approximately~~and Uother costs.S. ~~$141,000~~This ~~for~~decrease ~~the~~was ~~first year,~~partially ~~which~~offset ~~comprises~~by ~~50%~~(i) ofan ~~our~~increase ~~budget~~ of ~~approximately U.S.~~ $~~282~~48,000 for ~~that~~travel ~~period~~costs.

ByGeneral ~~the fourth quarter of 2013, Octane developed a first automation system prototype for culturing NurOwn cells,~~ and ~~for process development and optimization.~~Administrative

General and administrative expenses for the years ended December 31, 2025 and 2024 were $5,778,000 and $7,042,000, respectively. The decrease of $1,264,000 in general and administrative expenses is mainly due to: (i) a decrease of $852,000 in in payroll expenses and (ii) a decrease of $1,020,000 in the travel costs, consultants, rent costs, depreciation, stock costs and costs of our investor relations and public relations activities. This decrease was partially offset by an increase of $608,000 in stock-based compensation expenses.

~~Development of Cryopreservation Method~~

InTable ~~January 2013, we announced the development~~ of a proprietary method for cryopreservation, or freezing, of cells, which will enable long-term storage, and production of repeat patient doses of NurOwn without the need for additional bone marrow aspirations. We believe that cryopreservation will enable us to create a personalized NurOwn stem cell bank for each patient, for ongoing, repeat treatments.Contents

~~Orphan~~General ~~Drug~~and ~~Status~~administrative byexpenses for the ~~European~~quarters ~~Medicine~~ended ~~Agency~~March 31, 2026 and 2025 were $1,284,000 and $1,785,000, respectively. The decrease of $501,000 in general and administrative expenses is mainly due to: (~~EMA~~i) a decrease of $501,000 for costs related to payroll expenses and stock-based compensation expenses, and (ii) a decrease of $112,000 in rent costs, costs of our investor relations and public relations activities consultants and stock costs. This decrease was partially offset by an increase of $112,000 in consultants expenses.

OnFinancial July 17, 2013, we received Orphan Medicinal Product Designation for our NurOwn for the treatment of ALS from the European Commission. Orphan designation grants a 10-year marketing exclusivity in the EU for the designated indication, as well as several other regulatory incentives.Expenses

~~Clinical~~Financial ~~Trial~~expense ~~Update~~for the year ended December 31, 2025 was $533,000 as compared to financial expenses of $77,000 for the year ended December 31, 2024 as a result of interest paid for loans and due to conversion exchange rates.

OnFinancial ~~September~~expense 27, 2013, we announced that we had completed treatment of 12 patients in our ALS Phase IIa NurOwn dose-escalating clinical trial. We have been informed that one patient in the study expired due to a medical condition unrelated to the Clinical Trial. An interim safety summary for the ~~first~~quarter 12ended ~~patients~~March in31, ~~the study~~2026 was ~~submitted to the Hadassah Medical Center Ethical Committee about two months after transplantation of the 12th patient. One SAE (Serious Adverse Event~~$81,000 ~~death~~as ~~due~~compared to ~~cardiopulmonary~~financial ~~arrest)~~income ~~was reported as non-treatment related. The majority~~ of ~~the other~~$46,000 AEfor ~~observed were procedure related and not treatment related. In~~ the ~~three~~quarter ~~months~~ended ~~following~~March ~~this summary~~31, ~~one~~2025. ~~patient chose~~The tochange ~~undergo~~was ~~euthanasia~~primarily ~~and~~attributable ~~discontinued the study. Due~~ to ~~medical~~fluctuations ~~and technical considerations, two additional patients were enrolled~~ in ~~the~~foreign ~~trial~~currency inexchange ~~late~~rates ~~2013,~~and inincreased ~~order~~interest toexpense ~~preserve~~associated ~~the~~with ~~originally planned protocol design. These two patients were treated at~~ the ~~beginning~~Company’s ofoutstanding ~~the~~loan ~~second quarter of 2014~~obligations. ~~The complete and final statistical analysis of the Phase IIa data is expected to be available after 6 months of follow up with the patients.~~

OnNet December 10, 2013, we announced that Prof. Karussis presented some of his preliminary findings from our ALS Phase IIa NurOwn dose-escalating clinical trial at the 24th International Symposium on ALS/MND in Milan, Italy. According to Prof. Karussis, the safety data are "impressively positive," with only minimal and transient adverse events, even though the patients in this study were injected both intrathecally and intramuscularly with up to double the dose of NurOwn cells given in the Phase I trial. In addition, a number of patients showed some initial indications of clinical improvement.Loss

OnNet ~~March~~loss ~~24,~~for ~~2014~~the year ended December 31, ~~the~~2025 ~~Israeli~~was ~~Subsidiary~~$10,307,000, ~~entered~~as ~~into~~compared to a ~~clinical trial~~net ~~agreement~~loss ~~with~~of ~~MGH~~$11,623,000 tofor ~~conduct~~the year aended ~~Phase~~December 31, II2024. ~~clinical~~Net ~~trial~~loss ofper share for the year ~~Company’s~~ended ~~NurOwn~~December 31, in2025 ~~ALS~~and December 31, ~~pending~~2024 ~~FDA~~was $1.11 and ~~IRB~~$2.31, ~~approvals~~respectively.

OnThe ~~June~~weighted 1,average ~~2014,~~number ~~the~~of ~~interim~~shares ~~results~~of ~~from~~Common ~~our~~Stock ~~Phase~~used ~~IIa ALS trial conducted at Hadassah Medical Center~~ in ~~Jerusalem,~~computing ~~Israel~~basic ~~were presented at the Joint Congress of European Neurology by Principal Investigator Professor Dimitrios Karussis. The positive safety~~ and ~~preliminary~~diluted ~~efficacy~~net ~~results~~loss ~~observed~~per inshare ~~this~~for ~~study are consistent with results observed in~~ the year ~~Company's~~ended ~~previous~~December 31, ~~Phase~~2025 ~~I/II~~was ~~trial.~~9,268,976 ~~Between~~compared ~~these~~to ~~two studies~~5,021,798 afor ~~total~~the year ofended ~~26 patients have been treated with NurOwn~~December 31, ~~the Company’s stem cell therapy candidate for ALS~~2024.

OnThe ~~June~~increase 6,in ~~2014,~~the weweighted ~~announced~~average ~~that~~number ~~our~~of ~~Phase~~shares ~~II ALS clinical trial commenced with the enrollment~~ of ~~the~~Common ~~first~~Stock ~~patient~~used ~~at MGH~~ in ~~Boston,~~computing ~~Massachusetts.~~basic ~~Our~~loss ~~Phase~~per IIshare ~~trial~~for isthe year aended ~~randomized~~December 31, ~~double-blind, placebo~~2025 ~~controlled~~was ~~multi-center~~due ~~study designed~~ to: ~~evaluate~~ (i) the ~~safety~~issuance ~~and efficacy~~ of ~~transplantation~~shares ofto ~~Autologous~~employees ~~Mesenchymal Stem~~and ~~Cells~~directors; ~~Secreting Neurotrophic Factors~~ (~~MSC-NTF or NurOwn~~ii) issuance inand 48sale ~~ALS~~of ~~patients.~~shares ~~The~~of ~~trial~~Common isStock ~~also~~pursuant ~~being~~to ~~conducted at~~ the ~~UMass Memorial~~Distribution ~~Hospital~~Agreement ~~in Worcester, Massachusetts~~ and ~~the~~(iii) issuance ~~Mayo~~of ~~Clinic~~shares infor ~~Rochester,~~private ~~Minnesota~~placement.

~~Chief~~Net ~~Executive~~loss ~~Officer~~for the quarter ended March 31, 2026 was $2,127,000, as compared to a net loss of $2,864,000 for the quarter ended March 31, 2025. Net loss per share for the quarter ended March 31, 2026 and March 31, 2025 was $0.19 and $0.45, respectively.

OnThe ~~July~~weighted ~~28,~~average ~~2013,~~number ~~Alon Natanson, Chief Executive Officer~~ of ~~the~~ ~~Company,~~shares ~~informed us~~ of ~~his~~Common ~~resignation~~Stock ~~from~~used ~~his~~in ~~position~~computing ~~with~~basic ~~the~~and ~~Company~~diluted ~~effective~~net 90loss ~~days~~per ~~after~~share ~~the~~for ~~notice. Mr. Natanson continued to hold~~ the ~~title~~quarter ofended ~~Chief~~March ~~Executive~~31, ~~Officer~~2026 ofwas ~~the~~11,034,775 ~~Company~~compared ~~until~~to ~~October 28~~6, ~~2013~~342,002 ~~the~~for ~~end of~~ the 90quarter ~~day~~ended ~~notice~~March ~~period required~~31, ~~by Mr~~2025. ~~Natanson’s employment agreement.~~

Additional funding will be required to begin the commercialization efforts and to achieve a level of sales adequate to support the Company’s cost structure.

To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional public and private sales of its Common Stock and warrants, the exercise of warrants, the issuance of convertible promissory notes and other funding transactions. While the Company has been successful in raising financing recently and in the past, there can be no assurance that it will be able to do so in the future on a timely basis on terms acceptable to the Company, or at all. The Company’s common stock has been delisted from the Nasdaq and now trades on the OTCQB Venture Market. Accordingly, the August 9, 2021 ATM may no longer be available for use by the Company.

Management expects that the Company will continue to generate losses from the clinical development and regulatory activities, which will result in a negative cash flow from operating activity. The Company has completed regulatory review of the BLA for NurOwn for the treatment of ALS with the withdrawal of the BLA on November 3, 2023. The decision to withdraw the BLA was coordinated with FDA and is viewed by FDA as a withdrawal without prejudice. On November 20, 2023, we announced that the FDA granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting took place on December 6, 2023. On December 7, 2023, we announced the completion of a productive meeting with the FDA to discuss NurOwn®. The primary objective of the meeting was to discuss plans for an SPA with FDA on the overall protocol design for a planned Phase 3b registrational trial for NurOwn®. The ultimate goal of the SPA is to secure the FDA’s agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application. On February 23, 2024, we announced that we submitted the SPA request to the FDA for the planned Phase 3b clinical trial of NurOwn® for the treatment of ALS. On April 9, 2024, the Company announced that it received written agreement from the FDA, under an SPA, on the design for a Phase 3b trial of NurOwn® in ALS. The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating the Company’s adequacy in addressing objectives that

On August 1, 2013, the Company appointed Chaim Lebovits, the President of the Company, as its Principal Executive Officer, and to assume the duties and responsibilities of the Chief Executive Officer on an interim basis while we searched for a new Chief Executive Officer.

OnTable ~~June~~of ~~9, 2014, the Company appointed Dr. Tony Fiorino as our Chief Executive Officer.~~Contents

~~Our~~support ~~efforts~~a ~~are~~future ~~currently~~BLA ~~directed~~in ~~at:~~ALS. On June 26, 2024, the Company announced that it has reached alignment with FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm’s Phase 3b clinical trial for NurOwn®, its investigational therapy for ALS. This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a SPA agreement for its NurOwn Phase 3b trial.

·If ~~Completing~~the aCompany ~~Phase~~is ~~IIa~~not ~~dose-escalating~~able ~~clinical~~to ~~trial~~raise ofadditional ~~NurOwn~~capital for these purposes, the ~~treatment~~Company may not be able to continue to function as a going concern. The Company’s consolidated financial statements do not reflect any adjustments that might result from the outcome of ~~ALS~~this ~~with~~uncertainty. 14Our ~~ALS~~independent ~~patients~~registered inpublic ~~Israel;~~accounting firm has issued an audit report that includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern as of December 31, 2025.

·Liquidity ~~Conducting technology transfer of the NurOwn manufacturing process to the Mayo Clinic cell culture facility in Rochester~~ and ~~monitoring~~Capital the activities at the Dana Farber Cell culture facility (DFCI) in Boston, having completed the technology transfer to this site; · Fulfilling all requirements for IND approval; · Obtaining IRB approval at the Mayo clinical site; · Initiating a Phase II ALS clinical trial of NurOwn in the United States; · Collaborating with Octane on development of a customized NurOwn bioreactor; and · Completing pre-clinical studies of NurOwn for the treatment of MS.Resources

~~Stem~~Since ~~Cell~~inception, ~~Therapy~~the Company has financed its operations primarily through public and private sales of its Common Stock and warrants, the exercise of outstanding warrants, the issuance of convertible promissory notes, sales via the ATM programs and through various grants. At March 31, 2026 cash, cash equivalents and restricted cash amounted to $206,000. Subsequent to March 31, 2026, in May 2026, the Company received aggregate gross proceeds of $200,000 from the closing of two separate private placement transactions described under “Recent Financing Activities” below, which proceeds further supplemented the Company’s cash position.

~~Our~~Net ~~activities~~cash ~~are~~used ~~within~~in ~~the~~operating ~~stem~~activities ~~cell therapy field. Stem cells are non-specialized cells with a potential~~ for ~~both~~the ~~self-renewal~~three ~~and~~months ~~differentiation~~ended ~~into~~March ~~cell~~31, ~~types~~2026 ~~with~~was ~~a specialized function~~$1, ~~such as muscle~~320,000. ~~blood~~Cash orused ~~brain~~for ~~cells.~~operating ~~The~~activities ~~cells~~was ~~have~~primarily ~~the~~attributed ~~ability~~ to ~~undergo~~cost ~~asymmetric division such that one~~ of ~~the~~clinical ~~two~~trials, ~~daughter cells~~rent ~~retains the properties~~ of ~~the~~clean ~~stem~~room ~~cell, while the other begins to differentiate into a more specialized cell type. Stem cells are therefore central to normal human growth~~ and ~~development,~~materials ~~and also are a potential source of new cells~~ for ~~the~~clinical ~~regeneration of~~trials, ~~diseased~~payroll ~~and~~costs, ~~damaged~~rent, ~~tissue.~~outside ~~Stem~~legal ~~cell~~fee ~~therapy~~expenses ~~aims to restore diseased tissue function by the replacement~~ and~~/or~~ ~~addition~~public ~~of healthy~~relations ~~cells by stem cell transplants~~expenses.

~~Currently,~~Net ~~two~~cash ~~principal~~provided ~~platforms~~by ~~for~~financing ~~cell~~activities ~~therapy~~for ~~products are being explored: (i) embryonic stem cells (ESC), isolated from~~ the ~~inner~~three ~~mass~~months ofended aMarch ~~few days old embryo; and (ii) adult stem cells~~31, ~~sourced~~2026 ~~from~~was ~~bone marrow~~$1, ~~cord blood and various organs. Although ESCs are the easiest to grow and differentiate~~250,000 ~~their use~~from insales ~~human therapy is limited by safety concerns associated with their tendency to develop teratomas (a form~~ of ~~tumor)~~common ~~and~~stock ~~their potential~~under tothe ~~elicit~~private anplacement ~~immune reaction. In addition, ESC has generated much political~~ and ~~ethical~~proceeds ~~debate due to the derivation of ESCs~~ from ~~aborted~~short-term ~~fetuses~~loans.

~~Cell~~On ~~therapy~~August 9, ~~using~~2021, ~~adult~~the ~~stem~~Company ~~cells~~entered ~~avoids~~into ~~many~~an ofAmended ~~these~~and ~~concerns. Mesenchymal~~Restated ~~stem~~Distribution ~~cells~~Agreement (~~MSCs~~the “New Distribution Agreement”) ~~are~~with anthe ~~example~~Agents ofpursuant ~~adult~~to ~~stem~~which ~~cells.~~the ~~These~~Company ~~“multi-potent”~~may ~~cells~~sell ~~can~~from ~~produce~~time ~~more~~to ~~than one~~time, ~~type~~through ofthe ~~specialized~~Agents, ~~cell~~shares of ~~the~~Common ~~body~~Stock, ~~such~~having asan ~~bone~~aggregate offering price of up to $100,000,000 ~~fat~~(the “August 9, ~~cartilage~~2021, ~~and~~ATM”). ~~other~~Sales ~~types~~under ofthe ~~cells.~~August 9, ~~They~~2021, ~~secrete~~ATM ~~factors~~are ~~that~~to ~~promote tissue~~be ~~repair,~~made ~~and~~by ~~decrease~~any ~~inflammatory~~method ~~and~~permitted ~~immune~~by ~~reactions.~~law ~~The~~that ~~bone~~is ~~marrow~~deemed isto be an ~~invaluable~~“at ~~source~~the ofmarket” ~~MSCs.~~offering ~~Moreover,~~as ~~bone marrow~~defined ~~may~~in beRule 415 ~~obtained~~promulgated ~~through~~under athe ~~simple~~Securities ~~procedure~~Act, ofincluding, ~~aspiration~~without limitation, ~~from~~sales ~~the~~made ~~patient~~directly ~~himself,~~on ~~enabling~~the ~~autologous~~Nasdaq ~~cell~~Capital ~~therapy~~Market, ~~thus obviating~~on ~~the~~any ~~need~~other existing trading market for ~~donor~~the ~~matching~~Shares, ~~circumventing~~through ~~immune~~a ~~rejection~~market maker or as otherwise agreed by the Company and ~~other~~the ~~immunological~~Agents. ~~mismatch~~In ~~risks~~connection with the New Distribution Agreement, asthe ~~well~~Company asterminated ~~avoiding~~ the ~~need~~previous ~~for~~Distribution ~~immunosuppressive~~Agreement ~~therapy.~~and Wethe ~~believe~~September 25, ~~that~~2020, ~~autologous~~ATM. ~~bone~~During ~~marrow-derived~~the ~~mesenchymal~~nine months ~~stem~~ended ~~cells~~September 30, ~~which~~2025, ~~are~~the ~~capable of~~Company ~~in-vitro~~has ~~growth~~sold ~~and~~2,567,940 ~~multipotential~~shares ~~differentiation,~~of ~~are~~Common aStock ~~preferable~~for ~~source~~gross proceeds of ~~therapeutic~~approximately ~~stem~~$4,472 ~~cells~~under the August 9, 2021, ATM.

~~Neurodegenerative~~In ~~Diseases~~February 2026, the Company entered into two separate Securities Purchase Agreements (the “Agreements”) for the issuance of securities in private placement transactions, seeking to raise aggregate gross proceeds of up to $2,000,000. Under the terms of both Agreements, investors are purchasing units consisting of Common Stock at a purchase price of $0.60 per share, or Pre-Funded Warrants at a purchase price of $0.59995 per warrant (with an exercise price of $0.00005 per share) to comply with beneficial ownership limitations. In connection with these placements, the Company is also issuing Common Warrants exercisable for a number of shares equal to 120% of the purchased units at an exercise price of $1.00 per share, subject to standard anti-dilution adjustments.

Studies of neurodegenerative diseases suggest that symptoms that arise in afflicted individuals are secondary to defects in neuron cell function and neural circuitry. To date, these diseases have been treated effectively with systemic drug delivery. Consequently, alternative approaches for treating neurodegenerative diseases have been attempted, such as transplantation of cells capable of replacing or supplementing At-the-market ~~function~~(ATM) ~~of damaged neurons. For such cell replacement therapy to work, implanted cells must survive and integrate, both functionally and structurally, within the damaged tissue.~~Offerings:

On June 11, 2019, the Company entered into a distribution agreement with Raymond James & Associates, Inc. (“Raymond James”), pursuant to which the Company sold, through the Raymond James, shares of Common Stock having an aggregate offering amount of $20,000,000 (the “June 11, 2019 ATM”) in an “at the market” offering as defined in Rule 415 promulgated under the Exchange Act, including, without limitation, by sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and Raymond James.

On March 6, 2020, the Company entered into a new distribution agreement with Raymond James (the “Agent”), pursuant to which the Company was able to sell from time to time, through the Agent, shares of Common Stock, having an aggregate offering price of up to $50,000,000 (the “March 6, 2020, ATM”). Sales under the March 6, 2020 ATM were made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Exchange Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market

~~Amyotrophic Lateral Sclerosis (ALS)~~

~~ALS,~~Table often referred to as “Lou Gehrig's disease,” is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to death. As motor neurons degenerate, they can no longer send impulses to the muscle fibers that normally result in muscle movement. With voluntary muscle action progressively affected, patients in the later stages of the disease may become completely paralyzed. However, in most cases, mental faculties are not affected.Contents

~~Approximately~~maker ~~5,600~~or ~~people~~as inotherwise ~~the~~agreed ~~U.S.~~by ~~are~~the ~~diagnosed~~Company ~~with~~and ~~ALS each~~Raymond ~~year~~James. ItUnder isthe ~~estimated~~March 6, ~~that~~2020, ~~as many as 30~~ATM,~~000~~ ~~Americans have~~ the ~~disease~~Company atsold ~~any~~an ~~given~~aggregate ~~time.~~of ~~Estimated~~163,109 ~~annual~~shares ~~treatment~~of ~~costs for~~Common ~~advanced~~Stock ~~stage~~at ~~patients~~an ~~can~~average beprice asof ~~high~~$141.75 asper ~~$200~~share,~~000,~~ ~~representing~~raising angross ~~aggregate~~proceeds ~~direct cost to the healthcare system~~ of ~~more than~~approximately $623.11 ~~billion per year (Source: Alliance for Regenerative Medicine)~~million.

~~Early~~On ~~symptoms~~September 25, 2020, the Company entered into an Amended and Restated Distribution Agreement (the “Distribution Agreement”) with SVB Leerink LLC (“Leerink”) and Raymond James & Associates (together with Leerink, the “Agents”) pursuant to which the Company may sell from time to time, through the Agents, shares of ~~ALS~~Common ~~often~~Stock, ~~include~~having ~~increasing~~an ~~muscle~~aggregate ~~weakness~~ offering price of up to $45,000,000, which aggregate amount includes amount unsold pursuant to the March 6, 2020, ATM (the “September 25, 2020, ATM”). Sales under the September 25, 2020, ATM are to be made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Exchange Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or ~~stiffness~~as otherwise agreed by the Company and the Agents. The Distribution Agreement amends and restates in its entirety the Company’s prior agreement with Raymond James entered into on March 6, ~~especially~~2020 ~~involving~~(the “March 6, 2020, ATM”). The Company previously sold 163,109 shares of Common Stock for gross proceeds of approximately $23.11 million of Common Stock under the ~~arms~~March 6, 2020, ATM. During the quarter ended September 30, 2021, the Company did not sell any additional shares of its Common Stock pursuant to the September 25, 2020, ATM. Since inception and ~~legs~~as of September 30, ~~speech~~2021, ~~swallowing~~the orCompany ~~breathing~~had sold 314,752 shares of Common Stock for gross proceeds of approximately $29.1 million under the September 25, 2020, ATM.

~~ALS~~The isCompany ~~most~~has ~~often~~no ~~found~~obligation inunder the 40September 25, 2020, ATM to 70sell ~~year~~any ~~age~~shares ~~group~~and ~~with~~ may at any time suspend sales or terminate the ~~same~~September 25, ~~incidence~~2020, asATM ~~MS.~~in ~~There~~accordance ~~appear~~with its terms. Subject to bethe ~~more~~terms MSand ~~sufferers~~conditions ~~because~~of MSthe ~~patients~~Distribution ~~tend~~Agreement, the Agents will use their commercially reasonable efforts to ~~live~~sell ~~much~~on ~~longer~~the Company’s behalf, ~~some~~from ~~for~~time 30to ~~years~~ time consistent with its normal sales and trading practices, such Shares based upon instructions from the Company (including any price, time or ~~more~~size limits or other customary parameters or conditions the Company may impose). The ~~life~~Company ~~expectancy~~has ofprovided anthe ~~ALS~~Agents ~~patient~~with ~~averages~~customary ~~about~~indemnification ~~two~~rights, and the Agents will be entitled to ~~five~~a ~~years~~fixed commission of 3.0% of the aggregate gross proceeds from the ~~time~~Shares sold. The Distribution Agreement contains customary representations and warranties, and the Company is required to deliver customary closing documents and certificates in connection with sales of ~~diagnosis~~the Shares. ~~However~~Shares sold under the ATMs are issued pursuant to the Company’s existing Shelf Registration Statement, upand the Prospectus Supplement to ~~10% of~~the ~~ALS~~Registration ~~patients~~Statements ~~will~~filed ~~survive~~June 11, ~~more~~2019, ~~than~~March 6, ~~ten~~2020, ~~years~~and September 25, 2020, respectively.

~~Treatment~~On ~~decisions~~August 9, 2021, the Company entered into the New Distribution Agreement with the Agents pursuant to which the Company may sell from time to time, through the Agents, shares of Common Stock, having an aggregate offering price of up to $100,000,000 (the “August 9, 2021, ATM”). Sales under the August 9, 2021, ATM are ~~typically~~to ~~determined~~be made by any method permitted by law that is deemed to be an “at the ~~patient's symptoms~~market” offering as defined in Rule 415 promulgated under the Exchange Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and the ~~stage~~Agents. ofIn connection with the ~~disease~~New Distribution Agreement, the Company terminated the previous Distribution Agreement and the September 25, 2020, ATM. ~~Some~~During ~~medications~~the ~~used~~nine months ended September 30, 2025, the Company has sold 2,567,940 shares of Common Stock for ~~ALS~~gross ~~patients~~proceeds ~~include:~~of approximately $4,472 under the August 9, 2021, ATM.

·On ~~Riluzole~~April 2, -2024, ~~the~~we ~~only~~entered ~~medication~~into ~~approved~~Amendment ~~by the FDA to slow the progress of ALS~~No. 1 ~~While it does not reverse ALS, Riluzole has been shown~~ to ~~reduce nerve damage. Riluzole may extend~~ the ~~time~~New ~~before~~Distribution aAgreement ~~patient needs a ventilator~~ (a“Amendment ~~machine to assist breathing~~No. 1”) ~~and~~pursuant ~~may~~to ~~prolong~~which ~~the~~Leerink ~~patient's~~Partners ~~life~~ceased byto ~~several~~be ~~months;~~an agent.

·Recent ~~Baclofen~~Financing ~~or Diazepam - used to control muscle spasms, stiffness or tightening (spasticity) that interfere with daily activities; and~~Activities:

·On ~~Trihexyphenidyl~~October 31, or2025, ~~Amitriptyline~~the –Company ~~used~~entered into a securities purchase agreement (the “Vanquish Purchase Agreement”) with Vanquish Funding Group Inc., a Virgina corporation (“Vanquish”), pursuant to ~~treat~~which ~~patients~~the ~~who~~Company ~~have~~issued ~~excess~~to ~~saliva~~Vanquish ora ~~secretions~~promissory note (the “Note”) in the principal amount of $182,400 (including $22,400 of original issue discount) and ~~emotional~~received ~~changes~~funds of $155,000 after combined legal fees and due diligence fees of $5,000. Upon an event of default the Note is convertible into shares of common stock of the Company (“Conversion Shares”), subject to a 4.99% beneficial ownership limitation, at a 35% discount to the lowest trading price of the Company’s common stock for the 10 trading days prior to the conversion. The Note bears interest at 12%, which interest rate increases to 22% if not timely paid. The Note matures on August 30, 2026. Under the Note, $102,144 is payable on April 30, 2026 and $25,536 is payable on each of May 30, 2026, June 30, 2026, July 30, 2026, and August 30, 2026. The Vanquish Purchase Agreement provides that, subject to further agreement between Vanquish and the Company, Vanquish may provide additional tranches of financing during the next twelve (12) months of up to $2 million in the aggregate.

~~Other~~On ~~medications~~November 10, ~~may~~2025, bethe ~~prescribed~~Company toentered ~~help~~into ~~reduce~~a ~~such~~securities ~~symptoms as~~purchase ~~fatigue~~agreement (the “Securities Purchase Agreement”) with Labrys Fund II, L.P., ~~pain~~a Delaware limited partnership (“Labrys”), ~~sleep~~pursuant ~~disturbances~~to which the Company issued to Labrys a promissory note (the “Labrys Note”) in the principal amount of $143,750 ~~constipation~~(including $18,750 ~~and~~of ~~excess~~original ~~saliva~~issue discount) and ~~phlegm.~~received funds of $121,500

Multiple Sclerosis (MS)

MS is a chronic neurodegenerative disorder that affects the brain and spinal cord. Nerve cells are normally insulated with a protective layer called myelin, which allows nerve signals to travel properly. In MS, the myelin is destroyed (demyelination), causing loss of function of the nerve cells and disrupting transmission of brain messages to various parts of the body. While generally thought to be an autoimmune disease, the exact cause of MS is unknown.

There are currently over 2.5 million people with MS worldwide, with roughly 800,000 of these in the U.S. and Europe. Over 10,000 new cases are diagnosed annually in the U.S., with the majority of these in women between the ages of 20 and 50. Annual treatment costs for MS can be as much as $34,000 a year per patient.

MS can cause blurred vision, slurred speech, tremors, numbness, extreme fatigue, and problems with memory and concentration. Most MS patients experience muscle weakness in their extremities and difficulty with coordination and balance. These symptoms may be severe enough to impair walking or even standing. In the worst cases, MS can produce partial or complete paralysis. MS is not considered a fatal disease, as the vast majority of people with MS live a normal life-span. But the unpredictability of the disease can present many challenges, including the possibility of facing increasing limitations.

Most people experience MS symptoms between the ages of 20 and 40. At least two to three times more women than men have been diagnosed with MS. MS occurs in most ethnic groups, including African-Americans, Asians and Latinos, but is more common in Caucasians of northern European ancestry.

~~Treatment~~Table of MS focuses on symptom management, treatment of attacks, and reduction of disease progression. Of the nine FDA-approved, disease modifying treatments introduced since 1993, three are interferon-based, two are immunomodulators, one is an immunosuppressant, one is an antineoplastic, one is a monoclonal antibody, and one’s exact mechanism is unknown. (Source: National MS Society).Contents

~~While~~after ~~disease-modifying~~legal ~~treatments~~fees ~~reduce~~of $3,500. Upon an event of default, the ~~progression~~Labrys ~~rate~~ Note is convertible into shares of common stock of the ~~disease,~~Company ~~they~~(“Conversion doShares”), ~~not~~subject ~~stop~~to ita 4.99% Asbeneficial ~~multiple~~ownership ~~sclerosis progresses~~limitation, at a 25% discount to the ~~symptomatology~~lowest ~~tends~~trading price of the Company’s common stock for the 20 trading days prior to ~~increase~~the conversion. ~~Therefore,~~Under MSthe ~~treatment management~~Labrys ~~includes~~Note, ~~symptomatic~~$22,589 ~~treatments~~is aspayable ~~well~~on aseach ~~rehabilitative~~of ~~and~~May 11, ~~psychological~~2026, ~~approaches~~June 10, ~~such~~2026, asJuly 10, ~~physical~~2026, ~~therapy~~August 10, ~~speech therapy~~2026, ~~occupational~~September 10, ~~therapy~~2026, ~~support~~and ~~groups~~October 9, an2026. ~~exercise~~On ~~program~~November 10, a2026, ~~healthy~~the ~~lifestyle~~Note matures, ~~good~~and ~~nutrition,~~all ~~rest~~remaining principal and ~~relaxation~~any accrued and unpaid interests and other fees will be due.

~~The~~On ~~variable~~December 31, ~~clinical~~2025, ~~presentation~~January 5, of2026 MS and January 6, 2026, the ~~lack~~Company ofentered ~~established diagnostic~~into ~~laboratory~~three ~~tests~~separate ~~lead~~securities purchase transactions pursuant to ~~delays~~which ~~and~~it ~~difficulties~~issued inthree ~~diagnosis~~promissory notes to three institutional investors, as summarized below. ~~New~~Each ~~diagnostic~~transaction ~~methods~~was ~~are~~entered ~~being~~into ~~investigated~~in asreliance ~~well as~~upon ~~biomarkers~~exemptions ~~for~~from ~~monitoring~~registration ~~disease~~under ~~activity~~the Securities Act of 1933, as amended.

~~Parkinson’s~~On ~~Disease~~December 31, 2025, the Company entered into a Securities Purchase Agreement with Vanquish Funding Group Inc., under which the Company issued a note in the aggregate principal amount of $94,300 (PDincluding $12,300 original issue discount) for aggregate purchase price proceeds of $82,000, and with the agreement contemplating additional tranches of up to $2,000,000 subject to further agreement (the “Vanquish Note”). The Vanquish Note bears a one-time interest charge of 12%, matures October 30, 2026, and provides for five scheduled payments from June 30, 2026 through October 30, 2026, with a five-day grace period. The Company may prepay at specified discounts within 180 days after issuance. Five days after a material event of default, the holder may convert all or any portion of outstanding amounts into common stock at a price equal to 65% of the lowest trading price during the 10 trading days prior to conversion, subject to a 4.99% beneficial ownership limitation, customary adjustments, and specified liquidated damages for late delivery of conversion shares. The Vanquish Note includes customary covenants, events of default and related remedies, including a default payment equal to 150% of outstanding principal and accrued amounts, adjusted to 175% upon certain subsequent defaults, and is governed by Virginia law. The Vanquish Note is unsecured.

PDOn isJanuary 5, 2026, the Company entered into a ~~chronic,~~Note Purchase ~~progressive~~Agreement ~~disorder,~~with ~~affecting~~Quick ~~certain~~Capital, ~~nerve cells~~LLC, under which ~~reside~~the Company issued a convertible promissory note in the ~~Substantia~~principal ~~Nigra~~amount of ~~the~~$94,875, ~~brain~~ and ~~which~~received ~~produce~~aggregate ~~dopamine~~proceeds, of approximately $80,000, reflecting an original issue discount of $12,500 (the “Quick Capital Note”). The Quick Capital Note bears a ~~neurotransmitter~~one-time ~~that~~interest ~~directs~~charge equal to 10% of principal and ~~controls movement.~~matures In12 months PDfrom the issue date, ~~these~~with ~~dopamine-producing~~contractual monthly ~~nerve~~amortization ~~cells~~payments ~~break~~beginning ~~down~~July 5, ~~causing~~2026 ~~dopamine~~through ~~levels~~January 5, 2027. Upon an event of default, the holder may convert all or a portion of the outstanding amounts into common stock at a price per-share equal to ~~drop~~75% ~~below~~of the ~~threshold~~lowest ~~levels~~trading ~~and resulting~~price induring ~~brain~~the ~~signals~~20 ~~directing~~trading days ~~movement~~preceding conversion, subject to ~~become~~a ~~abnormal~~4.99% beneficial ownership limitation, customary adjustments, and specified liquidated damages for conversion delays. The ~~cause~~Quick Capital Note contains customary covenants, events of ~~the~~default, ~~disease~~cross-default provisions and remedies, including a default payment equal to 150% of outstanding principal and accrued amounts upon certain events of default. The Quick Capital Note is ~~unknown~~unsecured.

~~Over~~On January 6.3, ~~million~~2026, ~~people~~the ~~worldwide~~Company ~~suffer~~entered ~~from~~into PDa Securities Purchase Agreement with Auctus Fund, ofLLC, ~~whom~~under ~~about one~~which ~~million~~the ~~are~~Company issued a convertible promissory note in the ~~United~~aggregate ~~States.~~principal ~~Most~~amount ~~people~~of ~~are~~$140,000, ~~diagnosed~~including ~~with~~a ~~the~~$14,000 ~~disease~~original ~~between~~issue ~~the~~discount, ~~ages~~for cash proceeds of 55$126,000 ~~and~~before 65purchaser fees and ~~about~~due 85diligence costs withheld at closing (the “Auctus Fund Note”). The Auctus Fund Note bears a one-time interest charge of 12% of ~~people~~ ~~with~~principal, PDmatures ~~are~~12 months ~~over~~from the ~~age~~issue ofdate, 65and provides for scheduled amortization payments beginning 60 days after closing. ~~Prevalence~~Beginning six months after issuance, or earlier upon an event of PDdefault, the note is ~~increasing~~convertible inat ~~line~~a ~~with~~price ~~the~~equal ~~general~~to ~~aging~~65% of the ~~population.~~lowest ~~The~~traded ~~market for~~price ~~pharmaceutical~~during ~~treatments~~the ~~for~~15 PDtrading days ~~has~~prior ~~been~~to ~~estimated~~conversion, subject to bea ~~$2.~~4.99% ~~billion~~beneficial aownership ~~year~~limitation inand ~~the~~customary Uadjustments.~~S.,~~ ~~France,~~The ~~Germany,~~agreement ~~Italy,~~includes ~~Spain~~piggy-back registration rights, ~~the United~~a ~~Kingdom~~most favored nation provision and ~~Japan.~~variable ~~However~~rate transaction prohibitions, ~~these~~and ~~costs~~a ~~are~~right ~~dwarfed~~permitting ~~when~~the ~~compared~~holder to ~~the~~require ~~total~~up ~~economic~~to ~~burden~~50% of ~~the~~subsequent ~~disease,~~financing ~~which~~or ~~has been~~other ~~estimated~~specified bycash ~~the~~proceeds ~~National~~above ~~Parkinson~~a ~~Foundation~~$500,000 threshold to ~~exceed~~be ~~$14~~applied ~~billion~~to ~~annually~~repayment. inThe ~~the~~Auctus ~~U.S.~~Fund ~~alone,~~Note includes ~~including~~customary ~~costs~~events of ~~medical treatment~~default, ~~caring,~~remedies ~~facilities~~including a default amount equal to 150% of outstanding principal and ~~other~~accrued ~~services~~amounts, asliquidated ~~well~~damages asfor ~~loss~~conversion ofdelays, ~~productivity~~and ofprohibitions ~~both~~on ~~patients~~certain ~~and~~transactions. ~~caregivers~~The Auctus Fund Note is unsecured.

~~The~~In ~~symptoms~~February 2026, ofthe PDCompany ~~include~~entered ~~shaking~~into two separate Securities Purchase Agreements (~~tremor~~the “Agreements”) for the issuance of securities in private placement transactions, ~~stiff~~seeking ~~muscles~~to ~~(rigidity) and~~raise ~~slow~~aggregate ~~movement~~gross ~~(Bradykinesia)~~proceeds of up to $2,000,000. AUnder ~~person~~the ~~with~~terms ~~fully~~of ~~developed~~both PDAgreements, ~~may~~investors ~~also~~are ~~have~~purchasing aunits ~~stooped~~consisting ~~posture,~~of Common Stock at a ~~blank~~purchase ~~stare~~price orof ~~fixed~~$0.60 ~~facial expression~~per share, ~~speech~~or ~~problems~~Pre-Funded ~~and~~Warrants ~~difficulties~~at a purchase price of $0.59995 per warrant (with ~~balance~~an orexercise ~~walking~~price of $0.00005 ~~Although~~per itshare) ~~can~~to becomply ~~highly~~with ~~debilitating~~beneficial ownership limitations. In connection with these placements, the ~~disease~~Company is ~~not life~~also ~~threatening~~issuing ~~and~~Common anWarrants ~~average~~exercisable ~~patient’s~~for ~~life~~a ~~span~~number isof ~~approximately~~shares 20equal ~~years~~to ~~from~~120% of the ~~onset~~purchased units at an exercise price of ~~symptoms~~$1.00 per share, subject to standard anti-dilution adjustments.

~~Treatment~~On ofMay PD11, ~~primarily~~2026 ~~comprises~~the ~~dopamine~~Company ~~replacement,~~entered ~~either directly~~into two separate Securities Purchase Agreements (~~levodopa~~the “May 11 2026 SPAs”) for the issuance of securities in private placement transactions, ~~with~~seeking ~~dopamine~~to ~~mimetics~~raise oraggregate bygross ~~inhibition~~proceeds of ~~its~~up ~~breakdown~~to $1,000,000. ~~These~~Under ~~treatments~~the ~~focus~~terms onof ~~treating~~both ~~the~~May ~~symptoms of~~11, ~~the~~2026 ~~disease~~SPAs, ~~and~~investors are ~~not~~purchasing units consisting of Common Stock at a ~~cure~~purchase ~~for~~price PDof $0.95 per share, or Pre-Funded Warrants at a purchase price of $0.94445 per warrant (with an exercise price of $0.00005 per share) to comply with beneficial

Levodopa, which remains the standard and most potent PD medication available, has a propensity to cause serious motor response complications with long-term use. Moreover, effective drug dosage often requires gradual increase, leading to more adverse side effects and eventual resistance to its therapeutic action. This greatly limits patient benefit. Therefore, physicians and researchers have sought levodopa-sparing strategies in patients with early-stage disease to delay the need for levodopa.

PD is also treated by Deep Brain Stimulation (DBS), which consists of implanting electrodes deep into the brain to provide permanent electrical stimulation to specific areas of the brain and to cause a delay in the activity in those areas. However, DBS is problematic as it can cause uncontrollable and severe side effects such as bleeding in the brain, infection and depression. In addition, like drug therapy, DBS focuses on treating the symptoms of PD and does not provide a cure.

There is a greatly unsatisfied need for novel approaches towards management of PD, primarily to control levodopa-induced adverse side effects and motor dysfunction, as well as to delay the onset of disease-related dementia.

InTable addition to the symptomatic drug development approaches, there is an intense effort to develop cell and gene therapeutic “curative” approaches to restore the neural function in patients with PD, by (i) replacing the dysfunctional cells with dopamine producing cell transplant, or by (ii) providing growth factors and proteins, such as GDNF, that can maintain or preserve the patient’s remaining dopaminergic cells, protecting them from further degeneration. Preclinical evaluation of cell therapeutic approaches based on transplantation of dopaminergic neurons differentiated in-vitro from ESC, have been successful in ameliorating PD in animal models, as has direct gene therapy with vectors harboring the GDNF gene. However, these approaches are limited, in the first case, by the safety and ethical considerations associated with use of ESC, and, in the second case, by the safety risks inherent to gene therapy. As a result, intensive efforts have been made to develop an adult stem-cell based treatment.Contents

ownership limitations. In connection with these placements, the Company ~~Business~~is ~~Strategy~~also issuing Common Warrants exercisable for a number of shares equal to 120% of the purchased units at an exercise price of $1.45 per share, subject to standard anti-dilution adjustments.

~~Our~~On May 11, 2026, the Company isentered ~~focused~~into ona ~~advancing~~Securities Purchase Agreement with Vanquish Funding Group Inc., under which the ~~NurOwn~~Company ~~treatment~~issued a note in the aggregate principal amount of $151,800 (including $19,800 original issue discount) for aggregate purchase price proceeds of $132,000, and with the ~~goal~~agreement contemplating additional tranches of ~~obtaining~~up ~~FDA~~to ~~regulatory~~$2,000,000 ~~approval~~subject to further agreement. The note bears a one-time interest charge of 12%, matures February 27, 2026, and provides for ~~uses~~five asscheduled payments from October 30, 2026 through February 28, 2027, with a ~~treatment~~five-day grace period. The Company may prepay at specified discounts within 180 days after issuance. Five days after a material event of ~~ALS~~default, ~~patients~~the holder may convert all or any portion of outstanding amounts into common stock at a price equal to 65% of the lowest trading price during the 10 trading days prior to conversion, subject to a 4.99% beneficial ownership limitation, customary adjustments, and specified liquidated damages for late delivery of conversion shares. The note includes customary covenants, events of default and related remedies, including a default payment equal to 150% of outstanding principal and accrued amounts, adjusted to 175% upon certain subsequent defaults, and is governed by Virginia law. The note is unsecured.

·On ~~Phase~~May ~~IIa~~19, ~~dose-escalating~~2026 ~~safety~~the ~~and~~Company ~~preliminary~~entered ~~efficacy~~into ~~clinical~~a ~~trial~~Securities Purchase Agreements (the “May 19 2026 SPA”) for the issuance of securities in ~~Israel;~~private placement transactions, seeking to raise aggregate gross proceeds of $200,000. Under the terms of the May 19, 2026 SPA, the investor is purchasing units consisting of Common Stock at a purchase price of $0.95 per share, or Pre-Funded Warrants at a purchase price of $0.94445 per warrant (with an exercise price of $0.00005 per share) to comply with beneficial ownership limitations. In connection with these placements, the Company is also issuing Common Warrants exercisable for a number of shares equal to 120% of the purchased units at an exercise price of $1.45 per share, subject to standard anti-dilution adjustments.

·We ~~Phase~~expect IIthat ~~ALS~~we ~~safety~~will ~~and~~continue ~~preliminary~~to ~~efficacy~~generate losses from the clinical development and regulatory activities, which will result in a negative cash flow from operating activity. If we are granted an SPA with the FDA, additional capital raise will be needed to conduct a Phase 3b trial in ALS, to commercialize NurOwn® for ALS, and for future trials that may be needed for other indications. The actual amount of cash that the ~~United~~Company ~~States;~~will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our product candidates, along with cost to commercialize these product candidates.

·We ~~Phase~~anticipate ~~II/III~~that ~~repeat~~we ~~dose~~will ~~clinical~~need ~~efficacy~~to ~~trial~~raise substantial additional financing in the future to fund our operations. In order to meet these additional cash requirements, we may incur debt, license certain intellectual property, and seek to sell additional equity or convertible securities that may result in dilution to our stockholders. If we raise additional funds through the issuance of equity or convertible securities, these securities could have rights or preferences senior to those of our common stock and could contain covenants that restrict our operations. There can be no assurance that we will be able to obtain additional equity or debt financing on terms acceptable to us, if at all. Our future capital requirements will depend on many factors, including:

~~Additional~~● ~~strategic~~our ~~goals~~ability ofto ~~the~~obtain ~~Company:~~funding from third parties, including any future collaborative partners;

·● ~~Development~~the scope, rate of aprogress ~~customized~~and ~~NurOwn~~cost ~~bioreactor~~of ~~for~~our ~~optimization~~clinical trials and ~~scale-up~~other ofresearch ~~NurOwn~~and ~~production~~development programs;

·● ~~Development~~the oftime ~~additional~~and ~~clinical~~costs ~~indications,~~required ~~i.e.~~to MSgain regulatory approvals;

·● ~~Pursuing~~the ~~strategic~~terms ~~partnerships~~and ~~with~~timing ~~pharmaceutical~~of ~~companies~~any ascollaborative, welicensing ~~progress~~and ~~towards~~other ~~advanced~~arrangements ~~clinical~~that ~~development~~we ~~and~~may ~~commercialization.~~establish;

~~Sales~~● the costs of filing, prosecuting, defending and ~~Marketing~~enforcing patents, patent applications, patent claims, trademarks and other intellectual property rights;

We● ~~intend~~any toproduct ~~establish~~liability ~~and~~or ~~maintain~~other ~~fully-equipped~~lawsuits ~~cGMP-certified Cell-Processing~~related ~~Centers in strategic locations~~ to ~~conduct~~our ~~NurOwn~~product production and distribution over the broadest geographic area. Each Cell-Processing Center would receive an initial Bone Marrow sample of the patient, harvested at a medical center. The patient’s MSC cells would be isolated and expanded, in order to produce an initial dose of NurOwn cells. A master cell bank for each individual patient would be maintained for production of subsequent, future NurOwn doses on a long-term basis. These doses would be produced as needed and transported to the medical centers, where they would then be transplanted back into the patient.candidates;

We● ~~intend~~the toexpenses ~~seek~~needed ~~partnering~~to ~~opportunities~~attract ~~with~~and aretain ~~strategic partner~~skilled ~~as we progress towards advanced clinical development and commercialization.~~personnel;

~~Intellectual~~● ~~Property~~the costs and timing of future commercialization activities, including product manufacturing, marketing, sales, and distribution, for any of our product candidates for which we receive marketing approval;

~~Patents:~~● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;

On January 8, 2014 we announced that we received a Notice of Intention to Grant from the European Patent Office (EPO) for our patent application entitled "Isolated Cells and Populations Comprising Same for the Treatment of CNS Diseases" (European serial number EP 06766101.7) . This patent relates to the production method for the company's proprietary stem cells induced to secrete large quantities of neurotrophic factors for the treatment of neurodegenerative diseases.

On February 11, 2014 we were granted a U.S. Patent (No. 8,647,874) for the same patent application as above.

On March 4, 2014 we were granted a U.S. Patent (No. 8,663,987) for our “Mesenchymal Stem Cells for the Treatment of CNS Diseases” (serial number 12/994,761) patent application. This patent relates to our proprietary stem cells induced to secrete large quantities of neurotrophic factors for the treatment of neurodegenerative diseases.

WeTable ~~have~~of ~~pending patent applications in (1) the United States; (2) Europe; (3) Israel; and (4) Hong Kong, as follows:~~Contents

~~A. 1.~~● Athe ~~United~~general ~~States~~and ~~Provisional patent~~administrative ~~application~~expenses ~~filed~~related into ~~early~~being ~~2014.~~a public company;

2.● ~~United~~the ~~States~~effect ~~Provisional patent application Serial No. 61/679,822, filed August 6, 2012, entitled "Methods~~ of ~~Generating~~competition ~~Mesenchymal~~and ~~Stem~~market ~~Cells~~developments; ~~Which Secrete Neurotrophic Factors.” This application has now been filed as International Application No.: PCT IL2013/050660.~~and

~~This~~● ~~invention~~future ispre-clinical directed to a method of generating MSCs which secrete neurotrophic factors (NTFs) comprising incubating a population of undifferentiated MSCs in a differentiating medium comprising basic fibroblast growth factor (bFGF), platelet derived growth factor (PDGF), heregulin and ~~cAMP.~~clinical ~~The~~trial application also covers a method of treating a disease for which administration of neurotrophic factors is beneficial in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of isolated population of MSCs which secretes neurotrophic factors made according to the above methodresults. Also taught is a method of selecting MSCs which secrete NTFs from a mixed population of MSCs, comprising (a) analyzing the cells of said mixed population of cells for at least one of the following parameters: (i) cells which express CD44 below a predetermined threshold, or (ii) cells which express CD73 above a predetermined threshold; and (b) selecting cells which are positive for at least one of said parameters, thereby selecting the MSCs which secrete neurotrophic factors. The application teaches a pharmaceutical composition comprising the isolated population of MSCs as an active agent and a pharmaceutically acceptable carrier.

~~B. The~~Critical ~~Israeli Subsidiary~~Accounting is co-owner, with Ramot, in the invention entitled “Mesenchymal Stem Cells for the Treatment of CNS Diseases”, filed as a PCT application on May 26, 2009, currently pending as National Phase patent applications in the following countries:Policies

·Our ~~United~~consolidated ~~States:~~financial ~~Serial~~statements Noare prepared in accordance with accounting principles generally accepted in the U.S. ~~14/164~~The preparation of our consolidated financial statements and disclosures requires us to make judgments,~~286~~ estimates, and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported revenue and expenses during the reporting periods. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions and conditions.

·While ~~Europe:~~our ~~Serial~~significant ~~No.~~accounting ~~09754337~~policies are described in more detail in the notes to our audited consolidated financial statements appearing elsewhere in this Registration Statement on Form S-1, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.5

·Accounting ~~Europe:~~for ~~Serial~~stock-based ~~No. 13164650.7~~compensation:

·We ~~Israel:~~grant ~~Serial~~equity-based Noawards under share-based compensation plans. ~~209604~~We estimate the fair value of share-based payment awards using the Black-Scholes option valuation model. This fair value is then amortized over the requisite service periods of the awards. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. Share-based compensation expense is based on awards ultimately expected to vest, and therefore is reduced by expected forfeitures. Changes in assumptions used under the Black-Scholes option valuation model could materially affect our net loss and net loss per share.

·We ~~Hong~~have ~~Kong:~~no ~~Serial~~off-balance ~~No.~~sheet ~~11107062~~arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures, or capital resources.5

~~· Hong Kong: Serial No. 13109415.3~~

This invention is directed to an isolated human cell comprising at least one mesenchymal stem cell phenotype and secreting brain-derived neurotrophic factor (BDNF), wherein a basal secretion of the BDNF is at least five times greater than a basal secretion of the BDNF in a mesenchymal stem cell. Also disclosed in this application is an isolated cell population comprising human mesenchymal stem cells, wherein at least 50% of the cells express glial fibrillary acidic protein (GFAP) and secrete at least one neurotrophic factor. Also taught is an isolated cell population comprising human cells wherein (i) at least N% of said human cells secreting BDNF, wherein a basal secretion of said BDNF is at least five times greater than a basal secretion of the BDNF in a mesenchymal stem cell; (ii) at least M% of said human cells comprise at least one mesenchymal stem cell phenotype; and (iii) at least one of the human cells secretes the BDNF and the mesenchymal stem cell phenotype; where M and N are each independently selected between 1 and 99. Methods of generating same and uses of same are also disclosed. The method of generating cells useful for treating a CNS disease or disorder comprises (a) incubating mesenchymal stem cells in a culture medium comprising platelet lysate to generate propagated mesenchymal stem cells; and (b) incubating said propagated mesenchymal stem cells in a differentiating medium, thereby generating cells useful for treating the CNS disease or disorder. Another method taught is that of generating cells secreting neurotrophic factors, comprising (i) incubating mesenchymal stem cells in a serum free medium comprising platelet lysate to generate propagated mesenchymal stem cells; and (ii) incubating the propagated mesenchymal stem cells in a differentiating medium comprising at least one differentiating agent, said at least one differentiating agent being selected from the group consisting of platelet derived growth factor (PDGF), human neuregulin 1-b1, FGF2, EGF, N2, IBMX and cAMP, thereby generating cells secreting neurotrophic factors. The European applications claim an isolated human cell comprising a cell being non-genetically manipulated, and characterized by: a) expressing tyrosine hydroxylase, nestin and H-NF and b) secreting BDNF, and c) not secreting nerve growth factor (NGF) wherein a basal secretion of said BDNF is at least five times greater than a basal secretion of said BDNF in a mesenchymal stem cell; an isolated cell population comprising cells generated from human bone marrow derived cells expressing CD73, CD90 and CD105 and not expressing CD14, CD19, CD34, CD45 and HLA-DR, wherein at least 50% of the cells of the cell population express GFAP and secrete BDNF; and a method of generating cells useful for treating a CNS disease or disorder, the method comprising: (1) incubating bone marrow derived cells expressing CD73, CD90 and CD105 and not expressing CD14, CD19, CD34, CD45 and HLA-DR in a culture medium comprising human platelet lysate to generate propagated cells; and (2) incubating said propagated cells in a medium comprising a differentiating agent, thereby generating cells useful for treating the CNS disease or disorder, wherein said differentiating agent is selected from the group consisting of PDGF, human neuregulin 1-β1, FGF2, EGF, N2, IBMX and cAMP.

~~C. The Israeli Subsidiary is the licensee of the following patent applications owned by Ramot under terms set forth in the Second Ramot Agreement and the Assignment Agreement, as follows:~~

1.Table ~~Invention entitled “Isolated Cells and Populations Comprising Same for the Treatment~~ of ~~CNS Diseases”, filed as a PCT application on June 18, 2006, currently pending as National Phase patent applications in the following countries:~~Contents

~~· Europe: Serial No. 06766101.7~~BUSINESS

·Company ~~Europe: Serial No. 11000994.1~~Overview

·Brainstorm ~~Hong~~Cell ~~Kong:~~Therapeutics Inc. ~~Serial~~is Noa leading biotechnology company committed to the development and commercialization of best-in-class autologous cellular therapies for the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”, also known as Lou Gehrig’s disease), progressive multiple sclerosis (“PMS”), Alzheimer’s disease (“AD”), and other neurodegenerative diseases. ~~12112468~~NurOwn®, our proprietary cell therapy platform, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells (“MSCs”) to secrete high levels of neurotrophic factors (“NTFs”), modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival and improve neurological function.4

·NurOwn® ~~United~~has ~~States:~~completed ~~Serial~~its NoPhase 3 ALS and Phase 2 PMS clinical trials. ~~14/173~~On November 17,~~846~~ 2020, we announced top-line data from our Phase 3 ALS trial. On March 24, 2021, we announced positive top-line data from our Phase 2 trial evaluating three repeated intrathecal administrations of NurOwn®, each given 2 months apart, as a treatment for PMS. On June 24, 2020, we announced a new clinical program focused on the development of NurOwn® as a treatment for AD.

~~This~~On ~~invention~~August 15, is2022, ~~directed~~we announced our decision to ansubmit ~~isolated~~a ~~human~~Biologics ~~cell~~License Application (“BLA”) to the U.S. Food and ~~populations thereof~~Drug ~~comprising~~Administration at(“FDA”) ~~least~~for ~~one~~NurOwn® ~~astrocytic~~for ~~phenotype~~the ~~and~~treatment atof ~~least~~ALS. ~~one~~On ~~mesenchymal~~September 9, ~~stem~~2022, ~~cell~~we ~~phenotype~~filed a BLA to the FDA for NurOwn® for the treatment of ALS. On November 10, ~~wherein~~2022, we announced that we had received a refusal to file (“RTF”) letter from the ~~mesenchymal stem~~FDA ~~cell~~regarding ~~phenotype~~our isBLA. ~~not~~The FDA indicated that we may request a Type A meeting to discuss the content of the RTF letter. On December 12, 2022, we announced the submission of a Type A meeting request with the FDA to discuss the contents of the RTF letter previously issued by the FDA regarding the BLA for NurOwn® for the treatment of ALS. On December 27, 2022, we announced that the FDA granted a Type A meeting to discuss the contents of the RTF letter previously issued regarding our BLA for NurOwn® for the treatment of ALS. The Type A Meeting was held on January 11, 2023. The perspective shared by the FDA review team reflected what was in the previously issued RTF letter. Conversations with the FDA on the best pathway to resolve the outstanding questions that remained continued, following the Type A meeting. During these discussions, Brainstorm was presented with multiple options to return the BLA to regulatory review, which included the regulatory procedure to File over Protest. Additionally, within these discussions, the FDA committed to review amendments that were filed to address items raised in the RTF letter. These discussions resulted in Brainstorm requesting the FDA to File over Protest, as this was the regulatory procedure that would allow us to reach an ~~astrocytic~~FDA ~~phenotype;~~Advisory Committee (“ADCOM”) in the shortest amount of time. Brainstorm notified the FDA on February 6, 2023 of our decision to request the FDA to File over Protest the NurOwn® BLA for ALS. We received confirmation from the FDA that the BLA was re-filed on February 7, 2023. We received the FDA Type A meeting minutes on February 9, 2023. We submitted an ~~isolated~~amendment ~~human~~to ~~cell~~our ~~comprising~~BLA aton ~~least~~March 7, ~~one~~2023, ~~mesenchymal~~in ~~stem~~which ~~cell~~we ~~phenotype and~~responded atto ~~least~~the ~~one~~majority ~~astrocytic~~of ~~structural~~the ~~phenotype~~items included in the RTF letter. Written feedback was received on March 22, ~~wherein~~2023, from the ~~mesenchymal~~FDA ~~stem~~project ~~cell~~manager ~~phenotype~~associated iswith ~~not~~the BLA confirming the FDA’s decision to grant an ~~astrocytic~~ADCOM ~~structural~~for ~~phenotype; or~~the NurOwn® BLA for ALS. On March 27, 2023, we announced that the FDA will hold an ~~isolated~~ADCOM ~~human~~to ~~cell~~discuss ~~comprising~~the atcompany’s ~~least~~BLA ~~one~~for ~~mesenchymal~~NurOwn® ~~stem~~for ~~cell~~the ~~phenotype~~treatment ~~and~~of atALS. ~~least~~On ~~one~~June 6, ~~astrocytic~~2023, ~~functional~~we ~~phenotype~~announced that the advisory committee meeting has been scheduled for September 27, ~~wherein~~ 2023. On September 22, 2023, we submitted an amendment to our BLA to revise the ~~mesenchymal~~indication ~~stem~~to ~~cell~~NurOwn® ~~phenotype~~for isthe treatment of mild to moderate ALS. On September 27, 2023, we announced that the Advisory Committee voted, with 17 voting no, one voting yes, and one abstention, that NurOwn® did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS. On October 18, 2023, we announced that FDA invited the Company to request an ~~astrocytic~~expedited ~~functional~~face-to-face ~~phenotype~~meeting to discuss the path forward for NurOwn® as a treatment for ALS. ~~Also~~Brainstorm ~~taught~~remains committed to the ALS Community and is aactively ~~method~~exploring the next steps in support of ~~generating~~NurOwn®, ~~astrocyte-like cells~~including ~~expressing~~publication ~~S100~~of ~~beta~~emerging clinical data and development of a protocol for an additional clinical study. On October 18, ~~glial~~2023 ~~fibrillary~~Brainstorm ~~acidic~~announced ~~protein~~that ~~(GFAP)~~the BLA for NurOwn® would be withdrawn. The BLA was withdrawn on November 3, ~~glutamine~~2023. ~~sythetase~~The decision to withdraw the BLA was coordinated with FDA and is viewed by FDA as a withdrawal without prejudice. On November 20, ~~GLAST~~2023, ~~GLTI~~we ~~and~~announced ~~glial~~that ~~derived~~the ~~neurotrophic factor~~FDA ~~(GDNF)~~granted ~~comprising~~the (company a) ~~culturing~~meeting ~~mesenchymal~~to ~~stem~~discuss ~~cells~~the regulatory path forward for NurOwn® in ALS. The meeting took place on December 6, 2023. On December 7, 2023, we announced the completion of a ~~medium~~productive ~~comprising~~meeting ~~human~~with ~~epidermal~~the ~~growth~~FDA ~~factor~~to ~~(hEGF)~~discuss ~~and~~NurOwn®. ~~human basic~~The ~~fibroblast~~primary ~~growth~~objective ~~factor~~of ~~(hbFGF);~~the ~~and~~meeting was to discuss plans for a Special Protocol Assessment (b“SPA”) ~~incubating~~with FDA on the ~~mesenchymal~~overall ~~stem~~protocol ~~cells~~design infor a ~~differentiating~~planned ~~medium~~Phase ~~comprising~~3b ~~platelet derived~~registrational ~~growth~~trial ~~factor~~for NurOwn®. The ultimate goal of the SPA is to secure the FDA’s agreement that critical elements of the overall protocol design (~~PDGF~~e.g., entry criteria, endpoints, planned analyses) are adequate and ~~human~~acceptable ~~neuregulin~~for ~~1-b1~~a study intended to support a future marketing application. On February 23, ~~thereby~~2024, ~~generating~~we ~~astrocyte-like~~announced ~~cells~~that we submitted the SPA request to the FDA for the planned Phase 3b clinical trial of NurOwn® for the treatment of ALS. ~~Another~~On ~~disclosed~~April 9, ~~method~~2024, the Company announced that it received written agreement from the FDA, under a SPA, on the design for a Phase 3b trial of ~~generating astrocyte-like~~NurOwn® ~~cellse~~in ~~teaches~~ALS. ~~(i)~~The ~~incubating~~SPA ~~mesenchymal~~agreement ~~stem~~with ~~cells~~the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating the Company’s adequacy in addressing objectives that support a ~~medium~~future ~~comprising~~BLA ~~hEGF~~in ~~and~~ALS. ~~hbFGF~~On toJune 26, ~~generate~~2024, ~~cells~~the ~~predisposed to~~Company ~~generate~~announced ~~into~~that ~~astrocyte-like~~it ~~cells;~~has reached alignment with FDA on the Chemistry, Manufacturing, and Controls (ii“CMC”) ~~incubating~~aspects of Brainstorm’s Phase 3b clinical trial for NurOwn (R), its investigational therapy for ALS. This Type C meeting builds upon the ~~predisposed~~positive ~~cells~~momentum established in aApril 2024, ~~differentiating~~when ~~medium~~the ~~comprising~~FDA ~~PDGF~~granted ~~and human~~BrainStorm ~~neuregulin~~a ~~1-b1,~~SPA ~~thereby~~agreement ~~generating~~for ~~astrocyte-like~~its ~~cells~~NurOwn Phase 3b trial. Our wholly

2. Invention entitled “Methods, nucleic acid constructs and cells for treating neurodegenerative disorders”, filed on May 17, 2005 as United States patent application Serial No. 13/783,607. This invention is directed to a method of treating a neurodegenerative disorder by administering to an individual in need thereof cells capable of exogenously regulatable neurotransmitter synthesis. The cells are produced by incubating bone marrow stromal cells in a differentiating medium comprising docosahexaenoic acid or arachidonic acid and at least one differentiating agent.

Trademarks:

We own a pending United States application to register the trademark NUROWN (application no. 85154891, filed October 18, 2010) for use in connection with “compositions of cells derived from stem cells for medical purposes; stem cells for medical purposes.” The application was filed based on an intent-to-use the mark, but has not matured to registration yet.

The patent applications, as well as relevant know-how and research results are licensed from Ramot. We intend to work with Ramot to protect and enhance our mutual intellectual property rights by filing continuations and divisional patent applications. New discoveries arising in the course of research and development within the Company will be patented by us independently.

~~Research~~Table ~~and~~of ~~License Agreement with Ramot~~Contents

Onowned ~~July~~Israeli 12subsidiary, ~~2004,~~Brainstorm weCell ~~entered~~Therapeutics Ltd. ~~into a Research and License Agreement~~ (~~the~~“Israeli ~~Original Ramot Agreement~~Subsidiary”) ~~with Ramot~~, ~~the~~holds ~~technology~~exclusive ~~licensing~~rights ~~company~~to ofcommercialize ~~Tel~~NurOwn® ~~Aviv~~technology ~~University,~~through ~~which agreement was amended on March 30, 2006 by the Amended Research and License Agreement (described below). Under the terms of the Original Ramot Agreement, Ramot granted to us~~ a ~~license~~licensing toagreement ~~(i) the inventions, know-how and results made~~ with respect to the above-mentioned stem cell technology developed by the team led by Prof. Melamed and Prof. Offen in the course of performance of the research, and the patents and pending patent applications owned by Ramot, ~~and (ii)~~ the ~~results of further research to be performed by the same team on the development of the stem cell~~ technology. ~~Simultaneously~~transfer ~~with~~company ~~the execution~~ of ~~the~~Tel ~~Original~~Aviv ~~Ramot Agreement~~University, ~~we entered into individual consulting agreements with Prof~~Israel. Melamed and Prof. Offen pursuant to which all intellectual property developed by Prof. Melamed or Prof. Offen in the performance of services thereunder will be owned by Ramot and licensed to us under the Original Ramot Agreement.

OnNurOwn® ~~March~~has ~~30,~~a ~~2006~~strong and ~~May~~comprehensive ~~23,~~intellectual ~~2006,~~property weportfolio ~~entered into an Amended Research~~ and ~~License~~was ~~Agreement~~granted ~~and~~Fast anTrack ~~Amendment~~designation ~~Agreement~~by to the ~~Amended~~FDA ~~Research~~ and ~~License~~Orphan ~~Agreement,~~Drug ~~respectively~~status ~~(the~~by ~~Amended Research and License Agreement) with Ramot. Under~~ the ~~Amended~~FDA ~~Research~~ and ~~License Agreement,~~ the ~~funding~~European ofMedicines ~~further~~Agency research relating to the licensed technology in an amount of $570,000 per year was reduced to $380,000 per year. Moreover, under the Amended Research and License Agreement, the initial period of time that we agreed to fund the research was extended from an initial period of two (2“EMA”) ~~years~~for ~~to an initial period of three (3) years~~ALS. ~~The Amended Research and License Agreement also extended the additional two-year period in the Original Ramot Agreement to an additional three-year period, if certain research milestones were met.~~

WeOur ~~entered~~human ~~into~~capital aresource ~~Second~~objectives ~~Amended~~include, ~~and~~as ~~Restated~~applicable, ~~Research and License Agreement with Ramot on July 26~~identifying, ~~2007~~recruiting, ~~effective July 12~~retaining, ~~2004 (the Second Ramot Agreement)~~incentivizing, ~~which amended~~ and ~~replaced~~integrating ~~the~~our ~~Amended Research~~existing and ~~License~~new ~~Agreement.~~employees, ~~The~~advisors ~~Second~~and ~~Ramot~~consultants ~~Agreement~~to ~~imposed~~accomplish onour usgoal ~~development~~of ~~and~~developing ~~commercialization obligations, milestone~~ and ~~other~~launching ~~obligations.~~a ~~The~~novel ~~license~~cell ~~was~~therapy ~~granted in consideration~~ for ~~(i)~~neurodegenerative ~~royalty~~diseases. ~~payments~~The ~~ranging~~principal ~~from~~purposes ~~three percent (3%) to five percent (5%)~~ of ~~all~~our ~~net~~equity ~~sales~~ and ~~(ii)~~cash ~~potential~~incentive ~~payments~~plans ~~concerning~~are ~~sublicenses ranging from twenty percent (20%)~~ to ~~twenty-five percent~~attract, ~~(25%)~~retain ofand ~~sublicense~~reward ~~receipts.~~personnel Inthrough ~~addition, in~~ the ~~event~~granting ~~that~~of ~~the~~stock-based ~~research~~and ~~period~~cash-based ~~was~~compensation ~~extended~~awards, ~~for an additional three year period~~ in ~~accordance~~order ~~with~~to ~~the~~increase ~~terms~~stockholder ofvalue ~~the~~and ~~Second~~our ~~Ramot~~success ~~Agreement,~~by ~~then~~motivating wesuch ~~had~~individuals to ~~make~~perform ~~payments~~ to ~~Ramot for each year of~~ the ~~extended research~~best ~~period in the amount~~ of ~~$380,000.~~their Asabilities ~~of June 30, 2007, we owed Ramot an aggregate amount of $513,249 in overdue payments~~ and ~~patent~~achieve ~~fees~~our ~~under the Amended Research and License Agreement~~objectives.

OnWe ~~August~~currently 1,employ ~~2007,~~20 weemployees ~~obtained~~in athe ~~waiver~~United States and ~~release~~in ~~from~~Israel. ~~Ramot pursuant~~Most toof ~~which~~the ~~Ramot~~senior ~~agreed~~management toteam anare ~~amended~~based ~~payment~~in ~~schedule~~the ~~regarding~~United ~~our~~States, ~~payment~~and ~~obligations~~all ~~under~~of ~~the~~our ~~Second~~clinical ~~Ramot~~trial ~~Agreement~~ sites for ALS and ~~waived~~PMS ~~all~~from ~~claims~~our ~~against~~late usphase ~~resulting~~trials ~~from~~are ~~our~~in ~~previous~~the ~~breaches,~~United ~~defaults~~States. ~~and~~Our ~~non-payment~~R&D ~~under~~center ~~the~~is ~~Amended~~located ~~Research~~in ~~and License~~Petach ~~Agreement~~Tikva, Israel.

~~After~~Recent our failure to meet the amended payment schedule and subsequent negotiations, on December 24, 2009, we entered into a Letter Agreement and an amended agreement to the Second Ramot Agreement (collectively, the Letter Agreement) with Ramot, pursuant to which, among other things, Ramot agreed to: (i) release us from our obligation to fund three years of additional research (which would have totaled $1,140,000) and (ii) accept conversion of certain research payments due in the amount of $272,000 into 1,120,000 shares of our Common Stock. Pursuant to the Letter Agreement, we agreed, among other things, to: (i) reimburse Ramot for outstanding patent-related expenses; and (ii) abandon our rights in certain joint patent rights and patents of Ramot in certain countries.Developments

As● On July 16, 2025, the Company received a delisting notification from Nasdaq, informing the company that its common stock will be delisted from The Nasdaq Capital Market. Trading in BrainStorm’s common stock on Nasdaq was suspended at the open of ~~February~~trading ~~2011~~on July 18, ~~Ramot~~2025. ~~had~~The ~~sold~~delisting is a result of the company’s non-compliance with Nasdaq Listing Rule 5550(b)(1),~~120~~ pertaining to its minimum shareholder equity requirement. On October 9,~~000~~ ~~shares~~2025, ~~of Common~~Nasdaq ~~Stock~~filed ofwith the ~~Company~~SEC ~~for~~a ~~approximately~~notification ~~$235,000~~of removal from listing and weregistration ~~paid~~on Form 25 to effect the ~~remaining~~delisting ~~$5,000~~of ~~due~~the toCompany’s ~~Ramot~~securities from Nasdaq. ToThe ~~date~~Company’s ~~there~~common stock is nocurrently ~~additional debt~~quoted toon ~~Ramot~~the OTCQB Venture Market under the symbol “BCLI”.

●

On July 8, 2025, the Company acknowledged that the FDA consideration of a Citizen Petition requesting a new review of the data supporting NurOwn will provide a critical opportunity to reaffirm its potential as therapy for ALS. A Citizen Petition is a regulatory process that allows any interested party to formally request the FDA to take action on specific matters, such as reviewing data, issuing new guidance, or taking enforcement action. In this case, the Citizen Petition is requesting that the FDA review the data supporting NurOwn.

NurOwn® Proprietary Technology

NurOwn® technology is based on an innovative manufacturing protocol, which induces the differentiation of purified and expanded bone marrow-derived MSC and consistently generates cells that release high levels of multiple neurotrophic factors (“MSC-NTF” cells) to modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival and improve neurological function. These factors are known to be critical for the growth, survival and differentiation of neurons, including: glial-derived neurotrophic factor (“GDNF”); brain-derived neurotrophic factor (“BDNF”); vascular endothelial growth factor (“VEGF”); hepatocyte growth factor (“HGF”), and Galectin-1 among others. VEGF is one of the most potent neuronal and motor neuron survival factors and has demonstrated important neuroprotective effects in ALS and several other neurodegenerative diseases.

NurOwn® manufacturing involves a multi-step process that includes the following: harvesting and isolating undifferentiated stem cells from the patient’s own bone marrow; processing of cells at the manufacturing site; cryopreservation of MSC to enable multiple treatments from a single bone marrow sample; and intrathecal administration of MSC-NTF cells into the same patient by standard lumbar puncture. This administration procedure does not require hospitalization and has been shown to be generally well tolerated in multiple CNS clinical trials to date. The completed NurOwn® U.S. Phase 3 ALS and the NurOwn® U.S. Phase 2 PMS trials evaluated the therapeutic potential of repeated intrathecal MSC-NTF cell administration (three doses at bi-monthly intervals). Our highest priority is to obtain regulatory approval of NurOwn® for ALS. We are also strategically focused on fully executing the clinical development of NurOwn® in PMS, reviewing the optimal approach in AD and will consider the best course of action based on recent scientific and regulatory insights.

On December 20, 2011, we entered into an Assignment Agreement with our Israeli Subsidiary (the Assignment Agreement), with the consent of Ramot. Under the Assignment Agreement, we assigned and transferred all of our rights, interests, titles, liabilities and obligations (the Rights) under the Second Ramot Agreement to our Israeli Subsidiary, effective as of January 1, 2007 and our Israeli Subsidiary agreed to assume all such Rights. We agreed to be a guarantor of all obligations of our Israeli Subsidiary under the Second Ramot Agreement and Ramot can look to us to demand compliance with the Second Ramot Agreement.

InTable ~~May 2012, we, the Israeli Subsidiary and Prof. Offen entered into a Consulting Agreement, effective as~~ of January 1, 2012, which replaced the previous consulting agreement, dated July 31, 2004, pursuant to which all work product resulting from the provision of services will vest solely with the Israeli Subsidiary and if any work product resulting from the provision of services results in the creation or development of intellectual property it will be deemed a joint invention, and will be jointly owned by Ramot and the Israeli Subsidiary.Contents

~~Government~~The ~~Regulation~~proprietary technology and ~~Product~~manufacturing ~~Approval~~processing of NurOwn® (MSC-NTF cells) for clinical use is conducted in full compliance with current Good Manufacturing Practice. The NurOwn® proprietary technology is fully owned or developed by our Israeli Subsidiary. All granted patents related to NurOwn® (MSC-NTF cells) manufacturing process are fully assigned to or owned by our Israeli Subsidiary (please see Intellectual Property section for details).

~~Once~~The ~~fully developed, we intend to market our bone marrow derived differentiated neurothrophic-factor secreting cell products,~~ NurOwn,® ~~for~~Treatment autologous transplantation in patients by neurologists in medical facilities in the U.S., Europe, Japan and the Pacific Rim. We plan to submit biologics license application (BLA) in the United States for the development of NurOwn for the treatment of ALS patients. We initiated the regulatory process with a Pre-IND meeting with the FDA in September 2012, and submitted our IND application in December 2013. We have retained expert regulatory consultants to assist us in our approach to the FDA.Process

In● ~~January~~Bone ~~2013,~~marrow ~~the~~aspiration ~~EMA~~from ~~Committee~~the ~~for Advanced Therapies classified NurOwn as an Advanced Therapy Medicinal Product.~~patient;

~~Government~~● ~~authorities~~MSC inIsolation ~~the United States at the federal, state~~ and local level extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing, export and import of products such as those we are developing. Our product candidates must receive final approval from the FDA before they may legally be marketed in the United States or by the appropriate foreign regulatory agency before it may be legally marketed in foreign countries.propagation;

~~U.S.~~● ~~Drug~~MSC ~~Development Process~~Cryopreservation;

In● ~~the~~MSC ~~United~~thawing ~~States, the FDA regulates drugs under the Federal Food, Drug,~~ and ~~Cosmetic~~differentiation ~~Act,~~into or FDCA, and implementing regulations. Drugs are also subject to other federal, state and local statutes and regulations. Biologics are subject to regulation by the FDA under the FDCA, the Public Health Service Act, or the PHSA, and related regulations and other federal, state and local laws and regulations. Biological products are therapies used to treat disease and health conditions. They include a wide variety of products including vaccines, blood and blood components, gene therapies, tissue and proteins. Unlike most prescription products made through chemical processes, biological products generally are made from human and/or animal materials. To be lawfully marketed in interstate commerce, a biologic product must be the subject of a BLA, issued by the FDA on the basis of a demonstration that the product is safe, pure and potent, and that the facility in which the product is manufactured meets standards to assure that it continues to be safe, pure and potent. The FDA has developed and is continuously updating the requirements with respect to cell and gene therapy products and has issued documents concerning the regulation of cellular and tissueneurotrophic-~~based~~factor ~~products.~~secreting ~~Manufacturers of cell and tissue~~(MSC-~~based~~NTF; ~~products~~NurOwn®) ~~must~~cells; ~~comply with the FDA’s current good tissue practices, or cGTP, which are FDA regulations that govern the methods used in,~~ and the facilities and controls used for, the manufacture of such products. The primary intent of the cGTP requirements is to ensure that cell and tissue based products are manufactured in a manner designed to prevent the introduction, transmission and spread of communicable disease.

●

Intrathecal administration into the patient’s cerebrospinal fluid by standard lumbar puncture.

Differentiation before Treatment

We believe that the ability to induce autologous adult MSCs into differentiated MSC-NTF cells makes NurOwn® uniquely suited for the treatment of neurodegenerative diseases.

The specialized MSC-NTF cells secrete multiple neurotrophic factors and immunomodulatory cytokines that may result in:

●

Protection of existing neurons;

●

Promotion of neuronal repair;

●

Neuronal functional improvement; and

●

Immunomodulation and reduced neuroinflammation.

Autologous treatment

The NurOwn® technology platform is autologous, using the patient’s own bone-marrow derived stem cells for treatment. In autologous cellular treatment, there is no introduction of unrelated donor antigens that may lead to alloimmunity, no risk of rejection, and no need for treatment with immunosuppressive agents, which can cause severe and/or long-term side effects. In addition, the use of adult, autologous stem cells is free of several ethical concerns associated with the use of embryonic-derived stem cells in some countries.

NurOwn® ALS Clinical Program

We announced top-line data from the Phase 3 clinical trial of NurOwn® in ALS on November 17, 2020. We have been granted Fast Track designation by the FDA for this indication, and have been granted Orphan Drug Status, in the U.S. and Europe, which provides us the potential for an extended period of exclusivity. On August 15, 2022, we announced our decision to submit a BLA to the FDA for NurOwn® for the treatment of ALS. The BLA was filed on September 9, 2022. On November 10, 2022, we announced that we had received a RTF letter from the FDA regarding our BLA. The FDA indicated that we could request a Type A meeting to discuss the content of the RTF letter, and Type A meeting was held on January 11, 2023. On March 27, 2023, we announced that the FDA will hold an ADCOM to discuss the company’s BLA for NurOwn® for the treatment of ALS. On June 6, 2023, we announced that the advisory committee meeting has been scheduled for September 27, 2023. On September 22, 2023, we submitted an amendment to our BLA to revise the indication to NurOwn® for the treatment of mild to moderate ALS. On September 27, 2023 we announced that the Advisory Committee voted, with 17 voting no, one voting yes, and one abstention, that NurOwn® did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS. On October 18, 2023, we announced that the FDA invited the Company to request an expedited face-to-face meeting to discuss the path forward for NurOwn® as a treatment for ALS. Brainstorm remains committed to the ALS Community and is actively exploring the next steps in support of NurOwn®, including publication of emerging clinical data and development of a protocol for an additional clinical study. On October 18, 2023 Brainstorm announced that the BLA

The process of obtaining regulatory approvals and ensuring compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process, or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, product detention, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. The process required by the FDA before a biological product or drug may be marketed in the United States generally involves the following:

·Table ~~Completion~~ of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices or other regulations; · Submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin; · Performance of adequate and well-controlled clinical trials according to Good Clinical Practices, or GCP, to establish the safety and efficacy of the proposed biological product or drug for its intended use; · submission to the FDA of a new drug application, or NDA, for a new drug; or a biologic license application for a new biological product; · satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with Good Manufacturing Practices, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and purity; and · FDA review and approval of the BLA or NDA.Contents

for NurOwn® would be withdrawn. The ~~testing~~BLA was withdrawn on November 3, 2023. The decision to withdraw the BLA was coordinated with the FDA and ~~approval~~is ~~process~~viewed ~~require~~by ~~substantial~~the ~~time~~FDA as a withdrawal without prejudice. On November 20, ~~effort and~~2023, ~~financial~~we ~~resources~~announced ~~and~~that the FDA granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting took place on December 6, 2023. On December 7, 2023, we ~~cannot~~announced bethe ~~certain~~completion of a productive meeting with the FDA to discuss NurOwn®. The primary objective of the meeting was to discuss plans for a SPA with the FDA on the overall protocol design for a planned Phase 3b registrational trial for NurOwn®. The ultimate goal of the SPA is to secure the FDA’s agreement that ~~any~~critical ~~approvals~~elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for ~~our~~a ~~product~~study ~~candidates~~intended ~~will~~to besupport ~~granted~~a future marketing application. On February 23, 2024, we announced that we submitted the SPA request to the FDA for the planned Phase 3b clinical trial of NurOwn® for the treatment of ALS. On April 9, 2024, the Company announced that it received written agreement from the FDA, under a SPA, on the design for a ~~timely~~Phase ~~basis~~3b trial of NurOwn® in ALS. The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, if atdemonstrating ~~all~~the Company’s adequacy in addressing objectives that support a future BLA in ALS. On June 26, 2024, the Company announced that it has reached alignment with FDA on the CMC aspects of Brainstorm’s Phase 3b clinical trial for NurOwn®, its investigational therapy for ALS. This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a SPA agreement for its NurOwn Phase 3b trial.

~~Once~~Phase a1/2 ~~pharmaceutical~~ALS ~~product~~Open ~~candidate~~Label is identified for development, it enters the preclinical testing phase. Preclinical tests include laboratory evaluations of product chemistry, toxicity, formulation and stability, as well as animal studies. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, to the FDA as part of the IND. The sponsor must also include a protocol detailing, among other things, the objectives of the initial clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated if the initial clinical trial lends itself to an efficacy evaluation. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA places the clinical trial on a clinical hold within that 30-day time period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during trials due to safety concerns or non-compliance. Accordingly, we cannot assure you that submission of an IND will result in the FDA allowing clinical trials to begin or, once begun, issues will not arise that result in the suspension or termination of such trial.Trials

~~All~~We ~~clinical~~have ~~trials~~completed ~~must~~two beearly ~~conducted~~stage ~~under~~Phase ~~the~~1/2 ~~supervision of~~and ~~one~~2 oropen-label ~~more~~clinical ~~qualified~~trials ~~investigators~~of NurOwn® in ~~accordance~~patients with ~~GCP~~ALS ~~regulations.~~at ~~These regulations include~~ the ~~requirement~~Hadassah ~~that~~Medical ~~all~~Center ~~research subjects~~in ~~provide informed consent. Further~~Jerusalem, ~~an institutional review board~~Israel, oras ~~IRB,~~well ~~must~~as ~~review~~a ~~and~~Phase ~~approve~~2 ~~the~~double-blind, ~~plan~~placebo-controlled, ~~for~~multicenter ~~any~~ clinical trial ~~before it commences~~ at ~~any~~three ~~institution~~prestigious U.S. AnMedical ~~IRB~~centers - ~~considers, among other things, whether~~ the ~~risks~~Massachusetts toGeneral ~~individuals~~Hospital ~~participating~~ (“MGH”) in ~~the~~Boston, ~~trials~~Massachusetts ~~are~~Memorial ~~minimized~~Hospital ~~and are reasonable~~ in ~~relation~~Worcester, toMassachusetts, ~~anticipated benefits. The IRB also approves the information regarding the clinical trial~~ and the ~~consent~~Mayo ~~form~~Clinic ~~that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. Once an IND is~~ in ~~effect~~Rochester, ~~each~~Minnesota - ~~new~~all ~~clinical~~highly ~~protocol~~experienced ~~and~~in ~~any amendments to~~ the ~~protocol~~management, ~~must be submitted to the IND for FDA review~~investigation, and totreatment ~~the~~of ~~IRBs for approval~~ALS.

~~Human~~The ~~clinical~~first two open-label trials ~~are~~were ~~typically~~approved ~~conducted~~by the Israeli Ministry of Health (“MoH”). The first-in-human ~~three~~trial, ~~sequential phases~~a ~~that~~Phase ~~may~~1 ~~overlap~~safety and efficacy trial of NurOwn® administered either intramuscularly or beintrathecally in 12 ALS patients, was initiated in June 2011. In the Phase 2 dose-escalating study, 14 ALS patients were administered NurOwn® by a combined: route of intramuscular and intrathecal administration. These studies demonstrated the tolerability of NurOwn® by both routes of administration and showed preliminary signs of activity.

·In January 2016, the results of the two completed Phase 1/2 study and Phase 2 open label trials were published in JAMA Neurology. The ~~product~~results isdemonstrated ~~initially~~a ~~introduced~~slower ~~into~~rate ~~healthy~~of ~~human~~disease ~~subjects~~progression ~~and~~following ~~tested~~MSC-NTF ~~for~~cell ~~safety~~treatment as measured by the ALSFRS-R, ~~dosage~~the ~~tolerance~~gold standard for the evaluation of ALS functional status, ~~absorption~~and Forced Vital Capacity, ~~metabolism~~a measure of pulmonary function, ~~distribution~~as ~~and~~well ~~excretion.~~as Inpositive trends in the ~~case~~rate of ~~some~~decline ~~products~~of ~~for~~muscle ~~severe~~volume orand ~~life-threatening~~the ~~diseases,~~compound ~~especially~~motor ~~when~~axon potential. This was the ~~product~~first ~~may~~published beclinical ~~too~~data ~~inherently~~using ~~toxic~~autologous toMSCs ~~ethically~~induced ~~administer~~under culture conditions to ~~healthy~~produce ~~volunteers~~NTFs, with the ~~initial~~potential ~~human~~to ~~testing~~deliver ~~may~~a becombined ~~conducted~~neuroprotective and immunomodulatory therapeutic effect in ~~patients~~ALS ~~having~~and potentially modify the ~~specific~~course of this disease.

· Phase 2. ~~Phase~~ALS 2Randomized trials involve investigations in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and the optimal dosage and schedule.Trial

The Phase 2 U.S. study was conducted under an FDA Investigational New Drug application. This randomized, double-blind, placebo-controlled multi-center U.S. Phase 2 clinical trial evaluating NurOwn® in ALS patients was conducted at three clinical sites: (i) the MGH in Boston, (ii) Massachusetts Memorial Hospital in Worcester, Massachusetts, and (iii) the Mayo Clinic in Rochester, Minnesota. For this trial, NurOwn® was manufactured at the Connell and O’Reilly Cell Manipulation Core Facility at the Dana Farber Cancer Institute in Boston and at the Human Cellular Therapy Lab at the Mayo Clinic. In this study, 48 patients were randomized 3:1 to receive NurOwn® or placebo.

Results of this Phase 2 Study were published in the peer reviewed Journal ‘Neurology’. The publication titled “NurOwn, Phase 2, Randomized, Clinical Trial in Patients with ALS: Safety, Clinical, and Biomarker Results” was published in December 2019.

Key findings from the trial were as follows:

The study achieved its primary objective, demonstrating that NurOwn® treatment was well-tolerated. There were no discontinuations from the trial due to adverse events (“AEs”) and there were no deaths in the study. The most common AEs of mild or moderate severity, were transient procedure-related AEs such as headache, back pain, pyrexia arthralgia and injection-site discomfort, which were more commonly seen in the NurOwn®-treated participants compared to placebo.

· Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for regulatory approval and product labeling.

~~Post-approval~~Table ~~studies, also called Phase 4 trials, may be conducted after initial marketing approvals. These studies are used to obtain additional experience from the treatment~~ of ~~patients in the intended therapeutic indication and may be required by the FDA as part of the approval process.~~Contents

~~Progress~~NurOwn® ~~reports~~achieved ~~detailing~~multiple ~~the~~secondary ~~results~~efficacy ofendpoints, ~~the~~showing ~~clinical~~evidence ~~trials must~~of bea ~~submitted~~clinically atmeaningful ~~least annually to the FDA and safety reports must be submitted to the FDA and the investigators for serious and unexpected side effects~~benefit. ~~Phase 1~~Notably, ~~Phase~~response 2rates ~~and~~in ~~Phase 3 testing may not be completed successfully within any specified period, if at all. The FDA or~~ the ~~sponsor~~ALS ~~may~~functional ~~suspend~~rating orscale ~~terminate~~(48-point aALSFRS-R ~~clinical~~outcome ~~trial~~measure) atwere ~~any~~higher ~~time~~in onNurOwn®-treated ~~various grounds~~participants, ~~including~~compared ~~a finding that the research subjects or patients are being exposed~~ to ~~an unacceptable health risk. Similarly~~placebo, ~~an IRB can suspend or terminate approval of a clinical trial~~ at ~~its~~all ~~institution~~study iftimepoints ~~the~~over ~~clinical~~24 ~~trial is not being conducted in accordance with the IRB’s requirements or if the drug or biologic has been associated with unexpected serious harm to patients~~weeks.

~~Concurrent~~A ~~with~~pre-specified ~~clinical~~responder ~~trials,~~analysis ~~companies~~examined percentage ~~usually~~improvements ~~complete additional~~in ~~animal~~the ~~studies~~post ~~and~~treatment ~~must~~ALSFRS-R ~~also~~slope ~~develop~~(in ~~additional~~points ~~information~~change ~~about~~per month) ~~the~~compared ~~chemistry~~to ~~and~~pre-treatment ~~physical~~slope ~~characteristics~~and ofdemonstrated ~~the product~~that ~~and~~a ~~finalize~~higher aproportion ~~process~~of ~~for~~NurOwn® ~~manufacturing~~treated ~~the~~participants ~~product~~achieved ina ~~commercial~~100% ~~quantities~~improvement in ~~accordance~~the ~~with~~post-treatment ~~cGMP requirements~~vs. ~~The manufacturing~~pre-treatment ~~process~~slope, ~~must~~compared beto ~~capable~~the ofplacebo ~~consistently~~group. ~~producing~~This ~~quality~~analysis ~~batches~~also ofdemonstrated ~~the~~that ~~product~~a ~~candidate~~higher ~~and,~~proportion ~~among~~of ~~other things,~~ the ~~manufacturer~~NurOwn® ~~must~~treated ~~develop~~participants ~~methods~~achieved ~~for~~a ~~testing~~1.5 ~~the~~point ~~identity,~~per month ~~strength,~~or ~~quality~~greater ~~and~~improvement ~~purity~~in of the ~~final~~post-treatment ~~product~~vs. ~~Additionally, appropriate~~pre-treatment ~~packaging~~ALSFRS-R ~~must~~slope, becompared ~~selected and tested and stability studies must be conducted~~ to ~~demonstrate that~~ the ~~product~~placebo ~~candidate does not undergo unacceptable deterioration over its shelf life~~group.

~~During~~The ~~the~~treatment ~~development~~effects ofwere agreater ~~new~~in ~~drug or biologic, a sponsor may be able to request a Special Protocol Assessment, or SPA,~~ the ~~purpose~~rapid ofprogressor ~~which~~subgroup is to reach agreement with the FDA on the Phase 3 clinical trial protocol design and analysis that will form the primary basis of an efficacy claim. An SPA is intended to provide assurance that if the agreed upon clinical trial protocol is followed, the clinical trial endpoints are achieved, and there is (a ~~favorable risk~~pre-~~benefit~~specified ~~profile~~definition, ~~the data may serve as the primary basis for an efficacy claim~~ in ~~support~~which ofpretreatment aALSFRS-R ~~BLA~~declined orby an2 ~~NDA. However, an SPA is not a guarantee of an approval of a product candidate~~ or ~~any~~more ~~permissible~~points ~~claims~~in ~~about~~ the ~~product~~three months ~~candidate~~pre-treatment). In particular, SPAs are not binding on the FDA if previously unrecognized public health concerns arise during the performance of the clinical trial, other new scientific concerns regarding product candidate’s safety or efficacy arise, or if the sponsoring company fails to comply with the agreed upon clinical trial protocol.

~~The~~As ~~results~~an important confirmation of ~~product~~NurOwn®’s ~~development~~mechanism of action, ~~preclinical~~levels ~~studies~~of neurotrophic factors and ~~clinical~~ ~~trials,~~inflammatory ~~along~~markers ~~with~~were ~~descriptions~~measured ofin the ~~manufacturing~~cerebrospinal ~~process,~~fluid ~~analytical~~(“CSF”) ~~tests~~samples ~~conducted~~collected onfrom participants pre-treatment and two weeks post treatment. In the ~~biologic~~samples orof ~~drug~~those participants treated with NurOwn®, ~~proposed labeling~~statistically ~~and~~significant ~~other~~increases ~~relevant~~in ~~information~~levels of neurotrophic factors VEGF, ~~are~~HGF ~~submitted~~and toLIF ~~the~~and ~~FDA~~a asstatistically ~~part~~significant ofreduction anin ~~NDA~~inflammatory ormarkers ~~BLA~~MCP-1, ~~requesting~~SDF-1 ~~approval~~and toCHIT-1 ~~market~~were observed post-treatment. Furthermore, the ~~product~~observed reduction in inflammatory markers correlated with ALS functional improvements. ~~The~~ ~~submission~~These ofclinical-biomarker ancorrelations ~~NDA~~were ornot ~~BLA~~seen isin ~~subject~~placebo-treated toparticipants, ~~the~~consistent ~~payment~~with ofthe ~~substantial~~proposed ~~user~~combined ~~fees~~neuroprotective ~~which~~and ~~may~~immunomodulatory bemechanism ~~waived~~of ~~under~~action ~~certain~~of ~~limited~~NurOwn® ~~circumstances~~in ALS.

In summary, a higher proportion of NurOwn® treated participants, particularly those with more rapid disease progression, experienced stabilization or improvement in ALS function, as measured by the change in post-treatment vs. pre-treatment ALSFRS-R rate of decline or slope.

Phase 3 ALS Clinical Trial

Following successful completion of the Phase 2 study, we conducted a Phase 3 trial (a multi-dose double-blind, placebo-controlled, multicenter trial protocol) that was designed to generate data to potentially support a BLA submission in the U.S. for NurOwn® in ALS. In October 2019, the clinical trial completed enrollment of an enriched patient population of rapid progressors based on superior outcomes observed in the Phase-2 pre-specified sub-group. The study is registered at www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03280056).

We announced top-line data from our Phase 3 ALS trial on November 17, 2020. Results from the trial showed that NurOwn® was generally well tolerated in the population of rapidly progressing ALS patients. However, the trial did not reach statistically significant results. No new safety concerns were identified. On February 9, 2021, we announced feedback from our Type-C Meeting with the FDA to review specific aspects of our planned manufacturing modifications to support the development of a semi-automated commercial manufacturing process for NurOwn® (MSC-NTF cell). On February 22, 2021, we announced high-level FDA feedback on NurOwn® ALS clinical development program. The FDA concluded from their initial review that the clinical data provided at the time did not provide the threshold of substantial evidence that the FDA seeks to support a BLA. In addition, the FDA advised that this recommendation did not preclude the Company from proceeding with a BLA submission.

Key findings from the trial were as follows (which include the update to the data published in Muscle & Nerve 65(3):291-302 on August 12, 2022):

●

NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients.

●

While showing a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints, the trial did not reach statistically significant results.

●

The primary efficacy endpoint, a responder analysis evaluating the proportion of participants who experienced at least a 1.25 points per month improvement in the post-treatment ALSFRS-R slope compared to pre-treatment, was powered on assumed treatment response rates of 35% on NurOwn® versus 15% on Placebo. These estimates were based on available historical clinical trial data and the NurOwn® Phase 2 data. The response definition for the primary endpoint was met by 32.6% of NurOwn® participants versus 27.7% for Placebo (p=0.453). Therefore, the trial met the expected ~35% NurOwn® treatment

~~FDA Review of Biologics License Applications and New Drug Applications~~

~~The~~Table FDA reviews all BLAs and NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing. The FDA may request additional information rather than accept a BLA or an NDA for filing. In this event, the BLA or NDA must be re-submitted with the additional information. The re-submitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA has ten months in which to complete the initial review of a standard BLA or NDA and respond to the applicant and six months for a priority BLA or NDA. The FDA does not always meet its PDUFA goal dates for standard and priority BLAs or NDAs. The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality and purity. The FDA reviews a BLA to determine, among other things, whether the product is safe, pure, and potent and the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the products continued safety, purity and potency. Before approving an NDA or BLA, the FDA will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements, and additionally, in the case of biologics in accordance with cGTP guidelines, and adequate to assure consistent production of the product within required specifications. The FDA may refer the NDA or BLA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions. An advisory committee is a panel of independent experts who provide advice and recommendations when requested by the FDA on matters of importance that come before the agency. The FDA is not bound by the recommendation of an advisory committee.Contents

~~The~~group ~~approval~~efficacy ~~process~~response isassumption, ~~lengthy~~however ~~and difficult and~~ the ~~FDA~~high ~~may refuse~~rate toof ~~approve~~response ain ~~BLA~~placebo anparticipants ~~NDA~~exceeded if the ~~applicable~~placebo ~~regulatory~~response ~~criteria~~expected ~~are~~based ~~not~~on ~~satisfied~~contemporary orALS ~~may require additional clinical data or other data and information~~trials.

~~Even~~● ifThe ~~such~~secondary ~~data~~efficacy ~~and~~endpoint ~~information~~measuring isaverage ~~submitted,~~change ~~the~~in ~~FDA~~ALSFRS-R ~~may ultimately~~total ~~decide~~score ~~that the BLA or NDA does not satisfy the criteria for approval. Data obtained~~ from ~~clinical~~baseline ~~trials are not always conclusive and the FDA may interpret data differently than we interpret the same data. The FDA will issue a complete response letter if the agency decides not~~ to ~~approve~~Week ~~the~~28, ~~BLA~~was ~~or NDA in its present form~~-5.52 ~~The~~with ~~complete~~NurOwn® ~~response~~versus ~~letter usually describes all of the specific deficiencies that the FDA identified in the BLA or NDA~~-5.88 ~~The~~on ~~deficiencies identified may be minor~~Placebo, for example, requiring labeling changes, or major, for example, requiring additional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant might take to conform the application to a ~~condition~~difference ~~suitable~~of ~~for approval~~0.36 If(p= a complete response letter is issued, the applicant may either resubmit the BLA or NDA, addressing all of the deficiencies identified in the letter, withdraw the application, or request an opportunity for a hearing0.693).

If● aIn ~~product~~an ~~receives regulatory approval~~important, ~~the~~pre-specified ~~approval~~subgroup ~~may be~~early ~~significantly~~in ~~limited~~the todisease ~~specific~~course ~~diseases~~based ~~and~~on ~~dosages~~an orALSFRS-R ~~the~~baseline ~~indications~~score ~~for~~of ~~use~~35 ~~may~~or ~~otherwise~~greater, beNurOwn® ~~limited,~~demonstrated ~~which~~a ~~could~~clinically ~~restrict the~~meaningful ~~commercial~~treatment ~~value~~response ofacross the ~~product.~~primary ~~Further,~~and ~~the~~key ~~FDA~~secondary ~~may~~endpoints ~~require~~and ~~that~~remained ~~certain~~consistent ~~contraindications~~with our pre-trial, ~~warnings~~data-derived orassumptions. ~~precautions~~In bethis ~~included in~~subgroup, ~~the~~there ~~product~~were ~~labeling~~34.6% Inresponders ~~addition,~~who met the ~~FDA~~primary ~~may~~endpoint ~~require~~definition ~~Phase~~on 4NurOwn® ~~testing~~and ~~which~~15.6% ~~involves~~on ~~clinical~~Placebo ~~trials~~(p=0.305), ~~designed~~and tothe ~~further~~average ~~assess a~~change ~~drug’s~~from orbaseline ~~biologic’s~~to ~~safety~~week ~~and~~28 ~~effectiveness~~in ~~after~~ALSFRS-R ~~BLA~~total orscore ~~NDA~~was ~~approval~~-1.56 ~~and~~on ~~may~~NurOwn® ~~require testing~~ and ~~surveillance programs~~-3.65 toon ~~monitor~~Placebo ~~the~~(p=0.050), ~~safety~~an improvement of ~~approved~~2.09 ~~products~~ALSFRS-R ~~that~~points ~~have~~favoring ~~been commercialized~~NurOwn®.

~~Orphan~~● ~~Drug~~Additional ~~Designation~~sensitivity analyses have demonstrated consistent treatment effects with NurOwn® after accounting for the impact of the ALSFRS-R floor effect. Two methods include: (1) Total Score Threshold (“TST”), which removed participants with ALSFRS-R scores ≤ 25; and (2) Item Level Threshold (“ITL”), which removed participants with a baseline score of 0 or 1 in at least 5 of 6 of the ALSFRS-R’s Fine and Gross Motor scale items. Applying the TST and ITL sensitivity analysis methods resulted in the exclusion of 23% (n=44) and 16% (n=30) of trial participants from analyses, respectively. Both the TST and ILT sensitivity analysis methods show that, after controlling for the impact of the ALSFRS-R floor effect, participants treated with NurOwn® had a higher rate of clinical response (primary endpoint) and less function lost across 28 weeks (secondary endpoint), compared to placebo. Additional post-hoc analyses published for the secondary endpoint (average change from baseline in ALSFRS-R), showed a statistically significant benefit following treatment with NurOwn® in all subgroups with ALSFRS-R baseline total score of at least 26 to 35 (p≤0.050).

~~Under~~● ~~the~~The ~~Orphan~~NurOwn® ~~Drug~~Phase ~~Act,~~3 ~~the~~trial ~~FDA~~enrolled ~~may grant orphan designation to~~ a ~~drug~~broad orset ~~biological~~of ~~product~~participants, ~~intended~~including tosome ~~treat~~with aadvanced ~~rare~~ALS disease or(ALSFRS-R≤25) ~~condition~~at baseline, ~~which~~making isthis ~~generally~~trial asubject ~~disease~~to orthe ~~condition~~impact ~~that~~of ~~affects fewer~~floor ~~than~~effects ~~200,000~~of ~~individuals in~~ the ~~United~~ALSFRS-R ~~States,~~and orreduced ~~more~~ALSFRS-R ~~than~~sensitivity. ~~200,000~~A ~~individuals~~post-hoc inanalysis ~~the~~was ~~United~~done ~~States~~using ~~and~~participants ~~for~~with ~~which~~baseline ~~there is~~ALSFRS-R>25 nofor ~~reasonable expectation that~~ the ~~cost~~primary ofendpoint ~~developing~~ and ~~making a drug or biological product available in~~ the ~~United~~% ~~States~~ response for ~~this~~NurOwn® ~~type~~was ~~of disease or condition will be recovered from sales of the product~~34.7% ~~Orphan~~and ~~product designation must be requested before submitting an NDA or BLA~~20.5% ~~After~~for ~~the FDA grants orphan product designation~~Placebo, ~~the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA~~p=0.053. ~~Orphan~~This ~~product~~analysis ~~designation~~suggests ~~does~~a ~~not~~treatment ~~convey~~effect ~~any~~with ~~advantage~~NurOwn® in orparticipants ~~shorten the~~with ~~duration~~less ofadvanced ~~the~~disease. ~~regulatory~~CSF ~~review~~biomarker ~~and~~analyses ~~approval~~confirmed ~~process.~~that Intreatment ~~addition~~with toNurOwn® ~~the~~resulted ~~potential~~in ~~for~~ a ~~period~~statistically ofsignificant ~~exclusivity,~~increase ~~we may be eligible for grant funding~~ of upneurotrophic tofactors ~~$400,000~~(VEGF) ~~per~~and ~~year~~reduction ~~for~~in ~~four~~neurodegenerative ~~years~~(neurofilament) toand ~~defray~~neuroinflammatory ~~costs~~biomarkers of(MCP-1) ~~clinical~~that ~~trial~~was ~~expenses,~~not ~~tax~~observed ~~credits~~in ~~for clinical research expenses and potential exemption from~~ the ~~FDA~~placebo ~~application~~treatment ~~user fee~~group.

If● aPre-specified ~~product~~statistical ~~that~~modeling ~~has~~designed ~~orphan~~to ~~designation~~predict ~~subsequently~~clinical ~~receives the~~response ~~first~~with ~~FDA~~high ~~approval~~sensitivity ~~for~~and ~~the~~specificity ~~disease~~based oron ~~condition~~ALS ~~for~~biomarkers ~~which~~and itALS ~~has~~Function ~~such~~confirmed ~~designation, the product is entitled to orphan product exclusivity, which means~~ that ~~the~~NurOwn® ~~FDA~~treatment ~~may~~outcomes ~~not~~could ~~approve~~be ~~any~~predicted ~~other~~by ~~applications~~baseline toALS ~~market~~function ~~the~~as ~~same~~well ~~drug or biological product for the same indication for seven years, except in limited circumstances, such~~ as ~~(i)~~key ~~the~~CSF ~~drug’s~~neurodegenerative ~~orphan~~and ~~designation~~neuroinflammatory isbiomarkers. ~~revoked; (ii)~~Additional ~~its~~analyses ~~marketing~~focused ~~approval~~on ~~is withdrawn; (iii)~~ the ~~orphan~~trajectory ~~exclusivity holder consents to the approval~~ of ~~another~~biomarkers ~~applicant’s product;~~for ~~(iv)~~ the ~~orphan~~subgroups ~~exclusivity holder is unable to assure the availability~~ of aparticipants ~~sufficient~~with ~~quantity~~baseline ofALSFRS-R ~~drug;~~scores or>25 ~~(v)~~and a≤25, ~~showing of~~those ~~clinical~~most ~~superiority~~likely to ~~the~~be ~~product~~impacted ~~with orphan exclusivity~~ by ~~a competitor product. Competitors, however, may receive approval of different products for~~ the ~~indication~~floor ~~for~~effect which the orphan product has exclusivity or obtain approval for the same product but for a different indication for which the orphan product has exclusivity. Orphan product exclusivity also could block the approval of ~~one of our products for seven years if a competitor obtains approval of~~ the ~~same~~scale, ~~drug~~indicate orthat ~~biological~~NurOwn® ~~product~~had assimilar ~~defined by the FDA or if our drug or~~ biological ~~candidate~~effects ison ~~determined~~ALS toparticipants beregardless ~~contained~~of ~~within~~ the ~~competitor's~~level ~~product~~of ~~for~~disease ~~the~~progression ~~same~~at ~~indication or disease~~baseline. IfSpecifically, awe ~~drug~~observe ordecreases ~~biological~~in ~~product~~neuroinflammatory ~~designated~~and asneurodegenerative anmarkers ~~orphan~~and ~~product~~increases ~~receives~~in ~~marketing~~neuroprotective ~~approval~~markers ~~for~~in anNurOwn® ~~indication~~treated ~~broader than~~participants ~~what~~compared ~~is designated, it may not be entitled~~ to ~~orphan~~placebo ~~product exclusivity. Orphan drug status~~ in ~~the~~both ~~European Union has similar but not identical benefits in the European Union~~subgroups.

Decision to Submit BLA

New clinical analyses of NurOwn’s® Phase 3 clinical trial in ALS published August 12, 2022, led to a correction of data originally published in Muscle & Nerve in December 2021 and strengthened the Company’s original conclusions from the trial. The correction resulted in a statistically significant treatment difference (p=0.050) of more than 2 points for an important secondary endpoint, average change from baseline in ALSFRS-R, in the pre-specified efficacy subgroup of participants with a baseline score of at least 35. Analyses reported in the original publication utilized an efficacy model that unintentionally deviated from the trial’s pre-specified statistical analysis plan by erroneously incorporating interaction terms between the subgroup and treatment. The newly published results employ the efficacy model as pre-specified in the trial’s statistical analysis plan, correcting the analyses. The correction also relates to the other subgroup analyses published for this endpoint, demonstrating that all subgroups with ALSFRS-R baseline scores of greater than 26 to 35 showed a statistically significant benefit following treatment with NurOwn® (p≤0.050).

On August 15, 2022, we announced the decision to submit a BLA to the FDA for NurOwn® for the treatment of ALS. The BLA was filed on September 9, 2022. On November 10, 2022, we announced that we had received a RTF letter from the FDA regarding our BLA for NurOwn® for the treatment of ALS. The FDA informed us that the BLA is not sufficiently complete to enable a substantive review and that the FDA would therefore not file the BLA. The RTF letter contained a list of topics the FDA provided to Brainstorm as

In February 2011, we received Orphan Drug Designation for NurOwn for the treatment of ALS in the United States. In July 2013, we received Orphan Medicinal Product Designation for NurOwn for the treatment of ALS from the European Commission.

~~Patent~~Table ~~Term~~of ~~Restoration and Marketing Exclusivity~~Contents

~~Depending~~rationale ~~upon~~for the ~~timing,~~BLA ~~duration~~file ~~and~~being ~~specifics~~not ofsufficiently ~~FDA~~complete ~~marketing approval~~to ofenable ~~our~~a ~~product~~substantive ~~candidates, some of our U~~review.S. ~~patents~~According ~~may~~to bethe ~~eligible~~FDA, ~~for~~these ~~limited~~reasons ~~patent~~included ~~term~~one ~~extension~~item ~~under~~related to the ~~Drug~~trial ~~Price Competition~~not ~~and~~meeting ~~Patent~~the ~~Term~~standard ~~Restoration~~for ~~Act~~substantial evidence of ~~1984,~~effectiveness ~~commonly~~and ~~referred~~CMC torelated ~~as the Hatch-Waxman Amendments~~items. The ~~Hatch-Waxman~~FDA ~~Amendments permit~~indicated athat ~~patent~~we ~~restoration~~may ~~term~~request ofa upType toA ~~five~~meeting ~~years~~to asdiscuss ~~compensation~~the ~~for~~content ~~patent~~of ~~term lost during product development and~~ the ~~FDA regulatory~~RTF ~~review process~~letter. ~~However~~On December 12, ~~patent~~2022, ~~term~~we ~~restoration~~announced ~~cannot extend~~ the ~~remaining~~submission ~~term~~ of a ~~patent~~Type ~~beyond~~A ameeting ~~total~~request ofwith ~~14 years from~~ the ~~product’s~~FDA ~~approval~~to ~~date.~~discuss ~~The patent term restoration period is generally one-half~~ the ~~time~~contents ~~between (a) the effective date~~ of ~~an IND and~~ the ~~submission~~RTF ~~date~~letter ofpreviously aissued ~~BLA~~by ~~or an NDA plus (b)~~ the ~~time~~FDA ~~between~~regarding the ~~submission date of a~~ BLA orfor anNurOwn® ~~NDA~~for ~~and~~ the ~~approval~~treatment of ~~that application~~ALS. ~~Only~~On ~~one~~December 27, ~~patent~~2022, ~~applicable~~we toannounced anthat ~~approved~~the ~~drug~~FDA orgranted ~~biologic~~a isType ~~eligible~~A ~~for~~meeting ~~the~~to ~~extension~~discuss ~~and~~ the ~~application~~contents ~~for~~of the ~~extension~~RTF ~~must~~letter bepreviously ~~submitted~~issued ~~prior~~regarding toour ~~the~~BLA ~~expiration~~for ofNurOwn® for the ~~patent~~treatment ~~and within 60 days~~ of ~~approval of the drug or biologic~~ALS. The ~~U.S.~~Type ~~patent~~A ~~and~~Meeting ~~Trademark~~was ~~Office,~~held inon ~~consultation with the FDA~~January 11, ~~reviews and approves the application for any patent term extension or restoration~~2023.

~~Biologics~~The ~~Price~~perspective ~~Competition~~shared ~~and~~by ~~Innovation~~the ~~Act~~FDA review team reflected what was in the previously issued RTF letter. Conversations on the best pathway to resolve the outstanding questions that remained continued, following the Type A meeting. During these discussions, Brainstorm was presented with multiple options to return the BLA to regulatory review, which included the regulatory procedure to File over Protest. Additionally, within these discussions, the FDA committed to review amendments that were filed to address items raised in the RTF letter. These discussions resulted in Brainstorm requesting the FDA to file our BLA over Protest, as this was the regulatory procedure that would allow us to reach an ADCOM in the shortest amount of ~~2009~~time. Brainstorm notified the FDA on February 6, 2023 of our decision to request the FDA to file the NurOwn® BLA for ALS over Protest. We received confirmation from the FDA that the BLA was re-filed on February 7, 2023.

~~The~~We ~~Biologics~~received ~~Price~~the ~~Competition~~FDA ~~and~~Type ~~Innovation~~A ~~Act~~meeting minutes on February 9, 2023. We submitted an amendment to our BLA on March 7, 2023, in which we responded to the majority of ~~2009~~the items included in the RTF letter. Written feedback was received on March 22, or ~~BPCIA~~2023, ~~amended~~from the ~~PHSA~~FDA project manager associated with the BLA confirming the FDA’s decision to ~~create~~grant aan ~~new~~ADCOM ~~licensure~~for ~~framework~~the NurOwn® BLA for ~~biosimilar~~ALS. ~~products~~On March 27, ~~which~~2023, ~~could~~we ~~ultimately~~announced ~~subject~~that the FDA will hold an ADCOM to discuss the company’s BLA for NurOwn® for the treatment of ALS. On June 6, 2023, we announced that the advisory committee meeting has been scheduled for September 27, 2023. On September 22, 2023, we submitted an amendment to our ~~biological product~~BLA ~~candidates~~to revise the indication to ~~competition~~NurOwn® for the treatment of mild to moderate ALS. ~~Under~~On September 27, 2023 we announced that the ~~BPCIA~~Advisory Committee voted, awith ~~manufacturer~~17 ~~may~~voting ~~submit~~no, one voting yes, and one abstention, that NurOwn® did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS. On October 18, 2023, we announced that the FDA invited the Company to request an ~~application~~expedited face-to-face meeting to discuss the path forward for ~~licensure~~NurOwn® as a treatment for ALS. Brainstorm remains committed to the ALS Community and is actively exploring the next steps in support of NurOwn®, including publication of emerging clinical data and development of a ~~biological~~protocol ~~product~~ for an additional clinical study. On October 18, 2023 Brainstorm announced that isthe ~~"biosimilar~~BLA for NurOwn® would be withdrawn. The BLA was withdrawn on November 3, 2023. The decision to" orwithdraw ~~"interchangeable~~the BLA was coordinated with" the FDA and is viewed by the FDA as a ~~referenced~~withdrawal without prejudice. On November 20, ~~branded~~2023, ~~biologic~~we ~~product~~announced that the FDA granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. ~~Previously~~The meeting took place on December 6, ~~there had~~2023. ~~been~~On noDecember 7, ~~licensure~~2023, ~~pathway~~we ~~for~~announced ~~such~~the ~~biosimilar~~completion orof ~~interchangeable~~a ~~products~~productive meeting with the FDA to discuss NurOwn®. ~~For~~The ~~purposes~~primary objective of the ~~BPCIA,~~meeting was to discuss plans for a ~~reference~~SPA ~~product~~with the FDA on the overall protocol design for a planned Phase 3b registrational trial for NurOwn®. The ultimate goal of the SPA is ~~defined~~ asto secure the ~~single~~FDA’s ~~biological~~agreement ~~product~~that ~~licensed~~critical ~~under~~elements aof ~~full~~the ~~BLA~~overall ~~against~~protocol ~~which~~design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a ~~biological~~study ~~product~~intended isto ~~evaluated~~support ina anfuture marketing application . On February 23, 2024, we announced that we submitted the SPA request to the FDA for the planned Phase 3b clinical trial of NurOwn® for the treatment of ALS. On April 9, 2024, the Company announced that it received written agreement from the FDA, under a ~~follow-~~SPA, on the design for a Phase 3b trial of NurOwn (R) in ALS. The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating the Company’s adequacy in addressing objectives that support a future BLA in ALS. On June 26, 2024, the Company announced that it has reached alignment with FDA on the CMC aspects of Brainstorm’s Phase 3b clinical trial for NurOwn (R), its investigational therapy for ALS. This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a SPA agreement for its NurOwn Phase 3b trial.

~~The~~NurOwn® ~~BPCIA~~Clinical also created a 12-year period of reference product exclusivity, which can be extended to 12.5 years with pediatric exclusivity. The 12-year exclusivity period begins on the date of first licensure of the reference product under the PHSA and during which the licensure of a follow-on application for a biosimilar or interchangeable product cannot be made effective. During the first four years (or four and one-half years with pediatric exclusivity) of the 12-year period, an application for a biosimilar or interchangeable version of the reference product cannot be submitted to the FDA. Under budget proposals submitted by President Obama, the Administration has requested that reference product exclusivity would decrease from twelve to seven years. Congress has not yet enacted such a change in the BPCIA, but could move to enact such a decrease in the reference product exclusivity period.Manufacturing

~~The~~We ~~BPCIA~~have ~~includes~~developed ~~limits~~a onvalidated ~~obtaining~~cryopreservation 12process for the long-~~year~~term ~~reference~~storage ~~product exclusivity~~of ~~for~~MSC, ~~certain~~that ~~changes~~allows ormultiple ~~modifications~~doses of NurOwn® to be created from a single bone marrow harvest procedure in the ~~reference~~multi-dose ~~product~~clinical trials and to avoid the need for patients to undergo repeated bone marrow aspiration. A ~~separate~~validation ~~12-year~~study ~~reference~~was ~~product~~conducted ~~exclusivity~~in ~~period does~~2017 ~~not~~comparing ~~apply~~NurOwn® derived from fresh MSC to: those derived from cryopreserved MSC. Company scientists were successful in showing that the MSC can be stored in the vapor phase of liquid nitrogen for prolonged periods of time, while maintaining their characteristics. Cryopreserved MSC are capable of differentiating into NurOwn®, similar to the NurOwn® derived from fresh MSC from the same patient/donor, prior to cryopreservation and maintain their key functional properties including immunomodulation and neurotrophic factor secretion.

·We acontracted ~~BLA~~with ~~supplement~~City of Hope’s Center for Biomedicine and Genetics to manufacture clinical supplies of NurOwn® adult stem cells for our Phase 3 clinical study. City of Hope supported the ~~product~~manufacturing ~~that~~of isNurOwn® and placebo for the ~~reference~~participants ~~product;~~treated

· a subsequent BLA filed by the same reference product sponsor or manufacturer (or a licensor, predecessor in interest, or other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength; or

· a modification to the structure of the biological product that does not result in a change in safety, purity or potency.

In February 2012, the FDA issued three draft guidance documents on biosimilar product development. The FDA is soliciting comments on the draft guidance documents which are described by the FDA as follows: (1) Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, which is intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting an application, called a "351(k)" application, to the FDA. This draft guidance describes a risk-based "totality-of-the-evidence" approach that the FDA intends to use to evaluate the data and information submitted in support of a determination of biosimilarity of the proposed product to the reference product; (2) Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, which provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a 351(k) application; and (3) Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, which provides answers to common questions from people interested in developing biosimilar products. We cannot predict when or whether these draft guidance documents will ever be finalized or what changes the agency may make in its approach to implementation of the BPCIA.

InTable ~~addition to creating a 12-year period~~ of reference product exclusivity, the BPCIA clarifies the interaction of that exclusivity with orphan drug exclusivity, such that, if a reference product has been designated for a rare disease or condition the licensure of a biosimilar or interchangeable version of a reference product for such disease or condition may only occur after the later of the expiration of any applicable seven-year orphan drug exclusivity or the 12-year reference product exclusivity (or seven and one-half years and 12.5 years with pediatric exclusivity).Contents

~~Our~~in ~~biological~~the ~~product~~Phase ~~candidates,~~3 ~~if approved, could be considered reference products entitled to 12-year exclusivity~~study. ~~Even~~The ifConnell ~~our~~and ~~products~~O’Reilly ~~are~~Cell ~~considered~~Manipulation toCore beFacility ~~reference~~at ~~products~~the ~~eligible~~Dana ~~for~~Farber ~~exclusivity, another~~Cancer ~~company~~Institute ~~could~~(“DFCI”) ~~market~~in aBoston ~~competing~~was ~~version~~also ofcontracted ~~any~~to ofmanufacture ~~our~~NurOwn® ~~biological~~and ~~products~~placebo ~~if the FDA approves a full BLA~~ for ~~such~~our ~~product containing~~Phase ~~the~~3 ~~sponsor's~~ALS ~~own~~clinical ~~preclinical~~study ~~data~~participants and ~~data~~commenced ~~from~~manufacturing ~~adequate~~in ~~and~~October 2018. ~~well-controlled~~DFCI ~~clinical~~core ~~trials~~manufacturing tofacility ~~demonstrate~~also ~~the~~supplied ~~safety, purity~~NurOwn® ~~and~~for ~~potency~~our ofPhase ~~their~~2 ~~product~~PMS study.

~~The~~On ~~BPCIA~~October 22, ~~also~~2020, ~~sets~~we ~~forth~~announced a ~~complex~~partnership ~~mechanism~~with ~~for~~Catalent, ~~resolving patent~~the ~~disputes~~leading ~~that~~global ~~involves~~provider ~~a step-wise exchange~~ of ~~information~~advanced ~~prior~~delivery technologies, to ~~the~~manufacture ~~initiation~~NurOwn®, ofwhich ahas ~~patent~~been ~~infringement~~evaluated ~~lawsuit~~for ~~against a~~the ~~biosimilar~~treatment orof ~~interchangeable~~ALS ~~product~~in ~~sponsor.~~our ~~Unlike~~Phase ~~the~~3 ~~Hatch-Waxman~~clinical ~~Act,~~trial. ~~the~~If ~~BPCIA~~we ~~provides~~receive noFDA ~~automatic stay on~~ approval of afor ~~biosimilar~~NurOwn® ~~product~~in ~~application~~ALS, ~~except~~Catalent anwill ~~interchangeable~~be ~~product~~our ~~receives~~partner ~~the~~for ~~lesser~~manufacturing ~~of one year of exclusivity after the date of first~~ commercial ~~marketing~~quantities ~~or 18 months~~ of ~~exclusivity~~NurOwn® ~~after~~to atreat ~~final~~patients ~~court~~with ~~decision or dismissal of a patent challenge or, if the applicant has not been sued, after approval~~ALS. ~~The~~Our ~~BPCIA~~technology ~~does~~transfer ~~not~~to ~~prevent~~Catalent aHouston ~~competitor~~was ~~from~~successfully ~~conducting~~completed ~~its own clinical trials~~ and ~~submitting~~enabled acontinuous ~~full~~supply ~~BLA~~of onNurOwn® for the ~~same or similar product~~EAP.

~~Post-Approval~~On ~~Requirements~~December 7, 2021, we and Catalent announced completion of technology transfer for NurOwn® manufacturing at Catalent’s cell therapy facility in Houston, Texas.

~~Any~~Catalent ~~drugs~~Houston ~~for~~manufactured ~~which~~NurOwn® we receive FDA approval are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse effects with the product, reporting of changes in distributed products which would require field alert reports (FARs) for ~~drugs and biological product deviation reports (BPDRs), providing~~ the FDA with updated safety and efficacy information, product sampling and distribution requirements, complying with certain electronic records and signature requirements and complying with FDA promotion and advertising requirementsEAP. In ~~September~~As ~~2007, the Food and Drug Administration Amendments Act~~ of ~~2007 was enacted~~December 31, ~~giving the FDA enhanced post-marketing authority~~2022, ~~including~~seven ~~the~~participants ~~authority~~have tocompleted ~~require~~treatment ~~postmarketing studies and clinical trials, labeling changes based on new safety information, and compliance~~ with ~~risk~~NurOwn® ~~evaluations and mitigation strategies, or REMS, approved by the FDA. The FDA strictly regulates labeling, advertising, promotion and other types of information on products~~ that ~~are~~was ~~placed~~manufactured onat the ~~market.~~Catalent ~~Drugs~~facility ~~and~~as ~~biologics~~well may be promoted only for the approved indications and in accordance with the provisions of the approved label. Further, manufacturers of drugs and biologics must continue to comply with cGMP requirements, which are extensive and require considerable time, resources and ongoing investment to ensure compliance. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented and other types of changes to the approved product, such as ~~adding~~all ~~new~~Expanded ~~indications~~Access ~~and~~protocol ~~additional~~follow-up ~~labeling claims, are also subject to further FDA review and approval~~visits.

~~Drug~~Meetings ~~and biologic manufacturers and other entities involved in the manufacturing and distribution of approved drugs and biologics are required to register their establishments~~ with the FDA ~~and~~ ~~certain state agencies,~~ and ~~are subject to periodic unannounced inspections by the~~ FDA ~~and~~Senior certain state agencies for compliance with cGMP, GTP applicable to biologics, and other laws. The cGMP requirements apply to all stages of the manufacturing process, including the production, processing, sterilization, packaging, labeling, storage and shipment of the drug. Manufacturers must establish validated systems to ensure that products meet specifications and regulatory standards, and test each product batch or lot prior to its release.Management

In July 2019, the Brainstorm management team was invited to participate in a special in-person, high-level meeting with the senior management of the FDA Drug and Biologics Centers and, ‘I AM ALS’, a grassroots ALS advocacy group advocating for an ALS cure. FDA’s Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (“CBER”) and Dr. Janet Woodcock, former Director of the Center for Drug Evaluation and Research (“CDER”) were in attendance with senior FDA staff. Brainstorm’s Phase 3 ALS principal Investigators Dr. Robert Brown (Massachusetts Memorial Hospital, Worcester, Massachusetts) and Dr. Merit Cudkowicz (MGH, Boston) joined by teleconference. The meeting’s purpose was to discuss Brainstorm’s ongoing Phase 3 ALS clinical trial as well as efforts to speed treatment access to the ALS patient community. The meeting enabled an open and effective dialogue between the FDA and Brainstorm, setting the stage for future meetings to explore practical options to quickly bring our investigational treatment to those living with ALS.

On February 11, 2020, we announced that we held a high-level meeting with the FDA to discuss potential NurOwn® regulatory pathways for approval in ALS. In the planned meeting with senior CBER leadership and several leading U.S. ALS experts, the FDA confirmed that the Phase 3 ALS trial was collecting relevant data critical to the assessment of NurOwn® efficacy. The FDA indicated that they would look at the “totality of the evidence” in the expected Phase 3 clinical trial data.

On February 9, 2021, we announced feedback on a Type-C Meeting with the FDA on future NurOwn® manufacturing plans and to review specific aspects of our planned manufacturing modifications to support the development of a semi-automated commercial manufacturing process for NurOwn® (MSC-NTF cell). The meeting included a detailed review of the requirements for comparability testing to support future modifications along with geographic considerations in the sourcing of starting materials and future manufacturing production. We plan to incorporate feedback from the FDA meeting in 2021, our experience from Phase 3 manufacturing, in addition to feedback received in recent interactions with FDA including the Type A meeting on December 6, 2023, to formalize our plan to satisfy FDA’s expectations for CMC for a product in Phase 3 development.

On February 22, 2021, we announced high-level FDA feedback on NurOwn® ALS Clinical Development Program. The FDA concluded from their initial review that the current level of clinical data does not provide the threshold of substantial evidence that the FDA is seeking to support a BLA. In addition, the FDA advised that this recommendation does not preclude the Company from proceeding with a BLA submission. Following extensive consultations with principal investigators, ALS experts, expert statisticians, regulatory advisors, and ALS advocacy groups to discuss the best path forward to provide NurOwn® for ALS patients, Brainstorm filed a BLA on September 9, 2022. On November 10, 2022, we announced that we had received a RTF letter from the FDA regarding our BLA, which informed us that the BLA was not sufficiently complete to enable a substantive review and that the FDA. The RTF letter contained a list of topics the FDA provided to BrainStorm as rationale for the BLA file being not sufficiently complete to enable a substantive review. According to the FDA, these reasons included one item related to the trial not meeting the standard for substantial evidence of effectiveness and CMC related items. The FDA indicated that we could request a Type A meeting to discuss the content of the RTF letter, and the Type A meeting was held on January 11, 2023. We notified the FDA on February 6, 2023 of our decision to request the FDA to file the NurOwn® BLA for ALS over Protest. Written feedback was received on March 22, 2023 from the FDA project manager associated with the BLA confirming the FDA’s decision to grant an ADCOM for the NurOwn® BLA for ALS. We submitted an amendment to our BLA on March 7, 2023, in which we responded to the majority of the items included in the RTF letter. The BLA for NurOwn® to treat ALS is currently under active review by the FDA.

The FDA may withdraw a product approval if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market. Discovery of previously unknown problems with a product subsequent to its approval may result in restrictions on the product or even complete withdrawal of the product from the market. Further, the failure to maintain compliance with regulatory requirements may result in administrative or judicial actions, such as fines, warning letters, holds on clinical trials, product recalls or seizures, product detention or refusal to permit the import or export of products, refusal to approve pending applications or supplements, restrictions on marketing or manufacturing, injunctions or civil or criminal penalties.

~~From~~Table ~~time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing~~ of products regulated by the FDA. In addition to new legislation, the FDA regulations and policies are often revised or reinterpreted by the agency in ways that may significantly affect our business and our product candidates. It is impossible to predict whether further legislative or FDA regulation or policy changes will be enacted or implemented and what the impact of such changes, if any, may be.Contents

~~Foreign~~On ~~Regulation~~March 27, 2023, we announced that the FDA will hold an ADCOM to discuss the company’s BLA for NurOwn® for the treatment of ALS. On June 6, 2023, we announced that the advisory committee meeting has been scheduled for September 27, 2023. On September 22, 2023, we submitted an amendment to our BLA to revise the indication to NurOwn® for the treatment of mild to moderate ALS. On September 27, 2023 we announced that the Advisory Committee voted, with 17 voting no, one voting yes, and one abstention, that NurOwn® did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS. On October 18, 2023, we announced that the FDA invited the Company to request an expedited face-to-face meeting to discuss the path forward for NurOwn® as a treatment for ALS. Brainstorm remains committed to the ALS Community and is actively exploring the next steps in support of NurOwn®, including publication of emerging clinical data and development of a protocol for an additional clinical study. On October 18, 2023 Brainstorm announced that the BLA for NurOwn® would be withdrawn. The BLA was withdrawn on November 3, 2023. The decision to withdraw the BLA was coordinated with the FDA and is viewed by the FDA as a withdrawal without prejudice. On November 20, 2023, we announced that the FDA granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting took place on December 6, 2023. On December 7, 2023, we announced the completion of a productive meeting with the FDA to discuss NurOwn®. The primary objective of the meeting was to discuss plans for a SPA with the FDA on the overall protocol design for a planned Phase 3b registrational trial for NurOwn®. The ultimate goal of the SPA is to secure the FDA’s agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application. On February 23, 2024, we announced that we submitted the SPA request to the FDA for the planned Phase 3b clinical trial of NurOwn® for the treatment of ALS. On April 9, 2024, the Company announced that it received written agreement from the FDA, under a SPA, on the design for a Phase 3b trial of NurOwn (R) in ALS. The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating the Company’s adequacy in addressing objectives that support a future BLA in ALS. On June 26, 2024, the Company announced that it has reached alignment with FDA on the CMC aspects of Brainstorm’s Phase 3b clinical trial for NurOwn (R), its investigational therapy for ALS. This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a SPA agreement for its NurOwn Phase 3b trial.

InALS ~~addition~~Expanded toAccess regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our product candidates to the extent we choose to clinically evaluate or sell any products outside of the United States. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. As in the United States, post-approval regulatory requirements, such as those regarding product manufacture, marketing, or distribution would apply to any product that is approved outside the United States.Program

~~Third~~On ~~Party~~December 14, ~~Payor~~2020, ~~Coverage~~we announced the NurOwn® EAP through which NurOwn® would be made available for ALS patients who completed all Phase 3 scheduled treatments and ~~Reimbursement~~follow-up assessments and meet specific eligibility criteria.

~~Significant~~The ~~uncertainty~~protocol ~~exists~~for ~~as to~~ the ~~coverage~~EAP ~~and~~was ~~reimbursement status~~developed ofin ~~any~~partnership ofwith ~~our biologic or drug candidates for which we obtain regulatory approval. In both~~ the ~~United~~FDA ~~States and foreign markets, our ability~~ to ~~commercialize~~provide ~~our~~access ~~product candidates successfully, and~~ to ~~attract~~NurOwn® ~~commercialization partners~~ for ~~our~~Phase ~~product candidates,~~3 ~~depends~~clinical intrial ~~significant~~participants ~~part~~who onmeet ~~the~~specific ~~availability~~eligibility ofcriteria. ~~adequate~~Initially, ~~financial~~participants ~~coverage~~less ~~and~~severely ~~reimbursement~~affected ~~from~~by ~~third party payors~~ALS, ~~including,~~ ~~in the United States, governmental payors such~~ as ~~the~~measured ~~Medicare~~by ~~and Medicaid programs~~ALSFRS-R, ~~managed~~were ~~care organizations, and private health insurers. Medicare is a federally funded program managed by~~ the ~~Centers~~first ~~for Medicare and Medicaid Services, or CMS, through local fiscal intermediaries and carriers that administer coverage and reimbursement for certain healthcare items and services furnished~~ to ~~the~~receive ~~elderly and disabled~~treatment. ~~Medicaid~~This isapproach ~~an insurance program for certain categories of patients whose income and assets fall below state defined levels and who are otherwise uninsured that~~ is ~~both~~informed ~~federally and state funded and managed~~ by ~~each~~recently ~~state. The~~announced ~~federal~~top-line ~~government~~data ~~sets~~from ~~general~~the ~~guidelines~~Company’s ~~for~~Phase ~~Medicaid~~3 ~~and~~clinical ~~each state creates specific regulations that govern its individual program~~trial. ~~Each~~According ~~payor~~to ~~has its own process and standards for determining whether it will cover and reimburse a procedure or particular product. Private payors often rely on~~ the ~~lead~~FDA, ofEAPs, ~~the~~alternatively ~~governmental~~known ~~payors~~as in“compassionate ~~rendering~~use” ~~coverage and reimbursement determinations. Therefore~~programs, ~~achieving~~provide ~~favorable CMS coverage and reimbursement is usually~~ a ~~significant~~pathway ~~gating issue~~ for ~~successful~~patients ~~introduction of~~to areceive ~~new~~an ~~product.~~investigational ~~The~~medicine ~~competitive position of some of our products will depend, in part, upon the extent of coverage and adequate reimbursement~~ for ~~such~~a ~~products~~serious ~~and~~disease ~~for the procedures in which such products are used. Prices at which we~~ or ~~our~~condition ~~customers~~outside ~~seek reimbursement~~of ~~for~~a ~~our~~clinical ~~product candidates can be subject to challenge, reduction or denial by the government and other payors~~trial.

Through the EAP, the six clinical centers participating in the Phase 3 NurOwn® trial each had the opportunity to treat ALS participants who completed the trial. These six centers are: University of California, Irvine; Cedars-Sinai Medical Center; California Pacific Medical Center; MGH; University of Massachusetts Medical School; and the Mayo Clinic. EAP treatment of ALS participants who have completed the Phase 3 clinical trial did not interfere with data or regulatory timelines. The Cell Manipulation Core Facility (“CMCF”) at the Dana Farber Cancer Institute manufactured the investigational therapy, assisted by on-site Brainstorm personnel.

In the course of 2021, 10 eligible patients that had completed the Phase 3 study, were enrolled in the EAP at the six participating medical centers to receive three additional doses of NurOwn® eight weeks apart. Eight patients completed the program receiving all three treatment doses. Two participants withdrew consent after receiving two treatment doses. There were no serious adverse events AEs in the treated participants.

Patient Access Programs (ALS)

The Company, had worked collaboratively with the Sourasky Hospital, to treat ALS patients with NurOwn®, under the Israel Hospital Exemption (“HE”) regulatory pathway for Advanced Therapy Medicinal Products (“ATMP”), which was adopted by the Israeli MoH from the EMA regulation. Between the first quarter of 2019 and the fourth quarter of 2020, the Company enrolled and treated 12 ALS patients with NurOwn®, under the HE pathway. The Company received $3.4 million in gross proceeds in connection with the treatment of the aforementioned patients, which did not cover the costs of the trial. The remaining cost associated with the HE pathway were paid by Brainstorm.

The U.S. Congress and state legislatures may, from time to time, propose and adopt initiatives aimed at cost containment, which could impact our ability to sell our product candidates profitably. For example, in March 2010, President Obama signed into law the Patient Protection and Affordable Care Act and the associated reconciliation bill, which we refer to collectively as the Health Care Reform Law, a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. Effective October 1, 2010, the Health Care Reform Law revises the definition of “average manufacturer price” for reporting purposes, which could increase the amount of Medicaid drug rebates to states once the provision is effective. Further, the law imposes a significant annual fee on companies that manufacture or import branded prescription drug products. Substantial new provisions affecting compliance have also been enacted, which may require us to modify our business practices with healthcare practitioners. We will not know the full effects of the Health Care Reform Law until applicable federal and state agencies issue regulations or guidance under the new law.

~~Although~~Table ~~it is too early to determine the effect~~ of the Health Care Reform Law, the new law appears likely to continue the pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs. Moreover, in the coming years, additional changes could be made to governmental healthcare programs that could significantly impact the success of our product candidates.Contents

~~The~~NurOwn® ~~cost~~in ofProgressive ~~pharmaceuticals~~Multiple ~~continues~~Sclerosis to generate substantial governmental and third party payor interest. We expect that the pharmaceutical industry will experience pricing pressures due to the trend toward managed healthcare, the increasing influence of managed care organizations and additional legislative proposals. Our results of operations could be adversely affected by current and future healthcare reforms.(PMS)

~~Some~~On ~~third~~December 15, ~~party~~2018, ~~payors~~the ~~also~~FDA ~~require~~approved ~~pre-approval~~the ofCompany’s ~~coverage for~~IND ~~new~~to orconduct ~~innovative~~a ~~devices,~~Phase ~~biologics~~2 oropen-label ~~drug~~trial ~~therapies~~of ~~before~~repeated ~~they~~intrathecal ~~will~~administration ~~reimburse~~of ~~healthcare~~NurOwn® ~~providers~~in ~~that~~PMS ~~use~~(www.clinicaltrials.gov ~~such~~Identifier ~~therapies~~NCT03799718). ~~While~~ weThe ~~cannot~~study ~~predict~~titled ~~whether~~“A ~~any~~Phase ~~proposed~~2, ~~cost~~open-~~containment~~label, ~~measures~~multicenter ~~will~~study beto ~~adopted~~evaluate orthe ~~otherwise~~safety ~~implemented~~and inefficacy ~~the~~of ~~future, the~~repeated ~~announcement~~administration orof ~~adoption~~NurOwn® of(Autologous ~~these~~Mesenchymal ~~proposals~~Stem ~~could~~Cells ~~have~~Secreting aNeurotrophic ~~material~~Factors; ~~adverse~~MSC-NTF ~~effect~~cells) onin ~~our~~participants ~~ability~~with PMS was designed to ~~obtain~~recruit ~~adequate~~20 ~~prices~~PMS ~~for our~~participants ~~product~~at ~~candidates~~5 ~~and~~leading ~~operate~~U.S. ~~profitably~~Multiple Sclerosis centers.

~~Different~~On ~~pricing~~December 18, ~~and reimbursement schemes exist in other countries. In the European Community~~2019, ~~governments influence~~ the ~~price~~clinical oftrial ~~pharmaceutical~~independent ~~products~~Data ~~through~~Safety ~~their~~Monitoring ~~pricing~~Board ~~and~~(“DSMB”) ~~reimbursement~~for ~~rules and control of national health care systems that fund a large part of~~ the ~~cost of those products to consumers~~U. ~~Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed~~S. To ~~obtain~~Phase ~~reimbursement~~2 orPMS ~~pricing~~study ~~approval,~~completed ~~some of these countries may require~~ the ~~completion~~first, ofpre-specified ~~clinical~~interim ~~trials~~analysis, ~~that compare the cost-effectiveness~~ of asafety ~~particular~~outcomes ~~drug or biological candidate to currently available therapies. Other member states allow companies to fix their own prices~~ for ~~medicines,~~the ~~but~~first ~~monitor~~9 ~~and~~participants ~~control~~enrolled ~~company profits. The downward pressure on health care costs~~ in ~~general,~~the ~~particularly prescription drugs and biologics, has become very intense~~study. AsAfter acareful ~~result,~~review ~~increasingly high barriers are being erected to the entry~~ of ~~new~~all ~~products.~~available Inclinical ~~addition,~~trial ~~in some countries~~data, ~~cross-border~~the ~~imports~~DSMB ~~from~~unanimously ~~low-priced~~concluded ~~markets~~“the ~~exert a~~study ~~commercial~~should ~~pressure~~continue onas ~~pricing~~planned ~~within~~without aany ~~country~~protocol modification”.

~~Other~~In ~~Healthcare~~August 2021, ~~Laws~~the clinical trial independent DSMB for the U.S. Phase 2 PMS study issued an end-of-study statement concluding that, based on the data, the procedures and ~~Compliance~~treatment ~~Requirements~~involved in BCT-101-US were relatively safe and tolerable. Given that the study was “open-label” with no active comparator arm(s), it was not possible to evaluate efficacy, except through comparison to non-contemporaneous natural history data sets or to prior clinical trials of similar populations.

InPhase ~~the~~2 ~~United~~PMS ~~States,~~Clinical our activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including the Centers for Medicare and Medicaid Services, other divisions of the United States Department of Health and Human Services (e.g., the Office of Inspector General), the United States Department of Justice and individual United States Attorney offices within the Department of Justice, and state and local governments. These regulations include:Trial

·On March 24, 2021, the ~~federal~~Company ~~healthcare~~announced ~~program~~positive ~~anti~~top-~~kickback~~line ~~law~~data in the Phase 2 study evaluating three repeated administrations of NurOwn®, ~~which~~each ~~prohibits~~given 2 months apart, ~~among~~as ~~other~~a ~~things~~treatment for PMS. The 28-week open-label Phase 2 clinical trial enrolled 20 primary and secondary PMS patients based on the 2017 revised McDonald Criteria, ~~persons~~ages ~~from~~18-65, ~~soliciting~~with baseline Expanded Disability Status Scale (“EDSS”) scores between 3-6.5, ~~receiving~~without orevidence ~~providing~~of ~~remuneration~~relapse within 6 months of enrollment, ~~directly~~able to walk 25 feet in 60 seconds or ~~indirectly,~~less and were permitted to ~~induce~~be ~~either~~on ~~the~~a ~~referral~~stable dose of andisease ~~individual~~modifying therapy. Of the 20 patients enrolled, ~~for~~18 anwere ~~item~~treated orand ~~service~~16 or(80)% completed the ~~purchasing~~study. Two patients discontinued related to procedure-related AEs. There were no study deaths or ~~ordering~~AEs related to multiple sclerosis (“MS”) worsening. The mean age of astudy ~~good~~patients orwas ~~service~~47, ~~for~~56% ~~which~~were ~~payment~~female, ~~may~~and bemean ~~made~~baseline ~~under~~EDSS ~~federal~~score ~~healthcare~~was ~~programs~~5.4. ~~such~~The asclinical trial compared clinical efficacy outcomes with a 48-patient matched clinical cohort from the ~~Medicare~~Comprehensive Longitudinal Investigations in MS at the Brigham & Woman’s Hospital (CLIMB Study). MS Function and ~~Medicaid~~Cognition ~~programs~~measures in the top-line results included the timed 25-foot walk (T25FW); 9-hole peg test (9-HPT); Low Contrast Letter Acuity (LCLA); Symbol Digit Modality Test (SDMT); and the 12 item MS Walking Scale (MSWS-12).

·Key ~~federal~~findings ~~false claims laws which prohibit, among other things, individuals or entities~~ from ~~knowingly~~the ~~presenting,~~trial orwere ~~causing~~as ~~to be presented, claims for payment from Medicare, Medicaid, or other government reimbursement programs that are false or fraudulent;~~follows:

·● ~~the~~Prespecified ~~federal~~25% ~~Health~~improvements ~~Insurance~~in ~~Portability~~the ~~and~~timed ~~Accountability~~T25FW ~~Act~~and of9-HPT ~~1996,~~(combined ~~which~~average) ~~prohibits~~from ~~executing~~baseline ~~a scheme~~ to ~~defraud~~28 ~~any~~weeks ~~healthcare~~were ~~benefit~~observed ~~program~~in or14% ~~making~~and ~~false~~13% ~~statements~~of ~~relating~~NurOwn® totreated ~~healthcare~~patients, ~~matters~~respectively, and ~~which~~improvement ~~also~~in ~~imposes~~9-HPT ~~certain~~(combined ~~requirements~~average) ~~relating~~was toobserved ~~the~~in ~~privacy,~~0% ~~security~~of ~~and~~the ~~transmission~~pre-specified ofmatched ~~individually~~historical ~~identifiable~~controls ~~health~~in ~~information;~~the CLIMB registry.

●

38% of NurOwn® treated patients showed at least a 10-point improvement in the MSWS-12 from baseline to week 28, a patient reported outcome that evaluates walking function.

●

47% of NurOwn® treated patients showed at least an 8-letter improvement across 28 weeks in the LCLA binocular 1.25%, a visual function test. Additionally, 27% of NurOwn® treated patients showed at least an 8-letter improvement across 28 weeks in the LCLA binocular 2.5%,

●

67% of NurOwn® treated patients showed at least a 3-point improvement in the SDMT, a measure of cognitive processing.

●

NurOwn® treated patients showed a mean improvement from baseline of 10% in T25FW and a 4.8% improvement from baseline on the 9-HPT dominant hand, compared to 1.8% and 1.4% worsening respectively in matched historical controls from the CLIMB registry.

●

NurOwn® treated patients showed a 6% improvement from baseline in MSWS-12.

All results reported are based on observed data. Cerebrospinal fluid (CSF) biomarkers were obtained at 3 consecutive time points, just prior to each intrathecal administration of NurOwn®. We observed increases in neuroprotective molecules (VEGF, HGF) and decreases in neuroinflammatory biomarkers (MCP-1, and Osteopontin).

· the federal transparency requirements under the Health Care Reform Law requires manufacturers of drugs, devices, biologics, and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests;

·Table the FDCA, which among other things, strictly regulates drug and biologic product marketing, prohibits manufacturers from marketing drug or biologic products for off-label use and regulates the distribution of ~~drug samples; and~~Contents

·Additionally, ~~state~~we ~~law~~completed ~~equivalents~~secondary ofefficacy ~~each~~data ofand ~~the~~detailed ~~above~~CSF ~~federal~~and ~~laws,~~blood ~~such~~biomarker asanalyses. ~~anti-kickback~~We ~~and~~presented ~~false~~a ~~claims~~detailed ~~laws~~summary ~~which~~of ~~may~~the ~~apply~~study tooutcomes ~~items~~at orthe ~~services~~37th ~~reimbursed~~Congress byof ~~any~~the ~~third~~ECTRIMS ~~party~~on ~~payor~~October 14, ~~including~~2021 ~~commercial insurers,~~ and ~~state~~published ~~laws~~our ~~governing~~findings in the ~~privacy~~peer ~~and~~reviewed ~~security~~journal ofMultiple ~~health~~Sclerosis ~~information~~Journal in ~~certain circumstances~~September 15, ~~many~~2022. ofWe ~~which~~are ~~differ~~currently ~~from~~considering ~~each~~how ~~other~~best into ~~significant~~advance ~~ways~~NurOwn® ~~and~~as ~~often~~an ~~are~~innovative ~~not~~treatment ~~preempted~~option byin ~~federal laws, thus complicating compliance efforts~~PMS.

~~Compliance~~NurOwn® ~~with~~in ~~Environmental,~~Alzheimer’s ~~Health~~Disease ~~and Safety Laws~~(AD)

InOn ~~addition~~June 24, ~~to FDA regulations~~2020, we ~~are~~announced ~~also~~a ~~subject~~new toclinical ~~evolving federal,~~program ~~state~~focused ~~and~~on ~~local environmental, health and safety laws and regulations. In~~ the ~~past,~~development ~~compliance~~of ~~with~~NurOwn® ~~environmental,~~as ~~health and~~a ~~safety~~treatment ~~laws~~for ~~and~~AD. ~~regulations~~We ~~has~~are ~~not~~currently ~~had~~evaluating anext ~~material~~steps ~~effect~~based on ~~our~~emerging ~~capital~~scientific ~~expenditures.~~insights Weand ~~believe~~the ~~that~~changing weregulatory ~~comply~~landscape infor ~~all~~AD ~~material respects~~following ~~with~~the ~~existing~~recent ~~environmental,~~FDA ~~health~~decision ~~and safety laws and regulations applicable~~ to ~~us.~~grant ~~Compliance~~accelerated ~~with~~approval ~~environmental,~~of ~~health and~~Aducanumab ~~safety laws~~ and ~~regulations~~pending inregulatory ~~the~~reviews ~~future~~of ~~may~~other ~~require~~investigational ~~additional~~anti-amyloid ~~capital expenditures~~therapies.

~~Competition~~While many AD therapies have focused on a single target such as tau or beta-amyloid, we believe NurOwn® has the capability to simultaneously target multiple relevant biological pathways and bring a comprehensive approach to this multifactorial disease. Importantly, NurOwn®’s mechanism of action may allow the therapy to enable synergistic combinations with anti-tau or anti-beta-amyloid treatments, further underscoring its potential to address critical unmet needs in AD. In such a complex disease, addressing inflammation and neuroprotection is an innovative approach and a first in the world for this technology.

~~There are a number of clinical trials underway for potential treatments for ALS, of which only two are stem cell~~Non-~~based~~Dilutive trials being conducted by other commercial entities. One is US-based Neuralstem (CUR), which is currently conducting a Phase II trial for its allogeneic, human (fetal) spinal cord derived neural stem cells. The other is Corestem, a Korean company, which is currently conducting two Phase I stem cell-based clinical trials. One is a recently launched Phase I trial with allogeneic bone marrow derived mesenchymal stem cells, and a previous trial, which is not actively recruiting, is with autologous, bone marrow-derived mesenchymal stem cells. There is little public information available about Corestem. Five non-stem cell-based companies are undergoing Phase I/II, Phase II or Phase III clinical trials for ALS. A number of academic institutions are also developing treatment candidates for ALS.Funding

~~Employees~~In July 2017, we were awarded a grant in the amount of $15,912,390 from the California Institute for Regenerative Medicine (CIRM) to aid in funding the Company’s pivotal Phase 3 study of NurOwn®, for the treatment of ALS. We received $12,550,000 of the CIRM grant from 2017 to 2019: $9,050,000 from 2017 through 2018, and an additional $3,500,000 in 2019. On March 16, 2020, we received $2,200,000 from CIRM for achieving our pre-determined milestones. In July 2020, we received an additional $700,000 for making further progress in our Phase 3 study. On December 1, 2020, we received our final payment of $462,390. We have now received in full the total amount of the $15,912,390 grant funding awarded by CIRM. The grant does not bear a royalty payment commitment nor is the grant otherwise refundable.

WeOn ~~currently~~November 14, ~~have~~2019, 16we ~~employees~~were awarded a $495,330 14grant offrom ~~whom~~the ~~are~~National ~~full~~Multiple Sclerosis Society (NMSS), through its Fast Forward program, for serum and CSF biomarkers analysis in Brainstorm’s Phase 2 open-~~time~~label, multicenter clinical trial of repeated intrathecal administration of NurOwn® in participants with PMS. As ~~None~~ of ~~our~~December 31, ~~employees~~2025, iswe ~~represented~~have byreceived a$352,156 ~~labor~~out ~~union~~of the $495,330 awarded.

~~PROPERTIES~~On June 9, 2020, we announced that The ALS Association and I AM ALS have awarded us a combined grant of $500,000 to support an ALS biomarker research study. The grant will be used to draw insights from data and samples collected from patients who participated in Brainstorm’s Phase 3 clinical trial and treated with NurOwn®, and to further the understanding of critical biomarkers associated with treatment response for people with ALS. As of December 31, 2025, we have received $400,000 out of $500,000 awarded.

~~Our~~Intellectual executive offices are located in premises at 605 Third Avenue, 34th Floor, New York, NY 10158, which we use, free of charge, pursuant to an oral agreement with Malcolm Taub, a member of our Board of Directors.Property

OnA ~~December~~key 1,element ~~2004,~~of our ~~Israeli~~strategy ~~Subsidiary~~is ~~entered~~to ~~into~~establish aand ~~lease agreement~~maintain ~~(the~~a ~~Lease~~broad ~~Agreement)~~intellectual ~~for~~property ~~the~~portfolio ~~lease~~to ofprotect ~~premises~~our inproprietary 12technologies ~~Basel~~and ~~Street,~~products. ~~Petach~~BrainStorm ~~Tikva,~~holds ~~Israel, which include~~ approximately ~~600~~ ~~square~~30 ~~meters~~granted ofpatents, ~~office~~as ~~and~~well ~~laboratory~~as ~~space.~~pending ~~The~~applications, ~~original~~across ~~term of~~ the ~~lease~~United ~~was 36 months (the Lease Term)~~States, ~~commencing on April 1~~Europe, ~~2005,~~and ~~with~~other ~~two~~key ~~options~~global tomarkets, ~~extend:~~including ~~one for an additional 24 months (~~the ~~First~~Far ~~Option);~~East and ~~one~~South ~~for an additional 36 months (the Second Option)~~America.

OnAlong ~~November~~with ~~11,~~our ~~2012,~~existing ~~the~~intellectual ~~Israeli~~property ~~Subsidiary~~protection ~~entered~~for ~~into~~NurOwn® ~~an amendment to the Lease Agreement, pursuant to which the Lease Term~~ (~~including the First Option and the Second Option~~MSC-NTF) ~~was extended by an additional five years~~, ~~through March 31, 2018. After three years,~~ we ~~will~~ have ~~the~~been ~~right~~expanding toour ~~cancel~~portfolio ~~the agreement with 6 months’ notice. Rent is paid on a monthly basis~~ in ~~the~~recent years ~~amount~~to ofcover ~~NIS~~exosome-based 40technologies,~~000~~ ~~(approximately~~with ~~U.S.~~several ~~$11,000).~~key developments:

December 3, 2024 - We ~~expanded~~received a Notice of Allowance from the U.S. Patent & Trademark Office (USPTO) for patent application 16/981,757, covering our ~~Petach~~proprietary ~~Tikva~~exosome ~~facility~~technology. inThis ~~2008~~patent is expected to ~~include~~provide ~~an animal~~protection ~~research~~until ~~facility~~April 10, 2039, further solidifying our leadership in cellular and exosome-based therapeutics.

December 26, 2023 – We announced the European grant for NurOwn®, alongside the Australian and Israeli allowances for NurOwn® exosomes.

~~As part of the clinical trials with Hadassah, we pay $31,250 per month for rental and operation of a clean room at the Hadassah medical center GMP facilities in Jerusalem.~~

WeTable ~~believe that the current office and laboratory space is adequate to meet our needs or will be available in the U.S. to meet the needs~~ of ~~U.S. clinical trials.~~Contents

August 22, 2023 – The Israel Patent Office accepted Application No. 277447, titled “Cell-Type Specific Exosomes and Use Thereof.” The accepted claims include an isolated exosome population derived from MSC-NTF cells and a pharmaceutical composition for treating neurodegenerative diseases.

June 2, 2023 – The Australian Patent Office accepted Application No. 2019252987 for the same technology, strengthening our exosome-related intellectual property.

Recent Scientific and Industry Presentations

●

On May 8, 2025, Bob Dagher presented new pharmacogenomic data of new findings on NurOwn® at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting, in New Orleans. The data highlights the impact of the UNC13A genotype on clinical outcomes for amyotrophic lateral sclerosis (ALS) patients treated with NurOwn® (debamestrocel).

●

From May 12-14, 2025, the Company participated in the 4th Annual ALS Drug Development Summit in Boston, MA. Senior leaders shared key insights from the NurOwn® program and contributed to discussions shaping the future of ALS research. Dr. Netta Blondheim-Shraga presented new findings on CSF biomarkers and their link to clinical outcomes in ALS. Dr. Bob Dagher led a workshop on adaptive and decentralized trial models, and Mary Kay Turner moderated a panel on access to investigational therapies and the impact of the diagnostic journey.

●

On May 27, 2025, the Company announced that it has signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to manufacture NurOwn^® for its upcoming clinical trial.

●

On June 16, 2025, the Company announced new survival data from 10 participants in its Expanded Access Program (EAP) for NurOwn® in ALS. The EAP enrolled 10 participants who had previously completed the Phase 3 clinical trial.

●

On July 8, 2025, the Company acknowledged that the FDA’s consideration of a Citizen Petition requesting a new review of the data supporting NurOwn will provide a critical opportunity to reaffirm its potential as therapy for ALS. A Citizen Petition, submitted to the FDA under the Federal Food, Drug, and Cosmetic Act (21 CFR § 10.30), is a regulatory process that allows any interested party to formally request the Agency to take action on specific matters, such as reviewing data, issuing new guidance, or taking enforcement action. In this case, the Citizen Petition is requesting that the FDA review the data supporting NurOwn.

Research and Development

We are actively engaged in research and development to evaluate the potential for clinical development of NurOwn® and MSC-NTF derived Exosomes in various neurodegenerative disorders, neurodegenerative eye disease and acute respiratory distress syndrome (“ARDS”). MSC-NTF derived Exosomes are an example of ongoing research in additional specialized derivative cell products. Exosomes are extracellular nano-vesicles (secreted by the cells) that carry various molecular components of their cell of origin, including nucleic acids, proteins and lipids. Exosomes can transfer molecules from one cell to another, thereby mediating cell-to-cell communication, ultimately regulating many cell processes, which are suitable for clinical applications in multiple neurodegenerative diseases. NurOwn® derived exosomes may possess unique features for the enhanced delivery of therapeutics to the brain, due to their ability to cross the blood brain barrier and to penetrate the brain and spinal cord.

The exosome research efforts are primarily focused on manufacturing of MSC-NTF exosomes from bone marrow derived MSC:

Developing and optimizing large scale cell culture processes using bioreactors, to generate exosomes.

Developing advanced scalable purification GMP methods that can be applied to commercial use.

Quantification, characterization of phenotype and exosome cargo.

Assessment of MSC-NTF exosomes potency and stability.

Establishment of a method for exosomes modification.

~~LEGAL PROCEEDINGS~~

~~From~~Table ~~time to time, we may become involved in litigation relating to claims arising out~~ of operations in the normal course of business, which we consider routine and incidental to our business. We currently are not a party to any legal proceedings the adverse outcome of which, in management’s opinion, would have a material adverse effect on our business, results of operation or financial condition.Contents

Preclinical experiments in neurodegenerative and lung injury models.

NurOwn® derived exosomes have the potential to treat ARDS due to their ability to penetrate deep tissues and decrease the inflammatory response. ARDS is a type of respiratory failure associated with widespread inflammation and lung damage mediated by dysregulated cytokine production and is one of the severe features of COVID-19.

MSC exosomes may be delivered intravenously or directly into the lungs via intratracheal administration and have several practical advantages over cellular therapy including ease of storage, stability, formulation and low immunogenicity.

In a preclinical study, we evaluated MSCs and NurOwn® derived exosomes in an LPS ARDS-mouse model, relevant to severe acute lung injury. The results from the study showed that intratracheal administration of NurOwn® derived exosomes resulted in a statistically significant improvement in multiple lung parameters. These included the clinically relevant factors: functional lung recovery, reduction in pro-inflammatory cytokines and most importantly, attenuation of lung damage. Moreover, MSC-NTF cell derived exosomes exhibited a superior effect when compared to treatment with exosomes derived from naïve MSCs from the same donor. On January 20, 2021, we announced the peer-reviewed publication of this preclinical study in the journal Stem Cell and Research Therapy. The study, entitled “MSC-NTF (NurOwn®) exosomes: a novel therapeutic modality in the mouse LPS-induced ARDS model,” evaluated the use of NurOwn® (MSC-NTF cell) derived exosomes in a mouse model of ARDS.

On May 4, 2022, we made a presentation titled “MSC-NTF derived small extracellular vesicles display superior macrophage immunomodulation compared with vesicles derived from naïve MSCs” at the International Society of Cell & Gene Therapy (“ISCT”) 2022 Meeting in San Francisco, CA May 4-7. The presentation highlighted results of a preclinical study undertaken to understand the mechanisms underlying the superior preclinical efficacy of Exo MSC-NTF versus Exo-MSC in acute lung injury models.

On May 25, 2021, we made a scientific presentation of NurOwn® Exosome preclinical ARDS data at the ISCT 2021 New Orleans Virtual Meeting demonstrating that intratracheal administration of NurOwn-derived exosomes resulted in statistically significant improvements in multiple lung parameters in a mouse model of ARDS.

On May 26, 2022, we presented a poster titled “Therapeutic effect of MSC-NTF exosomes in experimental bleomycin-induced lung injury” at the ISEV 2022 Annual Meeting, Lyon France. Results from a preclinical study demonstrating superior outcomes of exosomes derived from MSC-NTF cells compared to exosomes derived from MSC cells were presented.

A poster titled, “Therapeutic Benefits of MSC-NTF (NurOwn®) Exosomes in Acute Lung Injury Models” was presented on October 19, 2021 at the NYSCF 2021 Virtual Meeting, which was held on October 19-20, 2021. Results in two different acute lung injury models showed that the beneficial effects of intratracheal administration of Exo MSC-NTF (MSC-NTF derived exosomes) were more active than Exo MSC (MSC-derived Exosomes) in multiple parameters, including increase in blood oxygen saturation and reduction in lung pathology, inflammatory infiltration and levels of proinflammatory cytokines in bronchoalveolar lavage fluid (“BALF”), in addition to reduction of lung fibrosis in the Bleomycin model.

The observed positive preclinical results suggest that intratracheal administration of Exo MSC-NTF may have clinical potential as a therapy for acute lung related pathologies and has the potential to modify physiological, pathological, and biochemical outcomes with greater activity than sEVs isolated from naïve MSCs.

For the completed multidose clinical studies in ALS and PMS, the Company has improved the efficiency of NurOwn® production and improved its stability, allowing manufacturing to take place at centralized clean room facilities from which NurOwn® is distributed to the clinical trial sites, where the cells are then administered to patients. The Company is also engaged in several research initiatives to further improve and scale-up manufacturing capacity and extend the shelf life of NurOwn®.

Corporate Information

We are incorporated under the laws of the State of Delaware. Our principal executive offices are located at 1325 Avenue of Americas, 28th Floor, New York, NY 10019, and our telephone number is (201) 488-0460. We also maintain an office in Petach Tikva, Israel and in Burlington, Massachusetts. We maintain a website at http://www.brainstorm-cell.com. The information on our website is not incorporated into this Registration Statement on Form S-1.

~~MARKET FOR OUR COMMON EQUITY~~

~~Market~~Table ~~Information~~of Contents

Our Common Stock is traded on the OTCQB Marketplace under the symbol “BCLI.” The following table contains information about the range of high and low sales prices for our Common Stock based upon reports of transactions on the OTCQB Marketplace.History

Quarter Ended	High		Low
June 30, 2014	$	0.38	$	0.23
March 31, 2014	$	0.37	$	0.17
December 31, 2013	$	0.23	$	0.10
September 30, 2013	$	0.26	$	0.15
June 30, 2013	$	0.25	$	0.19
March 31, 2013	$	0.27	$	0.22
December 31, 2012	$	0.27	$	0.17
September 30, 2012	$	0.38	$	0.21
June 30, 2012	$	0.30	$	0.21
March 31, 2012	$	0.34	$	0.20

In 2004, the Company entered into a research and license agreement with Ramot to acquire certain stem cell technology, commenced development of novel cell therapies for neurodegenerative diseases, and discontinued its previous business selling digital data recorders. The Company was reincorporated in the State of Delaware on November 15, 2006, and previously was incorporated in the State of Washington in September 2000. In October 2004, the Company formed the Israeli Subsidiary. The Israeli Subsidiary formed wholly owned subsidiaries Brainstorm Cell Therapeutics UK Ltd., in the United Kingdom on February 19, 2013 (currently inactive), Advanced Cell Therapies Ltd. in Israel on June 21, 2018 and Brainstorm Cell Therapeutics Limited in Ireland on October 1, 2019. The Company formed a wholly - owned subsidiary in Delaware, Brainstorm Cell Manufacturing LLC, on August 21, 2024.

~~The~~A ~~source~~reverse stock split of ~~these~~the ~~high~~Company’s ~~and~~shares ~~low~~of ~~prices~~Common Stock by a ratio of one-for-fifteen was effected after market close on September 15, 2014, in connection with the ~~OTCQB~~September 30, ~~Marketplace.~~ 2014 listing of the Company’s Shares of Common Stock on The ~~high~~Nasdaq ~~and~~Capital ~~low~~Market. ~~prices~~On ~~listed~~September 30, ~~have~~2024, ~~been~~the ~~rounded~~Company upeffected toa one - for - fifteen reverse stock split of the ~~next~~Company’s ~~highest~~shares ~~two~~of ~~decimal~~Common ~~places~~Stock. Unless otherwise indicated, all share numbers and exercise prices in this Registration Statement on Form S-1 are split-adjusted.

OnThe ~~July~~Company’s 9,Common ~~2014,~~Stock ~~the~~previously ~~closing~~traded ~~bid~~on ~~price~~the ofNasdaq ~~our~~Capital ~~Common~~Market ~~Stock as~~under ~~reported by~~ the ~~OTCQB~~ticker ~~Marketplace~~symbol ~~was $0~~“BCLI.~~38 per share.~~”

~~Trades~~On inJuly 17, ~~our~~2025, ~~Common~~the ~~Stock~~Company ~~may~~announced bethat ~~subject~~it tohas ~~Rule~~received ~~15g-9~~a ofdelisting ~~the Exchange~~notification ~~Act~~from Nasdaq, ~~which~~informing ~~imposes~~the ~~requirements~~company onthat ~~broker/dealers~~its ~~who~~common ~~sell~~stock ~~securities~~will ~~subject~~be todelisted from the ~~rule~~Nasdaq toCapital ~~persons~~Market. ~~other~~Trading ~~than~~of ~~established customers~~our ~~and~~common ~~accredited~~stock ~~investors.~~on ~~For~~Nasdaq ~~transactions~~was ~~covered~~suspended byat the ~~rule~~open of trading on July 18, ~~broker/dealers~~2025. ~~must~~The ~~make~~delisting is a ~~special~~result ~~suitability~~of ~~determination for~~our ~~purchasers~~non-compliance ofwith ~~the~~Nasdaq ~~securities~~Listing ~~and~~Rule 5550(b)(1), ~~receive~~pertaining ~~the~~to ~~purchaser~~its minimum shareholder equity requirement. The Company’s ~~written~~shares ~~agreement~~started totrading on the ~~transaction~~OTCQB ~~before~~Venture Market, a U.S. trading platform operated by OTC Markets Group, under the ~~sale~~same symbol, “BCLI”, beginning at the open of trading on July 18, 2025.

The Securities and Exchange Commission also has rules that regulate broker/dealer practices in connection with transactions in “penny stocks.” Penny stocks generally are equity securities with a price of less than $5.00 (other than securities listed on certain national exchanges, provided that the current price and volume information with respect to transactions in that security is provided by the applicable exchange or system). The penny stock rules require a broker/dealer, before effecting a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document prepared by the Securities and Exchange Commission that provides information about penny stocks and the nature and level of risks in the penny stock market. The broker/dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker/dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s account. The bid and offer quotations, and the broker/dealer and salesperson compensation information, must be given to the customer orally or in writing before effecting the transaction, and must be given to the customer in writing before or with the customer’s confirmation. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for shares of Common Stock of the Company. AsBusiness ~~a result of these rules, investors may find it difficult to sell their shares.~~Strategy

~~Dividends~~Our overarching strategy is to develop, obtain regulatory approval for, and commercialize our proprietary NurOwn® and Exosome-based products through a methodical, data-driven approach to research, development, and clinical trials. Our clinical programs are subject to the regulatory authority of global regulatory authorities, including the U.S. Food and Drug Administration (FDA). Our highest priority is securing regulatory approval for NurOwn® in ALS, including the potential submission of a Biologics License Application (BLA) to the FDA following the successful completion of our Phase 3b clinical trial, while simultaneously advancing its clinical development in Progressive Multiple Sclerosis (PMS). We are also strategically expanding our Exosome-based platform technology to explore new therapeutic applications.

WeWith ~~have~~NurOwn® ~~not~~as ~~paid~~our orfoundation ~~declared~~in ~~any~~stem ~~cash~~cell-based ortherapeutics, ~~other dividends on~~ our ~~Common~~next ~~Stock~~strategic ~~within~~platform ~~the~~is ~~last~~exosome-based ~~two~~technology. ~~fiscal~~This ~~years.~~platform ~~Any~~expands ~~future~~our ~~determination~~pipeline asbeyond toautologous ~~the~~cellular ~~payment~~therapy, ofharnessing ~~dividends~~the ~~will~~regenerative ~~depend~~and ~~upon~~immunomodulatory ~~our results~~properties of ~~operations,~~exosomes ~~and~~derived onfrom ~~our~~NurOwn® ~~capital~~(MSC-NTF ~~requirements~~cells). Notably, ~~financial~~exosomes ~~condition~~have ~~and~~the ~~other~~potential ~~factors~~to ~~relevant~~serve atas ~~the~~an ~~time.~~allogeneic, ~~See~~off-the-shelf ~~“Dividend Policy~~therapeutic product.”

~~Record~~We ~~Holders~~have generated compelling preclinical data demonstrating the potential of our exosome-based technology across multiple areas of unmet medical need. Our research continues to explore new therapeutic applications, leveraging the unique ability of exosomes to deliver bioactive molecules, modulate inflammation, and promote tissue repair. This strategic expansion positions BrainStorm at the forefront of exosome-based innovation, complementing our expertise in cellular therapy and broadening our opportunities for clinical translation.

AsNurOwn® ofin ~~June~~CNS ~~20, 2014, there were approximately 64 holders of record of our Common Stock.~~Disease

NurOwn® represents a platform technology designed to address a range of neurodegenerative diseases. Our primary objective is to achieve regulatory approval for ALS, including the submission of a BLA to the FDA, while advancing its clinical development in PMS and evaluating potential applications in other CNS disorders, including AD and Huntington’s Disease. This strategic approach leverages our extensive preclinical experience to maximize the therapeutic potential of the NurOwn® platform.

Amyotrophic Lateral Sclerosis (ALS)

ALS, often referred to as “Lou Gehrig’s disease,” is a progressive neurodegenerative disease that primarily affects motor nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles

~~MANAGEMENT’S DISCUSSION AND ANALYSIS OF~~

~~FINANCIAL~~Table ~~CONDITION~~of ~~AND RESULTS OF OPERATIONS~~Contents

~~Company~~throughout ~~Overview~~the body. The progressive degeneration of the motor neurons in ALS patients leads to progressive weakness, respiratory failure and eventually, death. The median survival for ALS patients is between 2 and 5 years from the onset of symptoms. Across the world, the prevalence of ALS is approximately 4-7 per 100,000. It is estimated that as many as 30,000 Americans have the disease at any given time, with about 50,000 individuals affected in the territory of the European Single Market. Estimated annual treatment and health care costs for advanced stage patients can be as high as $100,000-$200,000 per annum. Worldwide it is estimated that there are 450,000 patients with ALS.

WeApproved ~~are~~treatments afor ~~biotechnology~~Amyotrophic ~~company~~Lateral ~~developing~~Sclerosis ~~novel~~(ALS) ~~adult~~primarily ~~stem~~focus ~~cell~~ on managing symptoms rather than disease modification. Key opinion leaders and researchers suggest that a combination of therapies may be necessary for ~~debilitating~~disease ~~neurodegenerative~~modification. ~~disorders~~Treatment ~~such~~decisions asare ~~ALS,~~typically MSdetermined by the patient’s symptoms, preferences and PDthe stage of the disease. ~~These~~Currently, ~~diseases~~there ~~have~~are ~~limited~~four ~~treatment~~FDA-approved ~~options~~ALS therapies—Riluzole, Radicava, Relyvrio, and as ~~such~~Qalsody—each ~~represent~~showing ~~unmet~~modest ~~medical~~improvements ~~needs~~in survival or ALS function.

We● ~~believe~~Riluzole ~~that~~–approved ~~NurOwn,~~by ~~our~~the ~~proprietary~~FDA ~~process~~to ~~for~~treat ~~the~~ALS ~~propagation of~~in ~~MSC~~1995. ~~and~~Riluzole ~~their~~extends ~~differentiation~~the ~~into~~time ~~NTF~~to ~~secreting~~death ~~cells~~or ~~(MSC-NTF),~~ventilation ~~and~~by ~~their~~several ~~transplantation~~months; athowever, orit ~~near,~~has ~~the~~not ~~site~~been ofshown ~~damage, offers~~to improve the ~~hope~~daily functioning of ~~more~~ALS ~~effectively treating neurodegenerative diseases~~patients.

~~Our~~● ~~approach~~Radicava is(Edaravone) ~~considered~~– ~~safe~~a free radical scavenger- originally approved by the FDA (May 2017) as an intravenous (IV) infusion based on ~~our~~a ~~use~~single ofPhase ~~autologous cells~~3 study carried out in Japan. In 2022, ~~which~~Radicava ~~are~~ORS, ~~free~~an oforal suspension, was approved by the ~~risk~~FDA. The effectiveness of ~~rejection~~Radicava ~~and~~ORS ~~tumor~~was ~~formation.~~based Iton isa ~~also~~study ~~free~~demonstrating comparable levels of ~~the~~Radicava ~~controversy~~ORS ~~associated~~in ~~with~~the bloodstream to the ~~use of~~levels ~~embryonic~~from ~~stem~~the ~~cells~~IV informulation ~~some~~of ~~countries~~Radicava.

~~Critical~~● ~~Accounting~~Relyvrio ~~Policies~~(sodium phenylbutyrate and taurursodiol) – approved by the FDA in September 2022 as an oral treatment for ALS. In 2024, Amylyx Pharmaceuticals withdrew Relyvrio from the market following the failure of the Phase 3 PHOENIX trial to demonstrate significant benefit.

~~Our~~● ~~discussion~~Qalsody ~~and~~(tofersen) ~~analysis~~– ofwas ~~our~~approved ~~financial~~by ~~condition and~~the ~~results~~FDA ~~of operations are based on our financial statements, which have been prepared~~ in ~~accordance with accounting principles generally accepted in the U~~2023.S. ~~The~~Qalsody ~~preparation~~was ofgranted ~~these~~accelerated ~~financial~~approval ~~statements~~based requires us to make judgments, estimates, and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported revenue and expenses during the reporting periods. We continually evaluate our judgments, estimates and assumptions. We base our estimates on ~~the~~a ~~terms~~reduction of ~~underlying agreements~~neurofilament, ~~our~~a ~~expected~~marker ~~course~~ of ~~development,~~neurodegeneration. ~~historical~~Tofersen ~~experience~~targets ~~and other factors we believe are reasonable based on~~ the ~~circumstances,~~ultra-rare ~~the~~genetic ~~results of which~~ form ~~our management’s basis for making judgments about the carrying value~~ of ~~assets~~ ~~and~~ALS ~~liabilities~~known ~~that~~as ~~are~~Superoxide ~~not~~dismutase ~~readily~~1 ~~apparent~~(SOD1)-amyotrophic ~~from~~lateral ~~other sources~~sclerosis. Actual results may differ from these estimates. There were no significant changes to our critical accounting policies during the quarter ended March 31, 2014. For a discussion of our significant accounting policies, please see Note 2 to our financial statements included in this prospectus, starting on page F-19.

~~Results~~Progressive ofMultiple ~~Operations~~Sclerosis (PMS)

~~The~~PMS ~~Company~~is ~~has~~characterized ~~been~~by athe ~~development~~relentless ~~stage~~accumulation ~~company~~of ~~since~~central ~~its~~nervous ~~inception. For~~system ~~the~~injury ~~period~~due ~~from~~to ~~inception~~peripheral ~~(September~~and ~~22,~~compartmentalized ~~2000) until March 31~~inflammation, ~~2014~~demyelination, ~~the~~axonal ~~Company~~damage, ~~has~~and ~~not~~neuronal ~~earned~~degeneration ~~any~~and ~~revenues~~results ~~from~~in ~~operations. The~~increasing ~~Company~~motor, ~~does not expect to earn revenues from operations until 2017. In addition~~visual, ~~the~~and ~~Company~~cognitive ~~has~~impairment ~~incurred operating costs~~ and ~~other~~significant ~~expenses~~disability ofthat ~~approximately~~impacts ~~$1,031,000~~daily ~~during the three months ended March 31~~living, ~~2014~~employment, and ~~approximately~~socioeconomic ~~$50,989,000~~status. ~~for the~~There ~~period~~is ~~from~~currently ~~inception~~no ~~(September~~effective ~~22,~~regenerative ~~2000)~~therapy ~~until~~for ~~March~~this ~~31,~~disabling ~~2014.~~disease ~~Operating~~that ~~expenses~~affects ~~incurred since inception were~~ approximately ~~$21,203,000~~ ~~for~~one ~~general~~million ~~and~~individuals ~~administrative~~in ~~expenses~~the ~~and~~United ~~$29,786,000 for research and development costs~~States.

~~Year~~There ~~ended~~are ~~December~~currently 31over 1.25 million people with PMS worldwide, ~~2013~~with vsroughly 0.5 ~~year~~million ~~ended~~of ~~December~~these 31patients located in the United States. Over 10, ~~2012~~000 new cases are diagnosed annually in the United States, mostly affecting women between the ages of 20 and 50. Annual drug treatment costs for PMS can be as much as $80,000 a year per patient.

~~Research~~The lack of safe and ~~Development~~effective therapies in PMS, ~~net~~the intrinsic immunomodulatory properties of MSC-NTF cells and the potential of MSC-NTF secreted neurotrophic factors to promote neuronal repair and remyelination makes NurOwn® an attractive treatment option to evaluate in PMS.

~~Our~~Alzheimer’s ~~business~~Disease ~~model calls for significant investments in research and development. Our research and development expenditures~~ (iAD) in 2013 (before participation by the OCS) were $4,030,000, which included $51,000 in stock-based compensation and (ii) in 2012 (before participation by the OCS) were $2,688,000, which included $74,000 in stock-based compensation. Research and development expenses, net for the year ended December 31, 2013 and 2012 were $2,917,000 and $1,770,000, respectively. In addition, our grant from The Office of the Chief Scientist increased by $195,000 to $1,113,000 for the year ended December 31, 2013 from $918,000 for the year ended December 31, 2012.

AD is the most common form of dementia, a progressive brain disease that slowly destroys memories and thinking skills. The AD pathology starts 15-20 years before symptoms appear. Symptoms usually start with difficulty storing and retrieving new information. In advanced stages, symptoms include confusion, as well as mood and behavior changes, and inability to perform basic life tasks. Throughout the disease process there is a steady, unstoppable death of brain cells. This is a fatal disease with an average time of 8 years from diagnosis to death. No cure exists, but medications and management strategies may temporarily improve symptoms, in a modest fashion. In 2021, the FDA approved Aduhelm, a monoclonal antibody directed against amyloid for the treatment of AD. The implications of Aduhelm approval on the AD treatment market is evolving and we are actively reviewing the implications on the development of AD disease modifying therapies. Following its 2021 accelerated approval, Aduhelm was subsequently discontinued and withdrawn from the market by its manufacturer; however, the FDA has since granted approvals to Leqembi and Kisunla.

The increase in research and development expenses is primarily due to (i) an increase of $966,000 for the year ended December 31, 2013, compared to zero for the year ended December 31, 2012 for costs of activities related to commencement of the US Clinical Trial including IND submission fees to PRC Clinical and FDA Consultant, purchase and validation of cleanroom equipment at DFCI and Mayo Clinic, adaptation of cleanroom facility at DFCI, and on-site technology transfer training to DFCI cleanroom personnel; (ii) an increase of $153,000 in costs associated with the clinical trials, conducted in accordance with GMP in Hadassah, for an aggregate amount of $1,432,000 for the year ended December 31, 2013, compared to $1,279,000 for the year ended December 31, 2012; (iii) an increase of $296,000 in payroll costs due to recruitment of two additional employees to conduct the clinical trials; and (iv) an increase of $111,000 for patents, travel and rent costs. This increase was offset by: (i) a decrease in stock-based compensation expenses, of $23,000 in the year ended December 31, 2013 to $51,000, compared to $74,000 for the year ended December 31, 2012; and (ii) a decrease of $161,000 for consultants and depreciation from $406,000 in the year ended December 31, 2012 to $245,000 in the year ended December 31, 2013.

~~General~~Table ~~and~~of ~~Administrative~~Contents

~~General~~Over ~~and~~5 ~~administrative~~million ~~expenses~~people ~~for~~in the ~~years~~United ~~ended~~States ~~December 31,~~currently ~~2013~~have ~~and 2012 were $2,101,000 and $1,748,000, respectively~~AD. The ~~increase~~number inof ~~General~~Americans ~~and~~with ~~administrative~~AD ~~expenses for the year ended December 31, 2013,~~ is ~~mainly~~projected ~~due~~ to: ~~(i)~~triple anto ~~increase~~16 ofmillion ~~$222,000~~by in2050. ~~stock-based~~In ~~compensation~~the ~~expenses~~EU, ~~from~~it ~~$545,000~~is inestimated ~~the year~~that ~~ended~~greater ~~December~~than ~~31,~~7.5 ~~2012~~million topeople ~~$767,000~~currently inhave ~~the~~AD ~~year~~and ~~ended~~it ~~December~~is ~~31,~~projected ~~2013;(ii)~~to anreach ~~increase~~over of13 ~~$140,000~~million inby ~~payroll~~2050. ~~costs~~Worldwide ~~due to~~about ~~recruitment~~50 ofmillion ~~CEO~~people ~~during~~have ~~2013;~~some ~~(iii)~~form ~~an increase~~ of ~~$107~~dementia,~~000~~ ~~for travel, rent~~ and ~~stock~~someone ~~costs from $190,000~~ in the ~~year~~world ~~ended December~~develops ~~31,~~dementia ~~2012~~every tothree ~~$297,000 in the year ended December 31, 2013~~seconds. ~~This~~Every ~~increase~~65 ~~was~~seconds ~~partially~~someone ~~offset by a decrease of $116,000~~ in ~~consultants,~~United ~~depreciation~~States ~~and~~develops PRAD. ~~costs~~By ~~from~~2050 ~~$573,000~~this inis ~~the~~projected ~~year ended December 31, 2012~~ to ~~$457,000~~be inevery ~~the~~33 ~~year ended December 31, 2013~~seconds.

~~Financial~~Intellectual ~~Expenses~~Property

~~Financial~~We ~~income~~own ~~for~~a global patent portfolio protecting NurOwn® and our exosome-based platform technology, covering their composition, manufacturing processes, and therapeutic applications. These patents provide protection in key markets, including the ~~year~~United ~~ended~~States, ~~December~~Europe, 31Japan, ~~2013~~Canada, ~~was~~and ~~$144~~Israel. Our patents and proprietary trade secrets are foundational assets and integral to our business. In addition to our granted patents,~~000 compared~~ we rely on confidential manufacturing expertise and proprietary research knowledge to ~~income~~maintain ofour ~~$93~~competitive position. Patent terms are subject to expiration dates,~~000~~ ~~for~~potential extensions, and regulatory exclusivity periods that may be granted in some regions. We continue to evaluate opportunities to expand our intellectual property estate in support of the ~~year~~long-term ~~ended~~commercialization ~~December~~of ~~31,~~our ~~2012~~product pipeline.

~~The~~As ~~financial~~part ~~income~~of ~~for~~our ~~year~~strategy ~~ended December 31, 2013 is mainly due~~ to ~~income~~protect ~~from revaluation of warrants of $174,000~~ and ~~income~~expand ~~from~~our ~~interest~~proprietary ~~receivable from a bank deposit that were offset by conversion exchange rates and bank charges. The financial income for the year ended December 31~~technology, ~~2012,~~BrainStorm’s isintellectual ~~primarily~~property ~~due~~portfolio toincludes ~~a one-time~~patents ~~$192,000~~initially ~~financial~~licensed ~~income,~~ from ~~conversion~~Ramot ofat ~~debt~~Tel toAviv aUniversity ~~subcontractor~~alongside toa ~~our~~broader ~~Common~~range ~~Stock. The issuance~~ of ~~stock~~patents ~~to the subcontractor was in an amount~~ that ~~was~~we ~~lower~~have ~~than~~since ~~the~~developed ~~amount~~and ~~owed to the supplier~~own. ~~The~~We ~~value~~continue ofto ~~the~~strengthen ~~amount~~and ~~issued~~expand ~~was~~our ~~based~~intellectual ~~on the~~property ~~per~~estate ~~share price on the date of the grant. In addition, the financial income is due~~ to ~~(i)~~support anlong-term ~~increase~~growth ~~in financial income of $33,000 from conversion exchange;~~ and ~~(ii) an interest receivable from a bank deposit in the amount of $19,000~~commercialization.

~~Net~~NurOwn® ~~Loss~~has been designated an Advanced Therapy Medicinal Product (ATMP) by the European Medicines Agency (EMA). Additionally, the United States Adopted Names (USAN) Council and the World Health Organization (WHO) have designated Debamestrocel as the non-proprietary (generic) name for NurOwn®.

~~Net~~We ~~loss~~remain ~~for~~focused ~~the~~on ~~year~~advancing ~~ended~~FDA ~~December~~approval ~~31, 2013 was $4,899,000, as compared to a net loss of $3,430,000~~ for ~~the~~NurOwn® ~~year~~in ~~ended~~ALS ~~December~~while ~~31,~~ensuring ~~2012.~~compliance ~~Net~~with ~~loss~~Good ~~per~~Manufacturing ~~share~~Practices ~~for~~(GMP) ~~the~~and ~~year~~other ~~ended~~global ~~December~~regulatory ~~31, 2013 was $0~~standards.~~03, compared to net loss per share of $0.02 for the year ended December 31, 2012.~~

The increase in the net loss for the year ended December 31, 2013 is due to (i) an increase the progress of clinical trials conducted in GMP facilities in Hadassah and US Clinical Trial, and (ii) an increase in payroll costs, and (iii) an increase in stock-based compensation expenses. This increase was partially offset by an increase in OCS grants.Trademarks

~~The~~NurOwn® ~~weighted~~is ~~average~~a ~~number~~registered oftrademark ~~shares of Common Stock used~~ in ~~computing~~ ~~basic and diluted net loss per share for~~ the ~~year~~United ~~ended~~States ~~December~~and ~~31, 2013 was 161,071,968, compared to 137,596,391for the year ended December 31, 2012~~Israel.

~~The~~Research increase in the weighted average number of shares of Common Stock used in computing basic for the year ended December 31, 2013 was due to: (i) the issuance of shares of Common Stock in the 2013 Public Offering, as described in more detail below and inLicense ~~the~~Agreement ~~2012~~with ~~Public Offering, (ii) the exercise of options and warrants, and (iii) the issuance of shares to service providers.~~Ramot

Since 2004, we have maintained a commercial relationship with Ramot, the technology transfer group within Tel Aviv University, under a Research and License Agreement. The agreement, as subsequently amended, grants us rights to certain intellectual property developed at Tel Aviv University, including the NurOwn® technology. In 2011, the Company assigned the agreement to its Israeli subsidiary, with Ramot’s consent.

Under this agreement, our Israeli subsidiary pays royalties to Ramot ranging between three percent (3%) and five percent (5%) of all net sales derived from the licensed intellectual property, as well as twenty percent (20%) to twenty-five percent (25%) on revenues from sublicensing. In 2016, Ramot agreed to convert its exclusive licenses to outright transfers and assignments of the Ramot IP, thereby granting our Israeli subsidiary ownership.

The primary focus of our agreements (and subsequent amendments) with Ramot has and continues to be the commissioning of a group of scientists within Tel Aviv University to carry out research in the area of the stem-cell technology referenced above, and the granting of rights to the Company (and later our Israeli Subsidiary, after the assignment referenced above) in the inventions, know-how and results procured from such research (the “Ramot IP”).

In consideration for the rights granted to our Israeli Subsidiary in and to the Ramot IP, our Israeli Subsidiary is required to pay Ramot royalties ranging between three percent (3)% and five percent (5)% of all net sales realized from the exploitation of the Ramot IP, as well as remittances of between twenty percent (20)% and twenty-five percent (25)% on revenues received from the sub-licensing of the Ramot IP.

Non-Proprietary (generic) name

In June 2022, the United States Adopted Names (“USAN”) Council adopted ‘Demabestrocel’ as the non-proprietary (generic) name for the MSC-NTF cells for the treatment of neurodegenerative diseases with unmet need, such as ALS, MS and AD. The name

~~Quarter ended March 31, 2014 vs. quarter ended March 31, 2013~~

~~Research~~Table ~~and~~of ~~Development, net:~~Contents

~~Research~~was ~~and~~approved ~~development~~by ~~expenses, net for~~ the ~~three~~International ~~months~~Nonproprietary ~~ended~~Names ~~March~~(“INN”) ~~31,~~of ~~2014~~the ~~and~~World ~~2013~~Health ~~were~~Organization ~~$680,000~~(“WHO”) and ~~$522,000,~~published ~~respectively.~~on ~~In addition, the Company~~USAN’s ~~grant from~~website ~~The~~at ~~Office of the Chief Scientist increased by $6,000 to $286,000 for the three months ended March 31, 2014 from $280,000 for the three months ended March 31, 2013~~https://searchusan.ama-assn.org/finder/usan/search/DEBAMESTROCEL/relevant/1/.

~~The~~Government ~~increase~~Regulation ~~in research~~ and ~~development~~Product expenses for the three months ended March 31, 2014 is primarily due to an increase of $328,000, associated with the clinical trials in the US, for the three months ended March 31, 2014, compared to zero for the three months ended March 31, 2013. This increase was partially offset by a decrease of $173,000 for the clinical trials in Israel.Approval

~~General~~We intend to pursue regulatory approval for our bone marrow derived differentiated neurotrophic-factor secreting cell products, NurOwn®, for autologous treatment in patients by neurosurgeons in medical facilities in the U.S., Europe, Japan and ~~Administrative:~~Israel.

~~General~~In ~~and administrative expenses for the three months ended March 31, 2014 and~~ January 2013 ~~were $351~~,~~000~~ ~~and $559,000, respectively. The decrease in general and administrative expenses for~~ the ~~three month~~EMA ~~period~~Committee ended March 31, 2014 from the three month period ended March 31, 2013 is primarily due to: (i) a decrease of $122,000 in stock-based compensation expenses, from $226,000 in the three months ended March 31, 2013 to $104,000 in the three months ended March 31, 2014; (ii) a decrease of $38,000 in payroll costs from $130,000 in the three months ended March 31, 2013 to $92,000 in the three months ended March 31, 2014, and (iii) a decrease of $68,000 for IRAdvanced ~~and~~Therapies PRdesignated ~~costs,~~NurOwn® ~~travel~~as ~~and other costs, from $97,000 in the three months ended March 31, 2013 to $29,000 in the three months ended March 31, 2014. This decrease was partially offset by~~ an ~~increase~~Advanced ofTherapy ~~$20,000~~Medicinal ~~for rent and consulting fees~~Product.

~~Financial~~U.S. ~~Expenses:~~Biological Products Development Process

~~Financial~~The ~~expense~~FDA ~~for~~regulates drugs and biological products under the ~~three~~Federal ~~months~~Food, ~~ended~~Drug, ~~March~~and 31Cosmetic Act (the “FDCA”), ~~2014 was~~the $1Public Health Service Act (the “PHSA”),~~080~~ and related regulations and other federal,~~000~~ state and local laws and regulations. Biological products include a wide variety of products including vaccines, ~~compared~~blood toand blood components, gene therapies, tissue and proteins. Unlike most prescription products made through chemical processes, biological products generally are made from human and/or animal materials. To be lawfully marketed in interstate commerce, a ~~financial~~biologic ~~expense~~product must be the subject of $1a BLA,~~000~~ issued by the FDA on the basis of a demonstration that the product is safe, pure and potent, and that the facility in which the product is manufactured meets standards to assure that it continues to be safe, pure and potent. The FDA has developed and is continuously updating the requirements with respect to cell and gene therapy products and has issued documents concerning the regulation of cellular and tissue-based products. Manufacturers of cell and tissue-based products must comply with the FDA’s current Good Tissue Practice (“cGTP”) requirements which are FDA regulations that govern the methods used in, and the facilities and controls used for, the ~~three~~manufacture ~~months~~of ~~ended~~such ~~March~~products. 31The primary intent of the cGTP requirements is to ensure that cell and tissue-based products are manufactured in a manner designed to prevent the introduction, ~~2013~~transmission and spread of communicable disease.

The ~~financial~~process ~~expense~~of ~~for~~obtaining ~~the~~regulatory ~~three~~approvals ~~months~~and ~~ended~~ensuring ~~March~~compliance 31with appropriate federal, ~~2014 is~~state, ~~mainly~~local ~~due~~and toforeign astatutes ~~financial~~and ~~expense~~regulations ofrequires ~~$1,071,000~~the ~~that~~expenditure isof ~~due~~substantial totime ~~revaluation~~and offinancial ~~warrants~~resources. ~~issued~~Failure to ~~investors~~comply inwith the ~~2013~~applicable ~~Public Offering (the 2013 Warrants)~~U.S. ~~The~~requirements ~~2013~~at ~~Warrants~~any ~~contain~~time ~~anti-dilution~~during ~~provisions.~~the ~~Under~~product ~~generally~~development ~~accepted~~process, ~~accounting~~approval ~~principles~~process, ~~the~~ ~~anti-dilution~~or ~~provisions~~after ~~require~~approval, ~~the~~may ~~2013~~subject ~~Warrants~~an applicant to beadministrative ~~valued~~or ~~and~~judicial ~~classified~~sanctions. asThese asanctions ~~warrant~~could ~~liability~~include on the ~~balance~~FDA’s ~~sheet, resulting~~refusal into aapprove ~~reduction~~pending ofapplications, ~~stockholders’~~withdrawal ~~equity.~~of ~~This~~an ~~warrant~~approval, ~~liability~~a ~~will~~clinical behold, ~~revaluated~~warning ~~every~~letters, ~~quarterly~~product ~~report.~~recalls, Onproduct ~~April 25~~seizures, ~~2014~~product detention, ~~the~~total ~~Company~~or ~~exchanged~~partial ~~part~~suspension of ~~the~~production ~~2013~~or ~~Warrants~~distribution, ~~entitling~~injunctions, ~~the holders to purchase 11~~fines,~~662,059~~ ~~shares~~refusals of ~~Common~~government ~~Stock~~contracts, ~~$0.00005~~ ~~par value for 5~~restitution,~~831,031~~ ~~unregistered~~disgorgement ~~shares~~or ofcivil ~~Common~~or ~~Stock~~criminal penalties. The ~~exchange~~process ~~was~~required ~~done~~by ~~to facilitate~~ the ~~Company’s~~FDA ~~plans to~~before ~~uplist its stock to~~ a ~~national~~biological ~~securities~~product ~~exchange~~may ~~such~~be asmarketed ~~NASDAQ. No such revaluation expense was recorded~~ in the ~~three~~United ~~months ended~~States ~~March~~generally ~~31,~~involves ~~2013.~~the On March 24, 2014, ACCBT Corp. and ACC International Holdings Ltd. agreed to irrevocably waive all anti-dilution rights contained in all issued and outstanding warrants to purchase Company Common Stock held by ACCBT Corp. or ACC International Holdings Ltd.following:

~~The~~● ~~financial~~Completion ~~expense~~of ~~for~~preclinical ~~the~~laboratory ~~three months ended March 31~~tests, ~~2014 in~~animal ~~the~~studies ~~amount~~and offormulation ~~$9,000~~studies isaccording ~~due~~ to ~~conversion~~Good ~~exchange~~Laboratory ~~rates~~Practices ~~and bank charges that were offset by an interest receivable from a bank deposit~~(“GLP”), ~~compared~~requirements toor ~~$1,000~~other ~~for the three months ended March 31, 2013.~~regulations;

~~Net~~● ~~Loss:~~Submission to the FDA of an IND application which must become effective before human clinical trials may begin;

~~Net~~● ~~loss~~Performance ~~for~~of ~~the~~adequate ~~three~~and ~~months~~well-controlled ~~ended~~clinical ontrials ~~March~~according ~~31,~~to ~~2014~~Good ~~was~~Clinical ~~$2,111,000, as~~Practices ~~compared~~(“GCP”) to aestablish ~~net~~the ~~loss~~safety ofand ~~$1,082,000~~efficacy ~~for~~of the ~~three~~proposed ~~months~~biological ~~ended~~product ~~March 31, 2013. Net loss per share~~ for ~~the~~its ~~three~~intended ~~months ended March 31, 2014 and 2013 was $0.01.~~use;

●

Submission to the FDA of a BLA for a new biological product;

●

Satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current Good Manufacturing Practice, or cGMP, requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and purity; and

●

The FDA’s review and approval of the BLA.

The testing and approval process require substantial time, effort and financial resources and we cannot be certain that any approvals for our stem cell therapies will be granted on a timely basis, if at all.

All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCP regulations. These regulations include the requirement that all research subjects provide informed consent. Further, an institutional review board, or IRB, must review and approve the plan for any clinical trial before it commences at any institution. An IRB considers,

The weighted average number of shares of Common Stock used in computing basic and diluted net loss per share for the three months ended March 31, 2014 was 176,305,587, compared to 150,953,117 for the three months ended March 31, 2013.

~~The~~Table ~~increase in the weighted average number~~ of shares of Common Stock used in computing basic and diluted net loss per share for the three months ended March 31, 2014 was due to (i) the issuance of shares of Common Stock in the 2013 Public Offering, as described in more detail below, (ii) the exercise of options, and (iii) the issuance of shares to service providers and private investors. Contents

~~Liquidity~~among other things, whether the risks to individuals participating in the trials are minimized and ~~Capital~~are ~~Resources~~reasonable in relation to anticipated benefits. The IRB also approves the information regarding the clinical trial and the consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. Once an IND is in effect, each new clinical protocol and any amendments to the protocol must be submitted to the IND for FDA review, and to the IRBs for approval.

~~The~~Human ~~Company~~clinical ~~has~~trials ~~financed~~are ~~its~~typically ~~operations~~conducted ~~since inception primarily through public and private sales of its Common Stock and warrants and the issuance of convertible promissory notes. At March 31, 2014, the Company had $3,853,000~~ in ~~total~~three ~~current~~sequential ~~assets~~phases ~~and~~that ~~$1,607,000~~may inoverlap ~~total~~or ~~current~~be ~~liabilities.~~combined:

~~Net~~● ~~cash~~Phase ~~used~~1. inThe ~~operating~~product ~~activities~~is ~~was~~initially ~~$391,000~~introduced into healthy human subjects and tested for ~~the~~safety, ~~three months~~dosage ~~ended~~tolerance, ~~March~~absorption, 31metabolism, ~~2014~~distribution and excretion. ~~Cash~~In ~~used~~the case of some products for ~~operating~~severe ~~activities~~or ~~was~~life-threatening ~~primarily~~diseases, ~~attributed~~especially towhen ~~cost~~the ofproduct ~~clinical~~may ~~trials,~~be ~~rent~~too ofinherently ~~clean rooms~~toxic ~~and~~to ~~materials~~ethically ~~for~~administer ~~clinical~~to ~~trials~~healthy volunteers, ~~payroll~~the ~~costs,~~initial ~~rent,~~human ~~outside~~testing ~~legal~~may ~~fee~~be ~~expenses~~conducted ~~and~~in ~~public~~patients ~~relations~~having ~~expenses~~the specific disease.

~~Net~~● ~~cash~~Phase ~~used~~2. Phase 2 trials involve investigations in ~~investing~~a ~~activities~~limited ~~was~~patient ~~$85~~population to identify possible adverse effects and safety risks,~~000~~ ~~for~~to preliminarily evaluate the ~~three months~~efficacy ~~ended~~of ~~March~~the ~~31,~~product ~~2014~~for specific targeted diseases and to determine dosage tolerance and the optimal dosage and schedule.

~~There~~● isPhase no3. ~~Net~~Clinical ~~cash~~trials ~~provided~~are byundertaken ~~financing~~to ~~activities~~further ~~for~~evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These trials are intended to establish the ~~three~~ ~~months~~overall ~~ended~~risk/benefit ~~March~~ratio ~~31,~~of ~~2014~~the product and provide an adequate basis for regulatory approval and product labeling.

OnPost-approval ~~August 16~~studies, ~~2013,~~also ~~the~~called ~~Company~~Phase ~~raised approximately $~~4.0 ~~million through a public offering (the 2013 Public Offering) of its Common Stock. The Company issued a total of 23~~trials,~~529,411~~ ~~units~~may atbe aconducted ~~public offering~~after ~~price~~initial ofmarketing $0approvals.17 ~~per~~These ~~unit,~~studies ~~with~~are ~~each~~used ~~unit consisting of one share of Common Stock, and 0.75 of a warrant~~ to ~~purchase~~obtain ~~one share~~additional ofexperience ~~our~~from ~~Common~~the ~~Stock~~treatment ~~at an exercise price~~ of ~~$0.25~~patients ~~per~~in ~~whole~~the ~~share~~intended oftherapeutic ~~Common~~indication ~~Stock.~~and ~~The~~may ~~warrants~~be ~~are~~required ~~exercisable~~by ~~until~~ the ~~three~~ ~~year~~FDA ~~anniversary~~as ofpart ~~the date~~ of ~~issuance. After deducting closing costs and fees,~~ the ~~Company~~approval ~~received net proceeds of approximately $3~~process.~~3 million.~~

~~The~~Safety ~~Company’s~~reports ~~other~~detailing ~~material~~the ~~cash~~adverse ~~needs~~events ~~for~~identified in the ~~next~~course ~~12 months~~of ~~will~~the ~~include~~clinical ~~payments~~trials ofmust ~~(i)~~be ~~costs~~submitted ofannually to the ~~clinical~~FDA ~~trials~~and insafety reports must be submitted to the USFDA and ~~Israel;~~the ~~(ii)~~investigators ~~employee~~for ~~salaries;~~serious ~~(iii)~~and ~~patents;~~unexpected ~~(iv) construction~~side ~~fees~~effects. ~~for~~Phase ~~facilities~~1, toPhase 2 and Phase 3 testing may not be ~~used~~completed successfully within any specified period, if at all. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the ~~Company~~IRB’s ~~research~~requirements ~~and~~or ~~development~~if ~~and~~the ~~(v)~~stem ~~fees~~cell totherapy ~~Company~~has ~~consultants and~~been ~~legal~~associated ~~advisors~~with unexpected serious harm to patients.

~~Company's~~Concurrent ~~operations~~with ~~are~~clinical ~~very~~trials, ~~capital~~companies ~~intensive~~usually ~~and~~complete ~~will~~additional ~~require substantial~~animal ~~capital~~studies ~~raisings.~~and Ifmust ~~the~~also ~~Company~~develop isadditional ~~not~~information ~~able~~about tothe ~~raise~~chemistry ~~substantial~~and ~~additional~~physical ~~capital,~~characteristics itof ~~may~~the ~~not~~product beand ~~able~~finalize toa ~~continue to~~process ~~function~~for asmanufacturing athe ~~going~~product ~~concern~~in ~~and~~commercial ~~may~~quantities ~~have~~in toaccordance ~~cease~~with ~~operations~~cGMP requirements. ~~Even~~The ifmanufacturing ~~the~~process ~~Company~~must ~~obtains~~be ~~funding~~capable ~~sufficient~~of toconsistently ~~fund~~producing ~~its~~quality ~~operations in~~batches of the ~~short~~stem ~~term~~cell therapy and, itamong ~~would~~other ~~still~~things, bethe ~~required~~manufacturer tomust ~~raise~~develop amethods ~~substantial~~for ~~amount~~testing ofthe ~~capital~~identity, instrength, ~~the~~quality ~~future~~and inpurity ~~order~~of tothe ~~reach~~final ~~profitability and~~product. toAdditionally, ~~complete~~appropriate ~~the~~packaging ~~commercialization~~must ofbe ~~the~~selected ~~Company’s~~and ~~products.~~tested ~~The~~and ~~Company’s~~stability ~~ability~~studies must be conducted to ~~fund~~demonstrate ~~these~~that ~~future~~the ~~capital requirements~~stem ~~will~~cell ~~depend~~therapy ondoes ~~many~~not ~~factors,~~undergo ~~including~~unacceptable ~~the~~deterioration ~~following:~~over its shelf life.

·At ~~our~~times ~~ability~~during tothe ~~obtain~~development ~~funding~~of ~~from~~a ~~third~~biological ~~parties~~product, ~~including~~sponsors ~~any~~are ~~future~~given ~~collaborative~~opportunities ~~partners;~~to ·meet with the ~~scope,~~FDA. ~~rate~~This commonly occurs prior to submission of ~~progress~~an ~~and~~IND, ~~cost~~at the end of ~~our~~Phase ~~clinical~~2 ~~trials~~testing, and before a BLA is submitted. Meetings at other ~~research~~times ~~and~~may ~~development~~also ~~programs;~~be ·requested. These meetings provide an opportunity for the ~~time~~sponsor ~~and~~to ~~costs~~share ~~required~~information about the data gathered to ~~gain~~date, ~~regulatory~~for ~~approvals;~~the ·FDA to provide advice, and for the ~~terms~~sponsor and ~~timing~~the FDA to reach agreement on the next phase of ~~any~~development. ~~collaborative~~For example, ~~licensing~~prior ~~and~~to ~~other~~initiating ~~arrangements~~a Phase 3 study, sponsors have the option to submit a request for Special Protocol Assessment, or SPA, to the FDA which, if granted provides the FDA’s concurrence that wethe ~~may~~study, ~~establish;~~if conducted as designed and if successful, could support a regulatory approval for the product candidate.

·The ~~the~~results ~~costs~~ of ~~filing,~~product ~~prosecuting~~development, ~~defending~~preclinical studies and ~~enforcing~~clinical ~~patents~~trials, ~~patent~~along ~~applications~~with descriptions of the manufacturing process, ~~patent~~analytical ~~claims~~tests conducted on the stem cell therapy, ~~trademarks~~proposed labeling and other ~~intellectual~~relevant ~~property~~information, ~~rights;~~are ·submitted to the ~~effect~~FDA as part of ~~competition~~a ~~and~~BLA, requesting approval to market ~~developments;~~the ~~and~~product. ·The ~~future~~submission ~~pre-clinical~~of ~~and~~a ~~clinical~~BLA ~~trial~~is ~~results~~subject to the payment of substantial user fees which may be waived under certain limited circumstances.

The approval process is lengthy and difficult and the FDA may refuse to approve a BLA if the applicable regulatory criteria are not satisfied or may require additional clinical data or other data and information. The FDA has 60 days from its receipt of a BLA to determine whether the application will be accepted for filing based on the FDA’s threshold determination that it is sufficiently complete to permit a substantive review. If the FDA determines that the BLA is incomplete, the FDA may refuse to file the application.

~~Off Balance Sheet Arrangements~~

WeTable have no off balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of ~~operations, liquidity, capital expenditures or capital resources.~~Contents

~~Subsequent~~If ~~Events~~the FDA refuses to file a BLA, the applicant may refile the application with information addressing the FDA identified deficiencies, which refiling would be subject to FDA review before it is accepted for filing, or the applicant may request an informal meeting with the FDA about whether the application should be filed. After the meeting, the applicant may request that the application be Filed over Protest. When an application is Filed over Protest, the FDA is required to review the application as filed. Generally, the FDA does not favor the File over Protest procedure. There may also be certain consequences of filing an application over Protest. For example, such an application would not be eligible for certain FDA communications over the course of the review cycle.

~~Warrant~~In ~~Exchange~~addition, an applicant that receives an RTF can, in some circumstances, appeal the decision using the FDA’s dispute resolution procedures. After the BLA submission is accepted for filing, the FDA reviews the BLA to determine, among other things, whether a product meets the FDA’s approval standards and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality and purity. Under the performance goals and policies implemented by the FDA under the Prescription Drug User Fee Act, or PDUFA, for standard applications for original BLAs, the FDA targets ten months from the date the FDA files the application (i.e., the filing date) in which to complete its initial review of a standard application and respond to the applicant, and six months from the filing date for an application granted priority review by the FDA. The FDA does not always meet its PDUFA goal dates. The review process and the PDUFA goal date may be extended by an additional three-month review period when a major amendment, such as a major new clinical safety/efficacy study report or a major re-analysis of a previously submitted study, is submitted. However, when an application is filed with the FDA over Protest, the FDA generally will not review amendments to the application during any review cycle and will not issue information requests to the applicant during the agency’s review.

OnOnce ~~April~~the ~~25,~~submission ~~2014~~is accepted for filing, the ~~Company~~FDA ~~entered into~~begins ~~agreements~~an ~~with~~in-depth ~~holders~~substantive review of ~~warrants~~the ~~originally~~BLA. ~~issued~~The inFDA reviews the ~~Company’s~~BLA ~~2013~~to ~~Public~~determine, ~~Offering~~among (other things, whether the ~~2013~~proposed ~~Warrants)~~product tois ~~exchange outstanding~~safe, ~~2013~~pure ~~Warrants~~and ~~entitling~~potent, for its intended use, and whether the ~~holder~~product tois ~~purchase~~being anmanufactured ~~aggregate~~in ofaccordance 11with cGMP to ensure its continued safety,~~662,059~~ ~~shares~~purity ofand ~~Common~~potency. ~~Stock~~The FDA may refer applications for annovel ~~aggregate~~biological ~~of 5,831,031~~products ~~unregistered~~or ~~shares~~biological ofproducts ~~Common~~that ~~Stock.~~present ~~Each~~difficult ~~share~~or novel questions of ~~Common~~safety, ~~Stock~~efficacy, ~~issuable~~or ~~pursuant~~quality to ~~the~~an ~~2013~~advisory ~~Warrants~~committee, ~~(the~~typically ~~Warrant~~a ~~Shares) was~~panel ~~exchanged~~that includes clinicians and other experts, for ~~shares~~review, ofevaluation ~~unregistered~~and ~~Common~~a ~~Stock~~recommendation ~~equal~~as to ~~one-half~~whether (0the application should be approved and under what conditions.5) ofThe ~~the~~FDA ~~number~~is ofnot ~~Warrant~~bound ~~Shares~~by (the ~~Exchange~~recommendations ~~Shares)~~of an advisory committee, ~~provided~~ ~~that~~but init ~~the~~considers ~~event~~such recommendations carefully when making decisions. During the ~~number~~biological ofproduct ~~Exchange~~approval ~~Shares~~process, ~~resulted~~the inFDA also will determine whether a ~~fractional~~Risk ~~number~~Evaluation itand ~~was~~Mitigation ~~rounded~~Strategy, upor REMS, is necessary to assure the ~~nearest~~safe ~~whole share~~use of the biological product. ~~The~~If ~~2013~~the ~~Warrants~~FDA ~~were~~concludes ~~cancelled~~a ~~and~~REMS is needed, the sponsor of nothe ~~further~~BLA ~~force~~must ~~and~~submit ~~effect~~a proposed REMS; the FDA will not approve the BLA without a REMS, if required.

~~The offer~~Before ~~and~~approving ~~sale~~a ofBLA, the ~~Exchange~~FDA ~~Shares~~typically ~~were~~will ~~made~~inspect inthe ~~reliance~~facilities ~~upon~~at which the ~~exemption~~product ~~from~~is ~~registration~~manufactured. ~~provided~~The ~~for~~FDA bywill ~~Rule 506 of~~not ~~Regulation D~~approve ~~promulgated under~~ the ~~Securities~~product ~~Act. No~~unless ~~form~~it ofdetermines ~~general~~that ~~solicitation~~the ormanufacturing ~~general~~processes ~~advertising~~and ~~was used~~facilities byare ~~the~~in ~~Company,~~compliance orwith ~~any~~cGMP ~~representative~~requirements ofand ~~the~~adequate ~~Company,~~to inassure ~~connection~~consistent ~~with~~production of the ~~offer~~product orwithin ~~sale~~required ofspecifications. Where applicable, the ~~Exchange~~FDA ~~Shares. No underwriters~~also ~~were~~will ~~involved~~not ~~with~~approve the ~~issuance~~product ofif the ~~Exchange~~manufacturer ~~Shares~~is ~~and~~not ~~no commissions were paid~~ in ~~connection~~compliance with the ~~exchange~~cGTPs. ~~Each of~~ ~~the~~Additionally, ~~investors~~before ~~represented~~approving toa BLA, the ~~Company~~FDA ~~that~~will ~~they~~typically ~~are~~inspect anone ~~accredited~~or ~~investor. This~~more ~~prospectus~~clinical ~~shall~~sites ~~not~~to ~~constitute an~~assure ~~offer~~that tothe ~~sell~~clinical ortrials ~~the~~were ~~solicitation~~conducted ofin ancompliance ~~offer~~with toIND ~~buy,~~study ~~nor~~requirements ~~shall~~and ~~the~~GCP ~~Exchange~~requirements. ~~Shares~~To beassure ~~offered~~cGMP, orcGTP ~~sold~~and ~~absent~~GCP ~~registration~~compliance, or an ~~applicable~~applicant ~~exemption~~must ~~from~~incur ~~the~~significant ~~registration~~expenditure ~~requirements~~of ~~under~~time, money and effort in the ~~Securities~~areas ~~Act~~of ~~and~~training, ~~any~~record ~~applicable~~keeping, ~~state~~production ~~securities~~and ~~laws~~quality control.

~~The~~Under ~~Company believes that~~ the ~~exchange will~~Pediatric ~~help~~Research ~~facilitate~~Equity ~~the~~Act, ~~Company’s~~or ~~plans~~PREA, toa ~~uplist~~BLA ~~its~~or ~~stock~~supplement to a ~~national~~BLA ~~securities~~for ~~exchange~~a ~~such~~novel asproduct ~~NASDAQ~~(e.g., ~~The~~new ~~2013~~active ~~Warrants contain~~ingredient, ~~anti-dilution~~new ~~provisions~~indication, etc.) ~~Under~~must ~~generally~~contain ~~accepted~~data ~~accounting~~to ~~principles,~~assess the ~~anti-dilution~~safety ~~provisions~~and ~~require~~effectiveness of the ~~2013 Warrants~~biological product for the claimed indications in all relevant pediatric subpopulations and to besupport ~~valued~~dosing and ~~classified~~administration asfor aeach ~~warrant~~pediatric ~~liability~~subpopulation onfor which the ~~balance~~product ~~sheet,~~is ~~resulting~~safe inand aeffective. ~~reduction~~The ofFDA ~~stockholders’ equity.~~may ~~NASDAQ~~grant ~~requires~~deferrals asfor ~~part~~submission of ~~its~~data ~~initial~~or ~~listing~~full ~~standards~~or ~~that~~partial ~~the~~waivers. ~~Company~~Unless ~~have~~otherwise arequired ~~minimum~~by ofregulation, $5PREA ~~million~~does ofnot ~~stockholders’ equity,~~apply ~~which~~to ~~the~~any ~~exchange~~biological isproduct ~~anticipated~~for toan ~~help~~indication ~~facilitate~~for which orphan designation has been granted.

Filing Compare · BRAINSTORM CELL THERAPEUTICS INC.