As filed with the Securities and Exchange Commission on ~~August 4~~April 10, ~~2025~~2026

Registration No. 333-

UNITED STATES ~~SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549~~

~~FORM S-1 REGISTRATION STATEMENT UNDER THE~~ SECURITIES ~~ACT~~AND OFEXCHANGE ~~1933~~COMMISSION

~~Longeveron~~Washington, ~~Inc~~D. ~~(Exact~~C. ~~name of registrant as specified in its charter)~~20549

Form S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

Longeveron Inc.

(Exact name of registrant as specified in its charter)

Delaware

2834

47-2174146

(State or other jurisdiction of

incorporation or organization)

(Primary Standard Industrial

Classification Code Number)

(I.R.S. Employer

Identification No.)

1951 NW 7th Avenue, Suite 520 ~~Miami, Florida 33136 Telephone: (305) 909-0840 (Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)~~

~~Wa’el Hashad Chief Executive Officer Longeveron Inc. 1951 NW 7th Avenue, Suite 520~~ Miami, Florida 33136 ~~Telephone: (305) 909-0840 (Name, address, including zip code, and telephone number, including area code, of agent for service)~~

~~With~~Telephone: ~~copies~~(305) ~~to:~~909-0840

~~Jennifer Minter, Esq. Adam G. Wicks, Esq. Buchanan Ingersoll & Rooney PC Union Trust Building 501 Grant Street, Suite 200 Pittsburgh, PA 15219 Telephone:~~ (~~412) 562-8800 Rick A. Werner~~Address, ~~Esq.~~including ~~Jayun~~zip ~~Koo~~code, ~~Esq. Haynes~~ and ~~Boone~~telephone number, ~~LLP~~including 30area ~~Rockefeller Plaza~~code, ~~26th~~of ~~Floor~~registrant’s ~~New~~principal ~~York,~~executive ~~New York 10022 (212~~offices) ~~659-7300~~

~~Approximate~~Stephen ~~date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement is declared effective.~~Willard

IfChief ~~any~~Executive ~~of the 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. ☒~~Officer

Longeveron Inc.

1951 NW 7^th Avenue, Suite 520

Miami, Florida 33136

Telephone: (305) 909-0840

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

Copies to:

Jennifer Minter, Esq.

Adam Wicks, Esq.

Buchanan Ingersoll & Rooney PC

Union Trust Building

501 Grant Street, Suite 200

Pittsburgh, PA 15219

Telephone: (412) 562-8800

Approximate date of commencement of proposed sale to the public: From time to time after this registration statement becomes effective.

If any of the 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: ☒

If this 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. ☐

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. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) 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. ☐

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

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

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 the 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~~ Securities Act of 1933 or until this 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 preliminary prospectus is not complete and may be changed. WeThe selling stockholders may not sell these securities pursuant to this prospectus until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any ~~state~~jurisdiction where the offer or sale is not permitted.

~~Preliminary Prospectus~~ Subject to Completion, Dated ~~August~~April 410, ~~2025~~2026

~~Longeveron~~PRELIMINARY ~~Inc.~~PROSPECTUS

A blue and green logo Description automatically generated

~~Up to 3~~30,~~846~~865,~~154~~385 Shares of Class A ~~common stock Up to 3,846,154 Series A Class A~~ Common ~~Warrants to Purchase up to 3,846,154 Shares of Class A common stock~~Stock

UpThis prospectus relates to 3the re-sale or other disposition from time to time by certain selling stockholders identified herein (each,~~846~~ a “Selling Stockholder” and,~~154~~ ~~Series~~together, the B“Selling ~~Class~~Stockholders”) Aor ~~Common~~their ~~Warrants~~ pledgees, assignees, distributees and successors-in-interest, from time to ~~Purchase~~time, upof up to 330,~~846~~865,~~154~~385 ~~Shares~~shares of our Class A Common Stock, par value $0.001 per share (“Class A common stock”). Of the shares of Class A Upcommon tostock 3being registered for resale hereunder: (i) 6,~~846~~013,~~154~~384 ~~Pre-Funded~~shares ~~Warrants~~ were issued to certain of the Selling Stockholders upon the closing of the private placement contemplated by a Purchase Agreement executed March 10, 2026 (the “Purchase Agreement”), (ii) 22,832,770 shares are issuable to certain of the Selling Stockholders upon conversion of up to 311,~~846,154~~873.04 ~~Shares~~shares of ~~Class~~Series A Non-Voting ~~common~~Preferred Stock, par value $0.001 per share (“Series A preferred stock Up”) issued to ~~269,231~~ ~~Placement~~certain ~~Agent~~Selling ~~Warrants~~Stockholders toupon the closing of the private placement contemplated by the Purchase upAgreement, toand ~~269~~(iii) 2,019,231 ~~Shares~~shares are issuable to designees (or their assignees) of ~~Class~~the Aplacement ~~common~~agent ~~stock Up~~upon the exercise of placement agent warrants to ~~11,807,693~~purchase ~~Shares~~shares of ~~Class~~our Class A common stock ~~Underlying~~that were issued in accordance with the ~~Series~~engagement Aagreement ~~Common~~executed ~~Warrants~~as of June 11, ~~Series~~2025, Bas ~~Common~~amended ~~Warrants~~on August 3, ~~Pre- Funded~~2025 ~~Warrants~~ and December ~~Placement~~12, ~~Agent~~2025 upon the closing of the private placement (the “PA Warrants”).

We are offering up to 3,846,154 shares of our Class A Common Stock (the “Class A common stock”) together with up to 3,846,154 Series A Class A common warrants to purchase up to 3,846,154 shares of Class A common stock (the “Series A common warrants”) and up to 3,846,154 Series B Class A common warrants to purchase up to 3,846,154 shares of Class A common stock (the “Series B common warrants” and, together with the Series A common warrants, the “Class A common warrants”). Each share of our Class A common stock, or a pre-funded warrant in lieu thereof, is being sold together with a Series A common warrant to purchase one share of our Class A common stock and a Series B common warrant to purchase one share of our Class A common stock. The ~~shares~~PA ofWarrants ~~Class A common stock, Series A common warrant and Series B common warrant~~ are ~~immediately~~initially ~~separable~~exercisable ~~and~~at will be issued separately in this offering but must be purchased together in this offering. The assumed combined public offering price for each share of Class A common stock and accompanying Class A common warrants is $1.56, which is equal to the closing price of our Class A common stock on the Nasdaq Capital Market on July 29, 2025. Each Class A common warrant will have an ~~exercise price per share of $ , will~~ ~~be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon~~ exercise of the Class A common warrants (the “Warrant Stockholder Approval”), provided however, if the Pricing Conditions (as defined below) are met, the Warrant Stockholder Approval will not be required and the Class A common warrants will be exercisable upon issuance. The Series A common warrants will expire ( ) years from the date of issuance or the effective date of the Warrant Stockholder Approval, as applicable, and the Series B common warrants will expire ( ) months from the date of issuance or the effective date of the Warrant Stockholder Approval, as applicable. As used herein, the “Pricing Conditions” means that the combined public offering price ~~per share and accompanying Class A common warrants is such that the Warrant Stockholder Approval is not required under the rules~~ of The Nasdaq Stock Market LLC (“Nasdaq”) because either (i) the offering is an at-the-market offering under Nasdaq rules and such price equals or exceeds the sum of (a) the applicable “Minimum Price” per share as defined under Nasdaq Rule 5635(d) plus (b) $0.~~125~~65 per ~~whole~~ share of Class A common stock. ~~underlying~~We ~~each~~are ofregistering the ~~Series~~offer ~~A common warrants~~ and ~~Series~~sale ~~B common warrants or (ii) the offering is a discounted offering where the pricing and discount (including attributing a value~~ of ~~$0.125 per whole share of~~ Class A common stock ~~underlying~~on ~~each~~behalf of the ~~Series A~~Selling ~~common~~Stockholders ~~warrants~~to ~~and~~satisfy ~~Series~~certain Bregistration ~~common~~rights ~~warrants)~~that ~~meet~~we ~~the~~have ~~pricing~~granted ~~requirements~~to ~~under~~the ~~Nasdaq’s~~Selling ~~rules~~Stockholders.

WeEach ~~are~~Selling ~~also~~Stockholder ~~offering~~may, tofrom ~~each~~time ~~purchaser~~to ~~whose purchase~~time, ~~of shares of our Class A common stock in this offering would otherwise result in the purchaser~~sell, ~~together with its affiliates and certain related parties~~transfer, ~~beneficially~~or ~~owning~~otherwise ~~more~~dispose ~~than~~of ~~4.99%~~any (or, atall ~~the election~~ of the ~~holder, 9.99%) of our outstanding shares of~~ Class A common stock ~~immediately~~on ~~following~~any ~~consummation~~stock ~~of this offering~~exchange, ~~the opportunity to purchase~~market, ifor ~~the~~trading ~~purchaser~~facility soon ~~chooses, pre-funded warrants~~which ~~(the “pre-funded warrants”) to purchase~~ shares of our Class A common stock, orare ~~the~~traded ~~pre-funded~~or ~~warrants,~~ in ~~lieu~~private ~~of shares of Class A common stock~~transactions. ~~Each~~These ~~pre-funded~~dispositions ~~warrant~~may ~~will~~ be ~~exercisable~~at ~~for~~fixed ~~one~~prices, ~~share~~at ofprevailing ~~our~~market prices ~~Class~~at Athe ~~common~~time ~~stock. The purchase price~~ of ~~each~~sale, ~~pre-funded warrant~~at ~~and~~prices ~~accompanying~~related ~~Class~~to Athe ~~common~~prevailing ~~warrants~~market ~~will equal the~~ price, ~~per~~at ~~share~~varying ofprices ~~Class~~determined Aat ~~common stock and accompanying Class A common warrants being sold to~~ the ~~public~~time inof ~~this offering~~sale, ~~minus~~or $0at negotiated prices.~~001,~~ ~~and~~The ~~the~~Selling ~~exercise~~Stockholders ~~price of each pre-funded warrant~~ will bebear ~~$0.001~~all ~~per share.~~commissions ~~For~~and ~~each~~discounts, ~~pre-funded~~if ~~warrant~~any, ~~that~~attributable weto ~~sell,~~ the ~~number~~sales of ~~shares of our~~ Class A common stock. ~~that~~We ~~we are offering~~ will bebear ~~decreased on~~all aother ~~one-for-one~~costs, ~~basis.~~expenses, ~~This~~and ~~offering~~fees ~~also~~in ~~relates~~connection towith the ~~shares~~registration of the Class A common stock. ~~issuable~~See ~~upon exercise~~ “Plan of ~~the~~Distribution” ~~Class~~section Aof ~~common warrants~~this ~~and the pre-funded warrants~~prospectus.

~~This~~We are not offering ~~will~~any ~~terminate~~shares onof ~~August~~our ~~29,~~Class ~~2025,~~A ~~unless~~common westock ~~decide~~for tosale ~~terminate~~under ~~the~~this ~~offering~~prospectus. ~~(which~~We wewill ~~may~~not doreceive at any ~~time~~of inthe ~~our~~proceeds ~~discretion)~~from ~~prior~~the tosale ~~that~~or ~~date.~~other Wedisposition ~~will~~of ~~have~~our ~~one~~Class ~~closing~~A ~~for~~common ~~all~~stock by the ~~securities~~Selling ~~purchased~~Stockholders. inHowever, ~~this~~we ~~offering.~~may ~~The~~receive ~~combined~~proceeds ~~public~~of ~~offering~~up ~~price~~to ~~per~~approximately ~~share~~$1,312,500 ~~(or~~if ~~pre-funded~~all ~~warrant)~~of ~~and~~the ~~Class~~PA ~~A common~~Warrants ~~warrants~~covered ~~will~~by bethis ~~fixed~~prospectus are exercised for cash, based on the ~~duration~~per share exercise price of ~~this~~the ~~offering~~PA Warrants held by the Selling Stockholders.

Our Class A common stock is ~~listed~~traded on the ~~Nasdaq~~NASDAQ Capital Market under the symbol “LGVN.”. ~~Our~~On ~~Class~~April B9, ~~Common~~2026, ~~Stock~~the ~~(“Class B common stock”) is not registered. The~~ last reported sale price offor our Class A common stock as reported on the ~~Nasdaq~~NASDAQ Capital Market ~~on July 29, 2025,~~ was $1.5611 per share. All share, Class A common warrants and pre-funded warrant numbers are based on an assumed combined public offering price of $1.56 per share and the accompanying Class A common warrants and $1.559 per pre-funded warrant and the accompanying Class A common warrants, based on the Company’s closing price of the Class A common stock on July 29, 2025 as reported on the Nasdaq Capital Market. The actual combined public offering price per share of Class A common stock and accompanying Class A common warrants, and per pre-funded warrant and accompanying Class A common warrants, will be determined between us and investors based on market conditions at the time of pricing, and may be at a discount to the then current market price of our Class A common stock. The recent market price used throughout this prospectus may not be indicative of the actual combined public offering price. The actual combined public offering price may be based upon a number of factors, including our history and our prospects, the industry in which we operate, our past and present operating results, the previous experience of our executive officers and the general condition of the securities markets at the time of this offering. There is no established public trading market for the Series A common warrants, Series B common warrants or pre-funded warrants, and we do not expect a market for the Series A common warrants, Series B common warrants or the pre-funded warrants to develop. We do not intend to list the Series A common warrants, Series B common warrants or pre-funded warrants on the Nasdaq Capital Market, any other national securities exchange or any other trading system. Without an active trading market, the liquidity of the Series A common warrants, Series B common warrants and the pre-funded warrants will be limited.

WeInvesting ~~have~~in ~~engaged H.C. Wainwright & Co., LLC (the “placement agent”), to act as~~ our ~~exclusive~~securities ~~placement~~involves ~~agent~~a ~~in connection with this offering. The placement agent has agreed~~high todegree ~~use its reasonable best efforts to arrange for the sale~~ of ~~the securities offered by this prospectus~~risk. ~~The~~Before ~~placement~~making ~~agent is not purchasing or selling~~ any ofinvestment ~~the~~in ~~securities~~these ~~we are offering~~securities, ~~and~~you ~~the~~should ~~placement~~consider ~~agent~~carefully ~~is not required to arrange~~ the ~~purchase~~risks orand ~~sale~~uncertainties ~~of any specific number or dollar amount of securities. We have agreed to pay to the placement agent the placement agent fees set forth~~ in the ~~table below,~~“Risk ~~which~~Factors” ~~assumes~~section ~~that we sell all~~ of ~~the securities offered by~~ this prospectus. ~~Since~~and ~~we will deliver the securities to be issued~~ in this offering upon our receipt of investor funds, there is no arrangement for funds to be received in escrow, trust or similar arrangement. There is no minimum offering requirement as a condition of closing of this offering. Because there is no minimum offering amount required as a condition to closing this offering, we may sell fewer than all of the ~~securities~~other ~~offered~~documents ~~hereby, which may significantly reduce the amount of proceeds received by us. Investors in this offering will not receive a refund in the event~~ that we do not sell an amount of securities sufficient to pursue our business goals described in this prospectus. In addition, because there is no escrow account and no minimum offering amount, investors could be in a position where they have invested in our company, but we are ~~unable~~incorporated toby ~~fulfill all of our contemplated objectives due to a lack of interest in this offering~~reference. ~~We will bear all costs associated with the offering. See “Plan of Distribution” on page 32 of this prospectus for more information regarding these arrangements.~~

WeNeither ~~are~~the anSecurities ~~“emerging~~and ~~growth~~Exchange ~~company”~~Commission ~~under~~ (the ~~federal~~“SEC”) ~~securities~~nor ~~laws~~any ~~and,~~state assecurities ~~such,~~commission wehas ~~have~~approved ~~elected~~or todisapproved ~~comply~~of ~~with~~these ~~certain~~securities ~~reduced~~or ~~public~~passed ~~company~~upon ~~reporting~~the ~~requirements for~~adequacy ~~this~~or ~~prospectus~~accuracy ~~and~~of ~~future~~this ~~filings~~prospectus. ~~See~~Any ~~“Prospectus~~representation ~~Summary~~to -the ~~Implication~~contrary ofis ~~Being an Emerging Growth Company and~~ a ~~Smaller~~criminal ~~Reporting Company~~offense.”

Per Share and Class A Common Warrants

Per Pre-Funded Warrant and Class A Common Warrants

Total

Public Offering price

Placement Agent fees and expenses(1)

Proceeds to us, before expenses(2)

The date of this prospectus is , 2026

(1)

We have agreed to pay the placement agent a cash fee equal to 7.0% of the gross proceeds raised in this offering. We have also agreed to reimburse the placement agent for certain of its offering related expenses, including a management fee of 1.0% of the aggregate gross proceeds raised in the offering, reimbursement for non-accountable expenses in an amount of $10,000 and legal fees and other out of pocket expenses in the amount of $100,000. In addition, we have agreed to issue to the placement agent or its designees as compensation in connection with this offering warrants (the “Placement Agent Warrants”) to purchase a number of shares of Class A common stock equal to 7.0% of the shares of Class A common stock sold in this offering (including the shares of Class A common stock issuable upon exercise of the pre-funded warrants), at an exercise price of $ per share. See “Plan of Distribution” on page 32 of this prospectus for a description of the fees and expenses to be paid to the placement agent for services performed in connection with the offering.

(2)

Because there is no minimum number of securities or amount of proceeds required as a condition to closing in this offering, the actual public offering amount, placement agent fees, and proceeds to us, if any, are not presently determinable and may be substantially less than the total maximum offering amounts set forth above. The amount of the offering proceeds to us presented in this table does not give effect to the exercise, if any, of the pre-funded warrants or the Class A common warrants.

Investing in our securities involves a high degree of risk. See “Risk Factors” beginning on page 13 of this prospectus, as well as the risk factors and other information in any documents we incorporate by reference into this prospectus, to read about important factors you should consider.

Neither 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.

The delivery to purchasers of the shares of Class A common stock, pre-funded warrants and Class A common warrants in this offering is expected to be made on or about , 2025, subject to satisfaction of certain customary closing conditions.

H.C. Wainwright & Co.

The date of this prospectus is , 2025

TABLE OF CONTENTS

		Page
ABOUT THIS PROSPECTUS		ii
PROSPECTUS SUMMARY		1
THE OFFERING		9
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS		1210
RISK FACTORS		13
INDUSTRY AND MARKET DATA		11
USE OF PROCEEDS		23
RISK FACTORS		12
DIVIDEND POLICY		2421
DILUTION		24
USE OF PROCEEDS		21
DESCRIPTION OF SECURITIES WE ARE OFFERING		27
DETERMINATION OF OFFERING PRICE		22
PLAN OF DISTRIBUTION		32
THE SELLING STOCKHOLDERS		22
LEGAL MATTERS		35
PLAN OF DISTRIBUTION		27
WHERE YOU CAN FIND MORE INFORMATION		35
DESCRIPTION OF SECURITIES TO BE REGISTERED		29
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE		36
LEGAL MATTERS		32
SIGNATURES		II-8
EXPERTS		32
WHERE YOU CAN FIND MORE INFORMATION		32
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE		33

Neither we nor the placement agent have authorized anyone to provide you with information other than that contained in this prospectus, or any free writing prospectus prepared by or on our behalf or to which we have referred you. We and the placement agent take no responsibility for and can provide no assurance as to the reliability of, any other information that others may give you. We and the placement agent are offering to sell, and seeking offers to buy, securities only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date on the front cover page of this prospectus, or other earlier date stated in this prospectus, regardless of the time of delivery of this prospectus or of any sale of our securities. Our business, financial condition, results of operations and future prospects may have changed since that date.

No action is being taken in any jurisdiction outside the United States to permit a public offering of our securities or possession or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus applicable to that jurisdiction.

We and the placement agent are offering to sell, and seeking offers to buy, our securities only in jurisdictions where offers and sales are permitted. Neither we nor the placement agent 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 United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of our shares of Class A common stock, Class A common warrants and pre-funded warrants and the distribution of this prospectus outside of the United States.

~~About~~ABOUT ~~This~~THIS ~~Prospectus~~PROSPECTUS

This prospectus isprovides ~~part~~you ofwith a ~~registration~~general ~~statement~~description ~~that~~of ~~we have filed with~~ the ~~Securities~~Class ~~and~~A ~~Exchange~~common ~~Commission.~~stock ~~You~~that ~~should~~may ~~rely~~be ~~only~~resold onby the ~~information~~Selling ~~contained in this prospectus or any related prospectus supplement~~Stockholders. WeIn ~~have~~certain ~~not~~circumstances, ~~authorized~~we ~~anyone~~may to provide ~~you~~a ~~with~~prospectus ~~different information. If anyone provides you with~~supplement ~~different~~that orwill ~~inconsistent~~contain ~~information,~~specific ~~you should not rely on it. The~~ information ~~contained~~about inthe ~~this~~terms ~~prospectus~~of isa ~~accurate~~particular ~~only~~offering onby the ~~date~~ ofSelling ~~this prospectus~~Stockholders. ~~Our~~We ~~business,~~also ~~financial condition, results of operations and prospects~~ may ~~have~~provide ~~changed~~a ~~since such date. Other~~prospectus ~~than~~supplement asto ~~required~~add ~~under~~information ~~the federal securities laws~~to, weor ~~undertake no obligation to publicly~~ update or ~~revise~~change ~~such~~ information, ~~whether as~~contained ~~a result of new information~~in, ~~future~~this ~~events or any other reason~~prospectus. ~~This~~To ~~prospectus contains summaries of certain provisions contained in some of~~ the ~~documents~~extent ~~described~~there ~~herein, but reference~~ is ~~made~~a toconflict between the ~~actual documents for complete~~ information. ~~All~~contained ~~of the summaries are qualified~~ in ~~their~~this ~~entirety~~prospectus byand ~~the~~any ~~actual~~prospectus ~~documents.~~supplement, ~~Copies~~you ofshould ~~some~~rely ofon the ~~documents~~information ~~referred~~in tothe ~~herein~~prospectus ~~have been filed~~supplement, provided ~~will~~that beif ~~filed or~~any ~~will~~statement bein ~~incorporated~~one byof ~~reference~~these asdocuments ~~exhibits~~is toinconsistent ~~the~~with ~~registration~~a statement ofin ~~which~~another ~~this~~document ~~prospectus~~having is a ~~part,~~later ~~and you may obtain~~date — for ~~copies~~example, ofa ~~those~~document ~~documents~~incorporated asby ~~described~~reference ~~below.~~in ~~You should read~~ this prospectus inor ~~its~~any ~~entirety~~prospectus ~~before making an investment decision. You should also read and consider~~ supplement — the ~~information~~statement in the later-dated ~~documents~~document tomodifies ~~which~~or wesupersedes ~~have referred you in~~ the ~~section~~earlier ~~of the prospectus entitled “Where You Can Find More Information~~statement.”

This prospectus ~~does~~is ~~not~~part ~~constitute~~of ana ~~offer~~registration tostatement ~~sell~~that orwe have filed with the ~~solicitation~~Securities ofand anExchange ~~offer~~Commission pursuant to ~~buy~~which ~~any~~the ofSelling ~~our~~Stockholders ~~securities~~named ~~other~~herein ~~than~~may, from time to time, offer and sell or otherwise dispose of the ~~securities~~Class ~~covered~~A ~~hereby,~~common ~~nor~~stock ~~does~~covered by this prospectus. ~~constitute~~You should rely only on the information ancontained ~~offer~~in tothis ~~sell~~prospectus or ~~the~~any ~~solicitation~~related ofprospectus ansupplement. ~~offer~~We have not authorized anyone to ~~buy~~provide ~~any~~you ~~securities~~with indifferent ~~any~~information. If ~~jurisdiction~~anyone toprovides ~~any~~you ~~person~~with todifferent ~~whom~~or inconsistent information, you should not rely on it. isThe ~~unlawful~~information tocontained ~~make~~in this prospectus ~~such~~is ~~offer~~accurate oronly ~~solicitation~~on inthe date of this prospectus. Our business, financial condition, results of operations and prospects may have changed since such ~~jurisdiction~~date. ~~Persons~~Other ~~who~~than ~~come~~as ~~into~~required ~~possession~~under the federal securities laws, we undertake no obligation to publicly update or revise such information, whether as a result of ~~this~~new information, future events or any other reason. This prospectus contains summaries of certain provisions contained in ~~jurisdictions~~some ~~outside~~of the ~~United~~documents described herein, but reference is made to the actual documents for complete information. ~~States~~All of the summaries are ~~required~~qualified in their entirety by the actual documents. Copies of some of the documents referred to ~~inform~~herein ~~themselves~~have been ~~about~~filed, ~~and~~will tobe ~~observe~~filed, ~~any~~or ~~restrictions~~will be incorporated by reference as exhibits to the ~~offering~~registration statement of which this prospectus is a part, and ~~the~~you ~~distribution~~may obtain copies of those documents as described below. You should read this prospectus in its entirety before making ~~applicable~~an investment decision. You should also read and consider the information in the documents to ~~those~~which ~~jurisdictions~~we have referred you in the section of the prospectus entitled “Where You Can Find More Information.”

~~Industry~~This prospectus does not constitute an offer to sell or the solicitation of an offer to buy any of our securities other than the Class A common stock covered hereby, nor does this prospectus constitute an offer to sell or the solicitation of an offer to buy any securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about, and ~~Market~~to ~~Data~~observe, any restrictions as to the offering and the distribution of this prospectus applicable to those jurisdictions.

This prospectus ~~includes~~contains ~~industry~~references ~~data~~to ~~and forecasts~~trademarks, ~~that~~trade wenames ~~obtained from industry publications~~ and ~~surveys,~~service ~~public~~marks ~~filings~~belonging ~~and~~to ~~internal~~other ~~company sources~~entities. ~~Industry~~Solely ~~publications~~for ~~and~~convenience, ~~surveys and~~trademarks, ~~forecasts~~trade ~~generally~~names ~~state~~and ~~that~~service ~~the~~marks ~~information~~referred to ~~contained~~in ~~therein~~this ~~has~~prospectus ~~been~~may ~~obtained~~appear ~~from~~without ~~sources~~the ~~believed~~® toor beTM ~~reliable~~symbols, but ~~there can~~such bereferences noare ~~assurance~~not asintended to ~~the~~indicate, ~~accuracy~~in orany ~~completeness~~way, ofthat the applicable ~~included~~licensor ~~information.~~will ~~Statements~~not asassert, to ~~our~~the ~~market~~fullest ~~position~~extent ~~and~~under ~~market~~applicable ~~estimates are based on independent industry publications~~law, ~~government~~its ~~publications,~~rights ~~third~~to ~~party~~these ~~forecasts,~~trademarks ~~management’s estimates~~ and ~~assumptions about~~trade ~~our~~names. ~~markets~~We ~~and~~do not intend our ~~internal~~use ~~research.~~or ~~While~~display ~~we are not aware~~ of ~~any~~other ~~misstatements~~companies’ ~~regarding~~trade ~~the~~names, ~~market~~trademarks, ~~industry~~ or ~~similar~~service ~~data presented~~marks ~~herein, such data involve risks and uncertainties and are subject~~ to ~~change~~imply ~~based~~a onrelationship ~~various factors~~with, ~~including~~or ~~those discussed~~endorsement ~~under~~or ~~the~~sponsorship ~~headings~~of ~~“Risk~~us ~~Factors”~~by, ~~and~~any ~~“Cautionary~~other ~~Note Regarding Forward-Looking Statements” in this prospectus~~companies.

This prospectus contains references to trademarks, trade names and service marks belonging to other entities. Solely for convenience, trademarks, trade names and service marks referred to in this prospectus may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

PROSPECTUS SUMMARY

This summary highlights, and is qualified in its entirety by, the more detailed information and financial statements included elsewhere or incorporated by reference in this prospectus. This summary does not contain all of the information that may be important to you in making your investment decision. You should read this entire prospectus carefully, especially the “Risk Factors” section ~~beginning~~of onthis ~~page~~prospectus ~~13,~~ as well as “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Risk Factors” and our audited financial statements, unaudited financial statements and related notes thereto, which are incorporated by reference into this prospectus. In this prospectus, except as otherwise indicated, “Longeveron,” the “Company,” “we,” “our,” and “us” refer to Longeveron Inc., a Delaware corporation.

~~Business~~ Introduction and Overview

We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. Our lead investigational product candidate is laromestrocel~~. Longeveron received notice from the World Health Organization (“WHO”) on February 13~~, ~~2025~~also that the name “laromestrocel” for our Lomecel-B™ product has been adopted by the WHO and published in the International Nonproprietary Names (INN) list 132. Following that notice, we adopted referring to the investigational product as laromestrocel, and will continue to refer to the investigational product formerly referred to as Lomecel-~~BTM as laromestrocel on an ongoing basis~~B®.

Laromestrocel is a proprietary, scalable, allogeneic cellular therapy that has multiple potential modes of action that include pro-vascular, pro-regenerative, and anti-inflammatory mechanisms, ~~promoting~~that collectively appear to promote tissue repair and healing. ~~with~~Laromestrocel possesses broad potential applications across a spectrum of disease areas. ~~We are currently pursuing four pipeline~~ ~~indications: Hypoplastic Left Heart Syndrome (“HLHS”), Alzheimer’s disease (“AD”), pediatric Dilated Cardiomyopathy (“DCM”) and Aging-related Frailty.~~ Our mission is to continue to advance the development and regulatory approval of laromestrocel ~~and~~ in order to make it available tofor ~~all the~~ patients who may need it.

~~Operational~~Since ~~Overview.~~our ~~With~~founding ~~respect~~in ~~to HLHS~~2014, we ~~are~~have ~~exploring~~focused the majority ~~possibility~~of ~~that~~our ~~laromestrocel,~~time ~~when~~and ~~administered~~resources ~~directly~~on to the ~~myocardium~~following: oforganizing ~~affected~~and ~~infants,~~staffing ~~can~~our ~~improve~~company, ~~outcomes in~~building, ~~this~~staffing ~~devastating~~and ~~rare~~equipping ~~pediatric disease. The standard of care in HLHS is~~ a ~~series~~current ofgood manufacturing ~~three~~practice ~~heart surgeries~~ (~~staged surgical palliation~~“cGMP”) ~~that~~ ~~reconfigures~~manufacturing ~~the~~facility ~~single~~with ~~right~~research ~~ventricle~~and todevelopment ~~support~~labs, ~~system~~business ~~circulation. Despite these life-saving surgical interventions~~planning, itraising ~~is estimated~~capital, ~~that~~establishing ~~only~~and 50maintaining toour 60intellectual ~~percent~~property ofportfolio, ~~affected~~generating ~~individuals~~clinical ~~survive~~safety ~~until adolescence. The pro-vascular, pro-regenerative~~ and ~~anti-inflammatory properties~~efficacy ofdata ~~laromestrocel may improve the function of the right ventricle~~ in ~~these~~our ~~infants.~~selected ~~A previous Longeveron Phase 1 head-to-head~~disease ~~versus~~conditions ~~standard~~and ofindications, ~~care~~and ~~controlled~~developing ~~study~~and ~~(ELPIS~~expanding I)our ~~indicated~~manufacturing ~~that~~processes ~~such~~and acapabilities ~~benefit~~to ~~may~~support ~~exist~~both ~~when~~internal ~~outcomes~~and ~~were compared to historical controls.~~external ~~Longeveron~~development ~~is currently conducting a controlled study to determine the actual benefit of laromestrocel in these patients~~programs.

AsWe ofmanufacture ~~July~~our ~~17,~~own ~~2025,~~investigational weproduct candidates for early-phase clinical trials and have ~~completed~~initiated ~~five~~enhancements Uto our Chemistry, Manufacturing and Controls (“CMC”) infrastructure to support potential future Biologics License Application (“BLA”) submissions.S. These efforts include planning ~~clinical~~for ~~studies~~process and analytical method validation as well as commercial production readiness. As part of ~~laromestrocel:~~our ~~Phase~~ongoing 1preparations ~~AD,~~for ~~Phase~~a 1potential BLA ~~HLHS,~~submission ~~Phase~~for ~~1/2~~our ~~Aging-related~~lead ~~Frailty~~investigational product candidate for Hypoplastic Left Heart Syndrome (“~~HERA Trial~~HLHS”), ~~Phase~~we 2ahave ADmade ~~(“CLEAR~~a strategic ~~MIND~~decision ~~Trial~~to pursue commercial manufacturing through a third-party contract development and manufacturing organization (“CDMO”), rather ~~and~~than ~~Phase~~renovating 2bour ~~Aging~~existing Miami facility for commercial-~~related~~scale ~~Frailty~~production. WeThis ~~currently~~decision ~~have~~was ~~one~~based ~~fully~~on ~~enrolled~~a comprehensive evaluation of multiple factors, ~~ongoing~~including ~~clinical~~cost, ~~trial:~~timeline ~~Phase~~feasibility, 2band ~~HLHS~~scalability. ~~(“ELPIS~~We believe this approach offers a more cost-effective and ~~II”~~timely ~~trial)~~path to support our potential BLA submission and commercial launch. ~~Additionally~~Our Miami manufacturing facility, wewhich ~~sponsor~~includes aeight ~~registry~~clean rooms, intwo ~~The~~research ~~Bahamas~~and ~~under~~development ~~the~~laboratories, ~~approval~~and warehouse and ~~authority~~storage ofspace, ~~the~~will ~~National~~continue ~~Stem~~to ~~Cell~~support ~~Ethics~~clinical development, research ~~Committee.~~and ~~The~~early-phase ~~Bahamas~~manufacturing ~~Registry~~for ~~Trials~~our ~~may~~current ~~administer~~and ~~laromestrocel~~future toclinical ~~eligible~~trials. ~~participants~~We athave ~~private~~supply ~~clinics~~contracts inwith ~~Nassau~~multiple ~~for~~third aparties ~~variety~~for fresh ofbone ~~indications.~~marrow, ~~While~~which ~~laromestrocel~~we isuse ~~considered~~to anproduce our investigational product incandidate ~~The~~for ~~Bahamas,~~clinical ~~under~~testing ~~the~~and ~~approval~~research ~~terms~~and ~~from~~development. ~~the~~From ~~National~~time ~~Stem~~to ~~Cell Ethics Committee~~time, we ~~are~~enter ~~permitted~~into tocontract ~~charge~~development aand ~~fee~~manufacturing tocontracts ~~participate~~or inarrangements ~~the~~with ~~Registry~~third ~~Trial~~parties who seek to utilize our product development capabilities.

Since our founding in 2014, we have focused the majority of our time and resources on the following: organizing and staffing our company, building, staffing and equipping a cGMP manufacturing facility with research and development labs, business planning, raising capital, establishing our intellectual property portfolio, generating clinical safety and efficacy data in our selected disease conditions and indications, and developing and expanding our manufacturing processes and capabilities.

We manufacture our own product candidates for early-phase clinical trials and have initiated enhancements to our Chemistry, Manufacturing and Controls (CMC) infrastructure to support future Biologics License Application (BLA) submissions. These efforts include planning for process and analytical method validation as well as commercial production readiness. As part of our ongoing preparations for a potential BLA submission for our lead investigational product candidate for HLHS, we have made a strategic decision to pursue commercial manufacturing through a third-party contract development and manufacturing organization (CDMO), rather than renovating our existing Miami facility for commercial-scale production. This decision was based on a comprehensive evaluation of multiple factors, including cost, timeline feasibility, and scalability. We believe this approach offers a more cost-effective and timely path to support our BLA submission and potential commercial launch. Our Miami manufacturing facility includes eight clean rooms, two research and development laboratories, and warehouse and storage space. This facility will continue to support clinical development, research and early-phase manufacturing for our current and future clinical trials. We have supply contracts with multiple third parties for fresh bone marrow, which we use to produce our product candidate for clinical testing and research and development. From time to time, we enter into contract development and manufacturing contracts or arrangements with third parties who seek to utilize our product development capabilities.

~~Since~~Operational the time that we became a publicly traded company in February 2021, we have sold 12,686,240 shares of Class A common stock through our IPO and subsequent follow-on public and private equity offerings and transactions. Additionally, as of June 30, 2025, warrants exercisable for an aggregate of up to 6,802,668 shares of a Company’s Class A common stock remain outstanding at exercise prices ranging from $2.35 per share to $175.00 per share.Overview

~~When~~We ~~appropriate~~are ~~funding~~currently ~~opportunities arise, we routinely apply for grant funding to support our ongoing research and since 2016 we have received approximately $16.3 million~~ in ~~grant awards~~clinical ~~($11.5~~development ~~million~~ of ~~which has been directly awarded to us and is recognized as revenue when the performance obligations are met)~~a ~~from~~single ~~the~~investigational ~~National~~product ~~Institute~~candidate, ~~on Aging (“NIA”) of the National Institutes of Health (“NIH”)~~laromestrocel, ~~the~~for ~~National~~four ~~Heart Lung~~potential ~~and~~indications: ~~Blood Institute (“NHLBI”) of the NIH~~HLHS, ~~the~~ Alzheimer’s ~~Association,~~disease ~~the Maryland Stem Cell Research Fund~~ (“~~MSCRF~~AD”), ofPediatric ~~the~~Dilated ~~Maryland~~Cardiomyopathy ~~Technology~~(“pediatric ~~Development Corporation~~DCM”), ~~or TEDCO,~~ and ~~the XPRIZE Foundation, Inc. On May 12, 2025 we announced our selection as a semi~~Aging-~~finalist~~related ~~team and recipient of a $250,000 Milestone 1 Award in the XPRIZE Healthspan competition, a seven-year, $101 million global competition to identify therapeutic approaches to increase human health span~~Frailty.

~~HLHS~~Figure 1: Laromestrocel clinical development pipeline

~~Our~~* ~~HLHS~~potentially ~~program~~pivotal isPhase ~~focused~~2b onELPIS ~~the~~II potential clinical benefits of laromestrocel as an adjunct therapeutic to standard-of-care HLHS surgery. HLHS is a rare and devastating congenital heart defect in which the left ventricle is severely underdeveloped. As such, babies born with this condition die shortly after birth without undergoing a complex series of reconstructive heart surgeries. Despite the availability of life-saving surgical interventions, clinical studies show that only 50 to 60 percent of affected individuals survive to adolescence. Early clinical study ~~data shows the potential~~; ~~survival~~enrollment ~~benefit of laromestrocel for HLHS patients and supports Longeveron’s belief that these data show the potential to alter the treatment landscape for patients with HLHS. We have~~ completed aJune ~~Phase 1 open-label study (“ELPIS I”)1 that supported the safety and tolerability of laromestrocel for HLHS~~24, when directly injected into the functional right ventricle (“RV”) during the second-stage standard-of-care surgery (adding minimal additional time to the surgical procedure). Preliminary data revealed that several indices of right ventricular function show suggestions of either improvement or prevention of deterioration over one year following surgery. Heart transplant-free survival for patients who received laromestrocel intracardiac injection is favorable as compared to historical controls for survival. The ELPIS I trial showed 100 percent transplant-free survival in children up to 5 years after receiving laromestrocel, compared to a 20 percent mortality rate observed from historical control data. The improvement in HLHS survival following the Phase 1 ELPIS I clinical trial resulted in scientific presentations at the American Heart Association (“AHA”) in November 2023 and Congenital Heart Surgeons’ Society’s 51st Annual Meeting in October 2024.2025

~~Based~~** onNot these findings, the U.S. Food and Drug Administration (the “FDA”) granted laromestrocel Rare Pediatric Disease (“RPD”) Designation, Orphan Drug Designation (“ODD”), and Fast Track Designation for treatment of infants with HLHS. On September 3, 2024, Longeveron announced a positive Type C meeting with the FDA supporting the advancement of laromestrocel. Longeveron is currently conducting a controlled Phase 2b trial (“ELPIS II”) to compare the effects of laromestrocel as an adjunct therapeutic versus standard-of-care (HLHS surgery alone). We announced full enrollment of ELPIS II on June 24, 2025. While it is hard to predict study outcome due to the inherent risk associated with clinical trials, our plans are centered on a successful outcome, which could add to the clinical data suggesting the clinical benefit of laromestrocel as part of standard-of-care treatment in HLHS patients.active

As*** aWe ~~result~~plan ofto ~~the~~conduct ~~Type~~a Csingle ~~meeting~~potentially ~~with the FDA,~~pivotal wePhase ~~reached~~2 ~~foundational alignment on the~~ registrational ~~path to pursue traditional approval for laromestrocel for treatment of HLHS, based on the proposed~~ clinical ~~development~~trial ~~program,~~in ~~which~~accordance ~~includes~~with the ~~ongoing~~Investigational ~~Phase~~New 2bDrug ~~ELPIS~~(“IND”) IIapplication ~~study~~which asbecame ~~the pivotal study to provide primary~~effective ~~evidence of effectiveness. We anticipate top-line trial results for ELPIS II~~ in ~~the~~July ~~third quarter of 2026~~2025.

1As ~~Sunjay~~of ~~Kaushal,~~December ~~M.D.~~2025, ~~Ph.D.,~~we ~~Joshua~~have Mcompleted ~~Hare,~~five MU.DS., clinical ~~Jessica~~studies Rof ~~Hoffman,~~laromestrocel: ~~Ph.D.,~~ELPIS ~~Riley~~I M.Phase ~~Boyd,~~1 BA(HLHS), ~~Kevin~~Phase N.1 ~~Ramdas,~~and ~~M.D.,~~“CLEAR ~~MPH~~MIND Trial”, ~~Nicholas~~Phase ~~Pietris,~~2a ~~M.D.~~(AD), ~~Shelby~~Phase ~~Kutty,~~1/2 ~~M.D.,~~and PhPhase 2b Aging-related Frailty.~~D.,~~ ~~MS,~~We ~~James~~currently S.have ~~Tweddell,~~one ~~M.D.~~fully enrolled, Songoing ~~Adil~~clinical ~~Husain,~~trial: ~~M.D.,~~ELPIS ~~Shaji~~II CPhase 2b (HLHS). ~~Menon~~Additionally, ~~MBBS,~~we ~~M.D.,~~sponsor a ~~MS,~~registry ~~Linda~~in M.The ~~Lambert,~~Bahamas ~~MSN-cFNP,~~under ~~David~~the A.approval ~~Danford,~~and ~~M.D.,~~authority ~~Seth~~of J.the ~~Kligerman,~~National ~~M.D.,~~Stem ~~Narutoshi~~Cell ~~Hibino,~~Ethics ~~M.D.~~Committee, ~~Ph.D.,~~now ~~Laxminarayana~~known ~~Korutla,~~as ~~Ph.D.,~~the ~~Prashanth~~National ~~Vallabhajosyula,~~Longevity and ~~M.D.,~~Regenerative ~~MS,~~Therapy ~~Michael~~Ethics JReview Committee. ~~Campbell,~~The ~~M.D.,~~Bahamas ~~Aisha~~Registry ~~Khan,~~Trial ~~Ph.D.,~~may ~~Eric~~administer ~~Naioti,~~laromestrocel ~~MSPH,~~to ~~Keyvan~~eligible ~~Yousefi,~~participants ~~Pharm.D.,~~at private ~~Ph.D.,~~clinics ~~Danial~~in ~~Mehranfard~~Nassau, ~~PharmD,~~Bahamas ~~M.B.A.,~~for ~~Lisa~~a ~~McClain-Moss,~~variety ~~Anthony~~of Aindications. ~~Oliva,~~While ~~Ph.D.,~~laromestrocel ~~Michael~~is E.considered ~~Davis,~~an ~~Ph.D.,~~investigational ~~Intramyocardial~~product ~~cell-based~~in ~~therapy~~The ~~with~~Bahamas, under ~~Lomecel-B™~~the ~~during~~approval ~~bidirectional~~terms ~~cavopulmonary~~from ~~anastomosis~~the ~~for~~National ~~hypoplastic~~Stem ~~left~~Cell ~~heart~~Ethics ~~syndrome:~~Committee, ~~The~~we ~~ELPIS~~are ~~phase~~permitted Ito ~~trial,~~charge ~~European~~a ~~Heart~~fee ~~Journal~~to ~~Open,~~participate ~~2023~~in the Registry Trial.

Our current objective is to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in all four potential indications.

Hypoplastic Left Heart Syndrome (HLHS)

HLHS is a rare congenital heart condition affecting approximately 1,000 newborns in the U.S. annually. HLHS is a birth defect that affects normal blood flow through the heart. As the baby develops during pregnancy, the left side of the heart does not form correctly so that babies are born with an underdeveloped or absent left ventricle. It is one type of congenital heart defect present at birth. Because a baby with this defect needs surgery or other procedures soon after birth, HLHS is considered a critical congenital heart defect. To prevent certain death shortly after birth, these babies undergo a series of three heart surgeries (staged surgical palliation) that reconfigures the single right ventricle to support systemic circulation. Despite these life-saving surgeries, HLHS patients nevertheless still have high early mortality and morbidity rates due primarily to heart failure. We are exploring the possibility that laromestrocel, when administered directly to the myocardium of affected infants, can improve outcomes in this devastating rare pediatric disease.

The FDA granted Rare Pediatric Disease Designation (“RPD”) for laromestrocel for the treatment of HLHS (November 8, 2021), Orphan Drug Designation (“ODD”) (December 2, 2021), and Fast Track Designation (August 24, 2022). We are currently conducting an ongoing Phase 2b clinical trial (ELPIS II) under FDA IND 17677. ELPIS II is a multi-center, randomized, double-blind, controlled clinical trial designed to evaluate laromestrocel as an adjunct therapy to the standard-of-care second-stage HLHS heart reconstructive surgery which is typically performed at 4-6 months after birth. The primary objective is to evaluate change in right ventricular ejection fraction after laromestrocel treatment versus standard-of-care surgery alone (40 subjects total: 20 per arm).

ELPIS II is a next-step trial to our completed 10-patient open-label Phase 1 trial (ELPIS I) under the same IND. ELPIS I trial was designed to evaluate the safety and tolerability of laromestrocel as an adjunct to the second-stage HLHS surgery, and to obtain preliminary evidence of laromestrocel effect to support a next-phase trial. The primary safety endpoint was met: no major adverse cardiac events (“MACE”) or treatment-related infections during the first month post-treatment, and no triggering of stopping rules. Furthermore, fluid-based and imaging biomarker data supported multiple potentially relevant mechanisms-of-action of laromestrocel, and the potential to improve post-surgical heart function.

~~Alzheimer’s~~In ~~Disease~~January 2026, we announced that the FDA granted us a Type C meeting at the end of March 2026 to prepare for the anticipated third quarter 2026 data readout of ELPIS II.

InWe ~~September~~have ~~2023,~~filed wepatent ~~completed~~applications ~~our~~relating ~~Phase 2a AD~~to ~~clinical trial, known as~~ the ~~CLEAR~~administration ~~MIND~~of ~~trial.~~laromestrocel ~~This~~for ~~trial~~treating ~~enrolled~~HLHS ~~patients~~in ~~with~~Australia, ~~mild~~The ADBahamas, ~~and~~Canada, ~~was~~China, ~~designed~~the asEuropean aPatent ~~randomized~~Office, ~~double-blind~~Japan, Hong ~~placebo-controlled~~Kong, ~~study~~South ~~across~~Korea, ~~ten U.S. centers. Our primary objective was to assess safety~~Taiwan, and wethe ~~tested~~United ~~three distinct laromestrocel dosing regimens against placebo~~States.

The study demonstrated positive results. The established safety profile of laromestrocel for single and multiple dosing regimens was demonstrated in study data that showed no incidence of hypersensitivity or infusion-related reactions, there were no cases of amyloid-related imaging abnormalities (ARIA), and all laromestrocel treatment groups met the safety primary endpoint and showed slowing/prevention of disease worsening relative to placebo. There were statistically significant improvements in the secondary efficacy endpoint, composite AD score (“CADS”) for both the low-dose laromestrocel group and the pooled treatment groups compared to placebo. Other doses also indicated promising results in slowing/prevention of disease worsening. Additionally, a statistically significant improvement versus placebo was observed in the Montreal cognitive assessment (“MoCA”) and in the activity of daily living observed by a caregiver and measured by Alzheimer’s ~~disease~~Disease ~~Cooperative Study Activities of Daily Living~~ (~~“ADCS-ADL”). The study indicated potential preservation of the brain volumes in some but not all~~ AD ~~related areas of the brain 39 weeks after treatment commenced. Brain magnetic resonance imaging (“MRI”~~) results demonstrated a 48% reduction in whole brain volume loss, 62% reduction in hippocampal volume loss, and potential improvement in neuroinflammation in some but not all brain regions via diffusion tensor imaging (DTI).

~~The~~AD, ~~results~~a ofdevastating ~~the~~neurologic ~~CLEAR~~disease ~~MIND~~leading ~~trial were presented~~to incognitive ~~the~~decline, ~~Featured~~currently ~~Research~~has ~~Session~~very atlimited ~~the~~therapeutic ~~2024~~options. ~~Alzheimer’s~~An ~~Association~~estimated ~~International Conference (“AAIC”) in July 2024~~6. ~~The~~7 ~~brain~~million ~~volume~~Americans ~~results~~aged ~~measured~~65 byand ~~MRI~~older ~~results~~have ~~from~~AD, and this number ~~trial~~is ~~also~~projected ~~were~~to ~~presented~~more atthan ~~the~~double ~~poster~~by ~~presentation at AAIC~~2060. ~~These~~In ~~findings support~~September ~~both~~2023, ~~the~~we ~~safety~~completed ~~and~~our ~~potential~~Phase ~~therapeutic~~2a ~~benefit~~AD ofclinical ~~laromestrocel in managing mild AD~~trial, ~~and~~known weas ~~believe lay~~ the ~~groundwork~~CLEAR ~~for~~MIND ~~subsequent~~trial. ~~trials~~This intrial ~~this~~enrolled ~~indication.~~patients ~~Based~~with onmild ~~these~~AD ~~results,~~and ~~the~~was ~~FDA~~designed ~~granted~~as ~~Regenerative~~a ~~Medicine~~randomized, ~~Advanced~~double-blind, ~~Therapeutics~~placebo-controlled ~~(RMAT)~~study ~~Designation on~~across ~~July~~ten 5,U.S. centers. ~~2024,~~Our ~~and~~primary ~~Fast~~objective ~~Track~~was ~~designation~~to onassess ~~July 16~~safety, ~~2024,~~and topreliminary ~~laromestrocel~~efficacy for ~~the~~three ~~treatment~~distinct oflaromestrocel ~~mild~~dosing ADregimens against placebo.

~~Additional~~The ~~data~~study ~~from~~demonstrated ~~the~~positive ~~CLEAR~~results. ~~MIND~~The ~~trial~~safety profile of laromestrocel was ~~presented~~ safe and well tolerated when administered as single or multiple doses, with no incidence of hypersensitivity or infusion-related reactions. In addition, there were no cases of amyloid-related imaging abnormalities (ARIA). With regard to efficacy, laromestrocel showed slowing/prevention of disease worsening relative to placebo. The unadjusted p-values for a ~~late~~several ~~breaking~~secondary ~~poster~~efficacy endpoint ~~presentation~~composite atAD score (“CADS”) for both the ~~Clinical~~low-dose ~~Trials~~laromestrocel ongroup and the pooled treatment groups compared to placebo suggested significance, indicating potential signals of efficacy. Other doses also indicated promising results in slowing/prevention of disease worsening. Additionally, an improvement versus placebo was observed in the Montreal Cognitive Assessment (“MoCA”) and in the activity of daily living observed by a caregiver and measured by Alzheimer’s ~~Disease~~disease ~~Conference~~Cooperative Study Activities of Daily Living (“~~CTAD24~~ADCS-ADL”) with unadjusted p-values suggestive of significance. The study indicated potential preservation of the brain volumes in ~~October~~some ~~2024~~but not all AD related areas of the brain 39 weeks after treatment commenced. Brain magnetic resonance imaging (“MRI”) results demonstrated a 48% reduction in ~~Madrid~~whole brain volume loss, ~~Spain~~62% reduction in hippocampal volume loss, and potential improvement in neuroinflammation in some but not all brain regions via diffusion tensor imaging (DTI).

Based on ~~the~~these ~~totality~~results, ofin ~~the~~July ~~evidence~~2024, the FDA granted ~~our~~Regenerative ~~request~~Medicine ~~for~~Advanced aTherapy ~~Type~~(“RMAT”) BDesignation meeting. On March 20, 2025, Longeveron announced a positive Type B Meeting with the FDA supporting the advancement of laromestrocel as a potential treatment for mild AD. As a result of the Type B meeting, we reached foundational alignment with the FDA on the overall study design for a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel dose selection and ~~frequency,~~Fast ~~trial~~Track ~~duration,~~designation ~~and trial endpoints. To accelerate the pathway~~ to ~~potential approval of~~ laromestrocel for the treatment of mild AD~~, the FDA agreed to consider a BLA based on positive interim trial results from the planned single study~~. ~~Our objective is to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD.~~

~~Pediatric~~We ~~Dilated~~believe ~~Cardiomyopathy~~laromestrocel ~~(DCM)~~is the only investigational product candidate to be granted RMAT designation for mild AD to date. In March 2025, Longeveron announced a productive Type B Meeting with the FDA supporting the advancement of laromestrocel as a potential treatment for mild AD. As a result of the Type B meeting, we reached foundational alignment with the FDA on the overall study design for a proposed single, potentially pivotal, seamless adaptive Phase 2/3 clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel dose selection and frequency, trial duration, and trial endpoints. To accelerate the pathway to potential approval of laromestrocel for the treatment of mild AD, the FDA agreed to consider a BLA based on positive interim trial results from the planned single study.

~~DCM~~We ~~occurs~~have ~~when~~filed ~~the~~patent ~~muscles~~applications inrelating ~~one of more of~~to the ~~heart~~treatment ~~chambers~~of ~~become~~AD ~~enlarged~~using orlaromestrocel ~~stretched~~in ~~(dilated).~~Australia, The ~~other~~Bahamas, ~~chambers~~Canada, ofChina, the ~~heart~~European ~~need~~Patent toOffice, ~~work~~Hong ~~harder~~Kong, toIsrael, ~~compensate~~Japan, New ~~for~~Zealand, ~~the~~South ~~affected chambers~~Korea, ~~and may also become dilated and enlarged. As the condition progresses~~Singapore, ~~the~~South ~~heart becomes weaker~~Africa, and itthe ~~becomes~~United ~~more~~States. ~~difficult to~~We ~~pump~~have ~~blood~~also ~~through~~filed ~~the~~another ~~body.~~family ~~This~~of ~~can~~patent ~~lead~~applications relating to ~~congestive~~improving ~~heart~~Brain ~~failure~~Architecture ~~causing~~in aAlzheimer’s ~~build-up~~disease ofusing ~~fluid~~laromestrocel in ~~the~~The ~~lungs~~Bahamas, ~~liver~~Taiwan, ~~abdomen,~~in ~~and lower~~addition ~~legs.~~to Inan ~~the~~application under ~~majority of cases,~~ the ~~exact~~Patent ~~cause~~Cooperation ofTreaty ~~DCM cannot be determined~~ (~~idiopathic cardiomyopathy~~PCT).

Pediatric cardiomyopathies affect at least 100,000 children worldwide. DCM is the most common form of cardiomyopathy in children. About 50 to 60 percent of all pediatric cardiomyopathy cases are diagnosed as dilated. According to the Pediatric Cardiomyopathy Registry, DCM is reportedly more common in boys than girls. Although all age groups are affected, studies show that DCM is more common in infants (before age 1) than in older children. Current treatment for DCM focuses on managing symptoms, improving heart function, and preventing complications rather than addressing the underlying cause or causes. Many therapeutic agents with known efficacy in adults lack the same evidence in children.

On July 8, 2025, the company announced that the FDA approved the Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric Dilated Cardiomyopathy (DCM). The accepted IND application provides for moving directly to a single Phase 2 pivotal registration clinical trial.

Aging-related Frailty

Improvement of the quality of life for the aging population is one of the strategic directions of the Company. Life expectancy has substantially increased over the past century due to medical and public health advancements. However, this longevity increase has not been paralleled by ~~health~~healthspan ~~span~~ – the period of time one can expect to live in relatively good health and independence. For many developed and developing countries, health span lags life expectancy by over a decade. This has placed tremendous strain on healthcare systems in the management of aging-related ailments and presents additional socioeconomic consequences due to patient decreased independence and quality-of-life. Since these strains continue to increase with demographic shifts towards an increasingly older population, improving health span has become a priority for health agencies, such as the National Institute on Aging (“NIA”) of the National Institutes of Health (“NIH”), the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”), and the European Medicines Agency (“EMA”). As we age, we experience a decline in our own stem cells, a decrease in immune system function (known as “immunosenescence”), diminished blood vessel functioning, chronic inflammation (known as “inflammaging”), and other aging-related alterations that affect biological functioning. In April 2024, we discontinued our clinical trial in Japan to evaluate laromestrocel for Aging-related Frailty. We plan to continue enrolling patients on the Frailty and Cognitive Impairment registry trials in The Bahamas and also plan to launch an Osteoarthritis registry trial.

~~Implication~~Pediatric ofDilated ~~Being~~Cardiomyopathy ~~an Emerging Growth Company and Smaller Reporting Company~~(DCM)

WeDCM ~~are~~is ana ~~“emerging~~rare ~~growth~~and ~~company”~~life-threatening cardiovascular ascondition ~~defined~~with inunmet ~~the~~medical ~~Jumpstart~~needs. ~~Our~~Pediatric ~~Business~~cardiomyopathies ~~Startups~~affect ~~Act~~at ofleast ~~2012~~100,000 aschildren ~~amended, or the JOBS Act~~worldwide. WeDCM ~~will~~is ~~remain~~the anmost ~~emerging~~common ~~growth company~~form ~~until the earlier~~ of ~~(1)~~cardiomyopathy ~~the~~in ~~last~~children. ~~day~~About of50 ~~the~~to ~~fiscal~~60 ~~year~~percent ~~following~~of ~~the~~all ~~fifth~~pediatric ~~anniversary~~cardiomyopathy ofcases ~~the~~are ~~completion~~diagnosed ofas ~~our~~dilated. ~~initial~~DCM ~~public~~is ~~offering~~characterized ~~(i.e.,~~by ~~December~~dilation ~~31,~~and ~~2026),~~impaired ~~(2)~~systolic ~~the~~function ~~last day~~ of the ~~fiscal~~left ~~year~~ventricle inor ~~which~~both ~~we have total annual gross revenues of at least $1.235 billion~~ventricles, ~~(3)~~ ~~the~~typically ~~date on which we are deemed to be a “large accelerated filer” as defined~~ in ~~Rule 12b-2 under~~ the ~~Securities~~absence ~~Exchange Act~~ of ~~1934~~ischemia, asabnormal ~~amended (the “Exchange Act”)~~loading conditions, ~~which~~or ~~would~~physiologic ~~occur~~insult ~~if the market value of our Class A common stock held by non-affiliates exceeded $700~~(e.0g., ~~million as of the last business day of our most recently completed second fiscal quarter or (4~~sepsis) ~~the date on which we have issued more than $1~~.0 ~~billion~~Diagnostic incriteria ~~non-convertible~~for ~~debt~~DCM ~~securities~~include ~~during the prior three-year period. An emerging growth company may take advantage of specified~~ reduced ~~reporting~~measures ~~requirements and is relieved~~ of ~~certain~~ventricular ~~other~~function ~~significant requirements that are otherwise generally~~combined ~~applicable~~with toincreased ~~public~~ventricular ~~companies.~~volumes Asadjusted anfor ~~emerging~~body ~~growth~~size ~~company,~~on wecardiac ~~may~~imaging (i)left ~~reduce~~ventricular ~~our~~end-diastolic ~~executive~~diameter ~~compensation disclosure;~~ (iiLVEDD) ~~present only two years of audited financial statements, plus unaudited condensed financial statements for any interim period,~~ and ~~correspondingly reduced~~left ~~Management’s~~ventricular ~~Discussion~~end-systolic ~~and~~diameter ~~Analysis of Financial Condition and Results of Operations disclosure;~~ (~~iii~~LVESD) ~~avail~~z-scores ~~ourselves~~> of2). ~~the~~Treatments ~~exemption from~~for ~~the~~DCM ~~requirement~~aim to ~~obtain~~ameliorate ansymptoms, ~~attestation~~reduce ~~and~~progression ~~report from our auditors on the assessment~~ of ~~our internal control over financial reporting~~disease, ~~pursuant~~and toprevent ~~the Sarbanes~~life-~~Oxley~~threatening ~~Act~~arrhythmias. ofTreatment ~~2002;~~for ~~and~~DCM ~~(iv)~~remains ~~not~~a ~~require~~complex ~~stockholder~~challenge, ~~non-binding~~marked ~~advisory~~by ~~votes~~several ~~on executive compensation or golden parachute arrangements~~limitations.

WeClinical ~~have~~data ~~availed~~to ~~ourselves~~date with laromestrocel (a MSC therapy) indicates an acceptable safety profile in ~~this~~various ~~prospectus~~disease ofindications administered via either IV or intramyocardial injection. Additionally, the ~~reduced~~safety ~~reporting~~profile ~~requirements~~from ~~described~~MSC ~~above.~~therapies Asin ageneral ~~result~~has been acceptable, supported by the ~~information~~literature review showing that weMSC therapy ~~provide~~has ~~stockholders~~been ~~may~~evaluated bein ~~less~~over ~~comprehensive than~~one ~~what~~thousand ~~you~~clinical ~~might~~trials ~~receive~~globally, ~~from~~with ~~other~~a ~~public~~favorable ~~companies~~safety profile across numerous disease indications. DCM ~~When~~is weassociated ~~are~~with nothe ~~longer~~loss ~~deemed~~of tocardiomyocytes beand anwith ~~emerging~~the ~~growth~~replacement ~~company,~~of welost ~~will~~cardiomyocytes ~~not~~by benoncontractile fibrous tissue. Results ~~entitled~~from topreclinical ~~the~~and ~~exemptions~~clinical ~~provided~~trials inhighlight the ~~JOBS~~potential ~~Act~~of ~~discussed~~MSC ~~above~~therapy to promote cardiomyogenesis, reduce inflammation and fibrosis, and support neovascularization. WeIn adults with both ischemic cardiomyopathy and nonischemic dilated cardiomyopathy (DCM), MSC therapies have ~~elected~~demonstrated toimproved LV ~~avail~~function, ~~ourselves~~functional status, and quality of ~~the~~life ~~exemption~~(QoL). ~~that~~Pediatric ~~allows~~patients ~~emerging~~with DCM may be ideal candidates ~~growth~~for ~~companies~~MSC totherapy ~~extend~~because ~~the~~their ~~transition~~hearts, ~~period~~including ~~for~~cardiomyocytes ~~complying~~and ~~with~~progenitor ~~new~~cells, orare ~~revised~~more ~~financial~~responsive ~~accounting~~to ~~standards~~the signals from transplanted stem cells. ~~This~~Cell ~~election~~therapies have shown positive outcomes in DCM and other conditions, but further research is ~~irrevocable~~needed to confirm long-term safety and efficacy.

WeOur ~~are~~IND ~~also~~application ~~currently~~for alaromestrocel ~~“smaller reporting company”~~ as ~~defined in the Exchange Act. We may continue to be~~ a ~~smaller reporting company even after we are no longer an emerging~~potential ~~growth~~treatment ~~company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures~~ for sopediatric ~~long~~DCM asbecame ~~our~~effective ~~public~~in ~~float~~July ~~is less than $250~~2025.0 ~~million~~This ~~measured~~IND onprovides ~~the~~for ~~last~~moving ~~business~~directly ~~day of~~to our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our public float is less than $700.0 million measured on the last business day of our second fiscal quarter. In the event that we are still considered a ~~“smaller~~single ~~reporting~~potentially ~~company,”~~pivotal ~~at such time as we cease being an “emerging growth company,” the disclosure~~Phase we2 ~~will~~registrational beclinical ~~required~~trial tocurrently ~~provide~~targeted infor ~~our SEC filings will increase but will still be less than it would be if we were not considered either an “emerging growth company” or a “smaller reporting company.” Specifically~~2027, ~~similar~~with toplanning “emerging growth companies,” “smaller reporting companies” are able to provide simplified executive compensation disclosures in their filings; are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting; and ~~have~~preparation ~~certain~~beginning ~~other decreased disclosure obligations~~ in ~~their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports~~2026. Decreased disclosures in our SEC filings due to our status as an “emerging growth company” or “smaller reporting company” may make it harder for investors to analyze our results of operations and financial prospects.

Summary of Clinical Development Strategy

Our core strategy is to become a world-leading regenerative medicine company through the development, approval, and commercialization of novel cell therapy products for unmet medical needs, with a near-term focus on HLHS. Key elements are as follows.

● Execution of ELPIS II, ~~a Phase 2b randomized controlled trial set forth in greater detail below,~~ to measure the efficacy of laromestrocel in HLHS. This trial is ongoing and is being conducted in collaboration with the National Heart, Lung, and Blood Institute (“NHLBI”) through grants from the NIH. As announced on June 24, 2025, the trial has reached full enrollment and we anticipate top-line trial results for ELPIS II in the third quarter of 2026. WeIf ~~currently~~the ~~anticipate~~current aELPIS ~~potential~~II ~~BLA~~trial ~~filing~~in ~~with~~HLHS ~~the~~is ~~FDA~~successful inand ~~late~~deemed ~~2026~~pivotal, ifwe ~~the~~would ~~current~~intend ~~ELPIS~~to IIpursue ~~trial~~a inpotential ~~HLHS~~BLA isfiling ~~successful~~with the FDA and a commercialization partner.

● Continue to pursue the therapeutic potential of laromestrocel in mild AD. We completed a Phase 2a trial, the (“CLEAR MIND Trial”), which demonstrated the potential benefits of laromestrocel over placebo to maintain cognitive function and slow deterioration of brain structure atrophy, with no safety issues observed. Specifically, the safety primary endpoint was met across all study groups and the trial demonstrated a statistical significance in the second CADS endpoint. Overall, in laromestrocel groups, brain MRI demonstrated whole brain volume loss slowed accompanied by significant preservation of multiple brain regions, including left hippocampal volume relative to placebo. We plan to continue to analyze the data in order to further develop our clinical development strategy. Our objective is to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD.4

● ~~Preparation~~Continue ~~and~~to ~~initiation~~pursue the therapeutic potential of alaromestrocel in mild AD. Our Phase 22a ~~pivotal~~trial, ~~registrational~~CLEAR ~~clinical~~MIND Trial, met its primary safety endpoint across all treatment groups, with no safety concerns identified. The trial ~~for~~demonstrated ~~DCM~~nominal instatistical significance on the ~~first~~secondary ~~half~~CADS ofcomposite ~~2026~~endpoint, ~~subject~~suggesting toa ~~obtaining~~potential ~~necessary~~benefit ~~financing~~of laromestrocel compared with placebo in maintaining cognitive function and slowing brain structural decline. AsSpecifically, ~~announced~~MRI onanalyses ~~July~~indicated 8that patients treated with laromestrocel experienced a slowing of whole-brain volume loss and preservation of key brain regions, ~~2025~~including left hippocampal volume, ~~the~~relative ~~FDA~~to ~~approved~~placebo. These findings are hypothesis-generating and support further investigation of laromestrocel in mild AD. We plan to continue in-depth analyses of the ~~Investigational~~data ~~New~~to ~~Drug~~refine ~~(IND)~~our ~~application~~clinical ~~for~~development ~~its~~strategy. ~~stem~~Our ~~cell~~overarching ~~therapy~~objective is to advance laromestrocel asthrough astrategic ~~potential~~collaborations ~~treatment~~and ~~for~~partnerships, ~~pediatric~~with ~~Dilated~~the ~~Cardiomyopathy~~goal ~~(DCM)~~of addressing the significant unmet medical need in AD.

● ~~Limited~~Preparation ~~focus~~and oninitiation ~~our~~of ~~international~~a ~~program.~~Phase In2 ~~line~~potentially ~~with~~pivotal ~~the~~registrational ~~Company’s~~clinical ~~strategic~~trial ~~direction~~ for ~~2025~~pediatric ~~and~~DCM ~~moving~~in ~~forward~~2027. toOur ~~focus~~IND onapplication ~~HLHS~~for ~~and~~laromestrocel AD as ~~set~~a ~~forth~~potential ~~previously,~~treatment infor ~~April~~pediatric ~~2024,~~DCM ~~the~~became ~~Company~~effective ~~discontinued its clinical trial~~ in ~~Japan~~July to2025. ~~evaluate~~If ~~laromestrocel~~this ~~for~~trial ~~Aging-related~~is ~~Frailty.~~successful, ~~The~~we ~~Company~~would ~~will~~then ~~continue~~seek to ~~enroll~~partner ~~patients on~~ the ~~Frailty~~program ~~and~~for ~~Cognitive~~further ~~Impairment~~development ~~registry trials in The Bahamas~~ and ~~plans~~potential ~~to also launch an Osteoarthritis registry trial~~commercialization.

● Expand our manufacturing capabilities ~~to commercial-scale production~~. We operate a ~~current good manufacturing practice (“~~cGMP”)-compliant manufacturing facility and produce our own investigational product candidates for early-phase ~~clinical~~ testing. WeAs ~~continue~~part toof ~~improve and expand~~ our ~~capabilities~~HLHS ~~with~~commercialization ~~the~~strategy, ~~goal~~we ofpresently ~~achieving~~plan ~~cost-effective~~to ~~manufacturing~~utilize ~~that~~a ~~may~~CDMO ~~potentially~~for ~~satisfy future~~ commercial-scale ~~demand~~production, ~~for~~while ~~potential~~continuing ~~laromestrocel~~to ~~commercialization.~~leverage Asour ~~part~~Miami ofGMP ~~these~~facility ~~efforts,~~for weearly-phase ~~have~~clinical ~~made~~supply, aprocess ~~strategic~~development, ~~decision~~and toother ~~pursue~~supporting ~~commercial~~ manufacturing ~~through~~activities afor ~~third~~our early-~~party~~phase ~~CDMO,~~clinical ~~rather~~trials. ~~than~~We ~~renovating~~intend ~~our~~to ~~existing~~continue ~~facility~~to ~~for~~improve ~~commercial-scale~~and ~~production.~~expand ~~Our~~our ~~existing~~capabilities ~~Miami~~with ~~facility~~the ~~will~~goal ~~continue~~of toachieving ~~support~~cost-effective ~~clinical~~manufacturing ~~development,~~that ~~research~~may ~~and~~potentially ~~early-phase~~satisfy ~~manufacturing~~supply for ~~our~~clinical ~~current~~trials product and ~~future~~certain ~~clinical~~CDMO ~~trials~~contractual obligations.

● Advance BLA-enabling CMC activities, including process and analytical method validation planning and commercial production planning including technology transfer and commercial production readiness activities in support of third-party manufacturing.

●

Collaborative arrangements and out-licensing opportunities. We will be opportunistic and consider entering into co-development, out-licensing, or other collaboration agreements for the purpose of eventually commercializing laromestrocel and other products domestically and internationally if appropriate approvals are obtained.

● ~~Product~~Investigational product candidate development pipeline through internal research and development, and in-licensing. Through our research and development program, and through strategic in-licensing agreements, or other business development arrangements, we intend to actively explore promising potential additions to our pipeline.

●

Continue to expand our intellectual property portfolio. Our intellectual property is vitally important to our business strategy, and we have taken and continue to take significant steps to develop this property and protect its value. Results from our ongoing research and development efforts are intended to add to our existing intellectual property portfolio.

~~Clinical~~Implication ~~Development~~of ~~Pipeline~~Being inan ~~2025~~Emerging Growth Company and Smaller Reporting Company

We are ~~currently~~an “emerging growth company” as defined in ~~clinical~~the ~~development~~Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.235 billion, (3) the date on which we are deemed to be a ~~single~~“large ~~product~~accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, ~~laromestrocel~~as amended (the “Exchange Act”), which would occur if the market value of our Class A common stock held by non-affiliates exceeded $700.0 million as of the last business day of our most recently completed second fiscal quarter or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company, we may (i) reduce our executive compensation disclosure; (ii) present only two years of audited financial statements, plus unaudited condensed financial statements for ~~four~~any ~~potential~~interim ~~indications:~~period, and correspondingly reduced Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure; (iii) avail ourselves of the exemption from the requirement to obtain an attestation and report from our auditors ‘on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; and (iv) not require stockholder non-binding advisory votes on executive compensation or golden parachute arrangements.

~~Figure~~We 1:have ~~Laromestrocel~~availed ourselves in this prospectus of ~~clinical~~the ~~development~~reduced ~~pipeline~~reporting requirements described above. As a result, the information that we provide stockholders may be less comprehensive than what you might receive from other public companies. When we are no longer deemed to be an emerging growth company, we will not be entitled to the exemptions provided in the JOBS Act discussed above. We have elected to avail ourselves of the exemption that allows emerging growth companies to extend the transition period for complying with new or revised financial accounting standards. This election is irrevocable.

*We ~~Pivotal~~are ~~Phase~~also 2bcurrently ~~ELPIS~~a II“smaller ~~study;~~reporting company” ~~enrollment~~as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our public float is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed ~~June~~fiscal 24year and our public float is less than $700.0 million measured on the last business day of our second fiscal quarter. In the event that we are still considered a “smaller reporting company,” ~~2025~~at such time as we cease being an “emerging growth company,” the disclosure we will be required to provide in our SEC filings will increase but will still be less than it would be if we were not considered either an “emerging growth company” or a “smaller reporting company.” Specifically, similar to “emerging growth companies,” “smaller reporting companies” are able to provide simplified executive compensation disclosures in their filings; are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting; and have certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. Decreased disclosures in our SEC filings due to our status as an “emerging growth company” or “smaller reporting company” may make it harder for investors to analyze our results of operations and financial prospects.

**Recent ~~Not currently active for 2025~~Developments

~~***~~Private ~~IND approved by FDA in late June 2025; The accepted IND application provides for moving directly to a single Phase 2 pivotal registrational clinical trial~~Placement Transaction

~~Hypoplastic~~On ~~Left~~March ~~Heart~~10, ~~Syndrome~~2026, ~~(HLHS).~~we ~~The~~entered ~~FDA~~into ~~granted~~a ~~laromestrocel~~Purchase ~~for~~Agreement ~~the~~with ~~treatment~~certain ofinstitutional ~~HLHS~~and aaccredited ~~Rare~~investors ~~Pediatric~~(each, ~~Disease~~an (“~~RPD~~Investor”) ~~Designation~~and ~~(on November 8~~collectively, the ~~2021~~“Investors”), ~~Orphan~~ ~~Drug~~pursuant ~~Designation~~to ~~(“ODD”)~~which ~~(on~~we ~~December~~agreed 2,to ~~2021),~~issue and ~~Fast~~sell ~~Track~~shares ~~Designation~~of ~~(on~~the ~~August~~Company’s ~~24,~~Class ~~2022).~~A ~~HLHS~~common isstock aand ~~rare congenital~~Series ~~heart~~A ~~condition~~preferred ~~affecting~~stock ~~approximately~~(the 1“Series A preferred stock,~~000~~” ~~newborns~~and intogether with the USClass ~~annually.~~A ~~HLHS~~Common isStock, athe ~~birth~~“Securities”) to ~~defect~~the ~~that~~Investors ~~affects~~in ~~normal~~up ~~blood~~to ~~flow~~two ~~through~~ closings in a private placement (the ~~heart~~“Private Placement”). AsAt ~~the~~initial ~~baby~~closing ~~develops~~on ~~during~~March ~~pregnancy~~11, ~~the~~2026 we ~~left~~issued ~~side~~and sold an aggregate of ~~the~~6,013,384 ~~heart~~shares ~~does~~of ~~not~~Class ~~form~~A ~~correctly~~common sostock ~~that~~at ~~babies~~a ~~are~~purchase ~~born~~price ~~with~~of an$0.52 ~~underdeveloped or~~per ~~absent~~share ~~left~~and ~~ventricle~~11,873.04 Itshares of isSeries ~~one~~A ~~type~~preferred stock, convertible into an aggregate of ~~congenital~~22,832,770 ~~heart~~shares ~~defect~~of ~~present~~Class atA ~~birth.~~common ~~Because~~stock, at a ~~baby~~purchase ~~with~~price ~~this~~of ~~defect~~$1,000.00 per ~~needs~~Preferred ~~surgery~~Share. ~~or other~~Each ~~procedures~~share ~~soon~~of ~~after~~Series ~~birth,~~A ~~HLHS~~preferred stock is ~~considered~~convertible ainto ~~critical~~Class ~~congenital~~A ~~heart~~common ~~defect.~~stock Toat ~~prevent~~a ~~certain~~conversion ~~death~~price ~~shortly~~equal ~~after~~to ~~birth,~~$0.52 ~~these~~per ~~babies~~share. ~~undergo~~The apowers, ~~series~~preferences, ofrights, ~~three~~qualifications, ~~heart~~limitations ~~surgeries~~and ~~(staged~~restrictions ~~surgical~~applicable ~~palliation)~~to ~~that reconfigures~~ the ~~single~~Series ~~right~~A ~~ventricle~~preferred tostock ~~support~~are ~~systemic~~set ~~circulation.~~forth ~~Despite~~in ~~these~~the ~~life-saving~~Company’s ~~surgeries,~~Certificate ~~HLHS~~of ~~patients~~Designation ~~nevertheless~~of ~~still~~Preferences, ~~have~~Rights ~~high~~and ~~early~~Limitations ~~mortality~~of ~~and~~Series ~~morbidity~~A ~~rates~~Non-Voting Convertible ~~due~~Preferred ~~primarily~~Stock to(“Certificate ~~heart~~of ~~failure~~Designation”) filed on the initial closing date.

~~We are currently conducting an ongoing Phase 2b clinical trial (ELPIS II) under FDA IND 017677. ELPIS II is a multi-center~~Additionally, ~~randomized,~~the ~~double-blind, controlled clinical trial designed~~Company agreed to ~~evaluate~~sell ~~laromestrocel as an adjunct therapy~~ to the ~~standard-of-care~~Investors ~~second-stage~~an ~~HLHS~~interest ~~heart reconstructive surgery which is typically performed at 4-6 months after birth. The primary objective is to evaluate change~~ in ~~right~~50% ~~ventricular ejection fraction after laromestrocel treatment versus standard-~~of~~-care~~ ~~surgery~~proceeds ~~alone~~received (38after ~~subjects~~deducting ~~total:~~necessary, 19documented ~~per~~third-party ~~arm).~~fees ~~This~~or ~~trial has reached full enrollment and is funded~~charges) infrom ~~part by~~ the ~~NHLBI/NIH.~~potential Wefuture ~~anticipate~~sale ~~top-line trial results in the third quarter~~ of ~~2026. ELPIS II is~~ a ~~next-step~~Rare ~~trial~~Pediatric toDisease ~~our~~Priority ~~completed 10-patient~~Review ~~open-label~~Voucher ~~Phase 1 trial (ELPIS I) under the same IND. This Phase 1 trial was designed~~ to ~~evaluate~~ the ~~safety~~extent ~~and~~received ~~tolerability of~~from ~~laromestrocel as an adjunct to~~ the ~~second-stage HLHS surgery, and to obtain preliminary evidence of laromestrocel effect to support a next-phase trial~~U.S. ~~The~~FDA ~~primary~~in ~~safety endpoint was met: no major adverse cardiac events (“MACE”) or treatment-related infections~~connection ~~during~~with the ~~first~~Company’s ~~month post-treatment, and no triggering of stopping rules. Furthermore, fluid-based and imaging biomarker data supported multiple potentially relevant mechanisms-of-action of~~ laromestrocel, ~~and~~program ~~the~~for ~~potential to improve post-surgical heart function~~HLHS.

All ELPIS I patients had completed long-term follow-up, and 100% 5-years post-Glenn survival data were presented by Principal Investigator Dr. Sunjay Kaushal, Cardiovascular and Thoracic Surgery, University of Nevada, Las Vegas at American Heart Association (“AHA”) in November 2023 and Congenital Heart Surgeons’ Society’s 51st Annual Meeting in October 2024.

We have filed patent applications relating to the administration of laromestrocel for treating HLHS in Australia, the Bahamas, Canada, China, the European Patent Office, Japan, Hong Kong, South Korea, Taiwan, and the United States.

~~Alzheimer’s~~Pursuant ~~disease.~~to ADthe Purchase Agreement, subject to the occurrence of a ~~devastating neurologic~~Second ~~disease~~Closing ~~leading~~Trigger toDate ~~cognitive~~(as ~~decline~~defined below), ~~currently~~we ~~has~~agreed ~~very~~to ~~limited~~issue ~~therapeutic~~and ~~options.~~sell Anto ~~estimated~~the ~~6.7~~Investors additional ~~million~~shares ~~Americans~~of ~~aged 65~~Class A common stock and ~~older~~Series ~~have~~A ADpreferred stock, ~~and~~respectively, ~~this~~for ~~number~~additional isgross ~~projected~~proceeds toof ~~more~~approximately ~~than~~$15.0 million, ~~double~~before bydeducting ~~2060~~placement agent fees and other expenses. ~~Laromestrocel~~The ~~treated~~Second ~~patients~~Closing ~~showed~~Trigger anDate ~~overall~~shall ~~slowing/prevention~~occur upon satisfaction or waiver of ~~disease~~the ~~worsening~~closing ~~compared~~conditions toset ~~placebo~~forth inunder the ~~completed~~Purchase Agreement, including (i) the Company’s achievement, during the period from March 11, 2026 and ending on the announcement of Phase 2a2b study ~~(CLEAR~~results ~~MIND~~for HLHS demonstrating statistical significance of the primary endpoint(s) as ~~previously~~agreed ~~detailed~~between inthe ~~this~~Company ~~report~~and the U.S. FDA (the “Milestone”) and ~~met~~(ii) ~~its~~achievement of a volume weighted average ~~primary~~price ~~endpoint~~per share of ~~safety.~~Class ~~These~~A ~~results~~common ~~are~~stock ~~consistent~~equal to or greater than $1.85 with ~~those~~aggregate trading volume of ~~our~~at ~~earlier~~least ~~Phase~~25,000,000 Ishares ~~study.2~~(in ~~Based~~each oncase, ~~these~~subject ~~results~~to appropriate, inproportional ~~July~~adjustment ~~2024,~~for any stock splits or combinations occurring after the ~~FDA~~date ~~granted~~of ~~RMAT~~the ~~designation~~Purchase Agreement) ~~and~~(the ~~Fast~~“Price ~~Track~~Threshold”) ~~designation~~measured during any ten consecutive trading days prior to ~~laromestrocel~~expiration ~~for~~of the ~~treatment~~30 trading ofdays ~~mild~~following ~~AD.~~the Wedate ~~believe~~of ~~laromestrocel~~our isfirst ~~the~~announcement ~~only~~via ~~product~~press ~~candidate~~release toor bea ~~granted~~Current ~~RMAT~~Report ~~designation~~on ~~for~~Form ~~mild~~8-K ADof tothe ~~date~~occurrence of the Milestone. Investors Weholding ~~intend~~at toleast ~~forge strategic~~a ~~collaborations,~~majority ~~and/or~~in ~~partnerships~~interest ~~for~~of the ~~advancement~~Securities may choose to waive achievement of ~~laromestrocel~~the inMilestone ~~addressing~~and ADPrice Threshold and proceed with the second closing.

WeThe ~~have~~aggregate ~~filed~~gross ~~patent~~proceeds from ~~applications~~the ~~relating~~Initial ~~to the~~Closing ~~treatment~~were ofapproximately AD$15.9 ~~using~~million, ~~laromestrocel~~before indeducting ~~Australia,~~placement ~~the~~agent ~~Bahamas~~fees and other expenses. H.C. Wainwright & Co., ~~Canada~~LLC, ~~China~~or Wainwright, acted as the ~~European~~exclusive ~~Patent~~placement ~~Office,~~agent ~~Hong~~for ~~Kong,~~the ~~Israel,~~Private ~~Japan~~Placement, for which it received a cash fee equal to 7.0% ~~New~~of ~~Zealand,~~the ~~South~~aggregate ~~Korea,~~gross ~~Singapore,~~proceeds ~~South~~raised ~~Africa~~in the Private Placement, ~~and~~plus a management fee equal to 1.0% of the ~~United~~aggregate ~~States~~gross proceeds raised in the Private Placement and reimbursement for certain expenses. We ~~have~~ also ~~filed~~issued ~~another~~to ~~family~~designees of ~~patent~~the ~~applications~~Placement ~~relating~~Agent (or their assignees) unregistered warrants to ~~improving~~purchase ~~Brain~~up ~~Architecture~~to in2,019,231 ~~Alzheimer’s~~shares ~~disease~~of ~~using~~Class ~~laromestrocel~~A incommon ~~the~~stock ~~Bahamas,~~which ~~Taiwan~~have an exercise price of $0.65 per share, inare immediately ~~addition~~exercisable toand have a ~~PCT~~term ~~application~~of five years.

~~Aging-related~~Nasdaq ~~Frailty. Aging~~Non-related Frailty is a life-threatening geriatric condition that disproportionately increases risks for poor clinical outcomes from disease and injury. While the definition of Aging-related Frailty lacks consensus, would be a new indication from a regulatory standpoint, and has no approved pharmaceutical or biologic treatments, there are a number of companies now working to develop potential therapeutics for this unmet medical need.Compliance

WeMinimum ~~have~~Bid ~~previously~~Price completed two U.S. clinical trials under FDA IND 016644. One is a multi-center, randomized, placebo-controlled Phase 2b trial which showed that a single infusion of laromestrocel significantly improved 6-Minute Walk Test (“6MWT”) distance 9 months after infusion (although results were inconclusive at six months after infusion), and also showed a dose-dependent increase in 6MWT distance 6 months after infusion. The second is a multi- center, randomized, placebo-controlled Phase 1/2 trial (“HERA Trial”) intended primarily to evaluate safety, and explore the effect laromestrocel may have on specific biomarkers of immune system function in older, frail individuals receiving the high dose influenza vaccine, as well as to evaluate the potential effects of laromestrocel on signs and symptoms of Aging Frailty. Results from this study showed that laromestrocel was generally safe and well tolerated in patients with Aging-related Frailty. Additionally, hemagglutinin inhibition (“HAI”) assay results in the laromestrocel and placebo groups to influenza were not statistically different, indicating laromestrocel does not suppress the immune system.Requirement

WeOn ~~have~~September ~~filed~~22, ~~patent~~2025, ~~applications~~we ~~relating~~received a notice from the Listing Qualifications Department of Nasdaq that our Class A common stock did not meet the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”) as a result of the ~~administration~~closing bid price of ~~laromestrocel~~the Company’s Class A common stock for ~~Aging-related~~the ~~Frailty~~last 30 consecutive business days. The notice does not result in ~~Australia,~~the ~~Canada,~~immediate ~~China~~delisting of the Company’s Class A common stock and, pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the ~~European~~Company ~~Patent~~had ~~Office~~an initial period of 180 calendar days, ~~Hong~~or ~~Kong~~until March 23, ~~Israel~~2026, to regain compliance with the Minimum Bid Price Requirement. ~~Japan~~On March 24, ~~Singapore~~2026, ~~South~~following ~~Korea~~submission of a request by the Company, ~~New~~the ~~Zealand~~Company received written notice from Nasdaq granting a second compliance period of an additional 180 calendar days, ~~South~~or ~~Africa~~until September 21, ~~Taiwan~~2026 (the “Compliance Date”), to regain compliance with the ~~Bahamas~~Minimum Bid Price Requirement, as permitted pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(ii), due to the Company’s satisfaction of the continued listing requirements for the market value of publicly held shares and all other initial listing standards for the ~~United~~Nasdaq Capital ~~States~~Market, with the exception of the Minimum Bid Price Requirement, as well as its intention to cure the deficiency during the additional compliance period.

~~Pediatric~~If, ~~Dilated~~at ~~Cardiomyopathy.~~any ~~DCM~~time isbefore the Compliance Date, the abid ~~rare~~price ~~and~~closes ~~life-threatening~~at ~~cardiovascular~~$1.00 ~~condition~~or ~~with~~more ~~unmet~~per ~~medical~~share ~~needs.~~for ~~DCM~~a isminimum ~~characterized~~of byten ~~dilation~~consecutive ~~and~~business ~~impaired~~days ~~systolic function~~(subject ofto Nasdaq’s discretion to increase the ~~left~~minimum ~~ventricle~~period orto ~~both~~up ~~ventricles,~~to ~~typically~~20 inconsecutive ~~the~~business ~~absence~~days ofpursuant ~~ischemia,~~to ~~abnormal~~Nasdaq ~~loading~~Listing ~~conditions~~Rule 5810(c)(3)(H)), orNasdaq ~~physiologic~~would ~~insult~~provide written ~~(e.g.,~~notification ~~sepsis).~~to ~~Diagnostic~~the ~~criteria~~Company ~~for~~that ~~DCM~~it ~~includes~~again ~~reduced~~complies ~~measures~~with ofthe ~~ventricular~~Minimum ~~function~~Bid ~~combined~~Price ~~with~~Requirement ~~increased~~and ~~ventricular~~the ~~volumes~~Class A common stock will continue to ~~adjusted~~be eligible for ~~body~~listing ~~size~~ on ~~cardiac~~The ~~imaging~~Nasdaq ~~(left~~Capital ~~ventricular~~Market ~~end-diastolic~~unless ~~diameter~~other ~~(LVEDD)~~eligibility ~~and~~deficiencies ~~left~~exist. ~~ventricular~~However, ~~end-systolic~~pursuant ~~diameter~~to Nasdaq Listing Rule 5810(~~LVESD~~c)(3)(A)(iii), ~~z-scores~~if >the ~~2).~~Company’s ~~Treatments~~Class ~~for~~A ~~DCM~~common ~~aim~~stock tohas ~~ameliorate~~a ~~symptoms,~~closing ~~reduce~~bid ~~progression~~price of ~~disease,~~$0.10 ~~and~~or ~~prevent~~less ~~life-threatening~~for ~~arrhythmias.~~ten consecutive trading ~~Treatment~~days ~~for~~before ~~DCM~~the ~~remains~~Compliance Date, Nasdaq can issue a ~~complex~~Staff ~~challenge~~Determination Letter, ~~marked~~which, byunless ~~several~~appealed, ~~limitations~~would subject our Class A common stock to immediate suspension and delisting.

2If ~~Mark~~the ~~Brody,~~Company ~~Marc~~does ~~Agronin~~not regain compliance with the Minimum Bid Price Requirement by the Compliance Date, ~~Brad~~Nasdaq Jwill begin delisting procedures. ~~Herskowitz~~In the event of a delisting from the Nasdaq Capital Market, ~~Susan~~our Y.Class ~~Bookheimer~~A common stock would likely be traded in the over-the-counter inter-dealer quotation system, ~~Gary~~more Wcommonly known as the OTC. ~~Small,~~OTC ~~Benjamin~~transactions ~~Hitchinson,~~involve ~~Kevin~~risks ~~Ramdas,~~in ~~Tyler~~addition ~~Wishard,~~to ~~Katalina~~those ~~Fernández~~associated ~~McInerney,~~with ~~Bruno~~transactions ~~Vellas,~~in ~~Felipe~~securities ~~Sierra~~traded on the securities exchanges, ~~Zhijie~~such ~~Jiang~~as the Nasdaq Capital Market, ~~Lisa~~or ~~McClain~~Exchange-~~Moss,~~listed ~~Carmen~~stocks. ~~Perez,~~Many ~~Ana~~OTC ~~Fuquay,~~stocks ~~Savannah~~trade ~~Rodriguez,~~less ~~Joshua~~frequently Mand in smaller volumes than Exchange-listed stocks. ~~Hare~~Accordingly, ~~Anthony~~our Class A. ~~Oliva~~common ~~Jr.,~~stock ~~Bernard~~would ~~Baumel.~~be ~~“Results~~less ~~and~~liquid ~~insights~~than ~~from~~it awould ~~phase~~be Iotherwise. ~~clinical~~Also, ~~trial~~the prices of OTC ~~Lomecel~~stocks are often more volatile than Exchange-B™listed ~~for~~stocks. ~~Alzheimer’s~~Additionally, ~~disease”~~many ~~(2023)~~institutional ~~Alzheimer’s~~investors &are ~~Dementia:~~prohibited ~~The~~from ~~Journal~~investing in ofOTC ~~the~~stocks, ~~Alzheimer’s~~and ~~Association~~it ~~19:261-273~~might be more challenging to raise capital when needed.

~~Clinical~~The ~~data~~Company intends to ~~date~~monitor ~~with~~the ~~laromestrocel~~closing ~~(a MSC~~bid ~~therapy)~~price ~~indicates~~of anthe ~~acceptable~~Class ~~safety~~A ~~profile~~common instock ~~various~~and ~~disease~~assess ~~indications~~its ~~administered~~available ~~via~~options, ~~either~~including IVundertaking ora ~~intramyocardial~~reverse ~~injection. Additionally~~stock split, to regain compliance with the ~~safety~~Minimum ~~profile~~Bid ~~from~~Price ~~MSC~~Requirement, ~~therapies~~if innecessary, ~~general~~and ~~has~~continue ~~been~~listing ~~acceptable,~~on ~~supported~~The byNasdaq ~~the~~Capital ~~literature~~Market. ~~review~~There ~~showing~~can ~~that~~be ~~MSC~~no assurance that ~~therapy~~the ~~has~~Company ~~been~~will ~~evaluated~~be inable ~~over~~to ~~one~~regain ~~thousand~~compliance ~~clinical~~with ~~trials~~the ~~globally,~~Minimum ~~with~~Bid aPrice ~~favorable~~Requirement ~~safety~~or ~~profile~~will ~~across~~otherwise ~~numerous~~be ~~disease~~in ~~indications.~~compliance with other applicable ~~DCM~~Nasdaq islisting ~~associated~~rules. ~~with~~If among such options the ~~loss~~Company ofelects ~~cardiomyocytes~~to ~~and~~pursue ~~with~~a ~~the~~reverse ~~replacement~~stock ofsplit ~~lost~~to ~~cardiomyocytes~~regain bycompliance ~~noncontractile~~with ~~fibrous~~the ~~tissue.~~Minimum ~~Results~~Bid ~~from~~Price ~~preclinical~~requirement, ~~and~~there ~~clinical~~can ~~trials~~be ~~highlight~~no ~~the~~assurance ~~potential~~that ofit ~~MSC~~would ~~therapy~~accomplish tothis ~~promote~~objective ~~cardiomyogenesis,~~for ~~reduce~~any ~~inflammation~~meaningful ~~and~~period ~~fibrosis~~of time, or at all, or ~~and~~that ~~support~~it ~~neovascularization.~~would Inresult ~~adults~~in ~~with~~any ~~both~~permanent ~~ischemic~~or ~~cardiomyopathy~~sustained ~~and~~increase ~~nonischemic~~in ~~dilated~~the ~~cardiomyopathy~~market ~~(DCM),~~price ~~MSC~~of ~~therapies~~our Class A common stock; and if such an event would ~~have~~be ~~demonstrated~~viewed ~~improved~~unfavorably LVby ~~function~~the market, ~~functional~~it ~~status,~~could ~~and~~have ~~quality~~the effect of ~~life~~reducing ~~(QoL)~~our market capitalization. ~~Pediatric~~Furthermore, ~~patients~~pursuant ~~with~~to ~~DCM~~a ~~may~~recent modification beto ~~ideal~~Nasdaq’s ~~candidates for~~listing ~~MSC~~standards, ~~therapy~~if ~~because~~a ~~their~~company ~~hearts,~~effects ~~including~~a ~~cardiomyocytes~~reverse stock split and ~~progenitor~~within ~~cells,~~one ~~are~~year ~~more~~thereafter ~~responsive~~becomes tonon-compliant with the ~~signals~~Minimum ~~from~~Bid ~~transplanted stem~~Price ~~cells.~~Requirement, ~~Cell~~it ~~therapies~~would ~~have~~immediately ~~shown~~receive ~~positive~~a ~~outcomes~~notification inletter ~~DCM~~from ~~and~~the ~~other~~Nasdaq ~~conditions,~~Listing ~~but~~Qualifications ~~further~~Department commencing ~~research~~delisting isproceedings, ~~needed~~with tono ~~confirm~~opportunity ~~long-term safety~~for ~~and~~a ~~efficacy~~compliance period.

~~Given~~Audit ~~the~~Committee unmet medical need in DCM, accrued acceptable safety profile of laromestrocel in prior human experience, and literature review evidence suggesting a potential benefit in DCM, the Sponsor considers it is appropriate to assess the safety and efficacy of laromestrocel in clinical trial setting in pediatric participants with DCM aged from 6 months and beyond.Composition

WeOn ~~are~~March ~~planning~~4, to2026, ~~initiate~~the Company notified Nasdaq that, as a ~~Phase~~result 2of ~~pivotal~~the March 3, 2026 resignation of Mr. Richard Kender as a member of the Board of Directors (the “Board”) ~~registrational~~of ~~clinical~~the ~~trial~~Company ~~for~~and ~~DCM~~as chairman of the Audit Committee, the Company temporarily was no longer in compliance with Nasdaq Listing Rule 5605(c)(2)(A), which requires that the ~~first~~audit ~~half~~committee of ~~2026~~a listed company be composed of at least three independent directors and that at least one member “has past employment experience in finance or accounting, ~~subject~~requisite toprofessional ~~obtaining~~certification ~~necessary~~in ~~financing~~accounting, or any other comparable experience or background which results in the individual’s financial sophistication, including being or having been a chief executive officer, chief financial officer or other senior officer with financial oversight responsibilities” (the “financial sophistication requirements”).

On March 4, 2026, the Company appointed Dr. Roger Hajjar, an existing Board member, as a member of the Audit Committee to satisfy Nasdaq Listing Rule 5605(c)(2)(A)’s requirement that the audit committee of a listed company be composed of at least three (3) independent directors. However, because no member of the Company’s Audit Committee qualifies as an audit committee financial expert, the Company plans to appoint, or submit to the stockholders for election, at least one (1) director that will be deemed “independent”, an “audit committee financial expert,” as defined in Item 407(d)(5)(ii) of Regulation S-K promulgated under the Securities Act of 1933, as amended, and meet the financial sophistication requirements under Nasdaq Listing Rule 5605(c)(2)(A), at the earlier of the next annual shareholders meeting or within the 180-day cure period available under Nasdaq Listing Rule 5605(c)(4).

Risks of Investing

Investing in our securities involves substantial risks. Potential investors are urged to read and consider the risk factors relating to an investment in the offered securities set forth under “Risk Factors” in this prospectus as well as other information we incorporate or include in this prospectus.

Going Concern Opinion

Our working capital deficiency, stockholders’ deficit, and recurring losses from operations raise substantial doubt about our ability to continue as a going concern. As a result, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements for the year ended December 31, ~~2024~~2025 with respect to this uncertainty. Our ability to continue as a going concern will require us to obtain additional funding.

Corporate Information

We were initially formed as a Delaware limited liability company in October 2014, and as part of our initial public offering in February 2021, converted into a Delaware corporation pursuant to a statutory conversion, and changed our name to Longeveron Inc. Additional information about us is included in documents incorporated by reference in this prospectus. See “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.” Our principal executive offices are located at 1951 NW 7th Avenue, Suite 520, Miami, Florida 33136, and our telephone number is (305) 909-0840. Our website address is www.longeveron.com and we make our filings with the ~~Securities and Exchange Commission (~~SEC) available on the Investor Relations page ~~Page~~ of our website. The reference to our website is an inactive textual reference only, and the information contained therein, or connected thereto is not incorporated into and does not constitute a part of this prospectus or the registration statement of which it forms a part. Our Class A common stock is traded on the ~~NASDAQ~~Nasdaq Capital Market under the symbol “LGVN.”

THE OFFERING

Common stock offered by us		Up to 3,846,154 shares of our Class A common stock, Series A common warrants to purchase up to 3,846,154 shares of Class A common stock, and Series B common warrants to purchase up to 3,846,154 shares of Class A common stock, or pre-funded warrants to purchase up to 3,846,154 shares of Class A common stock, Series A common warrants to purchase up to 3,846,154 shares of Class A common stock, and Series B common warrants to purchase up to 3,846,154 shares of Class A common stock. The shares of Class A common stock (or pre-funded warrants to purchase shares of Class A common stock, as applicable), Series A common warrants and Series B common warrants are immediately separable and will be issued separately in this offering but must initially be purchased together in this offering. Each Class A common warrant has an exercise price of $ per share of Class A common stock, will be exercisable beginning on the effective date of the Warrant Stockholder Approval, provided however, if the Pricing Conditions are met, the Class A common warrants will be exercisable upon issuance. The Series A common warrants will expire on the ( ) year anniversary of the original issuance date or the effective date of the Warrant Stockholder Approval, as applicable. The Series B common warrants will expire ( ) months from the original issuance date or the effective date of the Warrant Stockholder Approval, as applicable. We are also registering up to 11,807,693 shares of Class A common stock issuable upon exercise of the Class A common warrants, pre-funded warrants and the Placement Agent Warrants pursuant to this prospectus.
Issuer:		Longeveron Inc.
Pre-funded warrants offered by us		We are also offering to those purchasers, if any, whose purchase of the Class A common stock in this offering would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or at the election of the purchaser, 9.99%) of our outstanding Class A common stock immediately following consummation of this offering, the opportunity to purchase, if they so choose, pre-funded warrants in lieu of the Class A common stock that would otherwise result in ownership in excess of 4.99% (or 9.99%, as applicable) of our outstanding Class A common stock.
Securities offered by Selling Stockholders:		We are registering the resale by the Selling Stockholders named in this prospectus, or their pledgees, assignees, distributees and successors-in-interest of an aggregate of 30,865,385 shares of Class A common stock, of which (i) 6,013,384 shares were issued to certain of the Selling Stockholders upon the closing of the Private Placement, (ii) 22,832,770 shares are issuable to certain of the Selling Stockholders upon conversion of up to 11,873.04 shares of Series A preferred stock issued upon the closing of the Private Placement, and (iii) up to 2,019,231 shares are issuable to designees (or their assignees) of the placement agent upon the exercise of the PA Warrants.
		The purchase price of each pre-funded warrant, accompanying Series A common warrant and Series B common warrant will equal the price per share of Class A common stock and accompanying Series A common warrant and Series B common warrant being sold to the public in this offering, minus $0.001, and the exercise price of each pre-funded warrant will be $0.001 per share.
Shares of Class A common stock outstanding prior to the Private Placement and this offering:		21,783,749 shares
		Each pre-funded warrant will be immediately exercisable and may be exercised at any time until exercised in full. There is no expiration date for the pre-funded warrants. To better understand the terms of the pre-funded warrants, you should carefully read the “Description of Securities We Are Offering” section of this prospectus. You should also read the form of pre-funded warrant, which is filed as an exhibit to the registration statement that includes this prospectus.
Shares of Class A common stock outstanding (assuming conversion of Series A preferred stock and exercise of PA Warrants)(1):		52,649,134 shares.
Shares of Class B common stock Outstanding		1,484,005 shares.
Terms of the offering:		The Selling Stockholders will determine when and how they will sell the Class A common stock offered in this prospectus, as described in the section of this prospectus titled “Plan of Distribution.”
Use of proceeds:		The Selling Stockholders will receive the proceeds from the sale of the shares of Class A common stock offered hereby. We will not receive any proceeds from the sale of the shares of Class A common stock. However, we may receive proceeds in the aggregate amount of up to approximately $1,312,500 if all of the PA Warrants are exercised for cash. See the “Use of Proceeds” section of this prospectus.
Voting rights:		Shares of Class A common stock are entitled to one (1) vote per share. Shares of Class B common stock are entitled to five (5) votes per share. Shares of Series A preferred stock have no voting rights. Holders of our Class A common stock and Class B common stock generally vote together as a single class, unless otherwise required by law or our certificate of incorporation (the “Certificate of Incorporation”). Each share of our Class B common stock is convertible into one share of our Class A common stock at any time and converts automatically upon certain transfers. The Class A common stock is not convertible into Class B common stock.
Dividend policy:		We have never declared or paid any dividends to the holders of our Class A common stock, and we do not expect to pay cash dividends in the foreseeable future. We currently intend to retain any earnings for use in connection with the operation of our business and for general corporate purposes.
Risk factors:		Since our inception, we have incurred substantial losses. We will need additional funding (including the funding which may be received pursuant to a cash exercise of all the PA Warrants described in this prospectus) to remain a going concern, maintain operations, and to continue our current and planned clinical trial activity. Our business and our ability to execute our business strategy are subject to a number of risks of which you should be aware before you decide to buy our securities. Investing in our securities involves a high degree of risk. In particular, you should carefully consider all of the risks which are discussed more fully in “Risk Factors” section of this prospectus and those incorporated by reference from our filings with the SEC.
Nasdaq Capital Market symbol:		LGVN

(1)	The number of shares of Class A common stock to be outstanding after this offering is based on 21,783,749 shares of Class A common stock, 1,484,005 shares of Class B common stock and 11,873.04 shares of Series A preferred stock outstanding as of April 2, 2026, and excludes:

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shares of Class A Common Stock issuable upon conversion of existing Class B Common Stock;

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22,326,547 shares of Class A Common Stock issuable upon exercise of outstanding warrants;

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1,000,265 shares issuable upon the vesting of RSUs under the Company’s 2021 Incentive Award Plan;

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837,887 stock options outstanding with an average exercise price of $2.61 as of April 2, 2026, issuable under the Company’s 2021 Incentive Award Plan; and

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stock options issued in July 2024 to a third-party service provider exercisable for up to 50,000 shares of Class A Common Stock, which such stock option has an exercise price of $2.15 per share, and vests quarterly over a three-year period.

Class A common warrants to be offered by us Each share of our Class A common stock and each pre-funded warrant to purchase one share of our Class A common stock is being sold together with a Series A common warrant to purchase one share of our Class A common stock and a Series B common warrant to purchase one share of our Class A common stock. The Series A common warrants and Series B common warrants are collectively referred to herein as the Class A common warrants. Each Class A common warrant will have an exercise price of $ per share (representing 100% of the price at which a share of Class A common stock and accompanying Class A common warrants are sold to the public in this offering), will be exercisable beginning on the effective date of the Warrant Stockholder Approval, provided however, if the Pricing Conditions are met, the Class A common warrants will be immediately exercisable. The Series A common warrants will expire on the ( ) year anniversary of the original issuance date or the effective date of the Warrant Stockholder Approval, as applicable. The Series B common warrants will expire ( ) months from the original issuance date or the effective date of the Warrant Stockholder Approval, as applicable. The shares of Class A common stock and pre-funded warrants, and the accompanying Class A common warrants, as the case may be, can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. This prospectus also relates to the offering of the shares of Class A common stock issuable upon exercise of the Class A common warrants. Because we will issue a Series A common warrant and a Series B common warrant for each share of our Class A common stock and for each pre-funded Warrant sold in this offering, the number of Class A common warrants sold in this offering will not change as a result of a change in the mix of the shares of our Class A common stock and pre-funded Warrants sold.

Common stock to be outstanding after this offering(1)		17,540,724 shares of Class A common stock, assuming no sale of any pre-funded warrants and no exercise of the Class A common warrants being offered in this offering and 1,484,005 shares of Class B common stock. To the extent pre-funded warrants are sold, the number of shares of Class A common stock sold in this offering will be reduced on a one-for-one basis.
Use of Proceeds		We estimate that the net proceeds of this offering based upon an assumed combined public offering price of $1.56 per share and accompanying Class A common warrants, which was the closing price of our Class A common stock on the Nasdaq Capital Market on July 29, 2025, after deducting placement agent fees and estimated offering expenses, will be approximately $5.2 million, assuming we sell only shares of Class A common stock and no pre-funded warrants and assuming no exercise of the Class A common warrants.
		We are conducting this offering to provide funding for our ongoing clinical and regulatory development of laromestrocel for the treatment of several disease states and indications, including HLHS, Alzheimer’s disease, and pediatric DCM, obtaining regulatory approvals, advancing CMC activities to support BLA readiness, capital expenditures, working capital and other general corporate purposes. See “Use of Proceeds” for a more detailed description of the intended use of proceeds from this offering.
Nasdaq Capital Market Symbol for Class A common stock		LGVN We do not intend to apply for the listing of the pre-funded warrants, Series A common warrants or Series B common warrants on any national securities exchange or other trading system. Without an active trading market, the liquidity of the pre-funded warrants and Class A common warrants will be limited.
Lock-up Agreements		The Company and our directors and officers have agreed with the placement agent, subject to certain exceptions, not to sell, transfer or dispose of, directly or indirectly, any of our common stock or securities convertible into or exercisable or exchangeable for our common stock for a period of forty-five (45) days after the closing of this offering. See “Plan of Distribution” for more information.
Risk Factors		Since our inception, we have incurred substantial losses. We will need additional funding (including the funding which may be received pursuant to the offering described in this prospectus) to remain a going concern, maintain operations, and to continue our current and planned clinical trial activity. Our business and our ability to execute our business strategy are subject to a number of risks of which you should be aware before you decide to buy our securities. Investing in our securities involves a high degree of risk. In particular, you should carefully consider all of the risks which are discussed more fully in “Risk Factors” section of this prospectus and those incorporated by reference from our filings with the SEC.

(1) The number of shares of common stock to be outstanding after this offering is based on 13,694,570 shares of Class A common stock and 1,484,005 shares of Class B common stock outstanding as of July 29, 2025, and excludes:

● any shares of Class A common stock issuable upon conversion of existing Class B common stock;

● 5,536 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $120.00 per share;

● 4,679 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $175.00 per share;

● 16,971 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $20.625 per share;

● 135,531 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $16.20 per share;

● 9,489 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $21.813 per share;

● 297,872 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $2.35 per share;

● 154,894 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $2.9375 per share;

● 2,349,744 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $2.35 per share;

● 167,982 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $3.25 per share;

● 49,130 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $2.9375 per share;

● 926,596 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $2.50 per share;

● 118,852 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $3.25 per share;

● 10,500 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $3.125 per share;

● 162,344 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $3.125 per share;

● 2,236,026 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $3.90 per share;

● 156,522 shares of Class A common stock issuable upon exercise of outstanding warrants at an exercise price of $5.0313 per share;

● 1,768,513 shares issuable upon the vesting of RSUs under the Company’s 2021 Incentive Award Plan;

● 735,967 stock options outstanding with an average exercise price, as of July 29, 2025, of $3.61 issuable under the Company’s 2021 Incentive Award Plan; and

● stock options issued in July 2024 to a third-party service provider exercisable for up to 50,000 shares of Class A common stock, which such stock option has an exercise price of $2.15 per share, and vests quarterly over a three-year period.

Unless otherwise indicated, all information in this prospectus supplement assumes (i) no exercise of outstanding options or warrants, (ii) no exercise of the Class A common warrants to be sold in this offering or the Placement Agent Warrants to purchase up to 269,231 shares at an exercise price of $ per share to be issued as compensation to the placement agent (or its designees) in connection this offering, and (iii) the exercise for cash of all pre-funded warrants issued in this offering.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

In this document, the terms “Longeveron,” “Company,” “Registrant,” “we,” “us,” and “our” refer to Longeveron Inc. weWe have no subsidiaries.

This prospectus contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that reflect our current expectations about our future results, performance, prospects and opportunities. Such forward-looking statements can involve substantial risks and uncertainties. All statements other than statements of historical facts contained herein, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectives of management are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements contained in this prospectus include, but are not limited to, statements about:

● our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; ● our financial performance, and ability to continue as a going concern; ● the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; ● the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; ● the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; ● the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; ● our ability to scale production and commercialize the product candidate for certain indications; ● the success of competing therapies that are or may become available; ● the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; ● our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; ● our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; ● our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; ● the need to hire additional personnel and our ability to attract and retain such personnel; and ● our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

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our financial performance, ability to continue as a going concern and ability to remain listed on the Nasdaq Capital Market;

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the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;

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the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;

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the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials;

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the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;

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our ability to scale production and commercialize the investigational product candidate for certain indications;

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the success of competing therapies that are or may become available;

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the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;

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our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions;

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our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue;

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our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others;

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the need to hire additional personnel and our ability to attract and retain such personnel; and

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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this prospectus and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this prospectus. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for management to predict all risk factors, nor can we assess the impact of all risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.

12INDUSTRY AND MARKET DATA

This prospectus includes industry data and forecasts that we obtained from industry publications and surveys, public filings, and internal company sources. Industry publications and surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but there can be no assurance as to the accuracy or completeness of the included information. Statements as to our market position and market estimates are based on independent industry publications, government publications, third party forecasts, management’s estimates and assumptions about our markets and our internal research. While we are not aware of any misstatements regarding the market, industry or similar data presented herein, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed under the headings “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in this prospectus.

RISK FACTORS

Investing in our securities involves a high degree of risk. You should consider and read carefully all of the risks and uncertainties described below, as well as risk factors and other information contained in this prospectus and which is incorporated by reference in our most recent Annual Report on Form 10-K ~~and Quarterly Report on Form 10-Q for the quarter ended March 31, 2025,~~ before making an investment decision with respect to our securities. The occurrence of any of the following risks or those incorporated by reference, or additional risks and uncertainties not presently known to us or that we currently believe to be immaterial could materially and adversely affect our business, financial condition, results of operations or cash flows. In any such case, the market price of our Class A common stock could decline, and you could lose all or part of your investment. This prospectus also contains forward-looking statements and estimates that involve risks and uncertainties. See “Cautionary Note Regarding Forward-Looking Statements.” Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including the risks and uncertainties described below and those incorporated by reference.

Risks Related to This Offering

~~Purchasers~~A ~~who~~significant ~~purchase~~number of our ~~securities~~shares inare eligible ~~this~~for ~~offering~~sale ~~pursuant~~and totheir asale ~~securities~~or ~~purchase~~potential ~~agreement~~sale may ~~have~~depress ~~rights~~the ~~not~~market ~~available~~price ~~to purchasers that purchase without the benefit~~ of aour ~~securities~~Class ~~purchase~~A ~~agreement~~common stock.

InSales ~~addition~~of toa ~~rights~~significant ~~and~~number ~~remedies~~of ~~available~~shares toof our ~~all~~Class ~~purchasers~~A common stock in ~~this~~the ~~offering~~public ~~under~~market ~~federal~~could ~~securities~~harm ~~and~~the ~~state~~market ~~law~~price of our Class A common stock. Most of our outstanding Class A common stock is available for resale in the public market, and the ~~purchasers~~registration ~~that~~statement ~~enter~~of ~~into~~which this prospectus is a ~~securities~~part ~~purchase~~registers ~~agreement~~for resale ~~will~~30,865,385 ~~also~~shares beof ~~able~~Class toA ~~bring~~common ~~claims~~stock, ofincluding ~~breach~~22,832,770 shares issuable upon conversion of ~~contract~~the ~~against~~Series ~~us.~~A ~~The~~preferred ~~ability~~stock and 2,019,231 shares exercisable with respect to ~~pursue~~the aPA ~~claim~~Warrants. ~~for~~If ~~breach~~a significant number of ~~contract~~shares ~~provides~~are ~~those~~sold in that offering or any future offerings, ~~investors~~such ~~with~~sales would increase the ~~means~~supply toof ~~enforce~~our ~~the~~Class ~~covenants~~A ~~uniquely~~common ~~available~~stock toand ~~them~~potentially ~~under~~cause ~~the~~a ~~securities~~decrease ~~purchase~~in ~~agreement~~its ~~including:~~market ~~(i)~~price. ~~timely delivery~~Some or all of our shares; ~~(ii)~~of ~~agreement~~Class A common stock may be offered from time to ~~not~~time ~~enter~~in ~~into~~the ~~variable~~open ~~rate~~market ~~financings~~pursuant ~~for~~to ~~one~~future ~~(1)~~effective ~~year~~registration ~~from~~statements and/or ~~closing~~compliance with Rule 144, ~~subject~~which sales could have a depressive effect on the market for our shares of Class A common stock. Subject to certain ~~exceptions; (iii)~~restrictions, ~~agreement~~a toperson ~~not~~who ~~enter~~has ~~into~~held ~~any~~restricted ~~financings~~shares for ~~forty-five~~ ~~(45)~~a ~~days from~~period ~~closing;~~of ~~and~~six ~~(iv)~~months ~~indemnification~~may ~~for~~generally ~~breach~~sell common stock into the market. The sale of ~~contract~~a significant portion of such shares when such shares are eligible for public sale may cause the value of our Class A common stock to decline in value.

This is a best efforts offering, with no minimum amount of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans, including our near-term business plans, nor will investors in this offering receive a refund in the event that we do not sell an amount of securities sufficient to pursue the business goals outlined in this prospectus.

The placement agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities in this offering. The placement agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to support our business goals and continued operations, including our near-term continued operations. Thus, we may not raise the amount of capital we believe is required for our operations in the short-term and may need to raise additional funds to complete such short-term operations. Such additional capital may not be available or available on terms acceptable to us, or at all.

There is no required minimum number of securities that must be sold as a condition to completion of this offering, and we have not, nor will we, establish an escrow account in connection with this offering. Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, placement agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth herein. Because there is no escrow account and no minimum offering amount, investors could be in a position where they have invested in us, but we are unable to fulfill our objectives due to a lack of interest in this offering. Further, because there is no escrow account in operation and no minimum investment amount, any proceeds from the sale of securities offered by us will be available for our immediate use, despite uncertainty about whether we would be able to use such funds to effectively implement our business plan. Investor funds will not be returned under any circumstances whether during or after the offering.

We have broad discretion in how we use the net proceeds of this offering, and we may not use these proceeds effectively or in ways with which you agree.

Our management will have broad discretion as to the application of the net proceeds of this offering and could use them for purposes other than those contemplated at the time of the offering. We intend to use the net proceeds, if any, from this offering to provide funding for our ongoing clinical and regulatory development of laromestrocel for the treatment of several disease states and indications, including HLHS and pediatric Dilated Cardiomyopathy (DCM), obtaining regulatory approvals, advancing Chemistry Manufacturing and Controls (CMC) activities to support Biologics License Application (BLA) readiness, capital expenditures, working capital and other general corporate purposes. Our stockholders may not agree with the manner in which our management chooses to allocate and spend the net proceeds. Moreover, our management may use the net proceeds for corporate purposes that may not increase the market price of our Class A common stock or other securities. See the section of this prospectus titled “Use of Proceeds.”

Raising additional capital may cause future dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or current product candidates.

Until such time, if ever, as we can generate the cash we need from operations, we expect to finance our cash needs through a combination of private and public equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We do not currently have any committed external source of funds and in order to raise additional capital, we may offer and issue additional shares of our common stock or other securities convertible into or exchangeable for our common stock in the future. WeUpon expiration of a standstill period on June 9, 2026, we are generally not restricted from issuing additional securities, including shares of Class A common stock, securities that are convertible into or exchangeable for, or that represent the right to receive, common stock or substantially similar securities. The issuance of securities in future offerings may cause further dilution to our stockholders, including investors in this offering. We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share paid by investors in this offering, and investors purchasing other securities in the future could have rights superior to existing stockholders. To the extent that we raise additional capital through the sale of Class A common stock or securities convertible into or exchangeable for Class A common stock, the ownership interest of our shareholders will be diluted, and the terms of these new securities may include liquidation or other preferences that materially adversely affect the rights of our shareholders. Debt financing, if available, would increase our fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or current or future product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, scale back or discontinue the development and commercialization of one or more of our product candidates, delay our pursuit of potential licenses or acquisitions, or grant rights to develop and market current or future therapeutic candidates that we would otherwise prefer to develop and market ourselves.

In addition, we have a significant number of stock options, restricted stock units and warrants outstanding. To the extent that outstanding stock options or warrants have been or may be exercised or other shares issued, you may experience further dilution.

A substantial number of shares of our Class A common stock are being sold in this offering, which could cause the price of our Class A common stock to decline.

In this offering we are selling up to 3,846,154 shares of Class A common stock. In addition, we are also selling Series A common warrants to purchase up to 3,846,154 shares of Class A common stock and Series B common warrants to purchase up to 3,846,154 shares of Class A common stock. In the aggregate, the maximum shares that could be issued in this offering represent approximately 78% of our outstanding Class A common stock and Class B common stock as of July 29, 2025, after giving effect to this offering. This sale and any future sales of a substantial number of shares of our Class A common stock in the public market, or the perception that such sales may occur, could adversely affect the price of our Class A common stock on the Nasdaq Capital Market. We cannot predict the effect, if any, that market sales of those shares of Class A common stock or the availability of those shares of Class A common stock for sale will have on the market price of our Class A common stock.

We do not currently intend to pay dividends on our Class A common stock and, consequently, your ability to achieve a return on your investment will depend on appreciation of the value of our Class A common stock.

We have never declared or paid any cash dividends on our equity securities. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to any appreciation in the value of our Class A common stock, which is not certain.

The price of our Class A common stock may be volatile or may decline regardless of our operating performance, and ~~shareholders~~stockholders may not be able to resell their shares at or above the price at which they purchase those shares.

Trading volume in shares of our Class A common stock on the Nasdaq Capital Market has been limited. You may not be able to sell your shares quickly or at the market price if trading in shares of our Class A common stock is not active. An active or liquid market in our Class A common stock may not develop or, if it does develop, it may not sustain. As a result of these and other factors, ~~shareholders~~stockholders may not be able to resell their shares of our Class A common stock at or above the price at which they purchase those shares in this offering.

Further, an inactive market may also impair our ability to raise capital by selling shares of our Class A common stock and may impair our ability to enter into strategic collaborations or acquire companies or products by using our shares of Class A common stock as consideration.

If you purchase our securities in this offering, you may incur immediate and substantial dilution in the book value of your shares of Class A common stock.

You may suffer immediate and substantial dilution in the net tangible book value of the Class A common stock you purchase in this offering. Based on the assumed public offering price of $1.56 per share and accompanying Class A common warrants, the last reported price of our Class A common stock on the Nasdaq Capital Market on July 29, 2025, we estimate our as adjusted net tangible book value per share of common stock as of March 31, 2025, after this offering will be $1.02. As a result, purchasers of securities in this offering will experience an immediate decrease of $0.54 per share in net tangible book value of our common stock. See the section of this prospectus titled “Dilution” for a more detailed description of these factors.

There is no public market for any pre-funded warrants or the Class A common warrants sold in this offering.

There is no established public trading market for the pre-funded warrants or Class A common warrants being sold in this offering. We will not list the pre-funded warrants, Series A common warrants or Series B common warrants on any securities exchange or nationally recognized trading system, including the Nasdaq Capital Market. Therefore, we do not expect a market to ever develop for the pre-funded warrants or Class A common warrants. Without an active market, the liquidity of the pre-funded warrants and Class A common warrants will be limited.

The pre-funded warrants and Class A common warrants are speculative in nature. Holders of the pre-funded warrants and the Class A common warrants offered hereby will have no rights as common stockholders with respect to the shares our Class A common stock underlying such warrants until such holders exercise their warrants and acquire our Class A common stock, except as otherwise provided in the pre-funded warrants and the Class A common warrants.

The pre-funded warrants and Class A common warrants do not confer any rights of Class A common stock ownership on their holders, such as voting rights or the right to receive dividends, but merely represent the right to acquire shares of Class A common stock at a fixed price. Commencing on the date of issuance or the Warrant Stockholder Approval, as applicable, holders of pre-funded warrants and Class A common warrants may exercise their right to acquire the underlying Class A common stock and pay the respective stated warrant exercise price per share. Following this offering, the market value of the Class A common warrants is uncertain and there can be no assurance that the market value of the Class A common warrants, if any, will equal or exceed their public offering prices. There can be no assurance that the market price of the shares of Class A common stock will ever equal or exceed the exercise price of the Class A common warrants, and consequently, whether it will ever be profitable for holders of Class A common warrants to exercise the Class A common warrants.

Until holders of pre-funded warrants and Class A common warrants acquire shares of our Class A common stock upon exercise thereof, holders of such pre-funded warrants and Class A common warrants will have no rights with respect to shares of our Class A common stock, except as provided in the pre-funded warrants, Series A common warrants and Series B common warrants, respectively. Upon exercise of the pre-funded warrants and Class A common warrants, such holders will be entitled to the rights of a Class A common stockholder only as to matters for which the record date occurs after the exercise date.

Resales of our shares of Class A common stock in the public market by our stockholders as a result of this offering may cause the market price of our shares of Class A common stock to fall.

We are registering 3,846,154 shares of Class A common stock, as well as up to 11,807,693 shares of Class A common stock, in the aggregate, issuable upon the exercise of the pre-funded warrants and the Class A common warrants offered under this prospectus, as well as the Placement Agent Warrants. Sales of substantial amounts of our shares of Class A common stock in the public market, or the perception that such sales might occur, could adversely affect the market price of our shares of Class A common stock. The issuance of new shares of Class A common stock could result in resales of our shares of Class A common stock by our current shareholders concerned about the potential ownership dilution of their holdings. Furthermore, in the future, we may issue additional shares of common stock or other equity or debt securities exercisable or convertible into shares of common stock. Any such issuance could result in substantial dilution to our existing shareholders and could cause our stock price to decline.

If we are required to obtain Warrant Stockholder Approval, until we are able to receive such approval the Class A common warrants will not be exercisable, and if we are unable to obtain such approval for the Class A common warrants, they will have no value.

The Class A common warrants will have an exercise price of $ per share and will be exercisable beginning on the Warrant Stockholder Approval Date if the Pricing Conditions are not met; provided, however, if the Pricing Conditions are met, the Class A common warrants will be exercisable upon issuance. The Series A common warrant will expire ( ) years from the Warrant Stockholder Approval Date, provided that if the Pricing Conditions are met, the Series A common warrants will expire ( ) years from the date of issuance, and the Series B common warrants will expire ( ) months from the Warrant Stockholder Approval Date, provided that if the Pricing Conditions are met, the Series B common warrants will expire ( ) months from the date of issuance.

If we are required to obtain the Warrant Stockholder Approval, the Class A common warrants will not be exercisable until, and unless, we obtain the Warrant Stockholder Approval from our stockholders. While we intend to promptly seek the Warrant Stockholder Approval, if required, there is no guarantee that the Warrant Stockholder Approval will ever be obtained. If we are unable to obtain the Warrant Stockholder Approval, the Class A common warrants will have no value. In addition, we will incur substantial cost, and management will devote substantial time and attention, in attempting to obtain the Warrant Stockholder Approval.

Risks Related to Our Class A Common Stock and the Securities Market

The price of our Class A common stock has been, and may continue to be, volatile, which could result in substantial or total losses for investors.

The trading price of our Class A common stock has been, and may continue to be, highly volatile and subject to wide fluctuations in response to various factors, some of which we cannot control. The stock market in general, and pharmaceutical and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

Broad market and industry factors may negatively affect the market price of our Class A common stock, regardless of our actual operating performance. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this prospectus, these factors include:

● the timing and results, or perception of the results, of preclinical studies and clinical trials of our product candidates or those of our competitors; ● the success of competitive products or announcements by potential competitors of their product development efforts; ● regulatory actions with respect to our or our competitors’ product candidates or approved products; ● actual or anticipated changes in our growth rate relative to our competitors; ● regulatory or legal developments in the U.S. and other countries;

~~● the success of competitive products or announcements by potential competitors of their product development efforts;~~13

● ~~regulatory~~developments ~~actions~~or ~~with~~disputes ~~respect~~concerning topatent ~~our~~applications, issued patents or other proprietary rights; ● the recruitment or departure of key personnel; ● announcements by us or our competitors’ ~~product~~of ~~candidates~~significant acquisitions, strategic collaborations, joint ventures, or ~~approved~~capital ~~products~~commitments;

16● actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● market conditions in the pharmaceutical and biotechnology sector; ● changes in the structure of healthcare payment systems; ● Class A common stock price and volume fluctuations attributable to inconsistent trading volume levels of our Class A common stock; ● announcement or expectation of additional financing efforts; ● sales of our Class A common stock by us, our insiders or our other stockholders; ● expiration of market stand-off or lock-up agreements; and ● general economic, industry and market conditions.

● actual or anticipated changes in our growth rate relative to our competitors;

● regulatory or legal developments in the U.S. and other countries;

● developments or disputes concerning patent applications, issued patents or other proprietary rights;

● the recruitment or departure of key personnel;

● announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, or capital commitments;

● actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

● fluctuations in the valuation of companies perceived by investors to be comparable to us;

● market conditions in the pharmaceutical and biotechnology sector;

● changes in the structure of healthcare payment systems;

● Class A common stock price and volume fluctuations attributable to inconsistent trading volume levels of our Class A common stock;

● announcement or expectation of additional financing efforts;

● sales of our Class A common stock by us, our insiders, or our other stockholders;

● expiration of market stand-off or lock-up agreements; and

● general economic, industry and market conditions.

The realization of any of the above risks or any of a broad range of other risks, including those described in this “Risk Factors” section, could have a dramatic and adverse impact on the market price of our Class A common stock. Additionally, in the past, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources.

There may not be sufficient liquidity in the market for our securities in order for investors to sell their shares.

We are a small company that is relatively unknown to stock analysts, stockbrokers, institutional investors and others in the investment community that generate or influence sales volume, and even if we came to the attention of such persons, they tend to be risk-averse and may be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable. There may be periods of several days or more when trading activity in our shares is minimal as compared to a mature issuer which has a large and steady ~~volume~~ volume of trading activity that will generally support continuous sales without an adverse effect on share price. It is possible that a broader or more active public trading market for our ~~Class A~~ common stock will not develop or be sustained, or that trading levels will not continue. These factors may materially adversely affect the market price of our Class A common stock, regardless of our performance.

17We will need to raise substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, scale back or discontinue some of our therapeutic candidate development programs or commercialization efforts.

The development of pharmaceutical drugs is capital intensive. We are currently advancing laromestrocel into clinical development. As a result of the recently completed Private Placement transaction, and based on current operating plans, we expect that our cash and cash equivalents as of December 31, 2025 plus proceeds from the Private Placement will ~~need~~fund operations into the fourth quarter of 2026. The Company also has access to ~~raise~~an ~~substantial~~At-The-Market (ATM) ~~additional~~equity financing vehicle for the sale of up to $10.7 million aggregate market value of shares of the Company’s Class A common stock; ~~funding~~however, the ATM facility is under a standstill restriction until June 9, 2026, and thereafter we have restrictions in place regarding our ability to use the ATM facility unless our Class A common stock is trading above $0.80 per share until September 7, 2026. We will require additional funds to advance further. If we are ~~unable~~capital constrained, we may not be able to ~~raise~~meet ~~capital~~our ~~when~~obligations. ~~needed~~If we are unable to meet our obligations, or we ~~could~~experience bea ~~forced~~disruption toin ~~delay~~our cash flows, ~~scale~~it ~~back~~could limit or ~~discontinue~~halt ~~some~~our ofability to continue to develop our current investigational product candidate ~~development~~ ~~programs~~ or ~~commercialization~~even ~~efforts~~to continue operations, either of which occurrence would have a material adverse effect on us.

The development of pharmaceutical drugs is capital intensive. We are currently advancing laromestrocel into clinical development. Our current cash resources are insufficient to fund our planned operations or development plans into the fourth quarter of 2025 based on our current operating budget and cash flow forecast. We will require additional funds to advance further. If we are capital constrained, we may not be able to meet our obligations. If we are unable to meet our obligations, or we experience a disruption in our cash flows, it could limit or halt our ability to continue to develop our current product candidate or even to continue operations, either of which occurrence would have a material adverse effect on us.14

We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we continue the research and development of, advance the preclinical and clinical activities of, and seek marketing approval for, our current investigational product ~~candidates~~candidate. Following a ~~successful~~productive Type C meeting with the FDA in August 2024 with respect to the HLHS regulatory pathway, we ~~have~~began ~~begun~~ ramping up ~~our~~ BLA enabling activities., Wewith ~~currently anticipate~~ a ~~potential~~focus ~~BLA~~on ~~filing~~clinical ~~with~~spend ~~the~~supporting ~~FDA~~HLHS instudy ~~late~~completion ~~2026~~and ifdelivering top-line results. If the current ELPIS II trial in HLHS is successful. ~~Our operating expenses~~ and ~~capital expenditure~~deemed ~~requirements~~pivotal ~~will~~by ~~increase~~the ~~throughout~~FDA ~~calendar~~to ~~2025~~support asthe afiling ~~result~~ of ~~these~~a ~~activities~~BLA, ~~including~~the ~~CMC~~Company ~~(Chemistry,~~would ~~Manufacturing, and~~intend ~~Controls)~~to ~~and~~move ~~manufacturing~~forward ~~readiness.~~with Wea ~~expect that our current operating plan will require increased spending and additional capital~~potential ~~investments~~BLA tofiling ~~support~~with ~~these~~the ~~initiatives~~FDA and ~~intend~~seeking toa ~~seek~~commercialization ~~additional financing/capital raises/non-dilutive funding options to support them~~partner. Additionally, following a ~~positive~~productive Type B meeting with the ~~U.S.~~ FDA in March 2025 with respect to the ~~Alzheimer’s~~AD ~~disease~~ regulatory pathway, we are focused on seeking partnership opportunities and/or non-dilutive funding for the ~~Alzheimer’s disease~~ AD program, including a proposed single, potentially pivotal, seamless adaptive Phase 2/3 clinical trial. ~~There~~The Company expects that its current operating plan will require increased spending and additional capital investments to support these initiatives, and intends to seek additional financing through capital raises, non-dilutive funding options, and commercial partnering across all indications. There can be no assurance wethe Company will be able to attain future financing at terms favorable to usthe Company or at all. In the event the Company is unable to attain the financing needed, it will need to materially revise its current operational plan. The Company may need to adjust its current and future spending levels if needed based on the level of cash available.

In addition, if we obtain marketing approval for any of our current or future investigational product candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. We may also need to raise additional funds sooner if we choose to pursue additional indications and/or geographies for our current investigational product candidates or otherwise expand more rapidly than we presently anticipate. Furthermore, we expect to continue to incur significant costs associated with operating as a public company. If we are unable to raise capital when needed, we could be forced to delay, scale back or discontinue the development and commercialization of one or more of our investigational product candidates, delay our pursuit of potential licenses or acquisitions, or significantly reduce or cease our operations.

WeAs ~~currently~~a ~~anticipate~~result of the recently completed Private Placement financing discussed in “Recent Events- Private Placement Transaction”, and based on current operating plans, we expect that our ~~existing~~current cash and cash equivalents will ~~enable~~fund usoperations into the fourth quarter of 2026. In past years, we have been able to fund ~~our~~a ~~operating~~large ~~expenses~~portion ~~and~~of ~~capital~~our ~~expenditure~~clinical ~~requirements~~programs ~~into~~with the ~~fourth~~use ~~quarter~~ of ~~2025~~grant funding. Our future capital requirements will depend on and could increase significantly as a result of many factors, including:

● the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our current or future investigational product candidates;

●

the potential additional expenses attributable to adjusting our development plans (including any supply-related matters) in response to global geopolitical conditions and/or future public health crises;

●

the scope, prioritization and number of our research and development programs;

● the costs, timing and outcome of regulatory review of our current or future investigational product candidates;

●

our ability to establish and maintain collaborations on favorable terms, if at all;

●

the achievement of milestones or occurrence of other developments that trigger payments under any additional collaboration agreements we obtain;

●

the extent to which we are obligated to reimburse, or are entitled to reimbursement of, clinical trial costs under future collaboration agreements, if any;

●

the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

● the extent to which we acquire or license other current or future investigational product candidates and technologies;

●

the costs of securing manufacturing arrangements for commercial production; and

● the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our current or future investigational product candidates.

Identifying potential current or future ~~product~~investigational product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes ~~years~~ years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve drug sales.

In addition, our current or future investigational product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of drugs that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to continue to rely on additional funding to achieve our business objectives.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our current or future investigational product candidates.

Disruptions in the financial markets in general have made equity and debt financing more difficult to obtain and may have a material adverse effect on our ability to meet our fundraising needs. We cannot guarantee that future financing will be available in sufficient amounts or on terms favorable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our Class A common stock to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness could result in fixed payment obligations, and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or current or future investigational product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

If we are unable to obtain funding on a timely basis, we may be required to significantly delay, scale back or discontinue one or more of our research or development programs, activities to prepare for a potential BLA filing, including CMC and manufacturing readiness, or the commercialization of any ~~product~~investigational product candidates or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.

If we continue to fail to meet the requirements for continued listing on Nasdaq, our Class A common stock could be delisted from trading on Nasdaq, which would likely reduce the liquidity of our Class A common stock and could cause our trading price to decline.

Minimum Bid Price Requirement

Our Class A common stock is currently listed for quotation on the Nasdaq Capital Market. We are required to meet listing requirements in order to maintain our listing on Nasdaq. We could lose our listing on Nasdaq if the closing bid price of our Class A common stock does not increase or if in the future, we fail to meet any of the other Nasdaq listing requirements. The loss of our Nasdaq listing would in all likelihood make our Class A common stock significantly less liquid and adversely affect its value.

On September 22, 2025, we received a notice from the Listing Qualifications Department of Nasdaq that our Class A common stock did not meet the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”) as a result of the closing bid price of the Company’s Class A common stock for the last 30 consecutive business days. The notice does not result in the immediate delisting of the Company’s Class A common stock and, pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company had an initial period of 180 calendar days, or until March 23, 2026 to regain compliance with the Minimum Bid Price Requirement. On March 24, 2026, following submission of a request by the Company, the Company received written notice from Nasdaq granting a second compliance period of an additional 180 calendar days, or until September 21, 2026 (the “Compliance Date”), to regain compliance with the Minimum Bid Price Requirement, as permitted pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(ii), due to the Company’s satisfaction of the continued listing requirements for the market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, as well as its intention to cure the deficiency during the additional compliance period.

If, at any time before the Compliance Date, the bid price closes at $1.00 or more per share for a minimum of ten consecutive business days (subject to Nasdaq’s discretion to increase the minimum period to up to 20 consecutive business days pursuant to Nasdaq Listing Rule 5810(c)(3)(H)), Nasdaq would provide written notification to the Company that it again complies with the Minimum Bid Price Requirement and the Class A common stock will continue to be eligible for listing on The Nasdaq Capital Market unless other eligibility deficiencies exist. However, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iii), if the Company’s Class A common stock has a closing bid price of $0.10 or less for ten consecutive trading days before the Compliance Date, Nasdaq can issue a Staff Determination Letter, which, unless appealed, would subject our Class A common stock to immediate suspension and delisting.

If the Company does not regain compliance with the Minimum Bid Price Requirement by the Compliance Date, Nasdaq will begin delisting procedures. In the event of a delisting from the Nasdaq Capital Market, our Class A common stock would likely be traded in the over-the- counter inter-dealer quotation system, more commonly known as the OTC. OTC transactions involve risks in addition to those associated with transactions in securities traded on the securities exchanges, such as the Nasdaq Capital Market, or Exchange-listed stocks. Many OTC stocks trade less frequently and in smaller volumes than Exchange-listed stocks. Accordingly, our Class A common stock would be less liquid than it would be otherwise. Also, the prices of OTC stocks are often more volatile than Exchange-listed stocks. Additionally, many institutional investors are prohibited from investing in OTC stocks, and it might be more challenging to raise capital when needed.

The Company intends to monitor the closing bid price of the Class A common stock and assess its available options to regain compliance with the Minimum Bid Price Requirement, if necessary, and continue listing on The Nasdaq Capital Market. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other applicable Nasdaq listing rules. If among such options the Company elects to pursue a reverse stock split to regain compliance with the Minimum Bid Price requirement, there can be no assurance that it would accomplish this objective for any meaningful period of time, or at all, or that it would result in any permanent or sustained increase in the market price of our Class A common stock; and if such an event would be viewed unfavorably by the market, it could have the effect of reducing our market capitalization. Furthermore, pursuant to a recent modification to Nasdaq’s listing standards, if a company effects a reverse stock split and within one year thereafter becomes non-compliant with the Minimum Bid Price Requirement, it would immediately receive a notification letter from the Nasdaq Listing Qualifications Department commencing delisting proceedings, with no opportunity for a compliance period.

Audit Committee Composition

On March 4, 2026, we notified Nasdaq that, as a result of the March 3, 2026 resignation of Mr. Richard Kender as a member of the Board and as chairman of the Audit Committee, we are temporarily no longer in compliance with Nasdaq Listing Rule 5605(c)(2)(A), which requires that the audit committee of a listed company be composed of at least three independent directors and that at least one member meets the financial sophistication requirements.

Also on March 4, 2026, we appointed Dr. Roger Hajjar, an existing Board member, as a member of the Audit Committee to satisfy Nasdaq Listing Rule 5605(c)(2)(A)’s requirement that the audit committee of a listed company be composed of at least three (3) independent directors. However, because no member of the Audit Committee qualifies as an audit committee financial expert, we plan to appoint, or submit to the stockholders for election, at least one (1) director that will be deemed “independent”, an “audit committee financial expert,” as defined in Item 407(d)(5)(ii) of Regulation S-K promulgated under the Securities Act of 1933, as amended, and meeting the financial sophistication requirements under Nasdaq Listing Rule 5605(c)(2), at the earlier of the next annual shareholders meeting or within the 180-day cure period available under Nasdaq Listing Rule 5605(c)(4).

The dual-class structure of our common stock may adversely affect the trading market for our Class A common stock.

We cannot predict whether our dual class structure will result in a lower or more volatile market price of our Class A common stock or in adverse publicity or other adverse consequences. For example, certain index providers have announced restrictions on including companies with dual class or multi-class share structures in certain of their indexes. Our dual class capital structure could make us ineligible for inclusion in certain indices and mutual funds, exchange-traded funds and other investment vehicles that attempt to passively track these indices will not be investing in our stock. These policies are still fairly new, and it is as of yet unclear what effect, if any, they will have on the valuations of publicly traded companies excluded from the indices, but it is possible that they may depress these valuations compared to those of other similar companies that are included. Furthermore, we cannot assure you that other stock indices will not take a similar approach to S&P, Dow Jones or FTSE Russell in the future. Exclusion from indices could make our Class A common stock less attractive to investors and, as a result, the market price of our Class A common stock could be adversely affected.

~~Our~~Holders ~~CMC~~of ~~readiness~~our Class B common stock exert considerable control over the direction of our business and ~~ability~~their toownership ~~manufacture~~of our Class B common stock can prevent other stockholders ~~for~~from ~~commercialization~~influencing ~~may~~significant bedecisions. ~~delayed~~Holders orof ~~unsuccessful~~our Series A preferred stock also have influence over certain significant corporate decisions.

~~Our~~As ~~BLA-enabling~~of ~~activities~~April 2, ~~including comparability protocols~~2026, ~~process~~three ~~and~~holders ~~analytical~~of ~~method~~our ~~validation~~Class B ~~are~~common ~~complex~~stock ~~and~~control ~~subject~~voting torights ~~regulatory~~over ~~review.~~approximately ~~Any~~21% ~~delays~~of orthe ~~failures~~combined invoting ~~these~~power ~~activities could~~of ~~impact~~ our ~~ability~~Class toA ~~meet~~common ~~regulatory~~stock and ~~investor~~Class ~~expectations~~B ~~for~~common stock. ~~product~~For ~~approval~~so orlong ~~commercial~~as ~~launch~~holders of ~~our~~Class ~~product~~B ~~candidates. Our~~common ~~ability~~stock continue to ~~complete~~hold ~~BLA-enabling~~their ~~activities~~current ~~may~~shares, ~~impact~~they ~~the~~will ~~clinical~~be ~~and~~able ~~commercial~~to ~~success~~significantly ~~of our current and any future product candidates.~~influence ~~In addition,~~ the ~~FDA~~composition orof ~~other relevant regulatory authorities may find~~ our ~~CMC~~Board ~~data~~of ~~insufficient~~Directors toand ~~support~~ the ~~quality~~approval of ~~our~~actions ~~product candidates.~~requiring ~~The~~stockholder ~~FDA’s~~ approval ofthrough atheir ~~BLA~~voting ispower. ~~not guaranteed~~Accordingly, for ~~and~~such ~~the~~period ~~review~~of ~~and approval process is expensive~~time, ~~uncertain~~these ~~and~~holders ~~may~~will ~~take several~~have ~~years.~~significant ~~The~~influence ~~FDA~~with ~~also~~respect ~~has~~to ~~substantial~~our ~~discretion~~management, inbusiness ~~the~~plans ~~approval~~and ~~process~~policies. ~~These~~The concentration ~~matters~~of ~~are~~ownership ~~subject~~could todeprive ~~confirmation~~stockholders ~~and~~of ~~interpretation by~~an ~~regulatory~~opportunity ~~authorities,~~to ~~which~~receive ~~could~~a ~~delay,~~premium ~~limit,~~for orshares ~~prevent~~of ~~regulatory~~Class ~~approval.~~A ~~Our~~common ~~clinical~~stock ~~development~~as ~~efforts may fail at any~~part ~~stage.~~of ~~Our~~a ~~financial~~sale ~~condition~~of ~~may~~our beCompany ~~materially~~and ~~adversely~~ultimately ~~affected~~might byaffect ~~any~~the ~~delay~~market orprice ~~inability~~of ~~to complete~~ our ~~CMC~~Class ~~readiness~~A ~~and~~common ~~BLA-enabling activities~~stock.

19Holders of shares of Series A preferred stock are entitled to receive dividends on shares of Series A preferred stock equal to, on an as-if-converted-to-Common Stock basis, and in the same form as dividends actually paid on shares of the Common Stock. Except as otherwise required by law, the Series A preferred stock does not have voting rights. However, as long as any shares of Series A preferred stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series A preferred stock, (a) alter or change adversely the powers, preferences or rights given to the Series A preferred stock, (b) alter or amend the Certificate of Designation, (c) amend its certificate of incorporation or other governing documents in any manner that adversely affects any rights of the holders of Series A preferred stock, (d) issue further shares of Series A preferred stock or increase or decrease the number of authorized shares of Series A preferred stock, subject to certain exceptions, or (e) consummate any Fundamental Transaction (as defined in the Certificate of Designation), certain change of control transactions or enter into any agreements with respect to the same. The Series A preferred stock does not have a preference upon any liquidation, dissolution or winding-up of the Company. Issuances of securities pursuant to the Purchase Agreement, however, will not be deemed a “Fundamental Transaction.”

~~Holders~~Subject to the terms and limitations contained in the Certificate of ~~our~~Designation, ~~Class~~the BSeries ~~common~~A preferred stock ~~exert~~issued in the Private Placement is immediately convertible, at the option ~~considerable~~of ~~control~~the ~~over~~holder, into shares of Common Stock at a conversion price equal to the ~~direction~~Share Price of ~~our~~$0.52, ~~business~~subject ~~and~~to ~~their~~certain ~~ownership~~limitations, including that shares of ~~our~~Series ~~Class~~A Bpreferred ~~common~~stock shall not be convertible if the conversion would result in a holder, together with its affiliates beneficially owning more than 4.99% of the Company’s shares of Common Stock outstanding (or deemed to be outstanding) as of the applicable conversion date, which may be increased at the holder’s option (not to exceed 9.99%), effective in accordance with the terms of the Certificate of Designation. The number of shares of Common Stock issuable upon conversion of each share of Series A preferred stock ~~can~~shall ~~prevent~~be ~~other~~determined ~~stockholders~~by dividing the stated value of $1,000 per share by the conversion price of $0.52 (subject to adjustment as ~~from~~set ~~influencing~~forth ~~significant~~in ~~decisions~~the Certificate of Designation).

As of July 29, 2025, three holders of our Class B common stock control voting rights over approximately 37% of the combined voting power of our Class A common stock and Class B common stock. For so long as holders of Class B common stock continue to hold their current shares, they will be able to significantly influence the composition of our Board of Directors and the approval of actions requiring stockholder approval through their voting power. Accordingly, for such period of time, these holders will have significant influence with respect to our management, business plans and policies. In particular, for so long as the Class B common stock remains outstanding, the holders may be able to cause or prevent a change of control of our Company or a change in the composition of our Board of Directors and could preclude any unsolicited acquisition of our Company. The concentration of ownership could deprive stockholders of an opportunity to receive a premium for shares of Class A common stock as part of a sale of our Company and ultimately might affect the market price of our Class A common stock.18

If securities or industry analysts do not publish research or reports, or if they publish negative, adverse, or misleading research or reports, regarding us, our business or our market, our Class A common stock price and trading volume could decline.

The trading market for our Class A common stock is influenced by the research and reports that securities or industry analysts publish about us, our business, or our market. We do not currently have significant research coverage and may never obtain significant research coverage by securities or industry analysts. If no or few securities or industry analysts provide coverage of us, the Class A common stock price could be negatively impacted. In the event we obtain significant, or any securities or industry analyst coverage and such coverage is negative, or adverse or misleading regarding us, our business model, our intellectual property, our stock performance or our market, or if our operating results fail to meet the expectations of analysts, our Class A common stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our Class A common stock price or trading volume to decline.

FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our securities.

Effective June 30, 2020, the SEC implemented Regulation Best Interest requiring that “A broker, dealer, or a natural person who is an associated person of a broker or dealer, when making a recommendation of any securities transaction or investment strategy involving securities (including account recommendations) to a retail customer, shall act in the best interest of the retail customer at the time the recommendation is made, without placing the financial or other interest of the broker, dealer, or natural person who is an associated person of a broker or dealer making the recommendation ahead of the interest of the retail customer.” This is a significantly higher standard for broker-dealers to recommend securities to retail customers than before under prior FINRA suitability rules. FINRA suitability rules do still apply to institutional investors and require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending securities to their customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information, and, for retail customers, determine that the investment is in the customer’s “best interest,” and meet other SEC requirements. Both SEC Regulation Best Interest and FINRA’s suitability requirements may make it more difficult for broker-dealers to recommend that their customers buy speculative, low-priced securities. They may affect investing in our Class A common stock, which may have the effect of reducing the level of trading activity in our securities. As a result, fewer broker-dealers may be willing to make a market in our Class A common stock, reducing a stockholder’s ability to resell shares of our Class A common stock.

Provisions in our ~~certificate of incorporation, as amended (the “~~Certificate of Incorporation”) and ~~bylaws (the “~~Bylaws”) and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock.

Our Certificate of Incorporation and Bylaws contain provisions that could depress the market price of our Class A common stock by acting to discourage, delay or prevent a change in control of our company or changes in our management that the stockholders of our company may deem advantageous. These provisions, among other things:

●

establish a classified Board of Directors so that not all members of our Board are elected at one time;

●

permit only the Board of Directors to establish the number of directors and fill vacancies on the Board;

●

provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders;

● provide for a dual class common stock structure, which provides certain affiliates of ours, including our co-founder and members of our Board, individually or together, with the ability to significantly influence the outcome of matters requiring stockholder approval, even if they own significantly less than a majority of the shares of our outstanding Class A common stock and Class B common stock;

●

authorize the issuance of “blank check” preferred stock that our Board could use to implement a stockholder rights plan (also known as a “poison pill”);

●

eliminate the ability of our stockholders to call special meetings of stockholders;

●

prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders;

●

prohibit cumulative voting;

●

authorize our Board to amend our Bylaws;

●

establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and

●

require a super-majority vote of stockholders to amend some of the provisions described above.

In addition, Section 203 of the General Corporation Law of the State of Delaware prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns, or within the last three years has owned, 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.

Any provision of our Certificate of Incorporation, Bylaws or Delaware law that has the effect of delaying or preventing a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock and could also affect the price that some investors are willing to pay for our Class A common stock.

We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our Class A common stock less ~~attractive~~ attractive to investors.

We are currently an emerging growth company, or EGC, as defined in the JOBS Act, enacted in April 2012. For as long as we continue to be an EGC, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not EGCs, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding nonbinding advisory votes on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an EGC for up to five years following the year in which we completed our initial public offering, although circumstances could cause us to lose that status earlier. We will remain an EGC until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offering (i.e., December 31, 2026), (b) in which we have total annual gross revenue of at least $1.235 billion or (c) in which we are deemed to be a large accelerated filer, which requires the market value of our common stock that is held by non-affiliates to exceed $700.0 million as of the prior June 30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

We may choose to take advantage of some, but not all, of the available exemptions. We cannot predict whether investors will find our Class A common stock less attractive if we rely on certain or all of these exemptions. If some investors find our Class A common stock less attractive as a result, there may be a less active trading market for our Class A common stock and our stock price may be more volatile.

Under the JOBS Act, EGCs can also delay adopting new or revised accounting standards until such time as those standards apply to private companies, which may make our financial statements less comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.

2120

The issuance of additional stock in connection with acquisitions or otherwise will dilute all other stockholdings.

We are not restricted from issuing ~~additional~~ additional shares of our Class A common stock, or from issuing securities that are convertible into or exchangeable for, or that represent the right to receive, Class A common stock, other than as described in this prospectus. As of ~~July~~April 292, ~~2025~~2026, we had an aggregate of 84,295,000 shares of Class A common stock authorized and of that approximately 572,~~200~~132,~~488~~887 shares that are not issued, outstanding or reserved for issuance (for purposes of warrant exercise, orconversion of outstanding Series A preferred stock, conversion of Class B common stock, under the Company’s current Third Amended and Restated 2021 Incentive Award Plan or otherwise, exclusive of shares that may be issued under the Company’s existing ATM Agreement). We may issue all of these shares without any action or approval by our stockholders. We may expand our business through complementary or strategic ~~business~~ business combinations or acquisitions of other companies and assets, and we may issue shares of Class A common stock in connection with ~~those~~ those transactions. The market price of our Class A common stock could decline as a result of our issuance of a large number of shares of of Class A common stock, particularly if the per share consideration we receive for the stock we issue is less than the per share book value of our Class A common stock or if we are not expected to be able to generate earnings with the proceeds of the issuance that ~~are~~ are as great as the earnings per share we are generating before we issue the additional shares. In addition, any shares issued in ~~connection~~ connection with these activities, the exercise of warrants or stock options or otherwise would dilute the percentage ownership held by our investors. We cannot predict the size of future issuances or the effect, if any, that they may have on the market price of our Class A common stock.

WeInvestors ~~have~~should acarefully ~~history~~consider ofthe ~~losses~~risks and uncertainties and all other information contained or incorporated by reference in this prospectus, ~~may~~including ~~not~~the berisks and uncertainties ~~able~~discussed tounder ~~achieve~~“Risk ~~profitability~~Factors” ~~going~~in ~~forward~~our most recent Annual Report on Form 10-K, ~~and~~as may be amended from time to time, and in subsequent filings that are incorporated herein by reference. All these risk factors are incorporated by reference herein in their entirety. These risks and uncertainties are not the only ones facing us. Our business, financial condition or results of operations could be ~~able~~materially toadversely ~~raise~~affected ~~additional~~by ~~capital~~any ~~necessary~~of these risks. The trading price of our Class A common stock could decline due to ~~continue~~any of these risks, and you may lose all or part of your investment. This prospectus and the incorporated documents also contain forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a ~~going~~result ~~concern~~of certain factors, including the risks mentioned in this prospectus.

WeDIVIDEND have experienced significant losses since inception and, at December 31, 2024 and 2023, had an accumulated deficit of approximately $109.6 million and $85.0 million, respectively. We expect to incur additional losses in the future and expect the cumulative losses to increase. We expect our operating expenses to increase and it is not likely that our grant revenues will fully fund our clinical programs.POLICY

~~As of March 31, 2025, we had cash and cash equivalents of $14.3 million.~~ We have ~~prepared~~never adeclared ~~cash~~nor ~~flow~~paid ~~forecast~~any ~~which indicates that we will only have sufficient~~ cash ~~to fund our operating expenses~~dividends, and ~~capital~~currently ~~expenditure~~intend ~~requirements~~to ~~into~~retain ~~the~~all ~~fourth~~our ~~quarter~~cash ofand ~~2025.~~any ~~Following~~earnings afor ~~successful~~use ~~Type C meeting with the FDA~~ in ~~August~~our ~~2024 with~~business ~~respect~~and, ~~to the HLHS regulatory pathway~~therefore, wedo ~~have~~not ~~begun ramping up our BLA enabling activities. We currently~~ anticipate apaying ~~potential~~any cash ~~BLA~~dividends ~~filing with the FDA~~ in ~~2026 if~~ the ~~current~~foreseeable ~~ELPIS II trial in HLHS is successful~~future. ~~Our~~Any ~~operating~~future ~~expenses~~determination ~~and~~to ~~capital~~pay ~~expenditure~~cash ~~requirements~~ dividends will ~~increase~~be ~~throughout~~at ~~calendar~~the ~~2025~~discretion asof athe ~~result~~Board of ~~these activities, including CMC (Chemistry, Manufacturing,~~ Directors and ~~Controls)~~will ~~and~~be ~~manufacturing readiness.~~dependent Weupon ~~expect that~~ our ~~current~~consolidated ~~operating~~financial ~~plan~~condition, ~~will~~results ~~require~~of ~~increased~~operations, ~~spending and additional~~ capital ~~investments~~requirements ~~to support these initiatives~~ and ~~intend~~such toother ~~seek~~factors ~~additional financing/capital raises/non-dilutive funding options to support them. Additionally, following~~as ~~a positive Type B meeting with~~ the ~~U.S.~~Board ~~FDA~~of inDirectors ~~March~~deems 2025 with respect to the Alzheimer’s disease regulatory pathway, we are focused on seeking partnership opportunities and/or non-dilutive funding for the Alzheimer’s disease program, including a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trialrelevant.

To continue as a going concern, we will need to obtain additional capital, which we will likely obtain through a variety of means, including through public or private equity, debt financings or other sources, including up-front payments and milestone payments from strategic collaborations. There are no assurances that we would be able to raise additional capital or on terms favorable to us. Our recurring losses from operations and negative cash flow raise substantial doubt about our ability to continue as a going concern without sufficient capital resources and we have included an explanatory paragraph in the notes to our financial statements for the year ended December 31, 2024, with respect to this uncertainty. Further, the report of our independent registered public accounting firm with respect to our audited financial statements for the year ended December 31, 2024 included an emphasis of matter paragraph stating that our recurring losses from operations and continued cash outflows from operating activities raised substantial doubt about our ability to continue as a going concern. Our financial statements do not include any adjustments that might result from the outcome of this going concern uncertainty and have been prepared under the assumption that we will continue to operate as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

If we are unable to continue as a going concern, we may be forced to liquidate our assets, which would have an adverse impact on our business and developmental activities. In such a scenario, the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. The reaction of investors to the inclusion of a going concern statement by our independent registered public accounting firm and our potential inability to continue as a going concern may materially adversely affect our stock price and our ability to raise new capital. Our ability to continue as a going concern is dependent on our available cash, how well we manage that cash, and our operating requirements. If we are unable to raise additional capital when needed, we would be forced to delay, reduce or eliminate our clinical trial programs, commercialization efforts and other business activities.

USE OF PROCEEDS

WeThis ~~estimate~~prospectus ~~that~~relates to the ~~net~~resale ~~proceeds~~by wethe ~~will receive~~Selling ~~from~~Stockholders ~~the~~of ~~sale~~up ofto ~~our~~30,865,385 ~~securities~~shares inof ~~this~~Class ~~offering,~~A ~~assuming~~common ~~all~~stock. ~~the~~The ~~securities~~Selling weStockholders ~~are~~will ~~offering~~receive ~~are~~all ~~sold,~~of ~~after~~the ~~deducting~~proceeds ~~placement~~from ~~agent~~this offering. ~~fees~~We ~~and~~will ~~other~~not ~~estimated~~receive ~~offering~~any ~~expenses~~of ~~payable~~the byproceeds ~~us,~~from ~~and~~the ~~assuming~~sale noor ~~sale~~other disposition of ~~any~~our ~~pre-funded~~Class ~~warrants~~A ~~and~~common nostock ~~exercise~~by of the ~~Class~~Selling Stockholders pursuant Ato ~~common~~this ~~warrants~~prospectus. ~~being~~However, ~~issued~~we may receive proceeds in ~~this~~the ~~offering,~~aggregate ~~will~~of beup to approximately $~~5.2~~1,312,500 ~~million~~if all of the PA Warrants are exercised for cash, based on anthe ~~assumed~~per ~~combined~~share ~~public~~exercise ~~offering~~ price of ~~$1.56~~the ~~per~~PA ~~share~~Warrants. ~~and~~We ~~accompanying~~cannot ~~Class~~predict Awhen, ~~common~~or ~~warrants~~if, ~~which~~the ~~was~~PA ~~the~~Warrants ~~closing~~will ~~price~~be ~~for~~exercised. It ~~our~~is ~~Class~~possible Athat ~~common~~the ~~stock~~PA onWarrants ~~the~~may ~~Nasdaq~~expire ~~Capital Market~~and onmay ~~July~~never ~~29,~~be ~~2025~~exercised for cash.

~~However,~~We ~~because~~currently ~~this~~intend isto ause ~~best~~any ~~efforts~~proceeds ~~offering~~from the exercise of the PA Warrants for funding our ongoing clinical and ~~there~~regulatory isdevelopment noof ~~minimum~~laromestrocel, ~~offering~~working ~~amount~~capital ~~required~~and asother ageneral corporate ~~condition~~purposes. We are subject to ~~the~~substantial ~~closing~~risks ofthat ~~this~~will ~~offering,~~require ~~the~~us ~~actual~~to ~~offering~~obtain ~~amount,~~additional ~~the~~funding ~~placement~~in order to achieve these objectives. ~~agent~~See ~~fees~~“Risk ~~and~~Factors.” ~~net~~We ~~proceeds~~will need substantial additional capital in the future, which could cause dilution to usour ~~are~~existing stockholders, ~~not~~restrict ~~presently~~our ~~determinable~~operations, or require us to relinquish rights, and if additional capital is not available, we may behave ~~substantially~~to delay, ~~less~~reduce, ~~than~~or cease operations. Our expected use of any proceeds from the ~~maximum~~exercise of the PA Warrants represents our current intentions based upon our present plans and business condition. The amounts ~~set~~and ~~forth~~timing of our actual use of any proceeds will vary depending on numerous factors, including our ability to obtain additional financing, the relative success and cost of clinical and regulatory development programs ~~cover~~and ~~page~~the amount and timing of ~~this~~product ~~prospectus~~revenue, ~~and~~if any. In addition, we ~~may~~might ~~not~~decide ~~sell~~to ~~any~~postpone or ~~all~~not pursue certain activities if, among other factors, the proceeds from the exercise of the ~~securities~~PA weWarrants and our other sources of cash are ~~offering~~less than expected. As a result, wemanagement will ~~may~~have ~~receive~~broad ~~significantly less~~discretion in ~~net~~the application of any proceeds from the exercise of the PA Warrants, and investors will be relying on our judgment regarding the application of such proceeds. Pending the uses described above, we intend to invest any proceeds in interest-bearing investment-grade securities or deposits.

~~The following table presents our estimated net proceeds if 100%, 75%, 50% or 25% of the securities in this offering are sold.~~21

		100%	% of Total			75%	% of Total			50%	% of Total			25%	% of Total
Gross Proceeds from Offering	$	6,000	100	%	$	4,500	100	%	$	3,000	100	%	$	1,500	100	%
Offering Expenses
Placement Agent Fee	$	420	7.00	%	$	315	7.00	%	$	210	7.00	%	$	105	7.00	%
Management Fee	$	60	1.00	%	$	45	1.00	%	$	30	1.00	%	$	15	1.00	%
Placement Agent Expenses	$	126	2.10	%	$	126	2.80	%	$	126	4.20	%	$	126	8.40	%
Other Offering Expenses	$	171	2.85	%	$	171	3.80	%	$	171	5.70	%	$	171	11.41	%
Total	$	777	12.95	%	$	657	14.60	%	$	537	17.90	%	$	417	27.80	%
Net Proceeds	$	5,223	87.05	%	$	3,843	85.40	%	$	2,463	82.10	%	$	1,083	72.20	%

The Selling Stockholders will pay any underwriting discounts and commissions and expenses incurred by the Stockholders for brokerage, accounting, tax or legal services or any other expenses incurred by the Selling Stockholders in disposing of the securities covered by this prospectus. We will bear the costs, fees and expenses incurred in effecting the registration of the securities covered by this prospectus, including all registration and filing fees, and fees and expenses of our counsel and our independent registered public accountants.

WeDETERMINATION ~~have~~OF ~~based~~OFFERING the estimates in the above table on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. The net proceeds from this offering are not expected to be sufficient to fund advancement of any of our therapeutic candidates through regulatory approval. We will need to raise substantial additional funds to complete development and commercialization of our therapeutic candidates which development or commercialization may not be successful.PRICE

We cannot currently ~~intend~~determine ~~to use~~ the ~~net~~price ~~proceeds~~or ~~from~~prices ~~this~~at ~~offering~~which ~~for our ongoing clinical and regulatory development of laromestrocel for~~ the ~~treatment~~shares of ~~several~~our ~~disease~~Class ~~states~~A ~~and~~common ~~indications, including~~stock ~~HLHS,~~may ~~Alzheimer’s~~be ~~disease,~~sold ~~and~~by pediatric DCM; obtaining regulatory approvals; advancing CMC activities to support BLA readiness, capital expenditures, working capital and other general corporate purposes. We are subject to substantial risks that will require us to obtain additional funding in order to achieve these objectives. See “Risk Factors.” We will need substantial additional capital in the ~~future,~~Selling ~~which~~Stockholders ~~could~~under ~~cause~~this ~~dilution to our existing stockholders, restrict our operations or require us to relinquish rights, and if additional capital is not available, we may have to delay, reduce or cease operations~~prospectus.

~~Our~~THE ~~expected~~SELLING use of net proceeds from this offering represents our current intentions based upon our present plans and business condition. The amounts and timing of our actual use of net proceeds will vary depending on numerous factors, including our ability to obtain additional financing, the relative success and cost of clinical and regulatory development programs and the amount and timing of product revenue, if any. In addition, we might decide to postpone or not pursue certain activities if, among other factors, the net proceeds from this offering and our other sources of cash are less than expected. As a result, management will have broad discretion in the application of the net proceeds, and investors will be relying on our judgment regarding the application of the net proceeds. Pending the uses described above, we intend to invest the net proceeds in interest-bearing investment-grade securities or deposits.STOCKHOLDERS

The shares of Class A common stock being offered by the Selling Stockholders are those issued to certain of the Selling Stockholders pursuant to the Private Placement transaction, shares issuable to certain of the Selling Stockholders upon conversion of Series A preferred stock, and shares issuable to certain of the Selling Stockholders upon exercise of the PA Warrants. For additional information regarding the issuance of the Class A Common Stock, Series A preferred stock, and issuance of the PA Warrants, see “Recent Developments – Private Placement Transaction” We are registering the Class A common stock in order to permit the Selling Stockholders to offer the Class A common stock for resale from time to time. Except for the purchase of the Class A common stock, Series A preferred stock, PA Warrants, and certain engagement letters with Wainwright, the Selling Stockholders have not had any material relationship with us within the past three years.

The table below lists the Selling Stockholders and other information regarding the beneficial ownership of our Class A common stock by each of the Selling Stockholders. The second column lists the number of shares of Class A common stock beneficially owned (including on an as-converted basis) by each Selling Stockholder as of April 6, 2026, assuming conversion of all shares of Series A preferred stock and exercise of all PA Warrants, without regard to any limitations on conversion or exercise. The third column lists the shares of Class A common stock being offered under this prospectus by the Selling Stockholders.

This prospectus generally covers the resale of the maximum number of shares of Class A common stock issuable upon conversion of the Series A preferred stock and exercise of the PA Warrants, determined as if all shares of Series A preferred stock were converted, and the outstanding PA Warrants were exercised in full, as of the trading day immediately preceding the date the registration statement of which this prospectus forms a part was initially filed with the SEC, without regard to any limitations on the conversion of the Series A preferred stock or exercise of the PA Warrants. The fourth column assumes the sale of all of the shares of Class A common stock offered by the Selling Stockholders pursuant to this prospectus. The percentage of beneficial ownership in the fourth column represents the percentage of the outstanding shares of both the Class A common stock and the Company’s Class B common stock, based upon 21,783,749 shares of Class A common stock outstanding and 1,484,005 shares of Class B common stock outstanding as of April 2, 2026 (prior to any deemed issuance of any shares of Class A common stock issuable upon conversion of the Series A preferred stock or exercise of the PA Warrants).

Under the terms of each of the Series A preferred stock and the PA Warrants, a Selling Stockholder may not convert any shares of Series A preferred stock, or exercise any portion of the PA Warrants, to the extent such conversion or exercise would cause the Selling Stockholder to own more than 4.99% of the Company’s outstanding Class A common stock immediately after giving effect to the issuance of shares of Class A common stock issuable upon conversion of such Series A preferred stock or the exercise of such warrant. A Selling Stockholder may decrease or, upon at least 61 days’ prior notice to us, increase such limitation. In no event shall such beneficial ownership limitation exceed 9.99%, other than in the event of Selling Stockholders receiving notice of a Company Fundamental Transaction, as defined in the Company’s Certificate of Designation, in which case a Selling Stockholder may waive any ownership limitation with respect to conversion of Series A preferred stock. The Selling Stockholders may sell all, some or none of their shares of Class A common stock in this offering. See “Plan of Distribution.”

Name of Selling Shareholder	Number of Shares of Class A common stock Owned Prior to Offering (1)			Maximum Number of Shares of Class A common stock to be Sold Pursuant to This Prospectus (2)		Number of Shares of Class A common stock Owned After Offering (3)		Percentage of Beneficial Ownership After Offering (3)
Coastlands Capital Partners LP(4)		14,519,231	(5)		14,519,231		0		—	%
Entities of Janus Henderson Investors US LLC(6)(7)		9,615,385	(7)		9,615,385		0		—	%
Kalehua Capital Partners LP(8)		1,403,773	(9)		1,403,773		0		—	%
Kalehua Equity Growth Master LP (10)		519,304	(11)		519,304		0		—	%
Logos Opportunities Fund V LP(12)		1,923,077	(13)		1,923,077		0		—	%
Stuywater Capital LLC(14)(15)		1,897,852	(15)		1,501,442		396,410		1.71	%
Augustus Trading LLC(16)		1,294,832	(17)		1,294,832		0		—	%
Wilson Drive Holdings LLC(18)(19)		110,624	(19)		68,149		42,475		*	%
Charles Worthman(20)		32,775	(21)		20,192		12,583		*	%

less than 1.0%

(1)

The Series A preferred stock and PA Warrants contain certain beneficial ownership limitations, which provide that a holder of the securities will not have the right to convert its shares of Series A preferred stock or exercise any portion of its PA Warrants if such holder, together with its affiliates and attribution parties, would beneficially own in excess of 4.99% of the number of shares of the Company’s Class A common stock outstanding immediately after giving effect to such conversion or exercise; provided that the holder may elect to decrease, or upon at least 61 days’ prior notice to the Company, increase such beneficial ownership limitation. In no event shall such beneficial ownership limitation exceed 9.99%, other than in the event of Selling Stockholders receiving notice of a Company Fundamental Transaction, as defined in the Company’s Certificate of Designation, in which case a Selling Stockholder may waive any ownership limitation with respect to conversion of Series A preferred stock. Additionally, stockholders may have acquired or sold shares of Class on the open market without the Company’s knowledge that may not be reflected.

(2)	Represents shares of the Company’s Class A common stock underlying the Series A preferred stock and PA Warrants issued to the Selling Stockholders in connection with the Private Placement and offered hereby.

(3)

We do not know when or in what amounts a Selling Stockholder may offer shares of our Class A common stock for sale. The Selling Stockholders might not sell any or might sell all of the shares of our Class A common stock offered by this prospectus. Because the Selling Stockholders may offer all or some of the shares of our Class A common stock pursuant to this offering, and because there are currently no agreements, arrangements or understandings with respect to the sale of any of the shares of our Class A common stock, we cannot estimate the number of shares of our Class A common stock that will be held by the Selling Stockholders after completion of the offering. However, for purposes of this table, we have assumed that, after completion of the offering, none of the shares of our Class A common stock covered by this prospectus will be held by the Selling Stockholders.

(4)

The securities are held by Coastlands Capital Partners LP (“Coastlands Capital”). Coastlands Capital LP is the investment adviser to Coastlands Capital, and Coastlands Capital GP LLC (“Coastlands GP”) is the general partner of Coastlands Capital. Coastlands Capital LLC is the general partner of Coastlands Capital LP. Pursuant to the Investment Adviser Agreement, Coastlands GP delegated its investment management obligations to Coastlands Capital LP, and Coastlands Capital granted Coastlands Capital LP full discretion over investment decisions regarding its assets, including authority to exercise rights incidental to ownership of securities, including proxy voting authority. Matthew D. Perry is the control person of the foregoing entities. The Coastlands Entities and Mr. Perry each disclaim membership in a group and beneficial ownership of the shares of Class A common stock except to the extent of their respective pecuniary interests therein. The address and principal office of the Coastlands Entities and Mr. Perry is 601 California St., Suite 1210, San Francisco, CA 94108.

DIVIDEND POLICY

(5)	These shares are comprised of (i) 1,287,000 shares of Class A common stock purchased in the Private Placement and (ii) 13,232,331 shares of Class A common stock issuable upon conversion of 6,880.76 shares of Series A preferred stock purchased in the Private Placement. The Series A preferred stock contains certain beneficial ownership limitations, which provide that a holder of the securities will not have the right to convert its shares of Series A preferred stock if such holder, together with its affiliates and attribution parties, would beneficially own in excess of 4.99% of the number of shares of the Company’s Class A common stock outstanding immediately after giving effect to such conversion; provided that the holder may elect to decrease, or upon at least 61 days’ prior notice to the Company, increase such beneficial ownership limitation. In no event shall such beneficial ownership limitation exceed 9.99%, other than in the event of the Selling Stockholder receiving notice of a Company Fundamental Transaction, as defined in the Company’s Certificate of Designation, in which case the Selling Stockholder may waive any ownership limitation with respect to conversion of Series A preferred stock.

(6)	The securities are held by Janus Henderson Biotech Innovation Master Fund Limited (“JHBI Master Fund”) or Janus Henderson Biotech Innovation Master Fund II Limited (“JHBI Master Fund II” and together with the JHBI Master Fund, the “Janus Funds”), as specified in footnote (7). Such securities may be deemed to be beneficially owned by Janus Henderson Investors US LLC (“Janus”), an investment adviser registered under the Investment Advisers Act of 1940, who acts as investment adviser for the Janus Funds and has the ability to make decisions with respect to the voting and disposition of the shares subject to the oversight of the board of directors of the Janus Funds. Under the terms of its management contract with the Janus Funds, Janus has overall responsibility for directing the investments of the Janus Funds in accordance with the Janus Funds’ investment objectives, policies and limitations. The Janus Funds have one or more portfolio managers appointed by and serving at the pleasure of Janus whom makes decisions with respect to the disposition of the shares of Class A common stock offered hereby. The address for Janus is 151 Detroit Street, Denver, CO 80206. The portfolio managers for the Janus Funds are: Andrew Acker, Daniel S. Lyons and Agustin Mohedas.

(7)	These shares are comprised of (i) 1,059,201 shares of Class A common stock purchased in the Private Placement by JHBI Master Fund, (ii) 6,854,261 shares of Class A common stock issuable upon conversion of 3,564.22 shares of Series A preferred stock purchased in the Private Placement by JHBI Master Fund, (iii) 227,799 shares of Class A common stock purchased in the Private Placement by JHBI Master Fund II, and (iv) 1,474,124 shares of Class A common stock issuable upon conversion of 766.54 shares of Series A preferred stock purchased in the Private Placement by JHBI Master Fund II. The Series A preferred stock contains certain beneficial ownership limitations, which provide that a holder of the securities will not have the right to convert its shares of Series A preferred stock if such holder, together with its affiliates and attribution parties, would beneficially own in excess of 4.99% of the number of shares of the Company’s Class A common stock outstanding immediately after giving effect to such conversion; provided that the holder may elect to decrease, or upon at least 61 days’ prior notice to the Company, increase such beneficial ownership limitation. In no event shall such beneficial ownership limitation exceed 9.99%, other than in the event of the Selling Stockholder receiving notice of a Company Fundamental Transaction, as defined in the Company’s Certificate of Designation, in which case the Selling Stockholder may waive any ownership limitation with respect to conversion of Series A preferred stock.

(8)	The securities are held by Kalehua Capital Partners LP. Kalehua Capital Management LLC is the general partner of Kalehua Capital Partners LP, and in such capacity has voting and investment power over the shares held by Kalehua Capital Partners LP. Tai-Li Chang is the sole Member and Manager of Kalehua Capital Management LLC, and in such capacity may be deemed to have voting and investment power over the shares held by Kalehua Capital Partners LP. Each of Tai-Li Chang and Kalehua Capital Management LLC disclaims beneficial ownership of such shares except to the extent of their respective pecuniary interests therein. The address for each of the foregoing entities is 3819 Maple Avenue, Dallas, Texas 75219.

(9)	These shares are comprised of (i) 939,461 shares of Class A common stock purchased in the Private Placement and (ii) 464,312 shares of Class A common stock issuable upon conversion of 241.44 shares of Series A preferred stock purchased in the Private Placement. The Series A preferred stock contains certain beneficial ownership limitations, which provide that a holder of the securities will not have the right to convert its shares of Series A preferred stock if such holder, together with its affiliates and attribution parties, would beneficially own in excess of 4.99% of the number of shares of the Company’s Class A common stock outstanding immediately after giving effect to such conversion; provided that the holder may elect to decrease, or upon at least 61 days’ prior notice to the Company, increase such beneficial ownership limitation. In no event shall such beneficial ownership limitation exceed 9.99%, other than in the event of the Selling Stockholder receiving notice of a Company Fundamental Transaction, as defined in the Company’s Certificate of Designation, in which case the Selling Stockholder may waive any ownership limitation with respect to conversion of Series A preferred stock.

We have never declared nor paid any cash dividends, and currently intend to retain all our cash and any earnings for use in our business. Any future determination to pay cash dividends will be at the discretion of the Board of Directors and will be dependent upon our financial condition, results of operations, capital requirements and such other factors as the Board of Directors deems relevant. Investors should not purchase our Class A common stock with the expectation of receiving cash dividends.

DILUTION

If you invest in our securities in this offering, your ownership interest may be diluted immediately depending on the difference between the effective public offering price per share of our Class A common stock (assuming the exercise for cash of all pre-funded warrants issued in this offering) and the as adjusted net tangible book value per share of our common stock immediately after this offering (assuming the exercise for cash of all pre-funded warrants issued in this offering).

At March 31, 2025, we had a net tangible book value of $13.9 million or $0.93 per share of common stock on a post-split basis. Net tangible book value per share represents our total tangible assets (total assets less intangible assets) less total liabilities at a particular date, divided by the total number of our outstanding shares of our common stock as of that date.

After giving effect to the sale and issuance of 3,846,154 shares of Class A common stock and accompanying Class A common warrants in this offering, at an assumed combined public offering price of $1.56 per share and accompanying Class A common warrant, based on the closing price of our Class A common stock on the Nasdaq Capital Market on July 29, 2025, assuming no sale of any pre-funded warrants in this offering, no exercise of any of the Class A common warrants being offered in this offering, no exercise of the Placement Agent Warrants to be issued to the placement agent or its designees as compensation in connection with this offering, and after deducting placement agent fees and estimated offering expenses payable by us, our as adjusted net tangible book value as of March 31, 2025, would have been approximately $19.1 million or $1.02 per share of our common stock. This represents an immediate increase in as adjusted net tangible book value of approximately $0.09 per share to our existing stockholders and an immediate decrease in such measure of $0.54 per share to new investors.

The dilution to investors participating in this offering is determined by subtracting the as adjusted net tangible book value per share after this offering from the effective public offering price per share paid by investors participating in this offering. The actual combined public offering price will be determined through negotiation between us, the placement agent and the investors in the offering and may be at a discount to the current market price. Therefore, the assumed public offering price used throughout this prospectus may not be indicative of the final public offering price. The following table illustrates this result on a per share basis:

Assumed combined public offering price per share and accompanying Class A common warrants			$	1.56
Net tangible book value per share of common stock at March 31, 2025	$	0.93
Increase in net tangible book value per share attributable to new investors	$	0.09
As adjusted net tangible book value per share of common stock after this offering				1.02
Dilution per share to new investors				0.54

A $0.10 increase in the assumed combined public offering price per share and accompanying Class A common warrants would increase the as adjusted net tangible book value by $0.02 per share and result in dilution to investors participating in this offering of $0.63 per share, and a $0.10 decrease in the assumed combined public offering price per share and accompanying Class A common warrants would decrease the as adjusted net tangible book value by $0.02 per share and result in dilution to investors participating in this offering by $0.46 per share, in each case assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and assuming no pre-funded warrants are sold in this offering, no exercise of the Class A common warrants being offered in this offering, that no value is attributed to such Class A common warrants and that such Class A common warrants are classified as and accounted for as equity, and after deducting placement agent fees and estimated expenses payable by us.

(10)	The securities are held by Kalehua Equity Growth Master LP. Kalehua Capital Management LLC is the investment manager of Kalehua Equity Growth Master LP, and in such capacity has voting and investment power over the shares held by Kalehua Equity Growth Master LP. Tai-Li Chang is the sole Member and Manager of Kalehua Capital Management LLC, and in such capacity may be deemed to have voting and investment power over the shares held by Kalehua Equity Growth Master LP. Each of Tai-Li Chang and Kalehua Capital Management LLC disclaims beneficial ownership of such shares except to the extent of their respective pecuniary interests therein. The address for each of the foregoing entities is 3819 Maple Avenue, Dallas, Texas 75219.

(11)	These shares are comprised of (i) 347,539 shares of Class A common stock purchased in the Private Placement and (ii) 171,765 shares of Class A common stock issuable upon conversion of 89.32 shares of Series A preferred stock purchased in the Private Placement. The Series A preferred stock contains certain beneficial ownership limitations, which provide that a holder of the securities will not have the right to convert its shares of Series A preferred stock if such holder, together with its affiliates and attribution parties, would beneficially own in excess of 4.99% of the number of shares of the Company’s Class A common stock outstanding immediately after giving effect to such conversion; provided that the holder may elect to decrease, or upon at least 61 days’ prior notice to the Company, increase such beneficial ownership limitation. In no event shall such beneficial ownership limitation exceed 9.99%, other than in the event of the Selling Stockholder receiving notice of a Company Fundamental Transaction, as defined in the Company’s Certificate of Designation, in which case the Selling Stockholder may waive any ownership limitation with respect to conversion of Series A preferred stock.

(12)	The securities are held by Logos Opportunities Fund V LP. Logos Opportunities V GP LLC (“GP V”) is the general partner of Logos Opportunities Fund V LP and may be deemed to have beneficial ownership of these securities. Arsani William and Graham Walmsley are the members of GP V. Mr. William and Mr. Walmsley each disclaim beneficial ownership of these securities except to the extent of his respective pecuniary interest therein.

(13)	These shares are comprised of (i) 1,287,000 shares of Class A common stock purchased in the Private Placement and (ii) 636,077 shares of Class A common stock issuable upon conversion of 330.76 shares of Series A preferred stock purchased in the Private Placement. The Series A preferred stock contains certain beneficial ownership limitations, which provide that a holder of the securities will not have the right to convert its shares of Series A preferred stock if such holder, together with its affiliates and attribution parties, would beneficially own in excess of 4.99% of the number of shares of the Company’s Class A common stock outstanding immediately after giving effect to such conversion; provided that the holder may elect to decrease, or upon at least 61 days’ prior notice to the Company, increase such beneficial ownership limitation. In no event shall such beneficial ownership limitation exceed 9.99%, other than in the event of the Selling Stockholder receiving notice of a Company Fundamental Transaction, as defined in the Company’s Certificate of Designation, in which case the Selling Stockholder may waive any ownership limitation with respect to conversion of Series A preferred stock.

(14)	The securities are held by Stuywater Capital LLC (“Stuywater”) or Noam Rubinstein, as specified in footnote (15). Noam Rubinstein is the managing member of Stuywater and holds voting and dispositive power over the securities that are held by him and by Stuywater. As a result, Mr. Rubinstein may be deemed to have beneficial ownership (as determined under Section 13(d) of the Exchange Act) of the securities reported herein that are held by Stuywater. Mr. Rubinstein is affiliated with H.C. Wainwright & Co., LLC, a registered broker-dealer. Neither Stuywater nor Mr. Rubinstein is a broker-dealer. The securities were acquired in the ordinary course of business and, at the time the securities were acquired, the selling stockholder had no agreement or understanding, directly or indirectly, with any person to distribute such securities. The registered business address of Stuywater and Mr. Rubinstein is 430 Park Avenue, 3rd Floor, New York, NY 10022.

An increase of 384,615 shares of Class A common stock and accompanying Class A common warrants offered by us from the assumed number of shares of Class A common stock and accompanying Class A common warrants set forth on the cover page of this prospectus would increase our pro forma as adjusted net tangible book value per share by less than $0.01 and our as adjusted net tangible book value per share would be $1.02, representing a decrease in as adjusted net tangible book value per share to new investors in this offering of $0.54. A decrease of 384,615 shares in the number of shares offered by us in this offering would decrease our as adjusted net tangible book value per share by approximately $0.01 resulting in an as adjusted net tangible book value per share of $1.01 and a decrease in as adjusted net tangible book value per share to new investors participating in this offering of $0.55 per share. The foregoing calculations assume that the combined public offering price remains the same, and are after deducting placement agent fees and estimated expenses payable by us.

The table and discussion above are based on 14,957,903 shares of common stock outstanding at March 31, 2025, and exclude, as of that date, the following:

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