AsRegistration Statement ~~filed with the U~~No.S. ~~Securities and Exchange Commission on October 11, 2016~~ 333-______

~~Registration~~UNITED STATES SECURITIES ~~Statement~~AND NoEXCHANGE COMMISSION Washington, D.C. ~~333-~~20549

~~UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549~~FORM S-1

~~FORM S-1~~ REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

Accelerated Pharma, Inc.

(Exact name of registrant as specified in its charter)

Delaware	2834	47-2380751
(State orjurisdiction ofincorporation ororganization)	(Primary StandardIndustrialClassificationCode Number)	(IRS EmployerIdentification No.)
(State or other Jurisdiction of Incorporation)	(Primary Standard Industrial Classification Code)	(IRS Employer Identification No.)

36 Church Lane ~~Westport, Connecticut 06880 (203) 520-3840~~

~~(Address~~Westport, Connecticut ~~including zip code, and telephone number, including area code, of registrant’s principal executive offices)~~ 06880

~~Michael Fonstein, PhD. Chief Executive Officer 36 Church Lane Westport, Connecticut 06880~~ Phone: (203) 520-3840

(~~Name~~Address, ~~address,~~ including zip code, and telephone number, including area code, of ~~agent~~registrant’s ~~for~~principal ~~service)~~executive offices)

~~Copies~~Michael Fonstein, ~~to:~~ PhD.

~~Barry~~Chief Executive I. Grossman, Esq.Lawrence A. Rosenbloom, Esq.Ellenoff Grossman & Schole LLP1345 Avenue of the AmericasNew York, New York 10105Phone: (212) 370-1300Fax: (212) 370-7889 Louis Taubman, Esq.Joan Wu, Esq.Hunter Taubman Fischer & Li LLC1450 Broadway, 26th FloorNew York, New York 10018Phone: (212) 732-7184Fax: (212) 202-6380Officer

~~Approximate~~36 Church ~~date~~Lane, ofWestport, ~~commencement~~Connecticut ~~of proposed sale to the public: As soon as practicable after the effective date of this registration statement.~~ 06880

IfPhone: (203) ~~any~~520-3840 ~~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. o~~

~~If this Form is filed to register additional securities for an offering pursuant to Rule 462~~(b)Name, address, ~~under~~including ~~the~~zip ~~Securities Act~~code, ~~please check the following box~~ and ~~list~~telephone ~~the~~number, ~~Securities~~including ~~Act~~area ~~registration~~code, ~~statement number~~ of ~~the~~agent ~~earlier effective registration statement~~ for ~~the same offering. o~~ service)

~~If this Form is a post-effective amendment filed pursuant~~ Copies 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. o~~ :

IfLawrence R. ~~this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act~~Lonergan, ~~check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering~~Esq. o

If96 Park ~~delivery of the Prospectus is expected to be made pursuant to Rule 434, check the following box. o~~ Street

~~Indicate by check mark whether the registrant is a large accelerated filer~~Montclair, NJ an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. 07042

~~Large accelerated filer o Accelerated filer o Non-accelerated filer o~~Phone: (~~Do not check if a smaller reporting company~~973) ~~Smaller reporting company x~~641-4012

~~TABLE OF CONTENTS~~and

~~CALCULATION~~280 Madison OFAvenue, ~~REGISTRATION~~Suite ~~FEE~~300

Title of Each Class of Securities to Be Registered	Amount to Be Registered		Proposed Maximum Offering Price per Share		Proposed Maximum Aggregate Offering Price		Amount of Registration Fee(3)
Shares of common stock, par value $0.0001 per share(1)(2)		—		—	$	19,550,000	$	2,265.85
Shares of common stock underlying representatives’ warrants(1)(2)		—		—		—		—
Shares of common stock underlying outstanding convertible promissory notes(1)(2)(3)		1,716,026	$	10.00	$	17,160,260	$	1,988.87
Total		—		—	$	36,710,260	$	4,254.72

New York NY 10016

Phone: (1973) Estimated solely for the purpose of calculating the registration fee under Rule 457(o) of the Securities Act of 1933, as amended (the “Securities Act”). Includes shares of our common stock that the underwriters have the option to purchase to cover over641-~~allotments, if any.~~4012

~~(2)~~Approximate date ~~Pursuant~~of tocommencement ~~Rule~~of ~~416~~proposed ~~under~~sale ~~the~~to ~~Securities Act,~~ the ~~securities~~public: ~~being~~As ~~registered~~soon ~~hereunder include such indeterminate number of additional shares of common stock~~ as ~~may~~practicable ~~be issued~~ after the effective date ~~hereof as a result~~ of ~~stock~~this ~~splits,~~registration ~~stock dividends or similar transactions~~statement.

~~(3)~~If any ~~Represents shares~~ of ~~common~~the ~~stock~~securities ~~issuable~~being toregistered ~~selling~~on ~~stockholders~~this ~~upon~~Form ~~the~~are ~~conversion~~to ofbe ~~convertible~~offered ~~promissory~~on ~~notes,~~a ~~including~~delayed ~~interest~~or ~~payable~~continuous ~~thereon~~basis ~~through~~pursuant ~~September~~to ~~30,~~Rule ~~2016,~~415 ~~issued~~under the bySecurities ~~the~~Act ~~registrant~~of in1933, acheck ~~private~~the ~~placement~~following ~~offering~~box. [X]

~~The Registrant hereby amends~~ If this ~~Registration~~Form ~~Statement~~is onfiled ~~such~~to ~~date~~register oradditional ~~dates~~securities asfor ~~may~~an beOffering ~~necessary~~pursuant to ~~delay~~Rule ~~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~~462(ab) ofunder the Securities Act ~~of 1933~~, asplease check ~~amended,~~the orfollowing ~~until~~box ~~this~~and ~~Registration~~list ~~Statement~~the ~~shall~~Securities ~~become~~Act ~~effective~~registration onstatement ~~such~~number ~~date~~of as the ~~Commission~~earlier ~~acting~~effective ~~pursuant~~registration tostatement for ~~said~~the ~~Section~~same ~~8(a) may determine~~Offering. [ ]

~~TABLE~~If this OFForm ~~CONTENTS~~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. [ ]

~~EXPLANATORY~~If this ~~NOTE~~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. [ ]

~~This~~If delivery ~~registration statement contains two forms~~ of ~~prospectus. One form of prospectus, which we refer to as~~ the ~~initial~~Prospectus ~~public offering prospectus,~~ is expected to be ~~used~~made inpursuant ~~connection with an initial public offering of up~~ to ~~1,888,889~~Rule ~~shares of our common stock. The other form of prospectus~~434, ~~which~~check ~~we refer to as~~ the ~~resale~~following prospectus, is to be used in connection with the potential resale by certain selling stockholders of an aggregate of 1,716,026 shares of our common stock issuable upon the conversion of our outstanding convertible notes upon the effectiveness of the registration statement of which such prospectus forms a partbox. The initial public offering prospectus and the resale prospectus will be identical in all respects except for the alternate pages for the resale prospectus included herein which are labeled “Alternate Page for Resale Prospectus.” [ ]

~~TABLE~~Indicate by OFcheck ~~CONTENTS~~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.

~~The~~Large ~~information~~accelerated infiler ~~this~~[ ~~preliminary~~] ~~prospectus~~Accelerated isfiler ~~not~~[ ~~complete~~] ~~and~~Non-accelerated ~~may~~filer be[ ~~changed.~~] ~~These~~Smaller ~~securities~~reporting ~~may~~company ~~not~~[X] be(Do ~~sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is~~ not ancheck ~~offer~~if toa ~~sell~~smaller ~~these~~reporting ~~securities~~company) ~~and~~Emerging isgrowth ~~not~~company ~~soliciting an offer to buy these securities in any state where the offer or sale is not permitted.~~ [X]

~~Preliminary~~If an ~~Prospectus~~emerging ~~Subject~~growth company, indicate by check mark if the registrant has elected not to ~~Completion,~~use ~~dated~~the ~~October~~extended ~~11,~~transition ~~2016~~period for complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act. [ ]

~~1,888,889~~CALCULATION OF ~~Shares~~REGISTRATION ~~of Common Stock~~FEE

This is the initial public offering of Accelerated Pharma, Inc. We are offering 1,888,889 shares of our common stock in this offering. Prior to this offering, there has been no public market for our common stock. We currently expect the initial public offering price per share to be between $8.00 and $10.00. We have applied to have our common stock listed on The NASDAQ Capital Market under the symbol “ACCP”.

Title of Class of Security being registered	Amount to be Registered		Proposed Offering Price per Unit share⁽²⁾⁽³⁾		Proposed Maximum Aggregate Offering Price^(1)(2)(3)		Amount of Registration Fee
Units, each consisting of one share of Common Stock, $0.001 par value and one Class A Warrant entitling the holder to purchase one additional share of Common Stock		750,000	$	4.00	$	3,000,000	$	363.60
Shares of Common Stock, $0.001 par value, included as part of the Units		750,000	$	—		—		—	⁽³⁾
Shares of Common Stock, $0.001 par value, underlying the Warrants included as part of the Units		750,000	$	__	$		$	—	⁽⁴⁾
Total		1,500,000	$		$		$	—

We(1) Estimated ~~are~~solely anfor ~~“emerging~~the ~~growth~~purpose ~~company”~~of ~~under~~computing the ~~federal~~registration ~~securities~~fee ~~laws~~pursuant ~~and have elected~~ to ~~comply~~Rule ~~with~~457 ~~certain~~of ~~reduced~~the ~~public~~Securities ~~company reporting requirements~~Act.

~~Investing~~(2) Offering inprice ~~our~~has ~~securities~~been isarbitrarily ~~highly~~determined ~~speculative~~by ~~and~~the ~~involves~~Board ~~a significant degree~~ of ~~risk~~Directors. ~~See “Risk Factors” beginning on page 9 of this prospectus for a discussion of information that should be considered before making a decision to purchase our securities.~~

	Per Share	Total
Public offering price
Discounts and commissions to underwriters(1)
Proceeds, before expenses, to us

(3) The Offering Price has been estimated solely for the purpose of computing the amount of the registration fee in accordance with Rule 457(o).

(14) In ~~See~~accordance ~~“Underwriting”~~with onRule ~~page~~457(g) 92under ofthe ~~this~~Securities ~~prospectus~~Act, ~~for~~because athe ~~description~~shares of our ~~arrangements~~Common ~~with~~Stock underlying the ~~underwriters~~Class A Warrants are registered hereby, no separate registration fee is required with respect to these Warrants registered hereby.

WeThe registrant ~~have~~hereby ~~granted~~amends athis 45registration ~~day~~statement ~~option~~on such date or dates as may be necessary to delay its effective date until the ~~representatives~~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 ~~underwriters~~Securities toAct ~~purchase~~of up1933 toor anuntil ~~additional~~the ~~283,334~~registration ~~shares~~statement ofshall ~~common~~become ~~stock~~effective on such date as the Securities and Exchange Commission, acting pursuant to ~~cover~~said ~~over-allotments~~Section 8(a), ifmay ~~any~~determine.

The information ~~underwriters~~in ~~expect~~this topreliminary ~~deliver~~prospectus ~~the~~is ~~shares~~not tocomplete ~~purchasers~~and onmay orbe ~~about ,~~changed. ~~2016~~These ~~through~~securities may not be sold until the ~~book-entry~~registration statement ~~facilities~~filed ofwith ~~The~~the ~~Depository~~Securities ~~Trust~~and ~~Company~~Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

~~Neither~~Preliminary ~~the~~Prospectus ~~Securities~~Subject ~~and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation~~ to ~~the~~Completion, ~~contrary~~dated is, ~~a criminal offense.~~ 2018

~~Rodman~~750,000 Units &consisting ~~Renshaw,a~~of ~~unit~~One Share of ~~H.C.~~Common ~~Wainwright~~Stock &and ~~Co.~~One ~~Maxim~~Class ~~Group~~A ~~LLC~~Warrant

This is the initial public Offering of Accelerated Pharma, Inc. We are Offering 750,000 Units (the “Units”), each Unit consisting of one (1) share of our Common Stock (the “Shares” or “Common Stock”) and one (1) Class A Warrant, exercisable on or before the five-year anniversary of issuance to purchase one (1) additional Share at an exercise price of $4.40 per Share. The ~~date~~Shares and the Class A Warrants that are part of the Units are immediately separable and will be issued separately but will be purchased together in this ~~prospectus~~Unit is Offering (the “Offering” or “Unit Offering”). The Units will not be issued, ~~2016~~certificated or traded. Prior to this Offering, there has been no public market for our Common Stock or Class A Warrants. We currently expect the initial public Offering Price to be $4.00 per Unit (the “Offering Price” or “Unit Offering Price”).

~~TABLE~~We are OFan ~~CONTENTS~~“emerging growth company” as defined in the Jumpstart Our Business Startups Act and have elected to comply with certain reduced public company reporting requirements.

~~TABLE~~There is OFno ~~CONTENTS~~established market for our Common Stock. The Offering Price of the Units has been determined arbitrarily by us. The price of our Common Stock and the Offering Price of the Units does not bear any relationship to our assets, book value, earnings, or other established criteria for valuing a privately held company. In determining the number of Units to be offered and the Offering Price, we took into consideration our capital structure and the amount of money we would need to implement our business plans. Accordingly, the Unit Offering Price should not be considered an indication of the actual value of our securities.

	Page
Prospectus Summary		1
Risk Factors		9
Cautionary Note Regarding Forward-Looking Statements		36
Use of Proceeds		37
Dividend Policy		39
Capitalization		40
Dilution		41
Management’s Discussion and Analysis of Financial Condition and Results of Operations		42
Business		48
Management		74
Executive Compensation		78
Principal Stockholders		82
Certain Relationships and Related Party Transactions		84
Description of Securities		85
Shares Eligible For Future Sale		90
Underwriting		92
Experts		96
Legal Matters		96
Where You Can Find More Information		96
Index to Financial Statements		F-1

Our Common Stock is not currently quoted on the OTC Market Group’s quotation system or any other quotation system or exchange and we have no ticker symbol for our Shares of Common Stock or Class A Warrants. There is no trading market for our securities whatsoever.

~~Please~~Investing in ~~read this prospectus carefully. It describes~~ our ~~business,~~securities ~~our~~is ~~financial~~highly ~~condition~~speculative and ~~our~~involves ~~results~~a ofsignificant ~~operations.~~degree Weof ~~have prepared this prospectus so that you will have the information necessary to make an informed investment decision~~risk. ~~You~~See ~~should~~“Risk ~~rely~~Factors” ~~only~~beginning on page ~~the~~11 ~~information~~of ~~contained in~~ this prospectus. Wefor ~~have~~a ~~not~~discussion ~~authorized~~of ~~anyone~~information tothat ~~provide~~should ~~you~~be ~~with~~considered ~~any~~before ~~information~~making ~~or to make~~ any ~~representations~~decision ~~about us, the securities being offered pursuant~~ to ~~this~~purchase ~~prospectus or any other matter discussed in this prospectus, other than the information and representations contained in this prospectus. If any other information or~~our ~~representation is given or made, such information or representation may not be relied upon as having been authorized by us~~securities.

~~The information contained in this~~ This prospectus is ~~accurate~~not ~~only~~an asoffer ofto ~~the~~sell ~~date~~these ofsecurities ~~this~~and ~~prospectus,~~it ~~regardless~~is ofnot the ~~time~~solicitation of ~~delivery~~an ofoffer ~~this~~to ~~prospectus~~buy orthese ~~of any sale of our common stock. Neither the delivery of this prospectus nor any distribution of~~ securities in ~~accordance with this prospectus shall, under~~ any state ~~circumstances,~~where ~~imply that there has been no change in our affairs since~~ the ~~date~~offeror ofsale ~~this~~is ~~prospectus.~~not ~~This prospectus will be updated and made available for delivery to the extent required by the federal securities laws~~permitted.

~~This~~The Unit ~~prospectus~~Offering ~~includes~~is ~~estimates,~~being ~~statistics and other industry data that we obtained from industry publications, research, surveys and studies~~ conducted byon ~~third parties and publicly available information. Such data involves~~ a ~~number~~self-underwritten, ofbest ~~assumptions~~efforts ~~and~~basis, ~~limitations~~which ~~and~~means ~~contains~~our ~~projections~~management and ~~estimates~~placement ofagent(s) will ~~the~~attempt ~~future~~to ~~performance~~sell of the ~~industries~~Units inbeing ~~which~~offered wehereby ~~operate~~on ~~that~~behalf ~~are subject to a high degree~~ of ~~uncertainty.~~the ~~This prospectus also includes data based on our own internal estimates~~Company. WeThere ~~caution~~is ~~you~~no ~~not~~underwriter tofor ~~give~~this ~~undue weight to such projections, assumptions and estimates~~Offering.

Completion iof this Unit Offering is not subject to us raising a minimum Offering amount. We do not have an arrangement to place the proceeds from this Offering in an escrow, trust or similar account. Any funds raised from the Offering will be immediately available to us for our immediate use.

~~TABLE~~The Company OFdoes ~~CONTENTS~~not plan to use this prospectus before the effective date.

For investors outside the United States: Neither we nor the underwriters have done anything that would permit this offering or possession or distribution of this prospectus or any free writing prospectus we may provide to you in connection with this offering in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus and any such free writing prospectus outside of the United States.

	Per Unit Share and Accompanying Class A Warrants		Total
Public Offering Price	$	4.00	$	3,000,000
Placement agent’s fees	$		$	300,000
Offering proceeds to Accelerated Pharma, before expenses	$		$	2,700,000

Because iithere is no minimum Offering amount required as a condition to closing in this Offering, the actual public Offering amount, prior placement agent’s 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.

~~TABLE~~Neither the OFSecurities ~~CONTENTS~~and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

~~PROSPECTUS~~The date ~~SUMMARY~~of this prospectus is , 2018.

~~This~~TABLE OF summary highlights selected information contained elsewhere in this prospectus. To understand this offering fully, you should read the entire prospectus carefully, including the “Risk Factors” section, the consolidated financial statements and the notes to the consolidated financial statements. Unless the context otherwise requires, references contained in this prospectus to “we,” “us,” “our” or similar terminology refers to Accelerated Pharma, Inc., a Delaware corporation. CONTENTS

Unless otherwise indicated, all share amounts and per share amounts in this prospectus have been presented on a pro-forma basis to reflect a forward stock split of the outstanding shares of our common stock at a ratio of 4.9-for-1 shares effected on , 2016.

	Page

Prospectus Summary	1
Risk Factors	11
Cautionary Note Regarding Forward-Looking Statements	36
Use of Proceeds	37
Dividend Policy	38
Capitalization	39
Dilution	40
Management’s Discussion and Analysis of Financial Condition and Results of Operations	41
Business	46
Management	73
Executive Compensation	77
Principal Stockholders	80
Certain Relationships and Related Party Transactions	80
Description of Securities	81
Shares Eligible For Future Sale	86
Plan of Distribution	88
Experts	92
Legal Matters	92
Where You Can Find More Information	92
Index to Consolidated Financial Statements	F-1

~~Overview~~Please read this prospectus carefully. It describes our business, our financial condition and our results of operations. We have prepared this prospectus so that you will have the information necessary to make an informed investment decision. You should rely only on the information contained in this prospectus. We have not authorized anyone to provide you with any information or to make any representations about us, the securities being offered pursuant to this prospectus or any other matter discussed in this prospectus, other than the information and representations contained in this prospectus. If any other information or representation is given or made, such information or representation may not be relied upon as having been authorized by us.

WeThe information ~~are~~contained ain ~~clinical~~this ~~stage~~prospectus ~~biopharmaceutical~~is ~~company~~accurate ~~focused~~only onas ~~utilizing~~of ~~our~~the ~~genomic~~date ~~technology~~of tothis ~~(i)~~prospectus, ~~enhance~~regardless of the ~~development~~time of ~~pre-existing~~delivery of ~~pharmaceutical~~this ~~products~~prospectus ~~for~~or of any sale of our Common Stock. Neither the ~~treatment~~delivery of ~~various~~this ~~cancer~~prospectus ~~indications~~nor any distribution of securities in accordance with this prospectus shall, ~~(ii)~~under ~~prospectively~~any ~~identify~~circumstances, ~~patients~~imply that ~~may~~there ~~respond~~has tobeen ~~such~~no ~~pharmaceutical~~change ~~products~~in ~~and~~our ~~(iii)~~affairs ~~commercialize~~since ~~such~~the date ~~pharmaceutical~~of ~~products~~this prospectus. This prospectus will be updated and made available for ~~sale~~delivery into ~~various~~the ~~markets.~~extent required by the federal securities laws.

~~Our~~This prospectus ~~lead~~includes ~~product candidate is Picoplatin~~estimates, astatistics ~~new~~and ~~generation~~other ~~platinum-based~~industry ~~cancer~~data ~~therapy~~ that ~~has~~we ~~the~~obtained ~~potential~~from ~~for~~industry ~~use in different formulations~~publications, ~~as a single agent or in combination with other anti-cancer agents~~research, ~~to treat multiple cancer indications. We hold~~ surveys and ~~are~~studies ~~the~~conducted ~~exclusive,~~by ~~worldwide~~third ~~licensee~~parties ~~of patented~~ and ~~proprietary~~publicly ~~technology~~available ~~related to Picoplatin~~information. WeSuch ~~will~~data ~~initially~~involves ~~use~~a ~~our~~number ~~genomic~~of ~~technology~~assumptions toand ~~identify~~limitations and ~~suitable~~contains ~~patients~~projections ~~prospectively~~and ~~for~~estimates ~~our~~of ~~anticipated~~the ~~Picoplatin~~future ~~clinical~~performance ~~trials described below in hope~~ of ~~obtaining regulatory approval for Picoplatin and commercializing~~ the ~~therapy.~~industries ~~Ultimately,~~in which we ~~believe~~operate that ~~our~~ ~~genomic~~are ~~program~~subject ~~will allow us~~ to ~~identify~~a ~~additional~~high degree ~~drug candidates that can be substantially improved for the treatment~~ of ~~various~~uncertainty. ~~cancer~~This ~~indications~~prospectus ~~and~~also ~~ultimately~~includes ~~create~~data abased ~~targeted,~~on ~~driven~~our ~~approach~~own ~~for~~internal ~~cancer~~estimates. ~~treatment~~We bycaution ~~selecting~~you ~~patients~~not ~~who~~to ~~will~~give ~~respond~~undue weight to ~~therapy~~such inprojections, ~~advance~~assumptions ofand ~~administering such therapy~~estimates.

~~Platinum-based~~For investors ~~drugs~~outside ~~are~~the ~~prescribed~~United ~~for~~States: aNeither ~~significant~~we ~~portion~~nor ofany ~~newly~~placement ~~diagnosed~~agents ~~cancer~~have ~~patients,~~done ~~generating~~anything ~~several~~that ~~billions~~would ofpermit ~~dollars~~this inOffering or ~~estimated~~possession ~~annual~~or ~~sales~~distribution ~~according~~of tothis aprospectus ~~review~~or ~~article~~any ~~published~~free inwriting ~~December~~prospectus ~~2007~~we inmay ~~Cancer~~provide ~~Therapy~~to ~~entitled~~you ~~“Designing Platinum Compounds~~ in ~~Cancer.”~~connection Inwith ~~many~~this Offering ~~cases, these treatments succeed~~ in ~~reducing~~any ~~the~~jurisdiction ~~size~~where ofaction ~~tumors.~~for ~~However,~~that ~~current~~purpose ~~platinum~~is ~~therapies suffer from two major shortcomings. First~~required, ~~platinum-based~~other ~~chemotherapy~~than ~~often causes serious side effects. Second, and even worse, recipients often do not respond to these treatments, resulting~~ in the ~~loss~~United ~~of critical time for alternative therapies~~States. ~~Therefore,~~You ~~while platinum drugs~~ are ~~widely~~required ~~viewed as effective in the treatment of cancer, improvements are needed. We believe that our strategy~~ to ~~integrate~~inform yourselves aabout ~~new~~and platinum molecule (Picoplatin) with improved properties into pre-existing pharmaceutical products can improve the success rates of such products, especially because we expect that our technology will allow us to ~~identify~~observe ~~prospectively~~any ~~patients~~restrictions ~~that~~relating ~~will be more likely~~ to ~~respond~~this ~~positively~~Offering toand the ~~treatment.~~distribution ~~We believe these factors make Picoplatin a potentially attractive compound for other pharmaceutical companies to partner with us for the commercialization~~ of ~~Picoplatin~~this ~~upon~~prospectus ~~or prior to the completion of our anticipated clinical trials~~ and~~/or~~ ~~U.S.~~any ~~Food~~such free ~~and~~writing ~~Drug~~prospectus ~~Administration~~outside ~~(or~~of ~~FDA) approval, particularly considering~~ the ~~platinum-based~~United ~~drug market which has been genericized due to the lack of recent developments and innovation~~States.

The goal of our genomics program with respect to Picoplatin is to use our genomics tools with associated predictive models to select patients who will respond to Picoplatin prospectively. Our genomics technology will be designed to both identify patients who will and who will not benefit from Picoplatin (the expected accuracy of prediction may be higher than 90%) before such patients begin receiving therapy. If a potential patient would not benefit from Picoplatin, such patient can be directed to alternative treatments saving precious time which otherwise would have been spent on a drug treatment therapy that would not havePROSPECTUS ~~been effective for them.~~ SUMMARY

WeThis summary ~~intend~~highlights toselected ~~conduct~~information ~~Phase~~contained IIelsewhere ~~clinical trials both~~ in ~~colorectal~~this ~~cancer~~prospectus. ~~(or~~To ~~CRC)~~understand ~~and~~this ~~squamous~~Offering ~~cell~~fully, ~~cancer~~you ofshould read the ~~head-and-neck~~entire ~~over~~prospectus carefully, including the ~~next~~“Risk 24Factors” ~~months~~section, ~~commencing~~the inconsolidated ~~November~~financial ~~2016~~statements and inthe ~~order~~notes to ~~determine~~ the ~~genomic~~consolidated ~~signatures~~financial ~~for Picoplatin with respect to these indications~~statements. InUnless ~~October 2016, following its review of our Investigational New Drug Application (or IND) for squamous cell cancer of~~ the ~~head~~context ~~and~~otherwise ~~neck~~requires, ~~the~~references ~~FDA~~contained ~~gave~~in usthis ~~permission~~ prospectus to ~~initiate~~“we,” ~~Phase~~“us,” II“our” ~~trials~~or ofsimilar ~~Picoplatin~~terminology inrefers ~~patients~~to ~~with~~Accelerated ~~squamous~~Pharma, ~~cell~~Inc., ~~carcinoma~~a ~~of the~~ Delaware corporation.

Unless otherwise indicated, all share amounts and per share amounts in this prospectus have been presented on a pro-forma basis to reflect a forward stock split of the outstanding shares of our Common Stock at a ratio of 4.9-for-1 shares effected on December 1, 2016.

~~TABLE OF CONTENTS~~Overview

~~head~~We are ~~and neck. If one or both of these trials meets their primary endpoints, we expect to conduct~~ a ~~Phase~~clinical ~~III~~stage ~~study~~biopharmaceutical incompany ~~order~~focused toon ~~utilize~~utilizing ~~the~~our genomic ~~classifiers~~technology to (~~which~~i) ~~are~~enhance ~~individual genes or sets of genes which allow~~ the ~~separation~~development of ~~tumors~~pharmaceutical products, ~~which differ in response to treatment by looking at their gene expressions~~(ii) ~~identified in the Phase II clinical trials to~~ prospectively identify patients that wemay ~~expect to~~ respond ~~positively~~ to ~~(and to not respond positively to) Picoplatin prior to receiving treatment~~ such ~~that~~pharmaceutical weproducts ~~can achieve positive progression-free survival endpoints, significantly increasing the patient response rate to Picoplatin. A gene expression is a conversion of the information from a gene~~ and ~~determines the phenotype~~ (~~trait~~iii) ~~defined~~commercialize bysuch apharmaceutical products ~~specific form of gene. This data will support submission~~ for ~~drug~~sale ~~approval from the FDA and other regulatory agencies, including~~ in ~~the~~various ~~Russian Federation~~markets.

Our first ~~Product~~product ~~Candidate~~candidate is Picoplatin, a new generation platinum-based cancer therapy that has the potential for use in different formulations, as a single agent or in combination with other anti-cancer agents, to treat multiple cancer indications. We hold and are the exclusive, worldwide licensee of patented and proprietary technology related to Picoplatin. We will initially use our genomic technology to identify suitable patients prospectively for our anticipated Picoplatin clinical trials described below in hope of obtaining regulatory approval for Picoplatin and commercializing the therapy. We believe that our genomic program will allow us to identify numerous drug candidates that can become more effective and ultimately create a targeted, genomics-driven approach for cancer treatment by selecting patients who will respond to therapy in advance of administering such therapy.

~~Picoplatin is a small molecule new~~Approximately one-~~generation~~half ~~platinum-based chemotherapeutic agent designed to address the major weaknesses~~ of ~~existing~~all ~~platinum~~patients ~~therapies.~~who Inreceive ~~clinical~~anticancer ~~trials,~~chemotherapy ~~Picoplatin~~are ~~has~~treated ~~demonstrated not only comparable efficacy but the ability to overcome platinum resistance and significantly reduced levels of certain of the side effects associated~~ with ~~platinum~~a ~~chemotherapy in solid tumors. Study data to date suggests that Picoplatin has an improved safety profile relative to existing~~ platinum~~-based~~ cancer therapies and can be safely administered in combination with multiple approved oncology products. To date, over 1,100 patients have received Picoplatin in clinical trials conducted by previous licensees of the drug. ~~Results~~(Johnstone ~~obtained suggest that decreased production of blood cells~~TC, orPark ~~myelosuppression~~GY, ~~is common but manageable~~Lippard SJ. ~~Kidney~~Understanding ~~damage, or nephrotoxicity,~~ and, ~~particularly,~~Improving ~~nerve~~Platinum ~~damage,~~Anticancer orDrugs ~~neurotoxicity,~~– ~~have~~Phenanthriplatin. ~~been~~Anticancer ~~significantly less frequent and less severe than is commonly observed with other currently-marketed platinum chemotherapy drugs~~research. ~~Picoplatin has shown evidence of anti~~2014;34(1):471-~~tumor activity in a variety of solid tumors, including tumors that have been treated with existing platinum-based therapeutics and became resistant to them~~476. )

~~Picoplatin~~In many ~~was~~cases, ~~first~~these ~~developed~~treatments bysucceed ~~Genzyme~~in ~~Corporation~~treating ~~(or Genzyme)~~tumors. InHowever, ~~2004~~platinum therapies suffer from two major shortcomings. First, they ~~Genzyme~~often ~~entered~~cause ~~into~~serious anside ~~exclusive~~effects. ~~worldwide~~Second, ~~license~~and ~~agreement~~even worse, asrecipients ~~amended~~often ~~(which~~do wenot ~~refer~~respond to asthese treatments, resulting in the ~~Genzyme~~loss ~~License),~~of ~~with~~critical ~~Poniard~~time ~~Pharmaceuticals,~~for ~~Inc~~alternative therapies. ~~(or~~Therefore, ~~Poniard)~~while ~~for~~platinum ~~the~~drugs ~~development~~are ~~and~~widely ~~commercialization~~used ofin ~~Picoplatin.~~the Ontreatment ~~November~~of 16cancer, improvements ~~2009,~~are ~~Poniard~~needed. ~~announced~~We believe that ~~its~~our ~~Phase~~strategy ~~III~~to ~~SPEAR~~integrate ~~(Study~~a ofnew platinum molecule (Picoplatin) ~~Efficacy~~with ~~After~~improved ~~Relapse)~~properties into ~~pivotal~~pre-existing ~~trial~~pharmaceutical ~~did~~products ~~not~~can ~~meet~~improve ~~its~~the ~~primary~~success ~~endpoint~~rates of ~~overall~~such ~~survival~~products. OnSeparately, ~~March~~and ~~24,~~even ~~2010~~more importantly, we ~~Poniard~~expect ~~announced~~ that itour ~~was~~technology ~~suspending~~will ~~its~~allow ~~effort~~us to ~~seek~~identify ~~regulatory~~prospectively ~~approval~~patients ~~for~~that ~~Picoplatin~~will inbe ~~small~~more ~~cell~~likely ~~lung~~to ~~cancer~~respond ~~(or SCLC). On~~positively ~~June~~to ~~30,~~the ~~2013, Encarta, Inc~~treatment. ~~(or~~We ~~Encarta),~~believe ~~the~~these ~~predecessor~~factors tomake ~~Tallikut~~Picoplatin ~~Pharmaceuticals,~~an ~~Inc.~~attractive ~~(or~~compound ~~Tallikut),~~for ~~acquired~~other ~~certain~~pharmaceutical ~~assets~~companies ofto ~~Poniard,~~partner with ~~including~~us for the ~~Genzyme~~commercialization ~~License~~of ~~and~~Picoplatin ~~all~~upon ~~related~~or ~~intellectual~~prior ~~property,~~to ~~providing~~the ~~Encarta~~completion ~~with all~~ of ~~Poniard’s~~our ~~rights~~anticipated toclinical ~~develop~~trials and/or ~~commercialize Picoplatin~~U.S. Food ~~All~~and ~~previous~~Drug ~~clinical~~Administration ~~trials~~(or ~~with~~FDA) ~~respect~~approval, toparticularly ~~Picoplatin~~considering ~~have~~the ~~been~~platinum-based ~~conducted~~drug bymarket ~~Poniard~~which ~~and~~has webeen ~~have~~genericized due ~~not~~to ~~yet~~the ~~initiated~~lack ~~any~~of ~~clinical~~recent ~~trials~~developments ~~with~~and ~~respect to Picoplatin~~innovation.

~~Led~~Although chemotherapy byhas ~~Michael~~been ~~Fonstein,~~an ~~our~~available ~~management~~treatment ~~team~~for ~~decided~~cancer tofor ~~form~~decades, athere ~~company~~have inbeen ~~2014~~many tonew ~~pursue~~drug ~~the~~therapies, ~~development~~such ofas ~~novel~~immunotherapy, that ~~cancer~~have ~~therapies~~shown ~~via~~promise ~~in-license.~~and ~~After~~have ~~extensive~~been ~~analysis of~~ the ~~Phase~~focus ~~III~~of ~~SPEAR~~much ~~trial~~of ~~which~~the werecent ~~received~~attention in ~~our~~the ~~due~~cancer ~~diligence~~treatment ofsector. ~~the~~While ~~Picoplatin opportunity,~~ we ~~came~~believe that tothese ~~the~~new ~~conclusion~~therapies ~~that~~have ~~the~~ significant ~~clinical~~potential ~~data produced~~ in the ~~Phase~~battle ~~III~~to ~~SPEAR~~combat ~~trial~~cancer, asrecent ~~well~~examples ashave ~~previous~~demonstrated ~~trials~~the ~~conducted~~continuing importance ~~indicate a strong potential effectiveness~~ of ~~Picoplatin.~~chemotherapy Weand ~~believe~~its ~~that~~critical ~~Ponaird’s~~role ~~trial~~as ~~design~~a ~~and~~standard ~~elements~~ of ~~its~~care ~~clinical~~in ~~trial~~treating ~~execution~~cancer. ~~(which~~For ~~were~~example, ~~explainable~~Celgene atCorporation’s Abraxane ~~the~~sales ~~time~~were ofapproximately ~~trials~~$967 ~~but~~million ~~which~~in ~~defects~~2015. ~~were~~after ~~clearly~~receiving ~~seen after~~FDA ~~the~~approval ~~fact)~~in 2012, and ~~not~~Oxaliplatin, the ~~drug~~last ~~itself,~~branded platinum-based ~~are~~chemotherapy ~~chiefly~~drug, togenerated ~~blame~~over ~~for~~$1 ~~its~~billion ~~unsuccessful~~of ~~Phase~~sales ~~III~~as ~~SPEAR~~late ~~trials.~~as ~~We further believe that~~2012, ~~despite~~which is the ~~seemingly~~last ~~unsuccessful~~year ~~Phase~~this ~~III~~drug ~~SPEAR~~was ~~trial~~under patent ~~performed~~protection. ~~by Poniard~~Additionally, ifin ~~certain~~2015, ~~subgroups~~the ofFDA ~~patients~~approved ~~had~~four ~~been~~new ~~excluded~~chemotherapeutic ~~from~~drugs, ~~the trials~~ and ~~the~~recently, ~~trial endpoints were more~~ in ~~line~~July ~~with that of other precedent cancer trials~~2016, ~~the~~Jazz ~~data~~Pharmaceuticals acquired ~~indicated~~Celator ~~that~~Pharmaceuticals ~~the~~for ~~trial~~$1.5 ~~would~~billion. ~~have~~Celator’s ~~met~~lead ~~its~~product ~~endpoints~~candidate ~~and~~is ~~been successful. Accordingly~~Vyxeos, ~~given~~a ~~the~~Phase ~~efficacy~~III ofchemotherapy compound ~~Picoplatin~~targeting ~~along~~acute ~~with~~myeloid ~~its~~leukemia. ~~vastly~~Our ~~improved~~goal ~~safety~~is ~~profile,~~to ~~our~~establish ~~management identified~~ Picoplatin as a ~~priority~~significant toentrant ~~license~~into as the ~~first compound for its drug development program enhanced by its genomics technology~~chemotherapy marketplace.

On June 17, 2014, we entered into an exclusive license agreement with Tallikut pursuant to which we acquired from Tallikut the exclusive, global license of all rights to develop and commercialize Picoplatin (we refer to such license, as amended in December 2014 and March 2016, as the Tallikut License). Under the Tallikut License, we paid $150,000 as consideration plus 100,000 shares of our Series A Convertible Preferred 1

We believe that our strategy to employ our genomic technology to develop Picoplatin is timely. Recently, there has been a significant focus on further developing and using genomics as an important tool in the treatment of cancer. Large pharmaceutical companies have recognized the value of genomics in their drug development efforts and have implemented large-scale changes to move in that direction. In an April 2016 press release, AstraZeneca announced “an integrated genomics initiative to transform drug discovery and development across its entire research and development pipeline” and that the company had sequenced “2 million genomes in the hunt for new drugs.” Additionally, in October 2016, the U.S. federal government’s Moonshot Task Force released its report entitled “Cancer Moonshot — Ending Cancer as We Know It”. This initiative successfully survived changes of US administrations and is alive and well in 2018. A significant portion of cancer Moonshot is dedicated to provide substantial funds to drug developers and research organizations in an effort to enhance genomics as a tool to fight cancer. The goal of our genomics program with respect to Picoplatin is to use our genomics tools with associated predictive models to select patients who will respond to Picoplatin prospectively. Our genomics technology will be designed to both identify patients who will and who will not benefit from Picoplatin (the expected accuracy of prediction may be higher than 90%) before such patients begin receiving therapy. If a potential patient would not benefit from Picoplatin, such patient can be directed to alternative treatments saving precious time, a matter, critical in cancer treatment.

~~TABLE~~We plan OFto ~~CONTENTS~~conduct Phase II clinical trials both in colorectal cancer (or CRC) and squamous cell cancer of the head-and-neck. We expect to first pursue a Phase II clinical trial in squamous cell cancer of the head-and-neck using the proceeds of this Offering. Commencing after the closing of this Offering and over the next 24 months thereafter, we expect to conduct a Phase II clinical trial in squamous cell cancer of the head-and-neck in order to determine the genomic signatures for Picoplatin with respect to this indication. We have not yet determined when we will begin a Phase II clinical trial for CRC. For more information on how we will spend the proceeds from this Offering, see “Use of Proceeds” below. In October 2016, following its review of our Investigational New Drug Application (or IND) for squamous cell cancer of the head and neck, the FDA, through a series of telephonic calls and a confirmatory e-mail in September 2016, gave us permission to initiate Phase II trials of Picoplatin in patients with squamous cell carcinoma of the head and neck. If one or both of these trials meets their primary endpoints, we expect to conduct a Phase III study in order to utilize the genomic classifiers (which are individual genes or sets of genes which allow the separation of tumors which differ in response to treatment by looking at their gene expressions) identified in the Phase II clinical trials to prospectively identify patients that we expect to respond positively to (and to not respond positively to) Picoplatin prior to receiving treatment such that we can achieve positive progression-free survival endpoints, significantly increasing the patient response rate to Picoplatin. A gene expression is a measure of activity for a gene. In our case, an expression profile (expression of multiple genes) determines whether a patient will response to a treatment or not. This data will support submission for drug approval from the FDA and other regulatory agencies, including in the Russian Federation.

~~Stock~~Our Product (or Series A Preferred Stock) and a warrant to purchase 80,000 shares of Series A Preferred Stock to Tallikut and were obligated to pay certain royalties to Tallikut relating to sales of Picoplatin in the United States and abroad. Candidate

OnPicoplatin is ~~March~~a ~~15,~~small ~~2016~~molecule, wea ~~entered~~new-generation ~~into~~platinum-based anchemotherapeutic ~~assignment~~agent ofdesigned ~~license~~to ~~agreement~~address ~~and~~the anmajor ~~assignment~~weaknesses ~~agreement~~of ~~(which~~existing platinum wetherapies. ~~refer~~In ~~to,~~clinical ~~collectively~~trials, asPicoplatin ~~the~~has ~~Assignment~~demonstrated ~~Agreement)~~not ~~with~~only ~~Tallikut~~comparable ~~pursuant~~efficacy tobut ~~which~~the weability ~~were~~to ~~assigned~~overcome ~~certain~~platinum resistance ~~assets~~and ofsignificantly ~~Poniard~~reduced ~~owned~~levels byof ~~Tallikut~~certain ~~and~~of ~~all~~the ~~related~~side ~~intellectual~~effects ~~property,~~associated ~~providing~~with usplatinum ~~with~~chemotherapy ~~all~~in ofsolid ~~Poniard’s~~tumors. Study ~~rights~~data to ~~develop~~date ~~and~~suggests ~~commercialize~~that Picoplatin. Wehas ~~also~~an ~~became~~improved ~~the~~safety ~~assignee~~profile ofrelative ~~the~~to ~~Genzyme~~existing ~~license~~platinum-based ~~which~~cancer ~~enabled~~therapies and uscan tobe ~~terminate~~safely ~~our~~administered ~~License~~in ~~Agreement~~combination with ~~Tallikut.~~multiple ~~Pursuant~~approved tooncology ~~the~~products. ~~Genzyme~~To ~~License~~date, ~~following~~over ~~FDA~~1,100 ~~approval~~patients wehave ~~will~~received Picoplatin ~~pay~~in ~~royalties~~clinical totrials ~~Genzyme~~conducted ~~ranging~~by ~~from~~previous 5%licensees toof athe ~~maximum~~drug. Results obtained suggest that decreased production of 9%blood ~~(based~~cells, onor myelosuppression, is common but manageable. Kidney damage, or nephrotoxicity, and, particularly, nerve damage, ~~designated~~or ~~product~~neurotoxicity, ~~sales~~have ~~levels)~~been ~~for~~significantly ~~annual~~less ~~net~~frequent ~~product~~and ~~sales~~less ofsevere ~~Picoplatin~~than is commonly observed with other currently-marketed platinum chemotherapy drugs. ~~Additionally,~~Picoplatin wehas ~~will~~shown beevidence ~~required~~of toanti-tumor ~~pay~~activity in a ~~total~~variety of upsolid ~~to $5~~tumors,~~000,000~~ ~~based~~including ~~upon~~tumors that ~~the~~have ~~achievement~~been oftreated ~~certain~~with ~~sales~~existing ~~milestones~~platinum-based intherapeutics ~~the~~and ~~United~~became ~~States~~resistant ~~following~~to ~~FDA approval~~them.

~~Our Strategy~~2

~~Our~~Picoplatin was ~~primary~~first ~~objective~~developed isby a subsidiary of AstraZeneca PLC which was subsequently sold to ~~establish~~Genzyme ~~Picoplatin~~Corporation (or Genzyme). In 2004, Genzyme entered into an exclusive worldwide license agreement, as amended (which we refer to as the ~~preferred~~Genzyme ~~platinum-based~~License), ~~drug~~with ~~choice~~Poniard Pharmaceuticals, Inc. (or Poniard) for ~~inclusion~~the indevelopment ~~treatment~~and ~~protocols~~commercialization byof ~~physicians~~Picoplatin. ~~treating~~On ~~cancer~~November ~~patients~~16, ~~and~~2009, toPoniard ~~establish~~announced that ~~the~~its ~~predictive~~Phase ~~capability~~III SPEAR (Study of ~~our~~Picoplatin ~~genomic~~Efficacy ~~technology~~After Relapse) pivotal trial did not meet its primary endpoint of overall survival. ~~The~~On ~~following~~March ~~represents~~24, ~~our~~2010, ~~current~~Poniard ~~plan~~announced ~~which~~that ~~could~~it ~~change~~was ~~based~~suspending ~~upon~~its ~~trial~~effort ~~results~~to seek regulatory approval for Picoplatin in small cell lung cancer (or SCLC). On June 30, ~~discussions~~2013, ~~with~~Encarta, Inc. (or Encarta), the ~~FDA~~predecessor to Tallikut Pharmaceuticals, Inc. (or ~~other~~Tallikut), ~~opportunities~~acquired orcertain ~~information~~assets ~~that~~of ~~could~~Poniard, ~~cause~~including usthe Genzyme License and all related intellectual property, providing Encarta with all of Poniard’s rights to ~~focus~~develop onand ~~other~~commercialize ~~cancer~~Picoplatin. ~~indications~~All previous clinical trials with respect to Picoplatin have been conducted by Poniard and we have not yet initiated any clinical trials with respect to Picoplatin. The previous ~~key~~developers ~~elements~~have ofspent ~~our~~a ~~strategy~~substantial amount of capital in the ~~U.S.~~development ~~are:~~of Picoplatin through its Phase III trials.

•Led by ~~Complete~~Michael ~~two~~Fonstein, ~~Phase~~our IImanagement ~~clinical~~team ~~trials~~decided ~~for Picoplatin. We intend~~ to ~~conduct~~form ~~two~~a ~~Phase~~company IIin ~~trials~~2014 ~~for~~to ~~the~~pursue ~~purpose of defining~~ the ~~genomic~~development ~~signature~~ of ~~the~~novel ~~Picoplatin~~cancer ~~response~~therapies via in-license. ~~patients~~After ~~with~~extensive ~~(a)~~analysis ~~squamous cell carcinoma~~ of ~~head~~the ~~and~~Phase ~~neck~~III ~~(or~~SPEAR ~~SCCHN)~~trial ~~as well as (b) metastatic CRC,~~ which iswe ~~the~~received ~~third leading cause of cancer death~~ in ~~both~~our ~~men~~due ~~and~~diligence ~~women~~of in the ~~U.S. and the second leading cause of cancer death of men and women combined. In October 2016~~Picoplatin opportunity, ~~following~~we ~~its~~concluded ~~review~~that of the ~~IND~~significant ~~for~~clinical ~~squamous~~data ~~cell~~produced ~~cancer~~in of the ~~head~~Phase ~~and~~III ~~neck,~~SPEAR ~~the~~trial ~~FDA~~as ~~gave~~well usas ~~permission to initiate Phase II~~ previous trials ofconducted ~~Picoplatin~~indicate ina ~~patients~~strong ~~with~~potential ~~squamous~~effectiveness ~~cell carcinoma~~ of ~~the head and neck~~Picoplatin. ~~The~~We ~~genomic~~believe ~~signatures~~that ~~which~~Ponaird’s wetrial ~~expect~~design toand ~~define~~elements of inits clinical ~~trials~~trial ~~represent~~execution ~~a set of 15-40 genes~~ (~~selected~~which ~~from~~were ~~22,000~~explainable ~~genes~~at ~~examined~~the intime anof ~~initial~~trials ~~analysis)~~but which ~~change~~defects ~~their~~were ~~“expression”~~clearly inseen aafter ~~tumor~~the tofact), and ~~produce~~not ~~more~~the ordrug ~~less~~itself, ~~mRNA~~are inchiefly ato ~~manner~~blame ~~which~~for ~~correlates~~its ~~with~~unsuccessful ~~tumor~~Phase ~~responses~~III toSPEAR ~~specified treatment regimens~~trials. We ~~expect~~further believe that, despite the seemingly ~~use~~unsuccessful ofPhase ~~such~~III ~~signatures~~SPEAR ~~will~~trial ~~enable~~performed ~~the~~by ~~selection of patients~~Poniard, ~~prospectively,~~if ~~who~~certain ~~will~~subgroups ~~have a significantly higher likelihood (potentially up to 90%)~~ of ~~responding~~patients tohad ~~Picoplatin~~been ~~treatment.~~excluded ~~Our~~from ~~clinical~~ the trials ~~may~~and ~~include studying~~ the ~~objective~~trial ~~response~~endpoints ~~rate~~were ~~(or~~more ~~ORR)~~ in aline ~~group~~with that of ~~patients~~other ~~selected~~precedent ~~based~~cancer ontrials, the ~~presence~~data ofindicated ~~the genomic signatures~~ that ~~we determine will predict positive responses to Picoplatin. An objective response rate is~~ the ~~percentage~~trial would ofhave ~~patients~~met ~~whose~~its ~~cancer~~endpoints ~~shrinks~~and orbeen ~~disappears after treatment~~successful. ~~It includes a complete response (CR) when all detectable tumors disappear~~Accordingly, ~~and~~given ~~partial response (PR), defined as at least a 50% decrease in~~ the ~~total~~efficacy ~~tumor~~of ~~volume~~Picoplatin along with ~~some~~its ~~residual~~vastly ~~disease~~improved safety ~~still~~profile, ~~remaining.~~our ~~ORR~~management ~~has~~identified ~~been~~Picoplatin ~~viewed~~ as a ~~“direct~~priority ~~measure of drug antitumor activity” according~~ to ~~the~~license ~~“Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”~~ as ~~set forth by~~ the ~~U.S.~~first ~~Department~~compound ~~of Health and Human Services Food and Drug Administration Center~~ for ~~Drug~~its ~~Evaluation~~drug ~~and~~development ~~Research~~program enhanced inby ~~2007.~~its ~~Accordingly,~~genomics ~~we believe that the increases in ORR should be viewed as a strong indicator of the efficacy of the drug~~technology.

•On June ~~Conduct~~17, a2014, ~~Phase~~we ~~III~~entered ~~clinical~~into ~~trial~~an ~~for~~exclusive ~~SCCHN~~license ~~and/or~~agreement ~~CRC~~with ~~patients~~Tallikut ~~treated~~pursuant byto ~~Picoplatin.~~which ~~Following~~we acquired from Tallikut the ~~completion~~exclusive, global license of ~~our~~all ~~Phase~~rights IIto ~~trials,~~develop and commercialize Picoplatin (we ~~intend~~refer to ~~conduct~~such alicense, ~~Phase~~as ~~III~~amended ~~clinical~~in ~~trial~~December ~~for~~2014 ~~either~~and March or2016, ~~both~~as the Tallikut License). Under the Tallikut License, we paid $150,000 as consideration plus 100,000 shares of ~~SCCHN~~our Series ~~and~~A ~~CRC~~Convertible ~~which~~Preferred ~~would~~Stock be(or ~~designed~~“Series A Preferred Stock”) and a warrant to ~~utilize~~purchase ~~these~~80,000 ~~genomic~~shares ~~classifiers~~of Series A Preferred Stock to ~~achieve~~Tallikut ~~the~~and ~~progression-free~~were orobligated ~~overall~~to ~~survival~~pay ~~endpoints~~certain ~~needed~~royalties to ~~move~~Tallikut relating to sales of Picoplatin in the ~~product~~United States ~~candidate~~and ~~forward~~abroad. This agreement was terminated and ~~significantly~~superseded ~~increase~~based upon entry into the ~~patient~~Assignment ~~response~~Agreement ~~rate~~as todescribed ~~Picoplatin~~below.

•On March ~~Submit~~15, an2016, ~~application~~we ~~for~~entered ~~registration~~into an assignment of ~~medicine~~license toagreement ~~the~~and ~~Ministry~~an ofassignment ~~Health~~agreement of(which ~~the~~we ~~Russian~~refer ~~Federation~~to, ~~for~~collectively, as the ~~right~~Assignment Agreement) with Tallikut pursuant to ~~market~~which we were assigned certain assets of Poniard owned by Tallikut and all ~~sell~~related ~~Picoplatin~~intellectual ~~for~~property, ~~Small~~providing ~~Cell~~us ~~Lung~~with ~~Cancer~~all inof ~~the~~Poniard’s ~~Russian~~rights ~~Federation~~to develop and commercialize Picoplatin. We also ~~believe~~became ~~that~~the assignee of the ~~Phase~~Genzyme IIlicense ~~and~~which ~~Phase~~enabled ~~III~~us ~~data~~to ~~for~~terminate ~~SCLC~~our ~~from~~License Agreement with Tallikut. Pursuant to the ~~Picoplatin~~Genzyme ~~trials~~License, ~~conducted~~following byFDA ~~Poniard~~approval iswe ~~sufficient~~will ~~for~~pay usroyalties to ~~submit~~Genzyme anranging ~~application~~from 5% to a maximum of 9% (based on designated product sales levels) for ~~registration~~annual net product sales of ~~medicine~~Picoplatin. Additionally, we will be required to pay a total of up to $5,000,000 based upon the achievement of certain sales milestones in the United States following FDA approval.

3Our Strategy

~~TABLE~~Our primary OFobjective ~~CONTENTS~~is to establish Picoplatin as the preferred platinum-based drug choice for inclusion in treatment protocols by physicians treating cancer patients and to establish the predictive capability of our genomic technology. Our strategy has been followed before, where a failed clinical trial of an otherwise promising drug was rescued and repurposed in a subsequent clinical trial. There have been many cases where drugs have had experienced initial trial failures only to achieve subsequent success. Viagra, Erbitux, Revlimid and Thalomid are several cases of rescued drugs which have general many billions of annual sales. A 2015 study published in Drug Discovery World found that drug rescue efforts have the potential to “reduce the costs of subsequent drug development by 85% when such activities are restarted from Phase II and increase the chances of success by 2.5 times.”

Ministry of Health of the Russian Federation for the permission to market and sell Picoplatin in the Russian Federation. We anticipate a filing in the fourth quarter of 2016. A decision by the Ministry of Health would be made within a year of filing.3

•The following ~~Seek~~represents aour ~~strategic~~current ~~partnership~~plan ~~with~~which acould ~~European~~change ~~partner~~based toupon ~~obtain~~trial ~~European~~results, ~~Union~~discussions ~~approval~~with ~~of Picoplatin for SCLC. The European Commission designated Picoplatin as an orphan medicinal product for~~ the ~~treatment of SCLC~~FDA, ~~which,~~or ifother ~~approved,~~opportunities or ~~would~~information ~~qualify~~that ~~Picoplatin~~could ~~for~~cause ~~ten~~us ~~years~~to offocus ~~marketing~~on ~~exclusivity~~other incancer ~~the European Union~~indications. ~~Accordingly,~~The wekey ~~will~~elements ~~seek~~of toour ~~enter~~strategy aover ~~strategic~~the ~~partnership~~next ~~with~~several years afollowing ~~European~~this ~~partner~~Offering ~~for obtaining approval of Picoplatin~~ in the ~~European Union~~U.S. are:

•● Complete ~~Commercially~~two ~~Launch~~Phase II clinical trials for Picoplatin. We intend to conduct two Phase II trials for the purpose of defining the genomic signature of the Picoplatin response in patients with (a) squamous cell carcinoma of head and neck (or SCCHN) as well as (b) metastatic CRC, which is the third leading cause of cancer death in both men and women in the U.S. ~~Although~~and wethe ~~may~~second ~~decide~~leading cause of cancer death of men and women combined. As described in more detail in “Use of Proceeds,” we expect to ~~utilize~~initially conduct a ~~small~~Phase ~~specialty~~II ~~sales~~clinical ~~strategy~~trial with patients suffering from SCCHN using the proceeds from this Offering. We have not yet determined when we will begin a Phase II clinical trial relating to CRC. In October 2016, following its review of the IND for ~~targeting~~squamous ~~oncologists~~cell cancer of the head and neck, the FDA, through a series of telephonic calls and a confirmatory e-mail, gave us permission to ~~launch~~initiate Phase II trials of Picoplatin ifin itpatients iswith ~~approved~~squamous cell carcinoma of the head and neck. More recently, in connection with our planned initiation of our Phase II clinical trial, the UFDA has requested us to supplement our clinical trial plan with a more detailed statistical plan to provide a robust justification for the patient sample size that we have proposed.S The FDA is requiring that we submit this plan before recruiting over twenty patients. With respect to our clinical trial plan, the FDA has also provided comments on sample collection and suggested that we begin discussions with the FDA regarding in vitro diagnostic genomic assay before we begin the second arm of our ~~primary~~clinical ~~focus~~trial. ~~will~~The begenomic ~~dedicated~~signatures which we expect to ~~entering~~define ~~into~~in clinical trials represent a ~~partnership~~set ~~with~~of 15-40 genes (selected from 22,000 genes examined in an initial analysis) which change their “expression” in a ~~pharmaceutical~~tumor ~~company~~to produce more or less mRNA in a manner which correlates with antumor ~~established~~responses ~~sales~~to ~~force~~specified ~~for~~treatment regimens. We expect that the ~~full~~use ~~commercialization~~of such signatures will enable the selection of patients, prospectively, who will have a significantly higher likelihood (potentially up to 90%) of responding to Picoplatin ~~and~~treatment. ~~retaining~~Our clinical trials may include studying the objective response rate (or ORR) in a ~~meaningful~~group ~~royalty~~of ~~percentage~~patients selected based ~~upon~~on ~~U.S.~~the ~~sales.~~presence ~~Outside~~of the ~~United~~genomic ~~States,~~signatures that we ~~expect~~determine will predict positive responses to ~~enter~~Picoplatin. ~~into~~An ~~distribution~~objective response rate is the percentage of patients whose cancer shrinks or disappears after treatment. It includes a complete response (CR) when all detectable tumors disappear, and ~~other~~partial ~~marketing~~response ~~arrangements~~(PR), defined as at least a 50% decrease in the total tumor volume with ~~third~~some ~~parties~~residual disease still remaining. ORR has been viewed as a “direct measure of drug antitumor activity” according to the “Guidance for ~~any~~Industry Clinical Trial Endpoints for the Approval of ~~our~~Cancer ~~product~~Drugs ~~candidates~~and Biologics” as set forth by the U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research in 2007. Accordingly, following FDA guidelines, we believe that ~~obtain~~the ~~marketing~~increases ~~approval~~in ORR should be viewed as a strong indicator of the efficacy of the drug.

•● Conduct ~~Pursue~~a ~~opportunities~~Phase toIII ~~develop~~clinical trial for SCCHN and/or ~~commercialize~~CRC ~~Picoplatin~~patients intreated ~~foreign~~by ~~markets~~Picoplatin. AsFollowing the completion of our Phase II trials, and assuming those trials meet the endpoints, we ~~engage~~intend into conduct a Phase III clinical ~~trials~~trial for ~~Picoplatin~~either inor both of SCCHN and CRC which would be designed to utilize these genomic classifiers to achieve the Uprogression-free or overall survival endpoints needed to move the product candidate forward and significantly increase the patient response rate to Picoplatin.S. As described elsewhere in this prospectus, we ~~will~~expect ~~also~~to ~~seek~~initially toconduct ~~enter~~only ~~into~~a ~~development~~Phase ~~and~~II ~~commercialization~~clinical ~~partnerships~~trial with ~~pharmaceutical~~patients ~~companies~~suffering from inSCCHN ~~foreign~~using ~~countries~~the proceeds from this Offering. We have not yet determined when we will begin a Phase II clinical trial relating to CRC.

•● Submit ~~Leverage~~an ~~our~~application ~~genomic~~for ~~technology~~registration byof ~~acquiring~~medicine ~~rights~~ to ~~other~~the ~~compounds.~~Ministry Ifof ~~our~~Health ~~clinical~~of ~~trials~~the Russian Federation for the right to market and sell Picoplatin for Small Cell Lung Cancer in the ~~use~~Russian ofFederation. ~~our~~We ~~genomics~~believe ~~classifiers~~that tothe ~~select~~Phase ~~patients~~II and Phase III data for SCLC from the Picoplatin ~~are~~trials ~~successful,~~conducted weby ~~will~~Poniard ~~seek~~is tosufficient ~~in-license~~for orus ~~acquire~~to ~~other~~submit ~~drug~~an ~~compounds~~application ~~that~~for weregistration ~~believe~~of ~~would~~medicine to bethe ~~well-suited~~Ministry ~~for~~of ~~our~~Health ~~genomic~~of ~~technology.~~the WeRussian ~~could~~Federation ~~also~~for ~~conceivably~~the ~~seek~~permission to ~~exploit~~market ~~our~~and ~~genomics~~sell ~~classifiers~~Picoplatin ~~even~~in ifthe ~~our~~Russian ~~clinical~~Federation. We ~~efforts~~anticipate ~~with~~a ~~Picoplatin~~filing ~~are~~during ~~not~~2018. ~~successful,~~A ~~but~~decision ~~our~~by ~~immediate~~the ~~priority~~Ministry isof toHealth ~~combine~~should ~~our~~be ~~genomic~~made ~~technology~~within ~~with~~a ~~Picoplatin~~year of filing.

~~Summary~~● Seek ~~Risks~~a ~~Associated~~strategic partnership with ~~Our~~a ~~Business~~European partner to obtain European Union approval of Picoplatin for SCLC. The European Commission designated Picoplatin as an orphan medicinal product for the treatment of SCLC, which, if approved, would qualify Picoplatin for ten years of marketing exclusivity in the European Union. Accordingly, we will seek to enter a strategic partnership with a European partner for obtaining approval of Picoplatin in the European Union.

Our business is subject to many significant risks, as more fully described in the section entitled “Risk Factors” immediately following this prospectus summary. You should read and carefully consider these risks, together with the risks set forth under the section entitled “Risk Factors” and all of the other information in this prospectus, including the financial statements and the related notes included elsewhere in this prospectus, before deciding whether to invest in our common stock. If any of the risks discussed in this prospectus actually occur, our business, financial condition or operating results could be materially and adversely affected. In particular, our risks include, but are not limited to, the following:4

•● Commercially WeLaunch ~~are~~Picoplatin in the U.S. Although we may decide to utilize a ~~clinical~~small ~~stage~~specialty ~~biotechnology~~sales ~~company~~strategy ~~with~~for notargeting oncologists ~~history~~to oflaunch ~~revenue~~Picoplatin ~~generating~~if ~~operations~~it is approved in the U.S., ~~and~~our itprimary focus will ~~take~~be ~~several~~dedicated ~~years~~ to ~~have~~entering ~~any~~into ~~proposed~~a ~~products~~partnership with ~~approved,~~a ~~assuming~~pharmaceutical ~~such~~company ~~approval~~with ~~can~~an beestablished ~~obtained~~sales atforce ~~all~~for the full commercialization of Picoplatin and retaining a meaningful royalty percentage based upon U.S. Wesales. ~~therefore~~Outside dothe ~~not~~United States, we expect to ~~generate~~enter ~~revenue~~into distribution and other marketing arrangements with third parties for atany ~~least~~of ~~the~~our ~~next~~product ~~several~~candidates ~~years~~that obtain marketing approval.

•● Pursue ~~Our~~opportunities ~~cash resources are presently limited, and there is a risk that our cash will be insufficient~~ to ~~advance~~develop ~~the clinical development of our therapies~~ and ~~ultimately~~commercialize ~~bring~~Picoplatin ~~our~~in ~~therapies~~foreign ~~to market~~markets. IfAs we ~~are~~engage ~~unable~~in toclinical ~~raise~~trials ~~additional~~for ~~funds~~ Picoplatin in the ~~future~~U.S., we ~~could~~will bealso ~~forced~~seek to ~~delay,~~enter ~~reduce~~into ordevelopment ~~eliminate~~and ~~our~~commercialization ~~product~~partnerships ~~development~~with ~~programs~~pharmaceutical orcompanies ~~commercialization~~in ~~efforts~~foreign countries ~~and~~including ~~our~~in ~~business could fail~~Asia.

•● Leverage Asour agenomic ~~result~~technology ofby ~~the~~acquiring ~~pre-revenue~~rights ~~nature~~to other compounds and by seeking to enter into strategic collaborations combining the pipelines of other drug companies with our ~~business~~genomic ~~and~~technology. If our ~~current~~clinical ~~lack~~trials and the use of ~~financial~~our ~~liquidity~~genomics classifiers to select patients for Picoplatin meet their endpoints, ~~our~~we ~~auditors’~~will ~~report~~seek to in-license or acquire other drug compounds that we believe would be well-suited for our ~~2015~~genomic ~~financial~~technology. ~~statements,~~We ~~which~~will ~~are~~also ~~included~~seek asto ~~part~~work oftogether ~~this~~with ~~prospectus,~~other ~~contains~~drug acompanies to ~~statement~~conduct ~~concerning~~clinical ~~the~~trials ~~substantial~~using ~~doubt~~their ~~regarding~~drugs combined with our ~~ability~~genomic technology. We could also conceivably seek to ~~continue~~exploit asour genomics aclassifiers ~~“going~~even ~~concern~~if our clinical efforts with Picoplatin are not successful, but our immediate priority is to combine our genomic technology with Picoplatin.”

•● File ~~The~~new ~~gene~~patents ~~expression~~with ~~studies~~respect ~~we have conducted~~ to ~~date~~the ~~are~~combination of aour ~~preliminary~~genomic ~~nature~~technology and ~~were~~Picoplatin ~~performed~~and ~~using~~possibly ~~data~~other ~~generated~~drug ~~from~~compounds. We ~~clinical~~believe ~~treatments~~that ~~using~~patent ~~other~~protection ~~platinum~~is ~~and~~available ~~non-platinum~~for ~~chemotherapeutic~~the ~~drugs.~~method ~~While~~of itusing is our ~~intent to confirm our~~ genomic technology ~~with~~in ~~respect~~combination towith Picoplatin as ~~through~~well ~~our~~as ~~planned~~other ~~clinical~~drug ~~trials,~~compounds ~~there~~in istreating nocancer ~~assurance~~and ~~that~~other wediseases. We will beseek ~~successful~~to infile ~~doing~~new sopatents, when appropriate, to protect our proprietary technology.

•● Publish ~~Our~~review ~~limited~~papers ~~operating~~and ~~history~~participate ~~makes~~in itrecognized ~~difficult~~genomic ~~for~~and ~~you~~other scientific conferences. Our management team will look to ~~evaluate~~publish peer review papers that describe our ~~business~~genomics totechnology ~~date~~and clinical trials we conduct in combination with Picoplatin and possibly other drug compounds. We will also participate in genomic and scientific conferences to ~~assess~~raise the profile and awareness of our ~~future~~genomic ~~viability~~technology in the scientific community.

4● Pursue federal and state grants to obtain funding for genomic research. Our management team has had success in the past in obtaining government research grants in order to fund drug research and development. We believe that our genomics technology and related capabilities position us to take advantage of the significant government focus on genomics. We intend to pursue federal and state grants to fund our genomic research efforts which will be geared towards enhancing our genomic capabilities and, potentially, providing us additional tools in expanding our drug pipeline.

~~TABLE~~While we OFwill ~~CONTENTS~~focus our efforts on achieving these or similar milestones, potential investors are cautioned that no assurances can be given that our Phase II clinical trials for Picoplatin will meet their endpoints (or in the case of CRC, that we will ever conduct a Phase II clinical trial), that our genomic technology will have the effect we expect on patient response to treatment, or that we will be able to achieve all or any of these or similar milestones over the next few years or ever. In describing our targeted milestones, potential investors are advised that we not projecting any specific timeline of results but are rather providing insight into our strategic priorities as a company.

~~• Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.~~5

•Summary Risks WeAssociated ~~are~~with ~~highly~~Our ~~dependent on our rights to Picoplatin, the loss of which could lead to the failure of our business.~~Business

•Our business Weis ~~face~~subject ~~substantial~~to ~~competition~~many significant risks, ~~which~~as ~~may~~more ~~result~~fully described in ~~others~~the ~~discovering~~section entitled “Risk Factors” immediately following this prospectus summary. You should read and carefully consider these risks, ~~developing~~together orwith ~~commercializing~~the ~~products~~risks set forth under the section entitled “Risk Factors” and all of the other information in this prospectus, including the financial statements and the related notes included elsewhere in this prospectus, before deciding whether to invest in our Common Stock. If any of the risks discussed in this prospectus actually occur, our business, financial condition or ~~more~~operating ~~successfully~~results ~~than~~could webe domaterially and adversely affected. In particular, our risks include, but are not limited to, the following:

• ● We are ~~subject~~a toclinical ~~extensive~~stage ~~regulation,~~biotechnology ~~and~~company ifwith weno ~~fail~~history toof ~~obtain~~revenue generating operations, orand ifit ~~there~~will ~~are~~take ~~delays~~several inyears to ~~obtaining,~~have ~~required~~any ~~regulatory~~proposed ~~approvals~~products approved, weassuming ~~will~~such ~~not~~approval can be ~~able~~obtained toat ~~commercialize~~all. ~~our~~We ~~product~~therefore ~~candidate,~~do ~~and~~not ~~our~~expect ~~ability~~ to generate revenue ~~and~~for ~~the~~at ~~viability~~least ofthe ~~our~~next ~~company~~several ~~will be materially impaired~~years.

~~Corporate~~● Our ~~Information~~cash resources are presently limited, and there is a risk that our cash will be insufficient to advance the clinical development of our therapies and ultimately bring our therapies to market. If we are unable to raise additional funds in the future, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts and our business could fail.

We● As ~~were organized as~~ a ~~corporation~~result ~~under~~of the ~~laws~~pre-revenue nature of ~~the~~our ~~State~~business and our current lack of ~~Delaware~~financial inliquidity, ~~May~~there ~~2014.~~is ~~Our~~a ~~principal~~substantial ~~executive~~doubt about ~~office~~our isability ~~located~~to atcontinue 36as ~~Church~~a ~~Lane~~going concern within one year after the financial statement issuance date, ~~Westport~~and accordingly, our ~~Connecticut~~auditors’ ~~06880~~report for our 2016 consolidated financial statements, ~~and~~which are included as part of this prospectus, contains a statement concerning the substantial doubt regarding our ~~phone~~ability ~~number~~to iscontinue ~~(203)~~as ~~520-3840.~~a “going concern.”

~~Implications~~● The gene expression studies we have conducted to date are of ~~Being~~a anpreliminary ~~Emerging~~nature ~~Growth~~and ~~Company~~were performed using data generated from clinical treatments using other platinum and non-platinum chemotherapeutic drugs. While it is our intent to confirm our genomic technology with respect to Picoplatin through our planned clinical trials, there is no assurance that we will be successful in doing so.

~~We qualify as an “emerging growth company” as defined in the Jumpstart~~ ● Our ~~Business~~limited ~~Startups~~operating ~~Act~~history ofmakes ~~2012~~it ~~(or~~difficult ~~the~~for ~~JOBS~~you ~~Act).~~to Asevaluate aour ~~result,~~business ~~we are permitted~~ to, date and ~~intend~~ to, ~~rely~~assess onour ~~exemptions~~future ~~from certain disclosure requirements that are otherwise applicable to public companies~~viability. ~~These provisions include, but are not limited to:~~

•● Raising ~~being~~additional ~~permitted~~capital tomay ~~present~~cause ~~only~~dilution ~~two~~to ~~years~~our ofstockholders, ~~audited~~restrict ~~financial~~our ~~statements~~operations ~~and~~or ~~only~~require ~~two~~us ~~years~~to ofrelinquish ~~related~~rights to ~~“Management’s~~our ~~Discussion~~technologies ~~and~~or ~~Analysis~~product ~~of Financial Condition and Results of Operations” in this prospectus;~~candidates.

•● We ~~not~~are ~~being~~highly ~~required~~dependent toon ~~comply~~our ~~with~~rights ~~the~~to ~~auditor~~Picoplatin, ~~attestation~~the ~~requirements~~loss of ~~Section~~which ~~404~~could oflead to the ~~Sarbanes-Oxley~~failure ~~Act~~ of ~~2002,~~our ~~as amended (or the Sarbanes-Oxley Act);~~business.

•● We ~~reduced~~face ~~disclosure~~substantial ~~obligations~~competition, ~~regarding~~which ~~executive~~may ~~compensation~~result in ~~our~~others ~~periodic reports~~discovering, ~~proxy~~developing ~~statements~~or ~~and~~commercializing ~~registration~~products ~~statements;~~before ~~and~~or more successfully than we do.

•● We ~~exemptions~~are ~~from~~subject ~~the~~to ~~requirements~~extensive ofregulation, ~~holding~~and aif ~~nonbinding~~we ~~advisory~~fail ~~vote~~to onobtain, ~~executive~~or ~~compensation~~if ~~and~~there ~~stockholder~~are ~~approval~~delays ofin ~~any~~obtaining, ~~golden~~required ~~parachute~~regulatory ~~payments~~approvals, we will not ~~previously~~be ~~approved~~able to commercialize our product candidate, and our ability to generate revenue and the viability of our company will be materially impaired.

InCorporate Financing addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period. Transactions-Rescinded

WeOn June ~~will~~29, ~~remain~~2017, anwe ~~emerging~~entered ~~growth~~into ~~company~~securities ~~until~~purchase ~~the~~agreements ~~earliest~~(which we refer to ~~occur~~herein ~~of:~~as the “Series B Purchase Agreements”) with various investors (iwith each of whom we had a preexisting relationship and collectively, are referred to as the “Preferred Investors”) ~~our~~pursuant ~~reporting~~to $1which ~~billion~~we oragreed ~~more~~to inissue ~~annual~~shares of Series B Convertible Preferred Stock and warrants to purchase 603,865 shares of our Common Stock for gross ~~revenues;~~proceeds of $2,500,000 (iior a price per share and warrant of $4.14). The closing of the ~~end~~Series B Private Placement and the related exchange transactions were subject to the closing of ~~fiscal~~the ~~year~~Company’s ~~2021;~~initial public offering on or prior to July 21, 2017 (~~iii~~the “2017 IPO”), ~~our issuance~~which, in afact ~~three~~did ~~year~~not ~~period~~occur. As a result, ofno ~~more~~shares ~~than~~of $1Series ~~billion~~B inConvertible ~~non-convertible~~Preferred ~~debt;~~Stock and ~~(iv)~~nor ~~the~~were any ~~end~~underlying ofwarrants issued. As a result, the ~~fiscal~~Series ~~year~~B inPurchase ~~which~~Agreements ~~the~~were ~~market~~cancelled, ~~value~~and the shares of ~~our~~Common ~~common~~Stock ~~stock~~sold and ~~held~~assigned by ~~non-affiliates~~the ~~exceeded~~Founders ~~$700~~(as ~~million~~that onterm is defined below) to the ~~last~~Private ~~business~~Investors ~~day~~has ofbeen ~~our~~canceled ~~second~~and ~~fiscal~~the ~~quarter.~~shares that had been delivered to the Private Investors were transferred and assigned by the Private Investors back to the Founders.

5Recent Developments: R&D

~~TABLE~~During 2016 OF– ~~CONTENTS~~2017, the following important developments took place:

~~The~~● ~~Offering~~Team of highly-experienced drug developers assembled ● Drug, Picoplatin, was manufactured under Good Manufacturing Practice (GMP) guidelines in theamounts sufficient to perform multiple drug trials ● Proof-of-principle Machine Learning analysis of expression signatures of existing platinum drugs paved the way for personalized-medicine-type strategy of Picoplatin clinical development

~~Securities~~During 2018 ~~Offered:~~and to date, we did not incur any research and development expenses due to our lack of financial resources and our inability to pay our executive officers. As a result, our executive officers were not actively involved in performing any services on behalf of the Company.

~~1,888,889 shares of our common stock at an anticipated offering price per share of between $8.00 and $10.00.~~6

~~Over-allotment Option~~Recent Developments: R&D

WeDuring 2016 ~~have~~– ~~granted the underwriters a 45 day option to purchase up to an additional 283~~2017,~~334~~ ~~shares of our common stock at~~ the following ~~initial~~important ~~public~~developments ~~offering~~took ~~price to cover over-allotments, if any.~~place:

~~Common~~● ~~Stock~~Team ~~Outstanding~~of ~~Before~~highly-experienced ~~this~~drug ~~Offering:~~developers assembled ● Drug, Picoplatin, was manufactured under Good Manufacturing Practice (1GMP) guidelines in theamounts sufficient to perform multiple drug trials ● Proof-of-principle Machine Learning analysis of expression signatures of existing platinum drugs paved the way for personalized-medicine-type strategy of Picoplatin clinical development

5During 2018 and to date,~~000~~ we did not incur any research and development expenses due to our lack of financial resources and our inability to pay our executive officers. As a result,~~450~~ ~~shares~~our executive officers were not actively involved in performing any services on behalf of the Company.

~~Common Stock to be Outstanding After this Offering:(1)~~Corporate Information

~~6,889,339~~We were ~~shares~~organized ~~(or~~as ~~7,172,673~~a ~~shares~~corporation ifunder the ~~underwriters~~laws ~~exercise~~of ~~their~~the ~~over-allotment~~State ~~option~~of Delaware in ~~full~~May 2014. Our principal executive office is located at 36 Church Lane, Westport, Connecticut 06880, and our phone number is (203) 520-3840.

~~Use~~ Implications of ~~Proceeds:~~Being an Emerging Growth Company

We qualify ~~intend~~as toan ~~use~~“emerging ~~the~~growth ~~net~~company” ~~proceeds~~as ofdefined ~~this~~in ~~offering~~the toJumpstart ~~fund~~Our ~~our~~Business ~~anticipated~~Startups ~~Phase~~Act IIof ~~clinical~~2012 ~~trials~~(or inthe ~~metastatic~~JOBS Act). ~~colorectal~~As ~~cancer~~a ~~and~~result, ~~head~~we ~~and~~are ~~neck~~permitted ~~cancer~~ to, ~~obtain~~and ~~genomic~~intend ~~signatures~~to, ~~the~~rely ~~costs~~on ofexemptions ~~producing~~from ~~drug~~certain ~~product~~disclosure ~~for~~requirements ~~trials~~that ~~and~~are ~~for~~otherwise applicable ~~working~~to ~~capital~~public ~~and~~companies. ~~general~~These ~~corporate~~provisions ~~purposes.~~include, ~~See~~but ~~“Use~~are ofnot ~~Proceeds.”~~limited to:

~~Proposed~~● being ~~Nasdaq~~permitted ~~Symbol:~~to present only two years of audited financial statements and only two years of related “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this prospectus;

We● not ~~have~~being ~~applied~~required to ~~list~~comply ~~our~~with ~~common~~the ~~stock~~auditor onattestation ~~The~~requirements ~~NASDAQ~~of ~~Capital~~Section ~~Market~~404 ~~under~~of the ~~symbol~~Sarbanes-Oxley ~~“ACCP.”~~Act of 2002, as amended (or the Sarbanes-Oxley Act);

~~Risk~~● reduced ~~Factors:~~disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and

An● exemptions ~~investment~~from inthe ~~our~~requirements ~~company~~of isholding ~~highly speculative and involves~~ a ~~significant~~nonbinding ~~degree~~advisory ofvote ~~risk.~~on ~~See~~executive ~~“Risk~~compensation ~~Factors”~~ and ~~other~~stockholder ~~information~~approval ~~included in this prospectus for a discussion~~ of ~~factors~~any golden ~~you~~parachute ~~should~~payments ~~carefully~~not ~~consider~~previously ~~before deciding to invest in shares of our common stock~~approved.

~~(1)~~In addition, ~~The~~the ~~number~~JOBS Act provides that an emerging growth company can take advantage of ~~shares~~an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of ~~common~~some ~~stock~~accounting standards ~~outstanding~~until ~~excludes:~~those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period.

•We could ~~490~~remain an emerging growth company for up to five years after the last day of the fiscal year following the fifth anniversary that it completes its initial public offering (“IPO”),~~000~~ ~~shares~~or until the earliest of ~~our~~(i) ~~common~~the ~~stock~~last ~~underlying~~day of the first fiscal year in which our ~~Series~~annual Agross ~~Convertible~~revenues ~~Preferred~~exceed ~~Stock~~$1 ~~held~~billion, by(ii) ~~Tallikut~~the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which ~~preferred~~would ~~stock~~occur ~~will~~if ~~automatically~~the bemarket ~~converted~~value ~~into~~of ~~shares~~our Common Stock that is held by non-affiliates exceeds $700 million as of the last business day of our ~~common~~most ~~stock~~recently ~~upon~~completed second fiscal quarter, or (iii) the ~~closing~~date ofon ~~this~~which we ~~offering;~~have issued more than $1 billion in non-convertible debt during the preceding three year period.

~~• 392,000 shares of our common stock underlying a preferred stock purchase warrant held by Tallikut;~~7

• 1,716,026 shares of our common stock underlying outstanding convertible notes (including conversion of accrued interest thereon through September 30, 2016) with a weighted average conversion price of $3.09 per share, which notes will automatically be converted into shares of our common stock upon the closing of this offering;The Offering

• 788,824 shares of our common stock underlying common stock purchase warrants issued to the holders of our outstanding convertible notes with a weighted average exercise price of $3.49;

Securities Offered:		750,000 Units, each Unit consisting of one (1) share of our Common Stock and one (a) Class A Warrant to purchase one (1) share of our Common Stock at an exercise price of $4.40 per share. The shares of Common Stock and the Class A Warrant that are part of the Units are immediately separable and will be issued separately but will be purchased together in this Offering. The Units will not be issued, certificated or traded. Each Unit will be offered at an Offering Price of $4.00 per Unit.

Common Stock Outstanding Before this Offering:⁽¹⁾		6,220,190 shares

Common Stock to be Outstanding After this Offering:⁽¹⁾		6,970,190 shares

Class A Warrants Outstanding Before this Offering:		There were no Class A Warrants outstanding prior to this Offering.

Class A Warrants Outstanding After this Offering:		750,000 Class A Warrants to be issued as part of the Units

Terms of Class A Warrants Offered:		The Class A Warrants will have an exercise price $4.40 per share and will be exercisable any time after the date of issuance until the five-year anniversary of the date of issuance. The terms of the Class A Warrants will be governed by the Class A Warrant Agreement between us and the investors. For more information regarding the Class A Warrants, you should carefully read the section entitled “Description of Securities” in this prospectus.

Use of Proceeds:		We intend to use the net proceeds of this Offering to fund our anticipated Phase II clinical trial in head and neck cancer to obtain genomic signatures, the costs of producing drug product for the trial and for working capital and general corporate purposes. See “Use of Proceeds.”

No Trading on the OTC Markets Trading System:		Our Common Stock does not trade anywhere currently. We do not yet trade on the OTC Markets Group’s quotation system or any other quotation system or exchange and our securities have not been assigned a ticker symbol by FINRA.

Risk Factors:		An investment in our company is highly speculative and involves a significant degree of risk. See “Risk Factors” and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of our securities.

•(1) The ~~145~~number of Shares of Common Stock outstanding excludes: (i) 490,~~856~~000 shares of our ~~common~~Common ~~stock~~Stock underlying ~~common~~our ~~stock~~Series A ~~purchase~~Convertible ~~warrants~~Preferred Stock (or “Series A Preferred Stock”) held by Tallikut, as discussed more fully below, which Series A Preferred Stock will automatically be converted into shares of our Common Stock upon the closing of this Offering; (ii) 75,000 shares of Common Stock to be issued to ~~Palladium~~the ~~Capital~~holder ~~Advisors~~of an outstanding promissory note in consideration for extending the maturity date of such note; and (iii) 2,719,639 ~~LLC~~shares of our Common Stock underlying outstanding convertible notes (including conversion of accrued interest thereon through July 31, 2018, with a weighted average ~~exercise~~conversion price of $32.~~49;~~97 per share, which notes will automatically be converted into shares of our Common Stock upon the closing of this Offering. The number of Shares also excludes the other options and warrants outstanding as of the date of filing of this registration statement.

• shares of our common stock reserved for future issuance under our 2016 Equity Incentive Plan (an aggregate of twenty percent (20%) of the outstanding common stock immediately following the consummation of this offering on a fully-diluted basis will be reserved for issuance under the 2016 Equity Incentive Plan); and8

•Summary Financial ~~436,100 shares of our common stock underlying outstanding options which were issued prior to the adoption of our 2016 Equity Incentive Plan with an exercise price of $0.41.~~Data

~~Summary~~The summary financial data below as of June 30, 2018 and for the six months ended June 30, 2018 and 2017 have been derived from our unaudited condensed consolidated financial statements as well as for the years ended December 31, 2017 and 2016 have been derived from our audited consolidated financial statements included elsewhere in this prospectus. The following summary financial information should be read in connection with, and is qualified by reference to, our consolidated financial statements and their related notes and “Management’s Discussion and Analysis of Financial ~~Data~~Condition and Results of Operations” included elsewhere in this prospectus. Our historical results for any prior period are not necessarily indicative of results to be expected in any future period.

~~The summary financial data below as~~ Statement of ~~and~~Operations ~~for~~Data: the six months ended June 30, 2016 and 2015 and the year ended December 31, 2015 and for the period from May 12, 2014 (date of inception) through December 31, 2014 have been derived from our unaudited and audited consolidated financial statements

	Six Months Ended			Six Months Ended			Year Ended December 31,
	June 30, 2018			June 30, 2017			2017			2016
	(unaudited)			(unaudited)
Operating expenses
General and administrative (5)	$	85,545		$	603,074		$	652,755		$	3,037,646
Research and development (5)		—			—			1,400			164,772
Total operating expenses		85,545			603,074			654,155			3,202,368
Loss from operations		(85,545	)		(603,074	)		(654,155	)		(3,202,368	)
Other income (expense)
Foreign currency exchange gain (loss)		(24,720	)		6,750			13,692			(5,803	)
Gain on change in fair value of warrant liability		-			84,975			85,464			112,391
Interest expense		(257,418	)		(591,878	)		(839,118	)		(834,080	)
Total other expense		(282,138	)		(500,153	)		(739,962	)		(727,492	)
Net loss		(367,683	)		(1,103,227	)		(1,394,117	)		(3,929,860	)
Net loss per common share, basic and diluted	$	(0.06	)	$	(0.21	)	$	(0.24	)	$	(0.79	)
Weighted average common shares outstanding, basic and diluted		6,220,190			5,355,348			5,791,323			4,988,320

~~TABLE~~Balance Sheet ~~OF CONTENTS~~Data:

included elsewhere in this prospectus. The following summary financial information should be read in connection with, and is qualified by reference to, our consolidated financial statements and their related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus. Our historical results for any prior period are not necessarily indicative of results to be expected in any future period.

	As of June 30, 2018
	Actual (unaudited)			Pro Forma As Adjusted⁽¹⁾⁽²⁾ (unaudited)
Cash	$	31,871		$	2,036,178
Working capital (deficit)		(6,936,763	)		195,807
Total assets		33,190			2,037,497
Total debt, net of debt discount of $70,511⁽³⁾		5,400,489			—
Preferred stock⁽⁴⁾		1			0
Accumulated deficit⁽⁵⁾		(12,110,843	)		(12,110,843	)
Total stockholders’ (deficit) equity		(7,774,682	)		5,270,807

~~Statement of Operations Data:~~9

	Six Months Ended June 30, 2016 (unaudited)			Six Months Ended June 30, 2015 (unaudited)			Year EndedDecember 31,2015			From May 12,2014 (date ofinception)throughDecember 31,2014
Operating expenses:
Selling general and administrative	$	1,695,565		$	484,638		$	1,482,506		$	2,009,384
Research and Development		389,036			116,259			2,269,520			150,000
Total operating expenses		2,084,601			600,897			3,752,025			2,159,384
Loss from Operations		(2,084,601	)		(600,897	)		(3,752,025	)		(2,159,384	)
Other income (expense):
Foreign currency exchange gain		(4,997	)		26,790			101,957			—
Gain on change in fair value of warrant liability		69,526			(105,534	)		112,911			2,068
Interest expense		(462,888	)		(225,214	)		(639,396	)		(1,431	)
Total other income (expense)		(398,359	)		(303,958	)		(424,528	)		(637	)
Net Loss		(2,482,960	)		(904,855	)		(4,176,553	)		(2,158,747	)
Net loss per common share, basic and diluted	$	(0.50	)	$	(0.18	)	$	(0.85	)	$	(0.58	)
Weighted average common shares outstanding, basic and diluted		4,976,058			4,900,000			4,900,000			3,715,832

(1) Amounts calculated on a pro forma as adjusted basis to give effect to:

7● the automatic conversion of all our outstanding convertible notes, together with any unpaid and accrued interest thereon, into an aggregate of 2,719,639 shares of our Common Stock upon the closing of this Offering;

~~TABLE~~● the OFrepayment ~~CONTENTS~~of other outstanding indebtedness in the amount of $565,693;

~~Balance~~● the ~~Sheet~~repayment ~~Data:~~of the net proceeds of $481,318 from a bridge financing in January 2017, which amount includes penalties and interest and the issuance of 115,000 shares of our Common Stock to the holder; and

	As of June 30, 2016
	Actual			Pro Forma(1)			Pro Forma As Adjusted(2)
Cash and Cash Equivalents	$	13,295		$	13,295		$	15,113,295
Working Capital		(4,536,518	)		1,360,834			13,379,166
Total Assets		119,366			119,366			15,219,366
Total debt, net of discount of $254,522(3)		3,595,478			—			—
Convertible Preferred stock(4)		1			—			—
Accumulated Deficit		(8,818,260	)		(8,818,260	)		(8,818,260	)
Total Stockholders’ (deficit) equity		(4,947,789	)		(1,352,310	)		13,747,690

● In conjunction with the exchange of warrants into Common Stock, a reclassification of warrant embedded derivative liabilities to additional paid-in capital

~~(1)~~● In ~~Amounts~~addition, ~~calculated~~75,000 onshares ashall ~~pro~~be ~~forma~~issued ~~basis~~in toconnection ~~give~~with ~~effect~~the extension of the maturity date of certain debt payable to: Firstfire Global Opportunity Fund LLC.

•(2) Amounts calculated on a pro forma as adjusted basis to give further effect to (i) our issuance and sale of 750,000 Units in this Offering at the ~~automatic~~assumed ~~conversion~~Offering Price of ~~all~~$4.00, ~~our~~after ~~outstanding~~deducting ~~convertible~~estimated ~~notes~~placement agent fees and commissions and estimated Offering expenses payable by us, ~~together~~payment ~~with~~of ~~any~~accrued ~~unpaid~~financing costs and the reclassification of deferred financing costs to additional paid-in capital; (ii) the issuance of 2,719,639 shares of Common Stock underlying outstanding convertible notes (including conversion of accrued interest thereon through July 31, ~~into~~2018, anwith ~~aggregate~~a weighted average conversion price of 1$2.97 per shares,~~716,026~~ which notes will be automatically converted into shares of our ~~common~~Common ~~stock~~Stock upon the closing of this ~~offering;~~Offering, and (iii) the payment of other outstanding indebtedness upon the closing of this Offering.

•(3) Total Indebt ~~conjunction~~represents ~~with~~ the ~~conversion~~carrying amount of our convertible notes: ~~(i) the accelerated amortization of $254,522 of unamortized debt discount~~ and ~~(ii) the reclassification of the warrant and embedded derivative liabilities to additional paid~~short-interm ~~capital~~notes ~~as, upon completion of this offering, neither is subject to re-measurement~~payable.

(24) Convertible ~~Amounts~~Preferred ~~calculated~~Stock onrepresents aour ~~pro~~Series ~~forma~~A asConvertible ~~adjusted~~Preferred ~~basis~~Stock, towhich ~~give~~was ~~further~~issued ~~effect~~on toFebruary ~~our issuance and sale of~~ 1,~~888,889~~ ~~shares~~2016 ~~of our common stock~~ in ~~this~~connection with ~~offering~~our atlicensing of the ~~assumed~~global ~~offering~~rights ~~price~~to ~~of $9.00~~Picoplatin, ~~after deducting estimated underwriting discounts~~ and ~~commissions~~convertible ~~and~~into ~~estimated offering expenses payable by us~~490,000 ~~payment~~shares of ~~accrued~~Common ~~financing~~Stock ~~costs~~upon ~~and~~ the ~~reclassification~~ consummation of ~~deferred~~this ~~financing costs to additional paid-in capital~~Offering.

(35) The ~~Total~~amounts ~~debt~~included ~~represents~~in General and Administrative (G&A) in the ~~carrying~~Statement ~~amount~~of Operations Data above include salaries of our executive ~~convertible~~officers ~~notes~~and approximately 70% of the professional time of our executive officers were devoted to the Company’s Research and Development activities (R&D) which is an essential part of the fiduciary duties of these executive officers. The Company, effective September 14, 2018, entered into a Modification Agreement to their executive officer’s respective employment agreements, superseding the former employment agreements dated June 10, 2016 in their entirety. Reference is made to the disclosure under “Employment Agreements” below. To date, no salaries have been paid nor accrued based upon the former employment agreements between the Company and its executive officers because: (i) the June 2016 employment agreements were only to become effective upon the closing of the 2017 IPO, which did not occur; and (ii) the executive officers did not provide services under these employment agreements because the Company lacked the capital resources to pay the salaries provided under the June 2016 employment agreements.

(4) Convertible Preferred Stock represents our Series A Convertible Preferred Stock, which was issued on February 1, 2016 in connection with our licensing of the global rights to Picoplatin, and convertible into 490,000 shares of common stock upon the consummation of this offering.10

8RISK FACTORS

~~TABLE~~An investment OFin ~~CONTENTS~~our securities involves substantial risks, including the risks described below. You should carefully consider the risks described below before purchasing our securities. The risks highlighted here are not the only ones that we may face. For example, additional risks presently unknown to us or that we currently consider immaterial or unlikely to occur could also impair our operations. If any of the risks or uncertainties described below or any such additional risks and uncertainties actually occur, our business, prospects, financial condition or results of operations could be negatively affected, and you might lose all or part of your investment.

~~RISK~~Risks Related ~~FACTORS~~to Our Business

AnWe are ~~investment~~a inpre-revenue ~~our~~biopharmaceutical ~~common~~company ~~stock~~and ~~involves substantial risks, including the risks described below. You should carefully consider the risks described below before purchasing our common stock. The risks highlighted here~~ are ~~not~~thus ~~the~~subject ~~only ones that we may face. For example, additional risks presently unknown~~ to ~~us or that we currently consider immaterial or unlikely to occur could also impair our operations. If any of~~ the risks orassociated ~~uncertainties~~with ~~described~~new ~~below~~businesses orin ~~any~~that such additional risks and uncertainties actually occur, our business, prospects, financial condition or results of operations could be negatively affected, and you might lose all or part of your investmentindustry.

~~Risks~~We acquired ~~Related~~the exclusive, global license of all rights to ~~Our~~develop ~~Business~~and commercialize Picoplatin on June 17, 2014 and have only recently begun to pursue this new business opportunity. As such, we are a clinical stage biopharmaceutical company with no history of revenue-generating operations, and our only assets consist of the intellectual property and related assets licensed to us by Genzyme and certain intellectual property of Poniard. Therefore, we are, and expect for the foreseeable future to be, subject to all the risks and uncertainties inherent in a new business, in particular new businesses engaged in the development of pharmaceuticals. We still must establish and implement many important functions necessary to operate a business, including the clinical development of Picoplatin, establishing our managerial and administrative structure and implementing financial systems and controls.

WeAccordingly, you ~~are~~should aconsider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in their pre-revenue ~~biopharmaceutical~~generating ~~company~~stages, ~~and~~particularly ~~are~~those ~~thus~~in ~~subject~~the topharmaceutical field. Potential investors should carefully consider the risks ~~associated~~and ~~with~~uncertainties that a new ~~businesses~~company inwith ~~that~~no ~~industry~~operating history will face. In particular, potential investors should consider that there is a significant risk that we will not be able to:

We● implement ~~acquired~~or ~~the~~execute ~~exclusive,~~our ~~global~~current ~~license of all rights to develop and commercialize Picoplatin on June 17, 2014 and have only recently begun to pursue this new~~ business ~~opportunity. As such~~plan, weor ~~are~~create a clinical stage biopharmaceutical company with no history of revenue-generating operations, and our only assets consist of the intellectual property and related assets licensed to us by Genzyme and certain intellectual property of Poniard. Therefore, we are, and expect for the foreseeable future to be, subject to all the risks and uncertainties inherent in a new business, inplan ~~particular~~that ~~new~~is businesses engaged in the development of pharmaceuticals. We still must establish and implement many important functions necessary to operate a business, including the clinical development of Picoplatin, establishing our managerial and administrative structure and implementing financial systems and controls. sound;

~~Accordingly,~~● maintain ~~you should consider~~ our ~~prospects~~anticipated inmanagement light of the costs, uncertainties, delays and difficulties frequently encountered by companies in their pre-revenue generating stages, particularly those in the pharmaceutical field. Potential investors should carefully consider the risks and uncertainties that a new company with no operating history will face. In particular, potential investors should consider that there is a significant risk that we will not be able to:team;

•● raise ~~implement~~sufficient orfunds ~~execute~~in ~~our~~the ~~current~~capital ~~business~~markets ~~plan,~~ or ~~create~~otherwise ato ~~business~~effectuate ~~plan~~our ~~that~~business ~~is sound~~plan;

•● determine ~~maintain~~that ~~our~~the ~~anticipated~~processes ~~management~~and ~~team~~technologies that we have developed are commercially viable; and/or

•● attract, ~~raise~~enter ~~sufficient~~into ~~funds~~or inmaintain ~~the~~contracts ~~capital~~with, ~~markets~~potential orcommercial ~~otherwise~~partners tosuch ~~effectuate~~as ~~our~~licensors ~~business~~of ~~plan;~~technology and suppliers.

•If we ~~determine~~cannot ~~that~~execute any one of the ~~processes~~foregoing, ~~and~~our ~~technologies~~business ~~that~~may wefail, ~~have~~in ~~developed~~which ~~are~~case ~~commercially~~you ~~viable;~~may ~~and/or~~lose the entire amount of your investment in our Company.

•In addition, ~~attract~~as a pre-revenue biopharmaceutical company, ~~enter~~we ~~into~~expect orto ~~maintain~~encounter ~~contracts~~unforeseen ~~with~~expenses, ~~potential~~difficulties, complications, delays and other known and unknown factors. We will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial ~~partners~~activities. ~~such~~We asmay ~~licensors~~not be able to reach such point of ~~technology~~transition ~~and~~or ~~suppliers~~make such a transition, which would have a material adverse effect on our company.

~~If we cannot execute any one of the foregoing, our business may fail, in which case you may lose the entire amount of your investment in our Company.~~ 11

~~In addition, as a pre-revenue biopharmaceutical company, we expect to encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors.~~ We have ~~will need to transition at some point from~~ a ~~company~~very ~~with~~limited aoperating ~~research~~history and ~~development~~are ~~focus~~expected to aincur ~~company~~significant ~~capable~~operating oflosses ~~supporting~~during ~~commercial~~the ~~activities.~~early Westage ~~may not be able to reach such point~~ of ~~transition or make such a transition, which would have a material adverse effect on~~ our ~~company~~corporate development.

We were ~~have~~organized aon ~~very~~May 12, 2014 and we acquired the rights to our product candidate Picoplatin in June 2014. Accordingly, we have a limited operating history. We have not sold our product candidate because it is currently investigational in nature and requires completion of additional clinical and non-clinical trials and studies in order to obtain regulatory approval in the U.S. and abroad. Therefore, our historical financial information consists only of our unaudited financial results as of and for the six months ended June 30, 2018 and 2017 and our financial results as of and for the years ended December 31, 2017 and December 31, 2016. This is very limited historical financial information upon which to base an evaluation of our performance. We are ~~expected~~an emerging company, and thus our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operation, particularly in the pharmaceutical industry. As of June 30, 2018, we have generated cumulative losses of approximately $12 million since inception, and we expect to ~~incur~~continue ~~significant~~to ~~operating~~incur losses ~~during~~until Picoplatin is approved by the ~~early~~FDA. ~~stage~~Even if regulatory approval is obtained, there is a risk that we will not be able to generate material sales of Picoplatin, which would cause us to continue to incur losses. We thus expect to incur substantial operating expenses over the next several years as our ~~corporate~~product development and marketing activities increase. The amount of future losses and when, if ever, we will achieve profitability are uncertain.

We have ~~were~~no ~~organized~~experience onas ~~May 12, 2014 and we acquired the rights to our product candidate Picoplatin in June 2014. Accordingly, we have~~ a ~~limited~~company ~~operating history. We have not sold our product candidate because it is currently investigational~~ in ~~nature~~obtaining ~~and requires completion of additional clinical and non-clinical trials and studies in order to obtain~~ regulatory approval ~~in the U.S. and abroad. Therefore, our historical financial information consists only of our unaudited financial results at and~~ for ~~the quarters ended June 30~~, ~~2016~~or ~~and 2015 and an audit of our financial results at and for the year ended December 31~~commercializing, ~~2015~~any ~~and the~~product ~~period~~candidate. ~~from~~

9As a company, we have never obtained regulatory approval for, or commercialized, any product candidate. It is possible that the FDA may refuse to accept our planned New Drug Application (or NDA) for Picoplatin for substantive review or may conclude after review of our data that our application is insufficient to obtain regulatory approval of Picoplatin or any future product candidates. If the FDA does not accept or approve our planned NDA for Picoplatin, it may require that we conduct additional clinical, preclinical or manufacturing validation studies, which may be costly, and submit that data before it will reconsider our applications. Depending on the extent of these or any other FDA required studies, approval of any NDA or application that we submit may be significantly delayed, possibly for several years, or may require us to expend more resources than we have available. Any delay in obtaining, or an inability to obtain, regulatory approvals would prevent us from commercializing Picoplatin, generating revenues and achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve any NDA we submit. If any of these outcomes occur, we may be forced to abandon our planned NDA for Picoplatin, which would materially adversely affect our business and could potentially cause us to cease operations. We may face similar risks for any approval in a foreign jurisdiction.

~~TABLE~~Our current OFand ~~CONTENTS~~future operations substantially depend on our management team and our ability to hire other key personnel, the loss of any of whom could disrupt our business operations.

~~May~~Our ~~12,~~business ~~2014~~depends ~~(date~~and ofwill ~~inception)~~continue ~~through~~to depend ~~December~~in ~~31,~~substantial ~~2014.~~part ~~This~~on isthe ~~very~~continued ~~limited~~service ~~historical~~of ~~financial~~Michael ~~information~~Fonstein, ~~upon~~Ekaterina ~~which~~Nikolaevskaya toand ~~base~~Dmitry anPrudnikov, ~~evaluation~~each of whom ~~our~~entered ~~performance~~into an employment agreement with the Company. WeThe ~~are~~Company anprevioulsy ~~emerging~~agreed ~~company,~~in ~~and~~principle ~~thus~~with our ~~prospects~~executive officers ~~must~~to beenter ~~considered~~into inamendments ~~light~~to of the ~~uncertainties,~~prior ~~risks,~~employment ~~expenses~~agreements, ~~and~~none ~~difficulties~~of ~~frequently~~which ~~encountered~~were byto ~~companies~~become ineffective ~~their~~until ~~early~~the ~~stages~~successful completion of ~~operation~~the 2017 IPO, ~~particularly~~which, in ~~the~~fact ~~pharmaceutical~~did ~~industry~~not occur. AsOn ofSeptember ~~June 30~~14, ~~2016~~2018, wethe ~~have~~Company ~~generated~~entered ~~cumulative~~into ~~losses~~a ofModification ~~approximately~~Agreement with ~~$8.8~~its ~~million~~executive ~~since inception~~officers, ~~and~~which wesuperseded ~~expect~~in totheir ~~continue~~entirety tothe ~~incur~~previous ~~losses~~executive ~~until~~officer ~~Picoplatin~~employment isagreements, which ~~approved~~never bybecame effective because the ~~FDA~~2017 ~~and~~IPO ~~foreign~~did ~~regulatory authorities,~~not ~~including~~close. Pursuant to the ~~Ministry~~Modification ofAgreement, ~~Health~~a copy of ~~the~~which ~~Russian~~is filed ~~Federation~~as Exhibit 10.35 ~~Even~~to ifthis ~~regulatory~~Registration ~~approval~~Statement, isupon ~~obtained~~successful closing of this Offering, of which there iscan abe no ~~risk~~assurance, ~~that~~Michael weFonstein, Ekaterina Nikolaevskaya and Dmitry Prudnikov will ~~not~~receive bebase ~~able~~annual salaries equal to 30% ~~generate~~of ~~material~~the ~~sales~~base salary, with respect to Michael Fonstein and 35% of ~~Picoplatin,~~the ~~which~~base ~~would~~salaries ~~cause~~with usrespect to ~~continue~~Ekaterina Nikolaevskaya toand ~~incur~~Dmitry ~~losses.~~Prudnikov, Weof ~~thus~~their ~~expect~~former toemployment ~~incur~~agreements. ~~substantial~~Reference ~~operating~~is ~~expenses~~made ~~over~~to the ~~next~~disclosure ~~several~~under ~~years~~“Employment Agreements” asbelow. ~~our~~We ~~product~~do ~~development~~not ~~and~~carry ~~marketing~~key ~~activities~~person ~~increase.~~life ~~The~~insurance ~~amount~~on any of ~~future~~our ~~losses~~management, ~~and~~which ~~when,~~would ifleave ~~ever,~~our wecompany ~~will~~uncompensated for ~~achieve~~the ~~profitability~~loss ~~are~~of ~~uncertain.~~any of our management.

WeOur future ~~have~~viability noand ~~experience~~ability asto aachieve ~~company~~sales and profit will also depend on our ability to attract, retain and motivate highly qualified personnel in ~~obtaining~~the ~~regulatory~~diverse ~~approval~~areas required for continuing our operations. There is a risk that we will be unable to attract, train or ~~commercializing~~retain qualified personnel, ~~any~~both ~~product~~near ~~candidate~~term or in the future, and our failure to do so may severely damage our prospects.

AsWe are ahighly ~~company,~~dependent weon ~~have never obtained regulatory approval for, or commercialized, any product candidate. It is possible that the FDA may refuse to accept~~ our ~~planned~~license ~~New~~agreement ~~Drug~~with ~~Application (or NDA) for Picoplatin for substantive review~~Genzyme, or may conclude after review of our data that our application is insufficient to obtain regulatory approval of Picoplatin or any future product candidates. If the FDA does not accept or approve our planned NDA for Picoplatin, it may require that we conduct additional clinical, preclinical or manufacturing validation studies, which may be costly, and ~~submit that data before it will reconsider our applications. Depending on~~ the ~~extent~~loss of ~~these~~this orlicense any other FDA required studies, approval of any NDA or application that we submit may be significantly delayed, possibly for several years, or may require us to expend more resources than we have available. Any delay in obtaining, or an inability to obtain, regulatory approvals would prevent us from commercializing Picoplatin, generating revenues and achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve any NDA we submit. If any of these outcomes occur, we may be forced to abandon our planned NDA for Picoplatin, which would materially ~~adversely~~impair ~~affect~~ our business plan and ~~could potentially cause us to cease operations~~viability. ~~We face similar risks for any approval in a foreign jurisdiction, including approval of an application for registration of medicine from the Ministry of Health of the Russian Federation.~~

~~Our~~We have ~~current~~secured exclusive rights to develop and ~~future~~commercialize ~~operations~~Picoplatin ~~substantially~~from ~~depend~~Genzyme on ~~our~~a ~~management~~worldwide ~~team~~basis, and Picoplatin is currently our ~~ability~~only product candidate. As such, our license agreement with Genzyme is critical to ~~hire~~our ~~other~~business. ~~key~~In ~~personnel~~the event that our license agreement with Genzyme is terminated, we would lose the ~~loss~~ability ofto ~~any~~develop ofand ~~whom~~commercialize ~~could~~Picoplatin, ~~disrupt~~and our business ~~operations~~prospects would be materially damaged, which could lead to the loss of your investment.

Our business depends and will continue to depend in substantial part on the continued service of Michael Fonstein, Randy S. Saluck, Ekaterina Nikolaevskaya and Dmitry Prudnikov, each of whom entered into an employment agreement with the Company which will be effective upon consummation of this offering. Such agreements have limited terms and may also be terminated by us with or without cause (as defined in the employment agreements) and by each of such officers voluntarily or with good reason (as defined in the employment agreements). The loss of the services of any of these individuals would significantly impede implementation and execution of our business strategy and may result in the failure to reach our goals. We do not carry key person life insurance on any of our management, which would leave our company uncompensated for the loss of any of our management. 12

~~Our~~Risks Related ~~future viability and ability~~ to ~~achieve~~Our ~~sales~~Financial ~~and~~Position ~~profit will also depend on our ability to attract, retain~~ and ~~motivate~~Need ~~highly~~For ~~qualified~~Additional personnel in the diverse areas required for continuing our operations. There is a risk that we will be unable to attract, train or retain qualified personnel, both near term or in the future, and our failure to do so may severely damage our prospects. Capital

We have ~~are~~never ~~highly~~generated ~~dependent~~revenue, onmay ~~our~~never ~~license~~generate ~~agreement with Genzyme~~revenue, ~~and~~are ~~the~~not ~~loss~~profitable ofand ~~this~~may ~~license~~never ~~would~~become ~~materially impair our business plan and viability~~profitable.

We expect ~~have~~to ~~secured~~incur ~~exclusive~~substantial ~~rights~~losses ~~to develop~~ and ~~commercialize~~negative ~~Picoplatin~~operating ~~from~~cash ~~Genzyme~~flow onfor athe ~~worldwide~~foreseeable ~~basis~~future, and ~~Picoplatin~~we ismay ~~currently~~never ~~our~~achieve ~~only~~or ~~product candidate~~maintain profitability. AsEven ~~such,~~if ~~our~~we ~~license~~are ~~agreement~~able ~~with Genzyme is critical~~ to ~~our~~launch ~~business. In the event that our license agreement with Genzyme is terminated~~Picoplatin, we ~~would~~expect ~~lose~~to ~~the~~incur ~~ability~~substantial tolosses ~~develop~~for ~~and~~the ~~commercialize~~foreseeable ~~Picoplatin,~~future and may ~~our~~never ~~business~~become ~~prospects would be materially damaged, which could lead to the loss of your investment~~profitable.

10As we have no operating revenue, we also expect to experience negative cash flow for the foreseeable future as we continue to fund our operating losses and capital expenditures. As a result, we will need to generate significant revenues in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the future. Our failure to achieve or maintain profitability would negatively impact the value of your securities and potentially require us to shut down our business, which would result in the loss of your investment.

~~TABLE~~We will OFrequire ~~CONTENTS~~additional funding to progress our business. If we are unable to raise additional capital, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts and our business could fail.

~~Risks~~We expect ~~Related~~that we will be required to ~~Our~~incur ~~Financial~~significant ~~Position~~expenses in connection with our ongoing activities, particularly as we engage in efforts to develop and ~~Need~~commercialize ~~For~~our ~~Additional~~Picoplatin. ~~Capital~~Accordingly, we will need to obtain long term additional funding in connection with our continuing operations. We will require over the next 12 months from the date of this prospectus approximately $2.57 million, the net proceeds of this Offering if all of the Units are sold, to fund our planned operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts, and our business might fail.

~~We have never generated revenue~~In addition, ~~may~~our ~~never~~future ~~generate~~capital ~~revenue,~~requirements ~~are~~will ~~not~~be ~~profitable~~significant and ~~may~~will ~~never~~depend ~~become~~on ~~profitable.~~many factors, including:

~~We expect to incur substantial losses and negative operating cash flow for~~ ● the ~~foreseeable~~progress ~~future,~~ and weresults ~~may~~of ~~never~~our ~~achieve~~development orefforts ~~maintain profitability. Even if we are able to launch Picoplatin, we expect to incur substantial losses~~ for ~~the foreseeable future and may never become profitable.~~ Picoplatin;

~~As we have no operating revenue, we also expect to experience negative cash flow for~~ ● the ~~foreseeable future as we continue to fund our operating losses and capital expenditures. As a result~~costs, wetiming ~~will need to generate significant revenues in order to achieve~~ and ~~maintain~~outcome ~~profitability.~~of Weclinical ~~may~~trials ~~not be able to generate these revenues or achieve profitability in the future. Our failure to achieve or maintain profitability would negatively impact the value~~ of ~~your securities and potentially require us to shut down~~ our ~~business,~~product ~~which~~candidate ~~would~~for ~~result~~one inor ~~the~~more ~~loss~~ types of ~~your investment.~~ cancer;

We● the ~~will require additional funding to progress our business. If we are unable to raise additional capital~~costs, wetiming ~~could~~and beoutcome ~~forced~~of toregulatory ~~delay,~~review ~~reduce~~of ~~or eliminate~~ our product ~~development~~candidate ~~programs~~for one or ~~commercialization~~more types ~~efforts~~of ~~and our business could fail.~~cancer;

We● the ~~expect~~costs ~~that~~and wetiming ~~will~~of ~~be required to incur significant expenses in connection with our ongoing activities~~preparing, ~~particularly~~filing ~~as we engage in efforts to develop~~ and ~~ultimately~~prosecuting ~~commercialize~~patent ~~our Picoplatin. Accordingly~~applications, wemaintaining ~~will~~and enforcing ~~need to obtain long term additional funding in connection with~~ our ~~continuing~~intellectual ~~operations.~~property Werights will require approximately $7,500,000 of funding over the next 12 months to fund our planned operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and ~~development~~defending ~~programs or~~ any ~~future~~intellectual ~~commercialization~~property-related ~~efforts, and our business might fail.~~ claims;

In● competing ~~addition,~~technological ~~our future capital requirements will be significant~~ and ~~will~~market ~~depend on many factors, including:~~developments;

•● market ~~the~~acceptance ~~progress~~of ~~and~~our ~~results~~product ofcandidate ~~our~~as ~~development~~a ~~efforts~~treatment for ~~Picoplatin~~one or more types of cancer;

• ● the costs, ~~timing~~ and ~~outcome~~timing of ~~clinical~~future ~~trials~~commercialization ofactivities, ~~our~~including product ~~candidate~~manufacturing, marketing, sales and distribution, for ~~one~~any orproduct ~~more~~candidate ~~types~~for ofwhich ~~cancer~~we receive marketing approval;

• ● the ~~costs~~revenue, ~~timing~~if ~~and~~any, ~~outcome~~received offrom ~~regulatory~~commercial ~~review~~sales of ~~our~~any product candidate for ~~one~~which orwe ~~more~~may receive ~~types~~marketing ~~of cancer~~approval;

• ● the ~~costs~~extent ~~and~~to ~~timing~~which ofwe ~~preparing,~~acquire ~~filing~~or ~~and~~in-license ~~prosecuting~~other ~~patent~~products ~~applications, maintaining~~ and ~~enforcing our intellectual property rights and defending any intellectual property-related claims~~technologies;

•● legal, ~~competing~~accounting, ~~technological~~insurance and ~~market~~other ~~developments~~professional and business-related costs; and

•● whether ~~market~~any ~~acceptance~~ of ~~our~~the ~~product~~Class ~~candidate~~A asWarrants aare ~~treatment~~exercised, ~~for~~of ~~one~~which orthere ~~more~~can ~~types~~be ofno ~~cancer;~~assurance.

•Developing pharmaceutical ~~the~~products, ~~costs~~conducting preclinical testing and ~~timing~~clinical trials and seeking regulatory approval of ~~future~~such ~~commercialization~~products ~~activities~~is a time-consuming, ~~including~~expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product ~~manufacturing~~sales. In addition, ~~marketing~~our product candidate, ~~sales~~if ~~and~~approved ~~distribution~~(of which no assurances may be given), ~~for~~may not achieve any level of commercial success. Our commercial revenues, if any, will be derived from sales of a product ~~candidate~~that we do not expect to be commercially available for ~~which~~several years, if at all. Accordingly, we ~~receive~~will need ~~marketing~~to ~~approval;~~continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. See “Use of Proceeds” below.

•We may ~~the~~have ~~revenue,~~difficulty ifin ~~any,~~raising ~~received~~capital ~~from~~and ~~commercial~~may ~~sales~~consume ofresources ~~any~~faster ~~product~~than ~~candidate~~expected. ~~for which we may receive marketing approval;~~

•We currently do not generate any revenue from product sales or otherwise, and we therefore have a limited source of cash to meet our future capital requirements. We do not expect to generate revenues for the ~~extent~~foreseeable future, and we may not be able to raise funds in the future, which wewould ~~acquire~~leave us without resources to continue operations and force us to resort to stockholder investments or loans, which may not be available to us. We may have difficulty raising needed capital in~~-license~~ the near or longer term as a result of, among other ~~products~~factors, the very early stage of our company, the rights of certain of our stockholders to participate in our future financings and ~~technologies;~~our lack of revenues as well as the inherent business risks associated with our company and present and future market conditions. Also, we may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated. Our inability to raise funds could lead to decreases in the price of our Common Stock and Class A Warrants and the failure of our business.

~~• legal, accounting, insurance and other professional and business-related costs.~~13

~~Developing~~Raising additional ~~pharmaceutical~~capital ~~products,~~may ~~conducting~~cause ~~preclinical~~dilution ~~testing~~to ~~and~~our ~~clinical trials and seeking regulatory approval of such products is a time-consuming~~stockholders, ~~expensive~~restrict ~~and~~our ~~uncertain~~operations ~~process~~or ~~that~~require ~~takes~~us ~~years~~ to ~~complete,~~relinquish ~~and~~rights ~~we may never generate the necessary data or results required~~ to ~~obtain regulatory approval and achieve product sales. In addition,~~ our ~~product~~technologies or ~~candidate, if approved (of which no assurances may be given), may not achieve any level of commercial success. Our commercial revenues, if any, will be derived from sales of a~~ product ~~that we do not expect to be commercially available for several years, if at all~~candidates. ~~Accordingly,~~

11Since we will be unable to generate any revenue from actual sales of products and expect to be in the early stages for the foreseeable future, we will need to seek equity or debt financing to provide the capital required to execute our business plan. We will need significant funding for developing our intellectual property, conducting clinical trials and entering into collaborations with third party partners as well as for working capital requirements and other operating and general corporate purposes.

~~TABLE~~There can OFbe ~~CONTENTS~~no assurance that we will be able to raise sufficient capital on acceptable terms, or at all. If such financing is not available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of business opportunities and our operations and financial condition may be adversely affected to a significant extent.

If we ~~will~~raise ~~need~~additional tocapital ~~continue~~by toissuing ~~rely~~equity onsecurities, ~~additional~~the ~~financing~~percentage toand/or ~~achieve~~economic ownership of our ~~business~~existing ~~objectives.~~stockholders may ~~Adequate~~be ~~additional~~reduced, ~~financing~~and accordingly these stockholders may ~~not~~experience besubstantial ~~available~~dilution. toWe usmay onalso ~~acceptable~~issue ~~terms~~equity securities that provide for rights, orpreferences atand ~~all.~~privileges ~~See~~senior ~~“Use~~to those of ~~Proceeds”~~our ~~below.~~Common Stock.

WeDebt financing, if obtained, may ~~have~~involve ~~difficulty~~agreements that include liens on our assets, covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, increases in ~~raising~~our ~~capital~~expenses and ~~may~~requirements ~~consume~~that ~~resources~~our ~~faster~~assets ~~than~~be ~~expected~~provided as a security for such debt. Debt financing would also be required to be repaid regardless of our operating results.

~~We currently do not generate any revenue from product sales or otherwise, and~~ If we ~~therefore have a limited source of cash to meet our future capital requirements. We do not expect to generate revenues for the foreseeable future, and we may not be able to~~ raise additional funds inthrough ~~the~~collaborations ~~future, which would leave us without resources to continue operations~~ and ~~force~~licensing ~~us to resort to stockholder investments or loans~~arrangements, ~~which~~we may ~~not~~ be ~~available~~required to ~~us.~~relinquish Wesome ~~may have difficulty raising needed capital in the near or longer term as a result of, among other factors, the very early stage of our company, the~~ rights ofto ~~certain of~~ our ~~stockholders to~~ ~~participate~~technologies inor ~~our~~product ~~future financings and our lack of revenues as well as the inherent business risks associated with our company and present and future market conditions. Also~~candidate, weor ~~may~~to ~~consume~~grant ~~available~~licenses ~~resources~~on ~~more~~terms ~~rapidly~~that ~~than~~are ~~currently~~not ~~anticipated,~~favorable ~~resulting in the need for additional funding sooner than anticipated. Our inability~~ to ~~raise funds could lead to decreases in the price of our common stock and the failure of our business~~us.

~~Raising~~Funding from ~~additional~~any ~~capital~~source may ~~cause~~be ~~dilution~~unavailable to ~~our~~us ~~stockholders~~on acceptable terms, ~~restrict~~or ~~our~~at ~~operations~~all. orIf ~~require~~we usdo tonot ~~relinquish~~have ~~rights~~sufficient capital to fund our ~~technologies~~operations and orexpenses, ~~product~~our ~~candidates~~business could fail.

~~Since~~As a weresult ~~will~~of beour ~~unable~~current tolack ~~generate~~of ~~any~~financial ~~revenue~~liquidity, ~~from~~there ~~actual~~is ~~sales~~substantial ofdoubt ~~products~~regarding ~~and~~our ~~expect~~ability to becontinue inas ~~the~~a ~~early stages for the foreseeable future~~“going concern,” wewithin ~~will~~one ~~need~~year tofrom ~~seek equity or debt financing to provide~~ the ~~capital~~issuance ~~required~~date toof ~~execute~~ our ~~business~~financial ~~plan~~statements. We will need significant funding for developing our intellectual property, conducting clinical trials and entering into collaborations with third party partners as well as for working capital requirements and other operating and general corporate purposes.

~~There~~As a ~~can~~result beof noour ~~assurance~~current ~~that~~lack weof ~~will~~financial beliquidity, ~~able~~there tois ~~raise~~substantial ~~sufficient~~doubt ~~capital~~regarding onour ~~acceptable~~ability ~~terms,~~to orcontinue atas ~~all~~a going concern. Our Iflack ~~such~~of ~~financing~~sufficient isliquidity ~~not~~could ~~available~~make onit ~~satisfactory~~more ~~terms,~~difficult orfor isus ~~not~~to ~~available~~secure atadditional ~~all,~~financing weor ~~may~~enter beinto ~~required~~strategic relationships on terms acceptable to ~~delay~~us, ~~scale~~if ~~back~~at orall, ~~eliminate~~and ~~the~~may ~~development~~materially ofand ~~business~~adversely ~~opportunities~~affect ~~and~~the ~~our~~terms ~~operations~~of ~~and~~any ~~financial~~financing ~~condition~~that we may beobtain ~~adversely~~and our ~~affected~~public tostock aprice, ~~significant extent~~generally.

IfOur continuation weas ~~raise~~a ~~additional~~going ~~capital~~concern byis ~~issuing~~dependent ~~equity~~upon, among other things, achieving positive cash flow from operations and, if necessary, augmenting such cash flow using external resources to satisfy our cash needs. Our plans to achieve positive cash flow include engaging in Offerings of securities, ~~the~~negotiating ~~percentage~~up-front and~~/or~~ ~~economic~~milestone ~~ownership~~payments on pipeline products under development and royalties from sales of our ~~existing~~products ~~stockholders~~which ~~may~~secure beregulatory ~~reduced,~~approval and ~~accordingly~~any ~~these~~milestone ~~stockholders~~payments ~~may~~associated ~~experience~~with ~~substantial~~such ~~dilution~~approved products. These Wecash ~~may~~sources ~~also~~could, ~~issue~~potentially, ~~equity~~be ~~securities~~supplemented ~~that~~by ~~provide~~financing ~~for~~or ~~rights~~other strategic agreements. However, ~~preferences~~we may be unable to achieve these goals and ~~privileges~~therefore ~~senior~~may be unable to ~~those~~continue ofas ~~our~~a ~~common~~going ~~stock~~concern.

~~Debt~~Risks Related ~~financing, if obtained, may involve agreements that include liens on our assets, covenants limiting or restricting our ability~~ to ~~take~~the ~~specific~~Clinical ~~actions,~~Development ~~such as incurring additional debt, increases in our expenses and requirements that our assets be provided as a security for such debt. Debt financing would also be required to be repaid regardless~~ of ~~our~~Our ~~operating~~Product ~~results.~~ Candidate

IfWe are wevery ~~raise~~early ~~additional~~in ~~funds~~our ~~through~~development ~~collaborations~~efforts for Picoplatin and ~~licensing~~Picoplatin ~~arrangements,~~is weour ~~may~~only beproduct ~~required~~candidate. toIf ~~relinquish~~we ~~some~~are ~~rights~~unable to ~~our~~clinically develop ~~technologies~~and orultimately ~~product~~commercialize ~~candidate,~~Picoplatin as an anti-cancer therapy or toexperience ~~grant~~significant ~~licenses~~delays onin ~~terms~~doing ~~that~~so, our ~~are~~business ~~not~~will ~~favorable~~be tomaterially usharmed.

~~Funding~~We are ~~from~~very ~~any~~early ~~source~~in ~~may~~our bedevelopment ~~unavailable~~efforts toand ushave ononly ~~acceptable~~one ~~terms~~product candidate, ornamely atPicoplatin ~~all.~~for Ifthe wetreatment doof ~~not~~cancer. We have ~~sufficient~~yet ~~capital~~ to ~~fund~~engage in our own clinical testing of Picoplatin, and our operations since our inception in 2014 have been limited to developing our own intellectual property and ~~expenses~~know how, ~~our~~while ~~business~~acquiring ~~could~~the ~~fail.~~technology and rights of others in order to pursue the clinical development of Picoplatin.

~~As a result of our current lack of financial liquidity, our auditors have expressed substantial doubt regarding our ability to continue as a “going concern.”~~14

~~As a result of our current lack of financial liquidity~~Moreover, the ~~our~~gene ~~auditors’~~expression ~~report~~studies ~~for~~we ~~our~~have ~~2015~~conducted ~~financial~~to ~~statements,~~date ~~which~~ are ~~included as part~~ of ~~this prospectus, contains~~ a ~~statement~~preliminary ~~concerning~~nature ~~substantial~~and ~~doubt~~were ~~regarding~~performed ~~our~~using ~~ability~~data togenerated ~~continue~~from clinical astreatments ausing ~~going~~other ~~concern.~~platinum ~~Our~~and ~~lack~~non-platinum ofchemotherapeutic ~~sufficient~~drugs. ~~liquidity~~While ~~could make~~ it ~~more~~is ~~difficult~~our ~~for~~intent us to ~~secure~~confirm ~~additional~~our ~~financing~~genomic technology orwith ~~enter~~respect ~~into~~to ~~strategic~~Picoplatin ~~relationships~~through onour ~~terms~~planned ~~acceptable~~clinical ~~to us~~trials, ifthere atis ~~all,~~no ~~and~~assurance ~~may materially and adversely affect the terms of any financing~~ that we ~~may~~will ~~obtain~~be ~~and~~successful ~~our~~in doing ~~public stock price generally~~so.

12Therefore, our ability to generate product revenues, which we do not expect will occur for several years, if ever, will depend heavily on our ability to develop and eventually commercialize our product candidate. The positive development of our product candidate will depend on several factors, including the following:

~~TABLE~~● positive OFcommencement ~~CONTENTS~~and completion of clinical trials;

~~Our~~● successful ~~continuation~~preparation asof aregulatory ~~going~~filings ~~concern is dependent upon, among other things, achieving positive cash flow from operations~~ and, ifreceipt ~~necessary, augmenting such cash flow using external resources to satisfy our cash needs. Our plans to achieve positive cash flow include engaging in offerings~~ of ~~securities,~~marketing ~~negotiating~~approvals ~~up-front and milestone payments on pipeline products under development and royalties~~ from ~~sales~~applicable ~~of our products which secure~~ regulatory approval and any milestone payments associated with such approved products. These cash sources could, potentially, be supplemented by financing or other strategic agreements. However, we may be unable to achieve these goals and therefore may be unable to continue as a going concern. authorities;

~~Risks~~● obtaining ~~Related~~and tomaintaining ~~the~~patent ~~Clinical~~and ~~Development~~trade ofsecret ~~Our~~protection ~~Product~~and ~~Candidate~~potential regulatory exclusivity for our product candidate and protecting our rights in our intellectual property portfolio;

We● maintaining ~~are very early in~~ our ~~development~~agreement ~~efforts~~with Genzyme for ~~Picoplatin~~the ~~and~~license ~~Picoplatin~~of is our ~~only~~ product candidate. If we are unable to clinically develop and ultimately commercialize Picoplatin as an anti-cancer therapy or experience significant delays in doing so, our business will be materially harmed.;

We● launching ~~are~~commercial ~~very~~sales ~~early~~of in our ~~development efforts and have only one~~ product ~~candidate~~, ~~namely~~if ~~Picoplatin for the treatment of cancer. We have yet to engage in our own clinical testing of Picoplatin,~~ and ~~our~~when ~~operations~~approved ~~since~~for ~~our~~one ~~inception~~or inmore ~~2014 have been limited to developing our own intellectual property and know how~~indications, ~~while~~whether ~~acquiring~~alone ~~the~~or ~~technology and rights of others~~ in ~~order~~collaboration with ~~to pursue the clinical development of Picoplatin.~~ others;

~~Moreover,~~● acceptance ~~the gene expression studies we have conducted to date are~~ of athe ~~preliminary~~product ~~nature~~for ~~and~~one ~~were~~or ~~performed~~more ~~using~~indications, ~~data~~if ~~generated from clinical treatments using other platinum~~ and ~~non-platinum~~when ~~chemotherapeutic~~approved, ~~drugs.~~by ~~While it is our intent to confirm our genomic technology with respect to Picoplatin through our planned clinical trials~~patients, ~~there~~the ismedical nocommunity ~~assurance~~and ~~that we will be successful in doing so.~~ third-party payors;

~~Therefore,~~● protection ~~our~~from ~~ability~~generic tosubstitution ~~generate~~based ~~product~~upon ~~revenues, which we do not expect will occur for several years, if ever, will depend heavily on~~ our ~~ability~~own toor ~~develop~~licensed ~~and~~intellectual ~~eventually~~property ~~commercialize our product candidate. The positive development of our product candidate will depend on several factors, including the following:~~rights;

•● effectively ~~positive~~competing ~~commencement~~with ~~and~~other ~~completion of clinical trials~~therapies;

•● obtaining ~~successful~~and ~~preparation~~maintaining ofhealthcare ~~regulatory~~coverage ~~filings~~ and ~~receipt~~adequate ~~of marketing approvals from applicable regulatory authorities~~reimbursement; and

~~• obtaining and~~ ● maintaining ~~patent~~a ~~and~~continued ~~trade~~acceptable ~~secret~~safety ~~protection~~profile ~~and~~of ~~potential regulatory exclusivity for~~ our product ~~candidate~~following ~~and~~approval, ~~protecting~~if ~~our rights in our intellectual property portfolio;~~any.

•If we ~~maintaining~~do ~~our~~not ~~agreement~~achieve ~~with~~one ~~Genzyme~~or ~~for~~more ~~the~~of ~~license~~these offactors in a timely manner or at all, we could experience significant delays or an inability to clinically develop and commercialize Picoplatin as a cancer therapy, which would materially harm our ~~product;~~business.

•If we ~~launching~~are ~~commercial~~unable ~~sales~~to demonstrate to physicians the benefits of ~~our~~Picoplatin ~~product~~as an anti-cancer therapy, if and when it is approved, ~~for~~we may ~~one~~incur delays or ~~more~~additional ~~indications,~~expense ~~whether~~in ~~alone~~our orattempt into ~~collaboration~~establish ~~with~~market ~~others;~~acceptance.

•Use of ~~acceptance~~Picoplatin as an anti-cancer therapy will require physicians to be informed regarding the intended benefits of the product. The ~~for~~time ~~one~~and cost of such an educational process may be substantial. Inability to carry out this physician education process may adversely affect market acceptance of Picoplatin. We may be unable to timely educate physicians in sufficient numbers regarding our intended application of Picoplatin to achieve our marketing plans or ~~more~~to ~~indications,~~achieve ifproduct ~~and~~acceptance. ~~when~~Any ~~approved,~~delay byin ~~patients~~physician education or acceptance may materially delay or reduce demand for our product candidate. In addition, ~~the~~we ~~medical~~may ~~community~~expend ~~and~~significant funds ~~third~~toward ~~party~~physician ~~payors;~~education before any acceptance or demand for Picoplatin as a cancer therapy is created, if at all.

•Clinical drug ~~protection~~development ~~from~~involves ~~generic~~a ~~substitution~~lengthy ~~based~~and ~~upon~~expensive ~~our~~process, ~~own~~with an uncertain outcome. We may incur additional costs or ~~licensed~~experience delays ~~intellectual~~in ~~property~~completing, ~~rights;~~or ultimately be unable to complete, the development and commercialization of our product candidate.

•The risk ~~effectively~~of ~~competing~~failure ~~with~~for product candidates in clinical development is high. It is impossible to predict when our sole product candidate, Picoplatin, will prove effective and safe in humans or will receive regulatory approval for any form of cancer or any other ~~therapies;~~indication. Before obtaining marketing approval from regulatory authorities for the sale of Picoplatin, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidate in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. Moreover, the outcome of early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. In addition, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their products.

~~• obtaining and maintaining healthcare coverage and adequate reimbursement; and~~15

•We may ~~maintaining~~experience anumerous ~~continued~~unforeseen ~~acceptable~~events ~~safety~~during, ~~profile~~or as a result of, clinical trials that could delay or prevent our ~~product~~ability ~~following~~to receive marketing approval, ifor ~~any.~~commercialize our product candidate, including:

If● regulators ~~we do not achieve one~~ or ~~more~~institutional ofreview ~~these~~boards ~~factors~~may innot aauthorize ~~timely~~us ~~manner~~ or atour ~~all,~~investigators weto ~~could~~commence ~~experience~~a ~~significant~~clinical ~~delays~~trial or anconduct ~~inability~~a clinical totrial ~~clinically~~at ~~develop and commercialize Picoplatin as~~ a ~~cancer~~prospective ~~therapy,~~trial ~~which would materially harm our business.~~ site;

If ● we ~~are~~may ~~unable~~experience todelays ~~demonstrate~~in toreaching, ~~physicians~~or ~~the~~fail ~~benefits~~to ~~of Picoplatin as an anti-cancer therapy~~reach, ifagreement ~~and~~on ~~when~~acceptable itclinical istrial ~~approved,~~contracts ~~we may incur delays~~ or ~~additional~~clinical ~~expense~~trial inprotocols with ~~our~~prospective ~~attempt~~trial ~~to establish market acceptance.~~sites;

~~Use~~● clinical trials of ~~Picoplatin~~our asproduct ancandidate ~~anti-cancer~~may ~~therapy~~produce ~~will~~negative ~~require~~or ~~physicians~~inconclusive toresults, ~~be informed regarding the intended benefits of the product. The time~~ and ~~cost~~we ofmay ~~such~~decide, anor ~~educational~~regulators ~~process~~ may berequire us, ~~substantial. Inability~~ to ~~carry~~conduct ~~out~~additional ~~this~~clinical ~~physician~~trials ~~education~~or ~~process~~abandon ~~may~~product ~~adversely~~development ~~affect~~programs, ~~market~~which ~~acceptance~~would ofbe ~~Picoplatin.~~time Weconsuming ~~may~~and ~~be unable~~ costly;

13● the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;

~~TABLE~~●we may OFhave ~~CONTENTS~~to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks;

to● clinical ~~timely~~trials ~~educate physicians in sufficient numbers regarding our intended application~~ of ~~Picoplatin to achieve~~ our ~~marketing plans or to achieve~~ product ~~acceptance.~~candidate ~~Any delay in physician education or acceptance~~ may ~~materially~~produce ~~delay~~negative or ~~reduce~~inconclusive ~~demand for our product candidate. In addition~~results, and we may ~~expend~~decide, ~~significant~~or ~~funds~~regulators ~~toward~~may ~~physician~~require us, ~~education~~to ~~before~~conduct ~~any~~additional ~~acceptance~~clinical trials or ~~demand~~abandon ~~for~~product ~~Picoplatin~~development asprograms, awhich ~~cancer~~would ~~therapy~~be istime ~~created,~~consuming ifand ~~at all.~~ costly;

~~Clinical~~● the ~~drug~~number ~~development~~of ~~involves~~patients arequired ~~lengthy~~for ~~and~~clinical ~~expensive~~trials ~~process,~~of ~~with~~our anproduct ~~uncertain~~candidates ~~outcome. We~~ may ~~incur~~be ~~additional~~larger ~~costs~~than orwe ~~experience~~anticipate, ~~delays~~enrollment in these ~~completing,~~clinical ortrials ~~ultimately~~may be ~~unable~~slower tothan ~~complete~~we anticipate, ~~the~~or ~~development~~participants ~~and~~may ~~commercialization~~drop out of ~~our~~these ~~product~~clinical ~~candidate.~~trials at a higher rate than we anticipate;

~~The~~● we ~~risk~~may ofhave ~~failure for product candidates in clinical development is high. It is impossible~~ to ~~predict~~suspend ~~when our sole product candidate, Picoplatin, will prove effective and safe in humans~~ or ~~will~~terminate ~~receive regulatory approval for any form of cancer or any other indication. Before obtaining marketing approval from regulatory authorities for the sale of Picoplatin, we must conduct extensive~~ clinical trials ~~to demonstrate the safety and efficacy~~ of our product ~~candidate~~candidates infor ~~humans.~~various ~~Clinical testing is expensive~~reasons, ~~difficult~~including toa ~~design~~finding ~~and~~that ~~implement, can take many years to complete and is uncertain as to outcome. A failure of one or~~the ~~more~~participants clinical trials can occur at any stage of testing. Moreover, the outcome of early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. In addition, preclinical and clinical data are ~~often~~being ~~susceptible~~exposed to ~~varying~~unacceptable ~~interpretations~~health ~~and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their products.~~ risks;

We● regulators ~~may~~or ~~experience~~institutional ~~numerous~~review ~~unforeseen~~boards ~~events~~may ~~during,~~require that we or asour ainvestigators ~~result~~suspend ~~of,~~or terminate clinical ~~trials~~research ~~that~~for various ~~could~~reasons, ~~delay~~including ornoncompliance ~~prevent~~with ~~our~~regulatory ~~ability~~requirements toor ~~receive~~a ~~marketing~~finding ~~approval~~that orthe ~~commercialize~~participants ~~our~~are ~~product~~being ~~candidate,~~exposed ~~including:~~to unacceptable health risks;

•● the ~~regulators~~cost orof ~~institutional~~clinical ~~review~~trials ~~boards~~ may ~~not~~be ~~authorize~~greater usthan orwe ~~our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site~~anticipate;

•● the wesupply ~~may~~or ~~experience~~quality ~~delays~~of inmaterials ~~reaching,~~necessary ~~or fail~~ to ~~reach,~~conduct ~~agreement on acceptable~~ clinical ~~trial~~trials ~~contracts~~of orour ~~clinical~~product ~~trial~~candidate ~~protocols~~may ~~with~~be ~~prospective~~insufficient ~~trial~~or ~~sites~~inadequate;

~~• clinical trials of~~ ● our product candidate may ~~produce~~have ~~negative~~undesirable orside ~~inconclusive~~effects ~~results,~~or ~~and~~other weunexpected ~~may decide~~characteristics, orcausing ~~regulators~~us ~~may~~or ~~require~~our usinvestigators, regulators ~~to conduct additional clinical trials~~ or ~~abandon~~institutional ~~product~~review ~~development~~boards ~~programs,~~to ~~which~~suspend ~~would~~or beterminate ~~time~~the ~~consuming~~trials; and ~~costly;~~

•● interactions ~~the~~with ~~number~~other of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;drugs.

• If we ~~may~~are ~~have~~required to ~~suspend~~conduct additional clinical trials or ~~terminate~~other testing of our product candidate beyond those that we currently contemplate, if we are unable to complete clinical trials of our product candidates ~~for~~or ~~various~~other ~~reasons~~testing, ~~including~~if athe ~~finding~~results ~~that~~of ~~the~~these trials ~~participants~~or tests are ~~being~~not ~~exposed~~positive toor ~~unacceptable~~are ~~health~~only ~~risks;~~modestly positive or if there are safety concerns, we may:

•● be ~~regulators~~delayed orin ~~institutional~~obtaining ~~review~~marketing ~~boards~~approval ~~may~~for ~~require that we or~~ our ~~investigators~~product ~~suspend~~candidate ~~or terminate clinical research~~ for ~~various~~one ~~reasons, including noncompliance with regulatory requirements~~ or amore ~~finding that the participants are being exposed to unacceptable health risks~~indications;

•● not ~~the~~obtain ~~cost~~marketing ofapproval ~~clinical~~at ~~trials~~all ~~may~~for beone ~~greater~~or ~~than~~more ~~we anticipate~~indications;

•● obtain ~~the~~approval ~~supply~~for indications or ~~quality~~patient ofpopulations ~~materials~~that ~~necessary~~are tonot ~~conduct~~as ~~clinical~~broad ~~trials~~as ofintended ~~our~~or ~~product~~desired ~~candidate~~(particularly, ~~may~~in beour ~~insufficient~~case, for ordifferent ~~inadequate~~types of cancer);

•● obtain ~~our~~approval ~~product~~with ~~candidate~~labeling ~~may~~that ~~have~~includes ~~undesirable~~significant ~~side~~use ~~effects~~ or ~~other~~distribution ~~unexpected~~restrictions ~~characteristics, causing us~~ or ~~our~~safety ~~investigators, regulators or institutional review boards to suspend or terminate the trials~~warnings; ~~and~~

•● be ~~interactions~~subject ~~with~~to ~~other~~additional ~~drugs.~~post-marketing testing requirements; or

14● have the product removed from the market after obtaining marketing approval.

~~TABLE~~Our product OFdevelopment ~~CONTENTS~~costs will also increase if we experience delays in testing or marketing approvals. We do not know which, if any, of our clinical trials will need to be restructured or will be completed on schedule, or at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidate or allow our competitors to bring products to market before we do and impair our ability to commercialize our product candidate and may harm our business and results of operations.

If we are required to conduct additional clinical trials or other testing of our product candidate beyond those that we currently contemplate, if we are unable to complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:16

•If we beexperience ~~delayed~~delays or difficulties in ~~obtaining~~the ~~marketing~~enrollment ~~approval~~of ~~for~~patients in clinical trials, including delays or difficulties resulting from the actions of regulatory authorities, our ~~product~~receipt ~~candidate~~of ~~for~~necessary ~~one~~regulatory approvals could be delayed or ~~more~~prevented. ~~indications;~~

•We may not ~~obtain~~be ~~marketing~~able ~~approval~~to atinitiate ~~all~~or continue clinical trials for ~~one~~our product candidate if we are unable to locate a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States. Further, even if we are able to locate a sufficient number of patients, we may not be permitted to enroll such patients in our clinical trials. For example, the FDA has recently requested us to supplement our clinical trial plan with a more detailed statistical plan to provide a robust justification for the patient sample size that we have proposed, and the FDA is requiring that we submit this plan before recruiting over twenty patients which will cause delays in the enrollment of patients for our clinical trials. If the FDA does not accept our plan, the FDA will likely require a modified statistical plan which could cause additional delays in our trials. If the FDA ultimately does not accept our statistical plan, then we will be unable to enroll over twenty patients and our planned clinical trial would be adversely affected. In addition, some of our competitors have ongoing clinical trials for product candidates that treat the same indications; as our product candidate, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates.

•Patient enrollment ~~obtain~~is ~~approval~~affected ~~for~~by ~~indications~~other orfactors ~~patient populations that are not as broad as intended or desired (particularly, in our case, for different types of cancer);~~including:

•●the severity ~~obtain~~of ~~approval~~the ~~with~~disease ~~labeling~~under ~~that includes significant use or distribution restrictions or safety warnings~~investigation;

•● the beeligibility ~~subject~~criteria tofor ~~additional~~the ~~post-marketing~~study ~~testing~~in ~~requirements~~question; or

•● the ~~have~~perceived ~~the~~risks ~~product~~and ~~removed~~benefits ~~from~~of the ~~market~~product ~~after~~candidate ~~obtaining~~under ~~marketing approval.~~study;

Our product development costs will also increase if we experience delays in testing or marketing approvals. We do not know which, if any, of our clinical trials will need to be restructured or will be completed on schedule, or at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have ● the ~~exclusive~~patient ~~right~~referral topractices commercialize our product candidate or allow our competitors to bring products to market before we do and impair our ability to commercialize our product candidate and may harm our business and results of ~~operations.~~ physicians;

~~If we experience delays or difficulties in~~ ● the ~~enrollment~~ability ofto monitor patients inadequately ~~clinical~~during ~~trials,~~and ~~our~~after ~~receipt~~treatment; ~~of necessary regulatory approvals could be delayed or prevented.~~and

We● the ~~may~~proximity ~~not be able to initiate or continue clinical trials for our product candidate if we are unable to locate~~ and ~~enroll~~availability ~~a sufficient number~~ of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States, including the Ministry of Health of the Russian Federation. In addition, some of our competitors have ongoing clinical ~~trials~~trial ~~for~~sites ~~product candidates that treat the same indications as our product candidate, and patients who would otherwise be eligible~~ for ~~our~~prospective ~~clinical trials may instead enroll in clinical trials of our competitors’ product candidates~~patients.

~~Patient~~Our inability ~~enrollment~~to islocate ~~affected~~and byenroll ~~other~~a ~~factors~~sufficient ~~including:~~number of patients for our clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidate, which would cause the value of our company to decline and otherwise materially and adversely affect our company.

•Poniard’s Phase ~~the~~III ~~severity~~trial of Picoplatin in small cell lung cancer failed to meet the ~~disease~~primary ~~under~~endpoint ~~investigation;~~of overall survival. Accordingly, there is a material risk that we will be unable to develop and successfully complete clinical testing for Picoplatin.

•Poniard was the ~~eligibility~~prior ~~criteria~~sponsor of clinical trials for our product candidate Picoplatin. In 2009, Poniard announced that its Phase III trial of Picoplatin failed to meet its primary endpoint of overall survival. While we believe this failure was attributable to the ~~study~~fact that inPoniard’s ~~question;~~clinical trial utilized a suboptimal group of patient and endpoints, there can be no assurance that our view is correct, and any trials we design for Picoplatin may fail for similar or unrelated reasons. Clinical trial design errors constitute a potential risk to the timeline and ultimate results of our planned pivotal clinical program and there is a material risk that our trials will not meet their designated endpoints. Additionally, the failure of Poniard’s Phase III trial could create additional obstacles for potential collaborators or investors to recognize the beneficial properties of Picoplatin and could delay the execution and funding of our planned clinical program.

•If serious ~~the~~adverse ~~perceived~~or ~~risks~~unacceptable ~~and~~side ~~benefits~~effects ofare identified during the development of our product candidate, ~~under~~we ~~study;~~may need to abandon or limit such development, which would adversely affect our company.

•If clinical testing of Picoplatin for the ~~patient~~treatment ~~referral~~of ~~practices~~cancer results in undesirable side effects or demonstrates characteristics that are unexpected, we may need to abandon such development or limit such development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Many compounds that initially showed promise in early stage testing for treating cancer have later been found to cause side effects that prevented further development of ~~physicians~~the compound. If we are unable to develop Picoplatin due to reported adverse effects or characteristics, our business would be severely harmed.

~~• the ability to monitor patients adequately during and after treatment; and~~17

• For the ~~proximity~~foreseeable ~~and~~future, ~~availability~~we ofexpect ~~clinical~~to ~~trial~~expend ~~sites~~our limited resources to pursue a particular product candidate, leaving us unable to capitalize on other product candidates or indications that may be more profitable or for ~~prospective~~which ~~patients~~there is a greater likelihood of clinical and commercial development.

~~Our~~Because we ~~inability~~have tolimited ~~enroll~~financial aand ~~sufficient~~managerial ~~number~~resources, ofwe ~~patients~~will focus for ~~our~~the foreseeable future only on the clinical ~~trials~~development of ~~would~~Picoplatin ~~result~~for inone ~~significant~~or ~~delays~~a ~~and~~relatively ~~could~~small ~~require~~number usof cancer indications. As a result, we may forego or be unable to ~~abandon~~pursue ~~one~~opportunities with other product candidates or ~~more~~for ~~clinical~~indications ~~trials~~other ~~altogether.~~than ~~Enrollment~~those ~~delays~~we inintend ~~our~~to ~~clinical~~pursue ~~trials~~that later prove to have greater commercial potential. Our resource allocation decisions may ~~result~~cause inus ~~increased~~to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on research and development ~~costs~~programs ~~for~~related ~~our~~to ~~product~~Picoplatin ~~candidate,~~may ~~which~~not ~~would~~yield ~~cause~~any ~~the~~commercially ~~value~~viable therapies. Because of this concentration of our ~~company~~efforts, toour ~~decline~~business ~~and~~will ~~otherwise~~be ~~materially~~particularly ~~and~~subject ~~adversely~~to ~~affect~~significant risk of failure of our one ~~company.~~current product candidate.

~~Poniard’s~~We expect ~~Phase~~to ~~III~~rely ~~trial~~on ofcollaborations ~~Picoplatin~~with inthird ~~small~~parties ~~cell~~for ~~lung~~key ~~cancer~~aspects ~~failed~~of toour ~~meet~~business. ~~the~~If ~~primary~~we ~~endpoint~~are ofunable ~~overall~~to ~~survival.~~secure ~~Accordingly,~~or ~~there~~maintain isany of athese ~~material~~collaborations, ~~risk~~or ~~that~~if wethese ~~will~~collaborations bedo ~~unable~~not toachieve ~~develop~~their ~~and~~goals, ~~successfully~~our ~~complete~~business ~~clinical~~would ~~testing~~be ~~for~~adversely ~~Picoplatin~~affected.

~~Poniard~~We presently ~~was~~have ~~the~~very ~~prior~~limited ~~sponsor~~capabilities ~~of clinical trials~~ for ~~our~~drug ~~product~~development ~~candidate~~and ~~Picoplatin.~~do Innot ~~2009,~~yet ~~Poniard~~have ~~announced~~any ~~that~~capability ~~its~~for ~~Phase~~manufacturing, ~~III~~sales, ~~trial~~marketing or ~~of Picoplatin failed to meet its primary endpoint of overall survival~~distribution. ~~While~~Accordingly, we ~~believe~~expect ~~this~~to ~~failure~~enter ~~was~~into ~~attributable~~collaborations towith ~~the~~other ~~fact~~companies that ~~Poniard’s~~we ~~clinical~~believe ~~trial~~can ~~utilized~~provide asuch ~~suboptimal~~capabilities. These ~~group~~collaborations ofmay ~~patient~~also ~~and~~provide ~~endpoints,~~us ~~there~~with ~~can~~important befunding nofor ~~assurance that~~ our ~~view~~development ~~is correct, and any trials we design for~~ programs.

15There is a risk that we may not be able to maintain our current collaboration or to enter into additional collaborations on acceptable terms or at all, which would leave us unable to progress our business plan. We will face significant competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. If we are unable to maintain or reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of our product candidate, reduce or delay its development program, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.

~~TABLE~~Moreover, even OFif ~~CONTENTS~~we are able to maintain and/or enter into such collaborations, such collaborations may pose a number of risks, including the following:

~~Picoplatin~~● collaborators may fail for similar or unrelated reasons. Clinical trial design errors constitute a potential risk to the timeline and ultimate results of our planned pivotal clinical program and there is a material risk that our trials will not ~~meet~~perform their ~~designated~~obligations ~~endpoints.~~as Additionally, the failure of Poniard’s Phase III trial could create additional obstacles for potential collaborators or investors to recognize the beneficial properties of Picoplatin and could delay the execution and funding of our planned clinical program. expected;

If● disagreements ~~serious~~with ~~adverse~~collaborators, including disagreements over proprietary rights, contract interpretation or ~~unacceptable~~the ~~side~~preferred ~~effects~~course of ~~are~~development, ~~identified~~might ~~during~~cause delays or termination of the research, development or commercialization of our product candidate, might welead ~~may~~to ~~need~~additional responsibilities for us with respect to ~~abandon~~such product candidate, or ~~limit~~might ~~such~~result ~~development~~in litigation or arbitration, any of which would ~~adversely~~be ~~affect~~time-consuming ~~our~~and ~~company.~~expensive;

If● collaborators ~~clinical~~could ~~testing~~independently ofdevelop ~~Picoplatin for the treatment of cancer results in undesirable side effects~~ or ~~demonstrates~~be ~~characteristics~~associated ~~that~~with ~~are~~products unexpected, we may need to abandon such development or limit such development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Many compounds that ~~initially~~compete ~~showed~~directly promise in early stage testing for treating cancer have later been found to cause side effects that prevented further development of the compound. If we are unable to develop Picoplatin due to reported adverse effects or ~~characteristics,~~indirectly with our ~~business would be severely harmed.~~ product candidate;

~~For~~● collaborators ~~the~~could ~~foreseeable~~have ~~future,~~significant wediscretion ~~expect~~in todetermining ~~expend~~the ~~our~~efforts ~~limited~~and resources tothat ~~pursue~~they awill ~~particular~~apply ~~product candidate, leaving us unable~~ to ~~capitalize~~our onarrangements with ~~other product candidates or indications that may be more profitable or for which there is a greater likelihood of clinical and commercial development.~~them;

~~Because~~● should weour ~~have~~product ~~limited~~candidate ~~financial~~achieve ~~and~~regulatory ~~managerial resources~~approval, ~~we will focus for the foreseeable future only on the clinical development of Picoplatin for one or~~ a ~~relatively~~collaborator ~~small~~with ~~number~~marketing ofand ~~cancer~~distribution ~~indications.~~rights ~~As a result, we may forego or be unable~~ to ~~pursue~~our ~~opportunities with other~~ product candidate ~~candidates or for indications other than those we intend to pursue that later prove to have greater commercial potential. Our resource allocation decisions~~ may ~~cause~~not uscommit tosufficient ~~fail~~resources to ~~capitalize~~the onmarketing ~~viable commercial products or profitable market opportunities. Our spending on research~~ and ~~development~~distribution ~~programs related to Picoplatin may not yield any commercially viable therapies. Because~~ of ~~this~~such ~~concentration of our efforts, our business will be particularly subject to significant risk of failure of our one current~~ product ~~candidate.~~ ;

We● collaborators ~~expect~~may tonot ~~rely~~properly onmaintain ~~collaborations~~or ~~with~~defend ~~third~~our ~~parties~~intellectual ~~for~~property ~~key~~rights ~~aspects~~or ofmay use our ~~business.~~proprietary Ifinformation wein ~~are~~such a ~~unable~~way as to ~~secure~~invite orlitigation ~~maintain~~that ~~any~~could ofjeopardize ~~these collaborations,~~ or ifinvalidate ~~these~~our ~~collaborations~~intellectual doproperty ~~not~~or ~~achieve~~proprietary ~~their~~information ~~goals,~~or ~~our~~expose us ~~business~~to ~~would~~potential ~~be adversely affected.~~litigation;

We● collaborators ~~presently~~may ~~have~~infringe ~~very~~the ~~limited~~intellectual ~~capabilities~~property ~~for~~rights ~~drug~~of ~~development~~third ~~and do not yet have any capability for manufacturing~~parties, ~~sales,~~which ~~marketing or distribution. Accordingly, we expect to enter into collaborations with other companies that we believe can provide such capabilities. These collaborations~~ may ~~also~~expose ~~provide~~ us ~~with~~to ~~important~~litigation ~~funding~~and ~~for~~potential liability; ~~our development programs.~~ and

~~There~~● collaborations ~~is a risk that we~~ may ~~not~~ be ~~able~~terminated to maintain our current collaboration or to enter into additional collaborations on acceptable terms or at all, which would leave us unable to progress our business plan. We will face significant competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for athe ~~collaboration~~convenience ~~will depend, among other things, upon our assessment~~ of the collaborator’s ~~resources~~ and ~~expertise~~, ~~the~~if ~~terms~~terminated, ~~and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. If~~ we ~~are~~could ~~unable~~be required to ~~maintain~~either ~~or reach agreements~~find ~~with~~alternative ~~suitable~~ collaborators on(which awe ~~timely~~may ~~basis,~~be onunable ~~acceptable~~to ~~terms,~~do) or atraise ~~all,~~additional wecapital ~~may have~~ to ~~curtail~~pursue ~~the~~further development ~~of our product candidate, reduce~~ or ~~delay its development program, delay its potential~~ commercialization ~~or reduce the scope~~ of ~~any sales or marketing activities, or increase~~ our ~~expenditures~~product ~~and~~candidate ~~undertake~~on ~~development or commercialization activities at~~ our own ~~expense~~.

~~Moreover,~~Our business ~~even~~would ifbe wematerially ~~are~~or ~~able~~perhaps tosignificantly ~~maintain~~harmed ~~and/or~~if ~~enter~~any ~~into~~of ~~such~~the ~~collaborations,~~foregoing ~~such~~or ~~collaborations~~similar ~~may~~risks ~~pose~~comes ato ~~number~~pass ofwith ~~risks,~~respect to ~~including~~our ~~the~~key ~~following:~~collaborations.

~~• collaborators may not perform their obligations as expected;~~18

•Our third-party ~~disagreements~~manufacturing ~~with~~ collaborators, ~~including~~are ~~disagreements~~subject ~~over~~to ~~proprietary~~significant ~~rights,~~regulatory ~~contract~~oversight ~~interpretation~~with orrespect ~~the~~to ~~preferred~~manufacturing ~~course~~our ofproduct candidate. ~~development,~~Third-party ~~might~~manufacturing ~~cause~~facilities ~~delays~~may ornot ~~termination~~meet ofregulatory ~~the~~requirements, which would adversely impact our business.

16The preparation of therapeutics for clinical trials or commercial sale is subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with Good Manufacturing Practice, or cGMP, requirements. These regulations govern manufacturing processes and procedures, including record keeping, and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of outside agents or other contaminants, or to inadvertent changes in the properties or stability of a product candidate that may not be detectable in final product testing. We must supply all necessary documentation in support of a marketing authorization application on a timely basis and must adhere to the FDA’s and other countries’ cGMP requirements which are enforced, in the case of the FDA, through its facilities inspection program. The facilities and quality systems of our third-party manufacturers must pass an inspection for compliance with the applicable regulations as a condition of regulatory approval. In addition, the regulatory authorities may, at any time, audit or inspect the third-party manufacturing facility or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If these facilities do not pass a plant inspection, marketing authorizations or approval of our product candidate will not be granted.

~~TABLE~~We do OFnot ~~CONTENTS~~directly control the manufacturing of, and are completely dependent on, our contract manufacturers for compliance with the cGMP. If our contract manufacturers cannot manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or foreign regulatory agencies, including the Ministry of Health of the Russian Federation, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In addition, we have no direct control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Furthermore, all of our contract manufacturers are engaged with other companies to supply and/or manufacture materials or products for such companies, which exposes our manufacturers to regulatory risks for the production of such materials and products. As a result, failure to meet the regulatory requirements for the production of those materials and products may generally affect the regulatory clearance of our contract manufacturers’ facility. Our failure, or the failure of our third parties, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products and product candidates.

~~research,~~Our dependence ~~development~~upon orothers ~~commercialization~~for the manufacture of our product ~~candidate,~~candidates ~~might~~may ~~lead~~adversely toaffect ~~additional~~our ~~responsibilities~~future ~~for~~profit usmargins ~~with~~and ~~respect~~our ability to ~~such~~commercialize ~~product~~any ~~candidate,~~products orthat ~~might~~receive ~~result~~regulatory inapproval ~~litigation~~on ora ~~arbitration,~~timely ~~any of which would be time-consuming~~ and ~~expensive;~~competitive basis.

•Any contamination ~~collaborators~~in ~~could~~our ~~independently~~manufacturing ~~develop~~process, shortages of raw materials or befailure ~~associated~~of ~~with~~any ~~products~~of ~~that~~our ~~compete~~key ~~directly~~suppliers orto ~~indirectly~~deliver ~~with~~necessary components could result in delays in our ~~product~~clinical ~~candidate;~~development or marketing schedules.

•Given the ~~collaborators~~nature ~~could~~of ~~have~~biologics ~~significant~~manufacturing, ~~discretion~~there inis ~~determining~~a ~~the~~risk ~~efforts~~of ~~and~~contamination. ~~resources~~Any ~~that~~contamination ~~they~~could ~~will~~materially ~~apply~~adversely affect our ability to produce Picoplatin on schedule and could, therefore, harm our ~~arrangements~~results ~~with~~of ~~them;~~operations and cause reputational damage.

•Some of ~~should~~the raw materials required in our ~~product~~manufacturing ~~candidate~~process ~~achieve~~are ~~regulatory~~derived ~~approval,~~from abiologic ~~collaborator~~sources. ~~with~~Such ~~marketing~~raw materials are difficult to procure and ~~distribution~~may ~~rights~~be subject to ~~our~~contamination ~~product~~or ~~candidate~~recall. ~~may~~A ~~not~~material ~~commit~~shortage, ~~sufficient~~contamination, ~~resources~~recall toor restriction on the ~~marketing~~use of biologically derived substances in the manufacture of Picoplatin could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which could materially and ~~distribution~~adversely affect our development timelines and our business, financial condition, results of ~~such~~operations ~~product;~~and prospects.

• collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;19

•Our reliance ~~collaborators~~on ~~may~~third ~~infringe~~parties ~~the~~requires ~~intellectual~~us ~~property~~to ~~rights~~share ofour ~~third~~trade ~~parties~~secrets, which ~~may~~increases ~~expose~~the uspossibility tothat ~~litigation~~a ~~and~~competitor ~~potential~~will ~~liability;~~discover them ~~and~~or that our trade secrets will be misappropriated or disclosed.

•Because we ~~collaborations~~will ~~may~~rely beon ~~terminated~~third parties to manufacture Picoplatin and to perform quality testing, and because we collaborate with various organizations for the ~~convenience~~advancement of ~~the~~our ~~collaborator~~technology, we must, at times, share our proprietary technology and confidential information, including iftrade ~~terminated~~secrets, wewith ~~could~~them. beWe ~~required~~seek to ~~either~~protect ~~find~~our ~~alternative~~proprietary technology, in part, by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar agreements with our collaborators, ~~(which~~advisors, weemployees ~~may~~and beconsultants ~~unable~~prior to ~~do)~~beginning research or ~~raise~~disclosing ~~additional~~proprietary ~~capital~~information. These agreements typically limit the rights of the third parties to ~~pursue~~use ~~further~~or ~~development~~disclose our confidential information. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others or ~~commercialization~~are disclosed or used in violation of these agreements. Given that our ~~product~~proprietary ~~candidate~~position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our ~~own~~proprietary technology and confidential information or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business, financial condition, results of operations and prospects.

~~Our~~Despite our ~~business~~efforts ~~would~~to beprotect ~~materially~~our ortrade ~~perhaps~~secrets, ~~significantly~~our ~~harmed~~competitors ifmay ~~any~~discover our trade secrets, either through breach of ~~the~~these ~~foregoing~~agreements, independent development or ~~similar~~publication ~~risks~~of ~~comes~~information toincluding ~~pass~~our ~~with~~trade ~~respect~~secrets toby third parties. A competitor’s discovery of our ~~key~~trade ~~collaborations.~~secrets would impair our competitive position and have an adverse impact on our business, financial condition, results of operations and prospects.

~~Our~~Risks Related ~~third party manufacturing collaborators are subject~~ to ~~significant~~the ~~regulatory~~Commercialization ~~oversight~~of ~~with~~Our ~~respect~~Product ~~to manufacturing our product candidate. Third-party manufacturing facilities may not meet regulatory requirements, which would adversely impact our business.~~Candidate

~~The~~Even if ~~preparation~~Picoplatin ofreceives ~~therapeutics~~marketing for clinical trials or commercial sale is subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with Good Manufacturing Practiceapproval, orit ~~cGMP,~~may ~~requirements.~~fail ~~These regulations govern manufacturing processes and procedures, including record keeping, and the implementation and operation of quality systems~~ to ~~control~~achieve ~~and assure~~ the ~~quality~~degree of ~~investigational~~market ~~products~~acceptance ~~and~~by ~~products approved for sale. Poor control of production processes can lead to the introduction of outside agents or other contaminants~~physicians, or to inadvertent changes in the properties or stability of a product candidate that may not be detectable in final product testing. We must supply all necessary documentation in support of a marketing authorization application on a timely basis and must adhere to the FDA’s and other countries’ cGMP requirements which are enforcedpatients, ~~in the case of the FDA, through its facilities inspection program. The facilities and quality systems of our~~ third party ~~manufacturers~~payors ~~must~~and ~~pass~~others anin ~~inspection for compliance with~~ the ~~applicable~~medical ~~regulations~~community asnecessary ~~a condition of regulatory approval. In addition, the regulatory authorities may, at any time, audit or inspect the third-party manufacturing facility or the associated quality systems~~ for ~~compliance~~commercial ~~with the regulations applicable to the activities being conducted~~success. ~~If these facilities do not pass a plant inspection, marketing authorizations or approval of our product candidate will not be granted.~~

WeEven if doPicoplatin ~~not~~receives ~~directly~~marketing ~~control~~approval ~~the~~in ~~manufacturing of, and are completely dependent on, our contract manufacturers for compliance with~~ the ~~cGMP~~U.S. Ifor ~~our~~elsewhere, ~~contract~~it ~~manufacturers~~may ~~cannot~~nonetheless ~~manufacture~~fail ~~material that conforms~~ to ~~our~~gain ~~specifications~~sufficient ~~and~~market ~~the~~acceptance by ~~strict~~physicians, ~~regulatory~~patients, ~~requirements~~third ofparty ~~the~~payors ~~FDA~~and orothers ~~foreign~~in ~~regulatory agencies, including~~ the ~~Ministry~~medical ofcommunity. ~~Health~~For ~~of the Russian Federation~~example, ~~they~~current ~~will~~cancer ~~not~~treatments besuch ~~able~~as chemotherapy ~~to secure~~ and~~/or~~ ~~maintain~~radiation ~~regulatory~~therapy ~~approval~~are ~~for~~well ~~their~~established ~~manufacturing~~in ~~facilities.~~the Inmedical ~~addition~~community, weand ~~have~~doctors nomay ~~direct~~continue ~~control~~to ~~over~~rely ~~the~~on ~~ability~~these oftreatments. If ~~our~~Picoplatin ~~contract~~does ~~manufacturers~~not toachieve ~~maintain~~an adequate ~~quality~~level ~~control,~~of ~~quality assurance and qualified personnel. Furthermore~~acceptance, ~~all~~we ofmay ~~our~~not ~~contract~~generate ~~manufacturers~~significant ~~are~~product ~~engaged~~revenues ~~with other companies to supply~~ and~~/or~~ ~~manufacture~~we ~~materials~~may ornot become ~~products~~profitable. ~~for~~The ~~such~~degree ~~companies,~~of ~~which~~market ~~exposes~~acceptance ~~our manufacturers to regulatory risks for the production~~ of ~~such materials and products. As a result~~Picoplatin, ~~failure~~if toapproved ~~meet the regulatory requirements~~ for ~~the~~commercial ~~production~~sale, ofwill ~~those~~depend ~~materials~~on ~~and~~a ~~products~~number ~~may generally affect the regulatory clearance~~ of factors, ~~our contract~~ including:

17● our ability to offer our products for sale at competitive prices;

~~TABLE~~● the OFconvenience ~~CONTENTS~~and ease of administration compared to alternative treatments;

~~manufacturers’ facility. Our failure, or~~ ● the ~~failure~~willingness of ~~our~~the ~~third~~target ~~parties,~~patient population to ~~comply~~try ~~with~~new ~~applicable~~therapies regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and ~~criminal prosecutions, any~~ of ~~which~~physicians ~~could~~to ~~significantly~~prescribe ~~and~~these ~~adversely affect supplies of our products and product candidates.~~ therapies;

~~Our dependence upon others for~~ ● the ~~manufacture~~strength of ~~our~~marketing ~~product candidates may adversely affect our future profit margins~~ and ~~our~~distribution ~~ability to commercialize any products that receive regulatory approval on a timely and competitive basis.~~ support;

~~Any~~● the ~~contamination~~availability ~~in our manufacturing process, shortages~~ of ~~raw~~third-party ~~materials~~coverage orand ~~failure~~adequate ~~of any of our key suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules.~~reimbursement;

~~Given~~ ● the ~~nature~~prevalence ~~of biologics manufacturing, there is a risk of contamination. Any contamination could materially adversely affect our ability to produce Picoplatin on schedule~~ and ~~could,~~severity ~~therefore, harm our results~~ of ~~operations~~any ~~and~~side ~~cause~~effects; ~~reputational damage.~~ and

~~Some~~● any ofrestrictions the raw materials required in our manufacturing process are derived from biologic sources. Such raw materials are difficult to procure and may be subject to contamination or recall. A material shortage, contamination, recall or restriction on the use of biologically derived substances in the manufacture of Picoplatin could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which could materially and adversely affect our ~~development~~product ~~timelines~~together ~~and~~with ~~our~~other ~~business, financial condition, results of operations and prospects~~medications.

~~Our~~If we ~~reliance~~are onunable ~~third parties requires us~~ to ~~share~~establish ~~our trade secrets~~sales, ~~which~~marketing ~~increases~~and ~~the~~distribution ~~possibility~~capabilities, ~~that~~we amay ~~competitor~~not ~~will~~be ~~discover~~able ~~them~~to orcommercialize ~~that~~ our ~~trade~~product ~~secrets~~candidate if ~~will~~and bewhen ~~misappropriated~~it oris ~~disclosed~~approved.

~~Because~~We do wenot ~~will~~have ~~rely~~a onsales ~~third~~or ~~parties~~marketing toinfrastructure. ~~manufacture~~To ~~Picoplatin~~achieve ~~and~~any tolevel ~~perform~~of ~~quality~~commercial ~~testing,~~success ~~and~~for ~~because~~any weproduct ~~collaborate with various organizations~~ for ~~the~~which ~~advancement~~we ofhave obtained ~~our~~marketing ~~technology~~approval, we ~~must,~~will atneed ~~times, share our proprietary technology and confidential information, including trade secrets, with them. We seek~~ to ~~protect~~establish ~~our~~a ~~proprietary~~sales ~~technology, in part, by entering into confidentiality agreements~~ and, ifmarketing ~~applicable,~~organization ~~material transfer agreements, collaborative research agreements, consulting agreements~~ or ~~other~~outsource ~~similar~~sales ~~agreements with our collaborators, advisors, employees~~ and ~~consultants~~marketing ~~prior to beginning research or~~functions ~~disclosing proprietary information. These agreements typically limit the rights of the third parties~~ to ~~use or disclose our confidential information. Despite the contractual provisions employed when working with~~ third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our proprietary technology and confidential information or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business, financial condition, results of operations and prospects.

~~Despite~~There are ~~our~~risks ~~efforts~~involved towith ~~protect~~establishing our ~~trade~~own ~~secrets~~sales, ~~our~~marketing ~~competitors~~and ~~may~~distribution ~~discover~~capabilities. ~~our~~For ~~trade secrets~~example, ~~either~~recruiting ~~through~~and ~~breach~~training a ofsales ~~these~~force ~~agreements,~~is ~~independent~~expensive ~~development~~and ortime ~~publication~~consuming and could delay any product launch. If the commercial launch of ~~information~~a ~~including~~product ~~our~~candidate for ~~trade~~which ~~secrets~~we byrecruit ~~third~~a ~~parties.~~sales Aforce ~~competitor’s~~and ~~discovery~~establish ofmarketing ~~our~~capabilities ~~trade~~is ~~secrets~~delayed ~~would~~or ~~impair~~does ~~our~~not ~~competitive~~occur ~~position~~for ~~and~~any reason, we would have anprematurely ~~adverse~~or ~~impact~~unnecessarily onincurred ~~our~~these ~~business,~~commercialization ~~financial~~expenses. ~~condition~~This may be costly, ~~results~~and ofour ~~operations~~investment would be lost if we cannot retain or reposition our sales and ~~prospects.~~marketing personnel.

~~Risks~~If approved, ~~Related~~factors that may inhibit our efforts to ~~the~~commercialize ~~Commercialization~~our ofproduct ~~Our~~on ~~Product~~our ~~Candidate~~own include:

Even if Picoplatin receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third party payors and others in the medical community necessary for commercial success.20

~~Even if Picoplatin receives marketing approval in~~ ● the ~~U.S.~~inability orof ~~elsewhere,~~sales itpersonnel ~~may~~to ~~nonetheless~~obtain ~~fail~~access to ~~gain sufficient market acceptance by~~ physicians, ~~patients,~~or ~~third~~persuade ~~party~~adequate ~~payors~~numbers ~~and~~of ~~others~~physicians ~~in the medical community. For example, current cancer treatments such as chemotherapy and radiation therapy are well established in the medical community, and doctors may continue~~ to ~~rely~~prescribe onour ~~these treatments. If Picoplatin does not achieve an~~ product;

18● the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

~~TABLE~~● unforeseen OFcosts ~~CONTENTS~~and expenses associated with creating an independent sales and marketing organization.

~~adequate~~If we ~~level~~are ofunable ~~acceptance~~to establish our own sales, wemarketing ~~may~~and ~~not~~distribution ~~generate~~capabilities ~~significant~~and instead enter into arrangements with third parties to perform these services, our product revenues and our profitability, if any, are likely to be lower than if we were to market, sell and distribute any products that we develop ourselves. In addition, we may ~~not~~be ~~become~~unable ~~profitable~~to enter into arrangements with third parties to sell, market and distribute our product candidate or may be unable to do so on terms that are favorable to us. ~~The~~We ~~degree~~likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market ~~acceptance~~our ofproduct ~~Picoplatin~~effectively. If we do not establish sales, ifmarketing ~~approved~~and ~~for~~distribution ~~commercial~~capabilities, either ~~sale~~on our own or in collaboration with third parties, we will ~~depend~~not onbe aable ~~number~~to ofcommercialize ~~factors~~our product candidate, ~~including:~~which would have a material adverse effect on our company.

•We face ~~the~~substantial ~~efficacy~~competition, ~~and~~which ~~potential~~may ~~advantages~~result ~~compared~~in toothers ~~alternative~~discovering, ~~treatments;~~developing or commercializing products before or more successfully than we do.

•The development and commercialization of new drug products, particularly in the area of cancer, is highly competitive. We face competition with respect to our ~~ability~~current product candidate and will face competition with respect to ~~offer~~any ~~our~~product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for ~~sale~~the attreatment ~~competitive~~of ~~prices;~~cancer. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

•Our commercial ~~the~~opportunity ~~convenience~~could be reduced or eliminated if our competitors develop and ~~ease~~commercialize ofproducts ~~administration~~that ~~compared~~are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to ~~alternative~~enter ~~treatments;~~the market.

•Many of the ~~willingness~~companies ofagainst which we are competing, or against which we may compete in the ~~target~~future, have significantly greater financial resources and expertise in research and development, manufacturing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient ~~population~~registration for clinical trials, as well as in acquiring technologies complementary to, ~~try~~or ~~new~~necessary for, ~~therapies~~our programs, and ofwe ~~physicians~~may be unable to ~~prescribe~~effectively compete with these ~~therapies;~~companies for these or other reasons.

•Even if we are able to commercialize any product candidates, the ~~strength~~products ofmay ~~marketing~~become ~~and~~subject ~~distribution~~to ~~support;~~unfavorable pricing regulations, third party reimbursement practices or healthcare reform initiatives, which would harm our business.

•The regulations ~~the~~that ~~availability~~govern ofmarketing ~~third~~approvals, ~~party~~pricing, coverage and ~~adequate~~ reimbursement; for new drug products vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.

~~• the prevalence and severity of any side effects; and~~21

•Our ability to commercialize any ~~restrictions~~product candidate also will depend in part on the ~~use~~extent ofto which coverage and adequate reimbursement for our product ~~together~~candidate ~~with~~will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage and reimbursement may not be available for any product that we commercialize and, even if these are available, the level of reimbursement may not be satisfactory. Reimbursement may affect the demand for, or the price of, any product candidate for which we obtain marketing approval. Obtaining and maintaining adequate reimbursement for our products may be difficult. We may be required to conduct expensive pharmacoeconomic studies to justify coverage and reimbursement or the level of reimbursement relative to other therapies. If coverage and adequate reimbursement are not available or reimbursement is available only to limited levels, we may not be able to commercialize any product candidate for which we obtain marketing approval.

IfIn addition, wethere ~~are~~may ~~unable~~be tosignificant ~~establish~~delays ~~sales~~in obtaining reimbursement for newly approved drugs, ~~marketing~~and coverage may be more limited than the purposes for which the drug is approved by the FDA. Moreover, eligibility for reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim ~~capabilities~~reimbursement levels for new drugs, weif applicable, may also not be ~~able~~sufficient to ~~commercialize~~cover our ~~product~~costs ~~candidate~~and ifmay not be made permanent. Reimbursement rates may vary according to the use of the drug and ~~when~~the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors. Third party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

WeProduct liability dolawsuits ~~not~~against ~~have~~us acould ~~sales~~cause orus ~~marketing~~to ~~infrastructure.~~incur Tosubstantial ~~achieve~~liabilities ~~any~~and ~~level~~to oflimit ~~commercial~~commercialization ~~success~~of ~~for~~ any ~~product~~products ~~for which~~ that we ~~have~~may ~~obtained marketing approval, we will need to establish a sales and marketing organization or outsource sales and marketing functions to third parties~~develop.

~~There~~We face ~~are~~an ~~risks~~inherent ~~involved~~risk ~~with~~of ~~establishing~~product ~~our~~liability ~~own~~exposure ~~sales,~~related ~~marketing~~to ~~and~~the ~~distribution~~testing ~~capabilities.~~of ~~For~~our ~~example,~~product ~~recruiting~~candidate ~~and~~in ~~training~~human aclinical ~~sales~~trials ~~force is expensive~~ and will ~~time~~face ~~consuming~~an ~~and~~even ~~could~~greater ~~delay~~risk ~~any~~if ~~product~~we ~~launch.~~commercially Ifsell ~~the~~any ~~commercial~~products ~~launch~~that ofwe amay ~~product~~develop. ~~candidate~~If ~~for which~~ we ~~recruit~~cannot adefend ~~sales~~ourselves ~~force~~against claims ~~and~~that ~~establish~~our ~~marketing~~product ~~capabilities~~candidate ~~is delayed~~ or ~~does~~products ~~not~~caused ~~occur for any reason~~injuries, we ~~would~~will ~~have~~incur ~~prematurely~~substantial ~~or unnecessarily incurred these commercialization expenses~~liabilities. ~~This~~Regardless ~~may~~of bemerit ~~costly, and our investment would be lost if we cannot retain~~ or ~~reposition~~eventual outcome, ~~our~~liability ~~sales~~claims ~~and~~may ~~marketing~~result ~~personnel.~~ in:

If● decreased ~~approved,~~demand ~~factors~~for ~~that~~any ~~may~~product ~~inhibit~~candidates ~~our~~or ~~efforts~~products tothat ~~commercialize~~we ~~our~~may ~~product on our own include:~~develop;

•● damage ~~our inability~~ to ~~recruit,~~our ~~train~~reputation and ~~retain~~significant ~~adequate~~negative ~~numbers~~media ~~of effective sales and marketing personnel~~attention;

•● withdrawal ~~the inability~~ of ~~sales~~clinical ~~personnel~~trial ~~to obtain access to physicians or persuade adequate numbers of physicians to prescribe our product~~participants;

•● significant ~~the~~costs ~~lack of complementary products~~ to bedefend ~~offered~~the byrelated ~~sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines~~litigation; ~~and~~

•● significant ~~unforeseen~~ costs ~~and~~to ~~expenses~~defend ~~associated~~the ~~with~~related ~~creating an independent sales and marketing organization.~~litigation;

If we are unable to establish our own sales, marketing and distribution capabilities and instead enter into arrangements with third parties to perform these services, our product revenues and our profitability, if any, are likely to be lower than if we were to market, sell and distribute any products that we develop ourselves. In addition, we may be unable to enter into arrangements with third parties to sell, market and distribute our product candidate or may be unable to do so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary● ~~resources~~substantial ~~and~~monetary ~~attention~~awards to ~~sell~~trial ~~and~~participants ~~market our product effectively. If we do not establish sales, marketing and distribution capabilities, either on our own~~ or ~~in collaboration with third parties, we will not be able to commercialize our product candidate, which would have a material adverse effect on our company.~~ patients;

We● loss ~~face~~of ~~substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.~~revenue;

~~The~~● reduced ~~development~~resources ~~and commercialization~~ of ~~new drug products, particularly in the area of cancer, is highly competitive. We face competition with respect to~~ our ~~current~~management ~~product candidate, and will face competition with respect~~ to ~~any~~pursue ~~product~~our ~~candidates~~business ~~that~~strategy; ~~we may seek to develop or commercialize in the~~ and

19● the inability to commercialize any products that we may develop.

~~TABLE~~We may OFbe ~~CONTENTS~~unable to obtain product liability insurance on reasonable terms or at all. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of cancer. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization. 22

~~Our~~Risks Related ~~commercial~~to opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our ~~competitors~~Intellectual also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. Property

~~Many of the companies against which~~ If we are ~~competing,~~unable orto ~~against~~obtain ~~which we may compete in the future, have significantly greater financial resources~~ and ~~expertise~~maintain inpatent ~~research~~protection ~~and~~for ~~development,~~our ~~manufacturing,~~technology ~~conducting clinical trials, obtaining regulatory approvals~~ and ~~marketing approved~~ products, ~~than~~or weif ~~do.~~the ~~Mergers~~scope ~~and~~of ~~acquisitions in~~ the ~~pharmaceutical~~patent ~~and~~protection obtained ~~biotechnology~~is ~~industries~~not ~~may~~sufficiently ~~result~~broad, ~~in even more resources being concentrated among a smaller number of~~ our competitors. ~~Smaller~~could ~~and~~develop ~~other early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large~~ and ~~established~~ ~~companies.~~commercialize ~~These~~technology ~~third parties compete with us in recruiting~~ and ~~retaining~~products ~~qualified~~similar ~~scientific~~or ~~and~~identical to ~~management personnel~~ours, ~~establishing clinical trial sites~~ and ~~patient~~our ~~registration~~ability ~~for clinical trials, as well as in acquiring technologies complementary~~ to, orcommercialize ~~necessary for,~~ our ~~programs,~~technology and weproducts may be ~~unable to effectively compete with these companies for these or other reasons~~impaired.

~~Even~~Our business ifplan wedepends ~~are~~in ~~able~~large part on our ability to ~~commercialize~~obtain ~~any~~and ~~product~~maintain ~~candidates,~~patent ~~the~~protection with respect to our proprietary technology and products, ~~may~~and ~~become~~in ~~subject~~particular, Picoplatin. We seek to ~~unfavorable~~protect ~~pricing~~our ~~regulations,~~proprietary ~~third~~position ~~party~~gained ~~reimbursement~~through ~~practices~~our orlicense ~~healthcare~~with ~~reform~~Genzyme by ~~initiatives~~filing patent applications in the United States and elsewhere related to our novel technologies, ~~which~~the ~~would~~issuance ~~harm~~of patents regarding our ~~business~~own intellectual property regarding our product candidate and also expect to license additional applicable patents from third parties.

The patent ~~regulations~~prosecution ~~that~~process ~~govern~~is ~~marketing~~expensive ~~approvals,~~and ~~pricing~~time-consuming, ~~coverage~~and we may not be able to file and ~~reimbursement~~prosecute ~~for~~all ~~new~~necessary ~~drug~~or ~~products~~desirable patent ~~vary~~applications ~~widely~~at ~~from~~a ~~country~~reasonable tocost ~~country~~or in a timely manner. ~~Current~~It is also possible that we will fail to identify patentable aspects of our research and ~~future~~development ~~legislation~~output before it is too late to obtain patent protection. Moreover, in some circumstances, we may ~~significantly~~not ~~change~~have the ~~approval~~right ~~requirements~~to control (in ~~ways~~whole or in part) the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that ~~could~~we ~~involve~~license ~~additional~~from ~~costs~~third parties. Therefore, these patents and ~~cause~~applications ~~delays~~may not be prosecuted and enforced in ~~obtaining~~a ~~approvals.~~manner consistent with the best interests of our business.

~~Our~~The patent ~~ability~~position toof ~~commercialize~~biotechnology ~~any~~and ~~product~~pharmaceutical ~~candidate~~companies ~~also will depend~~ in ~~part~~general onis ~~the~~highly ~~extent~~uncertain, toinvolves ~~which~~complex ~~coverage~~legal and ~~adequate~~factual questions ~~reimbursement~~and ~~for~~has ~~our~~in ~~product~~recent ~~candidate~~years ~~will~~been bethe ~~available~~subject ~~from~~of ~~government~~much ~~health~~litigation. ~~administration~~In ~~authorities~~addition, ~~private~~the ~~health~~laws ~~insurers~~of ~~and~~foreign ~~other~~countries ~~organizations.~~may ~~Government~~not ~~authorities~~protect our ~~and~~rights ~~third~~to ~~party~~the ~~payors,~~same ~~such~~extent as ~~private~~the ~~health~~laws ~~insurers~~of ~~and~~the ~~health~~United ~~maintenance~~States. ~~organizations~~For example, ~~decide~~European ~~which~~patent ~~medications~~law ~~they~~restricts ~~will~~the ~~pay~~patentability ~~for~~of methods ~~and~~of ~~establish~~treatment ~~reimbursement~~of ~~levels.~~the Ahuman ~~primary~~body ~~trend~~more inthan ~~the~~United ~~U.S.~~States ~~healthcare~~law ~~industry~~does. ~~and~~Publications ~~elsewhere~~of isdiscoveries ~~cost~~in ~~containment.~~the ~~Government~~scientific ~~authorities~~literature often ~~and~~lag ~~third~~behind ~~party~~the ~~payors~~actual ~~have~~discoveries, ~~attempted~~and topatent ~~control costs~~applications byin ~~limiting~~the ~~coverage~~United States and ~~the~~other ~~amount~~jurisdictions ofare ~~reimbursement~~typically ~~for~~not published ~~particular~~until ~~medications.~~18 ~~Increasingly~~months after filing, ~~third~~or ~~party~~in ~~payors~~some ~~are~~cases ~~requiring~~not ~~that~~at ~~drug~~all. ~~companies~~Therefore, ~~provide~~we ~~them~~cannot know with ~~predetermined~~certainty ~~discounts~~whether ~~from~~we ~~list~~were the ~~prices~~first ~~and~~to ~~are~~make ~~challenging~~ the ~~prices~~inventions ~~charged~~claimed ~~for~~in ~~medical~~our ~~products.~~owned ~~Coverage~~or ~~and~~licensed ~~reimbursement~~patents ~~may~~or ~~not~~pending bepatent ~~available~~applications, ~~for~~or ~~any product~~ that we ~~commercialize~~were ~~and,~~the first ~~even~~to iffile ~~these~~for ~~are~~patent ~~available,~~protection ~~the level~~ of ~~reimbursement~~such ~~may not be satisfactory~~inventions. ~~Reimbursement~~As ~~may~~a ~~affect~~result, the ~~demand~~issuance, ~~for~~scope, ~~or the price of~~validity, ~~any~~enforceability ~~product~~and ~~candidate~~commercial value ~~for~~of ~~which~~our wepatent ~~obtain~~rights ~~marketing~~are ~~approval~~highly uncertain. ~~Obtaining~~Our pending and ~~maintaining~~future ~~adequate~~patent ~~reimbursement~~applications ~~for our products~~ may benot ~~difficult.~~result Wein ~~may~~patents bebeing ~~required~~issued which toprotect ~~conduct~~our ~~expensive~~technology ~~pharmacoeconomic~~or ~~studies~~products, toin ~~justify~~whole ~~coverage~~or ~~and~~in ~~reimbursement~~part, or ~~the~~which ~~level~~effectively ofprevent ~~reimbursement~~others ~~relative~~from tocommercializing ~~other~~competitive technologies ~~therapies~~and products. IfChanges ~~coverage~~in ~~and~~either ~~adequate~~the ~~reimbursement~~patent ~~are~~laws ~~not~~or ~~available~~interpretation orof ~~reimbursement~~the ispatent ~~available~~laws ~~only~~in tothe ~~limited~~United ~~levels,~~States weand other countries may ~~not~~diminish bethe ~~able~~value toof ~~commercialize~~our ~~any~~patents ~~product~~or ~~candidate~~narrow ~~for~~the scope of our patent protection, which wecould ~~obtain marketing~~adversely ~~approval.~~affect our company.

InPatent reform ~~addition,~~legislation ~~there~~could ~~may~~further beincrease ~~significant~~the ~~delays~~uncertainties inand ~~obtaining~~costs ~~reimbursement~~surrounding ~~for~~the ~~newly~~prosecution ~~approved~~of ~~drugs,~~our patent applications and the ~~coverage~~enforcement ~~may~~or bedefense ~~more~~of ~~limited~~our ~~than~~issued ~~the~~patents. ~~purposes~~On ~~for~~September ~~which~~16, 2011, the ~~drug~~Leahy-Smith isAmerica ~~approved~~Invents byAct, or the ~~FDA~~Leahy-Smith Act, was signed into law. ~~Moreover,~~The ~~eligibility~~Leahy-Smith ~~for~~Act ~~reimbursement~~includes ~~does~~a ~~not~~number ~~imply~~of significant changes to United States patent law. These include provisions that aaffect ~~drug~~the ~~will~~way bepatent ~~paid~~applications ~~for~~are inprosecuted ~~all~~and ~~cases~~may oralso ataffect apatent ~~rate~~litigation. ~~that~~The ~~covers~~United ~~our~~States ~~costs,~~Patent Office ~~including~~has ~~research~~developed regulations and procedures to govern administration of the Leahy-Smith Act, ~~development~~and many of the substantive changes to patent law associated with the Leahy-Smith Act, ~~manufacture~~and in particular, ~~sale~~the ~~and~~first ~~distribution.~~to ~~Interim~~file ~~reimbursement~~provisions, ~~levels~~became ~~for~~effective ~~new~~on ~~drugs~~March 16, if2013. ~~applicable~~Accordingly, ~~may~~since ~~also~~we ~~not~~have bepatent ~~sufficient~~applications pending and plan to ~~cover~~file ~~our~~for ~~costs~~additional ~~and~~patents ~~may~~in the future, it is not beclear ~~made~~what, ~~permanent.~~if ~~Reimbursement~~any, ~~rates~~impact ~~may~~the ~~vary~~Leahy-Smith ~~according~~Act towill have on the ~~use~~operation of our business. However, the ~~drug~~Leahy-Smith Act and its implementation could increase the ~~clinical~~uncertainties ~~setting~~and incosts ~~which~~surrounding itthe isprosecution of our patent applications and the enforcement ~~used,~~or ~~may~~defense beof ~~based~~our onissued ~~reimbursement~~patents, ~~levels~~all ~~already~~of ~~set~~which ~~for~~could ~~lower~~have ~~cost~~a ~~drugs~~material ~~and~~adverse ~~may~~effect beon ~~incorporated~~our ~~into~~business ~~existing~~and financial condition.

20Moreover, we may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

~~TABLE OF CONTENTS~~23

~~payments~~Even if ~~for~~our ~~other~~owned ~~services.~~and ~~Net~~licensed ~~prices~~patent ~~for~~applications ~~drugs~~issue ~~may~~as bepatents, ~~reduced~~they bymay ~~mandatory~~not ~~discounts~~issue orin ~~rebates~~a ~~required~~form bythat ~~government~~will ~~healthcare~~provide ~~programs~~us orwith ~~private~~any ~~payors.~~meaningful protection, ~~Third~~prevent ~~party~~competitors ~~payors~~from ~~often~~competing ~~rely~~with ~~upon~~us ~~Medicare~~or ~~coverage~~otherwise ~~policy~~provide ~~and~~us ~~payment~~with ~~limitations~~any incompetitive ~~setting their own reimbursement policies~~advantage. Our ~~inability~~competitors may tobe ~~promptly~~able ~~obtain~~to ~~coverage~~circumvent ~~and~~our ~~adequate~~owned ~~reimbursement~~or ~~rates~~licensed ~~from~~patents ~~both~~by ~~government-funded~~developing ~~and~~similar ~~private~~or ~~payors~~alternative ~~for~~technologies ~~any~~or ~~approved~~ products ~~that~~in ~~we develop could have~~ a ~~material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition~~non-infringing manner.

~~Product~~The issuance ~~liability~~of ~~lawsuits~~a ~~against~~patent usis ~~could~~not ~~cause~~conclusive usas to ~~incur~~its ~~substantial~~inventorship, ~~liabilities~~scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit ~~commercialization~~our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of ~~any~~the patent protection of our technology and products. ~~that~~Given wethe amount of time required for the development, testing and regulatory review of our product candidate, patents protecting such candidate might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may ~~develop~~not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

WeChanges in ~~face~~U.S. anpatent ~~inherent~~law ~~risk~~could ofdiminish ~~product liability exposure related to~~ the ~~testing~~value of ~~our~~patents ~~product candidate~~ in ~~human~~general, ~~clinical~~thereby ~~trials~~impairing ~~and~~our ~~will~~ability ~~face~~to anprotect ~~even greater risk if we commercially sell any products that we may develop. If we cannot defend ourselves against claims that~~ our product candidate ~~or products caused injuries, we will incur substantial liabilities~~(s). ~~Regardless of merit or eventual outcome, liability claims may result in:~~

•The patent ~~decreased~~positions ~~demand~~of ~~for~~companies ~~any~~engaged in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. Two cases involving diagnostic method claims and “gene patents” have recently been decided by the Supreme Court of the United States, or the Supreme Court. On March 20, 2012, the Supreme Court issued a decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., or Prometheus, a case involving patent claims directed to a process of measuring a metabolic product ~~candidates~~in a patient to optimize a drug dosage for the patient. According to the Supreme Court, the addition of well-understood, routine or ~~products~~conventional activity such as “administering” or “determining” steps was not enough to transform an otherwise patent-ineligible natural phenomenon into patent-eligible subject matter. On July 3, 2012, the USPTO issued a guidance memo to patent examiners indicating that weprocess claims directed to a law of nature, a natural phenomenon or a naturally occurring relation or correlation that do not include additional elements or steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied and the claim amounts to significantly more than the natural principle itself should be rejected as directed to patent-ineligible subject matter. On June 13, 2013, the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., or Myriad, a case involving patent claims held by Myriad Genetics, Inc. relating to the breast cancer susceptibility genes BRCA1 and BRCA2. Myriad held that an isolated segment of naturally occurring DNA, such as the DNA constituting the BRCA1 and BRCA2 genes, is not patent eligible subject matter, but that complementary DNA may ~~develop;~~be patent eligible. On June 27, 2016, the Supreme Court refused to hear an appeal of Sequenom v. Ariosa, leaving in place a Federal Circuit appellate decision holding that there is no patentable subject matter where claims are directed to a method that “starts and ends with a naturally occurring phenomenon.”

•Recently, the ~~damage~~USPTO issued a guidance memorandum to patent examiners entitled “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection.” (May 4, 2016). This memorandum provides an update to “2014 Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products.” Cumulatively, these guidelines instruct USPTO examiners on the ramifications of the Prometheus and Myriad rulings and apply the Myriad ruling to natural products and principles including all naturally occurring nucleic acids, as well as methods related to such materials. Certain claims of our ~~reputation~~licensed patents and ~~significant~~patent applications ~~negative~~contain ~~media~~claims ~~attention;~~that relate to specific recombinant DNA sequences that are naturally occurring at least in part and, therefore, could be the subject of future challenges made by third parties. In addition, the recent USPTO guidance could impact our ability for us to pursue similar patent claims in patent applications we may prosecute in the future.

•We cannot ~~withdrawal~~assure you that our efforts to seek patent protection for our technology and product candidate will not be negatively impacted by the decisions described above, rulings in other cases or changes in guidance or procedures issued by the USPTO. We cannot fully predict what impact the Supreme Court’s decisions in Prometheus and Myriad may have on the ability of ~~clinical~~life ~~trial~~science ~~participants;~~companies to obtain or enforce patents relating to their products and technologies in the future. These decisions, the guidance issued by the USPTO and rulings in other cases or changes in USPTO guidance or procedures could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future.

~~• significant costs to defend the related litigation;~~24

•Moreover, although ~~substantial~~the ~~monetary~~Supreme ~~awards~~Court has held in Myriad that isolated segments of naturally occurring DNA are not patent-eligible subject matter, certain third parties could allege that activities that we may undertake infringe other gene-related patent claims, and we may deem it necessary to ~~trial~~defend ~~participants~~ourselves against these claims by asserting non-infringement and/or ~~patients;~~invalidity positions or paying to obtain a license to these claims. In any of the foregoing or in other situations involving third-party intellectual property rights, if we are unsuccessful in defending against claims of patent infringement, we could be forced to pay damages or be subjected to an injunction that would prevent us from utilizing the patented subject matter. Such outcomes could harm our business, financial condition, results of operations or prospects.

•We may ~~loss~~become ofinvolved ~~revenue;~~in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

•Competitors may ~~reduced~~infringe ~~resources~~our owned or licensed patents or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents. In addition, in a patent infringement proceeding, a court may decide that a patent of ~~our~~ours ~~management~~is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to ~~pursue~~stop the other party from using the technology at issue on the grounds that our ~~business~~patents do ~~strategy;~~not ~~and~~cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly.

•Third parties ~~the~~may ~~inability~~initiate tolegal ~~commercialize~~proceedings ~~any~~alleging ~~products~~ that we ~~may~~are ~~develop~~infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on our business.

WeOur business ~~may~~will bedepend ~~unable~~upon our ability, and the ability of our collaborators, to ~~obtain~~develop, manufacture, market and sell our product candidates ~~liability~~and ~~insurance~~use onour ~~reasonable~~proprietary ~~terms~~technologies orwithout atinfringing ~~all.~~the ~~Insurance~~proprietary ~~coverage~~rights of third parties. There is ~~increasingly~~considerable intellectual ~~expensive~~property litigation in the biotechnology and pharmaceutical industries. We may ~~not~~become beparty ~~able~~to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to ~~maintain~~our ~~insurance~~primary ~~coverage~~product atcandidate or aother ~~reasonable~~products ~~cost~~and technology, including interference or inderivation anproceedings ~~amount~~before ~~adequate~~the toUSPTO. ~~satisfy~~Third ~~any~~parties ~~liability~~may assert infringement claims against us based on existing patents or patents that may ~~arise.~~be granted in the future.

~~Risks~~If we ~~Related~~are found to ~~Our~~infringe ~~Intellectual~~a ~~Property~~third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

If we ~~are~~fail ~~unable~~ to ~~obtain~~comply ~~and~~with ~~maintain~~our ~~patent~~obligations ~~protection~~in ~~for~~ our ~~technology~~intellectual ~~and~~property ~~products,~~licenses orwith ifthird ~~the scope of the patent protection obtained is not sufficiently broad~~parties, ~~our~~we ~~competitors~~ could ~~develop~~lose ~~and~~rights ~~commercialize~~that ~~technology~~are important ~~and products similar or identical~~ to ~~ours, and~~ our ~~ability to commercialize our technology and products may be impaired~~business.

~~Our~~We are ~~business~~and ~~plan~~expect ~~depends~~to inbe ~~large~~party ~~part~~to onone ~~our~~or ~~ability~~more tolicense ~~obtain~~or ~~and~~similar ~~maintain~~agreements ~~patent~~that ~~protection~~may ~~with~~impose ~~respect~~due todiligence, ~~our~~development ~~proprietary~~and ~~technology~~commercialization timelines, ~~and~~milestone ~~products~~payment, royalty, insurance and inother ~~particular,~~obligations ~~Picoplatin~~on us. WeIf ~~seek~~we fail to ~~protect~~comply with our ~~proprietary~~obligations ~~position~~under current ~~gained~~or ~~through~~future licenses, our ~~license~~counterparties ~~with~~may ~~Genzyme~~have bythe ~~filing~~right ~~patent~~to ~~applications~~terminate these agreements, in ~~the~~which ~~United~~case ~~States~~we ~~and~~might ~~elsewhere~~not ~~related~~be able to ~~our~~develop, ~~novel~~manufacture ~~technologies,~~or market any product that is covered by these agreements or may face other penalties under the ~~issuance~~agreements. Such an occurrence could materially adversely affect the value of ~~patents~~the ~~regarding~~product candidate being developed under any such agreement. Termination of these agreements or reduction or elimination of our ~~own~~rights ~~intellectual~~under ~~property~~these ~~regarding~~agreements may result in our ~~product~~having ~~candidate~~to ~~and~~negotiate new ~~also~~or ~~expect~~reinstated agreements with less favorable terms or cause us to ~~license~~lose ~~additional~~our ~~applicable~~rights ~~patents~~under ~~from~~these ~~third~~agreements, ~~parties.~~including our rights to important intellectual property or technology.

The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, in some circumstances, we may not have the right to control (in whole or in part) the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. 25

~~The~~Intellectual property ~~patent~~litigation ~~position~~could ofcause ~~biotechnology~~us ~~and~~to ~~pharmaceutical~~spend ~~companies~~substantial inresources ~~general is highly uncertain, involves complex legal~~ and ~~factual~~distract ~~questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect~~ our ~~rights~~personnel tofrom ~~the~~their ~~same~~normal ~~extent as the laws of the United States~~responsibilities. ~~For example, European patent law restricts the patentability of methods of treatment of the human~~

21Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our Common Stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace.

~~TABLE~~Risks Related OFto ~~CONTENTS~~Regulatory Approval of Our Product Candidates and Other Legal and Compliance Matters

~~body~~If we ~~more~~fail ~~than~~to ~~United States law does. Publications of discoveries in the scientific literature often lag behind the actual discoveries~~obtain, ~~and~~or ~~patent~~if ~~applications~~there ~~in the United States and other jurisdictions~~ are ~~typically~~delays ~~not~~in ~~published until 18 months after filing~~obtaining, orrequired inregulatory ~~some cases not at all. Therefore~~approvals, we ~~cannot~~will ~~know~~not ~~with~~be ~~certainty~~able ~~whether we were the first~~ to ~~make~~commercialize ~~the inventions claimed in~~ our product ~~owned or licensed patents or pending patent applications~~candidate, ~~or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability~~ and ~~commercial value of~~ our ~~patent~~ability ~~rights are~~to ~~highly~~generate ~~uncertain.~~revenue ~~Our pending~~ and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the ~~patent~~viability ~~laws or interpretation~~ of ~~the patent laws in the United States and other countries may diminish the value of~~ our ~~patents~~company orwill ~~narrow~~be ~~the~~materially ~~scope of our patent protection, which could adversely affect our company~~impaired.

~~Patent~~Our product ~~reform~~candidate ~~legislation could further increase the uncertainties~~ and ~~costs surrounding~~ the ~~prosecution~~activities ofassociated ~~our~~with ~~patent~~its ~~applications~~clinical development and ~~the~~commercialization, ~~enforcement~~including ormatters ~~defense~~relating to ofdesign, ~~our~~testing, ~~issued~~manufacture, ~~patents.~~safety, Onefficacy, ~~September~~recordkeeping, 16labeling, ~~2011~~storage, ~~the~~approval, ~~Leahy-Smith~~advertising, ~~America Invents Act~~promotion, orsale ~~the Leahy-Smith Act~~and distribution, ~~was~~are ~~signed~~subject ~~into law. The Leahy-Smith Act includes a number of significant changes~~ to ~~United~~comprehensive ~~States~~regulation ~~patent~~by ~~law.~~the ~~These~~FDA ~~include~~(including ~~provisions~~under ~~that affect~~ the ~~way~~Federal ~~patent~~Food, ~~applications~~Drug ~~are prosecuted~~ and ~~may~~Cosmetic ~~also~~Act) ~~affect~~and other ~~patent~~regulatory ~~litigation.~~agencies ~~The~~in the United States ~~Patent~~and ~~Office~~by ~~has~~the ~~developed~~European ~~regulations~~Medicines ~~and~~Agency ~~procedures~~(known toas ~~govern administration of~~ the ~~Leahy-Smith~~EMA) ~~Act,~~ and ~~many~~similar ofregulatory ~~the~~authorities ~~substantive~~outside ~~changes to patent law associated with~~ the ~~Leahy-Smith~~United ~~Act~~States, ~~and~~including ~~in particular,~~ the ~~first~~Ministry toof ~~file~~Health ~~provisions,~~of ~~became~~the ~~effective~~Russian ~~on March 16, 2013~~Federation. ~~Accordingly,~~Failure ~~since we have patent applications pending and plan~~ to ~~file~~obtain marketing approval for ~~additional~~our ~~patents~~product incandidate ~~the~~will ~~future,~~prevent itus isfrom ~~not~~commercializing ~~clear what, if any, impact~~ the ~~Leahy-Smith~~product ~~Act~~candidate. ~~will~~We have onnot ~~the~~received ~~operation~~approval ofto market ~~our~~Picoplatin ~~business.~~or ~~However,~~any ~~the~~other ~~Leahy-Smith~~product ~~Act~~from ~~and~~regulatory ~~its~~authorities ~~implementation~~in ~~could~~any ~~increase~~jurisdiction ~~the uncertainties~~ and ~~costs~~it ~~surrounding~~will ~~the~~likely ~~prosecution~~be ofyears ~~our~~before ~~patent~~we ~~applications~~are even ~~and~~eligible ~~the~~to ~~enforcement~~receive orsuch ~~defense of our issued patents, all of which could have a material adverse effect on our business and financial condition~~approval.

~~Moreover,~~Securing marketing weapproval ~~may~~requires bethe ~~subject~~submission toof aextensive ~~third~~preclinical ~~party~~and ~~preissuance~~clinical ~~submission~~data ofand ~~prior~~supporting ~~art~~information to ~~the~~regulatory authorities ~~U.S.~~for ~~Patent~~each ~~and~~therapeutic ~~Trademark~~indication ~~Office,~~to orestablish ~~USPTO,~~the orproduct ~~become~~candidate’s ~~involved~~safety inand ~~opposition,~~efficacy. ~~derivation,~~Securing ~~reexamination,~~marketing approval ~~inter~~also ~~partes~~requires ~~review,~~the ~~post-grant~~submission ~~review~~of orinformation ~~interference~~about ~~proceedings~~the ~~challenging~~product ~~our~~manufacturing ~~patent~~process ~~rights~~to, orand ~~the~~inspection ~~patent~~of ~~rights~~manufacturing facilities ofby, ~~others~~the regulatory authorities. AnOur ~~adverse~~product ~~determination~~candidate inmay ~~any~~not ~~such~~be ~~submission~~effective, ~~proceeding~~may be only moderately effective or ~~litigation~~may prove ~~could~~to ~~reduce~~have ~~the~~undesirable ~~scope~~or ofunintended side effects, toxicities or ~~invalidate,~~other ~~our~~characteristics ~~patent~~that ~~rights,~~may ~~allow~~preclude ~~third~~us ~~parties~~from toobtaining marketing ~~commercialize~~approval ~~our~~or ~~technology~~prevent or ~~products~~limit ~~and~~commercial ~~compete~~use ~~directly~~of ~~with~~our usproduct. In particular, ~~without~~new ~~payment~~cancer todrugs ~~us,~~frequently orare ~~result~~indicated only infor ~~our~~patient ~~inability~~populations tothat ~~manufacture~~have ~~or commercialize~~not ~~products~~responded ~~without~~to ~~infringing~~an ~~third~~existing ~~party~~therapy ~~patent~~or ~~rights~~have relapsed. InEven ~~addition,~~ if ~~the~~our ~~breadth~~product orcandidate ~~strength~~receives marketing ofapproval ~~protection~~for ~~provided~~one byor ~~our~~more ~~patents~~indications, ~~and~~of ~~patent~~which ~~applications~~no isassurances ~~threatened~~may be given, itthe ~~could~~accompanying ~~dissuade~~labels ~~companies~~may ~~from~~limit ~~collaborating~~the ~~with~~approved use usof toour ~~license~~drug, ~~develop~~which orcould ~~commercialize~~limit ~~current~~sales orof ~~future~~the product ~~candidates~~.

~~Even~~The process of obtaining marketing approvals in the United States is very expensive, may take many years, if ~~our~~approval ~~owned~~is obtained at all, and ~~licensed~~can ~~patent~~vary ~~applications~~substantially ~~issue~~based asupon ~~patents~~a variety of factors, ~~they~~including ~~may~~the ~~not~~type, ~~issue~~complexity inand anovelty ~~form~~of ~~that~~the ~~will~~product candidate ~~provide~~involved. usChanges ~~with~~in ~~any~~marketing ~~meaningful~~approval ~~protection~~policies during the development period, ~~prevent~~changes ~~competitors~~in ~~from~~or ~~competing~~the ~~with~~enactment usof additional statutes or ~~otherwise~~regulations, ~~provide~~or uschanges ~~with~~in ~~any~~regulatory ~~competitive~~review ~~advantage.~~for ~~Our~~each ~~competitors~~submitted ~~may~~product beapplication, ~~able~~may tocause ~~circumvent~~delays ~~our~~in ~~owned~~the approval or ~~licensed~~rejection ~~patents~~of byan ~~developing~~application. ~~similar~~Regulatory orauthorities ~~alternative~~have ~~technologies~~substantial discretion in the approval process and may refuse to accept any application or ~~products~~may indecide athat ~~non-infringing~~our ~~manner.~~data are insufficient for approval and require additional preclinical, clinical or other studies.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Given the amount of time required for the development, testing and regulatory review of our product candidate, patents protecting such candidate might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. 26

~~Changes~~The regulatory inprocess ~~U.S.~~of ~~patent~~obtaining ~~law~~state ~~could~~registration ~~diminish~~of ~~the~~medicine ~~value~~in Russia has changed as of ~~patents~~January in2016. ~~general~~As a result of this, we ~~thereby~~may ~~impairing~~be required to delay our ~~ability~~regulatory tofiling ~~protect~~in Russia until our European manufacturer of drug product ~~candidate(s)~~obtains GMP certificate from Russian Authorities which became obligatory as of 2016.

~~The~~In addition, ~~patent~~varying ~~positions~~interpretations of ~~companies~~the ~~engaged~~data inobtained ~~the~~from ~~development~~preclinical and ~~commercialization~~clinical oftesting ~~biologics~~could ~~and~~delay, ~~pharmaceuticals~~limit ~~are~~or ~~particularly~~prevent ~~uncertain~~marketing approval of our product candidate. ~~Two~~Any ~~cases~~marketing ~~involving~~approval ~~diagnostic~~we ~~method~~ultimately ~~claims~~obtain ~~and~~may ~~“gene~~be ~~patents”~~limited ~~have~~or ~~recently~~subject ~~been~~to ~~decided~~restrictions byor post-approval commitments that render the ~~Supreme~~approved ~~Court~~product not commercially viable. If we experience delays in obtaining approval or if we fail to obtain approval of our product candidate, the ~~United~~commercial ~~States~~prospects for our product candidate will be harmed and our ability to generate revenues, orand the ~~Supreme~~viability ~~Court.~~of our company generally, will be materially impaired.

22We will be subject to healthcare laws, regulation and enforcement; our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.

~~TABLE~~Although we OFcurrently ~~CONTENTS~~do not directly market or promote any products, we may also be subject to several healthcare regulations and enforcement by the federal government and the states and foreign governments in which we conduct our business. The laws that may affect our ability to operate include:

~~On March 20, 2012,~~ ● the ~~Supreme~~federal ~~Court~~Health ~~issued~~Insurance aPortability ~~decision~~and inAccountability ~~Mayo~~Act ~~Collaborative~~of ~~Services~~1996 ~~v. Prometheus Laboratories, Inc.,~~ (or ~~Prometheus~~HIPAA), a case involving patent claims directed to a process of measuring a metabolic product in a patient to optimize a drug dosage for the patient. According to the Supreme Court, the addition of well-understood, routine or conventional activity such as ~~“administering”~~amended orby ~~“determining” steps was not enough to transform an otherwise patent-ineligible natural phenomenon into patent-eligible subject matter. On July 3, 2012,~~ the ~~USPTO~~Health ~~issued~~Information ~~a guidance memo to patent examiners~~Technology ~~indicating~~for ~~that~~Economic process claims directed to a law of nature, a natural phenomenon or a naturally occurring relation or correlation that do not include additional elements or steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied and ~~the~~Clinical ~~claim~~Health ~~amounts to significantly more than the natural principle itself should be rejected as directed to patent-ineligible subject matter. On June 13~~Act, ~~2013,~~which ~~the~~governs ~~Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., or Myriad, a case involving patent claims held by Myriad Genetics, Inc. relating to~~ the ~~breast~~conduct ~~cancer susceptibility genes BRCA1 and BRCA2. Myriad held that an isolated segment~~ of ~~naturally~~certain ~~occurring~~electronic ~~DNA,~~healthcare ~~such~~transactions ~~as the DNA constituting the BRCA1~~ and ~~BRCA2~~protects ~~genes, is not patent eligible subject matter, but that complementary DNA may be patent eligible. On June 27, 2016,~~ the ~~Supreme Court refused to hear an appeal of Sequenom~~ v.security ~~Ariosa, leaving in place a Federal Circuit appellate decision holding that there is no patentable subject matter where claims are directed to a method that “starts~~ and ~~ends~~privacy ~~with~~of aprotected ~~naturally~~health ~~occurring phenomenon.”~~ information;

~~Recently,~~ ● the ~~USPTO~~federal ~~issued~~healthcare aprograms’ ~~guidance~~Anti-Kickback ~~memorandum~~Law, towhich ~~patent~~prohibits, ~~examiners~~among ~~entitled~~other ~~“Formulating~~things, apersons ~~Subject~~from ~~Matter~~knowingly ~~Eligibility Rejection~~ and ~~Evaluating~~willfully soliciting, ~~the Applicant’s Response to a Subject Matter Eligibility Rejection.” (May 4~~receiving, ~~2016).~~Offering ~~This memorandum provides an update to “2014 Procedure for Subject Matter Eligibility Analysis of Claims Reciting~~ or ~~Involving~~paying ~~Laws of Nature/Natural Principles~~remuneration, ~~Natural~~directly ~~Phenomena, and/~~or ~~Natural Products.” Cumulatively~~indirectly, ~~these~~in ~~guidelines~~exchange ~~instruct~~for ~~USPTO~~or ~~examiners~~to oninduce either the ~~ramifications~~ referral of ~~the~~an ~~Prometheus~~individual ~~and~~for, ~~Myriad~~or ~~rulings and apply~~ the ~~Myriad ruling to natural products and principles including all naturally occurring nucleic acids~~purchase, asorder ~~well~~or asrecommendation ~~methods related to such materials. Certain claims~~ of, ~~our~~any ~~licensed~~good ~~patents~~or ~~and~~service ~~patent~~for ~~applications~~which ~~contain~~payment ~~claims~~may ~~that relate to specific recombinant DNA sequences that are naturally occurring at least in part and, therefore, could~~ be ~~the subject of future challenges~~ made byunder ~~third~~federal healthcare ~~parties.~~programs Insuch ~~addition,~~as the ~~recent~~Medicare ~~USPTO~~and ~~guidance~~Medicaid ~~could impact our ability for us to pursue similar patent claims in patent applications we may prosecute in the future.~~ programs;

We● federal ~~cannot~~false ~~assure~~claims ~~you~~laws ~~that~~which ~~our efforts to seek patent protection for our technology and product candidate will not be negatively impacted by the decisions described above~~prohibit, ~~rulings~~among in other ~~cases~~things, orindividuals ~~changes in guidance~~ or ~~procedures~~entities ~~issued~~from byknowingly ~~the~~presenting, ~~USPTO. We cannot fully predict what impact the Supreme Court’s decisions in Prometheus and Myriad may have on the ability of life science companies to obtain~~ or ~~enforce~~causing ~~patents relating~~ to be ~~their~~presented, ~~products~~claims ~~and~~for ~~technologies~~payment infrom ~~the~~Medicare, ~~future. These decisions~~Medicaid, ~~the~~or ~~guidance issued by the USPTO and rulings in~~ other ~~cases~~third-party orpayors ~~changes~~that inare ~~USPTO~~false ~~guidance~~ or ~~procedures could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future.~~ fraudulent;

~~Moreover,~~● federal ~~although~~criminal ~~the~~laws ~~Supreme Court has held in Myriad~~ that ~~isolated~~prohibit ~~segments~~executing of naturally occurring DNA are not patent-eligible subject matter, certain third parties could allege that activities that we may undertake infringe other gene-related patent claims, and we may deem it necessary to defend ourselves against these claims by asserting non-infringement and/or invalidity positions, or paying to obtain a ~~license~~scheme to ~~these~~defraud ~~claims. In~~ any ofhealthcare ~~the~~benefit ~~foregoing~~program or inmaking ~~other~~false ~~situations~~statements ~~involving third-party intellectual property rights, if we are unsuccessful in defending against claims of patent infringement, we could be forced to~~relating ~~pay damages or be subjected~~ to anhealthcare ~~injunction~~matters; ~~that would prevent us from utilizing the patented subject matter. Such outcomes could harm our business, financial condition, results of operations or prospects.~~ and

We● state ~~may~~law ~~become~~equivalents ~~involved~~of ineach ~~lawsuits~~of tothe ~~protect~~above orfederal ~~enforce~~laws, ~~our~~such ~~patents~~as oranti-kickback ~~other~~and ~~intellectual~~false ~~property,~~claims laws which ~~could~~may beapply ~~expensive,~~to ~~time~~items or ~~consuming~~services ~~and~~reimbursed ~~unsuccessful~~by any third-party payor, including commercial insurers.

~~Competitors~~If our ~~may~~operations ~~infringe~~are ~~our~~found ~~owned~~to orbe ~~licensed~~in ~~patents~~violation orof ~~other~~any ~~intellectual~~of ~~property.~~the Tolaws ~~counter~~described ~~infringement~~above or ~~unauthorized~~any ~~use,~~other wegovernmental ~~may~~regulations bethat ~~required~~ apply to ~~file infringement claims~~us, ~~which~~we ~~can~~may be ~~expensive~~subject ~~and~~to ~~time~~penalties, ~~consuming.~~including ~~Any~~civil ~~claims~~and wecriminal ~~assert~~penalties, ~~against~~damages, ~~perceived~~fines, ~~infringers~~the ~~could~~curtailment ~~provoke~~or ~~these~~restructuring of ~~parties~~our tooperations, ~~assert~~the ~~counterclaims~~exclusion ~~against~~from usparticipation ~~alleging~~in ~~that~~federal weand ~~infringe~~state ~~their~~healthcare ~~patents.~~programs Inand ~~addition~~imprisonment, inany ~~a patent infringement proceeding, a court may decide that a patent~~ of ~~ours~~which iscould adversely ~~invalid~~affect orour ~~unenforceable,~~ability into ~~whole~~operate orour inbusiness ~~part,~~and ~~construe~~our financial results.

23A fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process.

~~TABLE~~We may OFseek ~~CONTENTS~~“fast track” designation for our product candidate for one or more indications. If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA fast track designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe that Picoplatin may be eligible for this designation, we cannot assure you that the FDA would decide to grant it should we apply for this designation. Even if we do receive fast track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. 27

~~Third~~A breakthrough ~~parties~~therapy ~~may~~designation ~~initiate~~by ~~legal~~the ~~proceedings~~FDA ~~alleging~~for ~~that~~our weproduct ~~are~~candidate ~~infringing~~may ~~their~~not ~~intellectual~~lead ~~property~~to ~~rights,~~a ~~the~~faster ~~outcome~~development ofor ~~which~~regulatory ~~would~~review or beapproval ~~uncertain~~process, and ~~could~~it ~~have~~does anot ~~material~~increase ~~adverse~~the ~~effect~~likelihood onthat our ~~business~~product candidate will receive marketing approval.

~~Our~~We may ~~business~~seek ~~will~~a ~~depend~~“breakthrough ~~upon~~therapy” designation for our ~~ability,~~product ~~and~~candidate. ~~the~~A ~~ability~~breakthrough oftherapy ~~our~~is ~~collaborators,~~defined toas ~~develop,~~a ~~manufacture,~~drug that ~~market~~is ~~and~~intended, ~~sell~~alone ~~our~~or ~~product~~in ~~candidates~~combination ~~and~~with ~~use~~one ~~our~~or ~~proprietary~~more ~~technologies~~other ~~without~~drugs, ~~infringing~~to ~~the~~treat ~~proprietary~~a ~~rights~~serious ofor ~~third~~life-threatening ~~parties.~~disease ~~There~~or iscondition, and ~~considerable~~preliminary ~~intellectual~~clinical ~~property~~evidence ~~litigation~~indicates inthat the ~~biotechnology~~drug ~~and~~may ~~pharmaceutical~~demonstrate ~~industries.~~substantial Weimprovement ~~may~~over ~~become~~existing ~~party~~therapies ~~to,~~on one or ~~threatened~~more ~~with~~clinically significant endpoints, ~~future~~such ~~adversarial~~as ~~proceedings~~substantial ortreatment ~~litigation~~effects ~~regarding~~observed ~~intellectual~~early ~~property~~in ~~rights~~clinical ~~with~~development. ~~respect~~For todrugs and ~~our~~biologics ~~primary~~that ~~product~~have ~~candidate~~been ordesignated ~~other~~as ~~products~~breakthrough therapies, interaction and ~~technology,~~communication ~~including~~between ~~interference~~the orFDA ~~derivation~~and ~~proceedings~~the ~~before~~sponsor of the ~~USPTO.~~trial ~~Third parties~~can ~~may~~help ~~assert~~to ~~infringement~~identify ~~claims~~the ~~against~~most usefficient ~~based~~path onfor ~~existing~~clinical ~~patents~~development orwhile ~~patents~~minimizing ~~that~~the ~~may~~number beof ~~granted~~patients placed in ~~the~~ineffective ~~future~~control regimens. Drugs designated as breakthrough therapies by the FDA are also eligible for accelerated approval.

IfDesignation as wea ~~are~~breakthrough ~~found~~therapy tois ~~infringe~~within athe ~~third~~discretion ~~party’s~~of ~~intellectual~~the ~~property~~FDA. ~~rights~~Accordingly, even if we ~~could~~believe bethat ~~required~~Picoplatin tomeets ~~obtain~~the acriteria for ~~license~~designation ~~from~~as ~~such~~a ~~third~~breakthrough ~~party~~therapy tofor ~~continue~~one ~~developing~~or ~~and~~more ~~marketing~~indications, ~~our~~the ~~products~~FDA ~~and~~may ~~technology.~~disagree ~~However,~~and weinstead ~~may~~determine not ~~be able~~ to ~~obtain~~make such ~~any required license on commercially reasonable terms or at all~~designation. Even if wesuch ~~were~~designation ~~able~~is togranted, ~~obtain~~of awhich ~~license,~~no itassurances ~~could~~may be ~~non-exclusive~~given, ~~thereby~~the ~~giving~~receipt ~~our~~of ~~competitors~~a ~~access~~breakthrough totherapy designation ~~the~~for ~~same~~our ~~technologies~~product ~~licensed~~candidate tomay ~~us.~~not Weresult ~~could~~in bea ~~forced,~~faster ~~including~~development ~~by court order~~process, toreview ~~cease commercializing the infringing technology~~ or ~~product.~~approval Incompared ~~addition,~~to wedrugs ~~could be found liable~~ considered for ~~monetary~~approval ~~damages, including~~under ~~treble~~conventional ~~damages~~FDA procedures and ~~attorneys’~~does ~~fees~~not ifassure weultimate ~~are~~approval ~~found~~by tothe ~~have willfully infringed a patent~~FDA. AIn ~~finding~~addition, ofeven ~~infringement~~if ~~could~~Picoplatin qualifies ~~prevent~~as usa ~~from~~breakthrough ~~commercializing~~therapy ~~our~~for ~~product~~one ~~candidates~~ or ~~force~~more usindications, tothe ~~cease~~FDA ~~some~~may oflater ~~our~~decide ~~business~~that ~~operations,~~it ~~which~~no ~~could~~longer ~~materially~~meets ~~harm~~the ~~our~~conditions for ~~business.~~qualification ~~Claims~~or decide that wethe ~~have~~time ~~misappropriated~~period ~~the~~for ~~confidential~~FDA ~~information~~review or ~~trade~~approval ~~secrets~~will ofnot ~~third~~be ~~parties~~shortened, ~~could~~which ~~have~~would adeny ~~similar~~us ~~negative~~the ~~impact~~benefits of onsuch ~~our business~~designation.

IfWe may weseek ~~fail~~but be unable to ~~comply~~obtain ~~with~~orphan drug exclusivity for our ~~obligations~~product incandidate. If our ~~intellectual~~competitors ~~property~~are ~~licenses~~able ~~with~~to ~~third~~obtain ~~parties,~~orphan drug weexclusivity ~~could~~for ~~lose~~their ~~rights~~products that are ~~important~~the tosame drug as our ~~business~~product candidate, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.

WeRegulatory authorities ~~are and expect to be party to one or more license or similar agreements that~~ may ~~impose~~designate ~~due~~drugs ~~diligence,~~for ~~development~~relatively ~~and~~small ~~commercialization~~patient ~~timelines,~~populations ~~milestone~~as ~~payment,~~orphan ~~royalty, insurance and other obligations on us~~drugs. IfGenerally, weif ~~fail~~a toproduct ~~comply~~ with ~~our~~an ~~obligations~~orphan drug ~~under~~designation ~~current~~subsequently orreceives ~~future~~the ~~licenses,~~first ~~our~~marketing ~~counterparties~~approval ~~may~~for ~~have~~ the ~~right~~indication tofor ~~terminate these agreements, in~~ which ~~case~~it wehas ~~might~~such ~~not~~designation, bethe product ~~able~~is entitled to ~~develop,~~a ~~manufacture~~period orof market ~~any~~exclusivity, ~~product~~which, ~~that~~subject isto ~~covered~~certain byexceptions, ~~these~~precludes ~~agreements~~the orFDA ~~may~~from ~~face~~approving another ~~other~~marketing ~~penalties~~application ~~under~~for the ~~agreements.~~same ~~Such~~drug anfor ~~occurrence could materially adversely affect~~ the ~~value~~same ofindication ~~the~~for ~~product~~that ~~candidate~~time ~~being developed under any such agreement~~period. ~~Termination~~The ofapplicable ~~these~~market ~~agreements~~exclusivity period oris ~~reduction~~seven oryears ~~elimination of our rights under these agreements may result~~ in ~~our~~the ~~having~~United ~~to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology~~States.

~~Intellectual~~Obtaining orphan ~~property~~drug ~~litigation~~exclusivity ~~could~~for ~~cause~~Picoplatin usmay be important to ~~spend~~our ~~substantial~~commercial ~~resources~~strategy. If a competitor obtains orphan drug exclusivity for and ~~distract~~approval of a product with the same indication as our ~~personnel~~product before we do, and if the competitor’s product is the same drug or a similar medicinal product as ours, we could be excluded from ~~their~~the ~~normal~~market. ~~responsibilities~~Even if we obtain orphan drug exclusivity for Picoplatin, we may not be able to maintain it. For example, if a competitive product that is the same drug or a similar medicinal product as our product candidate is shown to be clinically superior to our product candidate, any orphan drug exclusivity we have obtained will not block the approval of such competitive product. In addition, orphan drug exclusivity will not prevent the approval of a product that is the same drug as our product candidate if the FDA finds that we cannot assure the availability of sufficient quantities of the drug to meet the needs of the persons with the disease or condition for which the drug was designated. If one or more of these events occur, it could have a material adverse effect on our company.

Even if ~~resolved~~we inobtain ~~our~~marketing ~~favor,~~approval ~~litigation~~for ~~or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract~~ our ~~technical~~product ~~and management personnel from their normal responsibilities. In addition~~candidate, ~~there~~we could be ~~public~~subject ~~announcements~~to ofpost-marketing ~~the~~restrictions ~~results of hearings, motions~~ or ~~other~~withdrawal ~~interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on~~ from the ~~price~~market ~~of our common stock. Such litigation or proceedings could substantially increase our operating losses~~ and ~~reduce~~we ~~the resources available for development activities or any future sales, marketing or distribution activities. We~~ may ~~not~~be ~~have~~subject ~~sufficient financial or other resources~~ to ~~conduct~~penalties ~~such~~if ~~litigation~~we orfail ~~proceedings adequately. Some of our competitors may be able~~ to ~~sustain~~comply ~~the~~with ~~costs~~regulatory ofrequirements ~~such litigation~~ or ~~proceedings~~if ~~more effectively than~~ we ~~can~~experience ~~because of their greater financial resources~~unanticipated problems. ~~Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace.~~

24Even if we obtain marketing approval for Picoplatin, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, we will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping. In addition, even if marketing approval of our product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, including the requirement to implement a risk evaluation and mitigation strategy. New cancer drugs frequently are indicated only for patient populations that have not responded to an existing therapy or have relapsed. If our product candidate receives marketing approval, the accompanying label may limit the approved use of our drug in this way, which could limit sales of the product.

~~TABLE OF CONTENTS~~28

~~Risks~~The FDA ~~Related~~may also impose requirements for costly post-marketing studies or clinical trials and surveillance to ~~Regulatory~~monitor ~~Approval~~the safety or efficacy of ~~Our~~our ~~Product~~product. ~~Candidates~~The FDA closely regulates the post-approval marketing and ~~Other~~promotion ~~Legal~~of drugs to ensure drugs are marketed only for the approved indications and ~~Compliance~~in ~~Matters~~accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we or any third-party partners of ours do not market our products for their approved indications, we may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug, and Cosmetic Act relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws.

~~If we fail to obtain~~In addition, orlater ifdiscovery ~~there~~of ~~are~~previously ~~delays~~unknown inadverse ~~obtaining,~~events ~~required~~or ~~regulatory~~other ~~approvals,~~problems wewith ~~will not be able to commercialize~~ our product ~~candidate~~, ~~and~~manufacturers ~~our~~or ~~ability~~manufacturing processes, toor ~~generate~~failure ~~revenue~~to ~~and~~comply ~~the~~with ~~viability~~regulatory ofrequirements, ~~our~~may ~~company~~yield ~~will~~various beresults, ~~materially impaired.~~including:

~~Our~~● restrictions ~~product~~on ~~candidate~~such ~~and the activities associated with its clinical development and commercialization~~product, including matters relating to design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA (including under the Federal Food, Drug and Cosmetic Act) and other regulatory agencies in the United States and by the European Medicines Agency (known as the EMA) and similar regulatory authorities outside the United States, including the Ministry of Health of the Russian Federation. Failure to obtain marketing approval for our ~~product~~manufacturers ~~candidate will prevent us from commercializing the product candidate. We have not received approval to market Picoplatin~~ or ~~any~~manufacturing ~~other product from regulatory authorities in any jurisdiction and it will likely be years before we are even eligible to receive such approval.~~ processes;

~~Securing~~● restrictions ~~marketing~~on ~~approval requires~~ the ~~submission~~labeling of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Our product candidate may not be effective, may be only moderately effective or ~~may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude us from obtaining~~ marketing ~~approval or prevent or limit commercial use~~ of our product. In particular, new cancer drugs frequently are indicated only for patient populations that have not responded to an existing therapy or have relapsed. Even if our product candidate receives marketing approval for one or more indications, of which no assurances may be given, the ~~accompanying labels may limit the approved use of our drug, which could limit sales of the~~ product. ;

~~The~~● restrictions ~~process~~ of obtaining marketing approvals in the United States is very expensive, may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product ~~candidate~~distribution involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. use;

~~The~~● requirements regulatory process of obtaining state registration of medicine in Russia has changed as of January 2016 and some critical procedures still are not defined in details and could cause significant delays in its implementation. As a result of this uncertainty, we may be required to ~~delay~~conduct ~~our~~post-marketing ~~regulatory~~studies ~~filing~~or inclinical ~~Russia until our European manufacturer of drug product obtains GMP certificate from Russian Authorities which became obligatory as of 2016.~~ trials;

~~In addition, varying interpretations of~~ ● the ~~data~~need ~~obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of our product candidate. Any marketing approval we ultimately obtain may be limited or subject~~ to ~~restrictions~~utilize orwarning ~~post-approval commitments that render the approved product not commercially viable.~~ letters;

If● suspension ~~we experience delays in obtaining approval~~ or ifwithdrawal ~~we fail to obtain approval~~ of ~~our~~marketing ~~product candidate, the commercial prospects for our product candidate will be harmed and our ability to generate revenues, and the viability of our company generally, will be materially impaired.~~ approvals;

25● withdrawal of the product from the market or product recalls;

~~TABLE~~● refusal OFby ~~CONTENTS~~regulatory authorities to approve pending applications or supplements to approved applications that we submit;

~~We will be subject to healthcare laws~~● fines, ~~regulation~~restitution ~~and~~or ~~enforcement;~~disgorgement ~~our failure to comply with those laws could have a material adverse effect on our results~~ of ~~operations~~profits ~~and~~or ~~financial conditions.~~revenues;

~~Although~~● product weseizure; ~~currently do not directly market~~ or promote any products, we may also be subject to several healthcare regulations and enforcement by the federal government and the states and foreign governments in which we conduct our business. The laws that may affect our ability to operate include:

•● injunctions ~~the federal Health Insurance Portability and Accountability Act of 1996 (~~or ~~HIPAA), as amended by~~ the ~~Health~~imposition ~~Information Technology for Economic and Clinical Health Act, which governs the conduct~~ of ~~certain~~civil ~~electronic~~or ~~healthcare~~criminal ~~transactions and protects the security and privacy of protected health information;~~penalties.

•We may ~~the~~face ~~federal~~similar ~~healthcare~~issues ~~programs’ Anti-Kickback Law, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly,~~ in ~~exchange~~connection ~~for~~with ornon-compliance towith ~~induce~~non-U.S. ~~either~~regulatory the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;requirements.

•Healthcare legislative ~~federal~~reform ~~false~~measures ~~claims~~may ~~laws~~have ~~which~~a ~~prohibit,~~material ~~among~~adverse ~~other~~effect ~~things,~~on ~~individuals~~our orbusiness ~~entities~~and ~~from~~results ~~knowingly~~of ~~presenting,~~operations. ~~or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;~~

•In the ~~federal~~United ~~criminal~~States ~~laws~~and ~~that~~some ~~prohibit~~foreign ~~executing~~jurisdictions, athere ~~scheme~~have been, and continue to ~~defraud~~be, ~~any~~several legislative and regulatory changes and proposed changes regarding the healthcare ~~benefit~~system ~~program~~that could prevent or ~~making~~delay ~~false~~marketing ~~statements~~approval ~~relating~~of toour ~~healthcare~~product ~~matters;~~candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.

•In the ~~state~~United ~~law~~States, ~~equivalents~~the Medicare Prescription Drug, Improvement, and Modernization Act of ~~each~~2003, or the MMA, changed the way Medicare covers and pays for pharmaceutical products. The MMA expanded Medicare coverage for outpatient drug purchases by those covered by Medicare under a new Part D and introduced a new reimbursement methodology based on average sales prices for Medicare Part B physician-administered drugs. In addition, the MMA authorized Medicare Part D prescription drug plans to limit the number of drugs that will be covered in any therapeutic class in their formularies. The MMA’s cost reduction initiatives and other provisions could decrease the ~~above~~coverage ~~federal~~and ~~laws~~price that we receive for any approved products. While the MMA applies only to drug benefits for Medicare beneficiaries, ~~such~~private aspayors ~~anti-kickback~~often follow Medicare coverage policy and ~~false~~payment ~~claims~~limitations ~~laws~~in ~~which~~setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from the MMA may ~~apply~~result toin ~~items~~a similar reduction in payments from private payors. Similar regulations or ~~services~~reimbursement ~~reimbursed~~policies bymay ~~any~~be ~~third-party~~enacted ~~payor,~~in ~~including~~international ~~commercial~~markets ~~insurers~~which could similarly impact our business.

IfMore recently, ~~our~~in ~~operations~~March ~~are~~2010, ~~found~~the toPatient beProtection inand ~~violation~~Affordable ofCare ~~any~~Act, ofas amended by the ~~laws~~Health ~~described~~Care ~~above~~and Education Reconciliation Act, or ~~any~~the ~~other~~PPACA, ~~governmental~~was ~~regulations~~passed, ~~that~~which ~~apply~~substantially tochanges ~~us,~~the weway ~~may~~healthcare beis ~~subject~~financed toby ~~penalties,~~both ~~including~~the ~~civil~~government and ~~criminal~~private ~~penalties~~insurers, and ~~damages,~~significantly ~~fines~~impacts the U.S. pharmaceutical industry. The PPACA, among other things: (i) addresses a new methodology by which rebates owed by manufacturers under the ~~curtailment~~Medicaid orDrug ~~restructuring~~Rebate ofProgram ~~our~~are ~~operations~~calculated for drugs that are inhaled, infused, instilled, implanted or injected; (ii) increases the ~~exclusion~~minimum ~~from~~Medicaid ~~participation~~rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in ~~federal~~Medicaid managed care organizations; (iii) establishes annual fees and ~~state~~taxes ~~healthcare~~on ~~programs~~manufacturers of certain branded prescription drugs; (iv) expands the availability of lower pricing under the 340B drug pricing program by adding new entities to the program; and ~~imprisonment~~(v) establishes a new Medicare Part D coverage gap discount program, ~~any~~in which manufacturers must agree to offer 50% point-of-sale ~~which~~discounts ~~could~~off ~~adversely~~negotiated ~~affect~~prices ~~our~~of ~~ability~~applicable brand drugs to ~~operate~~eligible ~~our~~beneficiaries ~~business~~during ~~and~~their ~~our~~coverage ~~financial~~gap ~~results.~~period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

~~A fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process.~~29

WeAdditional changes that may ~~seek~~affect ~~“fast~~our ~~track”~~business ~~designation~~include ~~for~~changes ~~our~~governing ~~product~~enrollment ~~candidate~~in ~~for~~federal ~~one~~healthcare orprograms, ~~more~~reimbursement changes, ~~indications.~~rules Ifregarding aprescription drug isbenefits ~~intended~~under ~~for~~ the ~~treatment~~health ofinsurance aexchanges ~~serious~~and orfraud ~~life-threatening~~and ~~condition~~abuse and ~~the~~enforcement. Continued ~~drug~~implementation ~~demonstrates~~of the ~~potential~~PPACA toand ~~address unmet medical needs for this condition,~~ the ~~drug~~passage ~~sponsor~~of ~~may~~additional ~~apply~~laws ~~for~~and ~~FDA~~regulations ~~fast track designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe that Picoplatin~~ may beresult ~~eligible~~in ~~for this designation, we cannot assure you that~~ the ~~FDA~~expansion ~~would~~of ~~decide~~new toprograms such ~~grant~~as itMedicare ~~should~~payment ~~we apply~~ for ~~this~~performance ~~designation. Even if we do receive fast track designation~~initiatives, weand may ~~not~~ ~~experience~~impact aexisting ~~faster~~government ~~development~~healthcare ~~process~~programs, ~~review~~such oras ~~approval~~by ~~compared to conventional FDA procedures. The FDA may withdraw fast track designation if it believes that~~ improving the ~~designation~~physician isquality noreporting ~~longer~~system ~~supported~~and byfeedback ~~data from our clinical development~~ program.

AFor each ~~breakthrough~~state ~~therapy~~that ~~designation~~does bynot choose to expand its Medicaid program, there likely will be fewer insured patients overall, which could impact the ~~FDA~~sales, ~~for~~business ~~our~~and ~~product~~financial ~~candidate~~condition ~~may~~of ~~not~~manufacturers ~~lead~~of branded prescription drugs. Where patients receive insurance coverage under any of the new options made available through the PPACA, the possibility exists that manufacturers may be required to pay Medicaid rebates on that resulting drug utilization, a ~~faster~~decision ~~development~~that orcould ~~regulatory~~impact ~~review~~manufacturer orrevenues. ~~approval~~The ~~process,~~U.S. ~~and~~federal government italso ~~does~~has ~~not~~announced ~~increase~~delays in the ~~likelihood~~implementation ~~that~~of key provisions of the PPACA. The implications of these delays for our ~~product~~and ~~candidate~~our ~~will~~potential ~~receive~~partners’ ~~marketing~~business ~~approval~~and financial condition, if any, are not yet clear.

WeAdditionally, the ~~may~~future ~~seek~~implementation aof ~~“breakthrough~~the ~~therapy”~~PPACA ~~designation~~is ~~for~~in ~~our~~no ~~product~~way ~~candidate~~assured. ABy ~~breakthrough~~way ~~therapy~~of isexample, ~~defined~~in asJanuary a2017, ~~drug~~Congress ~~that~~voted isto ~~intended,~~adopt ~~alone~~a orbudget resolution infor ~~combination~~fiscal ~~with~~year ~~one~~2017, or ~~more~~the ~~other~~Budget ~~drugs~~Resolution, tothat ~~treat~~authorizes athe ~~serious~~implementation orof ~~life-threatening~~legislation ~~disease~~that orwould ~~condition,~~repeal portions ~~and~~of ~~preliminary~~the ~~clinical~~PPACA. ~~evidence~~The ~~indicates~~Budget ~~that~~Resolution is not a law; however, it is widely viewed as the ~~drug~~first ~~may~~step ~~demonstrate~~toward ~~substantial~~the ~~improvement~~passage ~~over~~of legislation ~~existing~~that ~~therapies~~would onrepeal ~~one~~certain oraspects ~~more~~of ~~clinically~~the ~~significant~~PPACA. ~~endpoints~~Further, ~~such~~on asJanuary ~~substantial~~20, ~~treatment~~2017, ~~effects~~President ~~observed~~Trump ~~early~~signed inan ~~clinical~~Executive Order ~~development.~~directing ~~For~~federal ~~drugs~~agencies with authorities and ~~biologics~~responsibilities ~~that~~under ~~have~~the ~~been~~PPACA ~~designated~~to aswaive, ~~breakthrough~~defer, ~~therapies~~grant exemptions from, or ~~interaction~~delay ~~and~~the ~~communication~~implementation ~~between~~of any provision of the ~~FDA~~PPACA that would impose a fiscal or regulatory burden on states, individuals, ~~and~~healthcare ~~the~~providers, ~~sponsor~~health insurers, or manufacturers of pharmaceuticals or medical devices. Congress also could consider subsequent legislation to replace elements of the PPACA that are repealed.

26With the new administration and Congress, there may be additional legislative changes, including repeal and replacement of certain provisions of the PPACA. It remains to be seen, however, precisely what the new legislation will provide, when it will be enacted and what impact it will have on the availability of healthcare and containing or lowering the cost of healthcare. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain marketing approval and may affect our overall financial condition and ability to develop product candidates.

~~TABLE~~We expect OFthat ~~CONTENTS~~the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.

~~trial~~We expect ~~can~~that ~~help~~additional tostate ~~identify~~and ~~the~~federal ~~most~~healthcare ~~efficient~~reform ~~path~~measures ~~for~~will ~~clinical~~be ~~development~~adopted ~~while~~in ~~minimizing~~ the ~~number~~future, any of ~~patients~~which ~~placed~~could inlimit ~~ineffective~~the amounts ~~control~~that ~~regimens.~~federal ~~Drugs~~and ~~designated~~state asgovernments ~~breakthrough~~will ~~therapies~~pay byfor ~~the~~healthcare ~~FDA~~products ~~are~~and ~~also~~services, ~~eligible~~which could result in reduced demand for ~~accelerated~~Picoplatin ~~approval.~~or additional pricing pressures.

Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe that Picoplatin meets the criteria for designation as a breakthrough therapy for one or more indications, the FDA may disagree and instead determine not to make such designation. Even if such designation is granted, of which no assurances may be given, the receipt of a breakthrough therapy designation for our product candidate may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if Picoplatin qualifies as a breakthrough therapy for one or more indications, the FDA may later decide that it no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened, which would deny us the benefits of such designation. 30

WeWhile it ~~may~~is ~~seek~~our ~~but~~intention ~~be unable~~ to ~~obtain~~enter ~~orphan~~into ~~drug~~a ~~exclusivity~~strategic ~~for~~partnership ~~our~~with ~~product~~a ~~candidate.~~European Ifpartner ~~our competitors are able~~ to ~~obtain~~seek ~~orphan~~regulatory ~~drug~~approval ~~exclusivity~~ for ~~their~~Picoplatin ~~products that are~~ in the ~~same~~European ~~drug as our product candidate~~Union, we may not beenter ~~able~~into tosuch ~~have~~a ~~competing~~partnership ~~products~~and ~~approved~~even byif ~~the~~we ~~applicable~~do ~~regulatory~~enter ~~authority~~into ~~for~~such a ~~significant~~partnership, ~~period~~we ofmay ~~time~~not be successful in obtaining regulatory approval.

~~Regulatory~~The European ~~authorities~~Commission ~~may~~designated ~~designate~~Picoplatin ~~drugs~~as ~~for~~an ~~relatively~~orphan ~~small~~medicinal ~~patient~~product ~~populations~~for asthe ~~orphan~~treatment ~~drugs.~~of ~~Generally~~SCLC, which, if aapproved, ~~product~~would qualify ~~with~~Picoplatin anfor ~~orphan~~ten ~~drug~~years ~~designation~~of ~~subsequently~~marketing ~~receives~~exclusivity in the ~~first~~European ~~marketing~~Union. ~~approval~~Accordingly, ~~for~~we ~~the~~expect ~~indication~~to seek a strategic partnership with a European partner for ~~which~~obtaining itapproval ~~has~~of ~~such~~Picoplatin ~~designation,~~in the ~~product~~European isUnion. ~~entitled~~However, towe amay ~~period~~be ofunable ~~market~~to ~~exclusivity,~~find ~~which,~~a ~~subject~~strategic partner in Europe to ~~certain~~move ~~exceptions,~~forward ~~precludes~~with the ~~FDA~~regulatory ~~from~~approval ~~approving~~process ~~another~~or ~~marketing~~may ~~application~~determine ~~for~~that seeking regulatory approval in Europe is not in the ~~same~~best ~~drug~~interest ~~for~~of the ~~same~~company. ~~indication~~Furthermore, ~~for~~even ~~that~~if ~~time~~we ~~period.~~do ~~The~~secure ~~applicable~~a ~~market~~strategic ~~exclusivity~~partner, ~~period~~there is ~~seven~~no ~~years~~guarantee that the we will be able to obtain regulatory approval in the ~~United~~European ~~States.~~Union or that the terms of the strategic partnership will make such regulatory approval lucrative to us.

~~Obtaining~~Risks Related ~~orphan drug exclusivity for Picoplatin may be important~~ to ~~our~~an ~~commercial~~Investment ~~strategy.~~in IfOur aSecurities ~~competitor obtains orphan drug exclusivity for~~ and ~~approval~~this of a product with the same indication as our product before we do, and if the competitor’s product is the same drug or a similar medicinal product as ours, we could be excluded from the market. Even if we obtain orphan drug exclusivity for Picoplatin, we may not be able to maintain it. For example, if a competitive product that is the same drug or a similar medicinal product as our product candidate is shown to be clinically superior to our product candidate, any orphan drug exclusivity we have obtained will not block the approval of such competitive product. In addition, orphan drug exclusivity will not prevent the approval of a product that is the same drug as our product candidate if the FDA finds that we cannot assure the availability of sufficient quantities of the drug to meet the needs of the persons with the disease or condition for which the drug was designated. If one or more of these events occur, it could have a material adverse effect on our company. Offering

~~Even~~Our management ifhas webroad ~~obtain~~discretion ~~marketing~~as ~~approval for our product candidate, we could be subject~~ to ~~post-marketing~~the ~~restrictions~~use orof ~~withdrawal from~~ the ~~market~~net ~~and~~proceeds wefrom ~~may~~this ~~be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems~~Offering.

~~Even~~We intend ifto weuse ~~obtain~~the ~~marketing~~net ~~approval~~proceeds ~~for~~from ~~Picoplatin,~~this ~~along~~Offering ~~with~~to ~~the~~fund ~~manufacturing~~our ~~processes,~~Phase ~~post-approval~~II clinical ~~data,~~trial ~~labeling,~~in ~~advertising~~squamous ~~and~~cell ~~promotional~~cancer ~~activities~~of ~~for~~the ~~such~~head-and-neck and ~~product,~~related weexpenses ~~will~~and befor ~~subject~~working tocapital ~~continual requirements of~~ and ~~review~~general bycorporate ~~the~~purposes, ~~FDA~~however ~~and~~we ~~other~~cannot ~~regulatory~~specify ~~authorities,~~with ~~including~~certainty the ~~Ministry~~particular uses of ~~Health~~the ofnet ~~the~~proceeds ~~Russian~~we ~~Federation.~~will ~~These~~receive ~~requirements~~from ~~include~~this ~~submissions~~Offering. ofOur ~~safety~~management ~~and~~will ~~other~~have ~~post-marketing~~broad ~~information~~discretion ~~and~~in ~~reports,~~the ~~registration~~application ~~and~~of ~~listing~~the net ~~requirements~~proceeds, ~~cGMP~~including ~~requirements~~for ~~relating~~any toof ~~manufacturing,~~the ~~quality~~purposes ~~control,~~described ~~quality~~in ~~assurance~~“Use ~~and corresponding maintenance~~ of ~~records~~Proceeds.” ~~and documents~~Accordingly, ~~requirements~~ ~~regarding~~you ~~the~~will ~~distribution~~have ~~of samples~~ to ~~physicians~~rely upon ~~and~~the ~~recordkeeping.~~judgment ~~In addition, even if marketing approval~~ of our ~~product~~management ~~candidate~~with isrespect ~~granted,~~to the ~~approval~~use ~~may~~of ~~be subject to limitations on~~ the ~~indicated~~proceeds. ~~uses~~Our ~~for~~management ~~which the product~~ may bespend ~~marketed~~a portion or toall ~~the conditions~~ of ~~approval, including~~ the net ~~requirement~~proceeds tofrom ~~implement~~this aOffering ~~risk~~in ~~evaluation~~ways ~~and~~that ~~mitigation~~holders ~~strategy.~~of ~~New~~our ~~cancer~~Common ~~drugs~~Stock ~~frequently~~and ~~are~~Class ~~indicated~~A ~~only~~Warrants ~~for~~may ~~patient~~not ~~populations~~desire or that ~~have~~may not ~~responded~~yield a tosignificant anreturn ~~existing~~or ~~therapy~~any orreturn ~~have~~at ~~relapsed~~all. IfThe ~~our~~failure ~~product~~by ~~candidate~~our ~~receives~~management ~~marketing~~to ~~approval,~~apply ~~the~~these ~~accompanying~~funds ~~label~~effectively ~~may~~could ~~limit~~harm ~~the approved use of~~ our ~~drug~~business. Pending intheir ~~this way~~use, ~~which~~we ~~could~~may ~~limit~~also ~~sales~~invest of the ~~product.~~ net

27There is no public market for the warrants to purchase Common Stock in this Offering.

~~TABLE~~There is OFno ~~CONTENTS~~trading market for the warrants being offered in this Offering, and we do not expect a market to develop. In addition, we do not intend to apply for listing of the warrants on any securities exchange. Without an active market, the liquidity of the warrants will be limited.

~~The~~There is ~~FDA~~no ~~may~~existing ~~also~~market ~~impose requirements~~ for ~~costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of~~ our ~~product.~~Common ~~The~~Stock ~~FDA closely regulates the post-approval marketing~~ and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we ~~or any third party partners of ours~~ do not ~~market~~know ~~our~~if ~~products~~one ~~for~~will ~~their~~develop ~~approved indications, we may be subject~~ to ~~enforcement~~provide ~~action~~you ~~for~~with ~~off-label~~adequate ~~marketing~~liquidity. ~~Violations~~ of the Federal Food, Drug, and Cosmetic Act relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws.

InPrior to ~~addition~~this Offering, ~~later~~there ~~discovery~~has ofnot ~~previously~~been ~~unknown~~a ~~adverse~~public ~~events~~market orfor ~~other~~our ~~problems~~Common ~~with~~Stock. We cannot assure you that an active trading market for our ~~product,~~Common ~~manufacturers~~Stock orwill ~~manufacturing~~develop ~~processes~~following this Offering, or ~~failure~~if it does develop, it may not be maintained. You may not be able to ~~comply~~sell ~~with~~your ~~regulatory~~shares ~~requirements,~~of Common Stock quickly or at the market price if trading in our securities is not active. The initial public Unit Offering Price was arbitrarily determined by the Board of Directors and may ~~yield~~not ~~various~~be ~~results,~~indicative ~~including:~~of prices that will prevail in the trading market.

•The offered ~~restrictions~~securities onhave ~~such~~no ~~product~~prior public market, and our ~~manufacturers~~Common orStock ~~manufacturing~~prices ~~processes;~~could be volatile and could decline after this Offering.

•This Offering ~~restrictions~~constitutes on the ~~labeling~~initial public Offering of our shares of Common Stock and Class A Warrants, and no public market for our shares of our Common Stock or ~~marketing~~Class A Warrants currently exists. We do not intend to apply for listing of the ~~product;~~warrants on any securities exchange. Without an active market, the liquidity of the warrants will be limited.

•There can ~~restrictions~~be no assurance that an active trading market for our shares of ~~product~~Common ~~distribution~~Stock ~~use;~~will develop or be sustained after this Offering is completed. The initial public Unit Offering Price was arbitrarily determined by the Board of Directors and may not be indicative of prices that will prevail in the trading market.

•We intend ~~requirements~~to make our shares of Common Stock become subject to ~~conduct~~quotation ~~post-marketing~~of ~~studies~~the OTC Market Groups quotation system. However, we cannot ensure that an active public market for our shares of Common Stock will develop after this Offering, or ~~clinical~~that ~~trials;~~if it does develop, it will be sustained. In the absence of a public trading market:

~~• the need to utilize warning letters;~~31

•● you ~~suspension~~may not be able to liquidate your investment in our Common Stock or ~~withdrawal~~the ofClass ~~marketing~~A ~~approvals~~Warrants;

•● you ~~withdrawal~~may ofnot ~~the~~be ~~product~~able ~~from~~to resell your shares or the ~~market~~Class A Warrants at or ~~product~~above ~~recalls~~the initial public Offering Prices;

•● the ~~refusal~~market byprice ~~regulatory~~of ~~authorities~~our toCommon ~~approve~~Stock ~~pending~~or ~~applications~~the orClass ~~supplements~~A toWarrants ~~approved~~may ~~applications~~experience ~~that~~more weprice ~~submit~~volatility; and

•● there ~~fines,~~may ~~restitution~~be orless ~~disgorgement~~efficiency ofin ~~profits~~carrying orout ~~revenues;~~your purchase and sale orders.

•The market ~~product~~price ~~seizure;~~of our Common Stock and Class A Warrants may be highly volatile, and you could lose all or part of your investment.

•The trading ~~injunctions~~price of our Common Stock and Class A Warrants is likely to be volatile. This volatility may prevent you from being able to sell your securities at or above the ~~imposition~~price ofyou ~~civil~~paid orfor ~~criminal~~your ~~penalties~~securities. Our stock price could be subject to wide fluctuations in response to a variety of factors, which include:

We● whether ~~may~~we ~~face~~achieve ~~similar~~our ~~issues~~anticipated incorporate ~~connection with non-compliance with non-U.S. regulatory requirements.~~ objectives;

~~Healthcare~~● actual ~~legislative~~or ~~reform~~anticipated ~~measures~~fluctuations ~~may~~in ~~have a material adverse effect on~~ our ~~business~~quarterly ~~and~~or ~~results~~annual ofoperating ~~operations.~~results;

~~In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory~~ ● changes ~~and~~in ~~proposed~~financial ~~changes regarding the healthcare system that could prevent~~ or ~~delay~~operational ~~marketing~~estimates ~~approval of our product candidates, restrict~~ or ~~regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.~~ projections;

In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers and pays for pharmaceutical products. The MMA expanded Medicare coverage for outpatient drug purchases by those covered by Medicare under a new Part D and introduced a new reimbursement methodology based on average sales prices for Medicare Part B physician-administered drugs. In addition, the MMA authorized Medicare Part D prescription drug plans to limit the number of drugs that will be covered in any therapeutic class in their formularies. The MMA’s cost reduction initiatives and● ~~other~~our ~~provisions~~ability ~~could decrease the coverage and price that we receive for any approved products. While the MMA applies only~~ to ~~drug~~implement ~~benefits~~our ~~for Medicare beneficiaries~~pre-clinical, ~~private~~clinical ~~payors often follow Medicare coverage policy~~ and ~~payment~~other ~~limitations~~development ~~in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors. Similar regulations~~ or ~~reimbursement~~operational ~~policies may be enacted in international markets which could similarly impact our business.~~ plans;

~~More~~● termination ~~recently,~~of ~~in March 2010,~~ the ~~Patient~~lock-up ~~Protection~~agreement ~~and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act,~~ or ~~the~~other ~~PPACA,~~restrictions ~~was~~on ~~passed, which substantially changes~~ the ~~way~~ability ~~healthcare~~of isour ~~financed~~stockholders ~~by both the government~~ and ~~private~~other ~~insurers,~~security ~~and~~holders ~~significantly~~to ~~impacts~~sell shares ~~the~~after ~~U.S.~~this Offering;

28● changes in the economic performance or market valuations of companies similar to ours; and

~~TABLE~~● general OFeconomic ~~CONTENTS~~or political conditions in the United States or elsewhere.

~~pharmaceutical industry. The PPACA~~In addition, ~~among other things: (i) addresses a new methodology by which rebates owed by manufacturers under~~ the ~~Medicaid~~stock ~~Drug~~market ~~Rebate~~in ~~Program are calculated for drugs that are inhaled~~general, ~~infused, instilled, implanted or injected; (ii) increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program~~ and ~~extends~~ the ~~rebate~~stock ~~program~~of tobiotechnology ~~individuals~~companies ~~enrolled~~ in ~~Medicaid~~particular, ~~managed~~have ~~care~~experienced ~~organizations;~~extreme ~~(iii) establishes annual fees~~ price and ~~taxes~~volume onfluctuations ~~manufacturers~~that ofhave ~~certain~~often ~~branded~~been ~~prescription~~unrelated ~~drugs;~~or ~~(iv)~~disproportionate ~~expands the availability of lower pricing under the 340B drug pricing program by adding new entities~~ to the ~~program;~~operating ~~and~~performance ~~(v) establishes a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-~~of~~-sale~~ ~~discounts~~these ~~off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D~~companies. ~~Additionally,~~Broad market ~~in the United States, the Biologics Price Competition~~ and ~~Innovation~~industry ~~Act~~factors ofmay ~~2009~~negatively ~~created~~affect an abbreviated approval pathway for biologic products that are demonstrated to be “highly similar” or “biosimilar or interchangeable” with an FDA-approved biologic product. This new pathway could allow competitors to reference data from biologic products already approved after 12 years from the ~~time~~market price of ~~approval. This could expose us to potential competition by lower-cost biosimilars even if we commercialize a product candidate faster than~~ our ~~competitors.~~Common ~~Moreover~~Stock, ~~the~~regardless ~~creation~~ of ~~this abbreviated~~our ~~approval~~actual ~~pathway~~operating ~~does not preclude or delay a third party from pursuing approval of a competitive product candidate via the traditional approval pathway based on their own clinical trial data~~performance.

~~Additional changes that may affect~~ If our ~~business~~shares ~~include~~become ~~those~~subject ~~governing~~to ~~enrollment in federal healthcare programs, reimbursement changes, rules regarding prescription drug benefits under~~ the ~~health~~penny ~~insurance~~stock exchanges and fraud and abuse and enforcement. Continued implementation of the PPACA and the passage of additional laws and regulations may result in the expansion of new programs such as Medicare payment for performance initiativesrules, ~~and~~it ~~may~~would ~~impact~~become ~~existing~~more ~~government~~difficult ~~healthcare~~to ~~programs,~~trade ~~such~~our ~~as by improving the physician quality reporting system and feedback program~~shares.

~~For~~The Securities ~~each~~and ~~state~~Exchange Commission (or SEC) has adopted rules that ~~does~~regulate ~~not~~broker-dealer ~~choose~~practices toin ~~expand~~connection ~~its~~with ~~Medicaid~~transactions in ~~program~~penny stocks. Penny stocks are generally equity securities with a price of less than $4.40, ~~there~~other ~~likely~~than ~~will~~securities beregistered on ~~fewer~~certain ~~insured~~national ~~patients~~securities ~~overall~~exchanges or authorized for quotation on certain automated quotation systems, ~~which~~provided ~~could~~that ~~impact~~current price and volume information with respect to transactions in such securities is provided by the ~~sales,~~exchange ~~business~~or system. If we do not obtain or retain a listing on NASDAQ and ~~financial~~if ~~condition~~the price of ~~manufacturers~~our ofCommon ~~branded~~Stock ~~prescription~~is ~~drugs~~less than $4.40, ~~Where~~our ~~patients~~Common ~~receive~~Stock ~~insurance~~will ~~coverage~~be ~~under~~deemed a ~~any~~penny ofstock. ~~the~~The ~~new~~penny ~~options~~stock ~~made~~rules ~~available~~require ~~through~~a ~~the~~broker-dealer, ~~PPACA~~before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the ~~possibility~~penny ~~exists~~stock rules require that ~~manufacturers~~before ~~may~~effecting beany ~~required~~transaction toin ~~pay~~a ~~Medicaid~~penny ~~rebates~~stock onnot ~~that~~otherwise ~~resulting~~exempt ~~drug~~from ~~utilization~~those rules, a ~~decision~~broker-dealer must make a special written determination that ~~could~~the ~~impact~~penny ~~manufacturer~~stock ~~revenues.~~is ~~The~~a ~~U.S.~~suitable ~~federal~~investment ~~government~~for ~~also~~the ~~has~~purchaser ~~announced~~and ~~delays~~receive in(i) the ~~implementation~~purchaser’s written acknowledgment of ~~key~~the ~~provisions~~receipt of ~~the~~a ~~PPACA.~~risk ~~The~~disclosure ~~implications~~statement; of(ii) a written agreement to transactions involving penny ~~these~~stocks; ~~delays~~and ~~for~~(iii) ~~our~~a signed and ~~our~~dated ~~potential~~copy ~~partners’~~of ~~business~~a ~~and~~written ~~financial~~suitability ~~condition,~~statement. ifThese ~~any~~disclosure requirements may have the effect of reducing the trading activity in the secondary market for our Common Stock, ~~are~~and ~~not~~therefore ~~yet~~stockholders ~~clear.~~may have difficulty selling their shares.

WeThere can ~~expect that the PPACA, as well as other healthcare reform measures that may~~ be ~~adopted~~no inassurance ~~the future, may result in more rigorous coverage criteria and in additional downward pressure on the price~~ that we ~~receive~~will ~~for~~ever ~~any~~provide ~~approved~~liquidity ~~product.~~to ~~Any~~our ~~reduction~~investors inthrough ~~reimbursement from Medicare or other government programs may result in~~ a ~~similar~~sale ~~reduction in payments from private payors. The implementation~~ of ~~cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize~~ our ~~products~~company.

WeWhile acquisitions ~~expect~~of ~~that~~pharmaceutical ~~additional~~companies ~~state~~like ~~and~~ours ~~federal~~are ~~healthcare~~not ~~reform~~uncommon, ~~measures~~potential ~~will~~investors are cautioned that no assurances can be ~~adopted~~given inthat ~~the~~any ~~future~~form of merger, ~~any~~combination, or sale of ~~which~~our ~~could~~company ~~limit~~will ~~the~~take ~~amounts~~place following this Offering, or that ~~federal~~any ~~and~~merger, combination, ~~state~~or ~~governments~~sale, ~~will~~even ~~pay~~if consummated, would provide liquidity or a profit for ~~healthcare~~our ~~products~~investors ~~and~~following ~~services,~~this ~~which~~Offering. ~~could~~You should ~~result~~not invest in ~~reduced~~our ~~demand~~company ~~for~~with ~~Picoplatin~~the expectation that we will be able to sell the business in order to provide liquidity or ~~additional~~a ~~pricing~~profit ~~pressures.~~for our investors.

While it is our intention to enter into a strategic partnership with a European partner to seek regulatory approval for Picoplatin in the European Union, we may not enter into such a partnership and even if we do enter into such a partnership, we may not be successful in obtaining regulatory approval.32

The financial ~~European~~and ~~Commission~~operational ~~designated~~projections ~~Picoplatin~~and asstatements anregarding ~~orphan~~future ~~medicinal~~milestones ~~product~~that ~~for the treatment of SCLC, which, if approved, would qualify Picoplatin for ten years of marketing exclusivity in the European Union. Accordingly,~~ we ~~expect to seek a strategic partnership with a European partner for obtaining approval of Picoplatin in the European Union. However, we~~ may bemake ~~unable~~from totime ~~find a strategic partner in Europe~~ to ~~move~~time ~~forward~~are with the regulatory approval process or may determine that seeking regulatory approval in Europe is not in the best interest of the company. Furthermore, even if we do secure a strategic partner, there issubject ~~no guarantee that the we will be able~~ to ~~obtain~~inherent ~~regulatory approval in the European Union or that the terms of the strategic partnership will make such regulatory approval lucrative to us~~risks.

29The projections and statements regarding future milestones that we provide herein or our management may provide from time to time (including, but not limited to, those relating to potential peak sales amounts, clinical and regulatory timelines, production and supply matters, commercial launch dates, strategic collaborations and other financial or operational matters) reflect numerous assumptions made by management, including assumptions with respect to our specific as well as general business, regulatory, economic, market and financial conditions and other matters, all of which are difficult to predict and many of which are beyond our control. Accordingly, there is a risk that the assumptions made in preparing the projections, or the projections and targeted milestones themselves, will prove inaccurate or may not be achieved. There may be differences between actual and projected results, and actual results may be materially different from than those contained in the projections and statements regarding future milestones. The inclusion of the projections and statements regarding future milestones in this prospectus should not be regarded as an indication that we, our management or the underwriters considered or consider the projections or such statements to be a guaranteed prediction of future events, and the projections and such statements should not be relied upon as such.

~~TABLE~~In making OFyour ~~CONTENTS~~investment decision, you should understand that we and the underwriters have not authorized any other party to provide you with information concerning us or this Offering.

~~Risks~~You should ~~Related~~carefully toevaluate anall ~~Investment~~of the information in ~~Our~~this ~~Common~~prospectus ~~Stock~~before investing in our company. We may receive media coverage regarding our company, including coverage that is not directly attributable to statements made by our officers, that incorrectly reports on statements made by our officers or employees, or that is misleading as a result of omitting information provided by us, our officers or employees. We and the underwriters have not authorized any other party to provide you with information concerning us or this Offering, and you should not rely on this information in making an investment decision.

~~Our~~You will ~~management~~experience ~~has~~immediate ~~broad~~and ~~discretion~~substantial dilution as toa ~~the~~result ~~use~~ of ~~the~~this ~~net~~Offering ~~proceeds~~and ~~from~~may ~~this~~experience ~~offering~~additional dilution in the future.

WeYou will ~~intend~~incur toimmediate ~~use~~and ~~the~~substantial ~~net~~dilution ~~proceeds~~as ~~from~~a ~~this~~result ~~offering~~of tothis ~~fund~~Offering. ~~our~~After ~~clinical~~giving ~~trial~~effect ~~and~~to ~~related~~the ~~expenses~~sale ~~and~~by ~~for~~us ~~working~~of ~~capital~~all ~~and~~of the ~~general corporate purposes~~750,000 ~~however~~Units weoffered ~~cannot~~in ~~specify~~this ~~with~~Offering ~~certainty~~at the ~~particular~~Offering ~~uses~~Price of ~~the~~$4.00 ~~net~~per ~~proceeds~~Unit, weand ~~will~~after ~~receive~~deducting ~~from~~placement agent ~~this~~fees ~~offering.~~and ~~Our~~commissions ~~management~~and ~~will~~estimated ~~have~~Offering ~~broad~~expenses ~~discretion~~payable inby ~~the~~us, ~~application~~investors ofin ~~the~~this ~~net~~Offering ~~proceeds,~~can ~~including~~expect ~~for~~an ~~any~~immediate dilution of ~~the~~$4.75 ~~purposes~~per ~~described~~share, inor ~~“Use~~119% ofat ~~Proceeds.”~~the ~~Accordingly,~~assumed ~~you~~public ~~will~~Offering ~~have~~Price, toassuming ~~rely~~no ~~upon~~exercise of the ~~judgment~~Class ofA ~~our~~Warrants. ~~management~~You may ~~with~~experience ~~respect~~further dilution to the ~~use~~extent ofthat ~~the~~shares ~~proceeds.~~of ~~Our~~Common ~~management~~Stock ~~may~~are ~~spend~~issued aupon ~~portion~~exercise ~~or all~~ of the ~~net~~Class ~~proceeds~~A ~~from~~Warrants. ~~this~~In addition, ~~offering~~ in ~~ways that~~the ~~holders~~past, ofwe ~~our~~issued ~~common~~warrants ~~stock~~to ~~may~~acquire ~~not~~shares ~~desire~~of orCommon ~~that~~Stock. ~~may~~Additionally, ~~not~~to ~~yield~~the aextent ~~significant~~that ~~return~~these warrants, or ~~any~~options ~~return~~we atwill ~~all.~~grant ~~The~~to ~~failure by~~ our ~~management~~officers, todirectors ~~apply~~and ~~these~~employees, ~~funds~~are, ~~effectively~~in ~~could~~fact, ~~harm~~exercised, ~~our~~of ~~business.~~which ~~Pending~~there ~~their~~can ~~use~~be no assurance, weyou will sustain future dilution. We may also ~~invest~~acquire ~~the~~or ~~net~~license ~~proceeds~~other ~~from~~technologies ~~this~~or ~~offering~~finance instrategic aalliances by ~~manner~~issuing ~~that~~equity, ~~does~~which ~~not~~may ~~produce~~result ~~income~~in oradditional ~~that~~dilution ~~loses~~to ~~value.~~our stockholders.

~~There~~We are isan no“emerging ~~existing~~growth ~~market~~company,” ~~for~~and ~~our~~the ~~common~~reduced ~~stock~~disclosure ~~and~~requirements weapplicable doto ~~not~~emerging ~~know~~growth ifcompanies may ~~one~~make ~~will~~our ~~develop~~Common toStock ~~provide~~less ~~you~~attractive ~~with~~to ~~adequate liquidity~~investors.

~~Prior~~We are toan ~~this~~“emerging ~~offering~~growth company,” ~~there~~or ~~has~~EGC, ~~not~~as ~~been~~defined ain ~~public~~the ~~market~~Jumpstart ~~for~~Our ~~our~~Business ~~common~~Startups ~~stock~~Act of 2012, or the JOBS Act. We ~~cannot~~will ~~assure~~remain ~~you~~an ~~that~~EGC anuntil ~~active~~the ~~trading~~earlier ~~market~~of: ~~for~~(i) ~~our~~the ~~common~~last ~~stock~~day ~~will~~of ~~develop~~the ~~following~~fiscal ~~this~~year ~~offering,~~in which we have total annual gross revenues of $1 billion or ifmore; it(ii) ~~does~~the ~~develop,~~last itday ~~may~~of ~~not~~the befiscal ~~maintained.~~year ~~You~~following ~~may~~the ~~not~~fifth beanniversary ~~able~~of tothe ~~sell~~date ~~your~~of ~~shares~~the ~~quickly~~completion orof atthis Offering; (iii) the ~~market~~date ~~price~~on ifwhich ~~trading~~we inhave ~~our~~issued ~~common~~more ~~stock~~than is$1 ~~not~~billion ~~active.~~in ~~The~~nonconvertible ~~initial~~debt ~~public~~during ~~offering~~the ~~price~~previous ~~for~~three years; or (iv) the ~~shares~~date ~~will~~on bewhich ~~determined~~we byare ~~negotiations~~deemed ~~between~~to usbe ~~and~~a large accelerated filer under the ~~representatives~~rules of the ~~underwriters~~SEC. For so long as we remain an EGC, we are permitted and ~~may~~intend ~~not~~to berely ~~indicative~~on ofexemptions ~~prices~~from certain disclosure requirements that ~~will~~are ~~prevail~~applicable into ~~the~~other ~~trading~~public companies ~~market~~that are not emerging growth companies. These exemptions include, but are not limited to

~~The~~● deferring ~~market~~compliance ~~price~~with ofcertain ~~our~~changes ~~common~~in ~~stock~~accounting ~~may be highly volatile, and you could lose all or part of your investment.~~standards:

~~The~~● not ~~trading price of our common stock is likely to be volatile. This volatility may prevent you from~~ being ~~able~~required to ~~sell~~comply ~~your~~with ~~shares at or above~~ the ~~price~~auditor ~~you~~attestation ~~paid~~requirements ~~for~~of ~~your~~Section ~~shares.~~404 ~~Our~~of ~~stock~~the ~~price~~Sarbanes-Oxley ~~could be subject to wide fluctuations in response to a variety of factors~~Act, ~~which~~or ~~include:~~Section 404;

•● being ~~whether~~permitted weto ~~achieve~~provide ~~our~~only ~~anticipated~~two ~~corporate~~years ~~objectives~~of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure; and

•● reduced ~~actual~~disclosure orobligations ~~anticipated~~regarding ~~fluctuations~~executive ~~in our quarterly or annual operating results;~~compensation.

~~• changes in financial or operational estimates or projections;~~33

•We may ~~changes~~choose to take advantage of some, but not all, of the available exemptions. We have taken advantage of reduced reporting burdens in this prospectus. In particular, we have not included all of the ~~economic~~executive ~~performance~~compensation information that would be required if we were not an EGC. We cannot predict whether investors will find our Common Stock less attractive if we rely on certain or all of these exemptions. If some investors find our Common Stock less attractive as a result, there may be a less active trading market for ~~valuations~~our ofCommon ~~companies~~Stock ~~similar~~and toour ~~ours;~~stock price may be more volatile. Overall, we estimate that our incremental costs resulting from operating as a public company may be between $300,000 and $400,000 per year.

•We will ~~general~~incur ~~economic~~increased orcosts ~~political~~as ~~conditions~~a inresult ~~the~~of ~~United~~operating ~~States~~as ora ~~elsewhere~~public company, and our management will be required to devote substantial time to new compliance initiatives.

As a public company, and particularly after we are no longer an EGC, we will incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the ~~stock~~Sarbanes-Oxley ~~market~~Act inand ~~general,~~rules ~~and~~subsequently implemented by the ~~stock~~SEC have ofimposed ~~biotechnology~~various ~~companies~~requirements inon ~~particular~~public companies, ~~have~~including ~~experienced~~establishment ~~extreme~~and ~~price~~maintenance of effective disclosure and ~~volume~~financial controls ~~fluctuations~~and ~~that~~corporate ~~have~~governance ~~often~~practices. ~~been~~Our ~~unrelated~~management orand ~~disproportionate~~other personnel will need to ~~the~~devote ~~operating~~a ~~performance~~substantial amount of time to these ~~companies~~compliance initiatives. ~~Broad~~Moreover, ~~market~~these rules and ~~industry~~regulations ~~factors~~will ~~may~~increase ~~negatively~~our ~~affect~~legal ~~the~~and ~~market~~financial ~~price~~compliance ofcosts and ~~our~~will ~~common~~make ~~stock~~some activities more time-consuming and costlier. For example, ~~regardless~~we ofexpect ~~our~~that ~~actual~~these ~~operating~~rules ~~performance.~~and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.

~~The~~Pursuant to ~~NASDAQ~~Section ~~Capital~~404, ~~Market~~we ~~may~~will ~~not~~be ~~list~~required to furnish a report by our ~~securities~~management on our internal control over financial reporting, ~~which~~including an ~~could~~attestation ~~limit~~report ~~investors’~~on ~~ability~~internal control over financial reporting issued by our independent registered public accounting firm. However, while we remain an EGC, we will not be required to ~~make~~include ~~transactions~~an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our ~~securities~~internal control over financial reporting, which is both costly and challenging. ~~subject~~In usthis regard, we will need to ~~additional~~continue ~~trading~~to ~~restrictions~~dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as required by Section 404. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

WeAn investment ~~anticipate~~in ~~that~~ our ~~securities~~company ~~will~~may beinvolve ~~listed~~tax ~~on The NASDAQ Capital Market (or NASDAQ) upon consummation of this offering. Although~~implications, ~~after~~and ~~giving~~you ~~effect~~are toencouraged ~~this offering, we expect~~ to ~~meet,~~consult onyour aown ~~pro~~advisors ~~forma~~as ~~basis,~~neither ~~NASDAQ’s minimum initial listing standards, which generally mandate that~~ we ~~meet~~nor any ~~certain~~related ~~requirements~~party ~~relating~~is toOffering ~~stockholders’~~any ~~equity,~~tax ~~market~~assurances ~~capitalization,~~or ~~aggregate~~guidance ~~market~~regarding ~~value~~our ofcompany ~~publicly~~or ~~held~~your ~~shares and distribution requirements, we cannot assure you that we will be able to meet those initial listing requirements~~investment. ~~If NASDAQ does not list our securities for trading on its exchange, we could face significant material adverse consequences, including:~~

•The formation aof ~~limited~~our ~~availability~~company ofand ~~market~~our ~~quotations~~financings, ~~for~~as well as an investment in our ~~securities;~~company generally, involves complex federal, state and local income tax considerations. Neither the Internal Revenue Service nor any State or local taxing authority has reviewed the transactions described herein and may take different positions than the ones contemplated by management. You are strongly urged to consult your own tax and other advisors prior to investing, as neither we nor any of our officers, directors or related parties is Offering you tax or similar advice, nor are any such persons making any representations and warrants regarding such matters.

~~• reduced liquidity with respect to our securities;~~34

30Our ability to use our net operating loss carry-forwards and certain other tax attributes may be limited.

~~TABLE~~Under Section OF382 ~~CONTENTS~~of the Internal Revenue Code of 1986, as amended, referred to as the Internal Revenue Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change net operating loss carry-forwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income may be limited. We believe that, with this Offering, taken together with our private placements within a three-year period and other transactions that have occurred over the past three years, we may have triggered an “ownership change” limitation. We may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership, including as a result of the completion of this Offering when it is taken together with other transactions we may consummate in the succeeding three-year period. As a result, if we earn net taxable income, our ability to use our pre-change net operating loss carry-forwards to offset U.S. federal taxable income may be subject to limitations, which potentially could result in increased future tax liability to us.

•Because we ahave ~~determination~~elected ~~that~~to ~~our~~use ~~shares~~the ofextended ~~common~~transition ~~stock~~period ~~are~~for ~~“penny~~complying ~~stock”~~with ~~which~~new ~~will~~or ~~require~~revised ~~brokers~~accounting ~~trading~~standards infor ~~our~~an ~~shares~~“emerging growth ofcompany” ~~common~~our ~~stock~~financial tostatements ~~adhere~~may tonot ~~more~~be ~~stringent~~comparable ~~rules,~~to ~~possibly~~companies ~~resulting~~that incomply awith ~~reduced~~public ~~level~~company ofeffective ~~trading activity in the secondary trading market for our shares of common stock;~~dates.

•We have aelected ~~limited~~to ~~amount~~use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of ~~news~~the ~~and~~JOBS ~~analyst~~Act. ~~coverage~~This election allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, our financial statements may not be comparable to companies that comply with public company; effective dates, and thus investors may have difficulty evaluating or comparing our business, performance or prospects in comparison to other public companies, which may have a negative impact on the value and liquidity of our Common Stock.

•The Class A Warrants (issued as part of the Units) are a ~~decreased~~risky ~~ability~~investment. toYou ~~issue~~may ~~additional~~be ~~securities~~unable orto ~~obtain~~exercise ~~additional~~your ~~financing~~Class inA ~~the~~Warrants for ~~future~~a profit.

The amount ~~National~~paid ~~Securities~~for ~~Markets~~the ~~Improvement~~Units ~~Act~~in ofthis ~~1996,~~Offering ~~which~~in isexcess aof ~~federal~~the ~~statute,~~value ~~prevents~~of orour ~~preempts~~shares ~~the~~of ~~states~~Common ~~from~~Stock ~~regulating~~represents the ~~sale~~value of ~~certain~~your ~~securities,~~investment in ~~which~~the ~~are~~Class ~~referred~~A toWarrants. asThe ~~“covered~~value ~~securities.”~~of ~~Assuming~~the ~~our~~Class ~~common~~A ~~stock~~Warrants will bedepend ~~listed~~ on ~~NASDAQ, our common stock will be covered securities. Although~~ the ~~states~~value ~~are preempted from regulating the sale~~ of our ~~securities~~Common Stock, ~~the~~which ~~federal~~will ~~statute~~depend ~~does~~on factors ~~allow~~related ~~the~~and ~~states~~unrelated to ~~investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then~~ the ~~states~~success ~~can regulate or bar the sale~~ of ~~covered securities in a particular case. Furthermore, if we were no longer listed on NASDAQ,~~ our ~~common~~clinical ~~stock~~development ~~would~~program ~~not~~and cannot be ~~covered~~predicted ~~securities~~at ~~and~~this wetime. ~~would~~The beClass A ~~subject~~Warrants towill ~~regulation~~have inan ~~each~~exercise ~~state~~period inof ~~which~~five ~~we offer our securities~~years.

~~Our~~If the ~~failure~~price of our shares of Common Stock does not increase to ~~meet~~an amount sufficiently above the ~~continued~~exercise ~~listing~~price ~~requirements~~of the Class A Warrants during the exercise period of ~~The~~the ~~NASDAQ~~Class ~~Capital~~A ~~Market~~Warrants, ~~could~~you ~~result~~may be unable to recover any of your investment in athe ~~de-listing~~Class A Warrants. There can be no assurance that any of the factors that could impact the trading price of our ~~common~~Units ~~stock~~or Common Stock will result in the trading price increasing to an amount that will exceed the exercise price or the price required for you to achieve a positive return on your investment in the Class A Warrants.

IfThe shares ~~after~~of ~~listing~~Common weStock ~~fail~~that toare ~~satisfy~~issuable ~~the~~upon ~~continued~~exercise ~~listing requirements~~ of ~~NASDAQ, such as~~ the ~~corporate~~Class ~~governance~~A ~~requirements~~Warrants ~~or the minimum closing bid price requirement, NASDAQ~~ may take steps to de-list our common stock. Such a de-listing would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a de-listing, we would take actions to restore our compliance with NASDAQ’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the NASDAQ minimum bid price requirement or prevent future non-compliance with NASDAQ’s listing requirementsunregistered.

IfWe are ~~our~~registering, as part of the registration statement of which this prospectus forms a part, the issuance by us of the shares of ~~become~~Common ~~subject~~Stock toissuable upon exercise of the ~~penny~~Class ~~stock~~A ~~rules~~Warrants. However, itthere ~~would~~is ~~become~~no ~~more~~guarantee ~~difficult~~that the registration statement will remain effective at the time on which you exercise your Class A Warrants. If you exercise your Class A Warrants at a time where there is not an effective registration statement, the shares of Common Stock that you receive upon exercise of your Class A Warrants will be restricted and contain a restrictive legend. In this case, you will only be able to ~~trade~~sell ~~our~~these shares of Common Stock issued if a resale registration statement is filed or if there is an exemption from the registration requirements of the Securities Act.

The Securities and Exchange Commission (or SEC) has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price Holders of less than $5.00, other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided by the ~~exchange~~Class orA ~~system.~~Warrants ~~If we do not obtain or retain a listing on NASDAQ and if the price of our common stock is less than $5.00, our common stock~~ will be deemed a penny stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements may have ~~the~~no ~~effect~~rights ofas ~~reducing~~Common ~~the~~Stockholders ~~trading~~until ~~activity~~they inacquire ~~the secondary market for~~ our ~~common~~Common ~~stock, and therefore stockholders may have difficulty selling their shares~~Stock.

~~There~~Until you ~~can~~acquire beshares noof ~~assurance~~our ~~that~~Common weStock upon exercise of the Class A Warrants, you will ~~ever~~have ~~provide~~no ~~liquidity~~rights with respect to our ~~investors~~Common Stock ~~through~~issuable aupon ~~sale~~exercise of ~~our~~the ~~company~~Class A Warrants, including the right to receive dividend payments, vote or respond to tender offers. Upon exercise of your Class A Warrants, you will be entitled to exercise the rights of a Common Stockholder only as to matters for which the record date occurs after the exercise date.

While acquisitions of pharmaceutical companies like ours are not uncommon, potential investors are cautioned that no assurances can be given that any form of merger, combination, or sale of our company will take place following this offering, or that any merger, combination, or sale, even if consummated, would provide liquidity or a profit for our investors following this offering. You should not invest in our company with the expectation that we will be able to sell the business in order to provide liquidity or a profit for our investors. 35

31The Class A Warrants included in this Offering may not have any value.

~~TABLE~~The Class OFA ~~CONTENTS~~Warrants will expire on the five-year anniversary of the closing of the Offering. In the event our Common Stock price does not exceed the exercise price of the Class A Warrants during the period in which the Class A Warrants are exercisable, the Class A Warrants may not have any value.

~~The~~Anti-takeover provisions ~~financial~~in our charter documents and ~~operational~~Delaware ~~projections~~law ~~that~~could wediscourage, ~~may~~delay ~~make~~or ~~from~~prevent ~~time~~a tochange ~~time~~in ~~are~~control ~~subject~~of toour ~~inherent~~company ~~risks~~and may affect the trading price of our Common Stock.

The anti-takeover ~~projections~~provisions ~~that~~of wethe ~~provide~~Delaware ~~herein~~General orCorporation ~~our~~Law ~~management~~ may ~~provide~~discourage, ~~from~~delay ~~time~~or toprevent ~~time~~a ~~(including,~~change ~~but~~in ~~not~~control ~~limited~~by ~~to,~~prohibiting us ~~those~~from ~~relating~~engaging toin ~~potential~~a ~~peak~~business ~~sales~~combination ~~amounts,~~with ~~clinical~~an ~~and~~interested ~~regulatory~~stockholder ~~timelines,~~for ~~production~~a ~~and~~period ~~supply~~of ~~matters,~~three ~~commercial~~years ~~launch~~after ~~dates,~~the ~~and~~person ~~other~~becomes an ~~financial~~interested orstockholder, ~~operational~~even ~~matters)~~if ~~reflect~~a ~~numerous~~change ~~assumptions~~in ~~made~~control bywould ~~management,~~be ~~including~~beneficial ~~assumptions with respect~~ to our ~~specific~~existing asstockholders. ~~well~~In ~~as general business~~addition, ~~regulatory,~~our ~~economic,~~second amended ~~market~~ and ~~financial~~restated ~~conditions~~certificate ~~and other matters, all~~ of incorporation (which ~~are~~we ~~difficult~~refer to ~~predict~~as ~~and~~the ~~many~~certificate of ~~which~~incorporation) ~~are~~and ~~beyond~~amended ~~our~~and ~~control. Accordingly, there is a risk that the assumptions~~restated ~~made~~bylaws in(which ~~preparing~~we ~~the~~refer ~~projections,~~to oras the ~~projections~~bylaws) ~~themselves, will prove inaccurate. There~~ may ~~be differences between actual and projected results~~discourage, ~~and~~delay ~~actual~~or ~~results~~prevent ~~may~~a bechange ~~materially different from than those contained~~ in ~~the projections. The inclusion of the projections in this prospectus should not be regarded as an indication that we,~~ our management or ~~the~~control ~~underwriters~~over ~~considered~~us orthat stockholders may consider ~~the~~favorable. ~~projections~~Our tocertificate ~~be a guaranteed prediction~~ of ~~future~~incorporation ~~events,~~ and ~~the~~bylaws ~~projections should not be relied upon as such.~~ will:

In● provide ~~making~~that ~~your~~vacancies ~~investment~~on ~~decision,~~our ~~you~~Board ~~should~~of ~~understand~~Directors, ~~that~~including wenewly ~~and~~created ~~the~~directorships, ~~underwriters~~may ~~have~~be ~~not~~filled ~~authorized~~only ~~any~~by ~~other~~a majority ~~party~~vote toof ~~provide~~directors ~~you~~then ~~with~~in ~~information concerning us or this offering.~~office;

~~You~~● provide ~~should~~that ~~carefully~~special ~~evaluate~~meetings ~~all~~ of ~~the~~stockholders ~~information in this prospectus before investing in our company. We~~ may ~~receive~~only ~~media~~be ~~coverage~~called ~~regarding~~by our ~~company,~~Chairman ~~including~~and/or ~~coverage that is not directly attributable to statements made by our officers~~President, ~~that incorrectly reports on statements made by~~ our ~~officers~~Board orof ~~employees,~~ Directors or ~~that~~a issuper-majority ~~misleading~~(66 as2/3%) ~~a result~~ of ~~omitting information provided by us,~~ our officers or employees. We and the underwriters have not authorized any other party to provide you with information concerning us or this offering, and you should not rely on this information in making an investment decision. stockholders;

~~Future~~● place ~~sales~~restrictive byrequirements ~~our~~(including ~~stockholders~~advance ~~may~~notification ~~adversely~~of ~~affect~~stockholder ~~our~~nominations ~~stock~~and ~~price~~proposals) ~~and~~on ~~our~~how ~~ability~~special tomeetings of ~~raise~~stockholders ~~funds~~may inbe ~~new~~called ~~stock~~by ~~offerings.~~our stockholders;

Sales of our common stock in the public market following this offering could lower the market price of our common stock. Sales may also make it more difficult for us to sell equity securities or equity-related securities in the future at a time and price that our management deems acceptable or at all. Substantially all of our currently outstanding shares of common stock are, or will be, restricted immediately after the consummation of this offering, but approximately 1,716,026 shares of common stock issuable upon conversion of outstanding convertible notes (including interest thereon) will be registered for resale by the● holders of such notes pursuant to the resale prospectus included in this registration statement and 1,396,500 shares currently outstanding (including 490,000 shares underlying outstanding shares of preferred stock), representing shares not ~~held~~provide bystockholders ~~our~~with ~~“affiliates,” generally may be resold under SEC Rule 144 beginning 90 days from~~ the ~~effectiveness~~ability ofto ~~the~~cumulate ~~registration~~their ~~statement~~votes; ~~of which this prospectus forms a part (notwithstanding any lock-up agreements executed by stockholders).~~ and

~~Furthermore,~~● provide ~~warrants~~that ~~exercisable~~only ~~for~~a upsuper-majority ~~to 934,680 shares~~ of our ~~common~~stockholders ~~stock~~(66 ~~at exercise prices ranging from $~~2~~.94~~/3%) tomay ~~$4.75~~amend ~~per share and warrants exercisable for up to 80,000 shares of preferred stock which are convertible into 392,000 shares of~~ our ~~common stock at an exercise price of $2~~bylaws.94 were outstanding. The exercise of any of these warrants would result in additional dilution, and the sale of the shares issuable upon exercise of outstanding warrants could also lower the market price of our common stock.

~~You~~We do ~~will~~not ~~experience~~expect ~~immediate~~to ~~and~~pay ~~substantial~~dividends ~~dilution~~for ~~as a result of this offering and may experience additional dilution in~~ the foreseeable future.

~~You~~We do ~~will~~not ~~incur~~expect ~~immediate and substantial dilution as a result of this offering. After giving effect~~ to ~~the~~pay ~~sale~~dividends byon usour ofCommon ~~1,888,889~~Stock ~~shares of common stock~~ offered in this ~~offering~~transaction atfor ~~an assumed public offering price of $9.00 per share (~~the ~~mid-point~~foreseeable of the range indicated on the front cover of this prospectus), and after deducting underwriter discounts and commissions and estimated offering expenses payable by us, investors in this offering can expect an immediate dilution of $7future.53 ~~per share~~Accordingly, orany ~~83.7%~~potential investor atwho ~~the~~anticipates ~~assumed public offering price. In addition, in~~ the ~~past,~~need wefor ~~issued~~current ~~warrants~~dividends toshould ~~acquire~~not ~~shares~~purchase ~~of common stock. Additionally, to the extent that these warrants, or options we will grant to~~ our ~~officers, directors and employees, are ultimately exercised, you will sustain future dilution~~securities. ~~We may also acquire or license other technologies or finance strategic alliances by issuing equity, which may result in additional dilution to our stockholders.~~

32CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

~~TABLE~~This prospectus OFcontains ~~CONTENTS~~a number of “forward-looking statements”. Specifically, all statements other than statements of historical facts included in this prospectus regarding our financial position, business strategy and plans and objectives of management for future operations are forward-looking statements. These forward-looking statements are based on the beliefs of management at the time these statements were made, as well as assumptions made by and information currently available to management. When used in this prospectus and the documents incorporated by reference herein, the words “anticipate,” “believe,” “estimate,” “expect,” “may,” “will,” “continue” and “intend,” and words or phrases of similar import, as they relate to our financial position, business strategy and plans, or objectives of management, are intended to identify forward-looking statements. These statements reflect our current view with respect to future events and are subject to risks, uncertainties and assumptions related to various factors.

WeYou should ~~are~~understand anthat ~~“emerging~~the ~~growth~~following ~~company~~important factors,” ~~and~~in ~~the~~addition ~~reduced~~to ~~disclosure~~those ~~requirements~~discussed ~~applicable~~in our periodic reports to ~~emerging~~be ~~growth~~filed ~~companies~~with the ~~may~~SEC ~~make~~under the Securities Exchange Act of 1934, as amended, or the Exchange Act, could affect our ~~common~~future ~~stock~~results ~~less~~and ~~attractive~~could cause those results to ~~investors.~~differ materially from those expressed in such forward-looking statements:

WeA variety ~~are an “emerging growth company,” or EGC, as defined in the Jumpstart Our Business Startups Act~~ of ~~2012~~factors, orsome ~~the JOBS Act. We will remain an EGC until the earlier~~ of: ~~(i) the last day of the fiscal year in~~ which we have total annual gross revenues of $1 billion or more; (ii) the last day of the fiscal year following the fifth anniversary of the date of the completion of this offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are ~~deemed~~outside toour ~~be a large accelerated filer under the rules of the SEC. For so long as we remain an EGC~~control, wemay ~~are~~cause ~~permitted~~our ~~and~~operating ~~intend~~results to ~~rely~~fluctuate ~~on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies~~significantly. ~~These~~They ~~exemptions~~ include:

•● our ~~not~~lack ~~being required to comply with the auditor attestation requirements~~ of ~~Section~~operating ~~404 of the Sarbanes-Oxley Act, or Section 404~~history;

•● our ~~not~~current ~~being~~lack ~~required~~of ~~to comply with any requirement that may be adopted by~~ the ~~Public~~capital ~~Company~~resources ~~Accounting~~needed ~~Oversight Board regarding mandatory audit firm rotation or a supplement~~ to ~~the~~progress ~~auditor’s~~our ~~report~~business ~~providing additional information about the audit and the financial statements~~plan;

•● our ~~being~~current ~~permitted~~and tofuture ~~provide~~capital ~~only~~requirements ~~two~~and ~~years~~our ofability ~~audited financial statements, in addition~~ to ~~any~~satisfy ~~required~~our ~~unaudited~~capital ~~interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure~~needs;

•●our reliance ~~reduced~~on ~~disclosure~~Picoplatin ~~obligations~~as ~~regarding~~our ~~executive~~only ~~compensation;~~product ~~and~~candidate;

•● our ~~exemptions~~ability ~~from~~to ~~the~~complete ~~requirements~~required ofclinical ~~holding~~trials aof ~~nonbinding~~our ~~advisory~~product ~~vote~~candidate ~~on executive compensation~~ and ~~stockholder~~obtain approval offrom ~~any~~the ~~golden~~FDA ~~parachute~~or ~~payments~~other ~~not~~regulatory agencies ~~previously~~in ~~approved.~~different jurisdictions;

We may choose to take advantage of some, but not all, of the available exemptions. We have taken advantage of reduced reporting burdens in this prospectus. In particular, we have not included all of the executive compensation information that would be required if we were not an EGC. We cannot predict whether investors will find our common stock less attractive if we rely on certain or all of these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. Overall, we estimate that our incremental costs resulting from operating as a public company may be between $300,000 and $400,000 per year. 36

We● our ~~will~~ability ~~incur~~to ~~increased~~secure ~~costs~~and asmaintain akey ~~result~~development ofand ~~operating~~commercialization aspartners afor ~~public company, and~~ our ~~management~~product ~~will be required to devote substantial time to new compliance initiatives.~~candidate;

As● our aability ~~public~~to ~~company~~obtain, ~~and~~maintain ~~particularly~~or ~~after~~protect ~~we are no longer an EGC, we will incur significant legal, accounting and other expenses that we did not incur as a private company. In addition,~~ the ~~Sarbanes-Oxley~~validity ~~Act and rules subsequently implemented by the SEC and NASDAQ have imposed various requirements on public companies, including establishment and maintenance~~ of ~~effective~~our ~~disclosure~~patents and ~~financial controls and corporate governance practices. Our management and~~ other ~~personnel~~intellectual will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance. property;

~~Pursuant to Section 404, we will be required to furnish a report by~~ ● our ~~management~~ability on our internal control over financial reporting, including an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. However, while we remain an EGC, we will not be required to ~~include~~internally andevelop ~~attestation~~new ~~report~~inventions on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we will be engaged in a process to document and ~~evaluate~~intellectual our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and property;

33● our ability to retain key executive members; and

~~TABLE~~● interpretations OFof ~~CONTENTS~~current laws and the passages of future laws, rules and regulations applicable to our business.

~~improvement~~Although we ~~process~~believe ~~for~~that ~~internal~~our ~~control~~expectations ~~over~~(including ~~financial~~those ~~reporting.~~on ~~Despite~~which our ~~efforts,~~forward-looking ~~there~~statements isare abased) ~~risk~~are ~~that~~reasonable, ~~neither~~ we ~~nor~~cannot assure ~~our~~you ~~independent~~that ~~registered~~those ~~public~~expectations ~~accounting firm~~ will beprove ~~able~~ to ~~conclude~~be ~~within~~correct. ~~the~~Should ~~prescribed~~any ~~timeframe~~one ~~that~~or ~~our~~more ~~internal~~of ~~control~~these ~~over~~risks ~~financial~~or ~~reporting~~uncertainties ismaterialize, or ~~effective~~should asany ~~required~~underlying byassumptions ~~Section~~prove ~~404.~~incorrect, ~~This~~actual ~~could~~results ~~result~~may invary anmaterially ~~adverse~~from ~~reaction~~those described in ~~the~~our ~~financial~~forward-looking statements ~~markets~~as ~~due~~anticipated, tobelieved, aestimated, ~~loss~~expected ofor ~~confidence in the reliability of our financial statements~~intended.

AnExcept for ~~investment~~our inongoing ~~our~~obligations ~~company~~to ~~may~~disclose ~~involve~~material ~~tax~~information ~~implications~~under the federal securities laws, ~~and~~we ~~you~~undertake ~~are~~no ~~encouraged~~obligation to publicly ~~consult~~update ~~your~~or ~~own~~revise ~~advisors~~any forward-looking statements, whether as ~~neither~~a weresult ~~nor~~of ~~any~~new ~~related~~information, ~~party~~future isevents ~~offering~~or any ~~tax~~other ~~assurances~~reason. All subsequent forward-looking statements attributable to us or ~~guidance~~any ~~regarding~~person acting on our ~~company~~behalf are expressly qualified in their entirety by the cautionary statements contained or ~~your~~referred ~~investment~~to herein. In light of these risks, uncertainties and assumptions, the forward-looking events discussed in this prospectus and the documents incorporated by reference herein might not occur.

The formation of our company and our financings, as well as an investment in our company generally, involves complex federal, state and local income tax considerations. Neither the Internal Revenue Service nor any State or local taxing authority has reviewed the transactions described herein, and may take different positions than the ones contemplated by management. You are strongly urged to consult your own tax and other advisors prior to investing, as neither we nor any of our officers, directors or related parties is offering you tax or similar advice, nor are any such persons making any representations and warrantsUSE ~~regarding~~OF ~~such matters.~~ PROCEEDS

~~Our~~Assuming the ~~ability~~sale toof ~~use~~750,000 Units in this Offering at an Offering Price of $4.00 per Unit, the total proceeds from the sale of the Units we are Offering will be $3,000,000. After fees for our ~~net~~placement ~~operating~~agent ~~loss~~commission ~~carry-forwards~~and estimated Offering expenses payable by us, including professional fees and ~~certain~~related ~~other~~expenses, ~~tax~~the ~~attributes~~net ~~may~~proceeds of the Units we sell will be ~~limited~~approximately $2,570,000. We cannot predict when the Class A Warrants will be exercised, if at all. If all of the Class A Warrants sold in this Offering are exercised for cash, then we will receive an additional $3,000,000 of gross proceeds. It is possible that all or a portion of the Class A Warrants may expire prior to being exercised, in which case we will not receive any additional proceeds from such unexercised and expired Class A Warrants. If we receive proceeds from the exercise of Class A Warrants, we expect to use such proceeds for clinical development, research and general corporate purposes.

~~Under~~We intend ~~Section 382 of the Internal Revenue Code of 1986, as amended, referred~~ to asuse the ~~Internal~~proceeds ~~Revenue~~from ~~Code,~~this ifOffering ~~a corporation undergoes an “ownership change”~~ (~~generally~~after ~~defined~~deducting asplacement aagent ~~greater~~commissions ~~than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change net operating loss carry-forwards~~ and ~~other~~estimated ~~pre-change~~Offering ~~tax~~expenses ~~attributes~~payable by ~~(such as research tax credits~~us) to offset its post-change income may be limited. We believe that, with this offering, taken together with our private placements within a three-year period and other transactions that have occurred over the past three years, we may have triggered an “ownership change” limitation. We may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership, including as a result of the completion of this offering when it is taken together with other transactions we may consummate in the succeeding three-year period. As a result, if we earn net taxable income, our ability to use our pre-change net operating loss carry-forwards to offset U.S. federal taxable income may be subject to limitations, which potentially could result in increased future tax liability to us. fund:

~~Because~~● our weexpenses ~~have~~in ~~elected~~connection towith ~~use~~our ~~the~~Phase ~~extended~~II ~~transition~~clinical ~~period~~trial ~~for~~to ~~complying~~obtain ~~with~~genomic ~~new~~expression ordata ~~revised accounting standards~~ for anPicoplatin ~~“emerging~~in ~~growth~~patients ~~company” our financial statements may not be comparable to companies that comply~~ with head ~~public~~and ~~company~~neck ~~effective dates.~~cancer;

~~We have elected to use~~ ● the ~~extended~~manufacturing ~~transition~~expenses ~~period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This election allows us~~ to ~~delay~~procure ~~the~~additional ~~adoption~~drug ofproduct ~~new~~Phase orIII ~~revised~~clinical ~~accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election~~trials, ~~our~~assuming ~~financial~~initial ~~statements~~trials ~~may~~meet ~~not~~their ~~be comparable to companies that comply with public company effective dates~~endpoints, (drug ~~and~~substance ~~thus~~is ~~investors~~already ~~may~~produced ~~have difficulty evaluating or comparing our business, performance or prospects~~ in ~~comparison~~sufficient ~~to other public companies, which may have a negative impact on the value and liquidity of our common stock.~~ quantities):

If● the ~~securities~~payment orof ~~industry~~approximately ~~analysts~~$395,000 doto ~~not~~the ~~publish~~holder orof ~~cease~~the ~~publishing~~promissory ~~research~~note orin ~~reports~~the ~~about~~principal usamount of $345,000 ~~our~~that ~~business~~bears orinterest at ~~our~~a ~~market,~~rate orof if2% ~~they~~per ~~change~~annum ~~their~~and ~~recommendations~~that ~~regarding~~was ~~our~~payable ~~common~~on ~~stock~~April ~~adversely~~30, 2017 at a 15% premium to the ~~price~~principal amount (the proceeds of ~~our~~such note ~~common~~having ~~stock~~been used by us for general working capital purposes) plus default penalties and ~~trading~~interest ~~volume~~of ~~could~~$86,318 ~~decline.~~for an aggregate amount of $481,318(1);

~~The~~● the ~~trading~~payment ~~market~~of ~~for~~approximately ~~our~~$395,000 ~~common~~to ~~stock~~the ~~may~~holder beof ~~influenced by~~ the ~~research~~promissory ~~and~~note ~~reports~~in ~~that~~the ~~securities~~principal oramount ~~industry~~of ~~analysts may publish about us~~$345,000 ~~our~~that ~~business,~~bears ~~our~~interest at ~~market~~a orrate ~~our competitors. If any~~ of ~~the~~2% ~~analysts~~per ~~who~~annum ~~may~~and ~~cover~~that uswas ~~change~~payable ~~their~~on ~~recommendation~~April ~~regarding our common stock adversely~~30, or2017 ~~provide~~at ~~more~~a ~~favorable~~15% ~~relative~~premium ~~recommendations~~to ~~about~~the ~~our~~principal ~~competitors,~~amount (the ~~price~~proceeds of ~~our~~such note ~~common~~having ~~stock~~been ~~would~~used ~~likely~~by ~~decline.~~us Iffor ~~any~~general ~~analyst~~working ~~who~~capital ~~may~~purposes) ~~cover~~plus usdefault ~~was~~penalties toand ~~cease~~interest ~~coverage~~ of ~~our company or fail to regularly publish reports on us~~$86,318 wefor ~~could~~an ~~lose~~aggregate amount ~~visibility in the financial markets, which in turn could cause the price~~ of ~~our common stock or trading volume to decline.~~ $481,318(1);

34● the payment of $30,000 to the Fellowship for Interpretation of Genomes, the President of which is the wife of our Chief Executive Officer, in satisfaction of unsecured promissory note in the principal amounts of $35,000 that do not bear any interest and mature on July 15, 2017 (the proceeds of such note having been used by us for general working capital purposes);

~~TABLE~~● the OFpayment ~~CONTENTS~~of approximately $54,375 to the holder of an unsecured promissory note in the principal amount of $30,000 that bore fixed interest of $6,000, matured on December 31, 2016 and has accrued additional interest on the full amount of the note at a rate of 15% per annum following maturity (the proceeds of such note having been used by us for general working capital purposes); and

~~Anti-takeover provisions in~~ ● our ~~charter~~working ~~documents~~capital and ~~Delaware~~general ~~law~~corporate ~~could discourage, delay or prevent a change in control of our company and may affect the trading price of our common stock~~requirements.

~~Upon~~(1) This ~~the~~note ~~completion~~is ofin ~~our~~the ~~anticipated~~process ~~corporate~~of ~~conversion,~~being wesold ~~will~~and betransferred to a ~~Delaware~~third ~~corporation.~~party ~~The~~and ~~anti-takeover~~management ~~provisions~~believes ofthat the ~~Delaware~~maturity date ~~General~~will ~~Corporation~~be ~~Law~~extended ~~may discourage, delay or prevent a change~~ in ~~control~~connection ~~by prohibiting us from engaging in a business combination~~ with anthis ~~interested~~transaction, ~~stockholder~~although ~~for~~there acan ~~period~~be ofno ~~three~~assurance ~~years~~that ~~after~~ the ~~person~~note ~~becomes~~sale antransaction ~~interested stockholder~~will, ~~even if a change~~ in ~~control would be beneficial to our existing stockholders. In addition~~fact, ~~our certificate of incorporation and bylaws may discourage~~close, ~~delay~~ and/or ~~prevent a change in our management or control over us~~ that ~~stockholders~~the ~~may~~maturity ~~consider favorable.~~date ~~Our~~will ~~certificate~~be ~~of incorporation and bylaws will:~~extended.

~~• provide that vacancies on our board of directors, including newly created directorships, may be filled only by a majority vote of directors then in office;~~37

•While we ~~not~~expect ~~provide~~to ~~stockholders~~use ~~with~~the net proceeds for the ~~ability~~purposes todescribed ~~take~~above, ~~action~~the byamounts ~~written~~and ~~consent;~~timing of our actual expenditures will depend upon numerous factors, including the ongoing status and results of our clinical trials. We anticipate an approximate allocation of the use of net proceeds as follows:

• provide that special meetings of stockholders may only be called by our Chairman and/or President, our board of directors or a super-majority (66 2/3%) of our stockholders;

Use of Proceeds ⁽¹⁾	$		% (1) (2)
Fund the expenses in connection with our Phase II clinical trial to develop genomic expression data for Picoplatin in head and neck cancer patients	$	1,290,000		43.0
Fund the expenses of contract manufacturing the Picoplatin drug product to be used for our contemplated Phase II and Phase III trials	$	250,000		8.3
Repay existing indebtedness, including interest thereon	$	565,693		18.9
Fund working capital and general corporate purposes	$	464,307		15.5
Subtotal	$	3,000,000		85.7
Offering Expenses	$	430,000		14.3
Total	$	2,570,000		100.0

•(1) The ~~place~~percentages ~~restrictive~~are ~~requirements~~based ~~(including~~upon ~~advance~~the ~~notification~~gross proceeds of ~~stockholder~~$3,000,000, ~~nominations~~prior ~~and~~to ~~proposals)~~the ondeduction ~~how~~of ~~special~~Offering ~~meetings~~Expenses of ~~stockholders may be called by our stockholders;~~$430,000.

•(2) The ~~not~~percentages ~~provide~~are ~~stockholders~~approximate ~~with~~and ~~the~~are ~~ability~~rounded up or down to ~~cumulate~~the ~~their~~next ~~votes;~~1/10th ~~and~~of a percent.

•The expected ~~provide~~net proceeds from the sale of the Units offered hereby of approximately $2,004,307 after taking into account the Offering Expenses and the repayment of certain existing indebtedness, if added to our current cash, is anticipated to be sufficient to fund our operations through December 31, 2019, and we expect that ~~only~~the proceeds will be sufficient to complete our Phase II trial for head and neck cancer patients. In the event that our plans change, our assumptions change or prove to be inaccurate, or the net proceeds of this Offering are less than as set forth herein or otherwise prove to be insufficient, it may be necessary or advisable to reallocate proceeds or curtail expansion activities, or we may be required to seek additional financing or curtail our operations. As a ~~super-majority~~result of the foregoing, our ~~stockholders~~success ~~(66~~will ~~2/3%)~~be ~~may~~affected ~~amend~~by our ~~bylaws~~discretion and judgment with respect to the application and allocation of the net proceeds of this Offering.

WePending their douse, ~~not~~we ~~expect~~plan to ~~pay~~invest ~~dividends~~the ~~for~~net proceeds from this Offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the ~~foreseeable~~U.S. ~~future~~government.

We do not expect to pay dividends on our common stock offered in this transaction for the foreseeable future. Accordingly, any potential investor who anticipates the need for current dividends should not purchase our securities. DIVIDEND POLICY

35We have never declared or paid any cash dividend on our capital stock. We do not anticipate paying any cash dividends in the foreseeable future and we intend to retain all of our earnings, if any, to finance our growth and operations and to fund the expansion of our business. Payment of any dividends will be made in the discretion of our Board of Directors, after its taking into account various factors, including our financial condition, operating results, current and anticipated cash needs and plans for expansion. Any dividends that may be declared or paid on our Common Stock, must also be paid in the same consideration or manner, as the case may be, on our shares of preferred stock, if any.

~~TABLE OF CONTENTS~~38

~~CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS~~CAPITALIZATION

~~This~~The following ~~prospectus~~table ~~contains~~sets aforth ~~number of “forward-looking statements”. Specifically, all statements other than statements of historical facts included in this prospectus regarding~~ our ~~financial~~cash ~~position, business strategy~~ and ~~plans~~capitalization ~~and objectives of management for future operations are forward-looking statements. These forward-looking statements are based on the beliefs of management at the time these statements were made,~~ as well as assumptions made by and information currently available to management. When used in this prospectus and the documents incorporated by reference herein, the words “anticipate,” “believe,” “estimate,” “expect,” “may,” “will,” “continue” and “intend,” and words or phrases of ~~similar~~June ~~import~~30, as they relate to our financial position, business strategy and plans, or objectives of management, are intended to identify forward-looking statements. These statements reflect our current view with respect to future events and are subject to risks, uncertainties and assumptions related to various factors. 2018:

~~You~~● on ~~should~~an ~~understand~~actual that the following important factors, in addition to those discussed in our periodic reports to be filed with the SEC under the Securities Exchange Act of 1934, as amended, or the Exchange Act, could affect our future results and could cause those results to differ materially from those expressed in such forward-looking statements: basis;

A● on ~~variety~~a pro forma, as adjusted basis to give effect to (i) the issuance in connection with this Offering of ~~factors~~2,719,639 ~~some~~shares of our Common Stock underlying outstanding convertible notes (including conversion of accrued interest thereon through July 31, 2018) with a weighted average conversion price of $2.97 per share, which ~~are~~notes ~~outside~~will automatically be converted into shares of our ~~control~~Common Stock upon the closing of this Offering, ~~may~~(ii) ~~cause~~the issuance in connection with this Offering of 490,000 shares of our ~~operating~~Common ~~results~~Stock underlying toour ~~fluctuate~~currently ~~significantly~~outstanding Series A Convertible Preferred Stock held by Tallikut, which preferred stock will automatically be converted into shares of our Common Stock upon the closing of this Offering, (iii) our issuance and sale of 750,000 Units in this Offering at an assumed public Offering Price of $4.00 ~~They~~per ~~include:~~Unit, after deducting estimated underwriting commissions and estimated Offering expenses payable by us, (iv) the repayment of $565,693 of our short-term debt and related interest, and (v) our issuance of 75,000 shares of Common Stock to be issued to the holder of an outstanding promissory note in consideration for extending the maturity date of such note.

• our lack of operating history;

	As of June 30, 2018
	Actual (unaudited)			Pro Forma As Adjusted (unaudited)
Cash	$	31,871		$	2,036,178
Convertible Debt, net of Discount of $23,749 as of June 30, 2018		5,320,489			-
Short Term Debt		80,000			80,000
Common Stock, $0.00001 par value, 45,000,000 shares authorized, and 6,220,190 shares issued and outstanding at June 30, 2018 and 10,254,829 shares on a pro forma basis		62			102
Preferred Stock, $0.00001 par value, 5,000,000 shares authorized and 100,000 issued and outstanding at June 30, 2018 and -0- shares on a pro forma basis		1			1
Additional Paid in Capital		4,408,690			12,323,179
Accumulated deficit		(12,110,843	)		(12,110,843	)
Total Stockholders’ equity (deficit)		(7,774,682	)		139,847
Total Capitalization		(2,374,193	)		219,847

•The number ~~our~~of ~~current~~shares ~~lack~~outstanding ofin the ~~capital~~foregoing ~~resources~~table, ~~needed~~unless tootherwise ~~progress~~indicated, ~~our~~excludes ~~business~~the ~~plan;~~following:

•● 3,000,000 ~~our~~shares ~~current~~of ~~and~~Common ~~future~~Stock ~~capital~~issuable ~~requirements~~upon ~~and~~exercise ~~our~~of ~~ability~~the toClass ~~satisfy~~A ~~our~~Warrants ~~capital~~offered ~~needs~~hereby;

•● 392,000 shares of our ~~reliance~~Common onStock ~~Picoplatin~~underlying asa ~~our~~preferred ~~only~~stock ~~product~~purchase ~~candidate~~warrant held by Tallikut;

•● 145,863 ~~our~~shares ~~ability~~of toour ~~complete~~Common ~~required~~Stock ~~clinical~~underlying ~~trials~~Common ofStock ~~our~~purchase ~~product~~warrants ~~candidate~~issued ~~and~~to ~~obtain~~Palladium ~~approval~~Capital ~~from~~Advisors, ~~the~~LLC with ~~FDA~~a orweighted ~~other~~average ~~regulatory~~exercise ~~agencies~~price inof ~~different jurisdictions~~$3.49;

~~• our ability to secure and maintain key development and commercialization partners for our product candidate;~~39

•● shares of our ~~ability~~Common toStock ~~obtain,~~reserved ~~maintain~~for orfuture ~~protect~~issuance under our 2016 Equity Incentive Plan (an aggregate of twenty percent (20%) of the ~~validity~~outstanding Common Stock immediately following the consummation of ~~our~~this ~~patents~~Offering ~~and~~on ~~other~~a ~~intellectual~~fully-diluted ~~property~~basis will be reserved for issuance under the 2016 Equity Incentive Plan);

•● 436,100 shares of our ~~ability~~Common Stock underlying outstanding options which were issued prior to ~~internally~~the ~~develop~~adoption ~~new~~of ~~inventions~~our ~~and~~2016 ~~intellectual~~Equity ~~property;~~Incentive Plan with an exercise price of $0.41.

~~• our ability to retain key executive members; and~~DILUTION

•As described ~~interpretations~~elsewhere ofin ~~current~~this ~~laws~~prospectus, all share amounts and ~~the~~per ~~passages~~share ofamounts ~~future~~in ~~laws,~~this ~~rules~~prospectus ~~and~~have ~~regulations~~been ~~applicable~~presented on a pro-forma basis to reflect a forward stock split of the outstanding shares of our ~~business~~Common Stock at a ratio of 4.9-for-1 shares effected on December 1, 2016.

~~Although~~If you wepurchase ~~believe~~Units ~~that~~in ~~our~~this ~~expectations~~Offering ~~(including~~your ~~those~~interest onin ~~which~~ our ~~forward-looking~~Common ~~statements~~Stock ~~are based) are reasonable, we cannot assure you that those expectations~~ will ~~prove to~~ be ~~correct.~~diluted ~~Should~~immediately ~~any~~to ~~one~~the orextent ~~more~~ of ~~these~~the ~~risks~~difference between orthe ~~uncertainties~~assumed ~~materialize,~~public orOffering ~~should~~Price ~~any~~of ~~underlying~~$4.00 ~~assumptions~~per ~~prove~~Unit ~~incorrect,~~and ~~actual~~the ~~results~~as ~~may~~adjusted ~~vary~~net ~~materially~~tangible ~~from~~book ~~those~~value ~~described~~per inshare of our ~~forward-looking~~Common Stock ~~statements~~immediately asfollowing ~~anticipated,~~this ~~believed, estimated, expected or intended~~Offering.

~~Except~~Our ~~for~~net ~~our~~tangible ~~ongoing~~book ~~obligations~~value toas ~~disclose~~of ~~material~~June ~~information~~30, 2018 ~~under~~was ~~the~~$(7,774,682), ~~federal~~or ~~securities~~approximately ~~laws,~~$(1.25) weper ~~undertake~~share. noPro ~~obligation~~forma tonet ~~publicly~~tangible ~~update~~book orvalue ~~revise~~per ~~any~~share ~~forward-looking~~represents our ~~statements,~~total ~~whether~~tangible asassets aless ~~result~~total oftangible ~~new information~~liabilities, ~~future~~divided ~~events~~by orthe ~~any~~number ~~other~~of ~~reason.~~shares ~~All~~of ~~subsequent~~Common ~~forward-looking~~Stock ~~statements~~outstanding ~~attributable~~as toof usJune 30, or2018. ~~any~~Net ~~person~~tangible ~~acting~~book onvalue ~~our~~dilution ~~behalf~~per ~~are~~share ~~expressly~~to ~~qualified~~new ininvestors ~~their~~represents ~~entirety by~~ the ~~cautionary~~difference ~~statements~~between ~~contained~~the oramount ~~referred~~per toUnit ~~herein.~~paid by Inpurchasers ~~light~~in ofthis ~~these~~Offering ~~risks, uncertainties~~ and ~~assumptions,~~ the ~~forward-looking~~adjusted ~~events~~net ~~discussed~~tangible inbook ~~this~~value ~~prospectus~~per ~~and~~share ~~the~~of ~~documents~~Common ~~incorporated~~Stock byimmediately ~~reference~~after ~~herein might~~completion ~~not~~of ~~occur.~~this Offering.

36After giving effect to our sale of 750,000 Units in this Offering at an assumed public Offering Price of $4.00 per Unit, and after deducting the placement agent commission and estimated Offering expenses, our adjusted net tangible book value as of June 30, 2018 would have been approximately $(5,204,682) (1) or $(0.75) per share. This represents an immediate increase in net tangible book value of $0.58 per share to existing stockholders and an immediate dilution in net tangible book value of $4.67 per share to purchasers of shares being offered and sold in this Unit Offering. The following table illustrates this per share dilution:

TABLE OF CONTENTS

Assumed public Offering Price per share (as part of the Unit Offering)				$	4.00
Net tangible book value per share as of June 30, 2018	$	(1.25	)
Increase in net tangible book value per share attributable to new investors	$	0.50
Adjusted net tangible book value per share as of June 30, 2018, after giving effect to the Offering				$	(0.75	)

~~USE~~You will OFexperience ~~PROCEEDS~~further dilution if the Class A Warrants and other outstanding warrants are exercised.

~~We estimate that the net proceeds from the sale of the shares of common stock we are offering will be approximately $15.~~(1) Pro ~~million~~forma ~~based~~adjusted onnumbers anassume ~~assumed~~that ~~offering price of $9.00 per share (which represents~~ the ~~mid-point~~warrants offrom ~~the estimated range of the initial public offering price shown on the front cover of~~ this ~~prospectus).~~Offering Ifand the ~~underwriters~~Series ~~fully~~B ~~exercise~~Private ~~the~~Placement ~~over-allotment~~are ~~option,~~treated ~~the~~as ~~net proceeds of the shares we sell will be approximately $17~~equity instruments.~~4 million. “Net proceeds” is what we expect to receive after deducting the underwriting discount and commission and estimated offering expenses payable by us.~~

~~Each $1.00 increase (decrease) in the assumed offering price of $9.00 would increase (decrease) the net proceeds to us from this offering by approximately $1.7 million~~In addition, ~~after~~for ~~deducting~~purposes ~~estimated underwriting discount and commission and estimated offering expenses payable by us, assuming that the number~~ of ~~shares offered by us, as set forth on the cover page of~~ this ~~prospectus~~section, ~~remains~~ the ~~same.~~foregoing ~~Each~~does ~~increase~~not of 100,000 shares in the number of shares offered by us at the assumed public offering price would increase the net proceeds to us in this offering by approximately $0.8 million. Similarly, each decrease of 100,000 shares in the number of shares offered by us at the assumed public offering price would decrease the net proceeds to us from this offering by approximately $0.8 million. A change in the offering price or the number of shares by these amounts could have a material effect on our uses of the proceeds from this offering, and it may impact the amount of time prior to which we will need to seek additional capital. include:

We● 750,000 ~~intend~~shares toof ~~use~~Common ~~the~~Stock ~~proceeds~~issuable ~~from~~upon ~~this~~exercise ~~offering~~of ~~(after~~the ~~deducting~~Class ~~commissions~~A ~~and~~Warrants ~~estimated~~offered ~~offering expenses payable by us) to fund:~~hereby;

•● 490,000 ~~our~~shares ~~expenses~~of inour ~~connection~~Common ~~with~~Stock underlying our ~~Phase~~Series IIA ~~clinical~~Convertible ~~trial~~Preferred toStock ~~obtain~~held ~~genomic~~by ~~expression~~Tallikut, ~~data~~which ~~for~~preferred ~~Picoplatin~~stock will inautomatically ~~metastatic~~be ~~colorectal~~converted ~~cancer~~into ~~patients~~shares of our Common Stock upon the closing of this Offering;

•● 392,000 ~~our~~shares ~~expenses~~of ~~in connection with~~ our ~~Phase~~Common IIStock ~~clinical~~underlying ~~trial~~a topreferred ~~obtain~~stock ~~genomic~~purchase ~~expression~~warrant ~~data~~held ~~for~~by ~~Picoplatin in patients with head and neck cancer~~Tallikut;

•● 2,719,639 ~~the~~shares ~~manufacturing~~of ~~expenses~~our toCommon ~~procure~~Stock ~~sufficient~~underlying ~~drug~~outstanding ~~product~~convertible ~~for~~notes (including conversion of accrued interest thereon through June 30, 2017) with a weighted average conversion price of $2.97 per share, which notes will automatically be converted into shares of our ~~Phase~~Common IIStock ~~and~~upon ~~Phase~~the ~~III~~closing ~~clinical~~of ~~trials;~~this ~~and~~Offering

•● 145,856 shares of our ~~working~~Common ~~capital~~Stock ~~and~~underlying ~~general~~Common ~~corporate~~Stock ~~requirements~~purchase warrants issued to Palladium Capital Advisors, LLC with a weighted average exercise price of $3.49;

~~While we expect to use the net proceeds for the purposes described above~~● 115,000 ~~the~~shares ~~amounts and timing~~ of ~~our~~Common ~~actual~~Stock ~~expenditures~~to ~~will~~be ~~depend~~issued ~~upon~~to ~~numerous factors, including~~ the ~~ongoing~~holder ~~status and results~~ of ~~our~~an ~~clinical~~outstanding ~~trials.~~promissory Wenote ~~anticipate~~in anconsideration ~~approximate~~for ~~allocation~~extending of the maturity ~~use~~date of ~~net~~such ~~proceeds as follows:~~ note;

Use of Net Proceeds	$ (in millions)		%(approx.)
Fund the expenses in connection with our Phase II clinical trial to develop genomic expression data for Picoplatin in metastatic colorectal cancer patients	$	4.75		31.5
Fund the expenses in connection with our Phase II clinical trial to develop genomic expression data for Picoplatin in head and neck cancer patients	$	4.75		31.5
Fund the expenses of contract manufacturing the Picoplatin drug product to be used for our contemplated Phase II and Phase III trials	$	0.75		5.0
Fund working capital and general corporate purposes	$	4.85		32.1
Total	$	15.1		100

● shares of our Common Stock reserved for future issuance under our 2016 Equity Incentive Plan (an aggregate of twenty percent (20%) of the outstanding Common Stock immediately following the consummation of this Offering on a fully-diluted basis will be reserved for issuance under the 2016 Equity Incentive Plan); and

~~The~~● 436,100 ~~expected~~shares ~~net proceeds from the sale~~ of ~~the shares offered hereby, if added to~~ our ~~current~~Common ~~cash~~Stock isunderlying ~~anticipated~~outstanding tooptions bewhich ~~sufficient~~were toissued ~~fund~~prior ~~our operations through September 2018 and we expect that the proceeds will be sufficient~~ to ~~complete our Phase II trials for metastatic colorectal cancer and head and neck cancer patients. In~~ the ~~event~~adoption ~~that~~of our ~~plans~~2016 ~~change,~~Equity our assumptions change or prove to be inaccurate, or the net proceeds of this offering are less than as set forth herein or otherwise prove to be insufficient, it may be necessary or advisable to reallocate proceeds or curtail expansion activities, or we may be requiredIncentive toPlan ~~seek additional financing or curtail our operations. As a result of the foregoing, our success will be affected by our discretion and judgment~~ with ~~respect~~an toexercise ~~the~~price ~~application and allocation~~ of ~~the net proceeds of this offering~~$0. 41.

3740

~~TABLE~~MANAGEMENT’S DISCUSSION AND ANALYSIS OF ~~CONTENTS~~FINANCIAL CONDITION AND RESULTS OF OPERATIONS

~~Pending~~The following ~~their~~discussion ~~use~~and analysis is based on, weand ~~plan~~should tobe ~~invest~~read ~~the~~in ~~net~~conjunction ~~proceeds~~with ~~from~~our ~~this~~financial ~~offering~~statements, which are included elsewhere in ~~short-~~this prospectus. This Management’s Discussion and ~~intermediate~~Analysis of Financial Condition and Results of Operations contains statements that are forward-~~term~~looking. These statements are based on current expectations and assumptions that are subject to risk, ~~interest-bearing~~uncertainties ~~obligations~~and other factors. These statements are often identified by the use of words such as “may,” “will,” ~~investment-grade~~“expect,” ~~instruments~~“believe,” ~~certificates~~“anticipate,” of“intend,” ~~deposit~~“could,” “estimate,” or ~~direct~~“continue,” and similar expressions or ~~guaranteed~~variations. ~~obligations~~Actual results could differ materially because of the Ufactors discussed in “Risk Factors” elsewhere in this prospectus, and other factors that we may not know.S. ~~government~~As described elsewhere in this prospectus, all share amounts and per share amounts in this prospectus have been presented on a pro-forma basis to reflect a forward stock split of the outstanding shares of our Common Stock at a ratio of 4.9-for-1 shares effected on December 1, 2016.

38Overview

~~TABLE~~We are OFa ~~CONTENTS~~clinical stage biopharmaceutical company focused on utilizing our genomic technology to enhance the development of pharmaceutical products for the treatment of various cancer indications. We were formed in May 2014, and we acquired the worldwide rights to Picoplatin from a third party in December 2014. We thus have a very limited history of operations. We have not generated any revenues to date, having focused all of our effort on research and development activities.

~~DIVIDEND~~Results of ~~POLICY~~Operations

WeSix Months ~~have~~Ended ~~never~~June ~~declared or paid any cash dividend on our capital stock. We do not anticipate paying any cash dividends in the foreseeable future and we intend to retain all of our earnings~~30, if2018 ~~any,~~Compared to ~~finance~~Six ~~our~~Months ~~growth~~Ended ~~and~~June ~~operations and to fund the expansion of our business. Payment of any dividends will be made in the discretion of our Board of Directors~~30, after its taking into account various factors, including our financial condition, operating results, current and anticipated cash needs and plans for expansion. Any dividends that may be declared or paid on our common stock, must also be paid in the same consideration or manner, as the case may be, on our shares of preferred stock, if any. 2017

39Summary Table

~~TABLE~~The following OFtable ~~CONTENTS~~presents a summary of the changes in our results of operations for the six months ended June 30, 2018, compared with the six months ended June 30, 2017:

CAPITALIZATION

	Six Months Ended June 30,				Percentage Increase
	2018		2017		(Decrease)
Research and Development Expenses	$	—	$	—		-
General and Administrative Expenses	$	85,545	$	603,074		(80	)%
Total Expenses	$	367,683	$	1,103,227		(67	)%
Net Loss	$	367,683	$	1,103,227		(67	)%

~~As described elsewhere in this prospectus, all share amounts~~ General and ~~per~~Administrative share amounts in this prospectus have been presented on a pro-forma basis to reflect a forward stock split of the outstanding shares of our common stock at a ratio of 4.9-for-1 shares effected on , 2016. Expenses

General and administrative expenses were $85,545 for the six months ended June 30, 2018, and $603,074 for the six months ended June 30, 2017, a decrease of $517,529. The ~~following~~decrease ~~table~~in ~~sets~~general ~~forth~~and administrative expenses is primarily attributable to our significant reduction in our use of cash ~~and~~until ~~capitalization~~we received new financing as a result of the failure to complete the 2017 IPO in order to fund our operations which effectively were halted as a result. The Company neither accrued nor paid executive and employee salaries and/or expenses related to the compensation of key consultants to our Company for the six months ended June 30, 2018 because of the Company’s lack of resourced, extremely limited operations during this period and the fact that no services were provided by the executives during this period, principally because their June 2016: employment agreements provided that they would not become effective until the successful completion of the 2017 IPO, which did not occur. Reference is made to the disclosure under “Employment Agreements” below. On September 14, 2018, we entered into a Modification Agreement with our executive officers which provided, among other things, that no salaries were due and payable nor were any salaries accrued under the June 2016 employment agreements which, as noted above, never became effective. The Company has agreed in principle to pay its executive officers base salaries equal to from 30% to 35% of their previous base salaries set forth in the former but never effective June 2016 employment agreements, following the successful completion of this Offering, of which there can be no assurance.

•Other Income ~~on an actual basis;~~(Expense)

•Other expenses onwere aapproximately ~~pro~~$282,138 ~~forma~~for ~~basis to give effect to (i)~~ the ~~issuance~~six inmonths ~~connection~~ended ~~with~~June ~~this~~30, ~~offering of 1~~2018,~~716,026~~ ~~shares~~compared ofto ~~our~~$500,153 ~~common~~for ~~stock~~the ~~underlying~~six ~~outstanding~~months ~~convertible~~ended ~~notes (including conversion of accrued interest thereon through September~~ June 30, ~~2016) with a weighted average conversion price of $3.09 per share~~2017, which ~~notes~~was ~~will~~primarily ~~automatically~~due beto ~~converted into shares of our common stock upon~~ the ~~closing~~increase ~~of this offering and (ii) the issuance~~ in ~~connection~~interest ~~with~~expense ~~this offering~~ of ~~490~~218,~~000~~015 ~~shares~~in of our common stock underlying our currently outstanding Series A Convertible Preferred Stock held by Tallikut, which preferred stock will automatically be converted into shares of our common stock upon the ~~closing~~prior ~~of this offering;~~period.

• on a pro forma, as adjusted basis to give effect to the pro forma adjustments, and our issuance and sale of 1,888,889 shares of our common stock in this offering at an assumed public offering price of $9.00 per share, after deducting estimated underwriting commissions and estimated offering expenses payable by us.41

	Actual			As of June 30, 2016
				Pro Forma			Pro Forma As Adjusted
Cash	$	13,295		$	13,295		$	15,113,295
Convertible Debt, net of discount of $254,522 as of June 30, 2016	$	3,595,478			—
Stockholders’ (deficit) equity:
Common stock, $0.00001 par value, 45,000,000 shares authorized and 5,000,450 shares issued and outstanding at June 30, 2016		50			72			91
Preferred stock, $0.00001 par value, 5,000,000 shares authorized and 100,000 shares issued and outstanding at June 30, 2016		1			—			—
Additional paid-in capital		3,947,777			7,543,233			22,643,234
Accumulated deficit		(8,818,260	)		(8,818,260	)		(8,818,260	)
Total stockholders’ equity		(4,947,788	)		(1,352,310	)		13,747,690
Total capitalization	$	(1,352,310	)	$	(1,352,310	)	$	13,747,690

Net Loss

~~The~~Net loss ~~number~~was of$367,683 ~~shares~~for ~~outstanding~~the assix ofmonths ~~the~~ended ~~date~~June of30, ~~this~~2018, ~~prospectus~~compared to $1,103,227 asfor ~~used~~the ~~throughout~~six ~~this~~months ~~prospectus~~ended June 30, ~~including~~2017, ina ~~the~~decrease of ~~above~~$735,544 ~~discussion~~primarily ~~and~~due ~~table,~~to ~~unless~~a ~~otherwise~~decrease ~~indicated,~~in ~~excludes~~general and administrative expenses for the ~~following:~~reasons stated above.

•Net Cash ~~392,000~~Used ~~shares~~in ofOperating ~~our common stock underlying a preferred stock purchase warrant held by Tallikut;~~Activities

•Net cash ~~788~~used in operating activities was $105,~~824~~134 ~~shares~~for ofthe ~~our~~six ~~common~~months ~~stock~~ended ~~underlying~~June ~~common~~30, ~~stock~~2018. ~~purchase~~The ~~warrants~~net ~~issued~~loss tofor this period was greater than the ~~holders~~net cash used in operating activities by $262,549, which was primarily attributable to accrued interest of ~~our~~$218,909, and ~~outstanding~~the ~~convertible~~amortization ~~notes~~of ~~with~~debt adiscounts ~~weighted~~and ~~average~~deferred ~~exercise~~financing ~~price~~costs of $334,524.~~49;~~

•Net cash ~~145~~used in operating activities was $384,~~856~~017 ~~shares~~for ofthe ~~our~~six ~~common~~months ~~stock~~ended ~~underlying~~June ~~common~~30, ~~stock~~2017. ~~purchase~~The ~~warrants~~net ~~issued~~loss for this period was greater than the net cash used in operating activities by $719,210, which was primarily attributable to ~~Palladium~~share ~~Capital~~based ~~Advisors~~costs of $102,607, the ~~LLC~~amortization ~~with~~of adebt ~~weighted~~discounts ~~average~~for ~~exercise~~our ~~price~~convertible debt of $3154,324, and an increase in accounts payable, accrued compensation and accrued interest of $544,493 combined.~~49;~~

•Net Cash ~~shares~~Provided ofby ~~our~~Financing common stock reserved for future issuance under our 2016 Equity Incentive Plan (an aggregate of twenty percent (20%) of the outstanding common stock immediately following the consummation of this offering on a fully-diluted basis will be reserved for issuance under the 2016 Equity Incentive Plan); andActivities

•Net cash ~~436,100~~provided ~~shares~~by offinancing ~~our~~activities ~~common~~for ~~stock~~the ~~underlying~~six ~~outstanding~~months ~~options~~ended ~~which~~June ~~were~~30, ~~issued~~2018 ~~prior~~was $110,000, which was attributable to ~~the~~aggregate net ~~adoption~~proceeds of $110,000 received from our ~~2016~~bridge ~~Equity~~financing ~~Incentive~~of ~~Plan~~debt ~~with~~on anJanuary ~~exercise~~31, ~~price~~2018 and the reduction of $0deferred Offering costs.~~41.~~

40Net cash provided by financing activities for the six months ended June 30, 2017 was $325,000 comprised of net proceeds from convertible notes of $290,000 and $35,000 related party short term borrowings.

~~TABLE~~Year Ended OFDecember ~~CONTENTS~~31, 2017 Compared to Year Ended December 31, 2016

~~DILUTION~~Summary Table

AsThe following ~~described~~table ~~elsewhere~~presents ina ~~this~~summary ~~prospectus,~~of ~~all~~the ~~share~~changes ~~amounts and per share amounts~~ in ~~this~~our ~~prospectus~~results ~~have~~of ~~been~~operations ~~presented~~for onthe ayear ~~pro-forma~~ended ~~basis~~December to31, ~~reflect~~2017, acompared with ~~forward stock split of~~ the ~~outstanding~~year ~~shares~~ended ofDecember ~~our common stock at a ratio of 4.9-for-1 shares effected on~~ 31, 2016. :

If you purchase shares in this offering your interest will be diluted immediately to the extent of the difference between the assumed public offering price of $9.00 per share and the as adjusted net tangible book value per share of our common stock immediately following this offering.

	Year Ended December 31,				Percentage Increase
	2017		2016		(Decrease)
Research and Development Expenses	$	1,400	$	164,722		*
General and Administrative Expenses	$	652,755	$	3,037,646		(80	)%
Total Operating Expenses	$	654,155	$	3,202,368		(80	)%
Net Loss	$	1,394,117	$	3,929,860		(65	)%

~~Our~~* Not pro forma net tangible book value as of June 30, 2016 was approximately $(4,947,788), or approximately $(0.99) per share. Pro forma net tangible book value per share represents our total tangible assets less total tangible liabilities, divided by the number of shares of common stock outstanding as of June 30, 2016. Net tangible book value dilution per share to new investors represents the difference between the amount per share paid by purchasers in this offering and the adjusted net tangible book value per share of common stock immediately after completion of this offering. meaningful

After giving effect to our sale of 1,888,889 shares in this offering at an assumed public offering price of $9.00 per share (the mid-point of the range indicated on the front cover of this prospectus), Research and ~~after~~Development ~~deducting~~Expenses the underwriters’ commission and estimated offering expenses, our adjusted net tangible book value as of June 30, 2016 would have been approximately $10,152,212, or $1.47 per share. This represents an immediate increase in net tangible book value of $2.46 per share to existing stockholders and an immediate dilution in net tangible book value of $7.53 per share to purchasers of shares in this offering. The following table illustrates this per share dilution:

Assumed public offering price per share				$	9.00
Net tangible book value per share as of June 30, 2016	$	(0.99	)
Increase in net tangible book value per share attributable to new investors	$	2.46
Adjusted net tangible book value per share as of June 30, 2016, after giving effect to the offering				$	1.47
Dilution per share to new investors in the offering				$	7.53

Research and development expenses were approximately $1,400 for the year ended December 31, 2017 and $164,722 for the year ended December 31, 2016. Research and development expenses decreased primarily as a result of decreased manufacturing activity related to the manufacturing of our active pharmaceutical ingredients which we ordered primarily in 2016. Our research and development costs in 2017 consisted of preparing to commence phase II trials and communicating with the FDA as well as expenses relating to manufacturing Picoplatin in sufficient quantities as needed for our anticipated application to the Ministry of Health of the Russian Federation for the approval of Picoplatin and for the Phase II clinical trials which we expect to commence during 2018. The amounts included in General and Administrative (G&A) include salaries of our executive officers. Approximately 70% of the professional time of our executive officers was devoted to the Company’s Research and Development activities (R&D) which was and will, in the future, be an essential part of the fiduciary duties of these executive officers, assuming the successful completion of this Unit Offering.

~~The foregoing does not take into account:~~42

•General and ~~490,000~~Administrative ~~shares~~Expenses of our common stock underlying our Series A Convertible Preferred Stock held by Tallikut, which preferred stock will automatically be converted into shares of our common stock upon the closing of this offering;

•General and ~~392~~administrative expenses were approximately $652,~~000~~755 for the year ended December 31, 2017, and $3,037,646 for the year ended December 31, 2016, a decrease of $2,384,891. The decrease in general and administrative expenses is primarily attributable to (i) stock-based compensation of $751,435 in connection with the issuance of options and shares of Common Stock to certain of our executive ~~common~~officers, ~~stock~~key ~~underlying~~employees aand ~~preferred~~directors, ~~stock~~(ii) ~~purchase~~executive ~~warrant~~and ~~held~~employee bysalaries ~~Tallikut;~~of $788,125, and (iii) expenses related to the compensation of key consultants to our company of $467,891 paid in 2016.

•Other Income ~~1,716,026 shares of our common stock underlying outstanding convertible notes~~ (~~including conversion of accrued interest thereon through September 30, 2016~~Expense) ~~with a weighted average conversion price of $3.09 per share, which notes will automatically be converted into shares of our common stock upon the closing of this offering;~~

•Other expenses ~~788,824~~were ~~shares~~approximately of$739,962 ~~our~~for ~~common~~the ~~stock~~year ~~underlying~~ended ~~common~~December ~~stock~~31, ~~purchase~~2017, ~~warrants~~compared ~~issued~~ to ~~the~~$727,494 ~~holders~~for ofthe ~~our~~year ~~outstanding~~ended ~~convertible~~December ~~notes~~31, 2016, ~~with~~which awas ~~weighted~~substantially ~~average~~the ~~exercise~~same ~~price~~as ofthe $3prior year.~~49;~~

•Net Loss ~~145,856 shares of our common stock underlying common stock purchase warrants issued to Palladium Capital Advisors, LLC with a weighted average exercise price of $3.49;~~

•Net loss ~~shares~~was ofapproximately ~~our~~$1,394,117 ~~common~~for ~~stock~~the ~~reserved~~year ~~for~~ended ~~future~~December ~~issuance~~31, ~~under~~2017, ~~our~~compared ~~2016~~to ~~Equity~~$3,929,860 ~~Incentive~~for ~~Plan~~the ~~(an~~year ~~aggregate~~ended ofDecember ~~twenty~~31, 2016, ~~percent~~a ~~(20%)~~decrease of ~~the~~$2,535,743 ~~outstanding~~primarily ~~common~~due ~~stock~~to ~~immediately~~decreases ~~following~~in ~~the~~research ~~consummation~~and ofdevelopment ~~this~~costs ~~offering~~and onin ageneral ~~fully-diluted~~and ~~basis~~administrative expenses ~~will be reserved~~ for ~~issuance under~~ the ~~2016~~reasons ~~Equity~~stated ~~Incentive~~above. ~~Plan); and~~

•Net Cash ~~436,100~~Used ~~shares~~in ofOperating ~~our~~Activities ~~common stock underlying outstanding options which were issued prior to the adoption of our 2016 Equity Incentive Plan with an exercise price of $0.41.~~

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