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As filed with the U.S. Securities and Exchange Commission on ~~October~~January 47, ~~2013~~2026.

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

~~GlycoMimetics~~Crescent Biopharma, Inc.

(Exact name of registrant as specified in its charter)

Delaware	2834		06-1686563
Cayman Islands		2834		06-1686563
(State or other jurisdiction of incorporation or organization)	(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)
(State or other jurisdiction ofincorporation or organization)		(Primary Standard IndustrialClassification Code Number)		(I.R.S. EmployerIdentification No.)

~~401~~300 ~~Professional~~Fifth ~~Drive,~~Avenue ~~Suite 250~~

~~Gaithersburg~~Waltham, MDMA ~~20879~~02451

(~~240~~617) ~~243~~430-~~1201~~5595

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

~~Rachel~~Joshua ~~K. King~~ Brumm

Chief Executive Officer

~~GlycoMimetics~~Crescent Biopharma, Inc.

~~401~~300 ~~Professional~~Fifth ~~Drive, Suite 250~~ Avenue

~~Gaithersburg~~Waltham, MDMA ~~20879~~ 02451

(~~240~~617) ~~243~~430-~~1201~~5595

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

Copies to:

~~Brent~~Peter BN. ~~Siler~~HandrinosWesley ~~Christian E~~C. ~~Plaza~~HolmesSamuel ~~Brian F~~P. ~~Leaf~~NilesLatham ~~Cooley~~& ~~LLP~~Watkins ~~11951~~LLP200 ~~Freedom~~Clarendon ~~Drive Reston~~StreetBoston, VAMA ~~20190 Telephone:~~ 02116(~~703~~617) ~~456~~948-~~8000~~6000 ~~Fax:~~Barbara ~~(703) 456-8100 Divakar Gupta Cheston J~~H. ~~Larson~~BisphamCrescent ~~Latham & Watkins LLP 12636 High Bluff Drive~~Biopharma, ~~Suite~~Inc.300 ~~400~~Fifth ~~San Diego~~AvenueWaltham, CAMA ~~92130 Telephone:~~ 02451(~~858~~617) ~~523~~430-~~5400 Fax: (858) 523-5450~~5595

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

IfFrom ~~any~~time ~~of the securities being registered on this Form are~~ to betime ~~offered~~after ~~on a delayed or continuous basis pursuant to Rule 415 under~~ the ~~Securities~~effective ~~Act~~date of ~~1933,~~ ~~check~~this ~~the~~Registration ~~following box~~Statement. ¨

If ~~this~~any ~~Form~~of isthe ~~filed~~securities tobeing ~~register~~registered ~~additional~~on ~~securities~~this ~~for~~Form anare ~~offering pursuant~~ to ~~Rule~~be ~~462(b)~~offered ~~under~~on ~~the~~a ~~Securities~~delayed ~~Act,~~or ~~check~~continuous ~~the~~basis ~~following~~pursuant ~~box~~to ~~and~~Rule ~~list~~415 under the Securities Act ~~registration statement number~~ of ~~the~~1933, ~~earlier~~check ~~effective registration statement for~~ the ~~same~~following ~~offering~~box. ¨ ☒

If this Form is afiled ~~post-effective~~to ~~amendment~~register ~~filed~~additional securities for an offering pursuant to Rule 462(cb) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨ ☐

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

~~CALCULATION~~If ~~OF REGISTRATION~~this ~~FEE~~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. ☐

TITLE OF SECURITIES BEING REGISTERED		PROPOSED MAXIMUM AGGREGATEOFFERING PRICE(1)(2)		AMOUNT OFREGISTRATIONFEE
Common Stock, $0.001 par value per share		$86,250,000		$11,109.00

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

~~(1)~~Large Inaccelerated ~~accordance~~filer ~~with~~☐ ~~Rule~~Accelerated ~~457(o)~~filer ~~under~~☐ ~~the~~Non-accelerated ~~Securities~~filer ~~Act~~☒ ofSmaller ~~1933,~~reporting ascompany ~~amended,~~☒ ~~the~~Emerging ~~number~~growth ofcompany ~~shares being registered and the proposed maximum offering price per share are not included in this table.~~☐

~~(2)~~If ~~Estimated~~an ~~solely~~emerging ~~for~~growth ~~purposes~~company, ofindicate ~~computing~~by check mark if the ~~amount~~registrant ofhas elected not to use the ~~registration~~extended ~~fee~~transition period for complying with any new or revised financial accounting standards provided pursuant to ~~Rule 457~~Section 7(oa)(2)(B) ~~under~~of the Securities Act. ☐

~~Indicate~~The byRegistrant ~~check~~hereby ~~mark~~amends ~~whether~~this ~~the~~Registration ~~registrant~~Statement ison asuch ~~large~~date ~~accelerated~~or ~~filer,~~dates anas ~~accelerated~~may ~~filer,~~be anecessary ~~non-accelerated~~to ~~filer,~~delay orits aeffective ~~smaller~~date ~~reporting~~until ~~company.~~the ~~See~~Registrant ~~the~~shall ~~definitions~~file ofa ~~“large~~further ~~accelerated~~amendment ~~filer,” “accelerated~~which ~~filer”~~specifically ~~and~~states ~~“smaller~~that ~~reporting~~this ~~company”~~Registration Statement shall thereafter become effective in ~~Rule~~accordance with Section ~~12b-2~~8(a) ~~under~~of the Securities ~~Exchange~~ Act of ~~1934.~~1933 ~~(Check~~or ~~one~~until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a):, may determine.

~~Large~~The ~~accelerated~~information ~~filer~~in ¨this ~~Accelerated~~preliminary ~~filer~~prospectus ¨is ~~Non-accelerated~~not ~~filer~~complete xand ~~Smaller~~may ~~reporting~~be ~~company~~changed. ¨The selling securityholders named in this prospectus may not sell the securities until the registration statement filed with the Securities and Exchange Commission is declared effective. This preliminary prospectus is not an offer to sell these securities, and it is not soliciting an offer to buy these securities, in any jurisdiction where the offer or sale is not permitted.

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

~~Table~~Preliminary ofProspectus ~~Contents~~dated January 7, 2026.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted. PROSPECTUS

~~SUBJECT TO COMPLETION~~19, ~~DATED OCTOBER 4~~710,257 ~~2013~~Shares

~~PRELIMINARY~~Ordinary ~~PROSPECTUS~~ Shares

~~Shares~~Offered by the Selling Securityholders

~~Common~~This ~~Stock~~prospectus relates to the proposed resale or other disposition by the selling securityholders identified herein (the “Selling Securityholders”) of up to (i) 13,664,251 (the “Private Placement Shares”) outstanding ordinary shares with a par value of US$0.001 per share (“Ordinary Shares”) issued pursuant to the Private Placement (as defined below), (ii) 131,434 Ordinary Shares (the “Private Placement Pre-Funded Warrant Shares”) issuable upon the exercise of pre-funded warrants (the “Private Placement Pre-Funded Warrants”) issued pursuant to the Private Placement and (iii) 1,387,866 outstanding Ordinary Shares (the “Fairmount Shares”), 1,636,706 Ordinary Shares (the “Fairmount Pre-Funded Warrant Shares”) issuable upon the exercise of pre-funded warrants (the “Fairmount Pre-Funded Warrants”), and 2,890,000 Ordinary Shares (the “Fairmount Series A Conversion Shares”) issuable upon the conversion of Series A non-voting convertible preferred shares (the “Fairmount Series A Shares”), in each case, held by Fairmount Healthcare Fund II L.P. as of immediately prior to the closing of the Private Placement. The Private Placement Shares, the Private Placement Pre-Funded Warrant Shares, the Fairmount Shares, the Fairmount Pre-Funded Warrant Shares and the Fairmount Series A Conversion Shares are referred to herein as the “Resale Shares.”

WeThe ~~are~~Private ~~offering shares~~Placement ofShares ~~our~~and ~~common~~Private ~~stock~~Placement Pre-Funded Warrants were issued and sold to accredited investors in a private placement, which closed on December 8, 2025 (the “Private Placement”). ~~This~~The isFairmount ~~our~~Shares, ~~initial~~Fairmount ~~public~~Pre-Funded ~~offering~~Warrants and noFairmount ~~public~~Series ~~market~~A ~~currently~~Shares ~~exists for~~were ~~our~~issued ~~common~~and ~~stock~~sold to Fairmount prior to the closing of the Private Placement and were held by Fairmount as of immediately prior the closing of the Private Placement, and Fairmount is a Selling Securityholder hereunder. We ~~expect~~are not selling any Resale Shares under this prospectus and will not receive any of the ~~initial~~proceeds ~~public~~from ~~offering~~the sale or other disposition of Resale Shares by the Selling Securityholders. Upon any exercise of the Private Placement Pre-Funded Warrants or the Fairmount Pre-Funded Warrants by payment of cash, however, we will receive the nominal cash exercise price paid by the holders thereof. We intend to beuse ~~between~~those ~~$ and~~proceeds, ~~$ per~~if ~~share.~~any, for general corporate purposes.

WeThe ~~have~~Selling ~~applied~~Securityholders tomay ~~list~~sell ~~our~~the ~~common~~Resale ~~stock~~Shares on ~~The~~any ~~NASDAQ~~national ~~Global~~securities ~~Market~~exchange ~~under~~or quotation service on which the ~~symbol~~securities ~~“GLYC.”~~may Webe ~~are~~listed anor ~~“emerging~~quoted ~~growth~~at ~~company”~~the astime ~~that~~of ~~term is~~sale, ~~used~~on inthe over-the-counter ~~Jumpstart~~market, ~~Our~~in ~~Business~~one ~~Startups~~or ~~Act~~more transactions otherwise than on these exchanges or systems, such as privately negotiated transactions, or using a combination of ~~2012~~these methods, and at fixed prices, asat ~~such~~prevailing market prices at the time of the sale, ~~have~~at ~~elected~~varying toprices ~~comply~~determined ~~with~~at ~~certain~~the ~~reduced~~time ~~public~~of ~~company~~sale, ~~reporting~~or ~~requirements~~at ~~for~~negotiated prices. See the disclosure under the heading “Plan of Distribution” elsewhere in this prospectus ~~and~~for ~~future~~more ~~filings.~~information about how the Selling Securityholders may sell or otherwise dispose of their Resale Shares hereunder.

~~Investing~~The Selling Securityholders may sell any, all or none of the securities offered by this prospectus and we do not know when or in ~~our~~what ~~common~~amount ~~stock~~the ~~involves~~Selling Securityholders may sell their Resale Shares hereunder following the effective date of the registration statement of which this prospectus forms a ~~high~~part. ~~degree~~Discounts, concessions, commissions and similar selling expenses attributable to the sale of ~~risk~~the Resale Shares will be borne by the Selling Securityholders. ~~Please~~We ~~read~~will ~~“Risk~~pay ~~Factors”~~certain ~~beginning~~fees onand ~~page 11~~expenses (other than discounts, concessions, commissions and similar selling expenses) incident to the registration of ~~this prospectus~~the Resale Shares with the U.S. Securities and Exchange Commission (“SEC”).

~~Neither~~You ~~the~~should ~~Securities~~carefully ~~and~~read ~~Exchange~~this ~~Commission~~prospectus ~~nor~~and any ~~state~~applicable ~~securities commission has approved or disapproved of these securities or determined if this~~ prospectus issupplement ~~truthful~~before oryou ~~complete.~~invest ~~Any~~in ~~representation~~any toof the ~~contrary~~securities isbeing ~~a criminal offense~~offered.

~~PER~~Our ~~SHARE~~Ordinary ~~TOTAL~~Shares ~~Public~~are ~~Offering~~traded ~~Price~~on $The $Nasdaq ~~Underwriting~~Capital ~~Discounts~~Market ~~and~~under ~~Commissions~~the ~~Proceeds~~symbol to“CBIO.” ~~GlycoMimetics~~On January 6, ~~Inc~~2026, the last reported sale price for our Ordinary Shares was $11.07 per ~~before~~share. ~~expenses~~

~~Delivery~~An ofinvestment ~~the~~in ~~shares~~our ofsecurities ~~common~~involves ~~stock is expected to be made on or about , 2013. We have granted the underwriters an option for~~ a ~~period~~high ofdegree ~~30 days to purchase an additional shares~~ of ~~our common stock~~risk. IfYou ~~the~~should ~~underwriters~~carefully ~~exercise~~consider the ~~option~~information inunder ~~full,~~ the ~~total~~heading ~~underwriting~~“Risk ~~discounts~~Factors” ~~and~~beginning ~~commissions~~on ~~payable~~page by9 usof ~~will~~this ~~be $ ,~~prospectus and ~~the~~any ~~total~~applicable ~~proceeds~~prospectus ~~to us, before expenses, will be $~~ supplement.

~~Joint~~We ~~Book-Running~~are ~~Managers~~a “smaller reporting company” as defined under the U.S. federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements.

~~Jefferies~~Neither ~~Barclays~~the Securities and Exchange Commission nor any other regulatory body have approved or disapproved these securities, or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

~~Co-Managers~~The date of this prospectus is , 2026

~~Stifel~~Table ~~Canaccord~~of ~~Genuity~~Contents

Prospectus dated , 2013


ABOUT THIS PROSPECTUS			ii
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS			iii
PROSPECTUS SUMMARY			1
RISK FACTORS			9
USE OF PROCEEDS			57
DIVIDEND POLICY			58
INDUSTRY AND MARKET DATA			59
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS			60
BUSINESS			79
MANAGEMENT			137
EXECUTIVE AND DIRECTOR COMPENSATION			145
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS			152
PRINCIPAL SHAREHOLDERS			156
DESCRIPTION OF SHARE CAPITAL			159
SELLING SECURITYHOLDERS			166
PLAN OF DISTRIBUTION			171
LEGAL MATTERS			173
EXPERTS			173
WHERE YOU CAN FIND MORE INFORMATION			173
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS			F-1

~~Table of Contents~~i

~~TABLE~~ABOUT OFTHIS ~~CONTENTS~~ PROSPECTUS

	PAGE
PROSPECTUS SUMMARY		1
RISK FACTORS		11
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA		38
USE OF PROCEEDS		39
DIVIDEND POLICY		39
CAPITALIZATION		40
DILUTION		42
SELECTED FINANCIAL DATA		44
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		46
BUSINESS		63
MANAGEMENT		88
EXECUTIVE COMPENSATION		95
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS		105
PRINCIPAL STOCKHOLDERS		107
DESCRIPTION OF CAPITAL STOCK		109
SHARES ELIGIBLE FOR FUTURE SALE		114
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS		116
UNDERWRITING		120
LEGAL MATTERS		125
EXPERTS		125
WHERE YOU CAN FIND ADDITIONAL INFORMATION		125
INDEX TO FINANCIAL STATEMENTS		F-1

This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission. The Selling Securityholders may, from time to time, sell the securities described in this prospectus in one or more offerings.

WeThis ~~and~~prospectus contains information that you should consider when making your investment decision. Neither we, nor the ~~underwriters~~Selling Securityholders, have ~~not~~ authorized anyone to ~~provide~~give any information or to make any ~~representations~~representation other than those contained in this prospectus. orThe Selling Securityholders are offering to sell, and seeking offers to buy, our securities only in ~~any free~~jurisdictions ~~writing~~where ~~prospectuses~~it weis ~~have~~lawful ~~prepared~~to do so. We ~~and~~have ~~the~~not ~~underwriters~~authorized ~~take~~anyone noto ~~responsibility~~provide ~~for,~~you with different information. This prospectus and ~~can~~any ~~provide~~accompanying noprospectus ~~assurance~~supplement asdo not constitute an offer to sell or the ~~reliability~~solicitation of, an offer to buy any securities other ~~information~~than ~~that~~the ~~others~~securities ~~may~~described ~~give~~in ~~you.~~any ~~This~~accompanying prospectus issupplement or an offer to sell ~~only~~or the ~~shares~~ ~~offered~~solicitation ~~hereby,~~of ~~but~~an ~~only~~offer ~~under~~to ~~circumstances~~buy ~~and~~such securities in ~~jurisdictions~~any ~~where~~circumstances itin iswhich ~~lawful~~such tooffer door sosolicitation is unlawful. ~~The~~You should assume that the information ~~contained~~appearing in this prospectus, any prospectus supplement and any related free writing prospectus is ~~current~~accurate only as of ~~its~~their ~~date~~respective dates. Our business, financial condition, results of operations and prospects may have changed materially since those dates.

~~Through~~In ~~and~~this ~~including~~ prospectus, ~~2013~~unless (the ~~25th~~context ~~day~~otherwise ~~after~~requires, the ~~date~~terms of“Crescent,” ~~this~~the ~~prospectus)~~“Company,” ~~all dealers effecting transactions in these securities~~“we, ~~whether~~” ~~or not participating in this offering~~“us,” ~~may~~and be“our” ~~required~~refer to ~~deliver~~Crescent aBiopharma, ~~prospectus~~Inc., ~~This is in addition to~~ a ~~dealer’s~~corporation ~~obligation~~formed tounder ~~deliver~~the alaws ~~prospectus~~of ~~when~~the ~~acting~~Cayman asIslands, ~~an underwriter~~ and ~~with~~its ~~respect~~consolidated ~~to an unsold allotment or subscription~~subsidiaries.

~~For~~This ~~investors~~prospectus ~~outside~~contains ~~the~~trade ~~United~~names, ~~States:~~trademarks We and ~~the~~service ~~underwriters~~marks ~~have not done anything that would permit this offering or possession or distribution~~ of ~~this prospectus in any jurisdiction where action for that purpose is required~~others, ~~other~~which ~~than~~are in the ~~United~~property ~~States. Persons who come into possession~~ of ~~this~~their ~~prospectus~~respective ~~and~~owners. ~~any~~Solely ~~applicable~~for ~~free~~convenience, ~~writing~~trademarks ~~prospectus in jurisdictions outside the United States are required to inform themselves about~~ and totrade ~~observe~~names ~~any~~referred ~~restrictions as~~ to ~~this~~in ~~offering and the distribution of~~ this prospectus ~~and~~may ~~any~~appear ~~such~~without ~~free~~the ~~writing~~® ~~prospectus~~or ~~applicable~~™ ~~to that jurisdiction~~symbols.

~~Table of Contents~~ii

~~PROSPECTUS~~SPECIAL ~~SUMMARY~~NOTE REGARDING FORWARD-LOOKING STATEMENTS

This ~~summary~~prospectus ~~highlights~~contains ~~information~~“forward-looking ~~contained~~statements” ~~elsewhere~~within inthe ~~this~~meaning ~~prospectus~~of ~~and~~Section ~~does~~27A ~~not contain all~~ of the ~~information~~Securities ~~that~~Act ~~you~~of ~~should~~1933, ~~consider~~as inamended ~~making~~(the ~~your investment~~“Securities ~~decision.~~Act”), ~~Before~~and ~~investing~~Section in21E ~~our~~of ~~common~~the ~~stock,~~Securities ~~you~~Exchange ~~should~~Act ~~carefully~~of ~~read~~1934, ~~this~~as ~~entire~~amended ~~prospectus,~~(the ~~including~~“Exchange ~~our~~Act”). ~~financial~~These forward-looking statements ~~and~~involve ~~the~~a ~~related~~number ~~notes~~of ~~thereto~~risks and ~~the~~uncertainties. ~~information~~We ~~set~~caution ~~forth~~readers ~~under~~that ~~the~~any ~~sections~~forward-looking ~~“Risk~~statement ~~Factors” and~~is ~~“Management’s~~not ~~Discussion~~a ~~and~~guarantee ~~Analysis~~ of ~~Financial~~future ~~Condition~~performance and ~~Results~~that ofactual ~~Operations,”~~results incould ~~each~~differ ~~case~~materially ~~included~~from inthose ~~this~~contained ~~prospectus.~~in ~~Unless~~ the ~~context~~forward-looking ~~otherwise~~statement. ~~requires,~~These westatements ~~use~~are ~~the~~based ~~terms~~on ~~“GlycoMimetics,” “company,”~~current ~~“we,”~~expectations ~~“us”~~of ~~and~~future ~~“our” in this prospectus to refer to GlycoMimetics, Inc~~events.

~~Company~~All ~~Overview~~ statements other than statements of historical facts contained in this prospectus, including, without limitation, statements regarding our future results of operations and financial position, business strategy, the length of time that we believe our existing cash resources will fund our operations, our market size, our potential growth opportunities, our preclinical and future clinical development activities, the efficacy and safety profile of our product candidates, the potential therapeutic benefits and economic value of our product candidates, the timing and results of preclinical studies and clinical trials, the expected impact of macroeconomic conditions, and the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, are forward-looking statements. Forward-looking statements generally relate to future events or our future financial or operating performance. Forward-looking statements generally relate to future events or our future financial or operating performance. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “predict,” “target,” “intend,” “could,” “would,” “should,” “project,” “plan,” “expect,” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

WeThese forward-looking statements are subject to a ~~clinical~~number ~~stage~~of ~~biotechnology~~risks, ~~company~~uncertainties ~~focused~~and onassumptions. ~~the~~Moreover, ~~discovery~~we ~~and~~operate ~~development~~in ofa ~~novel~~very ~~glycomimetic~~competitive ~~drugs~~and torapidly ~~address~~changing ~~unmet~~environment, ~~medical~~and ~~needs resulting~~new risks emerge from ~~diseases~~time into ~~which~~time. ~~carbohydrate~~It ~~biology~~is ~~plays~~not apossible ~~key~~for ~~role.~~our ~~Glycomimetics~~management ~~are~~to ~~molecules~~predict ~~that~~all ~~mimic~~risks, nor can we assess the ~~structure~~impact of ~~carbohydrates~~all ~~involved~~factors inon ~~important~~our ~~biological~~business ~~processes.~~or ~~Using~~the ~~our~~extent ~~expertise~~to inwhich ~~carbohydrate~~any ~~chemistry~~factor, ~~and~~or ~~knowledge~~combination of ~~carbohydrate~~ ~~biology~~factors, wemay ~~are~~cause ~~developing~~actual aresults ~~pipeline~~to ofdiffer ~~proprietary~~materially ~~glycomimetics~~from ~~that~~those ~~inhibit~~contained ~~disease~~in any forward-~~related~~looking ~~functions~~statements ofwe ~~carbohydrates,~~may make. Factors that might cause such asa difference are disclosed in the ~~roles~~sections ~~they~~titled ~~play~~“Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” You should evaluate all forward-looking statements made in ~~inflammation,~~this ~~cancer~~prospectus in the context of these risks and ~~infection~~uncertainties. We ~~believe~~caution ~~this~~you ~~represents~~that anthe ~~innovative approach~~risks, touncertainties ~~drug~~and ~~discovery~~other factors referred to ~~treat~~in athis ~~wide~~prospectus ~~range~~may not contain all of ~~diseases.~~the risks, uncertainties and other factors that may affect our future results and operations.

WeIn ~~are~~addition, ~~focusing~~statements ~~our initial efforts on drug candidates for rare diseases~~ that “we believe ~~will~~” ~~qualify~~and ~~for~~similar ~~orphan~~statements ~~drug~~reflect ~~designation. We are developing~~ our ~~lead~~beliefs ~~drug~~and ~~candidate,~~opinions ~~GMI-1070,~~on ~~also~~the ~~known~~relevant assubject. ~~rivipansel~~These ~~sodium,~~statements ~~for~~are ~~the~~based ~~treatment~~on ofinformation ~~vaso-occlusive~~available ~~crisis,~~to orus ~~VOC,~~as ~~one~~ of the ~~most~~date ~~severe complications~~ of ~~sickle~~this ~~cell disease~~prospectus. ~~VOC~~While ~~is typically~~we ~~characterized~~believe ~~by excruciating, debilitating pain~~ that ~~occurs~~such ~~periodically~~information ~~throughout~~provides ~~the life of~~ a ~~person~~reasonable ~~with~~basis ~~sickle cell disease. According to the U.S. Centers~~ for ~~Disease~~these ~~Control and Prevention~~statements, ~~there~~such ~~were~~information ~~approximately~~may ~~73,000 hospitalizations~~be ~~related~~limited toor ~~VOC in the United States in 2010~~incomplete. ~~The~~Our ~~standard~~statements ofshould ~~care~~not inbe ~~the~~read ~~United~~to ~~States~~indicate ~~for~~that ~~people~~we ~~experiencing~~have ~~VOC~~conducted isan toexhaustive ~~manage~~inquiry ~~its symptoms~~into, ~~which~~or ~~typically~~review ~~includes hospitalization~~of, ~~narcotic~~all ~~pain~~relevant ~~management~~information. ~~and~~These ~~hydration.~~statements ~~There~~ are noinherently ~~approved~~uncertain, ~~therapies~~and ~~that~~investors ~~interrupt~~are ~~VOC~~cautioned ~~once~~not itto ~~has~~unduly ~~started~~rely oron ~~that~~these ~~treat the underlying cause of the pain~~statements.

InAll ~~April~~subsequent ~~2013,~~written weor ~~completed~~oral aforward-looking ~~Phase~~statements ~~2 clinical~~attributable ~~trial~~to inus ~~which~~or 76any ~~patients~~person ~~hospitalized~~acting ~~for~~on ~~VOC~~our ~~were~~behalf ~~treated~~are ~~with~~expressly ~~the~~qualified ~~standard~~in oftheir ~~care~~entirety ~~plus~~by ~~either~~the ~~GMI-1070~~cautionary orstatements ~~placebo.~~contained Inor ~~this~~referred ~~trial,~~to ~~patients treated with GMI-1070 experienced reductions~~ in ~~time~~this tosection. ~~reach~~We ~~resolution~~do ofnot ~~VOC,~~undertake ~~length~~any ~~of hospital~~obligation ~~stay~~to ~~and~~release ~~use~~publicly ofany ~~opioid~~revisions ~~analgesics for pain management, in each case as compared~~ to ~~patients~~these ~~receiving placebo. GMI~~forward-~~1070~~looking ~~has~~statements ~~received~~to ~~fast~~reflect ~~track~~events ~~designation~~or ~~from~~circumstances after the ~~U.S.~~date ~~Food~~of ~~and~~this ~~Drug~~prospectus ~~Administration,~~ or ~~FDA,~~to asreflect ~~well as orphan drug designation from~~ the ~~FDA~~occurrence inof ~~the~~unanticipated ~~United~~events, ~~States~~except ~~and~~as ~~from~~may ~~the~~be ~~European~~required ~~Medicines~~under ~~Agency~~applicable inU.S. ~~the~~securities ~~European Union~~laws. WeIf ~~believe~~we ~~that~~do ~~GMI-1070,~~update ifone ~~approved,~~or ~~would~~more beforward-looking ~~the first drug to interrupt the underlying cause of VOC~~statements, ~~thereby~~no ~~potentially~~inference ~~reducing~~should ~~the~~be ~~use of~~drawn ~~narcotics~~that ~~for~~we ~~pain~~will ~~management~~make ~~and~~additional ~~enabling~~updates ~~patients~~with respect to ~~leave~~those ~~the~~or ~~hospital~~other ~~more~~forward-looking ~~quickly~~statements.

In October 2011, we entered into a collaboration with Pfizer Inc., under which Pfizer is now responsible for the further clinical development, regulatory approval and potential commercialization of GMI-1070 for all indications and Pfizer has commercial rights to GMI-1070 worldwide. Under this collaboration, we received an upfront payment of $22.5 million from Pfizer. We are also eligible to receive up to $115.0 million in development milestone payments, up to $70.0 million in regulatory milestone payments and up to $135.0 million in commercial milestone payments. We are also eligible to receive tiered royalties, with percentages ranging from the low double digits to the low teens, based on net sales of GMI-1070 worldwide. iii

~~Our~~PROSPECTUS proprietary glycomimetics platform is based on our expertise in carbohydrate chemistry and our understanding of the role carbohydrates play in key biological processes. Most human proteins are modified by the addition of complex carbohydrates to the surface of the proteins. The addition of these carbohydrate structures affects the functions of these proteins and their interactions with other molecules. Our initial research and development efforts have focused on drug candidates targeting selectins, which are proteins that serve as adhesion molecules and bind to carbohydrates that are involved in the inflammatory component and progression of a wide range of diseases, including hematologic disorders, cancer and cardiovascular disease. SUMMARY

1This summary may not contain all the information that you should consider before investing in securities. You should read the entire prospectus carefully, including the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our consolidated financial statements and the related notes included elsewhere in this prospectus, before making an investment decision.

~~Table of Contents~~Overview

~~For~~We ~~example,~~are wea ~~believe~~clinical-stage ~~that~~biotechnology ~~members~~company offocused on delivering the ~~selectin~~next ~~family~~wave ~~play~~of transformative therapies to bring a ~~key~~brighter ~~role~~future infor people living with cancer. We have a bold vision to build the ~~onset~~next ~~and~~leading ~~progression~~biotechnology ofoncology ~~VOC~~company. ~~and~~We ~~that~~are ~~GMI~~executing across two distinct strategies to build our portfolio to achieve this vision. First, we are developing CR-~~1070~~001, which ~~binds~~we refer to ~~all~~as ~~three~~a ~~members~~PD-1 ofx ~~the~~VEGF ~~selectin~~bispecific ~~family,~~antibody Ebecause it is designed to bind both the PD-,1 Pimmune checkpoint (“PD- 1”) and ~~L-selectin~~Vascular Endothelial Growth Factor (“VEGF”), ~~inhibits~~which has potential to replace pembrolizumab, marketed by Merck as Keytruda®, as the ~~role~~foundational ~~that~~immuno-oncology ~~selectins~~backbone; ~~play~~second, we are building a robust portfolio of potentially best-in-class ~~VOC~~antibody drug conjugates (“ADCs”). WeImportantly, ~~believe~~as ~~our~~we ~~expertise~~execute inon ~~carbohydrate~~these ~~chemistry~~two ~~and~~strategies, ~~our~~we ~~understanding~~intend ofto ~~carbohydrate~~combine CR-~~protein~~001 ~~binding~~and ~~interactions~~ADC ~~enable~~therapies usto create what we believe will be best-in-class synergistic combinations to ~~design~~transform ~~selectin~~care ~~antagonists~~for multiple types of cancer. We anticipate initiation of CR-001, CR-002 and ~~other~~CR-003 ~~glycomimetics~~monotherapy ~~that inhibit~~clinical trials in 2026 as well as the ~~disease-related~~first ~~functions~~ADC ofcombination ~~certain~~trial ~~carbohydrates.~~with CR-001.

~~Building~~Figure ~~on our experience with GMI-1070, we are developing a pipeline of other glycomimetic drug candidates~~1. Our ~~second~~vision ~~most~~is ~~advanced~~to ~~drug~~create ~~candidate, GMI-1271, is~~ a ~~specific E~~world-~~selectin~~leading ~~inhibitor,~~oncology ~~which~~company ~~we are~~ developing toproducts bethat used in combination with chemotherapy to treat patients with acute myeloid leukemia, or AML, and potentially other hematologic cancers. E-selectin plays a critical role in binding cancer cells within vascular niches in the bone marrow, which prevents the cells from entering circulation where they can be ~~more~~used ~~readily~~as ~~killed~~monotherapies by chemotherapy. We believe that by inhibiting binding interactions between cancer cells and the bone marrow, GMI-1271 may mobilize cancer cells out of the bone marrow and make them more sensitive to chemotherapy, thereby improving response rates and duration of remission in patients with AML. We plan to file an investigational new drug application, or ~~IND, for GMI-1271~~ in the first quarter of 2014. Assuming the IND is accepted, we plan to initiate a Phase 1 dose-escalation clinical trial of GMI-1271 in healthy volunteers in the second quarter of 2014. We intend to follow this trial with Phase 1/2 dose-escalation clinical trials in AML patients. combination

~~Our~~Immune ~~preclinical~~checkpoint ~~pipeline~~inhibitors ~~also~~have ~~includes~~revolutionized ~~other~~the ~~E-selectin~~treatment ~~antagonists~~landscape ~~that~~for wevarious ~~are~~solid ~~designing~~tumors by reactivating the body’s immune system to target and ~~testing~~destroy ~~for~~cancer ~~oral~~cells. ~~availability~~These inhibitors, ~~glycomimetic~~which ~~compounds~~are ~~that~~antibodies ~~simultaneously~~against ~~target~~targets ~~both~~such Eas CTLA-~~selectin~~4 and aPD-1/PD-L1, ~~chemokine receptor~~have ~~known~~shown asunprecedented ~~CXCR4~~anti-tumor activity, and ~~glycomimetic~~have ~~compounds~~become ~~focused~~standard-of-care ontreatments ~~other~~for ~~targets.~~more ~~For~~than ~~example~~40 malignancies, weincluding ~~are~~melanoma, ~~investigating~~non-small ~~several~~cell ~~compounds,~~lung ~~including~~cancer ~~GMI~~(“NSCLC”) and microsatellite instability-~~1051,~~high tumors. These inhibitors have led to ~~treat~~significant ~~pseudomonas~~clinical ~~infections~~outcomes, with notable improvements in ~~combination~~survival ~~with~~rates ~~antibiotics~~and durable responses in patients who previously had limited treatment options. These products have also been successful commercially with worldwide annual sales estimated to be in excess of $50 billion, over half of which are driven by sales of Keytruda.

WeAlthough ~~have~~immune ~~retained~~checkpoint ~~the~~inhibitors ~~worldwide~~are ~~development~~highly ~~and~~effective ~~commercialization~~in ~~rights~~some indications, many patients with solid tumors fail to ~~all~~respond ofto ~~our~~these ~~drug~~therapies. ~~candidates~~Furthermore, ~~other~~patients ~~than~~who ~~GMI~~do respond do not always achieve long-~~1070~~lasting benefit. ~~Our~~There ~~intellectual~~have ~~property~~been ~~portfolio contains~~broad ~~issued~~efforts ~~patents~~by ~~and~~the ~~patent~~pharmaceutical ~~applications~~industry ~~directed~~to identify immuno-oncology products able to, ~~among~~address ~~other~~this ~~things~~unmet clinical need. Ivonescimab, ~~compositions~~a ofPD-1 ~~matter~~x ~~and~~VEGF ~~methods~~bispecific ofantibody ~~use~~in ~~for~~development ~~our~~by ~~drug~~Akeso ~~candidates~~Biopharma and Summit Therapeutics Inc., ~~Our~~is ~~issued~~the ~~patents~~first ~~directed~~drug candidate to ~~GMI-1070~~demonstrate ~~and~~significantly ~~methods~~improved ofprogression ~~use~~free ~~are~~survival ~~expected~~(“PFS”) compared to ~~expire~~Keytruda. ~~between~~In ~~2023~~the ~~and 2030~~HARMONi-2 trial, ~~and~~a ~~our~~randomized, ~~patent~~double-blind, ~~applications~~head-to-head ~~directed~~Phase to3 ~~GMI-1271~~clinical trial in naïve, ifor ~~issued~~not previously treated, ~~are~~advanced ~~expected~~and tometastatic ~~expire~~NSCLC, ~~between~~the ~~2032~~median ~~and~~PFS ~~2033~~with ivonescimab was 11.1 months compared to 5.8 months with Keytruda.

We were founded in 2003 and are headquartered in Gaithersburg, Maryland. Our principal investors are funds managed by New Enterprise Associates, Genzyme Corporation, Anthem Capital, Alliance Technology Ventures and Rosetta Capital. 1

~~Our~~CR-001 ~~Strategy~~is a new molecular entity designed to replicate the functional properties of ivonescimab. Through its ability to bind both PD-1 and VEGF, CR-001 has been shown to have cooperative binding and increased activity of cytotoxic T cell activation. These effects are similar to that observed with ivonescimab in the presence of these ligands which are commonly found in many tumors. We believe the emerging data from the clinical development of ivonescimab supports the rationale for developing CR-001 in light of CR-001 and ivonescimab sharing the same mechanism of action. We do not have any clinical data regarding cancer patients that have been treated with CR-001 and there can be no assurance that clinical trials of CR-001, which have not yet commenced and are expected to cover a broader set of indications than in HARMONi-2, will have similar or comparable results.

~~Our~~We ~~goal~~believe isthat toCR-001 behas the ~~leader~~potential into ~~the~~deliver ~~discovery, development~~improved ~~and~~clinical ~~commercialization~~efficacy ofand ~~novel~~safety ~~glycomimetic~~over ~~drugs~~Keytruda, towhich ~~address~~is ~~unmet~~the ~~medical~~best-selling ~~needs~~drug ~~resulting~~in ~~from~~the ~~diseases~~world inand ~~which~~is ~~carbohydrate~~approved ~~biology~~for ~~plays~~the atreatment ~~key~~of ~~role~~numerous cancers. ~~Leveraging~~Following the ~~potentially~~precedents ~~broad~~set ~~applicability~~by oftraditional ~~our~~PD-1 ~~proprietary glycomimetics platform~~inhibitors, ~~our~~such ~~initial~~as ~~focus~~Keytruda isand toOpdivo®, ~~internally~~we ~~develop~~plan ~~and~~to ~~advance~~seek ~~orphan~~regulatory ~~drug~~approvals ~~candidates~~for ~~targeted~~CR-001 atto ~~hematologic~~treat ~~cancers~~multiple ~~and~~solid ~~other~~tumor ~~diseases,~~indications utilizing monotherapies and tocombination ~~out-license~~treatment ~~any~~options. ~~drug~~We ~~candidates~~intend weto ~~may~~initiate ~~develop~~a ~~that~~Phase ~~are~~1/2 ~~targeted~~trial atof ~~larger~~CR-001 ~~market~~in ~~opportunities.~~NSCLC ~~The key~~and ~~elements~~other ofsolid ~~our~~tumors ~~strategy~~in ~~are~~the ~~to:~~first quarter of 2026.

nCR-002 ~~Support~~is ~~Pfizer’s~~an ~~further~~ADC ~~development~~that ofdelivers ~~our~~a ~~lead~~topoisomerase ~~drug~~toxin ~~candidate~~to cancer cells that express Programmed Death-Ligand 1 (“PD-L1”), ~~GMI~~a cell surface protein that suppresses T-~~1070~~cell activation. WePD-L1 ~~will~~expression ~~continue~~is toelevated ~~work~~in ~~with~~numerous ~~Pfizer~~solid astumors compared to normal tissues, making it ~~proceeds~~an ~~with~~attractive ~~further~~ADC ~~clinical~~target. ~~development~~CR-002 is differentiated from other ADCs through multiple properties. First, a critical feature of ~~GMI~~CR-~~1070~~002 is that it is more efficiently internalized into cancer cells than comparable ADCs. Second, ~~including~~the chemical linkage to its toxin is designed to be stable until it is internalized. Third, the ~~Phase~~cytotoxic 3payload ~~clinical~~is ~~trial~~a ~~that~~topoisomerase weinhibitor ~~expect~~which ~~Pfizer~~has been shown to ~~initiate~~have inhigher ~~mid-2014,~~antitumor activity and ~~pursues~~increased ~~regulatory~~tolerability ~~approval~~when ofincorporated ~~GMI-1070~~into other ADCs as compared to microtubule inhibitors. We ~~expect~~believe that CR-002 has the potential to ~~use~~have ~~any~~improved ~~milestone~~anti-tumor activity and ~~royalty~~tolerability ~~payments~~compared ~~that~~to weother ~~may~~PD-L1 ~~receive~~directed ~~from~~ADCs. ~~Pfizer~~We intend to ~~accelerate~~initiate ~~the~~a ~~development~~Phase 1/2 trial of ~~our~~CR-002 ~~other~~in ~~drug~~the ~~candidates~~second half of 2026.

nWe ~~Rapidly~~recently ~~advance~~announced ~~GMI-1271~~a ~~for~~partnership ~~the~~with ~~treatment~~Sichuan ofKelun-Biotech ~~AML~~Biopharmaceutical Co., WeLtd. ~~intend~~(“Kelun”), a leading Chinese biotech company with commercially approved ADCs, to ~~build~~acquire onexclusive ~~our~~rights ~~experience~~to ~~developing~~SKB105 ~~GMI-1070~~(also referred to ~~rapidly~~as ~~advance~~CR-003), ~~GMI~~an integrin beta-~~1271~~6 ~~for~~(“ITGB6”) ~~the~~directed ~~treatment~~ADC, outside of ~~AML~~mainland inChina, ~~combination~~Hong ~~with~~Kong, ~~chemotherapy~~Macau, and Taiwan (collectively, “Greater China”). WeITGB6 ~~plan~~is tooverexpressed ~~file~~in anmany ~~IND~~solid tumors and its high expression correlates with ~~the~~tumor ~~FDA~~size, invascular ~~the~~invasion, ~~first~~metastatic ~~quarter~~potential, ofdisease ~~2014~~recurrence ~~for~~and ~~this~~worse ~~indication~~prognosis. ~~Assuming~~We ~~the~~intend ~~IND~~to isdevelop ~~accepted~~SKB105 as CR-003, wea ~~plan~~product designation which previously referred to ~~initiate~~a preclinical ADC asset under the Paragon option agreement. ITGB6 is a ~~Phase~~target 1with ~~dose-escalation~~emerging clinical ~~trial~~data ingenerated ~~healthy~~by ~~volunteers~~third inparty ~~the~~ADCs. ~~second~~We ~~quarter~~believe ofthat ~~2014,~~CR-003 has the potential to bedeliver ~~followed~~potent byantitumor activity based on its improved potency and half-life in preclinical models. A Phase 1/2 ~~dose~~trial of CR-~~escalation~~003 ~~clinical~~is ~~trials~~anticipated to be initiated in the first quarter of 2026 in China.

2Combinations of immune checkpoint inhibitors and ADCs with a topoisomerase payload are a growing area of interest as third party results have demonstrated improvements in PFS. In the ASCENT-04 trial, sacituzumab govitecan, marketed as Trodelvy® by Gilead Sciences, in combination with pembrolizumab led to a statistically significant and clinically meaningful improvement in PFS versus chemotherapy plus pembrolizumab with durable responses, no new safety concerns and a lower rate of treatment discontinuation due to treatment-emergent adverse events (“TEAEs”) in patients with previously untreated, PD-L1–positive advanced triple negative breast cancer (“TNBC”).

~~Table~~The potential to combine CR-001 with ADCs is a key element of ~~Contents~~our partnership with Kelun. As part of our agreement, we granted Kelun exclusive rights to CR-001 in Greater China. With this partnership we can mutually advance CR-001 and CR-003 globally. Both companies have the ability to develop both of these molecules as monotherapies or in combinations with other therapies, including ADCs. We anticipate that clinical results generated by Kelun evaluating CR-001 in combination with their full suite of ADCs will inform and accelerate the development of both CR-001 and our own ADC pipeline in the rest of the world. This partnership enables parallel generation of clinical data for CR-001 in both Western and Chinese patients limiting the need for translate effects across populations. We anticipate initiating the first CR-001 ADC combination trial in the second half of 2026.

~~defined populations of patients with AML. We have retained worldwide development and commercialization rights to GMI-1271.~~2

~~n Identify and develop additional novel selectin antagonists to address unmet medical needs with significant market potential.~~ We ~~believe~~envision ~~our~~multiple ~~glycomimetics~~opportunities ~~platform will enable us~~ to ~~develop~~establish aand ~~broad~~maintain ~~pipeline of potential drug candidates that may be orphan drugs or may address larger~~ market ~~opportunities.~~leadership Wein ~~are~~oncology inthrough ~~the~~careful ~~process~~selection of ~~selecting~~ADC ~~and~~products ~~intend~~based toon ~~develop~~targets ~~a drug candidate that simultaneously inhibits both E-selectin~~ and ~~CXCR4 for use in the treatment of cancers with significant bone marrow involvement, such as myeloma~~payloads. We ~~are~~plan ~~also~~to ~~working~~continue to ~~design~~expand anour ~~orally~~product ~~available~~portfolio ~~E-selectin~~through ~~antagonist,~~a ~~which~~combination ~~we believe could be~~ of ~~significant~~internal ~~interest to potential collaborators for major market opportunities~~development, ~~such~~our asrelationship ~~the~~with ~~treatment~~Paragon ofand ~~cardiovascular~~external ~~disease~~sources.

nOur Apply our insights and our glycomimetics platform to other carbohydrate targets beyond selectins. We have identified additional opportunities where carbohydrates play critical roles in disease processes and where we believe we can apply our platform to create targeted glycomimetic drugs. One potential target is pseudomonas, a pathogenic form of bacteria that results in serious infections and is frequently resistant to treatment with antibiotics. We have observed results in animal models that suggest glycomimetic drugs can be used to improve treatment of pseudomonas infections. We have an active preclinical program testing and optimizing compounds to treat these infections.Pipeline

Our ~~Pipeline~~ Strategy

We ~~have~~are ~~discovered~~focused ~~our~~on ~~drug~~delivering ~~candidates~~the ~~internally~~next ~~through~~wave aof ~~rational~~transformative ~~drug~~therapies ~~design~~to ~~approach~~bring ~~that~~a ~~couples~~brighter ~~our~~future ~~expertise~~for inpeople ~~carbohydrate~~living ~~chemistry~~ with ~~our~~cancer. ~~knowledge~~We ofhave ~~carbohydrate~~a ~~biology.~~bold Wevision ~~are~~to ~~actively~~build ~~developing glycomimetic~~the ~~drug~~next ~~candidates~~leading ~~based~~biotechnology oncompany. ~~this~~Our ~~expertise.~~strategy is to:

~~GMI~~•Obtain clinical proof-~~1070—Targeting~~of-concept ~~Selectins~~data towith ~~Treat~~CR-001 ~~VOC~~in a Phase 1/2 trial.

We•Develop ~~are developing GMI~~CR-~~1070,~~001 a glycomimetic drug candidate that acts as a pan-selectin antagonist, meaning that it binds to all three members of the selectin family, to treat VOC. We believe that GMI-1070, by acting as a pan-selectin antagonist, inhibits the role that selectins play in ~~VOC.~~multiple ~~We have completed four clinical trials of GMI-1070 involving a total of 163 subjects~~indications.

In•Advance ~~April~~our ~~2013,~~ADC weprograms ~~completed~~into ~~a Phase 2~~ clinical ~~trial in 76 patients hospitalized for VOC~~development. This was a randomized, double-blind, placebo-controlled trial evaluating the safety, efficacy and pharmacokinetics of standard of care plus multiple intravenous, or IV, doses of either GMI-1070 or placebo in patients ranging from 12 to 60 years old. In this trial, patients treated with GMI-1070 experienced reductions in the time to reach resolution of VOC, length of hospital stay and use of opioid analgesics for pain management, in each case as compared to patients receiving placebo. The time to reach resolution of VOC, the primary endpoint of the trial, was reduced in the patients receiving GMI-1070 by over 40 hours, the time to hospital discharge was reduced

3•Develop CR-001 as a backbone therapy used in combination with ADCs.

~~Table~~•Expand our portfolio of ~~Contents~~product candidates.

byPrivate ~~over~~Placement 50of ~~hours,~~Ordinary ~~the~~Shares ~~time to transition off IV analgesics was reduced by over 45 hours~~ and the cumulative amount of opioid analgesic administered during hospitalization was reduced by over 80%. Although the study was not large enough to detect statistically significant differences, we believe the reductions we observed in these measures with GMIPre-~~1070~~Funded ~~therapy,~~Warrants ~~and~~& ~~the~~Issuance ~~consistency~~ of aOrdinary ~~positive~~Shares response across multiple measures related to a VOC episode, demonstrate the potential benefit of GMI-1070. Based on the data from our Phase 2 clinical trial for GMI-1070, we believe GMI-1070 has the potential to become the first drug approved to treat VOC in both adult and pediatric patient populations. Although Mast Therapeutics, Inc. is currently conducting a Phase 3 clinical trial of a drug candidate that may be used to treat an ongoing VOC episode, we believe that it is only being tested in pediatric patients ages 8 to 17 years old, unlike GMIPre-~~1070~~Funded ~~which~~Warrants ~~is being tested~~ to ~~treat both adult and pediatric patients experiencing VOC.~~ Fairmount

IfOn ~~GMI-1070~~December is8, ~~demonstrated~~2025, towe becompleted ~~safe~~the ~~and effective~~Private ~~for~~Placement ~~the~~of ~~treatment~~our ofPrivate ~~VOC,~~Placement weShares ~~believe~~and itPrivate ~~may~~Placement ~~show~~Pre-Funded ~~substantial~~Warrants ~~clinical~~pursuant ~~and~~to ~~pharmacoeconomic~~the ~~benefit~~Securities ~~and~~Purchase ~~may~~Agreement ~~therefore~~dated ~~result~~December in4, a2025 ~~significant~~(the ~~market~~“SPA”) ~~opportunity~~with ~~for~~the ~~GMI-1070~~Selling ~~worldwide~~Securityholders. InThe ~~addition,~~Selling ifSecurityholders ~~GMI-1070~~purchased is(i) ~~shown~~an toaggregate beof ~~safe~~13,664,251 Private ~~and effective~~Placement Shares at ~~reducing~~a ~~the~~price ~~duration~~per share of ~~VOC~~$13.41 inand ~~hospitalized~~(ii) ~~patients,~~Private itPlacement ~~could~~Pre-Funded ~~also~~Warrants beto ~~tested~~purchase inan ~~people~~aggregate ~~experiencing~~of ~~VOC~~131,434 ~~who~~Ordinary ~~are~~Shares ~~not~~at ~~hospitalized~~a topurchase ~~determine~~price ifof ~~hospitalization~~$13.409 ~~could~~per bePrivate ~~prevented.~~Placement ~~Following~~Pre-Funded Warrant, which represents the ~~completion~~per share purchase price of the ~~Phase~~Private 2Placement ~~clinical trial,~~Shares ~~Pfizer~~less isthe ~~responsible~~$0.001 exercise price for ~~all~~each ~~further~~Private ~~development~~Placement ~~and~~Pre-Funded ~~commercialization~~Warrant ~~efforts~~Share, ~~with~~for ~~respect~~an toaggregate ~~GMI-1070~~purchase price of approximately $185.0 million.

~~GMI-1271—Targeting~~In addition, prior to the ~~Bone Marrow~~closing ~~Microenvironment~~of the Private Placement, we previously issued and sold to ~~Treat~~Fairmount, ~~Hematologic~~and, ~~Cancers~~as of immediately prior to the closing of the Private Placement, Fairmount held, (i) 1,387,866 outstanding Fairmount Shares, (ii) Fairmount Pre-Funded Warrants to purchase 1,636,706 Ordinary Shares with an exercise price of $0.001 per Fairmount Pre-Funded Warrant Share, and (iii) Fairmount Series A Shares convertible into 2,890,000 Ordinary Shares.

WeThe ~~are~~sales ~~developing~~of ~~GMI-1271,~~Private aPlacement ~~specific E-selectin antagonist~~Shares, toPrivate bePlacement ~~used in combination with chemotherapy to treat AML and potentially other hematologic cancers. GMI~~Pre-~~1271~~Funded ~~targets interactions between cancer cells and the bone marrow microenvironment. Leukemia cells bind to E-selectin in the bone marrow~~Warrants, ~~where~~Fairmount ~~they are somewhat protected from chemotherapy. In preclinical studies~~Shares, EFairmount Pre-~~selectin~~Funded ~~inhibition~~Warrants ~~disrupted the adhesion of leukemia cells in the bone marrow~~ and ~~mobilized them out of~~ the ~~bone~~Fairmount ~~marrow~~Series ~~and~~A ~~into~~Shares ~~the~~were ~~bloodstream,~~not ~~making~~registered ~~them~~under ~~more sensitive to chemotherapy. In other preclinical studies, GMI-1271 reduced some of~~ the ~~toxic~~Securities ~~effects of chemotherapy~~Act, ~~such as neutropenia~~ and ~~mucositis,~~such onsales ~~normal cells. As a result, we believe GMI-1271 may improve chemotherapy response rates, duration of remission and, ultimately, survival in patients with hematologic cancers like AML.~~

AML, a hematologic cancer that is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells, is a relatively rare disease, but one that accounts for the largest number of annual deaths from leukemia in the United States. The American Cancer Society estimates that in 2013, approximately 15,000 people in the United States will be diagnosed with AML and over 10,000 people in the United States will die of the disease. 3

Wewere ~~are~~intended ~~planning~~ to ~~hold~~be aexempt ~~pre-IND~~from ~~meeting~~registration ~~with~~pursuant ~~the FDA in the fourth quarter of 2013 and~~ to ~~file~~Section an4(a)(2) ~~IND for GMI-1271 in the first quarter~~ of ~~2014. Assuming~~ the ~~IND~~Securities isAct ~~accepted,~~as wetransactions ~~plan to initiate a Phase 1 dose-escalation clinical trial in healthy volunteers in the second quarter of 2014, to be followed~~ by ~~Phase 1/2~~an ~~dose-escalation~~issuer ~~clinical~~not ~~trials~~involving ina ~~defined~~public ~~populations of patients with AML~~offering.

~~Drug~~Summary ~~Candidates~~Risk ~~Targeting~~Factors ~~E-selectin~~Associated ~~and~~with ~~CXCR4~~Our Business

~~We have~~The ~~identified~~following asummarizes ~~family~~the ofprincipal ~~drug~~factors ~~candidates~~ that ~~are~~make ~~designed~~an toinvestment ~~simultaneously~~in ~~inhibit~~us ~~both~~speculative ~~E-selectin~~or ~~and~~risky, ~~CXCR4.~~all Weof ~~intend~~which toare ~~select~~more ~~one~~fully ofdescribed ~~these~~in ~~drug~~the ~~candidates~~Risk toFactors section below. This summary should be ~~developed~~read ~~for~~in conjunction with the ~~treatment~~Risk ofFactors ~~cancers~~section ~~with~~and ~~significant~~should ~~bone~~not ~~marrow involvement,~~be ~~such~~relied upon as ~~myeloma.~~an ~~CXCR4~~exhaustive issummary aof ~~binding~~the ~~protein~~material onrisks ~~the~~facing ~~surface~~our business. The occurrence of ~~stem~~any ~~cells~~of ~~that~~these ~~keeps~~risks ~~them~~could inharm ~~the~~our ~~bone~~business, ~~marrow~~financial condition, results of operations and/or ~~prevents~~growth ~~them~~prospects ~~from~~or ~~entering~~cause ~~the~~our ~~bloodstream.~~actual ~~Due~~results to ~~the~~differ ~~similar~~materially ~~cellular~~from ~~functions~~those ofcontained Ein forward-~~selectin~~looking statements we have made in this prospectus and ~~CXCR4~~those aswe ~~adhesion molecules~~may ~~that~~make ~~bind~~from ~~cancer~~time ~~cells~~to intime. ~~the~~In ~~bone~~such ~~marrow~~case, wethe ~~believe~~trading ~~that~~price ~~targeting~~of ~~both~~our ~~E-selectin~~ordinary ~~and~~shares ~~CXCR4~~would ~~with~~likely adecline, ~~single~~and ~~compound~~you ~~could~~may ~~improve~~lose ~~efficacy~~all inor ~~the~~part ~~treatment~~ of ~~cancers~~your ~~that~~investment. ~~affect~~You should consider all the ~~bone~~risk ~~marrow,~~factors asdescribed ~~compared~~in tothis ~~targeting~~prospectus ~~CXCR4~~when ~~alone.~~ evaluating our business

~~GMI-1051~~Risks ~~and~~Related ~~Other~~to ~~Drug~~Our ~~Candidates~~Financial ~~Targeting~~Condition ~~Pseudomonas~~and ~~Virulence~~Capital ~~Factors~~ Requirements

~~Pseudomonas~~•We ~~bacteria express and secrete molecules known as virulence factors, which~~ are ~~involved~~a inclinical-stage ~~key~~biotechnology ~~functions~~company ofwith ~~bacterial~~a ~~survival~~limited ~~and~~operating ~~propagation.~~history ~~These~~on ~~virulence~~which ~~factors bind~~ to ~~specific~~assess ~~carbohydrate structures,~~our ~~which~~business; we ~~believe can be targeted with glycomimetic drugs. We~~ have ~~developed~~not ~~one~~completed ~~drug~~any ~~candidate,~~clinical ~~GMI-1051~~trials, ~~which~~and ishave anno ~~antagonist~~products ofapproved ~~two~~for ~~important~~commercial ~~pseudomonas virulence factors, PA-IL and PA-IIL~~sale. ~~We have~~

4•We have historically incurred losses and we anticipate that we will continue to incur losses for the foreseeable future.

~~Table~~•We ofhave ~~Contents~~never generated revenue from product sales and may never be profitable.

conducted a number of in vitro and in vivo preclinical studies of GMI-1051. In each study, GMI-1051 inhibited the functions of both PA-IL and PA-IIL and had greater affinity for these targets than did the native carbohydrates. •We ~~also~~may ~~studied~~not ~~GMI-1051~~be inable vivo in three animal models of pseudomonas infection. In one study, GMI-1051 improved survival of mice in a chronic lung infection model when given in combination with tobramycin, an antibacterial often used to ~~treat~~raise ~~pseudomonas~~the ~~infections,~~capital asthat ~~compared~~we toneed treatment with tobramycin alone. In two other studies, GMI-1051 reduced bacterial load in an acute lung infection model and improved survival in a model of surgical infection. We are actively testing and optimizing GMI-1051 and other similar compounds to ~~identify~~support ~~the~~our ~~most~~business ~~suitable candidates for further development~~plans.

~~Risks~~•Raising ~~Associated~~additional ~~with~~capital ~~Our~~may ~~Business~~cause dilution to our shareholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.

~~Our~~Risks ~~business~~Related ~~is subject~~ to aClinical ~~number~~Development ofand ~~risks~~Regulatory of which you should be aware before deciding to invest in our common stock. These risks are discussed more fully in the “Risk Factors” section of this prospectus. These risks include the following: Approval

n•Drug Wedevelopment ~~have~~and ~~incurred~~obtaining ~~significant~~and ~~losses~~maintaining ~~since~~regulatory ~~our~~approval ~~inception.~~for Wedrug ~~expect~~products tois ~~continue~~costly, totime-consuming, ~~incur losses over the next several years~~ and ~~may~~highly ~~never achieve or maintain profitability~~uncertain.

n •We ~~will~~are ~~need~~substantially ~~substantial~~dependent ~~additional~~on ~~funding~~the tosuccess ~~pursue~~of our ~~business~~lead ~~objectives. If we are unable to raise capital when needed~~program, ~~we could be forced to delay~~CR-001, ~~reduce~~and orour ~~eliminate~~anticipated ~~our~~clinical ~~drug~~trials ~~development~~of ~~programs~~such orprogram ~~potential~~may ~~commercialization~~not ~~efforts~~be successful.

n•We ~~Our~~may ~~research~~not ~~and~~be ~~development~~able isto ~~focused~~meet onrequirements ~~discovering~~for ~~and~~the ~~developing~~chemistry, ~~novel glycomimetic drugs~~manufacturing, and wecontrol ~~are~~of ~~taking~~our ~~an innovative approach to discovering and developing drugs, which may never lead to marketable drugs~~programs.

n •We ~~are~~face ~~very~~competition ~~early~~from inentities ~~our~~that ~~development efforts and~~ have ~~only~~developed ~~one~~or ~~drug~~may ~~candidate,~~develop ~~GMI-1070,~~programs ~~that~~for ~~has~~the ~~completed~~diseases aaddressed ~~clinical~~by ~~trial.~~product ~~All of our other drug~~ candidates ~~are~~developed ~~still~~by ~~in preclinical development~~us. ~~If we or our collaborators are unable to commercialize our drug candidates or experience significant delays in doing so, our business will be materially harmed.~~

n•The ~~Our~~United ~~success~~States isFood ~~highly~~and ~~dependent~~Drug onAdministration ~~our~~(“FDA”) ~~existing~~and ~~collaboration~~comparable ~~with~~foreign ~~Pfizer,~~regulatory ~~and~~approval ~~future~~processes ~~collaborations~~are ~~may~~lengthy ~~also~~and betime ~~important~~consuming toand ~~us.~~we Ifmay wenot ~~are~~be ~~unable~~able to ~~maintain~~obtain ~~any~~or ofmay ~~these~~be ~~collaborations,~~delayed orin ifobtaining ~~these~~regulatory ~~collaborations~~approvals ~~are~~for ~~not successful,~~ our ~~business~~product ~~could be adversely affected~~candidates.

n•Disruptions ~~Our~~at ~~future~~the ~~success~~FDA ~~depends~~and onother ~~our~~government ~~ability~~agencies tocould ~~retain~~negatively ~~key~~affect ~~executives~~the ~~and~~review toof ~~attract~~our regulatory submissions, ~~retain~~which ~~and~~could ~~motivate~~negatively ~~qualified~~impact ~~personnel~~our business.

n•Even Weif ~~face~~we ~~substantial~~obtain ~~competition,~~regulatory ~~which may result in others discovering~~approval, ~~developing~~we orwill ~~commercializing~~be ~~drugs~~subject ~~before~~to orongoing ~~more~~regulatory ~~successfully than we do~~obligations.

~~Corporate~~•We ~~Information~~may fail to achieve our projected development goals in the time frames we announce and expect.

WeRisks ~~were incorporated~~Related ~~under~~to ~~the laws of the State of Delaware in April 2003 and commenced operations in May 2003.~~ Our ~~principal~~Intellectual executive offices are located at 401 Professional Drive, Suite 250, Gaithersburg, Maryland 20879. Our telephone number is (240) 243-1201. Our website address is www.glycomimetics.com. The information contained on our website is not incorporated by reference into this prospectus, and you should not consider any information contained on, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our common stock. Property

~~“GlycoMimetics,”~~▪We ~~the GlycoMimetics~~do ~~logo~~not ~~and~~currently ~~other~~own ~~trademarks~~any orissued ~~service~~patents ~~marks~~and ofour ~~GlycoMimetics,~~patent ~~Inc.~~portfolio ~~appearing~~is in-licensed ~~this~~from ~~prospectus~~Paragon ~~are~~and ~~the property of GlycoMimetics, Inc~~Kelun. ~~This~~Our ~~prospectus~~ability ~~contains~~to ~~additional~~obtain ~~trade names, trademarks~~ and ~~service~~protect ~~marks~~patent ofrights ~~others,~~and ~~which~~protect ~~are the~~other ~~property~~proprietary ofrights ~~their~~is ~~respective owners~~uncertain.

~~Implications~~•We ofmay ~~Being~~fail anin ~~Emerging~~obtaining ~~Growth~~or ~~Company~~maintaining necessary rights to our programs.

As a company with less than $1 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from some of 4

5•We may be subject to patent infringement claims or may need to file such claims.

~~Table~~•Our ofability ~~Contents~~to protect our products may be impaired by changes to patent laws.

~~the~~•Our ~~reporting~~patent ~~requirements~~protection ~~that~~could ~~are~~be ~~applicable~~reduced toor ~~other~~eliminated ~~public~~for ~~companies~~non-compliance ~~that~~with ~~are~~legal ~~not emerging growth companies~~requirements. ~~These exemptions include:~~

n•We ~~being~~may ~~permitted~~fail to ~~provide~~identify ~~only~~or ~~two~~interpret ~~years~~relevant ofthird-party 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;patents.

n•We ~~not~~may ~~being~~become ~~required~~subject to ~~comply~~claims ~~with~~challenging the ~~auditor~~inventorship ~~attestation~~or ~~requirements~~ownership ~~in the assessment~~ of our ~~internal~~intellectual ~~control over financial reporting;~~property.

n•Patent ~~not~~terms ~~being required to comply with any requirement that~~ may be ~~adopted~~inadequate ~~by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement~~ to ~~the~~protect ~~auditor’s~~our ~~report~~competitive ~~providing~~position ~~additional~~of ~~information~~our ~~about the audit and the financial statements;~~programs.

n•Our ~~reduced~~technology ~~disclosure~~licensed ~~obligations~~from ~~regarding~~Paragon ~~executive~~and ~~compensation;~~Kelun and any technology licensed from other third-parties in the future may be subject to retained rights.

nRisks ~~not~~Related ~~being required~~ to ~~hold~~Our aReliance ~~non-binding advisory vote~~ on ~~executive~~Third ~~compensation or obtain stockholder approval of any golden parachute payments not previously approved.~~Parties

•We ~~may~~currently ~~take~~and ~~advantage~~in ~~of these reporting exemptions until we are no longer an emerging growth company. We will remain an emerging growth company until~~ the ~~earlier~~future ofexpect ~~(1) the~~to ~~last~~rely ~~day~~on ofagreements ~~the~~with ~~fiscal~~third ~~year~~parties ~~(a) following~~to ~~the~~develop ~~fifth~~our ~~anniversary~~product ofcandidates. ~~the~~If ~~completion of this offering, (b) in which~~ we ~~have~~are ~~total~~unable ~~annual~~to ~~gross~~maintain ~~revenue~~our ofcurrent ator ~~least~~future $1collaborations ~~billion~~ or ~~(c) in~~ ~~which~~licensing ~~we are deemed to be a large accelerated filer~~arrangements, ~~which~~or ~~means~~if ~~the market value of~~ our ~~common~~current ~~stock~~or ~~that~~future iscollaborations ~~held~~or bylicensing ~~non-affiliates~~arrangements ~~exceeds~~are $700 million as of the prior June 30th and (2) the date on which we have issued more than $1 billion in non-convertible debt during the prior three-year period. We may choose to take advantage of some, but not ~~all~~successful, ofour ~~the~~business ~~available~~could ~~exemptions. We have taken advantage of some reduced reporting burdens in this prospectus. Accordingly, the information contained herein may~~ be ~~different~~negatively ~~than the information you receive from other public companies in which you hold stock~~impacted.

In•Third ~~addition, under~~parties ~~the~~we ~~JOBS~~rely ~~Act,~~on ~~emerging~~for ~~growth~~the ~~companies~~execution ~~can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves~~ of ~~this~~nonclinical ~~exemption~~studies ~~from new or revised accounting standards~~ and, ~~therefore,~~clinical wetrials ~~will~~may befail ~~subject~~ to ~~the~~carry ~~same~~out ~~new~~their orcontractual ~~revised accounting standards as other public companies that are not emerging growth companies~~duties.

6•We may be unable to use third-party manufacturing sites, our third-party manufacturers may encounter difficulties in production, or we may need to switch or create third-party manufacturer redundancies.

~~Table~~Other ofRisk ~~Contents~~Factors - Risks Related to Employee Matters, Managing Growth, Other Risks Related to Our Business, and Owning Our Ordinary Shares

~~The~~•Our ~~Offering~~business is dependent on key personnel and we will be harmed if we cannot recruit and retain highly qualified personnel to successfully implement our business strategy.

~~Common~~•In ~~stock~~order ~~offered~~to bysuccessfully ~~GlycoMimetics~~implement ~~shares~~our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth.

~~Total~~•Our ~~common~~estimates ~~stock~~of market opportunity and forecasts of market growth may prove to be ~~outstanding~~inaccurate, ~~after~~and ~~this~~even ~~offering~~if ~~shares~~the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.

~~Option~~•Significant todisruptions ~~purchase additional shares~~ of ~~common~~information ~~stock~~technology Wesystems ~~have~~or ~~granted~~breaches ~~the underwriters an option for a period~~ of 30data ~~days~~security ~~from~~could ~~the~~adversely ~~date~~affect ~~of this prospectus to purchase an additional shares of~~ our ~~common stock~~business.

~~Use~~•Changes ofin ~~proceeds~~and Wefailures ~~expect the net proceeds~~ to uscomply ~~from~~with ~~this~~United ~~offering,~~States ~~after~~and ~~expenses,~~foreign toprivacy beand ~~approximately~~data $protection ~~million~~laws, ~~based on an assumed initial public offering price of $ per share~~regulations, ~~which~~and isstandards ~~the~~may ~~midpoint~~adversely ofaffect ~~the price range set forth on the cover page of this prospectus. The principal purposes of this offering are to create a public market for~~ our ~~common~~business, ~~stock~~operations, and toconsolidated ~~facilitate~~financial ~~our future access to the public equity markets, as well as to obtain additional capital~~performance. ~~We intend to use the net proceeds from this offering as follows:~~

n•We ~~approximately~~may $become ~~million~~exposed to ~~conduct~~costly ~~planned~~and ~~Phase~~damaging 1liability claims and ~~Phase~~our ~~1/2~~insurance ~~clinical~~may ~~trials~~not ofcover ~~GMI-1271;~~all damages from such claims.

n•Our ~~approximately~~business $could ~~million~~be toadversely ~~fund~~affected ~~the~~by ~~research~~macroeconomic ~~and development of our preclinical pipeline~~conditions, including ~~drug discovery; and~~tariffs.

n•We ~~the~~do ~~remainder~~not ~~for~~anticipate ~~working~~paying ~~capital~~any ~~and~~dividends ~~other~~in ~~general~~the ~~corporate~~foreseeable ~~purposes~~future.

~~See~~•Future ~~“Use~~sales of ~~Proceeds”~~shares onby ~~page~~existing 39shareholders ~~for~~could ~~additional~~cause ~~information~~our share price to decline.

~~Risk~~•Future ~~factors~~sales ~~See~~and ~~the~~issuances ~~section~~of ~~titled~~equity ~~“Risk Factors” beginning on page 11~~ and ~~the~~debt ~~other~~could ~~information~~result ~~included~~ in ~~this~~additional ~~prospectus~~dilution ~~for~~to aour ~~discussion~~shareholders ofand ~~factors~~could ~~you~~cause ~~should~~our ~~carefully~~share ~~consider~~price ~~before deciding~~ to ~~invest in our common stock~~decline.

~~Proposed NASDAQ Global Market symbol GLYC~~5

~~The~~Implications ~~number~~ of ~~shares~~Being ofa ~~our~~Smaller ~~common~~Reporting ~~stock that will be outstanding after this offering is based on 3,127,693 shares of common stock outstanding as of June 30, 2013, and excludes:~~ Company

nWe 4are a “smaller reporting company,~~876,698~~” ~~shares~~as ofdefined ~~our~~in ~~common~~the ~~stock~~Exchange ~~issuable~~Act. ~~upon~~We will continue to be a smaller reporting company as long as (i) the ~~exercise~~market value of ~~stock~~our ~~options~~ordinary ~~outstanding~~shares ~~under~~held by non-affiliates is less than $250.0 million or (ii) our ~~2003~~annual ~~stock~~revenue ~~incentive~~is ~~plan~~less asthan $100.0 million during the most recently completed fiscal year and the market value of ~~June~~our 30ordinary shares held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, ~~2013~~we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, atas a ~~weighted~~smaller ~~average~~reporting ~~exercise~~company, ~~price~~we may choose to present only the two most recent fiscal years of ~~$0.37~~audited ~~per~~financial ~~share;~~statements in our Annual Report on Form 10-K and smaller reporting companies have reduced disclosure obligations regarding executive compensation.

nCorporate shares of our common stock issuable upon the exercise of stock options granted as of the date of this prospectus under our 2013 equity incentive plan, at an exercise price equal to the initial public offering price of $ per share;Information

nWe ~~2,097,625~~were ~~shares~~incorporated under the laws of ~~our~~the ~~common~~State ~~stock~~of ~~issuable~~Delaware ~~upon~~in ~~exercise~~2003. ofOur ~~warrants~~company, ~~outstanding~~formerly known as GlycoMimetics, Inc. (“GlycoMimetics”), is a biotechnology company that is the result of ~~June~~a 30reverse recapitalization transaction with a private company named Crescent Biopharma, ~~2013~~Inc. (“Pre-Merger Crescent”). Prior to the reverse recapitalization transaction, atPre-Merger aCrescent ~~weighted~~was ~~average~~established ~~exercise~~and ~~price~~incorporated under the laws of $0the state of Delaware on September 19, 2024.12 ~~per~~Pre-Merger ~~share;~~Crescent was founded to research and develop cancer therapy candidates.

nOn anJune ~~additional~~16, ~~shares~~2025, ofin ~~our~~connection ~~common~~with ~~stock~~the ~~reserved~~reverse ~~for~~recapitalization ~~future~~transaction ~~issuance~~with ~~under~~Pre-Merger Crescent, we changed our ~~equity~~jurisdiction ~~incentive~~of ~~plans~~incorporation ~~following~~from ~~this~~the ~~offering~~State of Delaware to the Cayman Islands pursuant to a plan of conversion.

7Our principal executive offices are located at 300 Fifth Avenue, Waltham, MA 02451, and our telephone number is (617) 430-5595.

~~Table of Contents~~6

~~Except~~The ~~as otherwise indicated herein, all information in this prospectus, including the number of shares that will be outstanding after this offering, assumes or gives effect to:~~ Offering

n a -for- reverse stock split of our common stock expected to be effected prior to the completion of this offering;


Ordinary shares offered by the Selling Securityholders						Up to (i) 13,664,251 outstanding Ordinary Shares issued and sold to the Selling Securityholders in the Private Placement, (ii) 131,434 Ordinary Shares issuable upon the exercise of pre-funded warrants issued and sold to the Selling Securityholders in the Private Placement and (iii) 1,387,866 outstanding Ordinary Shares, 1,636,706 Ordinary Shares issuable upon the exercise of pre-funded warrants and 2,890,000 Ordinary Shares issuable upon the conversion of Series A non-voting convertible preferred shares, in each case, held by Fairmount Healthcare Fund II L.P. as of immediately prior to the closing of the Private Placement. The Ordinary Shares being registered for resale under the registration statement of which this prospectus forms a part are referred to herein as the “Resale Shares.”

Terms of the Offering						The Selling Securityholders will determine when and how they will dispose of the Resale Shares being registered for resale under the registration statement of which this prospectus forms a part.

Shares Outstanding						As of December 31, 2025, there were 27,556,767 Ordinary Shares outstanding and 2,890 Series A non-voting convertible preferred shares outstanding.

Use of proceeds						We will not receive any proceeds from the sale of the Resale Shares offered by the Selling Securityholders under this prospectus. The net proceeds from the sale of the Resale Shares offered by this prospectus will be received by the Selling Securityholders. Upon any exercise of the Private Placement Pre-Funded Warrants or Fairmount Pre-Funded Warrants by payment of cash, however, we will receive the nominal cash exercise price paid by the holders thereof. See the section titled “Use of Proceeds.”

Risk factors						See the section titled “Risk Factors” and other information included in this prospectus for a discussion of factors that you should consider carefully before deciding to invest in our securities.

Nasdaq Capital Market trading symbol						“CBIO”

nThe ~~the~~number ~~conversion~~ of ~~all outstanding shares of~~ our ~~convertible~~Ordinary ~~preferred~~Shares ~~stock~~outstanding ~~into~~above anexcludes ~~aggregate of 30,726,326 shares of our common stock, which will occur automatically upon~~ the ~~completion of this offering; and~~following:

n•2,890,000 noOrdinary ~~exercise~~Shares issuable upon conversion of ~~the~~our ~~underwriters’~~Series ~~option~~A tonon-voting ~~purchase~~convertible ~~additional~~preferred shares outstanding as of ~~our~~December ~~common~~31, ~~stock.~~2025;

8•2,898,556 Ordinary Shares issuable upon exercise of our pre-funded warrants outstanding as of December 31, 2025, with an exercise price of $0.01 per share (including the 131,434 Ordinary Shares issuable upon exercise of the Private Placement Pre-Funded Warrants and 1,636,706 Ordinary Shares issuable upon exercise of the Fairmount Pre-Funded Warrants);

~~Table~~•1,901,561 Ordinary Shares issuable upon the exercise of ~~Contents~~options outstanding as of December 31, 2025 under our 2025 Stock Incentive Plan (the “2025 Plan”), at a weighted-average exercise price of $13.18 per share;

~~Summary~~•303,068 ~~Financial~~Ordinary ~~Data~~Shares issuable upon the vesting of restricted share units outstanding as of December 31, 2025 under our 2025 Plan;

The following tables set forth summary financial data of GlycoMimetics, Inc. for the periods indicated. The following summary financial data for the years ended December 31, 2011 and 2012 are derived from our audited financial statements, which have been audited by Ernst & Young LLP, an independent registered public accounting firm, appearing elsewhere in this prospectus. The data should be read together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in conjunction with the financial statements, related notes and other financial information included elsewhere in this prospectus. The summary statement of operations data for the six months ended June 30, 2012 and 2013 and for the period from May 21, 2003 (date of inception) through June 30, 2013 and the summary balance sheet data as of June 30, 2013 are derived from unaudited financial statements appearing elsewhere in this prospectus. 7

~~The unaudited financial statements include all adjustments~~•3, ~~consisting of normal recurring accruals~~683,519 ~~that~~Ordinary ~~management~~Shares ~~considers~~issuable ~~necessary for~~upon ~~a fair presentation of~~ the ~~financial~~exercise ~~position and the results~~ of ~~operations~~options ~~for~~outstanding ~~these~~as ~~periods. Our historical results are not necessarily indicative~~ of ~~the~~December ~~results to be expected in the future~~31, ~~and~~2025 under our ~~operating~~2024 ~~results~~Equity ~~for~~Incentive Plan (the ~~six~~“2024 ~~months ended June 30~~Plan”), ~~2013~~at ~~are~~a ~~not~~weighted-average ~~necessarily~~exercise ~~indicative~~price of ~~the results that may be expected for the entire year ending December 31, 2013 or any other future period~~$7.90 per share;

	YEAR ENDEDDECEMBER 31,						SIX MONTHS ENDEDJUNE 30,						PERIOD FROMMAY 21, 2003(DATE OF INCEPTION)TO JUNE 30, 2013
(in thousands, except share and per sharedata)	2011			2012			2012			2013
Statement of Operations Data:
Revenue	$	3,814		$	15,257		$	7,542		$	3,863		$	23,465
Costs and expenses:
Research and development		7,799			9,438			4,256			5,624			64,723
General and administrative		2,100			2,157			1,090			1,263			14,233
Total costs and expenses		9,899			11,595			5,346			6,887			78,956
Income (loss) from operations		(6,085	)		3,662			2,196			(3,024	)		(55,491	)
Other income (expense):
Interest income (expense), net		8			21			12			1			(172	)
Other expense, net		(36	)		(27	)		(13	)		(4	)		(34	)
Total other expense		(28	)		(6	)		(1	)		(3	)		(206	)
Net income (loss)	$	(6,113	)	$	3,656		$	2,195		$	(3,027	)	$	(55,697	)
Net income (loss) per share of common stock—basic	$	(1.99	)	$	1.19		$	0.72		$	(0.98	)
Net income (loss) per share of common stock—diluted	$	(1.99	)	$	0.10		$	0.06		$	(0.98	)
Weighted average shares outstanding—basic		3,066,253			3,069,603			3,069,603			3,095,925
Weighted average shares outstanding—diluted		3,066,253			36,376,589			36,383,159			3,095,925
Pro forma net income (loss) per share—basic				$	0.11					$	(0.09	)
Pro forma net income (loss) per share—diluted				$	0.10					$	(0.09	)
Pro forma weighted average shares outstanding—basic					33,795,929						33,822,251
Pro forma weighted average shares outstanding—diluted					36,376,589						33,822,251

•438,386 Ordinary Shares issuable upon the vesting of restricted share units outstanding as of December 31, 2025 under our 2024 Plan;

9•581,074 Ordinary Shares issuable upon the exercise of options outstanding as of December 31, 2025 under our 2025 Employment Inducement Incentive Award Plan (the “2025 Inducement Plan”), at a weighted-average exercise price of $13.06 per share;

~~Table~~•141,333 Ordinary Shares reserved for future issuance under the 2025 Plan as of ~~Contents~~December 31, 2025, as well as any automatic increase in the number of Ordinary Shares reserved for future issuance under our 2025 Plan;

~~The~~•668,926 ~~following~~Ordinary ~~table~~Shares ~~presents~~reserved ~~our~~for ~~summary~~future ~~balance~~issuance ~~sheet~~under ~~data:~~the 2025 Inducement Plan; and

n•195,497 onOrdinary anShares ~~actual~~reserved ~~basis~~for future issuance under our 2025 Employee Stock Purchase Plan (the “ESPP”) as of ~~June~~December 3031, ~~2013;~~2025, as well as any automatic increase in the number of Ordinary Shares reserved for future issuance under our ESPP.

nExcept onas aotherwise ~~pro~~indicated, ~~forma~~all ~~basis~~information toin ~~give~~this ~~effect~~prospectus toassumes ~~the~~no ~~conversion~~exercise of ~~all~~ outstanding ~~shares~~options ofor ~~our~~warrants, ~~convertible~~no ~~preferred~~conversion ~~stock~~of ~~into~~outstanding anSeries ~~aggregate~~A ofnon-voting ~~30,726,326~~convertible preferred shares ofand ~~our~~no ~~common~~vesting ~~stock,~~of ~~which~~restricted ~~will~~share ~~occur~~units ~~automatically~~or ~~upon~~restricted ~~the~~ordinary ~~completion~~shares ofafter ~~this~~December ~~offering;~~31, ~~and~~2025.

n on a pro forma as adjusted basis to give further effect to our sale of shares of common stock in this offering at an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.8

~~The~~RISK pro forma as adjusted information presented in the summary balance sheet data is illustrative only and will change based on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease each of cash and cash equivalents, working capital, total assets and total stockholders’ equity on a pro forma as adjusted basis by approximately $ million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. FACTORS

	AS OF JUNE 30, 2013
(in thousands) Balance Sheet Data:	ACTUAL		PRO FORMA		PRO FORMAAS ADJUSTED
Cash and cash equivalents	$	10,778	$	10,778
Working capital		9,471		9,471
Total assets		11,554		11,554
Total liabilities		1,815		1,815
Total stockholders’ equity		9,738		9,738

You should carefully consider the risks and uncertainties described below and the other information in this prospectus before making an investment in our ordinary shares. The occurrence of any of these risks could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this prospectus and those we may make from time to time. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business.

10Risks Related to Our Financial Condition and Capital Requirements

~~Table~~We ofare ~~Contents~~a clinical-stage biotechnology company with a limited operating history on which to assess our business; we have not completed any clinical trials, have no products approved for commercial sale, have historically incurred losses, and we anticipate that we will continue to incur significant losses for the foreseeable future. Moreover, we have never generated revenue from product sales and may never be profitable.

~~RISK~~We ~~FACTORS~~are a clinical-stage biotechnology company with a limited operating history. We will need to raise substantial additional capital to continue to fund our operations in the future. We have based our estimates on assumptions that may prove to be wrong, and could exhaust our available financial resources sooner than we currently anticipate. We have devoted substantially all of our financial resources to identify, acquire, and develop our product candidates, organizing and staffing our company, and providing general and administrative support for our operations.

~~Investing~~Developing in our ~~common~~product ~~stock~~candidates ~~involves~~requires a ~~high~~substantial ~~degree~~amount of ~~risk~~capital. ~~Before~~We ~~you~~expect ~~invest~~our inresearch ~~our~~and ~~common~~development ~~stock,~~expenses ~~you~~to ~~should~~continue ~~carefully~~to ~~consider~~increase ~~the~~in ~~following~~connection ~~risks~~with its ongoing activities, particularly as ~~well~~we asadvance ~~general~~our ~~economic~~product candidates through preclinical studies and ~~business~~clinical ~~risks~~trials. We will need to raise additional capital to fund our operations, and such funding may not be available to us on acceptable terms, or at all, of and such funding may become even more difficult to obtain due to rising interest rates and the ~~other~~current ~~information~~downturn ~~contained~~in the U.S. capital markets and the biotechnology sector in ~~this~~general. ~~prospectus~~Competition for additional capital among biotechnology companies may be particularly intense during economic downturns. ~~Any~~We may be unable to raise capital through public offerings of ~~the~~our ~~following~~ordinary ~~risks~~shares and may need to turn to alternative financing arrangements. Such arrangements, if we pursue them, could ~~have~~involve athe ~~material~~issuance ~~adverse~~of ~~effect~~one onor ~~our~~more ~~business~~types of securities, ~~operating~~including ~~results~~ordinary ~~and~~shares, ~~financial~~preferred ~~condition~~shares, ~~and~~convertible ~~cause~~debt, warrants to acquire ordinary shares, or other securities. These securities could be issued at or below the ~~trading~~then prevailing market price offor our ~~common~~ordinary ~~stock~~shares. toIn ~~decline~~addition, ~~which~~if we issue debt securities, the holders of the debt would ~~cause~~ ~~you~~have a claim to ~~lose~~our ~~all~~assets orthat ~~part~~would be superior to the rights of ~~your~~shareholders ~~investment~~until the principal, accrued and unpaid interest, and any premium or make-whole has been paid. ~~When~~Interest ~~determining~~on ~~whether~~any tonewly-issued ~~invest~~debt securities and/or newly-incurred borrowings would increase our operating costs and reduce our net income (or increase our net loss), ~~you~~and ~~should~~these ~~also~~impacts ~~refer~~may tobe material. If the ~~other~~issuance ~~information~~of ~~contained~~new securities results in ~~this~~diminished ~~prospectus~~rights to holders of our ordinary shares, ~~including~~the market price of our ~~financial~~ordinary ~~statements~~shares ~~and~~could ~~the~~be ~~related~~materially ~~notes~~and ~~thereto~~adversely affected.

~~Risks~~We ~~Related~~do not currently have any products approved for sale and do not generate any revenue from product sales. Accordingly, we expect to rely primarily on equity and/or debt financings to fund our continued operations. Our ~~Financial~~ability ~~Position~~to raise additional funds will depend, in part, on the success of our preclinical studies and ~~Capital~~clinical ~~Needs~~trials and other product development activities, regulatory events, our ability to identify and enter into licensing or other strategic arrangements, and other events or conditions that may affect our value or prospects, as well as factors related to financial, economic, and market conditions, many of which are beyond our control. There can be no assurances that sufficient funds will be available to us when required or on acceptable terms, if at all.

WeIf ~~have~~we ~~incurred~~are ~~significant~~unable ~~losses since our inception. We expect~~ to ~~continue~~raise toadditional ~~incur~~capital ~~losses~~when ~~over~~required ~~the~~or ~~next~~on ~~several~~acceptable ~~years~~terms, ~~and~~we may ~~never~~be ~~achieve~~required orto: ~~maintain profitability.~~

~~Since~~•significantly ~~inception~~delay, wescale ~~have incurred significant operating losses. While we generated net income of $3.7 million for the year ended December 31~~back, ~~2012~~or asdiscontinue ~~a result of recognizing $15.0 million of revenue under our license agreement with Pfizer, we incurred net losses of $6.1 million for~~ the ~~year~~development ~~ended~~or ~~December 31,~~commercialization ~~2011 and $3.0 million for the six months ended June 30, 2013. As~~ of ~~June 30, 2013, we had an accumulated deficit of $55.7 million. We have financed~~ our ~~operations~~product tocandidates; date with $64.1 million raised in private placements of convertible debt and convertible preferred stock and $22.5 million received in 2011 as an upfront payment under our license agreement with Pfizer. We have not generated any meaningful revenue since our inception other than from the upfront payment.

We•seek ~~have~~strategic ~~devoted~~partnerships, ~~substantially~~or ~~all~~amend ofexisting ~~our~~partnerships, ~~financial~~for ~~resources and efforts to~~ research and development, ~~including~~programs ~~preclinical~~at ~~studies~~an ~~and~~earlier ~~clinical~~stage ~~trials.~~than Weotherwise ~~are~~would ~~still~~be indesirable ~~the~~or ~~early~~that ~~stages~~we ofotherwise ~~development~~would ~~of our drug candidates, and we~~ have ~~not~~sought ~~completed development of any drugs. We expect~~ to ~~continue~~develop to incur significant expenses and operating losses over the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year. Although responsibility for further developmentindependently, ~~regulatory~~or ~~approval~~on ~~and~~terms ~~potential~~that ~~commercialization~~are ofless ~~our~~favorable ~~lead~~than ~~drug~~might ~~candidate,~~otherwise ~~GMI-1070,~~be ~~has~~available ~~transferred~~in ~~to Pfizer under our collaboration with them following~~ the ~~recent~~future; ~~completion of our Phase 2 clinical trial, we anticipate that our expenses will increase substantially as we:~~

~~n commence clinical trials of GMI-1271;~~9

n•dispose ~~continue~~of ~~the~~technology ~~research~~assets, ~~and~~or ~~development~~relinquish ofor license on unfavorable terms, our ~~other~~rights ~~drug~~to technologies or any of our product candidates that we otherwise would seek to develop or commercialize ourselves;

n•pursue ~~seek~~the sale of the company to ~~discover~~a ~~and~~third ~~develop~~party ~~additional~~at ~~drug~~a ~~candidates~~price that may result in a loss on investment for our shareholders; or

n•file ~~seek~~for ~~regulatory~~bankruptcy ~~approvals~~or ~~for~~cease ~~any~~operations ~~drug~~altogether ~~candidates~~(and ~~that~~face ~~successfully~~any ~~complete~~related ~~clinical~~legal ~~trials;~~proceedings).

nAny ~~ultimately~~of ~~establish~~these aevents ~~sales,~~could ~~marketing~~have ~~and~~a ~~distribution~~material ~~infrastructure~~adverse ~~and~~effect ~~scale~~on upour ~~external~~business, ~~manufacturing~~operating ~~capabilities~~results, toand ~~commercialize any drugs other than GMI-1070 for which we may obtain regulatory approval;~~prospects.

n ~~maintain~~Even if successful in raising new capital, ~~expand~~we ~~and~~could ~~protect~~be ~~our~~limited ~~intellectual~~in ~~property~~the ~~portfolio;~~amount of capital we raise due to investor demand restrictions placed on the amount of capital we raise or other reasons.

nAdditionally, ~~hire~~any capital raising efforts are subject to significant risks and contingencies, as described in more detail under the risk factor titled “Raising additional ~~clinical~~capital may cause dilution to our shareholders, ~~quality~~restrict ~~control~~our ~~and~~operations, ~~scientific~~or ~~personnel;~~require us to relinquish rights.”

nWe ~~add~~have ~~operational,~~never ~~financial~~generated ~~and~~any ~~management~~revenue ~~information~~from ~~systems~~product ~~and~~sales ~~personnel, including personnel to support our drug development~~ and ~~planned~~may ~~future~~never ~~commercialization~~be ~~efforts;~~profitable. ~~and~~

nWe ~~incur~~have ~~additional~~no ~~legal~~products approved for commercialization and have never generated any revenue from product sales. Our ability to generate revenue and achieve profitability depends on our ability, ~~accounting~~alone or with strategic collaborators, to successfully complete the development of, and ~~other~~obtain ~~expenses~~the inregulatory ~~operating~~approvals asnecessary ato ~~public~~commercialize, ~~company~~one or more of our product candidates. We do not anticipate generating revenue from product sales for the foreseeable future. Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to:

To become and remain profitable, we must succeed in developing and eventually commercializing drugs that generate significant revenue. This will require us to be successful in a range of challenging activities, including •completing ~~preclinical~~research ~~testing~~ and ~~clinical~~development ~~trials~~ of our ~~drug~~product candidates; other than GMI-1070, obtaining regulatory approval for these drug candidates and manufacturing and commercializing any drugs for which we may obtain regulatory approval, as well as discovering additional drug candidates. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, may never generate revenue that is significant enough to achieve profitability.

In•obtaining ~~the case of GMI-1070, our ability to generate revenue is dependent upon the achievement of development,~~ regulatory ~~and~~approvals ~~commercial~~for ~~milestones and sales sufficient to generate royalties under~~ our ~~license~~product ~~agreement~~candidates ~~with~~for ~~Pfizer,~~which ~~and~~we ~~the~~complete ~~achievement~~clinical oftrials; ~~such milestones is largely out of our control. If Pfizer fails, or chooses not to~~

11•manufacturing product candidates and establishing and maintaining supply and manufacturing relationships with third parties that are commercially feasible, meet regulatory requirements and our supply needs in sufficient quantities to meet market demand for our product candidates, if approved;

~~Table~~•qualifying offor ~~Contents~~adequate coverage and reimbursement by government and third-party payors for any product candidates for which we obtain regulatory approval;

~~continue~~•marketing, ~~to further develop~~launching, ~~seek~~and ~~regulatory~~commercializing ~~approval~~product ~~for or commercialize GMI-1070, our ability to generate revenue with respect to GMI-1070 will be significantly reduced or eliminated. Because all of our drug~~ candidates ~~other~~for ~~than~~which ~~GMI-1070~~we ~~are~~obtain ~~still~~regulatory ~~in preclinical development~~approval, ifeither wedirectly ~~are~~or ~~unable to generate revenue from our license agreement~~ with ~~Pfizer,~~a wecollaborator ~~may~~or ~~never~~distributor; ~~become profitable, and we may not be able to invest in the further development of our other drug candidates.~~

~~Because~~•gaining ofmarket ~~the~~acceptance ~~numerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount~~ of increased expenses or when, or if, we will be able to achieve profitability. If we are required by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in completing our ~~clinical~~product ~~trials or the development of any of our drug~~ candidates, ~~our~~as ~~expenses~~treatment ~~could~~options; ~~increase.~~

~~Even~~•addressing ifany wecompeting doproducts ~~achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become~~ and ~~remain profitable~~technological ~~would depress the value of our company~~ and ~~could~~market ~~impair~~developments; our ability to raise capital, expand our business, maintain our research and development efforts or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

We•implementing ~~will~~internal ~~need~~systems ~~substantial~~and ~~additional~~infrastructure, ~~funding~~as ~~to pursue our business objectives. If we are unable to raise capital when~~ needed,; ~~we could be forced to delay, reduce or eliminate our drug development programs or potential commercialization efforts.~~

We•protecting ~~believe that the net proceeds from this offering, together with our existing cash~~ and ~~cash~~enforcing ~~equivalents as of June 30, 2013, will enable us to fund~~ our ~~operating~~intellectual ~~expenses~~property ~~and capital expenditure requirements for at least the next 12 months~~rights, ~~without~~including ~~giving effect to any potential milestone payments we may receive under our agreement with Pfizer. However~~patents, wetrade ~~will need to obtain substantial additional funding in connection with our continuing operations. Our future capital requirements will depend on many factors~~secrets, ~~including:~~and know-how;

n•negotiating ~~our~~favorable ~~agreement~~terms ~~with Pfizer remaining~~ in ~~effect and our ability to achieve milestones under this and~~ any ~~other~~collaboration, ~~license~~licensing, or ~~collaboration~~other ~~agreement~~arrangements ~~that~~into which we may enter ~~into~~ in the future~~, including a potential $35.0 million milestone payment upon dosing the first patient in a Phase 3 clinical trial, of which we may receive $15.0 million as an advance under specified circumstances~~;

n•obtaining ~~the~~coverage ~~progress~~ and ~~results~~adequate ofreimbursement ~~the~~from ~~Phase 3 clinical trial of GMI~~third-~~1070~~party ~~that~~payors weand ~~expect~~maintaining ~~Pfizer~~pricing tofor ~~commence~~our inproduct ~~mid-2014,~~candidates ~~pending~~that ~~approval~~supports ~~through~~profitability; ~~Pfizer’s~~and ~~governance process;~~

~~n the scope~~•attracting, ~~progress~~hiring, ~~results~~ and ~~costs~~retaining ofqualified ~~preclinical~~personnel. ~~development, laboratory testing and clinical trials for our other drug candidates, including our planned Phase 1 and Phase 1/2 clinical trials of GMI-1271;~~

nEven ~~the~~if ~~number~~one ~~and~~or ~~development~~more ~~requirements~~ of ~~other~~the ~~drug~~product candidates that we ~~may~~develop ~~pursue;~~is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by regulatory authorities to perform clinical and other studies in

~~n the costs, timing and outcome of regulatory review of our drug candidates;~~10

naddition ~~the~~to ~~costs~~those ~~and~~that ~~timing~~we anticipate. Even if we are able to generate revenues from the sale of ~~future~~any ~~commercialization~~approved ~~activities~~products, ~~including~~we ~~product~~may not become profitable and may need to obtain additional funding to continue operations. We will also have to develop or acquire manufacturing, ~~marketing,~~capabilities ~~sales~~or continue to contract with contract manufacturers in order to continue development and ~~distribution~~potential commercialization of our product candidates. For instance, ~~for~~if ~~any~~the costs of manufacturing our drug ~~candidates~~product ~~other~~are ~~than~~not ~~GMI-1070~~commercially ~~for~~feasible, ~~which~~we will need to develop or procure our drug product in a commercially feasible manner in order to successfully commercialize a future approved product, if any. Additionally, if we ~~receive~~are ~~marketing~~not ~~approval;~~able to generate revenue from the sale of any approved products, we may never become profitable.

nWe ~~any~~are ~~royalties~~a weclinical-stage ~~receive~~biotechnology ~~from~~company ~~Pfizer~~ with ~~respect~~a limited operating history on which to ~~sales~~assess ofour ~~GMI-1070~~business; we have not completed any clinical trials, ifhave itno ~~receives~~products ~~marketing~~approved ~~approval;~~for commercial sale, have historically incurred losses, and anticipates that we will continue to incur significant losses for the foreseeable future.

nWe ~~the~~are ~~revenue~~a clinical-stage biotechnology company with a limited operating history. Since September 19, if2024 ~~any~~(inception), ~~received~~we ~~from~~have ~~commercial~~incurred ~~sales~~significant operating losses. For the nine months ended September 30, 2025, we reported a net loss of $61.5 million and had an accumulated deficit of $79.4 million. We will need to raise substantial additional capital to continue to fund our ~~drug~~operations in the future. Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on our financial condition and our ability to develop our product candidates. ~~other~~Changing circumstances may cause us to consume capital significantly faster or slower than ~~GMI-1070~~we ~~for~~currently ~~which~~anticipate. If we ~~receive~~are ~~marketing~~unable ~~approval;~~to acquire additional capital or resources, we will be required to modify our operational plans to complete future milestones and we may be required to delay, limit, reduce, or eliminate development or future commercialization efforts of product candidates and/or programs. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available financial resources sooner than we currently anticipate. We may be forced to reduce our operating expenses and raise additional funds to meet our working capital needs, principally through the additional sales of our securities or debt financings or entering into strategic collaborations.

nWe ~~the~~have ~~costs~~devoted ~~and~~substantially ~~timing~~all of ~~preparing~~our financial resources to identify, ~~filing~~acquire, and ~~prosecuting~~develop ~~patent~~our ~~applications~~product candidates, ~~maintaining~~organizing and ~~enforcing~~staffing our ~~intellectual~~company, ~~property~~and ~~rights~~providing general and ~~defending~~administrative ~~any~~support ~~intellectual~~for ~~property-related~~our ~~claims;~~operations. To date, we have funded our operations primarily from the sale and issuance of convertible preferred and common equity securities and unsecured convertible notes. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity or debt financings, strategic collaborations, or grants.

nBiopharmaceutical ~~the~~product ~~extent~~development is a highly speculative undertaking and involves a substantial degree of risk. We expect our losses to ~~which~~increase as our product candidates enter more advanced clinical trials. It may be several years, if ever, before we ~~acquire~~complete pivotal clinical trials and/or have a product candidate approved for commercialization. We expect to invest significant funds into the research and development of our current programs to determine the potential to advance product candidates to regulatory approval. If we obtain regulatory approval to market a product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval, and our ability to achieve sufficient market acceptance, pricing, coverage, and adequate reimbursement from third-~~license~~party ~~other~~payors, ~~drug~~and adequate market share for our product candidates in those markets. Even if we obtain adequate market share for our product candidates, because the potential markets in which our product candidates may ultimately receive regulatory approval could be very small, we may never become profitable despite obtaining such market share and ~~technologies~~acceptance of our products.

~~Identifying~~We ~~potential~~expect ~~drug~~to ~~candidates~~continue ~~and conducting preclinical testing and clinical trials is a time consuming, expensive and uncertain process that takes years~~ to ~~complete,~~incur ~~and~~significant weexpenses and ~~Pfizer~~increasing oroperating ~~any~~losses ~~future collaborators~~for ~~may never generate~~ the ~~necessary~~foreseeable ~~data~~future ~~or results required to obtain regulatory approval~~ and ~~achieve product sales. In addition,~~ our ~~drug~~expenses ~~candidates, if approved, may not achieve commercial success. Our commercial revenue, if any,~~ will be ~~derived~~increase ~~from~~substantially ~~the sale of drugs that we do not expect to be commercially available for many years,~~ if atand ~~all.~~as ~~Accordingly,~~ we: will need to 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. 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.

12•continue the preclinical development and initiate the clinical development of our product candidates;

~~Table~~•continue ofefforts ~~Contents~~to discover and develop new product candidates;

~~Raising~~•continue ~~additional~~the ~~capital~~manufacturing ~~may cause dilution to our stockholders, including purchasers~~ of ~~common stock in this offering, restrict~~ our ~~operations~~product candidates or ~~require~~increase usvolumes tomanufactured ~~relinquish~~by ~~rights~~third toparties; ~~our drug candidates.~~

~~Until~~•advance ~~such time, if ever, as we can generate substantial revenue from the sale of~~ our ~~drugs,~~product wecandidates ~~expect~~into ~~to finance our cash needs through a combination of equity offerings~~larger, ~~debt~~more ~~financings~~expensive ~~and~~clinical ~~license~~trials; and development agreements. We do not currently have any committed external source of funds other than possible milestone payments and possible royalties under our license agreement with Pfizer. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our research programs or drug candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements with third parties when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to third parties to develop and market drug candidates that we would otherwise prefer to develop and market ourselves. 11

~~Our~~•initiate ~~operating~~additional ~~history~~preclinical ~~may~~studies ~~make~~or itclinical ~~difficult~~trials for ~~you to evaluate the success of~~ our ~~business~~product tocandidates; ~~date and to assess our future viability.~~

We•seek commenced operations in 2003, and our operations to date have been largely focused on raising capital, developing our expertise in carbohydrate chemistry and knowledge of carbohydrate biology, identifying potential drug candidates, undertaking preclinical studies and, with respect to GMI-1070, conducting clinical trials. All but one of our drug candidates are still in preclinical development. We have not yet demonstrated our ability to successfully complete later stage clinical trials, obtain regulatory approvals, ~~manufacture a commercial scale drug, or arrange for a third party to do so on our behalf, or conduct sales~~ and ~~marketing~~reimbursement ~~activities necessary~~ for ~~successful commercialization. Consequently, any predictions you make about~~ our ~~future~~product ~~success~~candidates; ~~or viability may not be as accurate as they could be if we had a longer operating history.~~

We•establish ~~may~~a ~~encounter unforeseen expenses~~sales, ~~difficulties~~marketing, ~~complications, delays~~ and ~~other~~distribution ~~known~~infrastructure ~~or unknown factors in achieving our business objectives. With respect~~ to ~~our~~ ~~drug~~commercialize ~~candidates~~any ~~other~~products ~~than~~for ~~GMI-1070,~~which we ~~will~~may ~~need~~obtain toregulatory ~~transition~~approval ~~at some point from a company with a research~~ and ~~development~~market ~~focus~~for toourselves; ~~a company capable of supporting commercial activities. We may not be successful in such a transition.~~

We•seek ~~expect our financial condition and operating results~~ to ~~continue~~identify, ~~to fluctuate significantly from quarter to quarter and year to year due to a variety of factors~~assess, ~~many of which are beyond our control. Accordingly~~acquire, ~~you should not rely upon the results of any quarterly~~ and/or ~~annual~~develop ~~periods~~other asproduct ~~indications~~candidates; ~~of future operating performance.~~

~~Our~~•make ~~ability~~milestone, toroyalty, ~~utilize~~or ~~our net operating loss carryforwards and certain~~ other ~~tax~~payments ~~attributes~~under ~~may~~third-party belicense ~~limited.~~agreements;

~~Under~~•seek Section 382 of the Internal Revenue Code of 1986, as amended, 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~~maintain, ~~or NOL~~protect, ~~carryforwards~~ and ~~other~~expand ~~pre-change tax attributes to offset its post-change income may be limited. We may experience ownership changes in the future as a result of shifts in~~ our ~~stock~~intellectual ~~ownership.~~property Asportfolio; of December 31, 2012, we had federal NOL carryforwards of $11.4 million, state NOL carryforwards of $1.8 million and research and development tax credit carryforwards of $3.3 million, each of which could be limited if we experience an ownership change.

~~Risks~~•are ~~Related~~required to ~~the~~pay ~~Discovery~~penalties ~~and~~under ~~Development~~our ofRegistration ~~Our~~Rights ~~Drug~~Agreement ~~Candidates~~for failing to timely register the applicable securities;

~~Our~~•seek ~~research and development is focused on discovering and developing novel glycomimetic drugs, and we are taking an innovative approach~~ to ~~discovering~~attract and ~~developing~~ ~~drugs,~~retain ~~which~~skilled ~~may~~personnel; ~~never lead to marketable drugs.~~

A•experience ~~key~~any ~~element~~delays ofor ~~our~~encounter ~~strategy~~issues iswith tothe ~~use~~development and ~~expand~~potential ~~our~~regulatory ~~platform~~approval ~~to build a pipeline~~ of ~~novel~~our ~~glycomimetic~~clinical ~~drug~~and product candidates ~~and~~such ~~progress~~as ~~these~~safety ~~drug~~issues, ~~candidates~~manufacturing ~~through~~delays, clinical ~~development~~trial ~~for~~accrual ~~the~~delays, ~~treatment~~longer offollow-up afor ~~variety~~planned ofstudies ~~diseases.~~or ~~The~~trials, ~~discovery~~additional ofmajor ~~therapeutic~~studies ~~drugs~~or ~~based~~trials, onor ~~molecules~~supportive ~~that~~trials ~~mimic~~necessary ~~the~~to ~~structure~~support ofregulatory ~~carbohydrates~~approval; isand an

13•incur additional costs associated with operating as a public company.

~~Table~~We have no significant experience as a company in initiating, conducting, or completing clinical trials. In part because of ~~Contents~~this lack of experience, we cannot be certain that our planned clinical trials will begin or be completed on time, if at all. In addition, we have not yet demonstrated an ability to obtain regulatory approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales, marketing, and distribution activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history. Further, the net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.

~~emerging~~Raising ~~field,~~additional ~~and~~capital ~~the~~may ~~scientific~~cause ~~discoveries~~dilution ~~that form the basis for our efforts~~ to discover and develop drug candidates are relatively new. The scientific evidence to support the feasibility of developing drug candidates based on these discoveries is both preliminary and limited. Although our ~~research and development efforts to date have resulted in a pipeline of glycomimetic drug candidates~~shareholders, werestrict ~~may not be able to develop drug candidates that are safe and effective. Even if we are successful in continuing to build~~ our ~~pipeline~~operations, ~~the potential drug candidates that we identify may not be suitable for clinical development, including as a result of being shown to have harmful side effects~~ or ~~other~~require ~~characteristics~~us ~~that indicate that they are unlikely~~ to berelinquish ~~drugs that will receive marketing approval and achieve market acceptance~~rights. If we do not successfully develop and commercialize drug candidates based upon our glycomimetics platform, we will not be able to obtain product revenue in future periods, which likely would result in significant harm to our financial position and adversely affect our stock price.

WeUntil ~~are~~such ~~very~~time, ~~early~~if inever, ~~our~~as ~~development~~we ~~efforts~~can ~~and~~generate ~~have~~substantial ~~only~~revenue ~~one~~from ~~drug~~the ~~candidate,~~sale ~~GMI-1070~~of our product candidates, ~~that~~we ~~has~~expect ~~completed~~to afinance ~~clinical~~our ~~trial.~~cash ~~All~~needs through a combination of ~~our~~equity ~~other~~offerings, ~~drug~~debt ~~candidates are~~financings, ~~still~~and inlicense ~~preclinical~~and development agreements. IfTo the extent that we raise additional capital through the sale of equity securities or ~~our~~convertible ~~collaborators~~debt ~~are~~securities, ~~unable~~the toownership ~~commercialize~~interest of our ~~drug~~shareholders ~~candidates~~will be diluted, and the terms of these securities may include liquidation or ~~experience~~other ~~significant~~preferences ~~delays~~that inadversely ~~doing~~affect sothe rights of holders of our ordinary shares. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ~~business~~ability ~~will~~to betake ~~materially~~specific ~~harmed~~actions, such as incurring additional debt, making capital expenditures, or declaring dividends.

WeIf ~~are~~we ~~very~~raise ~~early~~additional infunds ~~our~~through ~~development~~collaborations, ~~efforts~~strategic ~~and~~alliances, ~~have~~or ~~only one drug candidate~~marketing, ~~GMI-1070~~distribution, ~~that~~or ~~has~~licensing ~~completed~~arrangements awith ~~clinical~~third ~~trial.~~parties, ~~All~~we ofmay ~~our~~be ~~other~~required ~~drug~~to ~~candidates~~relinquish ~~are still~~valuable inrights ~~preclinical~~to ~~development.~~our Weresearch ~~have~~programs ~~not~~or ~~completed~~product ~~the development of any drug~~ candidates, weor ~~currently~~grant ~~generate~~licenses noon ~~revenue~~terms ~~from~~that ~~the sale of any drugs and we~~ may ~~never~~not be ~~able~~favorable to ~~develop a marketable drug~~us. WeIf ~~have~~we ~~invested~~are ~~substantially~~unable ~~all~~to ~~of our~~raise ~~efforts~~additional ~~and~~funds ~~financial~~through ~~resources~~equity inor ~~the~~debt ~~development~~financings ofor ~~our~~other ~~glycomimetics~~arrangements ~~platform,~~with ~~the~~third ~~identification~~parties ofwhen ~~potential~~needed, ~~drug~~we ~~candidates~~may ~~using~~be ~~that~~required ~~platform~~to ~~and~~delay, ~~the~~limit, ~~development of our drug candidates. Other than with respect to GMI-1070~~reduce, ~~for~~or ~~which~~terminate our ~~collaborator~~ ~~Pfizer~~product ~~now~~development ~~has~~or ~~the~~future ~~responsibility~~commercialization ~~for~~efforts ~~further~~or ~~development~~grant ~~and~~rights ~~commercialization,~~to ~~our~~third ~~ability~~parties to ~~generate~~develop ~~revenue~~and ~~from~~market ~~our~~product ~~other drug~~ candidates, ~~which~~that we dowould ~~not~~otherwise ~~expect~~prefer ~~will~~to ~~occur~~develop ~~for many years, if ever, will depend heavily on their successful development~~ and ~~eventual~~market ~~commercialization~~ourselves. ~~The success of those drug candidates will depend on several factors, including:~~

nTo ~~successful~~the ~~completion~~extent that we raise additional capital through the sale of ~~preclinical~~equity, ~~studies~~including pursuant to any sales under convertible debt or other securities convertible into equity, the ownership interest of our shareholders will be diluted, and ~~clinical~~the ~~trials;~~terms of these new securities may include liquidation or other preferences that adversely affect the rights of

~~n receipt of marketing approvals from applicable regulatory authorities;~~12

nour ~~obtaining~~shareholders. ~~and~~For ~~maintaining~~instance, ~~patent~~immediately prior to the consummation of the Merger, certain institutional and ~~trade~~accredited ~~secret~~investors ~~protection~~purchased shares of Pre-Merger Crescent common stock and ~~regulatory~~pre-funded ~~exclusivity~~warrants for ~~our~~an ~~drug~~aggregate ~~candidates;~~purchase price of $200.0 million (which includes $37.5 million of gross proceeds we previously received from the issuance of the Convertible Notes in October 2024).

nDebt financing, if available, would likely involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, making additional product acquisitions, or declaring dividends. If we raise additional funds through strategic collaborations or licensing arrangements with third~~-party~~ ~~manufacturers~~parties, ~~for~~we may have to relinquish valuable rights to our product candidates or future revenue streams or grant licenses on terms that are not favorable to us. We cannot assure that we will be able to obtain additional funding if and when necessary to fund our entire portfolio of product candidates to meet our projected plans. If we are unable to obtain funding on a timely basis, we may be required to delay or ~~establishing~~discontinue one or more of our development programs or the commercialization of any product candidates or be unable to expand our operations or otherwise capitalize on potential business opportunities, ~~commercial~~which ~~manufacturing~~could ~~capabilities;~~materially harm our business, financial condition, and results of operations.

nRisks ~~launching~~Related ~~commercial~~to ~~sales~~Discovery, ~~of the drugs~~Development, if and ~~when~~Commercialization ~~approved, whether alone or in collaboration with others;~~

nWe ~~acceptance~~face ofcompetition ~~the~~from ~~drugs,~~entities ifthat ~~and~~have ~~when~~developed ~~approved,~~or bymay ~~patients,~~develop programs for the ~~medical~~diseases ~~community~~addressed ~~and~~by ~~third-party~~product ~~payors;~~candidates developed by us.

nThe development and commercialization of drugs is highly competitive. Product candidates developed by us, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration. We compete with a variety of multinational biopharmaceutical companies, specialized biotechnology companies and emerging biotechnology companies, including Merck, Bristol Myers Squibb, Genentech, AstraZeneca, Summit Therapeutics Inc., BioNTech SE, LaNova Medicines Ltd., and Compass Therapeutics, Inc., as well as academic institutions, governmental agencies, and public and private research institutions, among others. Many of the companies with which we are currently competing or will compete against in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing regulatory approved products than we do, and are further along in the clinical development and/or commercialization process than we are. Mergers and acquisitions in the pharmaceutical and biotechnology industry may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with ~~other~~large ~~therapies;~~and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites, raising capital, registering patients for clinical trials, establishing and defending rights to intellectual property, as well as in acquiring technologies complementary to, or necessary for, our product candidates.

nOur ~~obtaining~~competitors have developed, are developing, or may in the future develop programs and ~~maintaining~~processes ~~healthcare~~competitive ~~coverage~~with our programs and ~~adequate~~processes. ~~reimbursement;~~Competitive therapeutic treatments include those that have already been approved and accepted by the medical community and any potential new treatments, including those currently under clinical development. Our success will depend partially on our ability to develop and commercialize products that have a competitive safety, efficacy, dosing, and/or presentation profile. Our commercial opportunity and success will be reduced or eliminated if competing products are safer, more effective, have a more attractive dosing profile or presentation or are less expensive than the products we develop, or if our competitors develop competing products or if biosimilars enter the market more quickly than we do and are able to gain market acceptance. Conversely, the lack of commercial success of other competing programs may raise concerns about the financial viability of our programs.

nWe ~~protecting~~are substantially dependent on the success of our ~~rights~~lead inprogram, CR-001, as well as our ~~intellectual~~ADC ~~property~~programs, ~~portfolio;~~CR-002 and CR-003, and our development programs may not be successful.

nOur ~~maintaining~~future asuccess ~~continued~~is ~~acceptable~~substantially ~~safety~~dependent ~~profile~~on ofour ~~the~~ability ~~drugs~~to ~~following~~timely obtain regulatory approval for, and then successfully commercialize, our lead program, CR-001. We also intend to advance our ADC programs, CR-002 and

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our drug candidates, which would materially harm our business. 13

~~Clinical~~CR-003. ~~drug~~We ~~development~~are ~~involves~~investing a ~~lengthy~~majority of our efforts and ~~expensive~~financial ~~process,~~resources ~~with~~into anthe ~~uncertain~~research ~~outcome~~and development of these programs. We ~~may~~believe ~~incur~~the ~~additional~~success ~~costs~~of ~~or experience~~CR-001 ~~delays~~is dependent on observing in ~~completing~~CR-001 the targeting, orbinding, ~~ultimately~~cooperativity beand ~~unable~~pharmacokinetics of ivonescimab, an anti-PD-1/anti-VEGF bispecific antibody that demonstrated significantly improved progression-free survival (“PFS”) to ~~complete~~market-leading pembrolizumab in a large third-party Phase 3 clinical trial, while avoiding the ~~development~~mechanistic risks that could perturb the balance of efficacy and ~~commercialization~~safety that define this new class of immunotherapy. To the extent we do not observe this recapitulation of ivonescimab in CR-001, or are otherwise unsuccessful in our ~~drug~~efforts ~~candidates~~to develop CR-001, it would significantly and adversely affect the clinical and commercial potential of CR-001.

~~All~~Our ~~but~~product ~~one of our drug~~ candidates ~~are~~will inrequire ~~preclinical~~additional clinical development, ~~and~~evaluation ~~their risk~~ of ~~failure~~clinical, ispreclinical, ~~high.~~and Itmanufacturing isactivities, ~~impossible~~product todevelopment, ~~predict when or if any of our drug candidates will prove safe or effective in humans or will receive~~ regulatory approval. ~~Before~~in ~~obtaining marketing~~multiple ~~approval~~jurisdictions, ~~from~~substantial ~~regulatory authorities for the sale of any drug candidate~~investment, ~~we or a collaborator must complete preclinical development~~ and ~~then~~significant ~~conduct~~marketing ~~extensive~~efforts ~~clinical~~before ~~trials~~we togenerate ~~demonstrate~~any ~~the~~revenues ~~safety~~from ~~and~~product ~~efficacy of the drug candidate in humans~~sales. ~~Clinical~~We ~~testing~~are isnot ~~expensive,~~permitted ~~difficult~~ to ~~design~~market ~~and implement, can take many years to complete and is uncertain as to outcome. A failure of one~~ or ~~more~~promote ~~clinical trials can occur at~~ any ~~stage~~ of ~~development.~~our ~~The~~product ~~outcome~~candidates ofbefore ~~preclinical testing~~we ~~and~~receive ~~early~~regulatory ~~clinical~~approval ~~trials~~from ~~may not be predictive of~~ the ~~success~~FDA ofand ~~later~~comparable ~~clinical~~foreign ~~trials~~regulatory authorities, and ~~interim~~we ~~results~~may ofnever areceive ~~clinical~~such ~~trial~~regulatory ~~do not necessarily predict final results~~approval. ~~Moreover,~~

14The success of our product candidates will depend on a variety of factors. We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights, and the manufacturing, marketing, distribution, and sales efforts of any current or future collaborator. Accordingly, we cannot assure you that we will ever be able to generate revenue through the sale of these product candidates, even if approved. If we are not successful in obtaining regulatory approval and commercializing our CR-001, CR-002, CR-003 and any future programs, including CR-004, or are significantly delayed in doing so, our business will be materially harmed.

~~Table~~If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of ~~Contents~~our product candidates may be delayed and our expenses may increase and, as a result, our share price may decline.

~~preclinical~~From ~~and~~time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, ~~data~~regulatory, ~~are~~and ~~often~~other ~~susceptible~~product development goals, which we sometimes refers to ~~varying~~as ~~interpretations~~milestones. These milestones may include the commencement or completion of scientific studies and ~~analyses~~clinical trials, ~~and~~such ~~many~~as ~~companies~~the ~~that~~expected ~~have~~timing ~~believed~~for ~~their~~the ~~drug~~anticipated ~~candidates~~commencement ~~performed~~of ~~satisfactorily~~our inPhase ~~preclinical~~ 1/2 studies, and clinical trials ~~have~~in ~~nonetheless~~solid ~~failed~~tumor and other target indications, as well as the receipt of clinical data, and submission of regulatory filings. From time to ~~obtain~~time, ~~marketing~~we ~~approval~~may publicly announce the expected timing of ~~their~~some ~~drugs~~of these milestones. All of these milestones are and will be based on numerous assumptions. The actual timing of these milestones can vary dramatically compared to our estimates, in some cases for reasons beyond our control. If we do not meet these milestones as publicly announced, or at all, the commercialization of our product candidates may be delayed or never achieved and, as a result, our share price may decline. Additionally, delays relative to our projected timelines are likely to cause overall expenses to increase, which may require us to raise additional capital sooner than expected and prior to achieving targeted development milestones.

WeAny ordrug ~~our~~delivery ~~current~~device ~~or future collaborators may experience numerous unforeseen events during, or as a result of, clinical trials~~ that ~~could~~we ~~delay~~potentially oruse ~~prevent~~to deliver our orproduct ~~their~~candidates ~~ability~~may tohave ~~receive~~its ~~marketing~~own ~~approval~~regulatory, ordevelopment, ~~commercialize~~supply ~~our~~and ~~drug~~other ~~candidates,~~risks. ~~including:~~

nWe ~~regulators~~expect to deliver our product candidates via a drug delivery device, such as an injector or ~~institutional~~other ~~review~~delivery ~~boards~~system. There may be unforeseen technical complications related to the development activities required to bring such a product to market, including primary container compatibility and/or dose volume requirements. Our product candidates may not ~~authorize~~be usapproved or ~~our~~may ~~investigators~~be substantially delayed in receiving approval if the devices that we choose to ~~commence~~develop ado ~~clinical~~not ~~trial~~gain and/or ~~conduct~~maintain their own regulatory approvals or clearances. Where approval of the drug product and device is sought under a ~~clinical~~single ~~trial~~application, atthe increased complexity of the review process may delay approval. For example, the FDA’s review of a ~~prospective~~marketing ~~trial~~application ~~site;~~for our product candidates may include the participation of both the FDA’s Center for Biologics Evaluation and Research and the FDA’s Center for Devices and Radiological Health. Although the FDA and comparable foreign agencies have or may have systems in place for the review and approval of combination products, we may experience additional delays in the development and commercialization of such product candidates due to regulatory timing constraints and uncertainties in the product development and approval process. Moreover, although we anticipate that the device component of any combination

~~n we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;~~14

nproduct ~~clinical~~candidates ~~trials~~we ofdevelop ~~our~~will ~~drug~~be ~~candidates~~reviewed ~~may~~within ~~produce~~the ~~negative~~usual ortime ~~inconclusive~~frames ~~results,~~expected ~~including~~for ~~failure~~the tounderlying ~~demonstrate~~biologic ~~statistical~~component ~~significance~~application, and wethat ~~may~~no ~~decide~~separate marketing application for the device components of such product candidates will be required in the United States, the FDA or ~~regulators~~comparable regulatory authorities may delay approval or require us, to conduct additional ~~clinical~~studies ~~trials~~with orthe ~~abandon~~device ~~drug~~which ~~development~~may ~~programs;~~delay the approval of the combination product.

nIn addition, some drug delivery devices are provided by single-source unaffiliated third-party companies. We may be dependent on the ~~number~~sustained cooperation and effort of ~~patients~~those third-party companies both to supply the devices and, in some cases, to conduct the studies required for ~~clinical~~approval ~~trials~~or other regulatory clearance of ~~our~~the ~~drug~~devices. ~~candidates~~Even if approval is obtained, we may also be ~~larger~~dependent ~~than~~on wethose ~~anticipate~~third-party companies continuing to maintain such approvals or clearances once they have been received. Failure of third-party companies to supply the devices, ~~enrollment~~to insuccessfully ~~these~~complete ~~clinical~~studies ~~trials~~on ~~may~~the bedevices ~~slower~~in ~~than~~a wetimely ~~anticipate~~manner, or ~~participants~~to ~~may~~obtain ~~drop~~or ~~out~~maintain required approvals or clearances of ~~these~~the ~~clinical~~devices ~~trials~~could atresult ain ~~higher~~increased ~~rate~~development ~~than~~costs, wedelays ~~anticipate;~~in or failure to obtain regulatory approval, and delays in product candidates reaching the market or in gaining approval or clearance for expanded labels for new indications.

nOur ~~our~~approach ~~third-party~~to ~~contractors~~the ~~may~~discovery ~~fail~~and todevelopment ~~comply~~of ~~with~~our ~~regulatory~~programs ~~requirements~~is orunproven, ~~meet~~and ~~their~~we ~~contractual~~may ~~obligations~~not tobe ussuccessful in our efforts to build a ~~timely~~pipeline ~~manner,~~of orprograms atwith ~~all;~~commercial value.

nOur ~~regulators~~approach orto ~~institutional~~the ~~review~~discovery ~~boards~~and ~~may~~development ~~require~~of our programs, particularly CR-001, leverages clinically validated mechanisms of action and incorporates the targeting, binding, cooperativity and pharmacokinetics of ivonescimab, an anti-PD-1/anti-VEGF bispecific antibody that wedemonstrated orsignificantly ~~our~~improved ~~investigators~~PFS ~~suspend~~to ormarket-leading ~~terminate~~pembrolizumab in HARMONi-2, a large Phase 3 clinical ~~research~~trial, ~~for~~sponsored ~~various~~by ~~reasons~~Akeso, ~~including~~for ~~noncompliance~~the ~~with~~treatment ~~regulatory~~of ~~requirements~~naïve, or anot ~~finding~~previously treated, advanced and metastatic non-small cell lung cancer (“NSCLC”). Our programs are purposefully designed to avoid mechanistic risks that could perturb the ~~participants~~balance of efficacy and safety that defines this new class of immunotherapy. However, the scientific research that forms the basis of our efforts to develop programs using ivonescimab-like technologies is ongoing and may not result in viable programs. There are ~~being~~limited ~~exposed~~clinical data available on product candidates utilizing the same mechanism of action as ivonescimab, especially in solid tumor indications, demonstrating whether they are safe or effective for long-term treatment in humans. The long-term safety and efficacy of these technologies and exposure profile of our programs compared to ~~unacceptable~~currently ~~health~~approved ~~risks;~~products is unknown. Additionally, there can be no assurance that our ongoing and planned clinical trials will generate results compared to those observed for ivonescimab, particularly where we conduct trials outside of NSCLC.

nWe may ultimately discover that reproducing ivonescimab’s established pharmacology for its specific targets and indications and any programs resulting therefrom does not possess certain properties required for therapeutic effectiveness. We currently have only preclinical data regarding the ~~cost~~ivonescimab-like properties of our programs and the same results may not be seen in humans. In addition, programs using ivonescimab-like technologies may demonstrate different chemical and pharmacological properties in patients than they do in laboratory studies. This technology and any programs resulting therefrom may not demonstrate the same chemical and pharmacological properties in humans and may interact with human biological systems in unforeseen, ineffective, or harmful ways. Many product candidates that appeared highly promising in preclinical studies or in early-stage clinical trials have failed when advanced into, or further in, clinical development. In addition, the failure of ~~our~~companies ~~drug~~that are developing products similar to us or targeting the same indications as we are to demonstrate safety and efficacy of their product candidates may be ~~greater~~harmful ~~than~~to weour ~~anticipate;~~business, financial condition, results of operations, and prospects.

nIn addition, we may in the ~~supply~~future orseek ~~quality~~to ofdiscover and develop programs that are based on novel targets and technologies that are unproven. If our discovery or business development activities fail to identify novel targets or technologies for drug ~~candidates~~development, or ~~other~~such ~~materials~~targets ~~necessary~~prove to ~~conduct~~be ~~clinical~~unsuitable ~~trials~~for oftreating human disease, we may not be able to develop viable additional programs. We and our ~~drug~~existing ~~candidates~~or future collaborators may never receive approval to market and commercialize any product candidate. Even if we or an existing or future collaborator obtains regulatory approval, the approval may be ~~insufficient~~for targets, disease indications, or ~~inadequate;~~patient populations that are not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings. If the products resulting from our programs prove to be ineffective, unsafe, or commercially unviable, such programs would have little, if any, value, which would have a material and adverse effect on our business, financial condition, results of operations and prospects.

n our drug candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials.15

IfPreclinical weand ~~are~~clinical ~~required~~development toinvolves ~~conduct~~a ~~additional~~lengthy ~~clinical~~and ~~trials~~expensive orprocess ~~other~~that ~~testing~~is ofsubject ~~our~~to ~~drug candidates~~delays ~~beyond~~and ~~those~~uncertain ~~that~~outcomes, weand ~~currently~~results ~~contemplate,~~of ifearlier westudies ~~are~~and ~~unable~~trials tomay ~~successfully~~not ~~complete~~be predictive of future clinical ~~trials~~trial ofresults. If our ~~drug~~preclinical ~~candidates~~studies orand ~~other~~clinical ~~testing,~~trials ifare ~~the~~not ~~results~~sufficient to support regulatory approval of ~~these~~any ~~clinical~~of ~~trials~~our orproduct ~~tests~~candidates, ~~are~~we ~~not~~may ~~positive~~incur additional costs or ~~are~~experience ~~only~~delays ~~modestly~~in ~~positive~~ completing, or ifultimately ~~there~~be ~~are~~unable ~~safety~~to ~~concerns~~complete, wethe ~~may:~~development of such product candidate.

nBefore beobtaining ~~delayed~~approval from regulatory authorities for the commercialization of any of our product candidates, we must conduct extensive clinical trials to demonstrate the safety purity, potency, and efficacy of the product candidate in ~~obtaining~~humans. ~~marketing~~Before ~~approval~~we can initiate clinical trials for any product candidates, we must submit the results of preclinical studies to the FDA or comparable foreign regulatory authorities along with other information, including information about product candidate chemistry, manufacturing and controls and our ~~drug~~proposed clinical trial protocol, as part of an Investigational New Drug application (“IND”) or similar regulatory submission. The FDA or comparable foreign regulatory authorities may require us to conduct additional preclinical studies for any product candidate before it allows us to initiate clinical trials under any IND or similar regulatory submission, which may lead to delays and increase the costs of our preclinical development programs. Moreover, even if we commence clinical trials, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials. Any such delays in the commencement or completion of our ongoing and planned clinical trials for our product candidates; could significantly affect our product development timelines and product development costs and harm our financial position.

nWe do not ~~obtain~~know ~~marketing~~whether ~~approval~~our planned preclinical studies or clinical trials will begin on time or be completed on schedule, if at all;. The timing for commencement, data readouts and completion of clinical trials can be delayed for a number of reasons, including delays related to:

n•inability ~~obtain~~to ~~approval~~generate ~~for~~sufficient ~~indications~~preclinical, toxicology, or ~~patient~~other ~~populations~~in ~~that~~vivo ~~are~~or ~~not~~in asvitro ~~broad~~data asto ~~intended~~support the initiation or ~~desired~~continuation of clinical trials;

n•obtaining ~~obtain~~allowance or approval ~~with~~from ~~labeling~~regulatory ~~that~~authorities ~~includes~~to ~~significant~~commence ~~use~~a trial or ~~distribution~~reaching ~~restrictions~~a orconsensus ~~safety~~with ~~warnings~~regulatory authorities on trial design;

n•the beFDA ~~subject~~or comparable foreign regulatory authorities disagreeing as to ~~additional~~the ~~post-marketing~~design ~~testing~~or ~~requirements~~implementation of our clinical trials; or

n•any ~~have~~failure ~~the~~or ~~drug~~delay ~~removed~~in ~~from~~reaching an agreement with Contract Research Organizations (“CROs”) and clinical trial sites, the ~~market~~terms ~~after~~of ~~obtaining~~which ~~marketing~~can ~~approval.~~be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

~~Our drug development costs will also increase if we experience~~ •delays in ~~testing or marketing approvals. We do not know whether any of our preclinical studies or clinical trials will begin as planned~~identifying, ~~will~~recruiting ~~need~~and ~~to be~~training ~~restructured~~suitable ~~or will be completed on schedule, or at all. Significant preclinical study or~~ clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our drug candidates or allow our competitors to bring drugs to market before we do, and thereby impair our ability to successfully commercialize our drug candidates. investigators;

If•obtaining weapproval orfrom ~~our collaborators~~one ~~experience delays~~ or ~~difficulties~~more ininstitutional ~~the~~review ~~enrollment~~boards, ofor ~~patients in clinical trials~~IRBs, ~~our~~or ~~receipt~~ethics ofcommittees ~~necessary~~at ~~regulatory~~clinical ~~approvals~~trial ~~could~~sites; ~~be delayed or prevented.~~

We•IRBs orrefusing ~~our collaborators may not be able~~ to ~~initiate~~approve, suspending or ~~continue~~terminating ~~clinical~~the ~~trials~~trial ~~for~~at ~~our~~an ~~drug~~investigational ~~candidates~~site, ifprecluding weenrollment ~~are~~of ~~unable~~additional tosubjects, ~~locate~~or ~~and~~withdrawing ~~enroll~~their aapproval ~~sufficient number~~ of ~~eligible patients to participate in these trials as required by~~ the ~~FDA~~trial; or

15•changes or amendments to the clinical trial protocol;

~~Table~~•clinical sites deviating from the trial protocol or dropping out of ~~Contents~~a trial;

~~similar~~•failure ~~regulatory~~by authorities outside the United States. In particular, because GMI-1070 and GMI-1271 are intended to treat patients with sickle cell disease and AML, respectively, both of which represent a relatively low percentage of the population as compared to other diseases, our orCROs ~~our collaborators’ ability~~ to ~~enroll~~perform ~~eligible patients may be limited or may result~~ in ~~slower~~accordance ~~enrollment~~with ~~than~~Good weClinical ~~anticipate.~~Practice In(“GCP”) ~~addition,~~requirements ~~some of our competitors have ongoing clinical trials for drug candidates that treat the same~~ or ~~similar~~applicable ~~indications~~regulatory asrules ~~our drug candidates,~~ and ~~patients~~guidelines ~~who would otherwise be eligible for our clinical trials may instead enroll~~ in ~~clinical trials of our competitors’ drug candidates. Patient enrollment is also affected by~~ other ~~factors, including:~~ countries;

n•manufacturing ~~the~~sufficient ~~severity~~quantities of ~~the~~our ~~disease~~product candidates, or ~~condition~~obtaining ~~under~~sufficient ~~investigation~~quantities of combination therapies for use in clinical trials;

n•subjects failing to enroll or remain in our trials at the ~~eligibility~~rate ~~criteria~~we expect, or failing to return for ~~the~~post-treatment ~~trial~~follow-up, including subjects failing to remain in our trials;

~~n the perceived risks and benefits of the drug candidate;~~16

n•patients choosing an alternative product for the ~~availability~~indications offor ~~drugs~~which ~~approved~~we toare ~~treat~~developing ~~the~~our ~~disease~~product candidates, or ~~condition~~participating ~~under~~in ~~investigation~~competing clinical trials;

n•lack ~~the~~of ~~efforts~~adequate funding to ~~facilitate~~continue ~~timely~~a ~~enrollment~~clinical intrial, ~~clinical~~or ~~trials~~costs being greater than we anticipate;

n•subjects ~~the~~experiencing ~~patient~~severe ~~referral~~or ~~practices~~serious ofunexpected ~~physicians~~drug-related adverse effects;

n•occurrence of serious adverse events in trials of the ~~ability~~same toclass ~~monitor~~of ~~patients~~agents ~~adequately~~conducted ~~during~~by ~~and~~other ~~after~~companies ~~treatment~~that could be considered similar to our product candidates; ~~and~~

n•selection ~~the~~of ~~proximity~~clinical ~~and~~endpoints ~~availability~~that require prolonged periods of clinical ~~trial~~observation ~~sites~~or ~~for~~extended ~~prospective~~analysis ~~patients.~~of the resulting data;

~~Our~~•transfer orof ~~our~~manufacturing ~~collaborators’~~processes ~~inability~~ to ~~enroll~~larger-scale afacilities ~~sufficient~~operated ~~number~~by ofa ~~patients~~contract ~~for~~manufacturing ~~clinical~~organization ~~trials~~(“CMO”), ~~would result in significant~~ delays ~~and could require us~~ or ~~them~~failure toby ~~abandon~~our ~~one~~CMOs or ~~more~~us ~~clinical~~to ~~trials altogether.~~make ~~Enrollment~~any ~~delays~~necessary inchanges ~~these~~to ~~clinical~~such ~~trials~~manufacturing ~~may~~process, ~~result~~or infailure ~~increased~~of ~~development~~our ~~costs~~CMOs ~~for~~to ~~our~~produce ~~drug~~clinical ~~candidates,~~trial ~~which~~materials ~~would~~in ~~cause~~accordance ~~the~~with ~~value~~current ofGood ~~our~~Manufacturing ~~company~~Practice to(“cGMP”) ~~decline~~or ~~and~~similar ~~limit~~foreign ~~our~~requirements, ~~ability~~regulations toor ~~obtain~~other ~~additional~~applicable ~~financing.~~requirements; and

If•third ~~serious~~parties ~~adverse~~being unwilling or ~~unacceptable~~unable ~~side~~to ~~effects~~satisfy ~~are~~their ~~identified~~contractual ~~during~~obligations ~~the development of our drug candidates, we may need~~ to ~~abandon~~us orin ~~limit~~a ~~the~~timely ~~development of some of our drug candidates~~manner.

IfClinical ~~our~~trials ~~drug~~must ~~candidates~~be ~~are~~conducted ~~associated~~in accordance with ~~undesirable~~the ~~side~~FDA ~~effects~~and inother ~~clinical~~applicable ~~trials~~regulatory orauthorities’ ~~have~~legal ~~characteristics that~~requirements, ~~are~~regulations ~~unexpected~~and guidelines, weand ~~may~~remain ~~need~~subject to ~~abandon~~oversight ~~their~~by ~~development~~these governmental agencies and ethics committees or ~~limit~~Institutional ~~their~~Review ~~development~~Boards to(“IRBs”) ~~more~~at ~~narrow~~the ~~uses~~medical institutions where such clinical trials are conducted. We could also encounter delays if a clinical trial is suspended or ~~subpopulations~~terminated by us, by the IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the ~~undesirable~~FDA ~~side~~or ~~effects~~comparable foreign regulatory authorities. Such authorities may impose such a suspension or ~~other~~termination ~~characteristics~~due ~~are~~to ~~less~~a ~~prevalent~~number of factors, ~~less~~including ~~severe~~failure to conduct the clinical trial in accordance with regulatory requirements or ~~more~~applicable ~~acceptable~~clinical trial protocols, adverse findings from inspections of clinical trial sites by the FDA or comparable foreign regulatory authorities, unforeseen safety issues or adverse side effects, failure to demonstrate a ~~risk-~~ benefit ~~perspective.~~from ~~Many~~using ~~drug~~a ~~candidates~~product ~~that~~candidate, ~~initially~~changes ~~showed~~in ~~promise~~governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in ~~early~~regulatory ~~stage~~requirements ~~testing~~and ~~have~~policies ~~later~~may ~~been~~occur, ~~found~~and we may need to ~~cause~~amend ~~side~~clinical ~~effects~~trial ~~that~~protocols ~~prevented~~to ~~their~~comply ~~further~~with ~~development~~these changes. Amendments may require us to resubmit our clinical trial protocols to regulators or to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial.

WeFurther, conducting clinical trials in foreign countries, as we may ~~expend~~do for our ~~limited~~future ~~resources~~product tocandidates, ~~pursue~~presents aadditional ~~particular~~risks ~~drug~~that ~~candidate~~may ordelay ~~indication~~completion ~~and~~of ~~fail~~our toclinical ~~capitalize~~trials. onThese ~~drug~~risks ~~candidates~~include orthe ~~indications~~failure ~~that~~of ~~may~~enrolled besubjects ~~more~~in ~~profitable~~foreign orcountries ~~for~~to ~~which~~adhere ~~there~~to isclinical protocols as a ~~greater likelihood~~result of ~~success~~differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, and political and economic risks, including war, relevant to such foreign countries.

~~Because~~Moreover, weprincipal ~~have~~investigators ~~limited~~for ~~financial~~our ~~and~~clinical ~~management~~trials ~~resources,~~may weserve ~~focus~~as onscientific aadvisors ~~limited~~or ~~number~~consultants ofto ~~research~~us ~~programs~~from time to time and ~~drug candidates~~receive compensation in connection with such services. AsUnder acertain ~~result~~circumstances, we may ~~forego~~be orrequired ~~delay~~to ~~pursuit~~report some of ~~opportunities~~these ~~with~~relationships ~~other~~to ~~drug~~the ~~candidates~~FDA or ~~for~~comparable ~~other~~foreign ~~indications~~regulatory ~~that~~authorities. ~~later~~The ~~prove~~FDA toor ~~have~~comparable ~~greater~~foreign ~~commercial~~regulatory ~~potential.~~authority ~~Our~~may ~~resource~~conclude ~~allocation~~that ~~decisions~~a ~~may~~financial ~~cause~~relationship between us toand ~~fail~~a toprincipal ~~capitalize on~~investigator ~~viable~~has ~~commercial~~created ~~drugs~~a conflict of interest or ~~profitable~~otherwise ~~market~~affected ~~opportunities.~~interpretation ~~Our~~of ~~spending~~the onstudy. ~~current~~The ~~and~~FDA ~~future~~or ~~research~~comparable ~~and~~foreign ~~development~~regulatory ~~programs~~authority ~~and~~may ~~drug~~therefore ~~candidates~~question ~~for~~the ~~specific~~integrity ~~indications~~of ~~may~~the ~~not~~data ~~yield~~generated ~~any~~at ~~commercially~~the ~~viable~~applicable ~~drugs.~~clinical Iftrial wesite doand ~~not~~the ~~accurately evaluate~~utility of the ~~commercial~~clinical ~~potential~~trial oritself ~~target~~may ~~market~~be ~~for~~jeopardized. This could result in a ~~particular~~delay ~~drug~~in ~~candidate~~approval, weor ~~may~~rejection, ~~relinquish~~of ~~valuable~~our ~~rights~~marketing toapplications ~~that~~by ~~drug~~the ~~candidate~~FDA ~~through~~or ~~collaboration~~comparable foreign regulatory authority, ~~licensing~~as orthe ~~other~~case ~~arrangements~~may inbe, ~~cases~~and inmay ~~which~~ultimately itlead ~~would~~to ~~have~~the ~~been~~denial ~~more advantageous~~of ~~for~~regulatory usapproval toof ~~retain~~one ~~sole~~or ~~development~~more ~~and~~of ~~commercialization~~our ~~rights~~product candidates.

~~Risks~~In ~~Related~~addition, many of the factors that cause, or lead to, ~~Our~~the ~~Dependence~~termination onsuspension ~~Third~~of, ~~Parties~~or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Any resulting delays to our clinical trials could shorten any period during which we may have the exclusive right to commercialize our product candidates. In such cases, our competitors may be able to bring

Our success is highly dependent on our existing collaboration with Pfizer, and future collaborations may also be important to us. If we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected. 17

Weproducts ~~have~~to ~~limited capabilities~~market ~~for~~before ~~drug~~we ~~development and~~ do ~~not yet have any capabilities for sales~~, ~~marketing or distribution. Under our license agreement with Pfizer, Pfizer is responsible for all further development, regulatory approval~~ and ~~potential commercialization~~the ~~efforts~~commercial ~~with~~viability ~~respect to GMI-1070. All~~ of our ~~drug~~product candidates ~~other~~could ~~than~~be ~~GMI-1070~~significantly ~~are~~reduced. ~~still~~Any inof ~~preclinical~~these ~~development,~~occurrences ~~and~~may ~~therefore~~harm our ~~success is highly dependent on our collaboration with Pfizer. We cannot assure you that Pfizer will continue to develop GMI-1070 in a timely manner~~business, orfinancial atcondition ~~all,~~and ~~or, if it achieves regulatory approval, that Pfizer will successfully commercialize GMI-1070~~prospects.

16In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted. For instance, the regulatory landscape related to clinical trials in the European Union (“EU”) recently evolved. The EU Clinical Trials Regulation (“CTR”), which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. While the EU Clinical Trials Directive required a separate clinical trial application (“CTA”), to be submitted in each EU member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. The CTR transition period ended on January 31, 2025, and all clinical trials (and related applications) are now fully subject to the provisions of the CTR. Compliance with the CTR requirements by us and our third-party service providers, such as CROs, may impact our developments plans.

~~Table~~If ofwe ~~Contents~~encounter difficulties enrolling patients in our future clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

~~Our~~Patient ~~Pfizer~~enrollment ~~collaboration~~is a significant factor in the timing of clinical trials, and ~~any~~the ~~future~~timing ~~collaborations~~of our clinical trials will depend, in part, on the speed at which we ~~might~~can ~~enter~~recruit ~~into~~patients to participate in our trials, as well as completion of required follow-up periods. We may ~~pose~~not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of ~~risks,~~eligible ~~including:~~ patients to participate in these trials to such trial’s conclusion as required by the FDA or other comparable regulatory authorities.

nPatient ~~collaborators~~enrollment ~~have significant discretion~~ in ~~determining~~clinical ~~the~~trials ~~efforts~~may ~~and~~be ~~resources~~affected ~~that~~by ~~they~~other ~~will~~factors, ~~apply~~including: ~~to these collaborations;~~

n•size ~~collaborators~~and ~~may~~nature ~~not~~of ~~perform~~the ~~their~~targeted ~~obligations~~patient ~~as expected~~population;

n•severity ~~collaborators~~of ~~may not pursue~~ the ~~commercialization~~disease ~~of any drug candidates that achieve regulatory approval~~ or ~~may~~condition ~~elect~~under not to pursue, continue or renew development or commercialization of drug candidates based on clinical trial results, changes in such collaborators’ strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing prioritiesinvestigation;

n•availability ~~collaborators~~and ~~may~~efficacy ~~delay~~of ~~clinical~~approved ~~trials,~~therapies ~~provide insufficient funding~~ for athe ~~clinical~~disease ~~trial program, stop a clinical trial~~ or ~~abandon~~condition aunder ~~drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing~~investigation;

n•patient ~~collaborators~~eligibility ~~could~~criteria ~~independently~~for ~~develop,~~the ortrial ~~develop~~in ~~with~~question ~~third~~as ~~parties,~~defined ~~drugs~~in ~~that~~the compete directly or indirectly with our drugs or drug candidates if such collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than oursprotocol;

n•perceived ~~drug~~risks ~~candidates~~and ~~discovered~~benefits inof ~~collaboration with us may be viewed by our collaborators as competitive with their own drug candidates or drugs, which may cause such collaborators to cease to devote resources to~~ the ~~commercialization~~product ofcandidate ~~our~~under ~~drug candidates~~study;

n•clinicians’ aand ~~collaborator~~patients’ ~~with~~perceptions ~~marketing~~as ~~and~~to ~~distribution~~the ~~rights~~potential toadvantages ~~one~~of orthe ~~more~~product ofcandidate ~~our~~being ~~drug~~studied ~~candidates~~in ~~that~~relation ~~achieve~~to ~~regulatory~~other ~~approval~~available therapies, including any products that may ~~not~~be ~~commit~~approved ~~sufficient~~for, ~~resources~~or toany ~~the~~product ~~marketing~~candidates ~~and~~under ~~distribution~~investigation offor, ~~such~~the ~~drug~~indications orwe ~~drugs~~are investigating;

n•efforts disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of drug candidates, might lead to ~~additional~~facilitate ~~responsibilities~~timely ~~for~~enrollment ~~us with respect to drug candidates or might result~~ in ~~litigation~~clinical ~~or arbitration, any of which would be time consuming and expensive~~trials;

n•patient ~~collaborators~~referral ~~may~~practices ~~not~~of properly maintain or defend our or their intellectual property rights or may use our or their proprietary information in such a way as to invite litigation that could jeopardize or invalidate such intellectual property or proprietary information or expose us to potential litigationphysicians;

~~n collaborators may infringe~~ •the ~~intellectual~~ability ~~property~~to ~~rights~~monitor ofpatients ~~third~~adequately ~~parties,~~during ~~which may expose us to litigation~~ and ~~potential~~after ~~liability~~treatment; ~~and~~

n•proximity ~~collaborations~~and ~~may~~availability ~~be terminated for the convenience~~ of ~~the~~clinical ~~collaborator~~trial ~~and,~~sites iffor ~~terminated,~~prospective wepatients; ~~could be required to raise additional capital to pursue further development or commercialization of the applicable drug candidates.~~

If•continued ~~our~~enrollment ~~collaboration with Pfizer or any other collaborations we might enter into in the future do not result in the successful development and commercialization~~ of ~~drugs,~~prospective orpatients ifby one of our collaborators terminates its agreement with us, we may not receive any future research funding or milestone or royalty payments under the collaboration, including the $35.0 million payment for the next milestone under the Pfizer agreement or the potential $15.0 million advance against that milestone payment. In addition, even if we are eligible to receive these payments, they could be substantially delayed. For example, under our license agreement, Pfizer has the option to commence another Phase 2 clinical trial ofsites; ~~GMI-1070,~~ and such commencement would delay or inhibit our ability to receive some of the milestone payments we might otherwise have received under the agreement. If we do not receive the funding we expect under these agreements, the development of our drug candidates could be delayed and we may need additional resources to develop our drug candidates. All of the risks relating to drug development, regulatory approval and commercialization described in this prospectus also apply to the activities of our collaborators.

If•the ~~Pfizer~~risk orthat apatients ~~future~~enrolled ~~collaborator of ours is involved~~ in aclinical ~~business~~trials ~~combination,~~will ~~the~~drop ~~collaborator~~out ~~might deemphasize or terminate development or commercialization~~ of ~~any~~such ~~drug~~trials ~~candidate~~before ~~licensed to it by us~~completion. If one of our collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our reputation in the business and financial communities could be adversely affected.

17Additionally, other pharmaceutical companies targeting these same diseases are recruiting clinical trial patients from these patient populations, which may make it more difficult to fully enroll any clinical trials. We also rely on,

~~Table of Contents~~18

~~For~~and ~~our~~will ~~drug~~continue ~~candidates~~to ~~other~~rely ~~than GMI-1070~~on, weCROs ~~may in the future determine to collaborate with pharmaceutical~~ and ~~biotechnology~~ ~~companies~~clinical ~~for~~trial ~~their~~sites ~~development and potential commercialization. We face significant competition in seeking appropriate collaborators. Our ability~~ to ~~reach~~ensure aproper ~~definitive agreement for a collaboration will depend, among other things, upon our assessment of a collaborator’s resources~~ and ~~expertise,~~timely ~~the~~conduct ~~terms and conditions~~ of ~~the~~our ~~proposed~~clinical ~~collaboration~~trials and ~~the~~preclinical ~~proposed collaborator’s evaluation of a number of factors~~studies. IfThough we ~~are~~have ~~unable~~entered tointo ~~reach~~ agreements ~~with~~governing ~~suitable collaborators~~their ~~on a timely basis~~services, ~~on acceptable terms, or at all,~~ we ~~may~~will have tolimited ~~curtail~~influence ~~the~~over ~~development~~their ofactual aperformance. ~~drug~~Our ~~candidate,~~inability ~~reduce~~to orenroll ~~delay~~a ~~its~~sufficient ~~development~~number orof ~~one~~patients orfor ~~more of~~ our ~~other~~clinical ~~development~~trials ~~programs,~~would ~~delay~~result ~~its~~in ~~potential~~significant ~~commercialization~~delays or ~~reduce~~ ~~the~~may ~~scope~~require ofus ~~any~~to ~~sales~~abandon orone ~~marketing activities~~ or ~~increase~~more ~~our~~clinical ~~expenditures~~trials ~~and~~altogether. ~~undertake~~Enrollment ~~development~~delays orin ~~commercialization activities at~~ our ~~own~~clinical ~~expense.~~trials Ifmay weresult ~~elect~~in toincreased ~~fund~~development ~~and~~costs ~~undertake~~for ~~development~~our orproduct ~~commercialization~~candidates ~~activities~~and onjeopardize our ~~own,~~ weability ~~may need~~ to obtain ~~additional~~regulatory ~~expertise~~approval ~~and~~for ~~additional~~the ~~capital,~~sale ~~which~~of ~~may~~our ~~not~~product becandidates. ~~available~~Furthermore, toeven usif ~~on acceptable terms or at all. If~~ we ~~fail~~are able to ~~enter~~enroll ~~into~~a ~~collaborations and do not have~~ sufficient ~~funds~~number orof ~~expertise~~patients tofor ~~undertake~~our ~~the~~clinical ~~necessary development and commercialization activities~~trials, we may ~~not~~have bedifficulty ~~able~~maintaining toenrollment ~~further~~of ~~develop~~such ~~our~~patients ~~drug~~in ~~candidates or bring them to market, which would impair~~ our ~~business~~clinical ~~prospects~~trials.

WePreliminary, ~~expect~~“topline”, toor ~~rely~~interim ondata ~~third~~from ~~parties to conduct~~ our ~~future~~ clinical trials ~~for~~that ~~drug~~we ~~candidates~~announce ~~other~~or ~~than~~publish ~~GMI-1070,~~from ~~and~~time ~~those~~to ~~third~~time ~~parties~~ may ~~not~~change ~~perform~~as ~~satisfactorily,~~more ~~including~~patient ~~failing~~data tobecome ~~meet~~available ~~deadlines for~~and ~~the~~are ~~completion~~subject ofto ~~such~~audit ~~trials~~and verification procedures.

WeFrom ~~currently~~time ~~expect~~ to ~~engage~~time, awe ~~third-party~~may ~~contract~~publicly ~~research~~disclose ~~organization,~~preliminary or ~~CRO,~~topline todata ~~conduct~~from our ~~planned~~ preclinical studies and clinical trials, ~~for~~which ~~GMI~~are based on a preliminary analysis of then-~~1271~~available data, and ~~any~~the ofresults ~~our~~and ~~other~~related ~~drug~~findings ~~candidates~~and ~~that~~conclusions ~~may~~are ~~progress~~subject to ~~clinical~~change ~~development~~following a more comprehensive review of the data. We ~~expect~~also tomake ~~continue~~assumptions, estimations, calculations, and conclusions as part of our analyses of these data without the opportunity to ~~rely~~fully onand ~~third~~carefully ~~parties~~evaluate complete data. As a result, ~~such~~the aspreliminary ~~CROs~~or topline results that we report may differ from future results of the same studies, ~~clinical~~or ~~data~~different ~~management~~conclusions ~~organizations~~or considerations may qualify such results, ~~medical~~once ~~institutions~~additional data have been received and ~~clinical investigators,~~fully evaluated or subsequently made subject to ~~conduct~~audit ~~those~~and ~~clinical~~verification ~~trials~~procedures. ~~Agreements~~As a result, any preliminary or topline data should be viewed with ~~such~~caution ~~third~~until ~~parties~~the ~~might~~final ~~terminate~~data ~~for~~are aavailable. ~~variety~~From oftime ~~reasons~~to time, ~~including~~we amay ~~failure~~also todisclose ~~perform~~interim bydata ~~the~~from ~~third~~our ~~parties~~preclinical studies and clinical trials. IfInterim wedata ~~need~~are subject to ~~enter~~the ~~into~~risk ~~alternative~~that ~~arrangements,~~one ~~that~~or ~~would~~more ~~delay~~ of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our ~~drug~~clinical ~~development~~trials ~~activities~~continue other treatments. Further, disclosure of such data by us could result in volatility in the price of our ordinary shares.

~~Our~~Further, ~~reliance~~others, onincluding ~~these~~regulatory ~~third~~agencies, ~~parties~~may ~~for~~not ~~research~~accept ~~and~~or ~~development~~agree ~~activities~~with ~~will reduce~~ our ~~control~~assumptions, ~~over~~estimates, ~~these activities~~calculations, ~~but~~conclusions, ~~will~~or ~~not~~analyses ~~relieve~~or usmay ofinterpret ~~our~~or ~~responsibilities.~~weigh ~~For~~the ~~example,~~importance weof ~~will~~data ~~remain~~differently, ~~responsible~~which ~~for~~could ~~ensuring~~impact ~~that~~the ~~each~~value of ~~our~~the ~~clinical~~particular ~~trials~~product iscandidate, ~~conducted~~the inapprovability ~~accordance~~or ~~with~~commercialization of the ~~general~~particular ~~investigational~~product ~~plan~~candidate and ~~protocols~~us ~~for~~in ~~the trial~~general. ~~Moreover~~ In addition, the ~~FDA~~information ~~requires~~we uschoose to ~~comply~~publicly ~~with~~disclose ~~standards,~~regarding ~~commonly~~a ~~referred~~particular topreclinical asstudy ~~good~~or clinical ~~practices,~~trial oris ~~GCPs,~~based ~~for~~on ~~conducting,~~what ~~recording~~is typically extensive information, and ~~reporting~~you ~~the~~or ~~results~~others ofmay ~~clinical~~not ~~trials~~agree towith ~~assure~~what ~~that~~we ~~data~~determine ~~and~~is ~~reported~~material ~~results~~or ~~are~~otherwise ~~credible~~appropriate ~~and accurate~~information ~~and~~to ~~that~~include ~~the~~in ~~rights~~our disclosure. As a result, ~~integrity~~you ~~and~~or ~~confidentiality~~others ofmay ~~trial~~have ~~participants~~reached ~~are~~different ~~protected.~~conclusions Webased ~~also~~on ~~are~~such ~~required~~extensive information in comparison to ~~register~~our ~~ongoing~~publicly ~~clinical~~disclosed ~~trials~~conclusion ~~and~~regarding ~~post~~a ~~the~~particular ~~results~~preclinical ofstudy ~~completed~~or clinical ~~trials~~trial. onIf athe ~~government-sponsored~~preliminary, ~~database~~topline, ~~ClinicalTrials.gov~~ or interim data that we report differ from actual results, ~~within~~or ~~specified~~if ~~timeframes.~~others, ~~Failure~~including toregulatory doauthorities, sodisagree ~~can~~with ~~result~~the inconclusions ~~fines~~reached, ~~adverse~~our ~~publicity~~ability ~~and~~to ~~civil~~obtain approval for, and ~~criminal~~commercialize, ~~sanctions~~our product candidates may be harmed, which could harm our business, operating results, prospects, or financial condition.

~~Furthermore, these~~Use ~~third~~of ~~parties~~our ~~may~~product ~~also~~candidates ~~have~~could ~~relationships with other entities, some of which may~~ be ~~our~~associated ~~competitors.~~with Ifadverse ~~these~~side ~~third~~effects, ~~parties~~adverse doevents ~~not~~or ~~successfully~~other ~~carry~~properties ~~out~~or ~~their~~safety ~~contractual duties~~risks, ~~meet~~which ~~expected~~could ~~deadlines~~delay or ~~conduct~~preclude ~~our~~approval, ~~clinical~~cause ~~trials~~us ~~in accordance~~to ~~with~~suspend ~~regulatory requirements~~ or ~~our~~discontinue ~~stated~~clinical ~~protocols~~trials, weabandon ~~will~~a ~~not~~product ~~be able to obtain~~candidate, orlimit ~~may~~the becommercial ~~delayed~~profile inof ~~obtaining,~~an ~~marketing~~approved ~~approvals~~product ~~for~~or ~~our~~result ~~drug~~in ~~candidates~~other ~~and~~significant ~~will~~negative ~~not~~consequences bethat ~~able~~could ~~to,~~severely orharm ~~may be delayed in~~ our ~~efforts~~business, toprospects, ~~successfully commercialize~~operating ~~our~~results ~~drug~~and ~~candidates.~~financial condition.

WeResults ~~also~~of ~~expect~~our toclinical ~~rely~~trials oncould ~~other~~reveal ~~third~~a ~~parties~~high toand ~~store~~unacceptable severity and ~~distribute~~prevalence ~~drug~~of ~~supplies~~side ~~for~~effects ~~our~~or ~~clinical~~unexpected ~~trials~~characteristics. ~~Any performance~~Undesirable ~~failure~~side effects caused by our product candidates, whether used alone on ~~the~~in ~~part~~combination ofwith ~~our~~other ~~distributors~~therapies, could cause us or regulatory authorities to interrupt, delay or halt clinical ~~development~~trials or ~~marketing~~lead ~~approval~~to the delay or denial of ~~our~~regulatory ~~drug~~approval ~~candidates~~by the FDA or ~~commercialization~~comparable offoreign ~~our~~regulatory ~~drugs~~authorities, ~~producing~~or, ~~additional~~if ~~losses~~such product candidates are approved, result in a more restrictive label and ~~depriving~~other uspost-approval requirements. Any treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial, or could result in potential ~~revenue~~product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.

WeIf ~~contract with third parties for the manufacturing of~~ our ~~drug~~product candidates ~~for~~are ~~preclinical~~associated ~~and~~with ~~clinical~~undesirable ~~testing~~side ~~and~~effects ~~expect~~or tohave ~~continue~~unexpected tocharacteristics doin sopreclinical ~~for commercialization.~~studies ~~This~~or ~~reliance~~clinical ontrials, ~~third~~when ~~parties~~used ~~increases~~alone ~~the~~or ~~risk~~in ~~that~~combination wewith ~~will~~other ~~not~~approved ~~have~~products ~~sufficient quantities of our drug candidates~~ or investigational drugs, orwe ~~such~~may ~~quantities~~need atto ~~an acceptable cost~~interrupt, ~~which could~~ delay, ~~prevent~~ or ~~impair~~abandon ~~our~~their development or ~~commercialization~~ ~~efforts.~~limit development to more

We do not have any manufacturing facilities or personnel. For our drug candidates other than GMI-1070, for which manufacturing responsibility has shifted to Pfizer, we rely, and expect to continue to rely, on third parties for the manufacturing of our drug candidates for preclinical and clinical testing, as well as for commercial manufacture if any of our drug candidates receive marketing approval. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates or drugs, or such quantities at an acceptable cost or quality, 19

18narrow 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.

~~Table~~Patients in our ongoing and planned clinical trials may in the future suffer significant adverse events or other side effects not observed in our preclinical studies or previous clinical trials. Patients treated with our product candidates may also be undergoing surgical, radiation or chemotherapy treatments, which can cause side effects or adverse events that are unrelated to our product candidate, but may still impact the success of ~~Contents~~our clinical trials. The inclusion of critically ill patients in our clinical trials may result in deaths or other adverse medical events due to other therapies or medications that such patients may be using or due to the gravity of such patients’ illnesses. If such significant adverse events or other side effects are observed in any of our ongoing or planned clinical trials, we may have difficulty recruiting patients to the clinical trials, or we may be required to abandon the trials or our development efforts of that product candidate altogether. We, the FDA, other comparable regulatory authorities or an IRB may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Even if the side effects do not preclude the product candidate from obtaining or maintaining regulatory approval, undesirable side effects may inhibit market acceptance due to tolerability concerns as compared to other available therapies. Any of these developments could materially harm our business, financial condition and prospects.

~~which~~Additionally, if any of our product candidates receives regulatory approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could ~~delay~~result. For example, ~~prevent~~the FDA could require us to adopt a Risk Evaluation and Mitigation Strategy (“REMS”), to ensure that the benefits of treatment with such product candidate outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring or ~~impair~~distribution systems and processes that are highly controlled, restrictive and more costly than what is typical for the industry. We or our ~~ability~~collaborators may also be required to ~~timely~~adopt ~~conduct~~a ~~our~~REMS ~~clinical~~or ~~trials~~engage in similar actions, such as patient education, certification of health care professionals or ~~our~~specific ~~other~~monitoring, ~~development~~if we or ~~commercialization~~others ~~efforts~~later identify undesirable side effects caused by any product that we develop alone. Other potentially significant negative consequences associated with adverse events include:

~~We also expect to rely on third-party manufacturers or third-party collaborators for the manufacturing of commercial supply of any other drug candidates for which~~ •we ~~or our collaborators obtain marketing approval. We~~ may be ~~unable~~required to ~~establish~~suspend ~~any~~marketing ~~agreements~~of ~~with~~a ~~third-party~~product, ~~manufacturers~~ or ~~to do so on acceptable terms. Even if~~ we ~~are~~may ~~able~~decide to ~~establish~~remove ~~agreements~~such ~~with~~product ~~third-party~~from ~~manufacturers,~~the ~~reliance on third-party manufacturers entails additional risks, including:~~ marketplace;

n•regulatory ~~reliance~~authorities onmay ~~the~~withdraw ~~third~~or ~~party~~change ~~for~~their ~~regulatory~~approvals ~~compliance~~of ~~and~~a ~~quality assurance~~product;

n•regulatory authorities may require additional warnings on the ~~possible~~label ~~breach~~or limit access of ~~the~~a ~~manufacturing~~product ~~agreement~~to byselective ~~the~~specialized ~~third~~centers ~~party~~with additional safety reporting and with requirements that patients be geographically close to these centers for all or part of their treatment;

n•we ~~the~~may ~~possible~~be ~~misappropriation~~required ofto ~~our~~create ~~proprietary~~a ~~information,~~medication ~~including~~guide ~~our~~outlining ~~trade~~the ~~secrets~~risks ~~and~~of ~~know~~a product for patients, or to conduct post-~~how;~~marketing ~~and~~studies;

n•we ~~the~~may ~~possible~~be ~~termination~~required orto ~~non-renewal~~change of the ~~agreement~~way ~~by the third party at~~ a ~~time~~product ~~that~~ is ~~costly or inconvenient for us.~~administered;

~~Third-party~~•we ~~manufacturers~~could ~~may not~~ be ~~able~~subject to ~~comply with current good manufacturing practices~~fines, ~~or cGMP~~injunctions, ~~regulations~~ or ~~similar regulatory requirements outside~~ the ~~United~~ ~~States.~~imposition ~~Our~~of ~~failure,~~criminal or ~~the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions,~~ civil penalties, ~~delays, suspension~~ or ~~withdrawal~~ ofbe ~~approvals,~~sued ~~license~~and ~~revocation,~~held ~~seizures~~liable orfor ~~recalls~~harm ofcaused ~~drug~~to ~~candidates~~subjects or ~~drugs,~~patients; ~~operating restrictions~~ and ~~criminal prosecutions, any of which could significantly and adversely affect supplies of our drugs.~~

~~Our~~•a ~~drug~~product ~~candidates and any drugs that we~~ may ~~develop~~become ~~may~~less compete with other drug candidates and drugs for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us. Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval. We do not currently have arrangements in place for redundant supply or a second source for bulk drug substance. We are currently manufacturing GMI-1271 through a third partycompetitive, ~~but the drug supply to treat patients in our planned Phase 1 clinical trial is not yet available~~ and ~~there is no guarantee that it will become available in time for the anticipated start of that trial. If~~ our ~~current~~reputation ~~contract manufacturers cannot perform as agreed, we~~ may ~~be required to replace such manufacturers and we may incur added costs and delays in identifying and qualifying any such replacement~~suffer.

~~Our~~Any ~~current~~of ~~and~~these ~~anticipated~~events ~~future~~could ~~dependence~~diminish ~~upon~~the ~~others~~usage ~~for~~or otherwise limit the ~~manufacturing~~ commercial success of our ~~drug~~product candidates orand ~~drugs~~prevent ~~may~~us ~~adversely~~from ~~affect~~achieving ~~our~~or ~~future~~maintaining ~~profit~~market ~~margins~~acceptance ~~and~~of our ~~ability~~product tocandidates, ~~commercialize~~if ~~any~~approved ~~drugs~~by ~~that~~the ~~receive~~FDA ~~marketing~~or ~~approval~~other onregulatory ~~a timely and competitive basis~~authorities.

~~Risks Related to the Commercialization of Our Drug Candidates~~ 20

~~Even~~We ifmay ~~any~~attempt to obtain accelerated approval of our ~~drug~~product candidates. ~~receives~~If ~~marketing~~we are unable to obtain accelerated approval, itwe may ~~fail~~be required to ~~achieve~~conduct clinical trials beyond those that we contemplate, or the ~~degree~~size and duration of ~~market~~our ~~acceptance~~pivotal byclinical ~~physicians~~trials could be greater than currently planned, ~~patients~~which could increase the expense of obtaining, ~~third-party payors~~reduce ~~and~~the ~~others~~likelihood inof obtaining, and/or delay the ~~medical~~timing ~~community~~of obtaining necessary ~~for~~regulatory ~~commercial~~approvals. ~~success~~Even if we receive accelerated approval from the FDA or comparable foreign regulatory authorities, the FDA or comparable foreign regulatory authorities may require that we conduct confirmatory trials to verify clinical benefit. If such confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-approval requirements, the FDA may seek to withdraw any accelerated approval we have obtained.

IfWe ~~any~~may ofseek accelerated approval for our ~~drug~~product candidates. ~~receives~~The ~~marketing~~FDA ~~approval,~~may itgrant ~~may nonetheless~~accelerated ~~fail~~approval to ~~gain~~a ~~sufficient~~product ~~market~~candidate ~~acceptance~~designed byto ~~physicians,~~treat ~~patients,~~a ~~third~~serious or life-~~party~~threatening ~~payors~~condition that provides meaningful therapeutic advantage over available therapies and ~~others~~upon ina determination that the ~~medical~~product ~~community.~~candidate Ifhas ~~our~~an ~~drug~~effect ~~candidates~~on doa ~~not~~surrogate ~~achieve~~endpoint anor ~~adequate~~intermediate ~~level~~clinical endpoint that is reasonably likely to predict clinical benefit. For the purposes of ~~acceptance~~accelerated approval, wea ~~may~~surrogate ~~not~~endpoint ~~generate~~is ~~significant~~a ~~revenue from~~marker, ~~drug~~such ~~sales~~as ~~and~~a welaboratory ~~may~~measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not ~~become~~itself ~~profitable~~a measure of clinical benefit. ~~The~~An ~~degree~~intermediate ofclinical ~~market~~endpoint ~~acceptance~~is ofa ~~our~~clinical ~~drug~~endpoint ~~candidates,~~that ifcan ~~approved~~be ~~for~~measured ~~commercial~~earlier ~~sale,~~than ~~will~~an ~~depend~~effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The FDA considers a ~~number~~clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of ~~factors,~~a ~~including:~~given disease.

nIf granted, accelerated approval is usually contingent on the ~~efficacy~~sponsor’s agreement to conduct, in a diligent manner, additional confirmatory studies to verify and ~~potential~~describe ~~advantages~~the ~~compared~~drug’s predicted effect on irreversible morbidity or mortality or other clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022, the FDA may require, as appropriate, that any such confirmatory study be initiated or substantially underway prior to ~~alternative~~the ~~treatments;~~submission of an application for accelerated approval. If such post-approval studies fail to confirm the drug’s clinical benefits relative to its risks, the FDA may withdraw its approval of the drug on an expedited basis.

nIf ~~our~~we ~~ability~~choose to ~~offer~~pursue ~~our~~accelerated ~~drugs~~approval, there can be no assurance that the FDA will agree that we have identified appropriate surrogate or intermediate endpoints. Similarly, there can be no assurance that after subsequent FDA feedback that we will continue to pursue accelerated approval or any other form of expedited development, review, or approval, even if we initially decide to do so. Furthermore, if we submit an application for ~~sale~~accelerated approval, there can be no assurance that such application will be accepted or that approval will be granted on a timely basis, or at ~~competitive~~all. ~~prices;~~The FDA also could require us to conduct further studies or trials prior to considering our application or granting approval of any type.

nEven if we receive accelerated approval of any of our product candidates from the ~~convenience~~FDA, we will be subject to rigorous post-approval requirements, including submission to the FDA of all promotional materials prior to their dissemination, and ~~ease~~will likely be required by FDA to conduct a confirmatory study to verify the predicted clinical benefit. The FDA could withdraw accelerated approval for multiple reasons, including our failure to conduct any required post-approval study with due diligence, or the inability of ~~administration~~such ~~compared~~study to ~~alternative~~confirm ~~treatments;~~the predicted clinical benefit. A failure to obtain accelerated approval or any other form of expedited review or approval for a product candidate could result in a longer time period prior to commercializing such product candidate, if ever, increase the cost of development of such product candidate, and harm our competitive position in the marketplace.

nWe ~~the~~may ~~willingness~~expend ofour ~~the~~limited ~~target~~resources ~~patient~~to ~~population~~pursue a particular program and fail to ~~try~~capitalize ~~new~~on ~~therapies~~programs ~~and~~that ofmay ~~physicians~~be tomore ~~prescribe~~profitable ~~these~~or ~~therapies;~~for which there is a greater likelihood of success.

nBecause we have limited financial and managerial resources, we focus our research and development efforts on certain selected programs. We have and may continue to utilize Paragon Therapeutics, Inc. (“Paragon”) to conduct certain research activities (primarily preclinical studies) pursuant to discovery and option agreements into which we may enter, such as the ~~strength~~Antibody ofDiscovery ~~marketing~~and Option Agreement, dated September 19, 2024 (the “Antibody Paragon Option Agreement”), and ~~distribution~~the ~~support;~~Amended and Restated ADC Discovery and Option Agreement, dated April 28, 2025 (the “ADC Paragon Option Agreement” and together with the Antibody Paragon Option Agreement, the “Paragon Option Agreements”), each by and among Crescent, Paragon and Parascent Holding LLC. For example, we are initially focused on our lead programs, CR-001, CR-002 and CR-003. As a result, we may forgo or delay

~~n the availability of third-party coverage and adequate reimbursement;~~21

19pursuit of opportunities with other programs such as CR-004 that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs for specific indications may not yield any commercially viable product candidates. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. In addition, historically we have selected product candidates amongst a variety of potential product candidates from Paragon, and the product candidates we have selected, initially CR-001 and CR-002, may fail to be viable commercial products or the product candidates we do not select may have a greater likelihood of success.

~~Table~~Any approved products resulting from our current programs or any future program may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors, and others in the medical community necessary for commercial success and we may not generate any future revenue from the sale or licensing of ~~Contents~~such products.

nEven if regulatory approval is obtained for a product candidate resulting from one of our current or future programs, they may not gain market acceptance among physicians, healthcare professionals, patients, healthcare payors, or the ~~prevalence~~medical community. We may not generate or sustain revenue from sales of the product due to factors such as whether the product can be sold at a competitive cost and ~~severity~~whether it will otherwise be accepted in the market. There are several approved products and product candidates in later stages of development for the treatment of solid tumors, including pembrolizumab. In addition, Opdivo, a PD-1 inhibitor, and Yervoy®, a CTLA-4 inhibitor, in combination are approved by the FDA for treating various cancers, including metastatic melanoma, advanced renal cell carcinoma, and certain types of colorectal cancer. CR-001 utilizes a proprietary anti-PD-1/anti-VEGF bispecific antibody for its proposed method of action, and is designed to recapitulate the targeting, binding, cooperativity and pharmacokinetics of ivonescimab, an anti-PD-1/anti-VEGF bispecific antibody that demonstrated significantly improved PFS to market-leading pembrolizumab in a large third-party Phase 3 clinical trial. Although checkpoint inhibitors are highly effective in some patients, most patients with solid tumors fail to respond to these therapies. Furthermore, patients who do respond do not always achieve durable responses. With respect to CR-002 and CR-003, regarding ADC development, we are aware of other ADC product candidates in clinical development for solid tumor indications, including, but not limited to, PDL1V (Pfizer), HLX-43 (Henlius), sigvotatug vedotin (Pfizer). Market participants with significant influence over acceptance of new treatments, such as clinicians and third-party payors, may not adopt a biologic that uses cooperative binding qualities for our targeted indications, and we may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement for, any ~~side~~programs ~~effects;~~developed by us or our existing or future collaborators. Serious adverse events, including fatal pulmonary hemorrhage, observed in anti-VEGF inhibitors, such as bevacizumab, may adversely affect our ability to gain market acceptance. Market acceptance of our product candidates may be negatively impacted by potential poor performance of our competitors, including the occurrence of serious adverse events in such competitors’ clinical trials or failure by such competitors to obtain and maintain regulatory approval for their product candidates.

nSales ~~any~~of ~~restrictions~~medical products also depend on the ~~use~~willingness of clinicians to prescribe the treatment. We cannot predict whether clinicians, clinicians’ organizations, hospitals, other healthcare providers, government agencies, or private insurers will determine that our ~~drugs~~product ~~together~~is safe, therapeutically effective, cost effective, or less burdensome as compared with ~~other~~competing ~~medications~~treatments. If any of our product candidates are approved but does not achieve an adequate level of acceptance by such parties, we may not generate or derive sufficient revenue from that product candidate and may not become or remain profitable. Market acceptance of our product candidates will depend on many factors, including factors that are not within our control.

IfCertain weof ~~are~~our ~~unable~~programs tomay ~~establish~~compete ~~sales,~~with ~~marketing~~our ~~and distribution capabilities for drug candidates~~ other ~~than GMI-1070~~programs, wewhich ~~may~~could ~~not~~negatively beimpact ~~successful~~our inbusiness ~~commercializing those drug candidates if~~ and ~~when~~reduce ~~they~~our ~~are approved~~future revenue.

We doare ~~not~~developing ~~have~~product acandidates ~~sales~~for ~~or marketing infrastructure and have no experience in~~ the ~~sale~~same indication, ~~marketing~~solid ~~or distribution of pharmaceutical drugs. Under our collaboration with Pfizer~~tumors, ~~Pfizer~~and ismay ~~responsible~~in ~~for~~ the ~~commercialization~~future ofdevelop ~~GMI-1070,~~ our ~~lead~~programs ~~drug candidate, if it receives regulatory approval. To achieve commercial success~~ for ~~any~~ other ~~drug~~ ~~candidate~~oncology ~~for~~indications. ~~which~~Each wesuch ~~may~~program ~~obtain~~targets ~~marketing approval, we will need to establish~~ a ~~sales~~different ~~and~~mechanism ~~marketing~~of ~~organization to market or co-promote such drugs~~action. ~~There are risks involved with establishing our own sales~~However, ~~marketing~~developing ~~and~~multiple ~~distribution capabilities.~~programs ~~For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a drug candidate~~ for ~~which we recruit~~ a ~~sales~~single ~~force~~indication ~~and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This~~ may benegatively ~~costly,~~impact ~~and~~ our ~~investment~~business ~~would be lost~~ if wethe ~~cannot~~programs ~~retain~~compete ~~or reposition our sales and marketing personnel.~~

~~Factors that may inhibit our efforts to commercialize our drugs on our own include:~~ 22

nwith ~~our~~each ~~inability~~other. toFor ~~recruit~~example, ~~train~~if ~~and~~multiple ~~retain~~programs ~~adequate~~are ~~numbers~~conducting clinical trials at the same time, they could compete for the enrollment of ~~effective~~patients. ~~sales~~In ~~and~~addition, ~~marketing~~if ~~personnel;~~multiple product candidates are approved for the same indication, they may compete for market share, which could limit our future revenue.

nWe ~~the~~intend ~~inability~~to ofconduct ~~sales~~clinical ~~personnel~~trials, toinitially ~~obtain~~for ~~access~~our toCR-001 ~~physicians~~program orand ~~persuade~~for ~~adequate~~future ~~numbers~~programs, ofat ~~physicians~~sites tooutside ~~prescribe~~the ~~any~~United ~~future~~States, ~~drugs;~~and the FDA may not accept data from trials conducted in such locations.

nWe intend to conduct clinical trials for CR-001 outside of the ~~lack~~United States, and expect to conduct one or more of ~~complementary~~our ~~drugs~~future clinical trials for CR-002, CR-003, and any other future programs outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to beconditions ~~offered~~imposed by ~~sales~~the ~~personnel~~FDA. In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the U.S., ~~which~~the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may ~~put~~be usconsidered atvalid awithout ~~competitive~~the ~~disadvantage~~need ~~relative~~for an on-site inspection by the FDA, or if the FDA considers such inspection to ~~companies~~be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, if the study was not otherwise subject to an IND, the FDA will not accept the data as support for an application for regulatory approval unless the study is well-designed and well-conducted in accordance with ~~more~~GCP ~~products;~~requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar requirements for clinical data gathered outside of their respective jurisdictions. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted.

nThere ~~unforeseen~~can ~~costs~~be ~~and~~no ~~expenses~~assurance ~~associated~~that ~~with~~the ~~creating~~FDA anor ~~independent~~any ~~sales~~comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the relevant jurisdiction. If the FDA does not accept the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which would be costly and ~~marketing~~time-consuming ~~organization~~and would delay or permanently halt our development of the applicable product candidates. Even if the FDA accepted such data, it could require us to modify our planned clinical trials to receive clearance to initiate such trials in the United States or to continue such trials once initiated.

~~If we are unable to establish our own sales~~Further, ~~marketing~~conducting ~~and~~international ~~distribution~~clinical ~~capabilities~~trials ~~and~~presents ~~enter~~additional ~~into~~risks ~~arrangements~~that ~~with~~may ~~third~~delay ~~parties~~completion toof ~~perform these services,~~ our ~~revenue~~ ~~and~~clinical ~~our~~trials. ~~profitability,~~These ifrisks ~~any,~~include ~~are~~the ~~likely~~failure toof beenrolled ~~lower~~patients ~~than~~in ifforeign wecountries ~~were~~ to ~~sell,~~adhere ~~market~~to ~~and~~clinical ~~distribute~~protocol ~~any~~as ~~drugs~~a ~~that~~result weof ~~develop~~differences ~~ourselves. In addition, we may not be successful~~ in ~~entering~~healthcare ~~into~~services ~~arrangements~~or ~~with~~cultural ~~third~~customs ~~parties~~that tocould ~~sell,~~restrict ~~market and~~or ~~distribute~~limit our ~~drug~~ability ~~candidates or may be unable~~ to doconduct soour onclinical ~~terms that are favorable to us. We likely will have little control over such third parties~~trials, ~~and any of them may fail to devote~~ the ~~necessary~~administrative ~~resources~~burdens ~~and~~of ~~attention~~conducting toclinical ~~sell~~trials ~~and~~under ~~market our~~multiple ~~drugs~~sets ~~effectively.~~of Ifforeign ~~we do not establish sales~~regulations, ~~marketing~~foreign ~~and~~exchange ~~distribution capabilities successfully~~fluctuations, ~~either~~diminished onprotection ~~our~~of ~~own~~intellectual orproperty in ~~collaboration~~some ~~with third parties~~countries, weas ~~will~~well ~~not~~as bepolitical ~~successful~~and ineconomic ~~commercializing~~risks ~~our~~relevant ~~drug~~to ~~candidates~~foreign countries.

WeRisks ~~face~~Related ~~substantial~~to ~~competition,~~Government ~~which~~Regulation ~~may result in others discovering, developing or commercializing drugs before or more successfully than we do.~~

The ~~development~~regulatory ~~and~~approval ~~commercialization~~processes of ~~new~~the ~~drugs~~FDA isand ~~highly~~other ~~competitive.~~comparable Weforeign ~~face~~regulatory ~~competition~~authorities ~~with~~are ~~respect~~lengthy, ~~to our current drug candidates~~time-consuming, and we ~~will~~inherently ~~face~~unpredictable. ~~competition~~If ~~with respect to any drug candidates that~~ we ~~may~~are ~~seek~~not able to ~~develop~~obtain, or ~~commercialize~~if inthere ~~the~~are ~~future,~~delays ~~from~~in ~~major pharmaceutical companies~~obtaining, ~~specialty~~required ~~pharmaceutical~~regulatory ~~companies,~~approvals ~~biotechnology~~for ~~companies,~~our ~~academic~~product ~~institutions~~candidates, ~~governmental~~ ~~agencies~~we ~~and~~will ~~public~~not ~~and~~be ~~private~~able ~~research~~to ~~institutions.~~commercialize, ~~Should any competitors’ drug candidates receive regulatory~~ or ~~marketing~~will ~~approval~~be ~~prior~~delayed toin ~~ours~~commercializing, ~~they~~our ~~may~~product ~~establish~~candidates, ~~a strong market position~~ and beour ~~difficult~~ability to ~~displace~~generate ~~or diminish~~revenue ~~the~~will ~~need~~be ~~for~~materially ~~our drug candidates~~impaired.

~~With~~The ~~respect~~process toof ~~GMI-1070~~obtaining regulatory approvals, weboth ~~are~~in ~~not~~the ~~aware~~United ofStates ~~any~~and ~~therapies~~abroad, ~~that~~is ~~have~~unpredictable, ~~been~~expensive, ~~approved~~and ~~for~~typically ~~treatment~~takes many years following commencement of ~~patients experiencing~~clinical ~~VOC.~~trials, ~~The~~if ~~only~~approval ~~drug~~is ~~approved~~obtained ~~for~~at ~~the~~all, ~~prevention~~and can vary substantially based upon a variety of ~~VOC~~factors, ~~but~~including ~~not~~the ~~for~~type, ~~the~~complexity, ~~resolution~~and novelty of anthe ~~ongoing~~product ~~VOC~~candidates ~~episode,~~involved. isWe ~~hydroxyurea,~~cannot ~~which~~commercialize isproduct ~~available~~candidates in ~~both~~the ~~generic~~United ~~and~~States ~~branded~~without ~~formulations~~first obtaining regulatory approval from the FDA. WeSimilarly, ~~are~~we ~~also~~cannot ~~aware~~commercialize product candidates outside of athe ~~company~~United States without obtaining regulatory approval from comparable foreign regulatory authorities. Before obtaining regulatory approvals for the commercial sale of our product candidates, ~~Mast~~including ~~Therapeutics~~our lead program, ~~Inc.~~ CR-001, ~~that~~and isother ~~developing~~planned aprograms, ~~drug~~CR-002, toCR-003 ~~treat~~and anCR-004, ~~ongoing~~we ~~VOC~~must ~~episode.~~demonstrate ~~Mast~~through islengthy, ~~currently~~complex, ~~conducting~~and aexpensive ~~Phase~~preclinical 3studies and clinical ~~trial~~trials inthat ~~pediatric~~our ~~patients~~product 8candidates toare 17both ~~years~~safe ~~old~~and ~~experiencing~~effective ~~VOC.~~for Ifeach ~~Mast’s~~targeted ~~drug~~indication, ~~achieves~~or ~~regulatory~~with ~~approval~~respect ~~before~~to ~~GMI-1070,~~our ~~it could~~product ~~adversely~~candidates ~~affect~~regulated ~~commercialization~~as ofbiologics, ~~GMI-1070~~that ifsuch itcandidates isare ~~approved.~~safe,

In addition to efforts to treat ongoing VOC episodes, we are aware of a number of companies developing therapies intended to prevent VOC from occurring in the first place. One company, Selexys Pharmaceuticals Corporation, is developing a therapy that, like our drug candidates, targets selectins. Selexys has announced that it has commenced enrollment in a Phase 2 clinical trial for its selectin antagonist drug candidate. Other companies are using different approaches to target a variety of biological mechanisms. We are also aware of efforts to develop cures for sickle cell disease through approaches such as bone marrow transplant and gene therapy. If any these approaches are successful and receive regulatory approval, it could limit the market for a drug such as GMI-1070. 23

20pure, and potent for their intended uses. Securing regulatory approval also requires the submission of information about the drug manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Further, our product candidates 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 our obtaining regulatory approval. The FDA and comparable foreign 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 data.

~~Table~~Our ofproduct ~~Contents~~candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including:

~~In addition, numerous non-profit and non-commercial foundations and interest groups also are committed to improving outcomes for patients with sickle cell disease. Advances in~~ •the ~~understanding~~FDA ofor ~~the~~comparable ~~signaling~~foreign ~~pathways~~regulatory ~~associated~~authorities ~~with sickle cell disease~~ may ~~lead~~disagree towith ~~further interest and development of treatment options. There is also increasing interest among for-profit companies in developing drugs for rare diseases, which may have~~ the ~~effect~~design ~~of increasing the development of drug candidates to treat sickle cell disease generally~~ or ~~VOC~~implementation in particular. Legislative action, such as the potential to expand the priority review voucher system to rare pediatric diseases, may generate further interest in developing drug candidates to treat sickle cell disease or VOC and increase competition. If an alternative effective treatment or cure for VOC or sickle cell disease receives regulatory approval, the potential commercial success of ~~GMI-1070~~our ~~could~~clinical betrials; ~~jeopardized.~~

In•we ~~addition, a competitor’s drug candidate with an orphan drug designation~~ may ~~receive~~be ~~marketing~~unable ~~approval~~to ~~prior~~demonstrate to ~~GMI-1070.~~the ~~For~~satisfaction ~~example,~~of wethe ~~believe~~FDA ~~Mast~~or ~~has~~comparable ~~already~~foreign ~~received~~regulatory ~~orphan~~authorities ~~drug~~that ~~designation~~a inproduct ~~Europe for its drug~~ candidate ~~intended to~~is ~~treat~~safe, anpure, ~~ongoing~~potent, ~~VOC~~or ~~episode.~~effective ~~If Mast receives orphan drug designation in the United States and marketing approval~~ for its ~~drug~~proposed ~~candidate~~indication(s); ~~prior to GMI-1070 receiving marketing approval, the commercial success of GMI-1070 could be significantly limited.~~

~~With~~•the ~~respect~~results ~~to GMI-1271 and its development for treatment~~ of ~~AML~~clinical ~~and~~trials ~~other~~may ~~hematologic~~not ~~cancers,~~meet ~~there~~the islevel ~~substantial~~of ~~potential~~statistical ~~competition from~~persuasiveness ~~other~~required therapies currently in development. While some chemotherapies in development for AML could potentially be complementary to GMI-1271, there are also therapies in development that could be directly competitive with GMI-1271. For example, Mozobil, which is currently marketed by ~~Sanofi, is being studied in combination with chemotherapy for~~ the ~~treatment~~FDA ofor ~~AML~~comparable ~~and~~foreign ~~myeloma.~~regulatory Asauthorities ~~the treatment landscape~~ for ~~AML~~approval; ~~changes, there is substantial risk that GMI-1271 might not provide additional benefit over other therapies.~~

~~Our~~•serious ~~commercial opportunity could be reduced or eliminated if our competitors develop~~ and ~~commercialize~~unexpected ~~drugs~~drug-related ~~that are safer, more effective, have fewer or less severe~~ side effects, ~~are more convenient or are less expensive than any drugs that we~~ may ~~develop.~~be ~~Our~~experienced ~~competitors~~by ~~also~~patients ~~may obtain FDA or other regulatory approval for their drugs more rapidly than we may obtain approval for ours, which could result~~ in our ~~competitors~~clinical ~~establishing~~trials aor ~~strong~~by ~~market~~individuals ~~position~~using ~~before~~drugs wesimilar ~~are able~~ to ~~enter~~our ~~the~~product ~~market.~~candidates;

~~In addition, because~~ •we ~~have no patents with respect to our glycomimetics platform, our competitors~~ may ~~use~~be ~~our~~unable ~~methods, or acquire similar expertise, in order~~ to ~~develop~~demonstrate ~~glycomimetic~~that ~~drug~~a ~~candidates~~product ~~and~~candidate’s ~~progress these drug candidates through~~ clinical ~~development~~ and ~~commercialization,~~other ~~which~~benefits ~~could~~outweigh ~~impair~~its ~~our~~safety ~~ability~~risks; ~~to successfully commercialize our drug candidates or otherwise limit our commercial opportunities.~~

~~Many of~~ •the ~~companies~~FDA ~~against which we are competing~~ or ~~against~~comparable ~~which~~foreign ~~we may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining~~ regulatory ~~approvals~~authorities ~~and marketing approved drugs than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries~~ may ~~result~~disagree inwith ~~even~~our ~~more~~interpretation ~~resources being concentrated among a smaller number~~ of ~~our~~data ~~competitors.~~from ~~Smaller~~preclinical ~~and~~studies ~~other~~or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical ~~trial sites and patient registration for clinical~~ trials,; ~~as well as in acquiring technologies complementary to, or necessary for, our programs.~~

~~Even~~•the ifdata wecollected orfrom clinical trials of our ~~collaborators~~product ~~are~~candidates ~~able~~may not be acceptable or sufficient to ~~commercialize~~support ~~any~~the submission of ~~our~~a ~~drug~~Biologics ~~candidates,~~License ~~the~~Application ~~drugs~~(“BLA”) ~~may~~or ~~become~~other ~~subject~~submission or to ~~unfavorable~~obtain ~~pricing regulations,~~regulatory ~~third-party~~approval ~~coverage~~in ~~and~~the ~~reimbursement~~United ~~policies~~States or ~~healthcare~~elsewhere, ~~reform~~and ~~initiatives.~~we may be required to conduct additional clinical trials;

~~Our~~•the ~~and~~FDA ~~our~~or ~~collaborators’ ability to commercialize any of our drug candidates successfully will depend, in part, on~~ the ~~extent~~applicable toforeign ~~which~~regulatory ~~coverage~~authority ~~and~~may ~~adequate~~disagree ~~reimbursement~~regarding ~~for these drugs and related treatments will be available from government payor programs at~~ the ~~federal and state levels authorities~~formulation, ~~including Medicare and Medicaid~~labeling, ~~private health insurers, managed care plans~~ and/or 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.~~specifications ~~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 drugs. Coverage and reimbursement may not be available for any drug that we or our ~~collaborators~~product ~~commercialize~~candidates; ~~and, even if these are available, the level of reimbursement may not be satisfactory. Inadequate reimbursement~~

21•the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

~~Table~~•and the approval policies or regulations of ~~Contents~~the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

~~levels~~In ~~may adversely affect the demand for~~addition, or the ~~price~~FDA ~~of,~~and ~~any~~comparable ~~drug~~foreign ~~candidate~~regulatory ~~for~~authorities ~~which~~may weundergo orleadership ~~our~~changes, ~~collaborators~~change ~~obtain~~their ~~marketing~~policies, ~~approval.~~issue ~~Obtaining~~additional ~~and~~regulations, ~~maintaining~~or ~~adequate~~revise ~~reimbursement~~existing ~~for our~~regulations, ~~drugs~~or ~~may~~take beother ~~difficult.~~actions, Wewhich may beimpact ~~required~~our toclinical ~~conduct~~development ~~expensive~~plans ~~pharmacoeconomic~~or ~~studies~~prevent ~~to justify coverage and reimbursement~~ or ~~the~~delay ~~level~~approval of ~~reimbursement~~our ~~relative~~programs tounder ~~other~~development ~~therapies.~~on Ifa ~~coverage~~timely ~~and~~basis. ~~adequate~~Such ~~reimbursement~~policy ~~are~~or ~~not~~regulatory ~~available~~changes ~~or reimbursement~~could isimpose ~~available~~additional ~~only~~requirements toupon ~~limited~~us ~~levels,~~that wecould ordelay our ~~collaborators~~ability ~~may not be able~~ to ~~successfully~~obtain ~~commercialize~~approvals ~~any~~and ~~drug~~increase ~~candidates~~the ~~for~~costs ~~which~~of ~~marketing approval is obtained~~compliance.

~~There~~Additionally, ~~may~~we beexpect ~~significant~~that ~~delays~~certain inproduct ~~obtaining~~candidates ~~coverage and reimbursement for newly approved drugs, and coverage~~ may be ~~more~~regulated ~~limited~~as ~~than~~a ~~the~~combination ~~indications~~product ~~for~~that ~~which~~consists ~~the~~of ~~drug~~both isa ~~approved~~biologic byand ~~the~~a ~~FDA~~medical ~~or similar regulatory authorities outside the United States~~device. ~~Moreover,~~Developing ~~eligibility for coverage~~ and ~~reimbursement~~obtaining ~~does~~regulatory ~~not~~approval ~~imply~~for ~~that~~combination aproducts ~~drug~~can ~~will~~pose beunique ~~paid~~challenges ~~for~~because inthey ~~all~~involve ~~cases~~components orthat atare aregulated ~~rate~~under ~~that~~different ~~covers~~types ~~our~~of ~~costs,~~regulatory ~~including~~requirements ~~research,~~and ~~development,~~potentially ~~manufacture,~~by ~~sale and~~different ~~distribution~~FDA ~~expenses~~centers. ~~Interim~~As ~~reimbursement~~a ~~levels for new drugs~~result, ifsuch ~~applicable,~~product candidates may ~~also~~raise ~~not~~regulatory, bepolicy ~~sufficient to cover our costs~~ and ~~may~~review ~~not~~management ~~be made permanent~~challenges. ~~Reimbursement~~Differences ~~rates may vary according to the use of the drug and the clinical setting~~ in ~~which~~regulatory itpathways ~~is used, may be based on reimbursement levels already set~~ for ~~lower~~each ~~cost~~component ~~drugs~~of ~~and~~a ~~may~~combination beproduct ~~incorporated~~can ~~into~~impact ~~existing~~the ~~payments~~regulatory ~~for~~processes ~~other services. Net prices~~ for ~~drugs~~all ~~may~~aspects ~~be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation~~ of ~~laws~~product ~~that~~development ~~presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare coverage policy~~ and ~~payment~~management, ~~limitations~~including inclinical ~~setting~~investigation, ~~their~~marketing ~~own~~applications, ~~reimbursement~~manufacturing ~~policies. Our or our collaborators’ inability to promptly obtain coverage~~ and ~~adequate~~quality ~~reimbursement~~control, ~~rates~~adverse ~~from~~event ~~both~~reporting, ~~government-funded~~promotion and ~~private payors for any approved drugs that we develop could adversely affect our operating results~~advertising, ~~our~~user ~~ability~~fees toand ~~raise~~post ~~capital~~approval ~~needed~~modifications. toAlthough ~~commercialize~~the ~~drugs~~FDA and ~~our~~similar ~~overall~~foreign ~~financial~~regulatory ~~condition.~~

The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drugs 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. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we or our collaborators might obtain marketing approval for a drug in a particular country, but then be subject to price regulations that delay commercial launch of the drug, possibly for lengthy time periods, and negatively impact our ability to generate revenue from the sale of the drug in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more drug candidates, even if our drug candidates obtain marketing approval. 24

~~There~~agencies ~~can~~have besystems noin ~~assurance~~place ~~that our drug candidates, if they are approved~~ for ~~sale in~~ the ~~United~~review ~~States~~and orapproval inof ~~other~~combination ~~countries,~~products ~~will~~such beas ~~considered medically reasonable and necessary for a specific indication~~ours, ~~that they~~we ~~will~~may beexperience ~~considered~~delays ~~cost-effective~~in bythe ~~third-party~~development ~~payors,~~and ~~that~~commercialization ~~coverage or an adequate level~~ of ~~reimbursement~~our ~~will~~product becandidates ~~available~~due orto ~~that~~regulatory ~~third-party~~timing ~~payors’~~constraints ~~reimbursement~~and ~~policies~~uncertainties ~~will~~in ~~not~~the ~~adversely~~product ~~affect~~development ~~our~~and ~~ability~~approval ~~to sell our drug candidates profitably if they are approved for sale~~process.

~~Product~~Of ~~liability~~the ~~lawsuits~~large ~~against~~number usof ~~could~~drugs ~~cause~~in usdevelopment, toonly ~~incur~~a ~~substantial~~small ~~liabilities~~percentage successfully complete the FDA or foreign regulatory approval processes and ~~to limit~~are ~~commercialization~~commercialized. The lengthy approval process as well as the unpredictability of ~~any~~future ~~drugs~~clinical ~~that~~trial weresults may ~~develop~~result in our failing to obtain regulatory approval to market our product candidates, which would significantly harm our business, results of operations and prospects.

WeIf ~~face~~we anwere ~~inherent~~to ~~risk~~obtain approval, regulatory authorities may approve any of our product ~~liability~~candidates ~~exposure~~for ~~related~~fewer or more limited indications than we request, including failing to approve the ~~testing~~most ofcommercially ~~our drug~~promising ~~candidates~~indications, inmay ~~human~~grant approval contingent on the performance of costly post-marketing clinical trials, ~~and~~or ~~will~~may ~~face~~approve ana ~~even~~product ~~greater~~candidate ~~risk~~with ifa welabel ~~commercially~~that ~~sell~~does ~~any~~not ~~drugs~~include ~~that~~the welabeling ~~may~~claims ~~develop~~necessary or desirable for the successful commercialization of that product candidate. If we ~~cannot~~are ~~successfully~~not ~~defend~~able ~~ourselves~~to ~~against~~obtain, ~~claims~~or ~~that~~if ~~our~~there ~~drug~~are ~~candidates~~delays orin ~~drugs~~obtaining, ~~caused~~required ~~injuries~~regulatory approvals for our product candidates, we will ~~incur~~ ~~substantial~~not ~~liabilities.~~be ~~Regardless~~able ofto ~~merit~~commercialize, or ~~eventual~~will ~~outcome~~be delayed in commercializing, ~~liability~~our ~~claims~~product ~~may~~candidates ~~result~~and ~~in:~~our ability to generate revenue will be materially impaired.

nWe ~~decreased~~may ~~demand~~not be able to meet requirements for ~~any~~the ~~drug~~chemistry, ~~candidates~~manufacturing, orand ~~drugs~~control ~~that~~of weour ~~may~~programs. ~~develop;~~

nIn ~~injury~~order to receive approval of its products by the FDA and comparable foreign regulatory authorities, we must show that we and our ~~reputation~~contract manufacturing partners are able to characterize, control, and ~~significant~~manufacture ~~negative~~our ~~media~~drug ~~attention;~~products safely and in accordance with regulatory requirements. This includes manufacturing the active ingredient, developing an acceptable formulation, manufacturing the drug product, performing tests to adequately characterize the formulated product, documenting a repeatable manufacturing process, and demonstrating that our drug products meet stability requirements. Meeting these chemistry, manufacturing, and control requirements is a complex task that requires specialized expertise. If we are not able to meet the chemistry, manufacturing, and control requirements, we may not be successful in getting our products approved.

nIn ~~withdrawal~~addition, as product candidates progress through clinical trials to regulatory approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize safety, efficacy, stability, purity, yield and manufacturing batch size, minimize costs and achieve consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives and/or may lead to delays and additional costs. Additionally, any changes we may make to our product candidates may cause such candidates to perform differently than in prior clinical trials, or could negatively affect our ability to utilize or interpret our existing data. Such changes could delay initiation or completion of clinical trials, lead to negative trial ~~participants;~~results, require the conduct of bridging studies or clinical trials or the repetition of one or more studies or clinical trials, increase development costs, delay potential regulatory approval and jeopardize our ability to commercialize our product candidates or generate revenue.

nOur ~~significant~~product ~~costs~~candidates for which we intend to ~~defend~~seek ~~the~~approval ~~related~~as ~~litigation;~~biologics may face competition sooner than anticipated.

nThe ~~substantial~~Patient ~~monetary~~Protection ~~awards~~and ~~paid~~Affordable Act, as amended by the Healthcare and Education Reconciliation Act (the “ACA”), includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created an abbreviated approval pathway for biological products that are biosimilar to ~~trial~~or ~~participants~~interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a highly similar or ~~patients;~~“biosimilar” product may not be submitted to the FDA until four years following the date that the reference product was first approved by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first approved. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity, and potency of their product.

nWe ~~loss~~believe that any of ~~revenue;~~our product candidates approved as biologics under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates to be reference products for competing

~~n reduced resources of our management to pursue our business strategy; and~~25

nproducts, potentially creating the ~~inability~~opportunity for competition sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of litigation. Moreover, the extent to ~~commercialize~~which a biosimilar, once approved, will be substituted for any ~~drugs~~reference products in a way that weis ~~may~~similar ~~develop~~to traditional generic substitution for non-biological products will depend on a number of uncertain marketplace and regulatory factors that are still developing.

22Even if we receive regulatory approval of our product candidates, we will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experiences unanticipated problems with our product candidates.

~~Table~~Any regulatory approvals that we may receive for our product candidates will require the submission of ~~Contents~~reports to regulatory authorities and surveillance to monitor the safety and efficacy of the product candidate, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions, or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician training, and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools. In addition, if the FDA or comparable foreign regulatory authorities approve our product candidates, our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export will be subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable foreign regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as on-going compliance with cGMPs and GCPs for any clinical trials that we conduct following approval. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMPs.

WeIf ~~currently~~we ~~hold~~or ~~$5.0~~a ~~million~~regulatory ofauthority discovers previously unknown problems with a product, ~~liability~~such ~~insurance~~as ~~coverage~~adverse inevents ~~the~~of ~~aggregate~~unanticipated severity or frequency, or problems with athe ~~per~~facilities ~~incident~~where ~~limit~~the ~~of $5.0~~product ~~million~~is manufactured, ~~which~~or ~~may~~if ~~not~~we beare ~~adequate~~unable to ~~cover~~comply ~~all~~with ~~liabilities~~applicable ~~that~~regulatory werequirements, ~~may~~a ~~incur.~~regulatory Weauthority may ~~need~~impose torestrictions ~~increase~~on ~~our~~that ~~insurance~~product, ~~coverage~~the asmanufacturing wefacility, ~~expand~~or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing, restrictions on our ability to conduct clinical trials, including full or ifpartial weclinical ~~commence~~holds ~~commercialization~~on ongoing or planned trials, refusals to approve pending applications, restrictions on the manufacturing process, warning or untitled letters, civil and criminal penalties, injunctions, product seizures, detentions or import bans, voluntary or mandatory publicity requirements, and imposition of ~~our~~restrictions ~~drug~~on ~~candidates.~~operations, ~~Insurance~~including ~~coverage~~costly ~~is increasingly~~new ~~expensive~~manufacturing requirements. WeThe occurrence of any event or penalty described above may ~~not~~inhibit beour ~~able~~ability to ~~maintain~~commercialize ~~insurance~~our ~~coverage~~product atcandidates aand ~~reasonable~~generate ~~cost~~revenue orand incould anrequire ~~amount~~us ~~adequate~~ to ~~satisfy~~expend ~~any~~significant ~~liability~~time ~~that~~and ~~may~~resources ~~arise~~in response and could generate negative publicity.

~~Risks~~The ~~Related~~FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay marketing authorization of any product candidates we develop. We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to ~~Our~~adapt ~~Intellectual~~to ~~Property~~changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action and we may not achieve or sustain profitability.

IfFor weinstance, ~~are~~the ~~unable~~EU topharmaceutical ~~obtain~~legislation ~~and~~is ~~maintain~~currently ~~patent~~undergoing ~~protection~~a ~~for our~~complete ~~drug~~review ~~candidates~~process, orin if the ~~scope~~context of the ~~patent~~Pharmaceutical ~~protection~~Strategy ~~obtained~~for isEurope ~~not~~initiative, ~~sufficiently~~launched ~~broad~~by the European Commission in November 2020. On April 26, ~~our~~2023, ~~competitors~~the ~~could~~European ~~develop~~Commission ~~and~~published ~~commercialize~~a ~~drug~~proposal ~~candidates~~for ~~similar~~a ornew ~~identical~~Directive and Regulation to ~~ours~~revise the existing pharmaceutical legislation. The European Parliament and the Council of the EU adopted their respective positions on April 10, 2024 and ~~our~~June ~~ability~~4, to2025 ~~successfully~~and ~~commercialize~~a ~~our~~common ~~drug candidates~~position ~~may~~on bethe ~~impaired.~~text was agreed upon on

Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to our drug candidates. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our drug candidates. 26

~~The~~December ~~patent~~11, ~~prosecution process is expensive and time consuming~~2025, ~~and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or~~ in athe ~~timely~~context ~~manner. It is also possible that we will fail to identify patentable aspects~~ of ~~our~~subsequent ~~research~~inter-institutional ~~and~~trilogue ~~development output before it is too late to obtain patent protection~~negotiations. WeThe ~~may~~proposed ~~not~~revisions ~~have~~remain ~~the right~~ to ~~control~~be ~~the preparation~~adopted, ~~filing~~ and ~~prosecution~~are ofnot ~~patent~~expected ~~applications, or~~ to ~~maintain~~become ~~the~~applicable ~~rights~~before ~~to patents licensed to third parties~~2028. ~~Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.~~

~~The~~Current ~~patent position of biotechnology~~ and ~~pharmaceutical~~future companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States, or vice versa. For example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. ~~law~~healthcare ~~does.~~reform ~~Publications~~legislation ofor ~~discoveries~~regulation inmay ~~the~~increase ~~scientific literature often lag behind~~ the ~~actual~~difficulty ~~discoveries,~~ and ~~patent~~cost ~~applications~~for inus ~~the United States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all. Therefore, we cannot know with certainty whether we were the first~~ to ~~make~~obtain ~~the~~coverage ~~inventions claimed in our patents or pending patent applications, or that we were the first to file~~ for ~~patent protection of such inventions. As a result, the issuance, scope, validity, enforceability~~ and ~~commercial~~commercialize ~~value~~any of our ~~patent~~current ~~rights~~or ~~are highly uncertain. Our pending and~~ future ~~patent~~product ~~applications may not result in patents being issued that protect our drug~~ candidates, ~~in whole or in part, or which effectively prevent others from commercializing competitive drug candidates. Changes in either the patent laws or interpretation of the patent laws in the United States~~ and ~~other countries~~ may ~~diminish~~adversely ~~the~~affect ~~value of our patents or narrow~~ the ~~scope~~prices ofwe ~~our~~may ~~patent protection~~set.

~~Recent~~In ~~patent reform legislation could increase~~ the ~~uncertainties~~ ~~and~~United ~~costs~~States ~~surrounding the prosecution of our patent applications~~ and ~~the~~some ~~enforcement~~foreign orjurisdictions, ~~defense~~there ofhave ~~our issued patents. On September 16~~been, ~~2011,~~and ~~the~~we ~~Leahy-Smith~~expect ~~America~~there ~~Invents~~will ~~Act,~~continue orto ~~the Leahy-Smith Act~~be, ~~was signed into law. The Leahy-Smith Act includes~~ a number of ~~significant~~legislative and regulatory changes to ~~U.S.~~the ~~patent~~healthcare ~~law.~~system, ~~These~~including ~~include~~cost-containment ~~provisions~~measures that ~~affect~~may ~~the~~reduce ~~way~~or ~~patent~~limit ~~applications~~coverage ~~are prosecuted~~ and ~~may~~reimbursement ~~also~~for ~~affect~~newly ~~patent~~approved ~~litigation.~~drugs ~~The U.S. Patent~~ and ~~Trademark~~affect ~~Office~~our ~~recently developed~~ability ~~new regulations and procedures~~ to ~~govern~~profitably ~~administration~~sell ofany ~~the Leahy-Smith Act, and many~~ of ~~the~~our ~~substantive~~current ~~changes~~or tofuture ~~patent~~product ~~law~~candidates ~~associated~~for ~~with~~which ~~the~~we ~~Leahy-Smith~~obtain ~~Act,~~regulatory ~~and~~approval. inIn particular, ~~the~~there ~~first~~have tobeen ~~file~~and ~~provisions,~~continue ~~only~~to ~~became~~be ~~effective on~~a ~~March 16,~~number ~~2013.~~of ~~Accordingly,~~initiatives itat ~~is not clear what, if any, impact~~ the ~~Leahy-Smith Act will have on the operation of our business~~U.S. ~~However,~~federal ~~the Leahy-Smith Act~~ and ~~its~~state ~~implementation~~levels ~~could~~that ~~increase~~seek ~~the~~to ~~uncertainties~~reduce ~~and~~healthcare costs ~~surrounding the prosecution of our patent applications~~ and improve the ~~enforcement~~quality ~~or defense~~ of ~~our issued patents, all of which could have a material adverse effect on our business and financial condition~~healthcare.

~~Moreover~~For example, wein ~~may~~March be2010, ~~subject~~the toPatient aProtection ~~third-party~~and ~~preissuance~~Affordable ~~submission~~Care ofAct, ~~prior~~as ~~art~~amended toby the ~~U.S.~~Health ~~Patent~~Care and ~~Trademark~~Education ~~Office~~Reconciliation Act of 2010, or ~~become~~the ~~involved~~ACA, was enacted in ~~opposition,~~the ~~derivation,~~United ~~reexamination,~~States. ~~inter~~The ~~partes~~ACA ~~review~~established an annual, ~~post-grant~~ ~~review~~nondeductible fee on any entity that manufactures or ~~interference~~imports ~~proceedings~~specified ~~challenging~~branded ~~our~~prescription ~~patent~~drugs ~~rights~~and orbiologic ~~the~~agents; ~~patent~~extended ~~rights~~manufacturers’ ofMedicaid ~~others.~~rebate Anliability ~~adverse~~to ~~determination~~covered drugs dispensed to individuals who are enrolled in ~~any~~Medicaid ~~such~~managed ~~submission,~~care ~~proceeding~~organizations; orexpanded ~~litigation~~eligibility ~~could~~criteria ~~reduce~~for Medicaid programs; expanded the ~~scope~~entities ~~of,~~eligible orfor ~~invalidate,~~discounts ~~our~~under ~~patent~~the ~~rights,~~340B ~~allow third~~drug ~~parties~~pricing toprogram; ~~commercialize~~increased ~~our~~the ~~drug~~statutory ~~candidates~~minimum ~~and~~rebates ~~compete~~a ~~directly~~manufacturer ~~with~~must ~~us,~~pay ~~without~~under ~~payment~~the Medicaid Drug Rebate Program; established a new Patient-Centered Outcomes Research Institute to usoversee, oridentify ~~result~~priorities in ~~our~~and ~~inability~~conduct comparative clinical effectiveness research, along with funding for such research; and established a Center for Medicare & Medicaid Innovation at CMS to ~~manufacture~~test orinnovative ~~commercialize~~payment ~~drugs~~and ~~without~~service ~~infringing~~delivery ~~third-party~~models ~~patent~~to ~~rights~~lower Medicare and Medicaid spending. InSince ~~addition~~its enactment, ifthere ~~the~~have ~~breadth~~been ~~or strength~~executive, ofjudicial ~~protection~~and ~~provided~~Congressional bychallenges ~~our~~to ~~patents~~certain ~~and~~aspects ~~patent~~of ~~applications~~the isACA. ~~threatened~~On June 17, it2021, ~~could~~the ~~dissuade~~U.S. ~~companies~~Supreme ~~from~~Court ~~collaborating~~dismissed ~~with~~the usmost recent judicial challenge to ~~license,~~the ~~develop~~ACA orbrought ~~commercialize~~by ~~current~~several orstates ~~future~~without ~~drug~~specifically ~~candidates~~ruling on the constitutionality of the ACA.

23In addition, other legislative changes have been proposed and adopted since the ACA was enacted. For example, beginning April 1, 2013, Medicare payments to providers were reduced under the sequestration required by the Budget Control Act of 2011, which will remain in effect through the 2032 fiscal year, unless additional Congressional action is taken. Additionally, on January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. On March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory cap on the Medicaid drug rebate, beginning January 1, 2024. The rebate was previously capped at 100% of a drug’s average manufacturer price.

~~Table~~Further, there has been heightened governmental scrutiny in the United States of ~~Contents~~pharmaceutical pricing practices in light of the rising cost of prescription drugs. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient assistance programs, and reform government program reimbursement methodologies for products. On August 16, 2022, the Inflation Reduction Act of 2022, or the IRA, was signed into law. Among other things, the IRA (i) directs the Department of Health and Human Services, or HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare; (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation; (iii) reduces the out-of-pocket cap for Medicare Part D beneficiaries to $2,000 starting in 2025. The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. HHS has and will continue to issue and update guidance as these programs are implemented. These provisions took effect progressively starting in fiscal year 2023. The Centers for Medicare & Medicaid Services, or CMS, published the negotiated prices for the initial ten drugs, which will first be effective in 2026, and the subsequent 15 drugs, which will first be effective in 2027. The implementation of the IRA is currently subject to ongoing litigation that challenges the constitutionality of the IRA’s drug price negotiation program provisions. The outcome of this litigation as well as the effects of the IRA on the pharmaceutical industry

Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative drug candidates in a non-infringing manner. 27

Incannot ~~addition,~~yet ~~the~~be ~~issuance~~fully ofdetermined abut ~~patent~~ is ~~not~~likely ~~conclusive as~~ to ~~its inventorship, scope, validity or enforceability, and our patents may~~ be ~~challenged~~ ~~in the courts or patent offices in the United States and abroad~~significant. ~~Such~~Additional ~~challenges~~drug ~~may~~pricing ~~result~~proposals incould ~~loss~~appear ~~of exclusivity or freedom to operate or~~ in ~~patent~~future 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 drug candidates, or limit the duration of the patent protection of our drug candidateslegislation. Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing drugs similar or identical to ours.

WeMore ~~may~~recently, ~~become~~the ~~involved~~One Big Beautiful Bill Act, which was enacted in ~~lawsuits~~July 2025, imposes significant reductions in the funding of the Medicaid program. Such reductions are expected to ~~protect~~decrease orthe ~~enforce~~number ~~our~~of ~~patents~~persons orenrolled ~~other~~in ~~intellectual property~~Medicaid and reduce the services covered by Medicaid, which could beadversely ~~expensive,~~affect ~~time~~our ~~consuming~~sales ~~and~~of ~~unsuccessful.~~any product candidate that we commercialize.

~~Competitors~~The ~~may~~current ~~infringe~~Presidential ~~our~~administration ~~issued~~is ~~patents~~pursuing ora ~~other~~two-fold ~~intellectual~~strategy ~~property. To~~to ~~counter~~reduce ~~infringement~~drug orcosts ~~unauthorized~~in ~~use,~~the weU.S. ~~may~~While beit ~~required~~is tounclear ~~file~~whether ~~infringement~~and ~~claims,~~how ~~which~~such ~~can~~policies will be ~~expensive~~implemented, ~~and~~the ~~time~~proposed ~~consuming.~~policies ~~Any~~are ~~claims~~likely weto ~~assert~~have ~~against~~a ~~perceived~~negative ~~infringers~~impact ~~could~~on ~~provoke~~the ~~these~~pharmaceutical ~~parties~~industry and on our ability to ~~assert~~receive ~~counterclaims~~adequate ~~against~~revenues ~~us alleging~~for ~~that~~our weproduct ~~infringe~~candidates, ~~their~~if ~~patents~~approved. InAs ~~addition~~part of this strategy, inPresident aTrump ~~patent~~has ~~infringement~~proposed ~~proceeding,~~imposing asignificant ~~court~~tariffs ~~may~~on ~~decide~~pharmaceutical manufacturers that ado ~~patent~~not ofadopt ~~ours~~pricing ispolicies ~~invalid~~such oras ~~unenforceable~~most favored nation pricing, which would tie the price for drugs in ~~whole~~the orU.S. to the lowest price in ~~part~~a group of other countries. In response, ~~construe~~multiple ~~the~~manufacturers ~~patent’s~~have ~~claims~~reportedly ~~narrowly~~entered orinto ~~refuse~~confidential topricing ~~stop~~agreements with the ~~other~~ ~~party~~federal ~~from~~government. ~~using~~In addition, the ~~technology~~Trump atadministration ~~issue~~is onpursuing ~~the~~traditional ~~grounds~~regulatory ~~that~~pathways ~~our~~to ~~patents~~impose dodrug pricing policies, although proposed regulations have not ~~cover~~yet ~~the~~been ~~technology~~published. AnIn ~~adverse~~addition, ~~result~~pharmaceutical pricing and marketing has long been the subject of considerable discussion in ~~any~~Congress ~~litigation~~and ~~proceeding~~among ~~could~~policymakers, ~~put~~and ~~one~~it oris ~~more~~possible ofthat ~~our~~Congress ~~patents~~could atenact ~~risk~~additional oflaws ~~being~~that ~~invalidated~~negatively oraffect ~~interpreted~~the ~~narrowly~~pharmaceutical industry.

WeAt ~~may~~the ~~need~~state level, state governments have increasingly passed legislation and implemented regulations designed to ~~license~~control ~~intellectual~~pharmaceutical ~~property~~and biological product pricing, including price or reimbursement constraints, discounts, restrictions on certain product access, marketing cost disclosure, drug price reporting and other transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Some states have enacted legislation creating so-called prescription drug affordability boards with the goal of imposing price limits on certain drugs in these states, while some states are also seeking to implement general, across the board price caps for pharmaceuticals, or are seeking to regulate drug distribution. Legally mandated price controls on payment amounts by third-party ~~parties~~payors or other restrictions could harm our business, financial condition, results of operations and ~~such~~prospects. ~~licenses~~In ~~may~~addition, ~~not~~regional behealthcare ~~available~~authorities orand ~~may~~individual ~~not~~hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be ~~available~~included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for any of our current and future product candidates, if approved, or put pressure on ~~commercially reasonable~~our ~~terms~~product pricing, which could negatively affect our business, financial condition, results of operations and prospects.

AWe ~~third~~expect ~~party~~that ~~may~~these ~~hold~~existing ~~intellectual~~laws ~~property,~~and ~~including~~other ~~patent,~~healthcare ~~rights~~reform ~~that~~measures ~~are~~both ~~important~~at ~~or necessary to~~ the ~~development~~federal ~~of our~~and ~~drug~~state ~~candidates.~~level Itthat may be ~~necessary~~adopted ~~for~~in usthe tofuture ~~use~~may ~~patented~~result orin ~~proprietary~~additional ~~technology~~reductions ofin ~~third~~Medicare ~~parties~~and toother ~~commercialize~~healthcare ~~our~~funding, ~~drug~~more ~~candidates~~rigorous coverage criteria, innew ~~which~~payment ~~case~~methodologies and additional downward pressure on the price that we ~~would~~receive befor ~~required~~any toapproved ~~obtain~~product. aAny ~~license~~reduction in reimbursement from ~~these~~Medicare ~~third~~or ~~parties~~other ongovernment ~~commercially reasonable~~programs ~~terms,~~may orresult ~~our~~in ~~business~~a ~~could~~similar bereduction ~~harmed,~~in ~~possibly~~payments ~~materially~~from private payors.

~~Third~~In ~~parties~~the EU, similar developments may ~~initiate~~affect ~~legal~~our ~~proceedings~~ability ~~alleging~~to profitably commercialize our product candidates, if approved. In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or EU member state level may result in significant additional requirements or obstacles that wemay ~~are infringing~~increase ~~their~~our ~~intellectual~~operating ~~property~~costs. ~~rights~~The delivery of healthcare in the EU, including the ~~outcome~~establishment and operation of ~~which~~health ~~would~~services beand ~~uncertain~~the pricing and ~~could~~reimbursement ~~have~~of medicines, is almost exclusively a ~~material~~matter ~~adverse~~for ~~effect~~national, rather than EU, law and policy. National governments and health service providers have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the ~~success~~pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of our ~~business~~product candidates, restrict or regulate post-approval activities and affect our ability to commercialize our product candidates, if approved. In markets outside of the United States and EU, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.

Our commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our drug candidates without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology and pharmaceutical industries. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our drug candidates, including interference or derivation proceedings before the U.S. Patent and Trademark Office. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future. 28

IfOn weDecember ~~are~~13, ~~found~~2021, toRegulation ~~infringe~~No a2021/2282 ~~third~~on ~~party’s~~Health ~~intellectual~~Technology ~~property~~Assessment ~~rights,~~(“HTA”) weamending ~~could~~Directive be2011/24/EU, ~~required~~was toadopted. ~~obtain~~The aRegulation ~~license~~entered ~~from~~into ~~such~~force ~~third~~in ~~party~~January ~~to continue~~2022 ~~developing~~ and ~~marketing~~has ~~our~~been ~~drug~~applicable ~~candidates.~~since ~~However~~January 2025, wewith ~~may~~phased ~~not~~implementation bebased ~~able~~on tothe ~~obtain~~type ~~any~~of ~~required~~product, ~~license~~i.e. ononcology ~~commercially~~and ~~reasonable~~advanced ~~terms~~therapy ormedicinal atproducts ~~all.~~as ~~Even~~of if2025, weorphan ~~were~~medicinal ~~able~~products toas ~~obtain~~of ~~a license~~2028, itand ~~could~~all beother ~~non-exclusive,~~medicinal ~~thereby~~products ~~giving~~by ~~our competitors~~2030. ~~access~~The Regulation intends to ~~the~~boost ~~same~~cooperation ~~technologies~~among ~~licensed~~EU tomember ~~us.~~states Wein ~~could~~assessing behealth ~~forced~~technologies, including bynew ~~court~~medicinal ~~order~~products, toand ~~cease~~provide ~~commercializing~~the basis for cooperation at the ~~infringing~~EU ~~drug~~level for joint clinical assessments in these areas. InIt ~~addition~~will permit EU member states to use common HTA tools, wemethodologies, ~~could~~and beprocedures ~~found~~across ~~liable~~the ~~for~~EU, ~~monetary~~working ~~damages~~together in four main areas, including ~~treble~~joint ~~damages~~clinical ~~and attorneys’~~assessment ~~fees~~of ifthe weinnovative ~~are~~health ~~found~~technologies towith ~~have~~the ~~willfully~~highest ~~infringed~~potential aimpact ~~patent.~~for Apatients, ~~finding~~joint ofscientific ~~infringement~~consultations ~~could~~whereby ~~prevent~~developers uscan seek advice from ~~commercializing~~HTA ~~our~~authorities, ~~drug~~identification ~~candidates~~of oremerging ~~force~~health ustechnologies to ~~cease~~identify ~~some~~promising oftechnologies ~~our~~early, ~~business~~and ~~operations~~continuing voluntary cooperation in other areas. ~~Claims~~Individual ~~that~~EU wemember ~~have~~states ~~misappropriated the~~will ~~confidential~~continue ~~information~~to orbe ~~trade~~responsible ~~secrets~~for ofassessing ~~third~~non-clinical ~~parties~~(e.g., ~~could~~economic, ~~have~~social, aethical) ~~similar~~aspects ~~negative~~of ~~impact~~health technology, and making decisions on ~~our~~pricing ~~business.~~and reimbursement.

WeOur ~~may~~revenue beprospects ~~subject~~could tobe ~~claims~~ affected by ~~third~~changes ~~parties~~in ~~asserting~~healthcare ~~that~~spending weand policy in the United States and abroad. We operate in a highly regulated industry and new laws, regulations or ~~our~~judicial ~~employees~~decisions, ~~have~~or ~~misappropriated~~new ~~their~~interpretations ~~intellectual~~of ~~property~~existing laws, regulations or ~~claiming~~decisions, ~~ownership~~related to healthcare availability, the method of ~~what~~delivery weor ~~regard~~payment asfor healthcare products and services could negatively impact our ~~own~~business, ~~intellectual~~operations ~~property~~and financial condition. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

~~Many~~•the ofdemand ~~our~~for ~~employees were previously employed at universities or other biotechnology or pharmaceutical companies. Although we try to ensure that~~ our ~~employees~~current ~~do not use the proprietary information~~ or ~~know-how~~future ~~of others~~product ~~in their work for us~~candidates, weif ~~may be subject to claims that these employees or~~ we ~~have~~obtain ~~used~~regulatory orapproval; ~~disclosed~~

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

~~Table~~•our ofability ~~Contents~~to obtain coverage and reimbursement approval for a product;

~~intellectual~~•our ~~property,~~ability ~~including~~to ~~trade~~generate ~~secrets~~revenue orand ~~other~~achieve ~~proprietary~~or ~~information,~~maintain ofprofitability; ~~any such employee’s former employer. Litigation may be necessary to defend against these claims.~~

~~In addition, while it is our policy to require our employees and contractors who may be involved in~~ •the ~~development~~level of ~~intellectual~~taxes ~~property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property~~ that we ~~regard~~are asrequired ~~our~~to ~~own.~~pay; ~~Our~~ and their assignment agreements may not be self-executing or may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property.

If•the weavailability ~~fail~~of ~~in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel~~capital. ~~Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to management.~~

~~Intellectual~~We ~~property~~are ~~litigation~~subject to various U.S. federal, state and foreign healthcare laws and regulations, which could ~~cause~~increase uscompliance costs, and our failure to ~~spend~~comply ~~substantial~~with ~~resources~~these laws and ~~distract~~regulations could harm our ~~personnel~~reputation, ~~from~~subject ~~their~~us ~~normal~~to ~~responsibilities~~significant fines and liability or otherwise adversely affect our business.

~~Even~~Our ifbusiness ~~resolved~~operations ~~in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses,~~ and ~~could~~current ~~distract our technical~~ and ~~management~~future ~~personnel~~arrangements ~~from~~with ~~their~~investigators, ~~normal~~healthcare ~~responsibilities.~~professionals, ~~In addition~~consultants, ~~there~~third-party ~~could be public announcements of the results of hearings~~payors, ~~motions~~patient ~~or other interim proceedings or developments~~organizations, and ~~if securities~~customers ~~analysts~~may orexpose ~~investors~~us ~~perceive these results~~ to bebroadly ~~negative~~applicable itfraud ~~could~~and ~~have~~abuse aand ~~substantial~~other ~~adverse~~healthcare ~~effect~~laws onand ~~the~~regulations. ~~price~~These oflaws ~~our~~may ~~common~~constrain ~~stock.~~the ~~Such~~business ~~litigation~~ or ~~proceedings~~financial ~~could~~arrangements ~~substantially increase our operating losses~~ and ~~reduce~~relationships ~~the resources~~through ~~available~~which ~~for~~we ~~development~~conduct ~~activities~~our ~~or any future sales~~operations, ~~marketing~~including orhow ~~distribution~~we ~~activities.~~research, Wemarket, ~~may~~sell, ~~not~~and ~~have~~distribute ~~sufficient~~our ~~financial~~product orcandidates, ~~other~~if ~~resources to conduct such litigation or proceedings adequately~~approved. ~~Some~~any ofproducts ~~our~~for ~~competitors~~which ~~may be able to sustain the costs of such litigation or proceedings more effectively than~~ we ~~can~~obtain ~~because~~regulatory ~~of their greater financial resources~~approval. ~~Uncertainties~~Such ~~resulting~~laws ~~from~~include: ~~the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace.~~

If•the wefederal ~~are~~Anti-Kickback ~~unable~~Statute, towhich ~~protect~~prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing any remuneration (including any kickback, bribe or certain rebates), directly or indirectly, overtly or covertly, in cash or in kind, in return for, either the ~~confidentiality~~referral of ~~our~~an ~~trade~~individual ~~secrets~~or the purchase, ~~our~~lease, ~~business~~or ~~and competitive~~order, ~~position~~or ~~would~~arranging for or recommending the purchase, lease, or order of any good, facility, item or service, for which payment may be ~~harmed~~made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation;

In•the ~~addition~~federal tofalse ~~seeking~~claims ~~patents for our drug candidates~~laws, weincluding ~~also~~the ~~rely~~civil onFalse ~~trade~~Claims ~~secrets~~Act, ~~including unpatented know-how, technology~~ and ~~other~~civil ~~proprietary~~monetary ~~information~~penalties laws, towhich ~~maintain our competitive position. For example~~prohibit, ~~our~~among ~~platform~~other is based on trade secrets that consist largely of expertise in carbohydrate chemistry and knowledge of carbohydrate biology. We do not believe that we can obtain patent protection for our platform. Thusthings, ~~our~~individuals ~~competitors~~or ~~may~~entities ~~use~~from ~~our~~knowingly ~~methods~~presenting, or ~~acquire~~causing ~~similar~~to ~~expertise~~be presented, ~~in order~~ to ~~develop~~the ~~glycomimetic~~federal ~~drug~~government, ~~candidates~~claims ~~and~~for ~~progress~~payment ~~these~~or ~~drug~~approval ~~candidates~~that ~~through clinical~~are ~~development~~false ~~and~~or ~~commercialization~~fraudulent, ~~which~~knowingly ~~could~~making, ~~impair our ability to successfully commercialize our drug candidates.~~

We seek to protect our trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed. 29

25using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making or causing to be made a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. Manufacturers can be held liable under the federal False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The federal False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the federal False Claims Act and to share in any monetary recovery. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act;

~~Table~~•the federal Health Insurance Portability and Accountability Act of ~~Contents~~1996, or HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

~~Risks~~•the ~~Related~~federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to ~~Regulatory~~report ~~Approval~~annually to CMS information related to payments and other “transfers of ~~Our~~value” ~~Drug~~made ~~Candidates~~to physicians (defined to include doctors, dentists, optometrists, podiatrists and ~~Other~~chiropractors), ~~Legal~~certain ~~Compliance~~non-physician ~~Matters~~practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiology assistants and certified nurse-midwives), and teaching hospitals and other healthcare providers, as well as ownership and investment interests held by physicians and their immediate family members; and

If•analogous westate orand ~~our~~foreign ~~collaborators~~laws ~~are~~and ~~not~~regulations, ~~able~~such toas ~~obtain~~state anti-kickback and false claims laws, which may apply to sales or ifmarketing ~~there~~arrangements ~~are~~and ~~delays~~claims ininvolving ~~obtaining,~~healthcare ~~required~~items ~~regulatory~~or ~~approvals~~services reimbursed by non-governmental third-party payors, weincluding orprivate ~~they~~insurers; ~~will~~some ~~not~~state belaws ~~able~~require pharmaceutical companies to ~~commercialize~~ ~~our~~comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug ~~candidates~~manufacturers to report information related to payments and ~~our~~other ~~ability~~transfers of value to ~~generate~~physicians ~~revenue~~and ~~will~~other behealthcare ~~materially~~providers ~~impaired~~or marketing expenditures; some state laws that require pharmaceutical companies to report information on the pricing of certain drug products; and some state and local laws that require the registration or pharmaceutical sales representatives.

~~Our~~Ensuring ~~drug~~that ~~candidates~~our ~~and~~internal ~~the~~operations ~~activities associated with their development~~ and ~~commercialization,~~future ~~including~~business ~~their~~arrangements ~~design,~~with ~~testing,~~third ~~manufacture,~~parties ~~safety,~~comply ~~efficacy,~~with ~~recordkeeping,~~applicable ~~labeling,~~healthcare ~~storage,~~laws ~~approval, advertising, promotion, sale~~ and ~~distribution,~~regulations ~~are~~will ~~subject~~involve tosubstantial ~~comprehensive regulation by the FDA and other regulatory agencies in the United States and by the European Medicines Agency, or EMA, and similar regulatory authorities outside the United States~~costs. ~~Failure~~If ~~to obtain marketing approval for a drug candidate will prevent us or~~ our ~~collaborators~~operations ~~from~~are ~~commercializing~~found ~~the~~to ~~drug~~be ~~candidate.~~in Weviolation ~~have~~of ~~not received approval to market~~ any of ~~our~~these ~~drug~~laws ~~candidates~~or ~~from regulatory authorities in~~ any ~~jurisdiction.~~other Wegovernmental ~~have~~laws ~~only limited experience in filing~~ and ~~supporting~~regulations ~~the applications~~that ~~necessary~~may apply to ~~gain~~it, ~~marketing~~we ~~approvals~~may ~~and~~be ~~expect~~subject to ~~rely~~significant onpenalties, ~~third-party~~including ~~CROs~~civil, tocriminal ~~assist~~and usadministrative inpenalties, ~~this~~damages, ~~process~~fines, ~~for~~exclusion ~~drug~~from ~~candidates other than GMI~~government-~~1070.~~funded ~~Securing~~healthcare ~~marketing~~programs, ~~approval~~integrity ~~requires~~oversight ~~the submission of extensive preclinical~~ and ~~clinical data~~reporting ~~and~~obligations ~~supporting information~~ to ~~regulatory~~resolve ~~authorities~~allegations ~~for~~of ~~each~~non-compliance, ~~therapeutic~~disgorgement, ~~indication~~individual toimprisonment, ~~establish~~contractual ~~the~~damages, ~~drug~~reputational ~~candidate’s~~harm, ~~safety~~diminished profits, and ~~efficacy. Securing marketing approval also requires~~ the ~~submission~~curtailment ofor ~~information~~restructuring ~~about the product manufacturing process to, and inspection~~ of ~~manufacturing~~our ~~facilities~~operations. byFurther, ~~applicable~~defending ~~regulatory~~against ~~authorities.~~any ~~Our~~such ~~drug~~actions ~~candidates~~can ~~may not~~ be ~~effective,~~costly ~~may~~and betime-consuming ~~only~~and ~~moderately effective or~~ may ~~prove~~require tosignificant ~~have~~personnel ~~undesirable~~resources. ~~or unintended side effects~~Therefore, ~~toxicities~~ oreven ~~other~~if ~~characteristics~~we ~~that~~are ~~may~~successful ~~preclude~~in ~~our~~defending ~~ability~~against ~~to obtain marketing approval or prevent or limit commercial use. If~~ any ofsuch ~~our~~actions ~~drug~~that ~~candidates receives marketing approval, the accompanying label~~ may ~~limit~~be ~~the~~brought ~~approved~~against ~~use~~it, of our ~~drug,~~ ~~which~~business ~~could~~may ~~limit~~be ~~sales of the drug~~impaired.

The ~~process~~successful commercialization of ~~obtaining~~any ~~marketing~~of ~~approvals,~~our ~~both~~current inor ~~the~~future ~~United~~product ~~States and abroad~~candidates, ~~is expensive and may take many years~~ if ~~additional clinical trials are required~~approved, ifwill ~~approval~~depend ~~is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the drug candidates involved. Changes~~ in ~~marketing approval~~part ~~policies~~on ~~during~~ the ~~development~~extent ~~period,~~to ~~changes~~which ingovernmental ~~or the enactment of additional statutes or regulations or changes in regulatory review for each submitted drug application may cause delays in the approval or rejection of an application. Regulatory~~ authorities ~~have substantial discretion in the approval process~~ and ~~may~~health ~~refuse~~insurers toestablish ~~accept any application~~coverage, oradequate ~~may~~reimbursement ~~decide~~levels ~~that our data is insufficient for approval~~ and ~~require~~favorable ~~additional~~pricing ~~preclinical, clinical or other studies~~policies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a drug candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved drug not commercially viable.

~~For~~The ~~marketing~~availability ~~exclusivity~~of incoverage and the ~~treatment~~adequacy of anreimbursement ~~ongoing~~by ~~VOC~~governmental ~~episode~~healthcare ~~in sickle~~programs ~~cell~~such ~~disease,~~as weMedicare ~~expect~~and toMedicaid, ~~rely~~private ~~primarily~~health oninsurers ~~the~~and ~~orphan~~other ~~drug~~third-party ~~designation~~payors ~~that~~are ~~the~~essential ~~FDA~~for ~~has~~most ~~granted~~patients usto ~~for~~be ~~GMI-1070,~~able ~~which~~to ~~includes~~afford ~~the~~prescription ~~treatment~~medications ofsuch ~~the~~as ~~complications~~any of ~~sickle~~our ~~cell~~current ~~disease.~~or ~~However,~~future inproduct ~~order to obtain marketing exclusivity~~candidates, ~~we must~~if ~~receive the first marketing approval for such indication~~approved. InOur ~~addition,~~ability ~~the~~to ~~orphan~~achieve ~~drug~~coverage ~~designation~~and ~~does~~acceptable ~~not~~levels ~~convey~~of ~~any~~reimbursement ~~advantage~~for ~~in,~~our orproducts ~~shorten~~by ~~the~~third-party ~~duration~~payors ~~of,~~will ~~the~~have ~~regulatory~~an ~~review~~effect ~~or approval process.~~

If we experience delays in obtaining approval or if we fail to obtain approval of our drug candidates, the commercial prospects for our drug candidates may be harmed and our ability to generate revenue will be materially impaired. 30

~~Even~~on ~~though~~our ability to successfully commercialize those products. Accordingly, we ~~have~~will ~~obtained~~need ~~orphan~~to ~~drug~~successfully ~~designation~~implement a coverage and reimbursement strategy for ~~our~~any ~~most~~approved ~~advanced drug~~product candidate,. ~~GMI-1070,~~Even if we ~~may~~obtain ~~not~~coverage befor ~~able~~a togiven ~~obtain~~product ~~orphan~~by ~~drug~~a ~~marketing~~third-party ~~exclusivity~~payor, ~~for~~the ~~this~~resulting ~~drug~~reimbursement ~~candidate~~payment rates may not be adequate or ~~any~~may ofrequire ~~our~~co-payments or other ~~drug~~cost-sharing ~~candidates.~~that patients find unacceptably high.

~~Regulatory~~Third-party ~~authorities~~payors inincreasingly ~~some~~are ~~jurisdictions,~~challenging ~~including~~prices ~~the~~charged ~~United~~for ~~States~~pharmaceutical products and ~~the~~services, ~~European~~and ~~Union,~~many orthird-party ~~EU,~~payors may ~~designate~~refuse ~~drugs~~to ~~for~~provide ~~relatively~~coverage ~~small~~and ~~patient~~reimbursement ~~populations~~for asparticular ~~orphan~~ drugs. ~~Under~~when ~~the~~an ~~Orphan~~equivalent ~~Drug~~generic ~~Act,~~drug ~~the FDA~~or ~~may designate~~ a ~~drug~~less asexpensive antherapy ~~orphan~~is ~~drug~~available. ifIt it is ~~intended~~possible tothat ~~treat~~ a ~~rare~~third-party ~~disease~~payor ormay ~~condition,~~consider ~~which~~our isproducts ~~generally defined~~ as asubstitutable ~~patient~~and ~~population~~offer ofto ~~fewer~~reimburse ~~than~~patients ~~200,000~~only ~~individuals~~for ~~annually~~a inless ~~the~~expensive ~~United~~competitor ~~States~~product. WeEven ~~have~~if ~~obtained~~we ~~orphan~~are ~~drug designation~~successful ~~from~~in ~~the~~demonstrating ~~FDA~~improved ~~and~~efficacy ~~the~~or ~~EMA~~improved ~~for~~convenience ~~GMI-1070 for the treatment~~ of ~~VOC,~~administration ~~and~~with ~~we may seek orphan drug designation for~~ our ~~other drug candidates. Generally~~products, ifpricing aof ~~drug~~existing ~~with~~drugs anmay ~~orphan~~limit ~~drug~~the ~~designation~~amount ~~subsequently~~we ~~receives~~will ~~the~~be ~~first~~able ~~marketing approval~~to charge for ~~the~~our ~~indication~~products. ~~for~~These ~~which~~payors itmay ~~has~~deny ~~such~~or ~~designation,~~revoke the ~~drug~~reimbursement isstatus ~~entitled~~of to a ~~period~~given ofproduct ~~marketing~~or ~~exclusivity,~~establish ~~which~~prices ~~precludes~~for ~~the~~new ~~FDA~~ or ~~the~~existing ~~EMA~~marketed ~~from~~products ~~approving~~at ~~another~~levels ~~marketing application for the same drug for~~ that ~~time~~are ~~period.~~too ~~The applicable~~low ~~period~~to isenable ~~seven~~us ~~years~~to inrealize ~~the~~an ~~United~~appropriate ~~States~~return ~~and~~on 10our ~~years~~investment in ~~the~~product EUdevelopment. ~~The~~If EUreimbursement ~~exclusivity~~is ~~period~~not ~~can~~available beor ~~reduced~~is toavailable ~~six~~only ~~years~~at iflimited alevels, ~~drug~~we nomay ~~longer~~not ~~meets~~be ~~the~~able ~~criteria~~to ~~for~~successfully ~~orphan~~commercialize ~~drug~~our ~~designation~~products orand ifmay ~~the~~not ~~drug~~be isable ~~sufficiently~~to ~~profitable~~obtain soa ~~that market~~satisfactory ~~exclusivity~~financial isreturn noon ~~longer~~products ~~justified.~~that ~~Orphan~~we ~~drug exclusivity~~ may bedevelop.

26There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States, third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs will be covered. Some third-party payors may require pre-approval of coverage or implement prior authorization or step therapy programs for new or innovative devices or drug therapies before they will reimburse patients who use such therapies, which may be time-consuming or costly for patients and lead to a reduction in revenue. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for any of our current or future product candidates.

~~Table~~Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of ~~Contents~~laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. 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. We cannot be sure that reimbursement will be available for any product candidate that we commercialize and, if reimbursement is available, the level of reimbursement. In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price and best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely. Further, these prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs.

~~lost~~Obtaining ifand ~~the~~maintaining ~~FDA~~reimbursement orstatus ~~EMA~~is ~~determines~~time-consuming, ~~that~~costly and uncertain. The Medicare and Medicaid programs increasingly are used as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs. However, no uniform policy for coverage and reimbursement for products exists among third-party payors in the ~~request~~United States. Therefore, coverage and reimbursement for ~~designation~~products ~~was~~can ~~materially~~differ ~~defective~~significantly orfrom ifpayor to payor. As a result, the ~~manufacturer~~coverage determination process is ~~unable~~often a time-consuming and costly process that will require us to ~~assure~~provide ~~sufficient~~scientific ~~quantity~~and ofclinical support for the ~~drug~~use of our products to ~~meet~~each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the ~~needs~~first instance. Furthermore, rules and regulations regarding reimbursement change frequently, and, in some cases, at short notice, and we believe that changes in these rules and regulations are likely. For products administered under the supervision of ~~patients~~ a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the ~~rare~~product ~~disease~~itself or ~~condition.~~the treatment or procedure in which the product is used may not be available, which may impact physician utilization.

~~Even~~Outside ifthe weUnited ~~obtain~~States, ~~orphan~~international ~~drug~~operations ~~exclusivity~~are ~~for~~generally asubject ~~drug~~to ~~candidate,~~extensive ~~that~~governmental ~~exclusivity~~price ~~may~~controls ~~not~~and ~~effectively protect~~other ~~the~~market ~~candidate~~regulations, ~~from~~and ~~competition~~we ~~because~~believe ~~different~~the ~~drugs~~increasing ~~can~~emphasis beon ~~approved~~cost-containment ~~for~~initiatives ~~the~~in ~~same~~Europe ~~condition.~~and ~~Even~~other ~~after~~countries anhas ~~orphan~~and ~~drug~~will iscontinue ~~approved,~~to put pressure on the ~~FDA~~pricing ~~can~~and ~~subsequently~~usage ~~approve~~of ~~another~~any ~~drug~~of ~~for~~our ~~the~~current ~~same~~or ~~condition~~future product candidates, if ~~the~~approved ~~FDA~~in ~~concludes~~these ~~that~~jurisdictions. ~~the~~In ~~later drug~~many iscountries, ~~clinically~~the ~~superior~~prices inof ~~that~~medical itproducts isare ~~shown~~subject to bevarying ~~safer,~~price ~~more~~control ~~effective~~mechanisms oras ~~makes~~part aof ~~major~~national ~~contribution~~health tosystems. ~~patient~~Other ~~care.~~countries allow companies to

~~The FDA fast track designation for GMI-1070 may not actually lead to a faster development or regulatory review or approval process.~~ 31

Iffix atheir ~~drug~~own isprices ~~intended~~ for ~~the treatment~~medical ofproducts abut ~~serious~~monitor ~~or life-threatening disease or condition~~ and ~~the~~control ~~drug~~company ~~demonstrates~~profits. ~~the~~Additional ~~potential~~foreign toprice ~~address~~controls ~~unmet~~or ~~medical~~other ~~needs~~changes ~~for~~in ~~this~~pricing ~~disease~~regulation orcould ~~condition,~~restrict the ~~drug~~amount ~~sponsor~~that ~~may~~we ~~apply~~are ~~for~~able ~~FDA~~to ~~fast~~charge ~~track~~for ~~designation~~our products. IfAccordingly, ~~fast~~in ~~track designation~~markets isoutside ~~obtained,~~ the ~~FDA~~United ~~may initiate review of sections of a new drug application~~States, ~~or NDA, before~~ the ~~application~~reimbursement isfor ~~complete.~~our ~~This~~products ~~“rolling~~may ~~review”~~be isreduced ~~available~~compared ifwith the ~~applicant~~United ~~provides,~~States and ~~the~~may ~~FDA~~be ~~approves,~~insufficient ato ~~schedule~~generate ~~for submission~~commercially ofreasonable ~~the~~revenue ~~individual~~and ~~sections of the application~~profits.

~~Although~~Moreover, weincreasing ~~have~~efforts ~~obtained~~by agovernmental ~~fast~~and ~~track~~third-party ~~designation~~payors ~~from~~in the ~~FDA~~United ~~for~~States ~~GMI-1070~~and abroad to ~~treat~~cap ~~VOC,~~or we reduce healthcare costs may ~~not~~cause ~~experience~~such aorganizations ~~faster~~to ~~development~~limit ~~process~~both coverage and the level of reimbursement for newly approved products and, ~~review~~as a result, they may not cover or ~~approval~~provide ~~compared~~adequate topayment ~~conventional~~for ~~FDA~~our ~~procedures~~products. ~~Our~~We ~~fast~~expect ~~track~~to ~~designation~~experience ~~may~~pricing bepressures ~~withdrawn~~in byconnection with the ~~FDA~~sale ifof itany ~~believes~~of ~~that~~our products due to the ~~designation~~trend istoward nomanaged ~~longer~~healthcare, ~~supported~~the byincreasing ~~data~~influence ~~from~~of ~~our~~health ~~clinical development~~maintenance ~~program~~organizations and additional legislative and regulatory changes. ~~Our~~The ~~fast~~downward ~~track~~pressure ~~designation~~on ~~does~~healthcare ~~not~~costs ~~guarantee~~in ~~that~~general, weand ~~will~~prescription ~~qualify~~drugs, ~~for~~surgical orprocedures beand ~~able~~other treatments in particular, has become very intense. As a result, increasingly high barriers are being erected to ~~take~~the ~~advantage~~entry of ~~the~~new ~~expedited~~products. ~~review~~See ~~procedures~~“Risks Related to Government Regulation—Current and future U.S. healthcare reform legislation or ~~that~~regulation wemay ~~will~~increase ~~ultimately~~the difficulty and cost for us to obtain ~~regulatory~~coverage ~~approval~~for and commercialize any of ~~GMI-1070.~~our current or future product candidates and may adversely affect the prices we may set” for additional related information.

~~Failure~~We are subject to ~~obtain~~U.S. ~~marketing~~and ~~approval~~certain inforeign ~~international~~export ~~jurisdictions~~and ~~would~~import ~~prevent~~controls, ~~our~~sanctions, ~~drug~~embargoes, ~~candidates~~anti-corruption ~~from~~laws, ~~being~~and ~~marketed~~anti-money ~~abroad~~laundering laws and regulations. We can face criminal liability and other serious consequences for violations, which can harm our business.

InWe ~~order~~are subject to ~~market~~export control and ~~sell~~import ~~our~~laws ~~drugs~~and inregulations, including the EUU.S. ~~and~~Export ~~any~~Administration ~~other~~Regulations, ~~jurisdictions~~U.S. Customs regulations, wevarious oreconomic ~~our~~and ~~collaborators~~trade ~~must~~sanctions ~~obtain~~regulations ~~separate~~administered ~~marketing~~by ~~approvals~~the ~~and~~U.S. ~~comply~~Treasury ~~with numerous~~Department’s ~~and~~Office ~~varying~~of ~~regulatory~~Foreign ~~requirements.~~Assets ~~The~~Controls, ~~approval~~the ~~procedure~~U.S. ~~varies~~Foreign ~~among~~Corrupt ~~countries~~Practices ~~and~~Act ~~can~~of ~~involve~~1977, ~~additional~~as ~~testing~~amended, the U.S. ~~The~~domestic ~~time~~bribery ~~required~~statute tocontained ~~obtain~~in ~~approval~~18 ~~may~~U.S.C. ~~differ~~§ ~~substantially~~201, ~~from~~the ~~that~~U.S. ~~required~~Travel toAct, ~~obtain~~the ~~FDA~~USA ~~approval.~~PATRIOT ~~The~~Act, ~~regulatory approval~~and ~~process~~other ~~outside~~state ~~the~~and ~~United~~national ~~States~~anti-bribery ~~generally~~and ~~includes~~anti-money ~~all~~laundering oflaws in the ~~risks~~countries ~~associated~~in ~~with~~which ~~obtaining~~we ~~FDA~~conduct ~~approval~~activities. InAnti-corruption ~~addition~~laws are interpreted broadly and prohibit companies and their employees, inagents, ~~many~~contractors, ~~countries~~and ~~outside~~other ~~the~~collaborators ~~United~~from ~~States~~authorizing, itpromising, isoffering, ~~required~~or ~~that~~providing, ~~the~~directly ~~drug~~or beindirectly, ~~approved~~improper ~~for~~payments ~~reimbursement~~or ~~before~~anything itelse ~~can be~~of ~~approved~~value ~~for~~to ~~sale~~or infrom ~~that~~recipients ~~country.~~in Wethe public or ~~our~~private ~~collaborators~~sector. We may ~~not~~engage ~~obtain~~third ~~approvals~~parties ~~from~~to ~~regulatory~~sell ~~authorities~~our products outside the United States, onto aconduct ~~timely~~clinical ~~basis~~trials, ifand/or atto ~~all~~obtain necessary permits, licenses, patent registrations, and other regulatory approvals. ~~Approval~~We byhave ~~the~~direct ~~FDA~~or ~~does~~indirect ~~not~~interactions ~~ensure~~with ~~approval~~officials byand ~~regulatory~~employees ~~authorities~~of ~~in other~~government ~~countries~~agencies or ~~jurisdictions~~government-affiliated hospitals, universities, and ~~approval~~other byorganizations. ~~one~~We ~~regulatory~~can ~~authority~~be ~~outside~~held liable for the ~~United~~corrupt ~~States~~or ~~does~~other ~~not~~illegal ~~ensure~~activities ~~approval~~of byour ~~regulatory~~employees, ~~authorities~~agents, incontractors, and other ~~countries~~collaborators, oreven ~~jurisdictions~~if we do not explicitly authorize or byhave ~~the~~actual ~~FDA~~knowledge of such activities. ~~However,~~Any ~~failure~~violations toof ~~obtain~~the ~~approval~~laws inand ~~one jurisdiction~~regulations ~~may~~described ~~impact~~above ~~our~~may ~~ability~~result toin ~~obtain~~substantial ~~approval~~civil ~~elsewhere.~~and Wecriminal orfines ~~our~~and ~~collaborators~~penalties, ~~may~~imprisonment, ~~not~~the beloss ~~able~~of toexport ~~file~~or ~~for~~import ~~marketing~~privileges, ~~approvals~~debarment, ~~and~~tax ~~may~~reassessments, ~~not~~breach ~~receive~~of ~~necessary~~contract ~~approvals~~and tofraud ~~commercialize~~litigation, ~~our~~reputational ~~drugs~~harm, inand ~~any~~other ~~market~~consequences.

AGovernments ~~variety~~outside ofthe ~~risks~~United ~~associated~~States ~~with~~tend ~~marketing~~to ~~our~~impose ~~drug~~strict ~~candidates~~price ~~internationally~~controls, ~~could~~which ~~hurt~~may adversely affect our ~~business~~revenue, if any.

WeIn orsome ~~our~~countries, ~~collaborators~~particularly ~~may~~member ~~seek~~states of the EU (“EU member states”), the pricing of prescription medicinal product is subject to governmental control. EU member states are free to restrict the range of pharmaceutical products for which their national health insurance systems provide reimbursement, and to control the prices and reimbursement levels of pharmaceutical products for human use. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of regulatory approval for ~~GMI-1070~~a ~~and~~medicinal ~~our~~product. In addition, there can be considerable pressure by governments and other ~~drug~~stakeholders ~~candidates~~on ~~outside~~prices and reimbursement levels, including as part of ~~the~~cost ~~United~~containment ~~States~~measures. Political, economic, and regulatory developments may further complicate pricing negotiations, ~~accordingly~~and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU member states and parallel distribution, weor ~~expect~~arbitrage ~~that~~between low-priced and high-priced EU member states, can further reduce prices. To obtain coverage and reimbursement or pricing approvals in some countries, we ~~will~~ or current or future collaborators may be ~~subject~~required to ~~additional~~conduct ~~risks~~a ~~related~~clinical trial or other studies that compare the cost-effectiveness of our product candidates to ~~operating~~other inavailable ~~foreign~~therapies ~~countries~~in iforder weto obtain ~~the~~or ~~necessary~~maintain ~~approvals~~reimbursement or pricing approval. This Health Technology Assessment (“HTA process”), ~~including:~~which is currently governed by the national laws of the individual EU member states,

~~n differing regulatory requirements in foreign countries;~~32

nis the ~~potential~~procedure ~~for~~according ~~so-called~~to ~~parallel~~which ~~importing~~the assessment of the public health impact, ~~which~~therapeutic isimpact ~~what~~and ~~happens~~the ~~when~~economic and societal impact of use of a ~~local~~given ~~seller,~~medicinal ~~faced~~product ~~with~~in ~~high~~the national healthcare systems of the individual country is conducted. The outcome of HTA regarding specific medicinal products will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU member states Publication of discounts by third-party payors or ~~higher~~authorities ~~local~~may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If reimbursement of any product candidate approved for marketing is unavailable or limited in scope or amount, ~~opts~~or toif ~~import~~pricing ~~goods~~is ~~from~~set aat ~~foreign~~unsatisfactory ~~market~~levels, ~~with~~our ~~low~~business, financial condition, results of operations, or ~~lower~~prospects ~~prices~~could ~~rather~~be ~~than~~materially ~~buying~~and ~~them~~adversely ~~locally;~~affected.

nBrexit ~~unexpected~~could ~~changes~~lead into ~~tariffs~~legal uncertainty and potentially divergent national laws and regulations, ~~trade~~including ~~barriers~~those related to the pricing of prescription pharmaceuticals, ~~price~~as ~~and~~the ~~exchange~~United ~~controls~~Kingdom ~~and~~(“UK”) ~~other~~determines ~~regulatory~~which ~~requirements;~~EU laws to replicate or replace. If the UK were to significantly alter its regulations affecting the pricing of prescription pharmaceuticals, we could face significant new costs.

nDisruptions ~~economic~~at ~~weakness~~the FDA, ~~including~~the ~~inflation~~SEC orand ~~political~~other ~~instability~~government agencies and regulatory authorities caused by funding shortages, changes or reductions in ~~particular~~agency ~~foreign~~personnel, ~~economies~~or global health concerns could hinder their ability to hire and ~~markets;~~retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

nThe ~~compliance~~ability ~~with~~of ~~tax~~the FDA to review regulatory filings and our ability to commence human clinical trials can be affected by a variety of factors, ~~employment~~including government budget and funding levels, ~~immigration~~ability to hire and ~~labor~~retain ~~laws~~key ~~for~~personnel ~~employees~~and ~~living~~accept orthe ~~traveling~~payment ~~abroad;~~of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC, and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

nDisruptions at the FDA and other agencies or comparable foreign ~~taxes~~regulatory authorities may also slow the time necessary for the review and approval of applications for clinical trial or marketing authorization, which would adversely affect our business. For example, in previous years, including ~~withholding~~in 2018 and 2019 and 2025, the U.S. government shut down and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities. In addition, the current U.S. Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities, or otherwise affect our ability to progress development of ~~payroll~~our ~~taxes;~~product candidates or obtain regulatory approval for our product candidates.

nIf ~~foreign~~a ~~currency~~prolonged ~~fluctuations~~government shutdown occurs, ~~which~~if ~~could~~there ~~result~~is a significant change or reduction in ~~increased~~agency ~~operating~~personnel, ~~expenses~~or ~~and~~if ~~reduced~~funding ~~revenues~~shortages prevent the FDA or other regulatory authorities from conducting their regular inspections, ~~and~~reviews, or other ~~obligations~~regulatory ~~related~~activities, it could significantly impact the ability of the FDA or other regulatory authorities to ~~doing~~timely ~~business~~review inand ~~another~~process ~~country;~~our regulatory submissions, which could have a material adverse effect on our business.

nRisks ~~difficulties~~Related ~~staffing~~to ~~and~~Our ~~managing~~Intellectual ~~foreign~~Property ~~operations;~~

nWe ~~workforce~~do ~~uncertainty~~not incurrently ~~countries~~solely ~~where~~own ~~labor~~any ~~unrest~~issued patents or pending patent applications. Therefore, our ability to obtain and protect our patent rights, and protect other proprietary rights, is ~~more~~uncertain, ~~common~~exposing ~~than~~us into the ~~United~~possible ~~States;~~loss of competitive advantage.

27Our success depends, and will continue to depend, in large part on our ability to obtain and maintain patent protection for our platform technologies, programs, and their uses, as well as our ability to operate without infringing on or violating the proprietary rights of others. Our ability to protect our technologies from unauthorized making, using, selling, offering to sell, or importing by third parties may depend on the extent to which we have rights under valid and enforceable patents that cover these activities. We rely, and will continue to rely, upon a combination of patents, trademarks, trade secret protection, confidentiality agreements, and licensing and

~~Table of Contents~~33

ncollaboration ~~potential~~arrangements ~~liability~~to ~~under~~protect and expand the ~~Foreign~~intellectual ~~Corrupt~~property ~~Practices~~related ~~Act~~to our programs and technologies. While we do not currently solely own any patents or ~~comparable~~patent applications, we in-license certain patent rights from Paragon pursuant to those certain License Agreements, dated each of April 28, 2025 (the “CR-001 License Agreement”) and November 5, 2025 (the “CR-002 License Agreement”), each by and between us and Paragon (collectively, the “Paragon License Agreements”) relating to certain of our product candidates, and patent rights from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun”) pursuant to that certain License and Collaboration Agreement, dated December 2, 2025, by and between us and Kelun relating to CR-003 outside of mainland China, Hong Kong, Macau and Taiwan. Paragon has filed and we, alone and/or jointly with Paragon, have filed or intend to file provisional patent applications directed to antibodies that target PD-1 and VEGF, including, for example, applications covering composition of matter, dosing, pharmaceutical formulations, and methods of using such antibodies, including, but not limited to, CR-001. In addition, Paragon has filed and we, alone and/or jointly with Paragon, intend to file provisional patent applications directed to ADCs, including, for example, applications covering composition of matter, dosing, pharmaceutical formulations, and methods of using such antibodies, including, but not limited to, CR-002. Kelun has filed, and we and Kelun, alone and/or jointly, intend to file patent applications directed to ADCs, including, for example, applications covering composition of matter, dosing, pharmaceutical formulations, and methods of using such antibodies, including, but not limited to, CR-003. However, we or our licensors may not be able to protect our owned or in-licensed intellectual property rights throughout the world and the legal systems in certain countries may not favor enforcement or protection of patents, trade secrets, and other intellectual property. Filing, prosecuting, and defending patents on programs worldwide would be expensive and our intellectual property rights in some foreign ~~regulations~~jurisdictions can be less extensive than those in the United States; the reverse may also occur. As such, we may not have patents in all countries or all major markets and may not be able to obtain patents in all jurisdictions even if we apply for them. Our competitors may operate in countries where we do not have patent protection and can freely use our technologies and discoveries in such countries to the extent such technologies and discoveries are publicly known or disclosed in countries where we do not have patent protection and/or pending patent applications.

nOur ~~challenges~~intellectual ~~enforcing~~property portfolio is at an early stage. We do not currently solely own any issued patents or pending patent applications. Our in-licensed or future solely owned patent applications may not result in patents being issued. Any issued patents may not afford sufficient protection of our ~~contractual~~programs ~~and~~or ~~intellectual~~their ~~property~~intended ~~rights~~uses against competitors, ~~especially~~nor incan ~~foreign~~there ~~countries~~be any assurance that the patents issued will not be infringed, designed around, invalidated by third parties, or effectively prevent others from commercializing competitive technologies, products, or programs. Even if these patents are granted, they may be difficult to enforce. If we do not ~~respect~~obtain ~~and~~patent ~~protect~~coverage ~~intellectual~~for ~~property~~the work we are conducting, or if we obtain such rights but they are invalidated or rendered unenforceable, we may be unable to exclude competitors from pursuing and marketing the same ~~extent~~or similar product candidates. Other risks we face if we are not able to obtain and maintain patent coverage for our product candidates are the reduction in valuation of our product candidates, and ultimately of us as a company, by potential investors, and our inability to assert claims for infringement against third parties or counterclaim against such third parties or negotiate more advantageous settlement parameters. Further, any issued patents that we may license or own covering our programs could be narrowed or found invalid or unenforceable if challenged in court and/or before administrative bodies in the United States; or abroad, including the United States Patent and Trademark Office (“USPTO”). Further, if we encounter delays in our clinical trials or delays in obtaining regulatory approval, the period of time during which we could market our product candidates under patent protection may be reduced. Thus, the patents that we may own and/or license may not afford us any meaningful competitive advantage.

nIn ~~production~~addition ~~shortages~~to ~~resulting~~seeking ~~from~~patents ~~any~~for ~~events~~some ~~affecting~~of ~~raw~~our ~~material~~technology ~~supply~~and programs, we may also rely on trade secrets, including unpatented know-how, technology, and other proprietary information, to maintain our competitive position. Any disclosure, either intentional or unintentional, by our employees, the employees of third parties with whom we share our facilities, or third-party consultants and vendors that we engage to perform research, clinical trials, or manufacturing ~~capabilities~~activities, ~~abroad;~~or misappropriation by third parties (such as through a cybersecurity breach) of our trade secrets or proprietary information could enable competitors to duplicate or surpass our technological achievements, thus eroding our competitive position in our market. In order to protect our proprietary technology and processes, we rely, and will continue to rely, in part on confidentiality agreements and, if applicable, material transfer agreements, consulting agreements, or other similar agreements prior to beginning research and/or disclosing proprietary information with parties, such as collaborators, employees, consultants, outside scientific

~~n business interruptions resulting from geo-political actions, including war and terrorism.~~34

~~These~~collaborators, and sponsored researchers and other ~~risks~~advisors. ~~associated~~We also enter into confidentiality and invention or patent assignment agreements with our ~~potential~~employees ~~international~~and ~~operations~~consultants under which they are obligated to maintain confidentiality and to assign their inventions to us. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. These agreements may ~~compromise~~not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. We may need to share our ~~ability~~proprietary information, including trade secrets, with current or future business partners, licensors, collaborators, contractors, and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or state actors and those affiliated with or controlled by state actors. In addition, while we undertake efforts to ~~achieve~~protect our trade secrets and other confidential information from disclosure, others may independently discover trade secrets and proprietary information, and in such cases, we may not be able to assert any trade secret rights against such party. Enforcing a claim that a party disclosed or misappropriated our trade secrets, or securing title to an employee- or consultant-developed invention if a dispute arises, is challenging and the outcome is unpredictable. In addition, courts outside of the United States may be less willing to protect trade secrets. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights and failure to obtain or maintain ~~profitability~~trade secret protection could adversely affect our competitive business position.

~~Any~~The ~~drug~~enforceability ~~candidate~~of ~~for~~confidentiality ~~which~~agreements wemay ~~obtain~~vary ~~marketing~~from ~~approval~~jurisdiction ~~could~~to bejurisdiction. ~~subject~~In toaddition, ~~post-marketing~~these ~~restrictions~~agreements ortypically ~~recall~~restrict orthe ~~withdrawal~~ability ~~from~~of ~~the~~our ~~market~~advisors, employees, third-party contractors, and weconsultants ~~may therefore~~to bepublish ~~subject~~data potentially relating to ~~penalties~~our iftrade wesecrets, ~~fail~~although our agreements may contain certain limited publication rights. Despite our efforts to ~~comply~~protect ~~with~~our ~~regulatory~~trade ~~requirements~~secrets, orcompetitors ifmay wediscover ~~experience~~our ~~unanticipated~~trade ~~problems~~secrets, ~~with~~either through breach of our ~~drug~~agreements ~~candidates~~with third parties, ~~when~~independent ~~and~~development, ifor publication of information by any of ~~them~~our ~~are~~third-party ~~approved~~collaborators. A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.

~~Any drug candidate for which we obtain marketing approval~~Lastly, ~~along~~if ~~with~~our ~~manufacturing~~trademarks ~~processes, post-approval clinical data, labeling, advertising~~ and ~~promotional activities~~trade ~~for~~names ~~such~~are ~~drug~~not ~~candidate,~~registered ~~will~~or beadequately ~~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~~protected, ~~registration and~~then ~~listing~~we 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. Even if marketing approval of a drug candidate is granted, the approval may not be ~~subject~~able to ~~limitations~~build onname ~~the~~recognition ~~indicated~~in ~~uses~~our ~~for~~markets ~~which the drug may be marketed or to the conditions~~ of ~~approval,~~interest ~~including the requirement to implement a risk evaluation~~ and ~~mitigation strategy. If any of~~ our ~~drug~~business ~~candidates receives marketing approval, the accompanying label~~ may ~~limit~~be ~~the~~adversely ~~approved use of our drug, which could limit its sales~~affected.

~~The~~If ~~FDA~~we ~~may~~are ~~also~~unable ~~impose requirements for costly post-marketing studies or clinical trials and surveillance~~ to ~~monitor~~obtain ~~the safety~~ or ~~efficacy~~maintain ofnecessary ~~the~~rights ~~drug. The FDA closely regulates the post-approval marketing and promotion of drugs~~ to ~~ensure~~our ~~drugs~~programs ~~are~~through ~~marketed~~acquisitions ~~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~~licenses, ~~and~~ ~~if we do not market~~ our ~~drugs~~business ~~for their approved indications, we~~ may be ~~subject~~materially ~~to enforcement action for off-label marketing~~harmed. 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 healthcare fraud and abuse laws, as well as state consumer protection laws.

InBecause ~~addition~~our development programs currently rely, ~~later discovery~~and will continue to rely, on intellectual property rights in-licensed from Paragon and Kelun under each of ~~previously~~the ~~unknown~~Paragon ~~adverse~~License ~~events~~Agreements and Kelun License Agreement, respectively, and may in the future require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license, or use these third-party proprietary rights. We may in the future be unable to acquire or in-license compositions, methods of use, processes, or other ~~problems~~third-party ~~with~~intellectual property rights from third parties that we identify as necessary for our ~~drugs~~programs. The licensing and acquisition of third-party intellectual property rights is a competitive area, ~~manufacturers~~and a number of more established companies may pursue strategies to license or ~~manufacturing~~acquire ~~processes~~third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources, and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or ~~failure~~license rights to ~~comply~~us. ~~with~~We ~~regulatory~~also ~~requirements~~may be unable to license or acquire third-party intellectual property rights on commercially reasonable terms or at all. If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we do obtain, our ability to commercialize any of our targeted therapeutics, if approved, would likely be delayed, or we may have ~~negative~~to ~~consequences~~abandon development of the relevant program, ~~including:~~which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

nCertain ~~restrictions~~of onour ~~such~~current ~~drugs~~or future in-licensed patent families were or may be drafted, ~~manufacturers~~filed, and prosecuted by our current or ~~manufacturing~~future ~~processes;~~licensors, including Paragon and Kelun, and even where we now control the right to prosecution of certain in-licensed patent families, we are and may in the future be required to solicit input and consider comments from Paragon, Kelun or other future licensors. Additionally, while we have obtained or intend to obtain the right to control the prosecution, defense, maintenance, and enforcement of certain patents relating to our programs, there may be times when the filing and prosecution activities for patents and patent applications relating to our programs are solely or substantially controlled by our future licensors or collaboration partners. If we, Paragon, Kelun or any

~~n restrictions on the labeling or marketing of a drug;~~35

nof ~~restrictions~~our onfuture licensors or collaboration partners fail to prosecute, maintain, and enforce such patents and patent applications in a manner consistent with the best interests of our business, including by payment of all applicable fees for patents covering our product ~~distribution~~candidates, we could lose our rights to the intellectual property or ~~use;~~our exclusivity with respect to those rights, our ability to develop and commercialize those product candidates may be adversely affected, and we may not be able to prevent competitors from making, using, selling, and importing competing products. In addition, even if patents are issued from patent applications prosecuted by our licensors, our licensors may determine not to pursue litigation against third parties that are infringing these patents or may pursue such litigation less aggressively than we would. In addition, even where we are granted the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our current or future licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution.

nOur ~~requirements~~current toor ~~conduct~~future ~~post~~licensors, including Paragon and Kelun, may rely on third-~~marketing~~party ~~studies~~consultants or ~~clinical~~collaborators ~~trials;~~or on funds from third parties such that our current or future licensors are not the sole and exclusive owners of the patents we in-license. If other third parties have ownership rights to our current or future in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

nIt ~~warning~~is ~~letters;~~possible that we may be unable to obtain licenses at a reasonable cost or on reasonable terms, if at all. Even if we are able to obtain a license, it may be non-exclusive, including with respect to the use, field, or territory of the licensed intellectual property, thereby giving our competitors access to the same technologies licensed to us. In that event, we may be required to expend significant time and resources to redesign our technology, programs, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize the affected product candidates, which could harm our business, financial condition, results of operations, and prospects significantly. We cannot provide any assurances that third-party patents do not exist which might be enforced against our current technology, manufacturing methods, programs, or future methods or products resulting in either an injunction prohibiting our manufacture or future sales, or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties, which could be significant.

nDisputes ~~recall~~may arise between us and our current or ~~withdrawal~~future licensors regarding intellectual property subject to a license agreement, including: the scope of rights granted under the ~~drugs~~license agreement and other interpretation-related issues; whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; our right to sublicense patents and other rights to third parties; our right to transfer or assign the license; the inventorship and ownership of inventions and know-how resulting from the ~~market~~joint creation or use of intellectual property by our current or future licensors or partners; and the priority of invention of patented technology. If we or our current or future licensors breach the terms of our license agreements, such breach may have a material adverse effect on our business and the commercialization efforts for our programs.

nOur ~~refusal~~current tocollaboration ~~approve~~with ~~pending~~Kelun ~~applications~~and orany ~~supplements~~collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to ~~approved~~develop ~~applications~~and ~~that~~commercialize weour ~~submit;~~products.

nOur ~~clinical~~current ~~holds;~~or future collaborations, including our current collaboration with Kelun, may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include that:

n•collaborators ~~fines,~~could ~~restitution~~independently develop, or ~~disgorgement~~develop ofwith ~~revenue~~third parties, products that compete directly or ~~profit~~indirectly with our product candidates;

n•collaborators ~~suspension~~may not pursue development and commercialization of our product candidates or ~~withdrawal~~may elect not to continue or renew development or commercialization programs based on trial or test results, changes in their strategic focus due to the acquisition of ~~marketing~~competitive ~~approvals~~products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;

~~n refusal to permit the import or export of our drugs;~~36

n•disputes ~~product~~may ~~seizure;~~arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources;

n•collaborators ~~injunctions~~have orsignificant discretion in determining the ~~imposition~~efforts ofand ~~civil~~resources orthat ~~criminal~~they ~~penalties.~~will apply to collaborations;

28•a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;

~~Table~~•we ofcould ~~Contents~~grant exclusive rights to our collaborators that would prevent us from collaborating with others;

~~Non-compliance~~•collaborators ~~with~~may EUuse ~~requirements~~our ~~regarding~~intellectual ~~safety~~property ~~monitoring~~ or ~~pharmacovigilance,~~proprietary ~~and~~information ~~with~~in ~~requirements~~a ~~related~~way ~~to the~~that ~~development~~gives ofrise ~~drugs~~to ~~for~~actual ~~the~~or ~~pediatric~~threatened ~~population,~~litigation ~~can~~that ~~also~~could ~~result~~jeopardize inor ~~significant~~invalidate ~~financial~~our ~~penalties.~~intellectual ~~Similarly,~~property ~~failure~~or toproprietary ~~comply with the EU’s requirements regarding the protection of personal~~ information ~~can~~or ~~also~~expose ~~lead~~us to ~~significant penalties~~potential ~~and~~liability ~~sanctions.~~or business risk;

~~Our~~•collaborations ~~current and future relationships with customers and third-party payors in the United States and elsewhere~~ may be ~~subject,~~ ~~directly or indirectly~~terminated, ~~to applicable anti-kickback, fraud~~ and ~~abuse~~, ~~false~~if ~~claims~~terminated, ~~transparency,~~may ~~health~~result ~~information~~in ~~privacy~~a ~~and~~need ~~security~~for ~~and~~additional ~~other~~capital ~~healthcare laws and regulations, which could expose us~~ to ~~criminal~~pursue ~~sanctions,~~further ~~civil penalties,~~development ~~contractual~~or ~~damages,~~commercialization ~~reputational~~of ~~harm,~~the ~~administrative~~applicable ~~burdens~~current ~~and~~or ~~diminished profits and~~ future ~~earnings.~~products or products;

~~Healthcare~~•collaborators ~~providers, physicians~~may ~~and~~own ~~third~~or co-~~party~~own ~~payors~~intellectual inproperty ~~the~~covering ~~United~~our ~~States~~product ~~and elsewhere will play a primary role in the recommendation and prescription of any drug~~ candidates ~~for~~that ~~which~~results wefrom ~~obtain~~our ~~marketing~~collaborating ~~approval. Our future arrangements~~ with ~~third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations~~them, ~~including, without limitation, the federal Anti-Kickback Statute~~ and ~~the~~in ~~federal~~such ~~False Claims Act~~cases, ~~which may constrain the business or financial arrangements and relationships through which~~ we ~~sell,~~would ~~market~~not ~~and~~have ~~distribute~~the ~~any~~exclusive ~~drugs~~right ~~for which we obtain marketing approval. In addition, we may be subject~~ to ~~transparency~~develop ~~laws~~or ~~and~~commercialize ~~patient~~such ~~privacy~~intellectual ~~regulation~~property; ~~by the U.S. federal~~ and state governments and by governments in foreign jurisdictions in which we conduct our business. The applicable federal, state and foreign healthcare laws and regulations that may affect our ability to operate include:

n•a ~~the~~collaborator’s ~~federal~~sales ~~Anti-Kickback Statute, which prohibits, among other things, persons from knowingly~~ and ~~willfully~~marketing ~~soliciting,~~activities ~~offering, receiving~~ or ~~providing~~other ~~remuneration,~~operations ~~directly~~may ornot ~~indirectly,~~be in ~~cash~~compliance orwith inapplicable ~~kind,~~laws toresulting ~~induce or reward, or~~ in ~~return~~civil ~~for, either the referral of an individual for,~~ or ~~the~~criminal ~~purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs, such as Medicare and Medicaid;~~proceedings.

nWe ~~federal~~may ~~civil~~be ~~and~~subject ~~criminal~~to ~~false~~patent infringement claims ~~laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower~~ or ~~qui~~may ~~tam~~need ~~actions, against individuals or entities for knowingly presenting, or causing~~ to befile ~~presented,~~claims to ~~the~~protect ~~federal~~our ~~government,~~intellectual ~~including the Medicare and Medicaid programs~~property, ~~claims~~which ~~for~~could ~~payment~~result ~~that~~in ~~are~~substantial ~~false~~costs orand ~~fraudulent~~liability orand ~~making~~prevent aus ~~false~~from ~~statement~~commercializing toour ~~avoid,~~potential ~~decrease~~products. ~~or conceal an obligation to pay money to the federal government;~~

nBecause the ~~federal~~intellectual ~~Health~~property ~~Insurance~~landscape ~~Portability~~in the biotechnology industry is rapidly evolving and ~~Accountability~~interdisciplinary, ~~Act~~it is difficult to conclusively assess our freedom to operate and guarantee that we can operate without infringing on or violating third-party rights. If certain of ~~1996~~our product candidates are ultimately granted regulatory approval, orpatent ~~HIPAA~~rights held by third parties, ~~which~~if ~~imposes~~found ~~criminal~~to be valid and ~~civil~~enforceable, ~~liability~~could ~~for~~be ~~executing~~alleged to render one or more of our product candidates infringing. If a ~~scheme~~third party successfully brings a claim against us, we may be required to ~~defraud~~pay substantial damages, be forced to abandon any ~~healthcare~~affected ~~benefit~~product ~~program~~candidate and/or ~~making~~seek ~~false~~a ~~statements~~license ~~relating~~from the patent holder. In addition, any intellectual property claims (e.g., patent infringement or trade secret misappropriation) brought against us, whether or not successful, may cause us to ~~healthcare~~incur ~~matters;~~significant legal expenses and divert the attention of our management and key personnel from other business concerns. We cannot be certain that our current or future owned or in-licensed patent applications and patents, if filed and issued, will not be challenged by others, whether in the course of litigation or in agencies like the USPTO or foreign administrative bodies. Some of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise funds.

nCompetitors ~~HIPAA,~~may asinfringe ~~amended~~or byotherwise ~~the~~violate ~~Health~~our ~~Information~~current ~~Technology~~or ~~for~~future ~~Economic~~patents, ~~and~~trademarks, ~~Clinical~~copyrights, ~~Health~~or ~~Act~~other ofintellectual ~~2009,~~property. To counter infringement or ~~HITECH~~other violations, ~~and~~we ~~their~~may ~~respective~~be ~~implementing~~required ~~regulations~~to file claims, which ~~impose~~can ~~obligations~~be onexpensive ~~covered~~and ~~healthcare~~time-consuming. ~~providers,~~Any ~~health~~such ~~plans,~~claims ~~and~~could ~~healthcare~~provoke ~~clearinghouses~~these parties to assert counterclaims against us, asincluding ~~well~~claims asalleging that we infringe their ~~business~~patents ~~associates~~or other intellectual property rights and/or that ~~create~~our patents are invalid and/or unenforceable. In addition, ~~receive~~in a patent infringement proceeding, ~~maintain~~a court or ~~transmit~~administrative ~~individually~~body ~~identifiable~~may ~~health~~decide ~~information~~that ~~for~~one or more of the patents we assert is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to prevent the other party from using the technology at issue on ~~behalf~~the ofgrounds that our patents do not cover the technology. Similarly, if we assert trademark infringement claims, a ~~covered~~court ~~entity~~or administrative body may determine that the marks we have asserted are invalid or unenforceable or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In such a case, ~~with~~we ~~respect~~could ultimately be forced to ~~safeguarding~~cease ~~the~~use ~~privacy~~of such marks. In any intellectual property litigation, ~~security~~even ~~and~~if ~~transmission~~we are successful, any award of ~~individually~~monetary ~~identifiable~~damages ~~health~~or ~~information;~~other remedy we receive may not be commercially valuable.

n the federal Open Payments program, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians and their immediate family members, with data collection beginning on August 1, 2013, requirements for manufacturers to submit reports to CMS by March 31, 2014, and the 90th day of each subsequent calendar year, and disclosure of such information to be made by CMS on a publicly available website beginning in September 2014; and37

nFurther, ~~analogous~~we ~~state~~may ~~and~~be ~~foreign~~required ~~laws~~to protect our future patents, if filed and ~~regulations~~issued, through procedures created to challenge the validity of a patent before administrative bodies in the United States such as ~~state~~the ~~anti~~USPTO or abroad. Such mechanisms include re-~~kickback~~examination, post grant review and ~~false~~equivalent ~~claims~~proceedings ~~laws~~in foreign jurisdictions, ~~which~~e.g., ~~may~~opposition ~~apply~~proceedings. toAn ~~sales~~adverse determination in any such submission or ~~marketing~~proceeding ~~arrangements~~could ~~and~~reduce ~~claims~~the ~~involving~~scope ~~healthcare~~or ~~items~~enforceability of, or ~~services~~invalidate, ~~reimbursed~~our bypatent ~~non-governmental~~rights, which could adversely affect our competitive position. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third- party ~~payors,~~could ~~including~~potentially ~~private~~provide ~~insurers;~~evidence ~~state~~in ~~and~~a ~~foreign~~USPTO ~~laws~~proceeding ~~that~~sufficient ~~require~~for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.

29In addition, if our programs are found to infringe the intellectual property rights of third parties, these third parties may assert infringement claims against our current or future licensors or licensees and other parties with whom we have business relationships and we may be required to indemnify those parties for any damages they suffer as a result of these claims, which may require us to initiate or defend protracted and costly litigation on behalf of licensees and other parties regardless of the merits of such claims. If any of these claims succeed, we may be forced to pay damages on behalf of those parties or may be required to obtain licenses for the products they use.

~~Table~~Furthermore, because of ~~Contents~~the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating to our intellectual property rights, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.

~~pharmaceutical~~We ~~companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that~~ may be ~~made~~subject to ~~healthcare~~claims ~~providers; state and foreign laws~~ that ~~require~~we ~~drug~~have ~~manufacturers~~wrongfully tohired ~~report~~an ~~information~~employee ~~related~~from toa ~~payments~~competitor ~~and~~or ~~other~~that ~~transfers~~our ofemployees, ~~value~~consultants, toor ~~physicians~~independent ~~and~~contractors ~~other~~have ~~healthcare~~wrongfully ~~providers~~used or ~~marketing~~disclosed ~~expenditures;~~confidential ~~and state and foreign laws governing the privacy and security of health~~ information ~~in certain circumstances, many~~ of ~~which~~third ~~differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts~~parties.

~~Efforts~~As tois ~~ensure~~common ~~that~~in ~~our~~the ~~business~~biotechnology ~~arrangements~~industry, ~~with~~in ~~third~~addition ~~parties~~to ~~will~~our ~~comply~~employees, ~~with~~we ~~applicable~~engage ~~healthcare~~the ~~laws~~service ~~and regulations~~of ~~may~~consultants ~~involve~~to ~~substantial~~assist ~~costs.~~us Itin isthe ~~possible~~development ~~that~~of ~~governmental~~our ~~authorities~~programs. ~~will~~Many ~~conclude~~of ~~that~~these ~~our~~consultants, ~~business~~and ~~practices~~many ~~may~~of ~~not~~our ~~comply~~employees, ~~with~~were ~~current~~previously oremployed ~~future statutes~~at, ~~regulations~~ or ~~case~~may ~~law~~have ~~involving~~previously ~~applicable~~provided ~~fraud~~or ~~and~~may ~~abuse~~be orcurrently ~~other healthcare~~providing ~~laws~~consulting ~~and~~services ~~regulations.~~to, Ifother ~~our~~biotechnology ~~operations~~or ~~are~~pharmaceutical ~~found~~companies toincluding beour incompetitors ~~violation~~or ofpotential ~~any~~competitors. ofWe ~~these~~could ~~laws~~in orthe ~~any~~future ~~other~~be ~~governmental~~subject ~~regulations~~to claims that ~~may~~we ~~apply~~or toour ~~us,~~employees wehave ~~may~~inadvertently beor ~~subject~~otherwise toused ~~significant~~or ~~civil,~~disclosed ~~criminal~~alleged ~~and~~trade ~~administrative~~secrets ~~penalties, including,~~or ~~without~~other ~~limitation,~~confidential ~~damages,~~information ~~fines,~~of ~~imprisonment,~~former ~~exclusion~~employers ~~from~~or ~~participation~~competitors. inAlthough ~~government~~we ~~healthcare~~try ~~programs,~~to ~~such~~ensure asthat ~~Medicare~~our ~~and~~employees ~~Medicaid,~~ and ~~the~~consultants ~~curtailment~~do ornot ~~restructuring~~use ofthe ~~our~~intellectual ~~operations~~property, ~~which~~proprietary ~~could~~information, ~~have~~know-how, aor ~~material~~trade ~~adverse effect~~secrets onof ~~our~~others ~~business.~~in Iftheir ~~any~~work offor ~~the~~us, ~~physicians~~we ormay ~~other~~become ~~healthcare~~subject ~~providers~~to orclaims ~~entities~~that ~~with~~we ~~whom~~caused wean ~~expect~~employee to dobreach ~~business,~~the ~~including~~terms ~~our~~of ~~collaborators,~~his isor ~~found~~her ~~not~~non-competition toor benon-solicitation inagreement, ~~compliance~~or ~~with~~that ~~applicable~~we ~~laws,~~or itthese ~~may~~individuals behave, ~~subject~~inadvertently toor ~~criminal~~otherwise, ~~civil~~ used or ~~administrative~~disclosed ~~sanctions,~~the ~~including~~alleged ~~exclusions~~trade ~~from~~secrets ~~participation~~or inother ~~government~~proprietary ~~healthcare~~information ~~programs,~~of ~~which~~a ~~could~~former ~~also~~employer ~~materially~~or ~~affect our business~~competitor.

~~Recently~~While ~~enacted~~we ~~and~~may ~~future~~litigate ~~legislation~~to ~~may~~defend ~~increase~~itself ~~the~~against ~~difficulty~~these claims, even if we are successful, litigation could result in substantial costs and ~~cost~~could ~~for~~be a distraction to management. If our defenses to these claims fail, in addition to requiring us to ~~obtain~~pay ~~marketing~~monetary ~~approval~~damages, a court could prohibit us from using technologies or features that are essential to our programs, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of ~~and~~the ~~commercialize~~former employers. Moreover, any such litigation or the threat thereof may adversely affect our ~~drug~~reputation, ~~candidates~~our ability to form strategic alliances or sublicense our rights to collaborators, engage with scientific advisors, or hire employees or consultants, each of which would have an adverse effect on our business, results of operations, and ~~affect~~ ~~the~~financial ~~prices~~condition. Even if we ~~may~~are ~~obtain~~successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

InChanges to patent laws in the United States and ~~some~~other ~~foreign~~ jurisdictions, ~~there~~could ~~have~~diminish ~~been a number of legislative and regulatory changes and proposed changes regarding~~ the ~~healthcare~~value ~~system that could prevent or delay marketing approval~~ of ~~our~~patents ~~drug~~in ~~candidates~~general, ~~restrict~~thereby orimpairing ~~regulate post-approval activities and affect~~ our ability to ~~profitably~~protect ~~sell~~our ~~any drug candidates for which we obtain marketing approval~~products.

~~Among~~Although ~~policy~~we ~~makers~~do ~~and~~not ~~payors~~currently inown ~~the~~or ~~United~~in-license ~~States~~any ~~and~~granted ~~elsewhere~~patents, ~~there~~if iswe ~~significant~~obtain ~~interest~~such patents in ~~promoting~~the future, changes in ~~healthcare~~ ~~systems~~either ~~with~~ the ~~stated~~patent ~~goals~~laws ofor ~~containing~~interpretation ~~healthcare~~of ~~costs,~~patent ~~improving~~laws ~~quality~~in ~~and expanding access. In~~ the United States, ~~the~~including ~~pharmaceutical~~patent ~~industry~~reform ~~has~~legislation ~~been~~such aas ~~particular focus of these efforts and has been significantly affected by major legislative initiatives. In March 2010, President Obama signed into law~~ the ~~Patient~~Leahy-Smith ~~Protection and Affordable Care~~ Act, ascould ~~amended~~increase by the ~~Health~~uncertainties ~~Care~~ and ~~Education~~costs ~~Affordability~~surrounding ~~Reconciliation Act, or collectively~~ the ~~PPACA,~~prosecution aof ~~sweeping~~our ~~law intended~~owned toand ~~broaden~~in-licensed ~~access~~patent toapplications, ~~health~~if ~~insurance~~any, ~~reduce~~and ~~or constrain~~ the ~~growth of healthcare spending~~maintenance, ~~enhance remedies against fraud and abuse~~enforcement, ~~add~~or ~~new~~defense ~~transparency~~of ~~requirements~~our ~~for~~owned ~~the healthcare~~ and ~~health~~in-licensed ~~insurance~~issued ~~industries~~patents, ~~impose~~if ~~new~~any. ~~taxes and~~The ~~fees~~Leahy-Smith onAct ~~the~~includes ~~health~~a ~~industry~~number ~~and~~of ~~impose~~significant ~~additional~~changes ~~health~~to ~~policy~~United ~~reforms.~~

~~Among the provisions of the PPACA of importance to our potential drug candidates are:~~ 38

nStates anpatent ~~annual~~law. These changes include provisions that affect the way patent applications are prosecuted, ~~nondeductible~~redefine ~~fee~~prior art, provide more efficient and cost-effective avenues for competitors to challenge the validity of patents, and enable third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent at USPTO-administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith Act, the United States transitioned to a first-to-file system in which, assuming that the other statutory requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. As such, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications, if any, ~~entity~~and ~~that~~the ~~manufactures~~enforcement or ~~imports~~defense ~~specified~~of ~~branded~~our ~~prescription~~issued ~~drugs~~patents, if any, all of which could have a material adverse effect on our business, financial condition, results of operations, and ~~biologic~~prospects. ~~agents~~Additionally, ~~apportioned~~the ~~among~~USPTO ~~these~~and ~~entities~~patent ~~according~~offices in other jurisdictions have often required that patent applications directed to ~~their~~pharmaceutical ~~market~~and/or ~~share~~biotechnology-related inventions be limited or narrowed substantially to cover only the specific innovations exemplified in ~~certain~~the ~~government~~patent ~~healthcare~~application, ~~programs;~~thereby limiting the scope of protection against competitive challenges. Accordingly, even if we or our licensors are able to obtain patents, the patents might be substantially narrower than anticipated. Thus, there is no assurance as to the degree and range of protections any of our patents, if issued, may afford us or whether patents will be issued.

nIn anaddition, ~~increase~~the patent positions of companies in the ~~statutory~~development ~~minimum~~and ~~rebates~~commercialization of biologics and pharmaceuticals are particularly uncertain. U.S. Supreme Court and U.S. Court of Appeals for the Federal Circuit rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations, including in the antibody arts. For example, the United States Supreme Court in Amgen, Inc. v. Sanofi (Amgen) recently held that Amgen’s patent claims to a ~~manufacturer~~class of antibodies functionally defined by their ability to bind a particular antigen were invalid for lack of enablement where the patent specification provided twenty-six exemplary antibodies, but the claimed class of antibodies covered a “vast number” of additional antibodies not disclosed in the specification. The Court stated that if patent claims are directed to an entire class of compositions of matter, then the patent specification must ~~pay~~enable ~~under~~a person skilled in the ~~Medicaid~~art ~~Drug~~to ~~Rebate~~make ~~Program~~and use the entire class of compositions. This decision makes it unlikely that we will be granted U.S. patents with composition of matter claims directed to 23antibodies functionally defined by their ability to bind a particular antigen.1% Even if we are granted claims directed to functionally defined antibodies, it is possible that a third party may challenge our patents, when issued, relying on the reasoning in Amgen or other recent precedential court decisions. Additionally, there have been proposals for additional changes to the patent laws of the United States and 13other countries that, if adopted, could impact our ability to enforce our proprietary technology.0% This combination of events has created uncertainty with respect to the ~~average~~validity ~~manufacturer~~and ~~price~~enforceability ~~for~~of ~~branded~~patents once obtained. Depending on future actions by the U.S. Congress, the federal courts and ~~generic~~the ~~drugs~~USPTO, ~~respectively;~~the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our patent rights and our ability to protect, defend, and enforce our patent rights in the future.

nGeopolitical ~~expansion~~instability in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of ~~healthcare~~patent ~~fraud~~applications and ~~abuse~~the ~~laws~~maintenance, ~~including~~enforcement, or defense of issued patents. For example, the ~~False~~United ~~Claims~~States ~~Act~~and foreign government actions related to Russia’s invasion of Ukraine may limit or prevent filing, prosecution, and ~~the~~maintenance ~~Anti-Kickback~~of ~~Statute~~patent applications in Russia. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of patents or patent applications, ~~new~~resulting in partial or complete loss of patent rights in Russia. If such an event were to occur, it could have a material adverse effect on our business. In addition, a decree was adopted by the Russian government ~~investigative~~in ~~powers~~March 2022 allowing Russian companies and ~~enhanced~~individuals ~~penalties~~to ~~for~~exploit ~~non~~inventions owned by patentees that have citizenship or nationality in, are registered in, or have predominately primary place of business or profit-~~compliance;~~making activities in the United States and other countries that Russia has deemed unfriendly without consent or compensation. Consequently, we would not be able to prevent third parties from practicing our inventions in Russia or from selling or importing products made using our inventions in and into Russia. Accordingly, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected.

n a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D;39

nIn ~~extension~~addition, a European Unified Patent Court (“UPC”) entered into force on June 1, 2023. The UPC is a common patent court that hears patent infringement and revocation proceedings effective for EU Member States. The broad geographic reach of the UPC could enable third parties to seek revocation of any of our future owned or in-licensed European patents in a ~~manufacturer’s~~single ~~Medicaid~~proceeding ~~rebate~~at ~~liability~~the UPC rather than through multiple proceedings in each of the individual European Union member states in which the European patent is validated. Under the UPC, a successful revocation proceeding for a European Patent under the UPC would result in loss of patent protection in those European Union countries. Accordingly, a single proceeding under the UPC could result in the partial or complete loss of patent protection in numerous European Union countries. Such a loss of patent protection could have a material adverse impact on our business and our ability to ~~covered~~commercialize ~~drugs~~our ~~dispensed~~technology and product candidates and, resultantly, on our business, financial condition, prospects, and results of operations. Moreover, the controlling laws and regulations of the UPC will develop over time and we cannot predict what the outcomes of cases tried before the UPC will be. The case law of the UPC may adversely affect our ability to ~~individuals~~enforce ~~who~~or ~~are~~defend ~~enrolled~~the invalidity ~~Medicaid~~of ~~managed~~our ~~care~~European ~~organizations;~~patents. Patent owners have the option to opt-out their European patents from the jurisdiction of the UPC, defaulting to pre-UPC enforcement mechanisms.

30Any such revocation and loss of patent protection could have a material adverse impact on our business and our ability to commercialize or license our technology and products. Moreover, the controlling laws and regulations of the UPC will develop over time, and may adversely affect our ability to enforce or defend the validity of any European patents we may obtain. We or our current or future licensors may decide to opt out from the UPC any future European patent applications that we or our current or future licensors may file and any patents we or such licensors may obtain. If certain formalities and requirements are not met, however, such European patents and patent applications could be challenged for non-compliance and brought under the jurisdiction of the UPC. We cannot be certain that any of our future owned or in-licensed European patents and patent applications will avoid falling under the jurisdiction of the UPC, even if we or our current or future licensors decide to opt out of the UPC.

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

nPeriodic ~~expansion~~maintenance fees, renewal fees, annuities fees, and various other governmental fees on patents and/or patent applications are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of ~~eligibility~~the ~~criteria~~patent ~~for~~and/or ~~Medicaid~~patent ~~programs~~application. byThe USPTO and various foreign governmental patent agencies also require compliance with a number of procedural, ~~among~~documentary, ~~other~~fee ~~things~~payment, ~~allowing~~and ~~states~~other tosimilar ~~offer~~provisions ~~Medicaid~~during ~~coverage~~the topatent ~~additional~~application ~~individuals~~process. ~~and~~While an inadvertent lapse can in many cases be cured by ~~adding~~payment ~~new~~of ~~mandatory~~a ~~eligibility~~late ~~categories~~fee ~~for~~or ~~certain~~by ~~individuals~~other means in accordance with ~~income~~the atapplicable rules, there are situations in which noncompliance can result in abandonment or ~~below~~lapse ~~133%~~of the patent or patent application, resulting in partial or complete loss of patent rights in the ~~federal~~relevant ~~poverty~~jurisdiction. ~~level~~Non-compliance ~~beginning~~events that could result in ~~2014,~~abandonment ~~thereby~~or ~~potentially~~lapse ~~increasing~~of a ~~manufacturer’s~~patent ~~Medicaid~~or ~~rebate~~patent ~~liability;~~application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. If we fail to maintain our current or future owned or in-licensed patents and patent applications covering our programs, our competitive position would be adversely affected.

nWe ~~expansion~~may ofnot ~~the~~identify ~~entities~~relevant ~~eligible~~third-party ~~for~~patents ~~discounts~~or ~~under~~may incorrectly interpret the ~~Public~~relevance, ~~Health~~scope, ~~Service~~or ~~pharmaceutical~~expiration ~~pricing~~of ~~program;~~a third-party patent, which might adversely affect our ability to develop and market our products.

nWe cannot guarantee that any of our patent searches or analyses, including the ~~new~~identification ~~requirements~~of ~~under~~relevant patents, the ~~federal~~scope ~~Open~~of ~~Payments~~patent ~~program~~claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and ~~its~~every ~~implementing~~third-party ~~regulations;~~patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our product candidates in any jurisdiction. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent, the patent’s prosecution history, and in some cases certain extrinsic evidence of the meaning of terms in a claim. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect. For example, we may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether a third-party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent

~~n a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and~~40

nin athe ~~new~~United ~~Patient-Centered~~States ~~Outcomes~~or ~~Research~~abroad ~~Institute~~that towe ~~oversee,~~consider ~~identify~~relevant ~~priorities~~may ~~in,~~be incorrect. Our failure to identify and ~~conduct~~correctly ~~comparative~~interpret ~~clinical~~relevant ~~effectiveness~~patents ~~research,~~may ~~along~~negatively ~~with~~impact ~~funding~~our ~~for~~ability ~~such~~to ~~research~~develop and market our products.

In addition, ~~other~~because ~~legislative~~some ~~changes~~patent ~~have~~applications ~~been~~in ~~proposed~~the ~~and~~United ~~adopted~~States ~~since~~may be maintained in secrecy until the ~~PPACA~~patents ~~was~~are ~~enacted.~~issued, ~~These changes~~patent ~~include~~applications ~~aggregate~~in ~~reductions~~the toUnited ~~Medicare~~States ~~payments~~and tomany ~~providers~~foreign ofjurisdictions upare totypically 2%not published until 18 ~~per~~months ~~fiscal~~after ~~year~~filing, ~~starting~~and publications in ~~2013.~~the Onscientific ~~March 1,~~literature ~~2013,~~often ~~the~~lag ~~President~~behind ~~signed~~actual andiscoveries, ~~executive~~we ~~order~~cannot ~~implementing~~be ~~the~~certain 2%that ~~Medicare~~others ~~payment~~have ~~reductions,~~not ~~and~~filed ~~on April 1,~~patent ~~2013,~~applications ~~these~~for ~~reductions~~technology ~~went~~covered ~~into~~by ~~effect.~~our Infuture ~~January~~owned ~~2013,~~or ~~President~~in-licensed ~~Obama~~issued ~~signed~~patents ~~into~~or ~~law~~our ~~the~~current ~~American~~or ~~Taxpayer~~future ~~Relief~~owned ~~Act~~or ofin-licensed ~~2012~~pending applications, ~~which~~if filed, ~~among~~or ~~other~~that ~~things,~~we ~~reduced~~were ~~Medicare~~the ~~payments~~first to ~~several~~invent ~~providers~~the ~~and~~technology. ~~increased~~Our ~~the~~competitors ~~statute~~may ~~of limitations~~have ~~period~~filed, ~~for~~and may in the ~~government~~future tofile, ~~recover~~patent ~~overpayments~~applications tocovering ~~providers~~products ~~from~~or ~~three~~technology similar to ~~five years~~ours. ~~These~~Any ~~new~~such ~~laws~~patent application may ~~result~~have inpriority ~~additional~~over ~~reductions~~our incurrent ~~Medicare~~or ~~and~~future ~~other~~owned ~~healthcare~~or ~~funding,~~in-licensed ~~which~~patent ~~could~~applications ~~have~~or apatents, ~~material~~if ~~adverse~~filed ~~effect~~and onissued, ~~customers for~~which ~~our~~could ~~drugs,~~require ifus ~~approved,~~to ~~and,~~obtain ~~accordingly,~~rights ~~our~~to ~~financial~~issued ~~operations~~patents covering such technologies.

We ~~expect that the PPACA, as well as other healthcare reform measures that~~ may be ~~adopted~~become insubject ~~the~~to ~~future,~~claims ~~may~~challenging ~~result in more rigorous coverage criteria and in additional downward pressure on~~ the ~~price~~inventorship ~~that we receive for any approved drug. Any reduction in reimbursement from Medicare~~ or ~~other~~ownership ~~government-funded programs may result in a similar reduction in payments from private payors. The implementation~~ of ~~cost~~our ~~containment~~patents ~~measures~~and or other ~~healthcare~~intellectual ~~reforms may prevent us from being able to generate revenue, attain profitability or commercialize our drugs~~property.

~~Legislative~~We ~~and~~may ~~regulatory~~be ~~proposals~~subject to claims that former employees, collaborators, or other third parties have ~~been~~an ~~made~~interest toin ~~expand~~our ~~post~~future owned or in-~~approval~~licensed ~~requirements~~patents, if filed and ~~restrict~~issued, ~~sales~~or ~~and~~other ~~promotional~~intellectual ~~activities~~property ~~for~~as ~~drugs~~an inventor or co-inventor. ~~We cannot~~The befailure ~~sure~~to ~~whether~~name ~~additional~~the ~~legislative~~proper ~~changes~~inventors ~~will~~on bea ~~enacted,~~patent orapplication ~~whether~~can result in the ~~FDA~~patents ~~regulations,~~issuing ~~guidance~~thereon being invalid or ~~interpretations~~unenforceable. ~~will~~Inventorship bedisputes ~~changed~~may arise from conflicting views regarding the contributions of different individuals named as inventors, orthe ~~what~~effects of foreign laws where foreign nationals are involved in the ~~impact~~development of ~~such~~the ~~changes~~subject onmatter of the ~~marketing~~patent, ~~approvals~~conflicting obligations of third parties involved in developing our ~~drug~~programs, ~~candidates~~or as a result of questions regarding co-ownership of potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership. While we typically require employees, ifconsultants, ~~any~~and contractors who may develop intellectual property on our behalf to execute agreements assigning such intellectual property to us, we may be unsuccessful in obtaining execution of assignment agreements with each party who in fact develops intellectual property that we regard as our own. In ~~addition~~Moreover, ~~increased~~even ~~scrutiny~~when bywe ~~the~~obtain ~~U.S.~~agreements ~~Congress~~assigning intellectual property to us, the assignment of intellectual property rights may not be self-executing or the ~~FDA’s~~assignment ~~approval~~agreements ~~process~~may be breached. In either case, we may ~~significantly~~be ~~delay~~forced to bring claims against third parties, or ~~prevent~~defend ~~marketing~~claims ~~approval~~that they may bring against us, to determine the ownership of what we regard as ~~well~~our intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as ~~subject~~exclusive usownership of, or right to ~~more~~use, ~~stringent~~valuable ~~product~~intellectual ~~labeling~~property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and ~~post-marketing~~be ~~testing~~a distraction to management and other ~~requirements~~ employees.

~~Governments~~Patent ~~outside~~terms ~~the~~may ~~United~~be ~~States~~inadequate ~~tend~~ to ~~impose~~protect ~~strict~~the ~~price~~competitive ~~controls,~~position ~~which~~of ~~may~~our ~~adversely~~product ~~affect~~candidates ~~our~~for ~~revenue,~~an ifadequate ~~any~~amount of time.

InPatents ~~some~~have ~~countries,~~a ~~particularly~~limited inlifespan. ~~the~~In ~~EU,~~ the ~~pricing~~United ofStates, ~~prescription~~if ~~pharmaceuticals~~all ismaintenance ~~subject~~fees toare ~~governmental~~timely ~~control. In these countries~~paid, ~~pricing~~ ~~negotiations~~the ~~with~~natural ~~governmental~~expiration ~~authorities~~of ~~can~~a ~~take~~patent ~~considerable~~is ~~time~~generally ~~after~~20 ~~the~~years ~~receipt~~from ofits ~~marketing~~earliest ~~approval~~United ~~for~~States anon-provisional ~~drug.~~filing Todate ~~obtain coverage and reimbursement~~ or ~~pricing~~international ~~approval~~Patent inCooperation ~~some~~Treaty ~~countries,~~Filing. weThe ~~may~~patent beterm ~~required~~of ~~to conduct~~ a ~~clinical trial~~U.S. ~~that~~patent ~~compares~~may ~~the~~be ~~cost-effectiveness~~lengthened ofby ~~our~~patent ~~drug~~term ~~candidate~~adjustment, towhich ~~other~~compensates ~~available~~a ~~therapies.~~patentee Iffor ~~reimbursement~~administrative ofdelays ~~our~~by ~~drugs~~the isUSPTO ~~unavailable or limited~~ in ~~scope~~granting ora ~~amount~~patent, or ifmay ~~pricing~~be isshortened ~~set~~if ata ~~unsatisfactory~~patent ~~levels,~~is ~~our~~terminally ~~business~~disclaimed ~~could~~over bean ~~harmed, possibly~~earlier-filed ~~materially~~patent.

IfVarious weextensions ~~fail~~may tobe ~~comply~~available, ~~with~~but ~~environmental,~~the ~~health~~life ~~and~~of ~~safety~~a ~~laws~~patent, and ~~regulations~~the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we ~~could~~may ~~become~~be ~~subject~~open to ~~fines~~competition from competitive products, including generics or ~~penalties~~ biosimilars. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might expire before or ~~incur~~shortly ~~costs~~after ~~that~~such ~~could~~product ~~harm~~candidates are commercialized. As a result, our ~~business~~owned and in-licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

WeIn ~~are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and~~ the ~~handling,~~United ~~use~~States, ~~storage, treatment and disposal of hazardous materials and wastes. Our operations involve~~ the ~~use~~Drug ofPrice ~~hazardous~~Competition and ~~flammable~~Patent ~~materials,~~Term ~~including~~Restoration ~~chemicals~~Act ~~and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal~~ of ~~these~~1984 ~~materials~~permits ~~and~~a ~~wastes.~~Patent WeTerm ~~cannot~~Extension ~~eliminate~~(“PTE”) ~~the risk~~ of ~~contamination~~up orto ~~injury~~five ~~from~~years ~~these~~beyond ~~materials. In~~ the ~~event~~normal ~~of contamination~~expiration ~~or injury resulting from our use~~ of ~~hazardous~~the ~~materials,~~patent ~~we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure~~ to ~~comply~~compensate ~~with~~patent ~~such~~owners ~~laws and regulations.~~

31 41

~~Table~~for loss of ~~Contents~~an enforceable patent term due to the lengthy regulatory approval process. A PTE grant cannot extend the remaining term of a patent beyond a total of 14 years from the date of the product approval. Further, PTE may only be applied once per product, and only with respect to an approved indication - in other words, only one patent (for example, covering the product itself, an approved use of said product, or a method of manufacturing said product) can be extended by PTE. We anticipate applying for PTE in the United States. Similar extensions may be available in other countries where we anticipate prosecuting patents, and we likewise anticipate applying for such extensions.

~~Although~~The wegranting ~~maintain~~of ~~workers’~~a ~~compensation~~PTE ~~insurance~~is not guaranteed and is subject to ~~cover~~numerous usrequirements. We might not be granted an extension because of, for ~~costs~~example, ~~and~~failure ~~expenses~~to weapply ~~may~~within ~~incur~~applicable ~~due~~periods, failure to ~~injuries~~ apply prior to ~~our~~the ~~employees~~expiration ~~resulting~~of relevant patents or otherwise failure to satisfy any of the numerous applicable requirements. In addition, to the extent we wish to pursue a PTE based on a patent that we in-license from a third party, we would need the ~~use~~cooperation of ~~hazardous~~that ~~materials~~third party. Moreover, ~~this~~the ~~insurance~~applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not ~~provide~~agree ~~adequate~~with ~~coverage~~our ~~against~~assessment ~~potential~~of ~~liabilities.~~whether Wesuch doextensions ~~not~~are ~~maintain~~available, ~~insurance~~and ~~for~~may ~~environmental~~refuse ~~liability~~to grant extensions to our patents, or ~~toxic~~may ~~tort~~grant ~~claims~~more ~~that~~limited extensions than we request. If this occurs, our competitors may be ~~asserted~~ ~~against~~able usto inobtain ~~connection~~approval ~~with~~of competing products following our ~~storage~~patent orexpiration ~~disposal~~by ofreferencing ~~biological~~our clinical and preclinical data and launch their product earlier than might otherwise be the case. If this were to occur, ~~hazardous~~it orcould ~~radioactive~~have ~~materials~~a material adverse effect on our ability to generate revenue.

InThe ~~addition,~~technology we ~~may~~currently ~~incur~~license ~~substantial costs~~from inParagon ~~order to comply with current or future environmental, health~~ and ~~safety~~Kelun ~~laws~~ and ~~regulations.~~any ~~These current or~~ future ~~laws~~technology ~~and~~we ~~regulations~~ may ~~impair~~license ~~our~~from ~~research,~~various ~~development~~third orparties ~~production~~in ~~efforts.~~the ~~Our~~future, ~~failure to comply with these laws and regulations also~~ may ~~result~~be insubject ~~substantial~~to ~~fines,~~retained ~~penalties or other sanctions~~rights.

~~Risks~~Our ~~Related~~current and future licensors may retain certain rights under the relevant agreements with us, including the right to ~~Employee~~use ~~Matters~~or license the licensed technology outside of the scope of our license, use the underlying technology for noncommercial academic and ~~Managing~~research ~~Our~~use, ~~Growth~~ to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether our licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse. In addition, while we seek to obtain certain restrictions on our current or future licensors’ abilities to develop products that could be competitive with ours, these restrictions may not prevent the possible future license or development by our current or future licensors, including Paragon or Kelun, of certain technology that could lead to product candidates competitive with ours. This could have a material adverse effect on our competitive position, business, financial condition, results of operations, and prospects.

~~Our~~Risks ~~future~~Related ~~success depends on our ability~~ to ~~retain~~Our ~~key~~Reliance ~~executives~~on ~~and~~Third ~~to attract, retain and motivate qualified personnel.~~ Parties

We ~~are~~currently ~~highly~~rely ~~dependent~~ on ~~the~~licensing ~~management,~~arrangements ~~research~~with ~~and~~Paragon ~~development, clinical, financial~~ and ~~business~~Kelun ~~development~~under ~~expertise~~the ofParagon ~~Rachel~~License ~~King,~~Agreement ~~our President~~ and ~~Chief~~Kelun ~~Executive~~License ~~Officer;~~Agreement ~~John Magnani, our Vice President of Research~~ and ~~Chief~~may ~~Scientific~~in ~~Officer;~~the ~~Helen~~future ~~Thackray,~~rely ~~our~~on ~~Vice President of Clinical Development and Chief Medical Officer; and Brian Hahn, our Chief Financial Officer, as well as the~~ other ~~members~~intellectual ofproperty ~~our~~licensed ~~scientific~~from ~~and~~third ~~clinical teams~~parties. InIf ~~particular,~~ we are ~~dependent~~unable ~~upon Dr. Magnani for key expertise in carbohydrate chemistry and knowledge of carbohydrate biology with respect~~ to ~~our~~maintain ~~glycomimetics platform, and the loss of his services would materially impair~~ our ~~future~~current ~~drug~~collaborations ~~discovery~~or ~~efforts.~~licensing ~~Although~~arrangements, weor ~~intend~~if ~~to enter into new employment agreements with~~ our ~~executive~~collaborations ~~officers~~or ~~that~~licensing ~~will~~arrangements beare ~~effective~~not ~~upon the completion of this offering~~successful, ~~each~~our ofbusiness ~~them~~could ~~may currently terminate their employment with us at any time and will continue to~~ be ~~able~~negatively ~~to do so after the completion of this offering~~impacted. ~~We do not maintain “key person” insurance for any of our executives or employees other than Ms. King and Dr. Magnani.~~

~~Recruiting~~We ~~and~~rely ~~retaining~~on ~~qualified~~our ~~scientific~~current and ~~clinical~~future ~~personnel~~licensing ~~and,~~arrangements ifwith weParagon ~~progress the development of our drug pipeline other than GMI-1070 toward scaling up for commercialization, sales~~ and ~~marketing~~Kelun ~~personnel,~~under ~~will also be critical to our success. The loss of~~ the ~~services~~Paragon ofLicense ~~our~~Agreements ~~executive officers or other key employees could impede the achievement of our research, development~~ and ~~commercialization~~Kelun ~~objectives~~License ~~and~~Agreement ~~seriously~~for ~~harm~~intellectual ~~our~~property ~~ability~~rights tounderlying ~~successfully implement~~ our ~~business~~current ~~strategy.~~product ~~Furthermore~~candidates, ~~replacing executive officers~~ and ~~key employees~~ may bein ~~difficult and may take an extended period of time because of~~ the ~~limited~~future ~~number~~rely ofon ~~individuals~~licensing inarrangements ~~our industry~~ with ~~the~~other ~~breadth~~third ofparties ~~skills and experience required to successfully develop, gain regulatory approval~~ for ~~and~~rights ~~commercialize our drug candidates. Competition~~ to ~~hire~~a ~~qualified~~substantial ~~personnel~~portion inof our ~~industry~~ isdiscovery ~~intense,~~capabilities and weproduct ~~may be unable to hire~~candidates, ~~train,~~including ~~retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies~~ for ~~similar~~CR-001 ~~personnel. We also experience competition for the hiring of scientific~~ and ~~clinical personnel from universities and research institutions~~CR-002. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.

WeOur ~~expect~~current ~~to expand~~or ~~our~~future ~~development~~collaborations or licensing arrangements may not be successful, and ~~regulatory~~any ~~capabilities~~success will depend heavily on the efforts and ~~potentially~~activities ~~implement~~of ~~sales~~such collaborators or licensors. If any of our current or future collaborators or licensors experiences delays in performance of, ~~marketing~~or ~~and~~fails ~~distribution~~to ~~capabilities~~perform, ~~and~~its asobligations aunder ~~result~~their agreement with us, disagrees with our interpretation of the terms of such agreement, or terminates their agreement with us, our programs could be adversely affected. If we ~~may~~fail ~~encounter~~to ~~difficulties~~comply with any of the obligations under our current or future collaborations or license agreements, including payment terms and diligence terms, such as requirements to use commercially reasonable efforts to develop and commercialize products covered by the licensed intellectual property rights in ~~managing~~our respective territory, our ~~growth~~current or future collaborators or licensors may have the right to terminate such agreements, in which ~~could~~event ~~disrupt~~we ~~our~~may ~~operations.~~ lose intellectual property rights and may not be able to develop,

As our development progresses, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of research, drug development, regulatory affairs and, if any of our drug candidates receives marketing approval, sales, marketing and distribution. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations. 42

32manufacture, market, or sell the products covered by our agreements or may face other penalties under our agreements. Our current or future collaborators and licensors may also fail to properly maintain or defend the intellectual property we have licensed from them, if required by our agreement with them, or even infringe upon, our intellectual property rights, leading to the potential invalidation of our intellectual property or subjecting us to litigation or arbitration, any of which would be time-consuming and expensive and could harm our ability to commercialize our product candidates. In addition, our current or future collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our programs and products if the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours.

~~Table~~As part of ~~Contents~~our strategy, we plan to evaluate additional opportunities to enhance our capabilities and expand our development pipeline or provide development or commercialization capabilities that complement ours. We may not realize the benefits of such collaborations or licensing arrangements. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing shareholders, or disrupt our management and business.

~~Our~~We ~~employees~~ may ~~engage~~face significant competition in ~~misconduct~~attracting appropriate collaborators, and more established companies may also be pursuing strategies to license or acquire third-party intellectual property rights that we consider attractive. These companies may have a competitive advantage over us due to their size, financial resources, and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Whether we reach a definitive agreement for a collaboration will depend upon, among other ~~improper~~things, ~~activities~~our assessment of the collaborator’s resources and expertise, ~~including~~the ~~non~~terms and conditions of the proposed collaboration, and the proposed collaborator’s evaluation of a number of factors. Collaborations are complex and time-~~compliance~~consuming ~~with~~to ~~regulatory standards~~negotiate, document, and ~~requirements~~execute. In addition, consolidation among large pharmaceutical and biotechnology companies has reduced the number of potential future collaborators. We may not be able to negotiate additional collaborations on a timely basis, on acceptable terms or at all. If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our product candidates or bring them to market.

We ~~are~~currently ~~exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA regulations~~rely, ~~to provide accurate information to the FDA, to comply with manufacturing standards we have established, to comply with federal~~ and ~~state~~plan ~~healthcare fraud and abuse laws and regulations,~~ to ~~report~~rely ~~financial information or data accurately or to disclose unauthorized activities to us. In particular, sales, marketing and business arrangements~~ in the ~~healthcare~~future, ~~industry~~on ~~are~~third ~~subject~~parties to ~~extensive~~conduct ~~laws~~ and ~~regulations~~support ~~intended~~our topreclinical ~~prevent~~studies ~~fraud, kickbacks, self-dealing~~ and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical trials~~, which could result in regulatory sanctions and serious harm to our reputation~~. ~~Effective~~If ~~upon~~these ~~the~~third ~~completion~~parties ofdo ~~this~~not ~~offering,~~properly ~~we will adopt a code of business conduct~~ and ~~ethics,~~successfully ~~but~~carry itout istheir ~~not~~contractual ~~always~~duties ~~possible~~or tomeet ~~identify~~expected ~~and deter employee misconduct~~deadlines, ~~and the precautions~~ we ~~take to detect and prevent improper activities~~ may not be ~~effective~~able ~~in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure~~ to beobtain inregulatory ~~compliance~~approval ~~with~~of ~~such laws~~ or ~~regulations.~~commercialize ~~If any such actions are instituted against us, and we are not successful in defending ourselves or asserting~~ our ~~rights,~~product ~~those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions~~candidates.

~~Risks~~We ~~Related~~have utilized and plan to ~~this~~continue ~~Offering~~to utilize and depend upon independent investigators and collaborators, ~~Ownership~~such as medical institutions, CROs, contract testing labs, and strategic partners, to conduct and support our preclinical studies and clinical trials under agreements with us. We will rely heavily on these third parties over the course of ~~Our~~our ~~Common~~preclinical ~~Stock~~studies and ~~Our~~clinical ~~Status~~trials, asand we control only certain aspects of their activities. As a ~~Public~~result, ~~Company~~we will have less direct control over the conduct, timing, and completion of these preclinical studies and clinical trials and the management of data developed through preclinical studies and clinical trials than would be the case if we were relying entirely upon our own staff. Nevertheless, we are responsible for ensuring that each of our studies and trials is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. We and our third-party contractors and CROs are required to comply with GCP regulations, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for all of our programs in clinical development. If we or any of these third parties fail to comply with applicable GCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving any marketing applications we may submit. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations. In addition, our clinical trials must be conducted with products produced under cGMP regulations or similar foreign requirements. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

~~An active trading market for our common stock may not develop and you may not be able to resell your shares of our common stock at or above the initial offering price, if at all.~~ 43

~~Prior~~Any tothird ~~this~~parties ~~offering,~~conducting ~~there~~our ~~has~~clinical ~~been~~trials nowill ~~public~~not ~~market~~be our employees and, except for remedies available to us under our ~~common~~agreements ~~stock.~~with ~~The~~such ~~initial~~third ~~public~~parties, ~~offering~~we ~~price~~cannot ~~for~~ control whether they devote sufficient time and resources to our ~~common~~programs. ~~stock~~These ~~will~~third parties may be ~~determined~~involved ~~through~~in ~~negotiations~~mergers, ~~with~~acquisitions, ~~the~~or ~~underwriters~~similar transactions and may ~~not~~have relationships with other commercial entities, including our competitors, for whom they may also be ~~indicative~~conducting ofclinical ~~the~~trials ~~price~~or atother product development activities, which ~~our~~could ~~common~~negatively ~~stock~~affect ~~will~~their ~~trade~~performance ~~upon~~on ~~the~~our ~~completion~~behalf ofand ~~this~~the ~~offering.~~timing ~~Although~~thereof weand ~~have~~could ~~applied~~lead to ~~list~~products ~~our~~that ~~common~~compete ~~stock~~directly onor ~~The NASDAQ~~indirectly ~~Global~~with ~~Market,~~our anproduct ~~active~~candidates. ~~trading~~In ~~market~~addition, principal investigators for our ~~shares~~clinical trials may ~~never~~be ~~develop~~asked to serve as scientific advisors or beconsultants ~~sustained~~to ~~following~~us ~~this~~from ~~offering~~time to time and may receive cash or equity compensation in connection with such services. If anthese ~~active~~relationships ~~market~~and ~~for~~any ~~our~~related ~~common~~compensation ~~stock~~result ~~does~~in ~~not~~perceived ~~develop~~or actual conflicts of interest, or isthe ~~not~~FDA ~~sustained~~concludes that the financial relationship may have affected the interpretation of the study, itthe integrity of the data generated at the applicable clinical trial site may be ~~difficult~~questioned ~~for~~and ~~you~~the toutility ~~sell~~of ~~shares~~the ~~you purchased~~clinical trial itself may be jeopardized, which could result in ~~this~~the ~~offering~~delay ator anrejection ~~attractive~~by ~~price,~~the ifFDA atof ~~all~~any application we submit. Any such delay or rejection could prevent us from commercializing our product candidates.

~~The~~In ~~trading~~addition, ~~price~~our ofCROs have the ~~shares~~right to terminate their agreements with us in the event of an uncured material breach and under other specified circumstances. If any of our ~~common~~relationships ~~stock~~with these third parties terminate, we may not be ~~volatile~~able to enter into arrangements with alternative third parties on commercially reasonable terms or at all. Switching or adding additional CROs, investigators and ~~purchasers of~~other third parties involves additional cost and requires our ~~common~~management’s ~~stock~~time ~~could~~and ~~incur~~focus. ~~substantial~~In ~~losses~~addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we work to carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

~~Our~~If ~~stock~~these ~~price~~third ~~may~~parties bedo ~~volatile.~~not ~~The~~successfully ~~stock~~carry ~~market~~out intheir ~~general~~contractual ~~and~~duties ~~the~~or ~~market~~obligations ~~for biopharmaceutical~~or ~~companies~~meet inexpected ~~particular~~deadlines, ~~have~~if ~~experienced~~they ~~extreme~~need ~~volatility~~to ~~that~~be ~~has~~replaced ~~often~~or ~~been~~if ~~unrelated to~~ the ~~operating~~quality ~~performance~~or accuracy of ~~particular~~the ~~companies.~~clinical Asdata athey ~~result~~obtain ofis ~~this~~compromised ~~volatility,~~due ~~investors~~to ~~may~~the ~~not~~failure beto ~~able~~adhere to ~~sell~~our ~~their~~clinical ~~common~~protocols ~~stock~~or at regulatory requirements or ~~above~~for ~~the~~other ~~price~~reasons, ~~paid~~our ~~for~~clinical ~~the~~trials ~~shares.~~may ~~The~~be ~~market~~extended, ~~price~~delayed, ~~for~~or ~~our~~terminated ~~common~~and ~~stock~~we may not be ~~influenced~~able byto ~~many~~complete ~~factors~~development of, ~~including:~~obtain regulatory approval of, or successfully commercialize our product candidates.

nWe ~~announcements~~rely ~~relating~~on tothird ~~development,~~parties ~~regulatory~~who ~~approvals~~operate orin ~~commercialization~~China, ofwhich ~~our~~may ~~drug~~expose ~~candidates;~~us to additional risks.

nIn ~~actual~~addition, orwe ~~anticipated~~currently ~~variations~~rely inon foreign CROs and CMOs, including WuXi Biologics (Hong Kong) Limited (“WuXi”) for CR-001 and CR-002, for formulation and manufacturing of our ~~operating~~stage ~~results~~1 clinical trial materials, and will likely continue to rely on foreign CROs and CMOs in the future. Kelun is also based in China. On December 18, 2025, President Trump signed into law the National Defense Authorization Act of 2026 (“NDAA”), which includes § 851 often referred to as “the BIOSECURE Act”. Under the BIOSECURE Act, U.S. government agencies cannot (1) buy or obtain biotechnology equipment or services provided by a “biotechnology company of concern” (“BCC”); (2) enter into, extend, or renew a contract with any entity using biotechnology equipment or services provided by a BCC; or (3) expend loan or grant funds for biotechnology equipment or services provided by a BCC, whether directly or through a loan or grant recipient. The BIOSECURE Act does not bar a U.S. company from all federal contracts or grants simply because it does business with a BCC. The restriction applies only when a federal contract or grant would procure covered biotechnology equipment or services—directly or indirectly—from a designated company. While WuXi is not currently listed as a BCC, earlier BIOSECURE drafts explicitly named it as a BCC. Additionally, on December 18, 2025, the chairmen of multiple Senate and House committees, including the House Select Committee on China, sent a letter to the Department of Defense recommending that WuXi be added to the Department of Defense’s 1260H list, which would make WuXi a BCC.

nHowever, ~~changes~~there inare ~~financial~~certain ~~estimates~~safe byharbors, uswaivers, and exceptions to the BIOSECURE Act. The BIOSECURE Act provides a five-year safe harbor for existing contracts with companies later designated as BCCs under the 1260H or OMB lists. The five-year window begins when the Federal Acquisition Regulations (“FAR”) are updated to implement the Act’s requirements, allowing entities five years to fulfill current contracts, transition to alternative suppliers, and wind down business with BCCs. This safe harbor is unavailable for existing contracts with companies named on the 1260H list as of December 18, 2025. Further, “biotechnology equipment or services” excludes items previously, but no longer, produced by ~~any~~BCCs. ~~securities~~Therefore, ~~analysts~~an ~~who~~entity ~~might~~may ~~cover~~retain ~~our~~and ~~stock;~~continue to use equipment or

~~n conditions or trends in our industry;~~44

ntechnology ~~changes~~produced inby ~~laws~~a orBCC ~~other~~prior ~~regulatory~~to ~~actions~~the ~~affecting~~BIOSECURE usAct’s orenactment. ~~our~~Additionally, ~~industry;~~the Act allows drug manufacturers to remain eligible for the Medicare and Medicaid Drug Part B Rebate Programs if the BIOSECURE Act restrictions are the only reason they cannot enter the VA master agreement required by the Veterans Health Care Act of 1992 (38 U.S.C. § 8126). Finally, the head of an executive agency may waive the Act’s restrictions for up to 365 days, with approval of the Director of the OMB. This waiver can be renewed once for an additional 180 days.

nForeign ~~stock~~CMOs ~~market~~may ~~price~~be subject to U.S. legislation, including the BIOSECURE Act, trade restrictions, and ~~volume~~other ~~fluctuations~~foreign regulatory requirements which could increase the cost or reduce the supply of ~~comparable~~material ~~companies~~available ~~and~~to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies. For example, in ~~particular~~April 2025, ~~those~~the ~~that~~United ~~operate~~States government imposed significant tariffs on imports from China and other countries and may impose more restrictions on goods, including biologically derived substances, manufactured in or imported from China or impose other restrictions on companies’ ability to work with Chinese biotech companies. Certain of these tariffs have gone into effect. There remains substantial uncertainty regarding future tariff rates and the ~~biopharmaceutical~~countries ~~industry;~~and products to which such tariffs would apply. To the extent these or future tariffs are applicable to the material we import from China and other countries, our financial condition could be adversely affected.

nFurther, ~~announcements~~the biopharmaceutical industry in China is strictly regulated by usthe Chinese government. Changes to Chinese regulations or government policies affecting biopharmaceutical companies are unpredictable and may have a material adverse effect on our ~~competitors~~collaborators in China which could have an adverse effect on our business, financial condition, results of ~~significant~~operations, ~~acquisitions~~and prospects. Evolving changes in China’s public health, ~~strategic~~economic, ~~partnerships~~political, and social conditions and the uncertainty around China’s relationship with other governments, such as the United States and the UK, could also negatively impact our ability to manufacture our product candidates for our planned clinical trials or ~~divestitures;~~have an adverse effect on our ability to secure government funding, which could adversely affect our financial condition and cause us to delay our clinical development programs. Furthermore, if any of our China-based collaborators or vendors—including WuXi—are designated a BCC under the BIOSECURE Act, our operations and financial condition could be adversely affected by delays or higher costs stemming from U.S. federal restrictions on contracts, grants, and loans involving BCCs, as well as other applicable foreign regulatory requirements. In addition, while we have established relationships with CROs and CMOs outside of China, moving to those suppliers in the event of a geopolitical instability affecting our collaborators in China could introduce delays into our development programs.

nWe ~~announcements~~currently rely and expect to rely in the future on the use of ~~investigations~~manufacturing sites in third-party facilities or ~~regulatory~~on ~~scrutiny~~third ofparties to manufacture our ~~operations~~product candidates, and we may rely on third parties to produce and process our products, if approved. Our business could be adversely affected if we are unable to use third-party manufacturing suites or ~~lawsuits~~if ~~filed~~the ~~against~~third-party ~~us;~~manufacturers encounter difficulties in production.

nWe ~~capital~~do ~~commitments;~~not currently own any facility that may be used as our clinical or commercial manufacturing and processing facility and must currently rely on CMOs to manufacture our product candidates. We have not yet caused any product candidates to be manufactured on a commercial scale and may not be able to do so for any of our product candidates, if approved. We currently have a sole source relationship for our supply of the CR-001 and CR-002 programs, and expect to have a sole source relationship for the supply of the CR-003 program. If there should be any disruption in such supply arrangements, including any adverse events affecting our sole supplier, it could have a negative effect on the clinical development of our programs and other operations while we work to identify and qualify an alternate supply source. We may not control the manufacturing process of, and may be completely dependent on, our contract manufacturing partners for compliance with cGMP requirements and any other regulatory requirements of the FDA or comparable foreign regulatory authorities for the manufacture of our product candidates. Beyond periodic audits, we have limited control over the ability of our CMOs to maintain adequate quality control, quality assurance, and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any approval in the future, we may need to find alternative manufacturing facilities, which would require the incurrence of significant additional costs, delays, and materially adversely affect our ability to develop, obtain regulatory approval for, or market our product candidates, if approved. Similarly, our failure, or the failure of our CMOs, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates

~~n investors’ general perception of our company and our business;~~45

nor ~~disputes~~drugs, ~~concerning~~operating restrictions, and criminal prosecutions, any of which could significantly and adversely affect supplies of our ~~intellectual~~product ~~property~~candidates or ~~other~~drugs ~~proprietary~~and ~~rights;~~harm our business and results of operations.

nMoreover, ~~recruitment~~our CMOs may experience manufacturing difficulties due to resource constraints, supply chain issues, or ~~departure~~as a result of ~~key~~labor ~~personnel;~~disputes or unstable political environments. If any CMOs on which we will rely fail to manufacture quantities of our product candidates at quality levels necessary to meet regulatory requirements and at a scale sufficient to meet anticipated demand at a cost that allows us to achieve profitability, our business, financial condition, and prospects could be materially and adversely affected. In addition, our CMOs are responsible for transporting temperature-controlled materials that can be inadvertently degraded during transport due to several factors, rendering certain batches unsuitable for trial use for failure to meet, among others, our integrity and purity specifications. We and any of our CMOs may also face product seizure or detention or refusal to permit the import or export of products. Our business could be materially adversely affected by business disruptions to our third-party providers that could materially adversely affect our anticipated timelines, potential future revenue and financial condition, and increase our costs and expenses. Each of these risks could delay or prevent the completion of our preclinical studies and clinical trials or the approval of any of our product candidates by the FDA, result in higher costs or adversely impact commercialization of our product candidates

nRisks ~~sales~~Related ofto ~~our~~Employee ~~common stock~~Matters, ~~including~~Managing ~~sales~~Growth byand ~~our~~Other ~~directors~~Risks ~~and~~Related ~~officers~~to orOur ~~specific~~Business ~~stockholders.~~

33In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth.

~~Table~~We expect to experience significant growth in the number of ~~Contents~~our employees and the scope of our operations, particularly in the areas of preclinical and clinical drug development, technical operations, clinical operations, regulatory affairs, and, potentially, sales and marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational, and financial personnel and systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team working together in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

InWe ~~addition,~~are inhighly ~~the~~dependent ~~past,~~on ~~stockholders~~our ~~have~~key ~~initiated~~personnel ~~class~~and ~~action~~anticipate ~~lawsuits~~hiring ~~against~~new ~~pharmaceutical~~key ~~and~~personnel. ~~biotechnology companies~~If ~~following~~we ~~periods~~are ofnot ~~volatility~~successful in ~~the~~attracting ~~market~~and ~~prices~~retaining ofhighly ~~these~~qualified ~~companies’ stock. Such litigation~~personnel, ifwe ~~instituted~~may ~~against~~not ~~us,~~be ~~could~~able ~~cause us~~ to ~~incur~~successfully ~~substantial~~implement ~~costs and divert management’s attention and resources from~~ our business. strategy.

IfWe ~~equity~~are ~~research~~a ~~analysts~~clinical dostage ~~not~~biotechnology ~~publish~~company ~~research~~with ora ~~reports,~~limited oroperating ~~publish~~history, ~~unfavorable~~and, ~~research~~as orof ~~reports~~December 31, ~~about~~2025, uswe had 44 full-time employees. We have been and will continue to be highly dependent on the research and development, ~~our~~clinical and business or development expertise of our ~~market~~executive officers, as well as the other principal members of our ~~stock~~management, ~~price~~scientific and ~~trading~~clinical ~~volume~~team. ~~could~~Any ~~decline~~of our management team members may terminate their employment with us at any time. We do not maintain “key person” insurance for any of our executives or other employees.

~~The~~Attracting ~~trading~~and ~~market~~retaining ~~for~~qualified ~~our~~personnel ~~common stock~~ will also be ~~influenced~~critical byto ~~the~~our ~~research~~success, ~~and reports~~including ~~that~~with ~~equity~~respect ~~research~~to ~~analysts~~any ~~publish~~strategic ~~about~~transaction usthat ~~and~~we ~~our~~may ~~business~~pursue. WeThe doloss ~~not~~of ~~currently~~the ~~have,~~services ~~and~~of ~~may~~our ~~never~~executive ~~obtain,~~officers ~~research~~or ~~coverage~~other bykey ~~equity~~employees ~~research~~could ~~analysts.~~impede ~~Equity~~the ~~research~~achievement ~~analysts~~of ~~may~~our ~~elect~~research, ~~not~~development, toand ~~provide~~commercialization ~~research~~objectives ~~coverage~~and ofseriously harm our ~~common stock~~ability ~~after~~to ~~the~~successfully ~~completion~~implement ofour ~~this~~business ~~offering~~strategy. Furthermore, ~~and~~replacing ~~such~~executive ~~lack~~officers ofand ~~research~~key ~~coverage~~employees may ~~adversely~~be ~~affect~~difficult ~~the~~and ~~market~~may ~~price~~take ofan ~~our~~extended ~~common~~period ~~stock.~~of Intime ~~the~~because ~~event~~of wethe dolimited ~~have~~number ~~equity~~of ~~research~~individuals ~~analyst~~in ~~coverage,~~our weindustry ~~will~~with ~~not have any control over~~ the ~~analysts~~breadth ~~or the~~of ~~content~~skills and ~~opinions~~experience ~~included~~required into ~~their~~successfully ~~reports.~~develop, ~~The~~facilitate ~~price~~regulatory approval of, ~~our~~and ~~stock~~commercialize ~~could~~product ~~decline~~candidates. ifCompetition ~~one~~to orhire ~~more~~from ~~equity~~this ~~research~~limited ~~analysts~~pool ~~downgrade~~is ~~our~~intense, ~~stock~~and orwe ~~issue~~may ~~other~~be ~~unfavorable~~unable ~~commentary~~to orhire, ~~research.~~train, Ifretain, ~~one~~ or ~~more~~motivate ~~equity~~these ~~research~~key ~~analysts~~personnel ~~ceases coverage~~on ofacceptable ~~our~~terms ~~company~~given orthe ~~fails~~competition toamong ~~publish~~numerous ~~reports~~pharmaceutical onand usbiotechnology ~~regularly,~~companies ~~demand~~ for ~~our~~similar ~~stock~~personnel. ~~could~~We ~~decrease,~~also ~~which~~experience incompetition ~~turn~~for ~~could~~the ~~cause~~hiring ~~our~~of ~~stock~~scientific ~~price~~and orclinical ~~trading~~personnel ~~volume~~from touniversities ~~decline~~and research institutions.

IfIn ~~you~~addition, ~~purchase~~we ~~shares~~rely ofon ~~our~~consultants ~~common~~and ~~stock~~advisors, inincluding ~~this~~scientific ~~offering~~and clinical advisors, ~~you~~to ~~will~~assist ~~suffer~~us ~~immediate~~in ~~dilution~~formulating ofour ~~your~~discovery ~~investment~~and nonclinical and clinical development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory

We expect the initial public offering price of our common stock to be substantially higher than the net tangible book value per share of our common stock. Therefore, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our pro forma as adjusted net tangible book value per share after this offering. Based on an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, you will experience immediate dilution of $ per share, representing the difference between our pro forma as adjusted net tangible book value per share after this offering and the assumed initial public offering price. 46

Incontracts ~~addition,~~with asother ofentities ~~June 30,~~that ~~2013,~~may welimit ~~had~~their ~~outstanding~~availability ~~stock options~~ to ~~purchase~~us. anIf ~~aggregate~~we ofare ~~4,876,698~~unable ~~shares~~to ofcontinue ~~common~~to ~~stock~~attract ~~at a weighted average exercise price of $0.37 per share~~ and ~~warrants~~retain tohigh ~~purchase an~~quality ~~aggregate of 2~~personnel,~~097,625~~ ~~shares~~our ofability ~~common~~to ~~stock~~pursue atour agrowth ~~weighted~~strategy ~~average exercise price of $0.12 per share. To the extent these outstanding options and warrants are exercised, there~~ will be ~~further dilution to investors in this offering~~limited.

AOur ~~significant~~future ~~portion~~growth ofmay ~~our~~depend, ~~total~~in ~~outstanding shares are restricted from immediate resale~~part, ~~but~~on ~~may~~our beability ~~sold~~to ~~into~~operate ~~the market~~ in ~~the~~foreign ~~near~~markets, ~~future.~~where ~~This~~we ~~could cause~~would ~~the~~be ~~market~~subject ~~price of our common stock~~ to ~~drop~~additional ~~significantly,~~regulatory ~~even~~burdens ifand ~~our~~other ~~business~~risks isand ~~doing well~~uncertainties.

~~Sales~~Our offuture agrowth ~~substantial~~may ~~number~~depend, ofin ~~shares~~part, of on our ~~common~~ability ~~stock~~to develop and commercialize our product candidates in ~~the~~foreign ~~public~~markets for which we may rely on collaboration with third parties. We are not permitted to market ~~could~~or ~~occur~~promote atany of our product candidates before we receive regulatory approval from the applicable foreign regulatory authority, and may never receive such regulatory approval for any ~~time~~of our product candidates. IfTo obtain separate regulatory approval in many other countries, we must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales, pricing and distribution of our ~~stockholders~~product ~~sell~~candidates, orand ifwe cannot predict success in these jurisdictions. If we fail to comply with the ~~market~~regulatory ~~perceives~~requirements ~~that~~in international markets and receive applicable regulatory approvals, our ~~stockholders~~target ~~intend~~market will be reduced and our ability to ~~sell~~realize the full market potential of our product candidates will be harmed and our business will be adversely affected. Moreover, ~~substantial~~even ~~amounts~~if we obtain approval of our ~~common~~product ~~stock~~candidates and ultimately commercialize our product candidates in ~~the~~foreign ~~public~~markets, ~~market~~we ~~following~~would ~~this~~be ~~offering~~subject to the risks and uncertainties, including the ~~market~~ ~~price~~burden of ~~our~~complying ~~common~~with ~~stock~~complex ~~could~~and ~~decline~~changing ~~significantly~~foreign regulatory, tax, accounting, and legal requirements and reduced protection of intellectual property rights in some foreign countries.

~~Upon~~Our ~~the~~estimates ~~completion~~ of ~~this~~market ~~offering,~~opportunity ~~we will have outstanding shares of common stock, assuming no exercise of outstanding options or warrants. Of these shares, the shares sold in this offering~~ and ~~additional~~ ~~shares~~forecasts ~~will be freely tradable, additional shares~~ of ~~common stock will be eligible for sale in the public~~ market ~~beginning~~growth 90may ~~days~~prove ~~after the date of this prospectus, subject~~ to ~~volume,~~be ~~manner of sale and other limitations of Rule 144 and Rule 701~~inaccurate, and ~~additional~~ ~~shares~~even ~~of common~~if ~~stock~~the ~~will~~markets ~~be available for sale~~ in ~~the~~which ~~public~~we ~~market~~compete ~~beginning~~achieve ~~180 days after~~ the ~~date~~forecasted ofgrowth, ~~this prospectus following the expiration of lock-up agreements between some of~~ our ~~stockholders~~business ~~and the underwriters. The representatives of the underwriters~~ may ~~release~~not ~~these~~grow ~~stockholders from their lock-up agreements with the underwriters~~ at ~~any~~similar ~~time~~rates, ~~which~~or ~~would~~at ~~allow for earlier sales of shares in the public market~~all.

InOur ~~addition,~~market ~~promptly~~opportunity ~~following~~estimates ~~the~~and ~~completion~~growth offorecasts ~~this~~are ~~offering,~~subject weto ~~intend~~significant touncertainty ~~file~~and ~~one~~are orbased ~~more~~on ~~registration~~assumptions ~~statements~~and onestimates ~~Form~~which ~~S-8~~may ~~registering~~not ~~the~~prove ~~issuance~~to ofbe ~~approximately shares~~accurate. ofOur ~~common~~estimates ~~stock~~and ~~subject~~forecasts relating to ~~options~~size orand ~~other~~expected ~~equity~~growth ~~awards~~of ~~issued~~our ortarget ~~reserved~~market ~~for~~may ~~future~~prove ~~issuance~~to ~~under~~be ~~our~~inaccurate. ~~equity incentive~~Even ~~plans.~~if ~~Shares~~the ~~registered~~markets ~~under~~in ~~these~~which ~~registration~~we ~~statements~~compete onmeet ~~Form~~our ~~S-8~~size ~~will~~estimates beand ~~available~~growth ~~for~~forecasts, ~~sale~~our inbusiness ~~the~~may ~~public~~not ~~market~~grow ~~subject~~at tosimilar ~~vesting~~rates, ~~arrangements~~or ~~and~~at ~~exercise~~all. ofOur ~~options~~growth is subject to many factors, ~~the~~including ~~lock-up~~our ~~agreements~~success ~~described~~in ~~above~~implementing ~~and~~our ~~the~~business ~~restrictions of~~strategy, ~~Rule~~which ~~144~~is insubject ~~the~~to ~~case~~many ofrisks ~~our~~and ~~affiliates~~uncertainties.

~~Additionally,~~Our ~~after~~revenue ~~this~~will ~~offering~~be dependent, in part, upon the ~~holders~~size of anthe ~~aggregate~~markets ofin 33the territories for which we gain regulatory approval,~~714~~ the accepted price for the product,~~229~~ ~~shares~~the ofability ~~our~~to ~~common~~obtain ~~stock~~coverage and ~~2,097,625 shares~~ reimbursement and whether we own the commercial rights for that territory. If the number of our ~~common~~addressable ~~stock~~patients ~~issuable~~is ~~upon~~not as significant as we estimate, the ~~exercise~~indication ofapproved ~~outstanding~~by ~~warrants~~regulatory authorities is narrower than we expect or the treatment population is narrowed by competition, physician choice, or ~~their~~treatment ~~transferees~~guidelines, ~~will~~we may not generate significant revenue from sales of such products, even if approved.

34Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

~~Table~~We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers, and vendors acting for or on our behalf may engage in misconduct or other improper activities. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of ~~Contents~~unauthorized activities to us that violate: (i) the laws and regulations of the FDA and other comparable foreign regulatory requirements, including those laws that require the reporting of true, complete and accurate information to such authorities, (ii) manufacturing standards, including cGMP requirements or similar foreign requirements, (iii) federal and state data privacy, security, fraud and abuse and other healthcare laws and regulations in the United States and abroad, (iv) laws that require the true, complete and accurate reporting of financial information or data, or (v) laws that prohibit insider trading. Activities subject to these laws also involve the improper use or misrepresentation of information obtained in the course of clinical trials, the creation of fraudulent data in our or our collaborators’ preclinical studies or clinical trials, or illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting

have rights, subject to some conditions, to require us to file one or more registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. If we were to register the resale of these shares, they could be freely sold in the public market. If these additional shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline. 47

~~Provisions~~us from governmental investigations or other actions or lawsuits stemming from a failure to be in ~~our~~compliance ~~corporate~~with ~~charter~~such ~~documents~~laws ~~and~~or ~~under~~regulations. ~~Delaware~~In ~~law~~addition, ~~may~~we ~~prevent~~are subject to the risk that a person or ~~frustrate~~government ~~attempts~~could by allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our ~~stockholders~~rights, tothose ~~change~~actions could have a significant impact on our ~~management~~business and ~~hinder~~financial ~~efforts~~results, toincluding, ~~acquire~~without alimitation, ~~controlling~~the ~~interest~~imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in usMedicare, Medicaid and ~~the~~other ~~market~~federal ~~price~~healthcare programs, imprisonment, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws and curtailment of our ~~common~~operations, ~~stock~~any ~~may~~of bewhich ~~lower~~could asadversely aaffect ~~result.~~our business, financial condition, results of operations and prospects.

~~There~~Our ~~are~~internal ~~provisions~~information intechnology ~~our~~systems, ~~certificate~~or those of ~~incorporation~~any ~~and~~of ~~bylaws~~our asCROs, ~~they~~manufacturers, ~~will~~other becontractors inor ~~effect~~consultants, ~~following this offering that may make it difficult for a~~ third -party toservice ~~acquire~~providers, or ~~attempt~~potential tofuture ~~acquire~~collaborators, ~~control~~may offail ~~our company,~~or ~~even~~suffer ifsecurity aor ~~change~~data inprivacy ~~control~~breaches ~~was~~or ~~considered favorable by you and~~ other ~~stockholders.~~unauthorized ~~For~~or ~~example,~~improper ~~our~~access ~~board of directors will have the authority~~ to ~~issue up to 5~~,~~000,000~~ ~~shares~~use of, ~~preferred~~or ~~stock.~~destruction ~~The board~~ of ~~directors~~our ~~can~~proprietary ~~fix~~or ~~the~~confidential ~~price~~data, ~~rights,~~ ~~preferences~~employee data, ~~privileges and restrictions of the preferred stock without any further vote~~ or ~~action~~personal bydata, ~~our~~which ~~stockholders.~~could ~~The~~result ~~issuance of shares of preferred stock may delay or prevent a change~~ in ~~control~~additional ~~transaction.~~costs, Asloss aof ~~result~~revenue, ~~the~~significant ~~market price~~liabilities, ofharm to our ~~common~~brand, ~~stock~~ and ~~the~~material ~~voting~~disruption ~~and other rights~~ of our ~~stockholders may be adversely affected~~operations. ~~An issuance of shares of preferred stock may result in the loss of voting control to other stockholders.~~

~~Our~~In ~~charter~~the ~~documents~~ordinary ~~will~~course ~~also~~of ~~contain~~our ~~other~~business, ~~provisions~~we ~~that~~and ~~could~~the ~~have~~third anparties ~~anti-takeover~~upon ~~effect~~which we rely collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, process) proprietary, confidential, and sensitive data, including: personal data, intellectual property, trade secrets, and other sensitive data (collectively, sensitive information).

nDespite ~~only~~the ~~one~~implementation of security measures in an effort to protect systems that store our ~~three~~information, ~~classes~~given their size and complexity and the increasing amounts of ~~directors~~information ~~will~~maintained beon ~~elected~~our ~~each~~internal ~~year;~~information technology systems and those of our third-party CROs, other contractors (including sites performing our clinical trials), third-party service providers and supply chain companies, and consultants, these systems are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war, and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by malicious third parties, which may compromise our system infrastructure or lead to the loss, destruction, alteration or dissemination of, or damage to, our data.

nSome ~~stockholders~~actors ~~will~~now ~~not~~engage beand ~~entitled~~are expected to ~~remove~~continue ~~directors~~to engage in cyber-attacks, including, without limitation, nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other ~~than~~major byconflicts, we, and the third parties upon which we rely, may be vulnerable to a 66heightened ~~2/3%~~risk ~~vote~~of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and ~~only~~operations, supply chain, and ability to produce, sell, and distribute our goods and services. In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in our operations, ability to provide our products or services, loss of sensitive data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for ~~cause;~~example, applicable laws or regulations prohibiting such payments.

nTo ~~stockholders~~the ~~will~~extent that any disruption or security breach were to result in loss, destruction, unavailability, alteration or dissemination of, or damage to, our data or applications, or for it to be believed or reported that any of these occurred, we could incur liability and reputational damage and the development and commercialization of our product candidates could be delayed. Further, our insurance policies may not be ~~permitted~~adequate to ~~take~~compensate ~~actions~~us byfor ~~written~~the ~~consent;~~potential losses arising from any such disruption in, or failure or security breach of, our systems or third-party systems where information important to our business operations or commercial development is stored.

nCertain ~~stockholders~~members ~~cannot~~of ~~call~~our aworkforce ~~special~~are ~~meeting~~remote, ofwhich ~~stockholders;~~may create additional risks for our information technology systems and data because our employees who work remotely utilize network connections, computers, and devices working at home, while in transit and in public locations. Additionally, business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.

~~n stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings.~~48

InWhile ~~addition,~~ we ~~are~~have ~~subject~~implemented security measures designed to ~~the~~protect ~~anti-takeover~~against ~~provisions~~security ofincidents, ~~Section 203~~there ofcan ~~the~~be ~~Delaware~~no ~~General~~assurance ~~Corporation~~that ~~Law,~~these ~~which~~measures ~~regulates~~will ~~corporate~~be ~~acquisitions~~effective. ~~by prohibiting~~We ~~Delaware~~may ~~corporations~~be ~~from~~unable ~~engaging~~in the future to detect vulnerabilities in ~~specified~~our ~~business~~information ~~combinations~~technology ~~with~~systems ~~particular~~because ~~stockholders~~such ofthreats ~~those~~and ~~companies.~~techniques ~~These~~change ~~provisions~~frequently, ~~could~~are ~~discourage~~often ~~potential~~sophisticated ~~acquisition~~in ~~proposals~~nature, and ~~could~~may ~~delay~~not orbe ~~prevent~~detected until after a ~~change~~security inincident ~~control transaction~~has occurred. ~~They~~Further, ~~could~~we ~~also~~may ~~have~~experience ~~the~~delays ~~effect~~in ofdeveloping ~~discouraging~~and ~~others~~deploying ~~from~~remedial ~~making~~measures ~~tender~~designed ~~offers~~to ~~for~~address ~~our~~any ~~common~~such ~~stock,~~identified ~~including~~vulnerabilities. ~~transactions~~Applicable ~~that~~data ~~may~~privacy beand insecurity ~~your~~obligations ~~best~~may ~~interests.~~require ~~These~~us ~~provisions~~to ~~may~~notify ~~also~~relevant ~~prevent~~stakeholders ~~changes~~of insecurity ~~our~~incidents. ~~management~~Such ordisclosures ~~limit~~are costly, and the ~~price~~ ~~that~~disclosure ~~investors~~or ~~are~~the ~~willing~~failure to ~~pay~~comply ~~for~~with ~~our~~such ~~stock~~requirements could lead to adverse consequences.

~~Concentration~~We ofrely ~~ownership~~on third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts. Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If our ~~common~~third-party ~~stock~~service ~~among~~providers experience a security incident or other interruption, we could experience adverse consequences. While we may be entitled to damages if our ~~existing~~third-party ~~executive~~service ~~officers~~providers fail to satisfy their privacy or security-related obligations to it, ~~directors~~ ~~and~~any ~~principal~~award ~~stockholders~~may be insufficient to cover our damages, or we may ~~prevent~~be ~~new~~unable ~~investors~~to ~~from~~recover ~~influencing~~such ~~significant~~award. ~~corporate~~In ~~decisions~~addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised.

~~Upon~~If ~~the~~we ~~completion~~(or ofa ~~this offering,~~third ~~our~~party ~~executive~~upon ~~officers,~~whom ~~directors~~we ~~and~~rely) ~~current~~experiences ~~beneficial~~a ~~owners~~security ofincident 5% or ~~more~~is ofperceived ~~our~~to ~~common~~have ~~stock~~experienced ~~and~~a ~~their~~security ~~respective~~incident, ~~affiliates~~we ~~will,~~may inexperience ~~the~~adverse ~~aggregate~~consequences, ~~beneficially~~such ~~own~~as ~~approximately %~~government ~~of our~~enforcement ~~outstanding~~actions ~~common~~(for ~~stock.~~example, ~~Further~~investigations, ~~funds~~fines, ~~controlled~~penalties, byaudits, ~~one~~and ~~investor,~~inspections); ~~New~~additional ~~Enterprise~~reporting ~~Associates,~~requirements and/or ~~NEA,~~oversight; ~~will~~restrictions ~~own %~~on ofprocessing ~~our~~sensitive ~~common~~information ~~stock.~~(including Aspersonal adata); ~~result,~~litigation ~~NEA~~(including ~~will~~class beclaims); ~~able~~indemnification toobligations; ~~control,~~negative ~~and~~publicity; ~~these~~reputational ~~other persons,~~harm; ~~acting~~monetary ~~together,~~fund ~~will~~diversions; beinterruptions ~~able~~in toour ~~significantly~~operations ~~influence,~~(including ~~all~~availability ~~matters~~of ~~requiring~~data); ~~stockholder~~financial ~~approval,~~loss; ~~including~~and ~~the~~other ~~election~~similar harms. Security incidents and ~~removal~~attendant ofconsequences ~~directors,~~may ~~any~~cause ~~merger,~~stakeholders ~~consolidation~~(including investors and potential customers) to stop supporting our platform, ~~sale~~deter ofnew ~~all~~customers orfrom ~~substantially~~products, ~~all~~and ofnegatively impact our ~~assets~~ability orto ~~other significant~~grow ~~corporate~~and ~~transactions~~operate our business.

~~Some~~Our ofcontracts ~~these~~may ~~persons~~not orcontain ~~entities~~limitations ~~may~~of ~~have~~liability, ~~interests~~and ~~different~~even ~~than~~where ~~yours.~~they ~~For example~~do, ~~because~~there ~~many~~can be no assurance that limitations of ~~these stockholders~~liability ~~purchased~~in ~~their~~our ~~shares~~contracts atare ~~prices~~sufficient ~~substantially~~to ~~below~~protect ~~the~~us ~~price~~from atliabilities, ~~which~~damages, ~~shares~~or ~~are~~claims ~~being~~related ~~sold~~to inour ~~this~~data ~~offering~~privacy and ~~have~~security ~~held~~obligations. ~~their~~We ~~shares~~cannot ~~for~~be asure ~~longer~~that ~~period,~~our ~~they~~insurance ~~may~~coverage will be ~~more~~adequate ~~interested~~or insufficient ~~selling~~to ~~our~~protect ~~company~~us from or to anmitigate ~~acquirer~~liabilities ~~than~~arising ~~other investors~~out of our privacy and security practices, orthat ~~they~~such ~~may~~coverage ~~want~~will uscontinue to ~~pursue~~be ~~strategies~~available ~~that~~on ~~deviate~~commercially ~~from~~reasonable ~~the~~terms ~~interests~~or ofat ~~other~~all, ~~stockholders~~or that such coverage will pay future claims.

35We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines and sanctions, private litigation, and/or adverse publicity and could negatively affect our operating results and business.

~~Table~~We and third parties who we work with are or may become subject to numerous domestic and foreign laws, regulations, and standards relating to privacy, data protection, and data security, the scope of ~~Contents~~which is changing, subject to differing applications and interpretations, and may be inconsistent among countries, or conflict with other rules. We are or may become subject to the terms of contractual obligations related to privacy, data protection, and data security. Our obligations may also change or expand as our business grows. The actual or perceived failure by us or third parties related to us to comply with such laws, regulations, and obligations could increase our compliance and operational costs, expose us to regulatory scrutiny, actions, fines, and penalties, result in reputational harm, lead to a loss of customers, result in litigation and liability, and otherwise cause a material adverse effect on our business, financial condition, and results of operations.

WeIf ~~are~~we anfail ~~“emerging~~to ~~growth~~comply ~~company~~with environmental,” health and assafety alaws ~~result~~and ofregulations, ~~the~~we ~~reduced~~could ~~disclosure~~become ~~and~~subject ~~governance requirements~~to ~~applicable~~fines toor ~~emerging~~penalties ~~growth~~or ~~companies,~~incur ~~our~~costs ~~common~~that ~~stock~~could ~~may~~have bea ~~less~~material ~~attractive~~adverse toeffect ~~investors~~on the success of our business.

We are ansubject ~~“emerging~~to ~~growth company”~~numerous asenvironmental, ~~defined~~health, inand ~~the~~safety ~~Jumpstart~~laws ~~Our~~and ~~Business~~regulations, ~~Startups~~including ~~Act~~those ofgoverning ~~2012,~~laboratory orprocedures and the ~~JOBS~~handling, ~~Act~~use, ~~and~~storage, wetreatment, ~~intend~~and todisposal ~~take advantage~~ of ~~some~~hazardous ofmaterials ~~the~~and ~~exemptions~~wastes. ~~from~~Our ~~reporting~~operations ~~requirements~~may ~~that~~involve ~~are~~the ~~applicable~~use toof ~~other~~hazardous ~~public~~and ~~companies~~flammable ~~that~~materials, ~~are~~including ~~not~~chemicals ~~emerging growth~~and ~~companies,~~biological ~~including:~~and

n being permitted to provide only two years 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;49

nradioactive ~~not~~materials. ~~being~~In ~~required~~addition, we may incur substantial costs in order to comply with ~~the~~current ~~auditor~~or ~~attestation~~future ~~requirements~~environmental, inhealth ~~the~~and ~~assessment~~safety oflaws, and regulations. These current or future laws and regulations may impair our ~~internal~~research, ~~control~~development, ~~over~~or ~~financial~~commercialization ~~reporting;~~efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties, or other sanctions.

nWe ~~not being required to comply with any requirement that~~ may be ~~adopted~~subject byto ~~the~~adverse ~~Public~~legislative ~~Company Accounting Oversight Board regarding mandatory audit firm rotation~~ or aregulatory ~~supplement~~tax tochanges ~~the~~that ~~auditor’s~~could ~~report~~negatively ~~providing~~impact ~~additional~~our ~~information about the audit and the~~ financial ~~statements;~~condition.

nThe ~~reduced~~rules ~~disclosure~~dealing ~~obligations~~with ~~regarding~~U.S. ~~executive~~federal, ~~compensation;~~state, and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which may have retroactive application) could adversely affect our shareholders or us. We assess the impact of various tax reform proposals and modifications to existing tax treaties in all jurisdictions where we have operations to determine the potential effect on our business and any assumptions we have made about our future taxable income. We cannot predict whether any specific proposals will be enacted, the terms of any such proposals or what effect, if any, such proposals would have on our business if they were to be enacted. For example, the United States enacted the Inflation Reduction Act of 2022 (“IRA”), which implements, among other changes, a 1% excise tax on certain stock buybacks. In addition, beginning in 2022, the Tax Cuts and Jobs Act eliminated the previously available option to deduct research and development expenditures and requires taxpayers to amortize them generally over five years for research activities conducted in the United States and over 15 years for research activities conducted outside the United States. On July 4, 2025, the U.S. Congress enacted the One Big Beautiful Bill Act, which includes provisions that allow for the immediate expensing of domestic U.S. research and development expenses, a general requirement to reduce the deduction for research and development expense by any research credit taken, and other changes to the U.S. taxation of profits derived from foreign operations. The impact of this newly enacted law on our tax position will depend on how the provision is implemented and interpreted by the Internal Revenue Service and other regulatory authorities. In addition, we have no assurance as to whether, when and how this provision may be subject to further amendment or repeal. Such changes, among others, may adversely affect our effective tax rate, results of operation, and general business condition.

nWe ~~not~~may ~~being~~acquire ~~required~~businesses toor ~~hold~~products, aor ~~non-binding~~form ~~advisory~~strategic ~~vote~~alliances, onin ~~executive~~the ~~compensation~~future, orand ~~obtain~~may ~~stockholder~~not ~~approval~~realize ofthe ~~any~~benefits ~~golden~~of ~~parachute~~such ~~payments not previously approved~~acquisitions.

We ~~cannot~~may ~~predict~~acquire ifadditional ~~investors~~businesses ~~will~~or ~~find~~products, ~~our~~form ~~common~~strategic ~~stock~~alliances, ~~less~~or ~~attractive~~create ~~because~~joint weventures ~~will~~with ~~rely~~third onparties ~~these~~that ~~exemptions.~~we Ifbelieve ~~some investors~~will ~~find~~complement ~~our~~or ~~common~~augment ~~stock~~our ~~less~~existing ~~attractive~~business. asIf awe ~~result,~~acquire ~~there~~businesses ~~may~~with bepromising amarkets ~~less~~or ~~active~~technologies, ~~trading~~we ~~market for our common stock and our stock price~~ may not be ~~more~~able ~~volatile.~~to Werealize ~~may~~the ~~take~~benefit ~~advantage~~ of ~~these~~acquiring ~~reporting~~such ~~exemptions~~businesses ~~until~~if we are nounable ~~longer~~to ~~an emerging~~successfully ~~growth~~integrate ~~company.~~them Wewith ~~will~~our ~~remain~~existing anoperations ~~emerging~~and ~~growth~~ company ~~until~~culture. ~~the~~We ~~earlier~~may ofencounter ~~(1) the~~numerous ~~last~~difficulties ~~day~~in ofdeveloping, ~~the~~manufacturing, ~~fiscal~~and ~~year~~marketing ~~(a) following~~any ~~the~~new ~~fifth~~product ~~anniversary~~candidates ofor ~~the~~products ~~completion~~resulting offrom ~~this~~a ~~offering,~~strategic ~~(b) in~~alliance ~~which~~or weacquisition ~~have~~that ~~total~~delay ~~annual gross~~or ~~revenue~~prevent ofus atfrom ~~least~~realizing ~~$1.0~~their ~~billion~~expected benefits or ~~(c) in~~enhancing ~~which~~our webusiness. ~~are~~There ~~deemed~~is tono beassurance ~~a large accelerated filer~~that, ~~which~~following ~~means~~any ~~the~~such ~~market~~acquisition, ~~value~~we ofwill ~~our~~achieve ~~common~~the ~~stock~~synergies ~~that~~expected isin ~~held~~order byto ~~non-affiliates~~justify ~~exceeds $700 million as of~~ the ~~prior~~transaction, ~~June 30th and (2) the date on~~ which wecould ~~have~~result ~~issued~~in ~~more~~a ~~than~~material ~~$1.0~~adverse ~~billion~~effect inon ~~non-convertible~~our ~~debt~~business ~~during~~and ~~the prior three-year period~~prospects.

~~Under~~We ~~Section 107(b) of~~maintain ~~the~~our ~~JOBS~~cash ~~Act,~~at ~~emerging~~financial ~~growth~~institutions, ~~companies~~often ~~can~~in ~~delay~~balances ~~adopting~~that ~~new~~exceed orfederally-insured ~~revised accounting standards until such time as those standards apply to private companies~~limits. WeThe ~~have~~failure ~~irrevocably elected not to avail ourselves~~ of ~~this~~financial ~~exemption~~institutions ~~from~~could ~~new~~adversely oraffect ~~revised accounting~~our ~~standards~~ability ~~and, therefore, we will be subject~~ to ~~the~~pay ~~same~~our ~~new~~operational expenses or ~~revised~~make ~~accounting standards as~~ other ~~public companies that are not emerging growth companies~~payments.

Our cash held in non-interest-bearing and interest-bearing accounts exceeds the Federal Deposit Insurance Corporation (“FDIC”) insurance limits. If wesuch banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance limitations. For example, the FDIC took control of Silicon Valley Bank on March 10, 2023. The Federal Reserve subsequently announced that account holders would be made whole. However, the FDIC may not make all account holders whole in the event of future bank failures. In addition, even if account holders are ultimately made whole with respect to ~~maintain~~a ~~proper~~future bank failure, account holders’ access to their accounts and ~~effective~~assets ~~internal~~held ~~controls,~~in their accounts may be substantially delayed. Any material loss that we may experience in the future or inability for a material time period to access our cash could have an adverse effect on our ability to ~~produce~~pay ~~accurate~~our ~~financial~~operational ~~statements~~expenses onor amake ~~timely~~other ~~basis~~payments, which could beadversely ~~impaired~~affect our business.

After the completion of this offering, we will be subject to the reporting requirements of the Securities Exchange Act of 1934, the Sarbanes-Oxley Act and the rules and regulations of The NASDAQ Global Market. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal controls over financial reporting. Commencing with our fiscal year ending December 31, 2014, we must perform system and process evaluation and testing of our internal controls over financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting in our Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act. This will require that we incur substantial additional professional fees and internal costs to expand our accounting and finance functions and that we expend significant management efforts. Prior to this offering, we have never been required to test our internal controls within a specified period, and, as a result, we may experience difficulty in meeting these reporting requirements in a timely manner. 50

WeRisks ~~may~~Related ~~discover~~to ~~weaknesses~~Owning ~~in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements.~~ Our ~~internal~~Ordinary control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected. Shares

IfPreferred wedirectors ~~are~~elected ~~not~~by ~~able to comply with~~ the ~~requirements~~holders of ~~Section 404~~our ofSeries ~~the~~A ~~Sarbanes-Oxley~~Preferred ~~Act~~Shares inhave athe ~~timely manner,~~ability ~~or if we are unable~~ to ~~maintain~~control ~~proper~~or ~~and~~significantly ~~effective~~influence ~~internal~~all ~~controls,~~matters wesubmitted ~~may~~to ~~not~~our beboard ~~able~~of todirectors ~~produce~~for ~~timely~~approval. ~~and~~

36Pursuant to our Certificate of Designation of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Shares (the “Series A Certificate of Designation”), at all times when at least 30% of the originally issued Series A Preferred Shares remains issued and outstanding: (i) the holders of our Series A Preferred Shares, exclusively and voting together as a separate class on an as-converted to ordinary shares basis, are entitled to elect two preferred directors (the “Preferred Directors”); and (ii) the holders of our ordinary shares and of any other class or series of voting shares (including our Series A Preferred Shares), exclusively and voting together as a single class on an as-converted to ordinary shares basis, are entitled to elect the balance of the total number of directors of our board. Each Preferred Director is entitled to three votes on each matter presented to our board of directors.

~~Table~~Following the completion of ~~Contents~~the Merger, Peter Harwin and Jonathan Violin were elected as the two Preferred Directors by the holders of our Series A Preferred Shares. These two directors, in the aggregate, have six votes on each matter presented to the board of directors, representing 60% of the total votes of the board. As a result, these two Preferred Directors are able to control or significantly influence all matters submitted to our board of directors for approval, including business plans and policies and the appointment and removal of our officers. The holders of our Series A Preferred Shares thereby have influence with respect to the composition of our board of directors and, to the extent they influence the actions of the Preferred Directors, if at all, actions of our board of directors. An affiliate of Fairmount is the sole holder of our Series A Preferred Shares. Mr. Harwin is a Managing Member at Fairmount, and Dr. Violin is a Venture Partner at Fairmount.

~~accurate~~The ~~financial~~decision ~~statements~~to enter into or amend any Paragon Option Agreement (or similar agreements) or license agreement with Paragon is subject to the approval of our board of directors. IfAs noted above, our board of directors includes two Preferred Directors that ~~were~~are affiliated with and elected by Fairmount. As a result, Fairmount may exert influence on the decisions of our board of directors and management, including as it relates to ~~happen~~the Paragon Option Agreements and decisions to exercise options or enter into license agreements thereunder, which interests may differ from the ~~market~~interests ~~price~~of our shareholders given Fairmount’s interest in both us and Paragon, and indirect interest in Parascent. All directors of our ~~stock~~board ~~could~~of ~~decline~~directors owe fiduciary duties pursuant to Cayman Islands law, and weare ~~could~~expected beto ~~subject~~comply with their respective fiduciary duties under Cayman Islands law relevant to ~~sanctions~~related orparty ~~investigations~~transactions. byIn ~~NASDAQ~~addition, we have adopted a related party transaction approval policy pursuant to which the ~~SEC~~Audit Committee of our board of directors is responsible for the review, consideration, and approval or ~~other~~ratification ~~regulatory authorities.~~of related party transactions.

We ~~will~~are ~~have~~governed ~~broad~~by ~~discretion~~Cayman inIslands ~~the~~law, ~~use of proceeds from this offering~~ and ~~may~~certain ~~invest~~provisions orof ~~spend~~our ~~the~~Articles ~~proceeds~~of inAssociation ~~ways~~have ~~with~~anti-takeover ~~which you do not agree and in ways that may not increase the value of your investment~~implications.

WeOur ~~will~~organizational ~~have~~documents ~~broad~~are ~~discretion~~governed ~~over~~by ~~the~~Cayman ~~use~~Islands oflaw, ~~proceeds~~and ~~from~~certain ~~this offering.~~provisions ~~You~~in ~~may not agree with~~ our ~~decisions,~~Articles ~~and our use~~ of ~~the~~Association ~~proceeds~~ may ~~not~~discourage, ~~yield~~delay, ~~any~~or ~~return~~prevent ona ~~your~~merger, ~~investment.~~acquisition, Weor ~~expect~~other tochange ~~use~~in ~~the~~control ~~net proceeds to us from this offering to conduct clinical trials~~ of ~~GMI-1271, to fund~~ the ~~research~~company ~~and development~~that ofshareholders ~~our~~may ~~preclinical~~consider ~~pipeline~~favorable, including ~~drug~~transactions ~~discovery,~~in ~~and~~which ~~for~~our ~~working~~ordinary ~~capital~~shareholders ~~and~~might ~~general~~otherwise ~~corporate~~receive ~~purposes.~~a ~~Our~~premium ~~failure~~price tofor ~~apply~~their ~~the~~ordinary ~~net~~shares. ~~proceeds~~These ~~from~~provisions ~~this offering effectively~~ could ~~compromise~~also ~~our~~limit ~~ability~~the toprice ~~pursue~~that ~~our~~investors ~~growth strategy~~might ~~and~~be wewilling ~~might~~to ~~not~~pay bein ~~able~~the tofuture ~~yield~~for aour ~~significant~~ordinary ~~return~~shares, ifthereby ~~any,~~depressing onthe ~~our~~market ~~investment~~price of ~~these~~our ~~net~~ordinary ~~proceeds~~shares. In addition, ~~the~~because ~~net~~our ~~proceeds~~board ~~from~~of ~~this~~directors ~~offering~~is ~~may~~responsible ~~not~~for beappointing ~~sufficient~~the ~~for~~members of our ~~anticipated~~management ~~uses~~team, ~~and~~these weprovisions may ~~need~~frustrate ~~additional~~or ~~resources to~~prevent ~~progress~~any ~~our~~attempts ~~drug~~by ~~candidates~~any shareholders to ~~the~~replace ~~stage~~or weremove ~~expect.~~our ~~You~~current ~~will~~management ~~not~~by ~~have~~making ~~the~~it ~~opportunity~~more todifficult ~~influence~~for ~~our~~shareholders ~~decisions~~to onreplace ~~how~~members toof ~~use~~ our ~~net~~board ~~proceeds~~of ~~from~~directors. ~~this~~Among ~~offering.~~other things, these provisions:

~~Because~~•provide wefor doa ~~not~~classified ~~anticipate~~board ~~paying~~of ~~any~~directors ~~cash~~such ~~dividends~~that onnot ~~our~~all ~~common~~members ~~stock~~of inour ~~the~~board ~~foreseeable future, capital appreciation, if any, will be your sole source~~ of ~~gains~~directors ~~and~~are ~~you~~elected ~~may~~at ~~never~~one ~~receive~~time; ~~a return on your investment.~~

~~You~~•allow ~~should~~the ~~not~~authorized ~~rely~~number onof andirectors ~~investment in our common stock~~ to ~~provide~~be ~~dividend~~changed ~~income.~~only Weby ~~have~~resolution ~~not~~of ~~declared or paid cash dividends on~~ our ~~common~~board ~~stock~~of ~~to date. We currently intend to retain our future earnings~~directors, ifsubject ~~any,~~ to ~~fund~~ the ~~development~~terms ~~and growth~~ of ~~our business. In addition,~~ the ~~terms~~Certificate of ~~any~~Designation ~~future debt agreements may preclude us from paying dividends. As a result, capital appreciation, if any,~~ of our ~~common~~Series ~~stock~~A ~~will~~Preferred beShares ~~your~~(the ~~sole~~“Certificate ~~source~~ of ~~gain~~Designation”); ~~for the foreseeable future. Investors seeking cash dividends should not purchase our common stock.~~

~~We will incur increased costs and demands upon management as a result of being a public company.~~ 51

As•limit ~~a public company listed in~~ the ~~United~~manner States, we will incur significant additional legal, accounting and other costs. These additional costs could negatively affect our financial results. In addition, changing laws, regulations and standards relating to corporate governance and public disclosure, including regulations implemented by the SEC and The NASDAQ Stock Market, may increase legal and financial compliance costs and make some activities more time consuming. These laws, regulations and standards are subject to varying interpretations and, as a result, their application in ~~practice~~which ~~may~~shareholders ~~evolve~~can ~~over~~remove ~~time~~directors as new guidance is provided by regulatory and governing bodies. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from ~~revenue-generating activities to compliance activities. If we do not comply with new laws, regulations and standards, regulatory authorities may initiate legal proceedings against us and~~ our ~~business~~board ~~may~~of bedirectors; ~~harmed.~~

~~Failure~~•provide tofor ~~comply with~~advance ~~these~~notice ~~rules~~requirements ~~might~~for ~~also~~nominations ~~make it more difficult~~ for uselection to ~~obtain~~the ~~some~~board ~~types~~ of ~~insurance,~~directors ~~including director and officer liability insurance, and we might be forced to accept reduced policy limits and coverage~~ or ~~incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult~~ for usproposing tomatters ~~attract~~that ~~and~~can ~~retain~~be ~~qualified~~acted ~~persons to serve~~ on ~~our~~at ~~board~~shareholder ofmeetings; ~~directors, on committees of our board of directors or as members of senior management.~~

37•limit who may call a general meeting of shareholders;

~~Table~~•authorize the board of ~~Contents~~directors to issue preferred shares without shareholder approval, which could be used to institute a “poison pill” that would work to dilute the share ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and

~~SPECIAL~~•require ~~NOTE~~a ~~REGARDING~~special ~~FORWARD~~resolution passed by the affirmative vote of not less than two-~~LOOKING~~thirds ~~STATEMENTS~~of ~~AND~~the ~~INDUSTRY~~votes ~~DATA~~ cast at a general meeting to amend provisions of the Articles of Association.

~~This~~In ~~prospectus~~addition, ~~contains~~the ~~forward-looking~~Certificate ~~statements~~of ~~that~~Designation ~~involve~~relating ~~substantial~~to ~~risks~~our ~~and~~Series ~~uncertainties.~~A ~~The~~Preferred ~~forward-looking~~Shares ~~statements~~may ~~are~~delay ~~contained principally~~or inprevent ~~the~~a ~~sections~~change ~~entitled~~in ~~“Prospectus~~control. ~~Summary,”~~At ~~“Risk~~any ~~Factors,”~~time ~~“Management’s~~while ~~Discussion~~at ~~and~~least ~~Analysis~~30% of ~~Financial~~the ~~Condition~~originally ~~and~~issued ~~Results~~Series ofA ~~Operations”~~Preferred Shares remain issued and ~~“Business~~outstanding,” ~~but~~we ~~are~~may ~~also~~not ~~contained elsewhere~~consummate ina ~~this~~Fundamental ~~prospectus.~~Transaction In(as ~~some~~defined ~~cases,~~in ~~you~~the ~~can~~Certificate ~~identify~~of ~~forward-looking~~Designation) ~~statements~~or byany ~~the~~merger ~~words~~or ~~“may,”~~consolidation ~~“might,”~~with ~~“will,”~~or ~~“could,”~~into ~~“would,”~~another ~~“should,”~~entity ~~“expect,” “intend,”~~or ~~“plan,”~~any ~~“objective,”~~share ~~“anticipate,”~~sale ~~“believe~~to,” ~~“estimate,”~~or ~~“predict,”~~other ~~“project,”~~business ~~“potential,”~~combination ~~“continue”~~in ~~and~~which ~~“ongoing,”~~our orshareholders ~~the negative~~immediately ofbefore ~~these~~such ~~terms,~~transaction ordo ~~other~~not ~~comparable~~hold ~~terminology~~at ~~intended~~least toa ~~identify~~majority ~~statements~~of ~~about~~ the ~~future.~~share ~~These~~capital ~~statements~~immediately ~~involve~~after ~~known~~such ~~and unknown risks~~transaction, ~~uncertainties~~without ~~and~~the ~~other~~affirmative ~~factors~~vote ~~that~~of ~~may~~the ~~cause~~Preferred ~~our~~Directors, ~~actual~~acting ~~results~~together, ~~levels~~or ofa ~~activity, performance~~simple ormajority ~~achievements~~of tothe bethen ~~materially~~issued ~~different~~and ~~from~~outstanding ~~the~~Series ~~information~~A ~~expressed~~Preferred orShares. ~~implied~~This byprovision ~~these~~of ~~forward-looking~~the ~~statements.~~Certificate ~~Although~~of weDesignation ~~believe~~may ~~that~~make weit ~~have~~more adifficult ~~reasonable~~us ~~basis~~to ~~for~~enter ~~each~~into ~~forward-looking~~any ~~statement~~of ~~contained~~the inaforementioned ~~this prospectus~~transactions, weeven ~~caution~~potential ~~you~~change ~~that~~of ~~these~~control ~~statements~~transactions ~~are~~that ~~based~~could onoffer a ~~combination~~premium ofover ~~facts~~market ~~and~~value ~~factors~~to ~~currently~~the ~~known~~ordinary byshareholders, usas ~~and~~it ~~our~~would ~~expectations~~require the separate consent of the ~~future~~Preferred Directors, ~~about~~acting ~~which~~together, weor ~~cannot~~a besimple ~~certain.~~majority ~~Forward-looking~~of ~~statements~~the ~~include~~issued ~~statements~~and ~~about:~~ outstanding Series A Preferred Shares.

nOur Articles of Association designate the courts of the Cayman Islands as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our ~~plans~~shareholders, which could limit your ability to ~~develop~~obtain ~~and~~a ~~commercialize~~favorable judicial forum for disputes with us or our ~~glycomimetic~~directors, ~~drug~~officers ~~candidates;~~or other employees.

nOur Articles of Association provide that, unless we consent in writing to the selection of an alternative forum, the courts of the Cayman Islands shall have exclusive jurisdiction over any claim or dispute arising out of or in connection with our ~~ability~~Articles of Association or otherwise related in any way to ~~achieve~~each ~~anticipated~~shareholder’s ~~milestones~~shareholding ~~under~~in us, including, but not limited to: (i) any derivative action or proceeding brought on behalf of us; (ii) any action asserting a claim of breach of any fiduciary or other duty owed by any of our ~~collaboration~~current ~~with~~or ~~Pfizer~~former ~~for~~directors, officers or other employees to us or our ~~drug~~shareholders; ~~candidate~~(iii) ~~GMI-1070~~any action asserting a claim arising pursuant to any provision of the Companies Act or our Articles of Association; or (iv) any action asserting a claim against us governed by the internal affairs doctrine (as such concept is recognized under the laws of the United States of America) and that each shareholder irrevocably submits to the exclusive jurisdiction of the courts of the Cayman Islands over all such claims or disputes. The forum selection provision in our Articles of Association does not apply to actions or suits brought to enforce any liability or duty created by the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, or any claim for which the federal district courts of the United States of America are, as a matter of the laws of the United States of America, the sole and exclusive forum for determination of such a claim.

nOur Articles of Association also provide that, without prejudice to any other rights or remedies that we may have, each of our ~~planned~~shareholders ~~clinical~~acknowledges ~~trials~~that damages alone would not be an adequate remedy for ~~our~~any ~~drug~~breach ~~candidate~~of ~~GMI-1271;~~the selection of the courts of the Cayman Islands as exclusive forum and that accordingly we are entitled, without proof of special damages, to the remedies of injunction, specific performance, or other equitable relief for any threatened or actual breach of the selection of the courts of the Cayman Islands as exclusive forum.

nThis ~~the~~choice ~~timing~~ of forum provision may increase a shareholder’s cost and ~~our~~limit the shareholder’s ability to ~~obtain~~bring ~~and~~a ~~maintain~~claim ~~regulatory~~in ~~approvals~~a judicial forum that it finds favorable for disputes with us or our ~~drug~~directors, ~~candidates;~~officers, or other employees, which may discourage lawsuits against us and our directors, officers, and other employees. Any person or entity purchasing or otherwise acquiring any of our shares or other securities, whether by transfer, sale, operation of law, or otherwise, shall be deemed to have notice of and have irrevocably agreed and consented to these provisions. There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of

~~n the clinical utility of our drug candidates;~~52

nforum provisions in other companies’ memorandum and articles of association or other charter documents has been challenged in legal proceedings. It is possible that a court could find this type of provisions to be inapplicable or unenforceable, and if a court were to find this provision in our ~~commercialization~~Articles of Association to be inapplicable or unenforceable in an action, ~~marketing~~we ~~and~~may ~~manufacturing~~incur ~~capabilities~~additional costs associated with resolving the dispute in other jurisdictions, which could have adverse effect on our business and ~~strategy;~~financial performance.

nFuture sales of shares by existing shareholders could cause our ~~intellectual~~share ~~property~~price ~~position;~~to decline.

nIf our ~~ability~~shareholders sell, or indicate an intention to ~~identify~~sell, ~~additional~~substantial ~~drug~~amounts ~~candidates~~of ~~with~~our ~~significant~~ordinary ~~commercial~~shares ~~potential~~in the public market after legal restrictions on resale lapse, the trading price of our ordinary shares could decline. In addition, our ordinary shares that are ~~consistent~~subject ~~with~~to our ~~commercial~~outstanding ~~objectives;~~options will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements and Rules 144 and 701 under the Securities Act.

nWe ~~our~~do ~~estimates~~not ~~regarding~~anticipate ~~future~~that ~~revenues,~~we ~~expenses~~will ~~and~~pay ~~needs~~any ~~for~~cash ~~additional~~dividends ~~financing~~in the foreseeable future.

~~You~~We ~~should~~do ~~refer~~not toanticipate ~~the “Risk Factors” section of this prospectus for a discussion of important factors~~ that ~~may~~we ~~cause~~will ~~our~~pay ~~actual~~any ~~results~~cash todividends ~~differ~~in ~~materially~~the ~~from~~foreseeable ~~those expressed or implied by our forward-looking statements~~future. AsThe acurrent ~~result~~expectation ofis ~~these~~that ~~factors,~~ we ~~cannot assure you that the forward-looking statements in this prospectus~~ will ~~prove~~retain toour befuture ~~accurate. Furthermore~~earnings, if ~~our~~any, ~~forward-looking statements prove~~ to befund ~~inaccurate,~~ the ~~inaccuracy may~~development beand ~~material.~~growth ~~In light~~ of ~~the~~our ~~significant~~business. ~~uncertainties~~As ina ~~these~~result, ~~forward-looking~~capital ~~statements~~appreciation, ~~you~~if ~~should not regard these statements as a representation or warranty by us or~~ any, ~~other~~of ~~person~~our ~~that~~ordinary weshares will ~~achieve~~be ~~our~~your ~~objectives~~sole ~~and~~source ~~plans~~of ~~in any specified time frame~~gain, orif ~~at all. We undertake no obligation to publicly update~~ any ~~forward-looking statements~~, ~~whether~~for asthe aforeseeable ~~result of new information,~~ future ~~events or otherwise, except as required by law~~.

~~You~~Our ~~should~~executive ~~read~~officers, ~~this~~directors, ~~prospectus~~ and ~~the~~principal ~~documents~~shareholders ~~that we reference in this prospectus and~~ have ~~filed~~the asability ~~exhibits~~ to ~~the~~control ~~registration~~or ~~statement,~~significantly ofinfluence ~~which~~all ~~this prospectus~~matters issubmitted ato ~~part, completely and with the understanding that~~ our ~~actual~~shareholders ~~future~~for ~~results may be materially different from what we expect~~approval. ~~We qualify all of our forward-looking statements by these cautionary statements.~~

~~This~~Our ~~prospectus~~executive ~~includes~~officers, ~~statistical~~directors, and ~~other~~principal ~~industry~~shareholders ~~and~~beneficially ~~market~~own ~~data~~a ~~that~~significant wepercentage ~~obtained~~of ~~from~~our ~~industry~~outstanding ~~publications~~ordinary ~~and~~shares. ~~research~~As a result, ~~surveys~~if ~~and~~these ~~studies~~shareholders ~~conducted~~were ~~by third~~to ~~parties.~~choose ~~Industry~~to ~~publications~~act ~~and~~together, ~~third~~they ~~party~~would ~~research~~be able to control or significantly influence all matters submitted to our shareholders for approval, ~~surveys~~as ~~and~~well ~~studies~~as ~~generally~~our ~~indicate~~management ~~that~~and ~~their~~affairs. ~~information~~For ~~has~~example, ~~been~~these ~~obtained~~shareholders, ~~from~~if ~~sources~~they ~~believed~~choose to beact ~~reliable~~together, ~~although~~would ~~they~~control door ~~not~~significantly ~~guarantee~~influence the ~~accuracy~~election of directors and approval of any merger, consolidation, or ~~completeness~~sale of ~~such information~~all or substantially all of our assets. This concentration of voting power could delay or prevent our acquisition on terms that other shareholders may desire.

38If equity research analysts do not publish research or reports, or publish unfavorable research or reports about us, our business or our market, our share price and trading volume could decline.

~~Table~~The trading market for our ordinary shares will be influenced by the research and reports that equity research analysts publish about us and our business. Equity research analysts may elect to not provide research coverage of ~~Contents~~our ordinary shares, and such lack of research coverage may adversely affect the market price of our ordinary shares. If we do have equity research analyst coverage, we will not have any control over the analysts or the content and opinions included in their reports. The price of our ordinary shares could decline if one or more equity research analysts downgrade our shares or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of us or fails to publish reports on us regularly, demand for our ordinary shares could decrease, which in turn could cause our share price or trading volume to decline.

~~USE~~Our OFability ~~PROCEEDS~~to use Net Operating Loss (“NOL”) carryforwards and other tax attributes may be limited, including as a result of the Merger.

WeGlycoMimetics ~~estimate~~incurred ~~that~~losses ~~the~~during ~~net~~its ~~proceeds~~history, ~~from~~and ~~our~~we ~~issuance~~do not expect to become profitable in the near future and ~~sale~~may ~~of shares~~never achieve profitability. As of ~~our~~December ~~common~~31, ~~stock~~2024, inGlycoMimetics ~~this~~had ~~offering~~NOL ~~will~~carryforwards beof approximately $ 351.8 million, or and approximately $ 10.9 million ifof ~~the~~research ~~underwriters~~and ~~exercise~~development ~~their~~credits ~~option~~that may be used to ~~purchase~~offset ~~additional~~future ~~shares~~taxable income. GlycoMimetics had operating loss carryforwards of ~~common~~$351.8 ~~stock~~million ingenerated ~~full~~prior to 2018, ~~based~~which ~~upon~~will anexpire ~~assumed~~beginning ~~initial~~in ~~public~~2025 ~~offering~~if ~~price~~not utilized. Under current law, GlycoMimetics’ U.S. federal NOLs of $ ~~per~~351.8 ~~share~~million incurred in tax years beginning after December 31, ~~which~~2017 ismay be carried forward indefinitely, but the ~~midpoint~~deductibility of ~~the~~such ~~price~~NOL ~~range~~carryforwards ~~set~~is ~~forth~~limited onto 80% of taxable income. It is uncertain if and to what extent various states will conform to federal law. In addition, under Sections 382 and 383 of the ~~cover~~

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