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1、Table of ContentsAs filed with the Securities and Exchange Commission on April 3,2025 Registration No.333-284230 UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON,D.C.20549 FORM S-1/A(Pre-Effective Amendment No.2)REGISTRATION STATEMENTUNDERTHE SECURITIES ACT OF 1933 COEPTIS THERAPEUTICS HOLD

2、INGS,INC.(Exact name of registrant as specified in its charter)Delaware283498-1465952(State or other jurisdictionof incorporation)(Primary Standard IndustrialClassification Code Number)(I.R.S.EmployerIdentification No.)105 Bradford Road,Suite 420Wexford,Pennsylvania 15090724-934-6467(Address,includi

3、ng zip code and telephone number,including area code,of registrants principal executive offices)David MehalickChief Executive OfficerCoeptis Therapeutics Holdings,Inc.105 Bradford Road,Suite 420Wexford Pennsylvania 15090724-934-6467(Name,address,including zip code,and telephone number,including area

4、 code,of agent for service)_ Copy to:Denis Dufresne,Esq.Meister Seelig&Fein PLLC125 Park Avenue,7th FloorNew York,New York 10017Tel:(212)655-3500Fax:(212)655-3535 Approximate date of commencement of proposed sale to the public:From time to time after the effective date of this Registration Statement

5、.If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933,check the following box.If this Form is filed to register additional securities for an offering pursuant to Rule 462(b)under the Securities

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

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

8、ective registration statement for the same offering.Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,a smaller reporting company or an emerging growth company.See thedefinitions of“large accelerated filer,”“accelerated filer,”“sm

9、aller reporting company”and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large accelerated filerAccelerated filerNon-accelerated filerSmaller reporting company Emerging growth company If an emerging growth company,indicate by check mark if the registrant has elected not to use the exten

10、ded transition period for complying with any new or revised financial accountingstandards provided pursuant to Section 7(a)(2)(B)of the Securities Act.The registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant s

11、hall file a further amendmentwhich 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 theRegistration Statement shall become effective on such date as the Commission,acting pursuant t

12、o said Section 8(a),may determine.The information in this preliminary prospectus is not complete and may be changed.The selling stockholders may not sell these securities until the registration statement filed withthe Securities and Exchange Commission is effective.This preliminary prospectus is not

13、 an offer to sell these securities and it is not soliciting an offer to buy these securities in anystate or jurisdiction where the offer or sale is not permitted.Subject To Completion Dated:April 3,2025 PRELIMINARY PROSPECTUS Up to 3,919,349 shares of Common Stock by Selling Stockholders This prospe

14、ctus relates to the resale from time to time by the selling stockholders named in this prospectus(the“Selling Stockholders”)of up to 3,919,349 shares of our common stock,par value$0.0001 per share(“Common Stock”),which includes:(i)100,000 shares of Common Stock held directly or indirectly by Selling

15、 Stockholders that we have issued or may issue andsell to such Selling Stockholders,(ii)up to 3,737,472 shares of Common Stock that we have issued or may issue and sell to a Selling Stockholder,YA II PN,LTD.,a Cayman Islands exemptlimited company(“Yorkville”),from time to time pursuant to the Standb

16、y Equity Purchase Agreement(the“SEPA”),dated November 1,2024,entered into with Yorkville,which consists of(A)20,000 shares of Common Stock we issued to Yorkville in connection with the execution of the SEPA as partial consideration for its commitment to enter into the SEPA(the“CommitmentShares”)and(

17、B)up to 3,717,472 shares of Common Stock that may be issued to Yorkville pursuant to the SEPA and(iii)81,877 shares issued to Yorkville in connection with the partialconversion of an outstanding convertible note.We will not receive any proceeds from the sale of such shares of Common Stock by the Sel

18、ling Stockholders.However,we may receive up to$20,000,000 aggregate gross proceeds from sales of Common Stock we may elect to make to Yorkville pursuant to the SEPA prior to or after the date of this prospectus.See“SummaryOverviewStandby Equity Purchase Agreement”for a description of the SEPA and“Se

19、lling Stockholders”for additional information regarding Yorkville.We will bear all of the registration expenses incurred in connection with the registration of these shares of Common Stock.The Selling Stockholder will pay discounts,commissions,fees of underwriters,selling brokers or dealer managers

20、and similar expenses,if any,incurred for the sale of these shares of Common Stock.Unless otherwise noted,all share and per share data in this prospectus gives effect to the 1-for-20 reverse stock split of our common stock implemented on December 30,2024,whichcombined each twenty shares of the common

21、 stock issued and outstanding as of the close of business on December 30,2024 into one share and is based on 42,318,593 pre-reverse split shares ofcommon stock issued and outstanding as of December 30,2024.For more information about our reverse stock split,please see“Recent Developments”and“Descript

22、ion of Securities”below.The Selling Stockholders identified in this prospectus may offer the shares from time to time on terms to be determined at the time of sale through ordinary brokerage transactions orthrough any other means described in this prospectus under the caption“Plan of Distribution.”T

23、he shares may be sold at fixed prices,at prevailing market prices,at prices related to prevailingmarket prices or at negotiated prices.For more information on the Selling Stockholder,see the section entitled“Selling Stockholders.”We may amend or supplement this prospectus from time to time by filing

24、 amendments or supplements as required.You should read the entire prospectus and any amendments orsupplements carefully before you make your investment decision.Our Common Stock is listed on the Nasdaq Capital Market(“Nasdaq”)under the symbol“COEP”.On April 2,2025,the last reported sales price of ou

25、r Common Stock was$9.48 pershare.We are an“emerging growth company”as defined in Section 2(a)of the Securities Act and are subject to reduced public company reporting requirements.This prospectus complieswith the requirements that apply to an issuer that is an emerging growth company.Investing in ou

26、r securities involves a high degree of risk.See“Risk Factors”beginning on page 11 of this prospectus,as well as the other information contained in orincorporated by reference in this prospectus or in any accompanying prospectus supplement before making a decision to invest in our securities.Neither

27、the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy oraccuracy of this prospectus.Any representation to the contrary is a criminal offense.The date of this prospectus is _ _,2025.TABLE OF CONTENTS Page

28、About this Prospectus ii Cautionary Statement Regarding Forward-Looking Statements iii Prospectus Summary 1 The Offering 10 Risk Factors and Special Considerations 11 Use of Proceeds 29 Dividend Policy 29 Managements Discussion and Analysis of Financial Condition and Results of Operations 30 Busines

29、s 36 Management 42 Executive Compensation 49 Certain Relationships and Related Party Transactions 57 Security Ownership of Certain Stockholders and Management 58 Determination of Offering Price 59 Selling Stockholders 60 Plan of Distribution 62 Description of Capital Stock 64 Legal Matters 70 Expert

30、s 70 Where You Can Find More Information 70 Index to Financial Statements F-1 i About this Prospectus This prospectus is part of a registration statement on Form S-1 that we filed with the Securities and Exchange Commission(the“SEC”)using the“shelf”registration process.Underthis shelf registration p

31、rocess,the Selling Stockholders(or their pledgees,donees,transferees or other successors-in-interest)may,from time to time,sell or otherwise dispose of the securitiesdescribed in this prospectus in one or more offerings.We will not receive any proceeds from the sale by such Selling Stockholders of t

32、he securities offered by them described in this prospectus.This prospectus provides you with a general description of the shares of Common Stock that the Selling Stockholders may sell or otherwise dispose of.You should rely only on theinformation provided in this prospectus,as well as the informatio

33、n incorporated by reference into this prospectus and any applicable prospectus supplement.If there is any inconsistencybetween the information in this prospectus and any prospectus supplement,you should rely on the information provided in the prospectus supplement.Neither we nor the Selling Stockhol

34、dershave authorized anyone to provide you with any information or to make any representations other than those contained in this prospectus or any applicable prospectus supplement.Neither wenor the Selling Stockholders take responsibility for,and can provide no assurance as to the reliability of,any

35、 other information that others may give you.You should not assume that theinformation in this prospectus or any applicable prospectus supplement is accurate as of any date other than the date of the applicable document.Since the date of this prospectus and thedocuments incorporated by reference into

36、 this prospectus,our business,financial condition,results of operations and prospects may have changed.Neither we nor the Selling Stockholders willmake an offer to sell these securities in any jurisdiction where the offer or sale is not permitted.We may also provide a prospectus supplement or post-e

37、ffective amendment to the registration statement to add information to,or update or change information contained in,thisprospectus.You should read both this prospectus and any applicable prospectus supplement or post-effective amendment to the registration statement together with the information inc

38、orporatedby reference herein or therein.For information about the distribution of securities offered,please see“Plan of Distribution”below.You should carefully read both this prospectus and anyprospectus supplement,together with the additional information described in“Where You Can Find More Informa

39、tion”and“Incorporation of Certain Information by Reference”before youmake any investment decisions regarding the securities.You may obtain the information incorporated by reference into this prospectus without charge by following the instructions under theheadings“Where You Can Find More Information

40、”and“Incorporation of Certain Information by Reference.”This prospectus summarizes certain documents and other information,and we refer you to them for a more complete understanding of what we discuss in this prospectus.All of thesummaries are qualified in their entirety by the actual documents.In m

41、aking an investment decision,you must rely on your own examination of the Company and the terms of the offering andthe securities,including the merits and risks involved.We are not making any representation to any purchasers of the securities regarding the legality of an investment in the securities

42、 by such purchasers.You should not consider anyinformation in this prospectus to be legal,business or tax advice.You should consult your own attorney,business advisor or tax advisor for legal,business and tax advice regarding aninvestment in the securities.Unless the context indicates otherwise,refe

43、rences in this prospectus to the“Company,”“Coeptis”,“we,”“us,”“our”and similar terms refer to Coeptis Therapeutics Holdings,Inc.,and,where appropriate,its subsidiaries.ii CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This prospectus,any prospectus supplement and any related free writing

44、prospectus,including the information incorporated by reference herein and therein,contains or may containforward-looking statements within the meaning of Section 27A of the Securities Act of 1933,as amended(the“Securities Act”)and Section 21E of the Securities Exchange Act of 1934,asamended(the“Exch

45、ange Act”)that involve substantial risks and uncertainties.These forward-looking statements depend upon events,risks and uncertainties that may be outside of our control.All statements other than statements of historical fact are forward-looking statements.The words“anticipate,”“believe,”“continue,”

46、“could,”“estimate,”“expect,”“intends,”“may,”“might,”“plan,”“possible,”“potential,”“predict,”“project,”“should,”“would”and similar expressions may identify forward-looking statements,but the absence of these words does not mean that astatement is not forward-looking.Forward-looking statements include

47、,without limitation,our expectations concerning the outlook for our business,productivity,plans and goals for futureoperational improvements and capital investments,operational performance,future market conditions or economic performance and developments in the capital and credit markets and expecte

48、dfuture financial performance,as well as any information concerning possible or assumed future results of operations.Forward-looking statements involve a number of risks,uncertainties and assumptions,and actual results or events may differ materially from those projected or implied in thosestatement

49、s.Important factors that could cause such differences include,but are not limited to We may not be able to successfully implement our growth strategy on a timely basis or at all;We may have difficulties managing our anticipated growth,or we may not grow at all;We have a history of losses,we expect t

50、o incur losses in the future and we may not be able to achieve or maintain profitability;We may not be able to initiate and complete preclinical studies and clinical trials for our product candidates which could adversely affect our business;We may not be able to obtain and maintain the third-party

51、relationships that are necessary to develop,commercialize and manufacture some or all of our product candidates;We may encounter difficulties in managing our growth,which could adversely affect our operations;We may face difficulties in integrating the use of the NexGen AI Affiliates Network platfor

52、m,and even if successful such use may result in reputational and operational harm,andany difficulties in integrating or using such platform could adversely affect our operations;We need to obtain financing in order to continue our operations;The drug development and approval process is uncertain,tim

53、e-consuming and expensive;Competition in the biotechnology and pharmaceutical industries may result in competing products,superior marketing of other products and lower revenues or profits for us;Federal laws or regulations on drug importation could make lower cost versions of our future products av

54、ailable,which could adversely affect our revenues,if any;The regulatory approval process is costly and lengthy,and we may not be able to successfully obtain all required regulatory approvals;Healthcare reform measures could adversely affect our business;iii Protecting and defending against intellect

55、ual property claims may have a material adverse effect on our business;If we are not able to retain our current senior management team and our scientific advisors or continue to attract and retain qualified scientific,technical and business personnel,our business will suffer;We may not be able to ma

56、intain our listing on the Nasdaq Capital Market;and There is a substantial doubt about our ability to continue as a going concern.We caution you not to rely on forward-looking statements,which reflect current beliefs and are based on information currently available as of the date a forward-looking s

57、tatement ismade.Forward-looking statements set forth herein speak only as of the date of this prospectus or the documents incorporated by reference in this prospectus,as applicable.Forward-lookingstatements are not guarantees of performance.There can be no assurance that future developments affectin

58、g us will be those that we have anticipated.These forward-looking statements involvea number of risks,uncertainties(some of which are beyond our control)or other assumptions that may cause actual results or performance to be materially different from those expressed orimplied by these forward-lookin

59、g statements.Other sections of this prospectus and the documents incorporated by reference herein describe additional factors that could adversely affect ourbusiness,financial condition or results of operations.We believe these factors include,but are not limited to,those described or incorporated b

60、y reference under“Risk Factors”.Should one ormore of these risks or uncertainties materialize,or should any of our assumptions prove incorrect,actual results may vary in material respects from those projected in these forward-lookingstatements.These factors should not be construed as exhaustive and

61、should be read in conjunction with the other cautionary statements that are included or incorporated by reference in thisprospectus or any applicable prospectus supplement.We operate in a very competitive and rapidly changing environment.New risks emerge from time to time.It is not possible for ourm

62、anagement to predict all risks,nor can we assess the impact of all factors on our business or the extent to which any factor,or combination of factors,may cause actual results to differmaterially from those contained in any forward-looking statements we may make.We undertake no obligation to publicl

63、y update or review any forward-looking statement,whether as a result ofnew information or future developments,except as otherwise required by law.iv PROSPECTUS SUMMARY This summary highlights,and is qualified in its entirety by,the more detailed information and financial statements included elsewher

64、e in this prospectus.Because it is a summary,itmay not contain all of the information that may be important to you.To understand this offering fully,you should read this entire prospectus carefully,including the information referencedunder the heading“Risk Factors”and in our financial statements,tog

65、ether with any accompanying prospectus supplements.Unless otherwise indicated or the context otherwise requires,allreferences in this prospectus to“we,“us,”“our,”the“Company,”“Coeptis”and similar terms refer to Coeptis Therapeutics Holdings,Inc.Pursuant to the Merger(as described below)we acquired o

66、ur primary operating subsidiary,Coeptis Therapeutics,Inc.Such Merger was accounted for as a“reverse merger,”andCoeptis Therapeutics,Inc.was deemed to be the accounting acquirer in the Merger.Consequently,the assets and liabilities,historical operations and the financial statements prior to theMerger

67、 that are reflected in this prospectus are those of Coeptis Therapeutics,Inc.,and the consolidated financial statements after completion of the Merger include the assets and liabilitiesand operations of us and our subsidiaries.Unless otherwise noted,all share and per share data in this prospectus gi

68、ves effect to the 1-for-20 reverse stock split of our common stock implemented on December 30,2024,whichcombined each share of the common stock issued and outstanding as of the close of business on December 30,2024 into one share and is based on 42,318,593 pre-reverse split shares ofcommon stock iss

69、ued and outstanding as of December 30,2024,For more information about our reverse stock split,please see“Recent Developments”and“Description of Securities”below.Overview We are a biopharmaceutical and technology company.The biopharmaceutical division focuses on developing innovative cell therapy pla

70、tforms for cancer,autoimmune,and infectiousdiseases.Coeptis aims to advance treatment paradigms and improve patient outcomes through its cutting-edge research and development efforts.The technology division focuses on enhancingoperational capabilities through advanced technologies.This division feat

71、ures AI-powered marketing software and robotic process automation tools designed to optimize business processes andimprove overall efficiency.We were originally incorporated in the British Virgin Islands on November 27,2018,under the name Bull Horn Holdings Corp.On October 27,2022,we domesticated fr

72、om the BritishVirgin Islands to the State of Delaware,and on October 28,2022,in connection with the closing of the Merger(defined below),we changed our corporate name from Bull Horn Holdings Corp.to“Coeptis Therapeutics Holdings,Inc.”Prior to October 28,2022,we were a special purpose acquisition com

73、pany with no operations.On October 28,2022,we acquired our primary operating subsidiary,CoeptisTherapeutics,Inc.,through the merger of our wholly owned subsidiary with and into Coeptis Therapeutics,Inc.(the“Merger”),with Coeptis Therapeutics,Inc.continuing as the survivingcompany.As a result of the

74、Merger,we acquired the business of Coeptis Therapeutics,Inc.,which now continues its existing business operations as our wholly owned subsidiary.We now operate through our direct and indirect subsidiaries SNAP Biosciences Inc.and GEAR Therapeutics Inc.,each of which is majority owned,and Coeptis The

75、rapeutics,Inc.,Coeptis Pharmaceuticals,Inc.and Coeptis Pharmaceuticals,LLC,each of which is wholly owned.Collaborations for Product Development Research and Development We believe that there is significant market opportunity related to each of the assets we are currently pursuing.Set forth below is

76、a brief summary of our current target assets.Product Pipeline ProgramTarget IndicationPre-ClinicalPhase IPhase IIPhase IIICD38-GEAR-NKProtect CD38+NK Cells from destruction by anti-CD38monoclonal antibodies CD38-DiagnosticDiagnostic tool to analyze if cancer patients might beappropriate candidates f

77、or anti-CD38 mAB therapy SNAP-CAR PlatformSNAP-CAR cells co-administered with one or more antibodyadaptors Unmodified Natural Killer Cells Acute Myeloid Leukemia Unmodified Natural Killer Cells Acute Respiratory Diseases 1 License of Stem Cell Expansion Platform&Acquisition of Phase 1 Studies On Aug

78、ust 16,2023,we entered into an exclusive licensing arrangement(the“License Agreement”)with Deverra Therapeutics Inc.(“Deverra”),pursuant to which we completed theexclusive license of key patent families and related intellectual property related to a proprietary allogeneic stem cell expansion and dir

79、ected differentiation platform for the generation ofmultiple distinct immune effector cell types,including natural killer(NK)and monocyte/macrophages.The License Agreement provides us with exclusive rights to use the license patents andrelated intellectual property in connection with development and

80、 commercialization efforts in the defined field of use(the“Field”)of(a)use of unmodified NK cells as anti-viral therapeutic forviral infections,and/or as a therapeutic approach for treatment of relapsed/refractory AML and high-risk MDS;(b)use of Deverras cell therapy platform to generate NK cells fo

81、r the purpose ofengineering with Coeptis SNAP-CARs and/or Coeptis GEAR Technology;and(c)use of Deverras cell therapy platform to generate myeloid cells for the purpose of engineering with theCompanys current SNAP-CAR and GEAR technologies.In support of the exclusive license,the Company also entered

82、into with Deverra(i)an asset purchase agreement(the“APA”)pursuantto which we purchased certain assets from Deverra,including but not limited to two Investigational New Drug(IND)applications and two Phase 1 clinical trial stage programs(NCT04901416,NCT04900454)investigating infusion of DVX201,an unmo

83、dified natural killer(NK)cell therapy generated from pooled donor CD34+cells,in hematologic malignancies and viral infectionsand(ii)a non-exclusive sublicense agreement(the“Sublicense Agreement”),in support of the assets obtained by the exclusive license,pursuant to which the Company sublicensed fro

84、mDeverra certain assets which Deverra has rights to pursuant a license agreement(“FHCRC Agreement”)by and between Deverra and The Fred Hutchinson Cancer Research Center(“FHCRC”).As consideration for the Deverra transaction described above,we paid Deverra approximately$570,000 in cash,issued to Dever

85、ra 4,000,000 shares of the Companys common stockand assumed certain liabilities related to the ongoing clinical trials.In addition,in accordance with the terms of the Sublicense Agreement,the Company agreed to pay FHCRC certain specifiedcontingent running royalty payments and milestone payments unde

86、r the FHCRC Agreement,in each case to the extent such payments are triggered by the Companys development activities.Until December 2024 we operated under a Shared Services Agreement(“SSA”)with Deverra,which provided for Coeptis and Deverra to share resources and collaborate on thedevelopment of Coep

87、tis GEAR and SNAP-CAR platforms.The Company is continuing its development focus on both GEAR and SNAP-CAR,and will be considering prospective strategicpartners for such development.CD38 Therapeutic and Diagnostic;Vy-Gen Bio,Inc.In May 2021,we entered into two exclusive option agreements(the“CD38 Agr

88、eements”)relating to separate technologies(described below)designed to improve the treatment ofCD38-related cancers(e.g.,multiple myeloma,chronic lymphocytic leukemia,and acute myeloid leukemia)with Vy-Gen-Bio,Inc.(“Vy-Gen”),a majority-owned subsidiary of Vycellix,Inc.,aTampa,Florida-based private,i

89、mmune-centric discovery life science company focused on the development of transformational platform technologies to enhance and optimize next-generationcell and gene-based therapies,including T-cell and Natural Killer(NK)cell-based cancer therapies.In August 2021,we exercised those two options and

90、acquired a 50%ownership interest insuch technologies.In December 2021,we completed our purchase of the 50%ownership interest in the CD38-Diagnostic,and subsequently in November 2022 we completed our purchase ofthe 50%ownership interest for the CD38-GEAR-NK product candidate.In March 2025,the Company

91、 reached an agreement with Vy-Gen to license the exclusive worldwide development andcommercialization rights to the GEAR(Gene Edited Antibody Resistant)Cell Therapy Platform,representing a potential approach to modifying potent cancer-targeting immune cells tooptimize the likelihood of deep remissio

92、n in patients with hematologic malignancies and other cancers.The Company had previously held limited co-development rights to GEAR.As part ofthis exclusive GEAR license agreement,the Company committed to paying a$400,000 license fee by August 1,2025,along with other license fees,milestone and royal

93、ty payments in 2026 andbeyond.The CD38 Agreements relate to two separate Vy-Gen drug product candidates,as follows:-CD38-GEAR-NK.This Vy-Gen drug product candidate is designed to protect CD38+NK cells from destruction by anti-CD38 monoclonal antibodies,or mAbs.CD38-GEAR-NKis an autologous,NK cell-ba

94、sed therapeutic that is derived from a patients own cells and gene-edited to enable combination therapy with anti-CD38 mAbs.We believe CD38-GEAR-NK possesses the potential to minimize the risks and side effects from CD38-positive NK cell fratricide.While third party license or collaboration agreemen

95、ts are notrequired in order for Vy-Gen to develop the product to commercial use,potential strategic relationships will be considered on an ongoing basis as a potential strategy.No licensesor collaborations are currently being actively pursued.2 Market Opportunity.We believe CD38-GEAR-NK could potent

96、ially revolutionize how CD38-related cancers are treated,by protecting CD38+NK cells from destruction by anti-CD38 mAbs,thereby promoting the opportunity to improve the treatment of CD38-related cancers,including multiple myeloma,chronic lymphocytic leukemia,and acute myeloidleukemia.Multiple myelom

97、a is the first cancer indication targeted with CD38-GEAR-NK.Our intent is to seek regulatory approval in the 8 major markets comprised of the United States,theUK,Germany,Spain,France,Italy,China,and Japan.The total multiple myeloma market size in these 8 countries was$16.27 billion in 2019 and is ex

98、pected to increase modestlythrough 2030,according to DelveInsight.GEAR-NK Product Plan Overview.GEAR-NK is an autologous,gene-edited,natural killer cell-based therapeutic development platform that allows for modified NK cells to be co-administered with targeted mAbs,which,in the absence of the GEAR-

99、NK,would otherwise be neutralized by mAb therapy.GEAR-NK is a pre-clinical in vitro proof-of-conceptproduct with in vivo evaluations planned for 2023.Vy-Gen is actively engaged in the research and development of GEAR-NK,and through the joint steering committee,we areassessing market opportunities,in

100、tellectual property protection and potential regulatory strategy.No human clinical trials have been conducted for GEAR-NK but are planned for2025.-CD38-Diagnostic.This Vy-Gen drug product candidate is an in vitro diagnostic tool to analyze if cancer patients might be appropriate candidates for anti-

101、CD38 mAb therapy.CD38-Diagnostic is an in vitro screening tool that is intended to provide the ability to pre-determine which cancer patients are most likely to benefit from targeted anti-CD38 mAbtherapies,either as monotherapy or in combination with CD38-GEAR-NK.Our management believes that CD38-Di

102、agnostic also has the potential to develop as a platformtechnology beyond CD38,including to identify patients likely to benefit for broad range of mAb therapies across myriad indications.CD38-Diagnostic is a discovery-stage productthat is advancing towards pre-clinical activities.Vy-Gen is actively

103、engaged in the research and development of CD38-Diagnostic,and through the joint steering committee,andwe are assessing market opportunities,intellectual property protection and potential regulatory strategy are all areas of focus.No human clinical trials have been conducted forCD38-Diagnostic as th

104、e clinical study requirements are not yet defined.Market Opportunity.We believe CD38-Diagnostic provides opportunity to make more cost-effective medical decisions for the treatment of B cell malignancies with high CD38expression,including multiple myeloma,which may help to avoid unnecessary administ

105、ration of anti-CD38 therapies.CD38-Diagnostic is anticipated to reduce the number ofpatients that are subjected to ineffective therapy and to potentially result in significant savings to healthcare systems.CD38-Diagnostic is viewed as a potential in-vitro diagnostic for determining patient suitabili

106、ty and likelihood of positive treatment outcomes for CD38-GEAR-NK and/or CD38monoclonal antibody therapies.On September 28,2023,we received FDAs response to our 513(g)request for information submission pertaining to the classification of the CD38-Diagnostic.The CD38-Diagnostichas been designated a C

107、lass II type device.The confirmation of this classification is beneficial as were now better able to plan for and execute future development activities.In May 2021,we made initial payments totaling$750,000 under the CD38 Agreements,to acquire the exclusive options to acquire co-development rights wi

108、th respect to CD38-GEAR-NK and CD38-Diagnostic.On August 15,2021,we entered into amendments to each of the CD38 Agreements.In connection with the two amendments,we delivered to Vy-Gen promissorynotes aggregating$3,250,000 with maturity dates of December 31,2021,and made a cash payment of$1,000,000,u

109、pon which cash payment we exercised the two definitive option purchaseagreements.In December 2021,we completed our payment obligations to secure our rights to 50%of the net revenue stream related to the CD38-Diagnostic,and in November 2022 wecompleted our purchase of the 50%ownership interest for th

110、e CD38-GEAR-NK product candidate.Details of the two August amendments and the December amendment are summarized in theamendments attached at Exhibits 4.1 and 4.2 to our Current Report on Form 8-K dated August 19,2021,and Exhibit 4.2 to our Current Report on Form 8-K dated December 27,2021.3 In conne

111、ction with the Vy-Gen relationship and the Companys rights in respect of the two product candidates described above,in December 2021 we entered into a co-developmentand steering committee agreement with Vy-Gen.The co-development and steering committee agreement provides for the governance and econom

112、ic agreements between the Company and Vy-Gen related of the development of the two Vy-Gen drug product candidates and the revenue sharing related thereto,including each company having a 50%representation on the steeringcommittee and each company receiving 50%of the net revenues related to the Vy-Gen

113、 product candidates.Related to the joint development,under the direction of the joint steering committee,we are currently assessing market opportunities,intellectual property protection and potential regulatory strategies for the CD38 Assets,and Vy-Gen is overseeing the development activitiesbeing c

114、onducted through the scientists at Karolinska Institute.Details of the co-development and steering committee agreement are summarized in the agreement attached as Exhibit 4.1 to ourCurrent Report on Form 8-K dated December 27,2021.SNAP-CAR Technologies;University of Pittsburgh The SNAP-CAR License:O

115、n August 31,2022,we entered into an exclusive license agreement with the University of Pittsburgh for certain intellectual property rights related to theuniversal self-labeling SynNotch and CARs for programable antigen-targeting technology platform.We paid the University of Pittsburgh a non-refundab

116、le fee in the amount of$75,000 for theexclusive patent rights to the licensed technology.In September 2023,we executed the first amendment to the SNAP-CAR License in which we expanded the field of use to include natural killer cells.We believe this is a valuableaddition as we continue to develop the

117、 SNAP-CAR platform as a universal therapeutic.A key potential benefit that we see in the licensed technology is its potential application in therapeutic treatments that involve solid tumors.While there are currently a number of FDA-approved CAR-T therapies for hematologic malignancies,there are curr

118、ently no CAR-T therapies marketed that are indicated for the treatment of solid tumors.Under the terms of the agreement,we have been assigned the worldwide development and commercialization rights to the licensed technology in the field of human treatment of cancerwith antibody or antibody fragments

119、 using SNAP-CAR T-cell technology,along with(i)an intellectual property portfolio consisting of issued and pending patents and(ii)options regardingfuture add-on technologies and developments.In consideration of these rights,we paid an initial license fee of$75,000,and will have annual maintenance fe

120、es ranging between$15,000 and$25,000,as well as developmental milestone payments(as defined in the agreement and royalties equal to 3.5%of net sales.Additionally,the agreement contemplates that we will enter into aSponsored Research Agreement with the University of Pittsburgh within ninety days of t

121、he execution of the agreement,with the goal of further researching and optimizing the SNAP-CARplatform.The Sponsored Research Agreement:In January 2023 we entered into a sponsored research agreement(“SRA”)with the University of Pittsburgh,the focus of which is to perform pre-clinical research as it

122、relates to our SNAP-CAR program.Our target objectives have been to:(i)test and validate CRO antibody conjugation chemistry and improve the activity of adaptors byinvestigating alternative chemical composition,(ii)investigate HER2 and other solid-tumor model in mice for both breast and ovarian cancer

123、s,(iii)identify and test other non-HER2 targets,(iv)further investigate multi-antigen targeting by dosing multiple adaptors simultaneously to address tumor heterogeneity/resistance in hematological and/or solid tumors and(v)expand thepotential impact of SNAP-CAR by performing in vitro screening of m

124、any additional antigen-antibody combinations in hematological and/or solid tumors.The term of the SRA expires by itsterms at the end of January 2025.The data generated during the term of the SRA will be instrumental in determining target indications,development plans,and clinical study designs.The S

125、NAP-CAR Platform:Chimeric antigen receptor(CAR)therapy is a treatment for cancer in which a patients T-cells(a type of immune cell)are genetically engineered to recognizecancer cells to target and destroy them.Cells are extracted from the patient and then genetically engineered to make the CAR and a

126、re re-introduced back into the patient.This therapy isrevolutionizing the treatment of many blood cancers including B cell leukemias and lymphomas by targeting specific proteins found on these cancers,and there is hope in treating additionalcancers including solid tumors by having them recognize new

127、 targets.The“SNAP-CAR”CAR cell therapy platform is being developed to be a universal therapeutic.The SNAP-CARtechnology is in the preclinical stage of development at the University of Pittsburgh.Instead of directly binding to a target on the tumor cell,the CAR T-cells are co-administered with one or

128、more antibody adaptors that bind to the tumor cells and are fitted with a chemical group that irreversibly connects them to the SNAP-CAR on the therapeutic cells via a covalent bond.Acovalent bond is the highest affinity bond possible,and we believe this binding could translate into highly potent th

129、erapeutic activity.4 Pre-clinical studies in mice have demonstrated a potential benefit that by targeting solid tumors via antibody adaptor molecules,the SNAP-CAR therapy may be able to provide ahighly programmable therapeutic platform,one that we envision could deliver several potential advantages

130、over standard CAR-T treatments,including:-Reduction of Potential Toxicity:The therapeutic activity of the SNAP-CAR T-cells is being developed to allow controls by way of the antibody dose,which we envision wouldallow clinicians to mitigate toxicity from over-activity.We also envision that the immune

131、 response against cancer may also be boosted in patients administered with additionaldoses of the tagged tumor-specific antibody;and -Reduction in Cancer Relapse:Relapse from CAR T-cell therapy often results from the loss or down-regulation of the targeted protein on the cancer.Our research anddevel

132、opment will continue the pre-clinical development efforts to date,which focuses in part on the potential avoidance of or reduction in relapses by combining SNAP-CAR T-cells with antibodies targeting multiple antigens at once.Market Opportunity:Due to its unique targeting and binding properties,we be

133、lieve the SNAP-CAR platform could help accelerate the utilization and effectiveness of CAR T-celltherapies for the treatment of solid tumors.By way of market size,according to Polaris Market Research,the CAR T-cell therapy market size is expected to reach$20.56 billion by 2029(from$1.96 billion in 2

134、021),representing a compound annual growth rate(CAGR)of 31.6%during the forecast period from 2022 to 2029.However,based on the anticipated application of thelicensed technology(i.e.initially focusing on solid tumor treatment)we cannot at this time project the market size of our target market until w

135、e further develop the licensed technology andsettle on the initial target indications and follow-up indications.Additional research and analysis are being conducted which will aid us in the proper identification and selection of the cancerindication(s)we intend to further study.Once the optimal indi

136、cation(s)are selected and the overall development strategy is further identified,the market opportunity can be further defined.CPT60621;Vici Health Sciences,LLC In 2019,we entered into a co-development agreement with Vici Health Sciences,LLC(“Vici”).Through this partnership,we would co-develop,seek

137、FDA approval and shareownership rights with Vici to CPT60621,a novel,ready to use,easy to swallow,oral liquid version of an already approved drug used for the treatment of Parkinsons Disease(PD).As wecontinue to direct its operational focus towards the Vy-Gen opportunities previously described,we ha

138、ve recently stopped allocating priority resources to the development of CPT60621.We arecurrently in negotiations in which Vici intends to buy-out most or all of our remaining ownership rights.Vy-Gen-Bio,Inc.We are currently exploring on a non-exclusive basis a previously announced strategic opportun

139、ity that we believe would add to our current GEAR developmentplatform and provide additional growth opportunities to our assets in the area of cellular immunotherapy.The acquisition of these assets,if completed,would allow us to expand ourcollaboration with Vy-Gen-Bio,beyond its current focus on the

140、 use of CD38-GEAR-NK,a natural killer(NK)cell therapy for the treatment of CD38+cancers for the treatment of multiplemyeloma,and the development of CD38-Diagnostic,an in vitro diagnostic tool aimed toward identifying cancer patients who may be appropriate candidates for anti-CD38 mAb therapy.Recent

141、Developments Series A Offering.In June 2024,Coeptis commenced a private offering of its series A preferred stock(the“Series A Preferred Stock”)to accredited investors(collectively,the“Series AInvestors”),and to date has raised$10,000,000 million in the sale of 10,000 shares of Series A Preferred Sto

142、ck,at a purchase price of$1,000 per share.The Series A Investors also received inthe aggregate a 15.0%non-voting equity ownership interest in two of the Companys newly formed subsidiaries,SNAP Biosciences Inc.and GEAR Therapeutics Inc.The key terms of theSeries A Preferred Stock are described elsewh

143、ere in this prospectus under“Description of Our Securities;Series A Preferred Stock.”In connection with the Series A offering,the Company created two new subsidiaries,GEAR Therapeutics,Inc.and SNAP Biosciences,Inc.,to operate in separate silos with respect tothe research and development efforts rela

144、ted to the Companys GEAR and SNAP platforms,respectively.In connection with the first closing under the Offering,the Company contributed to thenew subsidiaries,respectively,the assets used exclusively in connection with the GEAR research and development efforts and those assets used exclusively in c

145、onnection with the SNAPresearch and development efforts.Any assets that are not used exclusively for GEAR or SNAP,remain at the Company level and will be made available to the new subsidiaries throughintracompany arrangements.5 In connection with the sale of the Series A Preferred Stock,in June 2024

146、,the Company filed a Certificate of Designation of Preferences,Rights and Limitations of the Series APreferred Stock with the Secretary of State of the State of Delaware(the“Series A Certificate of Designations”).Standby Equity Purchase Agreement.On November 1,2024,the Company entered into the Stand

147、by Equity Purchase Agreement(“SEPA”)with YA II PN,LTD,a Cayman Islandsexempt limited partnership(“Yorkville”)pursuant to which the Company has the right to sell to Yorkville up to$20.0 million of Common Stock,subject to certain limitations and conditions setforth in the SEPA,from time to time during

148、 the term of the SEPA.The Company also entered into a Registration Rights Agreement with Yorkville pursuant to which it will register the resale ofshares of Common Stock issued to Yorkville pursuant to the SEPA.After the Yorkville Note(as defined below)has been repaid,sales of the shares of Common S

149、tock to Yorkville under theSEPA,and the timing of any such sales,are at the Companys option,and the Company is under no obligation to sell any shares of Common Stock to Yorkville under the SEPA(other than whilethe Yorkville Note remains outstanding).Upon the satisfaction of the conditions to Yorkvil

150、les purchase obligation set forth in the SEPA(including(i)having a registration statement registering the resale of the shares ofCommon Stock issuable under the SEPA declared effective by the Securities and Exchange Commission and(ii)having paid off in full all accrued and unpaid obligations under t

151、he YorkvilleNote(as defined below)the Company will have the right,but not the obligation,from time to time at its discretion,to direct Yorkville to purchase a specified number of shares of CommonStock(an“Advance”)by delivering written notice to Yorkville(an“Advance Notice”).While there is no mandato

152、ry minimum amount for any Advance,it may not exceed an amount equal to100%of the average of the daily traded amount during the five consecutive trading days immediately preceding an Advance Notice.The shares of Common Stock purchased pursuant to an Advance initiated by the Company will be purchased

153、at a price equal to 95%of the lowest daily VWAP of the shares ofCommon Stock during the three consecutive trading days commencing on the date of the delivery of the Advance Notice,other than the daily VWAP on a day in which the daily VWAP is lessthan a minimum acceptable price as stated by the Compa

154、ny in the Advance Notice or there is no VWAP on the subject trading day.The Company may establish a minimum acceptable price ineach Advance Notice below which the Company will not be obligated to make any sales to Yorkville.“VWAP”is defined as the daily volume weighted average price of the shares of

155、 CommonStock for such trading day on the Nasdaq Stock Market during regular trading hours as reported by Bloomberg L.P.through its“AQR”function.Additionally,Yorkville agreed to advance to the Company,in exchange for a convertible promissory note(the“Yorkville Note”),an aggregate principal amount of$

156、1,304,758.Interestshall accrue on the outstanding balance of the Yorkville Note at an annual rate equal to 8%,subject to an increase to 18%upon an event of default as described in the Yorkville Note.Thematurity date of the Yorkville Note is November 1,2025.Yorkville may convert the Yorkville Note in

157、to shares of Common Stock at any time at a conversion price equal to the lower of(i)$1.00(the“Fixed Price”)or(ii)a price per share equal to 95%of the lowest daily VWAP during the 5 consecutive trading days immediately prior to the conversion date of the Yorkville Note(the“Variable Price”),but which

158、Variable Price shall not be lower than a floor price of$0.04(the“Floor Price”).The Yorkville Note was issued as repayment in full of an existing promissory notethat was previously entered into between Yorkville and the Company in January 2024 that as of the date of the Yorkville Note had matured.At

159、any time during the Commitment Period that there is a balance outstanding under the Yorkville Note,Yorkville may deliver notice(an“Investor Notice”)to the Company to cause anAdvance Notice to be deemed delivered to Yorkville and the issuance and sale of shares of Common Stock to Yorkville pursuant t

160、o an Advance(an“Investor Advance”)in an amount not toexceed the balance owed under the Yorkville Note outstanding on the date of delivery of such Investor Notice.As a result of an Investor Advance,the amounts payable under the Yorkville Notewill be offset by such amount subject to each Investor Adva

161、nce.Under applicable Nasdaq rules and the terms of the SEPA and the Yorkville Note,in no event may the Company issue to Yorkville under the SEPA or the Yorkville Note shares ofCommon Stock equal to greater than 19.99%of the shares of Common Stock outstanding immediately prior to the execution of the

162、 SEPA(the“Exchange Cap”),unless the Company obtainsstockholder approval to issue shares of Common Stock in excess of the Exchange Cap in accordance with applicable Nasdaq rules.Moreover,the Company may not issue or sell any shares ofCommon Stock to Yorkville under the SEPA or the Yorkville Note whic

163、h,when aggregated with all other shares of Common Stock then beneficially owned by Yorkville and its affiliates(ascalculated pursuant to Section 13(d)of the Exchange Act and Rule 13d-3 thereunder),would result in Yorkville beneficially owning more than 4.99%of the outstanding shares of CommonStock.6

164、 Actual sales of shares of Common Stock to Yorkville as an Advance under the SEPA will depend on a variety of factors to be determined by(i)the Company from time to time,whichmay include,among other things,market conditions,the trading price of the Common Stock and determinations by the Company as t

165、o the appropriate sources of funding for our business andoperations and(ii)Yorkville at all times while the Yorkville Note remains outstanding.The SEPA will automatically terminate on the earliest to occur of(i)December 1,2027 or(ii)the date on which the Company shall have made full issuances of Adv

166、ances pursuant tothe SEPA.The Company has the right to terminate the SEPA at no cost or penalty upon five(5)trading days prior written notice to Yorkville,provided that there are no outstanding AdvanceNotices for which shares of Common Stock need to be issued and provided further that the Yorkville

167、Note is no longer outstanding.As consideration for Yorkvilles commitment to purchase the shares of Common Stock pursuant the SEPA,the Company paid Yorkville,(i)a structuring fee in the amount of$25,000and(ii)a commitment fee equal to 1%of the commitment amount under the SEPA to be paid(x)20,000 shar

168、es(on a post Reverse Split basis)on the date the SEPA was entered into and(y)and$120,000,to be paid in cash or by way of an Advance on the date upon which the Company has first received Advances in the aggregate amount of$5,000,000.The net proceeds under the SEPA to the Company will depend on the fr

169、equency and prices at which Common Stock is sold.The Company expects that proceeds received from suchsales will be used primarily for working capital and general corporate purposes.Reverse Stock Split.At the Companys annual stockholders meeting on December 18,2024,the Companys stockholders approved

170、a proposal to grant authority to our board ofdirectors to amend our certificate of incorporation to combine outstanding shares of our common stock into a lesser number of outstanding shares,or a“reverse stock split,”at a specific ratiowithin a range of one-for-three(1-for-3)to a maximum of a one-for

171、-forty(1-for-40)split,with the exact ratio to be determined by our board of directors in its sole discretion.On December 26,2024,the Company filed with the Secretary of State of the State of Delaware a certificate of amendment of the Companys amended and restated certificate of incorporation effecti

172、ng a reversestock split at a ratio of one-for-twenty(1-for-20)(the“Reverse Stock Split”),which was effected at 5:00 pm on December 30,2024.The primary purpose of the Reverse Stock Split is to assistwith the Companys compliance with the Minimum Bid Price Requirement,pursuant to Nasdaq Listing Rule 58

173、10(c)(3)(A).Technology Expansion.In December 2024 the Company acquired an AI-powered marketing software and advanced robotic process automation(RPA)platform called the NexGenAIAffiliates Network platform as part of its exploration towards adding a technology arm to the Companys offerings.Over the fi

174、rst half of 2025 the Company intends to focus on how to utilizethis platform as a source of revenue,with the goal of assisting itself and others to optimize marketing,operations and customer engagements and drive measurable results for users of theplatform.Our Growth Strategy To achieve our goals,we

175、 intend to deploy an aggressive,three-pronged,growth strategy listed below that we believe will help us maximize our success and deleverage some of the riskof finding,solely developing and funding our own products.Portfolio Optimization We will continue to evaluate,prioritize,optimize,and make appro

176、priate changes in our pipeline portfolio as market development dynamics and/or productopportunities change.For example,it may be a strategic business decision for us to divest certain products and/or agreements to other companies so we can best focus on its core assets.Strategic Partnerships We will

177、 focus on expanding our existing pipeline through establishing strategic partnerships with companies that have interesting products and technologies.We intend to focus on novel,preclinical and clinical assets in a variety of therapeutic areas,including oncology.Business Development We are actively s

178、eeking partnerships and/or strategic collaborations with companies that share in our vision for our therapeutic focus and/or our focus ontechnology expansion.Our platform technologies have expansive capabilities and thus we believe they are conducive to partnerships beyond our current focus.Sales an

179、d Marketing We currently do not have in-house commercial capabilities required to market and distribute FDA-approved products.Therefore,we will be required to partner with firms who arecapable of conducting all sales,marketing,distribution,contracting and pricing for our future products.There is no

180、assurance that we will be able to secure the services of such a firm or that anysuch firm will be able to achieve sales expectations.7 Employees Currently,we have six employees,of which four are full-time employees and two are part-time employees.Our employees are not represented by any labor union

181、or any collectivebargaining arrangement with respect to their employment with the Company.We have never experienced any work stoppages or strikes as a result of labor disputes.We believe that ouremployee relations are good.Certain of our employees have been reporting to work remotely and may continu

182、e to do so moving forward.Risks Associated with our Business There are a number of risks related to us and our operations.You should carefully review the risks described in“Risk Factors and Special Considerations”beginning on page 11.If anyof these risks actually occurs,our business,financial condit

183、ion,results of operations and prospects would likely be materially,adversely affected.In that event,the trading price of our CommonStock could be adversely impacted,and you could lose part or all of your investment.Below is a summary of some of the principal risks we face:We may not be able to succe

184、ssfully implement our growth strategy on a timely basis or at all;We may have difficulties managing our anticipated growth,or we may not grow at all;We have a history of losses,we expect to incur losses in the future and we may not be able to achieve or maintain profitability;We may not be able to i

185、nitiate and complete preclinical studies and clinical trials for our product candidates which could adversely affect our business;We may not be able to obtain and maintain the third-party relationships that are necessary to develop,commercialize and manufacture some or all of our product candidates;

186、We may encounter difficulties in managing our growth,which could adversely affect our operations;We may face difficulties in integrating the use of the NexGen AI Affiliates Network platform,and even if successful such use may result in reputational and operational harm,andany difficulties in integra

187、ting or using such platform could adversely affect our operations;We need to obtain financing in order to continue our operations;The drug development and approval process is uncertain,time-consuming and expensive;Competition in the biotechnology and pharmaceutical industries may result in competing

188、 products,superior marketing of other products and lower revenues or profits for us;Federal laws or regulations on drug importation could make lower cost versions of our future products available,which could adversely affect our revenues,if any;The regulatory approval process is costly and lengthy,a

189、nd we may not be able to successfully obtain all required regulatory approvals;Healthcare reform measures could adversely affect our business;Protecting and defending against intellectual property claims may have a material adverse effect on our business;If we are not able to retain our current seni

190、or management team and our scientific advisors or continue to attract and retain qualified scientific,technical and business personnel,our business will suffer;and We may not be able to maintain our listing on the Nasdaq Capital Market;and There is a substantial doubt about our ability to continue a

191、s a going concern.8 Emerging Growth Company As a company with less than$1.07 billion in revenue during our last fiscal year,we qualify as an emerging growth company,as defined in the JOBS Act.As an emerging growthcompany,we have elected to take advantage of specified reduced disclosure and other req

192、uirements that are otherwise applicable generally to public companies.These provisions include:Only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced Managements Discussion andAnalysis of Financial Condition and

193、Results of Operations disclosure.Reduced disclosure about our executive compensation arrangements.Not having to obtain non-binding advisory votes on executive compensation or golden parachute arrangements.Exemption from the auditor attestation requirement in the assessment of our internal control ov

194、er financial reporting.We may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company.We would cease to be an emerging growthcompany if we have more than$1.07 billion in annual revenue,we have more than$700 million in market value

195、 of our stock held by non-affiliates,or we issue more than$1 billion of non-convertible debt over a three-year period.We may choose to take advantage of some but not all of these reduced burdens.We have taken advantage of these reduced reporting burdens herein,and the information that we provide may

196、 be different than what you might get from other public companies in which you hold stock.Legal Proceedings From time to time,we may become involved in various lawsuits and legal proceedings,which arise in the ordinary course of business.However,litigation is subject to inherentuncertainties,and an

197、adverse result in these or other matters may arise from time to time that may harm our business.We are currently not aware of any such legal proceedings or claims that webelieve will have a material adverse effect on our business,financial condition or operating results.Description of Property We re

198、nt office space in Wexford,Pennsylvania for$3,805 per month.Our current lease ends on May 31,2026.These facilities are adequate for our current needs.9 THE OFFERING Common Stock to be offeredby Selling Stockholders Up to 3,919,349 shares,consisting of:(i)100,000 shares of Common Stock held directly

199、or indirectly by certain SellingStockholders;and(ii)up to 3,819,349 shares of Common Stock we have issued or may issue and sell to Yorkville pursuantto the SEPA,which consists of(A)20,000(post-Reverse Stock Split)Commitment Shares,(B)81,877 shares issued toYorkville in connection with the partial co

200、nversion of an outstanding convertible note and(C)up to an aggregate of3,717,472 shares of Common Stock that may be issued and sold to issue and sell to Yorkville from time to time pursuant toAdvances under the SEPA.Use of Proceeds We will not receive any proceeds from the sale of the shares of Comm

201、on Stock by the Selling Stockholders.However,wemay receive up to$20.0 million in aggregate gross proceeds from sales of our shares of Common Stock to Yorkville thatwe may,in our discretion,elect to make,from time to time after the date of this prospectus,pursuant to the SEPA.Weexpect to use the net

202、proceeds that we receive from sales of our Common Stock to Yorkville,if any,under the SEPA forworking capital and general corporate purposes.See“Use of Proceeds.”Exchange Listing Our shares of Common Stock are currently traded on The Nasdaq Capital Market under the symbol“COEP”,and certain ofour war

203、rants are traded on The Nasdaq Capital Market under“COEPW”.Plan of Distribution The Selling Stockholders may sell or otherwise dispose of the Common Stock covered by this prospectus in a number ofdifferent ways and at varying prices.For further information,see“Plan of Distribution”beginning on page

204、63.Risk Factors Investing in our securities involves a high degree of risk.See“Risk Factors and Special Considerations”and otherinformation included in this prospectus for a discussion of factors you should consider before investing in our securities.Except as otherwise indicated,all share informati

205、on in this prospectus gives effect to the 1-for-20 reverse stock split of our common stock implemented on December 30,2024,whichcombined each share of the common stock issued and outstanding as of the close of business on December 30,2024.As of April 2,2025,after giving effect to the Reverse Stock S

206、plit,therewere 3,364,939 shares of common stock issued and outstanding,which number does not include(shares and exercise prices below presented on a post-Reverse Stock Split basis):Warrants to purchase 422,355 shares of common stock at an average exercise price of approximately$216.99 per share;Shar

207、es issuable upon conversion of our Series A Preferred Stock;Prefunded Warrants to purchase 250,000 shares of common stock at an average exercise price of$0.002 per share;Warrants to purchase 506,250 shares of common stock at an average exercise price of$27.20;Warrants to purchase 16,500 shares of co

208、mmon stock at an average exercise price of$26.09;Options to purchase 367,000 shares of Common Stock at an average exercise price of$14.16 per share;Shares issuable upon the exercise of the warrants referenced above;Shares of our Common Stock reserved for future issuance under our equity incentive pl

209、ans;and Shares of our Common Stock issuable upon the exercise of the prefunded warrants.10 RISK FACTORS AND SPECIAL CONSIDERATIONS You should carefully consider the risks and uncertainties described below and the other information in this prospectus before making an investment in our common stock.Ou

210、r business,financial condition,results of operations,or prospects could be materially and adversely affected if any of these risks occurs,and as a result,the market price of our common stock coulddecline and you could lose all or part of your investment.This prospectus also contains forward-looking

211、statements that involve risks and uncertainties.See“Cautionary Statement RegardingForward-Looking Statements.”Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors,including thoseset forth below.We operate i

212、n a highly competitive and highly regulated business environment.Our business can be expected to be affected by government regulation,economic,political and socialconditions,business response to new and existing products and services,technological developments and the ability to obtain and maintain

213、patent and/or other intellectual property protectionfor our products and intellectual property.Our actual results could differ materially from managements expectations because of changes both within and outside of our control.Due to suchuncertainties and the risk factors set forth in this prospectus

214、,prospective investors are cautioned not to place undue reliance upon such forward-looking statements.Throughout this section,references to“Company,”“Coeptis,”“we,”“us,”“our”and similar terms refer collectively to Coeptis Therapeutics Holdings,Inc.,a Delaware corporation,and its operating subsidiari

215、es,as the context so requires.This prospectus contains forward-looking statements.Information provided in this prospectus may contain forward-looking statements which reflect managements current view withrespect to future events,the viability or efficacy of our products and our future performance.Su

216、ch forward-looking statements may include projections with respect to market size andacceptance,revenues and earnings,marketing and sales strategies and business operations,as well as efficacy of our products.The risk factors discussed below cover not only our currentproducts,product candidates and

217、relationships,but also the risks we expect to encounter when and if we add new product candidates and approved products to our proprietary portfolio,whichnew products,if added,we expect to be at various stages of pre-clinical and perhaps clinical development.Risks Related to the Development and Regu

218、latory Approval of Our Product Candidates Clinical trials are expensive,time consuming,difficult to design and implement,and involve uncertain outcomes.Results of previous pre-clinical studies and clinical trials may not bepredictive of future results,and the results of our current and planned clini

219、cal trials may not satisfy the requirements of the FDA or other regulatory authorities.Positive or timely results from pre-clinical or early-stage trials do not ensure positive or timely results in late-stage clinical trials or product approval by the FDA or comparable foreignregulatory authorities.

220、We will be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are safe and effective for use in a diversepopulation before we can seek regulatory approvals for their commercialization.Our planned clinical trials may produce negative

221、or inconclusive results,and we or any of our current and futurestrategic partners may decide,or regulators may require us,to conduct additional clinical or pre-clinical testing.Success in pre-clinical studies or early-stage clinical trials does not mean that future clinical trials or registration cl

222、inical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA and foreign regulatory authorities,despite having progressed through pre-clinical studiesand initial clinical trials.Produc

223、t candidates that have shown promising results in early clinical trials may still suffer significant setbacks in subsequent clinical trials or registration clinical trials.For example,a number of companies in the biopharmaceutical industry,including those with greater resources and experience than u

224、s,have suffered significant setbacks in advanced clinicaltrials,even after obtaining promising results in earlier clinical trials.Similarly,pre-clinical interim results of a clinical trial are not necessarily predictive of final results.11 If clinical trials for our product candidates are prolonged,

225、delayed or stopped,we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis,or at all,which would require us to incur additional costs and delay our receipt of any product revenue.We may experience delays in our ongoing or future pre-clinical studies

226、or clinical trials,and we do not know whether future pre-clinical studies or clinical trials will begin on time,need to be redesigned,enroll an adequate number of patients or be completed on schedule,if at all.The commencement or completion of these planned clinical trials could be substantiallydela

227、yed or prevented by many factors,including,but not limited to:discussions with the FDA or other regulatory agencies regarding the scope or design of our clinical trials;the limited number of,and competition for,suitable sites to conduct our clinical trials,many of which may already be engaged in oth

228、er clinical trial programs,including some thatmay be for the same indication as our product candidates;any delay or failure to obtain approval or agreement to commence a clinical trial in any of the countries where enrollment is planned;inability to obtain sufficient funds required for a clinical tr

229、ial;clinical holds on,or other regulatory objections to,a new or ongoing clinical trial;delay or failure to manufacture sufficient supplies of product candidates for our clinical trials;delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with

230、prospective sites or clinical research organizations(“CROs”),theterms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs;delay or failure to obtain institutional review board(“IRB”)approval to conduct a clinical trial at a prospective site;slowe

231、r than expected rates of patient recruitment and enrollment;failure of patients to complete the clinical trial;the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects;unforeseen safety issues,includ

232、ing severe or unexpected drug-related adverse effects experienced by patients,including possible deaths;lack of efficacy during clinical trials;termination of our clinical trials by one or more clinical trial sites;inability or unwillingness of patients or clinical investigators to follow our clinic

233、al trial protocols;inability to monitor patients adequately during or after treatment;12 clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner,or at all,deviating from the protocol or droppingout of a study;inability to add

234、ress any non-compliance with regulatory requirements or safety concerns that arise during the course of a clinical trial;the need to repeat or terminate clinical trials as a result of inconclusive or negative results or unforeseen complications in testing;and our clinical trials may be suspended or

235、terminated upon a breach or pursuant to the terms of any agreement with,or for any other reason by,current or future strategic partners thathave responsibility for the clinical development of any of our product candidates.Changes in regulatory requirements,policies and guidelines may also occur and

236、we may need to significantly amend clinical trial protocols to reflect these changes with appropriateregulatory authorities.These changes may require us to renegotiate terms with CROs or resubmit clinical trial protocols to IRBs for re-examination,which may impact the costs,timing orsuccessful compl

237、etion of a clinical trial.Our clinical trials may be suspended or terminated at any time by the FDA,other regulatory authorities,the IRB overseeing the clinical trial at issue,anyof our clinical trial sites with respect to that site,or us.Any failure or significant delay in commencing or completing

238、clinical trials for our product candidates may adversely affect our ability toobtain regulatory approval and our commercial prospects and our ability to generate product revenue will be diminished.The design or our execution of clinical trials may not support regulatory approval.The design or execut

239、ion of a clinical trial can determine whether its results will support regulatory approval and flaws in the design or execution of a clinical trial may not becomeapparent until the clinical trial is well advanced.In some instances,there can be significant variability in safety or efficacy results be

240、tween different trials of the same product candidate due tonumerous factors,including changes in trial protocols,differences in size and type of the patient populations,adherence to the dosing regimen and other trial protocols and the rate of dropoutamong clinical trial participants.We do not know w

241、hether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval to marketour product candidates.Further,the FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and in determining whe

242、n or whether regulatory approval will beobtained for any of our product candidates.Our product candidates may not be approved even if they achieve their primary endpoints in future clinical trials.The FDA or foreign regulatoryauthorities may disagree with our trial design and our interpretation of d

243、ata from pre-clinical studies and clinical trials.In addition,any of these regulatory authorities may change requirementsfor the approval of a product candidate even after reviewing and providing comments or advice on a protocol for clinical trial that has the potential to result in FDA or other age

244、ncies approval.In addition,such regulatory authorities may also approve a product candidate for fewer or more limited indications than we request or may grant approval contingent on the performance ofcostly post-marketing clinical trials.The FDA or foreign regulatory authorities may not approve the

245、labeling claims that we believe would be necessary or desirable for the successfulcommercialization of our product candidates which may have a material adverse effect on our business.We may find it difficult to enroll patients in our clinical trials given the limited number of patients who have the

246、diseases for which our product candidates are being studied which coulddelay or prevent the start of clinical trials for our product candidates.Identifying and qualifying patients to participate in clinical trials of our product candidate is essential to our success.The timing of our clinical trials

247、 depends in part on the rate atwhich we can recruit patients to participate in clinical trials of our product candidates,and we may experience delays in our clinical trials if we encounter difficulties in enrollment.If weexperience delays in our clinical trials,the timeline for obtaining regulatory

248、approval of our product candidates will most likely be delayed.13 Many factors may affect our ability to identify,enroll and maintain qualified patients,including the following:eligibility criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in

249、our clinical trials;design of the clinical trial;size and nature of the patient population;patients perceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in relation to other available therapies,includingany new drugs that may b

250、e approved for the indications we are investigating;the availability and efficacy of competing therapies and clinical trials;pendency of other trials underway in the same patient population;willingness of physicians to participate in our planned clinical trials;severity of the disease under investig

251、ation;proximity of patients to clinical sites;patients who do not complete the trials for personal reasons;and issues with CROs and/or with other vendors that handle our clinical trials.General Risks There is a substantial doubt about our ability to continue as a going concern.The report of our inde

252、pendent registered public accounting firm that accompanies our consolidated financial statements includes an explanatory paragraph indicating there is asubstantial doubt about our ability to continue as a going concern,citing our need for additional capital for the future planned expansion of our ac

253、tivities and to service our ordinary courseactivities(which may include servicing of indebtedness).The inclusion of a going concern explanatory paragraph in the report of our independent registered public accounting firm will make itmore difficult for us to secure additional financing or enter into

254、strategic relationships on terms acceptable to us,if at all,and likely will materially and adversely affect the terms of anyfinancing that we might obtain.Our consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty.We have incurred signif

255、icant losses in prior periods,and losses in the future could cause the quoted price of our Common Stock to decline or have a material adverse effect on ourfinancial condition,our ability to pay its debts as they become due,and on its cash flows.For the year ended December 31,2024,we incurred a net l

256、oss of$10,877,412 and,as of that date,we had an accumulated deficit of$98,233,673.For the year ended December 31,2023,we incurred a net loss of$21,266,537 and,as of that date,had an accumulated deficit of$87,356,260.Any losses in the future could cause the quoted price of our Common Stock todecline

257、or have a material adverse effect on our financial condition,its ability to pay its debts as they become due,and on its cash flows.14 To date,we have generated only minimal product revenue.We expect that our planned product development and strategic expansion pursuits will increase losses significan

258、tly over thenext five years.In order to achieve profitability,we will be required to generate significant revenue.We cannot be certain that we will generate sufficient revenue to achieve profitability.Weanticipate that we will continue to generate operating losses and experience negative cash flow f

259、rom operations at least through the end of 2024 or longer.We cannot be certain that we will everachieve profitability or that,if profitability is achieved,that is will be maintained.If our revenue grows at a slower rate than we anticipate or if our product development,marketing andoperating expenses

260、 exceed our expectations or cannot be adjusted accordingly,our business,results of operation and financial condition will be materially adversely affected and we may beunable to continue operations.We will not be able to generate meaningful product revenue unless and until one of our product candida

261、tes or co-development products successfully completes clinical trials andreceives regulatory approval.As some of our current and projected future product candidates or co-development products are,and we expect will be,at an early proof-of-concept stage,we donot expect to receive revenue from any of

262、these products for several years,if at all.We intend to seek to obtain revenue from collaboration or licensing agreements with third parties.We expectthat we will need to rely on key third-party agreements,in order to be in a position to realize material revenues in the future,and we may never enter

263、 into any such agreements or realizematerial,ongoing future revenue.Even if we eventually generate revenues,we may never be profitable,and,if we do achieve profitability,we may not be able to sustain or increase profitabilityon a quarterly or annual basis.If we are unable to manage future expansion

264、effectively,our business may be adversely impacted.In the future,we may experience rapid growth in our business,which could place a significant strain on our operations,in general,and our internal controls and other managerial,operating and financial resources,in particular.If we are unable to manag

265、e future expansion effectively,our business would be harmed.There is,of course,no assurance that we will enjoy rapiddevelopment in our business.The Companys ability to be successful will depend upon the efforts of the Companys Board and our key personnel and the loss of such persons could negatively

266、 impact the operations andprofitability of the Companys business.The Companys ability to be successful is dependent upon the efforts of the Companys board members and key personnel,in particular our President and Chief Executive OfficerDavid Mehalick.We cannot assure you that the Companys board memb

267、ers and key personnel will be effective or successful or remain with the Company.In addition to the other challengesthey will face,such individuals may be unfamiliar with the requirements of operating a public company,which could cause the Companys management to expend time and resources becomingfam

268、iliar with such requirements.We have employment agreements in place with Mr.Mehalick and Daniel Yerace,but no other persons.The loss of service of Mr.Mehalick,in particular,forany reason,could seriously impair our ability to effectuate our business plan,which could have a materially adverse effect o

269、n our business and future results of operations.We also have notpurchased any key-man life insurance.If we are unable to recruit and retain key personnel,our business may be harmed.If we are unable to attract and retain key personnel,our business may be harmed.Our failure to enable the effective tra

270、nsfer of knowledge and facilitate smooth transitions with regardto our key employees could adversely affect our long-term strategic planning and execution.Our business plan is not based on independent market studies.We have not commissioned any independent market studies concerning our business plan

271、s.Rather,our plans for implementing our business strategy and achieving profitability arebased on the experience,judgment and assumptions of our management.If these assumptions prove to be incorrect,we may not be successful in our business operations.Our Board of Directors may change our policies wi

272、thout shareholder approval.Our policies,including any policies with respect to investments,leverage,financing,growth,debt and capitalization,will be determined by our Board of Directors or officers to whomour Board of Directors delegate such authority.Our Board of Directors will also establish the a

273、mount of any dividends or other distributions that we may pay to our shareholders.Our Board ofDirectors or officers to which such decisions are delegated will have the ability to amend or revise these and our other policies at any time without shareholder vote.Accordingly,ourshareholders will not be

274、 entitled to approve changes in our policies,which policy changes may have a material adverse effect on our financial condition and results of operations.15 We need to obtain financing in order to continue our operations and pursue strategic transactions.On a prospective basis,we will require both s

275、hort-term financing for operations and long-term capital to fund our expected growth.We currently have no existing bank lines of creditand have not established any definitive sources for additional financing.We believe that cash on hand will be sufficient to meet our short-term financial requirement

276、s through the end of 2024assuming that we elect not to pursue and consummate strategic transactions prior to that time.However,we will require additional funds if we want to fully implement our business plan andgrowth strategy,including strategic transactions,which funds could come in the form of eq

277、uity,debt(including secured debt)or a combination of the two.Additional financing may not beavailable to us,or if available,then it may not be available upon terms and conditions acceptable to us.If adequate funds are not available,then we may be required to delay,reduce or eliminateproduct developm

278、ent or clinical programs.Our inability to take advantage of opportunities in the industry because of capital constraints may have a material adverse effect on our business andour prospects.If we fail to obtain the capital necessary to fund our operations,we will be unable to advance our development

279、programs and complete our clinical trials.In addition,our research and development expenses could exceed our current expectations.This could occur for many reasons,including:some or all of our product candidates and co-development candidates fail in clinical or preclinical studies and we are forced

280、to seek additional product candidates;our product candidates and co-development candidates require more extensive clinical or preclinical testing than we currently expect;we advance more of our product candidates and co-development candidates than expected into costly later stage clinical trials;we

281、advance more preclinical product candidates and co-development candidates than expected into early-stage clinical trials;we are required,or consider it advisable,to acquire or license rights from one or more third parties;or we determine to acquire or license rights to additional product candidates

282、and co-development candidates or new technologies.While we expect to seek additional funding through public or private financings,we may not be able to obtain financing on acceptable terms,or at all.In addition,the terms of ourfinancings may be dilutive to,or otherwise adversely affect,holders of ou

283、r common stock and other capital securities.We may also seek additional funds through arrangements withcollaborators or other third parties.These arrangements would generally require us to relinquish rights to some of our technologies,product candidates or products,and we may not be able toenter int

284、o such agreements,on acceptable terms,if at all.If we are unable to obtain additional funding on a timely basis,we may be required to curtail or terminate some or all of ourdevelopment programs,including some or all of our product candidates.We currently do not have sufficient cash to fully implemen

285、t our business plan.We have experienced a lack of adequate capital resources causing us to be unable to fully implement our full business plan.We believe that we need to raise or otherwise obtainadditional financing beyond our current cash position in order to satisfy our existing obligations and fu

286、lly implement our business plan.We do not expect to have positive cash flow for theforeseeable future.If we are not successful in obtaining additional financing we will not be able to fully implement our business plan and we may not be able to continue our operations.We have a limited operating hist

287、ory and a history of operating losses,and expect to incur significant additional operating losses.We began our business in 2017 and have a limited operating history.Although we have enlisted the assistance of pharmaceutical experts,our lack of experience may cause us toencounter unforeseen problems

288、that could have a material adverse effect on our business and financial condition.Further,there is limited historical financial information upon which to base anevaluation of our performance.16 The drug development and approval process is uncertain,time-consuming and expensive.The process of obtaini

289、ng and maintaining regulatory approvals for new therapeutic products is lengthy,expensive and uncertain.It also can vary substantially based on the type,complexity,and novelty of the product.We,or our co-development partners,must provide the FDA and foreign regulatory authorities with preclinical an

290、d clinical data demonstrating that ourproducts are safe and effective before they can be approved for commercial sale.Clinical development,including preclinical testing,is a long,expensive and uncertain process.It may take usseveral years to complete our testing,and failure can occur at any stage of

291、 testing.Any preclinical or clinical test may fail to produce results satisfactory to the FDA.Preclinical and clinical datacan be interpreted in different ways,which could delay,limit or prevent regulatory approval.Negative or inconclusive results from a preclinical study or clinical trial,adverse m

292、edical eventsduring a clinical trial or safety issues resulting from products of the same class of drug could cause a preclinical study or clinical trial to be repeated or a program to be terminated,even if otherstudies or trials relating to the program are successful.We will be required to sustain

293、and further build our intellectual property rights.We do not currently have any intellectual property rights in our name in respect of our current assets,and instead have rights in respect of our current assets through agreements withthird parties.We intend to fully protect any product,formulation a

294、nd process that we develop with appropriate intellectual property registrations.If we fail to sustain and further build our directand indirect intellectual property rights,competitors will be able to take advantage of our research and development efforts to develop competing products.If we are not a

295、ble to protect ourproprietary technology,trade secrets,and know-how,our competitors may use our inventions to develop competing products.Our future patents and patent applications,even if granted,may notprotect us against our competitors.Patent positions generally,including those of other pharmaceut

296、ical and biotechnology companies,are or will be generally uncertain and involve complexlegal,scientific and factual questions.The standards which the United States Patent and Trademark Office uses to grant patents,and the standards which courts use to interpret patents,are notalways applied predicta

297、bly or uniformly and can change,particularly as new technologies develop.Consequently,the level of protection,if any,that will be provided by our direct or indirectpatent rights from time to time if we attempt to enforce them,and they are challenged,is uncertain.In addition,the type and extent of pa

298、tent claims that will be issued to us in the future isuncertain.Any patents that are issued may not contain claims that permit us to stop competitors from using similar technology.In addition,we may also rely on unpatented technology,trade secrets,and confidential information.We may not be able to e

299、ffectively protect our rights to this technology orinformation.Other parties may independently develop substantially equivalent information and techniques or otherwise gain access to or disclose our technology.We will generally require eachof our employees,consultants,collaborators,and certain contr

300、actors to execute a confidentiality agreement at the commencement of an employment,consulting,collaborative,or contractualrelationship with us.However,these agreements may not provide effective protection of our technology or information or,in the event of unauthorized use or disclosure,they may not

301、 provideadequate remedies.Patent positions are often uncertain and involve complex legal and factual questions.In addition,the laws of some foreign countries do not protect proprietary rights to the same extentas the laws of the United States.Whether filed in the United States or abroad,our patent a

302、pplications may be challenged or may fail to result in issued patents.In addition,any future patents weobtain may not be sufficiently broad to prevent others from practicing our technologies or from developing or commercializing competing products.Furthermore,others may independentlydevelop or comme

303、rcialize similar or alternative technologies or drugs,or design around our patents.Our patents may be challenged,invalidated or fail to provide us with any competitiveadvantages.We may not have the funds available to protect our patents or other technology;such protection is costly and can result in

304、 further litigation expenses.If we do not obtain or we are unable to maintain adequate patent or trade secret protection for our products in the United States,competitors could duplicate them without repeating theextensive testing that we will be required to undertake to obtain approval of the produ

305、cts by the FDA.Regardless of any patent protection,under the current statutory framework the FDA isprohibited by law from approving any generic version of any of our products for a period of years that would be determined based on the nature of the product(i.e.an orphan drugs would get7 years,a new

306、chemical entity would get 5 years and a new clinical investigation would get 3 years).Upon the expiration of that period,or if that time period is altered,the FDA could approve ageneric version of our product unless we have patent protection sufficient for us to block that generic version.Without su

307、fficient patent protection,the applicant for a generic version of ourproduct would be required only to conduct a relatively inexpensive study to show that its product is bioequivalent to our product and may not have to repeat the studies that we will need toconduct to demonstrate that the product is

308、 safe and effective.In the absence of adequate patent protection in other countries,competitors may similarly be able to obtain regulatory approval inthose countries of products that duplicate our products.17 We will be required to comply with our obligations in our intellectual property licenses an

309、d other agreements with third parties.If we fail to comply with our obligations in our intellectual property licenses and other agreements with third parties,we could lose license rights that are important to our business.Weare not currently party to any intellectual property license agreement with

310、any third parties,but we anticipate that in-licensing and co-development will be strategies that we utilize as wecontinue to pursue our growth strategy.We expect to enter into licenses and co-development and other agreements in the future,and we expect these agreements to impose,various diligences,m

311、ilestone payment,royalty,insurance and other obligations on us.If we fail to comply with these obligations,the licensor may have the right to terminate the license,in which event we mightnot be able to market any product that is covered by the licensed patents.We may need to resort to litigation to

312、enforce or defend our intellectual property rights,including any patents issued to us.If a competitor or collaborator files a patent applicationclaiming technology also invented by us,in order to protect our rights,we may have to participate in an expensive and time-consuming interference proceeding

313、 before the United States Patentand Trademark Office.We cannot guarantee that our product candidates will be free of claims by third parties alleging that we have infringed their intellectual property rights.Third parties mayassert that we are employing their proprietary technologies without authori

314、zation and they may resort to litigation to attempt to enforce their rights.Third parties may have or obtain patents inthe future and claim that the use of our technology or any of our product candidates infringes their patents.We may not be able to develop or commercialize combination product candi

315、datesbecause of patent protection others have.Our business will be harmed if we cannot obtain a necessary or desirable license,can obtain such a license only on terms we consider to be unattractiveor unacceptable,or if we are unable to redesign our product candidates or processes to avoid actual or

316、potential patent or other intellectual property infringement.Obtaining,protecting anddefending patent and other intellectual property rights can be expensive and may require us to incur substantial costs,including the diversion of management and technical personnel.Anunfavorable ruling in patent or

317、intellectual property litigation could subject us to significant liabilities to third parties,require us to cease developing,manufacturing or selling the affectedproducts or using the affected processes,require us to license the disputed rights from third parties,or result in awards of substantial d

318、amages against us.There can be no assurance that we would prevail in any intellectual property infringement action,will be able to obtain a license to any third-party intellectual property oncommercially reasonable terms,successfully develop non-infringing alternatives on a timely basis,or license n

319、on-infringing alternatives,if any exist,on commercially reasonable terms.Anysignificant intellectual property impediment to our ability to develop and commercialize our products could seriously harm our business and prospects.Patent litigation or other litigation in connection with our intellectual

320、property rights may lead to publicity that may harm our reputation and the value of our common stock may decline.During the course of any patent litigation,there may be public announcements of the results of hearings,motions,and other interim proceedings or developments in the litigation.Ifsecuritie

321、s analysts or investors regard these announcements as negative,the value of our common stock may decline.General proclamations or statements by key public figures may also have anegative impact on the perceived value of our intellectual property.Protecting and defending against intellectual property

322、 claims may have a material adverse effect on our business.From time to time,we may receive notice that others have infringed on our proprietary rights or that we have infringed on the intellectual property rights of others.There can be noassurance that infringement or invalidity claims will not mat

323、erially adversely affect our business,financial condition or results of operations.Regardless of the validity or the success of theassertion of claims,we could incur significant costs and diversion of resources in protecting or defending against claims,which could have a material adverse effect on o

324、ur business,financialcondition or results of operations.We may not have the funds or resources available to protect our intellectual property.18 Our competitors and potential competitors may develop products and technologies that make ours less attractive or obsolete.Many companies,universities,and

325、research organizations developing competing product candidates have greater resources and significantly greater experience in financial,researchand development,manufacturing,marketing,sales,distribution,and technical regulatory matters than we have.In addition,many competitors have greater name reco

326、gnition and more extensivecollaborative relationships.Our competitors could commence and complete clinical testing of their product candidates,obtain regulatory approvals,and begin commercial-scale manufacturingof their products faster than we or our co-development partners are able to for our produ

327、cts.They could develop products that would render our product candidates and co-developmentcandidates,and those of our collaborators,obsolete and noncompetitive.If we are unable to compete effectively against these companies,then we may not be able to commercialize our productcandidates or achieve a

328、 competitive position in the market.This would adversely affect our ability to generate revenues.Competition in the biotechnology and pharmaceutical industries may result in competing products,superior marketing of other products and lower revenues or profits for us.There are many companies that are

329、 seeking to develop products and therapies for the treatment of the same diseases that we are currently targeting.Many of our competitors havesubstantially greater financial,technical,human and other resources than we do and may be better equipped to develop,manufacture and market technologically su

330、perior products.In addition,many of these competitors have significantly greater experience than we do in undertaking preclinical testing and human clinical studies of new pharmaceutical products and in obtainingregulatory approvals of human therapeutic products.Accordingly,our competitors may succe

331、ed in obtaining FDA approval for superior products.Other risks and uncertainties include:our ability to successfully complete preclinical and clinical development of our products and services.our ability to manufacture sufficient amounts of products for development and commercialization activities.o

332、ur ability to obtain,maintain and successfully enforce adequate patent and other proprietary rights protection of our products and services.the scope,validity and enforceability of patents and other proprietary rights held by third parties and their impact on our ability to commercialize our product

333、s and services.the accuracy of our estimates of the size and characteristics of the markets to be addressed by our products and services,including growth projections.market acceptance of our products and services.our ability to identify new patients for our products and services.the accuracy of our information regarding the products and resources of our competitors and potential competitors.the co