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1、2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm1/206As filed with the U.S.Securities and Exchange Commission on May 20,2025Registration No.UNITED STATESSECUR

2、ITIES AND EXCHANGE COMMISSIONWashington,D.C.20549 FORM S-1REGISTRATION STATEMENTUNDERTHE SECURITIES ACT OF 1933 REVELATION BIOSCIENCES,INC.(Exact name of registrant as specified in its charter)DELAWARE(Jurisdiction of incorporation or organization)2834 84-3898466(Primary Standard IndustrialClassific

3、ation Code Number)(I.R.S.EmployerIdentification Number)4660 La Jolla Village Drive,Suite 100,San Diego,CA 92122(Address,including zip code,and telephone number,including area code,of Registrants principal executive offices)650-800-3717(Registrants telephone number,including area code)James RolkeChie

4、f Executive OfficerRevelation Biosciences,Inc.4660 La Jolla Village Drive,Suite 100San Diego,California 92122650-800-3717(Name,address and phone number of agent for service)Copies of Communications to:J.P.Galda,Esq.J.P.Galda&Co.40 East Montgomery Avenue LTW 220Ardmore,Pennsylvania 19003(215)815-1534

5、 Charles Phillips,Esq.Ellenoff Grossman&Schole LLP1345 Avenue of the AmericasNew York,New York 10105(212)370-1300 Approximate date of commencement of proposed sale to the public:As soon as practicable after the effective date of thisRegistration Statement.If any of the securities being registered on

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

7、e Securities Act registration statement number of the earlier effective registration statement forthe same offering.2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelati

8、on.htm2/206If this form is a post-effective amendment filed pursuant to Rule 462(c)under the Securities Act,check the following box andlist the Securities Act registration statement number of the earlier effective registration statement for the same offering.If this form is a post-effective amendmen

9、t filed pursuant to Rule 462(d)under the Securities Act,check the following box andlist the Securities Act registration statement number of the earlier effective registration statement for the same offering.Indicate by check mark whether the registrant is a large accelerated filer,an accelerated fil

10、er,a non-accelerated filer,a smallerreporting company or an emerging growth company.See the definitions of“large accelerated filer,”“accelerated filer,”“smallerreporting company,”and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large accelerated filer Accelerated filer Non-accelerated f

11、iler Smaller reporting company Emerging growth company If an emerging growth company,indicate by check mark if the registrant has elected not to use the extended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B)of the Securi

12、ties Act.THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES ASMAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHERAMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALLTHEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SEC

13、TION 8(a)OF THE SECURITIES ACT OF 1933OR UNTIL THIS REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THECOMMISSION,ACTING PURSUANT TO SAID SECTION 8(a),MAY DETERMINE.2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archi

14、ves/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm3/206 The information in this preliminary prospectus is not complete and may be changed.We may not sell these securities untilthe registration statement filed with the Securities and Exchange Commission is effective.This preliminar

15、y prospectus isnot an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offeror sale is not permitted.Subject to Completion,Dated May 20,2025PRELIMINARY PROSPECTUS REVELATION BIOSCIENCES,INC.Up to 1,639,344 Shares of Common Stock 1

16、,639,344 Pre-Funded Warrants to Purchase up to 1,639,344 Shares of Common Stock and up to 1,639,344 Shares ofCommon Stock Underlying the Pre-Funded Warrants Up to 3,278,688 Class H-1 Common Stock Warrants to Purchase up to 3,278,688 Shares of Common Stock(which containsa zero exercise price option)a

17、nd up to 3,278,688 Shares of Common Stock Underlying the Class H-1 Common StockWarrants Up to 3,278,688 Class H-2 Common Stock Warrants to Purchase up to 3,278,688 Shares of Common Stock and up to3,278,688 Shares of Common Stock Underlying the Class H-2 Common Stock Warrants Up to 1,639,344 Class H-

18、3 Common Stock Warrants to Purchase up to 1,639,344 Shares of Common Stock and-1,639,344Shares of Common Stock Underlying the Class H-3 Common Stock Warrants This is a best efforts public offering of up to 1,639,344 shares of our common stock,Class H-1 warrants(the“Class H-1Warrants”)to purchase up

19、to 3,278,688 shares of our common stock,Class H-2 warrants(the“Class H-2 Warrants”)to purchaseup to 3,278,688 shares of our common stock and Class H-3 warrants(the“Class H-3 Warrants”and,collectively with the Class H-1Warrants and Class H-2 Warrants,the“Common Stock Warrants”)to purchase up to an ag

20、gregate of 1,639,344 shares of ourcommon stock,and the shares of common stock underlying the Common Stock Warrants,at an assumed combined public offeringprice of$3.05 per share of common stock and accompanying Common Stock Warrants.The Common Stock Warrants will beexercisable beginning on the effect

21、ive date of such stockholder approval as may be required by the applicable rules and regulationsof the Nasdaq Capital Market(or any successor entity)to permit the exercise of the Common Stock Warrants(“StockholderApproval”),provided that if a holder of Common Stock Warrants has not complied with any

22、 automatic exercise of such holdersClass H-3 Warrant(as described below),then such holders Class H-1 Warrant and Class H-2 Warrant will be exercisable for areduced amount of shares of common stock equal to 100%of the sum of such holders shares of common stock and pre-fundedwarrants initially purchas

23、ed at the closing of this offering.Each Common Stock Warrant is exercisable at an exercise price of$share and will expire five years from the initial exercise date.In addition upon Stockholder Approval,a holder of Class H-1 Warrants may,at any time and in its sole discretion,exercise its Class H-1 W

24、arrants in whole or in part by means of a one-timeonly“zero exercise price”option in which the holder is entitled to receive a number of shares of common stock that shall equal theproduct of(x)the aggregate number of shares of common stock that would be issuable upon exercise of the Class H-1 Warran

25、t inaccordance with its terms if such exercise were by means of a cash exercise rather than a cashless exercise and(y)10.As a result ofthis feature,we do not expect to receive any cash proceeds from the exercise of the Class H-1 Warrants because it is highly unlikelythat a Class H-1 Warrant holder w

26、ill elect to pay an exercise price in cash to receive one share of common stock when they couldelect the zero exercise price option in these circumstances to receive more shares of common stock than they would receive if theydid pay an exercise price.As an example,given the above provisions,holders

27、of the Class H-1 Warrants will be issued a maximumof 32,786,880 shares of common stock upon the exercise of the Class H-1 Warrants.Each Class H-1 Warrant includes oneunderlying share of common stock that may be obtained by exercising the Class H-1 Warrant at an assumed exercise price of$3.05based on

28、 the assumed public offering price of$3.05 per share of common stock;however if the holder elects the zero exercise priceoption,the number of shares of common stock could increase to up to 10 shares of common stock underlying each Class H-1Warrant.As such,holders of the Class H-1 Warrants may elect

29、to be issued up to 32,786,880 shares of common stock upon theexercise of the Class H-1 Warrants.The Class H-3 Warrants shall be automatically exercised upon Stockholder Approval at anexercise price of$share(provided that the other conditions provided in the Class H-3 Warrants are satisfied as of suc

30、h date).We are also offering to those purchasers,if any,whose purchase of common stock in this offering would otherwise result inany such purchaser,together with its affiliates,beneficially owning more than 4.99%(or,at the election of such purchaser,9.99%)2025/5/21 15:40sec.gov/Archives/edgar/data/1

31、810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm4/206of our outstanding common stock immediately following the consummation of this offering,the opportunity to purchase pre-funded warrants in lieu of sh

32、ares of our common stock that would otherwise result in such purchasers beneficial ownershipexceeding 4.99%(or,at the election of such purchaser,9.99%)of our outstanding common stock.The purchase price for each pre-funded warrant will equal the per share public offering price for the common stock in

33、 this offering less the$0.0001 per shareexercise price of each such pre-funded warrant.Each pre-funded warrant will be exercisable upon issuance and will not expireprior to exercise.This prospectus also relates to the shares of common stock that are issuable from time to time upon exercise ofthe pre

34、-funded warrants and Common Stock Warrants.2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm5/206 Our common stock is quoted for trading on the Nasdaq Capital

35、Market under the symbol“REVB”.On May 16,2025,the lastreported sales price for our common stock was$3.05 per share,which reflects the reverse stock split described below.The actualpublic offering price per share and accompanying Common Stock Warrants will be determined between us,the Placement Agenta

36、nd the investors in the offering,and may be at a discount to the then current market price of our common stock.Therefore,theassumed public offering price used throughout this prospectus may not be indicative of the final offering price.We do not intend toapply for listing of the Common Stock Warrant

37、s or pre-funded warrants on any national securities exchange or trading system.Effective January 28,2025,we effected a 1-for-16 reverse stock split and January 25,2024,we effected a 1-for-30 reversestock split,of our outstanding shares of common stock.Unless specifically provided otherwise herein,th

38、e share and per shareinformation that follows in this prospectus,other than in the historical financial statements and related notes included elsewhere inthis prospectus,assumes the effect of the reverse stock split.An investment in our common stock and warrants involves a high degree of risk.Before

39、 buying any securities youshould carefully read the discussion of the material risks of investing in our common stock and warrants in“Risk Factors”beginning on page 7 of this prospectus.We have engaged Roth Capital Partners,LLC as our exclusive placement agent(“Roth”or the“Placement Agent”)to use it

40、sreasonable best efforts to solicit offers to purchase our securities in this offering.The offering of the securities will terminate on theearlier of(i)the first date that we enter into securities purchase agreements to sell the securities offered hereby,or(ii)June 4,2025.The Placement Agent has no

41、obligation to purchase any of the securities from us or to arrange for the purchase or sale of anyspecific number or dollar amount of the securities.Because there is no minimum offering amount required as a condition to closingin this offering the actual public amount,placement agents fee,and procee

42、ds to us,if any,are not presently determinable and maybe substantially less than the total maximum offering amounts set forth above and throughout this prospectus.We have agreed topay the Placement Agent the placement agent fees set forth in the table below and to provide certain other compensation

43、to thePlacement Agent.See“Plan of Distribution”beginning on page 111 of this prospectus for more information regarding thesearrangements.NEITHER THE SECURITIES AND EXCHANGE COMMISSION(“SEC”)NOR ANY STATE SECURITIESCOMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR DETERMINED IF THISPROSPECTU

44、S IS TRUTHFUL OR COMPLETE.ANY REPRESENTATION TO THE CONTRARY IS A CRIMINALOFFENSE.Per Shareand relatedCommonStockWarrants(2)Per Pre-FundedWarrantandrelatedCommonStockWarrants(2)Total(3)Public offering price(1)$Placement Agent fees$Proceeds to us before offering expenses(4)$(1)The public offering pri

45、ce corresponds to(x)(i)a public offering price per share of$and(ii)a public offering price perCommon Stock Warrant of$0.0001,and(y)(i)a public offering price per pre-funded warrant of$and(ii)a publicoffering price per Common Stock Warrant of$0.0001.(2)Based on an assumed offering price of$3.05 per s

46、hare of common stock and associated Common Stock Warrants,or in thecase of pre-funded warrants,$3.0499 per pre-funded warrant to purchase one share of common stock and Common StockWarrants.The final offering price per share and associated Common Stock Warrants or pre-funded warrant to purchase onesh

47、are of common stock and Common Stock Warrants,as the case may be,will be determined by the Company,PlacementAgent and the investors in this offering and may be a discount to the market price of the Companys common stock.(3)This assumes no exercise of the Class H-3 Common Stock Warrant.In the event t

48、he Class H-3 Common Stock Warrant areexercised,the total public offering price,the total placement agent fees and the total net proceeds would be$_,$_,and$_,respectively.(4)We estimate the total expenses of this offering will be approximately$2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121

49、390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm6/206We expect this offering to be completed within two business days following the commencement of this offering and we willdeliver all securities to be issued in con

50、nection with this offering delivery versus payment upon receipt of investor funds receivedby us.Accordingly,there is no arrangement to receive or place investor funds in an escrow,trust or any similar account.We expect to deliver our shares,Common Stock Warrants and pre-funded warrants,if any,to pur

51、chasers in the offering on orabout May _,2025.Roth Capital Partners Dated:,2025 2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm7/206 TABLE OF CONTENTS PageMA

52、RKET AND INDUSTRY DATA iiTRADEMARKS iiINTRODUCTORY NOTE iiABOUT THIS PROSPECTUS iiPROSPECTUS SUMMARY 1SUMMARY OF THE OFFERING 4RISK FACTORS 7FORWARD-LOOKING STATEMENTS 43USE OF PROCEEDS 44MARKET INFORMATION FOR SECURITIES AND DIVIDEND POLICY 45CAPITALIZATION 46DILUTION 47MANAGEMENTS DISCUSSION AND A

53、NALYSIS OF FINANCIAL CONDITION AND RESULTS OFOPERATIONS 48DESCRIPTION OF THE COMPANYS BUSINESS 55DIRECTORS,EXECUTIVE OFFICERS,AND CORPORATE GOVERNANCE 84EXECUTIVE OFFICER AND DIRECTOR COMPENSATION OF REVELATION 89OUTSTANDING EQUITY AWARDS AT FISCAL YEAR END 91DIRECTOR COMPENSATION 95DESCRIPTION OF S

54、ECURITIES 96SECURITIES ACT RESTRICTIONS ON RESALE OF COMMON STOCK 109SECURITY OWNERSHIP OF MANAGEMENT AND CERTAIN BENEFICIAL OWNERS 110PLAN OF DISTRIBUTION 111CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS,AND DIRECTOR INDEPENDENCE 113INTERESTS OF NAMED EXPERTS AND COUNSEL 114DISCLOSURE OF CO

55、MMISSION POSITION OF INDEMNIFICATION FOR SECURITIES ACT LIABILITIES 115WHERE YOU CAN FIND MORE INFORMATION 116INDEX TO FINANCIAL STATEMENTS F-1 i2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/00012139002

56、5045828/ea0241635-s1_revelation.htm8/206 MARKET AND INDUSTRY DATA We are responsible for the disclosure contained in this prospectus.However,certain information contained in this documentrelates to or is based on studies,publications,surveys and other data obtained from third-party sources,and Revel

57、ations owninternal estimates and research.While we believe these third-party sources to be reliable as of the date of this prospectus,we havenot independently verified the market and industry data contained in this prospectus or the underlying assumptions relied ontherein.Finally,while we believe ou

58、r own internal research is reliable,such research has not been verified by any independentsource.The market and industry data used in this prospectus involve a number of assumptions and limitations,and any estimatesunderlying such market information and other factors,including those described in the

59、 section titled“Risk Factors,”could causeactual results to differ materially from those expressed in the third-party estimates and in our estimates.TRADEMARKS This document contains references to trademarks,trade names and service marks belonging to other entities.Solely forconvenience,trademarks,tr

60、ade names and service marks referred to in this prospectus may appear without the or symbols,butsuch references are not intended to indicate,in any way,that the applicable licensor will not assert,to the fullest extent underapplicable law,its rights to these trademarks and trade names.We do not inte

61、nd our use or display of other companies trade names,trademarks or service marks to imply a relationship with,or endorsement or sponsorship of us by,any other companies.INTRODUCTORY NOTE Effective January 28,2025,we effected a 1-for-16 reverse stock split of our outstanding shares of common stock.Un

62、lessspecifically provided otherwise herein,the share and per share information that follows in this prospectus,other than in thehistorical financial statements and related notes included elsewhere in this prospectus,assumes the effect of the reverse stock split.On January 25,2024,we effected the app

63、roved 1-for-30 reverse stock split of our outstanding shares of common stock.ABOUT THIS PROSPECTUS The registration statement of which this prospectus forms a part has been filed by us with the Securities and ExchangeCommission(the“SEC”),and includes exhibits that provide more detail of the matters

64、discussed in this prospectus.You shouldread this prospectus and the related exhibits filed with the SEC,together with the additional information described under theheadings“Where You Can Find Additional Information.”You should not assume that the information contained in this prospectusis accurate o

65、n any date subsequent to the date set forth on the front cover of this prospectus,even though this prospectus isdelivered or Shares of Common Stock are sold or otherwise disposed of on a later date.We have not authorized anyone to give any information or to make any representation to you other than

66、those contained in thisprospectus.You must not rely upon any information or representation not contained in this prospectus.This prospectus does notconstitute an offer to sell or the solicitation of an offer to buy any of our Shares of Common Stock other than the shares of ourcommon stock covered he

67、reby,nor does this prospectus constitute an offer to sell or the solicitation of an offer to buy any securitiesin any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction.Persons who comeinto possession of this prospectus in jurisdictions outside

68、the United States are required to inform themselves about,and to observe,any restrictions as to the offering and the distribution of this prospectus applicable to those jurisdictions.ii2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov

69、/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm9/206 PROSPECTUS SUMMARY This summary description about us and our business highlights selected information contained elsewhere in thisprospectus.To understand this offering fully,you should read carefully the entire prospect

70、us,including“Risk Factors”and“Cautionary Note Regarding Forward-Looking Statements.”Unless the context indicates or suggests otherwise,references to“we,”“our,”“us,”the“Company,”or the“Registrant”refer to Revelation Biosciences,Inc.,a Delaware corporation,and itssubsidiary.Overview Revelation is a cl

71、inical-stage life science company that is focused on rebalancing inflammation to optimize health using itsproprietary formulation Gemini.We have multiple ongoing programs to evaluate Gemini,including GEM-AKI as a preventionfor acute kidney injury(“AKI”),GEM-CKD as a treatment for chronic kidney dise

72、ase(“CKD”),GEM-PSI as a prevention forpost surgical infection(“PSI”),and GEM-PBI as a prevention of infection in severe burn patients requiring hospitalization(“PBI”).The Company was incorporated in the state of Delaware on November 20,2019(originally as Petra Acquisition,Inc.)and is based in San Di

73、ego,California.Our common stock and warrants sold in our initial public offering(“Public Warrants”)are listed on The Nasdaq StockMarket,LLC(“Nasdaq”)under the ticker symbol“REVB”and“REVBW,”respectively.Recent Developments 2025 Reverse Stock Split On January 17,2025,at a special meeting of stockholde

74、rs,our stockholders approved a Certificate of Amendment to ourThird Amended and Restated Certificate of Incorporation to effect a reverse stock split of our outstanding shares of commonstock at a specific ratio within a range of one-for-two(1-for-2)to a maximum of a one-for-fifty(1-for-50)split.Foll

75、owing thespecial meeting of stockholders and determination by the Board of Directors on the reverse split ratio,we filed a Certificate ofAmendment effective on January 28,2025,which effected a 1-for-16 reverse stock split of our outstanding shares of commonstock as of 12:01 a.m.Eastern Standard Time

76、 on January 28,2025.2024 Reverse Stock Split On January 17,2024,at a special meeting of stockholders,our stockholders approved a Certificate of Amendment to ourThird Amended and Restated Certificate of Incorporation to effect a reverse stock split of our outstanding shares of commonstock at a specif

77、ic ratio within a range of one-for-two(1-for-2)to a maximum of a one-for-fifty(1-for-50)split.On January 22,2024,we filed the Certificate of Amendment which effected a 1-for-30 reverse stock split of our outstanding shares of commonstock as of 12:01 a.m.Eastern Standard Time on January 25,2024.12025

78、/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm10/206 Business Strategy and Pipeline Revelation is developing a pipeline of potential high-value products based o

79、n Gemini.Gemini is Revelations proprietaryformulation of phosphorylated hexaacyl disaccharide(“PHAD”)an established Toll-like receptor 4(TLR4”)agonist that canstimulate the human bodys innate immune response to prevent and treat disease.Our current Gemini based programs consistof:Gemini-AKI,which is

80、 being developed for the prevention of AKI;Gemini-CKD for the treatment of CKD;Gemini-PSI,which is being developed for the prevention of PSI;and GEM-PBI as a prevention of infection in severe burn patients requiringhospitalization(our“Product Candidates”).Revelations pipeline is summarized in the fi

81、gure below:The Gemini Platform Our current therapeutic candidates are all based on our proprietary Gemini formulation of PHAD,a synthetic version ofmonophosphoryl lipid A(“MPLA”),that is known to stimulate TLR4.Stimulation of TLR4 via Gemini leads to a morecontrolled production of varied cytokines a

82、nd chemokines which modulate the activity of the innate and adaptive immuneresponse,relative to a lipopolysaccharide,a traditional TLR4 agonist.This“Immunostimulatory Preconditioning”with Geminiprepares the body to better guard against a rapid upregulation of multiple pro-inflammatory and microbial

83、gene products andproteins,such as pathogen-associated molecular patterns(“PAMPS”)and damage-associated molecular patterns(“DAMPS”)(damage-associated molecular proteins)(Zwirner 2017,Hernandez 2019,Ismaeli 2002).Modulated activities may includestimulation and recruitment of infection fighting immune

84、cells,reduction of inflammation,and/or regulation of inflammationdepending on the degree and nature of the stimulation,which enables the multiple potential product candidates in development.Figure 1:Interaction of PHAD with TLR4 2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/e

85、a0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm11/206 22025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-

86、s1_revelation.htm12/206 Gemini-AKI The Gemini-AKI program is being developed as a potential therapy for the prevention of AKI due to external stress orinsult(e.g.surgical procedure,chemotherapy toxicity).We believe immunologic preconditioning with Gemini prepares the bodyto handle biologic stress by

87、 redirecting the bodys immune system to have an attenuated response to the stress.Preclinical studies have demonstrated that preconditioning with PHAD significantly reduces the severity and duration ofAKI following an ischemia of the kidney.Additional data from these preclinical studies have been ac

88、cepted for presentation atThe International Conference on Advances in Critical Care Nephrology on March 12,2024.During 2024 we conducted a Phase 1 clinical study.safety and biomarker activity data from our Phase 1 clinical study wasannounced in June of 2024,showing a significant increase in anti-inf

89、lammatory cytokines including IL-1RA and IL-10.InJanuary of 2025 we announced the start of our Phase 1b clinical study in CKD patients.The Phase 1b clinical study will supportfurther development of Gemini-AKI.We expect data from our Phase 1b clinic study in the first half of this year.Gemini-CKD The

90、 Gemini-CKD program is being developed as a potential therapy for preventing the progression of CKD.We believeGemini may modulate the immune response from a pro-inflammatory state to an anti-inflammatory(protective)state torebalance the innate immune response and slow down or halt the progressive de

91、struction and scarring of organ tissue,allowingthe healing process to take place.Preclinical studies have demonstrated that Gemini significantly reduces the degree of scar tissue formation in ahyperinflammatory kidney injury model.In January of 2025 we announced the start of our Phase 1b clinical st

92、udy in CKD patients.The Phase 1b clinical study willsupport further development of Gemini-CKD.We expect data from our Phase 1b clinic study in the first half of this year.Gemini-PSI The Gemini-PSI program is being developed,through a license agreement with Vanderbilt University,as a potential therap

93、yfor the prevention or treatment of surgical site infection.We believe immunologic preconditioning with Gemini prepares thebody to resist infection by priming the bodys immune system to better and more rapidly respond to pathogen exposure.Multiple preclinical studies have shown that systemic pretrea

94、tment with PHAD results in a significantly augmentedimmune response leading to significantly reduced duration and severity of infection following bacterial challenge with eithergram-positive or gram-negative bacteria.Gemini-PBI The Gemini-PBI program is being developed,through a license agreement wi

95、th Vanderbilt University,as a potentialtherapy for the prevention of infection in severe burn patients requiring hospitalization.We believe Gemini administration tosevere burn patients will augment the patients immune response to resist infection by activating the bodys immune system tobetter and mo

96、re rapidly respond to pathogen exposure.Preclinical studies in a burn model have shown that systemic administration of MPLA(a bacterially derived mixture ofPHAD-like molecules)post-burn results in a significantly augmented immune response leading to significantly reducedduration and severity of infe

97、ction following pseudomonas challenge.Our Corporate History and Team The Company was incorporated in the state of Delaware on November 20,2019(originally as Petra Acquisition,Inc.)andis based in San Diego,California.We have assembled a management team of biopharmaceutical experts with extensiveexper

98、ience in drug development,manufacturing and commercialization of pharmaceutical products along with broad experiencein building companies from inception,including La Jolla Pharmaceutical Company,Pluromed,Inc.,and Horizon Pharma,Inc.We are also supported by a group of directors and leading investors

99、whose collective experience will assist us in realizing ourcorporate strategy.32025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm13/206 SUMMARY OF THE OFFERING

100、Shares of Common Stock Offeredby Us Up to 1,639,344 Shares of Common Stock.Common Stock WarrantsOffered by Us Class H-1 Warrants,Class H-2 Warrants and Class H-3 Warrants to purchase upto 8,196,720 shares of our common stock.The Common Stock Warrants will beexercisable upon the receipt of Stockholde

101、r Approval and ending five years from the initialexercise date at an exercise price of$per share of common stock.If a holder ofCommon Stock Warrants has not complied with any automatic exercise of such holdersClass H-3 Warrant,then such holders Class H-1 Warrant and Class H-2 Warrant will beexercisa

102、ble for a reduced amount of shares of common stock equal to 100%of the sum ofsuch holders shares of common stock and pre-funded warrants purchased at the closing ofthis offering.The Class H-1 Warrants include a one-time only“zero exercise price”optionin which the holders of Class H-1 Warrants are en

103、titled to receive a number of shares ofcommon stock that shall equal the product of(x)the aggregate number of shares ofcommon stock that would be issuable upon exercise of the Class H-1 Warrant inaccordance with its terms if such exercise were by means of a cash exercise rather than acashless exerci

104、se and(y)10.As a result of this feature,we do not expect to receive anycash proceeds from the exercise of the Class H-1 Warrants because it is highly unlikelythat a Class H-1 Warrant holder will elect to pay an exercise price in cash to receive oneshare of common stock when they could elect the zero

105、 exercise price option in thesecircumstances to receive more shares of common stock than they would receive if they didpay an exercise price.The Class H-3 Warrants shall be automatically exercised uponStockholder Approval at an assumed exercise price of$3.05 per share (provided that theother conditi

106、ons provided in the Class H-3 Warrants are satisfied as of such date).To betterunderstand the terms of the Common Stock Warrants,you should carefully read the“Description of Securities We are Offering-Common Stock Warrants”section of thisprospectus.You should also read the form of the Common Stock W

107、arrants,which are filedas an exhibit to the registration statement of which this prospectus forms a part.Pre-funded Warrants Offered byUs We are also offering to certain purchasers whose purchase of our common stock in thisoffering would otherwise result in the purchaser,together with its affiliates

108、,beneficiallyowning more than 4.99%(or,at the election of the purchaser,9.99%)of our outstandingshares of common stock immediately following the consummation of this offering,theopportunity to purchase pre-funded warrants in lieu of common stock that would otherwiseresult in any such purchasers bene

109、ficial ownership exceeding 4.99%(or,at the election ofthe purchaser,9.99%)of our outstanding shares of common stock.Each pre-fundedwarrant will be exercisable for one share of common stock.The purchase price of eachpre-funded warrant and the accompanying Common Stock Warrants will equal the price at

110、which the common stock and the accompanying Common Stock Warrants are being sold tothe public in this offering,minus$0.0001,and the exercise price of each pre-fundedwarrant will be$0.0001 per share.The pre-funded warrants will be exercisableimmediately and may be exercised at any time until exercise

111、d in full.For each pre-fundedwarrant we sell,the number of shares of common stock we are offering will be decreasedon a one-for-one basis.Because we will issue Common Stock Warrants for each share ofcommon stock and for each pre-funded warrant to purchase share of common stock sold inthis offering,t

112、he number of Common Stock Warrants sold in this offering will not changeas a result of a change in the mix of the shares of our common stock and pre-fundedwarrants sold.Shares of Common Stockoutstanding before the offering 963,796 Shares of Common Stock as of the date hereof(not including shares iss

113、uable uponexercisable warrants).Offering Price$per share of Common Stock and accompanying Common Stock Warrants,or pre-funded warrants and accompanying Common Stock Warrants,as applicable.Common Stock outstanding afterthis offering 2,603,140 Shares(assuming we sell only shares of common stock and no

114、 pre-fundedwarrants,and none of the Common Stock Warrants issued in this offering are exercised).Use of proceeds We estimate that we will receive net proceeds from this offering(assuming the automaticexercise of the Class H-3 Common Stock Warrant)of approximately$8,960,000 basedupon an assumed offer

115、ing price of$3.05 per share of Common Stock and accompanyingCommon Stock Warrants,or pre-funded warrant and accompanying Common StockWarrants,as applicable,which was also the last reported trading price of our common2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_r

116、evelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm14/206stock on The Nasdaq Capital Market on May 16,2025,after deducting Placement Agentfees and estimated offering expenses payable by us.We currently intend to use the netproceeds we receive fr

117、om this offering to further the development of our ProductCandidates including the(i)the completion of our ongoing Phase 1b clinical study,(ii)themanufacture of clinical drug supply,(iii)additional preclinical work for multipleindications,(iv)continue to develop other products and therapies,and(v)fu

118、nd workingcapital and general corporate purposes using any remaining amounts.Because this is a bestefforts offering with no minimum amount as a condition to closing,we may not sell all orany of the securities offered hereby.As a result,we may receive significantly less in netproceeds than we current

119、ly estimate.See“Use of Proceeds”on page 44.Nasdaq Trading Symbols Common Stock REVB Public Warrants REVBW Reverse Stock Split A 1-for-16 reverse stock split of our outstanding shares of common stock was effected onJanuary 28,2025,and a 1-for-30 reverse stock split of our outstanding shares of common

120、stock was effected on January 25,202442025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm15/206 Risk Factors Summary In evaluating the information in this prospe

121、ctus,you should carefully read this prospectus,including the annexes,andespecially consider the factors discussed in the section titled“Risk Factors.”Some of the risks related to Revelations business and industry are summarized below.Risks Related to Our Business We have a limited operating history

122、and no products approved for commercial sale.We have incurred net losses sinceour inception,we anticipate that we will continue to incur significant losses for the foreseeable future,and even if wewere to generate revenue,we may never achieve or maintain profitability.Risks Related to the Product De

123、velopment,Regulatory Approval,Manufacturing and Commercialization of Our ProgramProducts and Product Candidates If preclinical studies or clinical studies for our Program Products are unsuccessful or delayed,we will be unable tomeet our future development goals.The results of prior preclinical or cl

124、inical studies are not necessarily predictive of our future results.The Clinical Studies of our Program Products have been and may in the future be conducted outside the United States,and the FDA or comparable foreign regulatory authorities may not accept data from such studies.Our Program Products

125、and the administration of our Program Products may cause undesirable side effects or haveother properties that could delay or prevent their regulatory approval,limit the commercial profile of an approved labelor result in significant negative consequences following marketing approval,if any.Our busi

126、ness depends on the success of our Program Products,including obtaining regulatory approval to market ourProduct Candidates in the United States and/or other major foreign markets such as the European Union.Even if we obtain regulatory approval for a product candidate,our products and business will

127、remain subject toongoing regulatory obligations and review.Legislative or regulatory healthcare reforms in the United States or other countries may make it more difficult andcostly for us to obtain regulatory clearance or approval of our Program Products and to produce,market and distributeour Progr

128、am Products after clearance or approval is obtained.We face intense competition in an environment of rapid technological change and the possibility that our competitorsmay develop products and drug delivery systems that are similar,more advanced or more effective than ours,whichmay adversely affect

129、our financial condition and our ability to successfully market or commercialize our ProgramProducts.52025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm16/206 Ri

130、sks Related to our Reliance on Third Parties We rely on third parties to conduct certain elements of our preclinical and clinical studies and perform other tasks forus.If these third parties do not successfully carry out their contractual duties,meet expected deadlines or comply withregulatory requi

131、rements,we may not be able to obtain regulatory approval for or commercialize our Program Products.We rely on third parties to manufacture the raw materials,including the active pharmaceutical ingredients that we useto create our therapeutic product candidate,and to manufacture the diagnostic device

132、s,including the antibodies usedfor testing.Risks Related to Our Intellectual Property If we are unable to obtain and maintain effective patent rights for our Product Candidates or any future productcandidates,we may not be able to compete effectively in our markets.If we are unable to protect the co

133、nfidentiality ofour trade secrets or know-how,such proprietary information may be used by others to compete against us.We may not be able to protect our intellectual property rights throughout the world.We may not have sufficient patent lifespan to effectively protect our products and business.If we

134、 are unable to maintain effective proprietary rights for our Program Products or any future product candidates,wemay not be able to compete effectively in our markets.Risks Related to Our Business Operations Our future success depends in part on our ability to retain our senior management team,direc

135、tors and other keyemployees and to attract,retain and motivate other qualified personnel.General Risk Factors We are subject to several other risks of which other public companies are subject,including without limitation,the volatilityof our common stock price;our ability to comply with corporate go

136、vernance laws and financial reporting standards;and ourability to maintain an effective system of internal controls.62025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelat

137、ion.htm17/206 RISK FACTORS The following risk factors are not exhaustive and investors are encouraged to perform their own investigation with respect tothe business,prospects,financial condition and operating results of Revelation and our business,prospects,financial condition andoperating results.Y

138、ou should carefully consider the following risk factors in addition to the other information included in this proxystatement/prospectus,including matters addressed in the section titled“Cautionary Note Regarding Forward-LookingStatements.”We may face additional risks and uncertainties that are not p

139、resently known to us,or that we currently deemimmaterial,which may also impair our business,prospects,financial condition or operating results.The following discussionshould be read in conjunction with our financial statements and notes to the financial statements included herein.Risks Related to th

140、is Offering We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.Our management will have broad discretion in the application of the net proceeds,including for any of the purposes describedin the section of this prospectus entitled“Use of Procee

141、ds”.You will be relying on the judgment of our management with regard tothe use of these net proceeds,and you will not have the opportunity,as part of your investment decision,to assess whether the netproceeds are being used appropriately.The failure by our management to apply these funds effectivel

142、y could result in financiallosses that could have a material adverse effect on our business,cause the price of our securities to decline and delay thedevelopment of our product candidates.Pending the application of these funds,we may invest the net proceeds from this offeringin a manner that does no

143、t produce income or that loses value.You will experience immediate and substantial dilution in the net tangible book value of the shares you purchase in this offeringand may experience additional dilution in the future.The combined public offering price per share of common stock and related Common S

144、tock Warrant,and the combined publicoffering price of each pre-funded warrant and related Common Stock Warrant,will be substantially higher than the pro forma asadjusted net tangible book value per share of our common stock after giving effect to this offering.Assuming the sale of 1,639,344shares of

145、 our common stock and warrants to purchase up to 8,196,720 shares of common stock at an assumed combined publicoffering price of$3.05 per share and related Common Stock Warrants,the closing sale price per share of our common stock on theNasdaq on May 16,2025,assuming no sale of any pre-funded warran

146、ts in this offering,no exercise of the warrants being offeredin this offering and after deducting the placement agent fees and commissions and estimated offering expenses payable by us,youwill incur immediate dilution of approximately$0.26 per share.As a result of the dilution to investors purchasin

147、g securities in thisoffering,investors may receive significantly less than the purchase price paid in this offering,if anything,in the event of theliquidation of our company.See the section entitled“Dilution”below for a more detailed discussion of the dilution you will incur ifyou participate in thi

148、s offering.To the extent shares are issued under outstanding options and warrants at exercise prices lower thanthe public offering price of our common stock in this offering,you will incur further dilution.The Common Stock Warrants and pre-funded warrants are speculative in nature.The Common Stock W

149、arrants and pre-funded warrants offered hereby do not confer any rights of share of common stockownership on their holders,such as voting rights or the right to receive dividends,but rather merely represent the right to acquireshares of common stock at a fixed price.Specifically,commencing on the da

150、te of issuance,holders of the common warrants mayacquire the shares of common stock issuable upon exercise of such warrants at an exercise price of$per share of common stock,and holders of the pre-funded warrants may acquire the shares of common stock issuable upon exercise of such warrants at anexe

151、rcise price of$0.0001 per share of common stock.Moreover,following this offering,the market value of the warrants and pre-funded warrants is uncertain and there can be no assurance that the market value of the warrants or pre-funded warrants will equalor exceed their respective public offering price

152、s.There can be no assurance that the market price of the shares of common stockwill ever equal or exceed the exercise price of the warrants or pre-funded warrants,and consequently,whether it will ever beprofitable for holders of warrants to exercise the warrants or for holders of the pre-funded warr

153、ants to exercise the pre-fundedwarrants.If the Class H-1 Warrants are exercised by way of a one-time only“zero exercise price”option,stockholders may suffersubstantial dilution.If the Class H-1 Warrants are exercised by way of a one-time only“zero exercise price”option,assuming receipt ofStockholder

154、 Approval,such exercising holder will receive 10 shares of common stock for each Class H-1 Warrant they exercise,without any cash payment to us.If a“zero exercise price”option is utilized,such exercise will result in substantial dilution tostockholders.As a result of this feature,we do not expect to

155、 receive any cash proceeds from the exercise of the Class H-1 Warrantsin these circumstances because it is highly unlikely that a Class H-1 Warrant holder will elect to pay an exercise price in cash toreceive one share of common stock at a time when they could elect the zero exercise price option to

156、 receive more shares ofcommon stock than they would receive if they did pay an exercise price.If each holder of the Class H-1 Warrants elects the zeroexercise price option,the number of shares of common stock could increase to up to 32,786,880 shares of common stockunderlying each Class H-1 Warrant.

157、As such,holders of the Class H-1 Warrants may elect to be issued up to 32,786,880 shares of2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm18/206common stock

158、upon the exercise of the Class H-1 Warrants.If holders of the Class H-1 Warrants elect the zero exercise priceoption,on this basis,such exercise will result in substantial dilution to stockholders.The Common Stock Warrants are not exercisable until Stockholder Approval and may not have any value.Und

159、er Nasdaq listing rules,the Common Stock Warrants are not exercisable without Stockholder Approval for the issuance ofshares issuable upon exercise of such Common Stock Warrants.While we intend to use reasonable best efforts to seek StockholderApproval for issuances of shares of common stock issuabl

160、e upon exercise of the Common Stock Warrants,there is no guaranteethat the Stockholder Approval will ever be obtained.The Common Stock Warrants will be exercisable commencing on the dateStockholder Approval is obtained,at an initial exercise price per share of$per share.In the event that the price o

161、f a share of ourcommon stock does not exceed the exercise price of the Common Stock Warrants during the period when the Common StockWarrants are exercisable,the Common Stock Warrants may not have any value.If we are unable to obtain the StockholderApproval,the Common Stock Warrants will not be exerc

162、isable and therefore would have no value.In addition,we may incur substantial cost,and management may devote substantial time and attention,in attempting to obtainStockholder Approval of the issuance of shares of common stock upon exercise of the Common Stock Warrants issued in thisoffering.72025/5/

163、21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm19/206 Holders of the warrants offered hereby will have no rights as common stockholders with respect to the shares o

164、ur commonstock underlying the warrants until such holders exercise their warrants and acquire our common stock,except as otherwiseprovided in the warrants.Until holders of the warrants and the pre-funded warrants acquire shares of our common stock upon exercise thereof,suchholders will have no right

165、s with respect to the shares of our common stock underlying such warrants,except to the extent thatholders of such warrants will have certain rights to participate in distributions or dividends paid on our common stock as set forthin the warrants.Upon exercise of the common warrants and the pre-fund

166、ed warrants,the holders will be entitled to exercise therights of a common stockholder only as to matters for which the record date occurs after the exercise date.This is a best efforts offering,no minimum amount of securities is required to be sold,and we may not raise the amount ofcapital we belie

167、ve is required for our business plans,including our near-term business plans.The placement agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities in this offering.Theplacement agent has no obligation to buy any of the securities from us or to arrange for the

168、 purchase or sale of any specific numberor dollar amount of the securities.There is no required minimum number of securities that must be sold as a condition tocompletion of this offering.Because there is no minimum offering amount required as a condition to the closing of this offering,the actual o

169、ffering amount,placement agent fees and proceeds to us are not presently determinable and may be substantially lessthan the maximum amounts set forth above.We may sell fewer than all of the securities offered hereby,which may significantlyreduce the amount of proceeds received by us,and investors in

170、 this offering will not receive a refund in the event that we do notsell an amount of securities sufficient to support our continued operations,including our near-term continued operations.Thus,wemay not raise the amount of capital we believe is required for our operations in the short-term and may

171、need to raise additionalfunds,which may not be available or available on terms acceptable to us.Risks Related to Our Business Although our financial statements have been prepared on a going concern basis,we have a limited operating history and noproducts approved for commercial sale.We have incurred

172、 net losses since our inception,we anticipate that we will continue toincur significant losses for the foreseeable future,and even if we were to generate revenue,we may never achieve or maintainprofitability.We are a clinical stage biopharmaceutical company with a limited operating history may make

173、it difficult to evaluate thesuccess of our business to date and to assess our future viability.To date,our operations have been limited to organizing andstaffing our Company,business planning,raising capital,conducting research and development activities,including early clinicalstudies,and providing

174、 general and administrative support for these operations.Investment in biopharmaceutical productdevelopment and diagnostic device is highly speculative because it entails substantial upfront capital expenditures and significantrisk that any potential product candidate and/or diagnostic device will f

175、ail to demonstrate adequate effect and/or an acceptablesafety profile,gain regulatory approval or become commercially viable.We currently have no products approved for commercialsale,we have not generated any revenue from product sales to date and we continue to incur significant research and develo

176、pmentand other expenses related to our ongoing operations.We have limited experience as a Company conducting clinical studies and noexperience as a Company commercializing any products.We are not profitable and have incurred net losses since our inception.As of March 31,2025,we had an accumulated de

177、ficit of$42.6 million.Consequently,predictions about our future success or viability may not be as accurate as they would be if we had alonger operating history or a history of successfully developing and commercializing pharmaceutical products.We have spent,andexpect to continue to spend,significan

178、t resources to fund research and development of,conduct clinical studies,and seekregulatory approvals for,our Program Products,and any future product candidates.We expect to incur substantial and increasingoperating losses over the next several years as our research,development,preclinical testing a

179、nd clinical study activities increase.As a result,our accumulated deficit will also increase significantly.We may encounter unforeseen expenses,difficulties,complications,delays and other unknown factors that may adversely affect our business.The size of our future net losses willdepend,in part,on t

180、he rate of future growth of our expenses and our ability to generate revenue.Our prior losses and expectedfuture losses have,had and will continue to have a material adverse effect on our stockholders equity and working capital.We do not anticipate that our current cash and cash equivalents balance

181、will be sufficient to sustain operations within one-yearafter the date that our audited financial statements for December 31,2024 were issued,which raises substantial doubt about ourability to continue as a going concern.In our own required quarterly assessments,we may continue to conclude that ther

182、e issubstantial doubt about our ability to continue as a going concern,and future reports from our independent registered publicaccounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern.If we seek additional financing to fund our busine

183、ss activities in the future and there remains substantial doubt about goingconcern,investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmh

184、ttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm20/206at all.Our ability to raise more equity capital will depend in part on our ability to amend our certificate of incorporation toauthorize additional shares of common stock.The net losses we incur may flu

185、ctuate significantly from quarter-to-quarter such that a period-to-period comparison of ourresults of operations may not be a good indication of our future performance.82025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/

186、data/1810560/000121390025045828/ea0241635-s1_revelation.htm21/206 We have no products approved for marketing in any jurisdiction,and our Program Products are in early stages of development.We have never generated any revenue from product sales.Our ability to generate revenue and achieve profitabilit

187、y depends on ourability,alone or with strategic collaboration partners,to successfully complete the development of and obtain the regulatory andmarketing approvals necessary to commercialize one or more of our Program Products.We do not anticipate generating revenuefrom product sales in the next cou

188、ple of years.Even if we eventually generate product revenue,we may never be profitable and,ifwe do achieve profitability,we may not be able to sustain or increase profitability on a quarterly or annual basis.We may not be able to raise additional funding on acceptable terms,or at all.Failure to obta

189、in funding on acceptable terms andon a timely basis may require us to curtail,delay or discontinue our product development efforts or other operations.Raisingadditional funding may cause dilution to our stockholders.Developing our Program Products is expensive,and we expect our research and developm

190、ent expenses to increasesubstantially in connection with our ongoing activities,particularly as we advance our Program Products through clinical studies,manufacturing and regulatory approval.We expect to finance future cash needs through public or private equity or debt offerings orproduct collabora

191、tions.We do not have any committed external source of funds.We cannot guarantee that future financing will beavailable in sufficient amounts or on terms acceptable to us,if at all,and the terms of any financing may adversely affect theinterests or rights of our stockholders.Even if we believe that w

192、e have sufficient funds for our current or future operating plans,wemay seek additional capital if market conditions are favorable or if we have specific strategic considerations.The issuance ofadditional securities,whether equity or debt,by us,or the possibility of such issuance,may affect the valu

193、e of your investment.To the extent that we raise additional capital through the sale of equity or convertible debt securities,your ownership interestwill be diluted,and the terms of such securities may include liquidation or other preferences that adversely affect your rights as astockholder.Debt fi

194、nancing,if available,may involve covenants restricting our operations or our ability to incur additional debt.If we do not raise additional capital,we may not be able to expand our operations or otherwise capitalize on our businessopportunities,our business and financial condition will be negatively

195、 impacted,and we may need to:significantly delay,scale back or discontinue research and discovery efforts and the development or commercialization ofour Product Programs and future program candidates or cease operations altogether;seek strategic alliances for research and development programs when w

196、e otherwise would not,or at an earlier stage thanwe would otherwise desire or on terms less favorable than might otherwise be available;or relinquish,or license on unfavorable terms,our rights to technologies or any product candidates that we otherwise wouldseek to develop or commercialize ourselves

197、.Unfavorable global economic conditions,including any adverse macroeconomic conditions or geopolitical events,including theCOVID-19 pandemic,the conflict between Ukraine and Russia,and recent bank failures affecting the financial servicesindustry,could adversely affect our business,financial conditi

198、on,results of operations or liquidity,either directly or throughadverse impacts on certain of the third parties on which we rely to conduct certain aspects of our preclinical studies or clinicaltrials.Our results of operations could be adversely affected by general conditions in the global economy a

199、nd in the global financialmarkets.Global economic and business activities continue to face widespread uncertainties,and global credit and financial marketshave experienced extreme volatility and disruptions in the past several years,including severely diminished liquidity and creditavailability,risi

200、ng inflation and monetary supply shifts,rising interest rates,labor shortages,declines in consumer confidence,declines in economic growth,increases in unemployment rates,recession risks,and uncertainty about economic and geopoliticalstability.A severe or prolonged economic downturn,or additional glo

201、bal financial or political crises,could result in a variety ofrisks to our business,including delayed clinical trials or preclinical studies,delayed approval of our product candidates,delayedability to obtain patents and other intellectual property protection,weakened demand for our product candidat

202、es,if approved,or ourability to raise additional capital when needed on acceptable terms,if at all.The extent of the impact of these conditions on ouroperational and financial performance,including our ability to execute our business strategies and initiatives in the expectedtimeframe,as well as tha

203、t of third parties upon whom we rely,will depend on future developments which are uncertain and cannotbe predicted.A weak or declining economy also could strain our suppliers,possibly resulting in supply disruption.Any of theforegoing could harm our business and we cannot anticipate all of the ways

204、in which the current economic climate and financialmarket conditions could adversely impact our business.Furthermore,our stock price may decline due in part to the volatility of thestock market and the general economic downturn.92025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/e

205、a0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm22/206 Risks Related to the Product Development,Regulatory Approval,Manufacturing andCommercialization of Our Program Products and Product Candidates Significant reductions in FDA s

206、taffing and changes in federal regulatory policy may delay or adversely affect the approval andcommercialization of our product candidates.Recent actions by the current administration,including substantial reductions in the workforce of the U.S.Food and DrugAdministration(“FDA”),have created increas

207、ed uncertainty regarding the timing and outcome of regulatory reviews for new drugsand biologics.These staffing cuts,which have affected key divisions responsible for the review of innovative therapies,may resultin longer review times,missed milestones,and inconsistent or delayed feedback from the a

208、gency.In addition,the loss ofexperienced FDA personnel and potential further restructuring could lead to a loss of institutional knowledge and a reduced abilityto resolve complex regulatory questions efficiently.As a result,we may experience delays in the initiation,conduct,or completion of our clin

209、ical trials and in the review andapproval of our marketing applications.These delays could adversely impact our ability to bring our product candidates to market,disrupt our development timelines,and increase our costs.Furthermore,ongoing regulatory uncertainty may negatively affectinvestor confiden

210、ce and our ability to raise additional capital on favorable terms,particularly as small and mid-capbiopharmaceutical companies are more vulnerable to such disruptions.If the FDAs operational capacity continues to be reduced or if further policy changes are implemented that affect the agencysreview p

211、rocesses,our business,financial condition,and results of operations could be materially and adversely affected.If preclinical studies or clinical studies for our Program Products are unsuccessful or delayed,we will be unable to meet ourfuture development goals.Conducting clinical studies for any pro

212、duct candidates for approval in the United States requires filing an IND and reachingagreement with the FDA on clinical protocols,finding appropriate clinical sites and clinical investigators,securing approvals forsuch studies from the IRB at each such site,manufacturing clinical quantities of produ

213、ct candidates and supplying drug product ordevices to clinical sites.Currently,we do not have an active IND with the FDA in the United States for our Program Products.Ifour IND is not approved by the FDA,our clinical development timeline may be negatively impacted,and any future clinicalprograms may

214、 be delayed or terminated.Even if the clinical studies are approved by FDA or other regulatory agencies,clinical study is expensive and can takemany years to complete,and its outcome is inherently uncertain.A failure of one or more of our clinical studies can occur at anytime during the clinical stu

215、dy process.We do not know whether future clinical studies,if any,will begin on time,need to beredesigned,enroll an adequate number of patients on time or be completed on schedule,if at all.Clinical studies can be delayed,suspended or terminated for a variety of reasons,including failure to(i)generat

216、e sufficient positive preclinical and clinical data;(ii)recruit CROs,clinical investigators and patients in a timely manner;(iii)manufacture sufficient quantities at the requiredquality of Program Products for use in clinical studies;(iv)raise sufficient capital to fund a study;(v)comply with all ap

217、plicableregulatory requirements,whether in the United States or elsewhere,and(vi)obtain successful regulatory approval from regulatoryauthorities like the FDA.If we experience delays in completing any clinical study of our Program Products or successfully obtaining regulatoryapproval,the commercial

218、prospects of our Program Products may be harmed,and our ability to generate product revenues from anyof these product candidates will be delayed.In addition,any delays in completing our clinical studies will increase our costs,slowdown the development and approval process of our Program Products,and

219、 jeopardize our ability to commence product sales andgenerate revenues.Any of these occurrences may significantly harm our business and financial condition.In addition,many of thefactors that cause,or lead to,a delay in the commencement or completion of clinical studies may also ultimately lead to t

220、he denialof regulatory approval of our product candidates.Drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes,and the results ofprior preclinical or clinical studies are not necessarily predictive of our future results.Our clinical studies may fa

221、il toadequately demonstrate the safety and efficacy of our Program Products or any future product candidates.We are focused on the development of our Product Candidates,which are in pre-clinical and clinical development.There is a high failure rate for product candidates proceeding through clinical

222、studies.Failure can occur at any time during theclinical study process.Many companies in the pharmaceutical industry have suffered significant setbacks in late-stage clinicalstudies even after achieving promising results in preclinical testing and earlier-stage clinical studies.Data obtained from pr

223、eclinicaland clinical activities are subject to varying interpretations,which may delay,limit or prevent regulatory approval.In addition,wemay experience regulatory delays or rejections as a result of many factors,including changes in regulatory policy during thedevelopment period of our Program Pro

224、ducts.Success in preclinical testing and early clinical studies does not ensure that later2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm23/206clinical studi

225、es will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of aproduct candidate.Frequently,product candidates that have shown promising results in early clinical studies have subsequentlysuffered significant setbacks in later clinical studies.If we a

226、re unable to successfully demonstrate the safety and efficacy of ourProgram Products or other future product candidates and receive the necessary regulatory approvals,our business will be materiallyharmed.102025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation

227、.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm24/206 The Clinical Studies of our Program Products have been and are planned to be conducted outside the United States,and theFDA or comparable foreign regulatory authorities may not accept data from su

228、ch studies.We currently have not conducted any clinical studies in the United States to date.We have conducted and we plan to conductadditional clinical studies outside the United States,including Europe,Australia,or other foreign jurisdictions.The acceptance ofclinical study data by the FDA from cl

229、inical studies conducted outside the United States may be subject to certain conditions.Incases where data from clinical studies conducted outside the United States are intended to serve as the sole bases for regulatoryapproval in the United States,the FDA will generally not approve the application

230、on the basis of foreign data alone unless(i)thedata are applicable to the United States population and United States medical practices,(ii)the studies were performed by clinicalinvestigators of recognized competence and(iii)the data may be considered valid without the need for an on-site inspection

231、by theFDA or,if the FDA considers such an inspection to be necessary,the FDA is able to validate the data through an on-site inspectionor other appropriate means.Additionally,the FDAs clinical study requirements,including sufficient size of patient populations andstatistical powering,must be met.Man

232、y foreign regulatory bodies have similar approval requirements.In addition,such foreignstudies would be subject to the applicable local laws of the foreign jurisdictions where the studies are conducted.There can be noassurance that the FDA or any comparable foreign regulatory authority will accept d

233、ata from studies conducted outside of theUnited States or the applicable jurisdiction.If the FDA or any comparable foreign regulatory authority does not accept such data,itwould result in the need for additional studies,which would be costly and time-consuming and delay aspects of our business plan,

234、and may result in our Program Products not receiving regulatory approval or clearance for commercialization in the applicablejurisdiction.As an organization,we have never conducted pivotal clinical studies,and we may be unable to do so for any Program Productswe may develop.We will need to successfu

235、lly complete pivotal clinical studies in order to obtain the approval of the FDA,the EMA or otherregulatory agencies to market any of our Program Products.Carrying out later-stage clinical studies and the submission to the FDAof a successful NDA is a complicated process.As an organization,we have no

236、t previously conducted any later stage or pivotalclinical studies and have limited experience in preparing,submitting and prosecuting regulatory filings.We may be unable toconduct clinical studies at preferred sites,enlist clinical investigators,enroll sufficient numbers of participants or begin ors

237、uccessfully complete clinical studies in a timely fashion,if at all.In addition,the design of a clinical study can determine whetherits results will support approval of a product,and flaws in the design of a clinical study may not become apparent until the clinicalstudy is well advanced.Because we h

238、ave limited experience as a company designing clinical studies,we may be unable tosuccessfully and efficiently execute and complete necessary clinical studies in a way that leads to successful regulatory submissionand approval.We may require more time and incur greater costs than our competitors and

239、 may not succeed in obtaining regulatoryapprovals of product candidates that we develop.Failure to commence or complete,or delays in,our planned clinical studies,couldprevent us from or delay us in commercializing our Program Products.We rely on third parties to conduct certain elements of ourprecli

240、nical and clinical studies and perform other tasks for us.If these third parties do not successfully carry out their contractualduties,meet expected deadlines or comply with regulatory requirements,we may not be able to obtain regulatory approval for orcommercialize our Program Products.In addition,

241、Congress recently amended the FDCA to require sponsors of a Phase 3 clinical trial,or other“pivotal study”of anew drug to support marketing authorization,to design and submit a diversity action plan for such clinical trial.The action planmust describe appropriate diversity goals for enrollment,as we

242、ll as a rationale for the goals and a description of how the sponsorwill meet them.Although none of our product candidates has reached Phase 3 of clinical development,we must submit a diversityaction plan to the FDA by the time we submit a Phase 3 trial,or pivotal study,protocol to the agency for re

243、view,unless we are ableto obtain a waiver for some or all of the requirements for a diversity action plan.It is unknown at this time how the diversity actionplan may affect the planning and timing of any future Phase 3 trial for our product candidates or what specific information FDAwill expect in s

244、uch plans.However,initiation of such trials may be delayed if the FDA objects to our proposed diversity actionplans for any future Phase 3 trial for our product candidates,and we may experience difficulties recruiting a diverse population ofpatients in attempting to fulfill the requirements of any a

245、pproved diversity action plan.112025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm25/206 We may find it difficult to enroll patients in our clinical studies,whi

246、ch could delay or prevent us from proceeding with clinicalstudies.Identifying and qualifying patients to participate in clinical studies of our product candidates is critical to our success.Thetiming of our clinical studies depends in part on the speed at which we can recruit patients to participate

247、 in testing our ProgramProducts,and we may experience delays in our clinical studies if we encounter difficulties in enrollment.Patient enrollment andretention in clinical studies depends on many factors,including the size of the patient population,number and location of theclinical sites,significan

248、t adverse events or other side effects observed,if any,the nature of the study protocol,our ability to recruitclinical study investigators with the appropriate competencies and experience,the existing body of safety and efficacy data withrespect to the study drug,the number and nature of competing t

249、reatments and ongoing clinical studies of competing drugs for thesame indication,the proximity of patients to clinical sites,clinicians and patients perceptions as to the potential advantages of theProgram Products being studied in relation to other available therapies,including any drugs that may b

250、e approved for theindications we are investigating,the eligibility criteria for the study,our ability to obtain and maintain patient consents and the riskthat patients enrolled in clinical studies will drop out of the studies before completion.In addition,our competitors,some of whom have significan

251、tly greater resources than we do,are conducting clinical studies forthe same indications and seek to enroll patients in their studies that may otherwise be eligible for our clinical studies or studies,which could lead to slow recruitment and delays in our clinical programs.Further,since the number o

252、f qualified clinicalinvestigators is limited,we expect to conduct some of our clinical studies at the same clinical study sites that some of ourcompetitors use,which could further reduce the number of patients who are available for our clinical studies in these sites.Our inability to enroll sufficie

253、nt number of patients for our clinical studies would result in significant delays or may require usto abandon one or more clinical studies altogether.If we are unable to enroll sufficient number of patients that will completeclinical testing,we will be unable to seek or gain marketing approval for o

254、ur Program Products and any future product candidatesand our business will be harmed.Even if we are able to enroll a sufficient number of patients in our clinical studies or studies,delays in patient enrollment may result in increased costs or may affect the timing or outcome of our clinical studies

255、,which couldprevent completion of these studies and adversely affect our ability to advance the development of our Program Products and anyfuture product candidates.Our Program Products and the administration of our Program Products may cause undesirable side effects or have otherproperties that cou

256、ld delay or prevent their regulatory approval,limit the commercial profile of an approved label or result insignificant negative consequences following marketing approval,if any.The severity and frequency of undesirable side effects caused by our Program Products,could cause us or regulatoryauthorit

257、ies to interrupt,delay or halt clinical studies and could result in a more restrictive label,delay or denial of regulatoryapproval by the FDA or other regulatory agencies.Results of our studies could reveal a high and unacceptable severity andprevalence of these or other side effects.In such an even

258、t,our clinical studies could be suspended or terminated,and the FDA orother regulatory agencies could order us to cease further development of or deny or withdraw approval of our product candidatesfor any or all targeted indications.Moreover,during the conduct of clinical studies,patients report cha

259、nges in their health,including illnesses,injuries and discomforts,to their study doctor.Often,it is not possible to determine whether or not the productcandidate being studied caused these conditions.Drug-related,drug product-related,formulation-related and administration-related side effects could

260、affect patient recruitment,the ability of enrolled patients to complete the clinical study or result in potential product liability claims,which could exceed theinsurance coverage.Additionally,if one or more of our Program Products receives marketing approval,and we or others lateridentify undesirab

261、le side effects caused by such products,a number of potentially significant negative consequences could result.If we or others identify undesirable or unacceptable side effects caused by our Program Products or any future productcandidates or products:we may be required to modify,suspend or terminat

262、e our clinical studies;we may be required to modify or include additional dosage and administration instructions,warnings and precautions,contraindications,boxed warnings,limitations,restrictions or other statements in the product label for our approvedproducts,or issue field alerts to physicians an

263、d pharmacies;we may be required to conduct costly additional clinical studies;we may be subject to limitations on how we may promote our approved products;2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/0

264、00121390025045828/ea0241635-s1_revelation.htm26/206122025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm27/206 sales of our approved products may decrease signif

265、icantly;regulatory authorities may require us to take our approved products off the market;we may be subject to regulatory investigations,government enforcement actions,litigation or product liability claims;and our products may become less competitive,or our reputation may suffer.Interim,topline an

266、d preliminary data from our clinical studies that we announce or publish from time to time may change asmore patient data become available and are subject to audit and verification procedures that could result in material changes inthe final data.From time to time,we may publicly disclose preliminar

267、y or topline data from our clinical studies,which are based on apreliminary analysis of then-available data,and the results and related findings and conclusions are subject to change following amore comprehensive review of the data related to the particular study or studies.We also make assumptions,

268、estimations,calculations and conclusions as part of our analyses of data,and we may not have received or had the opportunity to fully andcarefully evaluate all data.As a result,the topline results that we report may differ from future results of the same studies,ordifferent conclusions or considerat

269、ions may qualify such results,once additional data have been received and fully evaluated.Topline data also remain subject to audit and verification procedures that may result in the final data being materially different fromthe preliminary data we previously published.As a result,topline data shoul

270、d be viewed with caution until the final data areavailable.From time to time,we may also disclose interim data from our clinical studies.In addition,we may report interimanalyses of only certain endpoints rather than all endpoints.Interim data from clinical studies that we may complete are subject t

271、othe risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient databecome available.In addition,adverse changes between interim data and final data could significantly harm our business and prospects.Additional disclosure of interim data by

272、 us or by our competitors in the future could also result in volatility in the price of ourcommon stock after this offering.Further,others,including regulatory agencies,may not accept or agree with our assumptions,estimates,calculations,conclusions or analyses or may interpret or weigh the importanc

273、e of data differently,which could impactthe value of the particular program,the approvability or commercialization of the particular product candidate or product and ourCompany in general.In addition,the information we choose to publicly disclose regarding a particular study or clinical study isbase

274、d on what is typically extensive information,and you or others may not agree with what we determine is the material orotherwise,appropriate information to include in our disclosure,and any information we determine not to disclose may ultimatelybe deemed significant with respect to future decisions,c

275、onclusions,views,activities or otherwise regarding a particular drug,drugcandidate or our business.If the topline data that we report differ from actual results,or if others,including regulatory authorities,disagree with the conclusions reached,our ability to obtain approval for,and commercialize,ou

276、r Program Products or any futureproduct candidates may be harmed,which could harm our business,financial condition,results of operations and prospects.Even if we complete the necessary clinical studies,we cannot predict when,or if,we will obtain regulatory approval tocommercialize any of our Program

277、 Products,and the approval may be for a more narrow indication than we seek or be subjectto other limitations or restrictions that limit its commercial profile.Our Program Products have not received regulatory approval.We do not expect our Program Products or any future productcandidate to be commer

278、cially available for years,if at all.Our Program Products are,and any future product candidate will besubject to strict regulation by regulatory authorities in the United States and in other countries.We cannot commercialize a productcandidate or diagnostic device until the appropriate regulatory au

279、thorities have reviewed and approved such product candidate ordiagnostic device.Even if our current or future Program Products meet safety and efficacy endpoints in pivotal clinical studies,theregulatory authorities may not complete their review processes in a timely manner,or we may not be able to

280、obtain regulatoryapproval.Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval orrestrictions on approval.132025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/da

281、ta/1810560/000121390025045828/ea0241635-s1_revelation.htm28/206 This may include approval of a product candidate for more limited indications than requested or they may impose significantlimitations in the form of warnings.In addition,we may experience delays or rejections based upon additional gove

282、rnmentregulation from future legislation or administrative action,or changes in regulatory authority policy during the period of productdevelopment,clinical studies and the review process.Our business depends on the success of our Program Products,including obtaining regulatory approval to market ou

283、r productcandidates in the United States and/or other major foreign markets such as the EU.We are focusing our time and financial resources in the clinical development of our product candidates.If we cannotsuccessfully develop,obtain regulatory approval for,and commercialize our Program Products,we

284、may not be able to continue ouroperations.The future regulatory approval and commercial success of our Program Products are subject to a number of risks,including the following:we may not have sufficient financial and other resources to complete the necessary clinical studies for our ProgramProducts

285、,including,but not limited to,the clinical studies needed to obtain regulatory approval for commercialization;we may not be able to obtain regulatory authorization to proceed with various clinical studies in the United States,andeven if we are able to proceed with clinical studies,the regulatory aut

286、horities may limit,delay,or put our clinical studieson hold;we may not be able to obtain adequate evidence from our clinical studies for our Program Products;the results of our clinical studies may not meet the level of statistical or clinical significance required by the FDA orcomparable foreign re

287、gulatory authorities for marketing approval;we cannot be certain of the number of types of clinical studies and non-clinical studies that the regulatory agencies willrequire in order to approve our Program Products;the data from clinical studies conducted outside of the United States may not be acce

288、pted by the FDA or other regulatoryauthorities;patients in our clinical studies may suffer serious adverse events for reasons that may or may not be related to our ProgramProducts,which could delay or prevent further clinical development;the regulatory agencies may find deficiencies without manufact

289、uring processes or facilities;the CROs,that we retain to conduct our clinical studies may take actions outside of our control that materially adverselyimpact our clinical studies;the regulatory agencies may not approve the formulation,labeling or specifications of our Product Candidates,or otherfutu

290、re product candidates;the regulatory agencies may change their approval policies or adopt new regulations;if approved,our Program Products will likely compete with products that may reach approval for the same indication oruse prior to our Program Products,products that are currently approved and th

291、e products that are currently marketedproducts;and we may not be able to obtain,maintain or enforce our patents and other intellectual property rights.Of the large number of drugs and devices in development in the pharmaceutical industry,only a small percentage results in thesubmission of a marketin

292、g authorization to the FDA or comparable foreign regulatory authorities and even fewer are approved forcommercialization.Furthermore,even if we do receive regulatory approval to market our Program Products,any such approvalmay be subject to limitations on the indicated uses or patient populations fo

293、r which we may market the products.Accordingly,evenif we are able to obtain the requisite financing to continue to fund our development programs,we may be unable to successfullydevelop or commercialize our Program Products.If we or any of our future development collaborators are unable to develop,or

294、 obtain regulatory approval for,or,if approved,successfully commercialize our Program Products,we may not be able to generate sufficient revenue to continue our business.2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar

295、/data/1810560/000121390025045828/ea0241635-s1_revelation.htm29/206142025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm30/206 Disruptions at the FDA and other na

296、tional and foreign government authorities caused by funding shortages or global healthconcerns,such as COVID-19,could hinder their ability to hire,retain or deploy key leadership and other personnel,orotherwise prevent new or modified products from being developed,approved or commercialized in a tim

297、ely manner or at all,which could negatively impact our business.The ability of the FDA and comparable foreign regulatory authorities to review and approve new products can be affected by avariety of factors,including government budget and funding levels,statutory,regulatory,and policy changes,the FD

298、As andforeign regulatory authorities ability to hire and retain key personnel and accept the payment of user fees,and other events thatmay otherwise affect the FDAs and comparable foreign regulatory authorities ability to perform routine functions.Average reviewtimes at the FDA and comparable foreig

299、n regulatory authorities have fluctuated in recent years as a result.In addition,governmentfunding of other government authorities that fund research and development activities is subject to the political process,which isinherently fluid and unpredictable.Disruptions at the FDA and other national an

300、d foreign authorities also may slow the timenecessary for new biologics or modifications to approved biologics to be reviewed and/or approved by necessary governmentauthorities,which would adversely affect our business.For example,over the last several years,including for 35 days beginning onDecembe

301、r 22,2018,the U.S.government has shut down several times and certain regulatory authorities,such as the FDA,havehad to furlough critical FDA employees and stop critical activities.Separately,in response to the COVID-19 pandemic,in March 2020,the FDA announced its intention to postpone mostinspection

302、s of foreign manufacturing facilities,and on March 18,2020,the FDA temporarily postponed routine surveillanceinspections of domestic manufacturing facilities.Subsequently,in July 2020,the FDA resumed certain on-site inspections ofdomestic manufacturing facilities subject to a risk-based prioritizati

303、on system.The FDA utilized this risk-based assessment systemto assist in determining when and where it was safest to conduct prioritized domestic inspections.Additionally,on April 15,2021,the FDA began conducting voluntary remote interactive evaluations of certain drug manufacturing facilities and c

304、linical researchsites,among other facilities in circumstances where the FDA determines that such remote evaluation would be appropriate based onmission needs and travel limitations.In May 2021,the FDA outlined a detailed plan to move toward a more consistent state ofinspectional operations,and in Ju

305、ly 2021,the FDA resumed standard inspectional operations of domestic facilities.Since that time,the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees andthose of the firms it regulates as it adapts to the evolving COVID-19 pandemi

306、c.Regulatory authorities outside the United States have adopted similar restrictions or other policy measures in response to theCOVID-19 pandemic.If a prolonged government shutdown occurs,or if global health concerns continue to prevent the FDA orother regulatory authorities from conducting their re

307、gular inspections,reviews,or other regulatory activities,it could significantlyimpact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions,which couldhave a material adverse effect on our business.Even if we obtain regulatory approval for a p

308、roduct candidate,our products and business will remain subject to ongoingregulatory obligations and review.Even if our Program Products are approved,they will be subject to ongoing regulatory requirements for manufacturing,labeling,packaging,storage,advertising,distribution,promotion,sampling,record

309、-keeping,conduct of post-marketing studies andsubmission of safety,efficacy and other post-market information,including both federal and state requirements in the United Statesand comparable requirements outside of the United States.Accordingly,we and others with whom we work must continue toexpend

310、time,money and effort in all areas of regulatory compliance,including manufacturing,production and quality control.If aregulatory agency discovers previously unknown problems with a product,such as adverse events of unanticipated severity orfrequency,quality of product or disagrees with the promotio

311、n,marketing or labeling of a product,such regulatory agency mayimpose restrictions on that product or us,including requiring recall or withdrawal of the product from the market.152025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archi

312、ves/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm31/206 In addition,manufacturers of drug products and their facilities are subject to continual review and periodic inspections by theFDA and other regulatory authorities for compliance with cGMP,regulations and standards.If we or

313、a regulatory agency discoverpreviously unknown problems with a product,such as adverse events of unanticipated severity or frequency,or problems with thefacility where the product is manufactured,a regulatory agency may impose restrictions on that product,the manufacturing facilityor us,including re

314、quiring recall or withdrawal of the product from the market or suspension of manufacturing.If we,our productcandidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements,orundesirable side effects caused by such products are identified,a

315、 regulatory agency may:issue safety alerts,Dear Healthcare Provider letters,press releases or other communications containing warnings aboutsuch product;mandate modification to promotional materials or require us to provide corrective information to healthcare practitioners;require that we conduct p

316、ost-marketing studies;require us to enter into a consent decree,which can include imposition of various fines,reimbursements for inspectioncosts,required due dates for specific action and penalties for noncompliance;seek an injunction or impose civil or criminal penalties or monetary fines;suspend m

317、arketing of,withdraw regulatory approval of or recall such product;suspend any ongoing clinical studies;refuse to approve pending applications or supplements to applications filed by us;suspend or impose restrictions on operations,including costly new manufacturing requirements;or seize or detain pr

318、oducts,refuse to import or export products or require us to initiate a product recall.The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generateproduct revenue.If one or more of our Program Products is approved for marketing in the Unite

319、d States or other countries,we may be subject,directly or indirectly,to United States or other countries equivalent federal and state healthcare fraud and abuse laws,falseclaims laws,physician payment transparency laws and health information privacy and security laws.If we are unable tocomply,or hav

320、e not fully complied,with such laws,we could face substantial penalties.Even if we obtain FDA or other comparable regulatory agencies approval for any of our Program Products and begincommercializing those products in the United States or other countries,our operations may be directly or indirectly

321、through ourrelationships with physicians,patients,third-party payors and customers,subject to broadly applicable fraud and abuse and otherhealthcare laws and regulations that may constrain our business or financial arrangements and relationships through which weresearch,market,sell and distribute ou

322、r Program Products.In addition,we may be subject to patient privacy regulation by both thefederal government and the states in which we conduct our business.The laws that may affect our ability to operate include,amongothers,the United States Anti-Kickback Statute,the False Claims Act,the United Sta

323、tes Health Insurance Portability andAccountability Act of 1996,and the Sunshine Act and analogous state laws.Ensuring that our internal operations and businessarrangements with third parties comply with all applicable healthcare laws and regulations will likely be costly.Legislative or regulatory he

324、althcare reforms in the United States or other countries may make it more difficult and costly for usto obtain regulatory clearance or approval of our Program Products and to produce,market and distribute our ProgramProducts after clearance or approval is obtained.From time to time,legislation is dr

325、afted and introduced in Congress that could significantly change the statutory provisionsgoverning the regulatory clearance or approval,manufacture and marketing of regulated products or the reimbursement thereof.Inaddition,FDA or other comparable regulatory agencies regulations and guidance are oft

326、en revised or reinterpreted by the FDA orother comparable regulatory agencies in ways that may significantly affect our business and our products.Any new regulations orrevisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our ProgramProducts.W

327、e cannot determine what effect changes in regulations,statutes,legal interpretation or policies,when and ifpromulgated,enacted or adopted may have on our business in the future.2025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archive

328、s/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm32/206162025/5/21 15:40sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htmhttps:/www.sec.gov/Archives/edgar/data/1810560/000121390025045828/ea0241635-s1_revelation.htm33/206 We face intense competition

329、in an environment of rapid technological change and the possibility that our competitors maydevelop products and drug delivery systems that are similar,more advanced or more effective than ours,which may adverselyaffect our financial condition and our ability to successfully market or commercialize

330、our Program Products.The pharmaceutical industry in which we operate is intensely competitive and subject to rapid and significant technologicalchange.We are currently aware of various existing therapies in the market and in development that may in the future compete withour Program Products.Even if

331、 approved,we will compete with currently approved therapies and therapies further along in development.Ourcompetitors both in the United States and abroad include large,well-established pharmaceutical and generic companies withsignificantly greater name recognition and an established market share.Ou

332、r competitors may be able to charge lower prices thanwe can,which may adversely affect our market acceptance.Many of these competitors have greater resources than we do,including financial,product development,marketing,personnel and other resources.If our competitors market products that are more ef

333、fective,safer or cheaper than our products or that reach the market soonerthan our products,we may not achieve commercial success.In addition,the biopharmaceutical industry is characterized by rapidtechnological change.Because our research approach integrates many technologies,it may be difficult for us to stay abreast of therapid changes in other technologies.If we fail to stay at the forefront o