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1、2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm1/228F-1/A 1 ea0242682-f1a2_regentisbio.htm AMENDMENT NO.2 TO FORM F-1As filed with the Securities and E

2、xchange Commission on May 19,2025.Registration No.333-285692 UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,DC 20549 AMENDMENT NO.2TOFORM F-1REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 REGENTIS BIOMATERIALS LTD.(Exact name of registrant as specified in its charter)State of Isr

3、ael 2834 Not Applicable(State or other jurisdiction ofincorporation or organization)(Primary Standard IndustrialClassification Code Number)(I.R.S.EmployerIdentification Number)60 Medinat HayehudimHerzliya,Israel 4676652Tel:+972(9)960-1917 Puglisi&Associates850 Library Ave.,Suite 204Newark,DE 19711Te

4、l:(302)738-6880(Address,including zip code,and telephone number,(Name,address,including zip code,and telephoneincluding area code,of registrants principal executive offices)number,including area code,of agent for service)Copies to:Mark Selinger,Esq.David Huberman,Esq.Gary Emmanuel,Esq.Greenberg Trau

5、rig,P.A.One Vanderbilt AvenueNew York,NY 10017-3852Telephone:(212)801-9221 Ronen Kantor,Esq.Doron Tikotzky KantorGutman Nass&Amit GrossB.S.R.4 Tower,33 Floor7 Metsada StreetBnei Brak 5126112 IsraelTelephone:+972(3)613-3371 Oded Har-Even,Esq.Angela Gomes,Esq.Sullivan&Worcester LLP1251 Avenue of the A

6、mericasNew York,NY 10019Tel:(212)660-5003 Reut Alfiah,Adv.Gal Cohen,Adv.Sullivan&WorcesterTel-Aviv(Har-Even&Co.)HaArbaa Towers28 HaArbaa St.North Tower,35th floorTel-Aviv,Israel 6473925Tel:+972(74)758-0480 Approximate date of commencement of proposed sale to the public:As soon as practicable after t

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

8、 the Securities Act,check thefollowing box and list the Securities Act registration statement number of the earlier effective registration statement for the sameoffering.If this form is a post-effective amendment filed pursuant to Rule 462(c)under the Securities Act,check the following box and listt

9、he Securities Act registration statement number of the earlier effective registration statement for the same offering.If this form is a post-effective amendment filed pursuant to Rule 462(d)under the Securities Act,check the following box and listthe Securities Act registration statement number of t

10、he earlier effective registration statement for the same offering.Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.Emerging growth company If an emerging growth company that prepares its financial statements in accordanc

11、e with U.S.GAAP,indicate by check mark if theregistrant has elected not to use the extended transition period for complying with any new or revised financial accountingstandards provided pursuant to Section 7(a)(2)(B)of the Securities Act.2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/0001213900

12、25045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm2/228The term“new or revised financial accounting standard”refers to any update issued by the Financial Accounting StandardsBoard to its Accounting Standards Codific

13、ation after April 5,2012.The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effectivedate until the registrant shall file a further amendment which specifically states that this registration statement shallthereafter become effective in ac

14、cordance with Section 8(a)of the Securities Act or until the registration statement shallbecome effective on such date as the Commission,acting pursuant to said Section 8(a),may determine.2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.s

15、ec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm3/228 The information in this prospectus is not complete and may be changed.We may not sell these securities until theregistration statement filed with the Securities and Exchange Commission is effective.This prospec

16、tus is not an offer to sellthese securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.PRELIMINARY PROSPECTUSSUBJECT TO COMPLETIONDATED MAY 19,2025 1,000,000 Ordinary Shares Regentis Biomaterials Ltd.This is a firm commitment initial

17、public offering of ordinary shares,no par value,or Ordinary Shares,of RegentisBiomaterials Ltd.The anticipated initial public offering price will be between$10.00 and$12.00 per Ordinary Share.The numberof Ordinary Shares offered hereby is based upon an assumed initial offering price of$11.00 per Ord

18、inary Share,the midpoint ofsuch estimated price range.For a discussion of the factors to be considered in determining the initial public offering price of theOrdinary Shares,see“Underwriting”.Prior to this offering,there has been no public market for our Ordinary Shares.We have applied to list our O

19、rdinary Shares on theNYSE American under the symbol“RGNT”.It is a condition to the closing of this offering that our Ordinary Shares shall havebeen approved for listing on the NYSE American.No assurance can be given that our application will be approved or that a tradingmarket will develop.We are bo

20、th an emerging growth company,as defined in the Jumpstart Our Business Startups Act of 2012,or the JOBS Act,and a“foreign private issuer,”as defined under the U.S.federal securities laws and are subject to reduced public company reportingrequirements.See“Prospectus SummaryImplications of Being an Em

21、erging Growth Company and a Foreign Private Issuer”foradditional information.Investing in our securities involves a high degree of risk.See“Risk Factors”beginning on page 14.None of the Securities and Exchange Commission,or the SEC,the Israeli Securities Authority,or any state or other foreignsecuri

22、ties commission has approved nor disapproved these securities or determined if this prospectus is truthful orcomplete.Any representation to the contrary is a criminal offense.Per Share Total Initial public offering price$Underwriting discounts and commissions(1)$Proceeds to us(before expenses)$(1)Un

23、derwriting discounts and commissions do not include a non-accountable expense allowance equal to 1.0%of the initial public offeringprice payable to the underwriters.We refer you to“Underwriting”beginning on page 133 for additional information regarding underwriterscompensation We have granted a 45-d

24、ay option to the representative of the underwriters to purchase up to 150,000 additional Ordinary Sharessolely to cover over-allotments,if any.The underwriters expect to deliver the Ordinary Shares on or about ,2025.ThinkEquity The date of this prospectus is ,2025.2025/5/20 10:55sec.gov/Archives/edg

25、ar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm4/228 2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar

26、/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm5/228 2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm6/228 2025/5/20 10:55sec.gov/Archiv

27、es/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm7/228 TABLE OF CONTENTS PROSPECTUS SUMMARY1THE OFFERING11SUMMARY FINANCIAL DATA13RISK FACTORS14SPECIAL NOTE REGARDING FORWARD-LOOKING

28、 STATEMENTS56USE OF PROCEEDS58DIVIDEND POLICY58CAPITALIZATION59DILUTION61MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OFOPERATIONS63BUSINESS69MANAGEMENT89PRINCIPAL SHAREHOLDERS112CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS114DESCRIPTION OF SHARE CAPITAL116DESCRIPTI

29、ON OF THE SECURITIES WE ARE OFFERING122SHARES ELIGIBLE FOR FUTURE SALE122TAXATION124CERTAIN MATERIAL U.S.FEDERAL INCOME TAX CONSIDERATIONS129UNDERWRITING133EXPENSES142LEGAL MATTERS142EXPERTS142ENFORCEMENT OF CIVIL LIABILITIES143WHERE YOU CAN FIND MORE INFORMATION144INDEX TO CONSOLIDATED FINANCIAL ST

30、ATEMENTSF-1 i2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm8/228 ABOUT THIS PROSPECTUS You should rely only on the information contained in this prosp

31、ectus or in any related free-writing prospectus.Weand the underwriters have not authorized anyone to provide any information or to make any representations other thanthose contained in this prospectus or in any free writing prospectus prepared by us or on our behalf or to which we havereferred you.W

32、e take no responsibility for,and can provide no assurance as to the reliability of,any information thatothers may give you.This prospectus is an offer to sell only the Ordinary Shares offered hereby,but only undercircumstances and in jurisdictions where it is lawful to do so.We are not making an off

33、er to sell these shares of OrdinaryShares in any jurisdiction where the offer or sale is not permitted or where the person making the offer or sale is notqualified to do so or to any person to whom it is not permitted to make such offer or sale.The information contained in thisprospectus is current

34、only as of the date of the front cover of the prospectus.Our business,financial condition,operatingresults and prospects may have changed since that date.Persons who come into possession of this prospectus and any applicable free writing prospectus in jurisdictionsoutside the United States are requi

35、red to inform themselves about and to observe any restrictions as to this offering and thedistribution of this prospectus and any such free writing prospectus applicable to that jurisdiction.See“Underwriting”foradditional information on these restrictions.Neither we nor the underwriters have authori

36、zed anyone to provide you with information that is different from thatcontained in this prospectus,any amendment or supplement to this prospectus,or in any free writing prospectus we may authorizeto be delivered or made available to you.Neither we nor the underwriters take responsibility for,and can

37、 provide no assurance as tothe reliability of,any other information that others may give you.We and the underwriters are offering to sell Ordinary Shares,andare seeking offers to purchase Ordinary Shares only in jurisdictions where offers and sales are permitted.The informationcontained in this pros

38、pectus is accurate only as of the date on the front of this prospectus,regardless of the time of delivery of thisprospectus or any sale of Ordinary Shares.Our business,financial condition,results of operations and prospects may have changedsince the date on the front cover of this prospectus.Neither

39、 we nor the underwriters have taken any action to permit this offering or possession or distribution of thisprospectus in any jurisdiction where action for that purpose is required,other than in the United States.You are required to informyourselves about and to observe any restrictions relating to

40、this offering and the distribution of this prospectus.The terms“shekel,”“Israeli shekel”and“NIS”refer to New Israeli Shekels,the lawful currency of the State of Israel,andthe terms“dollar,”“U.S.dollar”or“$”refer to United States dollars,the lawful currency of the United States of America.Allreferenc

41、es to“shares”in this prospectus refer to Ordinary Shares of Regentis Biomaterials Ltd.,no par value.All share numbers in this prospectus have been adjusted to give effect to a forward split of our outstanding OrdinaryShares,or the Split,at a ratio of 2.5 for 1,effected on March 20,2025.TRADEMARKS Ge

42、lrin and GelrinC are trademarks of ours that we use in this prospectus.This prospectus also includes trademarks,tradenames and service marks that are the property of other organizations.Solely for convenience,our trademarks and tradenamesreferred to in this prospectus appear without the or symbols,b

43、ut those references are not intended to indicate,in any way,thatwe will not assert,to the fullest extent under applicable law,our rights,or the right of the applicable licensor to our trademark andtradenames.MARKET,INDUSTRY AND OTHER DATA This prospectus contains estimates,projections and other info

44、rmation concerning our industry,our business,and themarkets for our product candidates.Information that is based on estimates,forecasts,projections,market research or similarmethodologies is inherently subject to uncertainties,and actual events or circumstances may differ materially from events andc

45、ircumstances that are assumed in this information.Unless otherwise expressly stated,we obtained this industry,business,marketand other data from our own internal estimates and research as well as from reports,research surveys,studies and similar dataprepared by market research firms and other third

46、parties,industry,medical and general publications,government data and similarsources.None of the reports or studies cited in this prospectus were commissioned by the Company.In addition,assumptions and estimates of our and our industrys future performance are necessarily subject to a highdegree of u

47、ncertainty and risk due to a variety of factors,including those described in“Risk Factors.”These and other factors couldcause our future performance to differ materially from our assumptions and estimates.See“Special Note Regarding Forward-Looking Statements.”2025/5/20 10:55sec.gov/Archives/edgar/da

48、ta/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm9/228ii2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/dat

49、a/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm10/228 PROSPECTUS SUMMARY This summary highlights selected information contained elsewhere in this prospectus and does not contain all of theinformation that you should consider in making your investment decision.Before deciding to invest in

50、 our Ordinary Shares,youshould read this entire prospectus carefully,including the sections of this prospectus entitled“Risk Factors”and“Managements Discussion and Analysis of Financial Condition and Results of Operations”and our consolidated financialstatements and the related notes included elsewh

51、ere in this prospectus.Unless the context otherwise requires,references in thisprospectus to the“Company,”“Regentis,”“we,”“us,”“our”and other similar designations refer to Regentis BiomaterialsLtd.Company Overview We are a regenerative medicine company dedicated to developing innovative tissue repai

52、r solutions that seek to restorethe health and enhance the quality of life of patients.Our current efforts are focused on orthopedic treatments using our Gelrinplatform based on degradable hydrogel implants to regenerate damaged or diseased tissue.Gelrin is a unique hydrogel matrix ofpolyethylene gl

53、ycol diacrylate(a polymer involved in tissue engineering)and denatured fibrinogen(a biologically inactivatedprotein that normally has a role in blood clotting).Our lead product candidate is GelrinC,a cell-free,off-the-shelf hydrogel thatis cured into an implant in the knee for the treatment of painf

54、ul injuries to articular knee cartilage.GelrinC was approved as adevice,with a Conformit Europene,or CE,mark in Europe,in 2017(number 3900600CE02);we plan to identify strategicpartners in Europe to bring our product to market.While we currently do not have any strategic partners in place in Europe,w

55、eplan to engage strategic partners in Europe in the future.With GelrinC,we aim to bring to market a product for the therapy of an unmet need for the large market of cartilageinjuries in the knee.Because GelrinC serves as an impenetrable barrier that stops cells from migrating away from the woundsedg

56、es,we believe our product is the only product that helps to regenerate cartilage inwards from the edges of the cell walls.Creating new contiguous tissue is not the natural,lowest energy,alternative for cartilage cells.If such cells were left alone,theywould tend to migrate and either not create new

57、cartilage tissue or create cartilage tissue that is fibrotic(containing an excessivedeposition of extracellular matrix,leading gradually to the disturbance and finally to loss of the original tissue architecture andfunction).By GelrinC creating such impenetrable barrier and thereby preventing the mi

58、gration of the cells,the cells are forcedto take a different route of creating aggregate and contiguous tissue.Unlike GelrinC,cellular products used by competingcompanies require a plug of two layers of which the lower layer is a mineral scaffold,which is a foreign body material that hasbeen enginee

59、red to be inserted into the bone tissue even though the bone is often healthy.Additionally,GelrinC does not haveany biological activity.As a result,we believe our product offers a simple and economic procedure,which we believe will allowpatients to recover quickly with potentially long-term outcomes

60、.Market Opportunities Knee cartilage injuries can be caused either by acute or repetitive trauma due to daily function,including those causedby sports activity.Knee cartilage does not usually heal by itself when injured.Without treatment,cartilage injuries may progressand cause degeneration of joint

61、s,osteoarthritis,and possibly require total knee replacement.Currently,the standard of careprocedure for cartilage injuries is microfracture surgery,which involves cleanup of the wound and creation of tiny punctures inthe underlying bone.Microfracture surgery provides only short-term relief to patie

62、nts and often requires additional surgicalintervention later since the cartilage resulting from this procedure tends to be fibrous and not as weight bearing as naturalhyaline cartilage.Because the cartilage produced from microfracture surgery tends to be fibrous,the cartilage is more prone todeterio

63、ration after a short period of time,with such relief from microfracture surgery lasting on average between nine to twelvemonths,according to Medline Plus online health information resource,medical encyclopedia.Unlike microfracture surgery,treatment using GelrinC does not produce fibrous cartilage,bu

64、t instead has been shown to grow hyalin cartilage,which isautologous to the natural cartilage of the patient.While determinations of safety and efficacy are solely within the authority ofthe United States Food and Drug Administration,or the FDA,and comparable regulatory bodies,we believe that in our

65、 clinicaltrials,GelrinC has been shown to have potentially longer-term positive outcomes of up to four years.As evidenced by a pilotstudy we completed in 2015 in northern Europe,or the Pilot Study,patients reported greater improvement and pain reductionregarding their knee and associated problems fo

66、r GelrinC at two years when compared to historical microfracture proceduredata at two years.Additionally,patients continued to report further improvement and greater pain reduction of their knee andassociated problems using GelrinC for four years.See“Business Clinical Development of GelrinC Complete

67、d Pilot Study”below.Beyond microfracture surgery,current commercial therapies for cartilage repair involve the use of autologous cellsharvested from the patients own healthy tissue.This approach has numerous disadvantages,including the need for expensivecell expansion facilities and the requirement

68、for two surgical procedures.2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm11/22812025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479

69、/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm12/228 Strategy&Solution We aim to provide patients with safe,effective,simple,and lasting treatments that are cost effective.With our leadproduct,GelrinC,patients may be tr

70、eated for cartilage injuries in the knee with an off-the-shelf product by a short and simpleprocedure that we believe will be cost effective.We believe that our Gelrin technology platform may also provide a solution toosteoarthritis and other cartilage injuries related to the ankle,wrist,and elbow.G

71、elrin is a family of hydrogels that derive their unique physical and chemical properties from polymer chainscrosslinked with trace quantities of denatured protein.In the body,Gelrin is eroded and resorbed over time through a pre-programmed and controlled gradual surface degradation process.Gelrin ca

72、n be applied in liquid form allowing it to completelyfill the entire tissue defect and is then cured into a rubbery implant by the use of ultraviolet light.It can also be introduced intonarrow bone crevices or large spaces,open or closed.GelrinC is specifically designed for the repair of articular c

73、artilage defects in the knee caused by acute trauma orrepetitive use.We believe that GelrinC will offer a cost effective,off-the-shelf product that will be simple to use,requiringapproximately a 10-minute procedure and a two-week recovery period.Research and Clinical Development We believe that the

74、cartilage repair market is in need for an off-the-shelf solution,which it currently lacks.GelrinC,being an off-the-shelf product,requiring a short procedure,believed by us to be easy to use by the surgeon and having efficienteconomics answer those needs very effectively.In both pre-clinical and clin

75、ical studies,all of these advantages were effectivelydemonstrated resulting in our decision to choose GelrinC as our lead product candidate.In the Pilot Study we completed on 56patients,it was demonstrated that GelrinC reduced pain significantly better than the leading gold standard procedure ofmicr

76、ofracture.Currently,the Company is conducting a pivotal trial and has recruited and treated 47 patients for such trial.41patients out of the 47 has completed the two-year follow up in this trial.Following the offering,the Company plans to enroll theremaining 39 patients required in order to submit t

77、he pre-market approval application,or PMA,to the Food and DrugAdministration,or the FDA.Having grown out of research from The Technion Israel Institute of Technology,our commitmentto research and innovation is best witnessed by the development we carried out on GelrinC to date from the underlying sc

78、ienceand our close relationship with our founder Professor Dror Seliktar of The Technion,Israel Institute of Technology in Haifa,Israel.We believe we have the leadership onboard to continue to build our product lines.In the Pilot Study,56 patients who complied with the acceptance and rejection crite

79、ria allowed by the FDA(whichincluded age,size of lesion and weight)in need of cartilage repair were treated with GelrinC for articular cartilage injuries.Theimprovements observed in the Knee Injury and Osteoarthritis Outcome Score,or KOOS,and Virtual Analog Scale,or VAS,pain measurement scores taken

80、 over two years following the treatment were superior(100%greater improvement)to those seenwith the traditional microfracture procedure,which is considered to be the current“gold standard”.Additionally,patientscontinued to report further improvement and greater pain reduction of their knee and assoc

81、iated problems using GelrinC forfour years.Based on these results,the FDA granted Regentis an investigational device exemption,or IDE,in September 2016 forour pivotal trial,permitting PMA submission with two-year follow-up data of 80 patients and with 40 additional patients to betreated thereafter.T

82、he pivotal trial that is currently being conducted in the United States and in Europe,under the FDAssanctioned protocol,is an open label study,with one arm only(treatment),using our own historical control(microfracture).To-date,we have treated 47 patients out of the 80 initial patients.We intend to

83、develop a pipeline of products that can be used for additional tissue regeneration opportunities.22025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm13/228

84、 Summary Risk Factors Investing in our securities involves substantial risk.The risks described under the heading“Risk Factors”immediatelyfollowing this summary may cause us to not realize the full benefits of our strengths or may cause us to be unable tosuccessfully execute all or part of our strat

85、egy.Some of the more significant challenges include the following:Risks Related to Our Financial Condition and Capital Requirements We have a limited operating history and we have incurred significant operating losses since our inception,andanticipate that we will incur continued losses for the fore

86、seeable future.We have not generated any revenue fromproduct sales and may never be profitable.Even if this offering is successful,we will need to raise substantial additional funding,which may not be availableon acceptable terms,or at all.Failure to obtain funding on acceptable terms and on a timel

87、y basis may require usto curtail,delay or discontinue our product development efforts or other operations.Our financial statements contain an explanatory paragraph regarding substantial doubt about our ability tocontinue as a going concern,which could prevent us from obtaining new financing on reaso

88、nable terms or at all.Risks Related to Our Business and Industry We may not succeed in advancing the development of our product,achieve manufacturing stability and capacity,demonstrate sufficient clinical evidence or commercialize our product and generate significant revenues.Clinical failure can oc

89、cur at any stage of clinical development.Our clinical experience to date does not necessarilypredict future results and may not have revealed certain potential limitations of the technology and potentialcomplications from GelrinC and may require further clinical validation.Any product version we adv

90、ance throughclinical trials may not have favorable results in later clinical trials or may not receive a regulatory approval.We operate in a very competitive business environment,and if we are unable to compete successfully against ourexisting or potential competitors,our business,financial conditio

91、n and results of operations may be adverselyaffected.We expect to derive most of our revenues from the sales of GelrinC.Our inability to successfully commercializethis product candidate or any subsequent decline in demand for this product candidate,could severely harm ourability to generate revenues

92、.If healthcare professionals do not recommend our product to their patients,GelrinC may not achieve marketacceptance and we may not become profitable We are dependent upon contract manufacturing organizations and raw material suppliers making us vulnerable tosupply shortages and problems,increased c

93、osts and quality or compliance issues,any of which could harm ourbusiness.We may not be able to replace our current manufacturing capabilities in a timely manner.Our business plan is dependent upon third-party service providers.If such third-party service providers fail tomaintain a high quality of

94、service,the utility of our products could be impaired,which could adversely affect thepenetration of our products,our business,operating results and reputation in the future.32025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archiv

95、es/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm14/228 Our business plan relies on certain assumptions about the market for our product,however,the size and expectedgrowth of our addressable market has not been established with precision and may be smaller than we estimate,and

96、 even if the addressable market is as large as we have estimated,we may not be able to capture additionalmarket share.We depend on third parties to manage our clinical studies and trials,perform related data collection and analysis,and to enroll patients for our clinical trials,and,as a result,we ma

97、y face costs and delays that are beyond ourcontrol.We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take otheractions to satisfy our obligations under our indebtedness,which may not be successful.Our business,operating results and growth rates ma

98、y be adversely affected by current or future unfavorableeconomic and market conditions and adverse developments with respect to financial institutions and associatedliquidity risk.We are highly dependent on key members of our executive management team.Our inability to retain theseindividuals could i

99、mpede our business plan and growth strategies,which could have a negative impact on ourbusiness and the value of your investment.Exchange rate fluctuations between the U.S.dollar and the New Israeli Shekel and inflation may negatively affectour results of operations,and we may not be able to hedge o

100、ur currency exchange risks successfully.The outcome of any future claims and litigation could have a material adverse impact on our business,financialcondition and results of operations.Certain of our directors,director nominees and/or officers may have interests that compete with ours and ourshareh

101、olders.Our management team has limited experience managing a public company.Risks Related to Our Reliance on Third Parties We will rely on third parties to conduct certain elements of our preclinical studies and clinical trials and performother tasks for us.If these third parties do not successfully

102、 carry out their contractual duties,meet expecteddeadlines or comply with regulatory requirements,we may not be able to obtain regulatory approval for orcommercialize our product candidates.Independent clinical investigators and clinical research organization,or CROs,that we will engage to conduct o

103、urclinical trials may not devote sufficient time or attention to our clinical trials or be able to repeat their past success.We rely on third parties to manufacture the raw materials that we use to create our product candidates.Ourbusiness could be harmed if existing and prospective third parties fa

104、il to provide us with sufficient quantities ofthese materials and products or fail to do so at acceptable quality levels or prices.Our reliance on third parties requires us to share our trade secrets and intellectual property,which increases thepossibility that a competitor will discover them or tha

105、t our trade secrets and intellectual property will bemisappropriated or disclosed.42025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm15/228 Risks Related

106、to Our Intellectual Property If we are unable to obtain patent protection for our products,or if our patents and other intellectual property rightsdo not adequately protect our products,we may be unable to gain significant market share and may be unable tooperate our business profitably.Obtaining an

107、d maintaining patent protection depends on compliance with various procedures,documentsubmission,fee payment and other requirements imposed by governmental patent agencies,and our patentprotection could be reduced or eliminated for non-compliance with these requirements.Although we are not presently

108、 a party to lawsuits or administrative proceedings involving patents or otherintellectual property,the possibility exists that we may be in the future.If we were to lose any future intellectualproperty lawsuits,a court could require us to pay significant damages and/or prevent us from selling our pr

109、oducts.If we fail to execute invention assignment agreements with our employees and contractors involved in thedevelopment of intellectual property or are unable to protect the confidentiality of our trade secrets,the value ofour products and our business and competitive position could be harmed.If

110、our trademarks and trade names are not adequately protected,we may not be able to build name recognition inour markets of interest and our competitive position may be harmed.Patent terms may not be sufficient to effectively protect our products and business for an adequate period of time.Our patent

111、portfolio has expiration dates between 2025 and 2036;if we are unable to obtain significant patentprotection for our products,or if our patents and other intellectual property rights do not adequately protect ourproducts,we may be unable to gain significant market share and be unable to operate our

112、business profitably.Changes in U.S.patent laws may limit our ability to obtain,defend and/or enforce our patents.We may be unable to enforce our intellectual property rights throughout the world.We may be subject to claims that we or our employees have misappropriated the intellectual property of a

113、thirdparty,including trade secrets or know-how,or are in breach of non-competition or non-solicitation agreementswith our competitors and third parties may claim an ownership interest in intellectual property we regard as ourown.We may be subject to claims that we or our employees have misappropriat

114、ed the intellectual property of a thirdparty,including trade secrets or know-how,or are in breach of non-competition or non-solicitation agreementswith our competitors and third parties may claim an ownership interest in intellectual property we regard as ourown.52025/5/20 10:55sec.gov/Archives/edga

115、r/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm16/228 Risks Related to Government Regulation Our product candidates and operations are subject to extensive government regulation and overs

116、ight both in theUnited States and abroad,and our failure to comply with applicable requirements could harm our business.We may not receive,or may be delayed in receiving,the necessary clearances or approvals for our future products,and failure to timely obtain necessary clearances or approvals for o

117、ur future products would adversely affect ourability to grow our business.Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions,includingsubstantial penalties,and might require us to recall or withdraw a product from the market.Our products must be man

118、ufactured in accordance with federal,state and foreign regulations,and we could beforced to recall our devices or terminate production if we fail to comply with these regulations.The misuse or off-label use of our products may harm our reputation in the marketplace,result in injuries that leadto pro

119、duct liability suits or result in costly investigations,fines or sanctions by regulatory bodies if we are deemedto have engaged in the promotion of these uses,any of which could be costly to our business.Our products may cause or contribute to adverse medical events or be subject to failures or malf

120、unctions that weare required to report to the FDA,and if we fail to do so,we would be subject to sanctions that could harm ourreputation,business,financial condition and results of operations.The discovery of serious safety issues with ourproducts,or a recall of our products either voluntarily or at

121、 the direction of the FDA or another governmentalauthority,could have a negative impact on us.Our relationships with customers and third-party payors will be subject to applicable anti-kickback,fraud andabuse and other healthcare laws and regulations,which could expose us to criminal sanctions,civil

122、 penalties,contractual damages,reputational harm and diminished profits and future earnings.Changes in laws or regulations relating to data protection,or any actual or perceived failure by us to comply withsuch laws and regulations or our privacy policies,could materially and adversely affect our bu

123、siness or could leadto government enforcement actions and significant penalties against us,and adversely impact our operatingresults.If we do not obtain and maintain international regulatory registrations,clearances or approvals for our products,we will be unable to market and sell our products outs

124、ide of the United States.Legislative or regulatory reforms in the United States or the European Union,or the EU,may make it moredifficult and costly for us to obtain regulatory clearances or approvals for our products or to manufacture,marketor distribute our products after approval is obtained.Heal

125、thcare reform laws could adversely affect our products and financial condition.Disruptions at the FDA and other government agencies caused by funding shortages or global health concernscould hinder their ability to hire,retain or deploy key leadership and other personnel,or otherwise prevent new orm

126、odified products from being developed,cleared or approved or commercialized in a timely manner or at all,which could negatively impact our business.62025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/0001

127、21390025045479/ea0242682-f1a2_regentisbio.htm17/228 Risks Related to this Offering and Investment in Our Ordinary Shares An active,liquid and orderly trading market for our Ordinary Shares may not develop,which may inhibit theability of our shareholders to sell Ordinary Shares following this offerin

128、g.The market price of our Ordinary Shares may be volatile,which could result in substantial losses for investorspurchasing shares in this offering.If our operating and financial performance in any given period does not meetany guidance that we provide to the public,the market price of our Ordinary S

129、hares may decline.Certain recent initial public offerings of companies with public floats comparable to the anticipated public float ofRegentis have experienced extreme volatility that was seemingly unrelated to the underlying performance of therespective company.If our operating and financial perfo

130、rmance in any given period does not meet any guidance that we provide to thepublic,the market price of our Ordinary Shares may decline.If securities analysts do not publish research or reports about our business or if they publish negative evaluationsof our shares,the price of our shares could decli

131、ne.If securities analysts do not publish research or reports about our business or if they publish negative evaluationsof our shares,the price of our shares could decline.Future sales of our Ordinary Shares could reduce the market price of our Ordinary Shares.We have not paid dividends in the past a

132、nd do not expect to pay dividends in the future,and,as a result,any returnon investment may be limited to the value of our shares.If we do raise additional capital,shareholders may be subject to dilution.Insiders will continue to have substantial influence over us after this offering,which could lim

133、it your ability toaffect the outcome of key transactions,including a change of control.The JOBS Act,allows us to postpone the date by which we must comply with some of the laws and regulationsintended to protect investors and to reduce the amount of information we provide in our reports filed with t

134、heSEC,which could undermine investor confidence in our company and adversely affect the market price of ourADSs or our Ordinary Shares.As a“foreign private issuer”we are permitted to and follow certain home country corporate governance practicesinstead of otherwise applicable SEC and NYSE American r

135、equirements,which may result in less protection thanis accorded to investors under rules applicable to domestic U.S.issuers.We may be a“passive foreign investment company,”or PFIC,for U.S.federal income tax purposes in the currenttaxable year or may become one in any subsequent taxable year.There ge

136、nerally would be negative taxconsequences for U.S.taxpayers that are holders of our Ordinary Shares if we are or were to become a PFIC.We have broad discretion to determine how to use the funds raised in this offering,and may use them in ways thatmay not enhance our operating results or the price of

137、 our Ordinary Shares.New investors purchasing our securities will experience immediate and substantial dilution 72025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regent

138、isbio.htm18/228 Risks Related to Israeli Law and Our Operations in Israel Political,economic and military instability in the State of Israel,including as a result of the“Iron Swords”war onIsrael,where our headquarters,members of our management team and our research and development facilities areloca

139、ted,may adversely affect our results of operations.Our operations may be disrupted as a result of the obligation of management or key personnel to perform militaryservice.The termination or reduction of tax and other incentives that the Israeli government provides to Israeli companiesmay increase ou

140、r costs and taxes.We may be required to pay monetary remuneration to our Israeli employees for their inventions,even if the rightsto such inventions have been duly assigned to us.We received Israeli government grants for certain of our research and development activities,the terms of whichmay requir

141、e us to pay royalties and to satisfy specified conditions in order to manufacture products and transfertechnologies outside of Israel.If we fail to satisfy these conditions,we may be required to pay penalties andrefund grants previously received.We may not be able to enforce covenants not-to-compete

142、 under current Israeli law that might result in addedcompetition for our products.Provisions of Israeli law and our amended and restated articles of association to be in effect upon the completionof this offering may delay,prevent or otherwise impede a merger with,or an acquisition of,us,which could

143、prevent a change of control,even when the terms of such a transaction are favorable to us and our shareholders.It may be difficult to enforce a judgment of a U.S.court against us and our executive officers and directors and theIsraeli experts named in this prospectus in Israel or the United States,t

144、o assert U.S.securities laws claims in Israelor to serve process on our executive officers and directors and these experts.Your rights and responsibilities as a shareholder will be governed in key respects by Israeli law,which differs insome material respects from the rights and responsibilities of

145、shareholders of U.S.companies.82025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm19/228 Corporate Information We are an Israeli corporation based in Israe

146、l and incorporated in 2004.Our address is 60 Medinat Hayehudim,Herzliya 4676652,Israel.Our telephone number is+972.9.960.1917.Our website address is www.regentis.co.il.Theinformation contained on our website and available through our website is not incorporated by reference into and should not becon

147、sidered a part of this prospectus,and the reference to our website in this prospectus is an inactive textual reference only.Implications of Being an“Emerging Growth Company”and a“Foreign Private Issuer”Emerging Growth Company As a company with less than$1.235 billion in revenue during our last fisca

148、l year,we qualify as an“emerging growthcompany”as defined in the JOBS Act.An emerging growth company may take advantage of specified reduced reporting andother burdens that are otherwise applicable generally to public companies.In particular,as an emerging growth company,we:may present only two year

149、s of audited financial statements and only two years of related ManagementsDiscussion and Analysis of Financial Condition and Results of Operations disclosure in our initial registrationstatement;are not required to provide a detailed narrative disclosure discussing our compensation principles,objec

150、tives andelements and analyzing how those elements fit with our principles and objectives,which is commonly referred toas“compensation discussion and analysis”;are not required to obtain a non-binding advisory vote from our shareholders on executive compensation or goldenparachute arrangements(commo

151、nly referred to as the“say-on-pay,”“say-on frequency”and“say-on-golden-parachute”votes);are exempt from certain executive compensation disclosure provisions requiring a pay-for-performance graph andchief executive officer pay ratio disclosure;and are exempt from the auditor attestation requirement i

152、n the assessment of our internal control over financialreporting pursuant to the Sarbanes-Oxley Act of 2002.92025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbi

153、o.htm20/228 We may take advantage of these provisions for up to five years or such earlier time that we are no longer an emerginggrowth company.We would cease to be an emerging growth company upon the earlier to occur of:(1)the last day of the fiscalyear in which we have total annual gross revenues

154、of$1.235 billion or more;(2)the date on which we have issued more than$1.0 billion in nonconvertible debt during the previous three years;or(3)the date on which we are deemed to be a largeaccelerated filer under the rules of the SEC.We may choose to take advantage of some but not all of these reduce

155、d burdens,andtherefore the information that we provide holders of our Ordinary Shares may be different than the information you mightreceive from other public companies in which you hold equity.In addition,Section 107 of the JOBS Act also provides that anemerging growth company can take advantage of

156、 an extended transition period for complying with new or revised accountingstandards applicable to public companies.We have elected to take advantage of the extended transition period to comply withnew or revised accounting standards and to adopt certain of the reduced disclosure requirements availa

157、ble to emerging growthcompanies.As a result of the accounting standards election,we will not be subject to the same implementation timing for newor revised accounting standards as other public companies that are not emerging growth companies which may makecomparison of our financials to those of oth

158、er public companies more difficult.In addition,the information that we provide inthis prospectus may be different than the information you may receive from other public companies in which you hold equityinterests.Foreign Private Issuer Upon consummation of this offering,we will report under the Secu

159、rities Exchange Act of 1934,as amended,or theExchange Act,as a non-U.S.company with foreign private issuer status.Even after we no longer qualify as an emerging growthcompany,as long as we continue to qualify as a foreign private issuer under the Exchange Act,we will be exempt from certainprovisions

160、 of the Exchange Act that are applicable to U.S.domestic public companies,including:the sections of the Exchange Act regulating the solicitation of proxies,consents or authorizations with respect to asecurity registered under the Exchange Act;the sections of the Exchange Act requiring insiders to fi

161、le public reports of their share ownership and tradingactivities and liability for insiders who profit from trades made in a short period of time;and the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containingunaudited financial statements and othe

162、r specified information,and current reports on Form 8-K upon theoccurrence of specified significant events.We will be required to file an annual report on Form 20-F within four months of the end of each fiscal year.Inaddition,we intend to publish our results on a quarterly basis through press releas

163、es,distributed pursuant to the rules andregulations of the NYSE American.Press releases relating to financial results and material events will also be furnished to theSEC on Form 6-K.However,the information we are required to file with or furnish to the SEC will be less extensive and lesstimely comp

164、ared to that required to be filed with the SEC by U.S.domestic issuers.As a result,you may not be afforded thesame protections or information,which would be made available to you,were you investing in a U.S.domestic issuer.We may take advantage of these exemptions until such time as we are no longer

165、 a foreign private issuer.We wouldcease to be a foreign private issuer at such time as more than 50%of our outstanding voting securities are held by U.S.residentsand any of the following three circumstances applies:(i)the majority of our executive officers or directors are U.S.citizens orresidents;(

166、ii)more than 50%of our assets are located in the United States;or(iii)our business is administered principally inthe United States.Both foreign private issuers and emerging growth companies are also exempt from certain more stringent executivecompensation disclosure rules.Thus,even if we no longer q

167、ualify as an emerging growth company,but remain a foreign privateissuer,we will continue to be exempt from the more stringent compensation disclosures required of companies that are neitheran emerging growth company nor a foreign private issuer.102025/5/20 10:55sec.gov/Archives/edgar/data/1912966/00

168、0121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm21/228 THE OFFERING Ordinary Sharescurrently issued andoutstanding 3,929,378 Ordinary Shares as of May 19,2025.Ordinary Shares to beoutstanding after thisoff

169、ering 4,929,378 Ordinary Shares(5,079,378 Ordinary Shares if the Representative exercises its over-allotment option to purchase additional Ordinary Shares in full).Over-allotment option We have granted the Representative an option for a period of up to 45 days after the closing of theoffering to pur

170、chase,at the public offering price,up to 150,000 additional Ordinary Shares(representing 15.0%of the total number of Ordinary Shares sold in the offering),less theunderwriting discount.RepresentativesWarrant Upon the closing of this offering,we have agreed to issue to the Representative(or its desig

171、natedassignees)warrants to purchase a number of our Ordinary Shares equal to an aggregate of up to50,000 shares based on the assumed public offering price(representing 5.0%of the total number ofOrdinary Shares sold in this offering,including any Ordinary Shares sold upon exercise of theRepresentativ

172、es over-allotment option),or the Representatives Warrants.The RepresentativesWarrants will have an exercise price equal to$13.75(representing 125.0%of the initial publicoffering price of the Ordinary Shares sold in this offering and may be exercised on a cashless basis ifnot covered by an effective

173、registration statement.The Representatives Warrants will not beexercisable for one hundred and eighty(180)days from the commencement of sales in this offering,and will expire four and one-half(4.5)year after the commencement of such sales.For additionalinformation regarding our arrangement with the

174、Representative,please see“Underwriting.”Lock-Up Agreements We,our directors and executive officers and current holders of our securities have agreed,for aperiod of twelve(12)months from the closing of this offering with respect to our directors andexecutive officers,and for a period of six(6)months

175、from the closing of this offering,with respect tothe Company and current holders of our securities,not to offer for sale,issue,sell,contract to sell,pledge or otherwise dispose of any of our Ordinary Shares or securities convertible into OrdinaryShares.Use of proceeds We expect to receive approximat

176、ely$9.1 million in net proceeds from the sale of Ordinary Shares inthis offering in this offering(approximately$10.6 million if the Representative exercises its over-allotment option in full),based upon an assumed public offering price of$11.00 per Ordinary Share,which is the midpoint of the price r

177、ange set forth on the cover page of this prospectus,and afterdeducting the underwriting discounts and commissions and estimated offering expenses payable byus.We currently expect to use the net proceeds from this offering for the following purposes:approximately$4.5 million for development activitie

178、s(including the completion of our pivotaltrial)and preparation of the PMA submission for GelrinC;approximately$1.0 million for operations(manufacturing,regulatory affairs and patents);approximately$0.5 million for research and development activities;approximately$0.5 million for EU marketing develop

179、ment(Medical Device Regulationqualification and scaleup);approximately$1.1 million for the repayment of the Bridge Loan,the loans under the 2024 LoanAgreements,the 2025 Loan Agreements and the December 2024 Loan Agreement(each,asdefined below)and accrued interest and applicable risk premium;$0.25 mi

180、llion to be paid to the Chairman of our board of directors in consideration of his servicesto the Company since 2019,for which he has not received compensation,which was approved byour shareholders on March 20,2025;and 2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f

181、1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm22/228 the remainder for working capital and general corporate purposes and possible futureacquisitions.The amounts and schedule of our actual expenditures will depend on multiple facto

182、rs.As a result,our management will have broad discretion in the application of the net proceeds of this offering.Foradditional information regarding the repayment of the Bridge Loan,see“Certain Relationships andRelated Party Transactions Other Financings.”112025/5/20 10:55sec.gov/Archives/edgar/data

183、/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm23/228 Risk factors Investing in our securities involves a high degree of risk.You should read the“Risk Factors”startingon page 14 of this prospec

184、tus for a discussion of factors to consider carefully before deciding toinvest in our Ordinary Shares.NYSE Americantrading symbol We have applied to list our Ordinary Shares on the NYSE American under the symbol“RGNT”.Thisoffering is contingent upon the Ordinary Shares being listed on the NYSE Ameri

185、can,and noassurance can be given that our application will be approved or that a trading market will develop.The number of the Ordinary Shares to be issued and outstanding immediately after this offering as shown aboveassumes that all of the Ordinary Shares offered hereby are sold,and is based on 3,

186、929,378 Ordinary Shares issued andoutstanding as of the date of this prospectus.This number excludes:79,290 Ordinary Shares issuable upon the exercise of options to consultants under our incentive option planoutstanding as of such date,at an exercise price of$3.97,of which 79,290 were vested as of s

187、uch date;465,533 Ordinary Shares issuable upon the exercise of options to be issued to the Chairman of our board ofdirectors upon the completion of this offering under our incentive option plan,at an exercise price of NIS 0.04;191,473 Ordinary Shares issuable upon the exercise of options to be issue

188、d to consultants and certain investorsupon the completion of this offering under our incentive option plan,at an exercise price of NIS 0.004;Ordinary Shares underlying warrants issuable to the Bridge Loan lenders to purchase such number of OrdinaryShares equal to two times the respective loan amount

189、 of each Bridge Loan due to such lenders,based on a priceper share equal to 75%of the lowest price per Ordinary Share during the first five trading days following theconsummation of this offering;Ordinary Shares underlying warrants issuable to the 2024 Loan Agreements lenders to purchase such number

190、 ofOrdinary Shares equal to two times the respective loan amount of each 2024 Loan Agreement due to such lenders,based on a price per share equal to 75%of the lowest price per Ordinary Share during the first five trading daysfollowing the consummation of this offering;Ordinary Shares underlying warr

191、ants issuable to the Companys chief executive officer to purchase such numberof Ordinary Shares equal to two times the respective loan amount due to the Companys chief executive officer,based on a price per share equal to 75%of the lowest price per Ordinary Share during the first five trading daysfo

192、llowing the consummation of this offering;and Ordinary Shares underlying warrants issuable to lenders under the 2025 Loan Agreements to purchase suchnumber of Ordinary Shares having a value equal to two times the respective loan amount of each 2025 LoanAgreement owed to such lender,based on a price

193、per share equal to 75%of the lowest price per Ordinary Shareduring the first five trading days following the consummation of this offering.Unless otherwise indicated,all information in this prospectus assumes or gives effect to:no exercise of the Representatives over-allotment option;no exercise of

194、Representatives Warrants;the automatic conversion of all outstanding preferred shares,no par value,of the Company,or the PreferredShares,into 2,603,652 Ordinary Shares,which will occur upon the completion of this offering;the issuance of 609,888 Ordinary Shares issuable upon the automatic conversion

195、 of the$900,000 outstandingprincipal amount of several convertible loan agreements entered into between August 2020 and February 2021,orthe 2020 CLAs,which will occur upon the completion of this offering;and the issuance of 553,640 Ordinary Shares issuable upon the automatic conversion of the$450,00

196、0 outstandingprincipal amount of several convertible loan agreements entered into in October 2024,or the 2024 CLAs,including related risk premium,which will occur upon the completion of this offering.See“Description of Share Capital”for additional information.2025/5/20 10:55sec.gov/Archives/edgar/da

197、ta/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm24/228122025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/da

198、ta/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm25/228 SUMMARY FINANCIAL DATA The following table summarizes our financial data.We have derived the following statements of comprehensive lossfor the years ended December 31,2024 and 2023 the balance sheet data as of December 31,2024 from o

199、ur audited financialstatements.Such financial statements have been prepared in accordance with U.S.Generally Accepted Accounting Principles,or U.S GAAP.Our historical results are not necessarily indicative of the results that may be expected in the future.Thefollowing summary financial data should b

200、e read in conjunction with“Managements Discussion and Analysis of FinancialCondition and Results of Operations”and our audited consolidated financial statements and related notes included elsewhere inthis prospectus.Year EndedDecember 31,(in thousands of USD,except share and per share data)2024 2023

201、 Statements of comprehensive loss:Research and development expenses:Horizon 2020 Grant 2,306 -Other research and development expenses (232)(806)General and administrative expenses (712)(1,125)Operating profit(loss)1,362 (1,931)Financial income(expense),net:Changes in fair value convertible notes 3,4

202、83 (2,019)Changes in fair value of warrant liability 463 62 Other financing income(expense),net (77)(244)Net income(loss)and comprehensive income(loss)5,231 (4,132)Basic and diluted net income(loss)per share 1.87 (24.09)Weighted average number of ordinary shares used in computing basic and diluted n

203、et income/(loss)pershare 2,765,850 173,508 As of December 31,2024(in thousands of USD)Actual Pro Forma(1)Pro FormaAs Adjusted(2)Balance Sheet Data:Cash and cash equivalents$229 529$8,292 Other current assets$253 253$73 Total assets$482 782$8,365 Current liabilities:Trade account payables$252 252$252

204、 Other accounts payable$701 701$951 Short term loans$573 873$-Convertible notes$4,372 -$-Warrant liability$160 -$-Total current liabilities$6,058 1,826$1,203 Temporary equity$35,098 -$-Total shareholders equity(deficit)$(40,674)(1,044)$7,162 Total liabilities,temporary equity and shareholders equity

205、(deficit)482 782$8,365 (1)The Pro Forma data gives effect to the following events as if each event had occurred on December 31,2024:(i)theissuance of 2,603,652 Ordinary Shares upon the automatic conversion of the 2,603,652 Preferred Shares issued andoutstanding as of the date hereof,which will autom

206、atically convert upon the completion of this offering at a 1:1 ratio;(ii)the issuance of 609,888 Ordinary Shares upon the automatic conversion of the$900,000 outstanding principal of the 2020CLAs,which will occur upon the completion of this offering;(iii)the issuance of 553,640 Ordinary Shares upon

207、theautomatic conversion of the$450,000 outstanding principal of the 2024 CLAs,which will occur upon the completion ofthis offering;(iv)the receipt of an additional$100,000 under the Bridge Loan subsequent to December 31,2024;(v)thereceipt of a loan in the total amount of$200,000 pursuant to the 2025

208、 Loan Agreements;and(iv)the expiration of certainoutstanding warrants to purchase up to 167,365 Ordinary Shares in March 2025.(2)The Pro Forma As Adjusted data gives additional effect to:(i)the sale of 1,000,000 Ordinary Shares in this offering at aninitial public offering price of$11.00 per Ordinar

209、y Share,which is the midpoint of the price range set forth on the coverpage of this prospectus,after deducting underwriting discounts and commissions and estimated offering expenses payableby us;(ii)repayment of the Bridge Loan in the total amount of$350,000 plus accrued interest and an aggregate ri

210、skpremium in the amount of$105,000;(iii)the repayment of the loan under the 2024 Loan Agreements in the total amount of$150,000 plus accrued interest and an aggregate risk premium in the amount of$50,000;(iv)the repayment of loan underthe December 2024 Loan Agreement in the total amount of$117,000 p

211、lus accrued interest and an aggregate risk premium2025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm26/228of approximately$35,100;and(v)the repayment of t

212、he loan under the 2025 Loan Agreements in the total amount of$200,000 plus accrued interest and an aggregate risk premium in the amount of$100,000.The as adjusted information discussed above is illustrative only and will be adjusted based on the actual initial publicoffering price and other terms of

213、 this offering determined at pricing.Each$0.25 increase(decrease)in the assumed initialpublic offering price of$11.00 per Ordinary Share,which is the midpoint of the price range set forth on the cover page of thisprospectus,would increase(decrease)the pro forma as adjusted amount of each of cash,cas

214、h equivalents and short-termdeposits,total assets and shareholders equity(deficiency)by$0.25 million,assuming that the number of Ordinary Sharesoffered by us,as set forth on the cover page of this prospectus,remains the same and after deducting the estimated underwritingdiscounts and commissions and

215、 estimated offering expenses payable by us.Similarly,each increase(decrease)of 100,000 in thenumber of Ordinary Shares offered by us at the assumed initial public offering price would increase(decrease)each of cash,cash equivalents and short-term deposits,total assets and shareholders equity(deficie

216、ncy)by$0.76 million.132025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm27/228 RISK FACTORS Investing in our Ordinary Shares involves a high degree of ris

217、k.You should carefully consider the risks and uncertaintiesdescribed below,in addition to the other information set forth in this prospectus,including the consolidated financial statementsand the related notes included elsewhere in this prospectus,before purchasing our securities.If any of the follo

218、wing risks actuallyoccurs,our business,financial condition,cash flows and results of operations could be negatively impacted.In that case,thetrading price of our Ordinary Shares would likely decline and you might lose all or part of your investment.Risks Related to Our Financial Condition and Capita

219、l Requirements We have a limited operating history and we have incurred significant operating losses since our inception,and anticipate thatwe will incur continued losses for the foreseeable future.We are a development-stage medical device company with a limited operating history.To date,we have foc

220、used almostexclusively on developing our lead product candidate,GelrinC,and our Gelrin hydrogel technology platform.We have funded ouroperations to date primarily through the issuance of our equity securities and convertible loans.We have only a limited operating history upon which you can evaluate

221、our business and prospects.In addition,we havelimited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertaintiesfrequently encountered by companies in new and rapidly evolving fields,particularly in the medical device industry.To date,wehave not

222、generated any revenue from the sale of our product candidate(see“Managements Discussion and Analysis of FinancialCondition and Results of Operations”for additional information).We have incurred losses in each year since our inception(exceptfor 2024 as a result of a one-time research and development

223、grant which resulted in a one-time income),including net income of$5.2 million and a loss of$4.1 million for the years ended December 31,2024 and 2023,respectively.As of December 31,2024,we had an accumulated deficit of approximately$41.7 million.Substantially all of our operating losses resulted fr

224、om costs incurredin connection with the development of our Gelrin hydrogel platform and from general and administrative costs associated with ouroperations.If we obtain the FDAs marketing approval for our GelrinC proprietary hydrogel platform we will likely incur significantsales,marketing,and outso

225、urced manufacturing expenses,as well as continued research and development expenses.Furthermore,in the period following this offering,we expect to incur additional costs associated with operating as a public company.As a result,we expect to continue to incur significant and increasing operating loss

226、es for the foreseeable future.Because of the numerous risksand uncertainties associated with developing a medical device,we are unable to predict the extent of any future losses or when wewill become profitable,if at all.We expect to continue to incur significant losses until we receive the necessar

227、y regulatory approvals to commercialize outlead product candidate,GelrinC,in the United States,which we may not be successful in achieving.We anticipate that ourexpenses will increase substantially if and as we:continue the research and development of our Gelrin hydrogel platform,products and produc

228、t candidates,includingthrough clinical trials;seek additional regulatory and marketing approvals;establish a sales,marketing,and distribution infrastructure to commercialize our products and product candidates;rely on our third-party suppliers and manufacturers to obtain adequate supply of materials

229、 and components for ourproducts seek to identify,assess,acquire,license,and/or develop other product candidates and subsequent generations of ourcurrent product candidate;seek to maintain,protect,and expand our intellectual property portfolio;142025/5/20 10:55sec.gov/Archives/edgar/data/1912966/0001

230、21390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm28/228 seek to attract and retain skilled personnel;create additional infrastructure to support our operations as a public company and our product candidate de

231、velopmentand planned future commercialization efforts;and experience any delays or encounter issues with respect to any of the above,including,but not limited to,failedstudies,complex results,safety issues or other regulatory challenges that require longer follow-up of existing studiesor additional

232、supportive studies in order to pursue marketing approval.The amount of any future operating losses will depend,in part,on the rate of our future expenditures and our ability toobtain funding through equity or debt financings,strategic collaborations or grants.Even if we obtain additional regulatorya

233、pprovals to market our Gelrin products and product candidates or any future product candidates,our future revenue will dependupon the size of any markets in which our products and product candidates receive approval and our ability to achieve sufficientmarket acceptance,pricing,reimbursement from th

234、ird-party payors for our products and product candidates.Further,the operatinglosses that we incur may fluctuate significantly from quarter to quarter and year to year,such that a period-to-period comparison ofour results of operations may not be a good indication of our future performance.Other una

235、nticipated costs may also arise.We have not generated any revenue from product sales and may never be profitable.While our GelrinC has been approved as a device with a CE mark in Europe since August 2017,we have not yet begun tocommercialize our products and have never generated any revenue from pro

236、duct sales.Our ability to generate revenue and achieveprofitability mainly depends on our ability to find a marketing partner for Europe after we scale-up our manufacturing and prepareour GelrinC product for launch.In parallel,we need to receive the necessary regulatory approvals to commercialize ou

237、r GelrinC inthe United States.We do not know when,or if at all,we will generate any such revenue.Our ability to generate future revenuefrom product sales will depend heavily on our success in many areas,including but not limited to:complete research and development of our Gelrin hydrogel platform an

238、d any future product candidates in a timelyand successful manner;complete our pivotal clinical study in the United States.and Europe successfully;obtain FDA approval for our GelrinC product obtain regulatory and marketing approval for any product candidates;maintain and enhance a commercially viable

239、,sustainable,scalable,reproducible and transferable manufacturingprocess for our GelrinC product and our hydrogel platform and any future product candidates that is compliant withcurrent good manufacturing practices,or cGMPs;establish and maintain supply and,if applicable,manufacturing relationships

240、 with third parties that can provide,inboth amount and quality,adequate products to support development and the market demand for our Gelrin hydrogelplatform and any future product candidates,if and when approved;identifying,assessing,acquiring and/or developing new product candidates;launch and com

241、mercialize any product candidates for which we obtain regulatory and marketing approval,eitherdirectly by establishing a sales force,marketing and distribution infrastructure,and/or with collaborators ordistributors in the United States,Europe and other potential markets that we will target;accurate

242、ly identifying demand for our Gelrin hydrogel platform or any future product candidates;152025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm29/228 expose

243、and educate physicians and other medical professionals to the use of our products;obtain market acceptance of our Gelrin hydrogel platform and any future product candidates from the medicalcommunity and third-party payors;ensure our product candidates are approved for reimbursement from governmental

244、 agencies,health care providers andinsurers in jurisdictions where they have been approved for marketing;address any competing technological and market developments that impact our Gelrin hydrogel platform and anyfuture product candidates or their prospective usage by medical professionals;negotiate

245、 favorable terms in any collaboration,licensing or other arrangements into which we may enter and performour obligations under such collaborations;maintain,protect and expand our portfolio of intellectual property rights,including patents,patent applications,tradesecrets and know-how;avoid and defen

246、d against third-party interference or infringement claims;and attract,hire and retain qualified personnel.We anticipate incurring significant incremental costs associated with commercializing such product candidates.Ourexpenses could increase beyond expectations if we are required by the FDA,or othe

247、r regulatory agencies,domestic or foreign,tochange our manufacturing processes or assays or to perform studies in addition to those that we currently anticipate.Even if we aresuccessful in obtaining additional regulatory approvals to market our GelrinC or any future product candidates,our revenue ea

248、rnedfrom such product candidates will be dependent in part upon the size of the markets in the territories for which we gain regulatoryapproval for such products,the accepted price for such products,our ability to obtain reimbursement for such products at any price,whether we own the commercial righ

249、ts for that territory in which such products have been approved and the expenses associatedwith manufacturing and marketing such products for such markets.Therefore,we may not generate significant revenue from thesale of such products.Further,if we are not able to generate significant revenue from t

250、he sale of our approved products,we may beforced to curtail or cease our operations.Due to the numerous risks and uncertainties involved in product development,it isdifficult to predict the timing or amount of increased expenses,or when,or if,we will be able to achieve or maintain profitability.Even

251、 if this offering is successful,we will need to raise substantial additional funding,which may not be available onacceptable terms,or at all.Failure to obtain funding on acceptable terms and on a timely basis may require us to curtail,delayor discontinue our product development efforts or other oper

252、ations.As of December 31,2024 and December 31,2023,our cash and cash equivalents were approximately$0.2 million and$0.3 million,respectively,and we had a negative working capital of approximately$5.5 million and$2.8 million,respectively,andan accumulated deficit of approximately$41.7 million and$46.

253、9 million,respectively.Based on our current plans,we believe thatour existing cash and,cash equivalents will be sufficient to enable us to fund our operating expenses and capital expenditurerequirements through June 2025 without giving effect to the proceeds from this offering.Even if this offering

254、is completed,weexpect that we will require substantial additional capital to commercialize our Gelrin hydrogel platform and any future productcandidates.In addition,our operating plans may change as a result of many factors that may currently be unknown to us,and wemay need to seek additional funds

255、sooner than planned.Our future funding requirements will depend on many factors,includingbut not limited to:the progress,results and costs of our ongoing and planned studies and pivotal clinical trials;the cost,timing and outcomes of regulatory review of our Gelrin hydrogel platform and any future p

256、roductcandidates;162025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm30/228 the costs of manufacturing product candidates,including costs related to engag

257、ing third-party manufacturers therefor;the scope,progress,results and costs of product development,testing,manufacturing,preclinical development and,ifapplicable,clinical trials for any other product candidates that we may develop or otherwise obtain in the future;the cost of our future activities,i

258、ncluding establishing sales,marketing and distribution capabilities for any product orproduct candidates in any particular geography where we receive marketing approval for such product candidates;the terms and timing of any collaborative,licensing and other arrangements that we may establish;the co

259、sts of preparing,filing and prosecuting patent applications,maintaining and enforcing our intellectual propertyrights and defending intellectual property-related claims;and the level of revenue,if any,received from commercial sales of any product candidates for which we receivemarketing approval.Any

260、 additional fundraising efforts may divert our management from their day-to-day activities,which may adverselyaffect our ability to develop and commercialize our Gelrin hydrogel platform and any future product candidates and any futureproduct candidates.In addition,we cannot guarantee that future fi

261、nancing will be available in sufficient amounts or on termsacceptable to us,if at all.Moreover,the terms of any financing may adversely affect the holdings or the rights of holders of oursecurities and the issuance of additional securities,whether equity or debt,by us,or the possibility of such issu

262、ance,may cause themarket price of our Ordinary Shares to decline.The incurrence of indebtedness could result in increased fixed payment obligations,and we may be required to agree to certain restrictive covenants,such as limitations on our ability to incur additional debt,limitations on our ability

263、to acquire,sell or license intellectual property rights and other operating restrictions that could adverselyimpact our ability to conduct our business.We could also be required to seek funds through arrangements with collaborativepartners or otherwise at an earlier stage than otherwise would be des

264、irable,and we may be required to relinquish rights to some ofour technologies or product candidates or otherwise agree to terms unfavorable to us,any of which may have a material adverseeffect on our business,operating results and prospects.Even if we believe that we have sufficient funds for our cu

265、rrent or futureoperating plans,we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.If we are unable to obtain funding on a timely basis,we may be required to significantly curtail,delay or discontinue oneor more of our research or develop

266、ment programs or the development or commercialization,if any,of our Gelrin hydrogel platformand any future product candidates,or any other product candidates or be unable to expand our operations or otherwise capitalize onour business opportunities,as desired,which could materially affect our busine

267、ss,financial condition and results of operations.Our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a goingconcern,which could prevent us from obtaining new financing on reasonable terms or at all.As described in Note 1d of our acco

268、mpanying financial statements,our audited financial statements as of December 31,2024,contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.This goingconcern opinion could materially limit our ability to raise additional funds through the issua

269、nce of equity or debt securities orotherwise.Further financial statements may include an explanatory paragraph with respect to our ability to continue as a goingconcern.Until we can generate significant recurring revenues,we expect to satisfy our future cash needs through debt or equityfinancing.We

270、cannot be certain that additional funding will be available to us on acceptable terms,if at all.If funds are notavailable,we may be required to delay,reduce the scope of,or eliminate research or development plans for,or commercializationefforts with respect to our products.This may raise substantial

271、 doubts about our ability to continue as a going concern.172025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm31/228 Risks Related to Our Business and Indu

272、stry We may not succeed in advancing the development of our product,achieve manufacturing stability and capacity,demonstratesufficient clinical evidence or commercialize our product and generate significant revenues.We are a development-stage company and are subject to all of the risks inherent in t

273、he establishment of a new businessenterprise.We have a limited operating history and only a preliminary and unproven business plan upon which investors mayevaluate our prospects.We have not yet fully demonstrated the feasibility of our regenerative hydrogel technology for commercialapplications.We m

274、ay not receive,or may be delayed in receiving,the necessary approval or clearance for GelrinC or our futureproducts.Furthermore,even if our technology becomes commercially viable,our business models may not generate sufficientrevenue necessary to support our business.If we are unable to address any

275、issues mentioned above,or encounter other problems,expenses,difficulties,complications,and delays in connection with the starting and expansion of our business,our entire businessmay fail,in which case you may lose part of,or your entire investment.We have a history of net losses and negative cash f

276、low from operations since inception and we expect such losses andnegative cash flows from operations to continue in the foreseeable future.We anticipate our losses will continue to increase fromcurrent levels because we expect to incur additional costs related to developing our business,including re

277、search and developmentcosts,manufacturing costs,employee-related costs,costs of complying with government regulations,intellectual propertydevelopment and prosecution costs,marketing and promotion costs,capital expenditures,general and administrative expenses,andcosts associated with operating as a

278、public company.Our ability to generate revenue from our operations and,ultimately,achieve profitability will depend on,among others,whether we can complete the development and commercialization of our technology,our future products and our services,including our GelrinC product candidate and platfor

279、m technology,whether we can manufacture GelrinC on a commercial scale insuch amounts and at such costs as we anticipate,and whether we can achieve market acceptance of our products,services andbusiness models.We may never generate any revenue or operate on a profitable basis.Even if we achieve profi

280、tability,we may notbe able to sustain it.Clinical failure can occur at any stage of clinical development.Our clinical experience to date does not necessarily predictfuture results and may not have revealed certain potential limitations of the technology and potential complications fromGelrinC and ma

281、y require further clinical validation.Any product version we advance through clinical trials may not havefavorable results in later clinical trials or receive a regulatory approval.Clinical failure can occur at any stage of clinical development.To date,we have performed the Pilot Study involving 56p

282、atients who were treated with GelrinC,and followed up for up to four years in multiple sites in northern Europe and in Israel.Toobtain marketing approval in the United States,we are currently carrying out an additional pivotal clinical study under an approvedIDE,or the Pivotal Study,in the United St

283、ates and Europe.As we have limited clinical experience,our ability to identify potentialproblems and/or inefficiencies concerning current and future versions of GelrinC in advance of its use in general and expandedgroups of patients may be limited,and we cannot assure you that actual clinical perfor

284、mances will be satisfactory to supportproposed indications and regulatory approvals and clinical acceptance and adoption,or that its use will not result in unanticipatedcomplications.However,if the results of such study are not satisfactory,our ongoing Pivotal Study could be delayed.Furthermore,ther

285、e can be no assurance that the implementation of our plan will be successful.Furthermore,the results from laboratory,non-clinical and completed clinical studies,as well as results from our ongoing clinical trials may not be indicative of final clinicalresults obtained from our current GelrinC versio

286、n or future versions of GelrinC on expanded screening populations.In addition,theresults of our clinical trials are subject to human analyses and interpretation of the data accumulated,which could be affected byvarious errors due to,among others,lack of sufficient clinical experience with GelrinC,as

287、sumptions used in the statistical analysisof results,interpretation errors in the analysis of the clinical trials results,or due to uncertainty in the actual efficacy of GelrinC inits current clinical stage.Therefore,the safety and efficacy of GelrinC and the clinical results to date will require fu

288、rtherindependent professional validation and require further clinical study.If GelrinC does not function as expected over time,we maynot be able to develop GelrinC at the rate or to the stage we desire,we could be subject to liability claims,our reputation may beharmed,GelrinC may not achieve regula

289、tory clearances,and GelrinC may not be widely adopted by healthcare providers andpatients.182025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm32/228 We op

290、erate in a very competitive business environment,and if we are unable to compete successfully against our existing orpotential competitors,our business,financial condition and results of operations may be adversely affected.Our existing products and procedures are,and any new products or procedures

291、we develop and commercialize will be,subject to intense competition.The industry in which we operate is competitive,subject to change and sensitive to the introductionof new products,procedures or other market activities of industry participants.Our ability to compete successfully will depend onour

292、ability to continue to train surgeons on the GelrinC hydrogel implant procedure and gain their acceptance of the procedure,develop additional products and procedures to improve GelrinC implementation and expand our product offerings that reach themarket in a timely manner,receive adequate coverage a

293、nd reimbursement from third-party payors and provide products that areeasier to use,safer,less invasive and more effective than the products and procedures of our competitors.We compete with large,diversified medical device and pharmaceutical companies,including Vericel and others.We alsocompete wit

294、h smaller companies similar to us.We also face potential competition from many different sources,including academicinstitutions,governmental agencies,and public and private research institutions.At any time,these competitors and other potential market entrants may develop new products,procedures or

295、treatmentalternatives that could render our products obsolete or uncompetitive.In addition,one or more of such competitors may gain amarket advantage by developing and patenting competitive products,procedures or treatment alternatives earlier than we can,obtaining regulatory clearances or approvals

296、 more rapidly than we can or selling competitive products at prices lower than ours.Ifmedical research were to lead to the discovery of alternative therapies or technologies that improve or cure tissue regeneration asan alternative to surgery,the use of pharmaceuticals or breakthrough bio-technologi

297、cal innovations or therapies,our profitabilitycould suffer through a reduction in sales or a loss in market share to a competitor.The discovery of methods of prevention or thedevelopment of other alternatives to tissue repair therapies could result in decreased demand for our product and,accordingly

298、,could have a material adverse effect on our business,financial condition and results of operations.Many of our current andpotential competitors have substantially greater sales and financial resources than we do.These competitors may also have moreestablished distribution networks,a broader offerin

299、g of products,entrenched relationships with surgeons and distributors or greaterexperience in launching,marketing,distributing and selling products or treatment alternatives.We also compete with our competitors to engage the services of independent sales agents,both those presently workingwith us an

300、d those with whom we hope to work with as we expand.In addition,we compete with our competitors in acquiringtechnologies and technology licenses complementary to our products or procedures or advantageous to our business.If we areunable to compete successfully against our existing or potential compe

301、titors,our business,financial condition and results ofoperations may be adversely affected,and we may not be able to grow at our expected rate,if at all.See“Business Competition”below.We expect to derive most of our revenues from the sales of our GelrinC.Our inability to successfully commercialize t

302、his productcandidate or any subsequent decline in demand for this product candidate,could severely harm our ability to generate revenues.We are currently dependent on the successful commercialization of GelrinC to generate revenues.As a result,factorsadversely affecting our ability to successfully c

303、ommercialize,or the pricing of or demand for,this product could have a materialadverse effect on our financial condition and results of operations.If we are unable to successfully commercialize or create marketdemand for GelrinC,we will have limited ability to generate revenues.Furthermore,we may be

304、 vulnerable to fluctuations in demand for GelrinC.Such fluctuations in demand may be due tomany factors,many of which are beyond our control,including,among others:market acceptance of a new product,including healthcare professionals and patients preferences;192025/5/20 10:55sec.gov/Archives/edgar/d

305、ata/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm33/228 market acceptance of the clinical safety and performance of GelrinC;development of similarly cost-effective products by our competitors;

306、development delays of GelrinC;adverse medical side effects suffered by patients using GelrinC,whether actually resulting from the use of GelrinC ornot;changes in regulatory policies toward tissue repair technologies;changes in regulatory approval,clearance requirements and licensure for our product;

307、third-party claims of intellectual property infringement;budget constraints and the availability of reimbursement or insurance coverage from third-party payors for GelrinC;adverse responses from certain of our competitors to the offering of GelrinC;and the shelf life of GelrinC.If healthcare profess

308、ionals do not recommend our product to their patients,GelrinC may not achieve market acceptance and wemay not become profitable.If healthcare professionals,including physicians,do not recommend or prescribe our product to their patients,GelrinCmay not achieve market acceptance and we may not become

309、profitable.In addition,physicians have historically been slow tochange their medical diagnostic and treatment practices because of perceived liability risks arising from the use of new products.Delayed adoption of GelrinC by healthcare professionals could lead to a delayed adoption by patients,as we

310、ll as government andprivate third-party payors.Healthcare professionals may not recommend GelrinC until certain conditions have been satisfiedincluding,among others:there is sufficient long-term clinical and health-economic evidence to convince them to alter their existing tissuerepair methods and r

311、ecommendations;there are recommendations from prominent physicians,educators and/or associations indicating that GelrinC is safeand effective;we obtain favorable data from clinical and health-economic studies for GelrinC;reimbursement or insurance coverage from government and private third-party pay

312、ors is available;healthcare professionals obtain required approvals and licensures for the handling,storage,dispensing and disposal ofGelrinC;and healthcare professionals become familiar with the complexities of GelrinC.We cannot predict when,if ever,healthcare professionals and patients may adopt t

313、he use of GelrinC.Even if favorabledata is obtained from clinical and health-economic studies for the regulatory approval of GelrinC,there can be no assurance thatprominent physicians would endorse it or that future clinical studies will continue to produce favorable data regarding GelrinC.Inadditio

314、n,prolonged market exposure may also be a pre-requisite to reimbursement or insurance coverage from government andprivate third-party payors.If GelrinC does not achieve an adequate level of acceptance by patients,healthcare professionals,andgovernment and private third-party payors,we may not genera

315、te significant product revenues and we may not become profitable.202025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm34/228 We are dependent upon contract

316、 manufacturing organizations and raw material suppliers making us vulnerable to supplyshortages and problems,increased costs and quality or compliance issues,any of which could harm our business.Some of the critical materials and components used in manufacturing GelrinC are sourced from single suppl

317、iers.Oursuppliers may encounter problems during manufacturing for a variety of reasons,including,for example,failure to follow specificprotocols and procedures,failure to comply with applicable legal and regulatory requirements,equipment malfunction andenvironmental factors,failure to properly condu

318、ct their own business affairs,and infringement of third-party intellectual propertyrights,any of which could delay or impede their ability to meet our requirements.An interruption in the supply of a key materialcould significantly delay our research and development process or increase our expenses f

319、or commercialization or development ofproduct.An interruption in the supply of a key material could significantly delay our research and development process or increaseour expenses for commercialization or development of products.Specialized materials must often be manufactured for the firsttime for

320、 use in drug delivery technologies,or materials may be used in the technologies in a manner that is different from theircustomary commercial uses.The quality of materials can be critical to the performance of a drug delivery technology,so a reliablesource that provides a consistent supply of materia

321、ls is important.Materials or components needed for our drug deliverytechnologies may be difficult to obtain on commercially reasonable terms,particularly when relatively small quantities are requiredor if the materials traditionally have not been used in pharmaceutical products.Our reliance on these

322、 third-party suppliers also subjects us to other risks that could harm our business,including:we are not currently a major customer of many of our suppliers,and these suppliers may therefore give othercustomers needs higher priority than ours;we may not be able to obtain an adequate supply in a time

323、ly manner or on commercially reasonable terms;our suppliers,especially new suppliers,may make errors in manufacturing that could negatively affect the efficacy orsafety of our products or cause delays in shipment;we may have difficulty locating and qualifying alternative suppliers;switching componen

324、ts or suppliers may require product redesign and possibly submission to the FDA or other similarforeign regulatory agencies,which could impede or delay our commercial activities;one or more of our suppliers may be unwilling or unable to supply components of our products;the occurrence of a fire,natu

325、ral disaster or other catastrophe impacting one or more of our suppliers may affect theirability to deliver products to us in a timely manner;and our suppliers may encounter financial or other business hardships unrelated to our demand,which could inhibit theirability to fulfill our orders and meet

326、our requirements.We may not be able to quickly establish additional or alternative suppliers,if necessary,in part because we may need toundertake additional activities to establish such suppliers as required by the regulatory approval process.Any interruption or delayin obtaining products from our t

327、hird-party suppliers,or our inability to obtain products from qualified alternate sources atacceptable prices in a timely manner,could impair our ability to meet the demand of our customers and cause them to switch tocompeting products.Given our reliance on certain suppliers,we may be susceptible to

328、 supply shortages whilst looking for alternatesuppliers.We may not be able to replace our current manufacturing capabilities in a timely manner.If our manufacturing facility suffers any type of prolonged interruption,whether caused by regulator action,equipmentfailure,critical facility services(such

329、 as water purification,clean steam generation or building management and monitoringsystem),fire,natural disaster or any other event that causes the cessation of manufacturing activities,we may be exposed to long-term loss of sales and profits.There are limited facilities which are capable of contrac

330、t manufacturing some of our products andproduct candidates.Replacement of our current manufacturing capabilities may have a material adverse effect on our business andfinancial condition.212025/5/20 10:55sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htmhttps:/www.

331、sec.gov/Archives/edgar/data/1912966/000121390025045479/ea0242682-f1a2_regentisbio.htm35/228 Our business plan is dependent upon third-party service providers.If such third-party service providers fail to maintain a highquality of service,the utility of our products could be impaired,which could adve

332、rsely affect the penetration of our products,our business,operating results and reputation in the future.The success of certain services and products that we may provide in the future are dependent upon third-party serviceproviders.Such service providers include manufacturers of custom materials for

333、 our GelrinC.As we expand our commercialactivities,an increased burden will be placed upon the quality of such third-party providers.If third-party providers fail to maintaina high quality of service,our products,business,reputation and operating results could be adversely affected.In addition,poorquality of service by third-party service providers could result in liability claims and litigation a