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1、2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm1/228F-1/A 1 ea0238002-f1a1_regentisbio.htm AMENDMENT NO.1 TO FORM F-1As filed with the Securities and Ex

2、change Commission on May 5,2025.Registration No.333-285692 UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,DC 20549 AMENDMENT NO.1TOFORM F-1REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 REGENTIS BIOMATERIALS LTD.(Exact name of registrant as specified in its charter)State of Israe

3、l 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 19711Tel:

4、(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 Trauri

5、g,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 Ame

6、ricasNew 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 the

7、 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 t

8、he 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 listthe

9、 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 the

10、 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 accordance

11、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.2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/0001213900250

12、39589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm2/228The term“new or revised financial accounting standard”refers to any update issued by the Financial Accounting StandardsBoard to its Accounting Standards Codificati

13、on 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 accor

14、dance 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.2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.g

15、ov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_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 prospectus

16、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 5,2025 1,000,000 Ordinary Shares Regentis Biomaterials Ltd.This is a firm commitment initial publi

17、c 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 Ordinary

18、 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 Ordina

19、ry 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 both an

20、 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 Emergin

21、g 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 foreignsecurities

22、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)Underwr

23、iting 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-day op

24、tion 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 ,2025.2025/5/9 09:08sec.gov/Archives/edgar/dat

25、a/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm4/228 2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1

26、912966/000121390025039589/ea0238002-f1a1_regentisbio.htm5/228 2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm6/228 2025/5/9 09:08sec.gov/Archives/edgar/

27、data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm7/228 TABLE OF CONTENTS PROSPECTUS SUMMARY1THE OFFERING11SUMMARY FINANCIAL DATA13RISK FACTORS14SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMEN

28、TS56USE OF PROCEEDS58DIVIDEND POLICY58CAPITALIZATION59DILUTION61MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OFOPERATIONS63BUSINESS69MANAGEMENT89PRINCIPAL SHAREHOLDERS112CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS114DESCRIPTION OF SHARE CAPITAL116DESCRIPTION OF THE

29、 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 STATEMENTSF

30、-1 i2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm8/228 ABOUT THIS PROSPECTUS You should rely only on the information contained in this prospectus or i

31、n 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.We take no

32、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 offer to sell

33、 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 only as of

34、 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 required to inf

35、orm 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 authorized anyone

36、 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 provide n

37、o 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 prospectus is

38、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 we nor th

39、e 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 this offer

40、ing 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.Allreferences to“shar

41、es”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 Gelrin and G

42、elrinC 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,but those r

43、eferences 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 information co

44、ncerning 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 andcircumstanc

45、es 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 parties,in

46、dustry,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 uncertainty

47、 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.”2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/

48、000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm9/228ii2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/00

49、0121390025039589/ea0238002-f1a1_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 our Ordinar

50、y 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 elsewhere in this

51、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 repair solutions

52、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 glycol diacryl

53、ate(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 painful injuries

54、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,weplan to eng

55、age 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 woundsedges,we believ

56、e 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 cartilage ti

57、ssue 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 migration of t

58、he 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 engineered to be in

59、serted 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.Market Oppo

60、rtunities 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 joints,osteoarthr

61、itis,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 patients and ofte

62、n 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 todeterioration after

63、 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,but instead ha

64、s 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 clinicaltri

65、als,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 for GelrinC at

66、 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 Completed Pilot Stud

67、y”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 for two surg

68、ical procedures.2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm11/22812025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a

69、1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_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 treated for cart

70、ilage 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.Gelrin is a fam

71、ily 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 can be applied i

72、n 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 cartilage defec

73、ts 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 cartilage repa

74、ir 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 clinical studies,a

75、ll 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 ofmicrofracture.Curr

76、ently,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 the pre-market

77、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 scienceand our c

78、lose 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 criteria allowed by

79、 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 over two year

80、s 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 associated problems

81、 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.The pivotal tri

82、al 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 develop a pipe

83、line of products that can be used for additional tissue regeneration opportunities.22025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm13/228 Summary Risk F

84、actors 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 strategy.Some of the

85、 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 foreseeable future.

86、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 timely basis may req

87、uire 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 reasonable terms or

88、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 occur at any stag

89、e 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 advance throughcli

90、nical 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 condition and results o

91、f 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.If healthcare

92、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 costs and qualit

93、y 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 service,the uti

94、lity of our products could be impaired,which could adversely affect thepenetration of our products,our business,operating results and reputation in the future.32025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/19

95、12966/000121390025039589/ea0238002-f1a1_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 even if the add

96、ressable 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 may face costs and

97、 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 may be adversely a

98、ffected 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 impede our busine

99、ss 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 our currency exch

100、ange 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 ourshareholders.Our manag

101、ement 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 carry out their

102、 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 ourclinical trial

103、s 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 fail to provide us

104、 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 that our trade secr

105、ets and intellectual property will bemisappropriated or disclosed.42025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm15/228 Risks Related to Our Intellectu

106、al 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 and maintaining pat

107、ent 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 a party to lawsu

108、its 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 products.If we fail

109、 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 our trademarks an

110、d 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 portfolio has exp

111、iration 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 business profitab

112、ly.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 thirdparty,includ

113、ing 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 misappropriated the intellectu

114、al 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.52025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000

115、121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm16/228 Risks Related to Government Regulation Our product candidates and operations are subject to extensive government regulation and oversight both in theUn

116、ited 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 our future products

117、 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 manufactured in accor

118、dance 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 product liability sui

119、ts 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 malfunctions that wear

120、e 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 the direction of

121、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 penalties,contrac

122、tual 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 business or could le

123、adto 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 outside of the United

124、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.Healthcare reform laws

125、 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 ormodified products f

126、rom being developed,cleared or approved or commercialized in a timely manner or at all,which could negatively impact our business.62025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea02

127、38002-f1a1_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 offering.The market price

128、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 Shares may decline.C

129、ertain 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 performance in any given

130、 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 decline.If securities an

131、alysts 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 and do not expect to

132、 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 limit your ability toa

133、ffect 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 theSEC,which could u

134、ndermine 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 requirements,which m

135、ay 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 generally would be ne

136、gative 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 our Ordinary Share

137、s.New investors purchasing our securities will experience immediate and substantial dilution 72025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm18/228 Risk

138、s 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 arelocated,may adversely af

139、fect 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 our costs and taxes.We

140、 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 require us to pay royaltie

141、s 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 under current Israe

142、li 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 couldprevent a change of

143、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,to assert U.S.securit

144、ies 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 shareholders of U.S.

145、companies.82025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm19/228 Corporate Information We are an Israeli corporation based in Israel and incorporated in

146、 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 beconsidered a part of thi

147、s 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 fiscal year,we qualify as

148、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 years of audited financia

149、l 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,objectives andelements and

150、 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(commonly referred to as th

151、e“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 in the assessment of o

152、ur internal control over financialreporting pursuant to the Sarbanes-Oxley Act of 2002.92025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm20/228 We may tak

153、e 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 of$1.235 billion or mo

154、re;(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 reduced burdens,andtherefore

155、 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 an extended transitio

156、n 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 available to emerging growth

157、companies.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 other public companies mo

158、re 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 Securities Exchange Act of

159、 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 of the Exchange Act t

160、hat 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 file public reports of t

161、heir 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 other specified informatio

162、n,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 releases,distributed pursuan

163、t 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 compared to that required

164、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 a foreign private iss

165、uer.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;(ii)more than 50%of our

166、 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 qualify as an emerging

167、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.102025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238

168、002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm21/228 THE OFFERING Ordinary Sharescurrently issued andoutstanding 3,929,378 Ordinary Shares as of May 5,2025.Ordinary Shares to beoutstanding after thisoffering 4,929,378 Ordinary

169、 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 purchase,at the public offe

170、ring 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 designatedassignees)warrants

171、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 theRepresentatives over-allotment option

172、),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 registration statement.T

173、he 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 Representative,please se

174、e“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 from the closing of this

175、 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 approximately$9.1 million in net p

176、roceeds 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 range set forth on the co

177、ver 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 activities(including the completi

178、on 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 development(Medical Device Regu

179、lationqualification 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;and the remainder for working ca

180、pital and general corporate purposes and possible futureacquisitions.2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm22/228 The amounts and schedule of o

181、ur actual expenditures will depend on multiple factors.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 Fina

182、ncings.”112025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm23/228 Risk factors Investing in our securities involves a high degree of risk.You should read

183、the“Risk Factors”startingon page 14 of this prospectus 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

184、 the Ordinary Shares being listed on the NYSE American,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 Ordinar

185、y Shares offered hereby are sold,and is based on 3,929,378 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 exercis

186、e price of$3.97,of which 79,290 were vested as of such date;465,533 Ordinary Shares issuable upon the exercise of options to be issued to the chairman of the board ofdirectors upon the completion of this offering under our incentive option plan,at an exercise price of NIS 0.04;191,473 Ordinary Share

187、s issuable upon the exercise of options to be issued 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 OrdinaryS

188、hares equal to two times the respective loan amount 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 2

189、024 Loan Agreements lenders to purchase such number 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 consummati

190、on of this offering;Ordinary Shares underlying warrants 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

191、Ordinary Share during the first five trading daysfollowing 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

192、LoanAgreement owed to such lender,based on a price 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 Re

193、presentatives over-allotment option;no exercise of 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 Ord

194、inary Shares issuable upon the automatic conversion 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 i

195、ssuable upon the automatic conversion of the$450,000 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 i

196、nformation.2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm24/228122025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_re

197、gentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_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

198、 balance sheet data as of December 31,2024 from our 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 fu

199、ture.Thefollowing summary financial data should be 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

200、 of USD,except share and per share data)2024 2023 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

201、),net:Changes in fair value convertible notes 3,483 (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 ordi

202、nary shares used in computing basic and diluted net 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 Curre

203、nt liabilities:Trade account payables$252 252$252 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 lia

204、bilities,temporary equity and shareholders equity(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 ando

205、utstanding as of the date hereof,which will automatically 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;(

206、iii)the issuance of 553,640 Ordinary Shares upon 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

207、 the total amount of$200,000 pursuant to the 2025 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 909,090 Ordinary Shares in this offering at anini

208、tial public offering price of$11.00 per Ordinary 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$35

209、0,000 plus accrued interest and an aggregate riskpremium 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

210、Loan Agreement in the total amount of$117,000 plus accrued interest and an aggregate risk premium2025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm26/228of

211、 approximately$35,100;and(v)the repayment of the 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 i

212、nitial publicoffering price and other terms of 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 pr

213、o forma as adjusted amount of each of cash,cash 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 estim

214、ated underwritingdiscounts and commissions and 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 deposit

215、s,total assets and shareholders equity(deficiency)by$0.76 million.132025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm27/228 RISK FACTORS Investing in our

216、Ordinary Shares involves a high degree of risk.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

217、purchasing our securities.If any of the following 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

218、Related to Our Financial Condition and Capital 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

219、limited operating history.To date,we have focused 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 o

220、perating history upon which you can evaluate 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 th

221、e medical device industry.To date,wehave not 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 r

222、esult of a one-time research and development 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.Substant

223、ially all of our operating losses resulted from 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 like

224、ly incur significantsales,marketing,and outsourced 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 in

225、cur significant and increasing operating losses 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 sig

226、nificant losses until we receive the necessary 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

227、 Gelrin hydrogel platform,products and product 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 manufac

228、turers to obtain adequate supply of materials 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;142025/5/9 0

229、9:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm28/228 seek to attract and retain skilled personnel;create additional infrastructure to support our operations as a

230、 public company and our product candidate developmentand 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

231、 follow-up of existing studiesor additional 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 gra

232、nts.Even if we obtain additional regulatoryapprovals 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 sufficientmar

233、ket acceptance,pricing,reimbursement from third-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 in

234、dication of our future performance.Other unanticipated 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 a

235、nd have never generated any revenue from product 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 necess

236、ary regulatory approvals to commercialize our 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 de

237、velopment of our Gelrin hydrogel platform and 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 candidate

238、s;maintain and enhance a commercially viable,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 a

239、nd,if applicable,manufacturing relationships 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 deve

240、loping new product candidates;launch and commercialize 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 po

241、tential markets that we will target;accurately identifying demand for our Gelrin hydrogel platform or any future product candidates;152025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/e

242、a0238002-f1a1_regentisbio.htm29/228 expose 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 a

243、pproved for reimbursement from governmental 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 prospecti

244、ve usage by medical professionals;negotiate 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 application

245、s,tradesecrets and know-how;avoid and defend 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 expecta

246、tions if we are required by the FDA,or other 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 a

247、ny future product candidates,our revenue earnedfrom 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 a

248、ny price,whether we own the commercial rights 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

249、able to generate significant revenue from the 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 abl

250、e to achieve or maintain profitability.Even 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 ou

251、r product development efforts or other operations.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 de

252、ficit of approximately$41.7 million and$46.9 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 proceed

253、s from this offering.Even if this offering 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

254、us,and wemay need to seek additional funds 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 ou

255、r Gelrin hydrogel platform and any future productcandidates;162025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm30/228 the costs of manufacturing product c

256、andidates,including costs related to engaging 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

257、future;the cost of our future activities,including 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

258、 arrangements that we may establish;the costs 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

259、for which we receivemarketing approval.Any 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 a

260、ddition,we cannot guarantee that future financing 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

261、debt,by us,or the possibility of such issuance,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 a

262、dditional debt,limitations on our ability 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

263、 earlier stage than otherwise would be desirable,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 believ

264、e that we have sufficient funds for our current 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 discont

265、inue oneor more of our research or development 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 desire

266、d,which could materially affect our business,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

267、at all.As described in Note 1d of our accompanying 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 t

268、o raise additional funds through the issuance 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

269、 needs through debt or equityfinancing.We 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

270、to our products.This may raise substantial doubts about our ability to continue as a going concern.172025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm31/2

271、28 Risks Related to Our Business and Industry 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

272、subject to all of the risks inherent in the 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 t

273、echnology for commercialapplications.We may 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

274、business.If we are unable to address any 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

275、history of net losses and negative cash flow 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 relate

276、d to developing our business,including research 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

277、,andcosts associated with operating as a 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

278、our GelrinC product candidate and platform 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

279、profitable basis.Even if we achieve profitability,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 p

280、otential complications fromGelrinC and may 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 hav

281、e performed the Pilot Study involving 56patients 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 approved

282、IDE,or the Pivotal Study,in the United States 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 cann

283、ot assure you that actual clinical performances 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 Pivota

284、l Study could be delayed.Furthermore,there 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

285、 obtained from our current GelrinC version 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 suffi

286、cient clinical experience with GelrinC,assumptions 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

287、 clinical results to date will require furtherindependent 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 ma

288、y beharmed,GelrinC may not achieve regulatory clearances,and GelrinC may not be widely adopted by healthcare providers andpatients.182025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea

289、0238002-f1a1_regentisbio.htm32/228 We operate 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

290、 are,and any new products or procedures 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

291、 compete successfully will depend onour 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 t

292、imely manner,receive adequate coverage and 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,includi

293、ng Vericel and others.We alsocompete with 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

294、 may develop new products,procedures or 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,obta

295、ining regulatory clearances or approvals 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 pharma

296、ceuticals or breakthrough bio-technological 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 decrease

297、d demand for our product and,accordingly,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

298、 distribution networks,a broader offering 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 agent

299、s,both those presently workingwith us and 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

300、 against our existing or potential competitors,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 i

301、nability to successfully commercialize this 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

302、 affecting our ability to successfully commercialize,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

303、 generate revenues.Furthermore,we may be 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;1

304、92025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htm33/228 market acceptance of the clinical safety and performance of GelrinC;development of similarly cost

305、-effective products by our competitors;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 requ

306、irements and licensure for our product;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 shel

307、f life of GelrinC.If healthcare professionals 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 m

308、arket acceptance and we may not become 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

309、to a delayed adoption by patients,as well 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 th

310、eir existing tissuerepair methods and recommendations;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

311、 government and private third-party payors 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

312、 professionals and patients may adopt the 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 fav

313、orable data regarding GelrinC.Inaddition,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 priva

314、te third-party payors,we may not generate significant product revenues and we may not become profitable.202025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_regentisbio.ht

315、m34/228 We are dependent upon contract 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

316、 GelrinC are sourced from single suppliers.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 andenvironme

317、ntal factors,failure to properly conduct 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 developm

318、ent process or increase our expenses for 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

319、 be manufactured for the firsttime for 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 p

320、rovides a consistent supply of materials 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 pharmac

321、eutical products.Our reliance on these 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

322、to obtain an adequate supply in a timely 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 al

323、ternative suppliers;switching components 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

324、products;the occurrence of a fire,natural 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 theira

325、bility to fulfill our orders and meet 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

326、 delayin obtaining products from our third-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 cert

327、ain suppliers,we may be susceptible to 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,equipmentf

328、ailure,critical facility services(such 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 f

329、acilities which are capable of contract manufacturing some of our products andproduct candidates.Replacement of our current manufacturing capabilities may have a material adverse effect on our business andfinancial condition.212025/5/9 09:08sec.gov/Archives/edgar/data/1912966/000121390025039589/ea02

330、38002-f1a1_regentisbio.htmhttps:/www.sec.gov/Archives/edgar/data/1912966/000121390025039589/ea0238002-f1a1_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 produc

331、ts could be impaired,which could adversely 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

332、manufacturers of custom materials for 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

333、 adversely affected.In addition,poorquality of service by third-party service providers could result in liability claims and litigation against us for damages or injuries.Our business plan relies on certain assumptions about the market for our product,however,the size and expected growth of ouraddressable market has not been established with precision and may be smaller than we estimate,and even i