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1、S-1/A 1 g084655_s1a.htm S-1/A As filed with the U.S.Securities and Exchange Commission on January 10,2025.Registration No.333-284183 UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,D.C.20549 Amendment No.1 to FORM S-1REGISTRATION STATEMENTUNDERTHE SECURITIES ACT OF 1933 ASPARGO LABS,INC.(E

2、xact name of registrant as specified in its charter)Delaware 2834 84-3757833(State or other jurisdiction ofincorporation or organization)(Primary Standard IndustrialClassification Code Number)(I.R.S.EmployerIdentification Number)Aspargo Labs,Inc.17 State Street,Suite 3220New York,NY 10004(646)503-12

3、60(Address,including zip code,and telephone number,including area code,of registrants principal executive offices)Michael DemurjianChief Executive OfficerAspargo Labs,Inc.17 State Street,Suite 3220New York,NY 10004(646)503-1260(Name,address,including zip code,and telephone number,including area code

4、,of agent for service)Copies to:Joseph M.Lucosky,Esq.Scott E.Linsky,Esq.Lucosky Brookman LLP101 Wood Avenue South,5th FloorWoodbridge,NJ 08830(732)395-4408 Approximate date of commencement of proposed sale to the public:As soon as practicable after this registration statementis declared effective.If

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

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

7、s 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 andlist the Securities Act registration statement number of the earlier e

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

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

10、ended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B)of the Securities Act.The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effectivedate until the registrant

11、shall file a further amendment which specifically states that this registration statement shallthereafter become effective in accordance with section 8(a)of the Securities Act of 1933 or until the registration statementshall become effective on such date as the commission,acting pursuant to said sec

12、tion 8(a),may determine.The information in this prospectus is not complete and may be changed.These securities may not be sold until theregistration statement filed with the Securities and Exchange Commission is effective.This prospectus is not an offer to buythese securities in any jurisdiction whe

13、re the offer or sale is not permitted.SUBJECT TO COMPLETION,DATED JANUARY 10,2025 PROSPECTUS Up to 176,986,993 Shares of Common Stock This prospectus relates to the registration of the resale of up to 176,986,993 shares,par value$0.0001 per share,of our commonstock by our stockholders identified in

14、this prospectus(the“Registered Stockholders”).Unlike an initial public offering,the resaleby the Registered Stockholders is not being underwritten by any investment bank.The Registered Stockholders may,or may not,elect to sell their shares of common stock covered by this prospectus,as and to the ext

15、ent they may determine.Such sales,if any,will be made through brokerage transactions on the New York Stock Exchange,or the NYSE.If the Registered Stockholders chooseto sell their shares of common stock,we will not receive any proceeds from the sale of shares of common stock by the RegisteredStockhol

16、ders.See“Plan of Distribution”.Currently,no public market for our common stock exists.However,we issued and sold shares of our common stock in privatetransactions.The sales price of our common stock for such private transactions during the year ended December 31,2023 and thenine-month period ended S

17、eptember 30,2024,was$0.87 per share.For more information,see“Sale Price History of our CommonStock”.The price at which shares of our common stock have been issued in private transactions may have little or no relation to theopening public price of our shares of common stock on the NYSE or the subseq

18、uent trading price of our shares of common stock onthe NYSE.Further,the listing of our common stock on the NYSE without underwriters is a novel method for commencing publictrading in shares of our common stock,and consequently,the trading volume and price of shares of our common stock may be morevol

19、atile than if shares of our common stock were initially listed in connection with an underwritten initial public offering.Based on information provided by the NYSE,the opening public price of our common stock on the NYSE will be determined bybuy and sell orders collected by the NYSE from broker-deal

20、ers.Based on such orders,the designated market maker will determinean opening price for our common stock in consultation with a financial advisor pursuant to NYSE Rule 7.35A.For moreinformation,see“Plan of Distribution”.We intend to apply to list our common stock on the NYSE under the symbol“AAGO”.W

21、e expect our common stock to begintrading on the NYSE on or about _,2025.We are an“emerging growth company”and a“smaller reporting company”as defined under the federal securities laws and,as such,we have elected to comply with reduced reporting requirements for this prospectus and may elect to do so

22、 in future filings.See“Prospectus Summary Implications of Being an Emerging Growth Company”and“Prospectus Summary Implications of Beinga Smaller Reporting Company”.See“Risk Factors”beginning on page 8 to read about factors you should consider before buying shares of our commonstock.The Securities an

23、d Exchange Commission and state securities regulators have not approved or disapproved these securitiesor determined if this prospectus is truthful or complete.Any representation to the contrary is a criminal offense.The date of this prospectus is ,2025 TABLE OF CONTENTS PageAbout This ProspectusiiT

24、rademarksiiMarket and Industry DataiiSpecial Note Regarding Forward-Looking StatementsiiProspectus Summary1Risk Factors9Use of Proceeds33Dividend Policy34Capitalization35Managements Discussion and Analysis of Financial Condition and Results of Operations36Business54Management89Executive and Director

25、 Compensation100Certain Relationships and Related Party Transactions104Principal and Registered Stockholders105Description of Capital Stock107Shares Eligible for Future Sale112Sale Price History of our Common Stock113Material U.S.Federal Income Tax Considerations for Non-U.S.Holders of our Common St

26、ock114Plan of Distribution117Legal Matters118Experts118Where You Can Find More Information118Index to Financial StatementsF-1 i ABOUT THIS PROSPECTUS This prospectus is a part of a registration statement on Form S-1 that we filed with the SEC using a continuous offering process.Under this process,th

27、e Registered Stockholders may,from time to time,sell the common stock covered by this prospectus in themanner described in“Plan of Distribution”.Additionally,we may provide a prospectus supplement to add information to,or updateor change information contained in,this prospectus.You may obtain this i

28、nformation without charge by following the instructionsunder“Where You Can Find More Information”appearing elsewhere in this prospectus.You should read this prospectus and anyprospectus supplement before deciding to invest in shares of our common stock.TRADEMARKS We claim trademark rights in the Uni

29、ted States and other international jurisdictions for the trademarks ASPARGO,the stylized“A”,and the brand names,“BANDOL”and“HEZKUE”.This prospectus contains references to our trademarks and to trademarksbelonging to other entities.Solely for convenience,trademark and trade names referred to in this

30、prospectus,including logos,artwork and other visual displays,may appear without the or symbols,but such references are not intended to indicate,in anyway,that we will not assert,to the fullest extent under applicable law,our rights to these trademarks and trade names.All othertrademarks,trade names

31、and service marks appearing in this prospectus are the property of their respective owners.We do notintend our use or display of other companies trade names or trademarks to imply a relationship with,or endorsement or sponsorshipof us by,any other companies.Other trademarks and trade names referred

32、to in this prospectus are the property of their respectiveowners.MARKET AND INDUSTRY DATA This prospectus contains statistical data and estimates based on independent industry publications or other publicly availableinformation,as well as other information based on our internal sources.This informat

33、ion involves a number of assumptions andlimitations.We are responsible for all of the disclosures contained in this prospectus and the documents incorporated by referenceherein and we believe that the data we use from third parties are reliable;however,we have not separately verified this data.Furth

34、er,while we believe that our internal research is reliable,such research has not been verified by any third party.You are cautioned notto give undue weight to any such information,estimates and projections.The industry in which we operate is subject to a highdegree of uncertainty and risk due to a v

35、ariety of factors,including those described in“Risk Factors”.SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This prospectus contains forward-looking statements within the meaning of the federal securities laws,which are statements thatinvolve substantial risks and uncertainties.Forward-looking st

36、atements generally relate to future events or our future financial oroperating performance.In some cases,you can identify forward-looking statements because they contain words such as“may,”“will,”“shall,”“should,”“expects,”“plans,”“anticipates,”“could,”“intends,”“target,”“projects,”“contemplates,”“b

37、elieves,”“estimates,”“predicts,”“potential,”or“continue”or the negative of these words or other similar terms or expressions that concernour expectations,strategy,plans,or intentions.Forward-looking statements contained in this prospectus include,but are not limitedto,statements about:our future fin

38、ancial performance,including our revenue,cost of revenue,and operating expenses;our ability to achieve widespread adoption of Sildenafil Oral Suspension or other oral liquid suspension drug productsunder development;our ability to achieve widespread adoption of our electronic drug delivery device un

39、der development our ability to effectively manage our growth and future expenses;our estimated market opportunity;our ability to maintain,protect,and enhance our intellectual property;our ability to comply with modified or new laws and regulations applying to our business;the attraction and retentio

40、n of qualified employees and key personnel;our anticipated investments in sales and marketing and research and development;the sufficiency of our cash,cash equivalents,and investments to meet our liquidity needs;our ability to successfully defendlitigation brought against us;and the increased expens

41、es associated with being a public company.We caution you that the foregoing list may not contain all the forward-looking statements made in this prospectus.ii You should not rely upon forward-looking statements as predictions of future events.We have based the forward-looking statementscontained in

42、this prospectus primarily on our current expectations and projections about future events and trends that we believemay affect our business,financial condition,results of operations,and prospects.The outcome of the events described in theseforward-looking statements is subject to risks,uncertainties

43、,and other factors described in“Risk Factors”and elsewhere in thisprospectus.Moreover,we operate in a competitive and rapidly changing environment.New risks and uncertainties emerge fromtime to time,and it is not possible for us to predict all risks and uncertainties that could have an impact on the

44、 forward-lookingstatements contained in this prospectus.The results,events,and circumstances reflected in the forward-looking statements may notbe achieved or occur,and actual results,events,or circumstances could differ materially from those described in the forward-looking statements.The forward-l

45、ooking statements made in this prospectus relate only to events as of the date on which the statements are made.Weundertake no obligation to update any forward-looking statements made in this prospectus to reflect events or circumstances afterthe date of this prospectus or to reflect latest informat

46、ion or the occurrence of unanticipated events,except as required by law.Wemay not actually achieve the plans,intentions,or expectations disclosed in our forward-looking statements and you should not placeundue reliance on our forward-looking statements.Our forward-looking statements do not reflect t

47、he potential impact of any futureacquisitions,mergers,dispositions,joint ventures,or investments we may make.In addition,statements that“we believe”and similar statements reflect our beliefs and opinions on the relevant subject.Thesestatements are based upon information available to us as of the dat

48、e of this prospectus,and while we believe such information formsa reasonable basis for such statements,such information may be limited or incomplete,and our statements should not be read toindicate that we have conducted an exhaustive inquiry into,or review of,all potentially available relevant info

49、rmation.Thesestatements are inherently uncertain,and you are cautioned not to unduly rely upon these statements.iii PROSPECTUS SUMMARY This summary highlights selected information contained elsewhere in this prospectus.This summary is not complete and does notcontain all the information that you sho

50、uld consider before deciding whether to invest in shares of our common stock.You shouldcarefully read the entire prospectus,including the risks associated with an investment in the company discussed in the“RiskFactors”section of this prospectus,before making an investment decision.Unless the context

51、 otherwise requires,the terms“Aspargo,”the“Company”,“us”and“our”in this prospectus refer to Aspargo Labs,Inc.(“Aspargo US”)and our whollyowned subsidiary,Aspargo Labs Italia,SRL(“Aspargo Italia”).Our fiscal year ends December 31.Overview Our mission is to improve patient outcomes by combining the th

52、erapeutic benefits of liquid dosage forms of medications withelectronic drug delivery devices and associated mobile apps that facilitate medication adherence.Aspargo is a commercial stage specialty pharmaceutical and med-tech company focused on designing,developing and marketingproprietary,oral liqu

53、id suspension formulations of leading oral solid dose prescription(Rx)and over-the-counter(OTC)medications dispensed through“smart”,digitally connected,container closure drug delivery systems and associated mobile apps.Our first commercial product,Sildenafil Oral Suspension,indicated for the treatme

54、nt of erectile dysfunction(ED),is an oral liquidsuspension formulation of sildenafil citrate,the active pharmaceutical ingredient contained in VIAGRA,administered through ametered dose container closure system consisting of a 30 ml bottle and mechanical pump.We market Sildenafil Oral Suspensionin Sp

55、ain under the brand name,BANDOL,and in Germany and the United Kingdom under the brand name,HEZKUE.Sildenafil Oral Suspension is approved for sale in multiple countries in the European Union(EU)and is undergoing the approvalprocess in the United States.Our core business strategy is to develop and pro

56、mote new uses for our licensed and self-developed technology and know-how,which make it possible to reformulate oral solid dose medications for administration as oral liquid suspensions,and to design andmanufacture novel,proprietary,digitally connected,electronic drug delivery devices and associated

57、 mobile apps foradministration of our proprietary oral suspension formulations to enhance patient centric care and medication adherence.History We started Aspargo because our founder and chief executive officer,Mr.Michael Demurjian,experienced first-hand that friendsand family members and their care

58、givers were frustrated by the experience of taking medicines in the form of traditional tablets,capsules,and pills.Some patients have difficulty swallowing solid dosage form medications,others forget whether they took theirprescribed dose at the times dictated by their physicians,and others self-med

59、icate and titrate their dose based on their symptomsand how they feel,by splitting or crushing tablets.Spouses,partners,relatives,and caregivers expressed the desire for an app-based alert that could send a message in real time as a reminder that it was time for their loved one or the patient under

60、their careto take his or her medications.Our CEO recognized that improved dosing convenience combined with real time dose monitoringwould likely improve compliance and medication dosing adherence,and thereby improve quality of life and overall userexperience for consumers of popular Rx and OTC medic

61、ations.Following discussions with university and practicing physicians,our CEO was inspired to create Aspargo to modernize drug delivery.1 Current Treatments and Their Limitations Disadvantages of oral solid dosage form Tablets and capsules,the oral dosage forms most prescribed by doctors,contain a

62、mixture of active pharmaceutical ingredients(API)with or without excipients.Although solid dose(tablets/capsules)is the major oral dosage form sold,the difficultiesswallowing tablets or capsules is an issue experienced by a wide range of people regardless of age or gender,with the elderly andyoung h

63、aving the most difficulty.In addition,different ages,weights,body mass indices,and metabolically impaired individuals require considerable dosingprecision that is not linearly scaled.Because medication errors are common in six percent of pediatric hospitalizations,dosetitration is critical,as a“one-

64、size-fits-all”dosing is ineffective in children due to their developmental variability and can provedeleterious for geriatric patients with hepatic or renal impairment.Medication nonadherence Moreover,though medications are effective in combating disease,often their full benefits are not realized be

65、cause approximately50%of patients do not take their medications as prescribed.Factors contributing to poor medication adherence are myriad andinclude those that are related to patients(e.g.,suboptimal health literacy and lack of involvement in the treatment decisionmakingprocess),those that are rela

66、ted to physicians(e.g.,prescription of complex drug regimens,communication barriers,ineffectivecommunication of information about adverse effects,and provision of care by multiple physicians),and those that are related tohealth care systems(e.g.,office visit time limitations,limited access to care,a

67、nd lack of health information technology).A lack offamily or social support is also predictive of nonadherence.Patients perceptions of adverse effects also contribute to decisionsregarding medication adherence.Our Solution Aspargos proprietary suspension formulations Liquid dosage forms play a cruci

68、al role in medication delivery,providing a convenient and effective means of administering drugsto patients of all ages.From syrups to suspensions and solutions,liquid medications offer advantages such as ease of ingestion,accurate dosing,and rapid onset of action.We believe that our licensed and se

69、lf-developed technology and know-how provides a“platform”technology that enables reformulation of a myriad of popular oral solid dose medications into liquid dosage forms.Keyto our proprietary formulation technology are unique methods for active pharmaceutical ingredient particle sizing,viscosityman

70、ipulation,and taste masking.“Smart”drug delivery devices Aspargos mission is to vastly improve patient medication adherence and therapeutic outcomes by combining the benefits of liquiddosage forms with digitally connected“smart”drug delivery devices that provide the opportunity for real-time dosing

71、data andcontinuous tracking of individual medication adherence behavior through connected mobile apps.Our“smart”device underdevelopment,which is designed to deliver consistent and accurate measured doses,integrates biometric security features to ensuresafe dosing,and facilitates communication betwee

72、n patients,healthcare providers,and loved ones via a mobile app.Thistechnology has the potential to offer unprecedented insights into patient adherence and optimize treatment regimens.Initial Commercial Product-Sildenafil Oral Suspension We are commercializing ASP-001,“Sildenafil Oral Suspension”,a

73、proprietary oral liquid suspension formulation of sildenafilcitrate,the active ingredient in VIAGRA,which is indicated for the treatment of erectile dysfunction(ED).Sildenafil OralSuspension is protected by US and European patents that extend through March 2036.Current Sales Activity Aspargo Italia

74、is the holder of marketing authorizations issued by national pharmaceutical product regulatory agencies in Spain,Germany,Ireland,the Netherlands and the UK for distribution of Sildenafil Oral Suspension.We purchased rights to distributeSildenafil Oral Suspension in Spain under the brand name,BANDOL

75、in 2022.We obtained marketing authorizations todistribute Sildenafil Oral Suspension in Germany,Ireland,the Netherlands and the UK under the brand name,HEZKUE,andinitiated distribution and promotional activities in Germany and the UK in September and October 2024,respectively.We intendto commence di

76、stribution of HEZKUE in Ireland and the Netherlands in Q1 2025.BANDOL and HEZKUE are administered via a metered dose container closure system,consisting of a 30 ml(about 1.01 oz)high-density polyethylene(HDPE)thermoplastic bottle and a mechanical pump with actuator that delivers the liquid equivalen

77、t of12.5 mg of solid dose tablet per push of the actuator.The BANDOL and HEZKUE discreet and easy-to-carry drug deliverysystems allow the user to administer the drug without water,and customize dosing,with physician direction,without resorting topill splitting or crushing common with the traditional

78、 tablet medications.2 Positioning of BANDOL in Spain focuses on highlighting the product as a groundbreaking innovation that enriches sex livesbecause of its discreet liquid technology,which enables flexible dosing and rapid absorption,so that users can achieve satisfactionwithout the need to plan.T

79、he ongoing communications plan focuses on BANDOLs unique value proposition of faster absorptionversus existing erectile dysfunction products as demonstrated in the bioavailability study that we conducted in 2023.Currently,this campaign is showcased in multiple Spanish media outlets,such as Actas Uro

80、logicas Espaolas and Urologia Internationalis,as well as the International Journal of Urology,Journal of Clinical Urology,The World Journal of Nephrology&Urology andothers.We launched HEZKUE in Germany in September 2024 by introducing HEZKUE at the 76th Congress of the German Society forUrology,held

81、 in Leipzig,Germany,attended by over 6,000 physician members.All attendees at the event were exposed toAspargos new HEZKUE campaign,and we provided approximately 1,000 product samples to prescribing physicians.To furthercapitalize on these Aspargo-health care professional(HCP)interactions,we develop

82、ed branded representative triggered emails(RTEs),allowing the sales force to distribute personalized messages to their HCP targets.The advantage of this effective andefficient communication vehicle is both the personalization as well as the physicians pre-approval for distribution.The overall goal o

83、f the promotional campaign for HEZKUE is to position the product as the primary choice for urologists andpatients,which we executed via the creation of the READY TO GET HIM READY campaign.The new and innovative campaignhas a modern disruptive approach differentiating HEZKUE from the competition and

84、showing the appropriateness of the productfor all relevant age groups.In October 2024,we initiated commercial launch activities in the UK by engaging a logistics provider with warehouse facilitiesand distribution operations to manage the supply chain activities in the UK on our behalf.Contracting/pr

85、icing negotiations havebegun with the NHS and additional strategies are in development for the private physician sector.Significant attention is beingpaid to both the retail/pharmacy and online distribution channels,which we anticipate will provide significant revenue upside.Wecommenced commercial s

86、ales activities in the UK in December 2024.Regulatory Approvals We commenced activities to obtain marketing authorizations to distribute HEZKUE in other jurisdictions in Europe,Asia,andSouth America in 2025.We are taking advantage of the“mutual recognition procedure”available in the European Union(“

87、EU)toobtain marketing authorizations in Europe without the need for additional clinical studies.Pursuant to the“mutual recognitionprocedure”available in the EU,the validity of the original,national marketing authorization for a medicine first authorized for usein one EU Member State,may be recognize

88、d in other EU Member States.We are relying on the current approvals in Spain andGermany and supporting data as evidence of safety and efficacy of BANDOL and HEZKUE in our submissions to healthauthorities in international jurisdictions outside the EU where the mutual recognition procedure is unavaila

89、ble.The process to obtain authorization from the U.S.Food and Drug Administration(“FDA”)to market Sildenafil Oral Suspensiondelivered through a mechanical,metered dose,mechanical container closure system in the United States is ongoing.We expect tofile a New Drug Application(“NDA”)with the FDA in mi

90、d-2025.Sildenafil Oral Suspension Comparative Bioavailability and Food Effect Studies In November and December 2023,we conducted a comparative bioavailability study in 53 subjects comparing the liquidequivalent of 100 mg of Sildenafil Oral Suspension(ASP-001)administered via a mechanical pump,to Via

91、gra film coated 100mg tablets.The study was powered for statistical significance.The pharmacokinetic results of the bioavailability study confirmedstatistically significant bioequivalence(p value of 0.05)between 100 mg equivalent of sildenafil administered as Sildenafil OralSuspension and 100 mg of

92、sildenafil administered as a Viagra film coated tablets(the“Reference Drug”).Adverse events wereconsistent with known effects of the Reference Drug and no serious adverse events were observed.Results of our study werepublished in the International Journal of Science and Research(Volume 13,Issue 6,Ju

93、ne 2024).The article,entitled“Pharmacokinetic Parameters of a Novel Sildenafil Oral Liquid Suspension Administered to Healthy Adult Men Under FastedConditions”,describes the extent of systemic exposure for Sildenafil Oral Suspension as compared to the Reference Drug.The results of the bioavailabilit

94、y study showed that ASP-001 reached approximately 15%higher peak levels in the bloodstream ascompared to the Reference Drug,as measured by“Cmax”,the highest concentration of the drug found in the blood followingadministration.The higher Cmax for ASP-001 suggests that ASP-001 acts faster or provides

95、a stronger initial effect than Viagratablets.The adverse effect profile of ASP-00,which is consistent with the Reference Drug as demonstrated in the trial,indicatesthat these results are obtained without compromising safety.Also in December 2023,we completed the dosing of 38 subjects in two cohorts

96、in a food effect study,comparing the amount ofactive drug in plasma after administration of a single oral dose of Sildenafil Oral Suspension(ASP-001)administered via amechanical,metered dose container under fasting and fed(following a meal)conditions.The study was not powered todemonstrate statistic

97、al significance for the food effect.Instead,it evaluated whether the pharmacokinetic(PK)parameters(Cmax,AUCt,and AUCi)fell within predefined bioequivalence criteria(80%125%).Results from the food effect study indicate that thatthe presence of food does not reduce the drugs effectiveness or its abili

98、ty to reach therapeutic levels.3 Sildenafil Oral Suspension Agreements Farmalider and Innovazone License Agreements We are the exclusive licensee of the patented suspension formulation of Sildenafil Oral Suspension in the United States andspecified countries outside the United States pursuant to Lic

99、ense Agreements with Farmalider,S.A.,a Spanish pharmaceuticalcompany(“Farmalider”),and Innovazone Labs LLC,a Florida limited liability company(“Innovazone”,and together withFarmalider,the“Licensors”).The Licensors are the joint owners of United States and corresponding European and otherinternationa

100、l granted patents related to Sildenafil Oral Suspension titled,Pharmaceutical Composition of Sildenafil Citrate in TheForm of A Suspension for Oral Use,which extend through March 2036.BANDOL Asset Purchase and Assignment and Assumption Agreements We are the exclusive licensee of the patented liquid

101、formulation of Sildenafil Oral Suspension in Spain authorized by the Spanishhealth authorities for distribution under the brand name,BANDOL,pursuant to a License and Supply Contract(the“FarmaliderLicense and Supply Contract”)between Farmalider and NutraEssntial OTC,S.L.,a wholly owned subsidiary of

102、Farmalider,andLaboratorios Rubi S.A.(“Rubio”),a pharmaceutical product marketing and distribution company located in Barcelona,Spain.InApril 2022,we purchased all of Rubios rights and interest related to BANDOL.Concurrent with the acquisition,we entered intoan Assignment and Assumption Agreement wit

103、h Rubio and Farmalider pursuant to which Aspargo Italia assumed from Rubio theexclusive rights to distribute BANDOL in Spain,which were granted to Rubio pursuant the Farmalider License and SupplyContract and reaffirmed in the Assignment and Assumption Agreement.We initiated commercial sales of BANDO

104、L in 2023following approval by the Spanish health authorities of the transfer of the BANDOL marketing authorization from Rubio toAspargo Italia.Sidus License and Distribution Agreement Argentina In November 2022,we entered into an Exclusive License Agreement(the“Argentina License”)with Laboratorios

105、SIDUS(“SIDUS”),a pharmaceutical group in Argentina,to market and distribute Sildenafil Oral Suspension in Argentina.SIDUSmanufactures and distributes in Argentina the MagnuS brand of sildenafil and tadalafil ED products.SIDUS has applied forregulatory approval from health authorities in Argentina to

106、 distribute Sildenafil Oral Suspension packaged in the container closuresystem used for BANDOL and HEZKUE.A decision from ANMAT is expected in Q1 2025.Sildenafil Oral Suspension Manufacturing Agreements International Manufacturing Agreements.BANDOL and HEZKUE are manufactured by Laboratorio Edefarm

107、S.L.,Valencia,Spain(“Edefarm”),a wholly owned subsidiaryof Farmalider.We purchase BANDOL from Farmalider for resale in the Spanish market pursuant to the Farmalider License andSupply Contract and Assignment and Assumption Agreement described above.We purchase HEZKUE from Farmalider for resalein the

108、German and UK markets pursuant to the Farmalider and Innovazone License Agreements referred to above.Domestic U.S.Manufacturing Agreements.In March 2020,we entered into a Technical Transfer and Manufacturing Services Agreement and Statement of Work withPharmaceutics International,Inc.(Pii),a contrac

109、t development and manufacturing organization(CDMO)located in Hunt Valley,MD(the“Pii MSA”),which provides for the technical transfer of the manufacturing process for Sildenafil Oral Suspension fromEdefarm to Pii and the manufacture of process feasibility and validation batches necessary to support ou

110、r submissions with theU.S.Food and Drug Administration(“FDA”).Pii completed the technical transfer and final development of the Sildenafil OralSuspension formulation,protocols and analytical methods;the manufacture of feasibility and technical transfer batches of drugproduct;the filling,packaging an

111、d labelling of the feasibility batches,stability testing of feasibility batches,and the manufacture,filling and packaging of the drug product supplies necessary to conduct the Sildenafil Oral Suspension clinical studies that weconducted in November and December 2023.In July 2024,we initiated the tec

112、hnical transfer of the manufacturing process for Sildenafil Oral Suspension to SaptalisPharmaceuticals,LLC(“Saptalis”),a U.S.based pharmaceutical company that specializes in the development,manufacturing,andcommercialization of niche generic and innovative specialty products.We executed a Master Ser

113、vice Agreement and Statement ofWork with Saptalis providing the terms and conditions,timelines and budget for the technical transfer,registration batchmanufacturing,and process performance qualification for Sildenafil Oral Suspension necessary to support our New DrugApplication(NDA)submission with t

114、he FDA.Our proprietary,digitally connected drug delivery device(under development)RKS Design,Inc.(“RKS”)is a product design firm,based in Thousand Oaks,California,that designs and develops consumer,medical,and industrial products,as well as user interfaces,and user experiences.Effective September 11

115、,2023,as amended in November 2024,we entered into a design agreement with RKS to design andengineer a slim,pocketable lifestyle,liquid pharmaceutical dispensing device(the“Generation 1 Design Project”).Effective May17,2024,we entered into an additional design agreement with RKS to design and enginee

116、r certain device enhancements,including functionality for multidrug usage,as compared to the Generation 1 system(the“Generation 1.5 Design Project”).4 The drug dispensing device and accompanying software under development by RKS for Aspargo epitomize Human-CenteredIndustrial Design(HCD)and user expe

117、rience by prioritizing medication administration through oral liquid dispensing via ahandheld device over pill swallowing.The handheld connected device under development is designed as a stylish,high-qualitypersonal accessory,intended to effortlessly dispense suspended medications.Featuring a biomet

118、ric fingerprint reader linked to amobile app,the centerpiece technology is designed to offer several key functions:prevention of unauthorized medicationdispensing,requirement for user authorization via the app for initialization,and connection to caregivers and personal networks toensure medication

119、adherence.For restricted medications,the device and app are intended to restrict dosing until authorized by theprescribing physician.Tampering with the cartridge triggers alerts to caregivers,pharmacists,and physicians,ensuring safe usage,especially for restricted medications by alerting through the

120、 app that the medication has not been taken as prescribed.Designed tobe as visually appealing and user friendly as an iPhone,the“smart”drug delivery device is intended to ensure medicationadherence and prevent overdosing,setting a new standard in User Experience.The design of the handheld,accessorie

121、s,and app iscentered around the need for an easy and convenient way for patients to receive“the right dose,at the right time,in the right wayand frequency.”Central to the device under development is the medication cartridge,uniquely identified and engineered to prevent independentdispensing,requirin

122、g the handheld device for operation.Upon insertion of the cartridge into the handheld device,the cartridge isdesigned to dispense medication following authorization,with the spray head of the cartridge emerging from the device silo for asingle use before retracting into the device,ensuring inaccessi

123、bility.Designed for mass production at low cost,the device andcartridge mechanism are intended to inherently meet specific requirements for child-resistant effectiveness as determined by theConsumer Product Safety Commission(CPSC).Intellectual Property In addition to the United States and internatio

124、nal Sildenafil Oral Suspension patents we license on an exclusive basis from ourLicensors,which expire in 2036,we have applied for 20 patents in the United States related to our proprietary digitally connecteddrug delivery device and accompanying software under development,of which five have been gr

125、anted.We claim trademark rights in our corporate name and logo and in our Sildenafil Oral Suspension brand names,HEZKUE andBANDOL,in various jurisdictions around the world.Also,we registered domain names for websites that we use in our business,such as ,www.hezkue.de,and similar variations.Growth St

126、rategy Our growth strategy is to develop,obtain regulatory approval,promote and distribute globally new drug device combinationproducts consisting of proprietary oral suspension formulations of popular Rx and OTC medications delivered in proprietary,digitally connected,drug administration devices wi

127、th accompanying mobile apps.In the near term,our growth strategy is to increase sales by focusing on the promotion and distribution of BANDOL in Spain,andHEZKUE in Germany,Ireland,Netherlands and the UK and obtaining authorization to market HEZKUE in the countries coveredby our license agreements wi

128、th Farmalider and Innovazone.In the medium term,our growth strategy is to generate increasingamounts of sales revenue by obtaining FDA approval to distribute Sildenafil Oral Suspension in the United States;developing andcommercializing liquid suspension formulations of other Rx and OTC medications d

129、elivered via a mechanical container closuresystem;and completing the development and commercialization of drug products delivered via our digitally connected,“smart”container closure system and accompanying mobile app under development.Competition The erectile dysfunction treatment products market a

130、nd the global pharmaceutical suspension market are competitive.There arenumerous players operating in these markets,which are fragmented with the presence of many companies.We compete withproducers and distributors of ED products,many of which are better capitalized,have greater name recognition,and

131、 have othercompetitive advantages as compared to Aspargo.The major players in the erectile dysfunction drugs market among others,arePfizer,Inc.,Eli Lilly and Company,and Bayer AG.Risks Factors Summary Our business and our ability to execute our business strategy are subject to several risks as more

132、fully described in“Risk Factors”beginning on page 8.These risks include,among others:we have a limited operating history,which makes it difficult to forecast our revenue and evaluate our business andprospects;we have a history of net losses,we anticipate increasing operating expenses in the future,a

133、nd we may not be able toachieve and,if achieved,maintain profitability;we may experience quarterly fluctuations in our results of operations due to several factors that make our future resultsdifficult to predict and could cause our results of operations to fall below analyst or investor expectation

134、s;5 the market in which we operate is competitive and rapidly changing,and if we do not compete effectively withestablished companies,our business,results of operations,and financial condition could be harmed;our listing differs significantly from an underwritten initial public offering;the public p

135、rice of our common stock may be volatile,and upon listing on the NYSE,could decline significantly andrapidly;none of our stockholders are party to any contractual lock-up agreements or other contractual restrictions on transfer,andfollowing our listing,sales of substantial amounts of our common stoc

136、k in the public markets or the perception that salesmight occur could cause the market price of our common stock to decline.Implications of Being an Emerging Growth Company As a company with less than$1.235 billion in annual gross revenue during our last fiscal year,we qualify as an“emerging growthc

137、ompany”as defined in Section 2(a)of the Securities Act of 1933,as amended(the“Securities Act”).An emerging growthcompany may take advantage of specified reduced reporting and other requirements that are otherwise applicable generally topublic companies.These provisions include:we are required to pre

138、sent only two years of audited financial statements and related managements discussion andanalysis of financial condition and results of operations in the registration statement of which this prospectus is a part;we are exempt from compliance with the requirement that our independent registered publ

139、ic accounting firm provide anattestation report on the effectiveness of our internal control over financial reporting;we are exempt from compliance with any requirement that the Public Company Accounting Oversight Board(the“PCAOB”)has adopted regarding communication of critical accounting matters an

140、d may adopt regarding mandatoryaudit firm rotation or a supplement to the auditors report providing additional information about the audit and thefinancial statements;we are exempt from the“say on pay,”“say when on pay,”and“say on golden parachute”non-binding advisory voterequirements;and we are eli

141、gible to provide reduced disclosures about our executive compensation arrangements.We may take advantage of each of the exemptions described above.It is possible,therefore,that some investors will find ourcommon stock less attractive,which may result in a less active trading market for our common st

142、ock and higher volatility in ourstock price.We may take advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the listing of ourstock or at such earlier time that we are no longer an emerging growth company.We would cease to be an emerging growthcompa

143、ny upon the earliest of:(i)the last day of the first fiscal year in which our annual gross revenues are$1.235 billion or more;(ii)the date on which we have,during the previous three-year period,issued more than$1 billion in non-convertible debtsecurities;or(iii)the date on which we are deemed to be

144、a“large accelerated filer,”which will occur as of the end of any fiscalyear in which we(x)have an aggregate market value of our common stock held by non-affiliates of$700 million or more as of thelast business day of our most recently completed second fiscal quarter,(y)have been required to file ann

145、ual and quarterly reportsunder the Securities Exchange Act of 1934,as amended(the“Exchange Act”),for a period of at least 12 months and(z)have filedat least one annual report pursuant to the Exchange Act.In addition,emerging growth companies may take advantage of the extended transition period provi

146、ded in Section 7(a)(2)(B)ofthe Securities Act for complying with new or revised accounting standards.In other words,an emerging growth company maydelay the adoption of certain accounting standards until those standards would otherwise apply to private companies.We may takeadvantage of the benefits o

147、f this extended transition period.For risks related to our status as an emerging growth company,see“Risk FactorsRisks Related to Listing and Ownership of Our Common Stock We are an“emerging growth company”asdefined in the U.S.federal securities laws and the reduced disclosure requirements applicable

148、 to us as an emerging growthcompany may make our common stock less attractive to investors.”Implications of Being a Smaller Reporting Company We are a“smaller reporting company”as defined in Item 10(f)(1)of Regulation S-K.Smaller reporting companies may takeadvantage of certain reduced disclosure ob

149、ligations,including,among other things,providing only two years of audited financialstatements.We will remain a smaller reporting company until the last day of any fiscal year for so long as either:(i)the marketvalue of our shares of common stock held by non-affiliates does not equal or exceed$250 m

150、illion as of the prior June 30th;or(ii)our annual revenues did not equal or exceed$100 million during such completed fiscal year.To the extent we take advantage ofsuch reduced disclosure obligations,it may also make the comparison of our financial statements with other public companiesdifficult or i

151、mpossible.“Risk FactorsRisks Related to Listing and Ownership of Our Common Stock We are a“smallerreporting company”as defined in the U.S.federal securities laws and,even if we no longer qualify as an emerging growthcompany,we may still be subject to reduced reporting requirements as a smaller repor

152、ting company.6 Corporate Information We were incorporated as a Delaware corporation on November 8,2019,under the name VirgaTech,Inc.Amended and RestatedCertificate of Incorporations were filed with the Secretary of State of the State of Delaware on June 30,2020 and March 1,2024under the names Asparg

153、o Laboratories,Inc.and Aspargo Labs,Inc.,respectively.Our telephone number is(646)503-1260.Ourmailing address is 17 State Street,Suite 3220,New York,NY 10004.Our website address is .Theinformation on our website is not incorporated by reference into this prospectus and does not form part of this pro

154、spectus or theregistration statement of which this prospectus is a part.7 Summary Consolidated Financial Data The following tables summarize our consolidated financial data as of the dates and for the periods presented.We have derived theconsolidated statement of operations data for the years ended

155、December 31,2023 and 2022 and the consolidated balance sheetdata as of December 31,2023 from our audited consolidated financial statements and related notes as of and for the years endedDecember 31,2023 and 2022 included elsewhere in this prospectus.We have derived the consolidated statement of oper

156、ationsdata for the nine months ended September 30,2024 and 2023 and the consolidated balance sheet data as of September 30,2024from our unaudited condensed consolidated financial statements and related notes as of and for the nine months ended September30,2024 and 2023 included elsewhere in this pro

157、spectus.Our historical results are not necessarily indicative of the results thatmay be expected in the future.You should read the following summary consolidated financial data in conjunction with the“Managements Discussion andAnalysis of Financial Condition and Results of Operations”and our financi

158、al statements and related notes included elsewhere inthis prospectus.Year Ended December 31,Nine Months Ended September 30,2023 2022 2024 2023 Consolidated Statement of Operations Data(AsRestated)(AsRestated)(Unaudited)(Unaudited)Total revenue,net$(64,842)$(211,554)$102,654$(13,401)Total operating e

159、xpenses$(13,151,297)$(5,367,043)$(16,632,849)$(7,034,261)Total non-operating gain(loss)$(1,173,076)$(147,429)$243,080$(1,264,387)Net loss$(14,389,215)$(5,726,026)$(16,287,115)$(8,312,049)Weighted-average common shares outstanding 86,448,749 92,369,155 117,135,066 81,248,455 Net loss per share$(0.17)

160、$(0.06)$(0.14)$(0.10)Total comprehensive loss$(14,394,154)$(5,714,807)$(16,226,392)$(8,296,745)As ofSeptember 30,2024 As ofDecember 31,2023 Consolidated Balance Sheet Data (Unaudited)(As Restated)Cash and cash equivalents$18,721,445$9,736,739 Working capital$16,894,626$7,751,153 Total assets$21,471,

161、645$11,604,486 Total stockholders equity$17,154,829$8,056,611 8 RISK FACTORS An investment in our common stock involves a high degree of risk.You should carefully consider the risks described below,togetherwith the other information included in this prospectus,before making an investment decision.If

162、 any of the following risks occur,ourbusiness,financial condition or results of operations could suffer.In that case,the price of our shares of common stock coulddecline and you may lose all or part of your investment.See“Cautionary Statement Regarding Forward Looking Statements”abovefor a discussio

163、n of forward-looking statements and the significance of such statements in the context of this prospectus.Risks Related to Our Business and Industry We have a limited operating history and may not be successful in developing profitable business operations.We commenced operations in January 2020.We p

164、urchased rights to distribute Sildenafil Oral Suspension in Spain under the brandname,BANDOL in 2022.We obtained marketing authorizations to distribute Sildenafil Oral Suspension in Germany,Ireland,theNetherlands and the UK under the brand name,HEZKUE,and initiated distribution and promotional activ

165、ities in Germany and theUK in September and October 2024,respectively.We have not commenced distribution of Sildenafil Oral Suspension or any otherproduct in any jurisdiction other than Spain,Germany and the UK,nor have we developed or obtained marketing approval for anynew oral suspension formulati

166、ons of other previously approved drugs or our“smart”electronic delivery device and associatedmobile app under development.Our future business operations must be considered considering the risks,expenses and difficultiesfrequently encountered in commercializing and distributing Rx and OTC products in

167、 multiple jurisdictions.Currently,there is littleinformation on which to base the assumption that we will successfully expand our business operations to market Sildenafil OralSuspension effectively in additional countries or develop new formulations and delivery devices.Our future operating results

168、willdepend on many factors,including our ability to comply with regulatory challenges,the competitive environment we will face,andour ability to attract and maintain key management and employees necessary to achieve our business goals.Although our current management has experience in the life scienc

169、es industry,we can provide no assurance that this experience willhelp us implement our business plan.Our prospects for success must be considered in the context of the fact that we are a newcompany in a highly competitive industry with few barriers to entry.We may encounter unforeseen expenses,diffi

170、culties,complications,and delays,which would reduce the probability of success of such a transition.We have a history of net losses,we anticipate increasing operating expenses in the future,and we may not be able to achieveand,if achieved,maintain profitability.We have incurred net losses since ince

171、ption,and we may not achieve or maintain profitability in the future.Because the market forthe therapeutic agents that we currently distribute and intend to distribute is highly competitive and evolving,it is difficult for us topredict our future results of operations or the limits of our market opp

172、ortunity.We expect our operating expenses to significantlyincrease over the next several years as we hire additional personnel,seek to develop new products and devices,and expandoperations and infrastructure,both domestically and internationally.In addition,as we grow and become a public company,we

173、willincur significant legal,accounting,and other expenses that we did not incur as a private company.If our revenue does not increaseto offset the expected increases in our operating expenses,we will not be profitable in future periods.Also,our revenue growthcould slow,or our revenue could decline f

174、or many reasons,including a decrease in the growth of our overall market,our failure tocapitalize on growth opportunities,slowing demand for our products,additional regulatory burdens,or increased competition.Anyfailure by us to achieve or sustain profitability on a consistent basis could cause the

175、value of our common stock to decline.We derive all our revenue from a single product,Sildenafil Oral Suspension.Currently,our sole commercial product is Sildenafil Oral Suspension,marketed under the brand names BANDOL and HEZKUE,packaged in a 30 ml bottle and administered via a mechanical pump and m

176、etered dose actuator,indicated for the treatment of ED.The market demand for and acceptance of Sildenafil Oral Suspension is critical to our success.Demand for Sildenafil OralSuspension is affected by many factors,many of which are beyond our control,including continued market acceptance,the timingo

177、f development and release of competing new products to treat ED,the development and acceptance of new formulations of existingdrugs to treat ED,price or product changes by us or our competitors,developments within the markets we serve,and generaleconomic conditions and trends.If we are unable to ach

178、ieve widespread market acceptance of Sildenafil Oral Suspension,ourbusiness,results of operations,and financial condition could be harmed.Changes in preferences of users of ED treatment agentsmay have a disproportionately greater impact on us in the near term than if we offered multiple products.If

179、demand for SildenafilOral Suspension declines for any of these or other reasons,our business could be adversely affected.We must obtain the approval of the FDA to market Sildenafil Oral Suspension in the United States.We are seeking approval from the FDA to market Sildenafil Oral Suspension,packaged

180、 in a 30 ml bottle and administered via amechanical pump and metered dose actuator as a drug/device combination product,with the primary mode of action(“PMOA”)attributable to sildenafil,by using the clearance pathway defined in Section 505(b)(2)of the Federal Food,Drug and Cosmetic Actof 1938(the“FD

181、CA”).Section 505(b)(2)provides an accelerated clearance process for new changes in dosage form,strength,formulation,dosing regimen or route of administration of previously approved products if certain conditions are met.In April 2020,we completed a successful pre-Investigational New Drug(pre-IND)mee

182、ting with the FDA,where the FDA provided guidance on,and was supportive of our Sildenafil Oral Suspension development and regulatory plan,which is based on utilizing the 505(b)(2)regulatory pathway.However,we can provide no assurance that the FDA will accept our 505(b)(2)New Drug Application(NDA)sub

183、mission.Further,even if the FDA agrees that Sildenafil Oral Suspension,packaged in a 30 ml bottle and administered via amechanical pump and metered dose actuator,qualifies for the Section 505(b)(2)regulatory pathway,there can be no guarantee thatthe FDA will grant us marketing approval for Sildenafi

184、l Oral Suspension,in which case our business would be materially andadversely affected.9 The regulatory approval process of the FDA is lengthy,time consuming and inherently unpredictable,and if we are unable toobtain FDA approval for Sildenafil Oral Suspension,our business will be substantially harm

185、ed.We have not obtained FDA approval to market Sildenafil Oral Suspension,and it is possible that we will not satisfy the agencysrequirements for such approval.Risks related to approval of Sildenafil Oral Solution by the FDA include:We may be unable to demonstrate to the satisfaction of the FDA that

186、 Sildenafil Oral Suspension delivered via a metereddose bottle and mechanical pump/actuator or digitally connected,container closure system is safe and effective for itsproposed indication.The FDA may disagree with our interpretation of data from our clinical trials.The data collected from our clini

187、cal trials may not be acceptable or sufficient to support the submission of an NDA toobtain regulatory approval.Serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals usingdrugs like Sildenafil Oral Suspension,or other products containin

188、g the active ingredient in Sildenafil Oral Suspension,maynegatively impact our efforts to obtain FDA approval.The FDA may fail to approve or find deficiencies with our Chemistry,Manufacturing and Controls(“CMC”)processes orfacilities of third-party manufacturers that produce our clinical and commerc

189、ial supplies.The approval policies or regulations of the FDA may significantly change in a manner rendering our clinical datainsufficient for approval.Such policy or regulatory changes could also impose additional requirements upon us that coulddelay our ability to obtain approvals,increase the cost

190、s of compliance or restrict our ability to maintain any marketingauthorizations we may have obtained.In addition,the FDA may approve Sildenafil Oral Suspension for a more limited indication or patient population than we originallyrequested,and/or may approve Sildenafil Oral Suspension with a label t

191、hat does not include the labeling claims necessary ordesirable for the successful commercialization of the product.Any of the foregoing scenarios could materially harm the commercialprospects for Sildenafil Oral Suspension.It is possible that none of our existing products or any products we may seek

192、 to develop inthe future will ever obtain FDA approval.Development of our product candidates and/or regulatory approval may also be delayedfor reasons beyond our control.We must obtain approvals from various government health authorities to market Sildenafil Oral Suspension in additionalcountries ou

193、tside the United States.We obtained regulatory approval for HEZKUE packaged in a 30 ml bottle and administered via a mechanical pump and metereddose actuator,in Germany,Ireland,Netherlands and the UK.However,we have yet to obtain marketing approval from the healthauthorities in the other countries w

194、here we own exclusive rights to commercialize the product.There can be no guarantee that thehealth authorities in other jurisdictions outside the United States will grant us marketing approval for Sildenafil Oral Suspension,inwhich case our business would be materially and adversely affected.Physici

195、ans and patients may not accept and use our drugs.Acceptance and use of Sildenafil Oral Suspension and future products that we may develop will depend upon many factors,including perceptions by members of the health care community about the safety and effectiveness of our drugs,cost-effectivenessof

196、our drugs relative to competing products,availability of reimbursement for our products from government or other health carepayors,restrictions on the use of our product such as boxed warnings or contraindications in labelling which may not be required ofalternative treatments and competitor product

197、s,and the effectiveness of our marketing and distribution efforts.The failure ofSildenafil Oral Suspension and future products to find market acceptance would materially and adversely affect our business.We may not be successful because of failure to compete effectively with competitors in the life

198、sciences industry,many of whomare large and well capitalized.Our business model involves the development and commercialization of novel formulations of currently marketed Rx and OTCdrug products delivered via digitally connected,electronic drug delivery devices.Many of the solid dose drug products w

199、e plan todevelop as oral suspension formulations are manufactured and distributed by large,multi-national companies that are wellcapitalized,have significant name recognition,and have other competitive advantages compared to Aspargo.Our initial commercialproduct,Sildenafil Oral Suspension,is indicat

200、ed for the treatment of erectile dysfunction(ED).The market for ED treatmentproducts is extremely competitive.Many of these ED products,manufactured by large,well-capitalized competitors,are generic andoffered at low prices.As patents and other intellectual property rights expire,or as new technolog

201、ies are developed or continue todevelop to treat ED,competition in the market in which we operate currently may increase.If we are unable to navigate thiscomplex,highly competitive industry,our financial condition,and business prospects may be adversely affected.10 We may face difficulties encounter

202、ed by companies in new and evolving markets.In assessing our prospects,you must consider the risks and difficulties frequently encountered by companies in new and evolvingmarkets.These risks include our ability to:manage rapidly changing and expanding operations;increase awareness of our brand and s

203、trengthen customer loyalty;successfully execute our business and marketing strategy;respond effectively to competitive pressures and developments;continue to develop and enhance our marketed products and products in development;obtain regulatory clearance or approval to commercialize new products an

204、d enhance our existing products;refrain from infringing on the intellectual property rights of others,and maintaining appropriate legal policies andprocedures;expand our presence in existing markets and commence operations in new markets;and attract,retain,and motivate qualified personnel.We rely on

205、 part-time personnel and consultants and failure to recruit a permanent management team could adversely affect ourbusiness.We are highly dependent on Mr.Michael Demurjian,our Chief Executive Officer and Chairman of our Board of Directors,MarioGuralnik,Ph.D.,our Chief Regulatory Officer,and Andrew Ch

206、amlin,our Chief Marketing Officer.Although we outsource manyaspects of our commercialization program to qualified consultants,we will require experienced personnel in many fields in whichthere are a limited number of qualified personnel,and we will compete for qualified individuals with numerous bio

207、pharmaceuticalcompanies,universities and other research institutions and other emerging entrepreneurial companies.Competition for suchindividuals,particularly in the New York area,where our offices are headquartered,is intense and we cannot be certain that oursearch for such personnel will be succes

208、sful.Furthermore,we are competing for employees against companies that are moreestablished than we are and can pay more cash compensation than we do.As a result,we may have difficulty in hiring and retaininghighly skilled employees.If we are unable to hire and retain management and other personnel,o

209、ur business,financial condition,operating results,and prospects could be materially and adversely affected.Our long-term growth depends on our ability to commercialize Sildenafil Oral Suspension in multiple countries,develop andobtain approval for our digitally connected drug delivery device in comb

210、ination with our drug products,and commercializeadditional drug products delivered by our proprietary electronic device through our research and development efforts.If we failto do so,we may be unable to compete effectively.Our industry is characterized by intense competition,including from lower-co

211、st competitors,rapid technological changes,newproduct introductions and enhancements and evolving industry standards.Moreover,we face competition from large pharmaceuticalcompanies with greater capital.Our business prospects depend in part on our ability to successfully introduce new liquidformulati

212、ons of oral solid dose drug products,delivered in electronic drug delivery devices.New pharmaceutical products,technologies,techniques,or other products could emerge that might offer better combinations of price and performance than ourproducts.It is important that we anticipate changes in technolog

213、y and market demand to successfully develop,obtain approval,andsuccessfully introduce new,enhanced,and competitive technologies to meet our prospective customers needs on a timely and cost-effective basis.We might be unable to successfully commercialize,develop,or obtain regulatory approvals to mark

214、et new drug products anddelivery devices.Additionally,these products and any future products,even if approved,might not be accepted by physicians orpatients.The success of any new product offering or enhancement to an existing product will depend on numerous additionalfactors,including our ability t

215、o:properly identify and anticipate clinician and patient needs;demonstrate the benefits associated with the use of our products when compared to the products and devices of ourcompetitors;develop and introduce new products or product enhancements in a timely manner;adequately protect our intellectua

216、l property and avoid infringing upon the intellectual property rights of third parties;11 demonstrate the safety and efficacy of new products;and obtain the necessary regulatory clearances or approvals for new products or product enhancements.If we do not develop and obtain regulatory clearances or

217、approvals for new products or indications or product enhancements in timeto meet market demand,or if there is insufficient demand for these products or enhancements,our results of operations will suffer.Our research and development efforts may require a substantial investment of time and resources b

218、efore we can determine thecommercial viability of a new product,technology,material,or other innovation.In addition,even if we can develop enhancementsor new generations of our products successfully,these enhancements or new generations of products may not produce sales inexcess of the costs of deve

219、lopment and they may be quickly rendered obsolete by changing customer preferences or the introductionby our competitors of products embodying new technologies or features.We must carefully manage our introduction of new products.If potential customers believe such products will offer enhancedfeatur

220、es or be sold for a more attractive price in the future,they may delay purchases until such products are available.We may alsohave excess or obsolete inventory as we transition to new products,and we have limited experience in managing product transitions.We have no manufacturing capabilities.If our

221、 designated third-party manufacturer in the United States fails to devote sufficienttime and resources to our concerns,our FDA submissions may be delayed.We have no internal manufacturing capabilities for Sildenafil Oral Suspension or our proprietary,electronic drug delivery deviceunder development.

222、We are a party to a Master Services Agreement with Saptalis Pharmaceuticals,LLC to manufacture our clinicalsupplies and commercial batches of Sildenafil Oral Suspension necessary for FDA submissions,and Design Agreements with RKSto design working prototypes of our proprietary electronic device under

223、 development.Saptalis may fail to devote sufficient time andresources to our projects and affairs,causing a delay in manufacturing commercial batches necessary for clinical and/or stabilitystudies necessary for FDA submissions.Similarly,RKS may fail to devote sufficient time and resources to our pro

224、jects and affairs,causing a delay in delivery of a manufacturing ready prototype of our planned device.In addition,reliance on third-partymanufacturers could expose us to other risks,such as substandard performance,difficulties in achieving volume production andpoor-quality control or noncompliance

225、with FDA and other regulatory requirements.If we decide to manufacture Sildenafil OralSuspension or our digitally connected drug delivery device ourselves,we will incur substantial start-up expenses and will need toacquire or build facilities and hire additional personnel.Our failure to raise additi

226、onal capital or generate the positive cash flows necessary to expand our operations could reduce ourability to compete successfully and harm the results of operations.We have funded our operations primarily through equity and debt issuances.Although we anticipate that our existing cash and cashequiv

227、alents will be sufficient to meet our cash needs for the near future,we expect that we will require additional financing,and wemay not be able to obtain debt or equity financing on favorable terms,if at all.We estimate that we will need approximately$20 million to commercially launch Sildenafil Oral

228、 Suspension in the United States.Inaddition,commercial launch expenses outside the United States,manufacturing expenses,license fees,sales and marketingexpenses,future business development activities,as well as administrative expenses(such as salaries,insurance expenses andgeneral overhead expenses,

229、legal compliance expenses and accounting expenses)will require a substantial amount of capital andcash flow.If we raise equity financing to fund operations or on an opportunistic basis,our stockholders may experience significant dilution oftheir ownership interests.If we engage in debt financing,we

230、may be required to accept terms that restrict our ability to incuradditional indebtedness,force us to maintain specified liquidity or other ratios or restrict our ability to pay dividends or makeacquisitions.The terms of securities we issue in future capital transactions may be more favorable to new

231、 investors,and may includepreferences,superior voting rights or the issuance of other derivative securities,which could have a further dilutive effect.We maynot be successful in identifying suitable financing transactions in the time required,and we may not obtain the capital we require byother mean

232、s.If we fail in raising additional capital,we could encounter difficulties funding our planned operations and may notcontinue in operations.Our ability to obtain financing,if necessary,may be impaired by such factors as the capital markets(both in general and in the lifesciences industry in particul

233、ar),our limited operating history,the national economy,and the departure of key members of ourmanagement team.Further,economic downturns may increase our requirements for capital.If the amount of capital we raise fromfinancing activities is not sufficient to satisfy our capital needs(even to the ext

234、ent that we reduce our operations),we may berequired to cease our operations,divest our assets at unattractive prices or obtain financing on unattractive terms.If any of theforegoing should happen,you could lose your entire investment.12 We rely on third-party logistics providers and contract sales

235、forces to distribute and promote our products internationally,and ifwe are unable to maintain and expand these relationships,or develop internal resources to perform these functions,we may beunable to generate anticipated sales.We rely,and expect to continue to rely in the future,on third-party logi

236、stics providers and contract sales forces to distribute andpromote,respectively,our products in certain international markets in which we operate or intend to operate.We may facesignificant challenges and risks in managing a geographically dispersed network of service providers,over whom we have lim

237、itedcontrol.Our service providers may be unable to successfully promote and distribute our products and may not devote sufficient timeand resources to support the marketing,sales,education,and training efforts that we believe enable the products to develop,achieveor sustain market acceptance.Additio

238、nally,in some international jurisdictions,we rely on drug product distributors to manage theregulatory process,while complying with all applicable rules and regulations,and we are dependent on their ability to do soeffectively.In addition,if a dispute arises with a service provider or we terminate t

239、heir services,or they go out of business,it maytake time to locate an alternative provider to seek appropriate regulatory approvals and to train new personnel to market ourproducts,and our ability to sell products in the region could be harmed.Any of these factors could reduce our revenues fromaffec

240、ted markets,increase our costs in those markets or damage our reputation.In addition,if a contract sales organization were todepart and be retained by one of our competitors,we may be unable to prevent that contract sales organization from helpingcompetitors solicit business from our existing custom

241、ers,which could further adversely affect our sales.As a result of our relianceon third-party service providers,we may be subject to disruptions and increased costs due to factors beyond our control,includinglabor strikes,third party errors,and other issues.If the services of any of these third-party

242、 service providers become unsatisfactory,we may experience delays in meeting consumer demands and we may be unable to find a suitable replacement on a timely basis oron commercially reasonable terms.Any failure to deliver products in a timely manner may damage our reputation and could cause aloss of

243、 potential customers.We face risks associated with our international business.We distribute Sildenafil Oral Suspension in Spain,Germany and the UK,and we plan to distribute Sildenafil Oral Suspension inother countries outside the United States.Also,we intend to develop,market and distribute other Rx

244、 and OTC drug products ininternational markets.The sale and shipment of our products across international borders,as well as the purchase of components and products frominternational sources,subjects us to extensive U.S.and other foreign governmental trade,import and export and customs regulationsan

245、d laws.Compliance with these regulations and laws is costly and exposes us to penalties for non-compliance.We expect ourinternational activities will be dynamic in the foreseeable future as we continue to pursue opportunities in international markets.Ourinternational business operations are subject

246、to a variety of risks,including:difficulties in staffing and managing foreign and geographically dispersed operations,to the extent we establish non-U.S.operations;difficulties in determining and creating the proper sales pathway in new,international markets;compliance with various U.S.and internati

247、onal laws,including export control laws,anti-bribery laws,sanctions laws,theU.S.Foreign Corrupt Practices Act of 1977,or the FCPA,and anti-money laundering laws;differing regulatory requirements for obtaining clearances or approvals to market our products;changes in,or uncertainties relating to,fore

248、ign rules and regulations that may impact our ability to sell our products,perform services or repatriate profits to the United States;tariffs and trade barriers,export regulations,sanctions,and other regulatory and contractual limitations on our ability to sellour products in certain foreign market

249、s;potential adverse tax consequences,including imposition of limitations on or increase of withholding and other taxes onremittances and other payments by foreign subsidiaries or joint ventures;imposition of differing labor laws and standards;armed conflicts or economic,political or social instabili

250、ty in foreign countries and regions;fluctuations in foreign currency exchange rates;an inability,or reduced ability,to protect our intellectual property,including any effect of compulsory licensing imposed bygovernment action;and availability of government subsidies or other incentives that benefit

251、competitors in their local markets that are not availableto us.13 Our expansion plans to international markets may not be realized,or if realized,may not be successful.We expect each market tohave its regulatory hurdles to overcome,and future developments in these markets,including the uncertainty r

252、elating togovernmental policies and regulations,could harm our business.Our employees,consultants,and other commercial partners may engage in misconduct or other improper activities,includingnon-compliance with regulatory standards and requirements.We are exposed to the risk that our employees,consu

253、ltants,and other commercial partners may engage in inappropriate,fraudulent,or illegal activity.Misconduct by these parties could include intentional,reckless or negligent conduct or other unauthorizedactivities that violate the regulations of the FDA and other U.S.healthcare regulators,as well as n

254、on-U.S.regulators,including byviolating laws requiring the reporting of true,complete and accurate information to such regulators,manufacturing standards,healthcare fraud and abuse laws and regulations in the United States and abroad or laws that require the true,complete and accuratereporting of fi

255、nancial information or data.Sales,marketing,and business arrangements in the healthcare industry,including the saleof medical devices,are subject to extensive laws and regulations intended to prevent fraud,misconduct,kickbacks,self-dealing andother abusive practices.These laws and regulations may re

256、strict or prohibit a wide range of pricing,discounting,marketing andpromotion,sales commission,customer incentive programs and other business arrangements.It is not always possible to identifyand deter misconduct by our employees,distributors and other third parties,and the precautions we take to de

257、tect and prevent thisactivity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmentalinvestigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.These risks may bemore pronounced,and we may find t

258、hat the processes and policies we have implemented are not effective at preventing misconduct.If any actions are instituted against us and we are not successful in defending ourselves or asserting our rights,those actions couldresult in the imposition of significant fines or other sanctions,includin

259、g the imposition of civil,criminal and administrativepenalties,damages,monetary fines,individual imprisonment,disgorgement,possible exclusion from participation in governmenthealthcare programs,additional reporting obligations and oversight if we become subject to a corporate integrity agreement or

260、otheragreement to resolve allegations of non-compliance with these laws,contractual damages,reputational harm,diminished profits andfuture earnings and the curtailment of our operations.Whether or not we are successful in defending against such actions orinvestigations,we could incur substantial cos

261、ts,including legal fees,and divert the attention of management in defending ourselvesagainst any of these claims or investigations.We do not have control of our outside scientific and medical advisors.They may pursue objectives which are contrary to ourinterest,which could impede our research and de

262、velopment efforts.We work with scientific and medical advisors who assist us in our research,development and marketing efforts and advise us withrespect to the commercialization of Sildenafil Oral Suspension and other potential drug products in the United States and abroad.Our advisors are not our e

263、mployees,and they may have other commitments that would limit their availability to us.Accordingly,wemay lose their services,which may negatively impact on our business operations.We rely on third parties to conduct our clinical trials.If these third parties fail to perform their duties on time or a

264、s expected,wemay be delayed or fail to obtain regulatory approval for Sildenafil Oral Suspension in the United States.Our clinical trials are managed by our own staff and consultants,but we rely on certain third parties,including clinical researchorganizations,or CROs,for,among other things,overseei

265、ng the conduct of our clinical trials at the clinical trial site,conductingmonitoring,and providing the statistical work and electronic data capture necessary to prepare the data from our clinical trials forFDA submissions.We bear the responsibility for ensuring that each of our clinical trials is c

266、onducted in accordance with applicableprotocols,and legal,regulatory,and scientific standards,including current good clinical practices,or cGCPs,which are regulationsand guidelines enforced by the FDA and comparable foreign regulatory authorities for clinical trials.If we or any such third partiesfa

267、il to comply with applicable cGCPs,the clinical data generated in such trials may be deemed unreliable and the FDA orcomparable foreign regulatory authorities may require us to perform additional clinical trials before approving a marketingapplication for any particular indication.In addition,if suc

268、h third parties do not devote sufficient time and resources to our clinicaltrials or otherwise carry out their contractual duties or obligations or meet expected deadlines,if they need to be replaced,or if thequality or accuracy of the clinical data they assist in obtaining is compromised due to the

269、 failure to adhere to our clinical protocols,regulatory requirements or for other reasons,our clinical trials may be extended,delayed or terminated,and we may be delayed orfail to obtain regulatory approval for or successfully commercialize our product candidates in a specified indication.Our direct

270、ors and scientific advisors may have relationships with other companies that may present potential conflicts of interest.Our current and future board members and scientific advisors may serve,from time to time,as directors,officers,or advisors ofother pharmaceutical companies and,accordingly,from ti

271、me to time,their duties,and obligations to us may conflict with theirduties and obligations to other entities.In addition,our board members and scientific advisors have other jobs and commitments andmay be subject to non-disclosure obligations that may limit their availability to collaborate with us

272、.We face risks of product liability claims and potential adverse publicity,which could result in expensive and time-consuminglitigation and payment of substantial damages.Like other companies that develop,manufacture,and distribute products designed to be ingested,we face an inherent risk ofexposure

273、 to product liability claims if the use of our products results in injury to consumers.Product liability claims may be assertedagainst us if it is believed that the commercial use or clinical testing of Sildenafil Oral Suspension has caused adverse side effects orother injuries.We may be subjected t

274、o product liability claims,including that the product contains contaminants,the productincludes inadequate instructions as to its use,or the product includes inadequate warnings concerning side effects and interactionswith other substances.In the event we do not have adequate insurance or contractua

275、l indemnification for such claims,these claimscould have a material adverse effect on the Company.If a product liability claim asserted against is successful,we could be requiredto limit commercialization of Sildenafil Oral Suspension or completely withdraw it from the market.14 Regardless of merit

276、or outcome,claims against us could result in significant diversion of our managements time and attention,expenditure of large amounts of cash on legal fees,expenses and damages and a decreased demand for our products and services.Moreover,there is a growing trend of class action litigation arising f

277、rom the sale of life science products.Even if a claim against usis dismissed or resolved in our favor,the costs of defending such a claim could be high,which along with the negative publicity thatcan arise from such a claim,could be materially detrimental to our business and operations.Our insurance

278、 policies protect us from some business risks but will leave us exposed to significant uninsured liabilities.We do not carry insurance for all categories of risk that our business may encounter.Some of the policies we currently maintaininclude general liability,property,workers compensation,products

279、 and clinical trial liability and directors and officers insurance.We do not know,however,if these policies will provide us with adequate levels of coverage.Any significant uninsured liability mayrequire us to pay substantial amounts,which would adversely affect our cash position and results of oper

280、ations.We are subject to anti-corruption,anti-bribery,and similar laws,and non-compliance with such laws can subject us to criminalpenalties or significant fines and harm our business and reputation.We are subject to anti-corruption and anti-bribery and similar laws,such as the U.S.Foreign Corrupt P

281、ractices Act of 1977,asamended,or the FCPA,the U.S.domestic bribery statute contained in 18 U.S.C.201,U.S.Travel Act,the USA PATRIOT Act,theU.K.Bribery Act 2010,and other anti-corruption,anti-bribery and anti-money laundering laws in countries in which we conductactivities.Anti-corruption and anti-b

282、ribery laws have been enforced aggressively in recent years and are interpreted broadly andprohibit companies and their employees and agents from promising,authorizing,making,or offering improper payments or otherbenefits to government officials and others in the private sector.As we increase our in

283、ternational sales and business,our risks underthese laws may increase.Noncompliance with these laws could subject us to investigations,sanctions,settlements,prosecution,other enforcement actions,disgorgement of profits,significant fines,damages,other civil and criminal penalties or injunctions,adver

284、se media coverage,and other consequences.Any investigations,actions or sanctions could harm our business,results ofoperations,and financial condition.We may seek to grow our business through acquisitions or investments in new or complementary businesses,products,ortechnologies,through the licensing

285、of products or technologies from third parties.The failure to manage acquisitions,investments,licenses or other strategic alliances,or the failure to integrate them with our existing business,could harm ourbusiness.Our success depends,in part,on our ability to continually enhance and broaden our pro

286、duct offerings in response to changingcustomer demands,competitive pressures,technologies and market pressures.Accordingly,from time to time we may consideropportunities to acquire,make investments in or license other technologies,products and businesses that may enhance ourcapabilities,complement o

287、ur current products,or expand the breadth of our markets or customer base.Potential and completedacquisitions,strategic investments,licenses,and other alliances involve numerous risks,including:difficulty assimilating or integrating acquired or licensed technologies,products or business operations;i

288、ssues maintaining uniform standards,procedures,controls and policies;unanticipated costs associated with acquisitions or strategic alliances,including the assumption of unknown or contingentliabilities and the incurrence of debt or future write-offs of intangible assets or goodwill;diversion of mana

289、gements attention from our core business and disruption of ongoing operations;adverse effects on existing business relationships with suppliers,distributors and customers;risks associated with entering new markets in which we have limited or no experience;potential losses related to investments in o

290、ther companies;potential loss of key employees of the acquired businesses;and increased legal and accounting compliance costs.We do not know if we will identify acquisitions or strategic relationships that we deem suitable,whether we will be able tosuccessfully complete any such transactions on favo

291、rable terms or at all or whether we will be able to successfully integrate anyacquired business,product or technology into our business or retain any key personnel,suppliers,or distributors.Foreign acquisitions involve unique risks in addition to those mentioned above,including those related to inte

292、gration of operationsacross different cultures,languages and legal and regulatory environments,currency risks and the economic,political and regulatoryrisks associated with specific countries.15 To finance any acquisitions,investments,or strategic alliances,we may choose to issue shares of our commo

293、n stock or other equity-linked securities as consideration,which could dilute the ownership of our stockholders.Additional funds may not be available onterms that are favorable to us,or at all.If the price of our common stock is low or volatile,we may be unable to consummate anyacquisitions,investme

294、nts or strategic alliances using our stock as consideration.We will need to increase the size of our organization to implement our plans and strategies,and we may experience difficulties inmanaging this growth.We had 11 full-time employees as of December 31,2024.We expect to need additional manageri

295、al,operational,sales,marketing,financial and other personnel to successfully implement our development and commercialization plans and strategies.Future growthwould impose significant added responsibilities on members of management,including:identifying,recruiting,integrating,maintaining and motivat

296、ing additional employees;managing our internal development efforts effectively,including the FDA,and other comparable foreign regulatoryagencies review process of Sildenafil Oral Suspension and any other product candidates we develop,while complyingwith any contractual obligations to contractors and

297、 other third parties we may have;and improving our operational,financial and management controls,reporting systems and procedures.Our future financial performance and our ability to successfully develop and,if approved,commercialize any of our current productcandidates and any other product candidat

298、e we may develop will depend,in part,on our ability to effectively manage any futuregrowth.Our management may need to divert a disproportionate amount of its attention away from day-to-day activities to devote asubstantial amount of time to managing these growth activities.We rely,and for the forese

299、eable future will continue to rely,in substantial part on certain independent organizations,advisors andconsultants to provide certain services,including key aspects of clinical development and manufacturing.We cannot assure you thatthe services of independent organizations,advisors and consultants

300、will continue to be available to us on a timely basis whenneeded,or that we can find qualified replacements.In addition,if we are unable to effectively manage our outsourced activities or ifthe quality or accuracy of the services provided by third-party service providers is compromised for any reaso

301、n,our clinical trialsmay be extended,delayed or terminated,and we may not be able to obtain marketing approval of any current or future productcandidates or otherwise advance our business.We cannot assure you that we will be able to manage our existing third-party serviceproviders or find other comp

302、etent outside contractors and consultants on economically reasonable terms,or at all.If we are not able to effectively expand our organization by hiring new employees and/or engaging additional third-party serviceproviders,we may not be able to successfully implement the tasks necessary to further d

303、evelop and commercialize our productcandidates and any future product candidates and,accordingly,may not achieve our research,development and commercializationgoals.Risks Related to Intellectual Property If we are not able to obtain and enforce patent protection for our technologies,products,deliver

304、y devices,or drug productcandidates,development and commercialization of our products and product candidates may be adversely affected.Our commercial success will depend in part on our success in obtaining and maintaining issued patents and other intellectualproperty rights in the United States and

305、elsewhere and protecting our proprietary technology.If we do not adequately protect ourintellectual property and proprietary technology,competitors may be able to use our technologies and erode or negate anycompetitive advantage we may have,which could harm our business and ability to achieve profit

306、ability.We have applied,and we intend to continue applying,for patents covering aspects of our technologies that we deem appropriate.However,the patent process is expensive and time consuming,and we may not be able to apply for patents on certain aspects of ourcurrent or future products and other te

307、chnologies in a timely fashion,at a reasonable cost,in all jurisdictions,or at all,and anypotential patent coverage we obtain may not be sufficient to prevent substantial competition.We cannot offer any assurances about which,if any,patents will be issued or whether any issued patents will be found

308、invalid andunenforceable or will be threatened by third parties.Any patent applications we file may be challenged and may not result in issuedpatents or may be invalidated or narrowed in scope after they are issued.We also cannot provide any assurances that any of ourpatents have,or that any of our

309、pending patent applications that mature into issued patents will include,claims with a scopesufficient to protect and provide exclusivity for our products,any additional features we develop for our products or any newproducts.Other parties may have designed around our claims or developed technologie

310、s that may be related or competitive to ourplatform,may have filed or may file patent applications and may have received or may receive patents that overlap or conflict withour patent applications,either by claiming the same methods or devices or by claiming subject matter that could dominate our pa

311、tentposition.Any successful opposition to these patents or any other patents owned by or,if applicable in the future,licensed to us coulddeprive us of rights necessary for the practice of our technologies or the successful commercialization of any products or productcandidates that we may develop.Si

312、nce patent applications in the US and most other countries are confidential for a period afterfiling,we cannot be certain that we or our licensors were the first to file any patent application related to our technologies,products,or product candidates.16 Furthermore,though an issued patent is presum

313、ed valid and enforceable,its issuance is not conclusive as to its validity or itsenforceability and it may not provide us with adequate proprietary protection or competitive advantages against competitors withsimilar products.Competitors may also be able to design around our patents.Other parties ma

314、y develop and obtain patent protectionfor alternative and possibly more effective technologies,designs,or methods.We may be unable to prevent the unauthorizeddisclosure or use of our technical knowledge or trade secrets by consultants,suppliers,vendors,former employees,and currentemployees.The laws

315、of some foreign countries do not protect our proprietary rights to the same extent as the laws of the UnitedStates,and we may encounter significant problems in protecting our proprietary rights in these countries.Our ability to enforce our patent rights depends on our ability to detect infringement.

316、It may be difficult to detect infringers who donot advertise the components that are used in their products.Moreover,it may be difficult or impossible to obtain evidence ofinfringement in a competitors or potential competitors product.We may not prevail in any lawsuits that we initiate,and thedamage

317、s or other remedies awarded if we were to prevail may not be commercially meaningful.The degree of future protection for our proprietary rights is uncertain,and we cannot ensure that:any of our patents,or any of our pending patent applications,if issued,or those of our licensors,will include claims

318、havinga scope sufficient to protect our products;any of our pending patent applications or those of our licensors may issue as patents;others will not or may not be able to make,use,offer to sell,or sell products that are the same as or similar to our own butthat are not covered by the claims of the

319、 patents that we own or license;we will be able to successfully commercialize our products on a substantial scale,if approved,before the relevant patentsthat we own,or license expire;we were the first to make the inventions covered by each of the patents and pending patent applications that we own o

320、rlicense;we or our licensors were the first to file patent applications for these inventions;others will not develop similar or alternative technologies that do not infringe the patents we own or license;any of the patents we own,or license will be found to ultimately be valid and enforceable;any pa

321、tents issued to us,or our licensors will provide a basis for an exclusive market for our commercially viable productsor will provide us with any competitive advantages;a third-party may not challenge the patents we own or license and,if challenged,a court would hold that such patents arevalid,enforc

322、eable and infringed;we may develop or in-license additional proprietary technologies or products that are patentable;the patents of others will not have an adverse effect on our business;our competitors do not conduct research and development activities in countries where we do not have enforceable

323、patentrights and then use the information learned from such activities to develop competitive products for sale in our majorcommercial markets;or our commercial activities or products will not infringe upon the patents of others.Where we obtain licenses from or collaborate with third parties,in some

324、 circumstances,we may not have the right to control thepreparation,filing and prosecution of patent applications,or to maintain the patents,covering technology that we license from thirdparties,or such activities,if controlled by us,may require the input of such third parties.We may also require the

325、 cooperation of ourlicensors and collaborators to enforce any licensed patent rights,and such cooperation may not be provided.Therefore,these patentsand applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.Moreover,if weobtain necessary licen

326、ses,we will likely have obligations under those licenses,and any failure to satisfy those obligations could giveour licensor the right to terminate the license.Termination of a necessary license,or expiration of licensed patents or patentapplications,could have a material adverse impact on our busin

327、ess.Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.Patents have a limited lifespan.In the United States,if all maintenance fees are timely paid,the natural expiration of a patent isgenerally 20 years after its first effecti

328、ve filing date.Various extensions may be available,but the term of a patent,and the protectionit affords,is limited.Even if patents directed to our product candidates are obtained,once the patent term has expired,we may beopen to competition from competitive products.Given the amount of time require

329、d for the development,testing and regulatoryreview of product candidates,patents directed to our product candidates might expire before or shortly after such candidates arecommercialized.As a result,our patent portfolio may not provide us with sufficient rights to exclude others from commercializing

330、products similar or identical to ours.In addition,although,upon issuance in the United States,the life of a patent can be increasedbased on certain delays caused by the USPTO,this increase can be reduced or eliminated based on certain delays caused by thepatent applicant during patent prosecution.17

331、 We may not identify relevant third-party patents or may incorrectly interpret the relevance,scope or expiration of a third-partypatent,which might adversely affect our ability to develop and market our product candidates.We cannot guarantee that any of our patent searches or analyses,including the

332、identification of relevant patents,the scope of patentclaims or the expiration of relevant patents,are complete or thorough,nor can we be certain that we have identified each and everythird-party patent and pending application in the United States and abroad that is relevant to or necessary for the

333、commercializationof our product candidates in any jurisdiction.The scope of a patent claim is determined by an interpretation of the law,the writtendisclosure in a patent and the patents prosecution history.Our interpretation of the relevance or the scope of a patent or a pendingapplication may be incorrect,which may negatively impact our ability to market our products.We may incorrectly determine