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Daré Bioscience(DARE) - 2024 Q3 - Quarterly Report
DAREDaré Bioscience(DARE)2024-11-14 21:01
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Financial Performance - Total revenue for the three months ended September 30, 2023, was 41,691,comparedto41,691, compared to 1,000,000 for the same period in 2022, representing a significant decrease [8]. - Total operating expenses for the three months ended September 30, 2023, were 4,723,040,downfrom4,723,040, down from 9,396,415 in the same period last year, indicating a reduction of approximately 50% [8]. - The net loss for the three months ended September 30, 2023, was (4,702,501),comparedtoanetlossof(4,702,501), compared to a net loss of (8,299,096) for the same period in 2022, showing an improvement of approximately 43% [8]. - The company reported a basic loss per share of (0.55)forthethreemonthsendedSeptember30,2023,comparedto(0.55) for the three months ended September 30, 2023, compared to (1.09) for the same period in 2022, indicating a reduction in loss per share [8]. - The company experienced a comprehensive loss of (4,679,566)forthethreemonthsendedSeptember30,2023,comparedto(4,679,566) for the three months ended September 30, 2023, compared to (8,314,126) for the same period in 2022, reflecting an improvement [8]. - Net loss for the nine months ended September 30, 2023, was (25,103,829),comparedto(25,103,829), compared to (1,452,799) for the same period in 2024 [13]. - The Company incurred a loss from operations of approximately 18.1millionfortheninemonthsendedSeptember30,2024[26].ResearchandDevelopment−ResearchanddevelopmentexpensesforthethreemonthsendedSeptember30,2023,were18.1 million for the nine months ended September 30, 2024 [26]. Research and Development - Research and development expenses for the three months ended September 30, 2023, were 2,656,772, down from 6,674,636inthesameperiodlastyear,reflectingadecreaseofabout606,674,636 in the same period last year, reflecting a decrease of about 60% [8]. - The company’s primary operations focus on research and development activities to advance product candidates through clinical development and regulatory approval [16]. - The company recorded research and development expense credits of approximately 4.8 million related to the DARE-LARC1 award for the nine months ended September 30, 2024 [124]. - The company is entitled to receive up to 10.0millioninmilestone−basedpaymentsfortheDARE−HPVdevelopmentprogram,contingentuponachievingspecifiedresearchobjectivesovera24−monthperiod[131].CashandLiquidity−Cashandcashequivalentsincreasedto10.0 million in milestone-based payments for the DARE-HPV development program, contingent upon achieving specified research objectives over a 24-month period [131]. Cash and Liquidity - Cash and cash equivalents increased to 11,532,609 at the end of the period from 10,811,056atthebeginningoftheperiod[13].−Thecompany’stotalcash,cashequivalents,andrestrictedcashdecreasedto10,811,056 at the beginning of the period [13]. - The company’s total cash, cash equivalents, and restricted cash decreased to 11,532,609 from 14,229,424[13].−Unrestrictedcashandcashequivalentsamounttoapproximately14,229,424 [13]. - Unrestricted cash and cash equivalents amount to approximately 11.2 million as of September 30, 2024 [26]. - The Company has working capital of approximately 1.8millionasofSeptember30,2024[26].−TheCompanyprepareditsfinancialstatementsonagoingconcernbasis,raisingsubstantialdoubtaboutitsabilitytocontinueoperationswithoutadditionalcapital[25].−TheCompanyexpectstoneedtoraisesubstantialadditionalcapitaltofunditsoperationsandexecuteitscurrentstrategy[27].AgreementsandMilestones−TheCompanyenteredintoaroyaltypurchaseagreementwithXOMA,receiving1.8 million as of September 30, 2024 [26]. - The Company prepared its financial statements on a going concern basis, raising substantial doubt about its ability to continue operations without additional capital [25]. - The Company expects to need to raise substantial additional capital to fund its operations and execute its current strategy [27]. Agreements and Milestones - The Company entered into a royalty purchase agreement with XOMA, receiving 22.0 million for future net royalty and milestone payments related to XACIATO, Ovaprene, and Sildenafil Cream [29]. - The Company is entitled to receive tiered double-digit royalties based on net sales and up to 180.0millionintieredcommercialandregulatorymilestonesunderthelicenseagreementwithOrganon[42].−TheCompanyhaspotentialfuturepaymentsofupto180.0 million in tiered commercial and regulatory milestones under the license agreement with Organon [42]. - The Company has potential future payments of up to 5.25 million for development and regulatory milestones and up to 64.0millionforcommercialsalesmilestonesundertheDouglasLicenseAgreement[55].−TheCompanyagreedtopayformerMBIstockholdersupto64.0 million for commercial sales milestones under the Douglas License Agreement [55]. - The Company agreed to pay former MBI stockholders up to 46.5 million contingent upon achieving specified funding and product development milestones, and up to 55.0millionbasedonaggregatenetsales[59].−TheCompanyenteredintoanexclusivelicenseagreementwithCatalentJNP,Inc.,payinga55.0 million based on aggregate net sales [59]. - The Company entered into an exclusive license agreement with Catalent JNP, Inc., paying a 250,000 upfront fee and a 100,000annualmaintenancefee,withpotentialmilestonepaymentstotalingupto100,000 annual maintenance fee, with potential milestone payments totaling up to 43.8 million [70]. Stock and Equity - The weighted average number of shares outstanding for the three months ended September 30, 2023, was 8,534,433, compared to 7,587,637 for the same period in 2022, indicating an increase in shares outstanding [8]. - A reverse stock split on July 1, 2024, reduced the number of outstanding shares from approximately 101.1 million to approximately 8.5 million [79]. - The Company has a total of 1,268,572 warrants outstanding as of September 30, 2024, with a weighted average exercise price of 7.49[89].−TheCompanyrecordedawarrantvalueof7.49 [89]. - The Company recorded a warrant value of 2.9 million from the September 2023 offering using the Black-Scholes model [87]. Future Commitments and Obligations - The Company has a total obligation of approximately 3.5millionrelatedtoacleanroomspacelease,withfixedpaymentsduequarterly[98].−TotalfutureminimumleasepaymentsundertheCompany′soperatingleasesasofSeptember30,2024,amountedto3.5 million related to a clean room space lease, with fixed payments due quarterly [98]. - Total future minimum lease payments under the Company's operating leases as of September 30, 2024, amounted to 1.61 million [102]. - The company is responsible for providing 5.5millioninpaymentstoNICHDfortheOvaprenePhase3study,with5.5 million in payments to NICHD for the Ovaprene Phase 3 study, with 0.5 million paid in July 2024 and 5.0millionpaidinprioryears[115].GrantsandFunding−Thecompanyhasreceivedapproximately5.0 million paid in prior years [115]. Grants and Funding - The company has received approximately 29.3 million in non-dilutive funding from the Bill & Melinda Gates Foundation for the DARE-LARC1 project as of September 30, 2024 [124]. - The company received a grant of up to approximately 10.7milliontosupporttheexpansionofstudysitesforthePhase3clinicaltrialofOvaprene,withaninitialpaymentof10.7 million to support the expansion of study sites for the Phase 3 clinical trial of Ovaprene, with an initial payment of 5.4 million due in 2024 [130].