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Daré Bioscience(DARE) - 2023 Q2 - Quarterly Report
DAREDaré Bioscience(DARE)2023-08-09 16:00
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Financial Performance - Total revenue for Q2 2023 was 0,comparedto0, compared to 10 million in Q2 2022, indicating a 100% decrease year-over-year[16] - Operating expenses for Q2 2023 were 8.99million,aslightdecreaseof6.58.99 million, a slight decrease of 6.5% from 9.62 million in Q2 2022[16] - Net loss for Q2 2023 was 8.76million,comparedtoanetincomeof8.76 million, compared to a net income of 414,000 in Q2 2022, reflecting a significant decline in financial performance[16] - The company reported a comprehensive loss of 8.79millionforQ22023,comparedtoacomprehensiveincomeof8.79 million for Q2 2023, compared to a comprehensive income of 278,000 in Q2 2022[16] - Basic loss per share for Q2 2023 was 0.10,comparedtonolosspersharereportedinQ22022[16]−ForthesixmonthsendedJune30,2023,thecompanyreportedanetlossofapproximately0.10, compared to no loss per share reported in Q2 2022[16] - For the six months ended June 30, 2023, the company reported a net loss of approximately 16.8 million, compared to a net loss of 7.98millionforthesameperiodin2022,representinga1107.98 million for the same period in 2022, representing a 110% increase in losses year-over-year[23] Cash and Assets - Cash and cash equivalents decreased to 13.33 million as of June 30, 2023, down from 34.67millionattheendof2022,representinga61.534.67 million at the end of 2022, representing a 61.5% decline[15] - Total assets decreased to 23.21 million as of June 30, 2023, from 43.83millionattheendof2022,indicatinga4743.83 million at the end of 2022, indicating a 47% reduction[15] - The company's cash and cash equivalents decreased to approximately 13.3 million as of June 30, 2023, down from 32.1millionattheendofJune2022,indicatingadeclineofabout5932.1 million at the end of June 2022, indicating a decline of about 59%[23] - As of June 30, 2023, the Company reported cash equivalents of 10,837,944, a decrease from 33,238,658asofDecember31,2022[41]LiabilitiesandDeficits−Currentliabilitiesincreasedto33,238,658 as of December 31, 2022[41] Liabilities and Deficits - Current liabilities increased to 24.70 million as of June 30, 2023, compared to 31.62millionattheendof2022,showinga21.931.62 million at the end of 2022, showing a 21.9% decrease[15] - The accumulated deficit grew to 157.88 million as of June 30, 2023, up from 141.07millionattheendof2022,reflectingaworseningfinancialposition[15]−Thetotalaccumulateddeficitreachedapproximately141.07 million at the end of 2022, reflecting a worsening financial position[15] - The total accumulated deficit reached approximately 157.9 million as of June 30, 2023, compared to 118.1millionatthesametimein2022,reflectinganincreaseofapproximately34118.1 million at the same time in 2022, reflecting an increase of approximately 34%[34] - The company has a working capital deficit of approximately 2.5 million as of June 30, 2023, indicating liquidity challenges[34] Research and Development - Research and development expenses for the first half of 2023 were 11.06million,downfrom11.06 million, down from 12.60 million in the same period of 2022, a decrease of 12.2%[16] - The company plans to continue its focus on research and development activities to advance its product candidates through clinical development and regulatory approval[27] Capital and Funding - The company expects to require substantial additional capital to fund its operations and execute its current strategy over the next 12 months[35] - The company raised 1.3millionfromtheexerciseofcommonstockwarrantsduringthesixmonthsendedJune30,2023,comparedto1.3 million from the exercise of common stock warrants during the six months ended June 30, 2023, compared to 120,149 in the same period of 2022, showing a significant increase in capital raised[23] Licensing and Revenue - The Company has recognized 10.0millioninlicensefeerevenuefromitslicenseagreementforXACIATO,allofwhichrepresentstheupfrontpaymentdue[45]−TheCompanyisentitledtoreceiveupto10.0 million in license fee revenue from its license agreement for XACIATO, all of which represents the upfront payment due[45] - The Company is entitled to receive up to 310.0 million in milestone payments related to the commercial sales of Ovaprene, contingent upon achieving specified milestones[50] - The license agreement with Organon includes tiered double-digit royalties based on net sales and up to 182.5millioninmilestonepayments[53]−TheCompanyhasnotrecognizedanycollaborationrevenuesasofJune30,2023[44]−TheCompanyhasnotrecognizedanyroyaltyrevenueasofJune30,2023[46]StockandCompensation−Totalstock−basedcompensationexpenseforthesixmonthsendedJune30,2023,was182.5 million in milestone payments[53] - The Company has not recognized any collaboration revenues as of June 30, 2023[44] - The Company has not recognized any royalty revenue as of June 30, 2023[46] Stock and Compensation - Total stock-based compensation expense for the six months ended June 30, 2023, was 1,274,807, compared to 1,069,930forthesameperiodin2022,reflectinganincreaseofapproximately19.11,069,930 for the same period in 2022, reflecting an increase of approximately 19.1%[100] - The number of shares of common stock available for future awards under the 2022 Stock Incentive Plan was 6,718,916 as of June 30, 2023[98] - The number of shares outstanding under the stock option plans increased from 6,612,554 at December 31, 2022, to 9,470,219 at June 30, 2023, reflecting an increase of approximately 43.5%[99] Agreements and Milestones - The Company agreed to pay former MBI stockholders up to 46.5 million contingent upon achieving specified funding, product development, and regulatory milestones[65] - The Company may pay MilanaPharm up to 500,000uponthefirstcommercialsaleoflicensedproductsintheU.S.,and500,000 upon the first commercial sale of licensed products in the U.S., and 1.0 million upon achieving 50millionincumulativeworldwidenetsales[68]−TheCompanyacquiredPearTreePharmaceuticalsforexclusiverightstodevelopaproprietaryformulationoftamoxifen,leadingtotheDARE−VVA1program[70]−TheCompanyagreedtopayformerstockholdersofPearTreeupto50 million in cumulative worldwide net sales[68] - The Company acquired Pear Tree Pharmaceuticals for exclusive rights to develop a proprietary formulation of tamoxifen, leading to the DARE-VVA1 program[70] - The Company agreed to pay former stockholders of Pear Tree up to 15.5 million for clinical milestones and up to 47millionforcommercialmilestones[72]GrantsandFunding−TheCompanyreceivedatotalofapproximately47 million for commercial milestones[72] Grants and Funding - The Company received a total of approximately 23.9 million in non-dilutive funding under the DARE-LARC1 grant agreement as of June 30, 2023, with a deferred grant funding liability of approximately 13.1millionrecorded[123]−TheCompanyreceivedagrantofapproximately13.1 million recorded[123] - The Company received a grant of approximately 385,000 from NICHD on July 28, 2023, to support preclinical development for a new therapeutic[127]