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Aspira Women’s Health (AWH) - 2024 Q4 - Annual Report

Financial Performance - Total revenue for the year ended December 31, 2024, was 9,182,000,aslightincreaseof9,182,000, a slight increase of 28,000 or 0.3% compared to 9,154,000in2023[305]ThenetlossfortheyearendedDecember31,2024,was9,154,000 in 2023[305] - The net loss for the year ended December 31, 2024, was 13,094,000, a decrease of 3,596,000or223,596,000 or 22% compared to a net loss of 16,690,000 in 2023[305] - Other income increased by 1,386,000in2024,primarilyduetoaonetimefederalgovernmentawardof1,386,000 in 2024, primarily due to a one-time federal government award of 2,000,000[315] - The accumulated deficit as of December 31, 2024, was approximately 531,397,000,withexpectationsofincurringanetlossin2025[303]ExpensesCostofproductrevenuedecreasedby531,397,000, with expectations of incurring a net loss in 2025[303] Expenses - Cost of product revenue decreased by 189,000 or 5% to 3,703,000in2024,primarilyduetoreducedconsultingcostsandlabsupplies[307]Researchanddevelopmentexpensesdecreasedby3,703,000 in 2024, primarily due to reduced consulting costs and lab supplies[307] - Research and development expenses decreased by 769,000 or 19% to 3,266,000in2024,mainlyduetoloweremploymentrelatedexpensesandclinicaltrialcosts[308]Salesandmarketingexpensesincreasedby3,266,000 in 2024, mainly due to lower employment-related expenses and clinical trial costs[308] - Sales and marketing expenses increased by 334,000 or 4% to 8,146,000in2024,drivenbycostsrelatedtothecontractedsalesteamandincreasedpersonnelcosts[310]Generalandadministrativeexpensesdecreasedby8,146,000 in 2024, driven by costs related to the contracted sales team and increased personnel costs[310] - General and administrative expenses decreased by 1,922,000 or 16% to 10,345,000in2024,attributedtoreductionsinemploymentrelatedexpensesandconsultingcosts[311]CashFlowNetcashusedinoperatingactivitieswas10,345,000 in 2024, attributed to reductions in employment-related expenses and consulting costs[311] Cash Flow - Net cash used in operating activities was 12,113,000 for the year ended December 31, 2024, primarily due to a net loss of 13,094,000andchangesinfairvalueofwarrantliabilitiestotalingapproximately13,094,000 and changes in fair value of warrant liabilities totaling approximately 1,346,000[318] - Net cash used in operating activities was 15,894,000fortheyearendedDecember31,2023,resultingfromanetlossof15,894,000 for the year ended December 31, 2023, resulting from a net loss of 16,690,000 and the forgiveness of a DECD loan of 1,000,000[319]Netcashprovidedbyfinancingactivitieswas1,000,000[319] - Net cash provided by financing activities was 11,064,000 for the year ended December 31, 2024, mainly from a registered direct offering with net proceeds of 4,830,000[321]Netcashprovidedbyfinancingactivitieswas4,830,000[321] - Net cash provided by financing activities was 5,216,000 for the year ended December 31, 2023, primarily from a registered direct offering with net proceeds of 4,119,000[322]FutureOutlookThecompanyplanstocontinueexpandingaccesstoitstestsamongMedicaidpatientsandadvocateforlegislationtoenhanceproductadoption[295]Thecompanyexpectstoraiseadditionalcapitalthroughpublicorprivateequityofferings,debtfinancing,collaborations,orlicensingarrangementstocontinueoperationsthrough2025andbeyond[328]Thecompanyexpectstoincuranetlossandnegativecashflowsfromoperationsin2025[369]Thecompanyexpectsrevenuefromitsproductstobeitsonlymaterial,recurringsourceofcashin2025[368]ShareIssuanceFortheyearendedDecember31,2023,thecompanysold472,312sharesforgrossproceedsofapproximately4,119,000[322] Future Outlook - The company plans to continue expanding access to its tests among Medicaid patients and advocate for legislation to enhance product adoption[295] - The company expects to raise additional capital through public or private equity offerings, debt financing, collaborations, or licensing arrangements to continue operations through 2025 and beyond[328] - The company expects to incur a net loss and negative cash flows from operations in 2025[369] - The company expects revenue from its products to be its only material, recurring source of cash in 2025[368] Share Issuance - For the year ended December 31, 2023, the company sold 472,312 shares for gross proceeds of approximately 1,578,000 under the 2023 Equity Line of Credit Agreement[345] - In 2024, the company sold 949,574 shares under the same agreement for gross proceeds of approximately 1,900,000,totaling1,310,517sharesandapproximately1,900,000, totaling 1,310,517 shares and approximately 3,078,000 over the agreement's life[346] - The company issued 1,650,473 shares at an offering price of 2.75pershare,generatinggrossproceedsofapproximately2.75 per share, generating gross proceeds of approximately 4.7 million from the 2023 Direct Offering[349] - The 2024 Direct Offering generated gross proceeds of approximately 5,563,000fromtheissuanceof1,368,600sharesatanofferingpriceof5,563,000 from the issuance of 1,368,600 shares at an offering price of 3.50 per share[352] - The company sold 1,073,050 shares under the 2024 At the Market Offering for gross proceeds of approximately 903,000duringtheyearendedDecember31,2024[360]Thecompanyraisedapproximately903,000 during the year ended December 31, 2024[360] - The company raised approximately 1,909,000 from the 2024 Private Placement Offering by issuing 1,248,529 shares and accompanying warrants[357] Licensing and Collaborations - The company entered into a licensing agreement with Harvard's Dana-Farber Cancer Institute, with an initial license fee of 75,000andpotentialroyaltypaymentsofupto75,000 and potential royalty payments of up to 1,350,000 based on regulatory approvals and commercialization milestones[336] - Royalty expenses for the years ended December 31, 2024, and 2023 totaled 293,000and293,000 and 324,000, respectively, related to a research collaboration agreement[333] Financial Position - The company has significant NOL carryforwards as of December 31, 2024, which are subject to a full valuation allowance due to a history of operating losses[323] - The company incurred an accumulated deficit of 531,397,000andastockholdersdeficitof531,397,000 and a stockholders' deficit of 2,563,000 as of December 31, 2024[368] - The company has 1,769,000incashandcashequivalentsand1,769,000 in cash and cash equivalents and 5,468,000 in current liabilities as of December 31, 2024[368]