Financial Performance - Total revenue for the year ended December 31, 2024, was 9,182,000,aslightincreaseof28,000 or 0.3% compared to 9,154,000in2023[305]−ThenetlossfortheyearendedDecember31,2024,was13,094,000, a decrease of 3,596,000or2216,690,000 in 2023[305] - Other income increased by 1,386,000in2024,primarilyduetoaone−timefederalgovernmentawardof2,000,000[315] - The accumulated deficit as of December 31, 2024, was approximately 531,397,000,withexpectationsofincurringanetlossin2025[303]Expenses−Costofproductrevenuedecreasedby189,000 or 5% to 3,703,000in2024,primarilyduetoreducedconsultingcostsandlabsupplies[307]−Researchanddevelopmentexpensesdecreasedby769,000 or 19% to 3,266,000in2024,mainlyduetoloweremployment−relatedexpensesandclinicaltrialcosts[308]−Salesandmarketingexpensesincreasedby334,000 or 4% to 8,146,000in2024,drivenbycostsrelatedtothecontractedsalesteamandincreasedpersonnelcosts[310]−Generalandadministrativeexpensesdecreasedby1,922,000 or 16% to 10,345,000in2024,attributedtoreductionsinemployment−relatedexpensesandconsultingcosts[311]CashFlow−Netcashusedinoperatingactivitieswas12,113,000 for the year ended December 31, 2024, primarily due to a net loss of 13,094,000andchangesinfairvalueofwarrantliabilitiestotalingapproximately1,346,000[318] - Net cash used in operating activities was 15,894,000fortheyearendedDecember31,2023,resultingfromanetlossof16,690,000 and the forgiveness of a DECD loan of 1,000,000[319]−Netcashprovidedbyfinancingactivitieswas11,064,000 for the year ended December 31, 2024, mainly from a registered direct offering with net proceeds of 4,830,000[321]−Netcashprovidedbyfinancingactivitieswas5,216,000 for the year ended December 31, 2023, primarily from a registered direct offering with net proceeds of 4,119,000[322]FutureOutlook−ThecompanyplanstocontinueexpandingaccesstoitstestsamongMedicaidpatientsandadvocateforlegislationtoenhanceproductadoption[295]−Thecompanyexpectstoraiseadditionalcapitalthroughpublicorprivateequityofferings,debtfinancing,collaborations,orlicensingarrangementstocontinueoperationsthrough2025andbeyond[328]−Thecompanyexpectstoincuranetlossandnegativecashflowsfromoperationsin2025[369]−Thecompanyexpectsrevenuefromitsproductstobeitsonlymaterial,recurringsourceofcashin2025[368]ShareIssuance−FortheyearendedDecember31,2023,thecompanysold472,312sharesforgrossproceedsofapproximately1,578,000 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,totaling1,310,517sharesandapproximately3,078,000 over the agreement's life[346] - The company issued 1,650,473 shares at an offering price of 2.75pershare,generatinggrossproceedsofapproximately4.7 million from the 2023 Direct Offering[349] - The 2024 Direct Offering generated gross proceeds of approximately 5,563,000fromtheissuanceof1,368,600sharesatanofferingpriceof3.50 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]−Thecompanyraisedapproximately1,909,000 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 75,000andpotentialroyaltypaymentsofupto1,350,000 based on regulatory approvals and commercialization milestones[336] - Royalty expenses for the years ended December 31, 2024, and 2023 totaled 293,000and324,000, 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 531,397,000andastockholders′deficitof2,563,000 as of December 31, 2024[368] - The company has 1,769,000incashandcashequivalentsand5,468,000 in current liabilities as of December 31, 2024[368]