Revenue Recognition - The company recognized revenue of 0.9millionfortheyearendedDecember31,2023,comparedto2.3 million for the previous year, primarily from the PEACE Phase 3 trial and early access programs [443]. - The company has not generated any revenue from commercial product sales and future revenues depend on successful development and regulatory approval of product candidates [441]. - For the year ended December 31, 2024, total revenue was 0,adecreaseof886,000 or 100% compared to 886,000in2023[481].−ThecompanydidnotrecognizeanyrevenueinconnectionwiththeImmedicaAgreementfortheyearendedDecember31,2024,comparedto0.9 million in 2023 [482]. - Total revenue for 2024 was 886,000,asignificantdecreasefrom2,329,000 in 2023, representing a decline of approximately 62% [537]. Expenses and Losses - Research and development expenses for the year ended December 31, 2023, included restructuring expenses of 6.4million,with5.3 million paid during the year [456]. - The company experienced an approximate 83% reduction in headcount by June 30, 2023, as part of a restructuring plan initiated in response to inconclusive interim trial results [454]. - An impairment loss of 0.9millionwasrecognizedrelatedtotheoperatingleaseright−of−useassetand1.7 million for leasehold improvements after abandoning the leased office space in Austin, Texas [458]. - Research and development expenses increased by 73.3million,or82162.8 million for the year ended December 31, 2024, from 89.5millionin2023[483].−Generalandadministrativeexpensesroseby5.8 million, or 15%, to 45.8millionfortheyearendedDecember31,2024,comparedto39.9 million in 2023 [481]. - The net loss for the year ended December 31, 2024, was 208.0million,adecreaseof130.8 million from a net loss of 338.8millionin2023[481].−Thenetlossfor2024was208,018,000, compared to a net loss of 338,790,000in2023,indicatinganimprovementofapproximately39208,140,000 for 2024, down from 338,440,000in2023,showingadecreaseofapproximately3815.0 million in upfront cash and up to 100.0millionincontingentmilestonepayments[445].−Cashusedinoperatingactivitieswas157.4 million in 2024, compared to 99.9millionin2023[502][503].−Cashprovidedbyfinancingactivitieswas410.9 million in 2024, up from 361.1millionin2023[506][507].−Thecompanyanticipatesneedingadditionalfinancinginthefuturetofundfurtherresearchanddevelopment[493].−TheCompanyraisedapproximately1.3 billion in gross proceeds from various financing activities since inception [566]. - The Company completed a public offering of 8,366,250 shares of common stock at a price of 27.50pershareinNovember2024,resultinginnetproceedsofapproximately215.9 million [564]. Assets and Liabilities - As of December 31, 2024, the company had an accumulated deficit of 972.4million[492].−Thecompanyheld603.1 million in cash, cash equivalents, marketable securities, and restricted cash as of December 31, 2024 [513]. - As of December 31, 2024, total assets increased to 608.5millionfrom341.9 million in 2023, representing a growth of approximately 78% [534]. - The total liabilities increased to 90.7millionin2024from73.3 million in 2023, reflecting a rise of about 24% [534]. - The CVR liability as of December 31, 2024, was recorded at 61.7million,withanincreaseof19.0 million for the year, primarily due to changes in fair value [529]. - The accumulated deficit grew to 972.4millionin2024from764.4 million in 2023, indicating an increase of approximately 27% [534]. - The total stockholders' equity rose to 517.8millionin2024,upfrom184.0 million in 2023, representing a growth of about 181% [534]. Internal Controls and Compliance - The Company reported a material weakness in internal control over financial reporting as of December 31, 2024, related to the evaluation of Series A and Series B Preferred Stock [520]. - The Company’s management is responsible for maintaining effective internal control over financial reporting, which was found to be ineffective in certain respects as of December 31, 2024 [520]. Research and Development - The company plans to investigate combination therapies of its proprietary antibodies to enhance efficacy in treating immune-mediated diseases [438]. - External research and development expenses increased to 140.7millionin2024from72.7 million in 2023, a rise of 93% [484]. - Internal research and development expenses rose to 22.1millionin2024from16.8 million in 2023, an increase of 31% [485]. - The increase in research and development expenses was primarily driven by a 43.4millionincreaseinmanufacturingcostsanda34.0 million increase in nonclinical and clinical development [483]. Marketable Securities - The estimated fair value of total marketable securities increased to 513.67millionin2024from150.38 million in 2023 [632]. - The company reported net unrealized losses on marketable securities of 0.1millionfortheyearendedDecember31,2024,comparedtonetunrealizedgainsof0.3 million in 2023 [631]. - The total unrealized losses on marketable securities as of December 31, 2024, were $493,000, with significant losses attributed to U.S. government treasury securities [630]. - The company classified all marketable securities as current assets, allowing for potential sales before maturity [633].
