Financial Performance - Research and development revenue increased to approximately 38.8millionin2023from17.0 million in 2022, primarily due to a 25.0millionmilestoneundertheBMSLicenseAgreement[410].−Non−cashroyaltyrevenuerelatedtoGSKincreasedby69.3 million to approximately 114.6millionin2023,drivenbyincreasednetsalesofGSK′svaccinescontainingtheQS−21STIMULONadjuvant[411].−TheaccumulateddeficitasofDecember31,2023,reached1.96 billion, indicating significant losses since inception[408]. - Non-operating income decreased by 12.5millionto37,000 for the year ended December 31, 2023, compared to 12.6millionin2022,primarilyduetominimalactivityin2023[415].−Interestexpense,netincreasedto97.9 million for the year ended December 31, 2023, from 61.9millionin2022,mainlyduetoincreasednon−cashinterestrelatedtotheRoyaltyPurchaseAgreement[416].−Theaccumulateddeficitreached1.96 billion as of December 31, 2023, with expectations of significant losses continuing over the next several years[426]. - Cash, cash equivalents, and short-term investments decreased to 76.1millionasofDecember31,2023,downby117.2 million from the previous year[431]. - Net cash used in operating activities was 224.2millionfortheyearendedDecember31,2023,comparedto175.4 million in 2022[437]. Research and Development - The company’s research and development expenses for 2023 were 234.6million,upfrom186.7 million in 2022[408]. - R&D expenses increased by 26% to 234.6millionfortheyearendedDecember31,2023,upfrom186.7 million in 2022, primarily due to a 44.6millionincreaseinthird−partyservicesandotherexpenses[413].−Totalresearchanddevelopmentexpensesfor2023amountedto234.6 million, with significant costs associated with antibody programs[419]. - The company launched SaponiQx to innovate in adjuvant discovery and vaccine design, focusing on the next-generation QS-21 STIMULON[404]. - Botensilimab, the lead program, received Fast Track designation from the FDA for treating patients with dMMR metastatic colorectal cancer, with plans to submit a BLA by the end of 2024[395]. - The company completed enrollment of approximately 150 patients in a Phase 1 trial and 230 patients in a randomized Phase 2 trial for botensilimab by October 2023[395]. - The company is pursuing a global regulatory strategy for botensilimab, aiming for accelerated approval in the U.S. and Europe[395]. Collaborations and Agreements - The company has established collaborations with several firms, including BMS and Merck, resulting in potential milestone payments exceeding 1.32billionfromBMSalone[403][396].−TheGileadCollaborationAgreementscouldyieldupto520.0 million in milestone payments and royalties on future sales[400]. - The company plans to enter into additional agreements with third-party providers, estimating total payments of 645.4millionoverthetermofrelatedactivities[435].FinancialObligationsandRisks−Long−termdebttotals14.384 billion, with less than 1.242billiondueinthenextyear[439].−Operatingleasesamountto119.297 million, with payments due between 2025 and 2036[439]. - Finance leases total 16.559million,with11.669 million due in the next year[439]. - The company is in discussions for potential structured financing and corporate collaborations to extend cash resources[433]. - The company is exposed to fluctuations in interest rates as it seeks debt financing and invests excess cash[448]. - Approximately 1.0% of cash used in operations for 2023 was from foreign subsidiaries, indicating exposure to foreign currency exchange rate fluctuations[447]. - The company does not currently employ hedging strategies to manage foreign currency exchange rate risks[447]. - The investment policy prohibits investing in structured investment vehicles and asset-backed commercial paper, focusing on preserving principal and maximizing yields[449]. - Non-cash interest expense related to the HCR Royalty Purchase Agreement is recorded based on estimated royalty payments from GSK, which could vary significantly[443]. - The company periodically reviews and amends its investment policy as necessary to manage credit risk and maintain liquidity[449].