Business
Agenus Reports 2025 Results; BOT+BAL Advances to Phase 3 and Early Access Programs Expand Globally with Initial Revenues Recognized
Early access programs expand globally: 200+ physician inquiries across 30+ countries; $4.2M in initial program revenue recognized CRC leads BOT+BAL clinical
About this update from Agenus Inc.
[{"type":"text","content":"\n\nEarly access programs expand globally: 200+ physician inquiries across 30+ countries; $4.2M in initial program revenue recognized\n\n\n\nCRC leads BOT+BAL clinical development: 42% two-year overall survival and ~21-month median overall survival in heavily pretreated microsatellite stable (MSS) metastatic CRC (mCRC) patients\n\n\n\nBATTMAN Phase 3 registrational trial underway: First global next-generation CTLA-4/PD-1 combination registrational trial in refractory MSS mCRC\n\n\n\nFrance expands reimbursed AAC access: Metastatic ovarian cancer and sarcoma added alongside MSS mCRC\n\n\n\nZydus collaboration strengthens balance sheet and manufacturing capacity: Strategic capital and dedicated U.S. biologics production secured to support BOT+BAL development for commercialization\n\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAgenus Inc. (Nasdaq: AGEN) today reported financial results for the fourth quarter and full year ended December 31, 2025, highlighting progress for the botensilimab (BOT) plus balstilimab (BAL) immunotherapy program across patient access, clinical execution, and commercial readiness. BOT+BAL is a next-generation CTLA-4/PD-1 immunotherapy combination which activates both innate and adaptive immunity and has demonstrated immunotherapy benefit in tumors historically resistant to checkpoint inhibition.\n\n\nThe BOT+BAL program entered global Phase 3 evaluation in refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC), expanded through regulatory-authorized early access pathways in multiple countries and recognized initial revenue associated with treatment supplied through these programs while preparing for potential future regulatory submissions in the United States and Europe.\n\n\n\"BOT+BAL is beginning to stand out for the reasons that matter most; patients with few options are actively seeking access, physicians are gaining experience with the regimen, and the clinical foundation continues to strengthen,\" said Garo H. Armen, PhD, Chairman and CEO of Agenus. \"When real-world interest and clinical relevance start to align, conviction builds. We believe BOT+BAL has the potential to become an important new immunotherapy franchise in CRC and across other difficult-to-treat cancers.\"\n\n\nKey Business Highlights\n\n\nEarly Access Programs Expand Patient Reach and Build Physician Experience\n\n\...