On November 10, 2025 Agenus Inc. (Nasdaq: AGEN) reported quarterly results for the period ended September 30, 2025, and provided a business update. Highlights include government‑funded, reimbursed compassionate access (AAC) in France for botensilimab plus balstilimab (BOT/BAL), new survival data presented at ESMO (Free ESMO Whitepaper) and ESMO (Free ESMO Whitepaper)‑GI across more than 400 patients spanning more than five refractory cancers, and initiation of the global Phase 3 BATTMAN trial.

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Access & Regulatory

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France authorizes reimbursed AAC for BOT/BAL. In September, France’s medicines agency (ANSM) authorized reimbursed compassionate access (Accès Compassionnel, AAC) for BOT/BAL in refractory MSS mCRC without active liver metastases—the first government-funded access for this population and the first reimbursed access provided for BOT/BAL by a regulatory agency. link

Clinical Highlights

BOT/BAL has demonstrated durable, long-term survival in patients with advanced solid tumors, reinforcing its potential to expand the reach of immunotherapy to those historically unresponsive to treatment.

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MSS metastatic colorectal cancer (ESMO‑GI 2025): In 123 heavily pretreated MSS mCRC patients without active liver metastases, BOT/BAL achieved 42% two‑year overall survival (OS) and 20.9‑month median OS. Median OS benchmarks in this third‑line‑plus setting is 8-14 months with current standards of care. link
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Pan‑tumor cohort (ESMO 2025): Updated Phase 1b results in >400 patients demonstrated 39% two‑year OS across more than five refractory cancers, including colorectal, ovarian, sarcoma, lung, and hepatocellular tumors. Important to note that responses were seen after prior checkpoint inhibitor failure; immune‑related AEs were treatable and reversible. link

Phase 3 Program

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Global registrational trial initiated. The BATTMAN (CCTG CO.33) Phase 3 trial conducted with the Canadian Cancer Trials Group and supported by AGITG (Australasia), and PRODIGE (France)—is launching in Q4 2025 across 100+ sites in Canada, France, Australia, and New Zealand to evaluate BOT/BAL versus best supportive care in refractory, unresectable MSS/pMMR colorectal cancer. link

Q3 2025 Financial Highlights

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Zydus transactions: In October, Agenus and Zydus agreed to a $10 million bridge facility ahead of the anticipated $91 million upon closing of the transaction which also includes an equity investment at $7.50 per share.

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MiNK deconsolidation: In July 2025, Agenus’ ownership of MiNK fell below 50%, resulting in deconsolidation in Q3 2025. This generated approximately $100.9 million gain, resulting in net income for the three‑month and nine-month period ended September 30, 2025.

Upcoming Catalysts

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BATTMAN patient enrollment to commence before year-end 2025
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BOT/BAL paid access programs: government reimbursed in France and self-pay in several European countries as well as other regions – patients currently under treatment in both pathways.
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Investigator‑initiated trials: Neoadjuvant and frontline data updates expected 1H 2026
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France AAC: Will generate real world evidence

Webcast and Conference Call Information

As part of Agenus’ newly launched webcast series, the Company will host a Stakeholder Briefing Webcast in late November, featuring internal and external experts. Additional details will be announced prior to the event.

(Press release, Agenus, NOV 10, 2025, View Source [SID1234659700])