Lexington, MA — November 10, 2025 — Leads & Copy — Agenus Inc. (Nasdaq: AGEN) has released its quarterly results for the period ending September 30, 2025, along with a business update highlighting recent clinical and financial achievements.
The company’s immuno-oncology programs have shown promise, with botensilimab plus balstilimab (BOT/BAL) receiving government-funded, reimbursed compassionate access (AAC) in France. New survival data presented at ESMO and ESMO-GI included over 400 patients across more than five refractory cancers.
Agenus has initiated the global Phase 3 BATTMAN trial.
In September 2025, France’s medicines agency, ANSM, authorized reimbursed compassionate access (Accès Compassionnel, AAC) for BOT/BAL in refractory MSS mCRC without active liver metastases. This marks the first government-funded access for this population and the first reimbursed access provided for BOT/BAL by a regulatory agency.
BOT/BAL has demonstrated long-term survival in patients with advanced solid tumors, potentially expanding immunotherapy’s reach to those historically unresponsive to treatment.
Data from ESMO-GI 2025 showed that in 123 heavily pretreated MSS mCRC patients without active liver metastases, BOT/BAL achieved a 42% two-year overall survival (OS) and a 20.9-month median OS. The median OS benchmarks in this third-line-plus setting are typically 8-14 months with current standards of care.
Updated Phase 1b results in over 400 patients, presented at ESMO 2025, demonstrated a 39% two-year OS across more than five refractory cancers, including colorectal, ovarian, sarcoma, lung, and hepatocellular tumors. Responses were observed after prior checkpoint inhibitor failure, and immune-related adverse events (AEs) were treatable and reversible.
The global registrational 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 over 100 sites in Canada, France, Australia, and New Zealand. The trial will evaluate BOT/BAL versus best supportive care in refractory, unresectable MSS/pMMR colorectal cancer.
In October, Agenus and Zydus agreed to a $10 million bridge facility ahead of the anticipated $91 million closing of the transaction, which includes an equity investment at $7.50 per share.
In July 2025, Agenus’ ownership of MiNK fell below 50%, resulting in deconsolidation in Q3 2025. This generated an approximately $100.9 million gain, resulting in net income for the three-month and nine-month period ended September 30, 2025.
Financial highlights for Q3 2025 include revenues of $30,200, an operating loss of $4,500, net income of $63,900, basic net income per share attributable to common stockholders of $2.00, diluted net income per share of $1.94, and cash used in operations of $14,700.
Upcoming catalysts for Agenus include the commencement of BATTMAN patient enrollment before year-end 2025, BOT/BAL paid access programs with government reimbursement in France and self-pay options in several European countries, and updates from investigator-initiated trials expected in the first half of 2026.
Agenus, founded in 1994 and headquartered in Lexington, MA, is committed to expanding patient populations benefiting from cancer immunotherapy through combination approaches, utilizing a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics), and adjuvants.
Agenus is dedicated to making investigational medicines available to patients with cancer. For more information, visit https://agenusbio.com/access-to-investigational-medicines-policy
Botensilimab (BOT) is designed to boost both innate and adaptive anti-tumor immune responses. Balstilimab is designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2.
Agenus Contact:
Janelle B. Frost
SVP, Corporate Communications & Investor Relations
+1 (781) 674-4408
janelle.frost@agenusbio.com
Source: Agenus
