Agenus (NASDAQ:AGEN) reported its financial results for the fourth quarter and full year ended December 31, 2025, marking a transition from a purely clinical-stage company to one generating initial pre-commercial revenue.
The Lexington, Massachusetts-based immunotherapy leader recognized $4.2 million in revenue for the year from regulatory-authorized early access programs for its botensilimab (BOT) and balstilimab (BAL) combination.
This program, which targets tumors traditionally resistant to standard checkpoint inhibitors, has now expanded into more than 30 countries following over 200 physician inquiries.
A key operational highlight was the launch of the BATTMAN Phase 3 registrational trial.
This global study is evaluating BOT+BAL in patients with refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC), a population with significant unmet medical need.
Clinical data previously presented by the company demonstrated a 42% two-year overall survival rate in this group—nearly triple the survival rates historically associated with standard-of-care therapies.
On the financial front, Agenus reported fourth-quarter 2025 operating income of $14.4 million, aided by a significant strategic collaboration with Zydus Lifesciences.