Agenus (NASDAQ:AGEN) told shareholders at its 2026 virtual annual meeting that it remains focused on advancing its botensilimab and balstilimab immunotherapy combination, known as BOT/BAL, while working to strengthen its financial position and pursue regulatory pathways in the United States and Europe.
Chairman and Chief Executive Officer Garo Armen said the past year had been “one of the most important periods” in the company’s history, but also “one of the most difficult.” He said Agenus had made “hard decisions” to sharpen its focus around BOT/BAL, which the company is developing in cancers that have historically resisted immunotherapy, including microsatellite stable, or MSS, colorectal cancer.
BOT/BAL Remains Lead Development Focus
Armen described BOT/BAL as a combination of an Fc-engineered CTLA-4 antibody and a PD-1 antibody, saying Agenus does not view the regimen as “simply another CTLA-4 and PD-1 doublet.” He said botensilimab was designed to help activate a broader immune response, including by priming T cells, reducing suppressive regulatory T cells, engaging myeloid cells and supporting immune memory.
Across phase 1 and phase 2 trials, Armen said approximately 1,300 patients have been treated with botensilimab and balstilimab, with clinical activity observed in more than nine metastatic late-line cancer settings. The company’s most mature data remain in refractory MSS metastatic colorectal cancer, which Armen said continues to be Agenus’ lead regulatory development focus.
In heavily pretreated MSS metastatic colorectal cancer patients without active liver metastases, Armen said BOT/BAL has demonstrated 42% two-year overall survival and median overall survival of about 21 months. He said the company has also observed activity across multiple difficult-to-treat tumors, including colorectal cancer, ovarian cancer, sarcoma, lung cancer, hepatocellular cancer and refractory or resistant melanoma.
Agenus Chief Medical Officer Dr. Steven O’Day said melanoma data presented at ASCO included 36 refractory metastatic patients, with a confirmed RECIST overall response rate of 22%. In a subgroup that had failed CTLA-4 and PD-1 therapy, he said the response rate was 29%, with survival plateaus between 40% and 60% after the data were allowed to mature for at least two and a half years.
Phase 3 BATMAN Trial Underway
Armen said the global phase 3 BATMAN trial began enrolling patients in April. The study is evaluating BOT/BAL against best supportive care in patients with refractory, unresectable MSS or pMMR metastatic colorectal cancer.
O’Day said the trial currently has 21 active sites in Canada and is expected to reach 30 sites “very shortly.” He said Australia and New Zealand are expected to open with a first patient in within the next month, with France to follow over the summer.
Because the trial is driven by overall survival events, O’Day said the company expects the first reporting of the survival analysis “probably in the second half of 2028.”
Regulatory Plans and Access Programs
Armen said Agenus is preparing for regulatory engagement in the U.S. and Europe, including potential accelerated approval and conditional marketing authorization pathways. He said the company is assembling a regulatory package based on more mature data and a safety data set covering roughly 1,300 or more patients.
Asked what Agenus is waiting for before filing with the FDA or European regulators, Armen said the company had previously received FDA guidance not to pursue accelerated approval when the data were less mature. He said the data are now “more mature” and “compelling,” but added that preparing an accelerated approval application requires substantial work and validation.
“It will not take years,” Armen said. “We hope that it will take a reasonable few quarters for us to be able to submit the data for accelerated approval.”
Armen also discussed patient access programs outside the U.S. He said BOT/BAL is available in France through the national Autorisation d’accès compassionnel framework for eligible French patients with MSS metastatic colorectal cancer without active liver metastases. He said platinum-resistant or platinum-refractory ovarian cancer and certain advanced soft tissue sarcomas are also allowed under the French AAC program.
Outside France, Armen said BOT/BAL may be available in select countries through paid named-patient programs where permitted by local regulation, including in parts of Europe and South America. He said the programs are physician-driven and not promotional.
Agenus recognized $3.2 million in initial income associated with BOT/BAL supplied through authorized access pathways in the fourth quarter of 2025 and $4.6 million in pre-commercial product revenue in the first quarter of 2026, Armen said.
Balance Sheet and Collaboration Updates
Armen said Agenus ended 2025 with approximately $3 million in cash and cash equivalents, calling it “a very difficult position.” He said the company’s January strategic collaboration with Zydus Lifesciences provided upfront capital, strengthened the balance sheet and secured dedicated U.S. biologics manufacturing capacity for clinical development, access programs and potential future commercial supply.
After the Zydus transaction and payments of several obligations, Agenus ended the first quarter of 2026 with approximately $35 million in cash and cash equivalents, Armen said. Subsequent to the quarter, the company received about $11.7 million in net proceeds from sales of common stock under its at-the-market program.
Armen said Agenus is targeting approximately $50 million in annualized ongoing operating expenses to support BOT/BAL. He said the company is evaluating financing and partnering opportunities as appropriate.
During the Q&A, Armen said interest in immuno-oncology partnerships had been weak for the past two years, but that Agenus received inbound inquiries at ASCO from companies, including regional companies. He said the company is renewing efforts to engage potential collaborators, with an emphasis on regional collaboration.
Shareholders Approve Annual Meeting Proposals
During the formal portion of the meeting, Chief Communications and Government Relations Officer Stefanie Nacar said holders representing at least 51% of outstanding shares were present in person or by proxy, establishing a quorum.
Nacar said shareholders approved all proposals presented at the meeting, including the election of Garo Armen and Jennifer Buell as Class 2 directors, equity plan-related amendments, a one-time stock option exchange program, an advisory vote on named executive officer compensation for 2025, and the ratification of KPMG LLP as independent registered public accounting firm for the fiscal year ending Dec. 31, 2026.
Agenus said it expects to report preliminary or final voting results in a Form 8-K filing with the SEC within four business days after the meeting.
About Agenus (NASDAQ:AGEN)
Agenus, Inc (NASDAQ:AGEN) is a clinical-stage immuno-oncology company headquartered in Lexington, Massachusetts. The company focuses on the discovery and development of therapies designed to modulate the immune system’s response to cancer. Leveraging proprietary platforms in checkpoint modulation, vaccine technology and adjuvant systems, Agenus aims to deliver combination regimens that enhance antitumor activity across a variety of solid tumors and hematological malignancies.
Agenus’ pipeline includes monoclonal antibodies targeting immune checkpoints, cytokine-based therapeutics and vaccine candidates built on its engineered heat shock protein (HSP) platform.
