LEXINGTON, Mass. — Agenus Inc. reported first-quarter financial results and said it is focusing its operations around the development and potential commercialization of its lead immuno-oncology program, botensilimab plus balstilimab.
The Lexington-based company said the first quarter marked a shift from foundation-building to execution for BOT+BAL, including broader physician engagement through regulatory-authorized access programs, the start of Phase 3 enrollment after the quarter ended and the closing of a strategic collaboration with Zydus Lifesciences.
BOT+BAL is designed to activate both innate and adaptive immunity and extend immunotherapy benefit to tumors that have historically shown limited responsiveness to checkpoint inhibition.
“First quarter 2026 was a defining quarter for Agenus and for BOT and BAL,” said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. “We saw continued physician requests and engagement treating patients with BOT and BAL through regulatory-authorized access pathways. Additionally, we advanced the program into Phase 3 enrollment and closed a transformative collaboration with Zydus that secured both capital and U.S. manufacturing capacity. BOT+BAL’s maturing data, particularly the durability of survival outcomes in refractory MSS colorectal cancer, continue to underpin our regulatory submissions in the United States and Europe.”
Agenus said it is concentrating resources on three priorities: supporting physician-initiated access through authorized pathways where permitted, advancing the Phase 3 BATTMAN trial and building the clinical, manufacturing and operational infrastructure needed for the next stage of development.
The company said BOT+BAL is available in France through the national Autorisation d’Accès Compassionnel framework for eligible patients, with reimbursed access across certain forms of metastatic colorectal cancer, ovarian cancer and advanced soft-tissue sarcomas. Outside France, the treatment may be available in select countries through paid named-patient programs, depending on local rules and individual coverage decisions.
In the first quarter, Agenus said paid named-patient activity expanded to additional countries in South and Central America and Europe. In April, the company named BAP Pharma as its global partner to support BOT+BAL access programs, including France’s compassionate access pathway and paid named-patient programs.
Agenus also said it expanded its medical affairs and early-access capabilities to respond to growing physician interest and support scientific exchange, access coordination, pharmacovigilance and collection of real-world safety and outcomes data where applicable.
The global Phase 3 BATTMAN trial began enrolling patients in April 2026. The study is evaluating BOT+BAL against best supportive care in patients with refractory, unresectable MSS/pMMR metastatic colorectal cancer, a setting where checkpoint inhibitors have historically shown limited benefit.
BATTMAN is being led by the Canadian Cancer Trials Group as an international cooperative-group trial, with participating academic networks in Canada, France, Australia and New Zealand. Agenus said site activation is continuing across participating regions.
The company also highlighted the January closing of its previously announced collaboration with Zydus Lifesciences. The deal provided upfront capital and dedicated biologics manufacturing capacity to support clinical development, authorized access programs and potential future commercial supply of BOT+BAL.
At closing, Zydus paid $91 million in upfront capital, subject to customary adjustments and escrow arrangements, and a $7 million Zydus promissory note was forgiven. The agreement included $75 million in cash consideration for the transfer of biologics manufacturing facilities in Emeryville and Berkeley, Calif., a $16 million equity investment in Agenus common stock, up to $50 million in contingent payments tied to BOT and BAL production orders and an exclusive license for Zydus to develop and commercialize BOT and BAL in India and Sri Lanka.
Agenus said clinical and translational data continue to support the potential for BOT+BAL across difficult-to-treat tumors. Across Phase 1 and Phase 2 studies, about 1,300 patients have been treated with botensilimab and/or balstilimab, with clinical activity observed across more than nine metastatic, late-line cancer settings.
For the first quarter, Agenus reported $33.7 million in total revenue, compared with $24.1 million in the same period a year earlier. Pre-commercial product revenue was $4.6 million, compared with none in the prior-year period. Non-cash royalty revenue rose to $29.1 million from $23.6 million.
The company reported operating income of $15.1 million, compared with an operating loss of $13.3 million in the first quarter of 2025. Net income was $39.2 million, compared with a net loss of $26.4 million a year earlier.
Cash, cash equivalents and short-term investments totaled $35 million as of March 31, compared with $18.5 million a year earlier. Agenus said it received an additional $11.7 million in net proceeds from sales of common stock under its at-the-market equity offering program after the quarter ended.
The company said first-quarter cash payments totaled about $51.8 million, primarily related to commercial-grade botensilimab supply, clinical data generation for planned regulatory submissions and obligations tied to the Zydus collaboration. Agenus said those payments were not representative of its recurring operating expense profile and that it continues to align expenses with a previously communicated framework of about $50 million in annualized operating expenses.
