Agenus Reports $34.5 Million in Q2 Revenue, Advances Phase 3 Colon Cancer Trial

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Garo Armen, Ph.D.

LEXINGTON, Mass. — Agenus Inc. reported second-quarter revenue of $34.5 million and said it is preparing to begin a Phase 3 trial of its botensilimab and balstilimab combination in patients with high-risk, resectable colon cancer.

Revenue increased from $25.7 million in the same quarter last year. The total included $6.4 million in pre-commercial product revenue from authorized patient-access programs and $28.1 million in non-cash royalty revenue.

The biotechnology company reported a net loss of $600,000 for the quarter, compared with a net loss of $30 million a year earlier. Operating income was $11.3 million, compared with an operating loss of $16.7 million in the second quarter of 2025.

Agenus had $18.7 million in cash and cash equivalents at the end of June. That figure does not include approximately $85 million in gross proceeds from a private placement completed in July.

The financing included warrants that could provide up to an additional $255 million if fully exercised. Agenus said the upfront proceeds are expected to support operations and preparations for the Phase 3 ROBBIN trial through the third quarter of 2027.

ROBBIN will evaluate botensilimab, known as BOT, in combination with balstilimab, or BAL, before surgery in patients with high-risk Stage II and Stage III microsatellite-stable colon cancer.

The company expects to initiate the trial and dose the first patient in the first quarter of 2027.

Agenus estimates that the trial’s targeted population includes about 38,000 newly diagnosed patients annually in the United States and more than 200,000 worldwide.

“The previously reported neoadjuvant findings support testing whether BOT+BAL before surgery can reduce recurrence and improve the potential for cure,” Chairman and CEO Garo H. Armen, Ph.D., said.

The trial is supported by previously reported results from the NEST and UNICORN studies. Among 38 patients treated with BOT and BAL, approximately 30 percent had no viable tumor detected at surgery, while about 40 percent had 10 percent or less viable tumor remaining.

Agenus said no disease recurrences had been reported as of the studies’ applicable data cutoffs. Longer-term follow-up manuscripts are expected during the second half of 2026.

The company also cited updated results from a 123-patient Phase 1b study in refractory microsatellite-stable metastatic colorectal cancer without active liver metastases. Median overall survival was 21.2 months, while the three-year overall survival rate was 33 percent.

Agenus expanded access to BOT and BAL during the quarter through France’s national compassionate-access program and physician-led named-patient programs in other countries. Pre-commercial product revenue from those programs increased from $4.6 million in the first quarter.

The company also ended its planned future funding for BATTMAN, a Phase 3 study of BOT and BAL in refractory metastatic colorectal cancer sponsored by the Canadian Cancer Trials Group. The group subsequently terminated the study.

Agenus said the decision was based on financing and development priorities rather than enrollment, efficacy or safety results. The company plans to continue supporting treatment for patients already enrolled when medically appropriate and permitted.

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