Agenus announced that it entered into a securities purchase agreement for an oversubscribed private placement of approximately $85 million in upfront gross proceeds and up to an additional $255 million if purchase warrants are fully exercised.
The financing was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals. If the warrants are fully exercised, the private placement would provide Agenus with up to $340 million in total gross proceeds.
Agenus plans to use the proceeds to support its strategic prioritization of botensilimab and balstilimab, known as BOT+BAL, for the neoadjuvant treatment of microsatellite-stable colon cancer.
The funding is expected to support advancement of ROBBIN1, Agenus’ planned registrational Phase 3 neoadjuvant trial in high-risk Stage II and Stage III MSS colon cancer. Agenus said that, assuming full exercise of the warrants, the financing is expected to fund completion of ROBBIN and provide runway through year-end 2031.
The private placement is expected to close on or around July 15, 2026, subject to customary closing conditions. Agenus said the upfront purchase price per share and the exercise prices for the Series A and Series B warrants were each priced at a premium to the market closing price per share as of July 10, 2026.
Agenus said high-risk Stage II and Stage III MSS colon cancer affects an estimated 38,000 patients annually in the U.S. and more than 200,000 patients worldwide. The company estimates the U.S. annual addressable sales opportunity at more than $7 billion.
The company is prioritizing this program based on emerging Phase 2 data from NEST and UNICORN, two independent studies evaluating neoadjuvant BOT+BAL in MSS colorectal cancer. Across the studies, Agenus said BOT+BAL produced pathologic responses in approximately 60% to 70% of patients, major pathologic responses in approximately 35% to 40% of patients, and pathologic complete responses in approximately 30% of patients.
Agenus also said that, with a median follow-up of approximately 9 to 18 months, all treated patients remained disease-free. The company cited deep pathologic responses and circulating tumor DNA clearance during treatment as supporting the rationale for prioritizing neoadjuvant BOT+BAL development in ROBBIN.
ROBBIN is planned as a randomized global Phase 3 trial evaluating neoadjuvant BOT+BAL followed by standard of care versus standard of care alone in previously untreated high-risk Stage II and Stage III MSS colon cancer. The trial is expected to enroll 850 patients, randomized 1:1, with event-free survival as the primary endpoint.
Following interactions with the FDA, Agenus said it has aligned with the agency on key elements of the Phase 3 design, including the patient population, experimental regimen, control arm, primary endpoint, and interim analysis plan.
Upcoming ROBBIN milestones include first patient dosing anticipated in the first quarter of 2027, interim pathologic response data expected in the second half of 2027, interim event-free survival analysis expected in the second half of 2029, and final event-free survival analysis expected in the second half of 2030.
As part of the strategic prioritization, Agenus plans to discontinue financial support for the ongoing BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer. The company said it will honor obligations to patients currently receiving treatment and work with the Canadian Cancer Trials Group and investigators to manage the transition.
Under the financing terms, Agenus will issue 23,035,227 shares of common stock, or pre-funded warrants in lieu of shares, along with Series A and Series B purchase warrants. The Series A warrants cover 21,144,277 shares at an exercise price of $4.02 per share, while the Series B warrants cover 33,797,214 shares at an exercise price of $5.03 per share.
Agenus also agreed to expand its board to nine directors and appoint two individuals designated by Commodore Capital Master LP to newly created Class III directorships following designation.
Agenus is an immuno-oncology company headquartered in Lexington, Massachusetts. The company is developing cancer therapies through immunological agents and combination approaches, including botensilimab, an Fc-enhanced anti-CTLA-4 antibody, and balstilimab, a PD-1-blocking monoclonal antibody.
KEY QUOTES:
“We have seen neoadjuvant and perioperative immunotherapy improve outcomes in immunologically ‘hot’ or ‘warm’ tumors such as melanoma and lung cancer, but MSS colon cancer — a ‘cold’ tumor — has resisted standard checkpoint inhibitors. BOT was engineered to overcome that resistance and has produced deep pathologic responses with no recurrences reported in the NEST and UNICORN studies. With the ROBBIN trial, we are bringing this regimen to patients with high-risk Stage II and Stage III MSS colon cancer, where treating an intact tumor gives BOT+BAL its greatest opportunity to generate a durable immune response and improve long-term outcomes.”
Dr. Steven O’Day, Chief Medical Officer of Agenus
“Since Agenus was founded 32 years ago, our mission has been to harness the immune system to improve outcomes and, where possible, cure cancer. Our plan to prioritize neoadjuvant BOT+BAL in MSS colon cancer reflects both the strength of the emerging clinical evidence and the opportunity to bring this important combination regimen to patients where it may have the greatest impact. With ROBBIN, we are advancing a randomized global trial designed to confirm the rapid and deep activity observed across the NEST and UNICORN trials.”
Garo H. Armen, Ph.D., Founder, Chairman and Chief Executive Officer of Agenus
