LEXINGTON, Mass., August 6, 2026

Agenus Inc. reported its second-quarter 2026 financial results while outlining significant progress in advancing the Phase 3 ROBBIN clinical trial evaluating botensilimab (BOT) in combination with balstilimab (BAL) as a neoadjuvant treatment for high-risk Stage II and Stage III microsatellite-stable (MSS) colon cancer. Supported by a previously completed oversubscribed $85 million private placement, with the potential to generate an additional $255 million through milestone-based warrants, the company expects to initiate the global registrational Phase 3 study and dose its first patient during the first quarter of 2027. Agenus estimates the program targets nearly 38,000 newly diagnosed U.S. patients annually, representing a potential market opportunity exceeding $7 billion, while addressing a disease setting where no new curative-intent therapies have been approved for more than two decades.

Clinical Evidence Supports Phase 3 Development Strategy

The ROBBIN trial is built upon encouraging results from the previously completed NEST and UNICORN neoadjuvant studies, which demonstrated meaningful anti-tumor activity for the BOT+BAL combination in patients with Stage II and Stage III MSS colorectal cancer. Across 38 treated patients, approximately 30% achieved a pathologic complete response (pCR) with no viable tumor remaining at surgery, while around 40% achieved a major pathologic response (MPR) with minimal residual tumor. Importantly, no disease recurrences had been reported at the applicable data cutoffs. Additional long-term follow-up manuscripts are expected during the second half of 2026, while updated findings from a 123-patient Phase 1b metastatic MSS colorectal cancer study presented at ESMO Gastrointestinal Cancers Congress 2026 demonstrated a median overall survival of 21.2 months, 33% three-year overall survival, and 17% of patients remaining alive without ongoing systemic cancer therapy, further reinforcing the durability of the BOT+BAL immunotherapy combination.

Financing and Commercial Access Strengthen Development

The company’s recently completed financing provides approximately $85 million in upfront proceeds, with warrants capable of generating up to $255 million in additional capital, aligning future funding with key ROBBIN clinical milestones. Agenus stated the financing is expected to support trial initiation, regulatory activities, manufacturing, patient-access programs, and company operations through the third quarter of 2027, with potential funding extending through 2031 if warrants are fully exercised. During the second quarter, authorized patient-access programs continued expanding into additional countries, generating $6.4 million in pre-commercial BOT+BAL revenue, compared with $4.6 million during the previous quarter. These expanded access initiatives continue providing treatment opportunities for eligible patients while strengthening physician engagement and supporting broader clinical adoption ahead of future regulatory submissions.

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Financial Performance and Upcoming Clinical Milestones

For the second quarter of 2026, Agenus reported total revenue of $34.5 million, compared with $25.7 million during the same period in 2025. Revenue included $6.4 million from BOT+BAL patient-access programs and $28.1 million in non-cash royalty revenue. Operating income reached $11.3 million, while the company reported a net loss of $0.6 million, reflecting continued investment in its oncology pipeline. Agenus also announced strategic prioritization of the ROBBIN program, discontinuing future funding commitments for the BATTMAN Phase 3 study to focus resources on registrational development in early-stage colon cancer. Looking ahead, investors can expect long-term NEST and UNICORN follow-up data, investigator-sponsored BOT+BAL presentations at ESMO 2026, and the launch of the Phase 3 ROBBIN trial with first patient dosing anticipated during the first quarter of 2027, positioning BOT+BAL as a potential next-generation immunotherapy for curative-intent treatment of MSS colon cancer.

Source:Agenus, press release