Agenus Reports Third Consecutive Quarter of Operating Income
Operating income was $11.4 million in the third quarter as cash rose to $86.9 million after an $85 million July placement.
Agenus Inc. (AGEN), an immuno-oncology company, reported operating income of $11.4 million for the third quarter ended September 30, 2026, the third consecutive quarter of positive operating income, compared with an operating loss of $4.6 million a year earlier.
Total revenue was $31.5 million, up from $30.2 million in the third quarter of 2025. The mix was still dominated by non-cash royalty revenue of $25.5 million, down from $28.1 million in the second quarter, while pre-commercial BOT+BAL product revenue was $6.0 million, compared with $6.4 million in the second quarter. Net income was $2.8 million.
Cash, cash equivalents and short-term investments were $86.9 million at September 30, compared with $18.7 million at June 30, after an oversubscribed July private placement that provided approximately $85 million in upfront gross proceeds. The company said the upfront proceeds are expected to support ROBBIN initiation, regulatory activities and operations through the third quarter of 2027. Milestone-aligned warrants could provide up to approximately $255 million in additional gross proceeds if fully exercised; assuming full exercise, the financing is expected to support the planned ROBBIN program and company operations through year-end 2031.
The quarter’s operating story was the build-out of ROBBIN, a global randomized Phase 3 trial of botensilimab plus balstilimab before surgery in high-risk Stage II and Stage III microsatellite-stable colon cancer. Investigator and site meetings in Madrid and São Paulo, site qualification and startup activities advanced toward first patient dosing anticipated in the first quarter of 2027. ROBBIN is designed with FDA feedback to enroll approximately 850 patients and will evaluate event-free survival as its primary endpoint, with an interim pathologic response assessment of the first 100 patients anticipated in the fourth quarter of 2027.
Peer-reviewed manuscripts from two independent Phase 2 studies of short-course BOT+BAL before surgery were published during the period. NEST, in Clinical Cancer Research, reported a 32% pathologic complete response rate in MSS tumors, with no observed colorectal cancer recurrences at median follow-up of 32.2 months in NEST-1 and 23.5 months in NEST-2. UNICORN, in Nature Medicine, reported a 29% pathologic complete response rate and 36% major pathologic response rate in its MSS cohort, with no observed recurrences at 19.2 months of median follow-up. The company said neoadjuvant BOT+BAL did not delay planned surgery in NEST and that 98% of patients in UNICORN underwent surgery on schedule, with no new safety concerns identified.
Chairman and Chief Executive Officer Garo H. Armen said the company had moved beyond planning ROBBIN to mobilizing investigators and activating sites, and that financing is aligned with key development milestones anticipated in 2027.
Shortly after quarter-end, Armenia’s Ministry of Health granted the first marketing authorizations for BOT and BAL anywhere in the world, each for use in combination in adult patients with MSS metastatic colorectal cancer without active liver metastases who have previously received available standard therapies. The authorizations are conditional and valid for one year, with renewal based on annual clinical updates. BOT+BAL remains investigational outside Armenia and is not approved by the U.S. Food and Drug Administration.
Pre-commercial product revenue from France’s AAC program and physician-initiated named-patient programs was $17.0 million for the first nine months of 2026. The company said those are non-promotional access programs and that recognized revenue can vary with country-specific pricing, reimbursement, taxation, distribution arrangements and timing.
Upcoming milestones include ROBBIN initiation and first patient enrollment in the first quarter of 2027, an anticipated 60 patients enrolled in the second quarter of 2027 as a Series A warrants milestone, and an anticipated interim pathologic response assessment in the second half of 2027 as a Series B warrants milestone.