Agenus reports Q3 2026 results, first BOT+BAL marketing nods, ROBBIN Phase 3 on track
Armenia granted the first marketing authorizations for botensilimab and balstilimab as Agenus advances its global Phase 3 ROBBIN trial toward first patient enrollment in early 2027.
Agenus Inc. reported financial results for the quarter ended September 30, 2026 on November 5, 2026, alongside updates on its global randomized Phase 3 ROBBIN trial of botensilimab plus balstilimab given before surgery in patients with high-risk Stage II and Stage III microsatellite-stable colon cancer, and the company's characterization of Armenia's decision to grant the first marketing authorizations for BOT and BAL anywhere in the world as an important step in bringing treatment options to patients with advanced disease who need it today.1
The ROBBIN trial remains on schedule. Site qualification and startup activities are advancing toward first patient dosing expected in the first quarter of 2027, with the global, randomized registrational Phase 3 trial designed with FDA feedback to enroll roughly 850 patients and assess event-free survival as the main endpoint, alongside a planned interim pathologic response look at the first 100 enrolled patients in the fourth quarter of 2027.1
Two peer-reviewed neoadjuvant studies support the rationale. The NEST study, published in Clinical Cancer Research, found a 32% pathologic complete response rate in MSS tumors with no recurrences recorded at median follow-up of 32.2 months in NEST-1 and 23.5 months in NEST-2.1 The UNICORN study, published in Nature Medicine, reported a 29% pathologic complete response rate and a 36% major pathologic response rate in its MSS cohort, with no recurrences observed at 19.2 months median follow-up.1
Armenia's Ministry of Health authorized Botvymo (botensilimab) and Evamplix (balstilimab) for combination use in adults with microsatellite stable metastatic colorectal cancer without active liver metastases who had previously received standard therapies, marking the first marketing authorizations for either drug worldwide.1
On financing, Agenus held $86.9 million in cash, cash equivalents and short-term investments as of September 30, 2026, up from $18.7 million at June 30, 2026.1 Upfront proceeds from the company's July private placement are expected to fund ROBBIN initiation, regulatory work and operations through the third quarter of 2027, and if warrants are fully exercised, the financing could extend support through year-end 2031.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.