Agenus announced early Phase 2 results from the mismatch repair-deficient colon cancer cohort of NEOASIS. NEOASIS is evaluating botensilimab, Agenus' multifunctional, Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab, Agenus' anti-PD-1 antibody, given before surgery in patients with solid tumors. The results were presented in a poster at the European Society for Medical Oncology, ESMO, Congress 2026 in Madrid, Spain. The cohort met its primary endpoint, with 83% of 18 patients achieving a major pathologic response, defined as 10% or less viable tumor remaining at surgery, and 72% achieving a pathologic complete response, with no cancer remaining in the tumor or nearby lymph nodes. These results were achieved in patients at the highest risk of their cancer returning. All patients had locally advanced colon cancer, and 100% of tumors were at least T3. Two-thirds were T4 tumors that had grown through the bowel wall. Nearly three-quarters had cancer that had spread to nearby lymph nodes. Treatment was a short 6-week course of immunotherapy alone with one 50 mg dose of BOT and two 450 mg doses of BAL, given three weeks apart, followed by surgery within eight weeks.

10/8 08:00

Agenus Receives Armenian Approval for BOT and BAL Combination Therapy

Agenus announced that the Ministry of Health of the Republic of Armenia has granted marketing authorizations for Botvymo, BOT, and Evamplix, BAL, each approved for use in combination with the other for the treatment of adult patients with microsatellite stable, MSS, metastatic colorectal cancer, mCRC, without active liver metastases who have previously received available standard therapies. These are the first marketing authorizations for either medicine anywhere in the world. The approvals are expected to benefit patients in Armenia as well as patients who travel to Armenia for treatment under the care of Armenian oncologists. "Armenia is the first country in the world to grant marketing approval for BOT+BAL," said Garo H. Armen, PhD, Chairman and Chief Executive Officer of Agenus. "The evidence behind this decision has been published in peer-reviewed journals and presented at major cancer conferences, and it has consistently pointed to clinical benefit for patients with metastatic colorectal cancer."

9/11 17:00

Selling Stockholders Offer 221,525 Shares of Common Stock

This filing relates to the offer and sale from time to time by the selling stockholders of up to 221,525 shares of common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.

8/26 10:30

Agenus Publishes Updated Results from NEST Phase 2 Trial

Agenus announced the peer-reviewed publication of updated results from the investigator-sponsored Phase 2 NEST trial evaluating neoadjuvant botensilimab, Agenus' multifunctional, Fc-enhanced anti-CTLA-4 antibody, and balstilimab, Agenus' anti-PD-1 antibody, in patients with resectable colon cancer. The manuscript, titled "Neoadjuvant botensilimab/balstilimab for localized mismatch repair proficient and deficient colon cancer: Results of the NEST phase 2 clinical trial," was published in Clinical Cancer Research. Earlier findings from NEST were presented at the 2025 ASCO Gastrointestinal Cancers Symposium. The publication provides longer follow-up and a fuller peer-reviewed analysis of tumor responses, circulating tumor DNA dynamics, disease-free follow-up and immune changes in the tumor microenvironment. At the March 31, 2026 data cutoff, no colorectal cancer recurrences had been observed, with median follow-up of 32.2 months in NEST-1 and 23.5 months in NEST-2. Among 22 mismatch repair proficient/microsatellite stable tumors, 59% achieved a pathologic response, including 41% with a major pathologic response and 32% with a pathologic complete response. NEST was a single-center, open-label, single-arm Phase 2 study that enrolled 24 eligible patients with 26 resectable colorectal tumors, including 22 pMMR/MSS tumors and four dMMR/MSI-H tumors. The study evaluated two pre-surgical treatment intervals; approximately four weeks in NEST-1 and approximately eight weeks in NEST-2. Patients in both cohorts proceeded to planned surgical resection without treatment-related delays.

8/7 16:30

Agenus Files to Sell 77.98M Shares of Common Stock

Agenus files to sell 77.98M shares of common stock for holders

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