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Agenus Inc. develops immuno-oncology therapies for cancer, with recurring updates centered on botensilimab (BOT) and balstilimab (BAL), its CTLA-4/PD-1 immunotherapy combination. Company news regularly covers clinical data in solid tumors, including metastatic colorectal cancer, melanoma and gastroesophageal cancer, as well as translational biomarker work and combination approaches that use antibody therapeutics, adoptive cell therapy through MiNK Therapeutics and adjuvants.
Agenus updates also address regulatory-authorized access pathways for BOT+BAL, including France's AAC framework and paid named-patient programs where permitted, along with financial results, equity financing activity, commercial readiness, manufacturing collaborations and corporate governance developments.
Agenus (Nasdaq: AGEN) has entered a securities purchase agreement for an oversubscribed private placement providing approximately $85 million in upfront gross proceeds and up to an additional $255 million upon full exercise of Series A and Series B warrants, for total potential proceeds of $340 million. The financing, led by Commodore Capital with several specialist investors, is priced at a premium to the July 10, 2026 closing share price and is expected, assuming full warrant exercise, to fund completion of ROBBIN, a planned 850‑patient global Phase 3 trial of neoadjuvant botensilimab plus balstilimab (BOT+BAL) in high‑risk Stage II/III MSS colon cancer, and support operations through year‑end 2031.
Agenus is prioritizing neoadjuvant BOT+BAL based on Phase 2 NEST and UNICORN data showing pathologic response in ~60‑70% of patients and pathologic complete response in ~30%, and will discontinue financial support for the BATTMAN Phase 3 metastatic MSS colorectal cancer study.
Agenus (Nasdaq: AGEN) reported three-year Phase 1b data for botensilimab (BOT) + balstilimab (BAL) in 123 patients with refractory MSS metastatic colorectal cancer without active liver metastases.
Median overall survival was 21.2 months, with 33% three-year OS and 17% of patients alive and off systemic anticancer therapy. No new safety signals or treatment-related deaths were observed; 98% of immune-mediated diarrhea/colitis cases resolved. The BOT 1 mg/kg + BAL regimen showed lower diarrhea/colitis rates than 2 mg/kg and supports the ongoing randomized Phase 3 BATTMAN trial in MSS/pMMR metastatic colorectal cancer.
Agenus (Nasdaq: AGEN) will present three-year survival data from its Phase 1b C-800-01 BOT+BAL study in microsatellite-stable metastatic colorectal cancer without active liver metastases at ESMO GI 2026 in Munich.
The poster covers updated findings from the fully enrolled 123-patient cohort, including longer-term durability of response and overall survival, reflecting an additional year of follow-up beyond prior two-year data.
Agenus (NASDAQ: AGEN) announced its 2026 Annual Shareholders Meeting will be held virtually only on June 16, 2026, at 10:00 a.m. ET, with registration starting at 9:45 a.m. ET.
Shareholders of record as of April 22, 2026, can vote and access the meeting online.
Agenus (Nasdaq: AGEN) reported Phase 2 data for botensilimab (BOT) plus balstilimab (BAL) in advanced checkpoint-refractory cutaneous melanoma (36 patients) to be presented at ASCO 2026.
Median overall survival was 16.6 months, 2‑year survival 42%, and median duration of response was not reached, with 86% of responders in response at 12 months.
Agenus (Nasdaq: AGEN) reported retrospective ASCO 2026 data using Noetik’s AI TARIO-2 platform to analyze routine pretreatment H&E tumor images from 113 patients treated with botensilimab (BOT) plus balstilimab (BAL).
In refractory MSS metastatic colorectal cancer without active liver metastases, an AI-identified subgroup showed a 64% response rate to BOT+BAL versus 9% in the remaining cohort, and significantly better overall survival, with median OS not reached and a hazard ratio of 0.18. TARIO-2 outperformed benchmark pathology foundation models and may support future image-based biomarker strategies for BOT+BAL, subject to prospective validation.
Agenus (Nasdaq: AGEN) reported Phase 1b data for botensilimab + balstilimab in treatment-refractory hepatocellular carcinoma after prior immunotherapy, published in Liver Cancer. The 19-patient cohort included 47% with ALBI grade 2 liver function.
Among 18 efficacy-evaluable patients, the combination showed a 17% ORR (one complete, two partial responses), 50% 18-week CBR, median PFS of 4.4 months, and median OS of 12.3 months. Safety was described as manageable, with no treatment-related deaths and no grade 4 or higher immune-mediated adverse events.
Agenus (Nasdaq: AGEN) reported Q1 2026 results and key BOT+BAL milestones. Total revenue was $33.7M (vs $24.1M Q1 2025), with net income of $39.2M (vs $(26.4)M loss). Cash was $35.0M at March 31, 2026.
BOT+BAL advanced into Phase 3 BATTMAN enrollment, authorized access expanded globally, and the $91M Zydus collaboration closed, adding capital and U.S. manufacturing capacity. The SEC investigation concluded with no enforcement action, and a related securities class action was dismissed.
Agenus (Nasdaq: AGEN) will release its first quarter 2026 financial results before the market opens on May 11, 2026.
The company plans a June webcast tied to its Annual Meeting to review strategic priorities, upcoming data milestones, and progress across the global botensilimab (BOT) and balstilimab (BAL) development programs.
Agenus (NASDAQ: AGEN) will present four abstracts at the 2026 ASCO Annual Meeting (May 29–June 2, 2026) covering botensilimab (BOT) alone and with balstilimab (BAL) across advanced cutaneous melanoma, colorectal cancer, and translational biomarker research.
The program includes the first Phase 2 melanoma data presentation, an AI biomarker poster, and two colorectal cancer trial updates with scheduled poster times and presenters noted.