Agenus Stock Price, News & Analysis

Zydus Lifesciences has announced its entry into the global biologics CDMO market through the acquisition of Agenus Inc.'s (NASDAQ: AGEN) U.S.-based biologics manufacturing facilities for $75 million upfront, plus $50 million in contingent payments. The deal includes two state-of-the-art facilities in Emeryville and Berkeley, California, establishing Zydus's presence in a major biotech hub. As part of the agreement, Zydus will become the exclusive manufacturer for Agenus's Phase-3 ready immunotherapy products Botensilimab and Balstilimab. The acquisition positions Zydus as a comprehensive biologics solution provider and aims to capitalize on the growing biologics CDMO market, which is projected to reach $84.9 billion by 2034, with a CAGR of 15.7% from 2025-2034.

Agenus (AGEN) has entered a strategic $141M collaboration with Zydus Lifesciences to advance their BOT/BAL immunotherapy program. The deal includes a $75M upfront payment for Agenus' biologics facilities in California, up to $50M in contingent payments, and a $16M equity investment at $7.50 per share. Zydus will launch a BioCDMO business using these facilities as U.S. flagship sites and become Agenus' first manufacturing customer. The agreement grants Zydus exclusive rights to develop and commercialize BOT/BAL in India and Sri Lanka, with Agenus receiving 5% royalties on net sales. This partnership aims to accelerate clinical development, scale manufacturing, and expand patient access to BOT/BAL cancer immunotherapy.

Agenus (AGEN) presented new translational data at ASCO 2025 demonstrating botensilimab's effectiveness in activating immune responses against microsatellite stable (MSS) colorectal cancer, which represents 85-95% of all colorectal cancers and is traditionally resistant to immunotherapy. The study shows that botensilimab-based therapy induces robust T cell immune responses within two weeks of treatment initiation. Key findings reveal that T-cells persist and expand across treatment cycles, correlating with improved clinical responses. The research, conducted in collaboration with Leuven University Hospitals, KU Leuven, and Omniscope, also found that blood-based immune markers can help identify patients most likely to respond to treatment, even before conventional imaging shows results.

Agenus (NASDAQ: AGEN) has announced it will present new data from its Phase 1 trial of botensilimab and balstilimab (BOT/BAL) combination therapy in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients at the ESMO Gastrointestinal Cancers Congress 2025. The expanded study now includes 123 patients, representing a 60% increase in patient enrollment, and will feature updated findings on clinical activity, durability of response, and both median and 2-year overall survival data.

The presentation, led by Dr. Benjamin Schlechter from Dana Farber Cancer Institute, will take place on July 4, 2025, at 3:30 PM CEST in Barcelona, Spain.

Agenus (NASDAQ: AGEN) reported Q1 2025 financial results and key updates on its botensilimab (BOT) and balstilimab (BAL) program. The company reported a net loss of $26.4 million ($1.03 per share) on revenue of $24.1 million. Cash position stood at $18.5 million, down from $40.4 million in December 2024. Key highlights include promising clinical data for BOT/BAL combination therapy in microsatellite stable (MSS) "cold tumors," with notable success in the NEOASIS study. The company achieved 100% pathological complete response in dMMR CRC patients at higher doses. Dr. Richard Goldberg joined as Chief Development Officer to advance the BOT/BAL program. Agenus plans to reduce its annual operating cash burn to below $50 million in H2 2025 and is finalizing a collaboration expected to provide substantial cash infusion. The company's cash used in operations decreased to $25.6 million from $38.2 million in the same period last year.

Agenus (NASDAQ: AGEN) has appointed Dr. Richard M. Goldberg as Chief Development Officer to lead the botensilimab/balstilimab (BOT/BAL) program development and regulatory strategy. Dr. Goldberg, an internationally recognized GI cancer expert with over 40 years of experience, joins Agenus after a distinguished career including leadership roles at West Virginia University Cancer Institute, Ohio State University's James Cancer Hospital, and North Carolina Cancer Hospital. His expertise is particularly relevant for advancing BOT/BAL, which shows promise for treating MSS colorectal cancer where immunotherapy benefits remain limited. Dr. Goldberg has authored over 430 peer-reviewed publications and received numerous accolades, including the ASCO Statesman Award. His appointment strengthens Agenus's position in developing innovative cancer treatments.

Agenus (Nasdaq: AGEN), a leading immunological cancer treatment developer, has scheduled its first quarter 2025 financial results announcement for Monday, May 12th, before market opening.

The company will host a conference call and webcast at 8:30 a.m. ET the same day, featuring company executives who will discuss quarterly results and provide a corporate update. Interested parties can access the event through:

• Conference call registration (Conference ID: 73242)
• Live webcast via the company's investor relations website
• Alternative webcast link through Q4's platform

A replay of the conference call will be made available through both the company website and Q4's platform for those unable to attend the live session.

Agenus presented promising results from their NEOASIS study at the AACR Annual Meeting, showcasing the effectiveness of their botensilimab and balstilimab (BOT/BAL) combination therapy in treating various solid tumors.

Key findings from the Phase 2 neoadjuvant study include:

• For dMMR/MSI-H tumors: 90% pathological response rate, 80% major pathological response, and 70% complete response
• For pMMR/MSS tumors: 80% pathological response rate, 70% major pathological response, and 20% complete response
• In triple-negative breast cancer patients, 63% achieved major pathological response

The study demonstrated that just two doses of BOT/BAL could induce significant responses across multiple cancer types, including triple-negative breast cancer. Importantly, no dose-limiting toxicities were observed, and all patients proceeded to surgery as scheduled. The treatment shows particular promise in early-stage cancers, including those typically resistant to immunotherapy.

Agenus (NASDAQ: AGEN) presented updated data from its Phase 1 study evaluating the combination of botensilimab (BOT) and balstilimab (BAL) in hepatocellular carcinoma (HCC) at the AACR Annual Meeting. The study focused on 19 heavily pretreated patients who had progressed after standard treatments, including immunotherapies.

Key results from the trial showed:

• Overall response rate: 17%
• Disease control rate: 72%
• Median progression-free survival: 4.4 months
• Median overall survival: 12.3 months

The BOT/BAL combination demonstrated durable responses in treatment-refractory HCC patients, including those who progressed on atezolizumab/bevacizumab. The safety profile remained consistent with previous cohorts and was manageable. The study results suggest potential clinical utility in treating advanced HCC patients who have options after progression on immune checkpoint inhibitors.