Agenus Stock Price, News & Analysis

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.

Agenus (Nasdaq: AGEN) announced three upcoming presentations at the 2025 ASCO Annual Meeting in Chicago (May 30 - June 3). The presentations include new translational data on botensilimab and balstilimab (BOT/BAL) in colorectal cancer and two trials-in-progress studies.

The first presentation focuses on T-cell dynamics monitoring in mismatch repair-proficient/microsatellite stable metastatic colorectal cancer. The other two presentations detail ongoing clinical studies of botensilimab-based combinations in advanced pancreatic cancer: one examining botensilimab with AGEN1423 (anti-CD73-TGFβ-trap bifunctional antibody), and another investigating a combination therapy including botensilimab, balstilimab, nab-paclitaxel, gemcitabine, cisplatin, chloroquine, and celecoxib.

Agenus (Nasdaq: AGEN) has announced two upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting in Chicago (April 25-30, 2025), highlighting their neoadjuvant immunotherapy program with botensilimab and balstilimab (BOT/BAL).

The presentations include:

• An oral presentation of initial results from the NEOASIS trial studying BOT/BAL in MMR proficient and deficient early-stage cancers, presented by Dr. Myriam Chalabi from Netherlands Cancer Institute on April 28, 2025
• A poster presentation featuring new data from the Phase 1 study of BOT/BAL in treatment-refractory hepatocellular carcinoma (HCC), presented by Dr. Anthony El-Khoueiry from USC Norris Comprehensive Cancer Center on April 29, 2025

These presentations build upon previous BOT/BAL data from two independent studies (UNICORN and NEST) in colorectal cancer presented earlier at ASCO-GI.

Agenus (NASDAQ: AGEN) has released findings from its national Colorectal Cancer in Focus survey, revealing critical gaps in current treatment options. The survey, conducted from October to December 2024, gathered insights from patients and healthcare providers (HCPs) about colorectal cancer (CRC) care.

Key findings show that over 50% of HCPs reported increased CRC diagnoses in adults under 50, with 82% of surveyed patients diagnosed before that age. An overwhelming 93% of HCPs believe current CRC treatments are insufficient. The survey highlighted that 61% of patients expressed interest in non-chemotherapy treatments, including immunotherapy, while 37% of HCPs identified immunotherapy as the most promising advancement in CRC treatment.

The study, conducted in partnership with the Colorectal Cancer Alliance and Fight Colorectal Cancer, emphasizes patients' prioritization of quality of life, with one-third citing minimal life impact as a top treatment priority. Most patients reported chemotherapy and radiation side effects as their most challenging aspect of treatment.