Emily Bodnar

Matthew Phipps

Mayank Mamtani

Colleen Hanley

Kelly Shi

Madeleine Stone

Madison Wynne El-Saadi

- Agenus's immunotherapy combination, **Botensilimab plus Balstilimab (BotBal)**, demonstrated **consistent efficacy data across various tumor types**, including "cold" tumors, in pan-tumor data presented at the Annual European Society for Medical Oncology (ESMO) Congress in Berlin.  **[0001098972_2194158_0]** **[0001098972_2194158_1]** **[0001098972_2194158_2]** 
- The **French National Agency of Medicines and Health Products Safety (ANSM)** granted **compassionate access (AAC) to BotBal** for patients with refractory metastatic microsatellite stable colorectal cancer, with **full reimbursement by the French government**.  **[0001098972_2194158_3]** **[0001098972_2194158_4]**  This marks the first country to validate its use in this context.  **[0001098972_2194158_3]** **[0001098972_2194158_4]** **[0001098972_2194158_5]** 
- A **Phase 3 BotBal study** in Canada, France, and Australia/New Zealand has received Canadian regulatory and IRB approvals, with the **first patient expected to be enrolled in November or December of this year**.  **[0001098972_2194158_8]** 
- The **partnership with Zydus Life Sciences** for BotBal in India and Sri Lanka is progressing, having achieved **Hart Scott Rodino clearance** and currently awaiting **CFIUS review**.  **[0001098972_2194158_7]**

Agenus Provides Update on BotBal Clinical Data, French Access Program, and Phase 3 Study

- Agenus's immunotherapy combination, **botensilimab plus balstilimab (bot/bal)**, demonstrated consistent efficacy across various tumor types, including those traditionally considered "cold" or resistant to immune response, with updated data presented at the ESMO Congress in Berlin.  **[0001098972_2194141_1]** **[0001098972_2194141_2]** **[0001098972_2194141_9]** 
- The **French National Agency of Medicines and Health Product Safety (ANSM)** granted compassionate access (AAC) to bot/bal for patients with **refractory metastatic microsatellite stable colorectal cancer**, with the French government fully reimbursing the treatment cost.  **[0001098972_2194141_3]** **[0001098972_2194141_4]** **[0001098972_2194141_5]** 
- The **Phase 3 Batman study** in Canada is anticipated to enroll its first patient in **November or December** of this year, having received approvals from Canadian authorities and Institutional Review Boards.  **[0001098972_2194141_8]** 
- The collaboration and partnership with **Zydus Lifesciences** is awaiting the final **CFIUS review** for closing, with other milestones already achieved.  **[0001098972_2194141_6]** **[0001098972_2194141_7]**

Agenus Provides Updates on Botensilimab/Balstilimab Development and French Market Access

- Agenus Inc. entered into a **Promissory Note Agreement** with Zydus Pharmaceuticals (USA) Inc. on **October 8, 2025**, for **up to $10,000,000** at an interest rate of **3.81% per annum**.  **[1098972_0001193125-25-235819_agen-20251008.htm:1]** 
- The Note's maturity is contingent upon the closing of an **Asset Purchase Agreement and Securities Purchase Agreement (APA/SPA)** signed on **June 3, 2025**, between Agenus and Zydus.  **[1098972_0001193125-25-235819_agen-20251008.htm:1]** 
- Proceeds from the Note are designated to fund **operational expenses for the Emeryville and Berkeley facilities for the fourth quarter of 2025** and to make payments related to assets under the APA.  **[1098972_0001193125-25-235819_agen-20251008.htm:1]** 
- A significant term of the Note is that the amount used for Q4 2025 operational expenses will be **forgiven and not repaid if the APA/SPA closes**.  **[1098972_0001193125-25-235819_agen-20251008.htm:1]** 
- As collateral for the Note, Agenus pledged **822,910 shares of common stock of MiNK Therapeutics, Inc.** owned by Agenus.  **[1098972_0001193125-25-235819_agen-20251008.htm:1]**

Agenus Inc. secures $10 million promissory note tied to Zydus M&A

- Agenus is developing its **BotVal** (Botanzilimab and Balstolimab) immunotherapy program for colorectal cancer (CRC), focusing on microsatellite stable (MSS) CRC, which accounts for **85-95%** of CRC cases.  **[1098972_tx_377953_4]** **[1098972_tx_377953_5]** 
- In a phase one study of **123** late-stage MSS CRC patients, **BotVal** demonstrated a **42% two-year survival rate** and a median overall survival of **21 months**, significantly exceeding the **10-14 months** from current standard of care.  **[1098972_tx_377953_5]** 
- A **Phase 3 Batman trial** for **BotVal** in late-line MSS CRC is commencing in collaboration with the Canadian Cancer Trials Group, with patient recruitment projected over **20-24 months**.  **[1098972_tx_377953_13]** **[1098972_tx_377953_21]** 
- Regulatory delays with the FDA, including a year-long insistence on a three-arm trial, impacted the timeline for the Phase 3 study.  **[1098972_tx_377953_21]**

AGENUS (AGEN)