Core Insights - Agenus Inc. has appointed José Iglesias, M.D. as Chief Medical Affairs Officer, effective November 10, 2025 [1] - Dr. Iglesias will oversee global medical affairs for botensilimab (BOT) and balstilimab (BAL) as they progress through Phase 3 evaluation [1] - The combination of BOT and BAL will be made available in selected countries through early-access mechanisms, including France's Autorisation d'Accès Compassionnel [1]

Financial Performance - Non-cash royalty revenue from GSK increased by $4.5 million to approximately $29.1 million for the three months ended September 30, 2025, compared to $24.7 million for the same period in 2024, due to increased net sales of GSK's vaccines containing the STIMULON QS-21 adjuvant [148]. - Non-cash royalty revenue related to GSK increased $2.5 million to approximately $77.5 million for the nine months ended September 30, 2025, from $75.0 million for the same period in 2024 [153]. - Cash and cash equivalents at September 30, 2025 were $3.5 million, with additional anticipated cash inflows of $91.0 million expected in the first quarter of 2026 [164]. Research and Development - Research and development expense decreased 43% to $23.6 million for the three months ended September 30, 2025, from $41.1 million for the same period in 2024 [149]. - Research and development expense decreased 41% to $71.8 million for the nine months ended September 30, 2025, from $121.8 million for the same period in 2024 [154]. - The company has a diverse pipeline supported by in-house capabilities, including cGMP manufacturing and clinical operations, to advance from target identification to clinical trials [131]. General and Administrative Expenses - General and administrative expenses decreased 37% to $10.9 million for the three months ended September 30, 2025, from $17.3 million for the same period in 2024 [150]. - General and administrative expenses decreased 17% to $42.1 million for the nine months ended September 30, 2025, from $50.9 million for the same period in 2024 [155]. Non-Operating Expenses - Non-operating expense increased to approximately $19.3 million for the three months ended September 30, 2025, from income of $19,000 for the same period in 2024 [151]. - Non-operating expense increased to approximately $19.6 million for the nine months ended September 30, 2025, from income of $6.1 million for the same period in 2024 [157]. Interest Expense - Interest expense, net decreased to approximately $13.2 million for the three months ended September 30, 2025, from $35.7 million for the same period in 2024 [152]. - Interest expense, net decreased to approximately $39.3 million for the nine months ended September 30, 2025, from $96.9 million for the same period in 2024 [158]. Collaborations and Agreements - The collaboration agreement with Incyte allows for potential milestone payments of up to $315 million plus royalties on future sales, although Incyte has terminated the OX40 program effective October 2023 [135]. - The license agreement with Merck includes potential milestone payments of up to $85 million for the ILT4 antibody, currently in a Phase 2 clinical trial [136]. - The company has entered into multiple collaborations, resulting in over a dozen antibody pre-clinical or clinical development programs with partners including BMS, Gilead, and Merck [134]. - The company received a non-refundable upfront payment of $200 million from BMS for the anti-TIGIT bispecific antibody program, AGEN1777, with additional milestones achieved in clinical trials [141]. - The company is eligible to receive approximately $49.4 million in potential development, regulatory, and commercial milestones from Merck after accounting for obligations under various agreements [143]. Strategic Initiatives - The company aims to expand its immuno-oncology portfolio through strategic partnerships and innovative therapies targeting CTLA-4 and PD-1 combined with novel immunomodulatory agents [131]. - The company launched SaponiQx in September 2021 to innovate in adjuvant discovery and vaccine design, focusing on saponin-based adjuvants [144]. Investment Policy - The investment policy aims to preserve principal, maintain liquidity for operating needs, and maximize yields [175]. - The investment policy prohibits investing in structured investment vehicles and asset-backed commercial paper [175]. - The company specifies credit quality standards for investments and limits credit exposure from any single issue, issuer, or type of investment [175]. - The company does not invest in derivative financial instruments, indicating no material market risk exposure from such instruments [175]. Interest Rate and Currency Exposure - There has been no material change to the company's interest rate exposure and approach toward interest rate and foreign currency exchange rate exposures [174].

Core Insights - Agenus reported quarterly earnings of $1.94 per share, missing the Zacks Consensus Estimate of $2.63 per share, compared to a loss of $3.17 per share a year ago, indicating an earnings surprise of -26.24% [1] - The company posted revenues of $30.2 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 71.95%, but showing an increase from year-ago revenues of $25.11 million [2] - Agenus shares have increased approximately 45.3% since the beginning of the year, outperforming the S&P 500's gain of 14.4% [3] Earnings Outlook - The future performance of Agenus stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][5] - The current consensus EPS estimate for the upcoming quarter is -$0.21 on revenues of $72.55 million, and for the current fiscal year, it is $0.61 on revenues of $229.95 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Agenus belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]

Financial Results - Agenus Inc. reported financial results for Q3 2025, ending September 30, 2025[6] - The company issued a press release detailing its financial performance on November 10, 2025[6] - Specific financial metrics and user data were not provided in the extracted content[6] - Future outlook and guidance were not mentioned in the available documents[6] Product and Market Information - Information regarding new products, technologies, market expansion, or acquisitions was not included in the content[6]

Core Insights - Agenus Inc. will release its third quarter 2025 financial results before the market opens on November 10, 2025 [1] - The company plans to host a stakeholder briefing webcast in late November to provide updates on corporate and clinical development [1] - Further details regarding the webcast will be announced in the coming weeks [1] Company Overview - Agenus is recognized as a leader in the field of immuno-oncology [1]

Core Insights - Agenus is focused on providing treatment options for cancer patients globally, emphasizing their commitment to oncology and immuno-oncology research [1] Group 1: Leadership and Expertise - The webcast features prominent figures in oncology, including Dr. Michael Gordon and Professor Alexander Eggermont, who will share insights on Agenus's immunotherapy combination, BOT/BAL [2][3] - Dr. Gordon will present pan-tumor data on the efficacy of BOT/BAL in treating refractory solid tumors, which was recently showcased at a major oncology congress [2] - Professor Eggermont will discuss the implications of BOT/BAL's inclusion in the French AAC program for colorectal cancer patients [3] Group 2: Engagement and Communication - Agenus leadership, including Dr. Steven O'Day, Dr. Richard Goldberg, and Robin Taylor, will participate in a live Q&A session to engage with stakeholders [3] - The company encourages audience interaction by inviting questions via email during the webcast [3]

Summary of Agenus Stakeholder Webcast Company Overview - **Company**: Agenus - **Focus**: Development of immunotherapy treatments for cancer patients globally Key Industry Insights - **Immuno-Oncology (IO) Landscape**: - Approximately 60% of cancer patients have access to approved IO therapies during their treatment journey, but only 11% achieve durable responses [9][10] - The need for novel treatments to extend benefits of IO to more patients is urgent, particularly for those with "cold" tumors that historically do not respond to existing therapies [9][10][12] Core Developments and Data - **Botensilimab and Balstilimab (bot/bal)**: - Studied in over 1,200 patients across more than nine tumor types, showing remarkable efficacy, especially in colorectal cancer [4][5][6] - Data presented at the European Society for Medical Oncology (ESMO) Congress indicated improved response rates when administered in earlier disease stages [5][6][15] - The combination has shown robust activity in traditionally cold tumors, with response rates and durability comparable to hot tumors [13][14][50] Regulatory and Market Developments - **French Approval**: - The French National Agency of Medicines and Health Product Safety granted compassionate access (AAC) for bot/bal in refractory metastatic microsatellite stable colorectal cancer, covering 100% of treatment costs for patients [17][22][57] - This approval is seen as a significant endorsement of bot/bal's efficacy and may influence other countries to adopt similar programs [25][28] Patient Access and Real-World Evidence - **Patient Access Programs**: - Agenus has initiated access programs in France, the U.S., and other regions to support patients with no viable treatment options [18][19] - The French AAC program will provide real-world evidence to support future full approval of bot/bal [21] Future Directions - **Clinical Trials**: - Ongoing studies in various cancer types, including plans for a neoadjuvant setting in colorectal cancer [55] - Anticipation of data from the phase 2 study and the Batman study in Canada, with enrollment expected to begin soon [32][47] Financial and Strategic Considerations - **Partnership with Zydus Lifesciences**: - Progressing towards closing a deal for manufacturing and market access in India and Sri Lanka, pending CFIUS review [34][36] Conclusion - The advancements in bot/bal and the regulatory support from France mark a pivotal moment for Agenus and the broader immuno-oncology field, with potential implications for patient care and treatment options globally. The company is committed to expanding access and gathering real-world evidence to further validate its therapies.

Core Insights - Agenus Inc. will host a virtual Stakeholder Briefing on October 21, 2025, focusing on updates regarding its immunotherapy combination botensilimab (BOT) and balstilimab (BAL) [1][3] - The briefing will feature insights from leading experts on recent clinical progress and expanding international access for BOT/BAL, moderated by Garo Armen, PhD, the company's CEO [1][3] Company Overview - Agenus is a leader in immuno-oncology with a comprehensive pipeline of immunological agents, founded in 1994 [4] - The company aims to expand patient populations benefiting from cancer immunotherapy through combination approaches, utilizing a variety of therapeutic methods [4] Product Information - Botensilimab (BOT) is designed to enhance anti-tumor immune responses and is effective in treating "cold" tumors that typically respond poorly to standard therapies [5][6] - Approximately 1,200 patients have been treated with BOT/BAL in phase 1 and phase 2 clinical trials, showing clinical responses across nine metastatic, late-line cancers [7] - Balstilimab (BAL) is a fully human monoclonal antibody that blocks PD-1 interactions, demonstrating clinical activity in over 900 patients [8]

Summary of the Conference Call Company Overview - The conference call features **Agenus**, discussing their lead asset **Botensilimab**, a next-generation Fc-enhanced CTLA-4 inhibitor [1][2]. Key Differentiation of Botensilimab - Botensilimab (BOT) has two-point mutations in the Fc region that enhance binding to antigen-presenting cells and myeloid cells, leading to a stronger immune response compared to the first-generation CTLA-4 inhibitor, ipilimumab [2]. - The design also includes a third-point mutation to reduce complement binding, resulting in a lower incidence of immune-mediated adverse events (AEs) such as hypophysitis, with rates below 1% compared to 5%-9% for ipilimumab [4]. Clinical Efficacy - Botensilimab shows efficacy in cold tumors, such as microsatellite stable metastatic colorectal cancer (MSS CRC) and pancreatic cancer, by increasing immune infiltration and depleting T-regs [3]. - In clinical trials, median overall survival for refractory colorectal cancer patients is around 20 months, with a response rate of approximately 20% and a 24-month survival rate of 42% [7][11]. Ongoing Studies and Development - Agenus has 35 active investigator-initiated studies across various cancer types, including CNS tumors, melanoma, and breast cancer [6]. - The **Batman trial** is a significant upcoming study with 834 patients, focusing on overall survival as the endpoint, comparing BOT-BELL to best supportive care [15]. Regulatory Feedback - The FDA provided positive feedback on the phase 3 design for the Batman trial, agreeing on the study parameters and the inclusion of both liver and non-liver metastasis patients [15][17]. Market Opportunity - The fourth-line treatment setting for colorectal cancer presents a substantial market opportunity, with an estimated patient population of about 10,000 in the U.S. [19]. - Discussions are ongoing for potential global partnerships for commercialization, with the capability to launch independently if necessary [19]. Future Plans - There are plans to explore earlier treatment settings for BOT-BELL in colorectal cancer, with ongoing studies showing promising early activity [20]. - Upcoming catalysts include the closing of a transaction with Zydus Lifesciences, expected to bring in $91 million, and the start of the Batman trial [22][24]. Financial Position - Agenus is anticipating additional funding through strategic transactions and has recently announced reimbursed access in France, which will provide supplemental income [22][23]. Upcoming Presentations - Four abstracts have been accepted for presentation at ESMO, highlighting the survival benefits observed in various tumor types [23].

Core Insights - The conference call will focus on the growing colorectal cancer crisis and emerging data from the BOT/BAL immunotherapy program [5] - The discussion will include perspectives from leading clinicians and address systemic regulatory challenges that delay access to life-extending treatments [5] Company Participants - Key executives from Agenus participating in the call include Garo H. Armen (Founder, Executive Chairman & CEO), Jennifer S. Buell (Director and President & CEO of MiNK Therapeutics), Richard M. Goldberg (Chief Development Officer), Stefanie Perna-Nacar (Chief Communications & Government Relations Officer), and Steven J. O'Day (Chief Medical Officer) [1][3] External Participants - The call will feature external thought leaders such as Dr. Nicholas DeVito (Assistant Professor of Medical Oncology, Duke University) and Dr. Chris O'Callaghan (Senior Investigator, Canadian Cancer Trials Group) [4]