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]

Summary of Agenus (AGEN) Update / Briefing August 27, 2025 Company Overview - **Company**: Agenus (AGEN) - **Focus**: Development of immunotherapies for cancer treatment, specifically targeting colorectal cancer Key Industry Insights - **Colorectal Cancer Crisis**: - Nearly 900,000 deaths annually worldwide, with projections indicating it could become the leading cancer killer in the U.S. for individuals aged 50 by 2030 [6][15] - Current treatments for metastatic patients provide only 6 to 11 months of survival [6] - The disease is increasingly affecting younger adults, including children, highlighting a significant unmet medical need [7][15] Core Points and Arguments - **Ineffectiveness of Current Treatments**: - Existing therapies are inadequate, with many patients suffering from severe side effects and limited survival [6][24] - The current healthcare system is criticized for bureaucratic delays that hinder access to potentially life-saving treatments [21][22] - **Agenus' Approach**: - Agenus aims to develop treatments that extend patient survival beyond the current standard of care, focusing on immunotherapy that avoids toxic chemotherapy [17][19] - The company has treated over 1,200 patients across various cancer types, showing promising results, particularly in earlier-stage patients [19][31] - **BotVal Immunotherapy**: - BotVal is a second-generation CTLA-4 targeting therapy designed for deeper immune activation with fewer side effects [31] - In a study of late-stage MSS colorectal cancer patients, a 42% two-year survival rate was observed, significantly higher than the 10-14 months typical with current treatments [32] - **Regulatory Challenges**: - The FDA's requirement for large phase three trials is seen as a barrier to rapid access for patients, despite strong efficacy signals from BotVal [36][38] - There is a call for regulatory reform to align with the pace of scientific advancements in immunotherapy [21][38] Additional Important Insights - **Patient-Centric Focus**: - The discussions emphasize the importance of prioritizing patient needs and experiences in the development of new therapies [4][5] - Anecdotal evidence from patients highlights the emotional and physical toll of current treatment paradigms [15][19] - **Collaborative Efforts**: - Agenus is working with various clinical trial groups, including the Canadian Cancer Trials Group, to expedite the development and approval of new therapies [76][80] - The enthusiasm from investigators and patients for innovative treatments is noted as a driving force behind trial recruitment [80][84] - **Future Directions**: - There is optimism about the potential for immunotherapy to transform treatment paradigms for colorectal cancer, particularly in early-stage settings [49][50] - The company is committed to exploring accelerated approval pathways to bring new therapies to market more quickly [86] This summary encapsulates the critical discussions and insights from the Agenus briefing, focusing on the urgent need for effective treatments for colorectal cancer and the innovative approaches being pursued by the company.

Core Viewpoint - Agenus reported a quarterly loss of $1 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.78, but an improvement from a loss of $2.52 per share a year ago [1] Financial Performance - The company posted revenues of $25.7 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 2.68% and showing an increase from $23.51 million in the same quarter last year [2] - Over the last four quarters, Agenus has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Performance - Agenus shares have increased approximately 75.2% since the beginning of the year, significantly outperforming the S&P 500's gain of 8.6% [3] Future Outlook - The company's earnings outlook will be crucial for determining the sustainability of its stock price movement, with current consensus EPS estimate for the coming quarter at -$0.20 on revenues of $24.97 million, and for the current fiscal year at $1.56 on revenues of $246.08 million [7] - The estimate revisions trend for Agenus was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Agenus belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, suggesting potential challenges ahead [8]

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section details Agenus Inc.'s unaudited condensed consolidated financial statements and management's analysis for Q2 2025 [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Presents Agenus Inc.'s unaudited condensed consolidated financial statements for Q2 2025, covering balance sheets, income, equity, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Details Agenus Inc.'s financial position at June 30, 2025, and December 31, 2024, including assets, liabilities, and equity Balance Sheet Highlights | Metric | June 30, 2025 (thousands) | December 31, 2024 (thousands) | Change (thousands) | | :----------------------------------- | :-------------------------- | :---------------------------- | :----------------- | | Cash and cash equivalents | $9,534 | $40,437 | $(30,903) | | Total current assets | $13,340 | $45,574 | $(32,234) | | Total assets | $185,221 | $226,271 | $(41,050) | | Total current liabilities | $234,563 | $221,401 | $13,162 | | Total stockholders' deficit | $(336,308) | $(306,424) | $(29,884) | - The company's total assets decreased by **-$41.05 million**, primarily driven by a significant reduction in cash and cash equivalents[10](index=10&type=chunk) - Total current liabilities increased by **$13.16 million**, while total stockholders' deficit worsened by **-$29.88 million**[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Summarizes Agenus Inc.'s financial performance for Q2 2025, detailing revenues, operating loss, and net loss Income Statement Highlights | Metric (thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $25,691 | $23,509 | $49,757 | $51,514 | | Operating loss | $(16,711) | $(30,193) | $(30,022) | $(63,076) | | Net loss | $(30,012) | $(54,797) | $(56,382) | $(118,251) | | Net loss attributable to Agenus Inc. common stockholders | $(28,009) | $(53,135) | $(53,329) | $(115,074) | | Basic and diluted net loss per share | $(1.00) | $(2.52) | $(2.03) | $(5.56) | - Total revenues for the three months ended June 30, 2025, increased by **$2.18 million** (**9.3%**) compared to the same period in 2024, primarily due to increased non-cash royalty revenue. However, for the six months, total revenues decreased by **-$1.76 million** (**3.4%**)[11](index=11&type=chunk) - The company significantly reduced its operating loss and net loss for both the three and six months ended June 30, 2025, compared to the prior year, driven by decreased operating expenses and interest expense[11](index=11&type=chunk) [Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Deficit](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Deficit) Outlines changes in Agenus Inc.'s convertible preferred stock and stockholders' deficit from December 31, 2024, to June 30, 2025 Stockholders' Deficit Changes | Metric (thousands) | December 31, 2024 | June 30, 2025 | | :----------------------------------- | :---------------- | :------------ | | Common Stock, Par Value | $236 | $300 | | Additional Paid-In Capital | $1,857,662 | $1,882,704 | | Accumulated Deficit | $(2,182,880) | $(2,236,101) | | Total Stockholders' Deficit | $(306,424) | $(336,308) | - The accumulated deficit increased by **$53.22 million** during the six months ended June 30, 2025, reflecting ongoing net losses[13](index=13&type=chunk) - Additional paid-in capital increased by **$25.04 million**, primarily due to shares sold at the market and share-based compensation[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Presents Agenus Inc.'s cash flow activities for the six months ended June 30, 2025, across operating, investing, and financing Cash Flow Summary | Cash Flow Activity (thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(45,840) | $(76,371) | | Net cash provided by (used in) investing activities | $338 | $(8) | | Net cash provided by financing activities | $14,536 | $93,913 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(30,903) | $17,578 | | Cash, cash equivalents and restricted cash, end of period | $13,168 | $97,357 | - Net cash used in operating activities decreased significantly by **$30.53 million**, from **-$76.37 million** in 2024 to **-$45.84 million** in 2025[17](index=17&type=chunk) - Net cash provided by financing activities decreased substantially from **$93.91 million** in 2024 to **$14.54 million** in 2025, primarily due to the absence of proceeds from the Ligand Purchase Agreement and private placement of subsidiary shares in 2025[17](index=17&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations for Agenus Inc.'s financial statements, covering business, liquidity, accounting policies, and other financial notes [Note A – Business, Liquidity and Basis of Presentation](index=9&type=section&id=Note%20A%20%E2%80%93%20Business%2C%20Liquidity%20and%20Basis%20of%20Presentation) Describes Agenus Inc.'s clinical-stage biotechnology focus, liquidity challenges, and going concern considerations - Agenus is a clinical-stage biotechnology company specializing in immuno-oncology, with a diverse pipeline including immune-modulatory antibodies (e.g., botensilimab, balstilimab), adoptive cell therapies (MiNK Therapeutics), and vaccine adjuvants (SaponiQx)[18](index=18&type=chunk)[23](index=23&type=chunk) - Cash and cash equivalents at June 30, 2025, were **$9.5 million**, a decrease of **-$30.9 million** from December 31, 2024[20](index=20&type=chunk) - The company anticipates receiving **$75.0 million** upfront and a **$16.0 million** equity investment from the Zydus Lifesciences Ltd agreements during Q3 2025[20](index=20&type=chunk) - As of June 30, 2025, Agenus had an accumulated deficit of **$2.2 billion**, leading to substantial doubt about its ability to continue as a going concern for one year after the 10-Q filing date[20](index=20&type=chunk)[22](index=22&type=chunk) - The company is actively seeking additional funding through out-licensing agreements, asset sales, project financing, and/or equity issuances to support operations and the planned launch strategy for botensilimab/balstilimab[22](index=22&type=chunk) [Note B – Net Loss Per Share](index=11&type=section&id=Note%20B%20%E2%80%93%20Net%20Loss%20Per%20Share) Explains basic and diluted net loss per share, noting anti-dilutive securities due to net loss Anti-Dilutive Securities | Anti-Dilutive Securities (thousands) | Three and Six Months Ended June 30, 2025 | Three and Six Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------------------- | :--------------------------------------- | | Warrants | 1,032 | 965 | | Stock options | 5,242 | 3,367 | | Non-vested shares | 1,313 |

[FORM 8-K CURRENT REPORT](index=1&type=section&id=FORM%208-K%20CURRENT%20REPORT) This current report provides essential administrative and financial disclosures, including operational results and exhibit details, as mandated by SEC regulations [Filing Information](index=1&type=section&id=Filing%20Information) This section details the registrant's administrative information, including company name, jurisdiction, and stock exchange listing - Registrant is **Agenus Inc.**, incorporated in Delaware[2](index=2&type=chunk) Registered Securities Information | Title of each class | Symbol(s) | Name of each exchange on which registered | | :------------------ | :-------- | :---------------------------------------- | | Common Stock, $0.01 par value per share | AGEN | The Nasdaq Global Market | - The registrant is not an emerging growth company[5](index=5&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) This section reports Agenus Inc.'s financial results for the quarter ended June 30, 2025, furnished via a press release - Agenus Inc. announced financial results for the quarter ended **June 30, 2025**, on **August 11, 2025**[6](index=6&type=chunk) - A press release, **Exhibit 99.1**, detailing financial results is furnished with this Form 8-K[6](index=6&type=chunk) - Information in Item 2.02 and Exhibit 99.1 is furnished, not filed, exempting it from Section 18 liabilities of the Securities Exchange Act of 1934[7](index=7&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section identifies the exhibits furnished with the Form 8-K, specifically Exhibit 99.1, the Press Release - **Exhibit 99.1** is the Press Release dated **August 11, 2025**[8](index=8&type=chunk) [Signatures](index=4&type=section&id=SIGNATURES) This section confirms the report's official signing by Christine M. Klaskin, VP, Finance, on August 11, 2025 - The report was signed on **August 11, 2025**[11](index=11&type=chunk) - Signed by **Christine M. Klaskin**, VP, Finance[11](index=11&type=chunk)

Core Insights - Top executives and analysts emphasize the importance of consistent earnings growth as a reflection of a company's profitability, with earnings acceleration having a more significant impact on stock prices [1][3] - Successful stocks typically experience a speed-up in earnings before their stock prices rise, indicating potential investment opportunities [1][3] Earnings Acceleration - Earnings acceleration refers to the incremental growth in a company's earnings per share (EPS), specifically when the quarter-over-quarter earnings growth rate increases over time [2] - This metric helps identify stocks that have not yet attracted investor attention, which can lead to a subsequent rally in share prices [3] Screening Parameters - The screening process involves identifying stocks where the last two quarter-over-quarter EPS growth rates exceed previous periods' growth rates, with projected EPS growth rates for the upcoming quarter expected to surpass prior periods [5][6] - Additional criteria include a current price of at least $5 and an average 20-day trading volume of 50,000 or more to ensure adequate liquidity [7] Highlighted Stocks - QuantumScape Corporation (QS) is focused on developing solid-state lithium-metal batteries for electric vehicles, with an expected earnings growth rate of 17% for the current year [9] - Civeo Corporation (CVEO) provides hospitality services for the natural resource industry, projecting an earnings growth rate of 69.8% for the current year [10] - Agenus Inc. (AGEN) is a clinical-stage biotechnology company developing cancer therapies, with a leading projected earnings growth rate of 114.7% for the current year [11]