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)

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 grew 15% year over year to $47.6 million, with adjusted EPS rising 14% to $1.6 per share, reflecting solid execution and continued operating leverage [32] - Royalty revenue increased 57% from the prior year to $36.4 million, underscoring the strength and momentum of partnered programs [32] - GAAP net income for the quarter was $4.8 million or $0.24 per diluted share, compared to a GAAP net loss of $51.9 million or $2.88 per share in the prior year period [38] Business Line Data and Key Metrics Changes - Key drivers of royalty revenue growth included strong performance from Varonis O2VARE, Trevyr's FILSPARI, Recordati's Carziva, and Merck's CapXiv and Vaxnuvanse [33] - Varonis reported a 45% sequential increase in Q2 2025 sales to $103 million, with expectations for continued strong launch trajectory [34] - FILSPARI showed strong commercial momentum, with Trevyr reporting Q2 sales in line with internal estimates, indicating robust year-over-year growth [34] Market Data and Key Metrics Changes - Merck's CapXiv generated $129 million in sales, a 21% sequential increase, while Vaxnuvanse generated $229 million in net sales, representing a 20% year-over-year increase [35] - Record ID reported sales of Carziva grew 12% in 2025, reaching €78.5 million, with Ligand earning a high teens royalty on Carziva sales [12] Company Strategy and Development Direction - The company aims to deliver profitable compounding growth by remaining disciplined in its investment approach and identifying high-quality assets that address significant unmet needs [21] - The strategic merger of Pylthos with Channel Therapeutics and a $40 million investment in Orchestra Biomed reflect the company's commitment to innovative therapies and expanding its portfolio [8][26] - The company is optimistic about the potential of its royalty assets, particularly with the expected blockbuster status of O2VARE by 2027 [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the strong launch trajectories of therapies and the potential for significant revenue growth from O2VARE and FILSPARI [44] - The company anticipates that Merck's acquisition of Verona will accelerate the launch of O2VARE, enhancing its market potential [76] - Management acknowledged the ongoing pricing pressure in the pharmaceutical industry but emphasized the importance of investing in high clinical value drugs to navigate this environment [63] Other Important Information - The company ended the quarter with $245 million in cash and investments, with approximately $450 million in deployable capital factoring in its undrawn credit facility [32] - The deconsolidation of Peltos effective July 1 will impact future financial reporting, with the estimated fair value of Ligand's stake in Peltos at approximately $100 million [41] Q&A Session Summary Question: Expectations for the Peltos launch - Management is optimistic about the launch of ZELSUMI, citing strong demand and a capable commercial team [47][48] Question: Impact of Vilsparri REMS removal on uptake - The removal of REMS restrictions is expected to enhance uptake, particularly among earlier stage patients [50][51] Question: Guidance on revenue and EPS growth - Management explained that operating expenses are being cautiously managed, and tax rates are impacting net income due to increased foreign revenue [56][57] Question: Merck's ownership of Verona and its impact on O2VARE - Management believes Merck's global capabilities will accelerate O2VARE's rollout compared to its previous management by Verona [76] Question: Orchestra Biomed's commercialization pathway - Medtronic and Tarumo are the commercial partners for Orchestra Biomed's AVIM technology and Virtu SAB balloon, respectively [77]

Financial Performance & Guidance - Q2 2025 royalty revenue increased by 57% compared to Q2 2024, driven by Ohtuvayre, Filspari, Qarziba, Capvaxive and Vaxneuvance[3, 26] - Q2 2025 adjusted EPS grew 14% to $1.60[3, 24, 25] - The company increased revenue guidance for 2025 from $180 million-$200 million to $200 million-$225 million, a 13% increase[3, 24, 33] - Adjusted EPS guidance for 2025 was raised from $6.00-$6.25 to $6.70-$7.00 per diluted share, a 12% increase[3, 24, 33] Portfolio & Investments - Ligand has approximately 50% equity interest in Pelthos and is entitled to a 13% royalty on Zelsuvmi sales[3, 6] - The company committed $35 million in long-term capital for royalty interest in Orchestra BioMed's AVIM therapy and Virtue SAB and invested $5 million in equity private placement[3, 20, 21] - Merck is set to acquire Verona for $10 billion, which will impact Ligand's 3% royalty on Ohtuvayre[3, 4, 8] Strategic Outlook - The company anticipates a long-term royalty revenue CAGR of greater than 22%[3, 27] - Ohtuvayre peak-sales consensus updated from $1.2 billion in December 2024 to $3.4 billion in August 2025[30] - Ligand has ~$450 million in deployable capital as of June 30, 2025[3, 24]

Core Insights - Ligand Pharmaceuticals reported a strong second quarter performance with total revenues of $47.6 million, a 15% increase from $41.5 million in the same period of 2024, driven by a 57% growth in royalty revenue [4][6] - The company has raised its full-year 2025 revenue guidance to $200 million - $225 million from a previous range of $180 million - $200 million, and adjusted earnings per diluted share guidance to $6.70 - $7.00 from $6.00 - $6.25 [12][13] Financial Performance - Royalty revenues for Q2 2025 were $36.4 million, up from $23.2 million in Q2 2024, primarily due to royalties from Recordati's Qarziba and Travere Therapeutics' Filspari [4][8] - Captisol sales increased to $8.3 million in Q2 2025 from $7.5 million in Q2 2024, while contract revenue and other income decreased to $2.9 million from $10.9 million due to timing of partner milestone events [4][5] - GAAP net income for Q2 2025 was $4.8 million, or $0.24 per diluted share, compared to a net loss of $51.9 million, or $2.88 per share, in Q2 2024 [6][11] Year-to-Date Results - For the six months ended June 30, 2025, total revenues were $93.0 million, a 28% increase from $72.5 million in the same period of 2024, with royalties reaching $63.9 million, up 51% from $42.3 million [8][11] - Adjusted net income for the six months ended June 30, 2025, was $58.6 million, or $2.94 per diluted share, compared to $47.6 million, or $2.61 per diluted share, for the same period in 2024 [11] Strategic Developments - Ligand announced the completion of its merger with Channel Therapeutics, forming Pelthos Therapeutics, which launched Zelsuvmi, the first FDA-approved at-home treatment for molluscum contagiosum [14][16] - The company earned a $5 million milestone payment from Pelthos following the launch of Zelsuvmi and is entitled to a 13% royalty on worldwide sales [17] - Ligand invested $25 million in Orchestra BioMed to fund late-stage cardiology programs, with potential additional funding of $15 million [18] Portfolio Updates - Merck's acquisition of Verona for approximately $10 billion is expected to accelerate the launch of Ohtuvayre, for which Ligand receives a 3% royalty on sales [19] - Agenus reported positive results for its BOT/BAL combination therapy, which may enhance Ligand's portfolio value through its partnerships [20] - Palvella Therapeutics announced full enrollment in a Phase 3 trial for Qtorin, with top-line results expected in early 2026 [21]