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]

Company Overview - Agenus (AGEN) shares increased by 19.3% to $7.06 in the last trading session, with a notable trading volume, and have gained 22.8% over the past four weeks [1][2] Clinical Data - The company announced positive clinical results for its combination therapy of botensilimab and balstilimab (BOT/BAL) in patients with microsatellite-stable metastatic colorectal cancer, showing a two-year survival rate of 42% in an expanded cohort of 123 patients, with a median overall survival of 21 months [2] Financial Expectations - Agenus is projected to report a quarterly loss of $0.78 per share, reflecting a year-over-year increase of 69.1%, with expected revenues of $25.03 million, up 6.5% from the previous year [3] - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Agenus is part of the Zacks Medical - Biomedical and Genetics industry, where Illumina (ILMN) closed 0.8% lower at $99.25, having returned 13.5% in the past month [5] - Illumina's consensus EPS estimate for its upcoming report is $1.02, representing a year-over-year change of 183.3%, and it currently holds a Zacks Rank of 3 (Hold) [6]

Core Insights - The focus on steady earnings growth is essential for assessing a company's profitability, but rapid earnings growth can significantly drive stock prices higher [1] - Research indicates that stocks with accelerating earnings often see their prices increase subsequently [1] Earnings Acceleration - Earnings acceleration refers to the incremental growth in a company's earnings per share (EPS), characterized by an increase in quarter-over-quarter earnings growth rates [3] - This metric helps identify stocks that have not yet attracted investor attention, potentially leading to a price rally once recognized [4] 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 [6][7][8] - 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 [8] Identified Stocks - The screening narrowed down to three stocks: Yext, Agenus, and NCR Voyix, all showing strong earnings acceleration [9] - NCR Voyix leads with an expected EPS growth rate of 152.7%, followed by Agenus at 114.7% and Yext at 37.1% for the current year [9] Company Profiles - **Yext**: Provides a platform for consumer inquiries globally, with an expected earnings growth rate of 37.1% [10] - **Agenus**: A biotechnology firm focused on developing immune therapies for cancer and infections, with an expected earnings growth rate of 114.7% [11] - **NCR Voyix**: Offers digital commerce solutions for retail and dining, with an expected earnings growth rate of 152.7% [12]

Group 1 - CVS Health is part of the Medical group, which consists of 996 companies and is currently ranked 7 in the Zacks Sector Rank [2] - CVS Health has a Zacks Rank of 2 (Buy), indicating a positive outlook based on earnings estimates and revisions [3] - The Zacks Consensus Estimate for CVS' full-year earnings has increased by 4% in the past quarter, reflecting improved analyst sentiment [3] Group 2 - CVS Health has gained approximately 51.8% year-to-date, significantly outperforming the average loss of 3.9% in the Medical sector [4] - Another outperforming stock in the Medical sector is Agenus, which has returned 79.2% year-to-date [4] - CVS Health belongs to the Medical Services industry, which has gained an average of 0.3% this year, indicating better performance compared to the industry average [5] Group 3 - Investors interested in the Medical sector should monitor CVS Health and Agenus for their strong performance [6]

Technical Analysis - Agenus Inc. (AGEN) has recently experienced a "golden cross" event, indicating a potential bullish breakout as its 50-day simple moving average has crossed above its 200-day simple moving average [1][2] - A golden cross is characterized by a short-term moving average surpassing a long-term moving average, typically the 50-day and 200-day, which suggests stronger breakout potential [2] Stock Performance - AGEN has rallied 22.1% over the past four weeks, suggesting positive momentum and potential for further gains [4] - The company currently holds a 2 (Buy) rating on the Zacks Rank, indicating favorable market sentiment [4] Earnings Outlook - Positive earnings outlook for AGEN is supported by recent revisions, with no earnings estimates decreasing in the past two months and two revisions higher, leading to an increase in the Zacks Consensus Estimate [4] - Investors are encouraged to monitor AGEN for potential gains due to its key technical levels and positive earnings estimate revisions [6]

Core Insights - Zydus Lifesciences Ltd. is entering the global biologics CDMO business by acquiring Agenus Inc.'s biologics CMC facilities in the U.S., marking a strategic investment in U.S.-based biologics manufacturing [1][2] - The acquisition includes two manufacturing facilities in California for an upfront payment of $75 million and a contingent payment of $50 million based on revenue milestones [2] - Zydus will become the exclusive contract manufacturer for Agenus, providing services for two Phase-3-ready immuno-oncology products, Botensilimab (BOT) and Balstilimab (BAL) [4] Financial Details - The total upfront consideration for the acquisition is $75 million, with an additional contingent payment of $50 million over three years [2] - Agenus aims to reduce its annualized operating cash burn below $50 million starting in the second half of 2025, supported by cost optimization measures [6] - Agenus ended Q1 2025 with a consolidated cash balance of $18.5 million, indicating sufficient funding to advance BOT/BAL through a Phase 3 trial expected to start in the second half of 2025 [7] Market Potential - HC Wainwright analyst estimates that BOT/BAL could receive U.S. and EU approval in 2028 and 2029, respectively, with peak market penetrations of 30% in the U.S. by 2034 and 15% in the EU by 2035 [8] - Peak sales for BOT/BAL in third-line MSS-CRC are estimated to be approximately $929 million by 2038 [8] Strategic Implications - The acquisition provides Zydus with immediate access to advanced biologics manufacturing capabilities and establishes a key presence in California [3] - Zydus intends to expand its team as part of the transaction, indicating a commitment to enhancing its operational capacity [4]