Agenus to Present New Data at AACR-IO Exploring Systemic and Tumor Inflammation Biomarkers with BOT/BAL in Immunologically Cold TumorsFeb 9, 2026 1:00 PM Eastern Standard Time# Agenus to Present New Data at AACR-IO Exploring Systemic and Tumor Inflammation Biomarkers with BOT/BAL in Immunologically Cold TumorsShare---LEXINGTON, Mass.--([BUSINESS WIRE])-- [Agenus Inc]. (Nasdaq: AGEN), a leader in immuno-oncology, today announced that new translational and clinical biomarker analyses from its botensilimab (BO ...

Core Insights - The company is entering a pivotal year marked by significant progress in patient access, clinical development, and operational readiness [1] - The discussion will include forward-looking statements that are subject to risks and uncertainties [2] Company Developments - Recent collaboration with Zydus has been closed, which is expected to enhance operational capabilities for the company [3] - There is an expansion of France's reimbursed AAC program, particularly relevant for sarcomas, indicating a growing interest from physicians and patients [3] Leadership Engagement - The leadership team, including the Chief Medical Officer, Chief Medical Affairs Officer, and Chief Commercial Officer, will participate in a live Q&A session to address stakeholder inquiries [4]

Core Insights - The Anglo-Swiss mining and trading company reported an 11% decline in copper production for the previous year, indicating a significant drop in output [1] - However, the company experienced a notable recovery in the second half of 2025, with copper production nearly 50% higher compared to the first half of the year [1] Company Performance - Copper production decreased by 11% year-over-year, reflecting challenges faced by the company in maintaining output levels [1] - The second half of 2025 showed a strong rebound, with production levels almost 50% higher than the first half, suggesting potential for recovery and growth in the upcoming periods [1]

Summary of Agenus Stakeholder Webcast Company Overview - **Company**: Agenus - **Industry**: Biotechnology, specifically focused on immuno-oncology treatments Key Points and Arguments Collaboration with Zydus Lifesciences - Agenus has closed a collaboration with Zydus Lifesciences, enhancing operational capabilities and securing long-term US-based biologics manufacturing capacity [3][4] - The collaboration involves the sale of Agenus's Emeryville facility and equity at a premium, providing necessary capital for strategic execution [3][4] - Zydus Lifesciences, valued at $10 billion, lacked a US biologics manufacturing facility, making this partnership crucial for both companies [18][19] Patient Access and Regulatory Developments - France's reimbursed AAC program has expanded to include sarcoma and ovarian cancer, allowing eligible patients access to BOT/BAL with full government reimbursement [5][11] - The urgency for patient access is emphasized, as confirmatory trials can take a long time, and patients need immediate options [6][11] - The societal burden of colorectal cancer is increasing, with it now being the leading cause of cancer-related deaths in individuals under 50, highlighting the need for innovative treatments [9] Clinical Trials and Efficacy - The BATMAN trial, a global phase 3 study for MSS metastatic colorectal cancer, is set to launch soon, with high expectations for quick enrollment based on previous trial data [10][11] - Early data from phase 1 and 2 trials involving nearly 500 patients show promising efficacy for BOT/BAL, particularly in historically resistant cancers [10][11] - The combination of BOT and BAL is showing potential in treating sarcomas, which have limited treatment options and are often immune-cold tumors [49][50] Medical Affairs and Infrastructure - Agenus is scaling up its medical affairs capabilities to support growing interest from physicians and patients, ensuring responsible access to treatments [12][57] - The company is hiring medical scientific liaisons to facilitate communication between sites and manage compassionate access requests [70][71] - Real-world data from compassionate access programs will be crucial for regulatory submissions and understanding treatment efficacy in broader populations [72] Future Priorities - Key priorities for 2026 include expanding patient access, preparing for global regulatory filings, and advancing the BATMAN trial [11][36] - There is a strong commitment to meeting the moral responsibility of providing access to treatments for patients in need [36][75] Additional Important Content - The collaboration with Zydus is seen as a strategic move to ensure that scientific momentum is matched by operational execution, particularly in oncology where treatment options are limited [39] - The role of immunotherapy is expanding, with a shift away from traditional chemotherapy towards more innovative treatments like BOT/BAL [12][60] - The importance of capturing real-world data and ensuring patient safety and efficacy is emphasized as the company moves forward with its initiatives [72][74] This summary encapsulates the critical discussions and insights shared during the Agenus stakeholder webcast, highlighting the company's strategic direction, collaborations, and commitment to patient care in the evolving landscape of oncology.

Core Viewpoint - Agenus Inc. is set to host its first Stakeholder Webcast of 2026, focusing on the global momentum of its botensilimab and balstilimab (BOT+BAL) program as it enters the new year [1][2]. Group 1: Webcast Details - The webcast will take place on January 28, 2026, at 4:00 p.m. ET and will feature insights from Agenus leadership and an international oncology expert [1][2]. - The session will include a live Q&A, allowing stakeholders to submit questions in advance [3]. Group 2: Featured Topics and Speakers - Garo Armen, PhD, will discuss a recent strategic collaboration with Zydus Lifesciences, emphasizing its role in strengthening Agenus' global development and patient access programs for BOT+BAL [4]. - Professor Robin Jones will provide a clinical perspective on the expansion of France's Autorisation d'Accès Compassionnel (AAC) program to include sarcoma patients, highlighting the unmet medical needs in this area [5]. - José Iglesias, MD, will address the expansion of Agenus' global medical affairs organization and its support for authorized access pathways as the BOT+BAL program progresses through Phase 3 evaluation [6]. Group 3: Company Overview - Agenus is a leading immuno-oncology company with a comprehensive pipeline of immunological agents, founded in 1994 [8]. - The company aims to expand patient populations benefiting from cancer immunotherapy through various therapeutic approaches, including antibody therapeutics and adoptive cell therapies [8]. Group 4: Product Information - Botensilimab is designed to enhance anti-tumor immune responses and has shown clinical responses across nine metastatic, late-line cancers, with approximately 1,200 patients treated in clinical trials [10][11]. - Balstilimab is a fully human monoclonal antibody that blocks PD-1 and has been evaluated in over 900 patients, demonstrating clinical activity across several tumor types [12].

Core Viewpoint - Zydus Lifesciences is considering acquiring a majority stake in US-based Ardelyx Inc., with the deal estimated to be valued between $2.2 billion and $2.5 billion, indicating a strategic move towards global innovative medicine [1][2]. Company Overview - Ardelyx Inc. is a biopharmaceutical company focused on developing first-in-class small-molecule drugs for gastrointestinal and cardio-renal diseases, addressing significant unmet patient needs. As of January 20, its market capitalization was $1.7 billion, with reported revenue of $378 million in 2025, reflecting an 18% increase [3]. Funding and Financial Strategy - The acquisition is expected to be financed through a ₹5,000-crore equity raise via a qualified institutional placement (QIP) and internal cash accruals, showcasing Zydus's commitment to expanding its innovative medicine portfolio [2]. Recent Acquisitions and Expansion - Zydus has been actively expanding its global presence through smaller acquisitions, including two biologics contract development and manufacturing facilities in the US for $75 million, and a 100% stake in French medical devices maker Amplitude Surgical for approximately €300 million, enhancing its capabilities in biologics and medtech [5][6]. Focus Areas in MedTech - The company has identified cardiology, nephrology, and orthopedics as key focus areas in the MedTech space, aiming to leverage Amplitude's portfolio to provide innovative solutions for diverse patient needs [7]. Consumer Wellness Segment - Zydus Wellness, a subsidiary, completed its first overseas acquisition by purchasing UK-based Comfort Click for around £239 million, indicating a strategic move into the consumer wellness market [8]. Competitive Landscape - The potential acquisition of Ardelyx comes amid reports of rival Sun Pharmaceutical's interest in acquiring Organon for approximately $10 billion, highlighting the competitive dynamics within the pharmaceutical industry [9]. Innovation and Clinical Development - Zydus is advancing its in-house innovation, with positive results from a Phase 2(b)/3 clinical trial of saroglitazar magnesium for primary biliary cirrhosis, and plans to file a new drug application with the US FDA in FY26 [11][12]. Financial Performance - Zydus reported a strong Q2 FY26 performance, with revenue increasing by about 17% year-on-year to approximately ₹6,100 crore and net profit rising nearly 38% to around ₹1,260 crore, driven by improved performance in its India and US formulation businesses [13][14].

Core Insights - Zydus Lifesciences Limited has successfully closed multiple agreements with Agenus Inc., including an Asset Purchase Agreement, Share Purchase Agreement, and an exclusive Licensing Agreement, following necessary regulatory approvals [1] - The transaction establishes Zydus' advanced manufacturing capabilities in the global biologics contract development and manufacturing organization (CDMO) sector through a new subsidiary, Zylidac Bio LLC [2] Group 1: Strategic Importance - Zylidac Bio LLC will provide biological manufacturing sites offering CDMO services to biopharmaceutical companies globally, supporting the U.S. landscape for secure and high-quality supply chains for advanced therapies [3] - The collaboration enhances Agenus' immunotherapy pipeline and U.S.-based clinical development capabilities while allowing Zydus to leverage its global manufacturing and commercial infrastructure [3] Group 2: Regulatory and Market Context - The establishment of Zylidac Bio LLC aligns with the BIOSECURE Act, which restricts U.S. agencies from contracting with certain biotechnology companies, thus providing a compliant manufacturing option for global biopharmaceutical firms [3] - Zydus has secured exclusive rights to commercialize Agenus' lead immuno-oncology assets, Botensilimab and Balstilimab, in India and Sri Lanka, enhancing its market position [4] Group 3: Financial and Operational Developments - Zydus completed an equity investment in Agenus Inc. through its venture capital arm, Zynext Ventures, complementing its strategic partnership with Formycon for a Keytruda® biosimilar [5] - The localized supply chain established by Zylidac Bio LLC ensures agility and security for Zydus' expanding biosimilar and innovative product portfolio [5]

Core Viewpoint - Agenus Inc. has successfully closed a strategic collaboration with Zydus Lifesciences Ltd to enhance the development and commercialization of its immunotherapy combination program involving botensilimab and balstilimab [1] Group 1: Collaboration Details - The agreement aims to accelerate global development and potential commercialization of the BOT+BAL immunotherapy combination program [1] - The collaboration provides Agenus with strategic capital and long-term biologics manufacturing capacity [1]

Core Viewpoint - Agenus (AGEN) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which are a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [4]. Company Performance and Investor Sentiment - The upgrade for Agenus reflects an improvement in the company's underlying business, suggesting that investors may respond positively by driving the stock price higher [5]. - Over the past three months, the Zacks Consensus Estimate for Agenus has increased by 77.2%, indicating a significant upward revision in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - Agenus' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Core Insights - Agenus Inc. announced promising clinical results for botensilimab plus balstilimab (BOT+BAL) in treating platinum-refractory ovarian cancer, indicating significant clinical activity in a challenging patient population [1][2][3] Clinical Results - The BOT+BAL combination achieved a 23% overall response rate and a 31% clinical benefit rate, with a median duration of response of 9.7 months and a median overall survival of 14.8 months, with 75% of patients alive at 12 months [3][4] - The study involved 44 women with treatment-refractory ovarian cancer, with nearly 75% being platinum-resistant or platinum-refractory, demonstrating activity across various ovarian cancer subtypes [8] Unmet Medical Need - Ovarian cancer results in approximately 13,000 deaths annually in the U.S. and 200,000 globally, with poor outcomes for patients with platinum-resistant tumors, highlighting the urgent need for effective therapies [5] Safety Profile - The BOT+BAL combination exhibited a manageable safety profile, with common treatment-related adverse events including diarrhea/colitis (43%; 16% grade 3), fatigue, and nausea (36%), all effectively managed [8] Future Development - BOT+BAL is advancing through global clinical development for multiple tumor types, with access available through regulatory-authorized early access mechanisms in certain countries [9]