OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer NANTES, France, November 17, 2025 – 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage biotechnology company developing immunotherapies for cancer and autoimmune diseases, today announced that the Independent Data Monitoring Committee (IDMC) overseeing the Company’s internat ...

Core Viewpoint - OSE Immunotherapeutics reported a significant decline in financial performance for the first half of 2025, with revenues dropping from €69.0 million in H1 2024 to €1.3 million in H1 2025, primarily due to the deferred recognition of licensing income and a lack of exceptional income compared to the previous year [2][7][8]. Financial Performance - Revenues for H1 2025 were €1.3 million, a decrease of 98.1% from €69.0 million in H1 2024 [2]. - Operating income fell to €1.3 million in H1 2025 from €82.6 million in H1 2024, reflecting the deferred recognition of a portion of the AbbVie licensing agreement [2][7]. - The net loss for H1 2025 was €15.1 million, compared to a profit of €57.2 million in H1 2024 [8]. Expenses - Research and development expenses increased by 6.7% to €14.8 million in H1 2025 from €13.9 million in H1 2024, driven by ongoing development programs [3]. - General and administrative expenses rose by 5.0% to €4.5 million in H1 2025, primarily due to increased legal fees related to governance changes [4]. - Share-based payments expenses increased to €2.2 million in H1 2025 from €1.1 million in H1 2024, reflecting non-cash expenses under IFRS2 [5]. Cash Flow and Position - Net cash flows from operating activities were negative at €(19.2) million in H1 2025, a significant decline from €66.4 million in H1 2024 [9]. - Net cash flows from investment activities were positive at €30.4 million in H1 2025, compared to a negative €(54.9) million in H1 2024 [10]. - Cash and cash equivalents at the end of H1 2025 were €25.4 million, slightly down from €25.9 million in H1 2024, with total cash position decreasing to €41.6 million from €64.2 million [11]. Future Outlook - The company estimates its cash runway extends until the beginning of Q4 2026, factoring in potential warrant exercises but excluding future milestone payments [12]. - To extend its runway, the company is exploring options such as new strategic partnerships, equity financing, and restructuring existing debt [13]. - The interim financial statements were prepared on a going concern basis, indicating material uncertainty regarding the company's ability to continue operations without additional funding [14].

Core Viewpoint - OSE Immunotherapeutics and the FoRT Foundation have completed patient enrollment in the Combi-TED Phase 2 clinical trial, which evaluates the therapeutic cancer vaccine Tedopi® in combination with nivolumab or docetaxel for patients with Non-Small Cell Lung Cancer (NSCLC) [1][4][8] Group 1: Clinical Trial Details - The Combi-TED trial is an open-label, randomized, three-arm Phase 2 study involving 105 HLA-A2 positive patients with metastatic NSCLC who have not shown evidence of EGFR mutations or ALK or ROS1 rearrangement after first-line treatment [3][8] - The primary endpoint of the trial is the 1-year survival rate, with results expected in the second half of 2026 [3][8] - The trial is sponsored by the FoRT Foundation and conducted across sites in Italy, France, and Spain [2] Group 2: Expert Commentary - Dr. Federico Cappuzzo, Chief Investigator, expressed optimism about the trial's completion, highlighting the potential of Tedopi® to enhance the effectiveness of checkpoint inhibitors or chemotherapy [4] - Silvia Comis, Chief Clinical and Medical Research Officer, noted that the trial represents a significant step in evaluating innovative second-line treatment combinations for NSCLC [5] Group 3: Company Background - OSE Immunotherapeutics is focused on developing first-in-class therapies in immuno-oncology and immuno-inflammation, aiming to address unmet patient needs [6] - The company collaborates with leading academic institutions and biopharmaceutical companies to develop transformative medicines for serious diseases [6]

Core Insights - OSE Immunotherapeutics is committed to value creation through innovative therapies in immuno-oncology and immuno-inflammation, supported by a strong portfolio and balanced governance [1][3][6] Strategic Focus - The company aims to achieve significant clinical milestones in 2026, 2027, and 2028 for its two flagship programs, leveraging differentiated assets with robust clinical data [2][3] - Development plans include Phase 2b for Lusvertikimab and Phase 3 for Tedopi®, with an emphasis on maintaining momentum and engaging strategic partners [3][5] Governance and Shareholder Dynamics - A minority shareholder group proposes a return to a previous model focused on a single asset, Tedopi®, which the company views as risky and lacking a clear strategy for Lusvertikimab [4][6][7] - The company emphasizes the importance of its current governance structure and the risks associated with a complete board overhaul proposed by minority shareholders [7][8][9] Financial and Operational Outlook - The company is focused on ensuring business continuity and financing for Tedopi®'s Phase 3 trial while continuing the development of Lusvertikimab [5][13] - The current trajectory is aligned with industry standards and aims to preserve and maximize shareholder value through a balanced pipeline of assets [6][13]

Core Viewpoint - OSE Immunotherapeutics is reaffirming its strategic priorities and addressing shareholder concerns ahead of its Annual General Meeting (AGM) scheduled for September 30, 2025, amidst shareholder activism and misinformation campaigns [1][3][4] Company Strategy - The company aims to leverage its two main programs, Tedopi® and Lusvertikimab, through strategic partnerships and financing, positioning itself as a leading European biotech in immunotherapy for oncology and inflammation [2][5] - OSE's strategy focuses on maintaining strategic optionality for its lead assets while balancing near-term financing and value creation to avoid premature dilution of shareholder value [5][6] Shareholder Activism - OSE has faced significant shareholder activism, including a misinformation campaign by minority shareholders, which has created confusion ahead of the AGM [3][8] - The company has initiated legal actions to protect all shareholders and ensure a fair debate, as the activist group has allegedly acted against sound governance principles [8][10] AGM and Legal Proceedings - The AGM has been postponed to September 30, 2025, to ensure fair voting conditions based on accurate information regarding the intentions of the activist shareholders [9][11] - Legal proceedings have been initiated to investigate the actions of minority shareholders, with potential implications for their voting rights if irregularities are confirmed [10][11] Financial and Development Plans - Tedopi® is in a pivotal Phase 3 clinical trial for non-small cell lung cancer, with enrollment completion expected in the second half of 2026 and initial readouts anticipated by the end of 2027 [14] - Lusvertikimab's development includes a Phase 2b trial in ulcerative colitis, expected to start in 2026, with readouts in 2027 and 2028 [14] - The company has clarified that the expected cost for the Lusvertikimab trial is in the tens of millions of euros, significantly lower than misleading figures circulated by activist shareholders [14] Governance and Communication - OSE emphasizes its commitment to transparent governance and has published a Shareholder Q&A to counter misinformation and provide clear information on its strategy and financial trajectory [7][12] - The company is dedicated to maintaining open dialogue with shareholders and encourages them to review the Q&A document for accurate information [13]

Core Viewpoint - OSE Immunotherapeutics is evolving its governance structure to enhance shareholder representation and align with strategic priorities ahead of its Annual General Meeting scheduled for September 30, 2025 [2][4]. Governance Evolution - The new governance framework aims to ensure balanced representation, featuring a Board structure with two current independent members, two new independent directors, two seats for concertist shareholders (representing 20% of equity), one for the CEO, and one for employee shareholders [4][5]. - This restructuring is intended to reflect the diversity of the shareholder base and prepare the company for future strategic opportunities and challenges [4][5]. Strategic Focus - The company remains committed to maximizing the potential of its key therapeutic assets, Tedopi® and Lusvertikimab, through strategic partnerships and financing [5][6]. - OSE Immunotherapeutics is actively pursuing business development partnerships and financing opportunities to ensure both programs are adequately resourced [5][6]. Clinical Development Plans - The company is advancing Tedopi® into a pivotal phase 3 study for lung cancer, with plans to complete enrollment next year [6][7]. - Lusvertikimab will enter a focused phase 2b study to determine optimal dosing and validate its formulation, reflecting feedback from potential partners [6][7]. Annual General Meeting Details - The Annual General Meeting will take place on September 30, 2025, at 10:00 a.m. CET, with electronic voting available for shareholders [8][9]. - A shareholder webinar is scheduled for September 18, 2025, to present key updates and engage with shareholders [10].

Core Insights - OSE Immunotherapeutics provided clinical updates on its neo-epitope-based cancer vaccine Tedopi® for pancreatic cancer and non-small cell lung cancer (NSCLC) at the ASCO Annual Meeting, highlighting promising results in ongoing trials [2][3][8]. Company Overview - OSE Immunotherapeutics is a biotech company focused on developing innovative immuno-oncology and immuno-inflammation therapies to meet unmet patient needs [13]. - The company is based in Nantes and Paris and is listed on Euronext [13]. Clinical Trial Updates - The TEDOPaM trial, a Phase 2 study, demonstrated a 12-month overall survival (OS) rate of 65% in patients receiving Tedopi® combined with FOLFIRI chemotherapy, meeting its primary endpoint [6][14]. - The trial enrolled 107 patients, with a median follow-up of 21 months, and reported minimal toxicity associated with Tedopi® [6][14]. - Two complete responses were observed in the experimental arm, while no complete responses were noted in the control arm [14]. Pancreatic Cancer Insights - Pancreatic cancer is a highly aggressive disease, with a five-year survival rate of only 10% globally, and it is projected that new cases will increase by 95.4% by 2050 [10]. - Surgical resection is only feasible for 15-20% of patients at diagnosis, emphasizing the need for effective systemic therapies [11]. NSCLC Developments - The ARTEMIA Phase 3 trial is ongoing, aiming to evaluate Tedopi® as a second-line treatment for HLA-A2 positive NSCLC patients with secondary resistance to anti-PD-(L)1 immunotherapy [9]. - The trial is being conducted across 14 countries and aims to enroll 363 patients [9].