NANTES, France, February 26, 2026 – 6pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced that the Independent Data Monitoring Committee (IDMC) has issued a second positive recommendation for the ongoing pivotal Phase 3 ARTEMIA trial evaluating Tedopi® in advanced non-small cell lung cancer (NSCLC). The IDMC advised that the study should continue as planned, with no protocol changes. In line with the predefined study oversight plan, the IDMC, composed of independent clinical ...

Core Insights - OSE Immunotherapeutics has selected chronic pouchitis and hidradenitis suppurativa as new clinical indications for lusvertikimab, aligning with its strategic plan for 2026-2028 to target high-value immune-mediated diseases [2][5] - The development of these indications is contingent on financing, with the first Phase 2 clinical trial expected to start in the second half of 2026 [2][15] Group 1: Indications and Rationale - Chronic pouchitis and hidradenitis suppurativa both show strong translational alignment with IL-7R biology, indicating a significant unmet medical need [3][9] - Chronic pouchitis affects approximately 70% of patients who undergo proctocolectomy for ulcerative colitis, with about 45,000 patients in the EU, North America, and Japan developing chronic pouchitis, highlighting a significant management challenge [6] - Hidradenitis suppurativa affects around 1% of the general population, equating to approximately 9.5 million individuals in the same regions, and is associated with a long diagnostic delay and severe quality of life impacts [7][9] Group 2: Development Strategy - The company aims to leverage the capital-efficient nature of chronic pouchitis as a rare disease opportunity while also pursuing the larger dermatology market for hidradenitis suppurativa [5][10] - The first Phase 2 clinical trial is designed to provide clear evidence of differentiated clinical efficacy and safety, supporting a fast, data-driven proof-of-concept strategy [10][11] - OSE plans to advance the ulcerative colitis indication alongside these new indications, developing a subcutaneous formulation of lusvertikimab to enhance its market potential [11]

Core Insights - OSE Immunotherapeutics has announced a new three-year strategic plan aimed at accelerating the development of its promising programs while ensuring financial discipline [1][3] - The plan focuses on creating multiple near-term catalysts and emphasizes the company's commitment to immunology innovation [1][3] Value Creation Opportunities - The strategy includes advancing one or two specialty indications and a subcutaneous formulation for Lusvertikimab, enhancing its value proposition and opening new business opportunities [3][4] - The company aims to complete the Tedopi Phase 3 trial in Non-Small Cell Lung Cancer (NSCLC) with limited additional financial resources, expecting a futility analysis in Q3 2026 and a full read-out in Q1 2028 [8] - Development of Lusvertikimab in one or two new rare/specialty indications is planned, utilizing the existing intravenous formulation to target diseases with high unmet medical needs [8] - A pivot to a subcutaneous formulation of Lusvertikimab for Ulcerative Colitis (UC) is underway, with the goal of partnering this asset once bioequivalence data is generated [8] - The company will maintain scientific leadership by leveraging its research engine to fuel innovation and optimize intellectual property management [8] Financial Strategy - OSE Immunotherapeutics aims to limit shareholder dilution while securing a reasonable cash runway through a mix of financing options, including equity and new debt [9] - The company currently has financial visibility until early Q4 2026, excluding additional financing or milestone payments from partnerships [9][10] - The strategic plan requires significantly less investment than the previously planned Phase 2b for Lusvertikimab IV in UC, although additional financial resources will still be necessary [9] Future Developments - The company is exploring new strategic partnerships for its proprietary assets and may receive milestone payments, such as a EUR 17.5 million payment from Boehringer Ingelheim related to a future acquisition [10] - Other proprietary assets will continue to advance in preclinical development at limited cost to maximize partnership opportunities [11]

Core Insights - OSE Immunotherapeutics has announced a strategic amendment to its partnership with AbbVie regarding the development of ABBV-230, a monoclonal antibody aimed at addressing chronic and severe inflammation [1][2] - The revised agreement allows OSE Immunotherapeutics to regain control over the early-stage development of ABBV-230, while AbbVie retains rights for future development and commercialization after Phase 1 [2][5] Summary by Sections Partnership Structure - OSE Immunotherapeutics will lead the preclinical and Phase 1 development of ABBV-230, utilizing its expertise in immunology [8] - AbbVie remains the exclusive licensee and will control development and commercialization post-Phase 1 [8] Financial Terms - Existing commercialization rights, including royalties on global net sales and sales-based milestone payments, remain unchanged [8] - OSE Immunotherapeutics will not receive the previously anticipated milestone payment for initiating the Phase 1 study but can earn milestone payments in later development stages if AbbVie advances the candidate [8] Product Development - ABBV-230 targets ChemR23, a dual-function receptor that plays a significant role in inflammation regulation and is being explored as a first-in-class therapy for inflammation resolution [4][5]

Core Insights - OSE Immunotherapeutics has announced a strategic amendment to its partnership with AbbVie regarding the development of ABBV-230, a monoclonal antibody aimed at addressing chronic and severe inflammation [1][2] - The amendment allows OSE Immunotherapeutics to regain control over the early-stage development of ABBV-230, while AbbVie retains rights for future development and commercialization after Phase 1 [2][5] Summary by Sections Partnership Agreement - The revised agreement reflects both companies' enthusiasm for ABBV-230 and aligns development responsibilities with their respective strengths [2] - OSE Immunotherapeutics will lead the preclinical and Phase 1 development of ABBV-230, leveraging its immunology expertise [7] Financial Terms - All existing commercialization rights, including royalties on global net sales and sales-based milestone payments, remain unchanged [7] - OSE Immunotherapeutics will not receive the previously anticipated milestone payment tied to the initiation of Phase 1 but will be eligible for milestone payments in subsequent development stages if AbbVie advances the candidate [7] Product Development - ChemR23, the dual-function receptor involved in inflammation, is central to the development of ABBV-230, which aims to be a first-in-class therapy for inflammation resolution [4]

Core Points - OSE Immunotherapeutics received a positive recommendation from the Independent Data Monitoring Committee (IDMC) to continue the Phase 3 ARTEMIA trial evaluating Tedopi® in non-small cell lung cancer (NSCLC) without modifications [1][3][4] - The ARTEMIA trial, launched in September 2024, aims to compare Tedopi® monotherapy to standard-of-care docetaxel in HLA-A2 positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors [3][4] - As of early October, 102 patients had been randomized in the trial, with recruitment expected to reach 120, aligning with enrollment projections for 2025 [3] - A second IDMC review is anticipated in Q1 2026, with completion of recruitment expected by the end of 2026 and primary endpoint readout for overall survival projected for Q1 2028 [4] Company Overview - OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing immunotherapies for cancer and autoimmune diseases [1][5] - The company collaborates with leading academic institutions and biopharmaceutical companies to develop transformative medicines for serious diseases [5] - OSE Immunotherapeutics is based in Nantes and Paris and is listed on Euronext [5]

Core Viewpoint - OSE Immunotherapeutics presents its innovative OSE-Cytomask® technology at the SITC 2025 Annual Meeting, which aims to enhance the therapeutic index of immunocytokines by enabling targeted cytokine activation in tumor-specific T cell populations [1][4]. Technology Overview - OSE-Cytomask® is a proprietary non-cleavable linker technology that allows for the creation of a new class of regulated and targeted cytokine therapeutics, addressing unmet needs in immunocytokine therapy [2][5]. - The technology keeps cytokines inactive until they reach the appropriate immune cells, specifically those expressing PD-1, thus minimizing unwanted activation in healthy tissues and reducing side effects [3][5]. Research and Development - The technology has been successfully tested with various antibodies and cytokines, including IL-15, IL-2, and IL-10, indicating its potential to enhance existing therapies and improve safety and effectiveness for patients with hard-to-treat solid tumors [5]. Company Background - OSE Immunotherapeutics is focused on developing first-in-class assets in immuno-oncology and immuno-inflammation, partnering with leading academic institutions and biopharmaceutical companies to bring transformative medicines to market [6].

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 Points - OSE Immunotherapeutics has appointed Marc Le Bozec as interim CEO following the termination of Nicolas Poirier's position [2][3] - The Board of Directors is conducting a formal search for a new permanent CEO while empowering Le Bozec to lead a strategic evaluation of the company's business [3][5] - Nicolas Poirier will continue as Chief Scientific Officer, and no compensation will be paid for his termination as CEO [4] Company Strategy - The focus of the strategic evaluation will be on maximizing value across partnerships, finances, and clinical development programs [3] - The Board aims to realign the company's strategy and accelerate progress during this transition [5] - Marc Le Bozec emphasized the importance of reassuring teams and maintaining a focus on therapeutic innovation [6] Leadership Background - Marc Le Bozec has extensive experience in the biotech sector, having created and managed two biotech investment funds and previously served as CFO of Cellectis [7][8] - His background includes raising €120 million for Cellectis and preparing the company for its Nasdaq listing [8] - Le Bozec's career began in organizational and strategy consulting before founding his first biotech company in 1998 [9] Company Overview - OSE Immunotherapeutics is dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation [10] - The company collaborates with leading academic institutions and biopharmaceutical companies to bring transformative medicines to market [10]

Core Points - OSE Immunotherapeutics held its Annual General Meeting, where shareholders representing approximately 56% of the share capital and over 62% of voting rights participated in key decisions for the company's future [1] - Dr. Markus Cappel was elected as the new Chairman of the Board of Directors, expressing enthusiasm for advancing the company's promising pipeline and novel medicines [3] - The company has a strong pipeline of innovative drug candidates and has achieved positive clinical trial results, positioning it as a significant player in the immunotherapy landscape [4] Board of Directors - The shareholders voted in favor of appointing new directors, including Dr. Markus Cappel and Alexis Peyroles [2] - The new Board of Directors held its first meeting post-election and confirmed its confidence in the employees' commitment to developing novel medicines [5] Dr. Markus Cappel's Background - Dr. Markus Cappel has over thirty years of experience in the biotechnology sector and is recognized for his entrepreneurial spirit and achievements [6] - As Chief Business Officer of ChemoCentryx, he led product development and negotiations that secured commercial rights and development control in the U.S. [7] - He played a key role in ChemoCentryx's acquisition by Amgen for $4 billion, which represented a 116% premium [8] Company Overview - OSE Immunotherapeutics is dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation, addressing unmet patient needs [11] - The company collaborates with leading academic institutions and biopharmaceutical companies to bring transformative medicines to market [11]