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 announced that over 90% of ulcerative colitis patients who responded to Lusvertikimab maintained symptomatic remission for an additional 24 weeks [2][4][15] - The open-label extension of the Phase 2 CoTikiS study demonstrated a significant improvement in remission rates, with 61% of previously non-responding participants achieving remission after further treatment [3][5][15] - Lusvertikimab showed a favorable safety profile throughout the study, with no increased rates of infection reported [4][15] Summary by Sections Study Findings - The Phase 2 CoTikiS study's open-label extension revealed that 89% of participants continued into the extension period, and 87% completed it [4][9] - Symptomatic remission rates improved across all dose groups during the extension period, indicating a deepening of treatment efficacy [5][9] - Participants receiving the 850 mg dose showed plateaued remission rates after Week 14, while those on the 450 mg dose continued to improve through Week 34 [9][15] Clinical Implications - The findings suggest Lusvertikimab's potential as a monotherapy for ulcerative colitis, addressing a significant unmet need in symptom management and patient quality of life [5][6] - The study results challenge the typical therapeutic ceiling, where only 25-30% of patients achieve and maintain remission with existing treatments [5][6] Future Development - The complete CoTikiS results bolster confidence in Lusvertikimab's novel mechanism of action and its potential application in other chronic autoimmune and inflammatory diseases [6][8] - The study supports the progression of Lusvertikimab's development towards a long-acting therapy aimed at treating underlying disease pathophysiology [6][8]