TMCnet News
OSE Immunotherapeutics Reports its Cash Position as of June 30, 2026, and Provides Business Update
“On the operational front, enrolment of Tedopi’s Phase 3 trial ARTEMIA in non-small cell lung cancer is on track. The interim futility analysis for ARTEMIA is event-driven. Deaths across the study have accrued more slowly than originally projected, and the analysis is now expected in early-2027, which is definitely interesting. In parallel, the subcutaneous formulation of lusvertikimab is moving as planned and results should be available by mid-2027 to support pursuing clinical development in ulcerative colitis. We are also very encouraged by our conversations with key opinion leaders to move rapidly into a Phase 2 trial with the current formulation in Chronic Pouchitis, a significant unmet need”, commented Marc Le Bozec, Chief Executive Officer of OSE Immunotherapeutics. “We have been actively engaging with institutional investors in the United States and in Europe for the past few months, helped by a flexible bridge financing in May, and are confident that the strength of our pipeline provides a solid foundation as we work to secure the financing needed to reach key value inflection points.” Cash Position as of June 30, 2026 As of June 30, 2026, OSE Immunotherapeutics’ cash position totalled €11.1 million, compared to €17.0 million as of March 31, 2026. The Company implemented a flexible bridge equity financing in May 2026 which, in addition to available cash, and based on its current plans, is estimated to be sufficient to fund its operations through December 2026. This cash runway does not include any potential future milestone payments from existing partnerships. This bridge financing was the first step of a global financing strategy aiming at securing OSE’s 3-year Strategic Plan and the Company continues to actively engage with institutional investors in the United States and in Europe in view to further extend its runway beyond 2026. In addition, the Company continues to evaluate several complementary options, including a potential new strategic partnership involving one of its proprietary assets, restructuring of its existing debt, and potential milestone payments from current partnerships. In the context of its ongoing financing efforts, the Company has deferred the publication of its half-year financial statements for 2026 and its Interim Financial Report to a later date. Pivotal Phase 3 clinical trial ARTEMIA of Tedopi® in second-line non-small cell lung cancer (NSCLC) Enrolment in the international pivotal Phase 3 clinical trial ARTEMI evaluating Tedopi® in 363 HLA-A2 positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors is on track for completion by end of December 2026, as planned. As per protocol, a futility analysis will be conducted independently by the statisticians of the Independent Data Monitoring Committee (IDMC). This analysis, performed when the trial reaches a predefined number of events, is based on an interim survival analysis and will remain blinded to the Sponsor, Regulatory Authorities, and all Investigators. Initial assumptions anticipated reaching the required and predefined number of deaths by Q3 2026. While enrolment of the study has progressed according to plan, the trial is showing a lower number of deaths than initially expected, and the Company now anticipates reaching the predefined number of death events by the end of 2026. Consequently, the futility analysis is now expected to take place early 2027. Other clinical trials evaluating Tedopi® in multiple indications TEDOVA in ovarian cancer In May 2026, the Company reported positive topline results from the TEDOVA/GINECO-OV244b/ENGOT-ov58 academic, international, Phase 2 trial sponsored by ARCAGY-GINECO and evaluating Tedopi®, with or without pembrolizumab, as a maintenance treatment in 185 patients with platinum-sensitive recurrent ovarian cancer (PSOC). The primary endpoint was progression-free survival (PFS) comparing Tedopi® combined with pembrolizumab and the best supportive care. It was met and results showed a statistically significant improvement in PFS for the combination of Tedopi® and pembrolizumab compared to best supportive care (median PFS: 4.1 months vs 2.8 months; HR=0.53; p<0.001). When comparing the two investigational arms, the addition of pembrolizumab to Tedopi® resulted in a 28% reduction in the risk of progression or death (HR=0.72, p=0.074). These results were presented by principal investigator Alexandra Leary, MD, PhD, at the ASCO 2026 Annual Meeting in May 2026 in Chicago, United States. Combi-TED in NSCLC Topline results from the Combi-TED Phase 2 international clinical trial sponsored by FoRT and evaluating Tedopi® in second-line treatment in combination with anti-PD1 or chemotherapy in 105 patients with metastatic NSCLC will be presented by principal investigator Federico Cappuzzo, MD, PhD, at the ESMO 2026 Annual Meeting on October 25, 2026, in Madrid, Spain. Subcutaneous formulation of lusvertikimab (IL-7R) in inflammatory bowel diseases (IBD) The subcutaneous formulation of lusvertikimab to be advanced in clinical development was selected and characterized earlier this year. The achieved concentration at 225mg per mL, based on previously evaluated intravenous efficacious doses in Phase 2 of 450mg and 850mg, is potentially compatible with the use of an autoinjector device. The application for authorization of a Phase I study in healthy volunteers is currently being prepared with a submission scheduled by the end of 2026, with results expected by mid-2027. ABOUT OSE IMMUNOTHERAPEUTICS Contacts OSE Immunotherapeutics: [email protected] FP2COM (Media Relations): Florence Portejoie: [email protected] I +33 6 07 768 283 Astr Partners (Investor Relations): Europe/UK: Guillaume Cabon: [email protected] I +33 6 95 06 92 06 United States: Brian korb: [email protected] I +1 917-653-5122 Forward-looking statements Attachment 
|
