OSE Immunotherapeutics (OSE) Chardan's 10th Annual Healthcare Conference summary

Lusvertikimab development

• Phase II UC remission benefit was 12 points placebo-adjusted overall; biomarker-positive patients showed a 46-point benefit, while biomarker-negative patients showed none.

• Biomarker combines clinical, histological and transcriptomic parameters; it may identify 30%-40% of the global UC population and will be tested as a secondary endpoint.

• Management estimates ~100 additional patients are needed to confirm the biomarker; the next trial is expected to add ~50, with confirmation also planned in a UC Phase IIb/III trial.

• A 47-patient chronic pouchitis trial is planned, based on IL-7 receptor expression and similarities to UC; management cited no FDA-approved drug for the indication and has identified potential participants.

• A subcutaneous formulation is in preparation for clinical validation in June 2027; dermatology studies and combinations with anti-IL-23 agents or JAK inhibitors are also under investigation.

Tedopi development

• A positive Phase II trial in 106 second-line NSCLC patients showed doubled survival with Tedopi plus nivolumab and/or chemotherapy versus chemotherapy alone.

• The registrational Phase III trial spans the U.S. and Europe, targets 363 patients and had enrolled ~260; readout is expected in early 2028.

• The event-driven trial’s next futility analysis was postponed to early 2027 because deaths were fewer than anticipated; the first Phase III was in third-line NSCLC.

• Tedopi has been administered to more than 800 patients; current dosing includes four-hour monitoring to manage CRS, with less monitoring anticipated as experience grows.

• Combinations have shown more severe adverse effects than Tedopi alone, but management described them as manageable; increased side effects were observed with PD-L1 or chemotherapy combinations.

Financing and strategic priorities

• Historical partnerships with J&J, Boehringer Ingelheim, AbbVie and others generated more than $200 million; financing included rounds at the 2015 IPO and in 2021.

• June cash was EUR 11.1 million, and management described runway as extending only into the coming weeks or months; attracting investors, particularly in the U.S., is under consideration.

• Management is seeking institutional investors to support the next stage, which could eventually include a Nasdaq dual listing; it cited a EUR 50 million market capitalization and no institutional shareholders.

• U.S. investor outreach aims to raise financial-community visibility and take development programs to the next level.