Interim report
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OSE IMMUNO THERAPEUTICS OSE Immunotherapeutics Announces H1 2021 Results and Provides a Corporate Update • Positive final Phase 3 results for TedopiⓇ in non - small cell lung cancer ( NSCLC ) after ICI failure . • Positive Phase 1 dose escalation results for BI 765063 ( CD47 / SIRPα pathway ) as monotherapy or in combination with ezabenlimab ( anti - PD - 1 ) in advanced solid tumor patients . • Initiation of two Phase 2 trials with OSE - 127 / S95011 in Sjögren's syndrome ( Servier sponsor ) and in ulcerative colitis ( OSE sponsor ) . • Initiation of two Phase 2 studies with TedopiⓇ in combination with ICI in NSCLC and in ovarian cancer in collaboration with oncology expert groups . • Global license agreement entered with Veloxis for FR104 in transplant indications for up to € 315 million . • Strong non - dilutive financing including € 11 million upfront / milestone payments and € 6.9 million public fundings . • € 9 million turnover and € 27.3 million available cash as of June 30 , 2021 providing financial visibility until Q3 2022 . • OSE Immunotherapeutics will hold a R & D Day with live webcast presentation on October 12th at 4:00 p.m. CET . • Conference call with live webcast today at 6:30 p.m. CET / 9:30 a.m. ET . Nantes , France , September 21 , 2021 - 6:00 PM CET - OSE Immunotherapeutics ( ISIN : FR0012127173 ; Mnémo : OSE ) today reported its consolidated half - year financial results as of June 30 , 2021 and provided updates on key milestones achieved during H1 2021 . Alexis Peyroles , CEO of OSE Immunotherapeutics , commented : " The first half of 2021 was marked by major clinical advances with promising data readouts on one hand and the initiation of new clinical trials on the other . We also secured additional non - dilutive financial resources to continue investing in our R & D drug discovery engine which has continued to identify novel therapeutics for patients with high medical need in immuno - oncology and autoimmune indications . The positive final results of the Tedopi® Phase 3 trial in non - small cell lung cancer patients in secondary resistance to ICIs presented at the recent ESMO conference include promising clinical benefit and good safety profile , and will support our discussions with the FDA and EMA on the best regulatory paths and next steps toward a potential approval . In parallel , the scope of Tedopi® is being broadened through two sponsored studies , one in combination with a PD - 1 inhibitor in NSCLC for patients in secondary resistance to checkpoints inhibitors and another in ovarian cancer .