Transgene’s Individualized Neoantigen Therapeutic Cancer Vaccine TG4050 Delivers Positive Randomized Phase I Data  Randomization to be Completed in Phase II Part in Q4 2025

Core Insights - Transgene reported positive Phase I data for TG4050, showing 100% disease-free survival after a median follow-up of 30 months in operable head and neck squamous cell carcinoma (HNSCC) patients [3][4][8] - The company is progressing into Phase II trials for TG4050, with initial patient screening completed and randomization expected by the end of 2025 [6][7] - Transgene's financial position is stable, with funding secured until the end of December 2026, allowing for continued development of its lead asset [22][23] Financial Performance - Operating income for the first half of 2025 was €4.6 million, an increase from €3.4 million in the same period of 2024 [20] - Research and development expenses rose to €17.9 million from €15.4 million year-over-year, while general and administrative expenses decreased to €3.8 million from €4.6 million [20] - As of June 30, 2025, Transgene had €16.8 million in cash, slightly up from €16.7 million at the end of 2024, with a cash burn of €18.8 million in the first half of 2025 [21] Clinical Development - TG4050 is the first candidate from Transgene's myvac® platform, which aims to provide individualized therapeutic cancer vaccines [4][26] - The company is preparing to initiate a new Phase I trial for a second indication, expanding the myvac® platform's potential [9] - Additional immunological data from the Phase I study will be presented in Q4 2025, with first immunogenicity data from the Phase II trial expected in H2 2026 [5][8] Governance and Leadership - Simone Steiner joined Transgene as Chief Technical Officer in April 2025, bringing expertise in CAR-T cell therapies to enhance the manufacturing of myvac®-based immunotherapies [16] - Emmanuelle Quilès was appointed as an independent Board member in July 2025, contributing 25 years of experience in the pharmaceutical industry [17] Other Assets and Collaborations - Transgene is also developing BT-001, an oncolytic virus, with updated data to be presented at ESMO 2025 [10][11] - The company is evaluating TG4001 for HPV-positive cancers and TG6050 for advanced non-small cell lung cancer, with ongoing assessments of their clinical development paths [13][14][15]