Transgene Announces Positive Phase I Data for TG4050 in Head and Neck Cancer

Strasbourg, France — September 16, 2025 — Leads & Copy — Transgene (Euronext Paris: TNG) has announced its financial results for the six-month period ended June 30, 2025, and provided an update on the myvac® platform, its lead asset TG4050, and upcoming plans. The biotech company, which designs and develops virus-based immunotherapies for the treatment of cancer, reported positive Phase I data with TG4050 in operable Head and Neck Squamous Cell Carcinoma (HNSCC), showing 100% disease-free survival after 2 years of follow-up. The data was presented at ASCO in June 2025.

Transgene will report additional immunological data at a scientific conference in Q4 2025. The Phase II part with TG4050 in operable HNSCC is ongoing, with patient screening completed and randomization expected in Q4 2025. First immunogenicity data is expected in H2 2026, and efficacy data expected in Q4 2027. The company is also preparing a new Phase I trial in an additional indication. Business is funded until the end of December 2026.

Dr. Alessandro Riva, MD, Chairman and CEO of Transgene, expressed pride in the Phase I trial results, noting the durable clinical benefit and robust immune responses observed. He said TG4050 continues to progress through Phase II and the company looks forward to sharing first data from his trial in 2026 and further immunological data from their Phase I study later this year.

Transgene is setting up a new Phase I trial in a second indication in an early treatment setting, with the aim to initiate it as soon as all conditions are met.

Updated data on Phase I/II trial evaluating BT-001 will be presented at ESMO 2025.

Simone Steiner joined Transgene as Chief Technical Officer and Emmanuelle Quilès as independent Board member.

Key financial elements include operating income of €4.6 million for the first six months of 2025 and cash of €16.8 million as of June 30, 2025. Transgene’s cash burn amounted to €18.8 million in the first half of 2025.

With a credit facility and the commitment of TSGH (Institut Mérieux), Transgene is now able to fund its business until the end of December 2026.

A conference call in English is scheduled today, September 16, 2025, at 6:00 p.m. CET (12:00 p.m. ET).

Contacts:
Media: Caroline Tosch, +33 (0)3 68 33 27 38, communication@transgene.fr
Investors & Analysts: Lucie Larguier, investorrelations@transgene.fr

Source: Transgene

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