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Transgene (TNG) investor relations material
Transgene H1 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H1 2025 earnings summary16 Sep, 2025
Executive summary
TG4050 achieved 100% disease-free survival at 2 years in Phase I for operable head and neck squamous cell carcinoma, with all endpoints met and durable immune responses, as presented at ASCO 2025.
Phase II trial for TG4050 is ongoing in HNSCC, with randomization to complete by Q4 2025 and first immunogenicity and efficacy data expected in H2 2026 and Q4 2027.
Manufacturing process optimization and leadership changes are underway to support scaling and parallel trials, with the MIVAC/myvac® platform and TG4050 as lead program.
Additional programs (BT-001, TG4001, TG650/TG6050) are under assessment, with BT-001 showing promising responses in melanoma and leiomyosarcoma, and TG650/TG6050 deprioritized or under review.
Company is focused on individualized neoantigen therapeutic vaccines for operable solid tumors, with expansion into new indications and combination trials in preparation.
Financial highlights
Operating income for H1 2025 was €4.6M, up from €3.3M in H1 2024, mainly due to higher Research Tax Credit; R&D expenses rose to €17.9M, and net loss widened to €19.3M.
Cash and current financial assets stood at €16.8M as of June 30, 2025, with net cash burn of €18.8M in H1 2025, down from €20.4M in H1 2024.
Business is funded through December 2026, supported by a €48M credit facility, with €28.8M drawn as of June 2025, and ongoing support from TSGH/Institut Mérieux.
Outlook and guidance
Multiple clinical catalysts expected through 2027, including additional immunogenicity and efficacy data from ongoing and new trials, with dense news flow anticipated.
Visibility on pivotal Phase III trial plans for TG4050 in HNSCC expected by Q2 2026.
New Phase I trial for TG4050 in a second solid tumor indication is planned, pending regulatory and financial approvals.
Additional immunogenicity data from Phase I to be presented at a major immunology conference in November 2025; 3- and 4-year DFS data expected in 2026 and 2027.
Details on TG4050 accelerated regulatory path
TG6050 future strategy
Funding plan beyond December 2026
When will TG4050 pivotal trial plans be shared?
New myvac Phase I trial initiation status
What is the development path for BT-001?
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Q3 20254 Nov, 2025
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Frequently asked questions
Transgene SA is a biotechnology company focused on developing innovative immunotherapies for cancer treatment. The company's core expertise lies in the design and development of therapeutic vaccines and oncolytic viruses. Transgene leverages advanced viral vector technology to create targeted treatments that aim to induce immune responses against cancer cells, either by directly attacking them or by enhancing the body's immune system to do so. Key products in its clinical-stage pipeline include TG4050, an individualized therapeutic vaccine developed using the myvac platform, and TG4001, aimed at treating HPV-positive cancers. The company also develops oncolytic viruses like BT-001 and TG6050 under its Invir.IO platform. The company is headquartered in Illkirch-Graffenstaden, France, and its shares are listed on the Euronext Paris.
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