Transgene (TNG) H1 2025 earnings summary

Executive summary

• TG4050 achieved 100% disease-free survival at 2 years in Phase I for operable head and neck squamous cell carcinoma (HNSCC), with durable T cell responses and all endpoints met, as presented at ASCO 2025.

• Phase II trial for TG4050 is ongoing in HNSCC, with last patient randomization expected by Q4 2025 and key data readouts planned for 2026 and 2027; expansion into additional indications and combination trials is in preparation.

• Focused resources on the myvac platform and TG4050, deprioritizing other programs due to the challenging financing environment.

• New CTO and independent board member appointed in 2025, strengthening technical and strategic leadership.

• ESG performance recognized with top industry ratings and awards.

Financial highlights

• Operating income for H1 2025 was €4.6M, up from €3.3M in H1 2024, mainly due to higher Research Tax Credit; cash and financial assets stood at €16.8M as of June 30, 2025.

• R&D expenses increased to €17.9M in H1 2025, reflecting clinical trial progress; net loss widened to €19.3M, with net cash burn at €18.8M.

• Financials are in line with forecasts, supported by strict cost control and case allocation.

• Business is funded until end of December 2026, aided by a €48M credit facility and support from Institut Mérieux/TSGH.

• No new investments in tangible or intangible assets in H1 2025.

Outlook and guidance

• Additional immunogenicity data from TG4050 Phase I to be presented at SITC in November 2025; three-year follow-up data expected mid-2026.

• Phase II immunogenicity data expected in H2 2026, with two-year efficacy data in Q4 2027.

• Visibility on pivotal Phase III plans for TG4050 anticipated by Q2 2026 after regulatory and expert consultations.

• New Phase I trial in a different solid tumor indication planned, pending regulatory and financial clearance.

• Dense news flow and multiple clinical catalysts expected through 2027 and beyond.