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 all endpoints met, durable T cell responses, and strong safety profile, as presented at ASCO 2025.

• Phase II trial for TG4050 is ongoing in HNSCC, with last patient randomization expected by Q4 2025 and key immunogenicity and efficacy data readouts planned for 2026 and 2027.

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

• New Phase I trial for TG4050 in a second solid tumor indication is being prepared, pending regulatory and financial conditions.

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

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 increased to €17.9M in H1 2025 from €15.4M in H1 2024, reflecting clinical trial progress.

• Net loss widened to €19.3M in H1 2025 from €16.5M in H1 2024; net loss per share was €0.15.

• Cash and current financial assets stood at €16.8M as of June 30, 2025, stable from year-end 2024.

• Net cash burn was €18.8M in H1 2025, down from €20.4M in H1 2024.

Outlook and guidance

• Business is funded through December 2026, supported by a €48M credit facility and institutional backing, with €28.8M drawn as of June 2025.

• 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.

• Updated data on BT-001 and TG4001 to be presented at ESMO 2025 and ASCO 2025.