Successful Fundraising and Balance Sheet Strengthening
Raised approximately EUR 105 million in December 2025 and converted EUR 39 million of debt into equity, leaving the company virtually debt-free and providing financial visibility/runway through early 2028.
TG4050 Phase I — Strong Disease-Free Survival Signal
In Phase I (adjuvant, HPV-negative head and neck cancer) all patients who received TG4050 remained disease-free after at least 2 years of follow-up (reported as 100% disease-free survival in the treated cohort), while the control arm experienced 3 relapses; trial met safety and feasibility endpoints.
TG4050 Immunogenicity and Durability
TG4050 induced neoantigen-specific T cell responses in 73% of evaluable patients; these immune responses were reported as durable, persisting 24 months after treatment initiation, with cytotoxic and effector phenotype markers observed up to 1 year after end of treatment. Phase I translational data published as a preprint and under journal review.
Progress to Randomized Phase II and Upcoming Milestones
Randomized Phase II portion of the Phase I/II trial is close to full randomization; primary endpoint is 2-year disease-free survival (regulatory-recognized). Expect first Phase II immunogenicity data in H2 2026, Phase I 3-year DFS data in Q2–Q3 2026, and Phase I 4-year follow-up in Q2–Q3 2027.
Positive Early Data for BT-001 Combination
BT-001 (intratumoral oncolytic virus, with BioInvent) in combination with pembrolizumab showed positive abscopal and sustained antitumor activity in both injected and non-injected lesions at ESMO 2025, consistent with the mechanistic hypothesis of converting cold tumors to hot tumors.
Manufacturing and Regulatory Preparedness Efforts
Active investments into manufacturing optimization, improved turnaround times, and preparation for increased production volumes; plan to have full GMP manufacturing by Q3 2027 to enable potential pivotal trials and strengthen partnering appeal.
Clear Strategic Focus and Execution Path
Company articulated focused priorities on TG4050/myvac platform, expansion to a second indication (Phase I planned to start in 2026), multiple meaningful milestones over the next 24 months, and an intent to engage with partners as value is created.