2025 Full-year results and business update
Transgene Continues Progress
to Reshape Early-Stage Cancer Treatment
through Individualized Neoantigen Therapeutic Vaccines (INTV) Backed by Financial Visibility Until Early 2028
TG4050, Transgene's first INTV, demonstrated durable clinical outcomes in resected head and neck squamous cell carcinoma (HNSCC) and potential to prevent cancer relapse
Randomization of Phase 2 patients nearly completed -Disease-free survival(1) from evaluable patients in the Phase 2 part of the Phase 1/2 study expected 2 years after completion of randomization
myvac$(R)$ platform: new Phase 1 trial in a second indication in operable solid tumors planned to start in 2026
BT-001: Phase 1 results in patients with advanced refractory tumors support further clinical development
EUR111.9 million in cash available as of December 31, 2025 -- business funded until early 2028
Conference call scheduled today at 6 p.m. CET (in English). See details below.
Strasbourg, France, March 24, 2026, 5:45 p.m. CET -- Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today publishes its full-year financial results for the year ended December 31, 2025, and provides an update on its lead INTV asset TG4050 developed from its myvac(R) platform together with upcoming plans for 2026.
Alessandro Riva, MD, Chairman and CEO of Transgene, commented, "In 2025, we achieved important clinical progress with TG4050, the first product based on myvac(R), our individualized neoantigen therapeutic vaccine platform. The positive randomized Phase 1 results, which demonstrated durable disease-free survival and persisting neoantigen-specific immune responses in early-stage head and neck cancer, strengthen our confidence in its transformative potential for patients. All Phase 2 patients are close to being randomized , with the primary endpoint being two-year disease-free survival. In parallel, we are preparing a new Phase 1 trial in a second indication in an early treatment setting, reflecting our strategy to expand the clinical evaluation of myvac(R) across operable solid tumors where significant unmet medical need remains.
"Together with the updated Phase 1 results for BT-001 presented at ESMO 2025, which support the program's next development steps, and the successful fundraising completed at the end of 2025, we are well positioned to deliver key milestones while maintaining financial visibility. This strengthened position allows us to confidently advance our innovative pipeline in our mission to bring meaningful benefits to patients and reshape early--stage cancer treatment with individualized neoantigen therapeutic vaccines."
TG4050: Data support TG4050's potential role in preventing cancer relapse
Our individualized neoantigen therapeutic vaccine (INTV) TG4050 is currently under evaluation in a randomized multicenter Phase 1/2 clinical trial (NCT04183166), as a single agent in the adjuvant treatment of HPV-negative head and neck cancer (head and neck squamous cell carcinoma or HNSCC).
ASCO 2025: TG4050 meets all Phase 1 endpoints, with 100% disease-free survival $(DFS)$ after more than 2 years of follow-up
Transgene presented positive data from the randomized Phase 1 part of the ongoing international Phase 1/2 trial in an oral presentation at the American Society of Clinical Oncology (ASCO 2025) Annual Meeting (see press release). All patients who received TG4050 remained disease-free for at least 2-years (median follow-up: 30 months).
The results successfully met all trial endpoints (including safety, tolerability and feasibility).
Compelling translational findings from Phase 1 in TG4050-treated patients confirm durable, neoantigen-specific T-cell responses
-- Immunogenicity data presented at the 2025 Society for Immunotherapy of
Cancer $(SITC)$ Annual Meeting in November 2025 (see press release),
confirmed clinical proof of principle for TG4050. This includes the
ability to induce neoantigen-specific cytotoxic CD8+ T cell responses
capable of targeting and eliminating tumor cells, thereby contributing to
the prevention of cancer relapse.
-- Translational data presented at SITC 2025 showed that TG4050 induced
neoantigen-specific T cell responses in the majority of treated patients
(73% of 15 evaluable patients). These responses were durable (persisting
24 months after the start of treatment), with cytotoxic and effector
phenotype markers expressed up to one year after the end of treatment.
A comprehensive analysis of the clinical and translational data from the Phase 1 part of the randomized Phase 1/2 trial of INTV-TG4050 was published on the preprint platform medRxiv(2) , in January 2026 (see press release). The article is under review by a peer-reviewed journal.
End of randomization in Phase 2 part close to being completed in the coming weeks -- Next clinical readout expected 2 years following completion of randomization
The randomized Phase 2 part of the study for adjuvant HNSCC is nearly completed.
The primary endpoint of the trial is 2-year disease-free survival (DFS). This will be as soon as all patients achieve 2-year follow-up from randomization unless an event (relapse, death or lost to follow-up) occurs earlier.
3-year disease-free survival (DFS) follow-up for all patients is expected in Q2/Q3 2026.
myvac(R) platform: Potential to reduce the risk of relapse across multiple operable solid tumor types
Transgene's INTV platform, myvac(R), could improve treatment across a range of solid tumors where in many cases a significant unmet medical need remains. In parallel with the ongoing Phase 1/2 trial in HNSCC, Transgene has begun start-up activities for a new Phase 1 trial in a second indication in an early treatment setting, with the aim of initiating later in 2026.
Transgene is also optimizing its manufacturing processes and capabilities to prepare for a potential pivotal clinical trial.
VacDesignR(R): Transgene's proprietary bioinformatics engine for cancer mutation selection and vector optimization
A poster on Transgene's proprietary VacDesignR(R) computational tool was presented at the European Society for Medical Oncology (ESMO) AI & Digital Oncology 2025 conference. Developed in-house, VacDesignR(R) is a computational design engine that optimizes recombinant plasmid architecture for Modified Vaccinia Ankara (MVA) vectors, a core component of Transgene's myvac(R) platform. By minimizing unwanted homologous recombination and intelligently selecting peptide sequences for cassette assembly among targets that have previously been identified as potentially immunogenic, VacDesignR(R) significantly improves production reliability and vector quality.
BT-001 (oncolytic virus for intratumoral administration): Updated Phase 1/2 data presented at ESMO 2025 demonstrated positive antitumoral activity
Transgene and partner BioInvent presented a poster on updated clinical results showing the positive antitumoral activity of BT-001 in patients with advanced refractory tumors at the ESMO Annual Meeting -- see press release.
These updated data from the Phase 1 trial (NCT04725331) evaluating BT-001 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab)(3) showed positive local, abscopal and sustained antitumoral activity in injected and non-injected lesions. Immune-mediated tumor shrinkage is consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns "cold" tumors into immunologically active or "hot" ones -- see poster.
The data support further clinical development of BT-001.
Governance: recent additions to leadership team to further accelerate the development of the myvac(R) platform
In April 2025, Simone Steiner joined Transgene as Chief Technical Officer $(CTO)$ and member of the Executive committee.
In February 2026, Feriel Marin was appointed Chief Quality Officer ad interim. As of April 1, 2026, Sandrine Lemius will become Deputy CEO - Responsible Pharmacist ad interim.
They temporarily join the Executive committee following the retirement of Christophe Ancel, and will remain in these roles until the appointment of his successor.
In addition, in July 2025, the Board of Directors appointed a new independent director, Emmanuelle Quilès (see press release).
Key financial events
Business funded until early 2028, supporting key clinical milestones
In December 2025, Transgene completed a successful fundraising of circa EUR105 million and the conversion of its EUR39 million debt to TSGH into shares -- see press release.
The net proceeds from the fundraising, combined with its existing cash, enables the acceleration of Transgene's INTV myvac(R) programs, and extends the Company's financial visibility until early 2028.
Key financials for 2025
-- Operating revenue of EUR7.2 million in 2025 compared to EUR6.4 million in
2024.
Operating revenue was mostly comprised of the research tax credit (EUR6.7 million in 2025 compared to EUR6.0 million in 2024).
-- Net operating expenses of EUR42.3 million in 2025 compared to
EUR42.0 million in 2024.
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