On March 24, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported 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 platform together with upcoming plans for 2026.

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Alessandro Riva, MD, Chairman and CEO of Transgene, commented, "In 2025, we achieved important clinical progress with TG4050, the first product based on myvac, 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 across operable solid tumors where significant unmet medical need remains.
"Together with the updated Phase 1 results for BT-001 presented at ESMO (Free ESMO Whitepaper) 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) (Free ASCO Whitepaper) (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) (Free SITC Whitepaper) 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 (Free SITC Whitepaper) 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 medRxiv2, 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 platform: Potential to reduce the risk of relapse across multiple operable solid tumor types

Transgene’s INTV platform, myvac, 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: Transgene’s proprietary bioinformatics engine for cancer mutation selection and vector optimization

A poster on Transgene’s proprietary VacDesignR computational tool was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) AI & Digital Oncology 2025 conference. Developed in-house, VacDesignR is a computational design engine that optimizes recombinant plasmid architecture for Modified Vaccinia Ankara (MVA) vectors, a core component of Transgene’s myvac 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 significantly improves production reliability and vector quality.

BT-001 (oncolytic virus for intratumoral administration): Updated Phase 1/2 data presented at ESMO (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper) 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 (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 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 €105 million and the conversion of its €39 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 programs, and extends the Company’s financial visibility until early 2028.

Key financials for 2025

Operating revenue of €7.2 million in 2025 compared to €6.4 million in 2024.
Operating revenue was mostly comprised of the research tax credit (€6.7 million in 2025 compared to €6.0 million in 2024).

Net operating expenses of €42.3 million in 2025 compared to €42.0 million in 2024.
These reflect patient accrual in the ongoing Phase 2 part of the Phase 1/2 clinical trial of TG4050 in head and neck cancer. Research and development (R&D) expenses were at €33.9 million in 2025 versus €34.3 million in 2024. General and administrative expenses amounted to €7.3 million in 2025 versus €7.8 million in 2024.

Operating loss of €35.1 million in 2025, compared to an operating loss of €35.7 million in 2024.
Net loss of €37.5 million in 2025, compared to a net loss of €34.0 million in 2024.
Net cash burn of €38.2 million in 2025, compared to €27.7 million in 2024.
Cash, cash equivalents and other financial assets as of December 31, 2025: €111.9 million, compared to €16.7 million at the end of 2024, following the capital raise in December 2025.
Current and non-current liabilities of €17.1 million at the end 2025, compared to €27.0 million at the end of 2024, resulting from the conversion into shares of debt drawn down from the current account advance granted by the Company’s major shareholder TSGH for an amount of circa €39 million in December 2025. Following the completion of the Reserved Capital Increase, the current account advance agreement has been terminated.
Total shareholder’s equity of €121.7 million at the end of 2025, compared to €15.2 million at the end of 2024, resulting mainly from the completion of the capital increases in December 2025.
The financial statements for 2025 as well as management’s discussion and analysis are attached to this press release (appendices A and B).

The Board of Directors of Transgene met on March 24, 2026, under the chairmanship of Dr. Alessandro Riva and closed the 2025 financial statements. Audit procedures have been performed by the statutory auditors and the auditor’s reports are in the process of being issued.

The Company’s universal registration document (URD), which includes the annual financial report, will be available early April 2026.

A conference call in English is scheduled today on March 24, 2026, at 6:00 p.m. CET (1:00 p.m. ET).

Webcast link to English language conference call:
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Please log in to the following link to obtain your personal telephone IDs:
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A replay of the call will be available on the Transgene website following the live event.

Next financial communications:

April 29, 2026: First Quarter 2026 Financial Results
May 22, 2026: Annual Shareholders’ Meeting

(Press release, Transgene, MAR 24, 2026, View Source [SID1234663866])