Economia
Transgene Provides Business and Financial Update for Q3 2025
Comprehensive immunogenicity data of individualized neoantigen therapeutic vaccine (INTV) TG4050, from the randomized Phase I study in operable Head and Neck Squamous Cell Carcinoma (HNSCC) patients, to be presented at SITC 2025
Strasbourg, France, November 4, 2025, 5:50 p.m. CET – today provides a , , and as of September 30, 2025.
Transgene and its partner NEC will jointly present a poster on at the (SITC) Annual Meeting.
Comprehensive immunogenicity data confirm the ability of TG4050 monotherapy to – see press release. These CD8+ T cells target multiple neoantigens encoded in the vaccine, have tissue resident cytosignature, and are still detectable up to two years after the start of TG4050 treatment. Overall, these data support the TG4050 mechanism of action that resulted in the reduction of risk of relapse observed in the randomized Phase I study.
These data have been generated from the randomized Phase I part of the ongoing Phase I/II trial evaluating TG4050 as a single agent in the adjuvant treatment of HPV-negative HNSCC, in patients that are in complete response following surgery and adjuvant (chemo-)radiotherapy.
at the American Society of Clinical Oncology (ASCO Annual Meeting – see press release)
The SITC is available both on the SITC and Transgene websites. The will take place on at the Conference and will be available on Transgene’s website following the presentation.
from 10:00 a.m. to 11:00 a.m. ET (16:00 to 17:00 CET). The webcast and the replay will be available here and on Transgene‘s website.
Transgene expects to complete the randomization of patients with operable HNSCC in the Phase II part of the trial by early 2026. First immunogenicity data from this Phase II part are expected to be available in H2 2026. The first efficacy data (2-year disease-free survival, DFS) will become available as soon as all patients are evaluable for two-year DFS with either an event (relapse or death) or 2-year follow-up whichever occurs first.
Transgene is currently evaluating the most efficient regulatory pathway to of its , , with the goal of bringing it to patients with operable HNSCC as quickly as possible.
Transgene’s INTV platform, ®, could be applied across a range of solid tumors where in many cases a . In parallel, Transgene is initiating start-up activities for a potential in a , with the aim of initiating once all conditions are met.
Transgene and BioInvent presented a poster at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting – see press release.
These updated data from the Phase I trial (NCT04725331) evaluating (Merck & Co., Inc., Rahway, NJ, USA) , KEYTRUDA (pembrolizumab) 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 ones.
The poster is available on Transgene’s website.
Transgene and BioInvent are exploring clinical development opportunities for intratumoral administration of BT-001 in collaboration with clinicians.
During the third quarter of 2025, the Research Tax Credit increased to €5.8 million compared to €4.8 million for the same period in 2024, reflecting the progress of the ongoing Phase II part of the clinical trial evaluating TG4050 in head and neck cancer, with sustained patient enrollment and related expenses, including the manufacturing of individualized batches.
compared to €16.7 million as of December 31, 2024.
Over the first nine months of 2025, Transgene’s net cash burn was €28.8 million (including the prefinancing of the 2024 Research Tax Credit for €5.2 million in June 2025) compared to €31.3 million for the same period in 2024.
(Institut Mérieux), which increased the total amount of the facility by €15 million to €48 million. As of September 30, 2025, the Company has drawn down €35.5 million from this facility.
(Institut Mérieux), , enabling the Company to deliver significant news flow on its ® platform over the next 12 months.
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Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. The Company’s clinical-stage programs consist of a portfolio of viral vector-based immunotherapeutics. TG4050, the first individualized therapeutic vaccine based on the platform is the Company’s lead asset, with demonstrated proof of principle in patients in the adjuvant treatment of head and neck cancers. The Company has other viral vector-based assets, including BT-001, an oncolytic virus based on the Invir.IO® viral backbone, which is in clinical development. The Company also conducts innovative discovery and preclinical work, aimed at developing novel viral vector-based modalities.
With Transgene’s platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The
® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations, identified and selected through advanced Artificial Intelligence technologies.
With its proprietary platform Invir.IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses.
Additional information about Transgene is available at: www.transgene.com
Follow us on social media: X (formerly Twitter): @TransgeneSA — LinkedIn: @Transgene — Bluesky: @Transgene
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