Transgene S.A.

Good day and thank you for standing by. Welcome to the Transgen 2025 Annual Results and Perspectives for 2026 Conference Call and Webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question and answer session. To ask a question during the session, you need to press star, 1, 1 on your telephone keypad. You will hear an automatic message advising your hand is raised. To withdraw a question, please press star, 1 and 1 again. If you wish to ask a question via the webcast, please use the Q&A box available on the webcast link anytime during live events. Please be advised that this conference has been recorded. I would now like to hand the conference over to our first speaker today, Lucie Larguer. Please go ahead.

Well, thank you, Nadia, and hello, everyone. So I'm Lucie Trifan, law officer at Transgen, and I'm with Dr. Alessandro Riva, our chairman and CEO today. We will review the progress over 2025 and answer any questions you may have. Before I turn the call over to Alessandro, I'd like to remind everyone that today's discussion contains forward-looking statements, which are subject to multiple risks and uncertainties. If you are following the webcast online, you can, as Nadia said, submit your questions via the chat function on the platform or also dial in. So, don't hesitate to let us know and make it as interactive as possible. With this, I now turn the call over to Alessandro.

Thanks, Lucy, and good morning, good evening with us and everyone. So, 2025 has been a year on meaningful clinical progress for Transgina. As you know, we advanced our individualized neoantigen therapeutic vaccine, INTV, TG4050, supported by compelling clinical and translational data in head and neck cancer that reinforce our confidence in its potential to prevent relapse in patients. I would say that there were three crucial moments this year that confirm our conviction that the MyVac platform can bring benefits to patients. First of all, our Phase 1 data being presented already at ASCO in the same session as two Phase 3 trials in the RNA cancer. Second, the immunogenicity data that we presented at the CITI conference in November in the United States of America. And third, the completion of 105 million euros of fundraising that provides financial visibility until the first quarter of 2028 to support our priority programs. With these three major achievements, Transgene is on track to continue building the scientific and operational capabilities to execute our strategy. And now, on the slide five, TG4050, the first IMTV based on our MyVac platform, is currently being evaluated in international randomized phase one, two clinical trial in the treatment of HPV negative squamous cell carcinoma. a setting with significant medical need as more than 30% of patients relapse after two years despite the recent advances in innovation with checkpoint inhibitors. At ASCO, we presented Phase I data showing that all patients with HPV-negative cancer who received the TG4050 after surgery and the standard chemo and radiotherapy remained disease-free after at least two years of follow-up. Importantly, the trial made all eight endpoints for both safety and feasibility. This 100% disease-free survival rate compared with three relapses observed in the control arm provides the first clinical evidence supporting a TG4050 potential to prevent cancer recurrence in early adenine cancer patients. In November, at the Society for Immunotherapy of Cancer annual meeting, we presented a compelling translational data that further strengthened the clinical approval principle for TG4050. In particular, the data showed that TG4050 induced neoantigen-specific T-cell responses in 73% of available patients. Importantly, these responses were durable, persisting 24 months after the start of treatment and show the cytotoxic and effect of phenotype markers up to one year after the end of treatment. Together, these findings demonstrated that TG4050 can generate potent and long-lasting immune responses capable of targeting and eliminating tumor cells, contributing to the prevention of relapses. In January 2026, a comprehensive analysis of the Phase I clinical and translational data was published on the pre-printed platform of Medi-Archive and is currently under review by P-Reviewer Journal. I'm on slide six now. Let me now turn on the ongoing Phase II part of the Phase I-II trial. The randomized Phase II part of the trial is in the same setting as the Phase I. All patients are close to being randomized, and this will be a key operational milestone for the program. The primary point of the Phase I-II study is two-year disease-free survival. That is very well recognized by the health authorities being an important and critical milestone, and we expect this efficacy redoubt once all patients reach two years of follow-up from randomization. In second half 2026, we also expect to share the first immunogenicity data from patient from the phase two cohort of the phase one to study. For the phase one part of the study, we plan to report the three-year follow-up data on disease-free survival in second third quarter 2026, followed by four-year follow-up in second third quarter 2027. Beyond the DNA cancer, we are working to broaden the spectrum of opportunity for MyVAC across additional solid tumor types where significant unmet medical needs remain. The platform, as you know, is designed to generate individualized antigen therapeutic vaccine tailored to each patient's tumor mutation profile. As mentioned, we are currently in the startup phase of the new phase one trial in a second not yet disclosed indication in an early treatment setting, and our goal is to initiate this trial in 2026. We are actively optimizing our manufacturing process, improving turnaround time, and preparing for increased production volumes. Importantly, part of the procedure is dedicated to advancing industrial and regulatory readiness including the alignment with the FDA and the MEA requirements as we move toward next stage development. Now, turning on slide 7, BT001, which is our intratumor-administered oncolytic virus, developed with our partner, BioInvent. It has more 2025. We presented a poster. We updated data. Evaluating Bt001 in combination with pembrolizumab in patients with advanced refractory tumors. This data shows positive docala, abscopala, and sustained anti-tumor activity in both injected and non-injected lesions. The tumor shrinkage observed is consistent with our mechanistic hypothesis. Bt001 in combination with pembrolizumab can convert cold tumors into immunologically active host tumors. This data supports for the development of BT.001, and you should be hearing from us about this development in the next couple of months. Now, I would like to turn over to Lucy for the financial updates. Lucy?