Transgene S.A.

And thank you for standing by. Welcome to the Transgenic 2025 Half-Year Financial Results 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, one, one on your cell phone keypad. You will hear an automatic message advising your hand is raised. To withdraw a question, please press star, one, and one 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 Larguet, Chief Financial Officer. Please go ahead, Madam.

Thank you, Nadia, and good afternoon, everyone. Thank you for joining us on today's call to discuss our progress over the first half of 2025, as well as our half-year results. You can access the press release issue today on the investor page of our website. On today's call is Dr. Alessandro Riva, our chairman and CEO. After Alessandro's discussion, we will take questions already on the telephone call and also on the web platform. Before we begin, I'd like to remind everyone that today's discussion contains forward-looking statements which are subject to a number of risks and uncertainties. And with this, I now hand over the call to Alessandro.

Thank you, Lucy, and good afternoon, everyone. I would say that it has been an exciting first half of the year, not only for transgene individualized therapeutic vaccine, but also, and more importantly, for the head and neck cancer community. We presented the full 24 months of this free survival data for all Phase I patients treated in a randomized Phase I trial in a rapid oral presentation at ASCO this year in a session that was dedicated to head and neck cancer. We are extremely proud that all operable head and neck squamous cell carcinoma patients treated with our individualized therapeutic vaccine TG4050 in the randomized phase one trial remained disease-free after a median follow-up of 30 months, as you can see from the Kappermeyer course projected in this slide. And now on slide five, all the trial endpoints of the randomized phase one study were met. Safety is extremely good. Immunogenicity has been demonstrated. And not only do we see the induction of a specific cellular immune response, But also, we see that these responses are durable and can still be seen after 24 months since the start of treatment. We will present additional immunological data from this trial at a scientific conference in Q4 2025, including insights into the phenotyping of patients' immune responses. In addition, as you can see in this slide, the ongoing Phase 2 trial is progressing at very good pace, and we are very confident that we will randomize the last patient in Q4 2025, allowing us to plan for the communication of the first numerogenicity data in the second semester 2026, and the two-year efficacy data in the Q4 2027. I'm now going to slide six, TG4050 randomized phase one data where presented ASCO along with other two trials with immunocheckpoint inhibitors in the adjuvant treatment of operable adenine squamous cell carcinoma, the Keynote 689 and the NEVO post-op trial. These two trials, as you can see, We are extremely encouraging data and pembrolizumab, as you know, is now approved for this patient population in the United States of America and probably soon in Europe. Nevertheless, 35% of patients relapse within two years after surgery. And that is exactly where the future lies for TG4050. improving the outcomes for these patients that do not benefit durably from injunal checkpoint inhibitors. Moving to slide 7, so as you can see, we want to build on the positive phase 1 data and the successful inclusion in the phase 2 trial. And for this reason, we are discussing with clinicians the best way forward for TG4050 in the head and neck cancer so that we can bring this potential new treatment to patients in need as quick as possible. In addition, our MyVac platform has broader potential in early solid tumor setting that goes beyond head and neck tumors. We want to continue to leverage this unique technology to address areas of high medical, unmet medical need. And that's why, in parallel, we continue to prepare a potential new phase one trial in the early treatment of a solid tumor with biology that differs from the head and neck tumors. We aim to initiate this study as soon as all conditions are met from a regulatory and financial point of view. As you know, and I'm on slide eight, the manufacturing is key for individualized vaccine as it is key for CAR-T cell therapy. That's a topic that we started to address from the beginning of our work on MyVac. We've demonstrated feasibility to deliver TG4050 to operable adenine cancer patients in the context of a multicentric, multinational phase 1-2 trial. The next step for us is to continue optimizing the manufacturing process for MyVac technology and for TG4050 to be able to scale up and run several trials in parallel, including a potential registration trial. Under the guidance of our chief technical officer, Simon Steiner, who joined Transgene before this summer, we will continue to invest to ensure smooth execution to support further acceleration of the MIVAC program. We believe that scientific excellence, strong data, and operational focus generated with TG4050 clearly differentiated transgene in this highly competitive and attractive field. Hence, the rationale, as you can see in this slide, of our decision to focus our efforts and resources on our lead program MyVac Plus platform and today TG4050. With regards to our other programs, we will present a poster at ESMO in Berlin on the data generated by BT001 in the phase one trial as monotherapy and in combination with pembrolizumab. We have seen interesting responses in patients with refractory diseases In particular, a leiomyosarcoma patient and a melanoma patient. Looking at the leiomyosarcoma patients, you can see that BT-001 was able to positively change the tumor microenvironment. The science generated around this initial trial constitute the basis of discussion with clinicians to continue the development of this candidate in the intratumoral setting. Looking at our two other candidates, the TG4001 and TG6050, we are assessing different scenarios in a context where the overall financing environment for biotech company is pushing us to focus on key value creating programs. And now I'm going to hand over to Lucie for some words on the financials. Lucie?