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?

Thank you, Alessandro. If we look at our financial position and what happened in 2025, we can definitely say that the most significant financial event of the year was the successful fundraising in December 2025, through which we raised approximately 105 million. And together with the conversion of 39 million Euro debt with TSGI into equity, It strengthens its balance sheet, reduced its financial liabilities. The company is now virtually debt-free, and we are now ready to move and fund it until early 2028. If we look at our cash burn over last year, it was approximately $38.2 million, so it reflects the investment in our phase two trial, the fact that we manufacture and enroll patients into this phase two in head and neck cancer. So I think that, and I'm convinced that with the budget that we have, the money that we have, we are funded to deliver on key milestones, which include the development of 4050, the MedVac platform, the planned phase one trial in the second indication, and also the work on manufacturing and process optimization, preparing late stage development. So, Alessandro, if you want to comment on outlook.

Yes, thank you, Lucy. As we look ahead, our priorities, as you know, are very clear. We remain focused on TG4050, our first INTV vaccine from the MyBank platform. We intend to continue to establish Transgina as a key player in the INTV field that is growing across the community and it attracts a lot of interest. With the progress we have made so far and with the financial sources that Lucia just mentioned, we believe that we have what we need to execute on the next phase of development. So overall, when we look at the next 24 months that are covered by our recent fundraising, we see a clear path of execution, multiple meaningful milestones, and the financial visibility as mentioned to support them throughout early 2028. Before opening the Q&A, let me also mention that we'll be participating in Investor Access events in Paris on April 9 and to the CAMP and Life Science Conference in Amsterdam on April 16. And we would, of course, be very pleased to meet with those of you who may be attending. With that, the team and I will be happy to take your questions. Operator, please, up to you.

Thank you so much. Dear participants, as a reminder, if you wish to ask a question over the phone, please press star 1 1 on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star 1 1 again. Alternatively, you can submit your questions via the webcast. This will take a few moments. And now we're going to take our first question. And it comes to the line of Chiara Monterori from Van Lanshot Campen. Your line is open. Please ask a question.

Hello, Alessandro. Hello, Lucy. Thanks for taking my question. I actually have a couple. So the first one, how should we be looking at the three years DFS data that are approaching in Q2, Q3, given that the primary endpoint and the benchmark are at two years? What do you expect to see here, and what will be a good result? And the second question is on the immunogenicity phase 2 data in H226. At which follow-up will be those data? Will be able to see the induction of the immune response, or also to understand that these immune responses are durable? Thank you.

Thank you, Chiara. So, the fourth question is on three years of disease-free survival data. First of all, you know, we plan to send an abstract for the ECMO conference, you know, in Q3 2026. And, you know, what we should expect, of course, we don't know because we have not analyzed the data. I mean, the base case scenario is, of course, that we continue to see that the two curves, you know, stay separated throughout the additional follow-up. So that's the base case scenario. You know, the best case scenario, which is, you know, which is not good for patients that have been randomized to the observation is to observe more relapses, right? in the arm that, you know, did not receive the TG4050. And therefore, you know, this scenario will show, you know, a larger magnitude of the separation of the two curves. And that's what, you know, and of course, there is a worst case scenario that is that we start to observe, you know, relapses in TG4050. So, but, you know, in the base case scenario, And in best-case scenario, this is going to be quite good for the program and, of course, for patients. Then in terms of the neurogenicity data of, you know, the Phase II study, you know, we expect to start having the first set of data, you know, by the end of 2026. And, of course, we will start to analyze, you know, the patients that were randomized first, right? Therefore, we expect, you know, that those patients have, you know, at least one year kind of, you know, follow-up with the potential to show durability, you know, over one year in the Phase II study. And, of course, this will be important to start also to, you know, strengthen the data that we presented earlier, you know, in 2025 with the Phase I. Hopefully, this is clear.

Yes, thank you.

Thank you, Kiana.

Thank you. Now we're going to take our next question. And the question comes line of Dominic from Intron Health. Your line is open. Please ask your question.

Hi, it's Dominic here. Thanks for taking my questions. I've got a couple as well. My first question is how do you think the GMP manufacturing reconfiguration will change the ability to get a deal done towards the end of the year. So, how impactful is that versus getting new data? And my second question is, what, if anything, do you hope to learn this year from the Moderna data readouts?

Okay. So, the first question is around the GMP manufacturing. So, as you know, it is important, you know, to continue to optimize manufacturing for an individualized So we plan to have, you know, full GMP manufacturing by, you know, by 2027, you know, Q3 2027. And of course, you know, having a full GMP manufacturing is an important value creation in my VAC program, and of course, you know, it strengthens the attacks, you know, from pharmaceutical companies for the simple reason that, you know, having a GMP manufacturing, you know, allow us or the potential partner, you know, to move forward to a, So that's the reason why we are investing significantly on the GMP. Again, it is critical, you know, to succeed in the individualized neoantigen-therapeutic vaccine. And then the second question was around the Moderna data. I mean, I guess you're referring to the Phase 2 that they've already published, but also the potential Phase 3 in adjuvant setting melanoma. So, first of all, I mean, the, you know, the long-term follow-up data set that they have published just recently, I would say conform what they've already published, you know, a few years ago in terms of the efficacy of their, you know, of their new INTV in adjuvant setting melanoma. And, of course, you know, they clearly say that they will disclose the phase three data always in adjuvant melanoma. by the end of the year, beginning of 2027. And, of course, you know, for the IMTV community, you know, the Phase III data will be quite important because, you know, if the data is positive, you know, the data will continue to de-risk the IMTV approach. And, of course, if the data is negative, then, you know, as you know, Transgene has a different technology with a different vector. And we think that we will have to, you know, to wait, you know, our data set in ADNEC, specifically the randomized phase two study, you know, before making any conclusion. Because, again, our technology is different from the modern one. But, you know, of course, for patients and for the field, we hope that the melanoma data, phase three, you know, is going to be, you know, positive, right? So, but, of course, we have to wait. So, and from a BioNTech point of view, right, so as you know, they, you know, they are doing some, you know, some changes in their leadership, and they have recently also announced, you know, that they plan to close their phase two trial in the Orotelia cancer because the competitive landscape has changed significantly, and therefore, you know, what they say, of course, they do some re-prioritization, and now they're staying focused on pancreatic cancer and colon cancer, and, you know, we don't know the data. The studies are still ongoing. And again, you know, of course, we hope to develop for all these studies that are in the IMTV field in early setting because, again, All these data points will help to continue to de-risk the field and, of course, for biotech companies to continue to accelerate the development.

Thanks. That's a very detailed answer. I appreciate it. Thank you.

Yeah. So we have received a few questions on the chat. So I'll take and read Lionel Labaudet's question. Lionel is from Biomed, in class. So the question is, regarding the new indication, the G4070 program as shown on the website, could you give us more information? Solid tumors, as far as I understand, will the population of patients be homogenic or will you address several types of solid tumors, single or multiple injections?

So this is going to be one indication. It's not a basket protocol. It's going to be randomized phase one study in a new indication that I would say very similar to what we did in Adenek, same type of methodology, but in another indication where the medical need is quite significant. And the indication would be very different from Adenek, from a biological standpoint, and also in terms of the potential of being you know, immunogenic tumor, and I cannot disclose exactly what we are going to plan. So we are in the kind of, you know, waiting for the regulatory feedback on the final protocol, and as soon as we have, of course, the approval from the agencies, we're going to disclose the indication and the timelines associated to. We're very confident that the study, you know, can start this year.

Thank you. So, we had a question from Jamila, but I think we've answered it within the current landscape. I also have a question from Marciel de Couture, OdoBHS, which is, as you expand MyVac platform, thanks to the additional tumor types, how do you see the long-term value Could we think that you will look for partners in the future, or could we think that you will continue alone for the long term? On TG4050, what level of efficacy could you consider as clinically relevant in the phase two? Thank you.

So let's start from the last question, perhaps. So, you know, everything that is similar to what we have observed in the randomized phase one, you know, makes a lot of sense for patients, you know, and what we have disclosed and the disease-free survivor curve. So, having a flat curve without any relapses by itself is very important for resetting adenoma cancer patients. So, we hope that, you know, we're going, as I said also, answering the question from Chiara, we hope to see the same kind of shape of the core, the same type of separation, and, of course, the same durability of the plateau that we are observing in the Phase I study. So in terms of the long-term strategy for transgene related to MyVac, so I would say that, first of all, our priority is to continue to create value, you know, for patients. So, and of course, by doing that, to stay very open, you know, on potential opportunities. And, you know, in terms of having a kind of constructive dialogue with the scientific community, with the pharmaceutical companies. And we think that, of course, as we generate more data in terms of phase two, in terms of optimization of the manufacturing in terms of showing that we're able to you know to do a second indication with a manufacturing process that is even better than what we have used in the phase one and the phase two study so all this kind of value creation activities and catalysts will help significantly to attract the interest of pharmaceutical companies. So the objective that we have is ultimately to bring the organization to a kind of starting block for launching a potential pivotal trial. And we hope that if we demonstrate that in the next 24 months, you know, we can generate interest from potential partners and working them together to launch a potential phase three trial. So value creation first dialogue in parallel with the industry, and so the potential collaboration to continue to accelerate our progress.

Okay. We have a quick, a few follow-up questions from Janina from . So any update on the media conference where you plan to report phase one data, particularly the three-year survival? Should we assume it's ASCO? Should we expect Phase 2 patient randomization to be completed during Q2 2026? And finally, how should we think about the timing for initiating a Phase 1 trial in a new indication this year?

So, I mean, the three years of survival data for the Phase 1 study of TG4050 will be potentially, that's our plan, you know, presented at ESMO. And, of course, this, you know, requires that ESMO accept our abstract. So we plan to submit it, and then we'll keep you posted, you know, whether this is accepted and ultimately disclosed and presented at the ESMO meeting. So that's, you know, your first question. So the second question related to the randomized phase two trial. So, I mean, the randomization will, I mean, will be completed certainly by Q2, right? So that's our plan, right? So, and of course, we will, you know, sign the announcement as soon as we have, you know, this milestone completed, but we are kind of optimistic that really we are close to the final recruitment. And then the third question, there was another one.

How should we think about the timing for initiating a phase one trial?

As we mentioned, it's going to be in 2026. As soon as we have the formal approval from the health authorities, we're going to move forward.

And I think that we have at least, I don't have additional questions. A few ones. Thank you very much everyone for your questions.

Thank you for the question. So just to close, I mean, we think that 2025 was a year of a stronger progress for Transgene. As I mentioned, we continue our journey to continue to establish Transgene as a key player in this field of individualized neuroantigen-therapeutic vaccine that can be potentially, you know, transformative for patients, and they can, as you have seen can go beyond one single indication. Looking ahead, we are confident in our strategy, in the transformative potential of the MyVac platform, and with the financial visibility until early 2028, and a clear path to clinical readouts, we are very well positioned to deliver meaningful value for patients and shareholders alike. We are grateful for your, of course, continuous support and looking forward to keep you updated on our progress. With this, I would like to conclude today's call. Have a great rest of the day and talk to you soon. Operator, please.

This concludes today's conference call. Thank you for participating. Immanuel will disconnect. Have a nice day.

Thank you.

Thank you.