Transgene (Euronext:TNG) Q4 2025 Earnings Call

0:01 Good day, and thank you for standing by. Welcome to the Transgen twenty twenty five Annual Results and Prospective for twenty twenty six Conference Call and Webcast. At this time, all participants are in listen only mode. After the speakers' presentation, there will be the question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Lucie Larguer. Please go ahead.

0:46 Well, thank you, Nadia, and hello, everyone. So I'm Lucie Trifan, L'Officer Transgene, and I'm with Doctor. 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 have followed 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.

1:33 Thanks, Lucy, and good morning, good evening, good afternoon, everyone. So 2025 has been a year on meaningful clinical progress for Transgene. As you all know, we advanced our individualizing antigen therapeutic vaccine, INTD, 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 benefit to patients. First of all, our phase one data being presented already at ASCO in the same session as two phase three trials in the redneck cancer.

2:21 Second, the immunogenicity data that we presented at SITC conference in November in The United States Of America. And third, the completion of €105,000,000 of fundraising that provides financial visibility until the first quarter twenty twenty eight to support our priority programs. With these three major achievements, Transgene is on track to continue building the scientific and operational capability to execute our strategy. And now we are on to slide five. CG4050, the first time TV based on our MyVac platform, is currently being evaluated in international randomized Phase onetwo clinical trial in the adjuvant treatment of HPV negative head and neck squamous cell carcinoma, a setting with significant unmet medical need, as more than thirty percent of patients relapse after two years despite the recent advances in innovation with checkpoint inhibitors.

3:19 At ASCO, we presented phase one data showing that all patients with HPV negative cancer who received the TG4050 after surgery and the standard chemotherapy remained disease free after at least two years of follow-up. Importantly, the trial met or hit endpoint for both safety and feasibility. This one hundred percent disease free survival rate compared with three relapses observed in the control arm provides the first clinical evidence supporting FTG4050 potential to prevent cancer recurrence in early head and neck 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.

4:12 In particular, the data showed that the TG4050 induced neoantigen specific T cell responses in seventy three percent of evaluable patients. Importantly, these responses were durable, persisting twenty four months after the start of treatment, and showed the cytotoxic and effector phenotype occurs up to one year after the end of treatment. Together, these findings demonstrated that Tg-four thousand and fifty can generate potent and long lasting immunoresponses 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 preprint platform of MedI Archive and is currently under review by peer review journal.

5:10 I'm on slide six now. Let me now turn on the ongoing phase two part of the phase onetwo trial. The randomized phase two part of the trial is in the same setting as the phase one. All patients are close to being randomized, and this will be a key operational milestone for the program. The primary endpoint of the phase onetwo 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 readout once all patients reach two years of follow-up from randomization. In second half twenty twenty six, we also expect to share the first immunogenicity data from patients from the phase two cohort of the phase onetwo study.

6:01 For the phase one part of the study, we plan to report a three year follow-up data on disease free survival in second, third quarter twenty twenty six, followed by four year follow-up in second, third quarter twenty twenty seven. Beyond the dead neck cancer, we are working to broaden the spectrum of opportunity for Nivalka across additional solid tumor types where significant unmet medical needs remain. The platform, as you know, is designed to generate individualized neoantigen therapeutic vaccine tailored to each patient's tumor mutational profile. As mentioned, we are currently in the startup phase of the new phase one trial in a second not yet disclosed indication in early treatment setting. And our goal is to initiate this trial in 2026.

6:54 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 late stage development. Now turning on slide seven, BT001, which is our intratumoral administered oncolytic virus developed with our partner BioInvent. At ESMO twenty twenty five. We presented a poster. We updated data, evaluating BT-one in combination with emerolizumab in patients with advanced refractory tumors.

7:42 This data shows positive local abscopal and sustained antitumor activity in both injected and non injected lesions. The immunomodiated tumor shrinkage observed is consistent with our mechanistic hypothesis. BT-one in combination with emerucinav can convert cold tumors into immunologically active host tumors. This data supports further development of BT-one, and you should be hearing from us about this development in the next couple of months. Now I would like to turn over to Lucille for the financial update. Lucie? Thank you, Alessandro.

8:29 So 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 105,000,000. And together with the conversion of €39,000,000 debt with TSGI into equity. Transgene S. Transits 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 twenty twenty eight.

9:15 If we look at our cash burn over last year, it was approximately 38,200,000, 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 4,050, the MedBack 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, you know, are very clear. We remain focused on TC4050, our first iNTV vaccine from the MyBack platform.

10:16 We intend to continue to establish Transgene as a key player in the iNTV field that is growing across the community, and it attracts a lot of interest. With the progress that we have made so far and with the financial resources that Lucie 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 twenty four months that is covered by our recent fundraising, we see a clear path of execution, meaningful milestones and the financial visibility as mentioned to support them throughout early twenty twenty eight. Before opening the Q and A, let me also mention that we'll be participating in Investor Relations events in Paris on April 9 and to the Campaign Life Science Conference in Amsterdam on April 16.

11:15 And we would, of course, be very pleased to meet with those of you who may be attending. With that, I the team and I will be happy to take your question. Operator, please, up to you. Thank you so much. And now we're going to take our first question. And it comes to the line of Chiara Muntiorari from Van Launschutt and Kempen. Your line is open. Please ask your question.

12:02 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 two data in H2 twenty six. At which follow-up will be those data? We'll be able to see the induction of the immune response or to understand that these immune responses are durable.

12:48 Thank you. Thank you, Kiera. So first question is on three year disease free survival data. First of all, we plan to send an abstract for the ESMO conference in Q3 twenty twenty six. And what we should expect, of course, we don't know because we have not analyzed the data. I mean, base case scenario is, of course, that we continue to see that the two cohorts stay separated throughout the additional follow-up. So that's the base case scenario. You know, the best case scenario, which is not good for patients that have been randomized to the observation is to serve more relapses in the arm that did not receive TCA4050.

13:43 And therefore, this scenario will show a larger magnitude of the separation of the two curves. And that's what, and of course, there is a worst case scenario that we start to observe relapses in TZ4050. But 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 the phase two study, we expect to start having the first set of data by the end of twenty twenty six. And of course, we will start to analyze patients that were randomized first, right? So therefore, we expect that those patients have at least one year kind of follow-up with the potential to show durability over one year in the phase two 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 one.

14:59 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 from the line of Dominique Rouse 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? Sort of 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?

15:50 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, you know, new antigen therapy company like Transgene. So we plan to have, you know, full GMP manufacturing by 2027, Q3 twenty twenty seven. And of course, having a full GMP manufacturing is an important value creation for IVAC program. And of course, you know, it's strengthening the effects 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 potential pivotal trial. So that's the reason why we are investing significantly on the GMP.

16:53 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 are referring to the phase two that they've already published, but also the potential phase three in adjuvant setting melanoma. So first of all, I mean, long term follow-up data set that they have published just recently, I would say confirm what they've already published a few years ago in terms of the efficacy of their INTD 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 twenty twenty seven. And of course, you know, for the INTV community, you know, the phase three data would be quite important because, you know, if the data is positive, you know, the data will continue to derisk the iNTV approach.

18:06 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 wait, you know, our data set in the next specifically the randomized Phase II study, you know, before making any conclusion, because again, our technology is different from MODELLA-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? But of course, we have to wait. So, and from a BioNTech point of view, right, so as they are doing some changes in their leadership.

18:55 And they have recently also announced that they plan to close their phase two trial in the oral thalia cancer because the competitive landscape has changed significantly. And therefore, you know, what they say is, of course, they do some reprioritization and now they are staying focused on pancreatic cancer and colon cancer. And, you know, we don't know the data. These studies are still ongoing. And again, you know, of course, we hope to develop for all these studies that are in the INTD field in all respecting because again, all these data points will help to continue to derisk the field and of course, for biotech companies to continue to accelerate the development.

19:50 Thanks. That's a very detailed answer. Appreciate it. Thank you. Yeah. So we have received a few questions on the chat. So I'll turn the I'll take and read Leonel Abode's question. Leonel is from Biomed in class. So the question is regarding the new indication, g four thousand seventy 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 the same type of methodology, but in other indication where the medical needs is quite significant.

20:54 And indication would be very different from a genetic from a biological standpoint. And also in terms of the potential of being immunogenic tumor. And I cannot disclose exactly what we are going to plan. So we are in the kind of 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 too. We're very confident that this study, you know, can start this year. Thank you. So we had a question from Jameela, but I think we've answered it within the current landscape.

21:44 I also have a question from Martian Descouture, Adobe HS, which is as you expand myVAC platform, 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 CG4050, 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 you will know what we have disclosed in the disease free survival curve. So having a flat curve without any relapse by itself is very important for resetting a genetic cancer patient. So we hope that, you know, we are going, as I said also, answering the question from Kiara, we hope to see the same kind of shape of the curve or the same type of separation.

22:56 And of course, the same durability of the plateau that we are observing in the phase one 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 for patients. And of course, by doing that, to stay very open on potential opportunities. And 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 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.

24:02 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 twenty four months, 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 product.

24:49 Okay. We have a quick few follow-up questions from Janila El Boubreni from AllInvest. So any updates 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 two patient randomization to be completed during Q2 twenty twenty six? And finally, how should we think about the timing for initiating a phase one trial in a new indication this year? So, I mean, three years survival data for the phase one study of TG4050 would be potentially, that's our plan, you know, presented at ESMO. And of course, this 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, your first question. So the second question related to the randomized Phase II trial. So I mean, the randomization will be completed certainly by Q2, right? So that's our plan, right? And of course, we will obviously send an announcement as soon as we have this milestone completed, but we are kind of optimistic that really we are close to

26:20 the recruitment. And then the third question, there was another one. How should we think about the timing for initiating a phase one trial? Yeah, as we mentioned, it's going to be in 2026. As soon as we have the formal program from the health authorities, we're going to move forward. And I think that we have, at least I don't have additional questions. Sorry, a few ones. Thank you very much, everyone, for your question. Thank you for the questions. 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 neuronal therapy vaccine that can be potentially transformative for patients and they can, as you have seen, can go beyond one single indication.

27:27 Looking ahead, we are confident in our strategy in the transformative potential of the MiVac platform. And with the financial visibility until early twenty twenty eight and a clear path to key 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 call. Have a great rest of your day and talk to you soon. Operator, please. This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

28:13 Thank you. Thank you.