Transgene SA ($TNG)

Good day, and thank you for standing by. Welcome to the Transgene 2025 Annual Results and Prospective for 2026 Conference Call and Webcast. [Operator Instructions] 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 Larguier. Please go ahead.

Well, thank you, Nadia, and hello, everyone. So I'm Lucie, Chief Financial Officer at Transgene, 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. [Operator Instructions] With this, I now turn the call over to Alessandro.

Thanks, Lucie, and good morning, good evening, good afternoon, everyone. So 2025 has been a year of meaningful clinical progress for Transgene. As you all 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 3 crucial moments this year that confirm our conviction that the myvac platform can bring benefit to patients. First of all, our Phase I data being presented already at ASCO in the same section as 2 Phase III trials in head and neck cancer. Second, the immunogenicity data that we present at the SITC conference in November in the United States of America; and third, the completion of EUR 105 million fundraising that provides financial visibility until the first quarter 2028 to support our priority programs. With these 3 major achievement, Transgene is on track to continue building the scientific and operational capability to execute our strategy. Now on Slide 5. TG4050, the first INTV based on our myvac platform is currently being evaluated in international randomized Phase I/II 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 30% of patients relapse after 3 years despite the recent advances in the innovation with checkpoint inhibitors. At ASCO, we presented Phase I data showing that all patients with HPV-negative cancer who received TG4050 after surgery and the standard chemo radiotherapy remained disease-free after at least 2 years of follow-up. Importantly, the trial met all endpoints for both safety and feasibility. This 100% disease-free survival rate compared with 3 relapses observed in the control arm provides the first clinical evidence supporting TG4050 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 proof of principle for TG4050. In particular, the data showed that TG4050 induced neoantigen-specific T cell responses in 73% of evaluable patients. Importantly, these responses were durable, persisting 24 months after the start of treatment and showed cytotoxic and effector phenotype markers up to 1 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 preprint platform of [ Med Archive ] and is currently under review by peer-review journal. I'm on Slide 6 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 endpoint on the Phase I/II study is 2-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 reached 2 years of follow-up from randomization. In second half 2026, we also expect to share the first immunogenicity data from patients from the Phase II cohort of the Phase I/II study. For the Phase I part of the study, we plan to report 3-year follow-up data on disease-free survival in second, third quarter 2026, followed by 4-year follow-up in second, third quarter 2027. Beyond head and neck 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 neoantigen therapeutic vaccine tailored to each patient's tumor mutational profile. As mentioned, we are currently in the start-up phase of the new Phase I trial in a second not yet disclosed indication in 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 proceed is dedicated to advancing industrial and regulatory readiness, including the alignment with the FDA and the EMEA requirements as we move toward late-stage development. Now turning on Slide 7, BT-001, which is our intratumor administered oncolytic virus developed with our partner, BioInvent. At ESMO 2025, we presented a poster data evaluating BT-001 in combination with pembrolizumab in patients with advanced refractory tumors. This data shows positive abscopal and sustained antitumor activity in both injected and non-injected lesions. The immune-mediated tumor shrinkage observed is consistent with our mechanistic hypothesis. BT-001 in combination with pembrolizumab can convert cold tumors into immunologically active hot tumors. This data supports further 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 Lucie for the financial update. Lucie?

Thank you, Alessandro. 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 and through which we raised approximately EUR 105 million. And together with the conversion of EUR 39 million debt with TSGH into equity, Transgene strengthened 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 EUR 38.2 million. So it reflects the investment in our Phase II trial, the fact that we manufacture and enroll patients into this Phase II 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 have funded to deliver on key milestones, which include the development of 4050, the myvac platform, the planned Phase I 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, Lucie. As we look ahead, our priorities as you know, are very clear. We remain focused on TG4050, our first INTV vaccine from the myvac platform. We intent being 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 we have made so far and with the finance sources that Lucie just mentioned, we believe that we have what do 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 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.

[Operator Instructions] And now we're going to take our first question. And it comes from the line of Chiara Montironi from Van Lanschot Kempen.

I actually have a couple. So the first one, how should we be looking at the 3 years DFS data that are approaching in Q2, Q3, given that the primary endpoint and the benchmark are 2 years? What do you expect to see here? And what will be a good result? And the second question is on the immunogenicity Phase II data in H2 '26? At which follow-up will be those data, we'll be able to see the induction of the immune response also to understand that these immune responses are durable?

Thank you, Chiara. So first question is on 3-year disease-free survival data. First of all, we plan to send an abstract for the ESMO conference in Q3 2026. And 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 2 curves stay separated throughout the additional follow-up. So that's the base case scenario. The best case scenario, which is 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 the TG4050. And therefore, this scenario will show a larger magnitude of the separation of 2 curves. And that's what -- and of course, there is a worst-case scenario that is that we start to observe relapses in TG4050. So -- but in the base case scenario, in best case scenario, this is going to be quite good for the program and of course, for patients. Then in terms of the immunogenicity data of the Phase II study, we expect to start having the first set of data by the end of 2026. And of course, we will start to analyze the patients that were randomized first, right? So therefore, we expect that those patients have at least 1 year kind of follow-up with the potential to show durability over 1 year in the Phase II study. And of course, this will be important to start also to strengthen the data that we have presented earlier in 2025 with the Phase I. Hopefully, this is clear.

And the question comes line of Dominic Rose from Intron Health.

It's Dominic here. 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 to continue to optimize manufacturing for an individualized antigen therapeutic company like Transgene. So we plan to have full GMP manufacturing by 2027, Q3 2027. And of course, having a full GMP manufacturing is an important value creation for myvac program and, of course, we strengthened the [indiscernible] from pharmaceutical companies for the simple reason that having a GMP manufacturing allow us or the potential partner to move forward to a potential pivotal trial. So that's the reason why we are investing significantly on the GMP. Again, it is critical to succeed in the individualized neoantigen therapeutic vaccine. And then the second question was around Moderna data. I mean, I guess you're referring to the Phase II that they've already published, but also the potential Phase III in adjuvant setting melanoma. So first of all, I mean, the 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 INTV in adjuvant setting melanoma. And of course, they clearly say that they will disclose the Phase III data always in adjuvant melanoma by the end of the year, beginning of 2027. And of course, for the INTV community, the Phase III data will be quite important because if the data is positive, the data will continue to derisk the INTV approach. And of course, if the data is negative, then as you know, Transgene has a different technology with a different vector. And we think that we will have to wait our data set in head and neck, specifically the randomized Phase II study before making any conclusion because, again, our technology is different from Moderna one. But of course, for patients for the field, we hope that the melanoma data, Phase III is going to be positive, right? So -- but of course, we have to wait. So -- and from a bio and tech point of view, right? So as you know, they are doing some changes in their leadership and they have recently also announced that they plan to close their Phase II trial in the [indiscernible] cancer because the competitive landscape has changed significantly. And therefore, what they said, of course, they do some reprioritization and now they are staying focused on pancreatic cancer and colon cancer, and we don't know the data, the studies are still ongoing. And again, of course, we hope for all it will be there for all the studies that are in the INTV field in early setting because, again, all the data points will help to continue to derisk the field and, of course, for biotech companies to continue to accelerate the development.

So we have received a few questions on the chat. So I'll take and read [indiscernible] question, [indiscernible] from Biomed Impact. So the question is regarding the new indication, TG4070 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 I study in a new indication that, I would say, very similar to what we did in head and neck, same type of methodology, but in another indication, where the medical need is quite significant. And the indication will be very different from head and neck 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 time lines associated to. We're very confident that this study can start this year.

So we had a question from [ Jamie Land ], but I think with [indiscernible] from all investment, I think we've answered it given the current landscape. I also have a question from Martial Descoutures, ODDO BHF, 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 II?

So let's start from the last question perhaps. So everything that is similar to what we have observed in the randomized Phase I makes a lot of sense for patients. And you know what we have disclosed and the disease-free survival curve. So having a flat curve without any relapses by itself is very important for early setting head and neck cancer patients. So we hope that we are going -- as I said also answering the question from Chiara, we hope to see the same kind of shape of the curve, 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 for patients. So -- and of course, by doing that to stay very open on potential opportunities 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 II, in terms of optimization of the manufacturing, in terms of showing that we are able to do a second indication with a manufacturing process that is even better than what we have used in the Phase I and the Phase II 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, we can generate interest from potential partners and working them together to launch a potential Phase III trial. So value creation first dialogue in parallel with the industry and third potential collaboration to continue to accelerate our program.

Okay. We have a quick few follow-up questions from [indiscernible] from [ All Invest ]. So any update on the media conference where you plan to report Phase I data, particularly the 3-year survival. Should we assume it's ASCO? Should we expect Phase II patient randomization to be completed during Q2 2026? And finally, how should we think about the timing for initiating a Phase I trial in a new indication this year?

So I mean the 3 years survival data for the Phase I study of TG4050 will be potentially that's our plan 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 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 -- I mean, will be completed certainly by Q2, right? So that's our plan, right? So -- and of course, we will obviously sign an announcement as soon as we have 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 I trial?

Yes. 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 wins. Thank you very much, everyone, for your questions.

Thank you for the questions. So just to close, I mean we think that 2025 was a year of strong progress for Transgene. As I mentioned, we continue our journey to continue to establish Transgene as a key player in this field of individualized neoantigen therapeutic vaccine that can be potentially transformative for patients and 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, so we are very well positioned to deliver meaningful value for patients and shareholders alike. We are grateful for your, of course, continued 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. You may now all disconnect. Have a nice day.