Thank you for standing by. Welcome to the Transgene 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 one one on your telephone keypad. You will hear an automatic message advising your hand is raised. To withdraw your 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 any time during live event. 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. 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. 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. 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, Lucie, morning, good evening, good afternoon, everyone. 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 three crucial moments this year that confirm our conviction that the myvac platform can bring benefits to patients. First of all, our phase I data being presented orally at ASCO in the same session as two phase III trials in head and neck cancer. Second, the immunogenicity data that we presented at SITC conference in November in the United States of America.
Third, the completion of EUR 105 million of fundraising that provides financial visibility until the Q1 2028 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. Now on the 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 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 chemoradiotherapy remained disease-free after at least two years of follow-up. Importantly, the trial met all 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 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 the 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 show the cytotoxic and effector phenotype markers up until 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 medRxiv and is currently under review by peer-reviewed journal. I'm on slide 6 now. Let me now turn to 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 of the phase I/II study is two-year disease-free survival. That is very well recognized by the health authorities as being an important and critical milestone, and we expect this efficacy readout once all patients reach two years of follow-up from randomization. In H2 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 a three-year follow-up data on disease-free survival in second, Q3 2026, followed by four year follow-up in second, Q3 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 startup phase of the new phase I trial in the second not yet disclosed indication in early treatment setting, and our goal is to initiate it, this trial, in 2026. We are actively optimizing our manufacturing process, improving turnaround time, and preparing for increased production volumes. Importantly, part of the proceeds is dedicated to advancing industrial and regulatory readiness, including the alignment with the FDA and the EMA requirements as we move toward late-stage development. Now turning to slide 7, BT-001, which is our intratumoral administered oncolytic virus developed with our partner, BioInvent.
At ESMO 2025, we presented a poster with updated final data evaluating BT-001 in combination with pembrolizumab in patients with advanced refractory tumors. This data shows a positive local 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. 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. 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 EUR 105 million. Together with the conversion of a EUR 39 million euro debt with TSG 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.
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 TG4050, 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. 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 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 we have made so far and with the financial resources that Lucie just mentioned, we believe that, you know, we have what we need to execute on the next phase of development. 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 Kempen Life Sciences 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 would be happy to take your question. 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 one one on your telephone keypad and wait for your name to be announced. To withdraw your question, please press star one one again. Alternatively, you can submit your questions via the webcast. Please stand by while we compile the Q&A queue. This will take a few moments. Now we're going to take our first question, and it comes from the line of Chiara Montironi from Van Lanschot Kempen. Your line is open. Please ask your question.
Hello, Alessandro. Hello, Lucie. Thanks for taking my question. I actually have a couple. 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? The second question is on the immunogenicity phase II data in H&N. At which follow-up will be those data, we'll 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. First question is on three years disease-free survival data. First of all, you know, we plan to send an abstract for the ESMO conference, you know, in Q3 2026. You know, what we should expect, of course, we don't know because we've 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. That's the base case scenario. You know, the best case scenario, which is, you know, which is not perhaps good for patients that have been randomized to the observation is to observe more relapses in the arm that you know, did not receive the TG4050.
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. Of course, there is a worst case scenario, that is, that we start to observe, you know, relapses in TG4050. 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. In terms of the immunogenicity 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. Of course, we start to analyze, you know, the patient 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. Of course, this will be important to start also to, you know, strengthen the data that we have presented earlier, you know, in 2025 with the phase I. Hopefully, this is clear.
Yes. Thank you.
Thank you, Chiara.
Thank you. Now we're going to take our next question. The question comes from the line of Dominic Sherouse 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? How impactful is that versus getting new data? My second question is, what, if anything, do you hope to learn this year from the Moderna data readouts?
Okay. The first question is around the GMP manufacturing. As you know, it is important, you know, to continue to optimize manufacturing for an individualized, you know, neoantigen therapeutic company like Transgene. 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 for the myvac® program and of course, you know, is strengthening the attractiveness, you know, from pharmaceutical companies. For the simple reason that, you know, having a GMP manufacturing, you know, it allows us or the potential partner, you know, to move forward to a potential pivotal trial. 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. The second one question was around the 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. First of all, I mean, you know, the long-term follow-up data set that they have published just recently, I would say confirm what they've already published, you know, a few years ago in terms of the efficacy of their INTV in adjuvant setting melanoma. Of course, you know, they clearly say that they will disclose the phase III data, also in adjuvant melanoma, by the end of the year, beginning of 2027.
Of course, you know, for the INTV 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 INTV approach. 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 would like, you know, to wait, you know, our data set in head and neck, specifically the randomized phase II study, you know, before making any conclusion because again, our technology is different from Moderna one. But you know, of course, for patients and for the field, we hope that the melanoma data phase III, you know, is going to be, you know, positive, right?
Of course, we have to wait. From a biotech point of view, right, so as you know, they, you know, they are doing some changes in their leadership, and they have recently also announced, you know, that they plan to close their phase II trial in the oropharyngeal cancer because the competitive landscape has changed significantly and therefore, you know, what they said, of course, they do some reprioritization, 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.
Again, you know, of course, we hope all the best for all the studies that are in the INTV 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. Appreciate it.
Thank you.
Yeah, we have received a few questions on the chat, so I'll take and read Lionel Laborde's question. Lionel is from BioMed Impact. The question is regarding the new indication TG 47 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 homogeneous or will you address several types of solid tumors, single or multiple injections?
This is going to be a one indication. It's not a basket protocol. It's going to be a 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 you know the medical need is quite significant. The indication will be you know very different from head and neck from a biological standpoint, and also in terms of you know the potential of being a you know immunogenic tumor. I cannot disclose exactly what we are going to plan. We are kind of waiting for the regulatory feedback on the final protocol.
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 the study, you know, can start this year.
Thank you. We had a question from Jamilia El Bougrini, but I think Jamilia El Bougrini from Investec Securities, but I think we've answered it within the current landscape. I also have a question from Martial Descoutr, 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? Thank you.
Let's start from the last question, perhaps. You know, everything that is similar to what we have observed in the randomized phase I, you know, makes a lot of sense for patients, you know, and you are well aware of what we have disclosed and the disease-free survival curve. Having a flat curve without any relapses by itself is very important for early-stage head and neck cancer patients. We hope that, you know, we are going as I said, also answering the question from Chiara, we hope to see the same kind of shape of the curve or the same type of separation and of course, the same durability of the plateau that we are observing in the phase I study.
In terms of the long-term strategy for Transgene related to myvac, I would say that first of all, our priority is to continue to create value, you know, for patients. Of course, by doing that, to stay very open, you know, on potential opportunities. You know, in terms of having a kind of constructive dialogue with the scientific community, with the pharmaceutical companies. 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'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 I and the phase II study.
All this kind of value creation activities and catalysts will help significantly to attract the interest of pharmaceutical companies. The objective that we have is ultimately to bring the organization to a kind of starting block for launching a potential pivotal trial. We hope that if we demonstrate that in the next 24 months, you know, we can generate interest from potential partners and working then together to launch a potential phase III trial. Value creation first dialogue in parallel with the industry, and so the potential collaboration to continue to accelerate our product.
We have a few follow-up questions from Jamilia El Bougrini from Investec Securities. Any update on the medical conference where you plan to report phase I data, particularly the three-year survival? Should we assume it's ASCO? Should we expect phase II patient randomization to be completed during Q2 2026? Finally, how should we think about the timing for initiating a phase I trial in a new indication this year?
I mean, the 3-year study survival data for the phase I study of TG4050 will be presented at ESMO. I mean, that's our plan, you know. Of course, this, you know, requires that ESMO accept our abstract. 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. That's your first question. The second question related to the randomized phase II trial. I mean, the randomization will be completed certainly by Q2. All right? That's our plan, right? Of course, we will, you know, obviously send an announcement as soon as we have, you know, this milestone completed.
We are kind of optimistic that really we are close to the final recruitment. Then the third question, there was another one was about-
How should we think about the timing for initiating a phase I trial?
Yeah. As we mentioned, it's going to be in 2026. You know, as soon as we have the formal approval from the health authorities, we're going to move forward.
I think that's all we have. At least I don't have additional questions. If you will, thank you very much, everyone, for your question.
Thank you for the question. Just to close, I mean, we think that 2025 was a year of stronger progress for Transgene. As I mentioned, we continue our journey to establish Transgene as a key player in this field of individualized antigen therapy vaccine that can be potentially, you know, transformative for patients. They can, as you have seen, go beyond one single indication. Looking ahead, we are confident in our strategy, in the transformative potential of the myvac® platform. With the financial visibility until early 2028 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'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.
Thank you.
Thank you.