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 this as interactive as possible. 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 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 benefit to patients.

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 the SITC conference in November in the United States of America.

Third, the completion of €105 million fundraising that provides financial visibility until the first quarter 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 this 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 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 chemoradiotherapy remained disease-free after at least two years of follow-up.

Importantly, the trial met all its endpoints for both safety and feasibility. This 100% disease-free survival rate compared with the three relapses observed in the control arm provides the first clinical evidence supporting TG4050's 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 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 the cytotoxic and effector 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 preprint platform of medRxiv, and is currently under review by peer-reviewed 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 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.

We expect this efficacy readout 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 II cohort of the Phase I/II study.

For the Phase I part of the study, we plan to report 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 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 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 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 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 on 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 Phase I data evaluating BT-001 in combination with pembrolizumab in patients with advanced refractory tumors.

This data showed 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, 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 updates. 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 €105 million.

Together with the conversion of €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 funded until early 2028.

If we look at our cash burn over last year, it was approximately €38.2 million, 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 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.

Alessandro, if you want to comment on outlook?

Yes, thank you, Lucie. As we look ahead, our priorities, as 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 had just mentioned, we believe that we have what we need to execute on the next phase of development. Overall, when we look at the next 24 months that have 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 Invest Securities events in Paris on April 9 and 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 questions.

Operator, please, up to you.

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-year 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 would be a good result?

The second question is on the immunogenicity Phase II data in H2 2026. 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. First question is on three-year disease-free survival data.

We plan to send an abstract for the ESMO conference in Q3 2026. What we should expect, of course, we don't know because we have not analyzed the data.

The base-case scenario is, of course, that we continue to see that the two curves stay separated throughout the additional follow-up. That's the base-case scenario.

The best-case scenario, which is not as good for patients that have been randomized to the observation, is to observe more relapses in the arm that did not receive TG4050. Therefore, this scenario will show a larger magnitude of the separation of the two curves.

Of course, there is a worst-case scenario that is that we start to observe relapses in TG4050. In the base-case scenario and the 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. Of course, we'll start to analyze the patients that were randomized first, right.

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 II study. 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?

Yes. Thank you.

Thank you, Chiara.

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 re-configuration 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? 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 it is important, to continue to optimize manufacturing for an individualized, neoantigen therapeutic company like Transgene. We plan to have, full GMP GMP manufacturing by, by 2027, Q3 2027.

Of course, having a full GMP manufacturing is an important value creation for the myvac program. Of course, it strengthens the the attract in or from pharmaceutical companies for the simple reason that, having a GMP manufacturing, it allow us, allow us or the potential partner, to move forward to a potential pivotal trial.

That's that's the reason why we are investing significantly on the GMP. Again, it is critical, to succeed in the individualized neoantigen therapeutic vaccine.

Then the second question was around the Moderna data. I guess you're referring to the to the Phase II that they've already published, but also the potential Phase III in in adjuvant setting melanoma.

The, the long-term follow-up datasets 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, of their neoan INTV in adjuvant setting melanoma. 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.

Of course, for the INTV community, the Phase III data would be quite important because, if the data is positive, they the data will continue to de-risk the INTV approach. Of course, if the data is negative, then, as Transgene has a different technology with a different vector, and we think that we will let go, to wait, our datasets in in head and neck, specifically the randomized Phase II study, before before making any conclusion, because again, our technology is different from Moderna one.

Of course, for patients and for the field, we hope that the melanoma data, Phase III, is going to be, positive, right. Of course, we have to wait.

From a BioNTech point of view, right, so as they they they're doing some some, some changes in their leadership, and they have recently also announced, that they plan to close their Phase II trial in the colorectal cancer because the competitive landscape has changed significantly, and therefore, they they what they said, of course, they they do some reprioritization, and now they're staying focused on pancreatic cancer and colon cancer. We don't know the data.

The studies are still ongoing. Again, of course, we hope for the best for all these 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.

I'll take and read Lionel Laborie's question. Lionel is from Biomed Impact.

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 homogenous 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 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. The indication will be very different from head and neck from a biological standpoint and also in terms of the potential of being an immunogenic tumor.

I cannot disclose exactly what we are going to plan. We are in the 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 to. We are very confident that the study can start this year.

Thank you. We had a question from Djamila El Bougrini from Allinwest, but I think we've answered it.

It was on 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?

Thank you."

Let's start from the last question perhaps. Everything that is similar to what we have observed in the randomized Phase I makes a lot of sense for patients.

You well know that what we have disclosed and the disease-free survival curve. Having a flat curve without any relapses by itself is very important for early setting head and neck cancer patients.

We hope that, 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. 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 for patients.

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. 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 do a second indication with a manufacturing process that is even better than what we have used in the Phase I and 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, 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 third, potential collaboration to continue to accelerate our program.

We have a few follow-up questions from Djamila El Bougrini from Allinwest. So, "Any update on the mid-year 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?"

The three-year disease-free survival data for the Phase I study of TG4050 will be potentially, that's our plan, presented at ESMO. Of course, this requires that ESMO accept our abstract.

We plan to submit it and then we will keep you posted 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. The randomization will be completed certainly by Q2, right, so that's our plan, right.

Of course, we will, Lucie send an announcement as soon as we have 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— Yes,

"How should we think about the timing for initiating a Phase I 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.

I think that's all we have. At least I don't have additional questions.

Sorry. A few words.

Thank you very much, everyone, for your questions.

Thank you for the questions. Just to close, we think that 2025 was a year of a 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 patient and that can, as you have seen, go beyond one single indication. Looking ahead, we're 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 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 the day and talk to you soon. Operator, please.

Thank you.

Thank you.