Good day, and thank you for standing by. Welcome to the Transgene 2025 Half Year Financial Results Conference Call and Webcast. [Operator Instructions] After the speaker's presentation, there will be the question and answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Lucie Larguier, Chief Financial Officer. Please go ahead, madam.

Thank you, Maria, and good afternoon, everyone. Thank you for joining us on today's call to discuss our progress over the First Half of 2025 as well as a half year results. You can access the press release issued today on the Investor page of our website. On today's call is Dr. Alessandro Riva, our Chairman and CEO. After Alessandro's discussion, we will take questions already on this telephone call and also on the web platform. Before we begin, I'd like to remind everyone that today's discussion contains forward-looking statements, which are subject to a number of risks and uncertainties. And with this, I now hand over the call over to Alessandro. .

Thank you, Lucie, and good afternoon, everyone. I would say that it has been an exciting first half of the year, not only for Transgene Individualized Therapeutic Vaccine, but also and more importantly, for the head and neck cancer community. We presented the full 24 months disease-free survival data for all Phase I patients treated in randomized Phase I trial in a rapid oral presentation at ASCO this year in a session that was dedicated to head and neck cancer. We are extremely proud that all operable head and neck squamous cell carcinoma patients treated with our Individualized Therapeutic Vaccine, TG4050 in the randomized Phase I trial remain disease-free after a median follow-up of 30 months, as you can see from the Kaplan-Meier course projected in this slide. And now on Slide 5, all the trial endpoints of the randomized Phase I study were met. Safety is extremely good. Immunogenicity has been demonstrated. And not only do we see the induction of a specific cellular immune response, but also we see that this response are durable and can still be seen after 24 months since the start of treatment. We will present additional immunological data from this trial at a scientific conference in Q4 2025, including insight into the phenotyping of patients' immune response. In addition, as you can see in this slide, the ongoing Phase II trial is progressing at a very good pace, and we are very confident that we will randomize the last patient in Q4 2025 allowing us to plan for the communication of the first immunogenicity data in the second semester 2026 and the 2-year efficacy data in the Q4 2027. I'm now going to Slide 6. TG4050 randomized Phase I data were presented at ASCO along with other 2 trials with immune checkpoint inhibitors in the adjuvant treatment of operable head and neck squamous cell carcinoma, the KEYNOTE 689 and the NivoPostOp trial. These 2 trials, as you can see, extremely encouraging data and pembrolizumab, as you know, is now approved for this patient population in the United States of America and probably soon in Europe. Nevertheless, 35% of patients relapse within two years after surgery and that is exactly where the future lies for TG4050, improving the outcomes for these patients that do not benefit durably from immune checkpoint inhibitors. Moving to Slide 7. So as you can see, we want to build on the positive Phase I data and the successful inclusion in the Phase II trial. And for this reason, we are discussing with clinicians the best way forward for TG4050 in the head and neck cancer so that we can bring this potential new treatment to patients in need as quick as possible. In addition, our myvac platform has broader potential in early solid tumor setting that goes beyond head and neck tumors. We want to continue to leverage this unique technology to address areas of high unmet medical need. And that's why in parallel, we continue to prepare a potential new Phase I trial in the early treatment of a solid tumor with biology that different from the head and neck tumors. We aim to initiate this study as soon as all conditions are met from a regulatory and financial point of view. As you know, and I'm on Slide 8, the manufacturing is key for Individualized Vaccine as it is key for CAR-T cell therapy. That's a topic that we started to address from the beginning of our work on myvac. We have demonstrated feasibility to deliver TG4050 to operable head and neck cancer patients in the context of a multicentric multinational Phase I/II trial. The next step for us is to continue optimizing the manufacturing process for myvac technology and for TG4050 to be able to scale up and run several trials in parallel, including a potential registrational trial. Under the guidance of our Chief Technical Officer, Simone Steiner, who joined Transgene before this summer, we will continue to invest to ensure smooth execution to support further acceleration of the myvac program. We believe that scientific excellence, strong data and operational focus generated with TG4050 clearly differentiated Transgene in this highly competitive and attractive field. Hence, the rationale, as you can see in this slide, of our decision to focus our efforts and resources on our lead program myvac platform and today TG4050. With regards to our other programs, we will present a poster at ESMO in Berlin on the data generated by BT-001 in the Phase I trial as monotherapy and in combination with pembrolizumab. We have seen interesting responses in patients with refractory diseases, in particular, leiomyosarcoma patient and melanoma patient. Looking at leiomyosarcoma patients, you can see that BT-001 was able to positively change the tumor microenvironment. The science generated around this initial trial constituted the basis of discussion with clinicians to continue the development of this candidate in the intratumoral setting. Looking at our two other candidates, TG4001 and TG6050, we are assessing different scenario in a context where the overall financing environment for biotech company is pushing us to focus on key value-creating programs. And now I'm going to hand over to Lucie for some words on the financials. Lucie?

Yes. Thank you. So our financials are, as usual, in line with our forecast, thanks to strict monitoring of [ dilution ] and stringent cost control in today's environment. In terms of outlook, and I think it's positive, we have extended our financial rhythm, and our business is now funded until the end of December 2026, thanks to the credit facility and the engagement support from TGH, which is, in fact, [indiscernible]. I now hand over to Alessandro for a few concluding words.

So to conclude, I will say that we are now building increasing momentum on the myvac platform. The data we presented at ASCO in operable head and neck cancer with 100% survival at two years represent a solid proof of principle for TG4050 in an indication where a significant medical need remains in spite of a great improvement delivered by immune checkpoint inhibitors. Our vision is clear with a focus on individualized cancer vaccine. In the next couple of years, we will continue to present clinical catalysts in head and neck, the Phase I will deliver additional and informative immunogenicity data that will be presented in Q4 2025 at a scientific conference. You can also expect the follow-up at three years from the same study in the middle of 2026. The Phase II trial in operable head and neck cancer patients is well on track and data are expected in second half 2026 regarding the first immunogenicity data and in Q4 2027, the 2-year disease-free survival data. When all conditions are met, as discussed, we'll be able to start an additional Phase I trial in a new indication in operable setting. The individualized cancer vaccine field continues to evolve and start to be derisked from both scientific and clinical point of view. And when looking at the economics, operable head and neck cancer alone represent a market of more than $1 billion per year at peak. We continue to work harder to deliver on our strategy with important milestone in sight, we are confident that Transgene is well positioned for the next step. And now Lucie and I will take your questions. Operator, please.

[Operator Instructions] And now we're going to take our first question from audio line. And it comes from the line of Clara Montoni from [indiscernible].

This is [ Clara Montoni ] from [indiscernible]. Congrats for the update. I was wondering if you could remind us when do you expect to announce more on the TG4050 development plans? Will this be pivotal plans? And also, can you talk a bit more about or in the context of the recent approval of Neoaduvant and Adjuvant KEYTRUDA in localized head and neck cancer. So specifically, I was wondering if those 35% of patients relapse, do they have particular baseline features? Could you please expand on that?

Okay. Thank you, Clara. So first of all, in terms of more clarity and visibility related to the next step for TG4050 in head and neck and in particular, the potential pivotal Phase III trial. We plan to have some visibility by Q2, 2026. The reason being that, of course, we are starting the discussion with some expecting clinicians in the field of head and neck. We're going to finalize the proposal that, of course, will be discussed with the health authorities, and we plan to update the community on the potential next step kind of around the second quarter of 2026. So -- And with regards to your second question related to KEYTRUDA pembrolizumab in the KEYNOTE 689. So if you look at the New England Journal of Medicine publication, that is the only source of information that we have -- it doesn't appear that there is a particular prognostic factor that is underscored in terms of potential risk of relapses. So this is something that will have to be explored further. And also when we will have more data from the other trial with nivolumab, NivoPostOp [indiscernible], we are going to clarify this topic. So the [ idea ] that we have independently of the risk factors is that knowing that there are around 35% of patients that unfortunately continue to relapse despite the immune checkpoint inhibitor is really to try to find the way TG4050 can further improve the treatment outcome, [ dependency ], I would say, of the prognostic factors.

So we have other questions coming from the web -- my mailbox. We have one from Amar Singh from [ Intron ] Health. Will the Phase I trial of TG4050 in a new indication still be initiated in Q4 2025? And can you provide us with any detail on this next indication?

So the answer, as we said during the call, so we are already working towards the finalization of the protocol. We are in discussion with the health authorities. And as soon as we have the green light from the health authorities, and the financial condition are met. In other words, we have the right financing for the trial. We're going to start the trial. And of course, we are still aiming towards an initiation of the trial as quick as possible. As I said, it will depend from the regulatory authorities' feedback and from financing that we are considering as we speak.

Another question that we have, well, two questions from [indiscernible]. Could you please disclose the conference -- well, at which conference the new data on TG4050 will be presented in Q4 -- and is an early access program a realistic opportunity for TG4050 probably in line of 36 months data.

Okay. So we are going to disclose the full data set of the immunogenicity data at the ST conference in November in the United States of America. This is an important conference for immunology in cancer. So -- and we have submitted an abstract to the conference that has been accepted for presentation. And of course, we look forward to sharing this very important information from the Phase I study. So -- and in terms of the early access program, we think that it is rather early to activate this type of program. And we think that this is something that we could eventually assess in the near future with additional information and additional data. So that's. Yes.

And we have a final question that I received from [indiscernible] that somehow overlaps with [indiscernible] Joni's question, but it is up to you. So in the press release, you highlight that [indiscernible] is currently evaluating the most efficient regulatory pathway to accelerate the development of 4050 and bring it to patients with operable head and neck cancer as quickly as possible. Could you elaborate these thoughts or objectives? What are the challenges or the next step to have more visibility on the regulatory pathway or market environment? It's a pretty broad question.

Yes. So it's a very broad question and it's very similar to what also [ Piara ] asked. So I mean, the bottom line is that we believe that there is a very significant momentum for innovation with immunotherapy in head and neck cancer operable patients. We believe that the data that we have shown at ASCO, know this very compelling in order to think about the potential next step given the fact that pembrolizumab is going to become a kind of standard in the early setting head and neck cancer. So we are brainstorming as we speak with clinicians with expertise, of course, in the head and neck on the potential trial design that could also be considered pivotal in nature. So -- and then based on the feedback, we are going also to have discussion with the health authorities. As I mentioned in my presentation, this process will last around 6, 9 months. And by Q2 2026, we'll be able to share with the community what's going to be the next step in terms of the next trial for squamous head and neck cancer patients.

I don't have -- I think we've covered all the questions. We have an additional question from Marcias. Could we have an update on TG6050? And what could we expect for this compound in the next steps? Will you disclose the Phase I data in a future conference?

Yes, we are going to -- first of all, TG6050 is our IV oncolytic virus. We have completed the Phase I study in relapsed/refractory non-small cell lung cancer patients. We are going to share the information with the community on this asset. However, we don't think that this is going to be an oncolytic virus that will be accelerated in the context of our priortization that I mentioned in the presentation and in the context also of that we are observing in heavily pretreated patient population. So this is TG6050 is not our focus, and we prefer, as mentioned, focusing on the value creation assets that we shared in todays call.

Sorry. So I don't see any other questions -- sorry for my voice. Alessandro, maybe a closing statement.

Yes, we do. So it has been -- I would say it has been a very exciting first 6 months. We are already in September, I would say also the third quarter is getting very, very interesting. As we try to convey to you, Transgene is ideally positioned to deliver multiple clinical milestones for myvac platform and TG4050. So -- and really, we are very well positioned to execute and focus on our key priorities. Obviously, we remain committed to deliver -- [indiscernible] in patient, in particular in operable. And with this, I would like to conclude today's call. Have a great afternoon and evening and talk to you soon and see you soon. Bye.

Goodbye.

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.