Transgene S.A.

And thank you for standing by. Welcome to the Transgenic 2025 Half-Year Financial Results 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 cell phone keypad. You will hear an automatic message advising your hand is raised. To withdraw a 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 anytime during live events. Please be advised that this conference has been recorded. I would now like to hand the conference over to our first speaker today, Lucie Larguet, Chief Financial Officer. Please go ahead, Madam.

Thank you, Nadia, 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 our half-year results. You can access the press release issue 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 the 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 to Alessandro.

Thank you, Lucy, 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 of this free survival data for all Phase I patients treated in a 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 one trial remained disease-free after a median follow-up of 30 months, as you can see from the Kappermeyer course projected in this slide. And now on slide five, all the trial endpoints of the randomized phase one 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 these responses 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 insights into the phenotyping of patients' immune responses. In addition, as you can see in this slide, the ongoing Phase 2 trial is progressing at 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 numerogenicity data in the second semester 2026, and the two-year efficacy data in the Q4 2027. I'm now going to slide six, TG4050 randomized phase one data where presented ASCO along with other two trials with immunocheckpoint inhibitors in the adjuvant treatment of operable adenine squamous cell carcinoma, the Keynote 689 and the NEVO post-op trial. These two trials, as you can see, We are 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 injunal checkpoint inhibitors. Moving to slide 7, so as you can see, we want to build on the positive phase 1 data and the successful inclusion in the phase 2 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 medical, unmet medical need. And that's why, in parallel, we continue to prepare a potential new phase one trial in the early treatment of a solid tumor with biology that differs 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 eight, 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've demonstrated feasibility to deliver TG4050 to operable adenine cancer patients in the context of a multicentric, multinational phase 1-2 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 registration trial. Under the guidance of our chief technical officer, Simon Steiner, who joined Transgene before this summer, we will continue to invest to ensure smooth execution to support further acceleration of the MIVAC 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 Plus platform and today TG4050. With regards to our other programs, we will present a poster at ESMO in Berlin on the data generated by BT001 in the phase one trial as monotherapy and in combination with pembrolizumab. We have seen interesting responses in patients with refractory diseases In particular, a leiomyosarcoma patient and a melanoma patient. Looking at the leiomyosarcoma patients, you can see that BT-001 was able to positively change the tumor microenvironment. The science generated around this initial trial constitute the basis of discussion with clinicians to continue the development of this candidate in the intratumoral setting. Looking at our two other candidates, the TG4001 and TG6050, we are assessing different scenarios 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?

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

So, to conclude, I will say that we are now building increasing momentum on the MyVACCIA platform. The data we presented at ASCO in operable adenine cancer with 100% is three survivors at two years. represent a solid proof of principle for TG4050 in an indication where a significant medical need remains in state of a great improvement delivered by immuno-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 one 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 in three years from the same study in the middle of 2026. The phase 2 trial in operable and in neck cancer patient is well on track, and data are expected in second half of 2026 regarding the first immunogenicity data, and in Q4 2027, the two-year disease-free survival data. When all conditions are met, as discussed, we'll be able to start an additional phase 1 trial in a new indication in operable settings. The individualized cancer vaccine field continues to evolve and starts to be de-risked from both scientific and clinical point of view. And when looking at the economics, operable head and neck cancer alone represents a market of more than a billion dollars per year at peak. We continue to work hard to deliver on our strategy. With important milestone insights, we are confident that Transgene is well positioned for the next step. And now, Lucy and I will take your questions. Operator, please.

Thank you so much. Dear participants, as a reminder, if you wish to ask a question, please press star 1, 1 on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star 1 and 1 again. Alternatively, you can submit your questions via the webcast. This time, I will compile the kernel study. It will take a few moments. And now we're going to take our first question on audio line. And it comes to the line of from . Your line is open. Please ask your questions.

Hello, Alessandro. Hello, Lucy. This is Chiara Montironi from Kempen. Congrats with the update and thanks for taking my question. 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 the Audiovant, Audiovant Getruda? in localized hidden 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, Chiara. So first of all, in terms of more clarity and visibility related to the next step for TG4050 in hidden neck and in particular the you know, potential pivotal phase three trial. We plan to have, you know, some visibility by Q2 2026, the reason being that, of course, you know, we are starting the discussion with, you know, some experts and clinicians in the field of early neck. We're going to finalize the proposal that, of course, will be discussed with, you know, the health authorities, and we plan to update the community on the potential next step, you know, kind of around the second quarter of 2026. So, and with regards to your second question related to 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, you know, is underscored in terms of a potential risk of relapse. So this is something that would have to be explored further. And also when we will have, you know, more data from the other trial with Nivo Luma, but Nivo Postop, perhaps we are going to clarify this topic. So the idea that we have, you know, independently of the risk factors is that knowing that the there are around 35% of patients that unfortunately continue to relapse despite the immune checkpoint inhibitor. It's really to try to find the way TG4050 can further improve the treatment outcome, independently, I would say, of the prognostic factors.

Thank you so much.

Thanks, Chiara.

Thank you.

So we have other questions coming from the web and my mailbox. We had one from Anna, I think, from Infant Health. Will the phase one trial of Q4050 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 say 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, you know, we have the right financing for the trial, we're going to start the trial, and of course, You know, 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 the financing that we are considering as we speak.

Another question that we have, well, two questions from Lionel Labourdette. 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-month data?

Okay, so we are going to disclose the full data set of the immunocytic data at the CIT 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 one study. So, and in terms of the early access program, we think that is rather early, you know, 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, yeah.

And we have a final question that I received from Marcial D. Couture at EUDO that somehow overlaps with Chiara Mancheroni's question, but it's up to you. So in the press release, you highlight that Rangène 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.

Yeah, so it's a very broad question, and it's very similar to what also Chiara 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, you know, is very compelling in order to think about the potential next step, but given the fact that, you know, pembrolizumab is going to become a kind of standard in the early setting adenine cancer. So, we are brainstorming as we speak with clinicians with expertise, of course, on the potential trial design that could also be considered pivotal in nature. And then based on the feedback, we are going to also have a discussion with the health authorities. As I mentioned in my presentation, this process will last around six, nine months, and by Q2 2026, we'll be able to share with the community what What's going to be the next step in terms of the next trial for squamous head and neck cancer patients?

Okay. I don't have any. I think we've covered all the questions. We have an additional question from Marciel. Could we have an update on TG6050 and what could we expect for this compound in the next steps? Will you disclose the phase one data in a future conference? Thank you.

Yeah, we're going to, first of all, TG6050 is our ID on colitic virus. We have completed the phase one study in relapsed refractory in osmosis and cancer patients. We're going to share the information with the community on this on this aspect however we don't think that this is going to be a a non-quality virus that will will be accelerated in the context of our prior authorization that i mentioned in the presentation and in the context also of the that we are absorbing in heavily pretreated patient population. So this is not our focus, and we prefer, as mentioned, focusing on the value creation assets that we share in today's call.

Sorry. I don't see any other questions. Sorry for my voice.

So you see as a... Well, a virus, in other words.

A virus, right. That's a natural thing. Alessandro, maybe a closing statement?

Yeah, would do. So it has been, I would say, it has been a very exciting, you know, first six months. We're 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 a MyVac platform, NTG4050. And really, we are very well-positioned to execute and focus on our key priorities. Obviously, we remain committed to deliver innovative

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.