Good day and thank you for standing by. Welcome to the Transgene 2023 Annual Results and Perspectives for 2024 conference call. 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 11 on your telephone keypad. You will then hear an automated message advising your hand is raised. To withdraw a question, please press star 11 again. 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. Thank you, Nadia. Hello, everyone. I'm Lucie. I have the pleasure to introduce you today to Dr. Alessandro Riva, who is our Chairman and CEO, along with several members of the executive committee, who will also be here to answer your questions. We will review today's announcement mostly in view of our exciting perspective for 2024, and we will then answer any questions you may have. Before I turn the call to Alessandro, I'd like to remind everyone that today's discussion contains forward-looking statements which are subject to numerous risks and uncertainties. If you're listening to this webcast via the internet, you will not be able to ask questions. So if you wish to ask questions, please make sure that you join us via one of the conference call members, or you can also send me directly an email to larguier@transgene.fr, and I'd be happy to read your question. With this, I now turn the call over to Alessandro Riva. Thank you, Lucie, and thank you, you, for joining today's call. Before updating you on our progress, I would like to acknowledge Lucie's appointment as the Chief Financial Officer. I guess you know her very well as you have been interacting with her over the last eight years at Transgene. Her in-depth knowledge of the company's portfolio and her expertise in financial transaction will contribute to moving Transgene to the next level. Congratulations, Lucie, and we look forward to your new role at Transgene. Thank you. This new, as you can see on slide four, comes at the same time as our extended financial visibility until Q4 2025. The additional support of EUR 30 million from Institut Mérieux, our reference shareholder, shows the confidence in our plans and in the potential of our product portfolio. Moving to slide five, as you can see at the AACR conference in April, Transgene will present updated immunogenicity and clinical data on TG4050, our individualized neoantigen therapeutic vaccine as an adjuvant treatment of early-stage head and neck cancer patients. Interestingly, the presentation comes at a time when there is a growing momentum and interest in the field of cancer vaccine. We believe that TG4050 has the potential to become a significant immunotherapeutic option for early-stage head and neck cancer patients, where immunotherapy, including checkpoint inhibitors, has not yet shown a therapeutic benefit. Transgene aims to be a leader in this space. We are really building on this momentum, and we can see the growing interest from clinicians, patients, industry, and the entire community. Going now to slide six. As you can see in this slide, the year 2024 will be a key year for Transgene and will allow us to define a new footprint for the company. You will see that we are expecting new data and updated data on all our clinical-stage assets in the next nine months, and obviously, we will disclose them to the community. Moving to slide seven. On our lead asset, TG4050, as you already know, we are moving forward with NEC, our partner, in head and neck cancer patients based on the randomized phase I data that we have already generated. We are in the process of receiving final clearance to initiate the extension of the randomized phase I trial into a phase II trial in a larger sample size than the phase I. I'm sure, and I'm on slide eight, that you remember the last data we presented at the AACR and ASCO last year. We had very promising immunology data on eight patients showing a strong immunogenicity of our individualized cancer vaccine, TG4050. Clinical follow-up was about 10 months at that time, with two relapses in the observational arm only. All patients who received TG4050 after first adjuvant therapy were disease-free. In April, at AACR, we plan to provide another exciting update on the immune response in all treated patients. You will see data on cell-mediated immune response to neoantigen as well as the longitudinal follow-up of the immune responses in certain patients. These are truly exciting data confirming the strong immunogenicity of TG4050. We will also provide an update on patients' clinical condition with a median follow-up over 18 months. As you know, with today's standard of care, which is simple monitoring of patients after standard adjuvant radiotherapy with or without chemotherapy, around 30% of patients relapse within 24 months. In the second half of 2024, we will provide a 24-month median follow-up of patients, which are key to assess the benefit for patients. Another key aspect of TG4050 is that it could be used in various solid tumors. We are currently performing preliminary work to start another Phase I trial in a new indication, and obviously, we will keep you updated on the progress of this work. Overall, we believe that our individual viral vector-based vaccine is very promising and may differentiate from the current individualized neoantigen therapeutic vaccine in development. Moving on to slide 10. Our HPV-positive cancer therapeutic vaccine, TG4001, remains an important therapeutic vaccine within an evolving treatment landscape. We are running a randomized phase II trial that compares TG4001 plus avelumab versus avelumab alone in HPV-induced anogenital cancer patients that have not received prior therapy with checkpoint blockers. At ASCO last year, we presented a poster showing that TG4001 induced a specific response against the vectorized antigen. We plan to present top-line data in the second semester 2024, and this is going to be the final data based on the primary endpoint. The next step of the program, including potential partnership, will be based on the randomized Phase II data. Moving to slide 11. With our oncolytic virus, Transgene capitalizes on its viral vector expertise to develop another type of innovative immunotherapy. Oncolytic virus, with their selective replication in tumor cells only, are ideal cargo transporters inducing site-specific expression of proteins in the tumor to boost the immune response. With the ability to be administered intravenously, our novel Invir.IO platform-based candidates can really be differentiated from other oncolytic viruses in development. Moving to slide 12. Our leading IV candidate is TG6050, a novel oncolytic virus that vectorizes interleukin-12 and anti-CTLA-4 antibody. We have obtained very encouraging preclinical data showing sustained expression of interleukin-12 in tumors, remodeling of the tumor microenvironment, activation of numerous innate and adaptive immunopathways, and very strong antitumor activity in several preclinical models. The first patient in our ongoing clinical trial in refractory non-small cell lung cancer was treated with monotherapy TG6050 at the beginning of 2023. We are enrolling patients at a very strong pace and plan to communicate initial data in the second semester 2024. This data will inform the basis of a future potential evaluation in combination with immuno checkpoint inhibitors. Moving to slide 13, BT001. It's our intratumoral OV program in collaboration with BioInvent. We communicated positive phase I data with the compound in solid tumors in May 2023. Out of 18 patients who received escalating doses of BT001, 2 showed a decrease of injected lesion size of 50% or more, and 11 had a stabilization of the injected lesion. The SEPTI data was also satisfactory. We are progressing the trial with our co-development partner, BioInvent, and MSD, who are supplying pembrolizumab for use in combination with BT001. The combination part of the trial with Pembro is enrolling patients, and we plan to report initial data for this combination in the second semester 2024. As you can see on slide 14, we will generate data on all our clinical assets in 2024. Again, this data will be key to define the profile of the company and to make sure that we are in the best possible setting to continue financing growth. I already look forward to discussing our next TG4050 data, which has been selected by AACR to be showcased in their own press conference. I hope this brief overview has clearly highlighted the potential of our immunotherapy pipeline. Transgene is well financed with a strong management team in place. Our focus remains to progress TG4050 and important upcoming data in 2024. I believe that Transgene is on the path of an exciting future ahead, and I look forward to telling you more about our plan as we continue progressing. Now I turn over to the operator or to Lucie for the Q&A. Yep. Thank you, dear participants. As a reminder, if you wish to ask a question over the phone, please press star 11 on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star 11 again. Listen back. We'll compile the Q&A roster. This will take a few moments. Once again, if you wish to ask a question, please press star 11 on your telephone keypad. Lucie, at this moment, we do not have any questions over the phones, and I would like now to hand over the call to you for any written questions. Yep. Thank you. So I have a question from Martial Descoutures, ODDO BHF. Well, the first one, could you come back on the phase II of TG4050 in head and neck? Could we still expect that this trial could be a pivotal one in patients having a high risk to recidivate at this time? The second question concerns the CapEx costs and what we could expect in short- and mid-term. Could you give us more details on the next steps of the manufacturing processes and the costs that we could expect? Thanks a lot. So thank you, Lucie. The first question is about the nature of the phase II trial, whether it's going to be pivotal or not pivotal. So the study has been designed to enlarge the sample size and to confirm the preliminary efficacy that we have seen in the randomized phase I study, and we are going to expand it in the randomized phase II study. At the moment, we do not have the intention to consider the trial as pivotal. However, based on the data that we will see, we will share the information and the data with the health authorities, and we will move forward according to the data and their opinion. Concerning the question on the manufacturing processes and the cost related to our work to continue to optimize manufacturing for TG4050, what we can say is that, number one, we are really moving forward very quickly to make manufacturing feasible and scalable for the next phase of development. The cost that we cannot disclose, and you know very well the reason, right? So are anyway within our current operating expenses. So therefore, Transgene, our operating expenses that are in the range of EUR 35 million-EUR 38 million, with this type of expenses, we can sustain the optimization of the manufacturing and preparing the organization for the next step of TG4050 development. And then I think that's it. Yeah. That's it for this question. I think we have another. We have a new question on the queue. Yes, we do. Jaz, give me a moment. Now we're going to take the question from Suzanne van Voorthuizen from Van Lanschot Kempen. Your line is open. Please ask your question. Hi. Good evening, team. Congrats, Lucie. Thank you for taking my question. Maybe for the upcoming data updates that you will present for the TG4050 program, can you elaborate or remind us what we should expect? What kind of data will you present in the first half and later in the year? And especially for the second update, can you provide some thoughts around benchmarks or what you would consider good data or what is the proportion of patients that you would normally expect to relapse and what you try to improve on? Thank you. Yeah. So yes, thank you, Suzanne, for the question. Just to summarize briefly, our plan is to show the updated data on TG4050 of the randomized phase I study comparing TG4050 versus observation at AACR, that is in a couple of weeks from now. So we will present 16-month median follow-up data. We will present the immunogenicity data on all patient population. You remember that we presented a subset at the previous conferences. At the AACR, you will have the data on all patients from an immunogenicity perspective at two months. And also, we will start to show data of immunogenicity at six months. So you will have a sense of the durability of the immunogenicity data in addition to the information on all patients at two months. And then, of course, we will update the community with the disease-free survival rate at 16 months. So during the second semester 2024, and we are thinking about a potential abstract to the European Society of Medical Oncology, we will share the two-year median follow-up data that is a kind of considered a milestone for this type of patient population to understand whether a compound or a therapeutic approach may have the potential to give a benefit to patients. So we will present the two-year median follow-up data at ESMO. And in addition, at ESMO, we will continue to update the community on the durability of the immunogenicity, which is another important factor for a therapeutic vaccine. In terms of your question on how we I mean, you or we should position this data in the context of the medical need for head and neck patients and in the context also of other companies, I would say two things. First of all, right, so the medical need is significant in this patient population. As you know, the checkpoint inhibitors did not succeed in showing a benefit in the adjuvant setting of head and neck cancer patients. So if we show in a kind of pilot experience, that is the randomized phase I with 2-year median follow-up data, that the TG4050 arm continues to deliver the benefit that we have already shared with the community, we think that, of course, there is a potential for this compound to find the journey as a therapeutic option for this significant unmet medical need. And number two, how to position this data in the context of other companies working on individualized therapeutic vaccine. I mean, it's difficult because we are, I would say, the most advanced company, and I would say the only one having randomized phase I study in this patient population. Therefore, we are leading this new field in head and neck cancer patients. And this is already, I would say, per se, a profound differentiation versus the competitors. As you know, head and neck cancer patients are very resistant to immunotherapy. The patient population that we have treated, and you will see the data again at the AACR, is very as a tumor that is very cold, is immune desert. And the fact that we have been able to induce immunogenicity in this kind of difficult tumor microenvironment is something that we consider very, very significant. So that's so far the answer to your question, and of course, more to come. Great. Thank you. Thank you, dear participants. As a reminder, if you wish to ask a question over the phone, please press star 11 on your telephone keypad. Once again, if you wish to ask a question, please press star 11 on your telephone keypad. There are no further questions at this time. I would like now to hand the conference over to your speaker, Alessandro Riva, for any closing remarks. Yeah. Thank you for the participation in this meeting. As you have seen, we are really making every effort to continue to develop our portfolio. The data that we are showing on TG4050 is very rewarding for the team here at Transgene, for the community, and the physicians that are involved in this important trial. There is a profound interest across the community to be involved in additional new studies that we are considering for this important compound. This is a new field. This is a very important field for patients. There is an opportunity to go to the next generation of immunotherapy. Of course, we count on the scientists that are with us. We count on our team. Of course, we count also on you to follow us as we go through this innovative journey. Thank you. Have a great remaining part of the day, and see you and talk to you soon. That does conclude our conference for today. Thank you for participating. You may now all disconnect. Have a nice day.