Transgene SA (TNG) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the Transgene 2023 Annual Results and Perspectives for 2024 Conference Call. [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. Please go ahead.

Thank you, Nadia, and 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. If you wish to ask questions, please make sure that you join us via one of the conference call numbers or you can also send me directly an e-mail to [email protected], and I'd be happy to read your question. With this, I now turn the call over to Alessandro Riva.

Thank you, Lucie, and thanks to you, for joining today's call. Before updating you on our progress, I would like to acknowledge Lucie appointment to the Chief Financial Officer. I guess you know her very well as you have been interacting with her over the last 8 years at Transgene. Her in-depth knowledge of the company, its 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. This new, as you can see on Slide 4, comes at the same time as our extended financial visibility until Q4 2025. The additional support of EUR 30 million from Institute Mérieux, our reference shareholder shows the confidence in our plans and in the potential of our product portfolio. Moving to Slide 5. As you can see at the ACR 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 patient. Interestingly, the presentation comes at 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 options for early-stage head and neck cancer patients where immunotherapy, including checkpoint inhibitors have 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 clinician patients industry and the DNTR community. Going now to Slide 6. As you can see in this slide, the year 2024 would 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 9 months. And obviously, we will disclose them to the community. Moving to Slide 7. On our lead asset, the 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 a final clearance to initiate the extension of the randomized Phase I trial into a Phase I/II trial in a larger sample size than the Phase I. I'm sure, and I'm on Slide 8 that you remember the last data we presented at ACR in ASCO last year. We had very promising immunology data on 8 patients showing a strong immunogenicity of our individualized cancer vaccine TG4050. Clinical follow-up was about 10 months at that time with 2 relapses in the observational arm only. All patients who received TG4050 after first adjuvant therapy were disease free. In April, at ACR, 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 neoantigens, 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 of 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 2024, we will provide a 24-month median follow-up of patients which are key to assess the benefits 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 Slide 10, our HPV-positive cancer therapeutic vaccine, TG4001 remains an important therapeutic vaccine winning 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 end point. The next step of the program, including a potential partnership will be based on the randomized Phase II data. Moving to Slide 11. With our oncolytic virus, Transgene capitalized 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 transporter 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 vectorize Interleukin 12 and anti-CTL-4 antibody. We have obtained a very encouraging preclinical data showing sustained expression of Interleukin 12 in tumors remodeling of the tumor microenvironment, activation of numerous innate and adaptive immune pathways and very strong antitumor activity in several preclinical models. The first patient in our ongoing clinical trial in relapse 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 immune checkpoint inhibitors. Moving to Slide 13, BT-001. It's our intratumoral OV program in collaboration with BioInvet. We communicated positive Phase I data with the compound in solid tumors in May 2023. Out of 18 patients who received escalating doses of BT-001, 2 show the decrease of injected lesion sites of 50% or more and 11 as the stabilization of the injected leision. The safety data was also satisfactory. We are progressing the trial with our codevelopment partner BioInvent and MSD who are supplying pembrolizumab for use in combination with BT-001. 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 the best possible setting to continue financing growth. I already look forward to discussing our next TG4050 data, which has been selected by ACR to be [ shopped case ] in their own press conference. I hope this brief overview has clearly highlighted the potential of our immune therapy pipeline. Transgene is well financed with a strong management team in place. Our focus stay remains to progress at TG4050 and important upcoming data in 2024. I believe that Transgene [ holds ] the path of an exciting future ahead, and I look forward to telling you more about our plan as we continue progressing. And now I turn over to the operator or to Lucie for the Q&A.

[Operator Instructions] Lucie, at this moment, we do not have any questions over the phone. And I would like now to hand over the call to you for any written questions.

Yes. Thank you. So I have a question from Martial Descoutures of ODDO BHF. Well, the first one, could you come back on the Phase II of TG4050 in head and neck? Could we expect that this trial could be a pivotal one in patients having a high risk to [ recidivate ] at this time? The second question comes, so as the CapEx costs and what we could expect in short-term and in midterm? Could you give us more details on the next steps of the manufacturing processes and the costs that we could expect?

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 this 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 a randomized Phase I/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 in 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 a manufacturing a 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 reading 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 it...

That's it for this question. I think we have another -- we have a new question on the queue.

Yes, we do. Just give me a moment. And now we're going to take the question from [ Suzanne van Voorthuizen ] from [ Van Lanschot Kempen].

Congrats, Lucie. 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?

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 with -- at ACR that is in a couple of weeks from now. So we will present 16 months median follow-up data. We'll present the immunogenicity data on all patient population. You remember that we presented a subset at the previous conferences. At the ACR, you will have the data on all patients from an immunogenicity perspective at 2 months. And also, we will start to show data of immunogenicity at 6 months. So you will have a sense of the durability of the immunogenicity data in addition to the information of all patients at 2 months. So -- and then, of course, we will update the community with this free survival rate at 16 months. So during the second semester of 2024 and we are thinking about a potential abstract to the European Society of Medical Oncology, we will share the 2-year median follow-up data that is a kind of consider 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 presented it 2 years 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 at this data in the context -- on the medical need for head and neck patients and the context also of other companies. I would say 2 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 -- if we show in a kind of pilot experience that is the randomized Phase I with 2 years 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 in the -- as a therapeutics options for this significant unmet medical need. And number two, how to position it this data in the context of other companies? Working on individualized therapeutic vaccine -- I mean, it's difficult because we are the -- I would say, the most advanced company and I will say the only one having a 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 competitor. As you know, head and neck cancer patients is very resistant to immunotherapy. The patient population that we have treated and you will see the data again at the ACR is very -- has a tumor that is very cold, it's immune desert and the fact that we have been able to induce immunogenicity in this kind of difficult tumor macro environment is something that we consider very, very significant. So that's so far the answer to your question, and of course, more to come.

[Operator Instructions] There are no further questions at this time. And I would like now to hand the conference over to your speaker, Alessandro Riva for any closing remarks.

Yes. 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. And there is a profound interest across the community to be involved in additional new studies that we may -- we are considering for this important compound. This is a new -- It's a new field. This is a very important field for patients. There is an opportunity to go to the next generation of immunotherapy and of course, we count on the scientists that are with us, we count on our team. And of course, we can't 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.