Transgene SA (TNG) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the Transgene 2024 Annual Results and Perspectives for 2025 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, Chief Financial Officer. Please go ahead.

Thank you, Nadia, and hello everyone. So I'm Lucie, Chief Financial Officer at Transgene. I have the pleasure to introduce you today Dr. Alessandro Riva, our Chairman and CEO. We will review our progress of over 2024, which was a great year, you'll see 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 a number of risks and uncertainties. If you are listening to this webcast via the Internet, you will not be able to ask questions. And if you wish to do so and ask questions. You can join us via the conference call numbers that are available in the press release issued today or you can also directly send me an e-mail or to [email protected] and we'll be happy to read your question and answer it. With this, I now turn the call over to Alessandro.

Thank you, Lucie, and thank you for joining today's call. 2024 was a successful year to build the foundation of future business at Transgene. We have delivered clinical approval concept for TG4050, our lead individualized therapeutic cancer vaccine generated by the myvac platform and we progressed across our other bio vector-based assets. Let's turn to the next slide and provide you with more granularity on myvac, our individualized cancer vaccine platform. In 2024, we obtained a clinical proof of principle for TG4050 in the Phase I part of our randomized trial in adjuvant treatment of resectable head and neck cancer patients. At the SITC conference in November last year, we confirmed that all patients treated with TG4050 remain a disease-free after a 24-month median follow-up while 3 patients in the control arm relapsed. Building on this promising data, we initiated a Phase II part of the study. The enrollment continues to progress at a good pace and patient randomization is expected to be completed in Q4 2025. We are very proud to hear the feedback from clinicians in this trial for this innovative therapy. We have submitted an abstract at an important oncology conference at the end of May, early June 2025. We are confident that we will be able to present the 24-months follow-up data for all patients for the Phase I trial as well as the long-term immunogenicity data. Positive updated data confirming the very promising clinical and immunogenicity results presented last November will serve as the basis for additional development for our myvac products. Based on our confidence in the program and our intention to become a key player in the field of individualized neoantigen therapeutic cancer vaccine, we are starting initial preparation for a new Phase I trial in a second undisclosed indication expected to start in Q4 2025. In parallel, we are making significant progresses on the manufacturing side with the objective of having a rapid integrated and scalable manufacturing process as we advanced significantly the myvac program. Finally, we are monitoring very closely in innovation in the adjuvant setting of operable head and neck cancer patients and assessing the potential next step to further accelerate the program. All these activities reflect our priority and ambition to demonstrate the potential significant impact of our myvac individualized vaccine in the treatment of early setting head and neck and other early setting cancer indication where the risk of relapse is still high despite the available therapies. In 2024, we also saw progresses on our other assets. We will be reporting that in Q2 2025 from the randomized Phase II trial evaluating TG4001 in combination with avelumab versus avelumab alone in patients with recurrent metastatic HPV16 positive cervical in anogenital tumors. While the trial did not meet its primary objective that was improvement in progression-free survival in the overall patient population, we will share the results of a pre-planned analysis in a cervical cancer patients, which show the positive efficacy trend at a scientific conference in the second quarter of 2025. We presented data with BT-001 at ESMO last year this intratumorally administered oncolytic virus showed first signs of efficacy with clinical response when given in combination with pembrolizumab in 2 out of 6 refractory patients, one with melanoma and second one with leiomyosarcoma. Of note, the pre and posttreatment biopsy of leiomyosarcoma patient showed that BT-001 was able to transform the tumor microenvironment from cold to hot. We expect to present the updated data in the second half 2025. In parallel, Transgene and our partner, BioInvent, are currently analyzing the final data to define the strategy for [indiscernible]. Our other oncolytic virus strategy TG6050 is administered intravenously. While this administration route represents a significant potential. The oncolytic virus community knows the challenge on the intravenous administration to reach the tumor without being neutralized by the patient immune system. Our Phase I trial in patients with relapse resistant advanced non-small cell lung cancer who have failed standard therapy options has now completed enrollment and we expected to report data from the Phase I trial in Q2 2025. This data will serve as basis to determine the best path forward for this candidate. I now turn the call over to Lucie for the financial update. Lucie, please?

Yes. Thank you, Alessandro. So let me walk you through a few words on finance. So our financial as usual, and as you can see them in our press release are in line with our forecast and particularly thanks to strict monitoring of budget allocation and stringent cost control. In terms of outlook, we have extended our financial horizon until early April 2026. The company has signed today an amendment to the current account advance with TSGH, so time which increases the total available amount and the new maximum of the current account advance to EUR 48 million. With this credit facility and the support of TSGH, the company is now funded, as I said, until the end of April 2026. Alessandro, I'll let you conclude this presentation.

Thanks Lucie, as we enter 2025, our priorities are clear and we expect to advance our lead asset at TG4050 of the myvac platform by presenting the 24-month data on all patients in the Phase I trial in operable head and neck cancer in Q2 2025, by completing Phase II enrollment in the same indication by Q4 2025. By assessing a potential acceleration of the head and neck program based on the evolving treatment landscape. And finally, by launching a new Phase I trial in a second indication in Q4 2025. With this milestone in sight, we are confident that Transgene is well positioned for the next step. The team and I will now take your questions. Operator, please?

[Operator Instructions] And it comes from the line of Amar Singh from Intron Health.

Can you provide any visibility on the next -- sorry. Will there be an interim readout for the Phase II study of TG4050 in SCCHN? it looks like the primary completion date isn't until H2 2027.

Thank you for the question. So we plan to disclose the immunogenicity data of the Phase II part of the trial by ASCO or ESMO 2026. So between June and September, October 2026. And also in terms of the efficacy analysis with a median follow-up of 2 years, we expect that the data will be available by the end of 2027, and we will be disclosing of course, the data at an international conference later on.

And the question comes the line of Suzanne van Voorthuizen from Van Lanschot Kempen.

This is [ Tarantin ], I'm on behalf of Suzanne. So I wanted to have a little bit more color on the data expected for TG4001. So I was wondering, should we then expect the data set to be sliced by PD-L1 expression or by tumor types? Any more glanurarity that you can provide will be very appreciated.

Okay. Thank you for the question. We plan to disclose the data of TG4001 in HPV16 anogenital and cervical cancer patients in Q2 2025 in international conference. The data will also be presented in terms of the different tumor types, including the cervical cancer, where we also the trend towards a better response rate and time to progression and survival. And we will discuss we will present also the correlation between the efficacy and the PD-L1 expression in the tumor in cervical cancer, where we have the majority of patients. And of course, also, there will be some [indiscernible] analysis in terms of the immunogenicity in terms of the against the HPV16 P67 antigens. So that's what we plan to disclose to the community in Q2 2025.

There are no further audio questions. And I would like to hand over to Lucie for any written questions. Please go ahead.

Well, thank you very much. It happens the question I had received by e-mail was covered by one of our analysts. So I don't have any questions on my side in my mailbox at the moment.

So then I guess we can...

Unless there are any question. We've covered it. Unless you have other questions on the line.

[Operator Instructions] There are no further questions, and I would like to hand over to the speakers for any closing remarks.

Thank you. As we mentioned in this call, Transgene is ideally positioned to deliver multiple clinical milestones in the next coming months, reinforcing our leadership in viral-vector-based immunotherapy. In particular, of course, we are very excited for the myvac program and TG4050 data in ead and neck cancer, the Phase II study that is progressing very rapidly and the expectation to open a new trial in a new indication by the end of the year. 2024 was certainly a successful year to build the foundation of future business, and we are now well positioned to execute on our next phase of growth, building on our 2025 key priorities that we discussed during this call. We are excited about the future and remain committed to delivering innovative viral vector-based immunotherapy that have the potential to change the treatment paradigm in cancer and specifically in [ resetting ] cancer patients with our myvac platform. We appreciate your continued support and look forward to keeping you updated on our progresses. With this, I would like to conclude today's call. Have a nice rest of the day for everyone. Thank you, and goodbye.

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