Transgene SA (TNG) Earnings Call Transcript & Summary

Thank you, Heidi, and hello, everyone. So I have the pleasure today to introduce you to Dr. Alessandro Riva, our Chairman and CEO at Transgene. Today, we will review our progresses over the first half of this year and answer any questions you may have. Before I turn the call over to Dr. Riva, I'd like to remind everyone that today's discussion contains forward-looking statements, which are subject to numerous risks and uncertainties. If you are listening to this webcast via the Internet, you will not be able to ask questions. If you wish to ask questions, please make sure you join us via one of the conference call numbers that are available in today's press release. You can also directly send me an e-mail to my personal e-mail or to [email protected]. We'll be happy to read your questions. With this, I now turn over the call to Alessandro Riva.

Thank you, Lucie, and thank you for joining today's call. It is a real pleasure to update you on the progress of Transgene. In 2024, Transgene continues to be one of the frontrunners in cancer immunotherapy innovation. This year represents a pivotal moment for our company as we push forward the development of our breakthrough treatment. TG4050, as you all know, is our lead product. It is an individualized therapeutic cancer vaccine based on the artificial intelligence and our MVA viral vector. We think that it is a clear example of our ability to innovate by combining the identification of immunogenic mutations through artificial intelligence and the latest advances in personalized medicine manufacturing. Over the period, TG4050 has reached several milestones in terms of clinical data and the progress of our clinical trials. In April, TG4050 randomized Phase I study in early setting head and neck patients on 32 patients recruited into the trial. At the time of the data cutoff, only patients in the control arm had relapsed while all patients who received TG4050 were disease-free. We interpret this data as a potential first sign of clinical benefit for early setting head and neck cancer patients. It is also important to note that TG4050 showed strong immunogenicity. While we had already reported that almost all patients developed a specific immune response against the target containing the vaccine, we announced for the first time that these patients displayed a cellular immune response against the specified neoantigen beyond 7 months. Based on the proof-of-concept data, Transgene and its artificial intelligence partner, NEC, have decided to move forward together with an extension of the randomized trial, evaluating early setting head and neck cancer patients that have been treated with surgery followed by the standard radio chemotherapy. The first patient was enrolled in the Phase II part of the trial in second quarter 2024. Patient screening and enrollment are active, with the aim of enrolling 80 patients internationally in this overall randomized trial. We submitted also an abstract on the randomized Phase I study at the Society for Immunotherapy of Cancer conference that will be held in Houston, Texas in November. If accepted, updated long-term immunogenicity and efficacy at 24 months median follow-up data will be presented. Personalized cancer vaccines, as you know, could also be utilized to treat other form of cancer to improve and extend the life of patients. As a result, Transgene is conducting preliminary work on a potential new randomized Phase I trial in another undisclosed indication that we will announce in 2025. We are continuing our progress on this very important, innovative and potentially transforming program for patients, and we look forward to sharing future updates on this very exciting candidate. Now moving on Slide 8 and TG4001, our shared antigen cancer vaccine against HPV-positive cancer. We have completed the enrollment of 90 patients in the randomized Phase II trial in advanced HPV-positive anogenital cancer. This trial compares TG4001 plus avelumab and immune checkpoint inhibitors versus avelumab alone in advanced metastatic patients that have not received prior therapy with checkpoint blockers. We confirm that the top line results are expected in Q4 2024. The next step of the program, including potential partnership, will be based on the results of this randomized Phase II study. Now moving to our oncolytic viruses platform that represents the third pillar of our portfolio. Our platform enables the design of potential oncolytic viruses that can be administered via multiple routes: intravenously for TG6050 and intratumorally for BT-001. This therapy aims at modulating the tumor microenvironment and inducing tumor lysis. BT-001 is our intra-tumoral oncolytic virus program that is developed in collaboration with BioInvent. We presented preliminary data at ESMO a couple of weeks ago, and we showed preliminary antitumor activity in refractory solid tumor in the ongoing Phase I/II trial in monotherapy and in combination with pembrolizumab. More precisely, we demonstrated that BT-001 replicates in the tumor where the payloads are expressed with undetectable systemic exposure. The safety profile was good in monotherapy and in combination with pembrolizumab. We reported a partial response in relapsed/refractory advanced melanoma and leiomyosarcoma. Of note, the patient with advanced melanoma failed a prior checkpoint inhibitor-containing regimen. In addition, the tumor microenvironment of the leiomyosarcoma patients that showed a partial response turned cold to hot, including T cell infiltration, a higher macrophage 1/2 ratio and a shift to PD(L)-1 positivity in the tumor microenvironment. We are encouraged by these results and continue treating patients in the ongoing Phase I trial. TG6050 is administered intravenously in patients with metastatic relapsed/refractory non-small cell lung cancer. This oncolytic virus can cause interleukin-12 and an anti-CTLA-4 antibody. Preclinical proof-of-concept data have recently been published in the Journal of ImmunoTherapy of Cancer, confirming the mechanism of action in several mouse models. The DELIVIR Phase I trial is ongoing in relapsed/refractory non-small cell lung cancer, and we plan to report first data before the end of 2024. Now turning on Slide 11, a few words on finance. In July, Transgene announced the conversion into equity of approximately EUR 33 million of debt drawn down under the outstanding current account advance with its majority shareholder, the TSGH, that is, as you know, Institut Mérieux, under the terms of the agreement with them first signed in 2023. The transaction took place at market price and without a discount on the price of the new share. TSGH now owns 69% of Transgene. As we have seen, Transgene has financial visibility confirmed until Q4 2025, enabling the company to deliver significant new flows on its portfolio over the next 12 months. Finally, I'm glad to welcome 2 new additions to the Executive Committee, Emmanuelle Dochy and Maurizio Ceppi as CMO and CSO, respectively. Dr. Dochy brings over 15 years of pharmaceutical industry experience, working in multiple development department roles focused on oncology. And Dr. Ceppi brings over 15 years of experience in oncology in the life science industry, specializing in cancer immunotherapy and precision medicine. As Transgene embarks on a critical phase of its future of development, the company can rely on a robust senior management team. This leadership will play a vital role in steering Transgene through its next stage of growth. I hope this overview has highlighted the potential of our immunotherapy pipeline. At the heart of our work lies innovation and differentiation driven by an approach that enhances success for all key stakeholders. I'm confident that Transgene is heading towards a promising future and I look forward to sharing more about our plans as we move forward in the coming months. Now I turn over to Lucie will manage the Q&A.

Exactly. We'll now take questions. [Operator Instructions]

[Operator Instructions] Your first question comes from the line of Natalya Davies from Intron Health.

Just three questions from me. The first is, how can we interpret the Phase Ib top line data of BT-001 versus the previous Ia data? For example, was the 2 out of 20 tumor shrinkage by more than 50%? My second question is, has the Phase I trial of TG4050 in other solid tumors been designed? And what will be the primary end points? And what type of cancer patients are expected to be enrolled? And then my third question is just on expected changes in R&D spend over the next 12 months given the potential new trial of TG4050 in other solid tumors.

Yes. Thank you for the question, Natalya. So I start from the first one that is related to BT-001. So the Phase I data with BT-001 as monotherapy showed tumor shrinkage at the level of individualized lesions. And on the other hand, the responses that we have showed for the combination with pembrolizumab were related to the overall partial response across all tumor lesions that the patients had at the study entry. So in other words, the data in combination with pembrolizumab are referring to the [ oncolytic ] partial response according to international RECIST criteria that takes into consideration all the metastatic lesions of the patients. Hopefully, this is clear. So the second question is related to TG4050 and the additional development of the product. So we are planning to develop TG4050 in new indications. The protocol has been already submitted to the health authorities. And we will disclose the indication and the design of the trial as soon as we approach to the start-up activities of the trial. So that's your second question. Your third question is related to the spending. So our current budget includes the new studies that we have just discussed, the randomized Phase II study in head and neck and also the randomized Phase I trial in a new indication. So we don't plan, as we speak, an increase of the budget during the next 12 months and, of course, an increase of spending accordingly.

Okay. On my side, I've received another question by e-mail, which is from Martial Descoutures at ODDO BHF. So this is Martial's question, Moderna has announced that the FDA doesn't want to approve its mRNA in melanoma after the positive Phase II data. Even though the discussions are still ongoing, we can think that the company should release its Phase II -- Phase III, sorry. Thus, seeing this FDA feedback, could you review your development programs maybe in terms of targeted pathology or on development plans? In parallel, second question, Nykode announced a repositioning of its DNA vaccine initially developed for HPV16-positive cancers to be focused in metastatic head and neck cancer and cervical cancer. What do you learn of this strategic review for your portfolio and your own strategy?

Yes. So thank you, Martial, for these two questions. The first one is related to the potential impact of the FDA feedback on the Moderna strategy in adjuvant setting in melanoma and the impact on our strategy, that the FDA feedback does not impact our strategy in head and neck. We are going to complete the randomized Phase II study as per the plan. This study will be extremely important to provide us the strong proof of concept that our therapeutic vaccine works in early setting head and neck where actually no immunotherapy so far have shown efficacy. And of course, we are going also to strategize on the potential pivotal trial for TG4050 in head and neck. And by the way, we have received already comments from the agency, from the Food and Drug Administration, related to the development strategy in head and neck, including the potential pivotal trial, and we will take that into consideration at the right moment. So the second question is about the potential impact of Nykode decision to stop the development of their own therapeutic vaccine HPV16 in advanced head and neck and cervical cancer patients. So we just noticed their decision. Of course, we cannot speculate about that. As for our development plan related to TG4001, we have to wait the results of the randomized Phase II study in advanced and relapsed/refractory anogenital cancer patients. And based on the results of this trial, we will share with the external community, with you, our plan for the next step. Please note, that's very important, that the trial that will be read out our trial is the first trial in randomized Phase II setting in HPV-positive advanced solid tumors. Therefore, this information that we disclose by the end of the year will be very important not only for Transgene but also for the oncology community working on HPV-positive solid tumor patients.

This concludes today's question-and-answer session. I will now hand back for closing remarks.

I would like to thank everyone for having participated in this call. We look forward to continue the dialogue with you as we advance our pipeline. Have a great evening, and talk to you soon. Bye.