Transgene SA (TNG) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the Transgene 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, CFO. Please go ahead.

Thank you, [ Sonya ] , and hello, everyone. So thanks for joining us today on this call. So I'm Lucie Larguier, Chief Financial Officer at Transgene. I am today with Dr. Alessandro Riva, our Chairman and CEO of Transgene, and we will be available to you until 4:00 PM CET, which makes our call 30 minutes long. Today, we will discuss the recent update on the TG4001 randomized Phase II clinical trial in advanced and metastatic HPV16-positive cervical and anogenital cancers. We will provide our view on the top line results before we take and answer your questions. 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're listening today's webcast via the Internet, you will not be able to ask a question after Alessandro's statements. If you wish to ask questions, please make sure you join us here in one of the conference call numbers that are available in today's press release. You can also directly send me an e-mail to [email protected], and I will be happy to your questions. With this, I now turn the call over to Dr. Riva.

Thank you, Lucie. Good afternoon, everyone, and thank you for joining this call. The objective of today's call is to walk through the press release on the results of the randomized Phase II study evaluating TG4001 to share the next step and to answer your question. The study compared the TG4001 in combination with avelumab versus avelumab Monotherapy in recurrent or metastatic cervical and anogenital cancer. The primary objective was improvement in progression-free survival in the overall patient population, secondary objectives were overall response rate, duration of response and survival. Predefined subgroup analysis were also planned to assess the efficacy and safety in cervical cancer, anal cancer and genital cancer subgroups. 100 patients have been enrolled in the trial, of whom 90, who did not have a liver metastasis, were analyzed; 54 were cervical cancer patients, 30% anal cancer, and 16% genital cancer. The analysis on the 10 patients with liver metastasis has not yet been performed, and will be disclosed with the full analysis of the trial. Patients had recurrent or metastatic disease and around 75% of them received one prior line of systemic therapy including chemotherapy and targeted agents for recurrent or metastatic disease. All patients were checkpoint inhibitors naive. As announced this morning, the trial did not meet the primary objective in the overall patient population. However, in a preprogrammed analysis, an efficacy trend in favor of TG4001-containing regimen was observed in the cervical cancer patients subgroup, that, as I say, represents 54% of the total patients enrolled in this study. This trend requires a further confirmation through additional analysis, including by tumor, PD-L1 status. TG4001 was well tolerated with adverse events consistent with prior observation. We are currently analyzing the full data set, and we plan to communicate the complete analysis, including the correlative signs data at an international conference that would be held during the first semester of 2025. Our goal remains to determine the best possible path forward for this TG4001 particularly in cervical cancer, where we saw an efficacy trend and also considering the evolving treatment landscape. I would like to take a moment to express our gratitude to the patients, clinicians, caregivers as well as the Transgene teams who contributed in this study. Transgene remains focused on advancing its pipeline of innovative immunotherapies, with a cash runway until Q4 2025. In particular, at the Society for Immunotherapy of Cancer conference that would be held in Houston in November, would be presented 24-month median follow-up data from the randomized Phase I study of our individualized cancer vaccine TG4050 in the adjuvant setting of HPV-negative head and neck cancer patient. Thank you for your attention, and we'll now open up for questions.

[Operator Instructions] As there are no further questions, I would like to hand back to Alessandro Riva for any closing remarks.

Thank you for your participation in this call. We will keep you informed on our progress. And we hope that we can meet with some of you in Houston, Texas to discuss the updated data of TG4050 in head and neck cancer. Thank you, and a great day. .

This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers please standby.