Transgene SA (FRA:TGNA) (Q2 2024) Earnings Call Transcript Highlights: Promising Clinical Data ...
Debt Conversion: Approximately EUR33 million converted into equity.
Majority Shareholder Ownership: TSGH now owns 69% of Transgene.
Financial Visibility: Confirmed until Q4 2025.
Release Date: September 24, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
TG4050, Transgene SA's lead product, has shown promising clinical data with all patients in the treatment arm remaining disease-free.
The company has successfully enrolled the first patient in the Phase II part of the TG4050 trial, aiming to enroll 80 patients internationally.
Transgene SA has completed the enrollment of 90 patients in the randomized Phase II trial for TG4001, with top-line results expected in Q4 2024.
The oncolytic virus BT-001 has demonstrated preliminary antitumor activity and a good safety profile in ongoing trials.
Transgene SA has financial visibility confirmed until Q4 2025, ensuring the company can deliver significant new developments over the next 12 months.
Negative Points
The company faces uncertainties and risks associated with forward-looking statements, which could impact future performance.
There is no guarantee that the promising early clinical data for TG4050 will translate into successful outcomes in larger, later-stage trials.
The development of TG4050 in new indications is still in preliminary stages, with details yet to be disclosed.
The financial stability of Transgene SA is heavily reliant on its majority shareholder, TSGH, which now owns 69% of the company.
The competitive landscape in cancer immunotherapy is intense, with other companies like Moderna and Nykode also pursuing similar therapeutic vaccines.
Q & A Highlights
Q: 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%? A: The Phase I data with BT-001 as monotherapy showed tumor shrinkage at the level of individualized lesions. The responses for the combination with pembrolizumab were related to the overall partial response across all tumor lesions that the patients had at the study entry. The data in combination with pembrolizumab refer to the overall partial response according to international RECIST criteria, considering all metastatic lesions of the patients. Alessandro Riva, CEO.
Q: Has the Phase I trial of TG4050 in other solid tumors been designed? What will be the primary endpoints, and what type of cancer patients are expected to be enrolled? A: We are planning to develop TG4050 in new indications. The protocol has been submitted to health authorities, and we will disclose the indication and design of the trial as we approach the start-up activities. Alessandro Riva, CEO.
Q: What are the expected changes in R&D spend over the next 12 months, given the potential new trial of TG4050 in other solid tumors? A: Our current budget includes the new studies discussed, including the randomized Phase II study in head and neck and the randomized Phase I trial in a new indication. We do not plan an increase in the budget or spending over the next 12 months. Alessandro Riva, CEO.
Q: Moderna has announced that the FDA doesn't want to approve its mRNA in melanoma after the positive Phase II data. Could you review your development programs in terms of targeted pathology or development plans? A: The FDA feedback does not impact our strategy in head and neck. We will complete the randomized Phase II study as planned. This study will provide strong proof of concept for our therapeutic vaccine in early-setting head and neck cancer. We are also strategizing on a potential pivotal trial for TG4050 in head and neck, considering comments from the FDA. Alessandro Riva, CEO.
Q: Nykode announced a repositioning of its DNA vaccine initially developed for HPV16-positive cancers to focus on metastatic head and neck cancer and cervical cancer. What do you learn from this strategic review for your portfolio and strategy? A: We noticed Nykode's decision but cannot speculate on it. For TG4001, we will wait for the results of the randomized Phase II study in advanced and relapsed/refractory anogenital cancer patients. Based on these results, we will share our next steps. This trial is the first in a randomized Phase II setting for HPV-positive advanced solid tumors, making the results significant for both Transgene and the oncology community. Alessandro Riva, CEO.
Q: Can you provide an update on the financial visibility and recent financial transactions? A: In July, Transgene announced the conversion into equity of approximately EUR33 million of debt with its majority shareholder, Institut Merieux. This transaction took place at market price without a discount. Transgene has financial visibility confirmed until Q4 2025, enabling significant progress on its portfolio over the next 12 months. Alessandro Riva, CEO.
Q: What are the recent developments in the TG4001 program? A: 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 versus avelumab alone in advanced metastatic patients. Top-line results are expected in Q4 2024, and the next steps, including potential partnerships, will be based on these results. Alessandro Riva, CEO.
Q: Can you elaborate on the progress of the oncolytic viruses platform? A: Our platform enables the design of oncolytic viruses administered via multiple routes. BT-001, developed with BioInvent, showed preliminary antitumor activity in refractory solid tumors. TG6050, administered intravenously in metastatic relapsed/refractory non-small cell lung cancer, has ongoing Phase I trials with first data expected before the end of 2024. Alessandro Riva, CEO.
Q: What are the recent additions to the executive committee, and how will they impact Transgene's future development? A: We welcomed Emmanuelle Dochy as CMO and Maurizio Ceppi as CSO. Dr. Dochy brings over 15 years of pharmaceutical industry experience in oncology, and Dr. Ceppi specializes in cancer immunotherapy and precision medicine. Their expertise will be vital in steering Transgene through its next stage of growth. Alessandro Riva, CEO.
Q: What are the next steps for TG4050 and its potential new indications? A: We are conducting preliminary work on a potential new randomized Phase I trial in another undisclosed indication, which we will announce in 2025. We continue to progress on this innovative program and look forward to sharing future updates. Alessandro Riva, CEO.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.