• Clinical Approval: TG 4,050 received clinical approval in phase one for adjuvant treatment of resectable head and neck cancer.
• Phase Two Enrollment: Patient randomization for phase two expected to complete in Q4 2025.
• Financial Outlook: Extended financial origin until early April 2026.
• Credit Facility: Current account advance increased to 48 million.

• Warning! GuruFocus has detected 8 Warning Signs with STU:TGNA.

Release Date: March 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Transgene SA (STU:TGNA) achieved clinical approval for TG 4,050, an individualized therapeutic cancer vaccine, in a phase one trial for head and neck cancer.
• All patients treated with TG 4,050 remained disease-free after a 24-month follow-up, indicating promising efficacy.
• The company is progressing well with the phase two trial of TG 4,050, with patient randomization expected to complete by Q4 2025.
• Transgene SA is preparing for a new phase one trial in a second, undisclosed indication, expected to start in Q4 2025.
• Financially, the company has extended its funding runway until April 2026, ensuring stability for ongoing projects.

Negative Points

• The phase two trial of ETV 4,001 did not meet its primary objective of improving progression-free survival in the overall patient population.
• The challenge of intravenous administration for the oncolytic virus 6,050 remains a significant hurdle due to potential neutralization by the immune system.
• The primary completion date for the phase two study of TG 4,050 is not until H2 2027, indicating a long timeline before potential market availability.
• The company is still in the early stages of developing a scalable manufacturing process for its MAC platform, which could delay commercialization.
• Despite promising data, the company faces competition and challenges in the evolving treatment landscape for head and neck cancer.

Q & A Highlights

Q: Will there be an interim readout for the phase two study of TG 4,050 in CCHN, given that the primary completion date is not until H2 2027? A: Yes, we plan to disclose the immunogenicity data of the phase two part of the trial by ASCO or SSO 2026, between June and October 2026. The efficacy analysis with a median follow-up of 2 years is expected to be available by the end of 2027, and we will disclose this data at an international conference.

Q: Can you provide more details on the data expected for TG 4,001? Will the data be sliced by PDL1 expression or by tumor types? A: We plan to disclose the data of the TG 4,001 trial in HPV 16 anogenital and cervical cancer patients in Q2 2025 at an international conference. The data will be presented in terms of different tumor types, including cervical cancer, where we observed a trend towards better response rates. We will also present the correlation between efficacy and PDL1 expression in tumors, particularly in cervical cancer, and analyze the immunogenicity against HPV 16 antigens.

Q: What are the financial outlook and funding status for Transgene SA? A: Our financials are in line with our forecasts, thanks to strict budget monitoring and cost control. We have extended our financial runway until early April 2026. The company has signed an amendment to the current account advance with THGH, increasing the total available amount to 48 million, ensuring funding until the end of April 2026.

Q: What are the key priorities for Transgene SA in 2025? A: Our priorities include advancing our lead asset, TG 4,050, by presenting 24-month data on all patients in the phase one trial for operable head and neck cancer in Q2 2025, completing phase two enrollment by Q4 2025, assessing potential acceleration of the head and neck program, and launching a new phase one trial in a second indication by Q4 2025.

Q: What progress has been made with the MyVAC platform and other assets in 2024? A: In 2024, we obtained clinical approval for TG 4,050 in a phase one trial for head and neck cancer, with all treated patients remaining disease-free after 24 months. We initiated a phase two study, with enrollment progressing well. We also made significant progress in manufacturing processes for the MyVAC program. Additionally, we are analyzing data from other assets, such as ETV 4,001 and BT 001, to define future strategies.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.