Economia
Transgene anticipates significant progress from immunotherapy pipeline in 2024 and extends financial visibility until Q4 2025
Strasbourg, France, March 27, 2024, 5:45 p.m. CET – today publishes its financial results for 2023, and provides an update on its product pipeline and upcoming plans.
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Key events and upcoming milestones
Additional data from the randomized Phase I trial in adjuvant head and neck cancer to be presented in H1 2024 The trial will be expanded in a randomized Phase I/II trial in the same indication. The Phase II part will start in Q2 2024.
In 2023, highly promising TG4050 data were presented at AACR and ASCO 2023 (see poster here ). These data show that this can induce strong immune responses, which are expected to result in longer remission periods for patients.
(NCT04183166) .
These data suggest that TG4050 can boost the immune system of patients despite a challenging tumor microenvironment at the time of tumor resection.
(poster presentation on April-10, 2024)
TG4050 has potential applicability across a range of solid tumors where the medical need is still significant despite the existing therapeutic option including immunotherapies. As a consequence, Transgene is performing preliminary work on a potential new Phase I trial in another undisclosed indication.
(NCT03260023) in H2 2024.
confirming that E6 and E7 in patients with advanced HPV16-positive anogenital cancers. Patients with a complete objective response showed strong vaccine-induced immunoreactivity.
evaluating TG4001 in combination with an immune checkpoint inhibitor were published in the September 2023 issue of the European Journal of Cancer ( https://doi.org/10.1016/j.ejca.2023.112981 ). This study showed that TG4001 in combination with avelumab is safe and demonstrated antitumor activity in heavily pretreated HPV16-positive cancer patients. It also served as the basis for the ongoing randomized Phase II trial.
In 2023, clinical data presented at AACR confirmed the mechanism of action and the safety of our Invir.IO® based oncolytic viruses, which offer a key competitive advantage with the ability to be administered intravenously.
TG6050: Initial Phase I data expected in H2 2024, from this novel Invir.IO® candidate administered intravenously
A first patient was dosed with TG6050, a novel oncolytic virus from Transgene's Invir.IO® platform, in 2023. This innovative candidate has been designed to express human IL-12, a cytokine known to trigger a potent antitumor immune response, and an anti-CTLA4 antibody. The Phase I Delivir trial (NCT05788926) is evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapeutic options.
BT-001: Positive single agent data — Part B of the Phase I trial (combination with pembrolizumab) to deliver initial data in H2 2024
(NCT04725331) Out of 18 patients who received escalating intratumoral doses of BT-001, two showed a decrease of injected lesion size of 50% or more, and eleven had a stabilization of the injected lesion. No safety concerns were reported.
Part B of the Phase I trial in combination with pembrolizumab (KEYTRUDA®) started in October 2023. KEYTRUDA® is provided by MSD (Merck & Co). Initial data from this part of the trial are expected in H2 2024.
As announced on May 5, 2023, AstraZeneca terminated its oncolytic virus research and development collaboration with Transgene following a strategic review of its pipeline.
In 2024, Transgene expects to communicate progress and significant results and readout on all of its clinical stage assets.
New leadership structure appointed to accelerate the development of Transgene's innovative immunotherapy portfolio
On May 5, 2023, Transgene announced its Alessandro Riva, who started as new CEO on June 1, 2023, has been the Chairman of Board of Directors since May 2022. Dr. Riva has an outstanding track record in the pharmaceutical and biotechnology industry, including responsibility for securing the approval of personalized oncology treatments in the US and in Europe, in particular CAR-T cell therapies.
Transgene's Management Committee is comprised of the following members:
In addition, on May 5, 2023, the Combined General Meeting . Carol Stuckley brings more than 35 years of experience as a strategic and international financial executive, with proven success leading finance teams and creating shareholder value for healthcare companies.
In March 2023, Transgene appointed . John C. Bell is Senior Scientist, Cancer Therapeutics Program at Ottawa Hospital Research Institute and Director, Canadian Oncolytic Virus Consortium and is an internationally renowned expert in the use of oncolytic viruses. Pedro Romero is an honorary professor at the University of Lausanne, focusing on tumor immunology and cancer immunotherapy, particularly on the biology and dynamics of cytolytic CD8 T lymphocyte (CTL) responses. He has also been Editor-in-Chief of the Journal for ImmunoTherapy of Cancer.
Key financials for 2023
Financial visibility extended until Q4 2025
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The credit facility will be available until the end of 2025 and Transgene will be able to draw on and repay the facility at its discretion. In September 2023, Transgene had signed an initial facility for a maximum of €36 million (24-month term).
The financial statements for 2023 as well as management's discussion and analysis are attached to this press release (Appendices A and B).
A conference call is scheduled today on .
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https://register.vevent.com/register/BI1e9b40a25efe464fa60306adcf6632d5
A replay of the call will be available on the Transgene website ( www.transgene.fr ) following the live event.
Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene's programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.
The Company's clinical-stage programs consist of a portfolio of therapeutic vaccines and oncolytic viruses:
TG4050, the first individualized therapeutic vaccine based on the ® platform, TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the Invir.IO® viral backbone.
With Transgene's ® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The
® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.
With its proprietary platform Invir.IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses.
Additional information about Transgene is available at:
www.transgene.fr
Follow us on social media: X (previously-Twitter):
@TransgeneSA – LinkedIn:
@Transgene
Revenue from collaboration and licensing agreements represented €1.2 million in 2023 versus €3.1 million in 2022. It came mainly from the collaboration with AstraZeneca. In the first half of 2023, AstraZeneca informed Transgene of its decision to end the collaboration following a strategic review.
Public funding for research expenses accounted for €6.4 million in 2023 (versus €6.9 million in 2022), mainly due to research tax credit.
Other revenue amounted to €0.3 million in 2023 as in 2022.
R&D expenses amounted to €29.6 million in 2023 versus €32.2 million in 2022.
The following table details R&D expenses by type:
General and administrative (G&A) expenses stood at €7.0 million in 2023 (€7.9 million in 2022).
The following table details G&A expenses by type:
Share-based payments generated a revenue of €0.3 million in 2023, compared to an expense of €1.3 million in 2022. This change is due to departures that occurred in 2023 and to the end of several significant free shares plans in 2022.
Financial income stood at €7.1 million in 2023 compared to a net loss of €2.9 million in 2022.
The valuation of ADNA conditional advances as of December 31, 2023, generated a financial revenue of €8.1 million, compared to €2.2 million in 2022.
The net loss was €22.3 million in 2023, compared with a net loss of €32.8 million in 2022.
The net loss was €0.22 per share in 2023, compared with a net loss per share of €0.33 in 2022.
Investments in tangible and intangible assets amounted €3.7 million in 2023 (€2.2 million in 2022).
As of December 31, 2023, the Company had €15.7 million in cash available, compared with €26.8 million as of December 31, 2022.
In addition, Transgene signed in September 2023 a current account advance agreement with Institut Mérieux for €36 million. Transgene used €12.9 million as of the end of 2023.
An amendment has been signed to extend this advance from €36 million to €66 million. This credit facility extends Transgene's financial visibility until Q4 2025.
The Company's net cash burn amounted to €24 million in 2023, versus €22.8 million in 2022, excluding capital increase and current account advance from Institut Mérieux.
An amendment to the current account service agreement with Institut Mérieux has been signed on to increase the amount of initial advance signed in September 2023 from €36 million to €66 million. This credit facility extends Transgene's financial visibility until Q4 2025.
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