Transgene confirms the potential of its two innovative platforms and expects significant clinical results in 2022

• TG4050 (myvac): First positive results from the two Phase I trials. Additional data to be presented at AACR 2022 in April.
• TG4001: First patient enrolled in Phase II study in June 2021. Active patient recruitment in Europe and trial initiation in the US. Interim analysis expected in Q4 2022.
• BT-001 (Invir.IO™): IND approval for Phase I/IIa trial in the US, ongoing enrollment in Europe. Next clinical update in Q2 2022.
• TG6002: Clinical proof-of-concept of the intravenous administration of an oncolytic virus presented at major congresses in 2021. End of Phase I expected in mid-2022.
• AstraZeneca collaboration (Invir.IO™): First option license for an oncolytic virus exercised in 2021. R&D collaboration to develop additional candidates ongoing.
• €49.6 million cash available at year-end 2021 providing financial visibility until end of 2023

Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today publishes its financial results for 2021 and provides an update on its product pipeline.

Hedi Ben Brahim, CEO of Transgene commented: “It has been more than a year since I joined Transgene as Chairman and Chief Executive Officer and I am pleased and proud to have experienced and delivered such a successful year for the Company.

Transgene achieved several important milestones in 2021. We announced the first positive data from two Phase I trials with TG4050, our individualized therapeutic vaccine based on our myvac® platform. These results demonstrated the immunogenicity of the vaccine, which led to the first signs of clinical activity. We expect to confirm these results in the coming months and to provide more in-depth data at major scientific congresses in 2022.

The Phase II trial with TG4001, our therapeutic vaccine against HPV16-positive anogenital cancers, was launched in 2021, with the first patient enrolled in June; recruitment is continuing at a steady pace. First data from an interim analysis, including up to 50 patients, is anticipated in the fourth quarter of 2022.

We also made significant progress with our oncolytic virus pipeline. We recruited the first patient into the Phase I/IIa study evaluating BT-001, our first candidate from our Invir.IO™ platform. We also presented the first Phase I data with TG6002 at two major conferences in 2021: AACR and ESMO. These results confirm the feasibility of intravenous administration of this oncolytic virus. The ability to be given intravenously would considerably extend the use of our Invir.IO™ based virus therapies in oncology, significantly expanding the market opportunity they can address.

In addition, our expertise and the clear benefits that our Invir.IO™ platform can deliver was recognized with the first license option exercised by AstraZeneca for an oncolytic virus in late 2021. This exercise results in an upfront payment of $8 million. The collaboration with AstraZeneca continues under the agreement for the development of other oncolytic immunotherapies by Transgene.

Following the successful completion of a €34.1 million private placement in June 2021 and the additional sale of Tasly BioPharmaceuticals shares in September 2021 for €17.4 million, Transgene has financial visibility until the end of 2023. This puts us in strong position to pursue Transgene`s mission: create value by developing new innovative cancer therapies.”