Transgene Reports Business Update and Q3 2023 Financial Position

Transgene continues to advance its innovative immunotherapy pipeline, with key clinical development catalysts expected in the next 12 months

Financial visibility until the end of 2024

STRASBOURG, France–(BUSINESS WIRE)–#HBV–Regulatory News:

Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces its business update and its financial position for the quarter ending September 30, 2023.

During the third quarter of 2023, Transgene’s clinical-stage immunotherapy portfolio continued to advance. Notable progress included the treatment of the first patient in the Part B of Phase I trial assessing the novel oncolytic virus BT-001 in combination with KEYTRUDA® (pembrolizumab) (NCT: 04725331).

In the next 12 months, key expected catalysts include:

– Updated data from the ongoing Phase I trial of the neoantigen cancer vaccine TG4050 in the adjuvant treatment of head and neck cancer in H1 2024 and the launch of a randomized Phase II trial in 2024,

– Data read out from ongoing randomized Phase II trial of TG4001 in HPV+ anogenital cancers in 2024,

– Completion of the Phase I trial of TG6050 administered intravenously in non-small cell lung cancer,

– The inclusion of the last patient in the Part B of the Phase I study of BT-001 in solid tumors in H1 2024.

Operating income

During the first nine months of 2023, operating revenue amounted to €6.2 million compared to €8.4 million in the same period in 2022. They are mainly derived from the research tax credit (€4.8 million for the first nine months of 2023, compared to €5.2 million for the same period in 2022) and Transgene’s collaboration agreement with AstraZeneca on the Invir.IO® program.

Revenue from collaborative and licensing agreements amounted to €1.2 million in the first nine months of 2023, compared with €3 million in the same period in 2022. In the first half of 2023, AstraZeneca informed Transgene of its decision to end the collaboration.

Cash, cash equivalents and other financial assets

Cash, cash equivalents and other financial assets stood at €16.4 million as of September 30, 2023, compared to €26.8 million as of December 31, 2022. In the first nine months of 2023, Transgene’s cash burn amounted to €13.8 million compared to a cash burn of €13.3 million for the same period in 2022.

During the reporting period, the Company reached an agreement for the sale of its remaining shares held in Tasly BioPharmaceuticals for a total amount of US$15.3 million (€14 million). The transaction was closed in July 2023 upon receipt of the funds.

On September 20, 2023, the Company signed a current account advance agreement with Institut Mérieux (TSGH) for a maximum of €36 million. The credit facility has a 24-month term and Transgene is able to draw on and repay the facility at its discretion. As of September 30, 2023, the Company had drawn €3.4 million on this facility.

This non-dilutive credit facility extends Transgene’s financial visibility until the end of 2024, enabling the Company to deliver significant milestones on key portfolio projects in the next 12 months.

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About Transgene

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 myvac® 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 myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® 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 (ex-Twitter): @TransgeneSA – LinkedIn: @Transgene

Disclaimer

This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document, available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.fr). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Contacts

Transgene:
Lucie Larguier
Director Corporate Communications & IR

+33 (0)3 88 27 91 04

[email protected]

Media: MEDiSTRAVA Consulting
Frazer Hall/Sylvie Berrebi
+44 (0)203 928 6900

[email protected]