Lyon, France – 14 February – 6pm CEST – Theranexus, a biopharmaceutical company innovating in the treatment of rare neurological diseases, today announces publication of its cash position as at 31 December 2023 and presents an update on its programs.

Theranexus CEO, Mathieu Charvériat, comments: " The results of our Phase I/II clinical trial after 12 months of treatment[1] demonstrate the strong therapeutic potential of Batten-1, our drug candidate in Batten disease. These results will enable us to close this trial very soon, after 18 months of treatment, and we will make together with BBDF every effort to continue offering this treatment to trial patients in view of its favorable risk-benefit profile. We are currently exploring every option – financing or a partnership – to ensure we have the necessary resources to implement our pivotal Phase III trial in Europe and the United States. At the same time, we will shortly be announcing the start of preclinical development of a new drug candidate."

As a reminder, the results after 6[2]and 12 months of treatment were the subject of communications, and the FDA[3] and the EMA[4] have also validated the design of the upcoming phase 3 study.

On 31 December 2023, total available funds stood at €4.9 M (compared with €6.0M on 30 September 2023), reflecting a careful and rigorous approach to expenditure control. Aside from the upcoming launch of the Phase III trial to evaluate Batten-1, which is subject to availability of additional resources (in the form of a capital raise or an industrial partnership), the rate of expenditure will fall significantly from Q2 2024 onwards due to completion of Phase I/II underway. The company has sufficient cash to cover its requirements until February 2025.

Next financial publication:

29 April: 2023 annual financial results & cash position for Q1 2024

About Theranexus

Theranexus is an innovative biopharmaceutical company. The company has a unique platform for the identification and characterization of advanced therapy drug candidates targeting rare neurological disorders and an initial drug candidate in clinical development for Batten disease.

Theranexus is listed on the Euronext Growth market in Paris (FR0013286259- ALTHX).

For more information: 

http://www.theranexus.com

Contacts:

THERANEXUS

Thierry LAMBERT

Chief Financial Officer

contact@theranexus.com

FP2COM

Florence PORTEJOIE

Medias Relations

+ 33 (0)6 07 76 82 83

fportejoie@fp2com.fr

Disclaimer

This press release contains certain forward-looking statements concerning Theranexus and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Theranexus considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the universal registration document of Theranexus filed with the AMF on 27 April 2023 under number D.23-0345 (a copy of which is available on www.theranexus.com) and to the development of economic conditions, financial markets and the markets in which Theranexus operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Theranexus or not currently considered material by Theranexus. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Theranexus to be materially different from such forward-looking statements. Theranexus expressly declines any obligation to update such forward-looking statements.

[1] https://www.theranexus.com/images/pdf/Theranexus_PR_NCL2023_Conference_VDEF.pdf

[2] https://www.theranexus.com/images/pdf/Theranexus_PR_Prelimary_Results_Phase_I_II_VDEF.pdf

[3] https://www.theranexus.com/images/pdf/Theranexus_PR_End_of_phase_2_meeting_VDEF1.pdf

[4] https://www.theranexus.com/images/pdf/Theranexus_PR_Positive_Opinion_EMA_VDEF.pdf