Lyon, September 30, 2021 – Theranexus, an innovative biopharmaceutical company in the treatment of neurological diseases and a pioneer in the development of drug candidates modulating the interaction between neurons and glial cells, today announces its results for the first half of 2021 and provides an update on the current state of its programs.
Franck Mouthon, Chairman and CEO and co-founder of Theranexus, made the following comments: “Our business activities during this period were marked by the IND approval of BBDF 101 for Batten disease and were supported by rigorous expense management. We strive to ensure at least 18 months visibility at all times and are fully committed and dedicated to ensuring the industrial development of the THN 102 drug candidate through an industrial partnership. “
Financial results for the first half of 2021
|In k â¬ (French GAAP)||S1-2021||S1-2020|
|Other purchases and external expenses||2 944||2 271|
|Salaries and social charges||1,388||1,174|
|Amortization and depreciation of fixed assets||195||188|
|Other operating expenses||34||0|
|Net operating income / (expenses)||-4,550||-3 363|
|Net financial income / (expense)||-112||163|
|Non-recurring income / (expenses)||0||0|
|Net income / (expense)||-3 723||-2 870|
The Company’s half-year report for the first half of 2021 will be available on its website on September 30, 2021.
Other purchases and external charges increased during the first half of 2021 to 2,944 K â¬ compared to 2,271 K â¬ in the first half of 2020. This increase is mainly due to regulatory preclinical expenses related to the development of the drug candidate BBDF 101 (work already started in H2-2020).
Salaries and social security charges amounted to â¬ 1,388,000 in the first half of 2021 compared to â¬ 1,174,000 over the same period in 2020. As of January 1, 2021, Theranexus no longer enjoys the status of Young Innovative Company (JEI) which provides social and tax contribution companies for employees carrying out research and development (R&D) activities. The company also hired a new employee to strengthen its R&D team during the period.
After recording â¬ 939,000 in tax income mainly from the Research Tax Credit, net losses amounted to â¬ 3,723,000 in the first half of 2021, compared to â¬ 2,870,000 in the first half of 2020. The Research Tax Credit for the first semester is particularly high because no subsidy or reimbursable advance was received over the period (in the second semester, the company expects the second payment of â¬ 1.0 million of advances and subsidies within the framework of the project Neurolead which will reduce the Research Tax Credit base).
The total funds available at June 30, 2021 amounted to â¬ 13.5 million compared to â¬ 11.2 million as at December 31, 2020. The Company’s cash position is relatively stable and offers financial visibility over the next 18 months in accordance with the objectives fixed.
Status of Theranexus’ main clinical programs
THN 102 Drug Candidate – Excessive Daytime Sleepiness (EDS) in Parkinson’s Disease
THN102 is the first potential treatment for excessive daytime sleepiness (EDS) in patients with Parkinson’s disease. Discussions with several potential industrial partners are continuing. The objective is to conclude an industrial agreement governing the format of use, the geographical areas concerned and the clinical development path.
BBDF 101 drug candidate for Batten disease, a rare orphan pediatric disease of the nervous system
Beginning of September 20211, Theranexus announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) to initiate a Phase I / II clinical trial of its drug candidate BBDF 101 for juvenile Batten disease, a rare and fatal disease.
The clinical program will start at the end of 2021 with Phase I / II. Phase III will begin after consultation with the FDA in the second half of 2022, once pharmacokinetic and safety results have been established during the first 4.5 months of Phase I / II treatment.
As a reminder, at the end of 2019, Theranexus and the Beyond Batten Disease Foundation (BBDF) signed an exclusive and worldwide license agreement for the development and commercial use of the drug candidate BBDF 101 in Batten disease.
Next financial publication:
Tuesday, October 19, 2021: Cash position at September 30, 2021
Theranexus is a clinical stage biopharmaceutical company created by the French Alternative Energies and Atomic Energy Commission (CEA) in 2013. It develops drug candidates for the treatment of diseases of the nervous system.
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1 See press release of September 9, 2021 (Theranexus and Beyond Batten Disease Foundation (BBDF) Obtain American Investigational New Drug (IND) Approval to Start Clinical Development of BBDF 101)
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