Lyon - Theranexus, an innovative biopharmaceutical company in the treatment of neurological diseases and a pioneer in the development of drug candidates playing on the interaction between neurons and glial cells, announces the signing of a non-dilutive credit agreement for 3.4 million euros and reviews its clinical developments.
Getting around EUR 6.5 million non-dilutive financing in 2 nd quarter 2020
The Company has just obtained non-dilutive financing of EUR 3.4 million in the form of a PGE from a consortium made up of its historic banking partners and Bpifrance. This loan provides a period of one year before the start of repayments with a staggered repayment over a maximum period of 5 years.
In addition, Theranexus also received the accelerated and full repayment of the 2019 Research Tax Credit (CIR) in the amount of EUR 2 million during the month of May 2020. Finally, the Company received from Bpifrance the first tranche of financing ( EUR 1 million) of its Neurolead R&D platform, developed in partnership with the College de France and the CEA and subject to PSPC [1] funding by Bpifrance. The Company must collect another EUR 3 million spread over the next 3 years as part of this project.
As a reminder, the Company's cash position at March 31, 2020 was EUR 7.8 million [2] and did not include any of the collections listed above.
Progress points on the advance of the THN102 and BBDF101 programs
Drug Applicant THN 102 - Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
The positive results of the phase 2 clinical study [3] position THN 102 as the first potential treatment for excessive daytime sleepiness (EDS) in patients with Parkinson's disease. In addition, the absence of residual drowsiness in more than 25% of patients after treatment with THN102 is promising for a rendered medical service.
According to a recent June 2020 study by the research and consultancy firm Clarivate Analytics, 40% of Parkinson's patients suffer from EDS in the absence of any available treatment. More than half of them suffer from an EDS which is sufficiently disabling both in terms of quality of life but also in terms of the overall course of the disease to require specific management of this symptom which would therefore be potentially treatable by THN102. Clarivate Analytics estimates that based on its Phase 2 efficacy and safety profile, the THN 102 could reach sales of more than $ 1 billion with a processing price of more than $ 20,000 in the United States. -United States and 5,000 dollars on average in Europe.
As previously announced, the objective of Theranexus is to conclude a partnership with an industrialist promoting the positive results of this phase 2 and ensuring the clinical development of this drug candidate until its commercial exploitation. As a reminder, this partnership is expected by the end of 2020. In this context, the first discussions with potential partners have confirmed the interest of a certain number of them for THN102 and make the confident team on this goal.
Drug candidate BBDF-101 in Batten's disease, a rare and orphan pediatric neurological disease
As a reminder, Theranexus and the BBDF foundation announced in December 2019 an exclusive and global license agreement for the drug candidate BBDF-101 which provides for the clinical development of the drug candidate BBDF-101 until its registration, as well as the commercial exploitation of it.
BBDF-101 is a drug candidate combining trehalose with miglustat, two active ingredients, each presenting its own activity of interest in the disease as well as synergistic activity.
The safety profile of each of these two compounds is well known and very favorable: miglustat being a drug already registered in another rare disease and trehalose being a commonly used excipient (especially in intravenous solutions). The clinical program for the treatment of pediatric patients over a long period of 24 months, the Food and Drug Administration [4](FDA) nevertheless asked Theranexus to confirm without delay the preclinical safety of trehalose over a long exposure period to supplement the data already available. Given the frequent use of trehalose, especially in intravenous solutions and miglustat, the Company is very confident about the outcome of this work. The completion of this preclinical stage was initially planned in parallel with the clinical program, but will be anticipated to allow the launch of the program in the second half of 2021. Interactions with the FDA have also made it possible to confirm that the envisaged clinical development would allow successful direct registration of the product. In addition, obtaining the status of 'orphan drug or Orphan Drug' from the FDA and the EMA[5] are expected in the coming weeks.
Franck Mouthon, Chairman and CEO and co-founder of Theranexus concludes: 'I would like to thank the French government as well as Bpifrance and our banking partners for their support and mobilization which allow us to consolidate our cash flow. All of the non-dilutive financing for this first half with nearly EUR 6.5 million will thus support the continuation of our activities and strengthen our position in the discussions of an industrial partnership for THN102 which we want to conclude by the end. for the year 2020. Such an agreement will be a strong catalyst in the promotion and development of the Company. '
About THN 102 in Parkinson's disease
THN102 successfully achieved the primary efficacy endpoint of the phase 2 clinical trial by significantly reducing EDS in Parkinson's patients with severe excessive daytime sleepiness (ESS of 16.5 on average) measured using the Epworth Sleepiness Scale (ESS). The ESS score improves by 3.9 points in patients after treatment with THN102-200 / 2. This improvement is highly significant (p = 0.01) compared to that of placebo (2.4 points). In addition, the proportion of patients who no longer exhibited excessive daytime sleepiness during the duration of treatment was significantly higher with THN102-200 / 2 than with placebo (p = 0.05). The study also demonstrated the excellent tolerance of the product THN102 and the absence of
About 40% of patients with Parkinson's disease are prone to excessive daytime sleepiness. This symptom is recognized by practitioners as an important medical need [6] and poses a significant accident-causing over-risk [7].
About BBDF 101 in Batten's disease
The juvenile form of Batten's disease or Spielmeyer-Vogt disease, or CLN3 disease, is a rare and fatal genetic disease of the nervous system for which there is no treatment. It belongs to the group of neuronal ceroid lipofuscinoses (CLN). The clinical development program allowing the registration of the product in the event of success, will be launched in 2021 and will include efficiency measures comparing the progression of the various symptoms with the natural evolution of the disease previously documented from cohorts of patients already followed by the safety and pharmacokinetics of BBDF-101. It will include an adolescent / adult cohort and a pediatric cohort: The program will begin with the enrollment of an adolescent / adult cohort of 6 patients, all of whom will receive the drug BBDF-101 in dose escalation, with establishment of tolerance and pharmacokinetics for 5 months. During the rest of the study, these patients will continue to receive BBDF-101 and will be subject to safety monitoring.
Once the pharmacokinetics and tolerance measures of the adolescent / adult cohort have been obtained, a pediatric cohort of 30 patients will be enrolled, and will be subject to regular measures to assess the progression of the disease (vision, cognition, motor symptoms , etc.) for a period of two years.
At the end of the trial, patient data will be compared with the natural course of the disease as measured in cohorts already monitored by American and European academic teams.
Next financial publication: Thursday July 9, 2020 (before market): Update on cash at June 30, 2020
About Theranexus
Founded in 2013, THERANEXUS is a biopharmaceutical company at the clinical stage, resulting from the CEA which develops drug candidates for the treatment of diseases of the nervous system. THERANEXUS has identified the major role of non-neuronal cells (otherwise called 'glial cells') in the response to psychotropic drugs (targeting neurons). The company is a pioneer in the design and development of drug candidates acting on the interaction between neurons and glial cells. The unique and patented technology exploited by THERANEXUS aims to increase the effectiveness of psychotropic drugs already approved and marketed by combining them with a glial cell modulator.
Proprietary and adaptable, the THERANEXUS platform allows the generation of different proprietary drug candidates with high added value in several indications.
Contact:
Tel: 33 (0) 6 07 76 82 83
Email: fportejoie@fp2com.fr
THERANEXUS 
