Theranexus, an innovative biopharmaceutical company in the treatment of neurological diseases and a pioneer in the development of drug candidates acting on the interaction between neurons and glial cells (the ' Company '), provides an update on its activity and announces the strengthening of its financial visibility for the medium term.
Update on the progress of activities
The Company is actively pursuing the development of its main programs, which today mainly focus on THN102 and BBDF-101.
Regarding the THN102 program (excessive daytime sleepiness in Parkinson's disease)
Theranexus confirms the continuation of its discussions with several potential partners, confirming the interest of the pharmaceutical industry in this drug candidate, with a view to signing an agreement by the end of the first half of 2021 allowing further development clinical study of THN102 in Parkinson's disease. Theranexus continues to assess the various opportunities in terms of the format and regionalization of partnerships as well as the clinical development path of its drug candidate, with the aim of maximizing value for the Company and its shareholders.
Regarding the BBDF-101 program (Batten disease)
During the fourth quarter, the Company obtained a favorable opinion from the US Food and Drug Administration ( US regulatory authority) concerning the preclinical development plan for BBDF-101. The Company now plans to obtain an IND ( Investigational New Drug Application ) from the FDA in mid-2021 and start the clinical trial by the end of the year. As a reminder, the planned clinical program (comprising a cohort of 6 adult patients and a cohort of 30 pediatric patients) aims to allow direct registration of the product in the event of success.
' Our various programs continue to follow their development plan. The partnership discussions concerning THN102 are certainly a little longer than initially anticipated, in particular due to the general context, but they are progressing and we are confident in our ability to conclude an agreement by the end of the first half of 2021. In order to secure a good financial visibility for the company in parallel with the partnership discussions on THN102, we have decided to set up a new line of equity financing. This line will allow us to keep pace with all our developments and, in particular, those of the BBDF-101 program. ' Specifies Franck Mouthon, Chairman and CEO of Theranexus.
Reinforcement of financial visibility - establishment of a new line of equity financing
Available cash at December 31, 2020 amounted to EUR 11.2 million compared to EUR 11.9 million as at September 30, 2020, and therefore remains virtually stable thanks in particular to the capital increases carried out within the framework of the equity financing announced by the Company on July 8, 2020 and realized through the exercise of bond issue warrants redeemable in new Company shares subscribed by IRIS.
The coming quarters will be marked in particular by continued spending on the BBDF-101 program with the end of preclinical studies leading to the obtaining of the IND and the start of clinical spending, in particular those related to the establishment of the 'test. In order to finance its growth and ensure financial visibility at 18 months while preserving its ability to negotiate the best possible terms of its potential partnership on THN102, the Company has decided to set up a new financing line. equity to a maximum total amount of EUR 8.4 million over 12 months to issue warrants (the ' warrants ') entitling to the subscription ofbonds redeemable in new shares of the Company (the ' Bonds') Fully reserved for IRIS (the' Investor ').
Legal basis of the issue
The Company's Board of Directors met today and duly delegated by the General Meeting held June 2, 2020 (the ' Meeting ') pursuant to its 19 th resolution, decided to issue free at benefit of the Investor of 3,360 Warrants each giving the right to the issue of a Bond with a nominal value of 2,500 euros on the basis of Articles L. 225-129-2, L. 22-10-49, L. 225-135, L-225-138 and L. 228- 91 et seq. Of the Commercial Code.
Objectives of the operation
This funding is intended to provide Theranexus with additional resources to support its growth. In particular, it will help finance the next stages of its clinical developments on its BBDF-101 program in Batten disease.
Terms of the operation and timetable
The 3,360 Warrants have been subscribed in full by the Investor today.
Subject to the conditions provided for in the issue contract being met, the Investor will subscribe for the Bonds upon exercise of the Warrants in 12 installments with a nominal amount of 700,000 euros each by January 18, 2022. The Company may, at its sole initiative and without charge or penalty, suspend or reactivate the issuance of Bonds, or even terminate the contract. The Bonds will be issued at their nominal value without discount at the initiative of the Investor. The redemption price in new shares and the other main characteristics of the Bonds appear in the appendix to this press release.
The Company could request the renewal of the line for a period of one additional year. The Company would issue a press release if it was decided to renew it.
The Warrants and Bonds will not be the subject of an application for admission to trading on any market and will therefore not be listed.
This transaction does not give rise to the publication of a prospectus to be approved by the Autorite des marches financiers.
On the basis of the assumptions appearing in the section 'Potential dilution - maximum number of shares' of the appendix to this press release, a shareholder holding 1% of the Company's capital and not participating in the transaction would see his participation increase to 0.91%, ie 9.49% dilution after issuance of 428,395 new shares. On the basis of these same assumptions, the breakdown of the Company's share capital before and after the redemption in shares of all the bonds will be, to its knowledge, as follows:
The Company will keep a summary table of the Warrants, Bonds and the number of shares outstanding on its website.
The public's attention is also drawn to the risk factors relating to the Company and its activity, presented in its universal registration document filed with the AMF on April 30, 2020 under number D.20-0414, available free of charge on the Company's website. The materialization of all or part of these risks is likely to have an unfavorable effect on the activity, financial situation, results, development or prospects of the Company.
Next financial publication:
Wednesday April 7, 2021 : annual financial results and cash flow update as of March 31, 2021
Founded in 2013, THERANEXUS is a clinical-stage biopharmaceutical company, born out of the CEA, which develops drug candidates for the treatment of diseases of the nervous system.
Thanks to its knowledge of neuro-glial interactions, THERANEXUS is a pioneer in the design and combination of approved substances and has a solid and diversified portfolio of active ingredients in the clinical phase. This strategy of combining repositioned drugs based on a solid commercial case and with a real ability to quickly demonstrate their clinical value allows the company to generate different candidate drug candidates with high added value, significantly reducing the time and costs of development and considerably increase the chances of market access for its drugs.
To this end, THERANEXUS is positioned in several indications, including Parkinson's disease and Batten disease, for which no treatment is currently available on the market.
Tel: +33 (0) 1 53 67 36 70
This press release contains forward-looking statements relating to Theranexus and its business, including its prospects and product development. Theranexus believes these forward-looking statements are based on reasonable assumptions. However, forward-looking statements are not guarantees of future performance, as they relate to future events and depend on circumstances which may or may not occur in the future, and on various risks and uncertainties, including those described in the Company's universal registration document filed with the AMF on April 30, 2020 under number D. 20-0414, a copy of which is available on the Company's website ( www.theranexus.com), and changes in economic conditions, financial markets and markets in which Theranexus is present. Forward-looking statements contained in this press release are also subject to risks unknown to Theranexus or which Theranexus does not consider material as of this date. The materialization of all or part of these risks could cause the actual results, financial conditions, performance or achievements of Theranexus to differ significantly from the results, financial conditions, performance or achievements expressed in these forward-looking statements. Theranexus assumes no responsibility for updating these forward-looking statements.