THERADIAG Provides an Update on Prestizia and Its Partnership with HOB Biotech

Regulatory News:

THERADIAG (ISIN: FR0004197747, Ticker: ALTER, eligible for PEA-PME equity savings plans) (Paris:ALTER) a company specialized in in vitro diagnostics and theranostics, today announced the discontinuation of its Prestizia research activity, a wholly-owned subsidiary of Theradiag, and provides an update on contracts renegotiation discussions with HOB Biotech.

Prestizia, a wholly-owned subsidiary of Theradiag, works on fundamental research projects with the aim of developing new diagnostic markers using its microRNA platform, in the fields of oncology (rectal and ovarian cancers) and HIV/AIDS. Although recent programs – miCRA and OVAmiR¹ – produced positive results in the identification of microRNA that are relevant and useful in the advancement of science, these are considered insufficiently robust to allow for the creation, industrial production and marketing of new diagnostic kits.

In addition, Theradiag had received European financial support with its South Korean partners for the collaborative PIONEER project for monitoring rectal cancer, managed by Prestizia. This represented a further step in Prestizia’s developments in rectal cancer and was intended to build on the work already completed in this area. Ultimately, however, the funding for this program was not received and Prestizia’s research efforts in this field could not be continued.

Given these results from research programs and the loss-making position of the Prestizia subsidiary, which had affected Theradiag’s accounts since 2011, in July 2017 the Board of Directors appointed a specialist life sciences industry consultant to help identify any potential partnership that would allow the continuation of Prestizia’s activity and the continued employment of its employees.

These discussions with possible partners not having produced concrete results, Theradiag is now obliged to close its Prestizia subsidiary.

"To have realistic hope of results likely to produce marketable kits, we would have had to devote far greater financial resources to our Prestizia subsidiary, to the detriment of the development of the rest of Theradiag’s activities, notably theranostics. The absence of medium term revenue prospects now forces us to separate ourselves from this research business. We will fully refocus our development efforts on our high added value products, in particular our LISA TRACKER® range,” commented Michel Finance, Theradiag’s Chief Executive Officer.

As previously announced², contracts renegotiation discussions have been initiated by our Chinese partner HOB Biotech. These have now reached an impasse and it is not possible at this stage to anticipate the consequences of this situation on the HOB Biotech partnership or the launch of BioCLIA. The outcome of these discussions and the consequences of any decision will be detailed in a press release as soon as possible.

About Theradiag

Capitalizing on its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag is thus participating in the development of customized treatment, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. Theradiag notably markets the Lisa Tracker® range (CE marked), which is a comprehensive multiparameter theranostic solution for patients with autoimmune diseases treated with biotherapies. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 70 employees.
For more information about Theradiag, please visit our website: www.theradiag.com

¹ The aim of the miCRA project was to use a microRNA signature to develop a simple, quick and non-invasive theranostic test providing early prediction of the response to radiochemotherapy and metastatic relapse in rectal cancer. The OVAmiR project concerned research into signatures capable of predicting the response to chemotherapy based on platinum salts and taxanes in ovarian cancer. It aimed to identify a combination of microRNA from a blood sample. The development of a test would have provided an early-stage assessment of the likely response to conventional treatment and thus would have met the urgent need for clinical decision-support tools in this field.
² Press releases of July 25, September 18 and October 26, 2017.

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