Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 GNRO):
The GNC-501 clinical trial is a Phase 2 study in patients suffering from post-COVID-19 neuropsychiatric syndromes, testing temelimab against placebo. The study enrolled over 200 patients in Switzerland, Spain and Italy who had tested positive for HERV-W ENV. The top-line results from this study show that treated patients had no clinically meaningful improvement compared to placebo on the primary endpoint measuring the improvement of fatigue with the PROMIS SF7a test. The majority of secondary endpoints did not show an effect either. The treatment was very well tolerated and safe, consistent with previous clinical trials in other indications.
Preliminary analyses suggest that shorter disease duration at time of inclusion, as well as the evolution of the underlying HERV-W ENV status, may have an impact on the efficacy outcome measures. The Company will continue to analyze complete results once they become available, including additional biomarkers.
GeNeuro thanks all the study participants, the investigators and all other site personnel for their commitment that made this novel study possible. The learnings from this study will certainly advance the knowledge of this new disease affecting millions of persons worldwide.
The Board of Directors of GeNeuro has taken note of these results and decided to further reduce its operating costs and workforce to conserve cash while considering all the strategic alternatives for the Company. As a result, the Swiss parent company GeNeuro SA has made redundant 7 of its 9 employment agreements, including all of the Executive Management. All employees and managers will work through their notice periods, of up to 6 months, to execute the strategy that will be defined by the Board over the coming days. An announcement detailing the strategic plan including the implications for the French R&D subsidiary will be made shortly thereafter. The Company will continue to seek paths to advance or monetize its pipeline assets against multiple sclerosis and amyotrophic lateral sclerosis, as well as its HERV platform, in order to generate value for all stakeholders.
About GeNeuro
GeNeuro's mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by HERVs, which represent 8% of human DNA.
GeNeuro is based in Geneva, Switzerland and has R&D facilities in Lyon, France.
For more information, visit: www.geneuro.com
Disclaimer:
This press release contains certain forward looking statements and estimates concerning GeNeuro's financial condition, operating results, strategy, projects and future performance and the markets in which it operates. Such forward-looking statements and estimates may be identified by words, such as "anticipate," "believe," "can," "could," "estimate," "expect," "intend," "is designed to," "may," "might," "plan," "potential," "predict," "objective," "should," or the negative of these and similar expressions. They incorporate all topics that are not historical facts. Forward looking statements, forecasts and estimates are based on management's current assumptions and assessment of risks, uncertainties and other factors, known and unknown, which were deemed to be reasonable at the time they were made but which may turn out to be incorrect. Events and outcomes are difficult to predict and depend on factors beyond the company's control. Consequently, the actual results, financial condition, performances and/or achievements of GeNeuro or of the industry may turn out to differ materially from the future results, performances or achievements expressed or implied by these statements, forecasts and estimates. Owing to these uncertainties, no representation is made as to the correctness or fairness of these forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.
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Contacts:
GeNeuro
Jesús Martin-Garcia
Chairman and CEO
+41 22 552 48 00
investors@geneuro.com
NewCap (France)
Louis-Victor Delouvrier (investors)
+33 1 44 71 98 52
Arthur Rouillé (media)
+33 1 44 71 00 15
geneuro@newcap.eu
