Paris and Boston, March 9th, 2020 - 6h30 pm CET - Neovacs (Euronext Growth Paris: ALNEV) announces that it has obtained a 6-month extension of its observation period and reports an update on the two research programs.
REOGANIZATION PROCEEDINGS
On November 26th, 2019 the Commercial Court of Paris decided the opening of reorganization proceedings of the company with an observation period initially set for 3 months. At the end of this period and after a hearing before the Tribunal held in the presence of the procedural bodies, the court extended this observation period for a period of 6 months, until August 26, 2020, by judgment dated February 26th, 2020. This decision results in particular from the fact that negotiations are under way to try to meet the conditions necessary for the presentation of a recovery plan. The outcome of these exchanges therefore conditions the outcome of the reorganization proceedings. The Company will inform the public of any significant update on this subject.
UPDATE ON R&D PROGRAMS
Lupus
In the frame of the reorganization proceedings and in agreement with the receiver, the decision was made to end the long-term follow-up (without administration of product) of the phase IIb study in lupus with the product IFN-alpha Kinoid.
In parallel, Neovacs received the report of the scientific advice with the ANSM following the request initiated by Neovacs on the possibility of using the LLDAS1 criterion as the primary endpoint of a Phase III clinical study following the results from his Phase IIb clinical trial in lupus. The ANSM notably underlined that the LLDAS approach is coherent with what is already in place in rheumatoid arthritis and other autoimmune diseases where it has a real impact on the management of the disease. The ANSM recommends at this stage to request a scientific advice from the European Medicines Agency (EMA).
In this context and given the level of funding required, the continuation of the Lupus program will depend on the signing of a global strategic partnership.
Allergy
Neovacs has completed the first key stages of its preclinical allergy research program in prophylactic and therapeutic models, the results of which will be submitted to a peer-reviewed scientific journal.
The continuation of all R&D programs will depend in all cases on the outcome of the company's reorganization proceedings.
Neovacs is a French biotech company listed on Euronext Growth since 2010. The Company is focused on therapeutic vaccines targeting the treatment of autoimmune diseases. Its innovative technology named Kinoid™, patented until 2038, induces a polyclonal immune response, applicable in several indications. Neovacs has developed the IFNα KINOID to treat lupus in a clinical phase IIb study, the main study is now ended and the full results have been presented at the 13th international Lupus Congress 2019. The Company also carried out preclinical work on IL-4/ IL-13 Kinoid, another therapeutic vaccine for the treatment of allergies. The aim of this "KINOID approach" is to enable patients to better cope with a life-long treatment that would be more effective, well tolerated and unburdensome. For more information: www.neovacs.fr.
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[1] LLDAS: Lupus Low Disease Activity State
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https://www.actusnews.com/documents_communiques/ACTUS-0-62461-20200305-cp_neovacs_en.pdf
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