NEOVACS PROVIDES CORPORATE UPDATE AND REPORTS FULL-YEAR 2017 FINANCIAL RESULTS

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NEOVACS PROVIDES CORPORATE UPDATE AND REPORTS FULL-YEAR 2017 FINANCIAL RESULTS

• COMPLETED PATIENT ENROLLMENT IN PHASE IIb CLINICAL STUDY OF IFNalpha KINOID FOR TREATMENT OF LUPUS
   
• RECEIVED U.S. FDA APPROVAL TO EXPAND ITS  PHASE I/IIa CLINICAL STUDY WITH IFNalpha KINOID FOR TREATMENT OF DERMATOMYOSITIS
   
• STRENGTHENED BALANCE SHEET THROUGH TWO TRANSACTIONS RESULTING IN APPROXIMATELY €11MILLION
   
• LAUNCH OF A REDEEMABLE STOCK WARRANT (BSAR) FREE ALLOCATION PLAN FOR THE BENEFIT OF ITS SHAREHOLDERS

Paris, March 30, 2018, 7:30 am CEST  - NEOVACS (Euronext Growth Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases,  provided today a corporate update and reported its financial results for the 12-months ended December 31, 2017, as approved by the Company's Board of Directors on March 29, 2018.

Miguel Sieler, CEO of Neovacs, said: "2017 was a year of significant progress for Neovacs, during which the Company completed patient enrollment of its Phase IIb study of IFNalpha Kinoid in lupus, strengthened its intellectual property, entered into new partnerships, and prudently managed its finances. Most importantly, our clinical and preclinical pipeline programs continued to advance as planned.  Looking ahead, we look forward to reporting the results of our phase IIb clinical trial in lupus,  - our most advanced program, in mid-2018. We are confident that Neovacs has laid a strong foundation to create significant shareholder value in 2018 and beyond."

KEY 2017 ACCOMPLISHMENTS

- Completed patient enrollment in phase the IIb clinical study of IFNalpha Kinoid in lupus.  185 patients have been enrolled in this trial, and top-line results are currently expected end of June 2018.

 

- Concluded third positive data review by iDSMB following completion of patient recruitment in phase IIb lupus trial.  There were no safety concerns identified following this review of the cumulative safety data by the independent data safety monitoring board (iDSMB),  and the board recommended the continuation of the study without modification.

- Received U.S. FDA approval to conduct a Phase I/IIa study of IFNalpha Kinoid in dermatomyositis (DM) in the United States. .  This Phase IIa clinical trial is a multicenter study currently being conducted in Europe (France, Italy, Germany, and Switzerland) in 30 adult patients. The objective of the study is to evaluate the immunogenicity, tolerability, and biological and clinical efficacy of IFNalpha Kinoid in this orphan indication.