NeuroVive Pharmaceutical AB Interim report January - September 2017

Continued positive trend for NeuroSTAT®

Business operations

Significant events July-September 2017 

  • NeuroVive received positive feedback from the European Medicines Agency (EMA) regarding the NeuroSTAT development plan.
  • NeuroVive signed a private placement agreement with Esousa Holdings LLC totalling SEK 4.5 million excluding transaction costs.
  • NeuroVive hosted a Mitochondria Day at IVA in Stockholm to raise awareness of mitochondrial disorders.

Important events after the end of the period 

  • NeuroVive received a positive opinion from the the European Medicines Agency’s (EMA) Committee on Orphan Drugs (COMP) on granting orphan drug designation for KL1333.
  • Greg Batcheller, NeuroVive’s Chairman of the Board for the past 17 years, resigned on 6 November. David Laskow-Pooley was elected new Chairman.
  • On November 3, NeuroVive conducted a directed new share issue to Floyd Associates Europe Limited totaling SEK 5.3 million excluding transaction costs.
  • NeuroVive and Lund University were granted funding by the Swedish Foundation for Strategic Research (SSF) for collaboration on liver cancer research.
  • NeuroVive signed a collaboration agreement with the University of Florida regarding the development of TBI biomarkers.
  • NeuroVive presented the results from preclinical TBI trials related to the NeuroSTAT project at the 2017 Nordic Neurotrauma Conference.
  • NeuroVive presented its innovative metabolic regulators for the non-alcoholic steatohepatitis (NASH) liver disease at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) held on 20-24 October 2017, in Washington DC.
  • NeuroVive’s partner, the Children’s Hospital of Philadelphia (CHOP), was awarded funding by the US National Institutions of Health (NIH) to study NeuroVive’s NVP015 compounds as countermeasures against chemical threats.

Financial information 

Third quarter (July-September 2017) 

  • Net revenues were SEK 0 (0) and other operating income was SEK 397,000 (16,000)
  • Loss before tax was SEK 13,179,000 (loss: 34,290,000)
  • Loss per share* was SEK 0.26 (loss: 0.86)
  • Diluted loss per share** was SEK 0.26 (loss: 0.86) 

First nine months (January-September 2017) 

  • Net revenues were SEK 27,000 (0) and other operating income was SEK 550,000 (90,000)
  • Loss before tax was SEK 56,824,000 (loss: 57,265,000)
  • Loss per share* was SEK 1.04 (loss: 1.42)
  • Diluted loss per share** was SEK 1.04 (loss: 1.42) 

* Profit/loss for the period divided by average number of shares before dilution at the end of the period.

** Profit/loss for the period divided by average number of shares after dilution at the end of the period

Please find the complete interim report attached below.

This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, at 08:30 a.m. CET on 21 November 2017. 

NeuroVive Pharmaceutical AB (publ)  

Medicon Village, SE-223 81 Lund, Sweden

Tel: +46 (0)46 275 62 20 (switchboard)

www.neurovive.com

About NeuroVive 

NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine, with one project in clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®) and one project in clinical phase I (KL1333) for genetic mitochondrial diseases. The R&D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to cancer and metabolic diseases such as NASH. The company’s strategy is to advance drugs for rare diseases through clinical development and into the market. The strategy for projects within larger indications outside the core focus area is out-licensing in the preclinical phase. NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF).

About Us

NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine, with one project in clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®) and one project in clinical phase I (KL1333) for genetic mitochondrial diseases. The R&D portfolio also consists of projects for genetic mitochondrial disorders, cancer and NASH. The company advances drugs for rare diseases through clinical development into the market. For projects for common indications the goal is out-licensing in the preclinical phase. A subset of compounds under NeuroVive’s NVP015 program has been licenced to Fortify Therapeutics, a BridgeBio company, for local treatment development of Leber’s Hereditary Optic Neuropathy (LHON). NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF). www.neurovive.com

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