NeuroVive Pharmaceutical AB Interim report January - June 2017

Strategic in-licensing broadens the project portfolio

Business operations

Significant events April-June 2017

  • The anti-fibrotic effects of NV556 in non-alcoholic steatohepatitis (NASH) was confirmed in an additional experimental model. The preclinical data was presented at The International Liver Congress™ in Amsterdam. 
  • At the Annual General Meeting on 27 April, two new board members were elected: Jan Törnell, adjunct Professor at the Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, and David Bejker, CEO of Affibody Medical AB 
  • NeuroVive entered into a global licensing agreement on Yungjin Pharm’s compound KL1333 for genetic mitochondrial disorders. The clinical phase I study of KL1333 was initiated in South Korea end of June.
  • In May, NeuroVive announced positive results from clinical and preclinical studies with its drug NeuroSTAT® for the prevention of the sequelae of traumatic brain injury (TBI). The results have enabled NeuroVive to proceed into the next stage of clinical development amd the company has therefore decided to close the clinical phase IIa study CHIC in advance and focus all TBI project efforts on preparing for the next clinical study with NeuroSTAT for TBI. Further analyses and additional data were presented at the Annual National Neurotrauma Symposium, Neurotrauma 2017, in Snowbird, Utah, on 9-12 July, by Michael Karlsson. 
  • NeuroVive received close to 1 million SEK in a research grant from Swedish innovation agency, Vinnova, for developing a new treatment for genetic mitochondrial diseases. Johannes Ehinger presented the project at UMDF’s (United Mitochondrial Disease Foundation) meeting in Washington DC end of June. 

Important events after the end of the period

  • NeuroVive signed a private placement agreement with Esousa Holdings LLC, a New York-based family office investing in emerging growth companies, which will raise gross proceeds of 9 million SEK divided in two equal tranches. The first tranche was completed on 18 July.  

Financial information

Second quarter (April-June 2017)

  • Net revenues were SEK 0 (0) and other operating income was SEK 88,000 (28,000)
  • Loss before tax was SEK 22,256,000 (loss: 12,059,000)
  • Earnings per share* was SEK -0.45 (- 0.34)
  • Diluted earnings per share** amounted to SEK -0.45 (- 0.34)

First six months (January-June 2017)

  • Net revenues were SEK 27,000 (0) and other operating income was SEK 152,000 (74,000)
  • Loss before tax was SEK 43,646,000 (22,975,000)
  • Earnings per share* were SEK -0.79 (-0.64)
  • Diluted earnings per share** were SEK -0.79 (-0.64)

*                 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, through the agency of the contact person set out above, at 08:30 a.m. CEST on 17 August 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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