NeuroVive Pharmaceutical AB Interim report January – September 2018

KL1333 approved for phase I clinical trial

Important events January-September 2018

  • NeuroVive’s genetic mitochondrial disease drug candidate KL1333 mechanism of action published in scientific journal
  • NeuroVive receives positive FDA feedback on its NeuroSTAT TBI development plan
  • NeuroVive’s NVP015 program will be supported through award of major research grant to Children’s Hospital of Philadelphia
  • NeuroVive and Yungjin reports positive KL1333 phase I clinical study results
  • KL1333 receives FDA Orphan Drug Designation for treatment of mitochondrial diseases
  • NeuroVive initiates collaboration with leading US TBI research organization TRACK-TBI
  • NeuroVive out-licenses targeted LHON therapy to BridgeBio Pharma’s new subsidiary Fortify Therapeutics
  • The company reported positive efficacy data in an experimental model, entailing a breakthrough for the NVP025 mitochondrial myopathy project
  • NeuroVive conducts a preferential rights issue

Important events after the reporting period

  • NeuroVive receives KL1333 clinical trial regulatory approval from the UK regulatory authority 
  • NeuroVive reports first NeuroSTAT clinical efficacy signal in TBI
  • NeuroVive presents first preclinical NV354 efficacy results in a model for mitochondrial disease
  • NeuroVive has been awarded SEK 1.5 million as a first tranche of total SEK 5 million in funding from Vinnova, Sweden’s innovation agency, and the Swelife call, for intensified development in the NVP015 project, the goal of which is to advance the candidate compound NV354 to clinical studies

Financials third quarter 
(July-September 2018)

  • Net revenues: SEK 0 (0) 
  • Other operating income: SEK 0 (397,000) 
  • Loss before tax: SEK -14,982,000 (-13,179,000) 
  • Loss per share:* SEK -0.20 (-0.26)
  • Diluted loss per share:** SEK -0.20 (-0.26) 

Financials first nine months 
(January-September 2018)

  • Net revenues: SEK 0 (27,000) 
  • Other operating income: SEK 1,452,000 (550,000) 
  • Loss before tax: SEK -53,516,000 (-56,824,000) 
  • Loss per share:* SEK -0.72 (-1.04)
  • Diluted loss per share:** SEK -0.72 (-1.04) 

* 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

This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below at 08:30 a.m. CET on 22 November 2018.

For more information please contact:
Erik Kinnman, CEO
+46 (0)46 275 62 20

NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard)
info@neurovive.com, www.neurovive.com
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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 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).

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