NeuroVive Pharmaceutical AB Year End Report January - December 2018

Positioned for clinical progress

Important events January-December 2018

Quarter 1

  • Positive experimental efficacy data for NVP025.
  • Decision on a rights issue (extraordinary general meeting).

Quarter 2

  • NeuroVive and Yungjin reports positive KL1333 phase I clinical study results.
  • KL1333 receives FDA Orphan Drug Designation for treatment of mitochondrial diseases.
  • Positive efficacy data in an experimental model, entailing a breakthrough for the NVP025 mitochondrial myopathy project.
  • NeuroVive initiates collaboration with leading US TBI research organization.
  • NeuroVive out-licenses targeted LHON therapy to BridgeBio Pharma’s new subsidiary Fortify Therapeutics.
  • Oversubscribed preferential rights issue (approximately MSEK 78.5 before issue expenses).
  • Annual General Meeting on 27 April in Lund, Sweden.

Quarter 3

  • KL1333 mechanism of action published in scientific journal.
  • Positive FDA feedback on the NeuroSTAT TBI development plan.
  • 4 MUSD grant to Children’s Hospital of Philadelphia for NVP015 research.

Quarter 4

  • KL1333 clinical trial regulatory approval from the UK regulatory authority (MHRA).
  • Signal of clinical efficacy from biomarker measurements in CHIC TBI-study.
  • Preclinical NV354 efficacy results in a model for mitochondrial disease.
  • Funding 5 million SEK from Vinnova for the development of NV354.
  • The exercise of warrants of series 2018:1 in November provides the Company with approximately SEK 480 000.
  • NeuroVive resolves on a rights issue of MSEK 123.8, subject to approval by the Extraordinary General Meeting, and summons to an extraordinary general meeting.

Important events after the reporting period

  • Decision on a rights issue (extraordinary general meeting).
  • NeuroVive is supplied with approximately MSEK 99.0 in share issue proceeds before issue costs of approximately MSEK 17.7.

Fourth quarter (October - December 2018)

  • Net revenues: SEK 5,000 (0)
  • Other operating income: SEK 1,009,000 (9,000)
  • Loss before tax: SEK -19,978,000 (-14,779,000)
  • Loss per share*: SEK -0,25 (-0,29)
  • Diluted loss per share**: SEK -0,25 (-0,29)

Twelve months (January - December 2018)

  • Net revenues: SEK 5,000 (27,000)
  • Other operating income: SEK 2,461,000 (248,000)
  • Loss before tax: SEK -73,494,000 (-71,603,000)
  • Loss per share*: SEK -0,94 (-1,33)
  • Diluted loss per share**: SEK -0,94 (-1,33)

 * 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

The complete Year End report is available for download below and through NeuroVive's web site www.neurovive.com.

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 28 February 2019.

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
For news subscription, please visit http://www.neurovive.com/press-releases/subscription-page/  

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

Abliva AB is a leader in mitochondrial medicine, with one project in clinical phase I (KL1333) for chronic treatment of primary mitochondrial diseases and one project, in preparation for clinical trials (NV354), for treatment of primary mitochondrial diseases with Complex I deficiency. NeuroSTAT for traumatic brain injury (TBI) is ready to enter a clinical phase II efficacy study. The R&D portfolio also consists of early projects. Abliva’s ambition is to take drugs for primary mitochondrial diseases through clinical development and all the way to market, with or without partners. For the TBI and NASH projects the goal is to enter strategic partnerships. A subset of compounds under the NVP015 program has been licenced to Fortify Therapeutics, a BridgeBio company, for local treatment development of Leber’s Hereditary Optic Neuropathy (LHON). Abliva is listed on Nasdaq Stockholm, Sweden (ticker: ABLI).

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Quotes

In summarizing 2018, we can say that it was a very successful year for our focus projects
Erik Kinnman, CEO