Significant events October-December 2017
- NeuroVive received a positive opinion from the EMA’s Committee for Orphan Medicinal Products (COMP) regarding orphan drug designation for KL1333.
- Greg Batcheller, the Chairman of NeuroVive’s Board for the past 17 years, resigned on November 6. The Board elected David Laskow-Pooley as the new Chairman.
- On November 3, 2017, NeuroVive issued shares totaling SEK 5.3 million before transaction costs through a private offering to Floyd Associates Europe Limited.
- NeuroVive and Lund University were granted funding by the Swedish Foundation for Strategic Research (SSF) for collaboration around liver cancer research.
- NeuroVive signed a collaboration agreement with the University of Florida for TBI biomarker development.
- NeuroVive presented 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) on October 20-24, 2017 in Washington DC, USA.
- NeuroVive’s partner, the Children’s Hospital of Philadelphia (CHOP), was granted research funding by the US National Institutions of Health (NIH) to study NeuroVive’s NVP015 compounds as countermeasures against chemical threats.
- NeuroVive selected a candidate compound in the NVP015 project for mitochondrial disorders for continued preclinical development.
- NeuroVive reported progress in the Korean Phase I trial of KL1333.
- KL1333 was granted orphan drug designation by the European Commission
Important events after the end of the period
- NeuroVive reported a breakthrough for the NVP025 project for mitochondrial myopathies.
- The Board of Directors of NeuroVive has resolved, subject to approval by the Extraordinary General Meeting, to issue shares and warrants with preferential rights for existing shareholders. Upon full subscription to the rights issue, NeuroVive will receive approximately MSEK 78.5 before issuance costs. In full exercise of the warrants issued in the Rights issue, NeuroVive will receive an additional MSEK 37.3 before issuance costs.
Fourth quarter (October-December 2017)
- Net revenues were SEK 0 (14,000) and other operating income was SEK 9,000 (14,000)
- Loss before tax was SEK 14,779,000 (loss: 14,580,000)
- Loss per share* was SEK 0.29 (loss: 0.34)
- Diluted loss per share** was SEK 0.29 (loss: 0.34)
Full-year (January-December 2017)
- Net revenues were SEK 27,000 (14,000) and other operating income was SEK 558,000 (104,000)
- Loss before tax was SEK 71,603,000 (loss: 71,845,000)
- Loss per share* was SEK 1.33 (loss: 1.67)
- Diluted loss per share** was SEK 1.33 (loss: 1.67)
* 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 the NeuroVive web site www.neurovive.com.
For more information concerning this report, please contact CEO Erik Kinnman. Telephone: +46 (0)46-275 62 20.
The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CET on 20 February 2018.
NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard)
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).