STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News:
Negative top-line result of phase III study and continued progress in other clinical projects
Second Quarter (1 Apr. 2015 – 30 Jun. 2015)
· Net revenues were SEK 2,502,000 (0) and other operating income was SEK 377,000 (1,128,000).
· Loss before tax was SEK -15,216,000 (-13,690,000).
· Earnings per share* were SEK -0.54 (-0.69).
· Diluted earnings per share** were SEK -0.54 (-0.69).
Six Months (1 Jan. 2015 – 30 Jun. 2015)
· Net revenues were SEK 2,502,000 (0) and other operating income was SEK 426,000 (1,171,000).
· Loss before tax was SEK -29,487,000 (-23,567,000).
· Earnings per share* were SEK -1.02 (-0.50).
· Diluted earnings per share** were SEK -1.02 (-0.50).
* Profit/loss for the period divided by the average number of shares before dilution at the end of the period.
**Profit/loss for the period divided by the average number of shares after dilution at the end of the period.
Business highlights in the second quarter of 2015
· A directed share issue was completed, and contributed SEK 59 million to the Company after transaction costs. The share issue was directed to a limited group of institutional US investors in order to strengthen the company’s ownership base in the US.
· The phase III CIRCUS study of CicloMulsion® in patients with a specific type of heart attack known as ST-segment elevation acute myocardial infarction (STEMI) did not meet its primary clinical endpoint in a topline analysis. This result does not contain specific data concerning the level of significance for either the composite endpoint or each individual element of the composite endpoint. It is anticipated that the full results of the 12-month data from the CIRCUS study will be made available in the third quarter.
· The development project NVP014 for the treatment of ischemic stroke is entering a new phase in collaboration with UK partner Isomerase Therapeutics.
· The independent safety committee has endorsed moving on to the next dose level, following the treatment of 10 of 20 patients in the ongoing clinical Phase IIa study for traumatic brain injury with the company’s drug candidate NeuroSTAT®. The study will continue as planned and move on to the next dose level for the final 10 patients.
· The first patient has been enrolled in a clinical phase II study for acute kidney injury using the company’s product CicloMulsion®.
· NeuroVive Pharmaceutical Asia group has signed a collaboration agreement with Sanofi’s local affiliate for the development and commercialization of CicloMulsion® in South Korea. Under the agreement NeuroVive Asia will get an upfront payment, a conditional milestone payment and royalty on potential future sales in South Korea.
· NeuroVive share upgraded on OTC Market in US.
Read the interim report below.
NeuroVive Pharmaceutical AB (publ) is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was provided to the media for publication at 8:30 CEST on August 19, 2015.
NeuroVive Pharmaceutical AB (publ) is a leading mitochondrial medicine company. The company is listed on NASDAQ OMX Stockholm, Small Cap, under the ticker symbol NVP. The share is also traded on the OTC market in the US, under the ticker symbol NEVPFUS
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