NeuroVive: Interim report 1 Jan. 2013 till 31 Mar. 2013

The listing on Nasdaq OMX creates possibilities for the future

“After NeuroVive’s IPO on NASDAQ OMX Stockholm Small Cap in April, the company has secured prospects for its continued work in its priority business segments relating to CicloMulsion®and NeuroSTAT®.”

CEO Mikael Brönnegård

First quarter (1 Jan. 2013 - 31 Mar. 2013)

• Net sales were SEK 0 (0) and other operating income was SEK 704,000 (9,000).
• The loss before tax was SEK -4,739,000 (-2,815,000).
• Earnings per share* were SEK -0.24 (-0.18).
• Diluted earnings per share** were SEK -0.24 (-0.18).

* 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 first quarter of 2013

• In March, NeuroVive acquired a portfolio of new cyclophilin inhibitors and the associated intellectual property from UK biotech enterprise Biotica Ltd. The purchase of these assets is a significant strategic step because it extends and deepens NeuroVive’s proprietary product portfolio of new mitochondrial pharmaceuticals. These new cyclophilin inhibitors are expected to serve as the basis of an upcoming generation of the company’s products addressing a broad spectrum of diseases including cardio and neuroprotection.

• On 22 March, NeuroVive reported that over 600 patients had been enrolled in the clinical phase III multi-center trial (CIRCUS), which is evaluating the effects of CicloMulsion®on treating reperfusion injury after stenting coincident with myocardial infarction.

• Nasdaq OMX’s Listing Committee approved NeuroVive’s application for a listing on Nasdaq OMX Stockholm Small Cap on 22 March.

Post balance sheet events

• On 10 April, NeuroVive was listed on Nasdaq OMX Stockholm Small Cap, with the stock symbol NVP.

• The previously reported arbitration procedure with CicloMulsion AG has been registered with the designated arbitration tribunal.

Comments from our CEO, Mikael Brönnegård

NeuroVive is continuing its intensive efforts to produce pharmaceuticals for patients in a segment with a growing medicinal need. The development of pharmaceuticals that can protect heart and brain cells after acute conditions such as myocardial infarction, stroke and traumatic brain damage is an increasing priority for the pharmaceutical industry, with a growing focus being put on mitochondrial function in health and disease. Cardiovascular disease and acute brain damage not only affect elderly people, but also those of an active and productive age. The current focus of NeuroVive’s operations is to complete the current European phase III trial on CicloMulsion®, which has enrolled over 700 patients to date, and to intensify patient enrollment in the recently commenced phased IIa trial on NeuroSTAT®being conducted at Rigshospitalet (the National Hospital) in Copenhagen.

By producing candidate drugs (CDs) for energy regulation and by acquiring new, potent cyclophilin inhibitors from Biotica Ltd already in the preclinical phase, NeuroVive has created promising prospects to maintain strong positioning in mitochondrial medicine. The energy regulation CDs will serve as a foundation for the future treatment of genetic defects that directly affect mitochondrial function resulting in compromised energy production. These new cyclophilin inhibitors are an all-new class of molecules defined as second-generation cyclophilin inhibitors after CsA for treating mitochondrial damage arising after acute heart and brain damage. The benefits of these new cyclophilin inhibitors is their more potent efficacy against mitochondrial dysfunction in preclinical trials, and that they also have very long-term patent protection.

Our collaboration with Sihuan in China is continuing as planned, and we hope to be able to commence a heart trial, complementary to the ongoing European phase III trial on CicloMulsion®. Moreover, the plan in time is to extend the collaboration with Sihuan, and after NeuroVive’s and Sihuan’s R&D teams met in Jinan, China in mid-March this year, a number of promising partnership projects were identified. Additionally, interest in NeuroVive’s products has increased in the Asian region after the agreement with Sihuan became public knowledge.

Our collaboration with Dutch company to-BBB has entered a phase in which various formulations of NVP014 are being trialed in preclinical stroke treatment models. The aim is to obtain the maximum nerve cell protection effect after suffering a stroke. The big challenge when developing CDs for stroke treatment is to ensure the compound penetrates the blood-brain barrier so the desired effect is achieved in the brain. Utilizing to-BBB’s technology and optimized formulation, NeuroVive hopes that NVP014 will have the desired effect on brain damage after a stroke.

After NeuroVive’s IPO on NASDAQ OMX Stockholm Small Cap in April, the company has secured prospects for its continued work in its priority business segments relating to CicloMulsion®and NeuroSTAT®.

Mikael Brönnegård

CEO, NeuroVive Pharmaceutical AB (publ)

NeuroVive

Operations

NeuroVive conducts research and development into pharmaceuticals that protect the mitochondria. Its drug development technology platform consists of versions of cyclosporine, as well as molecules with similar structures that together constitute a new class of pharmaceuticals called cyclophilin inhibitors. Its product portfolio also includes CDs for cellular energy regulation.

Cyclosporin-A is the active compound in CicloMulsion®/NeuroSTAT®(a CD with different names and application segments) and has been on the market as a pharmaceutical compound for nearly 30 years. There is extensive safety data available on the active compound.