On 28 February 2016, The Board of Directors of NeuroVive Pharmaceutical AB (publ) ("NeuroVive" or "the Company") decided to carry out a new issue of shares and warrants (units) with preferential rights for existing shareholders (the "New Issue"). The resolution is subject to approval by the forthcoming Extraordinary General Meeting. Upon full subscription of the New Issue, the Company will raise approximately SEK 94.4 m before issue expenses. Full exercise of the warrants will raise at least a further SEK 32.6 million for the Company. The proceeds from the New Issue will be used for NeuroVive's continued operations in drug development, clinical trials and partnership activities.
The New Issue is conditional on the approval of the Extraordinary General Meeting on 31 March 2016. For more information, please refer to a separate press release on the notice convening the Extraordinary General Meeting.
The New Issue in summary:
- NeuroVive's shareholders have preferential rights to subscribe for 1 unit consisting of 8 new shares, one (1) free-of-charge warrant of series 2016/2017:1 and one (1) free-of-charge warrant of series 2016/2017:2, for each 14 existing shares held on the record date of 8 April 2016.
- The subscription price is SEK 42 per unit, corresponding to SEK 5.25 per share.
- Upon full subscription of the New Issue, NeuroVive will raise approximately SEK 94.4 million before issue expenses.
- Upon full utilization of the warrants, NeuroVive will raise a minimum of a further SEK 32.6 million before issue expenses.
- The subscription period is 18 April – 2 May 2016.
- 75% of the New Issue is guaranteed through guarantee commitments.
NeuroVive conducts research and development aimed at generating candidate drugs for mitochondrial protection, as well as developing pharmaceuticals in other areas where cyclophilin inhibitors or changes in mitochondrial energy production are central mechanisms. The project portfolio consists of two projects for acute kidney injury (AKI) and traumatic brain injury (TBI) - both can potentially satisfy significant medical needs - with three drug candidates in clinical and pre-clinical development. In addition, the portfolio contains two platforms focusing on ischemic stroke and hereditary mitochondrial disorders.
In June 2015, NeuroVive announced the topline results from the external Phase III study (CIRCUS) which evaluated the effects of administering CicloMulsion® in patients undergoing percutaneous coronary intervention (PCI) after a specific type of acute myocardial infarction (STEMI). The study did not show any therapeutic effect in this patient group. Accordingly, NeuroVive decided to terminate the development of CicloMulsion® for the indication acute myocardial infarction in August. The reason for the negative results is thought to be an unexpectedly short treatment window for myocardial infarction, which means that CicloMulsion® would not have reached its intended target in time to have a therapeutic effect on the heart injury. However, the CIRCUS study provided NeuroVive with new and valuable understanding of the indications where CicloMulsion® can be effective, which led to a strategic refocus towards acute kidney injury for CicloMulsion®. NeuroVive assesses that this new strategic direction differs materially as pre-treatment with CicloMulsion® means that mitochondrial protection is in place before potential kidney injury arises. In 2015, an investor-initiated clinical Phase II study (CiPRICS) in pre-operative treatment was started in patients undergoing coronary heart surgery. The study will include a total of 150 patients and is expected to conclude in the second half of 2016. Given a positive outcome, a complementary smaller Phase II study will then be initiated.
The Company is currently conducting a further Phase II study (CHIC) which evaluates the drug candidate NeuroSTAT® in traumatic brain injury. Last year, an independent safety committee concluded that NeuroSTAT® is safe to use at the doses administered in the first dosage group and recommended that the study continue at the next dose level as planned. In November 2015, NeuroVive introduced strategic measures aimed at increasing the recruitment rate. These measures have been successful so far, and the Company estimates that the study will reach planned patient numbers and conclude towards the end of the year.
NeuroVive is also working on an additional project, NVP019, which is currently in the pre-clinical phase and has the potential to become the next generation cyclophilin inhibitor focusing on acute kidney injury, and the two development platforms for ischemic stroke and hereditary mitochondrial disorders (Complex I Deficiency) respectively.
As part of the Company's strategy to complement in-house research with collaborations alongside pharmaceutical companies and academic institutions, NeuroVive acquired a stake in the UK company Isomerase Therapeutics in January 2016. Part of the payment was made in newly issued shares in NeuroVive, with the aim of strengthening the collaboration and ensuring that NeuroVive's development projects remain a top priority for Isomerase.
NeuroVive's main aim is to complete the ongoing Phase II CiPRICS and CHIC studies before the end of 2016, and to complete a smaller follow-up study for these projects in spring 2017. Subsequently, NeuroVive plans to outlicense CicloMulsion® and NeuroSTAT® or otherwise enter into partnerships that will cover ongoing development costs and bring the product to the market. This would usually generate revenue in the form of upfront payments on outlicensing and milestone payments on the way to launch, as well as royalty based on sales. Outlicensing projects and collaborations with large pharmaceutical companies is central to NeuroVive's business model and the Company's long-term strategy of achieving risk-reduced and cost-effective development and commercialization of its products.
The main motivation for the SEK 94.4 million New Issue before issue expenses is to raise capital to bring CicloMulsion® for acute kidney injury and NeuroSTAT® for traumatic brain injury through clinical Phase II studies to licensing, and to complete pre-clinical studies in NVP019. A smaller proportion of the proceeds will be used for activities related to the Company's development platforms and for the development of the patent portfolio and the Company's ongoing expenses. The Company assesses that, before the completion of the New Issue, NeuroVive's working capital for the next twelve months is insufficient to implement the Company's business plan, but that NeuroVive's working capital requirement will be satisfied by the New Issue. In the event that the New Issue is not fully subscribed, the Company will step down its activities relating to the two development platforms and focus primarily on the Company's program for acute kidney injury and traumatic brain injury. The Company assesses that the guarantee commitments for the amount of SEK 70.85 million, corresponding to 75% of the New Issue, is sufficient to satisfy the working capital requirement for the coming twelve months given such a scenario.
Preliminary schedule (all dates in 2016)
Thursday 7 April First day of trading in shares excluding right to participate in the New Issue
Friday 8 April Record date for receiving unit rights and participating in the New Issue
Tuesday 12 April Estimated date of publication of prospectus
Monday 18 April Subscription period begins, Trading in unit rights begins
Thursday 28 April Trading in unit rights ends
Monday 2 May Subscription period ends
Tuesday 10 May Announcement of result of the New Issue
Terms and Conditions governing the New Issue
One (1) existing share in the Company entitles to one (1) unit right. Fourteen (14) unit rights entitle to subscription of one (1) unit, consisting of eight (8) new shares, one (1) warrant of series 2016/2017:1 and one (1) warrant of series 2016/2017:2.
The subscription price per unit is SEK 42, corresponding to a subscription price of SEK 5.25 per share. The warrants are issued without consideration.
One (1) warrant of series 2016/2017:1 entitles to subscription of one (1) share in the Company at a subscription price of SEK 6.50. Subscription for shares in the Company on the basis of warrants of series 2016/2017:1 may take place during the period from and including 2 January 2017 up to and including 28 February 2017.
One (1) warrant of series 2016/2017:2 entitles to subscription for one (1) share in the Company at a subscription price of 70% of the Company's volume-weighted average share price on Nasdaq Stockholm over 15 trading days before the beginning of the subscription period, subject to a minimum of SEK 8. Subscription for shares in the Company on the basis of warrants of series 2016/2017:2 may take place during the period from and including 1 June 2017 up to and including 30 June 2017.
The Rights Issue is guaranteed up to an amount of approximately SEK 70.9 million, corresponding to 75% of the New Issue, through guarantee commitments with external investors. Cash commission of ten per cent (10%) of the guaranteed amount is payable under the guarantee commitments. No cash funds or other assets have been pledged and no other security has been issued to secure the commitments. More information regarding the parties providing guarantee commitments will be published in the prospectus which is scheduled for publication in accordance with the above preliminary schedule on 12 April 2016.
Share structure and share capital
The Board of Directors has resolved to, subject to approval by the General Meeting, increase the Company's share capital by no more than SEK 899,248 through an issue of no more than 17,984,960 new shares.
Furthermore, the Board of Directors has resolved to, subject to approval by the General Meeting, issue no more than 2,248,120 warrants of series 2016/2017:1, entitling to subscription of no more than 2,248,120 shares in the Company, and no more than 2,248,120 warrants of series 2016/2017:2, entitling to subscription of no more than 2,248,120 shares in the Company, whereby the Company's share capital may, upon exercise of the warrants of series 2016/2017:1 and 2016/2017:2, increase by no more than SEK 224,812.
Existing shareholders not participating in the New Issue will be subject to a dilution effect, provided the New Issue is fully subscribed and given full utilization of the warrants, of 41.7%.
NeuroVive has appointed Stockholm Corporate Finance to act as Financial Advisor and Advokatfirman Lindahl KB to act as Legal Advisor in connection with the New Issue.
NeuroVive Pharmaceutical AB (publ), a leading mitochondrial medicine company, is developing a portfolio of products to treat acute cardiovascular and neurological conditions through mitochondrial protection. These medical conditions are characterized by a pressing medical need and have no approved pharmaceutical treatment options at present. NeuroVive's products CicloMulsion® (heart attack) and NeuroSTAT® (traumatic brain injury) are currently being evaluated in phase III and phase II studies, respectively. NeuroVive's research programs also include products for the treatment of brain cell injury in stroke patients, and drug candidates for cellular protection and treating mitochondria-related energy regulation diseases. NeuroVive's shares are listed on Nasdaq Stockholm, Sweden.
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 08.35 CEST on 29 February 2016.
Publication or distribution of this press release in certain jurisdictions may be subject to restrictions according to law and the people in jurisdictions where this press release has been made public or distributed should inform themselves and follow such legal restrictions. This press release does not contain and does not constitute or form part of an invitation to acquire or subscribe or a solicitation of any offer to buy or subscribe for shares, warrants or other securities in NeuroVive.
This press release may not be published or distributed, directly or indirectly, in or into the U.S., Australia, Hong Kong, Japan, Canada, New Zeeland, South Africa or in any other jurisdiction where such distribution would be prohibited by applicable law. The information in this press release may not be redistributed, reproduced or passed on in ways that conflict with applicable restrictions. Failure to comply with these restrictions may constitute a violation of the United States Securities Act of 1933 ("Securities Act") or applicable laws of other jurisdictions.
This press release contains certain forward-looking statements that reflect the Company's current perception and expectations regarding future events and financial and operational progress, including statements regarding the New Issue and statements regarding guidance, planning, prospects and strategies. Words such as "intends", "assesses", "expects", "plans", "estimates", "can", and other expressions that imply indications or predictions regarding future progress or trends and that are not based on historical facts, comprise forward-looking information. Even if the Company considers that these statements are based on reasonable assumptions and expectations, the Company cannot provide any guarantee that such forward-looking statements will materialize. As these forward-looking statements include both known and unknown risks and uncertainties, actual results may vary materially from those set forth in the forward-looking information. Forward-looking statements in the press release apply only at the time of publication of the press release and may be revised with out further notice. The Company does not undertake to publish updates or revisions of forward-looking statements as a result of new information, future events or similar, other than those stipulated by applicable legislation or stock market regulations.