The proceeds from the Rights issue will mainly be used to finance clinical development activities, namely the planned KL1333 clinical phase Ia/b study and preparations ahead of the start of the NeuroSTAT clinical Phase II efficacy study. In addition, proceeds will be used for further development of the Company’s pre-clinical projects, in particular the NVP015/NV354 program.
The resolution is subject to approval by an Extraordinary General Meeting to be held on 17 January 2019. See separate press release with notice of the Extraordinary General Meeting for further information.
The Rights issue in brief
- Shareholders in NeuroVive have the preferential right to subscribe for shares. One (1) existing share held on the record date of 18 January 2019, entitles to one (1) subscription right. One (1) subscription right entitles to subscription of one (1) newly issued share.
- The subscription price is SEK 1.35 per share.
- At full subscription of the Rights issue, NeuroVive is added approximately MSEK 123.8 before issuance costs.
- The Rights issue is guaranteed to 80 percent through subscription and guarantee commitments.
- The subscription period runs from 23 January – 6 February 2019.
"We have made very significant progress in our broad project portfolio during 2018 and have an exciting year ahead. Through a successful Rights issue, we will be able to take several important steps in our clinical development projects, NeuroSTAT and KL1333, where new clinical studies are planned to start in 2019. In addition, we will be able to take our preclinical drug development projects to critical milestones," says NeuroVive’s CEO Erik Kinnman.
Background and motive
NeuroVive’s project portfolio
The Company's project portfolio consists of two projects in clinical development phase: NeuroSTAT for traumatic brain injury (TBI) and KL1333 for genetic mitochondrial diseases. The portfolio contains two additional projects for genetic mitochondrial diseases (NVP015/NV354 and NVP025), two projects for the metabolic disease NASH (NV556 and NVP022), and NVP024, a project for liver cancer (HCC). Under 2019, the Company intends to initiate a Phase II clinical efficacy study of NeuroSTAT and a Phase Ia/b clinical study of KL1333.
Milestones and important events in 2018
- Positive KL1333 phase I clinical study results.
- FDA orphan drug designation received for KL1333.
- KL1333 clinical trial regulatory approval from the UK regulatory authority (MHRA).
- KL1333 mechanism of action published in scientific journal.
- Signal of clinical efficacy from biomarker measurements in CHIC TBI-study
- Positive FDA feedback on the NeuroSTAT TBI development plan.
- US TRACK-TBI collaboration initiated.
- Publication/presentation of results from the CHIC study and from the collaboration with Penn.
- Outlicensing of targeted LHON therapy to BridgeBio’s new subsidiary Fortify Therapeutics.
- In total 5 MSEK in funding from the Vinnova/Swelife call, to accelerate NV354 towards clinical development.
- Preclinical NV354 efficacy results in a model for mitochondrial disease.
- Continued experimental in vivo efficacy studies of the selected compound, NV354.
- Final results from the collaborative project with Dr. Marni Falk at CHOP for studies of NVP015 compounds in experimental disease models.
- Initial results from CHOP studies of NeuroVive’s NVP015 compounds as a therapeutic option for chemical threats.
- 4 MUSD grant to Children’s Hospital of Philadelphia for NVP015 research.
- Positive efficacy data in an experimental model, entailing a breakthrough for the NVP025 mitochondrial myopathy project.
- Selection of candidate compound within the NVP022 project.
- Initial results from the industrial PhD student collaboration within the NVP022 project.
- NeuroVive conducts an oversubscribed preferential rights issue in april.
Goals for 2019
- Start clinical phase Ia/b study in Europe during first half of 2019.
- Present initial results from the clinical phase Ia/b study.
- Prepare for phase II efficacy studies.
- Secure external non-dilutive financing for upcoming Phase II efficacy study.
- Receive approval of IND application for clinical development in the US.
- Start clinical phase II efficacy study.
- Present further results from preclinical in vivo dose-response studies.
- Scale up compound production.
- Initiate toxicology studies.
- Run experimental studies in cooperation with CHOP, financed by DoD grants.
- Perform dose-response studies in order to select candidate compound and route of administration.
- Select candidate compound.
- Out-license and/or partner liver fibrosis indication focused on NASH during the first half of 2019.
- Carry out dose-response studies of NV422 in a preclinical NASH model.
- Perform confirmatory tests in complementary preclinical experimental models.
- Select candidate compound.
Motive for the Rights issue
The motive for the Rights issue is primarily to acquire working capital to advance the Company's projects in clinical development. Insofar as the Rights issue is subscribed to a sufficient degree, part of the proceeds will be used for continued development of the Company's preclinical projects. The remaining part of the proceeds will be used to ensure the development of the patent portfolio, as well as for the Company's operating expenses. The Company's assessment is that the working capital requirement for the next twelve months after the completion of the Rights issue is sufficient to implement the Company's business plan. If the Rights issue is not fully subscribed, the Company will reduce the activities related to all projects and focus primarily on the Company's programs in the clinical development phase.
Preliminary timetable for the Rights issue (all dates refer to 2019)
Wednesday, 16 January Last day of trading in shares including the right to participate in the Rights Issue with preferential right
Thursday, 17 January First day for trading in shares without the right to participate in the Rights issue with preferential rights
Friday, 18 January Record date for the receipt of subscription rights and right to participate in the Rights issue with preferential rights
Tuesday, 22 January Estimated date for publication of prospectus
Wednesday, 23 January Subscription period starts
Wednesday, 23 January Trading of subscription rights starts
Wednesday, 23 January Trading in paid subscribed shares (Sw. BTA) starts and is ongoing until registration of the Rights Issue with the Swedish Companies Registration Office (Sw. Bolagsverket)
Monday, 4 February Trading of subscription rights ends
Wednesday, 6 February Subscription period ends
Monday, 11 February Announcement of the outcome of the Rights issue
Terms for the Rights issue
The Board of Directors has resolved to increase the Company's share capital by not more than SEK 4,584,853.80 by a rights issue of not more than 91,697,076 shares. The Board of Directors resolution is subject to approval of the Extraordinary General Meeting to be held on 17 January 2019. One (1) existing share entitles to one (1) subscription right. One (1) subscription right entitles to subscription of one (1) newly issued share. The subscription price per share is SEK 1.35. Upon full subscription, the Company's share capital will increase by SEK 4,584,853.80, from SEK 4,584,853.80 to SEK 9,169,707.60, through new issue of 91,697,076 shares, from 91,697,076 shares to 183,394,152 shares, which results in a maximum dilution for shareholders who choose not to participate in the Rights issue of 50 per cent.
Subscription and guarantee commitments
The Rights issue is guaranteed up to an amount of approximately MSEK 99.0, corresponding to 80 percent of the Rights issue, through subscription commitments from existing shareholders and guarantee commitments from external investors. Cash commission is payable under the guarantee commitment of ten (10) percent of the guaranteed amount. No cash or other assets have been pledged and no other collateral has been provided to secure the commitments. Further information regarding the parties who have entered into subscription and guarantee commitments can be found in the prospectus that is expected to be published on 22 January, 2019, in accordance with the above preliminary timetable.
NeuroVive has appointed Stockholm Corporate Finance AB as financial adviser, Advokatfirman Lindahl KB as legal advisor, and Hagberg & Aneborn Fondkommission AB as issuer agent in connection with the Rights issue.
New publication date of the Year End report 2018
The Board of Directors of NeuroVive has decided to postpone the publication date of the Year End Report from 21 February, 2019 to 28 February, 2019 due to preparation of the forthcoming rights issue.
This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CET on 10 December 2018.
For more information please contact:
Catharina Johansson, CFO, IR & Communications
+46 (0)46-275 62 21, firstname.lastname@example.org
NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard)
For news subscription, please visit http://www.neurovive.com/press-releases/subscription-page/
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 Stockholm Corporate Finance AB
Stockholm Corporate Finance is a Swedish, independent and privately owned financial advisor offering qualified transaction based advisory services by acting in capital raisings, changes in ownership, acquisition, merger and acquisitions (M&A) in listed and privately held companies. Stockholm Corporate Finance is the exclusive Swedish partner in the global network of M&A Worldwide consisting of 43 M&A advisors and investment banks in 44 countries. Stockholm Corporate Finance is an investment firm which is supervised by the FSA and is a member of the trade organization SwedSec Licensing AB.
Publication or distribution of this press release in certain jurisdictions may be subject to restrictions according to law and persons 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 an invitation or an offer to acquire, subscribe or otherwise trade in shares or other securities in NeuroVive.
This press release may not be published, distributed or made public, directly or indirectly, in or into the US, Australia, Hong Kong, Japan, Canada, New Zeeland, Switzerland, Singapore, South Africa or in any other jurisdiction where such action, completely or partially, is subject to legal restrictions. 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 or applicable laws of other jurisdictions.
This press release contains certain forward-looking statements that reflect the Company's current views and expectations of future events as well as financial and operational development, including statements regarding the Rights issue, and statements regarding guidance, planning, prospects and strategies. Words that are "referred", "expected", "planned", "estimated", "can", and other expressions that imply indications or predictions of future developments or trends, and which are not based on historical facts, are forward-looking information. Although the Company believes that these statements are based on reasonable assumptions and expectations, the Company cannot guarantee that such forward-looking statements will be implemented. As these forward-looking statements include both known and unknown risks and uncertainties, real outcomes can differ substantially from what is stated in forward-looking information. Prospective statements in the press release only apply at the time of the press release and may change without notice. The Company makes no commitment to publish updates or revisions of forward-looking statements as a result of new information or future events etc. beyond what is required by applicable laws or stock market regulation.