PRESS RELEASE:
Financing Supports Clinical Development of Sarizotan for Patients with Rett Syndrome, a Rare Neurodevelopmental Disease
MILAN–(BUSINESS WIRE)–November 20, 2015–
Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, announces that it has completed a private placement of 209,364 shares with a leading US-based biotechnology and healthcare specialist fund, raising gross proceeds of 5.4 million USD/CHF.
The subscription price was set at CHF 25.60 per share. Under the agreement, the fund holds an option to subscribe to another 209,364 newly issued shares no later than June 30, 2016, governed by the March 24, 2015 EGM authorization.
“The investment by this specialized institutional fund is a strong validation of our strategy to advance innovative CNS therapies for rare diseases where there are limited or no viable treatment options,” said Stefan Weber, CEO of Newron. “The proceeds will accelerate the advancement of the recently announced planned international pivotal trial with sarizotan for the treatment of patients with Rett syndrome.”
Mr. Weber added, “With Xadago® (safinamide) approved in the EU and in Switzerland for the treatment of Parkinson’s disease and a current U.S. PDUFA date of March 29, 2016, Newron is focused on accelerating the clinical development of sarizotan and building relationships with key opinion leaders, patient advocacy and other key stakeholders in the Rett’s community.”
The capital increase was approved at the Company’s Extraordinary Shareholder’s Meeting on March 24, 2015. Once issued, the new shares will be immediately and freely tradable. Closing of the transaction will be subject to customary Italian and Swiss regulatory requirements. The new shares will be listed and traded on the SIX Swiss Exchange under the same ISIN as the Company’s existing shares (ISIN: IT0004147952) on or around November 25, 2015.
Piper Jaffray acted as exclusive financial advisor to Newron in connection with the transaction.
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Marketing authorization in the EU for Xadago® (safinamide) for the treatment of Parkinson’s disease was granted by the EU Commission in February 2015, followed by the launch by Zambon in the first key EU country – Germany – in May 2015. The New Drug Application (NDA) has been accepted for review by the FDA, as reported in March 2015. In November 2015, Swissmedic has granted marketing authorization to Zambon, Newron’s partner. Zambon has the rights to develop and commercialize safinamide globally, excluding Japan and other key Asian territories, where Meiji Seika has the rights to develop and commercialize the compound. Newron’s additional projects are based on highly promising treatments for rare disease patients and are at various stages of clinical development. They include sarizotan for patients with Rett syndrome, for which Newron received Orphan Drug Designation in both the US and the EU, ralfinamide for patients with specific rare pain indications, and NW-3509 as potentially the first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For additional information, please visit http://www.newron.com.
Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s anticipated future revenues, capital expenditures and financial resources, and (4) assumptions underlying any such statements. In some cases these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements.
By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions.
Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programmes, development activities, commercialisation plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions.
Newron does not undertake any obligation to publicly up-date or revise forward looking statements except as may be required by applicable regulations of the SIX Swiss Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.
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Media
Newron Pharmaceuticals
Stefan Weber, +39 02 6103 46 26
CEO
pr@newron.com
or
UK/Europe
FTI Consulting
Julia Phillips, +44 (0)20 3727 1000
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Switzerland
IRF Communications
Martin Meier-Pfister, +41 43 244 81 40
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Germany
MC Services AG
Anne Hennecke, +49 211 52925222
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U.S.
LaVoieHealthScience
David Connolly, +1 617-374-8800, Ext. 108
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Investors and Analysts
Newron Pharmaceuticals
Stefan Weber, +39 02 6103 46 30
CEO
ir@newron.com
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Germany
MC Services AG
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
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U.S.
LaVoieHealthScience
Kristina Coppola, +1 617-374-8800, Ext. 105
kcoppola@lavoiehealthscience.com