– Funding Set to Accelerate Clinical Development of Novel Medicines for Rare Central Nervous System Disorders –
MILAN–April 30, 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 capital increase raising gross proceeds of CHF24.3 million/US$ 25.5 million, following the subscription by institutional investors of 843,072 newly issued shares. 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.
The fundraising was supported by current institutional shareholders and institutional investors from Europe and the U.S., including Aviva, J.P. Morgan Asset Management, Investor AB, Sphera Global HealthCare Fund and Nyenburgh. The subscription price was set at CHF 28.80 per share, slightly below the closing price of Newron's shares on April 27, 2015, of CHF29.60. The net proceeds from the fundraising will be used to accelerate the development of Newron's pipeline of innovative CNS therapeutics, primarily sarizotan for patients with Rett Syndrome, as well as NW-3509, a novel antipsychotic for patients with positive symptoms of schizophrenia. Additional compounds in development include sNN0031 for patients with Parkinson's disease who no longer respond to oral therapy and sNN0029 for patients with Amyotrophic Lateral Sclerosis (ALS).
Stefan Weber, CEO of Newron, commented: "With Xadago® (safinamide) approved in the EU, where it will shortly be launched in the first member states by our partner Zambon, and with the U.S. NDA under FDA review for marketing authorization, Newron's focus is now on expediting development of its highly promising CNS orphan compounds for which it holds the commercial rights. We thank existing and new shareholders for their support of Newron's strategy for sustainable growth."
Roberto Galli, Newron's VP Finance, added: "The funds raised will enable us to accelerate the development of sarizotan in Rett Syndrome and of NW-3509, a highly innovative add-on therapy for schizophrenia, for which we plan to start a Phase II study in Q3 2015."
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 May 6, 2015.
Bank am Bellevue and WG Partners acted as advisors 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) was granted by the EU Commission in February 2015, following the recommendation by the Committee for Medicinal Products for Human Use (CHMP) to approve the compound in the EU on Dec. 19, 2014. The New Drug Application NDA to the U.S. FDA, as informed early March, has been accepted for filing, after being re-submitted by Newron on Dec. 26, 2014. In March 2014, Zambon, a partner of Newron, submitted a MAA to Swissmedic. 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, including sarizotan for patients with Rett syndrome, sNN0031 for patients with Parkinson's disease, non-responsive to oral drug treatments, sNN0029 for patients with ALS and ralfinamide for patients with specific rare pain indications. Newron is also developing NW-3509 as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
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.
Stefan Weber, CEO, +39 02 6103 46 26
Julia Phillips, +44 (0)20 3727 1000
Martin Meier-Pfister, +41 43 244 81 40
David Connolly, +1 617-374-8800, Ext. 108
Investors and analysts
Stefan Weber, CEO, +39 02 6103 46 30
Kristina Coppola, +1 617-374-8800, Ext. 105