Newron AGM Result and Clinical and Business Update
Shareholders approve all motions on the agenda at the 2020 AGM
STARS study results for Rett syndrome remain on track
Start of forthcoming new clinical studies likely to be delayed due to the current global COVID-19 pandemic
Milan, Italy - March 31, 2020 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announced that its shareholders approved all motions on the agenda of the AGM 2020. The motions consisted of the approval of the Company's financial statements as of 31 December 2019 and the appointment of all members of the Board of Directors.
Newron today also provides an update on its clinical, business and operational activities, in light of the recent COVID-19 pandemic. The health and safety of patients, caregivers and our employees is paramount and Newron has proactively taken measures in response to the COVID-19 situation to protect all stakeholders and ensure business continuity.
This pandemic has led to the prioritization of all available hospital staff to provide care for COVID-19 patients over research studies, a decision that Newron fully supports as ethically and socially responsible. However, that decision means that the Company therefore anticipates a delay in the start of its planned studies with Evenamide in schizophrenia. The Company cannot predict how long the COVID-19 pandemic will delay the initiation of its clinical trials, but will continue to work to prepare the studies for initiation as soon as is safe and practical to do so.
With regards to Newron's STARS (Sarizotan Treatment of Apneas in Rett Syndrome) clinical study, the study was completed in December 2019 and the clinical database for the STARS study remains locked and blinded. Following its meeting with the US Food and Drug Administration, the Company continues to expect to share top-line results with the global Rett community and the financial community in Q2 2020. Newron has established channels to allow patients in the open label extension of the STARS study uninterrupted access to medication that they depend upon.
Newron will update the market with any material developments, as appropriate.
About Newron Pharmaceuticals
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago(R)/safinamide has received marketing authorization for the treatment of Parkinson's disease in the European Union, Switzerland, the USA, Australia, Canada, Brazil, Colombia, the United Arab Emirates and Japan, and is commercialized by Newron's Partner Zambon. US WorldMeds holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. In addition to Xadago(R)/safinamide for Parkinson's disease, Newron has a strong pipeline of promising treatments for rare disease patients at various stages of clinical development, including sarizotan for patients with Rett syndrome and ralfinamide for patients with specific rare pain indications. Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For more information, please visit: www.newron.com
For more information, please contact
Stefan Weber - CEO
+39 02 6103 46 26
Simon Conway / Natalie Garland-Collins, FTI Consulting
+44 20 3727 1000
Martin Meier-Pfister, IRF
+41 43 244 81 40
Anne Hennecke, MC Services
+49 211 52925222
Paul Sagan, LaVoieHealthScience
+1 617 374 8800, Ext. 112
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, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron's 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 difficulties in enrolling clinical trials, 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 programs, development activities, commercialization 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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