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Newron Pharmaceuticals (NWRN) Reports 2013 Financial Results Board Approves Agenda For March 27 AGM/EGM Change In Board Of Directors


3/4/2014 9:05:00 AM

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Milan, Italy – 4 March 2014 - Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, announces its financial results for the year ended 31 December 2013, reiterates material events so far and presents the outlook for 2014.

Key facts and events

- License income 2013 of EUR 3.2 million (2012: EUR 8.9 million), related to the milestone received from Zambon upon filing of the MAA for safinamide in Europe and the upfront payment obtained from Zambon, in 2012

- Net loss of EUR 7.1 million (2012: EUR 2.4 million) due to lower license income and increased investment into R&D projects

- EUR 18.4 million of cash in the bank, EUR 3.9 million committed funds by third parties (Dec. 31, 2013) and EUR 2.9 million proceeds from subscription of remaining 211,473 shares by J.P. Morgan AM in January 2014. With a total of EUR 25.2 million funds available, Newron is funded well into 2015, beyond key expected value inflexion points and related success payments

- Share price doubled from CHF 8.04 (trade closing 2012) to CHF 16.80 (trade closing 2013)

- Marketing Authorisation Application (MAA) submitted to European Medicines Agency (EMA) for safinamide for the treatment of Parkinson’s disease

- New Drug Application (NDA) to US FDA expected by end of April 2014, following final discussions in February 2014

- Safinamide Phase III study results presented at various congresses

- Close collaboration with partner Meiji Seika Pharma Co., Ltd. on development of safinamide in Japan and Asia

- sNN0031 Phase I/II safety and efficacy study in Parkinson’s disease results presented at the 17th International Congress of Parkinson’s disease and Movement Disorders (MDS), June (Sydney, Australia)

- EUR 2.5 million Strategic Translation Award from Wellcome Trust to develop sNN0029

Stefan Weber, CEO of Newron: “We are delighted to have completed the submission of the MAA for our lead compound safinamide in early and advanced Parkinson's disease (PD) in Europe, and currently are working on the filing of the NDA to the U.S. FDA. We are thrilled by the very real prospect of our first product becoming available for the treatment of patients with PD, soon.”“

Ravi Anand, Newron’s CMO, added: “Based on the final discussion with the US Food and Drug Administration (FDA) in February 2014, we are completing the filing package and expect to submit the NDA by end of April 2014.”

Safinamide: approval in Europe expected in 2014

Based on the submission of the Marketing Authorization Application (MAA) for safinamide to the European regulatory authorities on December 5, 2013, an approval is expected by end of 2014.

In 2013, safinamide efficacy and safety results were presented at key scientific congresses. These results from the MOTION and SETTLE studies as well as from prior studies, including a Phase III long term (24 months) placebo controlled study, further confirm the benefits obtained with safinamide as add-on therapy in early and advanced Parkinson’s disease.

There is growing awareness in the medical community that safinamide offers an exciting new treatment option for patients with early and mid- to late stage Parkinson’s disease. Newron is working closely with partner Zambon and the regulatory authorities to prepare the regulatory filing in the US. Management expects that safinamide will be sub-licensed to a US pharma partner in order to maximize the opportunity in this major market. For Japan and Asia, the collaboration with partner Meiji Seika Pharma Co., Ltd. to support the development of safinamide in their license territory, is progressing well.

In June, Newron presented encouraging data from the first Phase I/II safety and efficacy study of sNN0031 at the 17th International Congress of Parkinson’s disease and Movement Disorders (MDS). sNN0031 is a novel drug candidate for the treatment of Parkinson’s disease patients who no longer respond to oral therapy, designed to act on neural stem and progenitor cells in the brain. sNN0031 had already shown the ability to restore motor function and improve neurochemical deficits in animal models of PD.

Financial Highlights

- Licence income, amounting to EUR 3.2 million (2012: EUR 8.9 million) is related to the milestone payment received from Zambon S.p.A. upon submission of the MAA for safinamide in Europe and the 2012 upfront payment obtained from Zambon as part of the exclusivity and collaboration agreements related to safinamide.

- Research and development expenses were EUR 4.5 million (2012: EUR 3.5 million). R&D expenses related to safinamide have been reimbursed by Merck Serono until April 2012, and covered by Zambon Group since. R&D expenses include an impairment charge on HF0220. Gross R&D expense prior to reimbursement by Newron’s partners and grants received was EUR 11.9 million (2012: EUR 8.4 million)

- The net loss was EUR 7.1 million (2012: EUR 2.4 million) due to lower license income and increased investment into R&D projects

At EUR 18.4 million of cash in the bank, EUR 3.9 million committed funds by third parties (Dec. 31, 2013) and EUR 2.9 million proceeds from subscription of remaining 211,473 shares by J.P. Morgan AM in January 2014, Newron is funded well into 2015, beyond key expected value inflexion points and related success payments.

Outlook

For 2014, Newron is looking forward to the further filing of safinamide in the US and the progress of development in Japan and Asia. The ongoing development and progress in the innovative CNS pipeline, with a focus on the highly attractive orphan field, will ensure that new compounds fuel the future growth and build value for all stakeholders. Material efforts will be undertaken to attract additional leading institutional investors.

Changes in Board of Directors

The Directors of Newron’s Board need to be elected based upon applicable Italian law, at the AGM to be held on March 27, 2014.

At this occasion, Roberto Consonni, who had joined Newron’s Board as representative of Zambon upon closing of the Collaboration and License Agreement for Safinamide in June 2012, announced his decision to leave the Newron Board.

Ulrich Koestlin, Newron’s Chairman of the Board, commented: “We have appreciated the interaction with Roberto since he joined the Newron Board, helping get our collaboration on track towards the successful submission of the MAA and the NDA for safinamide.”

Newron’s Board presents two senior, internationally experienced industry executives for election by shareholders, as a replacement to the leaving Director and as an additional Director:

J. Donald deBethizy, PhD, as non-executive Director

Donald deBethizy, PhD, brings more than 20 years of experience in managing and financing life science related technologies, and has played a key role in building and advising several life science companies. Prior to joining Santaris Pharma as President, CEO and Director, Dr. deBethizy co-founded Targacept, Inc. and served as its President and CEO for 15 years. Dr. deBethizy led Targacept’s private and public financings totaling approximately $330 million including the company’s Initial Public Offering (IPO) in April, 2006. Dr. deBethizy played a key role in developing business relationships with GSK, AstraZeneca, Aventis, and Dr. Falk Pharma which generated non-dilutive revenues of over $300 million. In addition to his position in Santaris Pharma, Dr. deBethizy is Executive Chairman of the Board of Directors of Contera Pharma ApS, Denmark. Donald is a US citizen.

Luca Benatti, as non-executive Director

Luca Benatti is CEO of EryDel S.p.A. He has 27 year experience in Pharma and Biotech. He was Co-founder, CEO and Member of the Board of Newron Pharmaceuticals, until May 2012. Under his guidance, Newron developed a pipeline of innovative therapies, with most advanced compound safinamide now approaching worldwide regulatory filing for the treatment of Parkinson's disease. During his tenure, Newron raised significant capital from international venture capital firms, and was listed at the Swiss stock exchange. He also was instrumental in finalizing multimillion licensing deals with Merck Serono, Meiji Seika and Zambon, and in the acquisition of the UK biotech Company Hunter Fleming. Luca graduated and performed his post-doctoral training at Milano Genetics Institute. He is Vice President and member of the Board of Assobiotec, the Italian Biotech Association and member of Jury of the European Biotechnica Award. He has authored several scientific publications and holds numerous patents. Luca is Italian.

Newron’s Board of Directors has approved the below agenda for the March 27, 2014, 10:30 am CET, ordinary and extraordinary Shareholders’ meeting, which will take place at the Company’s registered office in Bresso (Mi), Italy., The formal invitation to shareholders will be issued and disclosed in the statutory papers on March 5, 2014. The full invitation and supporting material will be made available on the Company’s website at the same date.

1. Approval of the financial statements as at December 31st, 2013

2. Amendment of article 14 of the Newron’s By-Laws (Board of Directors – Composition)

3. Appointment of the Board of Directors for the financial years 2014, 2015 and 2016 and, therefore, until the approval of the financial statements as of December 31st, 2016, as follows:

- Ulrich Köstlin in quality of Chairman and non executive director

- Stefan Weber, in quality of executive director

- Patrick Langlois in quality of non executive director

- Hanns Moehler in quality of non executive director

- Bo Jesper Hansen in quality of non executive director

- Robert Leslie Holland in quality of non executive director

- Luca Benatti in quality of non executive director and, subject to the approval of the amendment of article 14 of the By-Laws,

- Donald deBethizy in quality of non executive director. Determination of the remuneration of the Board of Directors

4. Proposal of a share capital increase for payment, severable, with exclusion of the option right, for maximum nominal Euro 236,719.40, and therefore for maximum n. 1,183,597 Newron Pharmaceuticals S.p.A. ordinary shares and, in any event, within the limits of the 10% of the share capital in accordance with article 2441, paragraph fourth, second part, of the Italian Civil Code and with article 6 of Newron’s By-Laws (Share Capital). Amendment of article 6 of Newron’s By-Laws

5. Proposal of delegation to the administrative body, in accordance with article 2443 of the Italian Civil Code, for a share capital increase for payment, severable, for a maximum amount of nominal Euro 375,844.00 and therefore for maximum n. 1,879,220 Newron Pharmaceuticals S.p.A. ordinary shares, having the same features of the existing shares, to be offered for payment, with exclusion of the option right, in accordance with article 2441, paragraph fifth, of the Italian Civil Code in one or more times, to the Newron Pharmaceuticals S.p.A.’ shareholders and to one or more qualified investors. Amendment of article 6 of Newron’s By-Laws (Share Capital)

6. Subject to the approval and to the execution of the above mentioned share capital increase, as illustrated under point 5 of the current meeting, revocation, even partial, of the share capital increase, with option right, approved by the Extraordinary Shareholders’ meeting on April 2nd, 2010, severable, for payment, up to a maximum amount of nominal Euro 375,844.00, by issuance of a maximum number of Newron’s ordinary shares equal to n. 1,879,220

Pursuant to article 10 of the current Company’s By-Laws, in order to attend the Shareholders’ meeting, it is required a previous declaration sent by a financial intermediary admitted to the centralised system, which shows the ownership of the shares and the voting right. The declaration should arrive at the Company’s registered office no later than the working day before that established for the Shareholders’ Meeting.

In particular, in relation to the appointment of the Board of Directors according with point three of the agenda, the shareholders’ meeting will be called to express its favourable or contrary vote to the appointment of each candidate.

All the documents related to the current agenda, required by the applicable laws, will be available at the Company’s registered office in Via Ludovico Ariosto n. 21 Bresso (MI) Italy, during the 15 days preceding the first call of the Shareholders’ meeting.

Dial-in to media / analyst conference on 4 March 2014, 9.15-10.15am CET The Newron management team will present the full year results and provide an update and guidance for the development of Newron’s R&D pipeline.

The conference call can be accessed via the following dial-in numbers:

UK: +44 203 059 58 62

Switzerland: +41 58 310 50 00

Italy: +39 02 30 46 48 58

USA: +1 631 570 56 13

Germany: +49 69 25 511 4445

Sweden: +46 8 5051 0031

The slide deck used in the presentation is available at www.newron.com/ENG/Default.aspx?SEZ=5&PAG=180

Next events

Annual Shareholders' meeting 27 March 2014

Half year report 2014 16 September 2014

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. Following the submission of the Marketing Authorization Application (MAA) for safinamide for the treatment of Parkinson’s disease to the European Medicines Agency (EMA) in December 2013, Newron is working to complete the global filing of the compound, together with its partners. Zambon Group has the rights to 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 sNN0031 for patients with Parkinson’s disease, non-responsive to oral drug treatments, sarizotan for patients with Rett syndrome, sNN0029 for patients with ALS and ralfinamide for patients with specific rare pain indications. Newron is concurrently developing NW-3509 as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. www.newron.com

For more information

Media
Italy
Stefan Weber - CEO
Phone: +39 02 6103 46 26
E-mail: pr@newron.com

UK/Global media
Julia Phillips
FTI Consulting
Phone: +44 (0) 20 7269 7187

Switzerland
Martin Meier-Pfister
IRF Communications
Phone: +41 43 244 81 40

Investors and analysts

Stefan Weber - CEO
Phone: +39 02 6103 46 30
E-mail: ir@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 as-sumptions 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, commer-cialisation 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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