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Newron Pharmaceuticals (NWRN) Reports Half-Year Results 2013

9/10/2013 12:27:13 PM

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Milan, Italy – 10 September 2013 – Newron Pharmaceuticals S.p.A. (“Newron”, SIX: NWRN), a research and development company focused on the development of therapies for patients with Central Nervous System (CNS) and pain disorders, today announces its financial results for the half year ended June 30, 2013.

Half-Year 2013 Highlights

- Presentation of further Phase III data for safinamide at major scientific congresses

- Meetings with all relevant regulatory authorities completed in Europe; completion within short timeframe expected in the US; expected regulatory submission for marketing authorization of safinamide in the US and Europe confirmed for Q4 2013

- Ongoing support of partner Meiji Seika Pharma Co., Ltd., who are proceeding with their conduct of clinical development of safinamide in Japan

- Encouraging data from the first Phase I/II safety and efficacy study of sNN0031, a novel drug candidate for the treatment of patients with Parkinson’s disease, non-responsive to oral drug treatment, presented at the 17th International Congress of Parkinson’s disease and Movement Disorders

- Award of up to EUR2.5 million from the Wellcome Trust to support Phase I/II development of sNN0029 for patients with Amyotrophic Lateral Sclerosis

- Subscription of newly issued shares for EUR1.7 million by two existing long term shareholders, in execution of subscription undertakings by Zambon

- Integration of former NeuroNova (now Newron Sweden) successfully completed

- Ulrich Köstlin elected new non-executive Chairman, Robert Leslie Holland and Bo Jesper Hansen joining as non-executive directors

Phase III data on safinamide has been presented at the 65th Annual Meeting of the American Academy of Neurology, March (San Diego, USA), the 9th International Congress on Mental Dysfunction & Other Non-Motor Features in Parkinson’s Disease and Related Disorders, April, (Seoul, South Korea), and the 17th International Congress of Parkinson’s Disease and Movement Disorders, June (Sydney, Australia). The data presented further demonstrated that safinamide significantly improves both motor function in early Parkinson’s disease (PD) patients on a single dopamine agonist at a stable dose and motor fluctuations in mid- to late-stage PD patients on levodopa and other PD drugs at a stable dose. The data also showed safinamide benefits Quality of Life (QoL) during long term treatment in patients with both early and advanced PD.

Newron is working closely with partner Zambon and the regulatory authorities to prepare the regulatory filing for safinamide in the US and Europe, expected during Q4 2013. Also anticipated is the sub-licensing of safinamide by Zambon to a partner for the US, pre or post filing, in order to maximize the opportunity in this important market. Newron continues to work closely with partner Meiji Seika Pharma Co., Ltd., to support the development of safinamide in Japan and Asia.

Newron has also made good progress with the rest of the pipeline. 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. sNN0031 is a novel drug candidate for treatment of PD patients who no longer respond to oral therapy, designed to act on neural stem and progenitor cells in the brain. sNN0031 has been shown to restore motor function and improve neurochemical deficits in models of PD.

In February, Newron received an award of up to EUR2.5 million from the Wellcome Trust to support Phase I/II clinical development of its experimental compound sNN0029 for the treatment of patients with Amyotrophic Lateral Sclerosis (ALS). The trial is expected to start during H2 2013.

In June, Newron closed the subscription of newly issued shares for EUR1.7 million by two existing long term shareholders, in execution of subscription undertakings by Zambon.

The integration of former NeuroNova AB, renamed Newron Sweden AB, has been successfully completed, and the full competence of the entire organization is now at work to successfully develop the company’s assets.

Stefan Weber, CEO of Newron, said: “In the first six months of 2013 we have made substantial progress in the preparations for regulatory filing of safinamide in the US and Europe, which is expected to occur in Q4 of this year. We continue to develop and build our innovative product portfolio beyond safinamide. These achievements will position Newron as a leader in the development of new treatments for patients with CNS diseases.”

Interim financial statements

In the first six months of 2013, Newron has invested EUR4.4 million into drug development and preparations for regulatory submission of safinamide, up from EUR2.4 million in 2012. Of these investments, EUR3.6 million have been covered by our previous and current safinamide partners as well as by grants. Therefore, for the first six months of the year, net R&D expenses are EUR0.8 million, in line with the 2012 balance. G&A expenses reached EUR3.7 million in the first six months of 2013, for the first time including the remaining operations of former NeuroNova (now Newron Sweden) in Stockholm. In 2012 (excluding NeuroNova), G&A expenses had been at a comparable EUR3.6 million. Considering revenues of EUR2.2 million during the first half year of 2013, mostly stemming from recognition of a 2012 license down-payment over the period of collaboration with our partner Zambon, the net loss for the first six months of 2013 amounts to EUR2.4 million, compared to a profit of EUR2.7 million in 2012, which was due to one-time effects. Net cash used for operating activities was EUR7.3 million, compared to net cash provided of EUR 6.7 million in the previous year reporting period.

With EUR21.8 million of cash in the bank plus EUR7.5 million contractually committed by Zambon, the European Union and the Wellcome Trust to support our development projects and regulatory work, we continue to be sufficiently funded well into 2015, beyond expected key value inflexion points and inflow of related material milestone payments.

For further details see the Half-Year Report 2013 which is available for download at:

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. Based on the phase III results of safinamide for the treatment of Parkinson’s disease, Newron is working to expedite the global filing of the compound, together with its partners. Zambon Group has the rights to commercialise safinamide globally, excluding Japan and other key Asian territories, and Meiji Seika has the rights to develop and commercialise safinamide in Japan and other key Asian territories. Newron’s additional projects are primarily addressed towards 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’s syndrome, sNN0029 for patients with ALS, ralfinamide for patients with specific pain indications, and NW-3509 as potential first add-on therapy for the treatment of patients with schizophrenia.

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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