Newron Pharma Reports Half-Year 2016 Results

MILAN--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. (“Newron”, SIX: NWRN), a research and development company focused on novel Central Nervous System (CNS) and pain therapies, today announces its financial results for the half year ended June 30, 2016.

“Evenamide (NW-3509), a Putative Antipsychotic, Targets Abnormal Electrical Activity and Glutamatergic Abnormalities in Improving Psychotic Symptoms in Patients with Schizophrenia in a Phase II, Placebo-controlled Trial”

Half Year 2016 Highlights

• Xadago® (safinamide) launched by Zambon for patients with Parkinson’s disease in ten additional European countries (Switzerland, Spain, Italy, Belgium, Denmark, Sweden, the U.K., Luxembourg, the Netherlands and Norway)
• Re-submission of the New Drug Application (NDA) for Xadago® expected in 2016, following US FDA clearance
• Phase II study of Evenamide (NW-3509) presented at the 5th Biennial Schizophrenia International Research Society Conference
• Investigational New Drug application for sarizotan for the treatment of Rett syndrome approved by the US FDA
• “Sarizotan Treatment of Apneas in Rett Syndrome” (STARS) potentially pivotal trial design presented at US Rett Syndrome Symposium – study initiated in July
• Burden of Disease study initiated with International Advisory Board meeting at 2016 Rett Syndrome Foundation Meeting

Stefan Weber, CEO of Newron, commented: “It is exciting to see Xadago® available to patients with Parkinson’s disease in eleven European countries, being well received by patients and doctors and generating revenues with impressive growth rates. Since it was first launched in Germany roughly 12 months ago, we have received cumulated royalty revenues of EUR 1.3 million on product sales by Zambon, revenues growing at a rate of 50% over each prior quarter. We expect to be re-submitting the NDA for Xadago® to the US FDA in 2016, still, and look forward to hearing from the authority with regards to the US approval in due course. Our innovative pipeline of Central Nervous System (CNS) drugs is progressing well and with a solid cash position and strong pipeline, we are well placed to build and strengthen our position as a leading player in the CNS disease area.”

“We confirm our outlook for the full-year 2016 provided in March. On the basis of higher expected royalties on net sales of Xadago® in various European territories over the full year 2016 period, plus additional milestone payments and potential income from safinamide due from Zambon, 2016 revenue is expected to notably increase over 2015. R&D expenses will be higher compared to 2015, due to clinical development costs for the efficacy studies for sarizotan and NW-3509. Available liquidity will take Newron well through most of 2017, beyond expected key value inflection points,” Stefan Weber, CEO of Newron, added.

Xadago® available in four of the five key European pharmaceutical territories
During the first half of 2016, Xadago® was launched by Newron’s partner Zambon in Switzerland, Spain, Italy, Belgium, Denmark, Sweden, the UK, Luxembourg and, post period, The Netherlands and Norway. A substantially increased number of patients across Europe, including four of the five key European pharmaceutical territories, can now be treated using Xadago®, the first New Chemical Entity in ten years to receive Marketing Authorization from the European Union Commission for the treatment of Parkinson’s disease.

In March, Newron received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for Xadago®. However, at the end of July, the company and its partners Zambon and US WorldMeds were informed that the FDA no longer required Newron to perform any studies to clinically evaluate the potential abuse liability or dependence/withdrawal effects of Xadago®, that were the key subject of the CRL. As no additional data, studies or analyses for efficacy or safety in patients with Parkinson’s disease had been required under the CRL, as already communicated, Newron expects to be re-submitting the New Drug Application (NDA) to the US FDA in 2016, still.

Newron is committed to finding innovative therapies for patients suffering from Parkinson’s disease and other CNS diseases. In order to further strengthen this commitment, Newron in 2016 supported the Rare Disease Day, the Rett Symposium as well as World Parkinson’s Disease Awareness Day. These global initiatives are helping to raise awareness of rare diseases and Parkinson’s disease respectively and the company fully supports their mission to improve the lives of all patients affected.

Encouraging progress with sarizotan and Evenamide
In May, Newron received the U.S. FDA’s approval of its Investigational New Drug (IND) application for the evaluation of sarizotan for the treatment of patients with Rett syndrome. In July, Newron initiated the “Sarizotan Treatment of Apneas in Rett Syndrome” (STARS) study, which is a potentially pivotal clinical study to evaluate the efficacy, safety and tolerability of sarizotan in patients with Rett syndrome suffering from respiratory symptoms. The initiation of the STARS study is an exciting milestone in the company’s development program for sarizotan; Newron expects to be able to report the results of this trial in due course.

In April, Newron presented a poster at the 5th Biennial Schizophrenia International Research Society Conference on Evenamide (NW-3509), its new generation antipsychotic that acts through pathways that are not targeted by current treatments or other putative antipsychotics. The abstract was entitled: “Evenamide (NW-3509), a Putative Antipsychotic, Targets Abnormal Electrical Activity and Glutamatergic Abnormalities in Improving Psychotic Symptoms in Patients with Schizophrenia in a Phase II, Placebo-controlled Trial”. The research presented at this conference is another positive step in the development of Evenamide, whose Phase II clinical study results are anticipated to read out in Q4 2016.

Financial Highlights
In the first six months of 2016, Newron has invested EUR 9.2 million into drug development and preparations for regulatory submission of safinamide, up from EUR 7.6 million in 2015. The increase is predominantly due to the Phase II study of Evenamide in patients with schizophrenia and the preparations of the potentially pivotal study with sarizotan in Rett syndrome. Of these R&D expenses, EUR 1.0 million has been reimbursed by its safinamide partner Zambon. Therefore, for the first six months of this year, net R&D expenses were EUR 8.2 million, up from 2015 expenses of EUR 4.7 million. General and administrative expenses were EUR 4.4 million in the first six months of 2016, up from EUR 4.1 million in 2015. The company’s revenues for the first half of 2016 were EUR 3.9 million, up from EUR 2.0 million in 2015, including milestone payments under the collaboration with partner Zambon (EUR 3.0 million, up from EUR 1.8 million in 2015) and royalty payments on Xadago® sales, which were up to EUR 852 thousand in the first six months, from EUR 93 thousand in 2015. Newron’s net loss for the first six months of 2016 is EUR 8.8 million, compared to EUR 6.9 million in the first half of 2015.

Cash and short term investments at June 30, 2016 were at EUR 34.9 million, compared to EUR 40.9 million at the beginning of the year, also reflecting the exercise in March 2016 of a purchase option for 209,364 shares by a shareholder under a 2015 subscription and option agreement, generating proceeds of EUR 3.0 million.

Further details and the full financial details are available in Newron’s Half-Year 2016 Report, which is available for download at www.newron.com/financial-report.

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. Xadago® (safinamide) has received marketing authorization for the treatment of Parkinson’s disease in the European Union and Switzerland and is commercialized by Newron’s Partner Zambon. US WorldMeds holds the commercialization rights in the US. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. In addition to Xadago® 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 NW-3509 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.

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 update 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 announcement is not an offer for sale of securities in the United States, Canada, Australia or Japan or any other jurisdiction where such an offer or solicitation would otherwise be unlawful. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Newron does not intend to register any of its securities in the United States or to conduct a public offering of its securities in the United States. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of this document shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.