Newron 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.
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.