Newron Reports Half-Year 2015 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, 2015.

Half-Year 2015 Highlights

  • EU Commission approves Xadago® (safinamide) for mid- to late-stage
    Parkinson’s patients
  • Launch of Xadago® by partner Zambon in Germany
  • Xadago® New Drug Application accepted for filing by the U.S. Food and
    Drug Administration (FDA); PDUFA date 29 December 2015
  • Positive opinion received from the European Medicines Agency for
    Orphan Medicinal Product Designation for sarizotan to treat patients
    with Rett Syndrome; after end of reporting period, Orphan Drug
    Designation received from European Commission and U.S. FDA
  • Phase II study of sNN0031 in patients with Parkinson’s disease and
    Phase II study of sNN0029 in patients with Amyotrophic Lateral
    Sclerosis initiated
  • Completion of first-in-man U.S. Phase I study of novel sodium channel
    blocker NW-3509
  • Closing of EUR 23.4m private placement from leading EU and U.S.
    investors
  • Strong cash position of EUR 44.0m at 30 June 2015

Stefan Weber, CEO of Newron, commented: “We enter the second half of
2015 in a strong position, with EUR 44 million of cash and equivalents.
We are pleased that Xadago® is now commercially available to patients in
Germany and are excited by its future roll-out across Europe by our
partner Zambon. We are now also awaiting the decisions by the FDA,
following the successful refiling in the U.S., and by Swissmedic, which,
if positive, will trigger further milestones. Our key pipeline projects
sarizotan and NW-3509 are progressing well, with the commencement of new
studies during the remainder of 2015. We remain focused on building and
strengthening our position as a leading player in the CNS space.”

The European Commission approved the use of Xadago® for mid- to
late-stage Parkinson’s disease patients following the recommendation of
the Committee for Medicinal Products for Human Use (CHMP). This is the
first new chemical entity in 10 years to receive approval in Europe for
the treatment of Parkinson’s disease. In May, our partner Zambon
launched Xadago® in Germany, to be followed by the roll-out into other
EU territories. In addition, Newron received news from the U.S. Food and
Drug Administration (FDA) that the New Drug Application (NDA) for
Xadago® has been accepted for review. The completion of the NDA review
is currently expected on 29 December 2015 (the PDUFA date).

In the first half of 2015, Newron made good progress with sarizotan, a
new chemical entity for the treatment of Rett Syndrome. The Committee
for Orphan Medicinal Products (COMP) issued a positive opinion
recommending sarizotan as an orphan medicinal product to the European
Commission for the treatment of Rett Syndrome. After closing of the
reporting period, the European Commission and the U.S. FDA granted
Orphan Drug Designation to sarizotan for this indication. Newron has
conducted extensive discussions with regulatory authorities in Europe,
the U.S. and Canada and has consulted with the group of international
investigators who will be performing the study to finalize the protocol
for a potentially pivotal placebo-controlled study. If approved,
sarizotan is likely to be the first product that Newron commercializes
on its own.

Newron also announced the completion of the first-in-man U.S. Phase I
study of its novel, voltage-gated sodium channel blocker NW-3509, for
which an Investigational New Drug (IND) application was accepted by the
U.S. FDA as add-on to antipsychotics for patients with schizophrenia.
The Phase I study in 54 healthy subjects demonstrated that NW-3509 was
well tolerated at all doses. Based on these results, in 2015 we plan to
initiate a Phase II trial of NW-3509 as add-on treatment in
schizophrenic patients on stable and adequate doses of atypical
antipsychotics whose symptoms are not effectively controlled by their
medication.

In January, Newron initiated a Phase II study of sNN0031 as a
recombinant human platelet-derived growth factor-BB for the treatment of
severe, treatment-resistant Parkinson’s disease, an orphan indication.
This study of safety, tolerability and preliminary evidence of efficacy
is supported by a grant from the European Union. Based on preclinical
data and results from previous studies of sNN0031 in Parkinson’s disease
patients, the compound was well tolerated, and a dose-dependent,
positive effect was observed in dopamine uptake in brain regions damaged
in Parkinson’s disease. sNN0031 may offer a new therapeutic option for
those patients who do not benefit from treatment with current standard
of care using oral therapies.

In parallel, Newron initiated a Phase II study, supported by the
Wellcome Trust, of sNN0029, a novel recombinant human vascular
endothelial growth factor (rhVEGF-165) in patients with Amyotrophic
Lateral Sclerosis (ALS). Significant benefit was demonstrated in an
earlier study in ALS patients at the highest dose. sNN0029 has both
direct and indirect effects in preventing death of motor neurons,
suggesting it may represent a unique treatment opportunity for patients
with this life-threatening rare disease.

Both sNN0029 and sNN0031 are delivered into the brain with a medical
device from a third-party supplier. During the second quarter, the
device supplier entered into a consent decree with U.S. health
authorities that prevents it from commercializing the device until
certain quality issues are resolved. Although the FDA exempted the
performance of clinical studies from the ban, requests for additional
information from health authorities and ethics committees have impacted
the progress of the studies.

Shareholders demonstrated their support in March by approving a capital
increase of up to 1.3 million additional shares. In April, current and
new institutional investors from Europe and the U.S., including Aviva,
J.P. Morgan Asset Management, Investor AB, Sphera Global HealthCare Fund
and Nyenburgh, subscribed to 843,072 newly issued shares, raising gross
proceeds of EUR 23.4 million. These funds are being used to accelerate
the development of the innovative product pipeline, particularly the
lead clinical programs for sarizotan and NW-3509.

Interim financial statements

In the first six months of 2015, Newron invested EUR 7.6 million into
drug development and preparations for regulatory submission of Xadago®,
up from EUR 6.5 million in 2014. Of these, EUR 2.8 million have been
covered by our Xadago® partner Zambon as well as by grants. Therefore,
for the first six months of the year, net R&D expenses were EUR 4.7
million, up from 2014 expenses of EUR 2.6 million. G&A expenses reached
EUR 4.1 million, up from EUR 3.5 million in 2014. Revenues for the first
half of 2015 were EUR 2.0 million, stemming from milestone payments
under the collaboration with partner Zambon, as well as first royalties
from Xadago® sales in Germany. The net loss for the first six months of
2015 is EUR 6.9 million, compared to EUR 4.6 million in the first half
of 2014. With EUR 44.0 million cash and short-term investments, Newron
has a solid cash position, which should take the Company well beyond
expected key value inflexion points and related revenues.

               

Financial Summary (IFRS)
In EUR thousand (except per
share information)

          HY1 2015         HY1 2014
Licence income/Royalties         1,893         1,300
Other income         86         100
Research and development expenses*         4,723         2,620
General and administration expenses         4,058         3,498
Net loss         6,923         4,596
Loss per share         0.52         0.37
          30/6/2015         30/6/2014
Cash, cash equivalents, other short term fin. assets         44,000         31,390
Total assets         55,670         44,626
Net cash used in operating activities         5,257         4,443
 

* Net of safinamide development cost reimbursed by Zambon and net of R&D
grants/tax credits

For further details see the Half-Year 2015 Report, which is available
for download at:
http://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. Marketing authorization in the EU for Xadago®
(safinamide) was granted by the EU Commission in February 2015, followed
by the launch in the first key EU country – Germany – in May 2015. The
New Drug Application (NDA) has been accepted for filing by FDA as
reported in March 2015. In March 2014, Zambon, Newron’s partner,
submitted an MAA to Swissmedic. Zambon has the rights to develop and
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 sarizotan for patients with
Rett syndrome, for which Newron received Orphan Drug Designation in both
the US and the EU, sNN0031 for patients with Parkinson’s disease
non-responsive to oral drug treatments, and sNN0029 for patients with
ALS 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.

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 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.


Contacts

Media
Newron Pharmaceuticals
Stefan Weber, +39 02 6103
46 26
CEO
pr@newron.com
or
UK/Europe
FTI
Consulting
Julia Phillips, +44 (0)20 3727 1000
or
Switzerland
IRF
Communications
Martin Meier-Pfister, +41 43 244 81 40
or
Germany
MC
Services AG
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
or
U.S.
LaVoieHealthScience
David
Connolly, +1-617-374-8800, Ext. 108
dconnolly@lavoiehealthscience.com
or
Investors
and analysts

Newron Pharmaceuticals
Stefan Weber, +39 02
6103 46 30
CEO
ir@newron.com
or
Germany
MC
Services AG
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
or
U.S.
LaVoieHealthScience
Kristina
Coppola, +1-617-374-8800, Ext. 105
kcoppola@lavoiehealthscience.com