Newron Pharmaceuticals reports on its 2024 Investor Day in New York City

EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Miscellaneous
Newron Pharmaceuticals reports on its 2024 Investor Day in New York City

25.06.2024 / 17:45 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Newron Pharmaceuticals reports on its 2024 Investor Day in New York City

Clinical results and new findings of mechanism of action indicate evenamide
would be uniquely effective in patients with treatment resistant
schizophrenia

Leading schizophrenia experts predict earlier use of evenamide would benefit
patients with inadequate response

Evenamide's unique mechanism of action targets the core abnormalities in
patients with schizophrenia and reduces hippocampal dopaminergic activity,
improving symptoms of psychosis, social interactions and cognition

Long-term benefits of evenamide as an add-on therapy were presented: 25% of
treated patients met the criteria for remission suggesting evenamide may
positively affect the long-term course of schizophrenia in TRS patients

Milan, Italy and Morristown, NJ, USA - June 25, 2024 - Newron
Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a
biopharmaceutical company focused on the development of novel therapies for
patients with diseases of the central and peripheral nervous system (CNS),
welcomed investors, analysts and media today to its well-attended investor
day in New York City. The event focused on the Company's clinical,
scientific and commercial plans for evenamide, its investigational drug
candidate in Phase III clinical development for the potential treatment of
patients with chronic and TRS.

The event featured three leading schizophrenia experts who presented on the
unmet medical needs in schizophrenia, as well as new concepts and recent
neurobiological findings for treating poor responders and patients with TRS.
An outline of Newron's Phase III clinical development plan in TRS was also
presented.

Breakthrough pre-clinical data supporting evenamide in the treatment of TRS

Anthony Grace, Ph.D., Editor-in-Chief, International Journal of
Neuropsychopharmacology, Distinguished Professor of Neuroscience, and
Professor of Psychiatry and Psychology at the University of Pittsburgh,
stated, "The hippocampal hyper dopaminergic activity in patients with
schizophrenia contributes to the development of symptoms of psychosis, loss
of functioning, decreased social interactions and deterioration of
cognition."

Dr. Grace further stated, "Evenamide's glutamate modulation has produced
dramatic effects in the MAM model of schizophrenia, which closely mimics the
changes observed in patients with schizophrenia. In this model, evenamide
reversed abnormal hippocampal neuronal activity, normalized dopamine neuron
population activity, improved cognition and normalized social interactions.
Its effects on neuronal firing, which persisted well beyond its half-life,
indicated that it induces neuronal plasticity and may help with neuronal
repair. Furthermore, by acting at the site of pathology, evenamide might
also be effective for negative symptoms and cognitive dysfunction."

Data from first evenamide placebo-controlled randomized study

John Kane, M.D., Co-Director and Professor, Institute of Behavioural
Science, Feinstein Institutes for Medical Research, and Professor of
Psychiatry, Donald and Barbara Zucker School of Medicine at
Hofstra/Northwell stated: "A substantial proportion of patients with
schizophrenia do not respond well to first line medications, and this is
true even at the onset of illness. This may be because there are biological
changes in the brains of patients that show reduced benefit and non-response
to treatments, compared with patients who respond adequately to treatment."

"Patients who are poor responders are likely to relapse more than patients
who respond to medication," stated Kane. "To date, there are no studies
which have demonstrated that the addition of one antipsychotic to another,
or switching antipsychotics, has produced any benefit to inadequate
responders and TRS patients."

Dr Kane continued, "The evenamide 008A study is unique in demonstrating a
significant benefit in patients who were moderately to severely psychotic,
while being compliant with their antipsychotic medication. This therapeutic
benefit may derive from evenamide's glutamate modulation activity. The drug
was extremely well tolerated, without any of the usual side effects of
available antipsychotics."

Results from an open label, long-term study of evenamide as add-on therapy
in TRS

Stephen R. Marder, M.D., Distinguished Professor of Psychiatry, Semel
Institute of Neuroscience & Human Behavior, and Director, Section on
Psychosis, UCLA Neuropsychiatric Institute stated: "One-third of patients
with schizophrenia are treatment resistant and the only drug available,
clozapine, is used in less than 5% of patients. The use of higher doses, the
addition of another antipsychotic, or switching to another drug is
unsuccessful in patients with TRS."

Dr. Marder continued, "The one-year results from studies where evenamide was
added to antipsychotics are noteworthy, as the sustained and continuous
improvement across all efficacy measures is virtually unknown in patients
with TRS. Similarly, the conversion of TRS patients to a non-resistant
state, as well as the finding that 25% of patients met criteria for
remission, is remarkable and unprecedented."

A new placebo controlled, one-year trial in patients with TRS who are
receiving other antipsychotics is in planning with Dr. Marder as the
Principal Investigator.

An outline of the late-stage clinical development for evenamide in TRS

Ravi Anand, MD, Newron's Chief Medical Officer, provided an update on
evenamide's clinical program, outlining that evenamide's promising results
will be evaluated in a Phase III randomized, double-blind, one-year trial.
The trial will compare evenamide to placebo as add-on treatments in at least
400 TRS patients. The primary efficacy endpoint will be change from baseline
in PANSS (1) scores at 12 weeks. Following this initial period, subjects
will continue on their assigned treatment until week 26, for the second,
maintenance efficacy endpoint, and then on to 1 year for read-out of the
third (one-year, long term) efficacy endpoint. The long-term extension will
also serve to evaluate the long-term safety and tolerability of evenamide.

Stefan Weber, Chief Executive Officer of Newron Pharmaceuticals, commented:
"As highlighted by the three world-leading KOLs, evenamide has enormous
potential, if approved, in addressing the significant unmet medical needs of
patients with chronic and treatment-resistant schizophrenia. We continue to
explore all options, including partnering, that could enable us to complete
the Phase III clinical development of evenamide, which we believe could have
blockbuster potential."

A replay of the event is available on the Company's website for one month
after the date of the event:
https://www.newron.com/investors/reports-and-presentation/year/2024#reports,-presentations-&-webcasts

About evenamide

Evenamide, an orally available new chemical entity, specifically blocks
voltage-gated sodium channels (VGSCs) and is devoid of biological activity
at >130 other CNS targets. It normalizes glutamate release induced by
aberrant sodium channel activity (veratridine-stimulated), without affecting
basal glutamate levels, due to inhibition of VGSCs. Combinations of
ineffective doses of evenamide and other APs, including clozapine, were
associated with benefit in animal models of psychosis, suggesting synergies
in mechanisms that may provide benefit in patients who are poor responders
to current APs, including clozapine.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the
development of novel therapies for patients with diseases of the central and
peripheral nervous system. 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, Switzerland, the
UK, the USA, Australia, Canada, Latin America, Israel, the United Arab
Emirates, Japan and South Korea, and is commercialized by Newron's Partner
Zambon. Supernus Pharmaceuticals holds the commercialization rights in the
USA. Meiji Seika has the rights to develop and commercialize the compound in
Japan and other key Asian territories. Newron is also developing evenamide
as the potential first add-on therapy for the treatment of patients with
symptoms of schizophrenia. For more information, please visit:
www.newron.com

For more information, please contact:

Newron

Stefan Weber
CEO
+39 02 6103 46 26
pr@newron.com

UK/Europe

Simon Conway / Ciara Martin / Natalie Garland-Collins
FTI Consulting
+44 20 3727 1000
SCnewron@fticonsulting.com

Switzerland

Valentin Handschin
IRF
+41 43 244 81 54
handschin@irf-reputation.ch

Germany/Europe

Anne Hennecke / Caroline Bergmann
MC Services
+49 211 52925222
newron@mc-services.eu

USA

Paul Sagan
LaVoieHealthScience
+1 617 374 8800, Ext. 112
psagan@lavoiehealthscience.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, the
timing of commencement of various clinical trials and receipt of data and
current and future collaborations for the development and commercialization
of its product candidates, (2) the market for drugs to treat CNS diseases
and pain conditions, (3) Newron's 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 difficulties in
enrolling clinical trials, 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
programs, development activities, commercialization 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 or the Dusseldorf Stock 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.

(1) Positive and Negative Syndrome Scale (PANSS) is widely used in clinical
trials of schizophrenia and is considered the "gold standard" for assessment
of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)


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   Language:       English
   Company:        Newron Pharmaceuticals S.p.A.
                   via Antonio Meucci 3
                   20091 Bresso
                   Italy
   Phone:          +39 02 610 3461
   Fax:            +39 02 610 34654
   E-mail:         pr@newron.com
   Internet:       www.newron.com
   ISIN:           IT0004147952
   WKN:            A0LF18
   Listed:         Regulated Unofficial Market in Dusseldorf
                   (Primärmarkt); London, SIX
   EQS News ID:    1932927

End of News EQS News Service
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1932927 25.06.2024 CET/CEST