Newron announces positive top-line results from potentially pivotal Phase
II/III study 008A with evenamide in schizophrenia patients

EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study results
Newron announces positive top-line results from potentially pivotal Phase
II/III study 008A with evenamide in schizophrenia patients

30.04.2024 / 07:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Newron announces positive top-line results
from potentially pivotal Phase II/III study 008A with evenamide in
schizophrenia patients

Primary endpoint and key secondary endpoint of study met; drug was well
tolerated, with no safety concerns identified

Glutamatergic inhibition mechanism of action offers an innovative
therapeutic option to schizophrenia patients not benefitting from current
antipsychotic treatments

Next step: Potentially pivotal, Phase III, one-year, randomized,
double-blind, placebo-controlled trial in treatment resistant schizophrenia
(TRS)

International conference call today at 3:00 PM CET/9:00 AM ET

Milan, Italy, April 30, 2024, 07:00 am CEST - 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), today announced positive top-line
results from its potentially pivotal study 008A, evaluating the safety,
tolerability and efficacy of evenamide (30 mg bid) in patients with chronic
schizophrenia currently being treated with a second-generation antipsychotic
including clozapine, but demonstrating an inadequate response to that
treatment. The study met its primary endpoint of improvement on the Positive
and Negative Syndrome Scale (PANSS) Total Score as well as the key secondary
endpoint of improvement of the Clinical Global Impression of Severity
(CGI-S).

Study 008A was a four-week, international, randomized, double-blind and
placebo-controlled add-on Phase II/III study performed in 45 centers in 11
countries in Europe, Asia and Latin America. 291 patients were randomized to
treatment either with evenamide or placebo as add-on to their current
antipsychotic therapy.

Evenamide confirmed its favourable safety and tolerability profile, with a
high rate of completion. Two hundred and eighty of the 291 patients
completed the study with only three patients discontinuing the study due to
adverse events, two of them on evenamide and one patient on placebo who died
during the study. No new or specific concerns were raised in the study; only
25% of the patients in the study experienced at least one adverse event
(evenamide 25% versus placebo 25.8%). There was no difference in the
incidence of CNS, psychiatric, gastrointestinal or other adverse events
between evenamide and placebo. The most common adverse events reported in
patients treated with evenamide were headache, vomiting and nasopharyngitis
(three patients, each); similar numbers of patients on placebo experienced
these adverse events.

In the study, the addition of 30 mg (bid) of evenamide to the patients'
current antipsychotic medication was associated with a highly statistically
significant (p-value 0.006) reduction in the PANSS Total Score of 10.2
points, compared to 7.6 points in patients treated with placebo at day 29;
the least square mean difference (LS mean difference) was 2.5. For the key
secondary measure, the Clinical Global Impression of Severity (CGI-S), the
LS mean difference between patients treated with evenamide and placebo was
0.16; the corresponding p-value was 0.037.

Ravi Anand, MD, Chief Medical Officer of Newron, stated: "The results seen
in study 008A with evenamide are ground-breaking and unique from many
perspectives. This is the first major international study to demonstrate the
significant benefit of adding a new chemical entity (NCE) to poorly
responding, compliant schizophrenia patients being treated with a
second-generation antipsychotic. It is also the first demonstration of
efficacy in a placebo-controlled trial of a NCE acting exclusively through
glutamatergic inhibition. These results, together with the recently reported
one-year efficacy results in treatment-resistant patients, substantiate the
pivotal role of glutamate in finding new therapeutic options for
schizophrenia patients."

Additional details from the study will be disclosed in the coming weeks.

Media/analyst/investor Conference Call today at 3 pm CET

Newron's management team will be available today to discuss the top-line
results from study 008A. Please dial in five to ten minutes prior to the
beginning of the call using one of the following telephone numbers:

* Switzerland/Europe: +41 (0)58 310 50 00

* Germany: +49 (0)69 505 0 0082

* United Kingdom: +44 (0)207 107 0613

* United States: +1 (1)631 570 5613

* Japan: +81 35 050 5361

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.


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   Language:       English
   Company:        Newron Pharmaceuticals S.p.A.
                   via Ludovico Ariosto 21
                   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:    1892237

End of News EQS News Service
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1892237 30.04.2024 CET/CEST