Newron Pharmaceuticals — Positive interim trial results in schizophrenia

Newron Pharmaceuticals (SIX: NWRN)

Last close As at 26/04/2024

CHF6.69

−0.31 (−4.43%)

Market capitalisation

CHF125m

More on this equity

Research: Healthcare

Newron Pharmaceuticals — Positive interim trial results in schizophrenia

Newron Pharmaceuticals’ share price has responded well to its announcement of encouraging interim efficacy data for the use of evenamide as an add-on therapy to antipsychotics in moderate to severe treatment-resistant schizophrenia (TRS). Patients who completed (85 out of 100) the six-month (30-week) treatment period (study 015) were found to show statistically significant and clinically meaningful improvements in the symptoms of psychosis. Importantly, the six-month data showed a sustained and continued improvement in key efficacy measures compared to results after six weeks (study 014) of treatment, with the proportion of patients achieving clinically meaningful improvements increasing over time. We view these latest results as highly supportive of evenamide’s clinical utility in TRS, further justifying management’s strategy of expanding into this schizophrenia patient population.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Newron Pharmaceuticals

Positive interim trial results in schizophrenia

Clinical trial update

Pharma and biotech

3 January 2023

Price

CHF1.55

Market cap

CHF28m

CHF0.99/€

Net debt (€m) at end June 2022

15.5

Shares in issue

17.8m

Free float

99%

Code

NWRN

Primary exchange

SIX Swiss Exchange

Secondary exchange

N/A

Share price performance

Business description

Newron Pharmaceuticals is focused on the central nervous system. Xadago for Parkinson’s disease is sold in Europe, Japan and the United States. Evenamide, a novel schizophrenia add-on therapy, is involved in a Phase II/III trial programme targeting schizophrenia patients experiencing inadequate responses to current antipsychotic medications.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Adam McCarter

+44 (0)20 3077 5700

Newron Pharmaceuticals is a research client of Edison Investment Research Limited

Newron Pharmaceuticals’ share price has responded well to its announcement of encouraging interim efficacy data for the use of evenamide as an add-on therapy to antipsychotics in moderate to severe treatment-resistant schizophrenia (TRS). Patients who completed (85 out of 100) the six-month (30-week) treatment period (study 015) were found to show statistically significant and clinically meaningful improvements in the symptoms of psychosis. Importantly, the six-month data showed a sustained and continued improvement in key efficacy measures compared to results after six weeks (study 014) of treatment, with the proportion of patients achieving clinically meaningful improvements increasing over time. We view these latest results as highly supportive of evenamide’s clinical utility in TRS, further justifying management’s strategy of expanding into this schizophrenia patient population.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

DPS
(%)

Yield
(%)

12/20

5.26

(18.16)

(1.09)

0.0

N/A

N/A

12/21

5.76

(14.12)

(0.79)

0.0

N/A

N/A

12/22e

6.60

(15.51)

(0.87)

0.0

N/A

N/A

12/23e

7.89

(16.41)

(0.92)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

It is estimated that 30–60% of schizophrenia patients are diagnosed with TRS, resulting in increased morbidity, mortality and suicide, and TRS continues to represent an unmet medical need. With the positive trial results, we see a clear opportunity for evenamide as the first potential add-on therapy in schizophrenia treatment.

As a reminder, study 014 is a six-week, open-label study, in which Newron had previously reported encouraging data from the first 100 patients enrolled and randomized to receive add-on evenamide at either 7.5mg, 15mg or 30mg doses. Of these, 90 patients continued onto the extension study (study 015) to observe longer-term safety and efficacy effects. Assessment of efficacy is based on changes from baseline in the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression of Change (CGI-C), Severity of Illness (CGI-S) and Strauss-Carpenter Level of Functioning (LOF) scales.

After 30 weeks of treatment, the proportion of patients demonstrating a clinically meaningful PANSS improvement more than doubled from that observed at week 6 (16.5%). Additionally, the CGI-S responder rate increased from 60% at week 6 by an additional c 20% at week 30, while the CGI-C responder rate also increased from 27% at week 6 by 10% at week 30. Notably, nearly all of the 100 evaluated patients to date has received either the 7.5mg or 15mg dose, hence there is potential for even greater benefit to be shown in the 30mg dose arm once the study is completed.

Final results from study 014 and extension study 015 are expected in March 2023 and Q124 respectively and management intends to initiate a pivotal Phase III randomized, double-blind, placebo-controlled study for evenamide in TRS in 2023.

General disclaimer and copyright

This report has been commissioned by Newron Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by Newron Pharmaceuticals. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

More on Newron Pharmaceuticals

View All

Latest from the Healthcare sector

View All Healthcare content

Research: Healthcare

Respiri — New funding to support commercial traction

Respiri has announced a A$1.5m capital raise through a security purchase plan (SPP) to existing shareholders (up to 30m shares to be issued at A$0.05/share). We note that the SPP is fully underwritten with the new shares expected to enter circulation on 9 February 2023. We expect this cash injection to further support Respiri’s commercialization plans in the US, which have resulted in notable client wins over the past quarter. Six new accounts were signed in H2 CY22 and, most recently, the Arkansas Heart Hospital (AHH; deal signed in late November) commenced patient enrolment in the wheezo programme for cardiovascular patients, suffering from chronic obstructive pulmonary disease (COPD). We expect initial patient feedback (first data readout anticipated in early 2023) and remote patient monitoring (RPM) reimbursement to underpin Respiri’s longer-term growth potential.

Continue Reading

Subscribe to Edison

Get access to the very latest content matched to your personal investment style.

Sign up for free