Newron Pharmaceuticals — Positive top-line data to support clinical progress

Newron Pharmaceuticals (SIX: NWRN)

Last close As at 21/06/2024

CHF10.88

−0.08 (−0.73%)

Market capitalisation

CHF203m

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Research: Healthcare

Newron Pharmaceuticals — Positive top-line data to support clinical progress

Newron Pharmaceuticals has announced positive top-line results from its Phase II trial (study 014) assessing evenamide, a glutamate modulator, as an add-on therapy to antipsychotics in moderate-to-severe treatment resistant schizophrenia (TRS). While detailed data (for the full 161 patient cohort over the six-week treatment period) have not been disclosed, management asserts that the results were similar to the six-week interim safety and efficacy data from the first 100 patients reported in June 2022. Newron intends to begin a potentially pivotal multinational Phase III study (study 003) in TRS patients (expected to start in H223) and, in our view, its initiation represents a future catalyst for investor attention. We anticipate that the 52-week results from the full evenamide extension study (study 015) in Q124, if positive, will further enhance the existing evenamide data package and support future regulatory discussions.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Newron Pharmaceuticals

Positive top-line data to support clinical progress

Clinical trial update

Pharma and biotech

20 March 2023

Price

CHF5.68

Market cap

CHF109m

CHF/€1.01

Net debt (€m) at end December 2022

22.4

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 III trial programme targeting schizophrenia.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Adam McCarter

+44 (0)20 3077 5700

Nidhi Singh

+44 (0)20 3077 5700

Newron Pharmaceuticals is a research client of Edison Investment Research Limited

Newron Pharmaceuticals has announced positive top-line results from its Phase II trial (study 014) assessing evenamide, a glutamate modulator, as an add-on therapy to antipsychotics in moderate-to-severe treatmentresistant schizophrenia (TRS). While detailed data (for the full 161 patient cohort over the six-week treatment period) have not been disclosed, management asserts that the results were similar to the six-week interim safety and efficacy data from the first 100 patients reported in June 2022. Newron intends to begin a potentially pivotal multinational Phase III study (study 003) in TRS patients (expected to start in H223) and, in our view, its initiation represents a future catalyst for investor attention. We anticipate that the 52-week results from the full evenamide extension study (study 015) in Q124, if positive, will further enhance the existing evenamide data package and support future regulatory discussions.

Year end

Revenue (€m)

PBT*

(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/21

5.76

(14.12)

(0.79)

0.0

N/A

N/A

12/22

6.09

(16.99)

(0.95)

0.0

N/A

N/A

12/23e

6.46

(17.11)

(0.96)

0.0

N/A

N/A

12/24e

6.85

(22.27)

(1.25)

0.0

N/A

N/A

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

In June 2022, Newron announced encouraging interim results from the first 100 patients after the mandated six weeks of treatment in study 014. This group was primarily treated with the 7.5mg and 15mg bid dose and reported a 12% reduction in schizophrenic symptoms on the Positive and Negative Syndrome Scale (PANSS), which is considered the ‘gold standard’ for assessing antipsychotic treatment efficacy. Moreover, the Clinical Global Impressions (CGI) ratings showed a ‘responder’ rate of 77% and a Clinical Global Impression of Severity (CGI-S) improvement of 0.7. Patients who entered the extension study (study 015) continued to exhibit improvement in underlying symptoms, highlighting the incremental benefit from long-term treatment. In February 2023, Newron reported results from the first 100 randomised patients, of which 77 patients had completed the study after 52 weeks of treatment. The proportion of patients experiencing PANSS improvement was three times greater than that observed at week six, in addition to improvements in the Clinical Global Impression of Change (another 10% increase from 27% at week six) and CGI-S (doubled over the 10% figure at week six) scales.

As per the top-line results, of the 161 patients randomised, 153 (95%) completed the six-week treatment period and 144 (94%) advanced to the extension study (study 015). Management has said that top-line results (both safety and efficacy) were in line with those reported for the first 100 patients (at week six). Notably, similar efficacy was observed irrespective of the different dosage strengths (later cohorts were also administered the higher 30mg dose vs 7.5mg and 15mg primarily used for the initial participants). We anticipate that clinical benefit could continue to improve with treatment over a longer period (in line with the observed trend for the first 100 patients) and systematic differences between doses of evenamide, if observed, could become clearer with time. Newron now plans to commence a potentially pivotal Phase III randomised, placebo-controlled trial (study 003) for evenamide in patients with TRS in H223.  

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.

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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

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United Kingdom

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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.

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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.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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