Newron Pharmaceuticals — Encouraging efficacy data from evenamide trial

Newron Pharmaceuticals (SIX: NWRN)

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Research: Healthcare

Newron Pharmaceuticals — Encouraging efficacy data from evenamide trial

Newron has presented new efficacy data from its Phase II evenamide trial (study 014/015) at the CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society. These data, from the first 100 patients at the one-year timepoint, indicate significant and clinically important results, with continuous improvements across the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression of Change (CGI-C), Severity of Illness (CGI-S) and Strauss-Carpenter Level of Functioning (LOF) efficacy scales. While we anticipate full one-year results from the evenamide extension trial (study 015) in Q124, the company plans to initiate a potentially pivotal multinational Phase III trial (study 003) in treatment-resistant schizophrenia (TRS) patients in H223, which in our view, represents an important catalyst.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Newron Pharmaceuticals

Encouraging efficacy data from evenamide trial

Clinical trial update

Pharma and biotech

16 May 2023

Price

CHF4.35

Market cap

CHF78m

€1.03/CHF

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

Nidhi Singh

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Newron Pharmaceuticals is a research client of Edison Investment Research Limited

Newron has presented new efficacy data from its Phase II evenamide trial (study 014/015) at the CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society. These data, from the first 100 patients at the one-year timepoint, indicate significant and clinically important results, with continuous improvements across the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression of Change (CGI-C), Severity of Illness (CGI-S) and Strauss-Carpenter Level of Functioning (LOF) efficacy scales. While we anticipate full one-year results from the evenamide extension trial (study 015) in Q124, the company plans to initiate a potentially pivotal multinational Phase III trial (study 003) in treatment-resistant schizophrenia (TRS) patients in H223, which in our view, represents an important catalyst.

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.

The latest update from study 015 provides full efficacy data for 100 patients at the one-year timepoint, assessed by changes from baseline across the PANSS, CGI-C, CGI-S and LOF scales. We note that the primary objective of the study is to evaluate the safety and tolerability of evenamide (at three fixed doses of 7.5mg, 15mg and 30mg bid), with PANSS being the primary efficacy indicator. The results showed an increased reduction in the PANSS total score at all timepoints versus baseline, with a PANSS responder rate (defined as showing a >20% improvement) of 47%, a 3x increase from 16% at week six. The CGI-C scale measurements showed that 41% of patients were rated as ‘much’ or ‘very much’ improved versus baseline. CGI-S measurements showed improvements of 1.1 units versus baseline, with 29% of patients observing two or three category improvements.

Overall, 38% of patients met the threshold for being classified as ‘super-responders’ (described as a ‘full responder’ in a previous update from the company), defined by: a PANSS total score improvement of at least 20%; a CGI-C of at least ‘much improved’; a CGI-S of an at least one point improvement and at most ‘mildly ill’. This represents a 2.5x increase from week six, which in our view is supportive of evenamide as potentially the first add-on therapy for TRS patients.

As a reminder, the Phase II evenamide trial (study 014, six weeks and study 015, an extension study) is an international, randomised, open-label, rater-blinded assessment of evenamide (safety and efficacy) as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe TRS. With the encouraging efficacy data to date, we anticipate that improvements in clinical benefit over a longer period (in line with the observed trend for the first 100 patients), and systematic differences between doses of evenamide, if observed, will become clearer with time. One-year data from the full 161-patient cohort in extension study 015 are expected in Q124.

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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20 Red Lion Street

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London │ New York │ Frankfurt

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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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