Oryzon Genomics — Promising PORTICO interim results

Oryzon Genomics (BME: ORY)

Last close As at 22/06/2024

EUR1.89

0.00 (0.11%)

Market capitalisation

EUR121m

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Research: Healthcare

Oryzon Genomics — Promising PORTICO interim results

Oryzon has announced promising results from an interim analysis of the Phase IIb PORTICO study, a trial evaluating vafidemstat as a treatment for borderline personality disorder (BPD). An independent data monitoring committee (IDMC) conducted an analysis of the first 90 patients who completed the treatment and recommended that the trial continue without any modifications to the design. These interim results, along with positive safety data reported in September 2022, are encouraging for the clinical development of vafidemstat in this indication, in our view. Management anticipates that top-line data will be shared in early 2024 and we believe this represents the next most significant catalyst for the PORTICO trial.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Oryzon Genomics

Promising PORTICO interim results

Clinical update

Pharma and biotech

4 April 2023

Price

€2.40

Market cap

€135m

Net cash (€m) at end-December 2022

4.0

Shares in issue

56.3m

Free float

80%

Code

ORY

Primary exchange

Madrid Stock Exchange

Secondary exchange

N/A

Share price performance

Business description

Oryzon Genomics is a Spanish biotech focused on epigenetics. Iadademstat is being explored for acute leukaemias, small-cell lung cancer and neuroendocrine tumours. Vafidemstat, its central nervous system (CNS) asset, has completed several Phase IIa trials and a Phase IIb trial in borderline personality disorder is now the lead study, but Oryzon is rapidly expanding its CNS R&D pipeline.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Oryzon Genomics is a research client of Edison Investment Research Limited

Oryzon has announced promising results from an interim analysis of the Phase IIb PORTICO study, a trial evaluating vafidemstat as a treatment for borderline personality disorder (BPD). An independent data monitoring committee (IDMC) conducted an analysis of the first 90 patients who completed the treatment and recommended that the trial continue without any modifications to the design. These interim results, along with positive safety data reported in September 2022, are encouraging for the clinical development of vafidemstat in this indication, in our view. Management anticipates that top-line data will be shared in early 2024 and we believe this represents the next most significant catalyst for the PORTICO trial.

Year

end

Revenue
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/21

10.6

(7.2)

(0.09)

0.0

N/A

N/A

12/22

15.7

(6.6)

(0.07)

0.0

N/A

N/A

12/23e

17.3

(4.2)

(0.03)

0.0

N/A

N/A

12/24e

19.0

(10.0)

(0.14)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, other income and exceptional items.

Oryzon specialises in treatments for central nervous system (CNS) and oncology indications. The company’s lead CNS asset, vafidemstat, is a novel drug targeting the epigenetic modulator lysine-specific demethylase 1 (LSD1). The PORTICO study is a Phase IIb multicentre, double-blind, randomised, placebo-controlled trial investigating the use of vafidemstat for the treatment of BPD. In September 2022, Oryzon reported no serious adverse events from the first 43 patients enrolled in the trial and that approval for the study to continue was granted by an IDMC. The two independent primary objectives for the trial are improvements in agitation and aggression, as well as overall improvement of BPD.

This month, Oryzon announced the results from an interim analysis of the first 90 patients completing the treatment. This analysis, again conducted by an IDMC, has determined the trial to be non-futile and recommended that it should continue without any modifications. The results of this analysis provide further support that vafidemstat is a safe and well-tolerated drug and has the potential to be an effective treatment for BPD. The trial is actively recruiting patients in Europe and the United States, with the aim to enrol around 188 patients in total.

Management has said that top-line data will be available in early 2024, at which point Oryzon will carefully assess the primary, secondary and exploratory endpoints. A decision will then be made on next steps for the clinical development of vafidemstat in CNS indications and this may involve a follow-on Phase III clinical trial in BPD. We believe that the announcement of top-line data in early 2024 represents the next most significant catalyst for the PORTICO trial and Oryzon’s CNS portfolio.

Vafidemstat is also under development in the CNS space for the treatment of schizophrenia in the EVOLUTION study and updates are expected in 2023. Oryzon is also expecting to launch this year a personalised medicine programme for Kabuki syndrome (a rare CNS indication) as the therapeutic mechanism of LSD1 inhibition has been validated in pre-clinical studies.

General disclaimer and copyright

This report has been commissioned by Oryzon Genomics and prepared and issued by Edison, in consideration of a fee payable by Oryzon Genomics. 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.

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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 Oryzon Genomics and prepared and issued by Edison, in consideration of a fee payable by Oryzon Genomics. 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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