Oryzon Genomics — ALICE data published in The Lancet Haematology

Oryzon Genomics (BME: ORY)

Last close As at 19/07/2024

EUR1.92

0.00 (−0.21%)

Market capitalisation

EUR123m

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Research: Healthcare

Oryzon Genomics — ALICE data published in The Lancet Haematology

Oryzon Genomics has announced the publication of the final ALICE trial results in the recognised peer-reviewed journal The Lancet Haematology. The Phase IIa trial investigated iadademstat (Oryzon’s lead oncology LSD1 inhibitor) in combination with azacitidine for the treatment of acute myeloid leukaemia (AML) in newly diagnosed elderly/unfit patients. The trial demonstrated strong efficacy signals, with an objective response rate (ORR) of 81.5%, with three patients still on treatment through compassionate use and in complete remission after four years from the start of treatment. A Phase Ib, investigator-sponsored, dose-finding study evaluating iadademstat (in combination with azacitidine and venetoclax) in the first-line setting is expected to start recruitment by mid-2024. We note that the company’s near-term focus is the Phase Ib FRIDA study (in patients with advanced AML with an FLT3 mutation), from which interim data is expected imminently.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

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Healthcare

Oryzon Genomics

ALICE data published in The Lancet Haematology

Company update

Pharma and biotech

4 June 2024

Price

€2.00

Market cap

€124m

Net debt (€m) at 31 March 2024

3.7

Shares in issue

62.0m

Free float

82%

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 leukaemia, small-cell lung cancer and neuroendocrine tumours. Vafidemstat, its central nervous system asset, has completed several Phase IIa trials and a Phase IIb trial for borderline personality disorder (now the lead programme), and is in a Phase IIb trial for schizophrenia.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Oryzon Genomics is a research client of Edison Investment Research Limited

Oryzon Genomics has announced the publication of the final ALICE trial results in the recognised peer-reviewed journal The Lancet Haematology. The Phase IIa trial investigated iadademstat (Oryzon’s lead oncology LSD1 inhibitor) in combination with azacitidine for the treatment of acute myeloid leukaemia (AML) in newly diagnosed elderly/unfit patients. The trial demonstrated strong efficacy signals, with an objective response rate (ORR) of 81.5%, with three patients still on treatment through compassionate use and in complete remission after four years from the start of treatment. A Phase Ib, investigator-sponsored, dose-finding study evaluating iadademstat (in combination with azacitidine and venetoclax) in the first-line setting is expected to start recruitment by mid-2024. We note that the company’s near-term focus is the Phase Ib FRIDA study (in patients with advanced AML with an FLT3 mutation), from which interim data is expected imminently.

Year
end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/22

15.7

(6.3)

(0.07)

0.0

N/A

N/A

12/23

14.2

(6.0)

(0.06)

0.0

N/A

N/A

12/24e

12.9

(4.1)

(0.03)

0.0

N/A

N/A

12/25e

33.7

15.4

0.29

0.0

6.9

N/A

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

The Lancet Haematology is a recognised peer-reviewed medical journal and we see the publication of the final data from the ALICE trial as a reflection of Oryzon’s efforts in the epigenetics space. The Phase IIa trial was an open-label study assessing the safety, tolerability, efficacy and optimal dosing of iadademstat in combination with standard-of-care (SoC) azacitidine as a first-line therapy in adult patients (n=27) with AML. Final results from the trial were presented in December 2022, demonstrating an ORR of 81.5% (22/27). Fourteen patients (52%) achieved complete remission (CR) or CR with incomplete haematological recovery (CRi), with 10 of the 11 evaluable CR/CRi patients testing negative for measurable residual disease. More importantly, the treatment showcased efficacy in patients with difficult to treat mutations, such as M5 AML (typically non-responsive to SoC, three patients with the mutation achieved CR/CRi in the trial) and TP53 (CR/CRi rate of 63%), indicative of the treatment’s potential broad applicability. All three patients with the FLT3 mutation responded to the treatment.

Oryzon now plans to evaluate iadademstat in combination with azacitidine and venetoclax (in first-line AML patients under an investigator-sponsored Phase Ib trial, led by Oregon Health and Science University), recruitment for which is expected to commence by mid-2024. However, we expect that the emphasis will be on the in-house Phase Ib FRIDA study, due to present interim readouts imminently (at the European Hematology Association Congress to be held between 13 and 16 June 2024). The study, assessing iadademstat in combination with gilteritinib as second-line treatment (relapsed/refractory AML patients with FLT3 mutation), aims to recruit c 45 patients, with the first two cohorts (13 patients) completed and a third cohort currently being recruited. Another key near-term catalyst will be the initiation of the Phase I/II CRADA-MSKCC study (evaluating iadademstat in combination with checkpoint inhibitors for first-line, extensive-stage small cell lung cancer), expected to start by mid-2024.

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.

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Copyright: Copyright 2024 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

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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

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 2024 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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