Actinogen Medical — Further positive XanaCIDD results on depression

Actinogen Medical (ASX: ACW)

Last close As at 10/10/2024

AUD0.03

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Research: Healthcare

Actinogen Medical — Further positive XanaCIDD results on depression

New data were revealed from Actinogen Medical’s ongoing analysis of the now-completed XanaCIDD study that support the view that the company’s lead drug candidate, Xanamem, may provide consistent and durable benefits in treating depression symptoms compared to placebo. The XanaCIDD study was designed to assess a 10mg daily dose of Xanamem versus placebo in patients with major depressive disorder (MDD) over a six-week treatment period. In line with the top-line results reported on 12 August, the new data confirm that maximal treatment effects on depression on all endpoints occurred at week 10, or four weeks after the end of the six-week treatment period. The results appear to be consistent with the molecule having a durable clinical effect in terms of controlling brain cortisol and potentially exerting anti-depressant activity.

Written by

Pooya Hemami

Analyst - Healthcare

Healthcare

Actinogen Medical

Further positive XanaCIDD results on depression

Additional XanaCIDD data

Pharma and biotech

27 August 2024

Price

A$0.045

Market cap

A$122m

Net cash (A$m) at 30 June 2024

9.5

Shares in issue

2,712m

Free float

90%

Code

ACW

Primary exchange

ASX

Secondary exchange

N/A

Share price performance

Business description

Actinogen Medical is an ASX-listed Australian biotech developing its lead asset Xanamem, a specific and selective 11β-HSD1 inhibitor designed to reduce cortisol secretion in the brain. Xanamem is being advanced to treat cognitive impairment in patients with Alzheimer’s disease and as a therapy to treat depression symptoms in patients with major depressive disorder.

Analysts

Pooya Hemami OD
MBA CFA

+44 (0)20 3077 5700

Soo Romanoff

+44 (0)20 3077 5700

Actinogen Medical is a research client of Edison Investment Research Limited

New data were revealed from Actinogen Medical’s ongoing analysis of the now-completed XanaCIDD study that support the view that the company’s lead drug candidate, Xanamem, may provide consistent and durable benefits in treating depression symptoms compared to placebo. The XanaCIDD study was designed to assess a 10mg daily dose of Xanamem versus placebo in patients with major depressive disorder (MDD) over a six-week treatment period. In line with the top-line results reported on 12 August, the new data confirm that maximal treatment effects on depression on all endpoints occurred at week 10, or four weeks after the end of the six-week treatment period. The results appear to be consistent with the molecule having a durable clinical effect in terms of controlling brain cortisol and potentially exerting anti-depressant activity.

Year end

Revenue
(A$m)

PBT*
(A$m)

EPS*
(A$)

DPS
(A$)

P/E
(x)

Yield
(%)

06/22

3.6

(7.9)

(0.005)

0.0

N/A

N/A

06/23

4.9

(8.9)

(0.005)

0.0

N/A

N/A

06/24e

7.9

(14.2)

(0.006)

0.0

N/A

N/A

06/25e

7.6

(14.0)

(0.005)

0.0

N/A

N/A

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

Actinogen has reported new data from its Phase IIa XanaCIDD study that build on the earlier reported top-line results that showed a statistically significant (p<0.05) improvement at week 10 on the MADRS scale assessing depression symptoms. The newly reported results continue to demonstrate the strongest effects occurred at week 10, indicative of a durable treatment effect. Positive effects on the MADRS scale were also shown in five of six pre-specified subgroups. Effects on depression symptoms were also confirmed with findings from a second, well-validated endpoint, the Patient Global Impression of Severity score in depression. The company plans to host a webinar to discuss the updated trial results on 29 August at 11am, AEST.

If improvements in addressing depression symptoms are consistently shown in future trials, Xanamem has the potential to be differentiated from existing approved drug treatments for depression due to its unique mechanism of action involving the suppression of cortisol formation in the brain. So far, the drug has shown a favourable safety profile across multiple studies involving over 380 patients in total. Actinogen will assess the path forward with regulators and key opinion leaders for a Phase IIb study in MDD that could start as early as H2 CY25.

While the potential in depression is promising, we believe that the larger opportunity for Xanamem lies in its potential as a treatment to slow progression of cognitive impairment in patients with Alzheimer’s disease (AD). The largest potential clinical catalyst in this area will be the interim analysis (expected in mid-CY25) of the first c 100 patients from the ongoing Phase IIb XanaMIA study, which prospectively enrols AD patients with elevated pTau-181. Investors will look R=at whether these data will confirm the positive efficacy findings shown in the XanADu subset biomarker analysis.

General disclaimer and copyright

This report has been commissioned by Actinogen Medical and prepared and issued by Edison, in consideration of a fee payable by Actinogen Medical. 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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London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

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London │ New York │ Frankfurt

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United Kingdom

General disclaimer and copyright

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