Actinogen Medical — Continued focus on Xanamem

Actinogen Medical (ASX: ACW)

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Research: Healthcare

Actinogen Medical — Continued focus on Xanamem

Actinogen’s Q323 update reiterated the company’s focus on advancing its lead asset Xanamem. Patient recruitment in the Phase IIa XanaCIDD study in cognitive impairment (CI) associated with major depressive disorder (MDD) is ongoing, and the company plans to start the Phase IIb portion of the XanaMIA study in Q2 CY23 in the company’s lead indication, Alzheimer’s disease (AD). This study portion is designed to assess Xanamem in a population of patients with mild CI and/or mild AD, who at baseline will have been confirmed as biomarker-positive for progressive AD. We continue to see the results from the XanaCIDD study (expected in late CY23 or early CY24) as the next major clinical data milestone and a potential share price catalyst. We expect the company’s A$12.3m cash balance at 31 March to fund operations into Q4 CY23.

Written by

Pooya Hemami

Analyst - Healthcare

Healthcare

Actinogen Medical

Continued focus on Xanamem

Quarterly update

Pharma and biotech

2 May 2023

Price

A$0.07

Market cap

A$127m

A$0.66/US$

Net cash (A$m) at 31 March 2023

12.3

Shares in issue

1,816m

Free float

90%

Code

ACW

Primary exchange

ASX

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

1.5

(28.3)

(21.4)

Rel (local)

0.1

(26.5)

(20.4)

52-week high/low

A$0.14

A$0.04

Business description

Actinogen Medical is an ASX-listed Australian biotech developing its lead asset Xanamem, a specific and selective 11β-HSD1 inhibitor designed to treat cognitive impairment (CI) that occurs in chronic neurodegenerative and neuropsychiatric diseases. Currently, Actinogen is targeting CI in two indications: the early stages of Alzheimer’s disease and major depressive disorder.

Next events

Start enrolment for XanaMIA Part IIb study in biomarker-confirmed early AD

Q2 CY23

Results for Phase II XanaCIDD study in cognitive impairment associated with major depressive disorder

Q4 CY23 or H1 CY24

Analyst

Pooya Hemami OD MBA CFA

+1 646 653 7026

Actinogen Medical is a research client of Edison Investment Research Limited

Actinogen’s Q323 update reiterated the company’s focus on advancing its lead asset Xanamem. Patient recruitment in the Phase IIa XanaCIDD study in cognitive impairment (CI) associated with major depressive disorder (MDD) is ongoing, and the company plans to start the Phase IIb portion of the XanaMIA study in Q2 CY23 in the company’s lead indication, Alzheimer’s disease (AD). This study portion is designed to assess Xanamem in a population of patients with mild CI and/or mild AD, who at baseline will have been confirmed as biomarker-positive for progressive AD. We continue to see the results from the XanaCIDD study (expected in late CY23 or early CY24) as the next major clinical data milestone and a potential share price catalyst. We expect the company’s A$12.3m cash balance at 31 March to fund operations into Q4 CY23.

Year

end

Revenue
(A$m)

PBT*
(A$m)

EPS*
(A$)

DPS
(A$)

P/E
(x)

Yield
(%)

06/21

2.0

(3.3)

(0.002)

0.0

N/A

N/A

06/22

3.6

(7.9)

(0.005)

0.0

N/A

N/A

06/23e

4.0

(9.4)

(0.005)

0.0

N/A

N/A

06/24e

4.1

(37.6)

(0.021)

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.

XanaMIA Phase IIb expected to start imminently

We believe market participants will be keen to observe whether the Phase IIb portion of XanaMIA will confirm the positive AD efficacy findings shown by Xanamem in a subset biomarker analysis from the earlier XanADu study. We expect top-line results in late CY24 or H1 CY25, which if positive may lead to material out-licensing or value realisation opportunities given the significant unmet need in AD, the drug’s favourable safety profile demonstrated to date and its convenient oral dosing form. In the nearer term, data are expected in around six to 12 months from the six-week XanaCIDD proof-of-concept study in patients with persistent MDD and CI. As Xanamem targets excess brain cortisol, and given the benefits shown in healthy adults in earlier studies (XanaHES and the Phase Ib portion of XanaMIA), we believe it is plausible for cognitive benefits to also be shown in the MDD population.

Funding to be a key focus as trials progress

Actinogen reported an operating cash burn of A$2.2m in Q323 (broadly in line when annualised with our unchanged FY23e A$8.5m estimate) and had a cash balance of A$12.3m at 31 March. We believe the company remains funded into Q4 CY23 (Q224) and continue to model it will raise A$60m before end-FY24 given the expected rise in expenses once the AD study commences.

Valuation: Maintaining forecasts

Our forecasts are unchanged (please see our prior note for details) and our total equity valuation remains A$702m, or A$0.39 per share. While the total funding requirements to bring an AD drug to market are substantial, we believe Actinogen will seek non-dilutive funding and/or partnership arrangements, which may reduce the overall funding need, but such scenarios are not included in our base case forecasts.

Exhibit 1: Financial summary

A$(000)

2020

2021

2022

2023e

2024e

Year end 30 June

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

3,516

1,984

3,640

4,004

4,086

Cost of Sales

0

0

0

0

0

Gross Profit

3,516

1,984

3,640

4,004

4,086

Sales, General & Administrative

(2,962)

(3,111)

(4,558)

(4,999)

(4,337)

Net Research & Development

(5,537)

(2,406)

(8,215)

(9,394)

(36,364)

EBITDA

 

 

(4,983)

(3,533)

(9,133)

(10,389)

(36,614)

Amortisation of intangible assets

(314)

(313)

(313)

(313)

(313)

Depreciation & other

(99)

(74)

(88)

(93)

(279)

Normalised Operating Profit (ex. amort, SBC, except.)

(4,888)

(3,318)

(7,933)

(9,614)

(36,894)

Operating profit before exceptionals

(5,396)

(3,920)

(9,533)

(10,795)

(37,206)

Exceptionals including asset impairment

0

0

0

0

0

Other

(194)

(289)

(1,288)

(869)

0

Reported Operating Profit

(5,590)

(4,209)

(10,821)

(11,664)

(37,206)

Net Finance income (costs)

65

5

36

261

(736)

Profit Before Tax (norm)

 

 

(4,822)

(3,313)

(7,897)

(9,353)

(37,629)

Profit Before Tax (FRS 3)

 

 

(5,331)

(3,915)

(9,497)

(10,534)

(37,942)

Tax

0

0

0

0

0

Profit After Tax and minority interests (norm)

(4,822)

(3,313)

(7,897)

(9,353)

(37,629)

Profit After Tax and minority interests (FRS 3)

(5,331)

(3,915)

(9,497)

(10,534)

(37,942)

Average Basic Number of Shares Outstanding (m)

1,118.0

1,405.2

1,717.1

1,802.3

1,831.6

EPS - normalised (A$)

 

 

(0.004)

(0.002)

(0.005)

(0.005)

(0.021)

EPS - normalised and fully diluted (A$)

 

(0.004)

(0.002)

(0.005)

(0.005)

(0.021)

EPS - (IFRS) (A$)

 

 

(0.005)

(0.003)

(0.006)

(0.006)

(0.021)

Dividend per share (A$)

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

3,772

3,287

2,889

3,534

4,029

Intangible Assets

3,346

3,033

2,720

2,908

3,095

Tangible Assets

19

17

13

627

934

Investments in long-term financial assets

408

237

156

0

0

Current Assets

 

 

8,164

15,091

20,417

31,189

32,752

Short-term investments

0

0

0

0

0

Cash

5,040

13,457

16,370

27,556

29,119

Other

3,123

1,634

4,047

3,633

3,633

Current Liabilities

 

 

(744)

(755)

(1,480)

(1,708)

(1,708)

Creditors

(744)

(755)

(1,480)

(1,708)

(1,708)

Short term borrowings

0

0

0

0

0

Long Term Liabilities

 

 

(304)

(165)

(87)

(20,038)

(60,038)

Long term borrowings

0

0

0

(20,000)

(60,000)

Other long term liabilities

(304)

(165)

(87)

(38)

(38)

Net Assets

 

 

10,889

17,458

21,740

12,978

(24,964)

CASH FLOW STATEMENT

 

 

 

 

 

 

 

Operating Income

(5,590)

(4,209)

(10,821)

(11,664)

(37,206)

Movements in working capital

(3,591)

(1,513)

(3,143)

597

0

Net interest and financing income (expense)

65

5

36

261

(736)

Depreciation & other

99

74

88

93

279

Taxes and other adjustments

6,161

3,920

4,323

2,165

313

Net Cash Flows from Operations

 

(2,856)

(1,724)

(9,517)

(8,548)

(37,350)

Capex

(23)

(6)

(3)

(1,051)

(1,087)

Acquisitions/disposals

0

0

0

0

0

Interest received & other investing activities

0

0

0

0

0

Net Cash flows from Investing activities

 

(23)

(6)

(3)

(1,051)

(1,087)

Net proceeds from share issuances

0

10,195

12,491

903

0

Net movements in long-term debt

0

0

0

20,000

40,000

Dividends

0

0

0

0

0

Other financing activities

282

(84)

(71)

(39)

0

Net Cash flows from financing activities

282

10,111

12,420

20,864

40,000

Effects of FX on Cash & equivalents

0

0

49

(80)

0

Net Increase (Decrease) in Cash & equivalents

(2,596)

8,381

2,949

11,186

1,563

Cash & equivalents at beginning of period

7,637

5,040

13,422

16,370

27,556

Cash & equivalents at end of period

5,040

13,422

16,370

27,556

29,119

Closing net debt/(cash)

 

 

(5,448)

(13,694)

(16,527)

(7,556)

30,881

Lease debt

390

236

165

127

127

Closing net debt/(cash) inclusive of IFRS 16 lease debt

(5,058)

(13,458)

(16,361)

(7,429)

31,008

Free cash flow

(2,878)

(1,730)

(9,520)

(9,599)

(38,437)

Source: Actinogen Medical accounts, Edison Investment Research


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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.

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Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

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New Zealand

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United Kingdom

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London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

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London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

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: 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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