Actinogen Medical : Appendix 4D & Half-Year Financial Statements

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ASX ANNOUNCEMENT

ACW H1 FY2022 result - strong advances in clinical development pipeline

Sydney, 24 February 2022. Actinogen Medical ASX: ACW ("ACW" or "the Company") is pleased to announce the release of its financial report for the half year ended 31 December 2021.

Key Highlights

• Advanced the Xanamem® clinical development pipeline on multiple fronts:

1. Selected Major Depressive Disorder (MDD) as third indication for Xanamem based on strong scientific rationale. Planning underway for Phase 2 trial to commence in 2022, with headline results expected in CY2023

1. Received approval to proceed under a US FDA IND for Phase 2 XanaFX trial in adolescent and young adult patients

1. Expanded XanaFX trial to include sites in North America, added 5mg dose group and increased target enrolment from 50 to 75. Signed Letter of Intent and subsequent full work order with Worldwide Clinical Trials to operationalise the trial, which now spans four countries. Headline results expected in CY2023

1. Completed target enrolment of 105 patients for the XanaMIA Part A trial in Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD). Last patient visit completed February 2022 and expected results timeline narrowed from Q2 2022 to April 2022

• 1. Added a retrospective analysis of the effects of Xanamem on biomarkers of possible disease modification using stored samples from prior Phase 2 XanADu study in mild AD. Results expected in H2 2022 and, together with the XanaMIA Part A trial results expected in April 2022, will inform the design of the XanaMIA Part B trial and subsequent AD trials.
• Successfully completed a $13.3 million capital raising to fund expansion of the clinical development pipeline1 2
• Established two new Xanamem clinical advisory boards for FXS and Depression programs
• Filled key operational and technical positions to drive strategic initiatives including appointment of Chief Medical Officer in February 2022
• Xanamem is a registered trademark of Actinogen Medical Limited

1. Including the proposed $107,625 subscription to the placement by CEO Dr Steven Gourlay that is subject to shareholder approval.
2. Unless stated otherwise, all financial information relates to the half year ended 31 December 2021 and all financial data is quoted in Australian dollars.

Actinogen Medical Limited ACN 086 778 476

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Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 [phone] |actinogen.com.au

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• Finalised a clinical protocol for a strategic collaboration with Oxford University researchers to investigate the therapeutic potential for Xanamem to control the metabolic effects of excessive cortisol in a disease called Mild Autonomous Cortisol Secretion (MACS)
• Appointed leading global clinical research company Worldwide Clinical Trials to manage XanaFX Phase 2 clinical trial involving 75 participants in four countries
• Updated potential pharmaceutical industry partners on expanded clinical development pipeline and multiple near and medium-term milestones at international industry conferences in January 2022
• Strengthened the balance sheet - cash balance of A$22.2 million at 31 December 2021, including funds received from the capital raising.

The first half of the 2022 financial year marked significant advances in the execution of Actinogen's strategic action plan, which comprises three key elements:

• Operational excellence to deliver high-quality, timely data in 2022 and 2023
• Strengthening the team and developing strategic and expert partnerships
• Forward planning to optimise timelines to marketing approvals.

The Company continues to successfully execute its primary strategic priority of focusing on operational excellence in its clinical development program, which is designed to deliver timely and high-quality confirmation of clinical efficacy and safety in each of its disease programs. ACW is conducting its lead programs in AD and FXS under US IND oversight to ensure it adheres to a global standard of regulatory compliance for clinical development, non-clinical studies and manufacturing.

Dr Steven Gourlay, Actinogen CEO and MD, commented:

"The first half of the 2022 financial year marked significant advances in Actinogen's clinical development pipeline on multiple fronts. We selected Major Depressive Disorder (MDD) as our third disease indication for Xanamem and expanded the scope and size of our Phase 2 XanaFX trial for Fragile X Syndrome. We also completed target enrolment and patient visits for our XanaMIA Part A trial in Mild Cognitive Impairment due to Alzheimer's Disease, with results now expected in April 2022.

"Other achievements included successfully completing a $13 million capital raising to help support the expanded clinical pipeline, creating two new specialist clinical advisory boards led by world class experts in Fragile X Syndrome, Depression, and Cognition, and striking a strategic collaboration with researchers at Oxford University.

"We look forward to continuing this outstanding momentum through 2022 as we pursue our revolutionary therapy to help make a material difference to the quality of life for people and their families living with serious neurological conditions such as Alzheimer's Disease, Depression, and Fragile X Syndrome."

Statutory Financial Result

The statutory result for the first half of the 2022 financial year reflects the Company's ongoing investment in developing and advancing its lead molecule Xanamem for the treatment of Alzheimer's Disease, Fragile X Syndrome and Mild Depressive Disorder.

The net after-tax loss for the half year ended 31 December 2021 was $5,794,920 (2020: loss of $2,357,619).

The major expenditure item for the period was Research and Development costs of $3,747,128 (2020: $789,921) primarily relating to clinical trials.

Actinogen Medical Limited ACN 086 778 476

2

Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 [phone] |actinogen.com.au

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Financial Position

At 31 December 2021 the Company had a cash and cash equivalents balance of $22,228,524 (30 June 2021: $13,456,919), and Net Assets of $24,575,875 (30 June 2021: $17,458,081).

ENDS

	Investors	Media
Dr. Steven Gourlay	Michael Roberts	Randal Killip
CEO & Managing Director	Investor Relations	Profile for Media
P: [phone]	M: [phone]	M: [phone]
[e-mail]	[e-mail]	[e-mail]

Announcement authorised by the Board of Directors of Actinogen Medical

About Actinogen Medical

Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological diseases associated with dysregulated brain cortisol. There is a strong association between cortisol and detrimental changes in the brain, affecting cognitive function, harm to brain cells and long-term cognitive health.

Cognitive function means how a person understands, remembers and thinks clearly. Cognitive functions include memory, attention, reasoning, awareness and decision-making.

We are currently developing our lead compound, Xanamem®, as a promising new therapy for Alzheimer's Disease, Fragile X Syndrome, Depression and other neurological diseases where reducing cortisol inside brain cells could have a positive impact. The cognitive dysfunction, behavioural abnormalities, and neuropsychological burden associated with these conditions is debilitating for patients, and there is a substantial unmet medical need for new and improved treatments.

About Xanamem®

Xanamem's novel mechanism of action works by blocking the production of intracellular cortisol through the inhibition of the 11β-HSD1 enzyme in the brain. Xanamem is designed to get into the brain after it is absorbed in the intestines upon swallowing its capsule.

Chronically elevated cortisol is associated with cognitive decline in Alzheimer's Disease, potentially linked to cognitive impairment and anxiety in Fragile X Syndrome, and cognitive impairment in Depression and other diseases.

The Company has studied 11β-HSD1 inhibition by Xanamem in more than 300 volunteers and patients, so far finding a statistically significant improvement in cognition over placebo in healthy, older volunteers. A series of Phase 2 studies in multiple diseases is being conducted to further confirm and characterise Xanamem's therapeutic potential.

Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority. Xanamem® is a trademark of Actinogen Medical.

Disclaimer

This announcement and attachments may contain certain forward-looking statements that are based on subjective estimates and assumptions and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements involve known and unknown risks, uncertainties, and other factors (such as significant business, economic and competitive uncertainties and contingencies, and regulatory and clinical development risks and uncertainties) which may cause the actual results or the performance of Actinogen Medical to be materially different from the results or performance expressed or implied by such forward looking statements. Past performance is not a reliable indicator of future performance. There can be no assurance that any forward-looking statements will be realised. Actinogen

Actinogen Medical Limited ACN 086 778 476

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Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 [phone] |actinogen.com.au

Medical does not make any representation or give any warranty as to the likelihood of achievement or reasonableness of any forward-looking statements.

ACTINOGEN MEDICAL ENCOURAGES ALL CURRENT INVESTORS TO GO PAPERLESS BY REGISTERING THEIR DETAILS WITH THE DESIGNATED REGISTRY SERVICE PROVIDER, AUTOMIC GROUP.

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Actinogen Medical Limited ACN 086 778 476

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Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 [phone] |actinogen.com.au

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Appendix 4D

Half-Year Financial Report

Name of entity:

ACTINOGEN MEDICAL LIMITED

ABN or equivalent company reference:

14 086 778 476

Current Period:

1 July 2021 to 31 December 2021

(Previous corresponding period: 1 July 2020 to 31 December 2020)

RESULTS FOR ANNOUNCEMENT TO THE MARKET

	31/12/2021		31/12/2020		Change	Amount change
	$		$	$	$
Revenue from ordinary activities	14,872		16,313		-9%		(1,441)
Loss from ordinary activities after tax
attributable to members	5,794,920		2,357,619		59%		3,437,301
Net loss for the period attributable to
members	5,794,920		2,357,619	59%		3,437,301
Net tangible asset per share	0.012		0.008

BRIEF EXPLANATION OF THE ABOVE FIGURES

Revenues from ordinary activities relates to interest revenue from cash held in interest-bearing accounts and short-term deposits.

The total net loss after tax increased due primarily to an increase in Research & Development expenditure. Refer to the attached Directors' Report and financial statements for further information.

Details of entities over which control has been gained or lost during the period

Not applicable. There has been no entity over which control has been gained or lost during the period.

Dividend / Distribution Payments or Reinvestment Plans

Not applicable. No dividends have been paid or declared during the half year ended 31 December 2021, in the previous financial year ended 30 June 2021 or in the previous corresponding period. The Company does not propose to pay dividends in the immediate future.

Associates / Joint Ventures

Not applicable. The Company has not engaged in the acquisition of associates nor has it engaged in any joint ventures in the half year ended 31 December 2021.

Foreign Entities

Not applicable.

Review Conclusion

This Report is based on the Interim Financial Report for the half year ended 31 December 2021. The financial report has been subject to a review by an independent auditor and the review is not subject to qualification.

Dr Steven Gourlay

Managing Director

Date: 24 February 2022

Sydney, New South Wales