For personal use only

ASX ANNOUNCEMENT

AGM Presentations

Sydney, 10 November 2021. Actinogen Medical ASX:ACW ("ACW" or "the Company") is pleased to

attach the Chair's Address and CEO's presentation to be presented at today's Annual General Meeting which will be held virtually commencing at 11.00 am (AEDT).

ENDS

Investors

Media

Dr. Steven Gourlay

Michael Roberts

Randal Killip

CEO & Managing Director

Investor Relations

Profile for Media

P: +61 2 8964 7401

P: +61 2 8964 7401

M: +61 425 714 159

E:steven.gourlay@actinogen.com.au

E:michael.roberts@actinogen.com.au

E:randal@profileformedia.com.au

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, reasoning, awareness and decision-making, and to a large extent, influence our personality.

We are currently developing our lead compound, Xanamem®, as a promising new therapy for Alzheimer's Disease, Fragile X Syndrome, 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 other diseases.

The Company has studied 11β-HSD1 inhibition by Xanamem in more than 250 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

Actinogen Medical Limited ACN 086 778 476

1

Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 +61 2 8964 7401 |actinogen.com.au

For personal use only

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 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.

Actinogen Medical Limited ACN 086 778 476

2

Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000

+61 2 8964 7401 | actinogen.com.au

For personal use only

10 November 2021

ACW 2021 AGM Chair's Address

On behalf of the Board of Directors and staff of Actinogen Medical Ltd, I welcome you to our 2021 Annual General Meeting. I am pleased to report that Actinogen has managed to do well through the 2021 financial year, despite the COVID-19 pandemic, which has challenged the resilience of the healthcare industry, in particular for Actinogen as restrictions have affected the progress of clinical development worldwide.

Fortunately, with limited impediment to our operating progress, we have successfully executed our clinical pipeline objectives and the future of the Company remains extremely bright.

While the pandemic has forced us to conduct this AGM as a virtual meeting, it is pleasing to see that we are well-placed to emerge from the pandemic environment in a strong commercial and operating position for 2022 and beyond, driven by our corporate strategy and underpinned by the support of our shareholders.

As a highlight for the year, in March, Dr. Steven Gourlay joined us as Chief Executive Officer and Managing Director, following three months acquainting himself with the Company as our Consultant Chief Medical Officer. Steve brings a wealth of experience in the clinical development of novel small-molecule therapies, with an accomplished record of advancing several molecules from the preclinical stage to Phase 3, then on to approval and commercialisation.

Since taking the role, Steve has been proactive in developing and setting the Company's strategy with the Board, as well as building our stellar team to help optimise Actinogen's clinical development pipeline. The Board is delighted by Steve's eagerness, commitment and immediate impact, whilst his appointment has met with shareholder enthusiasm and broader market approval. We look forward to seeing the Company continuing to grow and prosper under Steve's leadership.

I don't mind pointing out that under Steve's guidance, the Actinogen share price has risen more than five- fold. It greatly pleases me that, at last, the Company is trading well above all prices that it has raised funds at in its past.

Turning to the balance sheet, Actinogen remains in a strong financial position with $11.8 million in cash as at 30 September 2021, sufficient to fund our currently planned phase 2 clinical trials. We added a further $1.4 million in cash in mid-October through the receipt of an R&D tax incentive refund.

In the middle of the financial year, in order to advance our clinical development pipeline, we completed a capital raising program exceeding $10.9 million. The Board was extremely pleased with the support received from both new and current investors, which has helped strengthen our financial position and allows us to implement certain strategic priorities.

Actinogen Medical Limited ACN 086 778 476

1

Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 +61 2 8964 7401 |actinogen.com.au

For personal use only

On corporate governance matters, your Board continually seeks improvement in its governance and management oversight capability. During the past year, we conducted our periodic review of all activities and responsibilities, including the annual Board skills matrix to identify gaps and opportunities for improvement. In saying that:

  • We will continue to assess the skills suitable for the Board and when appropriate, make changes and or additions to its composition.
  • Subsequent to the end of the financial year we established an inaugural audit sub-committee to, among several responsibilities, monitor and review the integrity of the Company's financial reporting. In line with best practice corporate governance, the committee is comprised of independent non-executive directors, including committee chair Malcolm McComas. The new committee charter is available on our website along with other corporate governance policies including the main board charter.

I also would like to take this opportunity to express our sincere thanks to Dr Bill Ketelbey for his valued contribution and executive leadership as CEO and Managing Director of the Company during the six years to February 2021. We wish Bill health and success in the future.

In conclusion, I would like to thank our dedicated and diligent leadership team, staff, consultant advisors and business partner organisations, who all contribute to the Company's operational excellence and success.

I also wish to thank my fellow Board members for their ongoing commitment to Actinogen Medical.

Actinogen has just completed a very active, achievement-filled 2021 financial year. The Board is confident about the Company's prospects and capability to build on that success under the leadership of our new CEO and his team. We will continue to proactively manage and drive excellence in our operations, such that we execute the Company's strategic priorities, thus maximising value in the best interests of our shareholders. We will do this at the same time as providing hope for sufferers of conditions like Alzheimer's Disease and Fragile X Syndrome.

Lastly, I would like to thank all of our Actinogen shareholders for their ongoing support and we look forward to updating you on our further progress during the year.

Dr Geoff Brooke

Chair

ENDS

Investors

Media

Dr. Steven Gourlay

Michael Roberts

Randal Killip

CEO & Managing Director

Investor Relations

Profile for Media

P: +61 2 8964 7401

P: +61 2 8964 7401

M: +61 425 714 159

E:steven.gourlay@actinogen.com.au

E:michael.roberts@actinogen.com.au

E:randal@profileformedia.com.au

Announcement authorised by the Board of Directors of Actinogen Medical

Actinogen Medical Limited ACN 086 778 476

2

Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000

+61 2 8964 7401 | actinogen.com.au

For personal use only

About Actinogen Medical

Actinogen Medical (ASX:ACW) is an ASX-listed biotechnology company developing novel therapies for neurological diseases associated with dysregulated brain cortisol. The Company is currently developing its lead compound, Xanamem®, as a promising new therapy for Alzheimer's Disease, Fragile X Syndrome, and other potential neurological diseases. The cognitive dysfunction, behavioural abnormalities, and neuropsychological burden associated with these conditions is significantly 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 - the stress hormone - through the inhibition of the 11β-HSD1 enzyme in the brain. There is a strong association between persistent stress and the production of excess cortisol that leads to detrimental changes in the brain, affecting memory, cognitive function and behaviour and neuropsychological symptoms.

The Company has studied 11β-HSD1 inhibition by Xanamem in approximately 300 volunteers and patients, finding a statistically significant improvement in cognition over placebo in healthy, older volunteers. A series of Phase 2 studies in multiple indications will be conducted to further confirm and characterise Xanamem's efficacy and safety.

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 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.

Actinogen Medical Limited ACN 086 778 476

3

Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000

+61 2 8964 7401 | actinogen.com.au

This is an excerpt of the original content. To continue reading it, access the original document here.

Attachments

  • Original document
  • Permalink

Disclaimer

Actinogen Medical Ltd. published this content on 09 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 November 2021 23:04:16 UTC.