ACW webinar today, The future of Alzheimers treatment
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Released
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Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
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ASX ANNOUNCEMENT
ACW Clinical Trials Science Forum webinar today – The future of Alzheimer’s disease
treatment
Sydney, 12 August 2026. Actinogen Medical ASX: ACW (“ACW” or “the Company”) will host a live
Clinical Trials Science Forum webinar at 11am (AEST) today.
After an introduction by the Company’s CEO, Dr Steven Gourlay, Chief Commercial Officer, Andy Udell, will
moderate a discussion on the future of Alzheimer's disease treatment with:
• Prof. Marwan Sabbagh, internationally recognized neurologist and Alzheimer's disease specialist
• Dr. Dana Hilt, Chief Medical Officer, Actinogen Medical.
The webinar is intended to provide investors and other stakeholders with expert clinical perspectives on how
Alzheimer's diagnosis and treatment are evolving, and what those changes could mean for future therapeutic
approaches. The conversation will explore the rapidly evolving Alzheimer's treatment landscape, real-world
experience with anti-amyloid therapies, the potential impact of blood-based biomarkers, and what physicians
seek in next-generation Alzheimer’s therapies.
Register any time this morning through to the 11am start at: https://tinyurl.com/yubcs5jr
A recording of the webinar will be available on the Company’s website and YouTube channel following the
event.
A copy of the webinar presentation is attached to this announcement.
View this announcement on our InvestorHub: https://investors.actinogen.com.au/link/P3xxBy
ENDS
Investors Media
Dr Steven Gourlay Michael Roberts George Hazim
CEO & Managing Director Communications Media & Public Affairs Australia
P: +61 2 8964 7401 M: +61 423 866 231 M: +61 417 516 262
E. steven.gourlay@actinogen.com.au E. michael.roberts@actinogen.com.au E: georgehazim@mediaaffairs.com.au
Announcement authorised by the Disclosure Committee of Actinogen Medical Limited
About Actinogen Medical
Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological and
neuropsychiatric 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.
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
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Actinogen is currently developing its lead compound, Xanamem, as a promising new therapy for Alzheimer’s Disease. It
has also conducted a phase 2 trial in patients with cognitive impairmentand depression andmay study Fragile X Syndrome
and other neurological and psychiatric diseases in the future. Reducing cortisol inside brain cells could have a positive
impactin these and many other diseases.The cognitive dysfunction,behavioural abnormalities,and neuropsychological
burden associated with these conditions is debilitating for patients,and there is a substantial unmetmedical need for new
and improved treatments.
Clinical Trials
The XanaMIA Phase 2b/3 Alzheimer’s disease trial is a double-blind, 36-week treatment, placebo-controlled, parallel
group design trial in 247 patients with mild to moderate AD and progressive disease, determined by clinical criteria and
confirmed by an elevated level of the pTau181 protein biomarker in blood.Patients receive Xanamem 10 mg or placebo,
once daily,and its ability to slow progression of Alzheimer’s disease is assessed with a variety of endpoints.The primary
endpointof the trial is the internationally-recognized CDR-SB (Clinical Dementia Rating scale – Sum of Boxes). The trial
is being conducted in Australia and the US and is now closed to participant recruitment. It has passed an independent
Data Monitoring Committee safety and efficacy futility review and final topline results are expected in November 2026.
The XanaMIA-OLE Alzheimer’s disease open-label extension is an open-label phase of up to 25 months treatment
where all participants will receive active Xanamem 10 mg once daily. The trial evaluates safety and a limited number of
efficacy endpoints such as the CDR-SB. The trial commenced in March 2026 and is open to all former and current
participants in the XanaMIA Phase 2b/3 trial.
The XanaCIDD Phase 2a depression trial was a double-blind, six-week proof-of-concept, placebo-controlled, parallel
group design trial in 167 patients with moderate, treatment-resistant depression and a degree of baseline cognitive
impairment. Participants were evenly randomized to receive Xanamem 10 mg once daily or placebo, in most cases in
addition to their existing antidepressanttherapy,and effects on cognition and depressionwere assessed.Trial results were
reported in August 2024 and showed clinically and statistically significantbenefits on depression symptoms with positive
effects on the MADRS scale (a validated scale of depression symptom measurement) and the PGI-S (a valid patient
reported assessmentof depression severity). Cognition improved markedly and to a similar extent in both Xanamem and
placebo groups. The peer-reviewed publication relating to this trial can be accessed for free via this link:
https://tinyurl.com/ckm63z63.
About Xanamem (emestedastat)
Xanamem’s novel mechanism is to control elevated levels of cortisol (aka the “stress hormone”) in the brain through the
inhibition of the cortisol synthesis enzyme,11β-HSD1,withoutaffecting production of cortisol by the adrenal glands which
is essential for the body’s normal functioning.Xanamem is a first-in-class,once-a-day pill designed to deliver high levels
of cortisol control in key areas of the brain related to Alzheimer’s and other diseases such as the hippocampus and frontal
cortex. To view Xanamem’s two-minute Mechanism of Action animation, click here.
Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be
toxic to brain cells. Cortisol itself is also associated with depressive symptoms and when targeted via other mechanisms
has shown some promise in prior clinical trials. The recent XanaCIDD trial demonstrated clinically and sometimes
statistically significant benefits on depressive symptoms, further validating the cortisol control mechanism for the
Xanamem 10 mg oral daily dose.
The Company has studied 11β-HSD1 inhibition by Xanamem in more than 500 volunteers and patients in eight clinical
trials. Xanamem has a promising safety profile and has demonstrated clinical activity in patients with depression,patients
with biomarker-positive Alzheimer’s disease and cognitively normal volunteers. High levels of target engagement in the
brain with doses as low as 5 mg daily have been demonstrated in a human PET imaging study.
Xanamem is an investigational productand 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 not historical facts; are
based on subjective estimates,assumptions andqualifications;and relate to circumstances and events thathave nottaken
place and may nottake place.Such forward looking statements should be considered “at-risk statements” - notto be relied
upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business,
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
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economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes
and uncertainties) that may lead to actual results being materially different from any forward looking statement or the
performance expressed or implied by such forward looking statements.You are cautioned not to place undue reliance on
these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any
obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to
reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future
performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of
achievementor reasonableness of any forward-looking statements and there can be no assurance or guarantee that any
forward-looking statements will be realised.
ACTINOGEN MEDICAL ENCOURAGES ALL CURRENT INVESTORS TO GO PAPERLESS BY REGISTERING THEIR DETAILS
WITH THE DESIGNATED REGISTRY SERVICE PROVIDER, AUTOMIC GROUP.
Disclaimer
This presentation has been prepared by Actinogen Medical Limited. (“Actinogen” or the “Company”) based on information available to it as at the date of this presentation. The information in this presentation is provided in summary form
and does not contain all information necessary to make an investment decision.
This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in Actinogen, nor does it constitute financial product advice or take into account any individual’s
investment objectives, taxation situation, financial situation or needs. An investor must not act on the basis of any matter contained in this presentation but must make its own assessment of Actinogen and conduct its own investigations.
Before making an investment decision, investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs, and seek legal, taxation and financial advice appropriate to
their jurisdiction and circumstances. Actinogen is not licensed to provide financial product advice in respect of its securities or any other financial products. Cooling off rights do not apply to the acquisition of Actinogen securities.
Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation or warranty, express or implied, is made as to the
fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, none of Actinogen its officers, directors, employees and agents, nor
any other person, accepts any responsibility and liability for the content of this presentation including, without limitation, any liability arising from fault or negligence, for any loss arising from the use of or reliance on any of the information
contained in this presentation or otherwise arising in connection with it.
The information presented in this presentation is subject to change without notice and Actinogen does not have any responsibility or obligation to inform you of any matter arising or coming to their notice, after the date of this
presentation, which may affect any matter referred to in this presentation.
This presentation is not for general distribution or third party reliance or use.
This presentation contains certain budget information, forecasts and forward looking statements that are based on the Company’s management’s beliefs, assumptions and expectations and on information currently available to
management in respect of which there is NO guarantee of future performance. Such budget information, forecasts and forward looking statements involve known and unknown risks, uncertainties, and other factors which may cause the
actual results or performance of Actinogen to be materially different from the results or performance expressed or implied by such forward looking statements. These risks and uncertainties include, but are not limited to the performance
of Actinogen in its clinical trials including whether it's technology proves to be a safe and effective treatment, market penetration, competition from any other similar products, intellectual property risks (including securing rights in
technology and patents) and global economic conditions. Furthermore, Actinogen's research, product development, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign
government regulatory authorities. There is no guarantee that Actinogen will obtain the required approvals, licences and registrations from the relevant authorities in jurisdictions in which it operates. Actinogen or others could identify
product and efficacy issues relating to the safety of our technology. Accordingly, all forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the political and
economic environment in which Actinogen will operate in the future, which are subject to change without notice. Past performance is not necessarily a guide to future performance and no representation or warranty is made as to the
likelihood of achievement or reasonableness of any forward looking statements or other forecast. There is no guarantee that Actinogen will achieve its stated objectives/milestones, that any of its forecasts will be met or that forward
looking statements will be realised. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-
looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
Neither Actinogen nor any other entity or person in or associated with Actinogen guarantee any return (whether capital or income) or generally the performance of Actinogen or the price at which its securities may trade. Any investment
in Actinogen is subject to investment risks including the possibility of loss of capital invested and no return of income or payment of any dividends.
To the maximum extent permitted at law, Actinogen and all of its representatives, directors, officers, partners, employees or professional advisers (Parties) exclude all direct and indirect liability arising out of or in connection with any use
or reliance of the information contained or described within this presentation. Other than to the extent required by law (and only to that extent), the Parties do not make any representation or give any assurance, guarantee or warranty
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presentation or any accompanying, previous or subsequent material or presentation.
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Alzheimer’s is personal
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Clinical Trials Science Forum August 2026
A disease that touches millions of patients, families and caregivers around the world
Alzheimer’s is one of healthcare’s greatest
challenges in the western world
• 57 million people worldwide were living with dementia in 2021
• Alzheimer’s disease accounts for 60-70% of all dementia cases
• Nearly 10 million new cases of dementia occur each year
• 139 million people are projected to be living with dementia by 2050
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Clinical Trials Science Forum August 2026
The growing global burden reinforces the need for
continued innovation in Alzheimer’s disease
A new era in Alzheimer’s disease has dawned
• Disease-modifying therapies have begun to reshape the treatment landscape
• Blood-based biomarkers have the potential to simplify the diagnosis and
identify patients earlier
• Scientific understanding continues to expand across multiple biological
pathways
• Earlier diagnosis and new treatment approaches may improve care for more
patients
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Clinical Trials Science Forum August 2026
Progress has begun, but the need for ongoing
innovation remains
Amyloid is a likely just a small part of the story ...
Recent advances have provided hope for some Alzheimer’s patients…
… but significant challenges remain:
• Clinical benefit can be modest
• Current therapies are not appropriate for all patients
• Treatment and monitoring can be complex
• Alzheimer’s disease is biologically complex and likely requires multiple
therapeutic approaches.
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Clinical Trials Science Forum August 2026
New mechanistic approaches are needed to address the
diverse needs of patients living with Alzheimer’s disease
Neurologists expect the Alzheimer’s landscape to
continue evolving
• 91% agree there remains a high unmet need for additional
disease-modifying therapies
• 86% expect the treatment of Alzheimer’s disease to change over
the next five years
“We’re not going to be just treating patients with an amyloid remover, but
also anti-neuroinflammation, mitochondrial enhancers, synaptic
enhancers and so on… in order to actually stop or substantially slow the
progression of the disease.” --U.S. Neurologist
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Clinical Trials Science Forum August 2026
We are just at the beginning of the journey towards
understanding the biology of Alzheimer’s disease
What do neurologists value most in Alzheimer’s
therapies?
Neurologists consistently value therapies that offer:
• Meaningful clinical benefit i.e. slowing or halting disease progression
• A favorable safety and tolerability profile
• Simple, convenient administration
• Broader patient eligibility
• The potential to complement other therapies.
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Clinical Trials Science Forum August 2026
Future Alzheimer’s therapies will need to deliver meaningful
benefit while fitting seamlessly into clinical practice
Attributes neurologists value for an Alzheimer’s
therapy
Attributes valued by neurologists Xanamem profile
✓ Meaningful clinical benefit Encouraging Phase 2 clinical efficacy signals*
✓ Favorable safety and tolerability Generally well tolerated in clinical trials
✓ Convenient administration Once-daily oral tablet
✓ Simplicity of treatment No infusion or routine MRI monitoring required
✓ Potential to complement other
therapies
Novel mechanism targeting excess brain cortisol,
distinct from anti-amyloid therapies
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Clinical Trials Science Forum August 2026
*Based on phase 2 clinical trials. XanaMIA phase 2b/3 topline results anticipated in November 2026
Xanamem’s profile aligns with the characteristics neurologists consider
important for future Alzheimer’s therapies
A different approach to Alzheimer’s disease
Xanamem controls brain cortisol levels
Unlike therapies that target amyloid, Xanamem targets excess brain cortisol by
inhibiting the enzyme 11β-HSD1
Per extensive scientific literature, reducing excess brain cortisol has the potential to
influence several processes associated with Alzheimer’s disease, including:
• Cognition and memory
• Neuroinflammation
• Synaptic function
• Tau biology.
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Targeting excess brain cortisol represents a unique and promising
approach to Alzheimer’s disease
The next chapter begins with the XanaMIA trial
Pivotal, phase 2b/3 trial in 247 participants with mild-moderate disease
Topline results anticipated in November 2026
If successful, Xanamem has potential to:
• Expand therapeutic options for patients living with Alzheimer’s disease
• Further validate brain cortisol control as a therapeutic mechanism
• Contribute to the next generation of Alzheimer's disease treatment.
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XanaMIA represents an important milestone for patients, physicians,
caregivers, and the future of Alzheimer’s disease treatment
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Contacts
Will Souter
CFO & Investor Relations
M: +61 402 035 716
E. will.souter@actinogen.com.au
Steven Gourlay
CEO & Managing Director
P: +61 2 8964 7401
E. steven.gourlay@actinogen.com.au
Join the Actinogen Investor Hub:
https://investors.actinogen.com.au/
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