Advance notice ACW progress update and Q&A webinar
Released
Released
Announcement PDF
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
Advance notice for ACW progress update and Q&A webinar
Sydney, 23 October 2025. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to
announce that it will be holding a live webinar at 11am next Tuesday, 28 October 2025. CEO, Dr Steven
Gourlay, will outline the company's significant progress over recent months and discuss key upcoming
milestones. Other members of the leadership team, Andy Udell, Will Souter & Dr Dana Hilt, will join Dr Gourlay
for a live Q & A session.
Pre-register now for this event on Tuesday, 28 October at 11am (Sydney time), or register and join on
the day: https://actinogenmedical.zoom.us/webinar/register/WN_L_TOuTmaR4qYvYnXrNzfDQ
A recording of the webinar will be made available as soon as possible after the conclusion of the event on the
Company’s website and YouTube channel.
View this announcement on our InvestorHub: https://investors.actinogen.com.au/link/eW3Qje
ENDS
Investors Media
Dr. Steven Gourlay Michael Roberts George Hazim
CEO & Managing Director Investor Relations 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 is currently developing its lead compound, Xanamem, as a promising new therapy for Alzheimer’s Disease and
Depression and hopes to study Fragile X Syndrome and other neurological and psychiatric diseases in the future. Reducing
cortisol inside brain cells could have a positive impact in 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 unmet medical 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 220 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,
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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once daily, and its ability to slow progression of Alzheimer’s disease is assessed with a variety of endpoints. The primary
endpoint of 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. The trial will be fully enrolled by the end of 2025 with initial results from an
interim analysis in late January 2026 and final topline results in mid Q4 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 will evaluate safety and a limited number of
efficacy endpoints such as the CDR-SB. The trial will commence in Q1 2026 and be 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 antidepressant therapy, and effects on cognition and depression were assessed. Trial results were
reported in August 2024 and showed clinically and statistically significant benefits 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 assessment of depression severity). Cognition improved markedly and to a similar extent in both Xanamem and
placebo groups.
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, without affecting 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 video, 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 approximately 400 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 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 not historical facts; are
based on subjective estimates, assumptions and qualifications; and relate to circumstances and events that have not taken
place and may not take place. Such forward looking statements should be considered “at-risk statements” - not to be relied
upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business,
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
achievement or 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.
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