Options underwriting cleansing notice
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
1
Cleansing Notice – Options Underwriting
Sydney, 23 September 2026: Actinogen Medical ASX: ACW (“ACW” or “the Company”)
announced today that it has issued 26,315,700 fully paid ordinary shares at an issue price of $0.0375
in the Company representing the shortfall shares in respect of the ACWAO and ACWAP unlisted options
being issued to Forrest Capital Pty Limited (or its nominees) under the Underwriting Agreement
announced on 1 September 2026 (Shortfall Shares).
The Company gives this cleansing notice (Notice) under section 708A(5)(e) of the Corporations Act
2001 (Cth) (Corporations Act).
As at the date of this Notice the Company advises that:
(a) the Shortfall Shares were issued without disclosure to investors under Part 6D.2 of the
Corporations Act.
(b) the Company has complied with:
(i) the provisions of Chapter 2M of the Corporations Act as they apply to the Company;
and
(ii) sections 674 and 674A of the Corporations Act; and
(c) there is no information that is "excluded information" within the meaning of sections 708A(7)
and (8) of the Corporations Act.
The release of this announcement was authorised by the Board of the Company.
Yours faithfully
Peter Webse
Company Secretary
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
2
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. It has also conducted a phase 2 trial in patients with cognitive impairment and depression and may 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 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 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 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 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. 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, 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 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
Share your feedback
Discover