Actinogen receives $9.0 million R&D tax incentive rebate
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ASX ANNOUNCEMENT
Actinogen receives $9.0 million R&D tax incentive rebate
Sydney, 12 November 2024. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to
announce that it has received a research and development (R&D) tax incentive rebate of $9,034,351 from the
Australian Tax Office for the 2024 financial year.
The R&D tax incentive is an Australian federal government program under which companies receive cash
refunds for eligible research and development expenditure. It is an important source of funding for the
Company and when combined with funds on hand, provides cash runway to mid-2026 to enable full enrolment
of 220 participants in our Alzheimer’s phase 2b/3 clinical trial.
ENDS
Dr. Steven Gourlay
CEO & Managing Director
P: +61 2 8964 7401
E. steven.gourlay@actinogen.com.au
Investors
Media
Michael Roberts
Investor Relations
M: +61 423 866 231
George Hazim
Media & Public Affairs Australia
M: +61 417 516 262
E. michael.roberts@actinogen.com.au
E: georgehazim@mediaaffairs.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 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.
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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Current Clinical Trials
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).
The XanaMIA Phase 2b 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,
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. Initial results from an interim analysis of the first 100 participants are anticipated
in mid 2025 and final results mid 2026.
About Xanamem
Xanamem’s novel mechanism of action is to control the level of cortisol in the brain through the inhibition of the cortisol
synthesis enzyme, 11β-HSD1, without affecting production of cortisol by the adrenal glands. Xanamem is designed to get
into the brain after it is absorbed in the intestines upon swallowing.
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.
The Company has studied 11β-HSD1 inhibition by Xanamem in more than 380 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.
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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