ACW September 2026 quarterly activity report & Appendix 4C
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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
1
ASX ANNOUNCEMENT
Actinogen September 2026 quarterly activity report and Appendix 4C
Sydney, 19 October 2026. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to
announce the release of its quarterly activity report and Appendix 4C for the three-month period ended 30
September 2026.
Highlights:
• Pivotal Alzheimer’s disease XanaMIA trial remains on track for topline final results in November this year
following the completion of the last patient visit in late September
• Strong ongoing enrolment in open-label extension (OLE) phase of the trial with 87% of main trial
participants choosing to immediately continue in the OLE where they receive active Xanamem® therapy
• Manuscript entitled “The role of cortisol in CNS disease - 11β-HSD1 inhibition as a potential new
therapeutic strategy for Alzheimer's disease and Major Depressive Disorder” accepted for on-line pre-
publication in the peer-review journal Clinical and Translational Neuroscience and can be accessed here:
https://www.preprints.org/manuscript/202610.1646/v1
• A successful Clinical Trials Science Forum webinar held in August entitled “The future of Alzheimer’s
disease treatment” featuring US Alzheimer’s expert Professor Marwan Sabbagh
• Exercise and underwriting of unlisted options during September provided an additional $5.3 million of
funding
• New patents granted covering Xanamem treatment for cognitively normal people in Australia and Israel
and manufacturing in China and Chile with patent expiry dates of 2040 and 2041 respectively
• September-end cash balance of $15.9m together with expected net proceeds of ~$6m from the accrued
R&D tax rebate provides a pro-forma cash balance of ~$21.9m, which gives the Company runway well
beyond XanaMIA trial final results to late CY2027 or into CY2028, assuming any new trials are substantially
funded via partnerships
• Up to $22.5m in additional funding may be received from listed option exercise (expiry dates May and
September 2027).1
Pivotal XanaMIA phase 2b/3 Alzheimer’s disease (AD) trial remains on track for topline results in
November following final participant visit
• The Company's pivotal XanaMIA phase 2b/3 Alzheimer's disease trial continued to progress during the
quarter, with treatment and follow-up activities proceeding as planned across participating clinical sites
until the last patient visit was completed in late September
• The trial remains on track to deliver topline final results in November this year
• The key focus ahead of the November trial results announcement is to finalise high-quality data from the
trial while planning streamlined pathways to the fastest possible regulatory approvals for Xanamem
• Preparations are underway for follow-on regulatory interactions and development activities that will allow
the Company to move confidently into the final pivotal trial of Xanamem in AD if XanaMIA topline results
are positive in November, most likely in partnership with one or more development partners.
®
Xanamem is a registered trademark of Actinogen Medical Limited
1
ASX listed option series ACWOD expires 31 May 2027 and series ACWOC expires 30 September 2027
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
2
XanaMIA AD trial open‑label extension advances
• Enrolment in the OLE phase of the XanaMIA Alzheimer's disease trial continued to advance strongly during
the September quarter. There are now 160 patients on treatment, with an 87% rollover rate for participants
completing the main trial and commencing the OLE.
• The OLE enables all current and former participants, who have completed the randomized phase of the
pivotal XanaMIA AD trial, the opportunity to receive active Xanamem 10 mg once daily for up to 25 months,
with no placebo control group
• This long-term extension is designed to provide access to active Xanamem therapy for all randomized trial
participants and gather extended safety data and observational information on key efficacy endpoints —
including CDR-SB,2 cognition, and activities of daily living
• Available data from the OLE phase will be reviewed at the same time as XanaMIA topline final results in
November.
Clinical Trials Science Forum on the future of Alzheimer’s disease treatment
• In mid-August the Company held another of its Clinical Trials Science Forum plain-English webinars. Chief
Commercial Officer, Andy Udell moderated a discussion on the future of Alzheimer's disease treatment
with Professor Marwan Sabbagh, an internationally recognized neurologist and Alzheimer's disease
specialist, along with the Company’s CMO Dr Dana Hilt and CEO, Dr Steven Gourlay
• The webinar provides 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 also explores 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 such as Xanamem.
• A recording of the webinar is available on the Company’s InvestorHub at https://tinyurl.com/yubcs5jr.
Commercial planning and partnering activities
• Presented a Xanamem poster describing the baseline and screening characteristics of the XanaMIA
pivotal trial and hosted an exhibit booth focussed on the unique nature of Xanamem’s cortisol control
mechanism at the Alzheimer’s Association International Conference (AAIC), a leading global forum for
Alzheimer’s research and clinical advances, increasing the program’s visibility among the international
scientific and clinical community
• Engaged with leading Alzheimer’s researchers and clinicians at AAIC to discuss Xanamem and
developments in the evolving treatment landscape, and continued discussions with key opinion leaders
and advisory board members to inform clinical and commercial planning
• Advanced partnering readiness ahead of the XanaMIA topline results and continued discussions with
potential global and regional commercialization partners regarding Xanamem’s development and
commercial opportunity.
New patent prosecution
• Continued national phase patent prosecution continued with the first grants received for new patents
covering 1) Xanamem treatment for cognitively normal people in Australia and Israel and 2) manufacturing
in China and Chile, with patent expiry dates of 2040 and 2041 respectively.
Presented at international and Australian conferences
• In early August, the Company’s CEO Dr Steven Gourlay provided an important corporate presentation
entitled Advancing Oral Xanamem in Alzheimer’s disease at the annual Bioshares Biotech Summit in
Queenstown, New Zealand. Dr Gourlay’s presentation highlighted the strong scientific rationale for
2
CDR-SB is the Clinical Dementia Rating Scale – Sum of Boxes
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
3
controlling cortisol in the brain with Xanamem in Alzheimer’s disease patients and the unique nature of
this mechanism of action
• In September, the Company’s CMO, Dr Dana Hilt, gave an academic oral presentation entitled Controlling
cortisol in CNS1 disease – Xanamem;® a selective 11β-HSD1 inhibitor as a potential new therapeutic for
neuropsychiatric diseases to the 6th International Conference on Cognitive and Behavioral Neurosciences
in Paris, France.
Finances – September cash position provides cash runway to late CY2027 or into CY2028
• September-end cash balance of $15.9 million together with expected net proceeds of ~$6 million from the
accrued R&D tax rebate provides a pro-forma cash balance of ~$21.9 million, which gives the Company
runway well beyond XanaMIA trial final results to late CY2027 or into CY2028, assuming any new trials
are substantially funded via partnerships
• Leading up to September 15 two tranches of unlisted options were partially exercised by holders and the
shortfall was underwritten, providing $5.3 million of funding in total
• As previously announced, the accrued R&D tax rebate is $10.8 million. After repaying loan funding
advanced against the R&D tax rebate, the Company anticipates net cash inflow of approximately $6 million
• In addition, up to $22.5 million may be received from listed option exercise in 2027 (expiry dates May and
September 2027)
• Operating expenditure of $6.2 million was incurred during the September quarter, with the majority of
spend associated with the XanaMIA clinical trial and with robust participation in the OLE phase of the trial.
With the trial rapidly approaching its conclusion and as final invoicing from vendors and sites close out
over the coming months, future quarterly cash burn related to the trial will begin to rapidly abate
• Consistent with ASX Listing Rule 4.7c.3, item 6 of the attached Appendix 4C of the cashflow report for the
quarter included payments to Related Parties of $0.34 million, comprising the salary and FY26 bonus for
the CEO/Managing Director, fees paid to Non-Executive Directors, and superannuation.
Actinogen CEO and MD, Dr Steven Gourlay said:
“Xanamem is a leading and unique oral therapy in late-stage clinical development for Alzheimer’s disease with
the potential to become a transformational treatment option for patients and their families living with this
devastating condition. Our current focus is to deliver high-quality pivotal trial results in November while at the
same time planning for the future activities and development partnerships needed to get Xanamem approved
as soon as possible by regulators around the world."
View this announcement on our InvestorHub: https://investors.actinogen.com.au/link/Pb6mGP
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 Board of Actinogen Medical Limited
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
4
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
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.
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
5
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.
Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
ACTINOGEN MEDICAL LIMITED
ABN Quarter ended (“current quarter”)
14 086 778 476 30 September 2026
Current
quarter
$A’000
Year to date
(3 months)
$A'000
1 Cash flows from operating activities
1.1 Receipts from customers - -
1.2 Payments for -
(a) research and development (4,332) (4,332)
(b) product manufacturing and operating costs -
(c) advertising and marketing -
(d) leased assets -
(e) staff costs (1,641) (1,641)
(f) administration and corporate costs (546) (546)
1.3 Dividends received (see note 3) -
1.4 Interest received 184 184
1.5 Interest and other costs of finance paid (7) (7)
1.6 Income taxes paid -
1.7 Government grants and tax incentives -
1.8 Other (working capital movements) 136 136
1.9 Net cash from / (used in) operating activities (6,206) (6,206)
2 Cash flows from investing activities
2.1 Payments to acquire or for:
(a) entities - -
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
2.2 Proceeds from disposal of: -
(a) entities - -
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
2.3 Cash flows from loans to other entities - -
2.4 Dividends received (see note 3) - -
2.5 Other (provide details if material) - -
2.6 Net cash from / (used in) investing activities - -
Consolidated statement of cash flows
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.
3 Cash flows from financing activities
3.1
Proceeds from issues of equity securities (excluding convertible
debt securities)
987 987
3.2 Proceeds from issue of convertible debt securities - -
3.3 Proceeds from exercise of options 4,566 4,566
3.4
Transaction costs related to issues of equity securities or
convertible debt securities
(217) (217)
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings - -
3.7 Transaction costs related to loans and borrowings - -
3.8 Dividends paid - -
3.9 Other (application for exercise of options not yet allotted) -
3.10 Net cash from / (used in) financing activities 5,336 5,336
4 Net increase / (decrease) in cash and cash equivalents for the period
4.1 Cash and cash equivalents at beginning of period 16,735 16,735
4.2 Net cash from / (used in) operating activities (item 1.9 above) (6,206) (6,206)
4.3 Net cash from / (used in) investing activities (item 2.6 above) - -
4.4 Net cash from / (used in) financing activities (item 3.10 above) 5,336 5,336
4.5 Effect of movement/adjustment in exchange rates on cash held - -
4.6 Cash and cash equivalents at end of period 15,865 15,865
5 Reconciliation of cash and cash equivalents
at the end of the quarter (as shown in the consolidated
statement of cash flows) to the related items in the accounts
5.1 Bank balances 5,365 2,735
5.2 Call deposits 10,500 14,000
5.3 Bank overdrafts - -
5.4 Other - -
5.5
Cash and cash equivalents at end of quarter (should equal item 4.6
above)
15,865 16,735
Current
quarter
$A’000
Previous
quarter
$A’000
6 Payments to related parties of the entity and their associates
Current
quarter
$A'000
6.1
Aggregate amount of payments to related parties and their
associates included in item 1
337
6.2
Aggregate amount of payments to related parties and their
associates included in item 2
-
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly
activity report must include a description of, and an explanation for,
such payments.
Payments relate to salaries & fees paid to Directors of the Company
during the quarter.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 3
+ See chapter 19 of the ASX Listing Rules for defined terms.
7 Financing facilities
Note: the term “facility’ includes all forms of financing arrangements
available to the entity.
Add notes as necessary for an understanding of the sources of finance
available to the entity.
7.1 Loan facilities 4,320 -
7.2 Credit standby arrangements - -
7.3 Other (please specify) - -
7.4 Total financing facilities 4,320 -
7.5 Unused financing facilities available at quarter end -
7.6
8 Estimated cash available for future operating activities $A’000
8.1 Net cash from / (used in) operating activities (item 1.9) (6,206)
8.2 Cash and cash equivalents at quarter end (item 4.6) 15,865
8.3 Unused finance facilities available at quarter end (item 7.5) -
8.4 Total available funding (item 8.2 + item 8.3) 15,865
8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) 2.56
Note: ifthe entity has reported positive net operating cash flows in item 1.9,
answer item 8.5 as “N/A”. Otherwise, a figure for the estimated quarters of
funding available must be included in item 8.5.
8.6
If item 8.5 is less than 2 quarters, please provide answers to
the following questions:
8.6.1 Does the entity expect that it will continue to have the
current level ofnet operating cash flows for the time being and,
ifnot, why not?
Answer:
8.6.2 Has the entity taken any steps, or does it propose to take
any steps, to raise further cash to fund its operations and, ifso,
what are those steps and how likely does it believe that they
will be successful?
Answer:
8.6.3 Does the entity expect to be able to continue its
operations and to meet its business objectives and, ifso, on
what basis?
Answer:
Note: where item 8.5 is less than 2 quarters, all ofquestions 8.6.1,
8.6.2 and 8.6.3 above must be answered.
Include in the box below a description of each facility above, including the lender, interest
rate, maturity date and whether it is secured or unsecured. If any additional financing
facilities have been entered into or are proposed to be entered into after quarter end,
include a note providing details of those facilities as well.
In an earlier quarter (31/3/26), the Company borrowed $4.32m in non-dilutive funding from
Endpoints Capital under a funding facility secured against the Company’s FY26 Research and
Development Tax Incentive ("RDTI"). The interest rate is 15.1% per annum and repayment is
the earlier of either: the date that the FY26 R&D Refund is received or the applicable maturity
date, this being 31 December 2026.
Total facility
amount at
quarter end
$A’000
Amount drawn
at quarter end
$A’000
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 4
+ See chapter 19 of the ASX Listing Rules for defined terms.
Compliance statement
1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.
2 This statement gives a true and fair view of the matters disclosed.
Date: 19 October 2026
Authorised by: By the Board
(Name of body or officer authorising release – see note 4)
Notes
1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity’s activities for
the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional
information over and above the minimum required under the Listing Rules is encouraged to do so.
2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of,
AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in accordance with other
accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.
3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the
accounting policy of the entity.
4. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has been
authorised for release to the market by a committee of your board of directors, you can insert here: “By the [name of board committee – eg
Audit and Risk Committee]”. If it has been authorised for release to the market by a disclosure committee, you can insert here: “By the
Disclosure Committee”.
5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with
recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and Recommendations, the board should
have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained,
that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their
opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively.
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