ACW December 2025 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 December 2025 quarterly activity report and Appendix 4C
Sydney, 30 January 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 31
December 2025.
Highlights and key events:
Pivotal XanaMIA phase 2b/3 Alzheimer’s disease (AD) trial – final, 247th participant randomized in
December 2025 and positive Interim Analysis outcome January 2026. Topline final results in November
2026
• The pivotal XanaMIA phase 2b/3 AD trial enrolled 247 participants (original target 220) with elevated levels
of the blood biomarker pTau181, designed to identify participants with biomarker-positive AD whose
disease is likely to progress during the 36-week treatment period of the trial, and therefore augment the
ability to detect a Xanamem® (emestedastat) treatment benefit
• The XanaMIA AD trial’s independent Data Monitoring Committee (DMC)1 has recommended that the trial
continue without amendment after its interim analysis. In doing so, the DMC determined that the unblinded
safety and efficacy data it reviewed support continuing the trial to its completion later in the year
• Previously, the Company announced in November a positiverecommendation from the first meeting of the
independent DMC overseeing the trial which reviewed all available safety data from 153 XanaMIA trial
participants to that date and concluded that the trial should continue without amendment2
• Trial topline final results are expected in November 2026.
The XanaMIA AD trial open label extension (OLE) phase to commence this quarter (Q1 2026)
• An open-label phase of up to 25 months treatment where all participants will receive active Xanamem 10
mg once daily and no placebo control group is used
• Open to all former and current participants in the XanaMIA phase 2b/3 AD trial
• Provides longer term safety data for at least 12 months and observational data on key efficacy endpoints
such as the CDR-SB, cognition and activities of daily living.
Other key activities
The Company continues to progress an important range of initiatives appropriate to late-stage clinical
development. These include:
• Manufacturing – completed manufacturing of drug product (10mg Xanamem tablets) at Catalent in the
US intended for the OLE phase of the XanaMIA AD trial
®
Xanamem is a registered trademark of Actinogen Medical Limited
1
The DMC comprisesindependent clinicaland statistical experts who are not connected to the day-to-day conduct or analysis of the
trial
2
Efficacy of Xanamem was not evaluated at the first meeting
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
• Commercial planning – the Company’s Chief Commercial Officer, Mr. Andy Udell, continues to refine the
Company’s communication materials to support a stronger presence at key AD scientific and business
meetings, and has further advanced commercial communication materials including the findings from the
Company’s independent market research. During the quarter, the Company convened its first Alzheimer’s
Disease Clinical Advisory Committee, expanding engagement with key thought leaders through a globally
representative group of nine experts to inform ongoing clinical and commercial planning
• Partnering – dialoguecontinues with multiple parties spanning potential regional and/or global partnership
arrangements, with an emphasis on those regional organizations that are interested in a breakthrough AD
product. Several of those parties are active in the Company’s dataroom. With the positive formal Interim
Analysis outcome and rapidly approaching final results, increased engagement with global and regional
partners is anticipated
• Intellectual property (IP) protection from future generic competition – the Company continues to
prosecute national phase patent applications for multiple new patents, designed to strengthen and extend
IP protection for Xanamem beyond that afforded by earlier patents and the data exclusivity laws that apply
to novel medicines
• Other ancillary studies – preparations continue for an open-label extension (OLE) trial to allow all
participants in the XanaMIA trial access to longer-term active Xanamem therapy. This trial is due to
commence in the current quarter (Q1) 2026.
Presented at international and Australian conferences and conducted investment and partnering
meetings:
• On 21 October 2025, CEO Dr Steven Gourlay presented a short review to analysts and investors at the
Canaccord Drug & Device Conference and conducted a number of small group meetings
• During the week commencing 3 November 2025, Dr Gourlay and Chief Commercial Officer, Mr Andy Udell
attended Europe’s largest partnering event, the BIO3 Europe partnering conference in Vienna Austria.
During the event, Dr Gourlay and Mr Udell engaged with international investors and potential biopharma
partners throughout the conference to discuss Actinogen’s late-stage AD clinical trial program and the
enormous market potential for Xanamem
• On 19 November 2025, Dr Gourlay and Chief Financial Officer, Mr Will Souter presented at the Bell Potter
Healthcare conference. The Company’s presentation was titled Oral Xanamem®: Controlling brain cortisol
to slow progression in Alzheimer’s disease and treat depression
• Earlier in January, Dr Steven Gourlay was joined by Andy Udell, Will Souter and Chief Medical Officer, Dr
Dana Hilt at the Sachs Associates 9th Annual Neuroscience Innovation Forum in San Francisco. While in
San Francisco, the team also participated in a significant number of partnering, analyst and investor
meetings associated with the 44th Annual J.P. Morgan Healthcare Conference, known as JPM Week.
Actinogen CEO and MD, Dr Steven Gourlay said:
“The December quarter of 2025 was significant for the achievement of early closing of recruitment in our pivotal
XanaMIA Alzheimer’s trial due to accelerated participant enrolment during the second half of the year, and
higher enrolment than originally anticipated.”
“The new year heralds further key late-stage milestones for Actinogen in our differentiated Alzheimer’s
program. These include the announcement today of the positive outcome of the interim analysis for the
XanaMIA trial conducted by an independent Data Monitoring Committee; the expected receipt of scientific
3
The BiotechnologyInnovation Organization (BIO) isthe world’s largest advocacyassociation for biotechnology and the producerof the
convention.
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
advice from the European Medicines Agency on Xanamem® development plans in Alzheimer’s in the second
quarter; and the topline final results of the XanaMIA trial due in November.”
“Positive XanaMIA results will position Xanamem as unique and differentiated – the first oral therapy to
convincingly slow or stabilize Alzheimer’s decline.”
Financial position
The Company incurred operating expenditure of $6.5m during the December quarter as the XanaMIA clinical
trial activity continued at a rapid pace with all 35 sites actively recruiting, culminating in the randomization and
treatment of the final, 247th trial participant on 17 December 2025.
On 15 October2025, the Company received a research and development tax incentive (RDTI) rebate of $5.5m
from the Australian Tax Office(ATO) forthe 2025 financial year. After repaying a $3.2m loan (including interest)
received on 30 June 2025 from Endpoints Capital secured against the FY25 RDTI, the net cash inflow was
$2.3m.
The Company is currently awaiting receipt from the ATO of a further RDTI rebate of $1.9m relating to an
approved Advanced Overseas Finding application for the 2025 financial year.
On 27 January 2026, the Company announced that it had further strengthened its balance sheet through the
receipt of a second tranche of non-dilutive funding from Endpoints Capital for $4.3m secured against the
Company’s forecast FY26 RDTI rebate.
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 $0.2m, comprising the salary for the CEO/Managing Director,
fees paid to Non-Executive Directors, and superannuation.
View this announcement on our InvestorHub: https://investors.actinogen.com.au/link/epJ69P
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 Board 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. 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.
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
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,
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. The trial is now closed to recruitment, with final topline results 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 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 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.
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 approximately 400 volunteers and patients in eightclinical
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,
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
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
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.
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 31 December 2025
Current
quarter
$A’000
Year to date
(6 months)
$A'000
1 Cash flows from operating activities
1.1 Receipts from customers - -
1.2 Payments for -
(a) research and development (5,125) (9,434)
(b) product manufacturing and operating costs -
(c) advertising and marketing -
(d) leased assets -
(e) staff costs (1,001) (2,612)
(f) administration and corporate costs (484) (1,092)
1.3 Dividends received (see note 3) -
1.4 Interest received 106 233
1.5 Interest and other costs of finance paid (8) (15)
1.6 Income taxes paid -
1.7 Government grants and tax incentives -
1.8 Other (working capital movements) (30) 278
1.9 Net cash from / (used in) operating activities (6,542) (12,642)
2 Cash flows from investing activities
2.1 Payments to acquire or for:
(a) entities - -
(b) businesses - -
(c) property, plant and equipment - (3)
(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) 5,490 5,490
2.6 Net cash from / (used in) investing activities 5,490 5,487
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)
- -
3.2 Proceeds from issue of convertible debt securities - -
3.3 Proceeds from exercise of options 319 331
3.4
Transaction costs related to issues of equity securities or
convertible debt securities
- -
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings - -
3.7
Transaction costs related to loans and borrowings
(repayment of RDTI Loan)
(3,149) (3,149)
3.8 Dividends paid - -
3.9 Other (application for exercise of options not yet allotted) -
3.10 Net cash from / (used in) financing activities (2,830) (2,818)
4 Net increase / (decrease) in cash and cash equivalents for the period
4.1 Cash and cash equivalents at beginning of period 10,413 16,504
4.2 Net cash from / (used in) operating activities (item 1.9 above) (6,542) (12,642)
4.3 Net cash from / (used in) investing activities (item 2.6 above) 5,490 5,487
4.4 Net cash from / (used in) financing activities (item 3.10 above) (2,830) (2,818)
4.5 Effect of movement/adjustment in exchange rates on cash held - -
4.6 Cash and cash equivalents at end of period 6,531 6,531
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 2,531 3,113
5.2 Call deposits 4,000 7,300
5.3 Bank overdrafts - -
5.4 Other - -
5.5
Cash and cash equivalents at end of quarter (should equal item 4.6
above)
6,531 10,413
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
204
6.2
Aggregate amount of payments to related parties and their
associates included in item 2
0
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.
Current
quarter
$A’000
Previous
quarter
$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 3
+ See chapter 19 of the ASX Listing Rules for defined terms.
8
Estimated cash available for future operating
activities
$A’000
8.1 Net cash from / (used in) operating activities (item 1.9) (6,542)
8.2 Cash and cash equivalents at quarter end (item 4.6) 6,531
8.3
Unused finance facilities available at quarter end
(item 7.5)
-
8.4 Total available funding (item 8.2 + item 8.3) 6,531
8.5
Estimated quarters of funding available (item 8.4
divided by item 8.1)
1.00
Note: if the 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 of net operating cash flows for the
time being and, if not, why not?
Answer: Yes, the Company will have
current level of cash flows similar to the December
2025 quarter and anticipates being able to fund these
as described below.
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, if so, what are those steps and how likely
does it believe that they will be successful?
Answer: Post-quarter end, the Company
has received $4.3m in loan funding from Endpoints
Capital secured against its FY26 RDTI and is expected to
receive a further $1.9M of RDTI rebate related to
eligible R&D expenditure incurred in FY25. The
Company also has access to other sources of capital
through the ongoing conversion of outstanding
options, potential partnership transactions, further
R&D loan funding or further equity raising.
8.6.3 Does the entity expect to be able to
continue its operations and to meet its business objectives
and, if so, on what basis?
Answer: Yes, the Company has access to
funding as described above.
Note: where item 8.5 is less than 2 quarters, all of
questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
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 - -
7.2 Credit standby arrangements - -
7.3 Other (please specify) - -
7.4 Total financing facilities - -
7.5 Unused financing facilities available at quarter end -
7.6
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.
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: 30 January 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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