ACW Appendix 4E and 2025 annual report
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
Actinogen Appendix 4E and 2025 digital annual report
Sydney, 25 August 2025. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to
announce its financial results for the year ended 30 June 2025.
The Appendix 4E and 2025 digital annual report documents are attached.
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 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.
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
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 triggered by the 100th participant reaching
24 weeks of treatment are anticipated in January 2026 and final results Q4 2026.
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
The XanaMIA-DUR Alzheimer’s disease open-label extension trial is an open-label trial of up to 24 months 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 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 a first-in-class,
once-a-day pill designed to deliver high levels of cortisol control in the brain. 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.
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.
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
ACTINOGEN MEDICAL LIMITED
APPENDIX 4E
1. Company details
Name of entity
ACTINOGEN MEDICAL LIMITED
ABN or equivalent company reference
Financial year ended
(‘reporting period’)
Financial year ended
(‘previous corresponding period’)
14 086 778 476
30 June 2025
30 June 2024
2.
Results for announcement to the market
Revenue from ordinary activities
Loss from ordinary activities after
tax attributable to members
Net loss for the period attributable
to members
Net tangible asset per share (a)
30/06/2025
$
685,253
30/06/2024
$
291,021
Change
%
135%
Amount change
$
394,232
(14,732,263)
(13,044,282)
13%
(1,687,981)
(14,732,263)
(13,044,282)
13%
(1,687,981)
0.005
0.007
(a) Includes right-of-use asset
3.
Statement of comprehensive income
Refer to attached financial statements.
4.
Statement of financial position
Refer to attached financial statements.
5.
Statement of cash flows
Refer to attached financial statements.
6.
Statement of changes in equity
Refer to attached financial statements.
7.
Dividends/distributions
No dividends declared in current or prior year.
8.
Details of dividend reinvestment plan
Not applicable.
9.
Details of entities over which control has been gained or lost during the period
Not applicable.
10.
Details of associates and joint venture entities
Not applicable.
11.
Any other significant information needed by an investor to make an informed assessment of the Company’s financial
performance and financial position
Refer to attached financial statements.
12.
Foreign entities
Not applicable.
ACTINOGEN MEDICAL LIMITED
APPENDIX 4E
13.
Commentary on results and explanatory information
Actinogen Medical Limited (‘the Company’) incurred a net loss after tax for the financial year ended 30 June 2025 of $14,732,263 (2024:
$13,044,282)
Full year ended
30/06/2025
$
Full year ended
30/06/2024
$
685,253
5,489,600
6,174,853
291,021
9,931,504
10,222,525
Research & development costs
Employment costs
Corporate & administration costs
Finance costs
Realised (loss) / unrealised gain on foreign currency
Share-based payment expenses
Amortisation expense
Depreciation expense (right-of-use asset)
Depreciation expense (office equipment)
Total expenses
(12,296,568)
(4,434,666)
(2,026,706)
(48,890)
(14,381)
(1,663,705)
(312,746)
(80,964)
(28,490)
(20,907,116)
(15,535,482)
(4,195,292)
(1,732,305)
(24,292)
(55,189)
(1,307,416)
(313,602)
(82,179)
(21,050)
(23,266,807)
Loss before income tax
Income tax expense
(14,732,263)
-
(13,044,282)
-
Loss for the year
(14,732,263)
(13,044,282)
Interest revenue
Other income
Total revenue & other income
Significantly more interest income was earned in the year as the company maintained a higher cash balance throughout the year, and
carefully managed its cash on hand to maximise its earning potential. Research and development costs overall decreased due to the
completion and close-out of the XanaCIDD study, and as the Phase 2b/3 XanaMIA study ramped up later in the financial year. There was a
slight increase in employment costs as the company finalised recruitment of key team members during the year, and as a result of salary
increases. Corporate and administration costs increased with greater investment in media and communications, business development
and investor relations.
For further information, refer to the Directors’ Report and the Financial Statements.
14.
Audit
This report is based on accounts which have been audited.
Dr Steven Gourlay
Managing Director
Sydney, New South Wales
25 August 2025
Authorised for release by the Board of Directors.
Annual Report
2025
Actinogen is advancing a
revolutionary oral therapeutic,
Xanamem®, through pivotal
trials to transform treatment
for Alzheimer’s disease and
major depressive disorder.
Our vision is to improve lives
by targeting brain cortisol
with precision and innovation.
® Xanamem is a registered trademark of Actinoen Medical Limited
Contents
Who we are
IFC
Highlights
2
The Xanamem pipeline
3
MDD trial results
4
XanaMIA phase 2b/3 Alzheimer’s disease trial
6
The Alzheimer’s market
7
Chair’s letter
8
Chief Executive Officer’s letter
10
Vision and strategy
12
Operating & financial review
14
Board of directors
24
Executive leadership team
26
Directors’ report
28
Remuneration report (Audited)
31
Auditor’s independence declaration
44
Financial report
45
Directors’ declaration
70
Independent auditor’s report
71
Shareholder information
75
Corporate directory
78
Disclaimer
This annual report 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.
Annual Financial Report
1
Highlights
Planning for
commercial readiness
Pivotal XanaMIA phase
2b/3 AD clinical trial passes
100th participant milestone.
Interim analysis scheduled
for Jan 2026; final results
Q4 2026
World Health Organization
granted new and unique
International Nonproprietary
Name ‘emestedastat’
to Xanamem and also
accepted in US as USAN2
Announced positive depression
results from XanaCIDD phase
2a trial supporting Xanamem’s
cortisol control mechanism &
confirming clinical activity of
10mg daily dose
Conducted successful
Type C regulatory meeting
on MDD1 with the US
FDA to reach common
understanding of path
to marketing approval of
Xanamem for MDD
Published an academic
manuscript in peerreviewed journal, Clinical
Pharmacology in Drug
Development detailing the
multiple trials supporting
the utility of Xanamem 10mg
Completed production
of 15kg scale-up batch
of drug substance from
contract manufacturer,
Asymchem, to be
manufactured in the
US into Xanamem tablets
Appointed experienced
inaugural Chief
Commercial Officer
(CCO), Andy Udell, based
in the USA to manage
commercialization
activities
Completed an $11.1m capitalraising, received a $9.0 million
R&D tax incentive rebate &
established a $13.8m nondilutive R&D tax incentive
funding facility. Funding
secured to mid-late CY 20263
Attended & presented at significant
international conferences and
conducted meetings at industry
gatherings to enable evaluation
of potential value-add regional
and global business development
opportunities
Delivered another in series
of ’plain English’ Clinical
Trials Science Forum
(CTSF) neuroscience
webinars titled: The critical
importance of preparing for
commercialization
Initiated clinical
pharmacokinetic trial and
other ancillary studies.
Commenced preparation for
an ‘open-label’ extension trial
beginning Q1 2026 to allow
XanaMIA trial participants
to continue with active
Xanamem therapy
Strengthened engagement
and understanding among
external stakeholders
through a high-quality,
two-minute mechanism-ofaction animation
View here
1 MDD = major depressive disorder
2 USAN = A United States Adopted Name (USAN) is a unique nonproprietary name assigned to a medication marketed in the United States
3 Unless stated otherwise, all financial data is in Australian dollars
2
Actinogen Medical Limited
The Xanamem pipeline
Progressing Xanamem in Alzheimer’s
disease, major depressive disorder
and other neurological indications
Indication
Preclinical
Phase 1
Alzheimer’s
disease
Phase 2b/3 interim analysis Jan 2026,
final results late 2026
MDD
Paused after phase 2a pending
phase 2b/3 trial funding
Fragile X
syndrome
Paused prior to phase 2
Phase 2
Phase 3
Open INDs
Frontotemporal
dementia
Lewy-body
dementia
Potential next indications
Parkinson’s
disease
Anxiety
disorders
MDD: Major depressive disorder
Annual Financial Report
3
MDD trial results
Further exploration of trial results showed
encouraging activity for Xanamem when
patients were also taking background
Selective Serotonin Reuptake Inhibitor
(SSRI) drugs – the commonest class of
anti-depressant therapy in clinical use.
MADRS depression scores favour Xanamem at Week 6 & 10 in patients
also taking SSRI drugs (n = 76)
• A clinically meaningful improvement
in depression symptoms, measured
by the MADRS score, was seen after
6 weeks of therapy vs. placebo, and
was then greater and statistically
significant after four weeks of
“blinded” post-treatment follow up
MADRS LS mean change from baseline (± SE)
XanaCIDD depression trial shows positive
Xanamem activity on top of background
SSRI therapy
• The placebo-subtracted treatment
difference of 4.3 MADRS points is
similar to that seen with currently
approved anti-depressants
• These data suggest that Xanamem
could be beneficial as “add-on”
therapy to SSRI drugs
Xanamem (n=37)
Baseline
Placebto (n=39)
Week 2
Week 4
Week 6
Week 10 PT
0
• Developing Xanamem in combination
with SSRI drugs is a viable and
pragmatic pathway to approval in
major depressive disorder
PT 4.2-point difference
Cohen’s d = 0.64
p = 0.03
-2
BETTER
-4
-6
-8
EOT 2.6-point difference
Cohen’s d = 0.38
p = 0.15
-10
-12
FOLLOW UP
ON TREATMENT
Patient Global Impression – Severity scores favour Xanamem from Week 2
in patients also taking SSRI drugs (n = 75)
Xanamem (n=36)
Baseline
Week 2
Placebo (n=39)
Week 4
Week 6
Week 10 PT
PGI-S LS mean change from baseline (± SE)
0
-0.2
PT 0.59-point difference
Cohen’s d = 0.62
-0.4
-0.6
-0.8
-1
-1.2
-1.4
EOT 0.41-point difference
Cohen’s d = 0.43
-1.6
ON TREATMENT
FOLLOW UP
Abbreviations: MADRS = Montgomery-Åsberg Depression Rating Scale; EOT: End of Treatment;
PT: Post Treatment; SSRI = selective serotonin reuptake inhibitor;
4
Actinogen Medical Limited
BETTER
The XanaCIDD depression benefits show that controlling
cortisol levels in key areas of the brain has a clinically
important effect, increasing our confidence in positive
outcomes for trials in depression, Alzheimer’s disease and
other diseases where cortisol plays a role.
Analysis of patients also taking SSRI drugs suggests that
Xanamem’s benefit on depressive symptoms may be
greater in this patient population and points us toward
studying this combination in future clinical trials.
Dr Dana C Hilt
Actinogen’s Chief Medical Officer
Annual Financial Report
5
XanaMIA phase 2b/3 Alzheimer’s disease trial rapidly approaching major milestones
10mg Xanamem vs Placebo (n=220)
Interim Analysis
Final Results
January 2026
Late 2026
2026
2027
and beyond
More than
50% enrolled
Target full
enrolment
Q3 2025
Q4 2025
Open label
extension commences
Q1 2026
Key trial criteria
Key Inclusion
Criteria
Primary
Endpoint
Key Secondary
Endpoints
Implementation
• Blood pTau
biomarker positive
• CDR-SB (functional
and cognitive
measure) @36
weeks
• Cognitive Test
Battery (7 cognitive
measures
well‑validated in the
Alzheimer’s field)
• Enrolment at 15
Australian & 20
US sites
• Mild-moderate
Alzheimer’s by
NIA‑AA criteria
• Also measured at
12 and 24 weeks
• Amsterdam Activity
of Daily Living
(functional measure)
NIA-AA=National Institute of Aging - Alzheimer’s Association; CDR-SB Clinical Dementia Rating Scale – Sum of Boxes
6
Actinogen Medical Limited
• Interim analysis
January 2026
(efficacy futility
& safety)
• High quality
endpoint monitoring
The Alzheimer’s market
Large and unsatisfied Alzheimer’s market
Growing Alzheimer’s disease market - U.S.
13.8M
$1T
91%
of neurologists agree
there is a high unmet
need for DMTs for
early AD
86%
of neurologists expect
their approach to
treating early AD
will change over the
next 5 years as novel
DMTs launch
7.2M
$384B
2025
2060
2025
(Est.)
Number of patients
(65+ years old)
2050
(Est.)
Cost to treat (USD)
Sources: U.S. burden of Alzheimer’s
disease, related dementias to double
by 2060 | CDC Online Newsroom
| CDC, US Alzheimer’s Prevalence
Surpasses 7 Million
Source: The Cost of Dementia in 2025
- April 23, 2025 - USC Schaeffer
Positive reaction to Xanamem’s potential advantages per clinician feedback
Advantages of Xanamem (Unaided) % of respondents
64%
“Oral agent with distinctive mechanism
of action, no safety concern.”
38%
32% 31%
“More efficacious, oral, no concern
for ARIA, can be used in more
advanced AD.”
18%
12%
Oral
Safety
profile
Novel Efficacy
MOA
No
ARIA
No
DDI
8%
13%
Tolerability Other
profile
“It appears to be quite safe. There is
little work to be done on the part of
the clinician or the patient (dosing,
labs, titration, etc.)”
Above and right: Spherix Global Insights: Market Dynamix Early Alzheimer’s Disease
(US) Q2 2025 (n=101) and Custom Quantitative Analysis (US) July/August 2025 (n=91)
DMTs: Disease modifying therapies
ARIA: Amyloid-related imaging abnormalities
Annual Financial Report
7
Chair’s letter
Actinogen has continued to make excellent progress in the
fulfillment of its business priorities and strategic objectives in
the 2025 financial year.
Dear Shareholder,
I am pleased to present
to you the Actinogen
Medical Annual Report
for the financial year
ended 30 June 2025
reflecting on a period
of significant progress
in a dynamic global
environment.
The past year has been marked by a rebound of interest in
small-cap biotechnology, particularly those advancing into
later stages of clinical development. In both the United States
and Australia, investor sentiment has gradually improved,
buoyed by more favourable economic conditions and renewed
appetite for innovation in healthcare. This has led to a general
rotation of capital into high-quality small- and mid-cap
biotechs, especially those with promising phase 2/3 assets.
Actinogen is in exactly that “sweet spot” with its Xanamem
pivotal trial program.
Against this backdrop, Actinogen has delivered a year
of meaningful progress. Our novel, small molecule asset,
Xanamem, advanced in two major indications—Alzheimer’s
disease and major depressive disorder—both of which
represent areas of significant unmet medical need. For
now, Alzheimer’s disease is the primary focus for company
resources given the immense potential value a new, oral
therapy for this disease represents.
Addressing a significant global health need
Alzheimer’s disease remains one of the most pressing
healthcare challenges of our time. With over 55 million people
affected globally and no cure currently available, the demand
for effective therapies is only growing. Recent drug approvals
for anti-amyloid infusion therapies, that have only modest
benefit, underscore the opportunity for next-generation
therapies such as oral Xanamem.
Actinogen’s focus on modifying the progression of Alzheimer’s
by controlling brain cortisol positions us as unique in this
space. There is no other similar drug in development for CNS
diseases to our knowledge. We are proud to be contributing to
a global effort to slow, halt, or even reverse the functional and
cognitive decline associated with this devastating condition.
Executive leadership
I would also like to commend the outstanding performance
of our high-calibre senior leadership team, impeccably led
by Dr. Steven Gourlay. Their strategic leadership, scientific
knowledge and expertise, and unwavering commitment have
been instrumental in driving the company’s progress. We
also welcomed Mr Andrew (Andy) Udell to the team as Chief
Commercial Officer. His commercial expertise adds valuable
depth to our executive team as we complete later-stage
clinical development and prepare the path to product launch.
I also extend my appreciation to our wider executive
team, dedicated employees, and key contractors. Their
professionalism and dedication have been vital in maintaining
a highly effective and efficient clinical development program
and the corporate operations required of a publicly listed
biotechnology company. Their collective efforts continue to
drive Actinogen forward with purpose and momentum.
8
Actinogen Medical Limited
Board, corporate governance and advisory boards
Annual General Meeting
Our Board remains committed to the highest standards of
corporate governance and management oversight capability.
This year’s Annual General Meeting will be held in person
in Sydney on Wednesday 19 November 2025, and we look
forward to engaging with shareholders on our progress and
future plans. Details of the meeting time and Sydney location
will be announced in due course.
During the year, we reviewed our governance practices
and reassessed the Board skills matrix to identify areas for
enhancement and future capability needs. We continue to
evolve our governance framework to reflect the company’s
growth and operational complexity.
Our commitment to transparency and accountability remains
strong, with all key corporate policies and governance
materials available on our website. This framework supports
the effective management and execution of both our longterm strategic vision and annual priorities.
I would like to express my sincere appreciation to my fellow
Board members for their valuable contributions and leadership
throughout the year. Their strategic insight, governance
leadership, and steadfast commitment have been instrumental
in supporting Actinogen as we continue to navigate the
complexities of late-stage clinical development.
The Board also acknowledges the valuable insights and
guidance provided by our scientific and medical advisory
boards, which provide strategic guidance as we navigate
clinical and regulatory pathways.
Further details on the Actinogen corporate board, advisory
boards and senior executive personnel can be found on the
company’s website.
Capital management
We strengthened our financial position through a
successful capital raise of $11.1 million, the completion
of which was announced in October 2024, comprising
an $8.1 million placement and a $3.0 million Share Purchase
Plan. Subscribers also received listed options as part of
the capital raising, so the company now has two series
of options trading on the ASX. This provides flexibility for
shareholders and potential capital for future growth if and
when those options are exercised.
In addition, we received a $9.0 million R&D tax incentive
rebate in October 2024 for the 2024 financial year
and recently secured access to up to A$13.8 million
via a non‑dilutive loan funding facility secured against
the company’s future Research and Development Tax
Incentive (RDTI) rebates.
Outlook
We enter the new financial year with optimism. The interim
analysis of efficacy and safety of our pivotal XanaMIA AD trial,
expected in January 2026, will be an important milestone.
Assuming it is positive, it will provide valuable momentum for
the clinical program and support ongoing engagement with
potential partners and stakeholders. It will also mean that we
will be even closer to final topline trial results expected late in
2026, which are keenly anticipated.
In closing, I would like to sincerely thank you, our
shareholders, for your continued support and confidence in
Actinogen. Your backing enables us to pursue our work with
focus and determination, and we are grateful for your ongoing
engagement as we progress through this pivotal phase of
development. We look forward to sharing further updates with
you over the coming year as we continue working to deliver
meaningful innovation for patients and value for shareholders.
Dr Geoff Brooke
Chair
25 August 2025
If you have any questions relating to your
shareholding in Actinogen, please contact Automic
at hello@automicgroup.com.au or on 1300
288 664 (within Australia) or +61 2 9698 5414
(outside Australia).
Visit the Automic website https://investor.
automic.com.au/#/home to register as an ACW
shareholder or log in to your existing account.
Annual Financial Report
9
Chief Executive Officer’s letter
I am pleased to provide you with an update on Actinogen
Medical’s progress over the past year. Since July 2024,
we have made significant strides in advancing our clinical
programs, strengthening our financial position, and preparing
for commercialization of our lead asset, Xanamem.
Clinical Development Milestones and Peer-Review
Publications
Dear Shareholder,
Approaching key
Xanamem pivotal
trial results in
Alzheimer’s disease.
Our commitment to developing Xanamem as a novel therapy
for Alzheimer’s disease (AD) continues to yield promising
results. In June 2025, we reached a major milestone with
the enrolment of the 100th participant in our XanaMIA phase
2b/3 AD trial. This achievement sets the stage for our interim
analysis in January next year, which is expected to provide
valuable insights into the efficacy and safety of Xanamem in
this population. The interim analysis will be conducted by an
Independent Data Monitoring Committee and look at available
data for participants at 12, 24 and 36 weeks of treatment.
Full enrolment of all 220 participants in the XanaMIA trial is
expected by the time of the interim analysis, with topline,
final results for 36 weeks of treatment expected in Q4 2026.
A new “open label” extension trial to provide active Xanamem
to all participants who complete the XanaMIA trial will start
enrolment in Q1 of 2026.
Earlier in the year, our Chief Medical Officer presented positive
depression data from the XanaCIDD phase 2a trial at the
American Psychiatric Association 2025 conference, reinforcing
the therapeutic potential of Xanamem in major depressive
disorder (MDD), AD and other brain diseases. The finding of
clinical benefits on depressive symptoms confirms the clinical
activity in the brain of the 10 mg dose of Xanamem – highly
relevant to the XanaMIA trial where the same dose is used.
The XanaCIDD data were discussed in our Type C meeting
with the FDA in March 2025, where we clarified the regulatory
pathway for Xaname
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