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 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
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
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
2
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
A P P E N D I X 4 E
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
30/06/2025
$
30/06/2024
$
Change
%
Amount change
$
Revenue from ordinary activities
685,253
291,021
135%
394,232
Loss from ordinary activities after
tax attributable to members
(14,732,263)
(13,044,282)
13%
(1,687,981)
Net loss for the period attributable
to members
(14,732,263)
(13,044,282)
13%
(1,687,981)
Net tangible asset per share (a)
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
A P P E N D I X 4 E
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
Full year ended
30/06/2025
30/06/2024
$
$
Interest revenue
685,253
291,021
Other income
5,489,600
9,931,504
Total revenue & other income
6,174,853
10,222,525
Research & development costs
(12,296,568)
(15,535,482)
Employment costs
(4,434,666)
(4,195,292)
Corporate & administration costs
(2,026,706)
(1,732,305)
Finance costs
(48,890)
(24,292)
Realised (loss) / unrealised gain on foreign currency
(14,381)
(55,189)
Share-based payment expenses
(1,663,705)
(1,307,416)
Amortisation expense
(312,746)
(313,602)
Depreciation expense (right-of-use asset)
(80,964)
(82,179)
Depreciation expense (office equipment)
(28,490)
(21,050)
Total expenses
(20,907,116)
(23,266,807)
Loss before income tax
(14,732,263)
(13,044,282)
Income tax expense
-
-
Loss for the year
(14,732,263)
(13,044,282)
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
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
Pivotal XanaMIA phase
2b/3 AD clinical trial passes
100th participant milestone.
Interim analysis scheduled
for Jan 2026; final results
Q4 2026
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
Appointed experienced
inaugural Chief
Commercial Officer
(CCO), Andy Udell, based
in the USA to manage
commercialization
activities
Delivered another in series
of ’plain English’ Clinical
Trials Science Forum
(CTSF) neuroscience
webinars titled: The critical
importance of preparing for
commercialization
World Health Organization
granted new and unique
International Nonproprietary
Name ‘emestedastat’
to Xanamem and also
accepted in US as USAN2
Published an academic
manuscript in peer-
reviewed journal, Clinical
Pharmacology in Drug
Development detailing the
multiple trials supporting
the utility of Xanamem 10mg
Completed an $11.1m capital-
raising, received a $9.0 million
R&D tax incentive rebate &
established a $13.8m non-
dilutive R&D tax incentive
funding facility. Funding
secured to mid-late CY 20263
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
Announced positive depression
results from XanaCIDD phase
2a trial supporting Xanamem’s
cortisol control mechanism &
confirming clinical activity of
10mg daily dose
Completed production
of 15kg scale-up batch
of drug substance from
contract manufacturer,
Asymchem, to be
manufactured in the
US into Xanamem tablets
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
Strengthened engagement
and understanding among
external stakeholders
through a high-quality,
two-minute mechanism-of-
action animation
View here
Actinogen Medical Limited
2
The Xanamem pipeline
Progressing Xanamem in Alzheimer’s
disease, major depressive disorder
and other neurological indications
Alzheimer’s
disease
MDD
Fragile X
syndrome
Indication
Preclinical
Phase 1
Phase 2
Phase 3
Paused after phase 2a pending
phase 2b/3 trial funding
Paused prior to phase 2
Phase 2b/3 interim analysis Jan 2026,
final results late 2026
Open INDs
Frontotemporal
dementia
Lewy-body
dementia
Parkinson’s
disease
Anxiety
disorders
MDD: Major depressive disorder
Potential next indications
Annual Financial Report
3
MADRS depression scores favour Xanamem at Week 6 & 10 in patients
also taking SSRI drugs (n = 76)
Patient Global Impression – Severity scores favour Xanamem from Week 2
in patients also taking SSRI drugs (n = 75)
MADRS LS mean change from baseline (± SE)
ON TREATMENT
-12
0
Baseline
Week 2
Xanamem (n=37)
Placebto (n=39)
Week 4
Week 6
Week 10 PT
-2
-4
-6
-8
-10
FOLLOW UP
PT 4.2-point difference
Cohen’s d = 0.64
p = 0.03
EOT 2.6-point difference
Cohen’s d = 0.38
p = 0.15
BETTER
BETTER
-1.4
-1.6
0
-0.4
-0.2
-0.6
-0.8
-1
-1.2
PT 0.59-point difference
Cohen’s d = 0.62
EOT 0.41-point difference
Cohen’s d = 0.43
PGI-S LS mean change from baseline (± SE)
Xanamem (n=36)
Placebo (n=39)
Baseline
Week 2
Week 4
Week 6
Week 10 PT
ON TREATMENT
FOLLOW UP
Abbreviations: MADRS = Montgomery-Åsberg Depression Rating Scale; EOT: End of Treatment;
PT: Post Treatment; SSRI = selective serotonin reuptake inhibitor;
• 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
• 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
• Developing Xanamem in combination
with SSRI drugs is a viable and
pragmatic pathway to approval in
major depressive disorder
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.
MDD trial results
XanaCIDD depression trial shows positive
Xanamem activity on top of background
SSRI therapy
Actinogen Medical Limited
4
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
NIA-AA=National Institute of Aging - Alzheimer’s Association; CDR-SB Clinical Dementia Rating Scale – Sum of Boxes
Key Inclusion
Criteria
• Blood pTau
biomarker positive
• Mild-moderate
Alzheimer’s by
NIA‑AA criteria
Primary
Endpoint
• CDR-SB (functional
and cognitive
measure) @36
weeks
• Also measured at
12 and 24 weeks
Key Secondary
Endpoints
• Cognitive Test
Battery (7 cognitive
measures
well‑validated in the
Alzheimer’s field)
• Amsterdam Activity
of Daily Living
(functional measure)
Implementation
• Enrolment at 15
Australian & 20
US sites
• Interim analysis
January 2026
(efficacy futility
& safety)
• High quality
endpoint monitoring
2026
2027
and beyond
Interim Analysis
January 2026
Final Results
Late 2026
Q3 2025
More than
50% enrolled
Q4 2025
Target full
enrolment
Q1 2026
Open label
extension commences
Key trial criteria
10mg Xanamem vs Placebo (n=220)
Actinogen Medical Limited
6
The Alzheimer’s market
Large and unsatisfied Alzheimer’s market
Growing Alzheimer’s disease market - U.S.
2025
2025
2060
(Est.)
13.8M
7.2M
64%
38%
32%
31%
18%
12%
8%
13%
$384B
$1T
2050
(Est.)
Number of patients
(65+ years old)
Cost to treat (USD)
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)
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
Advantages of Xanamem (Unaided) % of respondents
Oral
Safety
profile
Novel
MOA
Efficacy
No
ARIA
No
DDI
Tolerability
profile
Other
Positive reaction to Xanamem’s potential advantages per clinician feedback
of neurologists agree
there is a high unmet
need for DMTs for
early AD
91%
of neurologists expect
their approach to
treating early AD
will change over the
next 5 years as novel
DMTs launch
86%
DMTs: Disease modifying therapies
ARIA: Amyloid-related imaging abnormalities
“Oral agent with distinctive mechanism
of action, no safety concern.”
“More efficacious, oral, no concern
for ARIA, can be used in more
advanced AD.”
“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.)”
Annual Financial Report
7
Chair’s letter
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.
Actinogen has continued to make excellent progress in the
fulfillment of its business priorities and strategic objectives in
the 2025 financial year.
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.
Actinogen Medical Limited
8
Board, corporate governance and advisory boards
Our Board remains committed to the highest standards of
corporate governance and management oversight capability.
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 long-
term 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.
Annual General Meeting
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.
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
Dear Shareholder,
Approaching key
Xanamem pivotal
trial results in
Alzheimer’s disease.
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
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 Xanamem in MDD, laying the groundwork for
future pivotal trials should the company’s focus shift away
from AD as its lead indication.
We continued to work towards peer-review of all our key
trial results with the publication of a manuscript in the
Clinical Pharmacology in Drug Development journal entitled
“Clinical Pharmacology and Approach to Dose Selection
of Emestedastat, a Novel Tissue Cortisol Synthesis Inhibitor
for the Treatment of Central Nervous System Disease”.
In addition, multiple academic posters were presented
at scientific AD meetings.
Actinogen Medical Limited
10
Commercialization Preparation
We are actively preparing for the commercialization of
Xanamem, which is likely to be in collaboration with one
or more biopharmaceutical partners. In recognition of the
importance of this work, in October last year we appointed
Mr Andrew (Andy) Udell to the position of Chief Commercial
Officer, based in Connecticut, USA.
In January we announced the award of the generic or official
chemical name for Xanamem of “emestedastat”, determined
by the naming committee of the World Health Organization
and later agreed to by a similar committee in the US. The new
and unique suffix of “- stedastat” acknowledged Xanamem
as the first-in-class inhibitor of its target cortisol production
enzyme, 11β-HSD1.
Our Clinical Trials Science Forum held in May 2025 focused on
the marketing planning activities associated with the transition
towards commercialization. Dana Hilt, CMO, and Andy Udell,
CCO, with AD expert guest Associate Professor Michael
Woodward, discussed the AD field and Xanamem’s position
in it as we look beyond pure clinical development to market
planning and execution, a critical future step in delivering
value to patients and shareholders.
Throughout the year Mr Udell and Dr Hilt have increasingly
engaged with thought leaders in both AD and MDD to
refine the product offering Xanamem will represent to
prescribing physicians and their patients. This included
advisory board meetings, one-on-one interactions and
formal market research.
Manufacturing
During the year, our Head of Manufacturing, Ms Fujun Li,
worked diligently to achieve several key milestones. The most
important of these was the successful scale-up of production
of the active pharmaceutical ingredient (API) of Xanamem to
the 15 kg level. This API will be manufactured into our intended
commercial tablet formulation in the US.
Financial Strength and Funding
Actinogen remains financially robust as a result of
the successful execution of multiple funding initiatives
throughout the year. At the end of June, our cash balance
was $16.5 million, contributing to a cash runway beyond
mid CY2026 in combination with our RDTI future income.
We continue to explore funding from strategic partnerships
and other non-dilutive funding sources to support our growth
while preserving shareholder value.
Strategic Engagements
Actinogen’s visibility in the global biotech community has
grown. We presented at the BIO International Partnering
Conference in June 2025, engaging with potential
collaborators and investors. Similarly, our presence at the
Sachs Neuroscience conference in January 2025 provided
opportunities to update and engage multiple large and mid-
tier biopharmaceutical companies on our progress. These
efforts are part of our broader strategy to attract synergistic
strategic partners and position Actinogen as a leader in AD
drug development.
Looking Ahead
The coming year will be pivotal. We anticipate interim results
from our AD pivotal trial, further regulatory engagement with
both the FDA and European Medicines Agency (EMA) on AD,
and continued progress in our commercialization strategy.
Our team remains focused on executing with excellence
and transparency.
I want to thank you—our shareholders—for your continued
support and belief in our mission. Actinogen is entering a
transformative phase, and your partnership is vital as we
work to bring Xanamem to patients in need.
Warm regards,
Dr Steven Gourlay
CEO & Managing Director
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
11
Vision and strategy
Our fundamentals
In conjunction with the US FDA and
other regulatory authorities, we strive
for excellence in science and clinical data
within our programs. As a result, we’ve
conducted multiple high-quality clinical
trials to bring our molecule, Xanamem,
to this phase 2/3 stage of development.
Quality
Valued
We are valued and respected by
patients, physicians, and industry
peers to bring Xanamem’s development
forward. Science, data and transparency
guide us to bring hope and potentially
change the world of cognitive
impairment forever.
Bold
Building on the solid scientific rationale
for Xanamem’s action, we are rapidly
developing programs in multiple disease
areas, with a priority on Alzheimer’s
disease and depression.
Next-Gen
Xanamem is a cutting-edge therapy
and world-class product that reduces
cortisol (the “stress hormone”) levels
in the brain. As a result, it is a catalyst
for new approaches in managing
neurodegenerative and other illnesses.
Our Vision
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.
Actinogen Medical Limited
12
FY2026 Strategic priorities
Accelerate clinical
development
of Xanamem in
Alzheimer’s disease
• Meet with FDA and
EMA to define the most
efficient path to approval
• Enrolment of 220
participants with mild to
moderate disease in the
pivotal XanaMIA trial
• Perform an interim safety
and efficacy futility
analysis in January
CY2026
• Efficient prescreening
in XanaMIA to identify
people with progressive
disease using elevated
blood pTau181
• Implement an extension
trial in which all XanaMIA
participants can receive
active Xanamem
• Ensure high quality
rating training and
standardization to
minimize noise in key
efficacy endpoints
• Leverage ‘hands on’
clinical operations and
management model in
Australia and the US
to optimize quality and
reduce cost
Commercial
readiness to
prepare the market
for Xanamem &
support future
partnerships
• Strengthen AD advisory
board and elicit updated
program guidance
• Engage with a broad
range of key opinion
leaders and principal
investigators in AD
• Communicate Xanamem’s
novel mechanism of action
and its differentiated
therapeutic profile via
multiple channels
• Refine Xanamem target
product profile in AD
based on feedback from
market research and
AD experts
Scaled up
manufacturing
and related patent
protection
• Production of a large
batch of Xanamem tablets
by Catalent, US
• Manufacture of an
additional 15 kg of API
by Asymchem, China
• National phase entry
for three manufacturing
patents
Proactively engage
with prospective
development
and commercial
partners
• Identify and partner with
one or more synergistic
regional biopharma
companies
• Continue to develop
relationships with
potential, future large-cap
partners
• Review detailed Xanamem
data with selected parties
under confidentiality
agreements
• Attend key international
and national scientific and
business meetings
• Form collaborative
relationships with all
major global regulatory
authorities
Annual Financial Report
13
1 The timing of the interim data analysis is “triggered” when at least 100 patients reach at least 24 weeks of treatment which is expected to be in late December 2025.
Given the year-end holiday season, the independent DMC will conduct the IA in January 2026.
Operating & financial review
1.
PRINCIPAL ACTIVITIES
The principal activity of the company during the year focused on the ongoing clinical development of Xanamem, a
unique inhibitor of the 11β-HSD1 enzyme that achieves target engagement in the brain. It is an oral medication for
neurological diseases amenable to its mechanism of lowering cortisol in brain cells. Brain cortisol is associated with a
number of neurological diseases, including neurodegenerative diseases such as Alzheimer’s Disease (AD),
neuropsychiatric diseases such as major depressive disorder (MDD), and Fragile X syndrome (FXS).
2. OPERATIONS REVIEW
Highlights – Accelerating toward pivotal trial results in Alzheimer’s disease:
Advanced two major clinical trial programs:
•
XanaMIA phase 2b/3 AD clinical trial passed 100th participant milestone. Interim analysis scheduled for January
2026 and final results expected Q4 2026
•
Completed XanaCIDD phase 2a MDD trial – using the data to support development in Alzheimer’s disease
pending independent funding for additional MDD trials.
World Health Organization (WHO) granted new and unique International Nonproprietary Name (INN) ‘emestedastat’ to
Xanamem
Successfully conducted a Type C regulatory meeting on major depressive disorder (MDD) with the US Food & Drug
Administration (FDA)
Conducted commercial readiness planning in all other major aspects of the business including appointing an
experienced Chief Commercial Officer (CCO) to manage commercialization activities, conducting partnering meetings
& discussions, protecting intellectual property (IP), conducting regulatory meetings, initiating the clinical
pharmacokinetic trial and other ancillary studies
Published an academic manuscript in peer-reviewed journal, Clinical Pharmacology in Drug Development
Completed production of a 15kg scale-up batch of drug substance from contract manufacturer, Asymchem, which
will be manufactured in the US into Xanamem tablets for use in the current and future trials, and confirm readiness for
future commercial quantity production
Completed an $11.1m capital-raising, received a $9.0 million Research & Development (R&D) tax incentive rebate and
established a $13.8m non-dilutive R&D tax incentive funding facility. Funding secured to mid-late CY2026
Delivered another in the series of ’plain English’ Clinical Trials Science Forum (CTSF) neuroscience webinars with the
subject title: The critical importance of preparing for commercialization
CEO, CMO and CCO presented at numerous significant international conferences and conducted meetings at industry
gatherings to continue evaluating potential value-add regional and global business development opportunities.
The Company’s 2025 financial year was marked by robust clinical pipeline progress and several major milestones and
events including planning for the approaching commercialization of Xanamem.
XanaMIA phase 2b/3 AD clinical trial passes 100th participant milestone. Interim analysis scheduled for January
2026 and final results expected Q4 2026
•
The pivotal XanaMIA phase 2b/3 AD trial is enrolling 220 participants 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
•
As at late August more than 55% of the planned 220 participants are enrolled in the trial, with full enrolment
expected by the coming December or January
•
Thirty-five recruitment sites are open in the USA (20) and Australia (15), and the enrolment process continues to
be optimized
•
The timeline for a planned safety and efficacy futility interim analysis (IA) by an independent Data Monitoring
Committee (DMC) has been established with the enrolment of the 100th participant on 30 June 2025.1 The DMC
review of all available data will occur in January 2026 after which the results of the IA will be announced
Actinogen Medical Limited
14
•
The DMC comprises independent clinical and statistical experts who are not connected to the day-to-day conduct
or analysis of the trial. The committee will confidentially review unblinded data for safety and efficacy futility from
all available participant visits including many who will have already completed the 36-week treatment period.
Further details of the IA process are available in an ASX announcement issued by the Company on 30 June 2025,
which can be viewed here
•
Final results for the full enrolment of 220 participants are expected in Q4 2026.
XanaCIDD phase 2a MDD trial completed
•
The XanaCIDD trial was a six-week phase 2a, proof-of-concept, placebo-controlled, parallel group trial in 165
patients with cognitive impairment in major depressive disorder (MDD). Xanamem (10 mg) or placebo was added
to the existing anti-depressant therapy (n=134) or, in patients with a previous history of anti-depressant
treatment not currently on an anti-depressant, as a stand-alone treatment (n=31). Results were reported in
August 2024
•
There was a clinically meaningful and persistent improvement in depression measured by the key secondary
endpoint of MADRS and in the Patient Global Impression of Severity (PGI-S) measure at multiple timepoints.
Improvement in depressive symptoms was statistically significant in the overall population four weeks after the
end of 6 weeks of treatment (Week 10), and at both Week 6 and Week 10 in participants taking a background
selective serotonin reuptake inhibitor anti-depressant simultaneously. Cognition improved to a similar extent in
both Xanamem and placebo groups (p not significant)
•
This outcome provides further evidence to support Xanamem as a cortisol control mechanism and indicates that
the 10 mg daily dose is clinically effective at reducing symptoms of depression, supporting the selection of 10mg
as a clinically active dose for the XanaMIA AD trial
•
The company has completed its data analysis and is exploring the path forward for larger trials in MDD with
regulators, global thought leaders and potential strategic partners.
New and unique name ‘emestedastat’ granted to Xanamem
•
In January 2025, the WHO granted the nonproprietary name ‘emestedastat’ to Actinogen for Xanamem. An INN is
a unique, globally recognized name for a pharmaceutical drug or active ingredient. Each active substance that is
to be marketed as a pharmaceutical must be granted a unique name of worldwide acceptability to ensure the
clear identification, safe prescription and dispensing of medicines to patients. Nonproprietary names are
intended for wide use ranging from labelling and product information to drug regulation and scientific literature
•
By granting the INN, the WHO recognized Xanamem (emestedastat) as the first drug to be named for the class
of enzyme inhibitors of 11β-HSD1 by assigning it the unique suffix of ‘-stedastat’ pertaining to its mechanism of
action on 11β-HSD1. Emestedastat is a unique orally administered molecule in its own class as a ‘brain tissue
cortisol synthesis inhibitor’.
•
Subsequently a similar committee in the US also agreed to emestedastat as the United States Adopted Name
(USAN)
Regulatory planning with FDA and EMA
•
In March 2025, the company announced the successful conduct of its scheduled Type C meeting on major
depressive disorder (MDD) with the US Food & Drug Administration (FDA)
•
In a successful and collaborative meeting, Actinogen and the FDA reached a common understanding of the
additional clinical trials, ancillary clinical pharmacology trials and nonclinical studies required to apply for
marketing approval of Xanamem for MDD
•
The agreements reached at the meeting with the FDA’s Psychiatry Division represent a major accomplishment
for the company and will be important in future discussions with potential partners and granting bodies as
sources of non-dilutive funding are sought to support the program
•
A similar Type C meeting for Alzheimer’s disease will be held with the FDA’s Neurology Division in September to
define the optimal path to a marketing approval and subsequently with the EMA.
Published clinical pharmacology academic manuscript in peer-reviewed journal, Clinical Pharmacology in Drug
Development
•
In February 2025 the company announced the publication of its latest peer-reviewed journal article entitled
Clinical Pharmacology and Approach to Dose Selection of Emestedastat, a Novel Tissue Cortisol Synthesis
Inhibitor for the Treatment of Central Nervous System Disease in the journal associated with the American
College of Clinical Pharmacology, Clinical Pharmacology in Drug Development. The review confirms the utility of
the 10 mg daily dose of Xanamem being used in current clinical trials. The journal article can be accessed here.
Manufacturing
•
During the June 2025 quarter, the company completed production of a 15kg scale-up batch of drug substance
via its contract manufacturer, Asymchem, which will be manufactured in the US into Xanamem tablets for use in
the current and future trials. Scaled-up manufacturing is a key step towards regulatory approval of a commercial
production process and an important component of preparedness for potential commercialization partnerships.
Annual Financial Report
15
2 Biotechnology Innovation Organization (BIO) is the world’s largest advocacy association representing biotechnology companies, academic and research institutions,
state biotechnology centers and related organizations across the United States and in more than 30 other nations.
Funding secured to mid-late 2026
•
In September and October 2024, the company successfully raised $11.1m via an $8.1m share placement to
existing and new sophisticated investors (underpinned by a $1m subscription to the placement by CEO Dr
Steven Gourlay), along with a $3.0m share purchase plan offer to existing shareholders on the same financial
terms as the placement
•
In November 2024, the company announced that it had received a $9.0 million R&D tax incentive rebate 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.
•
On 30 June 2025 the company announced the establishment of a $13.8m R&D loan facility. The initial $3.0m
tranche was drawn down and secured against the company’s FY25 Research and Development Tax Incentive
(RDTI). Conditional commitments have been received for a further $2.9m drawdown in the September 2025
quarter in relation to the final full year FY25 RDTI, and up to $7.9m conditionally approved against the forecast
FY26 RDTI
•
The company is funded to mid-late CY2026.
Neuroscience webinar for investors
•
On 15 May 2025 the company conducted another in its series of ‘plain English’ CTSF webinars titled: The critical
importance of preparing for commercialization
•
ACW’s Chief Medical Officer (CMO), Dr Dana Hilt and guest A/Prof Michael Woodward from Austin Health led a
highly informative presentation and panel discussion that reviewed the scope of leading current and potential
treatments in development for Alzheimer’s disease and the ongoing significant unmet medical need for effective
therapies. Chief Commercial Officer (CCO), Mr Andy Udell, followed with a presentation on what
commercialization planning means for a late-stage clinical development company like Actinogen
•
Watch the 2025 CTSF webinar video recording: click here.
Planning for commercial readiness
The company believes Xanamem’s action to control tissue production of cortisol in the brain, also known as ‘The
Cortisol Hypothesis’, is now well-established as a new therapeutic mechanism. With the Xanamem program in late-
stage clinical development, the company is actively engaging in an important range of initiatives in addition to those
outlined above to prepare for the approaching commercialization phase. These include:
•
Commercial leadership - appointed Mr Andrew (Andy) Udell as inaugural CCO, based in Connecticut, USA. Mr
Udell is a commercial leader with demonstrated success taking biotech companies from the clinic through
market planning, commercial readiness and full commercial integration. Recently, he has been expanding
thought leader engagement with AD experts across the US and refining the company’s communication materials
to support a stronger presence at key AD scientific and business meetings
•
During the June 2025 quarter the company released its new two-minute Xanamem Mechanism of Action
animation, which can be viewed here
•
Regulatory meetings – the company held a successful meeting with the FDA in March 2025 on its depression
program (see above) and continues to plan its path forward in AD with the outcome of a type C meeting
expected in September that will guide registrational requirements for marketing approvals. A similar meeting with
the EMA regarding European requirements will be held subsequently.
•
Partnering – dialogue continues with multiple parties spanning potential regional and/or global partnership
arrangements, with an emphasis on those organizations that are interested in AD or both AD and MDD. The
company continues to engage with potential partners directly and at international partnering conferences such
as US and European BIO2 international conventions
•
Intellectual property protection from future generic competition – as a new chemical entity and unique class of
drug, Xanamem has additional commercial protection from data exclusivity laws independent of protection
provided by approved patents. Data exclusivity laws provide protection against generic manufacturers using
Actinogen’s clinical or nonclinical data for a substantial period from the date of marketing approval and therefore
effectively block generic competition from the market during that time. Data exclusivity periods vary by country,
for example, five years in Australia and the US and ten years in the EU
•
In addition, patents typically have a period of 20 years from the date of grant. Actinogen has key patents
granted for the Xanamem molecule’s chemistry and continues to prosecute newer patents in multiple countries
covering the treatment of cognitively normal people, manufacturing process and the treatment of patients with
depression supporting an overall robust framework of intellectual property protection
•
Clinical pharmacokinetic trial – this trial commenced at the CMAX site in Adelaide and will measure blood levels
for the tablet formulation of Xanamem and study the potential effect of food on absorption and other
pharmacokinetic parameters
•
Other ancillary studies – preparation has commenced for an “open-label” extension trial to allow all participants
in the XanaMIA trial to continue with active Xanamem therapy. This trial is due to commence in Q1 2026.
Actinogen Medical Limited
16
CEO, CMO and CCO presented at numerous significant international conferences and conducted meetings at
industry gatherings to continue evaluating potential value-add regional and global business development
opportunities, including:
•
CMO Dr Dana Hilt presented an academic poster at the Alzheimer’s Association International Conference (AAIC)
in Philadelphia, USA on 29 July 2024 summarizing the comprehensive clinical pharmacology approach used by
the company integrating data from multiple clinical trials to determine the target dose range for Xanamem. The
AAIC is a leading global forum to advance dementia science
•
CEO Dr Steven Gourlay presented to the Pitt Street Research Conference in Sydney in September 2024,
discussing Xanamem’s attractive therapeutic profile for the treatment of neurologic conditions by controlling
brain cortisol, and the positive outlook for the company as it enters late-phase clinical trials
•
Dr Gourlay presented at the Dementia Trials Australia Annual Scientific Meeting in Sydney in October 2024. His
presentation included an analysis of the important validation of Xanamem’s mechanism of action to control brain
cortisol provided by the anti-depressant activity identified in the XanaCIDD phase 2a depression trial
•
Also in October, Dr Hilt and Senior Clinical Scientist Dr Jack Taylor presented an academic poster at the Clinical
Trials on Alzheimer’s Disease (CTAD) conference in Madrid, Spain. The poster presented data to show that
elevated plasma pTau181 is useful in predicting clinical decline in patients with mild, clinically diagnosed AD
•
Dr Hilt and Dr Gourlay presented at the Sachs Associates 8th Annual Neuroscience Innovation Forum in San
Francisco in January 2025. Their presentation was titled Oral emestedastat (Xanamem®/UE2343): Controlling
brain cortisol to slow progression in Alzheimer’s disease. While in San Francisco, members of the ACW leadership
team participated in a significant number of partnering, analyst and investor meetings associated with the 43rd
Annual J.P. Morgan Healthcare Conference
•
In March 2025, Dr Gourlay presented at the ASX small & mid-caps conference in Sydney. His presentation
outlined the attractive therapeutic profile of ACW’s novel small molecule drug Xanamem and provided an update
as the company approaches critical milestones in its phase 2b/3 Alzheimer’s trial
•
In early April 2025, Dr Hilt presented an academic poster at the 19th International Conference on Alzheimer’s &
Parkinson’s Diseases and Related Neurological Disorders (AD/PD™25). Dr Hilt’s poster detailed the promising
benefits of Xanamem treatment over 12 weeks in patients with elevated blood pTau181. It also reported that
higher levels of blood pTau181 can identify patients with AD who have more rapid clinical progression. Taken
together, these data inform the design of the current XanaMIA phase 2b/3 pivotal AD trial using the pTau181
plasma biomarker for selection of patients and the choice of its key endpoints of CDR-SB, cognition and
activities of daily living
•
In May, Dr Hilt jointly presented an academic poster at the American Psychiatric Association (APA) 2025 Annual
Meeting in Los Angeles, USA with poster co-author and renowned psychiatrist Professor Michael Berk PhD from
Deakin University in Melbourne. The poster detailed the promising benefits of Xanamem treatment on symptoms
of depression reflected in a variety of measurements, indicating a durable therapeutic effect resulting from
effective control of brain cortisol levels
•
In June, CCO Mr Andy Udell, and Dr Hilt conducted meetings and delivered a company presentation at the BIO
International Convention (BIO 2025) in Boston, USA
•
In early July 2025, Dr Gourlay and CFO, Mr Will Souter, conducted numerous in person and virtual meetings with
existing shareholders and other stakeholders focused on the key achievement of the 100th patient enrolled in
XanaMIA and resulting confirmation of the results timeline for the trial
•
In July 2025, Dr Hilt and Dr Taylor presented an academic poster at the Alzheimer’s Association International
Conference (AAIC 2025) in Toronto, Canada. The poster was titled Validating the cortisol hypothesis: Xanamem
demonstrates positive clinical effects by lowering CNS cortisol in MDD and describes the clinically and
statistically significant benefits of Xanamem in patients with moderately severe major depressive disorder
(MDD).
For further information on all the above events, please refer to the ASX announcements section under the
Investor Centre tab on the Actinogen website www.actinogen.com.au.
Annual Financial Report
17
3. FINANCIAL REVIEW
(a) Financial performance
The financial performance of the Company during the year ended 30 June 2025 is as follows:
Full year ended
Full year ended
30/06/2025
30/06/2024
Revenue and other income ($)
6,174,853
10,222,525
Net loss after tax ($)
(14,732,263)
(13,044,282)
Loss per share (cents)
(0.49)
(0.60)
Dividend ($)
-
-
(b) Financial position
The financial position of the Company as at 30 June 2025 is as follows:
As at
As at
30/06/2025
30/06/2024
$
$
Cash and cash equivalents
16,504,230
9,450,735
Net assets / Total equity
18,335,903
19,696,499
Contributed equity
115,726,615
100,023,653
Accumulated losses
(96,468,098)
(81,735,835)
Actinogen Medical Limited
18
4. MATERIAL RISKS
In addition to risks associated with any business there are specific, material risks that, either individually or in combination,
may materially and adversely affect the future operating and financial performance and prospects of Actinogen and the
value of its shares. Some of these risks may be mitigated by Actinogen’s internal controls and processes but some are
outside the control of Actinogen, its directors and management. The material risks identified by management are
described below:
Risk
Implication
Mitigation
Research and
Development
Activities
Actinogen’s future success is dependent on the
performance of Actinogen’s lead molecule, Xanamem®,
in clinical trials and whether it proves to be a safe and
effective treatment. Xanamem is an experimental
product in phase 2/3 clinical development. Product
commercialization resulting in potential product sales
revenues are likely to be years away without any
guarantee that it will be successful. It requires
additional research and development, including
ongoing clinical evaluation of safety and efficacy in
clinical trials and regulatory approval prior to
marketing authorization. Until Actinogen is able to
provide further clinical evidence of the ability of
Xanamem to improve outcomes in patients, the future
success of its technology remains speculative.
Research and development risks include uncertainty
of the outcome of results, difficulties or delays in
development and generally the uncertainty that
surrounds the scientific development of
pharmaceutical products.
Mitigation measures include
‘following the science’ of the data
generated for Xanamem to date,
hiring expert clinical development
professionals to design, oversee and
analyse the trial program,
engagement of leading contract
research organisations to manage
components of the trials and drive
recruitment as well as engagement
of well-qualified clinical sites
experienced in clinical trial execution
and in the relevant therapeutic areas.
Regulatory
Approvals
Actinogen operates within a highly regulated industry,
relating to the manufacture, distribution and supply of
pharmaceutical products. There is no guarantee that
Actinogen will obtain the required approvals, licenses
and registrations from relevant regulatory authorities
in jurisdictions in which it operates. The
commencement of clinical trials may be delayed and
Actinogen may incur further costs if the Food and
Drug Administration (FDA) and other regulatory
agencies are tardy or observe deficiencies that
require resolution or request additional studies be
conducted in addition to those that are currently
planned. A change in regulation may also adversely
affect Actinogen’s ability to commercialize and
manufacture its treatments.
Mitigation measures include
operating under a US FDA
Investigational New Drug (IND)
process, engagement of suitably
qualified and experienced persons
with expertise in the regulation of
small molecule therapies,
establishing relationships with
regulators to facilitate feedback and
guidance from them, regular review
of evolving regulatory requirements
and analysis of the company’s
activities and plans against
regulatory expectations in key
jurisdictions, and ensuring that the
expectations and uncertainties
related to regulatory approvals, and
the timing of such approvals, are
included in business plans.
Intellectual
Property
Securing rights in technology and patents is an
integral part of securing potential product value in the
outcomes of biotechnology research and
development. Competition in retaining and sustaining
protection of technology and the complex nature of
technologies can lead to patent disputes. Actinogen’s
success depends, in part, on its ability to obtain
patents, maintain trade secret protection and operate
without infringing the proprietary rights of third
parties. Because the patent position of biotechnology
companies can be highly uncertain and frequently
involves complex legal and factual questions, neither
the breadth of claims allowed in biotechnology
patents nor their enforceability can be predicted.
There can be no assurance that any patents which
Mitigation measures include use of
expert patent attorneys, regular
review of the relevant patent
landscape, filing of additional patents
and maintenance of patents in a
broad geography covering major
pharmaceutical markets.
Annual Financial Report
19
Risk
Implication
Mitigation
Actinogen may own, access or control will afford
Actinogen commercially significant protection of its
technology or its products or have commercial
application or that access to these patents will mean
that Actinogen will be free to commercialise its
technology. Competitors may file patents which could
limit the company's freedom to operate for its
technologies. The granting of a patent does not
guarantee that the rights of others are not infringed or
that competitors will not develop technology or
products to avoid Actinogen's patented technology.
Actinogen’s current patenting strategies do not cover
all countries which may lead to generic competition
arising in those markets.
Partnership
Model
While undertaking its phase 2/3 clinical program the
company is actively pursuing value-add partnership(s)
to expand the trial program further and secure
commercialization pathways in one or more territories.
This model, which typically involves entering into
commercial arrangements, with other companies by
which Actinogen would license its Xanamem
technology to the partner in one or more indications
and/or geographies and the partner assumes some or
all responsibility for progressing, and paying for, the
clinical trials and eventual commercialization. This
strategy involves the risk that the company will lose
some or all control of the development timetable of its
products to its commercial partner(s), which may give
rise to an unanticipated delay in any commercial
returns. Further, the company may be unable to enter
into arrangements with suitable commercial partners
in respect of relevant indications. If either of these
outcomes occurred, the company’s business and
operations may be adversely affected.
Mitigation measures employed by the
company include: using expert
business development professionals
to build relationships with potential
partners, performing rigorous due
diligence, establishing a
comprehensive virtual ‘dataroom’ for
confidential information sharing,
ensuring that the commercial terms
negotiated are fair and utilising
expert legal advice to ensure that
appropriate warranties and
commitments are included in
contracts, and that the contracts
reflect the agreed commercial
position. The company also seeks to
form partnerships with relevant
regulatory agencies including the
FDA, EMA, MHRA, and TGA.
Manufacturing
The company’s products are manufactured using a
specialised manufacturing process at an expert third
party facility, as is the norm in the industry. An
inability of these third party contract manufacturing
organisations to continue to manufacture the
Company’s products in a timely, economical and/or
consistent manner, including any scale up of
manufacturing processes, or to maintain legally
compliant manufacturing to maintain product supply,
could adversely impact on the progress of the
company’s development programs and potentially on
the financial performance of the company.
Mitigation measures include
performing rigorous due diligence on
contract manufacturers, engaging
contract manufacturers with strong
track records and sufficient
capability to meet the company’s
foreseeable needs, employing senior
managers responsible for managing
and monitoring the performance of
contract manufacturers, and
maintenance of quality systems and
related documentation.
Fundraising risk
Actinogen is reliant upon fundraising to fund its
operations. Funds may be available in the future from
grants, development and commercial partnerships, tax
incentives and capital markets but are not guaranteed.
Capital market volatility may impact Actinogen’s ability
to raise future funds.
Mitigation measures include filing of
multiple grant applications, key
management focus on partnership
relationships, use of specialist
advisors in tax, business
development and investor relations,
maintaining high quality analyst
coverage, frequent communications
to retail and institutional investors
and having a presence at many
scientific and business conferences.
Actinogen Medical Limited
20
5. BUSINESS STRATEGY & OUTLOOK
Actinogen’s FY2026 strategic priorities are focused on four key elements:
•
Accelerating clinical development of Xanamem in Alzheimer’s disease
•
Commercial readiness planning to prepare the market for Xanamem and support future partnerships
•
Scaling up manufacturing and enhancing its patent protection
•
Proactively engaging with prospective development and commercial partners
Accelerate clinical development of Xanamem in Alzheimer’s disease
The ongoing XanaMIA phase 2b/3 trial in patients with mild to moderate AD is in the latter stages of recruitment with an
interim analysis due in January 2026 and final results expected at the end of 2026. Approximately 220 participants are
being recruited across 35 clinical sites in Australia and the US.
In the coming month the Xanamem development team will meet with the FDA Division of Neurology to discuss all aspects
of the AD program needed to get to the earliest possible marketing approval in the US. Next year, a similar meeting will be
held with the European Medicines Agency to seek their feedback on the program.
Key features of the phase 2b/3 trial implementation phase are:
•
Enrolment of the same profile of patients where the large Xanamem treatment benefit was seen in a prior trial in
patients with mild or moderate AD and elevated pTau181 protein in the blood (a diagnostic test to confirm AD
diagnosis and progressive phenotype)
•
Reduce high screen failure costs traditionally associated with AD trials by rapidly and cost-effectively pre-screening
patients for elevated blood pTau181
•
A 36-week treatment period designed to show a treatment benefit for Xanamem compared to placebo treatment,
after which all participants can then receive active Xanamem in an “extension” trial
•
High quality rating training and standardization to minimize noise in subjective endpoints like the Clinical Dementia
Rating Scale – Sum of Boxes (CDR-SB) primary endpoint
•
‘Hands on’ clinical operations and management based in Australia supplemented by select use of US contractors to
optimize quality, speed timelines and reduce cost.
Plan for commercial readiness to prepare the market for Xanamem and support future partnerships
Appropriate to its late stage of clinical development, Actinogen has begun the process of qualitative and quantitative
assessment of Xanamem’s Target Product Profile in multiple markets, with an initial focus on the US. Activities and
achievements to date include:
•
Appointed Mr Andrew (Andy) Udell as Chief Commercial Officer in October 2024, based in the US
•
Granted unique INN and USAN name emestedastat for Xanamem
•
Initiated an Advisory Board meeting of key opinion leaders to review and provide feedback on XanaCIDD phase 2a
depression data
•
Engaged with key US opinion leaders in AD at International scientific meetings, US clinical sites and directly
•
Developed a high-tech animation to educate physicians and external stakeholders on Xanamem’s novel mechanism
of action and its differentiated therapeutic profile
•
Conducted in-depth qualitative and quantitative market research with neurologists and high-volume AD-treating
physicians to understand reaction to Xanamem’s draft “target product profile”, assess current and future market
dynamics, and evaluate Xanamem’s potential value in Alzheimer’s disease
Scale up manufacturing and enhance its patent protection
During the year considerable advances were made in the scale up synthesis of the Active Pharmaceutical Ingredient (API)
for Xanamem. This culminated in the successful manufacture of more than 15 kg of API, with a substantially improved
yield by the highly respected manufacturer, Asymchem. Previously, the largest API batch size produced was 3.2 kg. This
new API batch will be shipped to the US, where Xanamem tablets will be produced by pharmaceutical manufacturer
Catalent for use in upcoming clinical trials.
In parallel with production activity, the company prosecuted a variety of national phase patents related to manufacturing.
These include two different manufacturing process patents along with a patent for the tablet formulation.
Proactively engage with prospective development and commercial partners
Our active business development plan maintains and develops relationships with all potential drug development partners,
both large and small, regional and global. At the January 2025 Sachs Associates Neuroscience conference and again at
the June 2025 BIO partnering meeting in Boston, the company had productive meetings with many parties as well as
giving formal, podium presentations. Feedback at both meetings was encouraging for companies like Actinogen who have
mid to late-stage clinical assets, in contrast to companies with earlier, preclinical assets who may find partnering more
challenging in the 2025 biopharma environment. We remain actively engaged with many prospective partners who have
an interest in Xanamem's unique and promising profile for the treatment of neurological diseases.
The Company also seeks to form partnerships with relevant regulatory agencies including the FDA, MHRA, EMA and TGA,
an example of which is the highly collaborative meeting held with the FDA to define the potential pathways to approval for
Xanamem in major depressive disorder. Currently we have three open Investigational New Drug applications with the US
FDA, using the Alzheimer’s program as the “core” dossier. Further collaboration is planned in the coming months with the
FDA covering manufacturing, quality, clinical and nonclinical matters for the AD program.
Annual Financial Report
21
Our FY2026 strategic priorities are also summarized in an infographic on page 13 of this annual report and on the
Company’s website www.actinogen.com.au.
Outlook
The company remains confident about its prospects in FY2026 and beyond as we look to build on a successful FY2025.
Actinogen continues its transformational clinical development of Xanamem as it surpasses halfway in recruitment for the
XanaMIA phase 2b/3 AD trial, with final results for 220 participants anticipated in late 2026.
XanaMIA is planned as one of two pivotal trials to support the earliest possible marketing approvals for Xanamem in AD.
Should the trial prove positive as expected, pathways to accelerated approvals will also be explored with regulators.
Actinogen is in an enviable position, with multiple, independent trials providing clinical validation of Xanamem’s brain
cortisol control mechanism relevant to AD, depression and related diseases:
•
Positive results on depressive symptoms in a well-controlled, phase 2 trial
•
Encouraging pilot data (Taylor et al 2024) suggesting stabilization of mild AD
•
High brain target enzyme binding in a human PET scan study (Villemagne et al 2024)
•
No serious adverse events and promising safety profile in more than 400 people treated with active drug for up to 36
weeks.
Upcoming news events include notification of a new peer-reviewed publication, academic presentations, results of FDA
and EMA interactions on AD, clinical trial updates, interim data from the XanaMIA phase 2b/3 AD trial in January 2026, and
final results in late 2026.
We continue to prioritize manufacturing, regulatory, clinical pharmacology and nonclinical planning and activities to enable
rapid expansion on successful phase 2b/3 results.
The company remains committed to proactive management of all aspects of its business to ensure the best possible
outcomes for shareholders. This includes optimizing our current clinical trials program, forward planning for marketing
approvals while balancing partnering efforts and building optimal shareholder returns.
Actinogen Medical Limited
22
Board of directors and Executive leadership team
Standing L-R: Peter Webse (Co Sec), Malcolm McComas, Dr George Morstyn
Seated L-R: Dr Steven Gourlay, Dr Geoffrey Brooke, Dr Nicki Vasquez
Standing L-R: Andrew Udell, William Souter, Michael Roberts
Seated L-R: Cheryl Townsend, Dr Steven Gourlay, Dr Dana Hilt
Absent: Dr Fujun Li
Photos taken at the company’s April 2025 strategy day at the K&L Gates Sydney office
Annual Financial Report
23
Board of directors
BOARD OF DIRECTORS
Dr Geoffrey Brooke
MBBS, MBA
Non-Executive Chair (appointed 1 March 2017)
Dr Brooke is a healthcare industry and venture capital veteran with over 30 years’ international experience as the founder, lead
investor and/or Chair/Director of numerous healthcare companies. Most notably, Dr Brooke was a Managing Director and
Founder of leading life sciences venture capital firm, GBS Ventures - one of Asia Pacific’s premier investors in the healthcare
space. There, Dr Brooke was responsible for GBS’s healthcare venture activity in the region and raised $450 million in venture
and private equity funds, focused on biopharmaceuticals, medical devices and services.
Dr Brooke was also responsible for numerous investments and exits via NASDAQ and ASX public listings and trade sales, as
well as being lead investor in numerous investments syndicated in multiple rounds with premier US venture firms. Dr Brooke
was also President and Founder of US-based seed healthcare venture capital firm, Medvest Inc., with investors including the
venture capital arm of leading global multinational medical devices, pharmaceutical and consumer packaged goods
manufacturer, Johnson & Johnson. Medvest was focused on founding companies based upon healthcare-related technology,
including pharmaceuticals, biotechnology, therapeutic devices, medical services and information systems.
Dr Brooke now acts as a private investor in, and independent director for, a number of small to medium-sized Australian and
US private and public companies. He holds a Bachelor of Medicine and a Bachelor of Surgery from Melbourne University
(Australia) and a Masters of Business Administration from IMEDE (Switzerland), now IMD.
During the past three years Dr Brooke has served as a Director of the following ASX-listed companies:
•
Non-Executive Director of Acrux Limited (ASX:ACR) – Current
•
Non-Executive Chair of Cynata Therapeutics Limited (ASX:CYP) – Current
Dr Steven Gourlay
MBBS FRACP PhD MBA
Managing Director (appointed 24 March 2021)
Chief Executive Officer (appointed 15 March 2021)
Dr Gourlay has more than 30 years of experience in the development of novel therapeutics and brings considerable skills and
experience to Actinogen as the Company moves into advanced phase 2/3 clinical development of its lead compound
Xanamem. Formerly the founding Chief Medical Officer (CMO) at US-based Principia Biopharma Inc., Dr Gourlay was
responsible for the supervision of multiple pre-clinical, first-in-human, phase 2 and 3 clinical trial programs in orphan
immunological diseases, multiple sclerosis and cancer. The data generated by these trials, and Dr Gourlay’s roadshow
presentations, supported a successful NASDAQ IPO of Principia Biopharma Inc. in 2018 - subsequently followed by an
acquisition by Sanofi for US$3.7 billion in 2020.
Prior to Principia Biopharma, Dr Gourlay was a Partner at GBS Venture Partners, the Australian specialist life sciences and
healthcare venture capital firm, where he contributed to the success of multiple clinical stage therapeutic companies including
Elastagen, Spinifex and Peplin. Before GBS, and after a post doctorate in clinical pharmacology at the University of California,
San Francisco, he held positions of increasing responsibility at Genentech, Inc. in the areas of pharmacoepidemiology and early
clinical development.
Dr Gourlay has significant drug regulatory experience with the US Food and Drug Administration (FDA), European Medicines
Agency (EMA) at many levels, including filing more than 10 Investigational New Drug (IND) applications, achieving several
orphan drug status approvals for his Company's product(s), and completing several biologics license applications.
Dr Gourlay is based in Sydney and is an internal medicine physician with a Bachelor of Medicine, Bachelor of Surgery (MB,BS)
from the University of Melbourne, a PhD in Medicine from Monash University, and an MBA from Macquarie University.
Dr Gourlay has held no other ASX-listed directorships during the past three years.
Actinogen Medical Limited
24
Dr George Morstyn
MBBS FRACP PhD FTSE
Non-Executive Director (appointed 1 December 2017)
Dr Morstyn has more than 25 years’ experience in the biotechnology industry including as Senior Vice President of
Development and Chief Medical Officer at Amgen Inc. Dr Morstyn had overall responsibility globally for drug development in all
therapeutic areas including neuroscience at Amgen Inc. and was a member of the Operating Committee. Many new products
were approved and launched during Dr Morstyn’s tenure.
Prior to joining Amgen Inc. Dr Morstyn was the principal investigator on the earliest clinical studies of the haemopoietic colony
stimulating factors (CSF). The CSFs were subsequently approved and launched and were a major medical breakthrough that
have been used to reduce side effects of chemotherapy and enable transplantation in more than 20 million patients worldwide.
The CSFs have become multi-billion dollar drugs.
Since returning to Australia, Dr Morstyn has been a Non-Executive Director of various for-profit and not-for-profit companies,
including many biotechnology companies. Dr Morstyn is a medical graduate of Monash University (Australia) and obtained a
PhD at the Walter and Eliza Hall Institute of Medical Research (Australia) and a FRACP in Medical Oncology following a
Fellowship at the National Cancer Institute in the USA. Dr Morstyn is currently a director of SymBio (Tokyo) and an adviser to
TroBio, and a Director of PioTx. He is a Member of the Australian Institute of Company Directors and a Fellow of the Australian
Academy of Technological Sciences and Engineering.
Dr Morstyn has held no other ASX-listed directorships during the past three years.
Dr Vasquez joined Actinogen in March 2023. Dr Vasquez is an immunologist and biopharmaceutical executive with more than
30 years of biopharmaceutical discovery research and development experience. Dr Vasquez most recently served as Chief
Portfolio Strategy & Alliance Officer at Sutro Biopharma, a clinical stage oncology company in San Francisco where she was
responsible for program management, portfolio strategy, and alliance management.
Prior to joining Sutro, Dr Vasquez was Vice President of Program & Portfolio Management at StemCells, Inc., where she was
responsible for establishing project management of research and clinical stage programs exploring stem cell therapy for
Alzheimer’s disease, spinal cord injury and dry Age-related Macular Degeneration. Earlier in her career Dr Vasquez worked at
Elan Pharmaceuticals where she held positions of increasing responsibility in Alzheimer’s disease and autoimmune discovery
research, to Vice President Research Operations & Program Management, and Vice President Development Program & Portfolio
Management.
Dr Vasquez obtained her doctoral degree in immunology at the University of California, San Diego. Dr Vasquez is US-based
and strengthens the Actinogen Board with skills and experience in partnering and alliance management, strategic licensing, as
well as a strong depth of knowledge in clinical development. Dr. Vasquez is NACD Directorship Certified®, (National
Association of Corporate Directors, USA).
Dr Vasquez has held no other ASX-listed directorships during the past three years.
Mr McComas is a company director with experience in healthcare including drug development, clinical trials, the regulatory
environment and medical devices. Mr McComas was previously an investment banker with 30 year career experience in
financial services covering mergers and acquisitions, debt and equity funding across multiple industry sectors including
healthcare, FMCG, resources, financial services and privatisations.
Mr McComas has held leadership roles with Grant Samuel as Director, County NatWest (now Citigroup) as Managing Director
and Head of Corporate Finance and Morgan Grenfell (now Deutsche Bank) working in Australia and the UK. Previously, Mr
McComas was a lawyer at Herbert Geer specialising in tax and company law. Mr McComas has for-purpose experience as a
director of Australasian Leukaemia and Lymphoma Group (ALLG), the blood cancer clinical trials group and peak body
experience as past President of the Financial Services Institute of Australia. Mr McComas is a Fellow of the Australian Institute
of Company Directors and holds degrees in Law and Economics from Monash University (Australia).
During the past three years Mr McComas has served as a Director of the following ASX-listed companies:
•
Chair of Syntara Limited (ASX:SNT) – Resigned October 2023
•
Chair of Fitzroy River Corporation Limited (ASX:FZR) – Resigned December 2024
•
Non-Executive Director of Core Lithium Limited (ASX:CXO) – Current
Dr Nicki Vasquez (appointed 1 March 2023)
PhD, NACD.DC
Non-Executive Director (appointed 1 March 2023)
Mr Malcolm McComas
BEc, LLB (Monash), FAIDC
Non-Executive Director (appointed 4 April 2019)
Annual Financial Report
25
Dr Hilt joined Actinogen in February 2023 and has more than 25 years of drug development experience, primarily of Central
Nervous System (CNS) drugs. Dr Hilt has extensive experience in phases 1 to 4 of development for conditions including
Alzheimer’s disease, depression, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis, schizophrenia, and
other non-CNS conditions including CNS malignancies.
Dr Hilt gained his medical degree from Tufts University School of Medicine in Boston and trained in internal medicine at
Harvard Medical School and Neurology at the Johns Hopkins Hospital. He has held academic neurology positions at the
University of Maryland and University of Southern California where he conducted molecular biological research, taught clinical
neurology and basic neurobiology, and cared for patients with neurodegenerative conditions such as Alzheimer’s disease,
Parkinson’s disease, and ALS.
Dr Hilt was most recently the Chief Medical Officer at Frequency Therapeutics and has held senior development and
management positions as Chief Medical Officer at several pharmaceutical companies, including Lysosomal Therapeutics,
Guilford Pharmaceuticals, Ascend Pharmaceuticals, and Critical Therapeutics. Prior to that, Dr Hilt worked with Amgen,
establishing a Clinical Neuroscience Group that focused on the potential therapeutic applications of neurotrophic factors in
degenerative neurologic diseases such as Parkinson’s disease.
As part of Actinogen’s Leadership Team, US-based Dr Hilt brings world-leading expertise and experience to the role as an
eminent neurologist and a clinical trial specialist in Alzheimer’s disease, depression and other neurologic and neuropsychiatric
diseases.
Dr Steven Gourlay
MBBS FRACP PhD MBA
Chief Executive Officer (appointed 15 March 2021)
Executive leadership team
Dr Steven Gourlay
MBBS FRACP PhD MBA
Chief Executive Officer (appointed 15 March 2021)
Mr William Souter
Chief Financial Officer
Dr Dana Hilt
Chief Medical Officer
See biography on page 24.
Mr Souter joined Actinogen as full time Chief Financial Officer (CFO) in February 2024. He has extensive experience in an
executive and advisory capacity, particularly in capital markets and transaction environments using his commercial, legal,
strategic and financial skills.
Prior to joining Actinogen, Mr Souter was the CFO of Atomo Diagnostics Limited, where his leadership functions included
contributing to a successful capital raising and initial public offering (IPO), board advisor, managing the finance and investor
relations functions, and providing critical guidance on a range of corporate operations.
Mr Souter is also an experienced non-executive director having held numerous listed and unlisted positions. Previously, Mr
Souter was the CFO and Board Advisor at Verton Technologies Australia, an Executive Director at RFC Ambrian, and Director in
the Deals team at PricewaterhouseCoopers.
Mr Souter has a Bachelor of Laws and Commerce from the University of Adelaide, is a Graduate Member of the Australian
Institute of Company Directors and has a Graduate Diploma of Legal Practice (admitted to the Supreme Court of NSW).
Actinogen Medical Limited
26
Ms Townsend joined Actinogen in March 2022 and brings 30 years of international clinical research experience to the
Company, including senior positions in clinical operations and medical affairs in pharmaceutical companies and clinical
research organisations. Ms Townsend has worked across many therapeutic spheres ranging from phase 1 through phase 4
trials, including 10 years working in rare diseases. Most recently Ms Townsend held increasingly senior positions in clinical
operations at Alexion Pharmaceuticals Australasia.
Ms Townsend is a registered nurse with post graduate degrees in Nursing and Clinical Research as well as a Master’s degree in
Health Law. As part of the Actinogen team, Ms Townsend is responsible for Actinogen’s clinical operations and the successful
delivery of the company’s clinical trial program.
Ms Cheryl Townsend
Vice President of Clinical Operations
Dr Li joined Actinogen in February 2022, bringing over 30 years of experience in chemistry, manufacturing, and controls (CMC)
across all phases of drug development, and management of contract manufacturing organizations for both drug substance and
drug product development and manufacturing. Dr Li also has extensive experience in regulatory CMC, including the
preparation of CMC dossiers for regulatory submissions.
Prior to joining Actinogen, Dr. Li served as Vice President of Analytical and Pharmaceutical Development at Principia
Biopharma (a Sanofi company). Before that, she held several leadership roles in CMC at both large and small pharmaceutical
companies, including Executive Director at XenoPort and Research Leader at Roche.
Dr Li holds a Doctor of Philosophy in Environmental Medicine from New York University, Master of Science in Analytical
Chemistry from Chinese Academy of Sciences, and Bachelor of Science in Chemistry from Beijing University.
As part of the Actinogen team, Dr Li is responsible for Drug Manufacturing.
Dr Fujun Li
Head of Manufacturing
Mr Roberts joined Actinogen in May 2021 and is a corporate communications specialist with more than 25 years’ experience
working with prominent ASX 50 Australian companies including Brambles, Lion Nathan and Foster’s Group.
Mr Roberts built his early career in finance and treasury before moving into corporate communications, with specialist senior
executive roles in investor relations and corporate affairs. Prior to joining Actinogen, Mr Roberts was the Investor
Communications Director at Sydney design and branding agency Designate Group where he provided advisory and consulting
services to clients from a broad range of ASX listed companies and industries. Mr Roberts holds a Bachelor of Economics
(Hons) from Monash University and a Graduate Diploma of Applied Finance & Investment from the Financial Services Institute
of Australasia. Mr Roberts is a Certified Practising Accountant (CPA) and a Fellow of the Financial Services Institute of
Australasia (F FIN).
As part of the Actinogen Leadership Team, Mr Roberts heads the Company's investor relations and corporate communications
function.
Mr Michael Roberts
Investor Relations
Mr Udell joined Actinogen as Chief Commercial Officer in October 2024. He is a commercial leader with demonstrated success
taking biotech companies from the clinic through market planning, commercial readiness and full commercial integration.
Most recently Mr Udell was President, North America at Calliditas Therapeutics -beginning as the sole US employee and taking
this small Swedish biotech through phase 3, market readiness and a successful US company and product launch for a rare
disease (the company was acquired by Asahi Kasei Corporation in 2024). Prior to this experience, he was Vice President
Commercial for North America for Neuroderm prior to it being acquired by Mitsubishi Tanabe Pharma. In addition to rare
disease, he has experience working in the depression, Parkinson’s Disease, and other large CNS markets.
Mr Udell has a Bachelor of Science degree from Lehigh University and received a Master of Business Administration from the
University of Connecticut.
Mr Andrew Udell
Chief Commercial Officer
Annual Financial Report
27
Your Directors present their report pertaining to Actinogen Medical Limited
(‘Actinogen Medical’ or ‘the Company’) for the year ended 30 June 2025.
1.
BOARD OF DIRECTORS
The names and details of the Company’s Directors in office during the financial year and until the date of this report are
as follows. Directors were in office for the entire period, unless otherwise stated.
Name
Position
Appointed
Resigned
Dr Geoffrey Brooke
Non-Executive Chairman
1/03/2017
Current
Dr Steven Gourlay
Managing Director / Chief Executive Officer
24/03/2021
Current
Dr George Morstyn
Non-Executive Director
1/12/2017
Current
Mr Malcolm McComas
Non-Executive Director
4/04/2019
Current
Dr Nicki Vasquez
Non-Executive Director
1/03/2023
Current
Details of Directors qualifications and experience are set out on pages 24 to 25 of this annual report.
Interests in the shares and options of the Company and related bodies corporate
As at the date of this Report, the interests of the Directors in the shares, loan shares and options of the Company were as
follows:
Director
Fully paid
ordinary shares
Loan shares
(a)
Unlisted
options
Listed
options
Dr Geoffrey Brooke
6,022,072
22,500,000
1,101,592
1,250,001
Dr Steven Gourlay
61,565,848
89,362,300
4,842,647
25,000,000
Dr George Morstyn
8,141,463
7,500,000
981,287
1,250,001
Mr Malcolm McComas
2,671,836
7,500,000
424,808
750,000
Dr Nicki Vasquez
366,667
7,500,000
183,334
-
Total
78,767,886
134,362,300
7,533,668
28,250,002
(a) Loan shares are issued as ordinary shares that carry voting and divided rights. However, they also carry trading
restrictions and have therefore been accounted for as “in-substance options”. Refer to Section 11.3(C)(b)(ii) within the
Remuneration report for information on these loan shares.
2. DIRECTORS’ MEETINGS
The following table sets out the number of meetings of the Company’s directors held while each director was in office and the
number of meetings attended by each director.
Board of Directors
Number of meetings
available to attend
Number of meetings
attended
Dr Geoffrey Brooke
7
7
Dr Steven Gourlay
7
7
Dr George Morstyn
7
7
Mr Malcolm McComas
7
7
Dr Nicki Vasquez
7
7
Due to size and scale of the Company, there are no Remuneration or Nomination Committees at present. Matters typically dealt
with by these Committees are, for the time being, referred to the Board of Directors. The Company has an established Audit
and Risk Committee. In line with best practice corporate governance, the Audit and Risk Committee comprises independent
non-executive directors.
Directors’ report
Actinogen Medical Limited
28
Audit and Risk Committee
Number of meetings
available to attend
Number of meetings
attended
Mr Malcolm McComas
2
2
Dr Geoffrey Brooke
2
2
Dr George Morstyn
2
2
The Audit and Risk Committee charter is available on our website along with other corporate governance policies including the
main board charter. For details of the function of the Board please refer to the Corporate Governance Statement which is not
included as part of this Annual Report but can be referenced via the Company’s website.
3.
COMPANY SECRETARY
Mr Peter Webse (appointed 10 October 2013)
B.Bus, FGIA, FCG
Mr Webse joined Actinogen in 2013 and has over 30 years of company secretarial experience. Mr Webse is a Director of
Governance Corporate Pty Ltd, a company specialising in providing company secretarial, corporate governance, and corporate
advisory services. Mr Webse attended Edith Cowan University of Western Australia to obtain his degree in Accounting and
Finance. Mr Webse is a highly experienced company secretary and is a Fellow of the Governance Institute of Australia (FGIA),
and a Fellow of the Chartered Governance Institute (FCG).
4.
CORPORATE GOVERNANCE
The Board recognises the recommendations of the ASX Corporate Governance Council and has disclosed its level of compliance
with those guidelines within the Corporate Governance Statement which can be referenced via the Company’s website.
5.
SHARES UNDER OPTION
As at 30 June 2025, there were 621,275,626 unissued ordinary shares under option:
Quantity Type of Option
Grant Date
Exercise Price
Expiry Date
1,600,000 Unlisted employee options
28-09-20
$0.0460
27-09-25
85,775,526 Unlisted rights issue options
11-09-23
$0.0375
11-09-26
80,791,930 Unlisted shortfall options
15-09-23
$0.0375
15-09-26
175,545,902 Listed placement & rights issue options
14-05-24
$0.0500
31-05-27
277,562,268 Listed placement & share purchase plan options
30-09-24
$0.0500
30-09-27
621,275,626
Total unissued ordinary shares under option
For further information refer to the Remuneration Report and Note 16(c) Contributed Equity.
6.
DIVIDENDS
No amounts have been paid or declared by way of dividend since the date of incorporation. The Directors recommend that no
final dividend be paid.
7.
EVENTS SUBSEQUENT TO THE END OF FINANCIAL YEAR
No matter or circumstance has arisen since the end of the financial year which is not otherwise dealt with in this report that has
significantly affected or may significantly affect the operations of the Company, the results of those operations or the state of
affairs of the Company in subsequent financial years.
8.
SIGNIFICANT CHANGES IN THE STATE OF AFFAIRS
Other than as disclosed in the financial statements, there were no significant changes in the state of affairs of the Company
during the financial year.
Annual Financial Report
29
9.
OPERATING AND FINANCIAL REVIEW
Please refer to pages 14 to 22 of this annual report for information on the Company's principal activities, operations,
financial position, material risks and business strategy and outlook, and pages 12 and 13 for a summary of the Company’s
vision and strategy.
10. BUSINESS STRATEGY & OUTLOOK
Please refer to pages 21 and 22 of this annual report for information on the Company's business strategy and outlook. Please
also refer to pages 12 and 13 for a summary of the Company's vision and strategy.
Directors’ report
Actinogen Medical Limited
30
Remuneration report (audited)
11. REMUNERATION REPORT
The information contained in the Remuneration Report has been audited, as required by Section 308(3C) of the Corporations
Act 2001. The Remuneration Report is set out under the following main headings:
11.1
INTRODUCTION
The Remuneration Report details the remuneration arrangements for Key Management Personnel (KMP) who are defined as
those having authority and responsibility for planning, directing and controlling the major activities of the Company, directly or
indirectly, including any Director (whether executive or otherwise). The performance of the Company depends upon the
quality of its KMP. To prosper, the Company must attract, motivate and retain appropriately skilled Directors and executives.
The Company’s broad remuneration policy is to ensure the remuneration package properly reflects the person’s duties and
responsibilities and that remuneration is competitive in attracting, retaining and motivating people of the highest quality. The
people considered to be KMP during the financial year were:
Name
Position
Current / Resigned
Dr Geoffrey Brooke
Non-Executive Chairman
Current
Dr Steven Gourlay
Managing Director / Chief Executive Officer
Current
Dr George Morstyn
Non-Executive Director
Current
Mr Malcolm McComas
Non-Executive Director
Current
Dr Nicki Vasquez
Non-Executive Director
Current
Mr William Souter
Chief Financial Officer
Current
Dr Dana Hilt
Chief Medical Officer
Current
Mr Andrew Udell
Chief Commercial Officer
Current
There were no other changes to KMP after the reporting date and before the date that the financial report was authorised for
issue. All KMP's in the abovementioned table were KMPs for the full year, except for Mr Andrew Udell who was appointed as
Chief Commercial Officer on 15 October 2024.
11.1
Introduction
11.2
Remuneration governance
11.3
Remuneration arrangements
A. Remuneration principles and structures
B. Elements of remuneration
C. Details of short-term incentive and long-term incentive plans that existed during FY25
11.4
Key Management Personnel remuneration outcomes and performance during the financial year
11.5
Executive employment agreements
11.6
Non-Executive Director fee arrangements
11.7
Disclosures relating to shares
11.8
Disclosures relating to options and loan shares
11.9
Loans to Key Management Personnel and their related parties
11.10
Other transactions & balances with Key Management Personnel and their related parties
11.11
Consequences of performance on shareholder’s wealth
Annual Financial Report
31
Remuneration report (audited)
11.2
REMUNERATION GOVERNANCE
The Board has not established a separate Remuneration Committee at this point in the Company’s development nor has the
Board engaged the services of a remuneration consultant to provide recommendations when setting the remuneration received
by Directors. Therefore, remuneration of Directors is currently set by the Board of Directors, which is put to shareholders at the
Annual General Meeting (AGM). At the AGM held on 14 November 2024, Actinogen Medical received 91.26% of votes in favour
of its Remuneration Report for the 2024 financial year. The Company did not receive any specific feedback at the AGM or
throughout the year on its remuneration practices.
It is considered that the size of the Board, along with the level of activity of the Company, renders having a Remuneration
Committee impractical, and the full Board considers in detail all of the matters for which the Directors are responsible. All
matters of remuneration are performed in accordance with the Corporations Act 2001 requirements, especially in respect of
related party transactions. Refer to the Corporate Governance Statement located on the Company’s website for further
information.
11.3
REMUNERATION ARRANGEMENTS
(A) Remuneration principles and structures
The Company aims to reward executives with a level and mix of remuneration commensurate with their position and
responsibilities within the Company and aligned with market practice. The nature and amount of remuneration of executives is
assessed on a periodic basis by the Board (in the absence of a Remuneration Committee) for their approval, with the overall
objective of ensuring maximum stakeholder benefit from the retention of high performing executives.
The main objectives sought when reviewing executive remuneration is that the Company has:
•
coherent remuneration policies and practices to attract and retain executives
•
executives who will create value for shareholders
•
competitive remuneration offered benchmarked against the external market
•
fair and responsible rewards to executives having regard to the performance of the Company, the performance of the
executives and the general pay environment.
(B) Elements of remuneration
The Company aims to reward executives with a level and mix of remuneration appropriate to their position and responsibilities,
while being market competitive. The Company’s remuneration structure for executives can include a mix of fixed remuneration,
short term incentives and long-term incentives as outlined below.
Fixed remuneration component
Fixed remuneration is represented by total employment cost and comprises base salary, statutory superannuation
contributions (where applicable) and other benefits. It is paid by the Company to compensate fully for all requirements of the
executive’s employment with reference to the market and the individual’s role and experience. It is subject to annual review
considering market data and the performance of the Company against appropriate market comparisons with the comparator
group criteria being market capitalisation.
Short-term incentive (STI) component
The STI component is in the form of a cash bonus to executives of the Company (bonuses are also applicable to selected
employees).
Long-term incentive (LTI) component
The Board is of the opinion that the loan shares and options currently on issue provide a sufficient LTI to align the goals of the
KMP with those of the shareholders to maximise shareholder wealth.
Directors’ report
Actinogen Medical Limited
32
Details of how the STI and LTI is structured is outlined in the table below.
Short-Term Incentive (STI)
Long-Term Incentive (LTI)
How is it paid?
Up to 100% of any STI award is paid as a cash bonus
after the assessment of annual performance and
achievement of business goals.
The LTI component is in the form of employee
and Director options and/or loan shares upon
payment of a pre-determined exercise price.
How much can
executives
earn?
The majority of employees have a maximum STI
opportunity of 20% of fixed remuneration. Mr William
Souter (Chief Financial Officer), Dr Dana Hilt (Chief
Medical Officer) and Mr Andrew Udell (Chief
Commercial Officer) have a maximum STI opportunity
of 25% of fixed remuneration. Dr Steve Gourlay
(Managing Director/CEO) has a maximum STI
opportunity of 35% of fixed remuneration.
The LTI opportunity is at the discretion of the
Board. The value of options and/or loan shares
granted is determined using the fair value at the
date of grant using a Black Scholes option
pricing model, taking into account the terms
and conditions upon which the options and/or
loan shares were granted.
How is
performance
measured?
STI awards are determined based on the achievement
of annual Key Performance Indicator’s (“KPI’s”) and
individual performance. KPI’s and their relative
weightings for staff other than the CEO are suggested
by the Executive Leadership Team to the Board for
approval. KPIs for the CEO are set by the Board. A
semi-annual review is conducted with the Board and
amendments or additions to KPIs are made where
appropriate and necessary. KPI’s can include, but are
not limited to, the following: drug development, product
manufacture, patient enrolment, clinical development,
regulatory approvals, rebate incentives, business
development activities, grant submissions, corporate
communications, successful capital raising activities
and share-price performance.
LTI's vest according to vesting conditions set at
the date of grant. The performance measures
are tested at the end of each reporting period
where it is determined how many options
and/or loan shares have vested according to
the vesting conditions set. Options and/or loan
shares may lapse if the performance measures
are not met at the end of the performance
period.
When is it paid?
The STI award is determined after the end of the
financial year following a review of performance over
the year against the STI performance measures by the
Board (and in the case of the CEO, by the Non-
Executive Directors). The Board approves the final STI
award based on this assessment of performance.
Non-cash payment is in the form of vested
options and/or loan shares subject to vesting
conditions being achieved and the terms and
conditions upon which the options and/or loan
shares were granted.
What happens if
an executive
leaves?
If an executive ceases employment during the
performance period by reason of redundancy, ill health,
death, or other circumstances approved by the Board,
then subject to Board discretion, the executive may be
entitled to a pro-rata cash payment based on
assessment of performance up to the date of ceasing
employment for that year.
If an executive resigns or is terminated for
cause, any unvested LTI awards are forfeited,
unless otherwise determined by the Board. If an
executive ceases employment during the
performance period by reason of redundancy, ill
health, death, or other circumstances approved
by the Board, the executive will generally be
entitled to a pro-rata number of unvested
options and/or loan shares based on
achievement of the performance measures over
the period up to the date of ceasing
employment (subject to Board discretion). The
treatment of vested and unexercised awards
will be determined by the Board with reference
to the circumstances of cessation.
What happens if
there is a
change of
control?
In the event of a change of control, a pro-rata cash
payment may be made based on assessment of
performance up to the date of the change of control, at
the Board’s discretion.
In the event of a change of control, a pro-rata
assessment may be made up to the date of the
change of control. Further, under the terms and
conditions of the options and/or loan shares any
unvested awards may vest on a change of
control.
Annual Financial Report
33
Remuneration report (audited)
11.3
REMUNERATION ARRANGEMENTS
(C) Details of short-term incentive and long-term incentive plans that existed during FY25
During the financial year ended 30 June 2025, the Board of Directors had in place various Short-term Incentives and Long-
term Incentives which are outlined below.
(a) Short-term Incentives
The Board of Directors put in place various STIs that when achieved, a cash bonus is paid. Examples of such short-term
performance conditions include clinical development, pre-clinical development, product development, project analysis, patient
enrolments, studies, planning, regulatory, budgeting, data read-out, executed confidentiality agreements with potential
partners, drug development, regulatory plan, cash flow management, capital raising and share price movement. During the
2024 and the 2025 calendar years, the Board agreed that the following KMPs received a bonus due to meeting a number of
these short-term performance conditions:
Financial
year
Bonus $
(a)
STIs Met
STIs
Forfeited
Financial
year
Bonus $
(b)
STIs
Met
STIs
Forfeited
Dr Steven Gourlay
2024
$ 128,082
89%
11%
2025
$71,054
48%
53%
William Souter
2024
$ 28,045
87%
13%
2025
$69,319
83%
17%
Dr Dana Hilt
2024
$ 27,126
87%
13%
2025
$102,000
85%
15%
Mr Andrew Udell
-
-
-
-
2025
$55,675
85%
15%
(a) These cash bonuses were in connection with performance conditions met and accrued for in the 2024 financial year.
(b) These cash bonuses have been accrued at 30 June 2025 in connection with performance conditions met during the
2025 financial year. They will be paid during the quarter-end 30 September 2025.
(b) Long-term Incentives
The LTIs currently in place are in the form of loan shares and are summarised below:
Reference
Type of LTI
Relating to KMP
(ii)
Loan shares
204,362,300
Total loan shares on issue
204,362,300
(i)
Director options
During the year ended 30 June 2025, the only director options on issue were 5,000,000 options issued to Dr Brooke. These
fully vested in a prior period and expired on 24 March 2025.
A summary of terms and conditions are outlined below:
Director Options
Director
Geoff Brooke
Grant Date
24/03/2017
Quantity
5,000,000
Exercise Price
$0.100
Expiry Date
24/03/2025
Status
Expired
Directors’ report
Actinogen Medical Limited
34
(ii) Loan shares
As at 30 June 2025, the following KMP held the following loan shares issued to them under an employee incentive scheme
called the Employee Share Plan (‘Plan’). The specific details, vesting conditions and a summary of terms and conditions are
outlined below:
Loan shares issued to Directors
Director
Steven Gourlay
Steven Gourlay
Geoff Brooke
George Morstyn
Malcolm McComas
Grant Date
15/03/2021
15/03/2021
18/11/2021
18/11/2021
18/11/2021
Quantity
24,181,150
24,181,150
2,500,000
1,000,000
1,000,000
Exercise Price
$0.035
$0.045
$0.20
$0.20
$0.20
Expiry Date
15/03/2026
15/03/2026
18/11/2026
18/11/2026
18/11/2026
Vesting Condition
Refer (a)
Refer (a)
Refer (b)
Refer (b)
Refer (b)
Loan shares issued to Other KMP
Other KMP
Dana Hilt
Dana Hilt
William Souter
Dana Hilt
William Souter
Andrew Udell
Grant Date
20/03/2023
8/11/2023
9/2/2024
16/12/2024
16/12/2024
16/12/2024
Quantity
10,000,000
8,000,000
18,000,000
7,000,000
12,000,000
15,000,000
Exercise Price
$0.085
$0.022
$0.038
$0.035
$0.035
$0.035
Expiry Date
19/03/2028
7/11/2028
8/2/2029
16/12/2029
16/12/2029
16/12/2029
Vesting Condition
Refer (b)
Refer (b)
Refer (b)
Refer (b)
Refer (b)
Refer (b)
(a) Loan shares to vest over 3 years, with 1/4 vesting after 12 months from Grant Date and the remainder to vest in equal
monthly increments over the remaining 24 months.
(b) Loan shares to vest over 3 years, with 1/3 vesting after 12 months from Grant Date and the remainder to vest in equal
quarterly increments over the remaining 24 months.
There must be continuity of employment to receive the vesting benefits. While there are no performance conditions attached
to these loan shares, the awards are to provide adequate incentive for continued service to the Company.
They have been valued using a Black-Scholes option pricing model, whereby the total share-based payment is being expensed
over the vesting period. Refer to Note 22: Share-based Payments for further information.
Loan shares issued to Directors
Director
Steven Gourlay
Geoff Brooke
George Morstyn
Malcolm McComas
Nicki Vasquez
Grant Date
1/12/2023
1/12/2023
1/12/2023
1/12/2023
1/12/2023
Quantity
20,000,000
12,000,000
4,500,000
4,500,000
5,500,000
Exercise Price
$0.03125
$0.03125
$0.03125
$0.03125
$0.03125
Expiry Date
30/11/2028
30/11/2028
30/11/2028
30/11/2028
30/11/2028
Vesting Condition
Refer (b)
Refer (b)
Refer (b)
Refer (b)
Refer (b)
Loan shares issued to Directors
Director
Steven Gourlay
Geoff Brooke
George Morstyn
Malcolm McComas
Nicki Vasquez
Grant Date
24/3/2025
24/3/2025
24/3/2025
24/3/2025
24/3/2025
Quantity
21,000,000
8,000,000
2,000,000
2,000,000
2,000,000
Exercise Price
$0.0425
$0.0425
$0.0425
$0.0425
$0.0425
Expiry Date
24/03/2030
24/03/2030
24/03/2030
24/03/2030
24/03/2030
Vesting Condition
Refer (b)
Refer (b)
Refer (b)
Refer (b)
Refer (b)
Annual Financial Report
35
Remuneration report (audited)
11.3
REMUNERATION ARRANGEMENTS
(ii) Loan shares
Summary terms & conditions:
•
loan shares are issued by way of provision of a limited recourse loan.
•
the shares carry voting and dividend rights however they also carry a restriction on being able to trade.
•
the total subscription price of the loan shares issued to each officer is the total number of loan shares multiplied by the
exercise price, which equates to the “Loan Amount”. However, given that these shares are considered to be “in-substance
options” or “rights” under AASB 2 Share-based Payment, no loan amount is recognised in the financial statements.
•
the loan may only be applied towards the subscription price for the loan shares.
•
the loan is interest free, provided that if the loan is not repaid by the repayment date set by the Board, the loan will incur
interest at a default interest rate per annum after that date which will accrue on a daily basis and compounds annually on
the then outstanding loan balance.
•
by signing and returning a limited recourse loan application, the participant of the Plan acknowledges and agrees that the
loan shares will not be transferred, encumbered, otherwise disposed of, or have a security interest granted over it, by or
on behalf of the Participant until the loan is repaid in full to the Company.
•
the Company has security over the loan shares as security for repayment of the loan;
•
the Outstanding Loan Balance becomes due and payable (unless extended by the Company in its absolute discretion) on
the first to occur of the following:
(a) 90 days after the Continuous Employment (or other permitted engagement) of the Participant ceases for any reason,
(b) by the legal personal representative of the Participant, 120 days after the Participant ceases to be an employee,
officer or director of the Company due to their death, and
(c) the Repayment Date: which is 5 years from the date on which the Company advances the loan to the Participant.
Directors’ report
Actinogen Medical Limited
36
11.4
KEY MANAGEMENT PERSONNEL REMUNERATION OUTCOMES AND PERFORMANCE
DURING THE FINANCIAL YEAR
During the financial years ended 30 June 2025 and 30 June 2024 (as set out in Table 1 and Table 2, respectively), KMP’s
received either or all of the following benefits: short-term benefits: cash salary, cash fees and cash bonuses, termination
benefits, post-employment benefits, other benefits, and share-based payments. All remuneration has been valued at the cost
to the Company and expensed.
Table 1: Remuneration of KMP for the year ended 30 June 2025
Key Management
Personnel
Short-term
benefits
Termination
benefits
Post-
employment
Other
benefits
Share-based
payments
Percentage of Total
Year ended
30 June 2025
Cash,
salary
and fees
$
Cash
Bonus
$ (c)
Termination
payments
$
Super-
annuation
$
Accrued
leave
benefits
$
Loan
shares
$
Total
$
SBP-
related
Perfor-
mance-
related
Geoffrey Brooke (a)
109,633
-
-
12,608
-
137,759
260,000
53%
53%
Steven Gourlay
427,393
71,054
-
29,932
33,920
255,693
817,992
31%
40%
George Morstyn (a)
72,029
-
-
-
-
47,412
119,441
40%
40%
Malcolm McComas (a)
72,029
-
-
-
-
47,412
119,441
40%
40%
Nicki Vasquez (a)
72,029
-
-
-
-
53,863
125,892
43%
43%
William Souter
334,068
69,319
29,932
26,513
287,871
747,703
39%
48%
Dana Hilt
481,123 102,000
-
28,292
39,540
193,139
844,094
23%
35%
Andy Udell (b)
267,529
55,675
-
25,958
23,656
116,066
488,884
24%
35%
Total KMP (d)
1,835,833 298,048
-
126,722
123,629
1,139,215 3,523,447
(a)
The total Non-Executive Director fees including superannuation during the year totalled $338,328.
(b)
Mr Andrew Udell was appointed as Chief Commercial Officer (CCO) on 15 October 2024.
(c)
For further information on short-term incentive cash bonuses, refer to Section 11.3(C)(a).
(d)
For detailed information of KMP employment arrangements, refer to Section 11.5 and Section 11.6 of the Remuneration Report.
Table 2: Remuneration of KMP for the year ended 30 June 2024
Key Management
Personnel
Short-term
benefits
Termination
benefits
Post-
employment
Other
benefits
Share-based
payments
Percentage of Total
Year ended
30 June 2024
Cash,
salary
and fees
$
Cash
Bonus
$ (d)
Termination
payments
$
Super-
annuation
$
Accrued
leave
benefits
$
Loan
shares
$
Total
$
SBP-
related
Perfor-
mance-
related
Geoffrey Brooke (a)
105,416 - - 11,596
-
117,376 234,388
50%
50%
Steven Gourlay
412,337 128,082 - 27,399 34,361
151,932 754,111
20%
37%
George Morstyn (a)
69,258 - - -
-
45,009 114,267
39%
39%
Malcolm McComas (a)
69,258 - - -
-
45,009 114,267
39%
39%
Nicki Vasquez (a)
69,297 - - -
-
35,576 104,873
34%
34%
William Souter (b)
131,857 28,045
11,416
11,201
96,314 278,833
35%
45%
Tamara Miller (c)
79,681 -
155,223 9,133 6,324
35,802 286,163
13%
13%
Jeff Carter (c)
62,260 - - -
-
1,569 63,829
2%
2%
Dana Hilt (e)
422,849 93,997 - 34,027 35,503
326,897 913,273
36%
46%
Total KMP (f)
1,422,213 250,124
155,223 93,571 87,389
855,484 2,864,004
(a)
The total Non-Executive Director fees including superannuation during the year totalled $324,825.
(b)
Mr William Souter was appointed as Chief Financial Officer (CFO) on 5 February 2024.
(c)
Ms Tamara Miller was made redundant from her position of Senior Vice President of Product Development on 29 September 2023, and Mr
Jeff Carter ceased providing consultancy CFO services on 30 November 2023.
(d)
For further information on short-term incentive cash bonuses, refer to Section 11.3(C)(a).
(e)
Dr Hilt’s cash bonus comprises: $66,871 that relates to the current year ended 30 June 2024 plus $27,126 that relates to the prior year
ended 30 June 2023 but was not accrued for at the time and instead was recorded and paid in the current period.
(f)
For detailed information of KMP employment arrangements, refer to Section 11.5 and Section 11.6 of the Remuneration Report.
Annual Financial Report
37
Remuneration report (audited)
11.5
EXECUTIVE EMPLOYMENT AGREEMENTS
During the financial year the following executives were remunerated for their roles in the Company and were subject to the
following contractual arrangements:
Dr Steven Gourlay – Managing Director and Chief Executive Officer
•
Commencement of employment: 15 March 2021
•
Remuneration: A total employment cost basis of $457,235 per annum (inclusive of superannuation guarantee) with four
weeks annual leave entitlement. With effect from 1 July 2025, the total employment cost basis was increased to $468,759
(inclusive of superannuation guarantee).
•
A specific short-term incentive component is also provided for within the Managing Director’s remuneration package.
Currently this an annual bonus subject to satisfying performance objectives to be determined by the Board in its discretion
annually. The target incentive bonus will be up to a maximum of 35% of Base Salary and the Board's determination of
whether the performance objectives have been achieved will be final and binding on the Employee. The Board may (but
without assuming any obligation in future periods) for an exceptional performance in any year as determined by the Board
in its discretion, award a bonus in excess of 35% of Base Salary.
Mr William Souter – Chief Financial Officer
•
Commencement of employment: 5 February 2024
•
Remuneration: A total employment cost basis of $364,000 per annum (inclusive of superannuation guarantee) with four
weeks annual leave entitlement, prorated to the date of commencement of employment. With effect from 1 July 2025, the
total employment cost basis was increased to $373,100 (inclusive of superannuation guarantee).
•
A specific short-term incentive component is also provided for within the remuneration package, subject to satisfying
performance objectives to be determined by the Board in its discretion annually. The target incentive bonus will be up to a
maximum of 25% of Base Salary and the Board's determination of whether the performance objectives have been
achieved will be final and binding on the Employee.
The following term and termination clauses apply to both Dr Gourlay and Mr Souter:
•
Term: Appointment will continue on an ongoing basis unless terminated earlier in accordance with termination provisions.
•
Termination: The Company or the individual may terminate the contract by giving three months’ written notice. In the
event of breach or criminal activity, termination is effective immediately without payment other than the fee accrued to
the date of termination.
Dr Dana Hilt – Chief Medical Officer
•
Commencement of employment: 1 February 2023
•
Remuneration: An employment cost basis of USD $312,000 (plus statutory employment and healthcare contributions) for
working a 0.70 full-time equivalent role. With effect from 1 July 2025, the total employment cost basis was increased to
USD $319,800 (plus statutory employment and healthcare contributions).
Mr Andrew Udell – Chief Commercial Officer
•
Commencement of employment: 15 October 2024
•
Remuneration: An employment cost basis of USD $240,000 (plus statutory employment and healthcare contributions) for
working a 0.68 full-time equivalent role. With effect from 1 July 2025, the total employment cost basis was increased to
USD $246,000 (plus statutory employment and healthcare contributions).
The following short-term incentive and termination clause apply to both Dr Hilt and Mr Udell
•
A specific short-term incentive component is also provided for within the remuneration package, subject to satisfying
performance objectives to be determined by the Board in its discretion annually. The target incentive bonus will be up to a
maximum of 25% of Base Salary, prorated to commencement of employment (in Mr Udell’s instance) and the Board's
determination of whether the performance objectives have been achieved will be final and binding on the Employee.
•
Termination: The Company or Consultant may terminate the contract by giving thirty day’s written notice. In the event of
breach or criminal activity, termination is effective immediately without payment other than the fee accrued to the date of
termination.
Directors’ report
Actinogen Medical Limited
38
11.6
NON-EXECUTIVE DIRECTOR FEE ARRANGEMENTS
Non-Executive Directors
Non-Executive Directors are remunerated by way of fees, in the form of cash, non-cash benefits and superannuation
contributions and do not normally participate in schemes designed for the remuneration of executives. As noted above, fees
for Non-Executive Directors are generally not directly linked to the performance of the Company, however, to align Directors’
interests with shareholder interests, the Directors are encouraged to hold shares in the Company.
The maximum aggregate remuneration approved by shareholders for Non-Executive Directors, at an Annual General Meeting
held on 12 November 2015, is $500,000 per annum. The Directors set the individual Non-Executive Directors fees within the
limit approved by shareholders. Total fees, including superannuation, paid to Non-Executive Directors during the year were
$338,328. During the financial year the following Non-Executive Directors were remunerated for their respective roles and
were subject to the following contractual arrangements:
Dr Geoffrey Brooke – Non-Executive Chairman – Appointed 1 March 2017
•
Director Fees set at $109,633 per annum (plus GST and superannuation guarantee) with effect from 1 July 2024. Subject
to annual review, it was determined that these fees increase to $109,633 per annum (plus GST and superannuation
guarantee) with effect from 1 July 2025.
Dr George Morstyn – Non-Executive Director - Appointed 1 December 2017
•
Director Fees set at $72,029 per annum (plus GST and exclusive of superannuation) with effect from 1 July 2024. Subject
to annual review, it was determined that these fees increase to $73,829 per annum (plus GST and exclusive of
superannuation guarantee) with effect from 1 July 2025.
Mr. Malcolm McComas – Non-Executive Director- Appointed 4 April 2019
•
Director Fees set at $72,029 per annum (plus GST and exclusive of superannuation) with effect from 1 July 2024. Subject
to annual review, it was determined that these fees increase to $73,829 per annum (plus GST and exclusive of
superannuation guarantee) with effect from 1 July 2025.
Dr Nicki Vasquez – Non-Executive Director- Appointed 1 March 2023
•
Director Fees set at $72,029 per annum with effect from 1 July 2024. Dr Vasquez is US-based therefore GST and
superannuation are not applicable. Subject to annual review, it was determined that these fees increase to $73,829 per
annum with effect from 1 July 2025.
In all instances, the abovementioned Non-Executive Directors appointments are subject to retirement by rotation under the
Company’s Constitution. Additionally, their termination may arise if the other members of the Board request that the officer
resign with immediate effect in the event that the Board deems the individual’s performance unsatisfactory, or the Company’s
shareholders may resolve to seek the officer’s removal by members’ resolution. Alternatively, the individual may resign from
the Board.
Annual Financial Report
39
Remuneration report (audited)
11.7
DISCLOSURES RELATING TO SHARES
The shareholding of KMP as at 30 June 2025 is as follows:
KMP
Balance at
beginning of
year 1/7/2024
Granted as
remuneration
On
exercise
of options
Accounted
for as
options (a)
Net change
other (b)
Balance at end
of year
30/6/2025
Geoffrey Brooke
4,355,404
-
-
-
1,666,668
6,022,072
Steven Gourlay
28,232,514
-
-
-
33,333,334
61,565,848
George Morstyn
6,474,795
-
-
-
1,666,668
8,141,463
Malcolm McComas
1,671,836
-
-
-
1,000,000
2,671,836
Nicki Vasquez
366,667
-
-
-
-
366,667
William Souter
400,000
-
-
-
295,774
695,774
Dana Hilt
-
-
-
-
-
-
Andrew Udell
-
-
-
-
-
-
Total share holding
41,501,216
-
-
-
37,962,444
79,463,660
(a)
Loan Shares on issue, although issued as ordinary shares that carry voting and dividend rights, also carry a restriction on
being able to trade and have therefore, been accounted for as “in-substance options”. Refer to Section 11.3(C)(b)(ii)
within the Remuneration Report for information on these Loan Shares, and Section 11.7 for how these shares have been
accounted for as options in respect of value and quantity.
(b)
During the year, various KMP participated in, and purchased placement shares on 24 September 2024. These placement
shares were issued with 28,471,833 free attaching listed options at a strike price of $0.05 each. For directors
participating, their shares were allotted following shareholder approval on 4 November 2024.
11.8
DISCLOSURES RELATING TO OPTIONS AND LOAN SHARES
At the date of this Report, the unissued ordinary shares of Actinogen Medical under option carry no dividend or voting rights.
When exercisable, each option is convertible into one fully paid ordinary share of the Company. Loan Shares on issue, although
issued as ordinary shares that carry voting and dividend rights, also carry a restriction on being able to trade.
Refer below to table (i) for the quantity of options and loan shares held by KMP as at 30 June 2025; and table (ii) for value of
options and loan shares awarded, vested and lapsed during the financial year.
Directors’ report
Actinogen Medical Limited
40
(i)
Quantity of option and loan share holdings of KMP as at 30 June 2025
KMP
Unit
Price
($)
Grant
Date
Expiry
Date
Balance at
beginning of year
1 July 2024
Granted as
remuneration
Net
change other
Balance at
end of year
30 June 2025
Vested at
beginning of year
1 July 2024 (a)
Vested
during
the year
Vested at
end of year
30 June 2025
Unvested at
end of year
30 June 2025
G. Brooke
Options (expired)
0.10000
24-03-17
24-03-25
5,000,000
-
(5,000,000)
-
-
-
-
-
Loan Shares
0.20000
18-11-21
18-11-26
2,500,000
-
-
2,500,000
2,500,000
-
2,500,000
-
Loan Shares
0.03125
01-12-23
30-11-28
12,000,000
-
-
12,000,000
-
5,250,000
5,250,000
6,750,000
Loan Shares
0.04250
14-03-25
24-03-30
-
8,000,000
-
8,000,000
-
-
-
8,000,000
9,500,000
8,000,000
(5,000,000)
22,500,000
2,500,000
5,250,000
7,750,000
14,750,000
S. Gourlay
Loan Shares
0.03500
15-03-21
15-03-26
24,181,150
-
-
24,181,150
24,181,150
-
24,181,150
-
Loan Shares
0.04500
15-03-21
15-03-26
24,181,150
-
-
24,181,150
24,181,150
-
24,181,150
-
Loan Shares
0.03125
01-12-23
30-11-28
20,000,000
-
-
20,000,000
-
8,750,000
8,750,000
11,250,000
Loan Shares
0.04250
14-03-25
24-03-30
-
21,000,000
-
21,000,000
-
-
-
21,000,000
68,362,300
21,000,000
-
89,362,300
48,362,300
8,750,000
57,112,300
32,250,000
G. Morstyn
Loan Shares
0.20000
18-11-21
18-11-26
1,000,000
-
-
1,000,000
1,000,000
-
1,000,000
-
Loan Shares
0.03125
01-12-23
30-11-28
4,500,000
-
-
4,500,000
-
1,968,750
1,968,750
2,531,250
Loan Shares
0.04250
14-03-25
24-03-30
-
2,000,000
-
2,000,000
-
-
-
2,000,000
5,500,000
2,000,000
-
7,500,000
1,000,000
1,968,750
2,968,750
4,531,250
M. McComas
Loan Shares
0.20000
18-11-21
18-11-26
1,000,000
-
-
1,000,000
1,000,000
-
1,000,000
-
Loan Shares
0.03125
01-12-23
30-11-28
4,500,000
-
-
4,500,000
-
1,968,750
1,968,750
2,531,250
Loan Shares
0.04250
14-03-25
24-03-30
-
2,000,000
-
2,000,000
-
-
-
2,000,000
5,500,000
2,000,000
-
7,500,000
1,000,000
1,968,750
2,968,750
4,531,250
N. Vasquez
Loan Shares
0.03125
01-12-23
30-11-28
5,500,000
-
-
5,500,000
-
2,406,250
2,406,250
3,093,750
Loan Shares
0.04250
14-03-25
24-03-30
-
2,000,000
-
2,000,000
-
-
-
2,000,000
5,500,000
2,000,000
-
7,500,000
-
2,406,250
2,406,250
5,093,750
W. Souter
Loan Shares
0.03800
09-02-24
08-02-29
18,000,000
-
-
18,000,000
-
7,500,000
7,500,000
10,500,000
Loan Shares
0.03500
16-12-24
16-12-29
-
12,000,000
-
12,000,000
-
-
-
12,000,000
18,000,000
12,000,000
-
30,000,000
-
7,500,000
7,500,000
22,500,000
D. Hilt
Loan Shares
0.08500
20-03-23
19-03-28
10,000,000
-
-
10,000,000
4,166,667
3,333,333
7,500,000
2,500,000
Loan Shares
0.02200
08-11-23
07-11-28
8,000,000
-
-
8,000,000
-
-
-
8,000,000
Loan Shares
0.03500
16-12-24
16-12-29
-
7,000,000
-
7,000,000
-
-
-
7,000,000
18,000,000
7,000,000
-
25,000,000
4,166,667
3,333,333
7,500,000
17,500,000
A.Udell
Loan Shares
0.03500
16-12-24
16-12-29
-
15,000,000
-
15,000,000
-
-
-
15,000,000
-
15,000,000
-
15,000,000
-
-
-
15,000,000
Total KMP Holding
140,362,300
69,000,000
(5,000,000)
204,362,300
57,028,967
31,177,083
88,206,050
116,156,250
(a)
Prior year 30 June 2024 vested closing balance was 69,381,567. At 1 July 2024, the opening balance is 57,028,967. The difference of 12,352,600 is due to 7,352,600 loan shares held by former KMP employees, and
5,000,000 options expiring during the year.
Annual Financial Report
41
(ii) Value of options and loan shares awarded and lapsed during the financial year
KMP
Unit
Price
($)
Financial
Year
Balance as at
1 July 2024
(quantity)
Expired
(quantity)
Balance as at
30 June 2025
(quantity)
Fair value
per option /
loan share
($)
Total
Share-based
payment (SBP)
valuation ($)
Total SBP
expensed
as at
1 July 2024 ($)
Value SBP
recognised
during
the year ($)
Total SBP
expensed
as at
30 June 2025 ($)
Value SBP to be
recognised
in future
years ($)
Remuneration
consisting of
loan shares for
the year (%)
G. Brooke
Options
0.10000
2017
5,000,000
(5,000,000)
-
0.04906
245,285
245,285
-
245,285
-
-
Loan Shares
0.20000
2022
2,500,000
-
2,500,000
0.11881
297,026
292,634
4,392
297,026
-
2%
Loan Shares
0.03125
2024
12,000,000
-
12,000,000
0.01760
211,200
77,622
98,500
176,122
35,078
38%
Loan Shares
0.04250
2025
8,000,000
-
8,000,000
0.02070
165,600
-
34,867
34,867
130,733
13%
27,500,000
(5,000,000)
22,500,000
919,111
615,541
137,759
753,300
165,811
53%
S. Gourlay
Loan Shares
0.03500
2021
24,181,150
-
24,181,150
0.01584
383,027
383,027
-
383,027
-
0%
Loan Shares
0.04500
2021
24,181,150
-
24,181,150
0.01451
350,963
350,963
-
350,963
-
0%
Loan Shares
0.03125
2024
20,000,000
-
20,000,000
0.01760
352,000
129,370
164,167
293,537
58,463
26%
Loan Shares
0.04250
2025
21,000,000
-
21,000,000
0.02070
434,700
-
91,526
91,526
343,174
14%
89,362,300
-
89,362,300
1,520,690
863,360
255,693
1,119,053
401,637
40%
G. Morstyn
Loan Shares
0.20000
2022
1,000,000
-
1,000,000
0.11881
118,810
117,053
1,757
118,810
-
1%
Loan Shares
0.03125
2024
4,500,000
-
4,500,000
0.01760
79,200
29,108
36,938
66,046
13,154
31%
Loan Shares
0.04250
2025
2,000,000
-
2,000,000
0.02070
41,400
-
8,717
8,717
32,683
7%
7,500,000
-
7,500,000
239,410
146,161
47,412
193,573
45,837
40%
M. McComas
Loan Shares
0.20000
2022
1,000,000
-
1,000,000
0.11881
118,810
117,053
1,757
118,810
-
1%
Loan Shares
0.03125
2024
4,500,000
-
4,500,000
0.01760
79,200
29,108
36,938
66,046
13,154
31%
Loan Shares
0.04250
2025
2,000,000
-
2,000,000
0.02070
41,400
-
8,717
8,717
32,683
7%
7,500,000
-
7,500,000
239,410
146,161
47,412
193,573
45,837
40%
N. Vasquez
Loan Shares
0.03125
2024
5,500,000
-
5,500,000
0.01760
96,800
35,576
45,146
80,722
16,078
36%
Loan Shares
0.04250
2025
2,000,000
-
2,000,000
0.02070
41,400
-
8,717
8,717
32,683
7%
7,500,000
-
7,500,000
138,200
35,576
53,863
89,439
48,761
43%
W. Souter
Loan Shares
0.03800
2024
18,000,000
-
18,000,000
0.02031
365,511
96,314
195,018
291,332
74,179
32%
Loan Shares
0.03500
2025
12,000,000
-
12,000,000
0.02156
258,745
-
92,853
92,853
165,892
15%
30,000,000
-
30,000,000
624,256
96,314
287,871
384,185
240,071
48%
D. Hilt
Loan Shares
0.08500
2023
10,000,000
-
10,000,000
0.04940
494,036
378,730
94,761
473,491
20,545
17%
Loan Shares
0.02200
2024
8,000,000
-
8,000,000
0.01260
100,800
41,055
44,214
85,269
15,531
8%
Loan Shares
0.03500
2025
7,000,000
-
7,000,000
0.02156
150,934
-
54,164
54,164
96,770
10%
25,000,000
-
25,000,000
745,770
419,785
193,139
612,924
132,846
35%
A.Udell
Loan Shares
0.03500
2025
15,000,000
-
15,000,000
0.02156
323,431
-
116,066
116,066
207,365
35%
15,000,000
-
15,000,000
323,431
-
116,066
116,066
207,365
35%
Total KMP Holding
209,362,300
(5,000,000))
204,362,300
-
4,750,278
2,322,898
1,139,215
3,462,113
1,288,165
Actinogen Medical Limited
42
Remuneration report (audited)
11.9
LOANS TO KMP AND THEIR RELATED PARTIES
During the year, limited recourse interest free loans were provided to KMP’s in the form Loan Shares. Due to the nature of
these loans, they were not accounted for as loans, rather they were accounted for as “in-substance options”. Refer to the
Remuneration Report: Section 11.3(C)(b)(ii) for further information. As at 30 June 2025, there are no other loans held with any
other KMP or any of their related entities.
11.10 OTHER TRANSACTIONS AND BALANCES WITH KMP AND THEIR RELATED PARTIES
There were no other transactions with any Director or KMP or any of their related entities during the year.
11.11 CONSEQUENCES OF PERFORMANCE ON SHAREHOLDER’S WEALTH
The table below sets out the performance of the Company and the consequences of share price performance on shareholders’
wealth over the past five years as at 30 June year end. No dividends have been declared or paid in the current or prior years.
2025
2024
2023
2022
2021
2020
Quoted price of ordinary shares at year end (cents)
2.3
6.0
5.0
5.0
12.0
2.2
Loss per share (cents)
0.49
0.60
0.60
0.55
0.28
0.48
End of Remuneration report (Audited)
12. INDEMNIFICATION OF AUDITOR
To the extent permitted by law, the Company has agreed to indemnify its auditor, Ernst & Young, as part of the terms of its
audit engagement agreement against claims by third parties arising from the audit (for an unspecified amount). No payment
has been made to indemnify Ernst & Young during or since the financial year.
13. INDEMNIFICATION AND INSURANCE OF DIRECTORS AND OFFICERS
During the financial year, Actinogen Medical paid a total of $88,165 including stamp duty to insure the Directors and Officers of
the Company. The liabilities insured are legal costs that may be incurred in defending civil or criminal proceedings that may be
brought against the officers in their capacity as officers in the Company, and any other payments arising from liabilities
incurred by the officers in connection with such proceedings. This does not include such liabilities that arise from conduct
involving ha wilful breach of duty by the officers or the improper use by the officers of their position or of information to gain
advantage for themselves or someone else or to cause detriment to the Company. It is not possible to apportion the premium
between amounts relating to the insurance against legal costs and those relating to other liabilities.
14. PROCEEDINGS ON BEHALF OF THE COMPANY
No person has applied for leave of Court, under section 237 of the Corporations Act 2001, to bring proceedings on behalf of
the Company or intervene in any proceedings to which the Company is party for the purpose of taking responsibility on behalf
of the Company for all or part of these proceedings. The Company was not a party to any such proceedings during the year.
15. ENVIRONMENTAL REGULATIONS
The Company's operations are not subject to significant environmental regulation under the Australian Commonwealth or State
law.
16. AUDIT & NON-AUDIT SERVICES
Total amounts paid or payable to the external auditor and its associated entities for an audit or review of the financial
statements of the Company during the financial year ended 30 June 2025 totalled $89,281 (2024: $82,680). Total non-audit
services paid to the external auditor and its associated entities during the year ended 30 June 2025 was $Nil (2024: $Nil).
17. AUDITOR’S INDEPENDENCE DECLARATION
The Auditor’s Independence Declaration as required under section 307C of the Corporations Act 2001 for the year ended 30
June 2025 forms a part of the Directors’ Report and can be found on page 44. Signed in accordance with a resolution of the
Board of Directors.
Dr Steven Gourlay
Managing Director
Sydney, New South Wales
25 August 2025
Directors’ report
Annual Financial Report
43
Auditor’s independence declaration
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Ernst & Young
9 The Esplanade
Perth WA 6000 Australia
GPO Box M939 Perth WA 6843
Tel: +61 8 9429 2222
Fax: +61 8 9429 2436
ey.com/au
Auditor’s independence declaration to the directors of Actinogen
Medical Limited
As lead auditor for the audit of the financial report of Actinogen Medical Limited for the financial year
ended 30 June 2025, I declare to the best of my knowledge and belief, there have been:
a.
No contraventions of the auditor independence requirements of the Corporations Act 2001 in
relation to the audit;
b.
No contraventions of any applicable code of professional conduct in relation to the audit; and
c.
No non-audit services provided that contravene any applicable code of professional conduct in
relation to the audit.
Ernst & Young
Timothy Dachs
Partner
25 August 2025
Actinogen Medical Limited
44
Statement of comprehensive income
Statement of financial position
Statement in changes of equity
Statement of cash flows
Notes to the financial statements
1
Corporate information
2
Summary of material accounting policies
3
Segment information
4
Financial risk management
5
Critical accounting estimates and judgements
6
Other income and expenses
7
Income tax
8
Cash and cash equivalents
9
Other receivables and prepayments
10
Property, plant and equipment
11
Right-of-use asset & lease liability
12
Intangible assets
13
Trade and other payables
14
Interest-bearing loan
15
Losses per share
16
Contributed equity
17
Reserves
18
Remuneration of auditor
19
Commitments and contingencies
20
Related party transactions
21
Key management personnel disclosures
22
Share-based payments
23
Events subsequent to the end of financial year
Consolidated entity disclosure statement
Directors’ declaration
Independent auditor’s report
Financial report
46
47
48
49
50
50
50
55
55
58
58
59
60
61
61
62
62
63
63
63
64
66
66
66
66
66
67
68
69
70
71
Annual Financial Report
45
Full year ended
30/06/2025
Full year ended
30/06/2024
Note
$
$
Interest revenue
685,253
291,021
Other income
5,489,600
9,931,504
Total revenue & other income
6
6,174,853
10,222,525
Research & development costs
6
(12,296,568)
(15,535,482)
Employment costs
(4,434,666)
(4,195,292)
Corporate & administration costs
(2,026,706)
(1,732,305)
Finance costs
(48,890)
(24,292)
Realised (loss) / unrealised gain on foreign currency
(14,381)
(55,189)
Share-based payment expenses
(1,663,705)
(1,307,416)
Amortisation expense
12
(312,746)
(313,602)
Depreciation expense (right-of-use asset)
11
(80,964)
(82,179)
Depreciation expense (office equipment)
10
(28,490)
(21,050)
Total expenses
(20,907,116)
(23,266,807)
Loss before income tax
(14,732,263)
(13,044,282)
Income tax expense
-
-
Loss for the year
(14,732,263)
(13,044,282)
Other comprehensive income
Items that may be reclassified subsequently to profit and loss:
Other comprehensive income
-
-
Total comprehensive loss for the year
(14,732,263)
(13,044,282)
Loss per share for attributable to the ordinary equity
holders of the Company
Basic and diluted loss per share in cents
15
(0.49)
(0.60)
The above Statement of comprehensive income should be read in conjunction with the accompanying Notes.
Statement of comprehensive income
For the year ended 30 June 2025
Actinogen Medical Limited
46
As at
30/06/2025
As at
30/06/2024
Note
$
$
Current Assets
Cash and cash equivalents
8
16,504,230
9,450,735
Other receivables and prepayments
9
5,925,516
9,425,548
Total Current Assets
22,429,746
18,876,283
Non-Current Assets
Property, plant and equipment
10
33,920
24,389
Intangible assets
12
1,781,364
2,094,110
Right-of-use assets
11
236,121
317,085
Total Non-Current Assets
2,051,405
2,435,584
TOTAL ASSETS
24,481,151
21,311,867
Current Liabilities
Trade and other payables
13
2,726,773
1,179,426
Interest-bearing loan
14
3,006,051
-
Provision for employee entitlements
154,027
116,873
Lease liability
11(b)
71,764
60,673
Total Current Liabilities
5,958,615
1,356,972
Non-Current Liabilities
Lease liability
11(b)
186,633
258,396
Total Non-Current Liabilities
186,633
258,396
TOTAL LIABILITIES
6,145,248
1,615,368
NET ASSETS
18,335,903
19,696,499
Equity
Contributed equity
16(a)
115,726,615
100,023,653
Reserve shares
16(b)
(14,478,367)
(10,483,367)
Reserves
17
13,555,753
11,892,048
Accumulated losses
(96,468,098)
(81,735,835)
TOTAL EQUITY
18,335,903
19,696,499
The above Statement of financial position should be read in conjunction with the accompanying Notes.
Statement of financial position
As at 30 June 2025
Annual Financial Report
47
Contributed
Equity
Accumulated
Losses
Option/
Loan Share
Reserve
Reserve
Shares
Total
Full year ended 30 June 2025
$
$
$
$
$
Balance as at 1 July 2024
100,023,653
(81,735,835)
11,892,048
(10,483,367)
19,696,499
Loss for the year
-
(14,732,263)
-
-
(14,732,263)
Other comprehensive income
-
-
-
-
-
Total comprehensive loss for the year
-
(14,732,263)
-
-
(14,732,263)
Transactions with equity holders in
their capacity as equity holders:
Shares issued during the year
16,232,808
-
-
(3,995,000)
12,237,808
Capital raising costs
(529,846)
-
-
-
(529,846)
Share-based payments
-
-
1,663,705
-
1,663,705
Balance as at 30 June 2025
115,726,615
(96,468,098)
13,555,753
(14,478,367)
18,335,903
Contributed
Equity
Accumulated
Losses
Option/
Loan Share
Reserve
Reserve
Shares
Total
Full year ended 30 June 2024
$
$
$
$
$
Balance as at 1 July 2023
78,712,128
(68,691,553)
10,584,632
(7,197,992)
13,407,215
Loss for the year
-
(13,044,282)
- -
(13,044,282)
Other comprehensive income
-
- - -
-
Total comprehensive loss for the year
-
(13,044,282)
- -
(13,044,282)
Transactions with equity holders in
their capacity as equity holders:
Shares issued during the year
22,391,070
-
-
(3,285,375)
19,105,695
Capital raising costs
(1,079,545)
-
-
-
(1,079,545)
Share-based payments
-
-
1,307,416
-
1,307,416
Balance as at 30 June 2024
100,023,653
(81,735,835)
11,892,048
(10,483,367)
19,696,499
The above Statement of changes in equity should be read in conjunction with the accompanying Notes.
Statement in changes of equity
For the year ended 30 June 2025
Actinogen Medical Limited
48
Full year ended
Full year ended
30/06/2025
30/06/2024
Note
$
$
Cash Flows from Operating Activities
Interest received
685,253
291,021
Interest paid
11(a)
(38,067)
(20,120)
Payments to suppliers and employees
(6,097,951)
(5,714,352)
Payments for research and development
(11,127,483)
(16,300,284)
Government R&D tax rebate and grants received
9,022,474
4,792,865
Net cash outflow from operating activities
8
(7,555,774)
(16,950,870)
Cash Flows from Investing Activities
Purchase of property, plant and equipment
10
(38,021)
(8,163)
Net cash outflow from investing activities
(38,021)
(8,163)
Cash Flows from Financing Activities
Proceeds from issue of shares
16
11,104,996
18,879,650
Proceeds from exercise of options
16
1,132,812
226,024
Transaction costs associated with issue of shares
16
(529,846)
(1,064,284)
Proceeds from borrowings
14
3,000,000
-
Principal repayment on leases
11(a)
(60,672)
(91,696)
Net cash inflow from financing activities
14,647,290
17,949,694
Net increase in cash and cash equivalents
7,053,495
990,661
Cash and cash equivalents at beginning of the year
9,450,735
8,460,074
Effect of movement in exchange rates on cash held
-
-
Cash and cash equivalents at the end of the year
8
16,504,230
9,450,735
The above Statement of cash flows should be read in conjunction with the accompanying Notes.
Statement of cash flows
For the year ended 30 June 2025
Annual Financial Report
49
1. CORPORATE INFORMATION
The financial statements of Actinogen Medical Limited (Actinogen Medical or the Company) for the year ended 30 June 2025
were authorised in accordance with a resolution of Directors on 25 August 2025. Actinogen Medical is a for profit company
limited by shares incorporated and domiciled in Australia whose shares are publicly traded on the Australian Securities
Exchange (ASX). The nature of operations and principal activities of the Company are described in the Directors’ Report. The
registered office of the Company is located at Suite 901, Level 9, 109 Pitt Street, Sydney, NSW, Australia.
2. SUMMARY OF MATERIAL ACCOUNTING POLICIES
The principal accounting policies adopted in the preparation of these financial statements are set out below. These policies
have been consistently applied to all the years presented, unless otherwise stated below. The financial statements of the
Company are for the financial year ended 30 June 2025.
(a) Basis of preparation
These general-purpose financial statements have been prepared in accordance with Australian Accounting Standards, other
authoritative pronouncements of the Australian Accounting Standards Board, and the Corporations Act 2001. The financial
statements have been prepared on a going concern basis. The financial statements are presented in Australian dollars.
(b) Going concern basis
This financial report has been prepared on the going concern basis which contemplates the continuity of normal business
activity and the realisation of assets and settlement of liabilities in the normal course of business.
During the year ended 30 June 2025, the Company incurred a net loss after tax of $14,732,263 (2024: $13,044,282) and had
net cash outflows from operating activities of $7,555,774 (2024: $16,950,870). As reported, with $16,504,230 cash at bank at
30 June 2025 together with the anticipated research and development tax incentive (“RDTI”) of $5,489,600 expected to be
received during the quarter ended 31 December 2025, the Company is well funded to allow it to continue ongoing research and
development activities, as well as cover its corporate and administrative requirements to late CY2026.
In the Directors’ opinion, there are reasonable grounds to believe that the Company has the ability to raise further funding to
continue operations beyond late CY2026 as and when required based on its past ability to raise equity funding. In forming this
view the Directors have taken into consideration the following:
•
The Company has $16,504,230 in cash and cash equivalents as at 30 June 2025. This amount does not include an
additional anticipated inflow of $2,302,189 (the net result of the proposed research and development tax incentive refund
of $5,489,600 (refer Note 9) less the repayment of the Endpoints loan plus interest) during the quarter end 31 December
2025. A further $1,874,143 of potential RDTI remains subject to an Advanced Overseas Finding which is awaiting approval
from the Australian Taxation Office.
•
The Company is listed on the ASX and therefore has access to the Australian equity capital markets, as evidenced by
recent capital raisings including raising approximately $20.0 million (before costs) in two tranches during CY2024, and the
completion of a Placement and Rights Issue during CY2023. Furthermore, the Company has a substantial amount of
potential capital available in the event that outstanding options on issue, as summarized in Note 16(c), are converted to
ordinary shares in the Company. During FY2025, new capital from the conversion of options of approximately $1.1 million
was received.
•
The Company has the ability to modify its planned but not committed expenditure on Clinical Trial activities if required in
order to continue as a going concern.
No adjustments have been made relating to the recoverability and classification of recorded asset amounts and the
classification of liabilities that might be necessary should the Company not continue as a going concern.
(c) Compliance with IFRS
The financial statements of the Company also comply with International Financial Reporting Standards (IFRS) as issued by the
International Accounting Standards Board (IASB).
(d) Historical cost convention
These financial statements have been prepared under the historical cost convention.
Notes to the financial statements
For the year ended 30 June 2025
Actinogen Medical Limited
50
(e) Critical accounting estimates and judgements
The preparation of financial statements requires the use of certain critical accounting estimates. It also requires management
to exercise its judgement in the process of applying the Company’s accounting policies. The areas involving a higher degree of
judgement or complexity, or areas where assumptions and estimates are significant to the financial statements are disclosed in
Note 5.
(f) Plant & equipment
Each asset of plant and equipment is stated at cost, net of accumulated depreciation and impairment losses, if any.
Assets are depreciated from the date the asset is ready for use. Items of plant and equipment are depreciated using
the diminishing value method over their estimated useful lives to the Company. The depreciation rates used for each
class of asset for the current period are as follows, computer equipment rates at 25% to 67%.
An asset is de-recognised upon disposal or when no future economic benefits are expected from its use or disposal.
Any gain or loss arising on de-recognition of the asset (calculated as the difference between the net disposal proceeds
and the carrying amount of the asset) is included in the Statement of Comprehensive Income when the asset is de-
recognised. The assets’ residual values, useful lives and methods of depreciation are reviewed, and adjusted if
appropriate, at each balance date.
(g) Impairment of non-financial assets
At each reporting date, the Company reviews the carrying values of its assets to determine whether there is any
indication that those assets have been impaired. If such an indication exists, the recoverable amount of the asset, being
the higher of the asset’s fair value less costs of disposal and value in use, is compared to the assets carrying value. Any
excess of the assets carrying value over its recoverable amount is expensed to the Statement of Comprehensive
Income. Where it is not possible to estimate the recoverable amount of an individual asset, the Company estimates the
recoverable amount of the cash-generating unit to which the asset belongs. In assessing value in use, the estimated
future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market
assessments of the time value of money and the risks specific to the asset. In determining fair value less cost of
disposal, recent market transactions are taken into account. If no such transactions can be identified, an appropriate
valuation model is used. These calculations are corroborated by valuation multiples, quoted share prices for publicly
traded companies or other available fair value measures.
(h) Intangible assets
Intangible assets acquired separately are measured on initial recognition at cost. The cost of intangible assets acquired
in a business combination is their fair value at the date of acquisition. Following initial recognition, intangible assets are
carried at cost less any accumulated amortisation and accumulated impairment losses. Internally generated intangibles,
excluding capitalised development costs, are not capitalised and the related expenditure is reflected in profit or loss in
the period in which the expenditure is incurred.
The useful lives of intangible assets are assessed as either finite or indefinite. Intangible assets with finite lives are
amortised over the useful economic life and assessed for impairment whenever there is an indication that the intangible
asset may be impaired. The amortisation period and the amortisation method for an intangible asset with a finite useful
life are reviewed at least at the end of each reporting period. Changes in the expected useful life or the expected
pattern of consumption of future economic benefits embodied in the asset are considered to modify the amortisation
period or method, as appropriate, and are treated as changes in accounting estimates and adjusted on a prospective
basis. The amortisation expense on intangible assets with finite lives is recognised in the Statement of Comprehensive
Income. Intangible assets with indefinite useful lives are not amortised, but are tested for impairment annually, and
when indicators of impairment exist, individually or at the cash-generating unit level. The assessment of indefinite life is
reviewed annually, or when indicators of impairment exist, to determine whether the indefinite life continues to be
supportable. If not, the change in useful life from indefinite to finite is made on a prospective basis. Gains or losses
arising from derecognition of an intangible asset are measured as the difference between the net disposal proceeds
and the carrying amount of the asset and are recognised in the Statement of Comprehensive Income when the asset is
derecognised.
(i)
Research and development costs
Development expenditure on an individual project is recognised as an intangible asset when the Company can
demonstrate:
•
The technical feasibility of completing the intangible asset so that the asset will be available for use or sale
•
Its intention to complete and its ability to use or sell the asset
•
How the asset will generate future economic benefits
•
The availability of resources to complete the asset
•
The ability to measure reliably the expenditure during development
•
The ability to use the intangible asset generated
Following initial recognition of the development expenditure as an asset, the asset is carried at cost less any
accumulated amortisation and accumulated impairment losses. Amortisation of the asset begins when development is
Annual Financial Report
51
complete, and the asset is available for use. It is amortised over the period of expected future benefit. During the period
of development, the asset is tested for impairment annually. The Company assessed whether the above criteria had
been met for the financial year ended 30 June 2024. The Company did not meet this criterion and as a consequence all
research and development costs were expensed to profit and loss for the current year.
(ii)
Intellectual property
The Company’s intangible assets relate to intellectual property for upfront payments to purchase patents and licenses. The
patents and licenses have been granted for a period of 20 years by the relevant government agency with the option of renewal
at the end of this period. As a result, those patents and licenses are amortised on a straight-line basis over the period of the
patents and license. The remaining life of the patents and licenses is 8 years. Refer to Note 12: Intangible Assets.
(i)
Government grants
Research and development tax rebates are treated as a government grant. Government grants are recognised as income
where there is reasonable assurance that the grant will be received, and all attached conditions will be complied with. When
the grant relates to an expense item, it is recognised as income on a systematic basis over the periods that the costs, which it
is intended to compensate, are expensed.
(j)
Income tax
The charge for current income tax expense is based on the result for the year adjusted for any non-assessable or disallowed
items. It is calculated using the tax rates that have been enacted or are substantially enacted by the end of the reporting
period.
Deferred income tax is accounted for using the liability method on temporary differences arising between the tax bases of
assets and liabilities and their carrying amounts in the financial statements. However, the deferred income tax from the initial
recognition of an asset or liability, in a transaction other than a business combination is not accounted for if it arises that at the
time of the transaction and affects neither accounting or taxable profit or loss. Deferred income tax is determined using tax
rates (and laws) that have been enacted or substantially enacted by the end of the reporting period and are expected to apply
when the asset is realised, or liability is settled. Deferred tax assets are recognised for deductible temporary differences and
unused tax losses only if it is probable that future taxable amounts will be available to utilise those temporary differences and
losses.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets and liabilities
and when the deferred tax balances relate to the same taxation authority. Current tax assets and tax liabilities are offset where
the entity has a legally enforceable right to offset and intends either to settle on a net basis, or to realise the asset and settle
the liability simultaneously. Current and deferred tax is recognised in profit or loss, except to the extent that it relates to items
recognised in other comprehensive income or directly in equity. In this case, the tax is also recognised in other comprehensive
income or directly in equity, respectively.
(k)
Employee benefits
Provision is made for the Company’s liability for employee benefits arising from services rendered by employees to balance
date. Employee benefits that are expected to be settled within one year have been measured at the amounts expected to be
paid when the liability is settled, plus related on-costs. Employee benefits payable later than one year have been measured
using the projected unit credit valuation method to estimate future cash outflows to be made for those benefits discounted
using the interest rate on high quality corporate bonds with terms to maturity approximating the terms of the liability.
(l)
Share-based payments
The Company provides benefits to employees (including Directors) and consultants of the Company in the form of share-based
payment transactions, whereby employees and consultants render services in exchange for shares or rights over shares
(‘equity-settled transactions’). The cost of these equity-settled transactions with employees is measured by reference to the
fair value at the date at which they are granted. The fair value is determined by an internal valuation using a Black-Scholes
option pricing model.
The cost of equity-settled transactions is recognised, together with a corresponding increase in equity, over the period in
which the performance conditions are fulfilled, ending on the date on which the relevant employees become fully entitled to
the award (‘vesting date’). The cumulative expense recognised for equity-settled transactions at each reporting date until
vesting date reflects (i) the extent to which the vesting period has expired and (ii) the number of awards that, in the opinion of
the Directors of the Company, will ultimately vest. This opinion is formed based on the best available information at balance
date. No adjustment is made for the likelihood of market performance conditions being met as the effect of these conditions is
included in the determination of fair value at grant date.
No expense is recognised for awards that do not ultimately vest, except for awards where vesting is only conditional upon a
market condition. Where an equity-settled award is cancelled, it is treated as if it had vested on the date of cancellation, and
any expense not yet recognised for the award is recognised immediately. However, if a new award is substituted for the
cancelled award and designated as a replacement award on the date that it is granted, the cancelled and new award are
treated as if they were a modification of the original award.
Actinogen Medical Limited
52
(m) Cash and cash equivalents
For the purpose of the Statement of Cash Flows, cash and cash equivalents includes cash on hand, deposits held at call
with financial institutions, bank overdrafts and other short term, highly liquid investments with original maturities of
three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant
risk of changes in value.
(n) Interest income:
Interest income is recorded using the effective interest rate method (EIR). EIR is the rate that exactly discounts the
estimated future cash payments or receipts over the expected life of the financial instrument, or a shorter period,
where appropriate, to the net carrying amount of the financial asset or liability. Interest income is included in finance
income in the Statement of Comprehensive Income.
(o) Goods and services tax (GST)
Revenues, expenses and assets are recognised net of the amount of GST, except where the amount of GST incurred is
not recoverable from the ATO. In these circumstances the GST is recognised as part of the cost of acquisition of the
asset or as part of the expense. Receivables and payables in the Statement of Financial Position are shown inclusive of
GST. Cash flows are presented in the Statement of Cash Flows on a gross basis, except for the GST component of
investing and financing activities, which are disclosed as operating cash flows.
(p) Contributed equity
Ordinary issued share capital is recognised at the fair value of the consideration received by the Company. Any
transaction costs arising on the issue of ordinary shares are recognised directly in equity as a reduction in share
proceeds received.
(q) Trade and other payables
Liabilities for trade creditors and other amounts are subsequently carried at amortised cost after initial recognition at
fair value. Interest, when charged by the lender, is recognised as an expense on an accrual basis.
(r) Provisions
Provisions for legal claims and make good obligations are recognised when the Company has a present legal or
constructive obligation as a result of past events, it is probable that an outflow of resources will be required to settle
the obligation, and the amount has been reliably estimated. Provisions are not recognised for future operating losses.
Where there are a number of similar obligations, the likelihood that an outflow will be required in settlement is
determined by considering the class of obligations as a whole. A provision is recognised even if the likelihood of an
outflow with respect to any one item included in the same class of obligations may be small. Provisions are measured at
the present value of management’s best estimate of the expenditure required to settle the present obligation at the
reporting date. The discount rate used to determine the present value reflects current market assessments of the time
value of money and the risks specific to the liability. The increase in the provision due to the passage of time is
recognised as interest expense.
(s) Earnings per share
Basic earnings per share
Basic earnings per share is calculated by dividing the result attributable to owners of the Company, excluding any costs
of servicing equity other than ordinary shares, by the weighted average number of ordinary shares outstanding during
the financial year, adjusted for bonus elements in ordinary shares issued during the year.
Diluted loss per share
Diluted loss per share is calculated by dividing the loss after income tax expense by the weighted average number of
ordinary shares outstanding during the year. Given the loss position of the Company, share options have not been
taken into account in the diluted loss per share calculation since they are anti-dilutive.
(t) Financial assets
Receivables are recognised initially at fair value and subsequently measured at amortised cost using the effect interest
method, less allowance for impairment. The Company recognises an allowance for expected credit losses (ECLs) for
financial assets not held at fair value through profit or loss. ECLs are based on the difference between the contractual
cash flows due in accordance with the contract and all the cash flows that the Company expects to receive, discounted
at an approximation of the original effective interest rate. Trade receivables are generally due for settlement within 30
days. While the Company has policies in place to ensure that transactions with third parties have an appropriate credit
history, the management of current and potential credit risk exposures is limited as far as is considered commercially
appropriate. Up to the date of this Report, the Board has placed no requirement for collateral on existing debtors.
Annual Financial Report
53
(u) Leases
Right-of-use asset:
The Company recognises a right-of-use asset at the commencement date of the lease (i.e., the date the underlying asset is
available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and
adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities
recognised, initial direct costs incurred, and lease payments made at or before the commencement date less any lease
incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease
term, the recognised assets are depreciated on a straight-line basis over the shorter of its estimated useful life and the lease
term. A right-of-use asset is subject to impairment.
Lease liabilities:
At the commencement date of the lease, the Company recognises lease liabilities measured at the present value of lease
payments to be made over the lease term. The lease payments include fixed payments (including in-substance fixed
payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts
expected to be paid under residual value guarantees. The lease payments also include the exercise price of a purchase option
reasonably certain to be exercised by the Company and payments of penalties for terminating a lease, if the lease term reflects
the Company exercising the option to terminate. The variable lease payments that do not depend on an index or a rate are
recognised as expense in the period on which the event or condition that triggers the payment occurs.
In calculating the present value of lease payments, the Company uses the incremental borrowing rate at the lease
commencement date if the interest rate implicit in the lease is not readily determinable. After the commencement date, the
amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition,
the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the in-
substance fixed lease payments or a change in the assessment to purchase the underlying asset.
Short-term leases and leases of low-value assets:
The Company applies the short-term lease recognition exemption to its short-term leases (i.e., those leases that have a lease
term of 12 months or less from the commencement date and do not contain a purchase option). It also applies the lease of low-
value assets recognition exemption to leases of office equipment that are considered of low value (i.e., below USD$5,000).
Lease payments on short-term leases and leases of low-value assets are expensed on a straight-line basis over the lease term.
(v) Segment reporting
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision
maker. The chief operating decision maker, who is responsible for allocating resources and assessing performance of the
operating segments, has been identified as the Board of Directors.
(w) Borrowings
All financial liabilities are recognised initially at fair value and, in the case of loans and borrowings and payables, net of directly
attributable transaction costs. After initial recognition, interest-bearing loans and borrowings are subsequently measured at
amortised cost using the EIR method. Gains and losses are recognised in profit or loss when the liabilities are derecognised as
well as through the EIR amortisation process. Amortised cost is calculated by taking into account any discount or premium on
acquisition and fees or costs that are an integral part of the EIR. The EIR amortisation is included as finance costs in the
statemen of profit or loss.
(x) New accounting standards and interpretations issued but not yet effective
Certain new accounting standards and interpretations have been published that are not mandatory for 30 June 2025
reporting periods and have not been early adopted by the Company. These new standards and interpretations, and the
status of the Company’s assessment of impact on the Company, are set out below.
Reference
Title
Application date of standard
Application date for Company
AASB 2022-5
Amendments to AASs – Lease Liability in a Sale and
Leaseback
1 January 2024
1 July 2024
Summary:
In a sale and leaseback transaction recognised as a sale under AASB 15 Revenue from Contracts with Customers, AASB 16 requires the seller-
lessee to measure the right-of-use asset arising from the leaseback at the proportion of the previous carrying amount of the asset that
relates to the right of use retained by the seller-lessee. The standard, however, does not specify how the liability arising in a sale and
leaseback is measured. This impacts the measurement of the right-of-use asset and could result in recognition of a gain or loss on the right-
of-use asset retained. Of particular concern is the impact of excluding from the lease liability, variable lease payments that do not depend on
an index or rate.
The issue has been addressed in the amendment, which specifies that the seller-lessee measures the lease liability arising from the leaseback
in such a way that they would not recognise any gain or loss on the sale and leaseback relating to the right-of-use asset retained. The
amendment does not prescribe specific measurement requirements for the lease liability arising from a leaseback. The seller-lessee will need
to establish an accounting policy that results in information that is relevant and reliable in accordance with AASB 108 Accounting Policies,
Changes in Accounting Estimates and Errors. The amendment, however, includes examples illustrating the initial and subsequent
Actinogen Medical Limited
54
measurement of the lease liability in a sale and leaseback transaction with variable lease payments that do not depend on an index or rate.
The amendment may represent a significant change in accounting policy for entities that enter into sale and leaseback transactions with such
variable payments. The amendment to AASB 16 is applied retrospectively to sale and leaseback transactions entered into after the beginning
of the annual reporting period in which an entity first applied AASB 16. Earlier application of the amendment is permitted.
AASB 18
Presentation and Disclosure in Financial
Statements
1 January 2027
1 July 2027
Summary:
AASB 18 replaces AASB 101 as the standard describing the primary financial statements and sets out requirements for the presentation and
disclosure of information in AASB-compliant financial statements. Amongst other changes, it introduces the concept of the “management-
defined performance measure” to financial statements and requires the classification of transactions presented within the statement of profit
or loss within one of five categories – operating, investing, financing, income taxes, and discontinued operations. It also provides enhanced
requirements for the aggregation and disaggregation of information.
In the process of assessment of the impact, the Company has not early adopted any other accounting standard,
interpretation or amendment that has been issued but is not yet effective. The application of the new and amended
accounting standards and interpretations did not have a material impact on the financial position or performance of the
Company.
3. SEGMENT INFORMATION
The Company’s sole operations are within the biotechnology industry within Australia. Given the nature of the
Company, its size and current operations, the Company’s management does not treat any part of the Company as a
separate operating segment. Internal financial information used by the Company’s decision makers is presented on a
“whole of entity” manner without dissemination to any separately identifiable segments. Accordingly, the financial
information reported elsewhere in this financial report is representative of the nature and financial effects of the
business activities in which it engages and the economic environments in which it operates. All non-current assets are
held in Australia and all income is derived in Australia.
4. FINANCIAL RISK MANAGEMENT
The Company’s principal financial liabilities comprise trade and other payables, interest-bearing loan, and lease liabilities. The
Company’s principal financial assets include receivables, and cash and short-term deposits. The Company is exposed to
market risk, credit risk and liquidity risk. The Company’s Board and senior management oversees the management of these
risks however, the Company’s overall risk in these areas is not significant enough to warrant a formalised specific risk
management program. Risk management is carried out in their day-to-day functions as the overseers of the business.
Set out below is an overview of the financial instruments held by the Company as at 30 June 2025:
As at 30 June 2025
Cash and
cash equivalents
$
Financial assets / liabilities
at amortised cost
$
Financial assets
Cash and cash equivalents
16,504,230
-
Other receivables and prepayments
-
238,924
Total current assets
16,504,230
238,924
Total financial assets
16,504,230
238,924
Financial liabilities
Trade and other payables
-
2,726,773
-
3,006,051
Lease liabilities - current
-
71,764
Total current liabilities
-
5,804,588
Lease liabilities - non-current
-
186,633
Total non-current liabilities
-
186,633
Total financial liabilities
-
5,991,221
Net exposure
16,504,230
(5,752,297)
Annual Financial Report
55
4. FINANCIAL RISK MANAGEMENT
Set out below is an overview of the financial instruments held by the Company as at 30 June 2024:
As at 30 June 2024
Cash and
cash equivalents
$
Financial assets / liabilities
at amortised cost
$
Financial assets
Cash and cash equivalents
9,450,735
-
Other receivables and prepayments
-
219,483
Total current assets
9,450,735
219,483
Total financial assets
9,450,735
219,483
Financial liabilities
Trade and other payables
-
1,179,426
Lease liabilities - current
-
60,673
Total current liabilities
-
1,240,099
Lease liabilities - non-current
-
258,396
Total non-current liabilities
-
258,396
Total financial liabilities
-
1,498,495
Net exposure
9,450,735
(1,279,012)
(a) Market Risk
(i) Interest rate risk
Interest rate risk is the risk of loss to the Company arising from adverse changes in interest rates. The Company has
interest-bearing debt (refer to Note 14) and is also exposed to interest rate risk in respect of amounts held in current,
interest-bearing bank accounts and demand deposits. At 30 June 2025, the Company held $15,718,435 (2024:
$9,417,297) in such accounts and deposits.
A 100 basis points decrease is used when reporting interest rate risk internally to key management personnel and
represents management’s assessment of the reasonable and possible change in interest rates. For each interest rate
movement of 100 basis points lower, assuming all other variables were held constant, the Company’s loss would
increase by $157,184 (2024: $94,173).
Sensitivity analysis:
Interest rate risk
-1%
+1%
Carrying amount
Profit/Equity
Profit/Equity
$
$
$
15,718,435
(157,184)
157,184
9,417,297
(94,173)
94,173
As at 30/6/2025
As at 30/6/2024
Weighted average
interest rate
Balance
Weighted average
interest rate
Balance
%
$
%
$
3.50
15,718,435
4.14
9,417,297
30 June 2025
Financial Assets
Cash and cash equivalents
30 June 2024
Financial Assets
Cash and cash equivalents
Variable rate instruments:
Cash and cash equivalents
Actinogen Medical Limited
56
(b) Credit risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash
and cash equivalents and receivables. The maximum credit risk is the face value of these financial instruments.
However, the Company considers the risk of non-recovery of these accounts to be minimal.
The Company trades only with recognised, creditworthy third parties and as such collateral is not requested nor is it the
Company’s policy to securitise its trade and other receivables. Receivable balances are monitored on an ongoing basis
with the result that the Company does not have a significant exposure to bad debts.
The Company has the following concentrations of credit risk:
(i) Cash
Credit risk from balances with banks and financial institutions is managed by the Company’s finance department.
Investments of surplus funds are made only with approved counterparties and within credit limits assigned to each
counterparty.
The Directors believe that there is negligible credit risk with the Company’s cash and cash equivalents, as funds are
held at call with National Australia Bank (rating: AA-), a reputable Australian Banking institution.
(ii) Receivables
While the Company has policies in place to ensure that transactions with third parties have an appropriate credit
history, the management of current and potential credit risk exposures is limited as far as is considered commercially
appropriate. Up to the date of this Report, the Board has placed no requirement for collateral on existing debtors.
(c) Liquidity risk
Liquidity risk is the risk that the Company will not be able to meet its financial liabilities as and when they fall due. Prudent
liquidity risk management implies maintaining sufficient cash and marketable securities, the availability of funding through an
adequate amount of committed credit facilities and the ability to close out market positions.
The Company manages liquidity risk by continuously monitoring forecast and actual cash flows. Surplus funds are generally
only invested at call or in bank bills that are highly liquid and with maturities of less than six months.
(i)
Financing arrangements
The Company does have financing arrangements as at 30 June 2025, refer to Note 14 for further detail (2024: None).
(ii)
Maturities of financial liabilities
The Company’s debt relates to trade and other payables, where payments are generally due within 30 days, an interest-
bearing loan (refer to Note 14 for further detail) and lease liabilities (refer to Note 11 for further detail). The table below
summarises the maturity profile of the Company’s financial liabilities based on contractual undiscounted payments:
Less than
3 to 12
1 to 5
3 months
months
years
Total
$
$
$
$
As at 30 June 2025
Trade and other payables
2,726,773
-
-
2,726,773
Interest-bearing loan
-
3,006,051
-
3,006,051
Lease liabilities
23,358
71,060
205,972
300,390
2,750,131
3,077,111
205,972
6,033,214
As at 30 June 2024
Trade and other payables
1,179,426
- -
1,179,426
Lease liabilities
22,385
59,693
308,176
390,254
1,201,811
59,693
308,176
1,569,680
Annual Financial Report
57
5. CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS
•
Key estimates: Share-based payments
The Company initially measures the cost of equity-settled transactions with employees by reference to the fair value of the
equity instruments at the date at which they are granted. Estimating fair value for share-based payment transactions requires
determination of the most appropriate valuation model, which is dependent on the terms and conditions of the grant. This
estimate also requires determination of the most appropriate inputs to the valuation model including the expected life of the
share option, volatility and dividend yield and making assumptions about them. The assumptions and models used for
estimating fair value for share-based payment transactions are disclosed in Note 22.
•
Key estimates: Impairment of intangible assets
The Company assesses impairment for intangible assets at each reporting date or when an impairment indicator exists, by
evaluating conditions specific to the Company and to the particular asset that may lead to impairment. These include product,
technology, economic and political environments and future expectations. If an impairment indicator exists, the recoverable
amount of the asset is determined. For further information on intangible assets refer to Note 2(h).
•
Significant judgement: Research and development tax rebate
In line with accounting policy 2(i) research and development tax rebates are treated as government grants and are recognised
as income where there is reasonable assurance that the grant will be received, and all attached conditions will be complied
with. The Company applies judgment in assessing that all attached conditions will be complied with based on the nature of the
expenditure incurred and the activities of the Company undertaken during the year.
•
Significant judgement in determining the lease term of contracts with renewal options:
The Company determines the lease term as the non-cancellable term of the lease, together with any periods covered by an
option to extend the lease if it is reasonably certain to be exercised, or any periods covered by an option to terminate the
lease, if it is reasonably certain not to be exercised. The Company has the option under some of its leases to lease the assets
for additional terms. The Company applies judgement in evaluating whether it is reasonably certain to exercise the option to
renew. That is, it considers all relevant factors that create an economic incentive for it to exercise the renewal. After the
commencement date, the Company reassesses the lease term if there is a significant event or change in circumstances that is
within its control and affects its ability to exercise (or not to exercise) the option to renew and renewal periods (e.g. a change
in business strategy).
6. OTHER INCOME AND EXPENSES
Full year ended
Full year ended
30/06/2025
30/06/2024
$
$
Income
Interest income
685,253
291,021
Other income
R&D tax rebate
5,489,600
9,931,504
Total other income
5,489,600
9,931,504
Total income
6,174,853
10,222,525
Expenses
Research and development costs:
Laboratory & clinical trial expenses
11,362,639
15,122,815
Regulatory & clinical development consultants
228,967
145,785
Other expenses
704,962
266,882
Total research and development costs
12,296,568
15,535,482
Actinogen Medical Limited
58
7. INCOME TAX
Full year ended
Full year ended
30/06/2025
30/06/2024
$
$
Reconciliation of operating loss to prima facie income tax
expense
Operating loss before income tax
(14,732,263)
(13,044,282)
Tax benefit at the Australian tax rate of 30% (2024: 30%)
(4,419,679)
(3,913,284)
Tax effect of amounts that are not deductible / taxable in
calculating taxable income:
Non-deductible expenses
3,833
3,545
Share-based payments
499,112
418,712
Research and development
1,748,749
2,601,461
Realised foreign exchange gain/(loss)
-
-
Deferred income tax asset not brought to account
2,167,985
889,566
Income tax expense
-
-
Tax losses
Unused tax losses for which no deferred tax asset has been
recognised
32,879,787
25,902,283
Potential tax benefit @ 30% (2024: 30%)
9,863,936
7,770,685
Unrecognised temporary differences
Temporary differences for which deferred tax assets have not
been recognised.
- Provisions and accruals
207,067
153,683
- Intangible assets
2,355,089
2,042,343
- Capital raising costs
875,825
850,775
- Legal expenses
18,428
22,084
- Right of use adjustments
22,276
1,984
- Unrealised foreign exchange gain
7,079
9,036
- Fixed assets
(33,920)
(24,388)
3,451,845
3,055,517
Unrecognised deferred tax asset relating to the above temporary
differences @ 30% (2024: 30%)
1,035,553
916,655
The tax benefit of tax losses and other deductible temporary differences will only arise in the future where the Company
derives sufficient net taxable income and is able to satisfy the carried forward tax loss recoupment rules. The Directors believe
that the likelihood of the Company achieving sufficient taxable income in the future is currently not probable and the tax
benefit of these tax losses and other temporary differences have not been recognised.
Annual Financial Report
59
8. CASH AND CASH EQUIVALENTS
As at
As at
30/06/2025
30/06/2024
$
$
Cash at bank and on hand
6,018,544
2,235,135
Short term deposits
10,485,686
7,215,600
Total cash and cash equivalents
16,504,230
9,450,735
During the year ended 30 June 2025, the Company received interest revenue through holding cash and cash equivalents.
Additionally, subject to ATO approval, the Company is expecting to receive a research and development tax incentive
estimated at $5,489,600 for eligible expenditure incurred during the year ended 30 June 2025. This has been recognised as a
receivable at year end. Refer to Note 9.
Reconciliation of net cash flows from operating activities
Full year ended
Full year ended
30/06/2025
30/06/2024
$
$
Loss for the year
(14,732,263)
(13,044,282)
Non cash items:
Depreciation (computer equipment)
28,490
21,050
Depreciation (lease: office rental)
80,964
82,179
Amortisation expense
312,746
313,602
Share-based payment expense
1,663,705
1,307,416
Interest and borrowing costs
6,051
-
Unrealised foreign currency gain
-
(15,240)
Change in assets and liabilities:
Increase in trade and other receivables
3,500,032
(5,197,237)
Increase in trade and other payables
1,547,347
(380,044)
Increase in provisions
37,154
(38,314)
Net cash outflow used in operating activities
(7,555,774)
(16,950,870)
Non-cash operating activities:
During the year, the Company issued ordinary shares to a employees, contractors and directors by way of provision of a
limited recourse loan. Given that these shares are considered to be “in-substance options” or “rights” under Generally
Accepted Accounting Principles, no loan amount is recognised in the financial statements. Refer to section 11.3(C)(ii) of the
Remuneration Report for further information. There were no other non-cash operating activities that occurred during the year
ended 30 June 2025.
Financing facilities available:
As at 30 June 2025, the Company had no financing facilities available (2024: None). For the purposes of the Statement of cash
flows, cash includes cash on hand and in banks and investments in money market instruments, net of outstanding bank
overdrafts.
Interest rate risk exposure:
The Company’s exposure to interest rate risk is discussed in Note 4.
Credit risk exposure:
The maximum exposure to credit risk at the end of the reporting period is the carrying amount of each class of cash and cash
equivalents mentioned above.
Actinogen Medical Limited
60
9.
OTHER RECEIVABLES AND PREPAYMENTS
None of the other receivables and prepayments are impaired. Due to their short-term nature, carrying amounts
approximate their fair value.
As at
As at
30/06/2025
30/06/2024
$
$
Prepaid insurance
129,009
108,829
Goods and services tax receivable
196,992
183,591
Research and development tax rebate receivable (i)
5,489,600
9,022,474
Other receivables
109,915
110,654
Total other receivables and prepayments
5,925,516
9,425,548
(i)
In addition to the $5,489,600 RDTI receivable recognised, there is a portion of research and development expenditure
incurred during the year, totalling $3,864,212, that has been assessed by the company as receivable but not yet
recognised at year-end because it is subject to the ATO’s review and approval of the company’s Advanced Overseas
Finding application. Should this application be approved, there will be a further $1,874,143 of potential RDTI received
during the quarter end 31 December 2025.
10. PROPERTY, PLANT AND EQUIPMENT
As at
As at
30/06/2025
30/06/2024
$
$
At cost
114,668
76,646
Accumulated depreciation
(80,748)
(52,257)
Total property, plant and equipment
33,920
24,389
Movements during the year:
Computer Equipment
Total
$
$
Opening balance at 1 July 2023
37,276
37,276
Acquisitions
8,163
8,163
Depreciation
(21,050)
(21,050)
Closing balance at 30 June 2024
24,389 24,389
Opening balance at 1 July 2024
24,389
24,389
Acquisitions
38,021
38,021
Depreciation
(28,490)
(28,490)
Closing balance at 30 June 2025
33,920
33,920
Annual Financial Report
61
11. RIGHT-OF-USE ASSET & LEASE LIABILITY
Set out below are the amounts recognised in the statement of comprehensive loss for the year ended 30 June 2025:
Full year ended
Full year ended
30/06/2025
30/06/2024
$
$
Depreciation expense on right-of-use asset
80,964
82,179
Interest expense on lease liabilities
29,191
5,172
Rent expense - short-term leases
-
-
Total amounts recognised in profit or loss
110,155
87,351
Set out below are the carrying amounts of the Company’s assets and lease liabilities recognised in the statement of financial
position and the movements during the year ended 30 June 2025:
Right-of-use Assets
Leased Premises
Lease Liability
Leased Premises
$
$
As at 1 July 2023
75,432
86,933
Recognition of new lease (commencing 1 June 2024)
323,832
323,832
Depreciation expense
(82,179)
-
Interest expense
-
5,172
Payments
-
(96,869)
As at 30 June 2024
317,085
319,069
As at 1 July 2024
317,085
319,069
Depreciation expense
(80,964)
-
Interest expense (a)
-
29,191
Payments (a)
-
(89,863)
As at 30 June 2025 (b)
236,121
258,397
(a) The lease payments made during the year totalled $89,863 comprising a principal component of $60,672 and an interest
component of $29,191.
(b) Of the total lease liability amounting to $258,397, the amount of $71,764 is current, and $186,633 is non-current.
12. INTANGIBLE ASSETS
As at
As at
30/06/2025
30/06/2024
$
$
At cost
5,756,743
5,756,743
Accumulated amortisation
(3,975,379)
(3,662,633)
Total intangible assets
1,781,364
2,094,110
Movements during the year:
Intellectual
Property
$
Opening balance at 1 July 2023
2,407,712
Amortisation expense
(313,602)
Closing balance at 30 June 2024
2,094,110
Opening balance at 1 July 2024
2,094,110
Amortisation expense
(312,746)
Closing balance at 30 June 2025
1,781,364
Actinogen Medical Limited
62
Intellectual property
On 8 December 2014, Actinogen Medical entered into an Assignment of Licence Agreement with Corticrine Limited for the
assignment of all of Corticrine’s interest in, to and under the Licence Agreement to Actinogen Medical and the assumption by
the Company of all of Corticrine's obligations in respect of such Assignment. When the Company acquired the intellectual
property from Corticrine, this comprised patents and licences, as well as the value of research performed to date, and the
progression of testing to human trials. The intellectual property is supported by several patent families, the most recent of
which will expire in 2031, with the composition of matter patents in most key markets extendable up to 2036. The patent useful
life has been aligned to the patent term and as a result, those patents are amortised on a straight-line basis over the period of
the patent. As at 30 June 2025, the Company assessed there were no indicators of impairment reversal.
Subsequent patent applications (not included in Intangible Assets)
Actinogen continues to proactively extend its IP portfolio. During the period, costs associated with this follow-on patent related
activity have been expensed. This is consistent with prior years. Only the prime patents on acquisition of Corticrine have been
carried forward and amortised over the life of the patents.
13. TRADE AND OTHER PAYABLES
As at
As at
30/06/2025
30/06/2024
$
$
Trade payables
1,925,518
597,236
Accruals and other payables
721,482
506,625
Provision for payroll tax
25,000
25,000
Employee tax liabilities
54,773
50,565
Total trade and other payables
2,726,773
1,179,426
Trade and other payables are non-interest-bearing liabilities stated at amortised cost and settled within 30 days.
14. INTEREST-BEARING LOAN
As at
As at
30-06-25
30-06-24
$
$
Interest-bearing loan
3,006,051
-
Total interest-bearing loan
3,006,051
-
The company received an initial tranche of $3,000,000 on 30 June 2025 in non-dilutive funding with Endpoints Capital. This is
secured against the research and development tax incentive (RDTI), estimated at $5,489,600 for eligible expenditure incurred
during the year ended 30 June 2025, and is due from the Australian Taxation Office (ATO). The loan attracts interest at a rate
of 15.5 percent per annum and is expected to be repayable in the quarter ended 31 December 2025, contemporaneous with
receipt of the ATO refund.
As announced on 30 June 2025, the company also has conditional commitments with Endpoints for a further $2.9 million to be
made available in the December 2025 quarter in relation to the final RDTI receivable, and up to $7.9 million conditionally
approved against the forecasted FY2026 RDTI. This equates to a total funding facility of up to $13.8 million.
15. LOSSES PER SHARE
Full year ended
Full year ended
30/06/2025
30/06/2024
Net loss used in calculating loss per share ($)
(14,732,263)
(13,044,282)
Weighted number of ordinary shares used as the denominator ('000)
2,979,633
2,174,301
Basic and diluted loss per share from continuing operations attributable to
the ordinary shareholders of the Company (cents)
(0.49)
(0.60)
As at 30 June 2025, there were 621,275,626 (2024: 378,165,568) unissued ordinary shares under option and 295,012,300 loan
shares (2024: 200,595,627) excluded from the calculation of diluted earnings per share that could potentially dilute basic
earnings per share in the future but are anti-dilutive for the current period presented.
There have been no other transactions involving ordinary shares or potential ordinary shares between the reporting date and
the date of authorization of these financial statements.
Annual Financial Report
63
16. CONTRIBUTED EQUITY
(a)
Fully paid ordinary shares
As at
As at
30/06/2025
30/06/2024
$
$
Fully paid ordinary shares
122,276,714
106,043,906
Capital raising costs
(6,550,099)
(6,020,253)
Total contributed equity
115,726,615
100,023,653
As at 30 June 2025 there were 3,177,147,241 ordinary shares on issue (of which 295,012,300 are Loan Shares, refer 16(b)
below for further information). Ordinary shares entitle the holder to participate in dividends and the winding up of the Company
in proportion to the number and amount paid on the share held.
Movement of fully paid ordinary shares during the year were as follows:
Date
Quantity
Unit Price $
Total $
Balance at 30 June 2023
1,816,252,150
78,712,128
Issue of rights issue shares
11/09/2023
185,803,027
0.02500
4,645,076
Issue of shortfall shares
15/09/2023
214,254,911
0.02500
5,356,373
Capital raising costs
-
-
-
(453,831)
Cancellation of employee loan plan shares
16/10/2023
(2,000,000)
-
-
Issue of employee loan plan shares
8/11/2023
39,750,000
0.02200
874,500
Issue of director loan plan shares
1/12/2023
46,500,000
0.03125
1,453,125
Issue of employee loan plan shares
1/12/2023
6,750,000
0.02900
195,750
Issue of employee loan plan shares
9/02/2024
18,000,000
0.03800
684,000
Exercise of unlisted options
15/02/2024
3,430,453
0.03750
128,642
Exercise of unlisted options
21/02/2024
2,431,645
0.03750
91,187
Exercise of unlisted options
7/03/2024
165,198
0.03750
6,195
Issue of employee loan plan shares
3/04/2024
1,000,000
0.03800
38,000
Cancellation of employee loan plan shares
12/04/2024
(5,416,673)
-
-
Exercise of unlisted options
8/05/2024
550
0.03750
21
Placement shares
14/05/2024
200,000,000
0.02500
5,000,000
Rights Issue
6/06/2024
155,128,047
0.02500
3,878,201
Capital raising costs
-
-
0.00000
(625,714)
Issue of employee loan plan shares
17/06/2024
1,000,000
0.04000
40,000
Balance at 30 June 2024
2,683,049,308
100,023,653
Exercise of unlisted options (note 1)
-
27,433,891
$0.0375
1,028,771
Exercise of listed options (note 2)
-
2,018,208
$0.0500
100,910
Placement shares
24-09-24
232,500,014
0.03000
6,975,000
Share purchase plan (SPP) shares
04-11-24
99,999,867
0.03000
2,999,996
Placement shares to directors
04-11-24
37,666,670
0.03000
1,130,000
Capital raising costs
-
-
-
(529,846)
Cancellation of employee loan plan shares
28-11-24
(5,416,662)
-
-
Cancellation of employee loan plan shares
03-12-24
(4,000,000)
-
-
Exercise of listed options
05-12-24
62,499
0.05000
3,125
Issue of employee loan plan shares
16-12-24
59,500,000
0.03500
2,082,500
Exercise of unlisted options (note 2)
30-01-25
111
0.05000
6
Issue of director loan plan shares
24-03-25
35,000,000
0.04250
1,487,500
Issue of employee loan plan shares
24-03-25
10,000,000
0.04250
425,000
Cancellation of employee loan plan shares
24-03-25
(666,665)
-
-
Balance at 30 June 2025
3,177,147,241
115,726,615
Note 1: A total of 27,433,891 unlisted options exercisable at $0.0375 each were exercised during the quarter ended 30 September 2024,
specifically 6,516,565 were unlisted rights issue options and 20,917,326 unlisted shortfall options.
Note 2: A total of 2,018,319 listed options exercisable at $0.005 each were exercised, specifically, 2,018,208 options were exercised during the
quarter ended 30 September 2024, and 111 options were exercised on 30 January 2025.
Actinogen Medical Limited
64
(b)
Reserve shares (“Loan shares”)
Date
Quantity
Unit Price $
Total $
Balance at 30 June 2023
(95,012,300)
(7,197,992)
Cancellation of employee loan plan shares
16/10/2023
2,000,000
-
-
Issue of employee loan plan shares
8/11/2023
(39,750,000)
0.02200
(874,500)
Issue of director plan shares
1/12/2023
(46,500,000)
0.03125
(1,453,125)
Issue of employee loan plan shares
1/12/2023
(6,750,000)
0.02900
(195,750)
Issue of employee loan plan shares
9/02/2024
(18,000,000)
0.03800
(684,000)
Issue of employee loan plan shares
3/04/2024
(1,000,000)
0.03800
(38,000)
Cancellation of employee loan plan shares
12/04/2024
5,416,673
-
-
Issue of employee loan plan shares
17/06/2024
(1,000,000)
0.04000
(40,000)
Balance at 30 June 2024
(200,595,627)
(10,483,367)
Cancellation of employee loan plan shares
28-11-24
5,416,662
-
-
Cancellation of employee loan plan shares
03-12-24
4,000,000
-
-
Issue of employee loan plan shares
16-12-24
(59,500,000)
0.03500
(2,082,500)
Issue of director loan plan shares
24-03-25
(35,000,000)
0.04250
(1,487,500)
Issue of employee loan plan shares
24-03-25
(10,000,000)
0.04250
(425,000)
Cancellation of employee loan plan shares
24-03-25
666,665
-
-
Balance at 30 June 2025
(295,012,300)
(14,478,367)
Reserve shares (‘Loan shares’) are ordinary shares that have historically been accounted for as “in-substance options”. No loan
amount is recognised in the financial statements. During the year, 104,500,000 loan shares were issued to directors,
employees and contractors of the Company; and 10,083,327 loan shares were cancelled by the Company due to forfeiture by
the holders of these loan shares ceasing employment and not repaying the balance payable in accordance with the terms and
conditions of the Employee Loan Share Scheme. Refer to section 11.3(C)(b) of the Remuneration Report for information on
these loan shares.
(c) Unissued ordinary shares under option
Quantity
Type of Option
Grant Date
Exercise Price
Expiry Date
1,600,000 Unlisted employee options
28-09-20
$0.0460
27-09-25
85,775,526 Unlisted rights issue options (i)
11-09-23
$0.0375
11-09-26
80,791,930 Unlisted shortfall options (ii)
15-09-23
$0.0375
15-09-26
175,545,902 Listed options (iii)
14-05-24
$0.0500
31-05-27
277,562,268 Listed options (iv)
30-09-24
$0.0500
30-09-27
621,275,626
Total unissued ordinary shares under option
During the year:
(i)
Of 92,292,091 unlisted rights issue options on issue at 1 July 2024, 6,516,565 of these options were exercised at $0.0375
each, leaving a closing balance of 85,775,526 options on issue at 30 June 2025.
(ii) Of 101,709,256 unlisted shortfall options on issue at 1 July 2024, 20,917,326 of these options were exercised at $0.0375
each, leaving a closing balance of 80,791,930 at 30 June 2025.
(iii) Of 177,564,221 listed options on issue at 1 July 2024, 2,018,319 were exercised at $0.05 each, leaving a closing balance
of 175,545,902 options on issue at 30 June 2025.
(iv) 277,624,767 listed options were issued under a placement and share purchase plan announced in September 2024. Of
these, 62,499 were exercised at $0.05 each, leaving a closing balance of 277,562,268 options on issue at 30 June 2025.
(v) 5,000,000 director options issued in a prior period expired
No option holder has any right, by virtue of the option, to participate in any share issue of the Company or any related body
corporate.
(d) Terms and Conditions of Issued Capital
At shareholders’ meetings each ordinary share is entitled to one vote when a poll is called, otherwise each shareholder has a
vote on a show of hands. Ordinary shares have no par value.
(e) Capital risk management
The Company’s objectives when managing capital are to safeguard its ability to continue as a going concern, so it can provide
returns to shareholders and benefits to other stakeholders. The Company considers capital to consist of cash reserves on
hand. Consistent with the Company’s objective, it manages working capital by issuing new shares, investing in and selling
assets, submitting applications for research and development rebates to the Australian Tax Office or modifying its planned
research and development program as required. Given the stage of the Company’s development there are no formal targets
set for return on capital. The Company is not subject to externally imposed capital requirements. The net equity of the
Company is equivalent to capital. Net capital is obtained through capital raisings on the ASX and receipt of Research and
Development rebates from the Australian Tax Office.
Annual Financial Report
65
17. RESERVES
Reserves are made up of the option and loan share reserve. The option and loan share reserve records items recognised as
share-based payment (SBP) expenses for employee and director options and loan shares. Details of the movement in reserves
is shown below.
As at
As at
30/06/2025
30/06/2024
$
$
Option and loan share reserve
13,555,753
11,892,048
Total reserves
13,555,753
11,892,048
Movements during the year:
Year ended
Year ended
30/06/2025
30/06/2024
$
$
Balance at the beginning of the period
11,892,048
10,584,632
Share-based payment expense on employee options
-
100
Share-based payment expense on employee loan shares
1,133,106
912,413
Share-based payment expense on director loan shares
530,599
394,903
Balance at end of period
13,555,753
11,892,048
Total share-based payment expenses recognised during the year amounted to $1,663,705. For further information refer to
Note 22. For further information on loan shares and unissued ordinary shares under option refer to Note 16.
18. REMUNERATION OF AUDITOR
Full year ended
Full year ended
30/06/2025
30/06/2024
$
$
Amounts paid or payable to Ernst & Young for:
An audit or review of the financial statements of the entity
89,281
82,680
89,281
82,680
19. COMMITMENTS AND CONTINGENCIES
The directors are not aware of any material commitments, contingent liabilities or assets that exist at 30 June 2025 (2024:
$Nil).
20. RELATED PARTY TRANSACTIONS
There were no related party transactions that occurred during the year other than transactions with KMP as set out in Note 21.
21. KEY MANAGEMENT PERSONNEL DISCLOSURES
Key Management Personnel (KMP) of the Company and their compensation during the year are listed below: Further detail is
provided in the audited Remuneration Report on pages 31 to 43.
Name
Position
Current / Resigned
Dr Geoffrey Brooke
Non-Executive Chairman
Current
Dr Steven Gourlay
Managing Director / Chief Executive Officer
Current
Dr George Morstyn
Non-Executive Director
Current
Mr Malcolm McComas
Non-Executive Director
Current
Dr Nicki Vasquez
Non-Executive Director
Current
William Souter
Chief Financial Officer
Current
Dr Dana Hilt
Chief Medical Officer
Current
Mr Andrew Udell
Chief Commercial Officer
Current
Full year ended
Full year ended
30/06/2025
30/06/2024
$
$
Short-term employee benefits
2,133,881
1,672,337
Termination benefits
-
155,223
Post-employment benefits
126,722
93,571
Other benefits
123,629
87,389
Share-based payments
1,139,215
855,483
3,523,447
2,864,003
Actinogen Medical Limited
66
22. SHARE-BASED PAYMENTS
The table below summarises movements in quantity of options and loan shares on issue, the movements in share-based payments during the year, and the assumptions used in valuing SBP in prior
periods and the current financial year:
Type of SBP
Quantity
as at
1 July 2024
Quantity
issued,
(lapsed /
forfeited
or expired)
during the year
(a)(b)
Quantity
as at
30 June
2025
Grant Date
Expiry
Date
Expected
Volatility
Risk-
free
Interest
Rate
Fair
value
per
option/loan
share ($)
Total
SBP
valuation
($)
Opening
value
SBP expense
as at
1 July 2024
($)
Value
recognised
during the
year
($)
Closing value
of SBP
expense
as at
30 June
2025
($)
Value to be
recognised
in future
years
($)
Value of
unvested
SBP
expense
($)(c)
Options
Director
5,000,000
(5,000,000)
-
24-03-17
24-03-25
100%
2.61%
0.0491
245,286
245,286
- 245,286
-
-
Employee
1,600,000
- 1,600,000
28-09-20
27-09-25
60%
0.32%
0.0093
14,948
14,948
- 14,948
-
-
Total
6,600,000
(5,000,000)
1,600,000
260,234
260,234
-
260,234
-
-
Loan shares
Loan shares
48,362,300
- 48,362,300
15-03-21
15-03-26
80%
0.71%
0.0145
733,990
733,990
- 733,990
-
-
Loan shares
7,733,330
(3,333,330)
4,400,000
16-09-21
16-09-26
100%
0.62%
0.0642
764,395
722,649
1,130
723,779
- 40,616
Loan shares
4,500,000
- 4,500,000
18-11-21
18-11-26
100%
1.38%
0.1188
534,646
526,740
7,906
534,646
-
-
Loan shares
3,666,665
(666,665)
3,000,000
13-01-22
13-01-27
100%
1.47%
0.1109
443,577
428,115
7,313
435,428
- 8,149
Loan shares
13,083,332
(2,083,332)
11,000,000
24-05-22
24-05-27
100%
3.04%
0.0517
827,144
735,808
34,734
770,542
- 56,602
Loan shares
250,000
- 250,000
15-07-22
14-07-27
95%
3.16%
0.0412
10,299
9,335
951
10,286
13
-
Loan shares
10,000,000
- 10,000,000
20-03-23
19-03-28
80%
2.95%
0.0494
494,036
378,730
94,761
473,491
20,545
-
Loan shares
39,750,000
(4,000,000)
35,750,000
23-10-23
07-11-28
100%
4.24%
0.0126
500,850
203,996
197,582
401,578
69,400
29,872
Loan shares
46,500,000
- 46,500,000
22-11-23
30-11-28
100%
4.14%
0.0176
818,400
300,785
381,689
682,474
135,926
-
Loan shares
6,750,000
- 6,750,000
22-11-23
30-11-28
100%
4.14%
0.0176
118,800
43,662
55,406
99,068
19,732
-
Loan shares
18,000,000
- 18,000,000
09-02-24
08-02-29
85%
3.67%
0.0203
365,511
96,314
195,018
291,332
74,179
-
Loan shares
1,000,000
- 1,000,000
01-04-24
01-04-29
85%
3.57%
0.0213
21,253
3,977
12,682
16,659
4,594
-
Loan shares
1,000,000
- 1,000,000
17-06-24
16-06-29
85%
3.77%
0.0196
19,600
657
14,260
14,917
4,683
-
Loan shares
-
59,500,000
59,500,000
05-12-24
16-12-29
95%
3.806
0.0216
1,282,942
- 460,395
460,395
822,547
-
Loan shares
-
35,000,000
35,000,000
14-03-25
24-03-30
95%
3.83%
0.0207
724,500
- 152,544
152,544
571,956
-
Loan shares
-
10,000,000
10,000,000
22-03-25
24-03-30
95%
3.82%
0.0241
241,000
- 47,334
47,334
193,666
-
Total
200,595,627
94,416,673
295,012,300
7,900,943
4,184,758
1,663,705
5,848,463
1,917,241
135,239
Total SBP
207,195,627
89,416,673
296,612,300
8,161,177
4,444,992
1,663,705
6,108,697
1,917,241
135,239
Annual Financial Report
67
Common to all classes of share-based payments on issue are the following factors and assumptions:
•
All loan shares on issue vest over 3 years with either 1/4 or 1/3 vesting after 12 months from Grant Date and the remainder
vesting in equal monthly or quarterly increments over the remaining 24 months.
•
The fair value of options and loan shares granted have been valued using a Black-Scholes option pricing model, taking into
account the terms and conditions upon which the share options were granted. Where vesting conditions are applicable, they are
expensed over the vesting period.
•
The assumed dividend payable during the term of the options and loan shares is deemed to be nil.
•
A volatility of the share price fluctuation was calculated by considering the historical movement of the share price over a period of
time as well factoring market conditions of its competitors to predict the distribution of relative share performance.
•
The exercise price of the options and loan shares is equal to the market price of the underlying shares on the date of grant.
•
The Company does not have a past practice of cash settlement or cash settlement alternatives for these awards.
(a) 5,000,000 options expired during the year. Refer to Note 16(c) for further information on options.
(b) 10,083,327 loan shares were cancelled by the Company due to forfeiture by the holders of these loan shares ceasing employment.
Refer to Note 16(b) for information on loan shares.
(c) $135,239 represents the value of share-based payment expense relating to the unvested loan shares that were forfeited by the
holders of these loan shares ceasing employment.
23. EVENTS SUBSEQUENT TO THE END OF FINANCIAL YEAR
No matter or circumstance has arisen since the end of the financial year which is not otherwise dealt with in this report that has
significantly affected or may significantly affect the operations of the Company, the results of those operations or the state of affairs
of the Company in subsequent financial years.
Actinogen Medical Limited
68
Disclosure of subsidiaries and their country of tax residency, as required by the Corporations Act 2001, does not apply to the
Company as the Company is not required by accounting standards to prepare consolidated financial statements.
Consolidated entity disclosure statement
Annual Financial Report
69
In the Directors’ opinion:
1.
The Financial Statements and Notes set out on pages 46 to 68, are in accordance with the Corporations Act 2001
including:
(a) complying with Accounting Standards, the Corporations Regulations 2001 and other mandatory professional reporting
requirements,
(b) giving a true and fair view of the Company’s financial position as at 30 June 2025 and of its performance for the year
ended on that date,
2.
The remuneration disclosure included in the audited Remuneration Report in the Directors’ Report complies with Section
300A of the Corporations Act 2001.
3.
The Directors have been given the declaration by the Managing Director and Chief Financial Officer (or equivalent) as
required by section 295A of the Corporations Act 2001.
4.
The Company has included in the Notes to the Financial Statements an explicit and unreserved statement of compliance
with International Financial Reporting Standards as issued by the International Accounting Standards Board.
5.
Subject to the matter set out in Note 2(b) to the financial statements, there are reasonable grounds to believe that the
Company will be able to pay its debts as and when they become due and payable.
6.
The consolidated entity disclosure statement required by section 295(3A) of the Corporations Act 2001 is true and
correct.
This declaration is made in accordance with a resolution of the Directors.
Dr Steven Gourlay
Managing Director
Sydney, New South Wales
25 August 2025
Directors’ declaration
Actinogen Medical Limited
70
Independent auditor’s report
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Ernst & Young
9 The Esplanade
Perth WA 6000 Australia
GPO Box M939 Perth WA 6843
Tel: +61 8 9429 2222
Fax: +61 8 9429 2436
ey.com/au
Independent auditor’s report to the members of Actinogen Medical
Limited
Report on the audit of the financial report
Opinion
We have audited the financial report of Actinogen Medical Limited (the Company), which comprises the statement
of financial position as at 30 June 2025, the statement of comprehensive income, statement of changes in equity
and statement of cash flows for the year then ended, notes to the financial statements, including material
accounting policy information, the consolidated entity disclosure statement and the directors’ declaration.
In our opinion, the accompanying financial report of the Company is in accordance with the Corporations Act
2001, including:
a.
Giving a true and fair view of the Company’s financial position as at 30 June 2025 and of its financial
performance for the year ended on that date; and
b.
Complying with Australian Accounting Standards and the Corporations Regulations 2001.
Basis for opinion
We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under those
standards are further described in the Auditor’s responsibilities for the audit of the financial report section of our
report. We are independent of the Company in accordance with the auditor independence requirements of the
Corporations Act 2001 and the ethical requirements of the Accounting Professional and Ethical Standards
Board’s APES 110 Code of Ethics for Professional Accountants (including Independence Standards) (the Code)
that are relevant to our audit of the financial report in Australia. We have also fulfilled our other ethical
responsibilities in accordance with the Code.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our
opinion.
Key audit matters
Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of
the financial report of the current year. These matters were addressed in the context of our audit of the financial
report as a whole, and in forming our opinion thereon, but we do not provide a separate opinion on these matters.
For each matter below, our description of how our audit addressed the matter is provided in that context.
We have fulfilled the responsibilities described in the Auditor’s responsibilities for the audit of the financial report
section of our report, including in relation to these matters. Accordingly, our audit included the performance of
procedures designed to respond to our assessment of the risks of material misstatement of the financial report.
The results of our audit procedures, including the procedures performed to address the matters below, provide
the basis for our audit opinion on the accompanying financial report.
Annual Financial Report
71
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Page 2
Research and development rebate
Why significant
How our audit addressed the key audit matter
The Company has recognised a rebate receivable of
$5,489,600 from the Australian Taxation Office (ATO) for
eligible Research & Development (R&D) expenditure (R&D
rebate) relating to its ongoing research activities for the
development of Xanamem during the 30 June 2025 year.
This amount has been included in other receivables and
prepayments on the statement of financial position as at 30
June 2025 and in Note 9 of the financial report.
Due to judgment involved in determining whether
expenditure incurred in R&D activities meets the eligibility
criteria to qualify for inclusion in the R&D rebate receivable
calculation and the significance of this source of cash inflow
for the Company, we considered this to be a key audit
matter.
We involved our R&D taxation specialists to assess the
eligibility of expenditure included in the R&D claim and the
overall appropriateness of the R&D rebate receivable
calculated by the Company’s external expert.
We evaluated the qualifications, competency and objectivity
of the Company’s external expert.
We assessed the appropriateness of the Company’s
accounting treatment of the R&D rebate under Australian
Accounting Standard - AASB 120 Accounting for
Government Grants and Disclosure of Government
Assistance.
We assessed the adequacy of the disclosures in the financial
report.
Information other than the financial report and auditor’s report thereon
The directors are responsible for the other information. The other information comprises the information
included in the Company’s 2025 annual report but does not include the financial report and our auditor’s report
thereon.
Our opinion on the financial report does not cover the other information and accordingly we do not express any
form of assurance conclusion thereon, with the exception of the Remuneration Report and our related assurance
opinion.
In connection with our audit of the financial report, our responsibility is to read the other information and, in
doing so, consider whether the other information is materially inconsistent with the financial report or our
knowledge obtained in the audit or otherwise appears to be materially misstated.
If, based on the work we have performed, we conclude that there is a material misstatement of this other
information, we are required to report that fact. We have nothing to report in this regard.
Responsibilities of the directors for the financial report
The directors of the Company are responsible for the preparation of:
▪
The financial report (other than the consolidated entity disclosure statement) that gives a true and fair view
in accordance with Australian Accounting Standards and the Corporations Act 2001; and
▪
The consolidated entity disclosure statement that is true and correct in accordance with the Corporations
Act 2001; and
Actinogen Medical Limited
72
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Page 3
For such internal control as the directors determine is necessary to enable the preparation of:
▪
The financial report (other than the consolidated entity disclosure statement) that gives a true and fair view
and is free from material misstatement, whether due to fraud or error; and
▪
The consolidated entity disclosure statement that is true and correct and is free of misstatement, whether
due to fraud or error.
In preparing the financial report, the directors are responsible for assessing the Company’s ability to continue as
a going concern, disclosing, as applicable, matters relating to going concern and using the going concern basis of
accounting unless the directors either intend to liquidate the Company or to cease operations, or have no realistic
alternative but to do so.
Auditor’s responsibilities for the audit of the financial report
Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from
material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion.
Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance
with the Australian Auditing Standards will always detect a material misstatement when it exists. Misstatements
can arise from fraud or error and are considered material if, individually or in the aggregate, they could
reasonably be expected to influence the economic decisions of users taken on the basis of this financial report.
As part of an audit in accordance with the Australian Auditing Standards, we exercise professional judgment and
maintain professional scepticism throughout the audit. We also:
▪
Identify and assess the risks of material misstatement of the financial report, whether due to fraud or error,
design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient
and appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement
resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery,
intentional omissions, misrepresentations, or the override of internal control
▪
Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of
the Company’s internal control
▪
Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates
and related disclosures made by the directors
▪
Conclude on the appropriateness of the directors’ use of the going concern basis of accounting and, based
on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that
may cast significant doubt on the Company’s ability to continue as a going concern. If we conclude that a
material uncertainty exists, we are required to draw attention in our auditor’s report to the related
disclosures in the financial report or, if such disclosures are inadequate, to modify our opinion. Our
conclusions are based on the audit evidence obtained up to the date of our auditor’s report. However, future
events or conditions may cause the Company to cease to continue as a going concern
Annual Financial Report
73
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Page 4
▪
Evaluate the overall presentation, structure and content of the financial report, including the disclosures,
and whether the financial report represents the underlying transactions and events in a manner that
achieves fair presentation.
We communicate with the directors regarding, among other matters, the planned scope and timing of the audit
and significant audit findings, including any significant deficiencies in internal control that we identify during our
audit.
We also provide the directors with a statement that we have complied with relevant ethical requirements
regarding independence, and to communicate with them all relationships and other matters that may reasonably
be thought to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards
applied.
From the matters communicated to the directors, we determine those matters that were of most significance in
the audit of the financial report of the current year and are therefore the key audit matters. We describe these
matters in our auditor’s report unless law or regulation precludes public disclosure about the matter or when, in
extremely rare circumstances, we determine that a matter should not be communicated in our report because the
adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such
communication.
Report on the audit of the Remuneration Report
Opinion on the Remuneration Report
We have audited the Remuneration Report included in the directors’ report for the year ended 30 June 2025.
In our opinion, the Remuneration Report of Actinogen Medical Limited for the year ended 30 June 2025,
complies with section 300A of the Corporations Act 2001.
Responsibilities
The directors of the Company are responsible for the preparation and presentation of the Remuneration Report in
accordance with section 300A of the Corporations Act 2001. Our responsibility is to express an opinion on the
Remuneration Report, based on our audit conducted in accordance with Australian Auditing Standards.
Ernst & Young
Timothy Dachs
Partner
Perth
25 August 2025
Actinogen Medical Limited
74
Substantial shareholders:
The Company has no substantial shareholders as at 8 August 2025.
Distribution of ordinary shareholders as at 8 August 2025
Range of Holding
Holders
Shares
1-1,000
124
13,466
1,001-5,000
236
854,893
5,001-10,000
488
3,960,666
10,001 - 100,000
2,502
106,246,248
100,001 – over
2,075
3,066,071,968
Total
5,425
3,177,147,241
Shareholders with less than a marketable parcel
1,632
Voting Rights: Each fully paid ordinary share carries voting rights of one vote per share. No voting rights attach to unlisted
options.
Distribution of listed 31 May 2027 $0.05 option holders as at 8 August 2025
Range of Holding
Holders
Shares
1-1,000
88
42,012
1,001-5,000
161
468,619
5,001-10,000
84
652,911
10,001 - 100,000
258
10,679,711
100,001 – over
197
163,702,649
Total
788
175,545,902
Shareholders with less than a marketable parcel
495
Distribution of listed 30 September 2027 $0.05 option holders as at 8 August 2025
Range of Holding
Holders
Shares
1-1,000
1
1
1,001-5,000
1
2,500
5,001-10,000
-
-
10,001 - 100,000
96
6,065,748
100,001 – over
217
271,494,019
Total
315
277,562,268
Shareholders with less than a marketable parcel
2
Shareholder information
Annual Financial Report
75
Twenty Largest holders of quoted ordinary shares as at 8 August 2025
Quantity of Shares
% of Issued Capital
Dr Steven Gourlay
127,010,514
4.00%
HSBC Custody Nominees (Australia) Limited
108,916,231
3.43%
Ardroy Securities Pty Ltd
64,409,142
2.03%
Mr Guillermo Cesar Orselli & Dr David Matthew Krelle
60,000,000
1.89%
Citicorp Nominees Pty Limited
53,450,563
1.68%
BNP Paribas Noms Pty Ltd
51,503,213
1.62%
Old College Capital Holdings Limited
48,147,864
1.52%
SVE Capital Pty Ltd
42,533,056
1.34%
Tisia Nominees Pty Ltd
41,100,300
1.29%
Garnsworthy Pension Fund Pty Ltd
36,500,000
1.15%
Souter Family Holdings Pty Ltd
30,000,000
0.94%
Rickenbacker Capital Investments Pty Ltd
28,850,000
0.91%
Kaleidoscope Holdings Pty Ltd
27,345,559
0.86%
Ware Superfund Holdings Pty Limited
26,089,245
0.82%
BNP Paribas Nominees Pty Ltd
25,012,151
0.79%
Dr Dana Hilt
25,000,000
0.79%
Spiceme Capital Pty Ltd
25,000,000
0.79%
JSC Wealth Management Pty Ltd
24,157,218
0.76%
Dr Geoffrey Edward Duncan Brooke
24,054,039
0.76%
Alua Nominees Pty Ltd
22,688,291
0.71%
TOTAL
891,767,386
28.08%
Twenty largest holders of quoted 31 May 2027 $0.05 options as at 8 August 2025
Quantity of Shares
% of Issued Capital
Precision Opportunities Fund Ltd
30,000,000
17.09%
Mrs Sarah Cameron
10,000,000
5.70%
Celtic Finance Corp Pty Ltd
5,000,000
2.85%
Alua Nominees Pty Ltd
5,000,000
2.85%
Denlin Nominees Pty Ltd
5,000,000
2.85%
Longreach 52 Pty Ltd
4,000,000
2.28%
Rickenbacker Capital Investments Pty Ltd
4,000,000
2.28%
Tets Pty Ltd
4,000,000
2.28%
Kendali Pty Ltd
4,000,000
2.28%
Tisia Nominees Pty Ltd
3,498,494
1.99%
Mr Peter Kyros
3,000,000
1,71%
Giokir Pty Ltd
3,000,000
1.71%
Citicorp Nominees Pty Limited
2,465,776
1.40%
HSBC Custody Nominees (Australia) Limited
2,442,347
1.39%
Goldstake Corporation Pty Ltd
2,266,667
1.29%
Stow Super Investments Pty Ltd
2,000,000
1.14%
John Dahlsen Superannuation Fund Pty Ltd
2,000,000
1.14%
Mr Peter James Nixon
2,000,000
1.14%
JP & LA Frohnert Pty Limited
2,000,000
1.14%
Pumpkin Point Pty Ltd
2,000,000
1.14%
TOTAL
97,673,284
53.94%
Actinogen Medical Limited
76
Twenty largest holders of quoted 30 September 2027 $0.05 options as at 8 August 2025
Quantity of Shares
% of Issued Capital
Citicorp Nominees Pty Limited
38,039,998
13.71%
JP Morgan Nominees Australia Pty Limited
25,000,000
9.01%
Dr Steven G Gourlay
25,000,000
9.01%
BNP Paribas Noms Pty Ltd
16,250,001
5.85%
Morgan Stanley Australia Securities (Nominee) Pty Limited
14,999,999
5.40%
Precision Opportunities Fund Ltd
12,537,501
4.52%
Mr Scott Crank & Ms Lola Crank
5,740,000
2.07%
Mr Shane Justin Butsch
5,000,000
1.80%
Garnsworthy Accumulation Super Fund Pty Ltd
4,516,862
1.63%
Mr Guillermo Cesar Orselli & Dr David Matthew Krelle
4,028,421
1.45%
Kendali Pty Ltd
3,646,713
1.31%
Alua Capital Pty Ltd
3,146,714
1.13%
Mrs Gillian Karen Nes & Mr Ronald Nes
2,665,000
0.96%
HSBC Custody Nominees (Australia) Limited
2,615,611
0.94%
HSBC Custody Nominees (Australia) Limited – A/C 2
2,500,002
0.90%
Riya Investments Pty Ltd
2.250,000
0.81%
Ware Superfund Holdings Pty Limited
2,188,118
0.79%
Mr Wayne Peter Marriott
2,000,000
0.72%
Garnsworthy Pension Fund Pty Ltd
1,650,000
0.59%
Structure Investments Pty Ltd
1,565,551
0.56%
TOTAL
173,090,491
63.16%
Unquoted Securities as at 8 August 2025
1.
There were 1,600,000 unlisted employee share option plan options exercisable at $0.046 each and expiring on 27
September 2025 held by one holder, on issue.
2.
There were 85,775,526 unlisted options exercisable at $0.0375 each and expiring on 11 September 2026 held by 607
holders, on issue, with no one holder holding more than 20%.
3.
There were 80,791,930 unlisted options exercisable at $0.0375 each and expiring on 15 September 2026 held by 29
holders, on issue, with no one holder holding more than 20%.
Restricted Securities
The Company has no securities on issue that are subject to either ASX or voluntary escrow.
On-Market Buy-Back
There is no current on-market buy back in place.
The Corporate Governance Statement is not included as part of this Annual Report but can be referenced via the Company’s
website.
Annual Financial Report
77
Board of Directors
Dr Geoffrey Brooke - Non-Executive Chairman
Dr Steven Gourlay - Managing Director & Chief Executive Officer
Dr George Morstyn - Non-Executive Director
Mr Malcolm McComas - Non-Executive Director
Dr Nicki Vasquez - Non-Executive Director
Company Secretary
Mr Peter Webse
Investor Relations
Mr Michael Roberts
Principal Place of Business / Registered Office
Suite 901
Level 9
109 Pitt Street
Sydney NSW 2000
Contact Details
Telephone: 02 8964 7401
info@actinogen.com.au
www.actinogen.com.au
ABN 14 086 778 476
Lawyers
K&L Gates
Level 25 South Tower
525 Collins Street
Melbourne VIC 3000
Share Register
Automic Group
Level 5
126 Phillip Street
Sydney NSW 2000
Auditor
Ernst & Young
Australia
Actinogen Medical Limited shares are listed on
the Australian Securities Exchange ('ASX').
ASX Code: ACW
AGM details
Actinogen Medical Limited
ABN: 14 086 778 476
Annual General Meeting
This year’s Annual General Meeting will be held in person.
Date: 19 November 2025
Meeting time and details to be advised.
Corporate directory
Actinogen Medical Limited
78