2024
Annual report
Who we are
1
Highlights
2
The Xanamem pipeline
3
XanaCIDD depression trial results
4
Xanamem progressing to advanced clinical trial phase
6
Clinical trials program overview
7
Chair’s letter
8
Chief Executive Officer’s letter
10
Vision and strategy
12
Operating & financial review
14
Board of directors
22
Executive leadership team
24
Directors’ report
26
Remuneration report (Audited)
29
Auditor’s independence declaration
42
Financial report
43
Notes to the financial statements
48
Directors’ declaration
68
Independent auditor’s report
69
Shareholder information
73
Corporate directory
75
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.
Contents
Actinogen is a
neurotherapeutics
developer realizing a
revolutionary therapy
so neurology patients
and their families can
live their best lives.
Annual Financial Report
1
Highlights
Positive depression results in the phase 2a XanaCIDD
trial confirm clinical activity and validate Xanamem’s
brain cortisol control mechanism
Announced positive
depression results in the
XanaCIDD phase 2a trial,
confirming the clinical
activity of 10 mg Xanamem®
dose and validating its brain
cortisol control mechanism
Commenced screening
& enrolment in Australia
for XanaMIA phase 2b AD
trial with additional five
sites opening in the USA
in Q3 CY2024
Received approval from
the UK MHRA1 for an
Innovation Passport under
Innovative Licensing and
Access Pathway (ILAP) for
Xanamem treatment of AD
Recruited and treated
167 patients in phase 2a
depression trial in circa
16 months reinforcing
excellence of hybrid model
of clinical trial operations
Completed and published
two academic manuscripts
in peer-reviewed journal, The
Journal of Alzheimer’s disease
including groundbreaking
phase 2a biomarker trial
Strengthened IP portfolio
with development of
an improved synthetic
manufacturing process of
Xanamem drug substance
Facilitated potential partner
engagement and relationship
building as a phase 2 clinical
stage company through
attendance at significant
international conferences
Secured $19 million2 in two
successful capital raisings,
providing essential funds to
support ongoing clinical trial
program to late CY2025
Initiated strategic
changes and additions
to the executive and
operational teams including
new full‑time CFO and
strategic reorganization
of clinical operations team
Conducted two highly
informative “plain English”
neuroscience webinars
Improved drug substance
manufacturing process
with 1 kg demonstration
batch at our new
manufacturer Asymchem
Presented Actinogen
and met with most key
neuroscience companies
at the Sachs neuroscience
meeting in San Francisco
® Xanamem is a registered trademark of Actinogen Medical Limited
1 UK Medicines and Healthcare products Regulatory Agency. ILAP is the UK version of the FDA’s “breakthrough” designation
2 Unless stated otherwise, all financial data is in Australian dollars
Actinogen Medical Limited
2
The Xanamem pipeline
Indication
Preclinical
Phase 1
Phase 2
Phase 3
Topline results phase 2a
Major depressive
disorder
Fragile X syndrome
Phase 2a paused
Ongoing phase 2b
Alzheimer’s disease
Open INDs
phase 2 trials
Schizophrenia
- CIAS
Frontotemporal
dementia
Lewy-body
dementia
CI and
dementia PD
Potential next indications
CIAS: Cognitive impairment associated with schizophrenia; CI: Cognitive impairment; PD: Parkinson’s disease
Annual Financial Report
3
XanaCIDD depression
trial results
Xanamem benefit at Week 6 & 10
All randomized participants (n = 165)
Xanamem PGI-S separation from Week 2
All randomized participants (n = 165)
MADRS LS mean change from baseline (± SE)
ON TREATMENT
-12
0
Baseline
Week 2
Xanamem
Placebo
Week 4
Week 6
Week 10 post treatment
-2
-4
-6
-8
-10
FOLLOW UP
PT 2.7-point difference
Cohen’s d = 0.43
p = 0.02
EOT 1.5-point difference
Cohen’s d=0.24
p=0.11
BETTER
BETTER
-1.2
-1.4
0
-0.2
-0.4
-0.6
-0.8
-1
PGI-S LS mean change from baseline (± SE)
Xanamem
Placebo
Baseline
Week 2
Week 4
Week 6
Week 10 post treatment
ON TREATMENT
FOLLOW UP
EOT 0.22-point difference
Cohen’s d = 0.23
p = 0.19
PT 0.28-point difference
Cohen’s d = 0.29
p = 0.13
Abbreviations: MADRS = Montgomery-Åsberg Depression Rating Scale; EOT: End of Treatment; PT: Post Treatment
• 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
• This outcome indicates potential
modification of the underlying
biology of depression as a result
of inhibition of tissue cortisol
synthesis – a completely novel
mechanism for the treatment
of depression.
Actinogen has achieved
clinically and statistically
significant superiority
of Xanamem over
placebo in depression in
XanaCIDD phase 2a trial:
This encouraging result
on depression is very
positive to the whole
Xanamem program and
confirms 10 mg daily
is an active clinical
dose with the ability
to potentially modify
underlying biological
processes in the brain.
Dr Dana C Hilt
Actinogen’s Chief Medical Officer
Actinogen Medical Limited
4
The excellent safety profile
of Xanamem was again
demonstrated in this trial
and the significant treatment
benefits seen in depression
are encouraging for both the
depression and Alzheimer’s
disease programs. We believe
the trial confirms the ability of
Xanamem 10 mg daily to safely
provide benefit to patients by
controlling levels of cortisol in
the brain.
Dr Steven Gourlay
Actinogen’s CEO
Annual Financial Report
5
Xanamem progressing to
advanced clinical trial phase
Major Xanamem development risks mitigated
Highly attractive phase 2/3 profile in dementia and major depression
Recently
Now and in future
Previously
Positive human PET
study confirms 5-10
mg daily target dose
Positive phase 1b
trials on cognition
Positive phase 2a
depression data
Positive phase 2a
AD data
To-be-marketed
tablet formulation
Excellent safety
profile (n>380)
Phase 2b/3 trials in AD
and depression
1500-person safety
database
Marketing approvals
In the beginning
Positive 11B-HSD1
AD mouse model
Low in vitro drug-
drug interaction
potential
6
Actinogen Medical Limited
Clinical trials program overview
Phase 2 and 3 trials to achieve
marketing approvals
Current phase 1 & 2 datasets
Safety, cognition activity (n>380)
Phase 2b
Alzheimer’s disease
1x Phase 3
Alzheimer’s disease
Phase 2a
Cognitive impairment
and depression
2x Phase 2b/3
Depression
Annual Financial Report
7
Chair’s letter
Dr Geoff Brooke, Chair
Dear Shareholder,
I am pleased to present
to you the Actinogen
Medical Annual Report for
the financial year ended
30 June 2024.
The Company continues to make compelling progress in the
execution of its strategy, focusing on “following the science”
in the successful development of our novel, small molecule
drug Xanamem, to treat illnesses such as Alzheimer’s disease
and depression. We continue to believe that Xanamem’s
mechanism of “tissue cortisol synthesis inhibition” to reduce
excess cortisol inside brain cells has the potential to have
a major impact on the lives of patients and their families
suffering from many neurological and neuropsychiatric
conditions.
It was great to witness gradually improving conditions in
the biotech market from the start of 2024, especially as key
licensing and M&A activity signalled a change in sentiment
from the very challenging market headwinds of 2023,
particularly in the small-cap biotech sector.
A year of achievement
The Company enjoyed a productive financial year with
the achievement of several major milestones including the
execution of two phase 2 trials running concurrently during
the second half. It takes significant effort to get a trial to the
starting line, let alone manage the complexities of running two
sizeable trials across different jurisdictions simultaneously.
The XanaCIDD phase 2a depression trial completed its final
patient treatment on 1 July 2024, having recruited 167 patients
in 16 months – a tremendous effort from Actinogen staff, our
collaborators and the participants. An unexpectedly high
placebo effect impacted our ability to see a potential Xanamem
effect in the cognition primary endpoint. In the targeted
secondary endpoint, we were very pleased to see positive
benefits on depression, confirming the clinical activity of our
10 mg dose and validating the drug’s mechanism to control
brain cortisol.
The XanaMIA phase 2b Alzheimer’s disease trial commenced in
April 2024 and, typical of early phases in a trial, screening and
enrolment is gradually ramping up in Australia and will be aided
by the addition of new sites opening in the USA.
In another highlight, the Company received approval from the
UK Medicines and Healthcare products Regulatory Agency
of its application for a UK Innovation Passport as part of the
Innovative Licensing and Access Pathway (ILAP) for Xanamem
in the treatment of Alzheimer’s disease. This UK version of
the FDA’s “breakthrough” designation represents a significant
independent endorsement by an international regulator of the
potential medical importance of the Xanamem program.
The team has also continued to work diligently to complete
two academic manuscripts that were published in the peer-
reviewed journal, The Journal of Alzheimer’s Disease in the
second half of the financial year, with further academic
papers planned.
Executive leadership
CEO Dr Steven Gourlay has continued to lead the executive
team with distinction. He has the relevant experience needed
of a biotech CEO for a Company in the mid-late stage of vital
clinical development with a view to commercialisation. Steven
navigates the big-picture strategy with a clear view and plans
for later-stage requirements yet is proactive and attentive to
the many details and intricacies of the here and now of drug
clinical development. I firmly believe he has the experience and
agility to steer through complex situations while balancing our
budget in a high-cost industry.
Dr Gourlay leads a small but innovative, high calibre executive
leadership team with complementary skills that produces
results. We added to the team’s skillset this year with the
appointment of the Company’s first full-time Chief Financial
Officer, Mr Will Souter, who is a first-class CFO with a wealth of
biotech, financial and corporate communications experience.
Will has taken responsibility for finance, communications,
information technology and human resources, and is skilfully
leading capital management activities with the CEO.
I also commend the hard work and achievements of Ms Cheryl
Townsend and her clinical operations team during the past
year. I cited earlier the complexities of running two sizeable
trials simultaneously across different jurisdictions, including
significant pre-trial preparations, and the successful
delivery of those responsibilities is due in no small part to
Cheryl’s leadership.
And I take this opportunity to thank the wider executive
leadership team and the Actinogen workforce, as well as
key contractors, who all work so diligently to manage a very
effective and efficient clinical development program and
corporate functions required of a listed biotech.
Board, corporate governance and advisory boards
The board seeks continuous improvement in its governance
and management oversight capability. During the past year we
again conducted a review of all activities and responsibilities,
including assessing the Board skills matrix to identify gaps
and opportunities for improvement. Our significant corporate
Actinogen Medical Limited
8
policies and other corporate governance materials are
posted on our website, and we maintain a robust corporate
governance framework to support the management and
execution of our long-term strategy and annual strategic
priorities.
I thank my fellow board members for their contributions during
a productive year which has necessarily required a significant
planning agenda for the next stages in the Company’s
development. I would especially like to acknowledge the
contribution of Dr Nicki Vasquez who joined the board in March
2023 and with her astute insights, has proven to be a valuable
contributor to board deliberations. We will continue to assess
our corporate board skillsets and, where appropriate, make
changes or additions as we did with Dr Vasquez’s appointment.
Actinogen continues to utilise world-leading advisors on our
advisory boards to help drive our strategic initiatives and
ensure the success of our clinical development program.
This year we welcomed Dr Steve Targum, a world-renowned
psychiatrist as an external advisor and chair of the XanaCIDD
trial safety committee. Shareholders may have seen Dr
Targum as an external expert commentator on the XanaCIDD
results webinar providing valuable input to the understanding
of the topline trial results. I thank all our esteemed independent
external advisory board and committee members for their
important contributions to the success of the Company
in FY2024.
Further details on the Actinogen corporate board, advisory
boards and senior executive personnel can be found on the
Company’s website: https://actinogen.com.au/our-team/
Capital management
The Company successfully completed two capital raisings
totalling $18.9 million during the year and I thank shareholders
for your strong support in the 2023 entitlement offer and the
recent May 2024 raising, where the entitlement offer was
oversubscribed approximately 1.8 times. Additional funding has
been received from the conversion of options associated with
those two capital raisings.
A further $9.0 million related to the 2024 R&D tax incentive
rebate is expected to be received in Q4 CY2024.
With a cash balance of $9.5 million at 30 June 2024 and the
additional funding sources described above, the company and
its current programs are funded to late CY2025.
Annual General Meeting
This year’s Annual General Meeting will be held in Sydney
on Thursday 14 November 2024, and we invite shareholders
to attend in person. Details of the meeting time and Sydney
location will be announced in due course.
Outlook
Actinogen has again proven its ability to deliver high quality
clinical trials in an efficient and effective manner. A key focus
in FY2025 will be on planning for follow on activities in our
depression trial program following the release of positive
topline results for the XanaCIDD phase 2a trial announced
earlier this month. This includes deeper analysis of the full
results dataset and announcing and publishing additional
information where relevant. Plus, we will be undertaking
discussions with regulators such as the FDA, EMA and the TGA
to identify the optimal trial design as we enter the next phase.
We look forward to making further progress in our XanaMIA
phase 2b Alzheimer’s disease clinical trial in FY2025 as we
activate sites in the USA and ramp up patient screening and
enrolments at all locations, ahead of an interim analysis in mid
CY2025. The design and enrolment criteria for this phase 2b
trial are based on the strong scientific rationale derived from
the findings of the biomarker trial, published recently in the
peer reviewed Journal of Alzheimer’s Disease, which showed
that Xanamem potentially slows disease progression in AD
patients with elevated levels of plasma pTau.
The board looks forward with confidence to a very exciting
2025 financial year for Actinogen. As always, we remain
vigilant in our governance and proactive in our management as
we deliver on our strategic priorities.
On behalf of the Board, I would like to thank you, our
shareholders, for your ongoing support, and we look forward
to updating you on our progress during the coming year.
Dr Geoff Brooke
Chair
30 August 2024
The Actinogen team has again proven its ability to effectively and
efficiently deliver high quality clinical trial programs, with the
depression trial successfully concluded and the pivotal Alzheimer’s
phase 2b trial well under way as we head into the new financial year.
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
Dr Steven Gourlay, CEO & Managing Director
Dear Shareholder,
The Xanamem program is
now in advanced late-stage
clinical development.
Actinogen has now reached a transformational stage in its
clinical development of Xanamem, with positive results on
depression in our XanaCIDD phase 2a trial. The improvements
seen in depression symptoms clearly show that Xanamem’s
mechanism of action in the brain to inhibit tissue production
of cortisol has major clinical impact. The associated lack of
superiority over placebo in short-term cognitive enhancement
was surprising but instructive for the depression program.
The FDA has long argued that cognitive dysfunction improves
as depression improves, although the scientific literature has
established that the correlation is by no means universal.
Based on our XanaCIDD results, we will be pursuing depression
itself, not short-term cognitive enhancement, in future clinical
trials – a much more straightforward path with regulators
like the FDA, EMA and TGA. In contrast, trials of Xanamem
in patients with Alzheimer’s disease will continue to include
both functional and cognitive measures in order to adequately
describe the potential slowing of disease progression in this
confirmatory, late-stage trial.
So how did we get here and where do we go to from here? As
we have explained before, the science of clinical development
is all about getting many details right and I’m pleased to say it
has the potential to pay off handsomely for the many possible
future patients who may benefit from Xanamem.
The “rights” for Xanamem:
• Hitting the right target – 11β-HSD1 in the brain
• Having a drug with the right properties – brain-penetrant,
low dose, low drug interaction potential
• Using the right biomarkers and assessments –
hormone, PET and blood biomarkers like pTau
• Targeting the right dose – multiple trials show clinical
activity of doses of ≤ 10 mg daily
• Selecting the right trial participants – for example,
patients with AD and elevated pTau
• Using the right trial design – world-class trials
and statistics approved by the FDA
• Ensuring the right safety profile – excellent safety
profile in >380 people treated.
The “stages” for Xanamem:
Completed
• Preclinical: animal studies, laboratory benchtop studies
etcetera
• Phase 1: measuring levels of the drug and its effects on
systems in the body, typically healthy volunteers, in order
to select a dose range for future testing and establish early
human safety
• Phase 2: trials in patients to show clinical activity and select
future sensitive endpoints and the ideal patients for phase 3
Coming up or in progress
• Phase 3 or 2b/3: “pivotal”, confirmatory trials designed to
inform marketing approvals with the FDA and other regulators
• Phase 4: post-marketing studies to primarily monitor the
safety of the drug in the “real world”
Moving ahead in major depressive disorder (MDD)
Our latest phase 2a trial, XanaCIDD, has provided positive data
on depression and an extensive, high-quality dataset from
which future trials can be designed in conjunction with input
from experts and regulators.
Initial, topline results indicate that Xanamem had benefit on
MDD symptoms in multiple subgroups of patients. These
findings are being explored by additional analyses intended to
confirm the characteristics of the potential responder population
compared to the overall population. This analysis will guide the
selection criteria for patients with MDD in future trials.
Moving ahead with the phase 2b trial in Alzheimer’s
disease (AD)
Publication of our groundbreaking phase 2a biomarker trial
data in the Journal of Alzheimer’s Disease1 in June was
1 Plasma pTau181 Predicts Clinical Progression in a phase 2 Randomized Controlled Trial of the 11β-HSD1 Inhibitor Xanamem® for Mild Alzheimer’s Disease Jack Taylor, Mark
Jaros, Christopher Chen, John Harrison and Dana Hilt. Article published to the Journal of Alzheimer’s Disease 26 June 2024.
Xanamem is a unique orally administered molecule
in its own class as a “brain tissue cortisol synthesis
inhibitor”. In fact, the International Non-proprietary
Names for Pharmaceutical Substances (INN) of the
World Health Organization recognized this by giving
its future “generic” or non-proprietary name a unique
suffix (name to be announced in early 2025 pending
final vetting). No other brain-penetrant modifiers of
tissue cortisol synthesis are in development to our
knowledge and no other 11β-HSD1 inhibitors have
ever received an INN name.
Actinogen Medical Limited
10
validation of the methods used to analyze the effects of
Xanamem in patients with a biomarker-positive signature.
Elevated levels of pTau in the blood are being increasingly
recognized as a highly accurate way to diagnose progressive
Alzheimer’s disease and have been incorporated into new,
draft US guidelines for the disease2. Elevated pTau is a key
entry criterion for the on-going XanaMIA phase 2b trial.
The key findings reported in the Journal of Alzheimer’s
disease were:
• Patients with elevated pTau181 had much more rapid
progression than patients with lower pTau181 levels in
four key clinical endpoints: ADCOMS (p<0.001), CDR-SB
(p<0.001), MMSE (p=0.12) and ADAS-Cog14 (p=0.19)3
• In the 34 patients with lower pTau181 there was no
progression in any of those endpoints, indicating that
approximately half of the original trial population had non-
progressive disease and perhaps in many cases, did not
have Alzheimer’s disease
• In the 34 patients with elevated pTau181 a potentially
large and clinically meaningful Xanamem treatment effect
compared to placebo was seen in the CDR-SB (mean
difference 0.6 units, p=0.09) and positive trends were
observed in a Neuropsychological Test Battery of cognition
(LS mean difference 1.8 units, p=NS).
Using the biomarker trial data as a simulation of the phase
2b trial, a design was chosen that enables assessment of
Xanamem’s potential benefit to slow disease progression by
accurately evaluating performance on both clinical function,
measured with endpoints like the CDR-SB and activities of
daily living scores, and a broad testing system for cognition.
Thirty-six weeks duration has been chosen for the XanaMIA
phase 2b trial to enable sufficient time for Xanamem treatment
effects to become evident in AD patients, especially those
effects of improving clinical function (slowing progression).
The trial is further enhanced by using our new, to-be-marketed
tablet formulation.
Interim results are anticipated by mid-2025, with final results
in 2026.
In my view, this trial has a high probability of success given
the benefits seen in the biomarker-positive patients with
Alzheimer’s disease and our new findings on depression that
validate clinical activity of the 10 mg daily dose level.
Moving ahead with Good Manufacturing Practice
(GMP) manufacturing
Because Xanamem is a low dose drug we are in the fortunate
position of needing only a modest volume of drug supply
and few manufacturing runs to complete the clinical trial
program. We intend to make scale up batches in the coming
year to further validate the commercially-ready manufacturing
process. Our tablets are produced in the USA by Catalent, Inc.
using drug substance produced by Corden in Switzerland or
Asymchem in China.
Business development & partnering
Business development and partnering activities have been
strengthened with the new XanaCIDD trial data and the
two peer-reviewed publications published earlier this year.
We continue to see a high level of interest in our programs
especially as biopharma market conditions have gradually
improved since their 2023 nadir with notably stronger merger,
licensing and funding activity in the neuroscience sector in late
2023 and 2024.
We again attended many important international conferences
during the year to enhance Actinogen’s credentials as a
phase 2 clinical-stage company and facilitate potential
partner engagement and relationship building. At the
recent Alzheimer’s Association International Conference
(AAIC 2024) in late July our CMO Dr Dana Hilt presented an
academic poster that summarized the comprehensive clinical
pharmacology approach used by Actinogen integrating data
from multiple clinical trials to determine the target dose range
for Xanamem. Other meetings included a CMO presentation
at the Sachs Neuroscience Innovation Forum and meetings
at Biopartnering @JPM associated with the 42nd annual JP
Morgan HealthCare Conference in San Francisco in January.
Xanamem clinical data keeps getting stronger
Xanamem’s promising story as a breakthrough oral therapy
for Alzheimer’s disease and many other illnesses continues
to mature, with our latest XanaCIDD trial showing activity on
depression in patients with pre-treated MDD. We are delighted
with our success in the past year, and I would like to extend my
thanks to the team for all their hard work.
Based on the results of our trials conducted in >380 patients
so far, we firmly believe that Xanamem has the potential to be
a first-in-class drug for the treatment of AD and potential as
a first-in-class antidepressant with a novel mechanism unlike
any competitors.
Thank you for your ongoing support for Actinogen and we look
forward to updating you on our progress in the near future with
each successive trial and corporate milestone.
Yours sincerely,
Dr Steven Gourlay,
CEO & Managing Director
30 August 2024
Our strategy is to extend phase 2a clinical validation of
Xanamem’s brain cortisol mechanism in Alzheimer’s disease
and major depressive disorder into phase 2b/3 trials.
2 https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13859
3 ADCOMS: Alzheimer’s Disease Composite Score; CDR-SB: Clinical Disease Rating Scale – Sum of Boxes; MMSE: Mini Mental State Examination; ADAS-Cog14: Alzheimer’s
Disease Assessment Scale – Cognition version 14
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 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
To realize a revolutionary
therapy so that
neurology patients
and their families can live
their best lives.
Actinogen Medical Limited
12
FY2024 Strategic priorities
Accelerate clinical
development in
Alzheimer’s disease
• Enrol same patient
population where the
large Xanamem effect
was seen in patients
with AD elevated blood
pTau181 protein
• Rapidly pre-screen
patients for elevated pTau
and key clinical criteria
to minimize later costly
screening failures
• Ensure high quality
rating training and
standardization to
minimize noise in
subjective endpoints like
the CDR-SB
• Leverage ‘hands on’
Australian-based
clinical operations
and management
supplemented by select
use of US contractors
to speed timelines
and reduce cost.
Evaluate the
optimal phase
2b trial design
in depression
• Complete full analysis of
phase 2a clinical trial data
to identify ideal population
and endpoints for future
trials
• Discuss results and
proposed protocol design
with major stakeholders,
including local and
global thought leaders in
MDD, potential strategic
development partners and
key regulators
• Submit protocol to the
FDA IND dossier and wait
30 days for clearance.
Forward planning
• Optimize manufacturing
processes for supply of
future clinical trials and
marketed product
• Use to-be-marketed
tablet formulation in
all trials
• Leverage regulatory
designations such as
ILAP (granted for AD)
and FDA breakthrough
(planned for AD and
possibly depression)
where possible
• Integrate global regulatory
strategic planning
to optimize path to
marketing approvals in
multiple geographies
• Plan and conduct
required regulatory
nonclinical studies to
the Good Laboratory
Practice standard
• Plan and conduct ancillary
clinical pharmacology
studies required for
marketing approvals.
Proactively engage
with prospective
development
and commercial
partners
• Consider all types of
value-add partnerships
in the near term once
XanaCIDD results
are finalized
• Proactively engage with
the universe of potential
biopharma partners
who could bring co-
development synergies
to the Xanamem programs
• Maintain close working
relationships with key
regulators such as the
US FDA, UK MHRA and
the EMA
• Partner with
leading clinical trial
implementation providers
• Partner with key
community AD and
depression organizations
in Australia and globally.
Annual Financial Report
13
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 - Continuing to Follow the Science:
Received approval of application for a UK Innovation Passport as part of the Innovative Licensing and Access
Pathway (ILAP) for Xanamem in the treatment of Alzheimer’s disease
Advanced two major phase 2 clinical trial programs:
•
XanaCIDD phase 2a depression trial completed with clinically and statistically significant benefits announced on
depression as measured by MADRS without measurable effects on cognition greater than placebo
•
In the XanaMIA phase 2b Alzheimer’s disease trial, the Australian trial site start up process is complete with
fifteen Australian clinical sites active. The US site activation process has commenced with successful submission
of the protocol to the FDA and first patient screening imminent. Final results are expected in CY2026 with an
interim analysis due in mid CY2025.
Published two academic manuscripts in peer-reviewed journal, the Journal of Alzheimer’s Disease (JAD):
•
Xanamem human brain PET study
•
Positive Xanamem phase 2a biomarker trial.
Received a $4.8 million Research & Development (R&D) tax incentive rebate in October 2023
Completed the development of an improved synthetic process of Xanamem drug substance and manufacture of a
1kg demonstration batch at a new supplier, Asymchem, as a prelude to larger scale manufacture
Initiated strategic changes and additions to the executive and operational teams:
•
Appointed new full time Chief Financial Officer and conducted limited reorganization of Clinical Operations team
to align with business requirements
•
Continued to fill strategic operational roles to ensure the success of its clinical development program, including
those required for the XanaMIA phase 2b Alzheimer’s disease trial in Australia and the USA.
Completed two informative “plain English” neuroscience webinars during the year
Presented at numerous international and Australian AD, investment and partnering meetings
Funding secured to late calendar 2025.
The Company’s 2024 financial year was marked by robust clinical pipeline progress and several major milestones and
events:
Approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of an application for an
Innovation Passport as part of the ILAP for Xanamem in the treatment of Alzheimer’s disease
•
Represents an independent endorsement by an international regulator of the potential impact of the Xanamem
program
•
Key benefits of this type of “breakthrough” approval include:
o
Entry point to the ILAP which aims to accelerate time to market
o
Linkage to a portfolio of activities through the product-specific creation of the Target Development Profile
(TDP) in conjunction with the MHRA
o
Opportunities for enhanced regulatory and other stakeholder input including from partner agencies such as
the MHRA and National Institute for Health and Care Excellence (NICE).
Advancing two phase 2 trial programs:
•
XanaCIDD phase 2a depression clinical trial:
o
The just-completed XanaCIDD trial was a phase 2a, proof-of-concept, placebo-controlled, parallel group
trial in patients with cognitive dysfunction in major depressive disorder (MDD)
o
Final patient visit was completed on 1 July 2024
o
Positive topline results for depressive symptoms announced 12 August 2024.
Actinogen Medical Limited
14
•
XanaMIA phase 2b Alzheimer’s disease (AD) clinical trial:
o
The XanaMIA 2b AD trial will enrol 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 thus augment the ability to detect a Xanamem treatment benefit
o
The Australian trial site start up process is now complete with fifteen Australian clinical sites active
o
The US site activation process has commenced with successful submission of the protocol to the FDA and
the first patient screening imminent – it is anticipated that at least five US clinical sites will be added to the
trial to maintain target enrolment
o
Use of the tau protein as an imaging biomarker was successfully used by Eli Lilly Inc. in their program for
donanemab, the newly approved anti-amyloid antibody for AD
o
Participants have undergone pre-screening for elevated pTau181 levels with the planned “screen-fail rate”
of approximately 60% observed. Seventeen patients have been randomized and treated with additional
participants at various stages in the screening phase
o
An interim analysis will occur when approximately 100 patients reach 24 weeks of treatment (expected mid
CY2025)
o
Final results are anticipated in CY2026.
Published two academic manuscripts in peer-reviewed journal, the Journal of Alzheimer’s Disease (JAD):
•
Xanamem human brain PET study published on 19 January 2024:
The study concluded that:
o
Xanamem achieved high target occupancy of 66-85%, which exceeded the 30-60% inhibition required for
effectiveness in animal models
o
A dose level of 10 mg daily achieved near saturation of the enzyme target, meaning that higher doses
achieved little additional occupancy
o
The study results support exploring doses of ≤10 mg in clinical trials, consistent with the Company’s
ongoing phase 2 trials
o
Access the publication via the following link https://pubmed.ncbi.nlm.nih.gov/38250767/
•
Positive Xanamem phase 2a biomarker trial published on 25 June 2024 in 100th edition of JAD:
o
Participants comprised 72 patients from the previous XanADu phase 2a trial of mild Alzheimer’s disease
(AD) who had available stored plasma (blood) samples and gave informed consent for the new trial
o
Patients with elevated pTau181 above the median level had much more rapid progression than patients with
lower levels in four key clinical endpoints: ADCOMS (p<0.001), CDR-SB (p<0.001), MMSE (p=0.12) and
ADAS-Cog14 (p=0.19)
o
In the 34 patients with elevated pTau181 a potentially clinically meaningful Xanamem treatment effect
compared to placebo was seen in the CDR-SB (LS mean difference 0.6 units, p=0.09) and positive trends
were observed in a Neuropsychological Test Battery of cognition (LS mean difference 1.8 units, p=NS)
o
Access the publication via the following link: https://content.iospress.com/download/journal-of-alzheimers-
disease/jad231456?id=journal-of-alzheimers-disease%2Fjad231456
$4.8 million R&D tax incentive rebate:
•
In November, the Company announced that it had received an R&D tax incentive rebate of $4.8 million from the
Australian Tax Office for the 2023 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.
Manufacturing:
•
The Company’s new contract manufacturer, Asymchem, has completed the development of an improved
synthetic process of Xanamem drug substance and completed the manufacture of a 1kg demonstration batch as
a prelude to larger scale manufacture
•
Tablets are produced in the USA by Catalent, Inc. using drug substance produced by Corden in Switzerland or
Asymchem in China.
Executive and clinical operations teams:
•
In November 2023, the Company appointed Mr Will Souter as a new full time Chief Financial Officer. Mr Souter
commenced in the role in February 2024
•
The Company also initiated a limited reorganization which resulted in the position of Senior Vice President,
Product Development being made redundant. Ms Cheryl Townsend, Vice President Clinical Operations, now
reports directly to the CEO
•
The Company continues to fill strategic operational roles to ensure the success of its clinical development
program, including those required for the XanaMIA phase 2b Alzheimer’s disease trial in Australia and the USA.
Neuroscience webinars for investors:
•
Following the Science is fundamental to all Actinogen’s activities and is the foundation for the Company’s
ongoing Clinical Trials Science Forum (CTSF) series of plain English educational webinars
•
In August 2023, leading neuroscience and cognition expert Professor Paul Maruff joined Actinogen’s Chief
Medical Officer Dr Dana Hilt to discuss recent progress in the AD clinical development field and cognitive
dysfunction associated with depressive disorder:
o
This discussion and Q&A session focused on interpreting the various testing methods that have been
applied to cognition in AD and cognitive dysfunction associated with MDD and used to evaluate the efficacy
of new drugs such as Xanamem
o
Xanamem works on lowering brain tissue cortisol and is one of only a few development programs that has
demonstrated clinical activity on cognition in multiple placebo-controlled trials.
Annual Financial Report
15
•
In another informative CTSF in May 2024, ACW CMO and renowned neurologist Dr Hilt was joined by guests
Professor John Harrison and Professor Paul Rolan, leaders in their respective fields of cognition and clinical
pharmacology to explore the unique properties of Xanamem for the potential treatment of cognitive dysfunction
in multiple diseases:
o
This panel discussion and Q&A session focused on the unique pharmacology and properties of ACW’s easy
to use, oral medication Xanamem, and the clinical need for effective treatments of cognitive dysfunction in
numerous neurodegenerative and neuropsychiatric conditions.
CEO and CMO 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:
•
The Alzheimer’s Association International Conference (AAIC) in Amsterdam, The Netherlands on 17-20 July
2023. CMO Dr Dana Hilt presented an academic poster which summarized data from three earlier phase 1 and 2a
Xanamem trials and concluded that Xanamem displays activity in multiple domains of cognition, and that
treatment with Xanamem results in clinically meaningful slowing of disease
•
The 2023 Bioshares Biotech Summit in Hobart on 25 July, which brought together biotech companies and
investors for company presentations, industry engagement and investor meetings. Dr Gourlay’s presentation
summarized the Xanamem story and near-term phase 2 clinical and regulatory milestones
•
The Dementia Trials Australia Annual Scientific Meeting in Sydney, Australia on 6 October where the theme was:
The new era in AD therapies. ACW CEO Dr Steven Gourlay provided a presentation titled Targeted modification
of brain cortisol – a novel, nonamyloid approach
•
The 17th international congress of the Asian Society Against Dementia (ASAD) in Bandung, Indonesia on 29
September where ACW Clinical Scientist Dr Jack Taylor presented to an audience comprising neurologists,
psychiatrists, geriatricians, and other experts from local, national, and world-class institutions focused on
accelerating scientific discoveries in cognitive dysfunction, dementia and Alzheimer’s disease. The Company
congratulates Dr Taylor who received the congress prize for Best Young Research Oral Presentation
•
The BIO Investor Forum in San Francisco, USA on 18 October, where CEO Dr Steven Gourlay conducted investor
and industry meetings
•
The 16th annual CTAD conference in Boston, USA on 25 October where CMO Dr Dana Hilt presented an
academic poster that provided an overview of the Xanamem therapeutic rationale, the positive results of two
prior placebo-controlled trials in healthy volunteers demonstrating pro-cognitive effects, and a biomarker trial in
patients with mild Alzheimer’s disease that showed cognitive and clinical benefit. CEO Dr Steven Gourlay also
attended the conference and was joined by Dr Hilt in key external meetings with other Biotech/Pharma
companies and investors
•
The Sachs Associates 7th Annual Neuroscience Innovation Forum in San Francisco, USA in early January. CMO
Dr Dana Hilt recapped the strong scientific rationale for modification of brain tissue cortisol levels with
Xanamem, presented the clinical benefits seen in multiple trials to date and outlined the design of the two on-
going phase 2 trials, with near-term major results in depression and Alzheimer's disease in 2024 and 2025
respectively
•
Immediately following the Sachs Forum, CEO Dr Steven Gourlay and CMO Dr Hilt participated in a significant
number of partnering, analyst and investor meetings associated with the 42nd Annual J.P. Morgan Healthcare
Conference from 8 to 12 January
•
The Australian Dementia Research Forum (ADRF) in June 2024. ACW Clinical Scientist Dr Jack Taylor presented
an academic poster entitled Clinical pharmacology and development of Xanamem®, a tissue specific inhibitor of
11β- HSD1. The poster described Xanamem’s clinical pharmacology, including Actinogen’s innovative approach to
dose selection. It also summarized the multiple streams of data supporting the selection of Xanamem doses of ≤
10 mg daily for the treatment of cognitive dysfunction in a number of diseases
•
The AAIC2024 in Philadelphia USA from 28 July to 1 August where CMO Dr Dana Hilt presented an academic
poster that summarized the comprehensive clinical pharmacology approach used by Actinogen integrating data
from multiple clinical trials to determine the target dose range for Xanamem. Data types used in the analysis
included blood and cerebrospinal fluid levels of Xanamem, blood levels of the cortisol regulating hormone ACTH,
PET nuclear imaging of the brain, functional cognitive testing, and clinical trial evidence of reduced disease
progression in patients with biomarker-positive mild Alzheimer’s disease.
Trial funding secured to late calendar 2025:
•
Successfully completed two capital raisings totalling $18.9 million during the year.
o
In September 2023, the Company announced the successful completion of a $10 million non-renounceable
rights issue offer to existing shareholders. All shares on offer were taken up by existing shareholders and
through shortfall commitments from existing and new shareholders.
o
In May 2024, the Company successfully closed an $8.9 million capital raising comprising a $5 million
placement and a $3.9 million entitlement offer. The capital raising was strongly supported with
oversubscriptions of approximately 1.8x received in the entitlement offer.
•
Funding has also been received from the conversion of options associated with the past two capital raisings.
•
In addition, a further $9.0m related to the R&D tax incentive rebate is expected to be received in Q4 CY2024
•
Given a cash balance of $9.5 million at 30 June 2024 and the additional significant funding sources described
above, the company and its current programs are funded to late CY2025.
For further information on all the above events, please refer to the ASX announcements section under the
Investor Centre tab on the Actinogen website www.actinogen.com.au.
Actinogen Medical Limited
16
3. FINANCIAL REVIEW
(a) Financial Performance
The financial performance of the Company during the year ended 30 June 2024 is as follows:
Full year ended
Full year ended
30/06/2024
30/06/2023
Revenue and other income ($)
10,222,525
5,254,589
Net loss after tax ($)
(13,044,282)
(10,752,270)
Loss per share (cents)
(0.60)
(0.60)
Dividend ($)
-
-
(b) Financial Position
The financial position of the Company as at 30 June 2024 is as follows:
As at
As at
30/06/2024
30/06/2023
$
$
Cash and cash equivalents
9,450,735
8,460,074
Net assets / Total equity
19,696,499
13,407,215
Contributed equity
100,023,653
78,712,128
Accumulated losses
(81,735,835)
(68,691,553)
Annual Financial Report
17
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 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.
Actinogen Medical Limited
18
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 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, 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 seeks to form
partnerships with relevant regulatory
agencies including the FDA, EMA,
and MHRA. This was most recently
evidenced by the grant of a UK
Innovation Passport.
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.
Annual Financial Report
19
5. BUSINESS STRATEGY & OUTLOOK
Actinogen’s strategic priorities are focused on four key elements:
•
Accelerate clinical development in Alzheimer’s disease
•
Evaluate the optimal phase 2b trial design in depression
•
Forward planning
•
Proactively engage with prospective development and commercial partners
Accelerate clinical development in Alzheimer’s disease
The phase 2a clinical biomarker trial highlighted the considerable potential benefits of Xanamem in biomarker-positive
patients. These results strongly supported the feasibility of using both cognitive testing and the CDR-SB endpoint for our
XanaMIA phase 2b AD trial. These data were used to simulate and design the phase 2b trial to increase its chances of
achieving successful outcomes.
Key features of the phase 2b trial implementation phase are:
•
Enrolment of the same patient population where the large Xanamem effect was seen in patients with mild AD and
elevated pTau181 protein in the blood (an indication of progressive AD)
•
Rapidly pre-screen patients for elevated pTau and key clinical criteria to reduce later screening failures which are
more costly
•
High quality rating training and standardization to minimize noise in subjective endpoints like the CDR-SB
•
‘Hands on’ clinical operations and management based in Australia supplemented by select use of US contractors to
speed timelines and reduce cost
Evaluate the optimal phase 2b trial design in depression
The positive phase 2a XanaCIDD trial in patients with MDD and cognitive dysfunction provided a rich dataset with which to
explore potential responder characteristics and design the upcoming phase 2b trial. Given the surprising but informative
lack of cognitive benefit over and above placebo, the primary endpoint of the phase 2b is expected to be the MADRS
scale measuring depression. Xanamem treatment showed clinically significant MADRS benefits at the end of treatment
and in some cases, 4 weeks after stopping treatment.
Key actions of the phase 2b design phase are:
•
Complete full analysis of phase 2a clinical trial data to identify ideal population and endpoints for future trials
•
Discuss results and proposed protocol design with key stakeholders, including:
o
Local and global thought leaders in MDD
o
Potential strategic development partners
o
The FDA and possibly the EMA
•
Submit protocol to the FDA IND dossier and wait 30 days for clearance
Forward planning
In addition to conducting high quality clinical trials there are numerous other important activities for successful drug
development which form part of the Company’s forward planning:
Key actions under this strategic priority are:
•
Optimize manufacturing processes for supply of future clinical trials and marketed product
•
Use to-be-marketed tablet formulation in all trials
•
Leverage regulatory designations such as ILAP (granted for AD) and FDA breakthrough (planned for AD and possibly
depression) where possible
•
Integrate global regulatory strategic planning to optimize path to marketing approvals in multiple geographies
•
Plan and conduct required regulatory nonclinical studies to the Good Laboratory Practice standard
•
Plan and conduct ancillary clinical pharmacology studies required for marketing approvals.
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. The Company also seeks to form partnerships with relevant regulatory agencies
including the FDA, MHRA and EMA, an example of which is the recent grant of a UK Innovation Passport.
Our engagement with partners has been further strengthened with the positive clinical data on depression from the
XanaCIDD trial and the peer-reviewed publications of our human PET study and the phase 2a biomarker trial. All three
pieces of data point to 10 mg daily as a clinically relevant, safe and effective dose level for depression and Alzheimer’s
disease, as is being used in the XanaMIA phase 2b trial.
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 phase 2b depression trial. We also aim to build and maintain good working
relationships with other global regulators such as the European Medicines Agency (EMA) and the UK Medicines and
Healthcare products Regulatory Agency.
Actinogen Medical Limited
20
Key actions under this strategic priority are:
•
Consider all types of value-add partnerships in the near term once XanaCIDD results are finalized
•
Proactively engage with the universe of potential biopharma partners who could bring co-development synergies to
the Xanamem programs
•
Maintain close working relationships with key regulators such as the US FDA, UK MHRA and the EMA
•
Partner with leading clinical trial implementation providers
•
Partner with key community AD and depression organizations in Australia and globally.
Our FY2025 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 Board is confident about Actinogen’s prospects in FY2025 and beyond as we look to build on a successful FY2024.
Actinogen has now reached a transformational stage in its clinical development of Xanamem with the positive phase 2a
results on depressive symptoms.
Our XanaCIDD trial showed that Xanamem’s mechanism of action in the brain to inhibit tissue production of cortisol has
significant clinical benefits. Based on XanaCIDD’s further confirmation of Xanamem’s effective mechanism of action at the
10 mg daily dose, recruitment of our XanaMIA phase 2b trial in 220 patients with biomarker-positive Alzheimer’s disease
will be accelerated as much as possible.
Based on our XanaCIDD results, we are exploring depression (MADRS endpoint) with a longer treatment period, not short-
term cognitive enhancement, in future clinical trials – a much more straightforward path with regulators like the FDA, EMA
and TGA.
Upcoming news events include publication of new peer-reviewed publications, academic presentations, results of FDA
and/or EMA interactions, clinical trial updates, interim data from the XanaMIA phase 2b AD trial mid CY2025, and final
results CY2026. A phase 2b trial in depression may also start mid CY2025, subject to further phase 2a data analysis and
stakeholder consultation.
Meanwhile manufacturing, regulatory, clinical pharmacology and nonclinical planning and activities continue in high order
to enable rapid expansion on successful phase 2 results.
We are committed to proactive management of all aspects of our 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.
Annual Financial Report
21
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 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
22
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 an advisor to Symbio (Tokyo) and TroBio, and
Chairman 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.
Mr Malcolm McComas
BEc, LLB (Monash), SFFin, FAIDC
Non-Executive Director (appointed 4 April 2019)
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 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 Pharmaxis Limited (ASX:PXS) – Resigned October 2023
•
Chair of Fitzroy River Corporation Limited (ASX:FZR) – Current
•
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)
Dr Vasquez joined Actinogen in March 2023. Dr Vasquez is an immunologist and biopharmaceutical executive with more than
25 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. 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 Certified Directors, USA).
Dr Vasquez has held no other ASX-listed directorships during the past three years.
Annual Financial Report
23
Executive leadership team
Dr Steven Gourlay
MBBS FRACP PhD MBA
Chief Executive Officer (appointed 15 March 2021)
See biography on page 22.
Mr William Souter
Chief Financial Officer
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.
In his most recent role as CFO of Atomo Diagnostics Limited, Mr Souter’s 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).
Dr Dana Hilt
Chief Medical Officer
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.
Actinogen Medical Limited
24
Cheryl Townsend
Vice President of Clinical Operations
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.
Dr Fujun Li
Head of Manufacturing
Dr Li joined Actinogen in February 2022 and has over 30 years of experience in development of chemistry, manufacturing, and
controls (CMC) activities from early to late phase and management of contract manufacturing organization for drug substance
and drug product manufacturing. Dr Li also has extensive experience in regulatory CMC and preparations of CMC dossiers for
regulatory submissions.
Dr Li was most recently the Vice President of Analytical and Pharmaceutical Development at Principia Biopharma (a Sanofi
Company). Prior to this, Dr Li had multiple CMC leadership roles in 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.
Michael Roberts
Investor Relations
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.
Annual Financial Report
25
Directors’ report
Your Directors present their report pertaining to Actinogen Medical Limited
(‘Actinogen Medical’ or ‘the Company’) for the year ended 30 June 2024.
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 22 to 23 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 and options of the Company were as follows:
Director
Fully paid
ordinary shares
Loan shares
(a)
Unlisted
options
Dr Geoffrey Brooke
4,355,405
14,500,000
6,101,592
Dr Steven Gourlay
28,232,514
68,362,300
4,842,647
Dr George Morstyn
6,474,795
5,500,000
981,287
Mr Malcolm McComas
1,671,836
5,500,000
424,808
Dr Nicki Vasquez
366,667
5,500,000
183,334
Total
41,101,217
99,362,300
12,533,668
(a) Loan shares are issued 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)(iii) 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
11
11
Dr Steven Gourlay
11
11
Dr George Morstyn
11
10
Mr Malcolm McComas
11
11
Dr Nicki Vasquez
11
11
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. In a prior year, the Board established an
Audit Committee which expanded to an Audit and Risk Committee during the year. In line with best practice corporate
governance, the Audit and Risk Committee comprises independent non-executive directors.
Audit 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
Actinogen Medical Limited
26
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
Peter Webse (appointed 10 October 2013)
B.Bus, FGIA, FCG, FCPA
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 CPA and is a Fellow of the CPA Australia (FCPA). He is also 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 2024, there were 378,165,568 unissued ordinary shares under option:
Quantity
Type of Option
Grant Date
Exercise Price
Expiry Date
5,000,000
Director Options
24/03/2017
$0.1000
24/03/2025
1,600,000
Employee Options
28/09/2020
$0.0460
27/09/2025
92,901,734
Rights Issue Options
11/09/2024
$0.0375
11/09/2026
(609,643)
Exercise of Rights Issue Options
11/09/2024
$0.0375
11/09/2026
107,127,459 Shortfall Options
15/09/2024
$0.0375
15/09/2026
(5,418,203)
Exercise of Shortfall Options
15/09/2024
$0.0375
15/09/2026
177,564,221 Placement & Rights Issue Options
14/05/2024
$0.0500
31/05/2027
378,165,568
Total unissued ordinary shares under option
For further information refer to the Remuneration Report and Note 14(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
Other than what is outlined below, no other 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.
•
5,793,564 Rights Issue Options, were exercised at $0.0375 each
•
20,917,326 Shortfall Options were exercised at $0.0375 each
•
2,018,208 Placement & Rights Issue options were exercised at $0.05 each
•
On 12 August 2024, the Company announced that Xanamem treatment had clinically and statistically significant (p <
0.05) benefits on depression in its phase 2a XanaCIDD trial of Xanamem in patients with cognitive dysfunction and
major depressive disorder (MDD). This outcome indicates potential modification of the underlying biology of
depression as a result of inhibition of tissue cortisol synthesis – a completely novel mechanism for the treatment of
depression. The trial did not meet the primary endpoint of improving the “Attention Composite” in the context of an
unexpectedly large improvement in the placebo group.
•
On 26 August 2024, the Company announced that ongoing analysis of the XanaCIDD phase 2a depression trial data
found a consistent benefit of Xanamem® treatment on symptoms of depression in a variety of different endpoints.
The consistent benefits observed support the conclusion that a 10 mg Xanamem dose is clinically active in controlling
brain cortisol and has clinically significant anti-depressant activity.
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
27
Directors’ report
9. OPERATING AND FINANCIAL REVIEW
Please refer to pages 14 to 21 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 20 and 21 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.
Actinogen Medical Limited
28
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
William Souter
Chief Financial Officer
Current
Dr Dana Hilt
Chief Medical Officer
Current
Ms Tamara Miller
Senior Vice President - Product Development
Resigned
Mr Jeff Carter
Chief Financial Officer
Resigned
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 William Souter who was appointed as
Chief Financial Officer on 5 February 2024, Ms Tamara Miller who resigned on 29 September 2023 and Mr Jeff Carter who
resigned on 30 November 2023.
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 FY24
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 options
11.8
Disclosures relating to 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
29
Directors’ report
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 17 November 2023, Actinogen Medical received 98.07% of votes in favour
of its Remuneration Report for the 2023 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 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.
Actinogen Medical Limited
30
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) and Dr Dana Hilt (Chief
Medical 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 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
31
Directors’ report
Remuneration Report (Audited)
11.3
REMUNERATION ARRANGEMENTS
(C) Details of short-term incentive and long-term incentive plans that existed during FY24
During the financial year ended 30 June 2024, 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
2023 and the 2024 calendar years, the Board agreed that the following KMPs received a bonus due to meeting a number of
these short-term performance conditions:
•
Dr Steven Gourlay was paid a $63,677 bonus in connection with performance conditions met and accrued for in the 2023
financial year. A bonus of $128,082, representing 89% of the maximum bonus potential set for Dr Gourlay, has been
accrued for at 30 June 2024 in connection with performance conditions met during the 2024 financial year. This bonus
will be during the quarter-end 30 September 2024. Of Dr Gourlay's performance conditions set during the year, 11% were
not met and subsequently forfeited.
•
Mr William Souter was awarded a bonus of $28,045 in connection with performance conditions met during the 2024
financial year, representing 87% of the maximum bonus potential set for Mr Souter, prorated from commencement of his
employment. This amount was accrued for at 30 June 2024 and will be paid during the quarter-end 30 September 2024.
Of Mr Souter’s performance conditions set during the year, 13% were not met and subsequently forfeited.
•
Dr Dana Hilt was paid a $27,126 bonus in connection with performance conditions met but not accrued for in the 2023
financial year. A bonus of $66,871 representing 87% of the maximum bonus potential set for Dr Hilt, has been accrued for
at 30 June 2024 in connection with performance conditions met during the 2024 financial year. This bonus will be paid
during the quarter-end 30 September 2024. Of Dr Hilt’s performance conditions set during the year, 13% were not met
and subsequently forfeited.
(b) Long-term Incentives
The LTIs currently in place are in the form of Employee Options, Director Options and Loan Shares, and are summarised below:
Reference
Type of LTI
Relating to KMP
Relating to Non-KMP
Total
(i)
Employee Options
1,600,000
-
1,600,000
(ii)
Director Options
5,000,000
-
5,000,000
Total Options on issue
6,600,000
-
6,600,000
(iii)
Loan Shares
140,778,962
59,816,665
200,595,627
Total Loan Shares on issue
140,778,962
59,816,665
200,595,627
Total LTIs on issue
147,378,962
59,816,665
207,195,627
(i)
Employee Options
Directors are not eligible to receive Employee Options under the Employee Option Plan currently in place with the Company.
This Plan allows for employees, contractors and consultants to participate on a selected basis and at the discretion of the
Board. During the year, Mr Jeff Carter and Ms Tamara Miller were considered KMP up to their cessation dates, this being 30
November 2023 and 29 September 2023, respectively. They each held the following options issued under the Employee
Option Plan as outlined below:
Employee Options
Employee
Jeff Carter
Tamara Miller
Grant Date
28/09/2020
12/12/2018
Quantity
1,600,000
4,000,000
Exercise Price
$0.046
$0.085
Expiry Date
27/09/2025
12/12/2023
Status
On Issue
Expired
Actinogen Medical Limited
32
Vesting Conditions:
•
Mr Jeff Carter – during the year, 133,336 options vested prior to Mr Carter’s resignation. Up to the date of his resignation,
all 1,600,000 options had fully vested, therefore, none were forfeited. The Employee options were independently valued
using a Black-Scholes option pricing model, whereby the total share-based payment is expensed over the vesting period.
Refer to Note 22: Share-based Payments for further information.
•
Ms Tamara Miller - 4,000,000 options fully vested in the 2022 financial year; and expired in the current financial year.
Summary Terms & Conditions:
•
Entitlement: Each Option gives the holder (Option holder) the right to subscribe for one fully paid ordinary share in the
Company (Share) upon exercise of the Option.
•
Issue Price of Options: Options are issued for no consideration.
•
Other terms: The rights, restrictions and obligations which apply to Options, including in relation to vesting, disposal and
forfeiture, are pursuant to the terms of the offer letters accepted and signed by the Employee at the time of the offer.
While there are no performance conditions attached to these Employee Options, the award is a reward for service and to
provide adequate incentive for continued service to the Company.
(ii) Director Options
There were no Director Options issued to current Directors during the financial year ended 30 June 2024. In prior years,
Directors Options were issued to current Directors of the Company. The specific details, vesting conditions and a summary of
terms and conditions are outlined below:
Director Options
Director
Geoff Brooke
Geoff Brooke
George Morstyn
Malcolm McComas
Grant Date
28/11/2018
24/03/2017
28/11/2018
4/04/2019
Quantity
4,900,000
5,000,000
1,500,000
3,000,000
Exercise Price
$0.085
$0.100
$0.085
$0.100
Expiry Date
27/11/2023
24/03/2025
27/11/2023
4/04/2024
Status
Expired
On Issue
Expired
Expired
Vesting Conditions:
As at 30 June 2024, it is only the 5,000,000 Director Options issued to Dr Brooke that remain on issue and are fully vested,
whilst the other Director Options expired during the year. All Director Options were issued to vest over a period of three years
from the date of grant and were subject to continuous service to the Company by each Non-Executive Director during the
period from the date of grant up to and including the applicable vesting dates. While there were no performance conditions
attached to these Director Options, the awards are reward for fulfilling the role of Non-Executive Director of the Company and
to provide adequate incentive for continued service to the Company.
Summary Terms & Conditions:
•
Each Option gives the holder (Option holder) the right to subscribe for one fully paid ordinary share in the Company
(Share) upon exercise of the Option.
•
Issue Price of Options: Options are issued for no consideration.
•
Valuation Methodology: Due to the vesting conditions attached to all Director Options issued, they have been
independently valued using a Black-Scholes option pricing model, whereby the total share-based payment is expensed
over the vesting period. Refer to Note 22: Share-based Payments for further information.
•
Other terms: The rights, restrictions and obligations which apply to Options, including in relation to vesting, disposal and
forfeiture, are pursuant to the terms of each Director’s engagement with the Company, and the option offer letters
accepted and signed by the Director at the time of the offer.
(iii) Loan Shares
As at 30 June 2024, 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) below
Refer (a) below
Refer (b) below
Refer (b) below
Refer (b) below
Annual Financial Report
33
Directors’ report
Remuneration Report (Audited)
11.3
REMUNERATION ARRANGEMENTS
(iii) Loan Shares
Loan Shares issued to Other KMP
Other KMP
Tamara Miller
Tamara Miller
Jeff Carter
Dana Hilt
Dana Hilt
William Souter
Grant Date
16/09/2021
24/05/2022
16/09/2021
20/03/2023
8/11/2023
9/2/2024
Quantity
5,000,000
5,000,000
500,000
10,000,000
8,000,000
18,000,000
Cancelled
(1,666,670)
(2,916,668)
(500,000)
-
-
-
Balance
3,333,330
2,083,332
-
10,000,000
8,000,000
18,000,000
Exercise Price
$0.110
$0.088
$0.110
$0.085
$0.022
$0.038
Expiry Date
27/10/2024
27/10/2024
16/09/2026
19/03/2028
7/11/2028
8/2/2029
Vesting
Condition
Refer (a) below
Refer (a) below
Refer (a) below
Refer (b) below
Refer (c) below
Refer (b) below
(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.
(c) Loan Shares to vest over 3 years, with 1/4 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 reward for fulfilling their assigned role within the Company and 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.
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 Generally Accepted Accounting Principles, 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:
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 (c) below
Refer (c) below
Refer (c) below
Refer (c) below
Refer (c) below
Actinogen Medical Limited
34
(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.
11.4
KEY MANAGEMENT PERSONNEL REMUNERATION OUTCOMES AND PERFORMANCE
DURING THE FINANCIAL YEAR
During the financial years ended 30 June 2024 and 30 June 2023 (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 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
& Options
$
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.
Table 2: Remuneration of KMP for the year ended 30 June 2023
Key Management
Personnel
Short-term
benefits
Termination
benefits
Post-
employment
Other
benefits
Share-based
payments
Percentage of Total
Year ended
30 June 2023
Cash,
salary
and fees
$
Cash
Bonus
$ (d)
Termination
payments
$
Super-
annuation
$
Accrued
leave
benefits
$
Loan shares
& Options
$
Total
$
SBP-
related
Perfor-
mance-
related
Geoffrey Brooke (a)
100,877
-
-
10,592
-
130,140
241,609
54%
54%
Steven Gourlay
395,508
63,677
-
25,292
29,963
142,448
656,888
22%
31%
George Morstyn (a)
66,276
-
-
-
-
52,056
118,332
44%
44%
Malcolm McComas (a)
66,276
-
-
-
-
52,056
118,332
44%
44%
Nicki Vasquez (a)(b)
22,092
-
-
-
-
-
22,092
-
-
Tamara Miller
305,000
60,619
-
25,292
23,106
281,377
695,394
40%
49%
Jeff Carter
130,320
-
-
-
-
13,627
143,947
9%
9%
Paul Rolan (c)
55,500
-
-
-
-
97,032
152,532
64%
64%
Dana Hilt (c)
153,970
-
-
10,367
10,583
92,888
267,808
35%
35%
Total KMP (e)
1,295,819 124,296
-
71,543
63,652
861,624 2,416,934
(a)
The total Non-Executive Director fees including superannuation during the year totalled $266,113.
(b)
Dr Nicki Vasquez was appointed as Non-Executive Director on 1 March 2023.
(c)
Dr Dana Hilt was appointed, and Professor Rolan ceased, as Chief Medical Officer on 1 February 2023, respectively. Professor Rolan
continues providing pharmacology consulting services to the Company.
(d)
For further information on short-term incentive cash bonuses, refer to Section 11.3(C)(a).
(e)
For detailed information of KMP employment arrangements, refer to Section 11.5 and Section 11.6 of the Remuneration Report.
Annual Financial Report
35
Directors’ report
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 $439,736 per annum (inclusive of superannuation guarantee) with four
weeks annual leave entitlement. With effect from 1 July 2024, the total employment cost basis was increased to $457,325
(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, prorated to the date of
commencement of Employment for the first year 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.
•
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.
Mr William Souter – Chief Financial Officer
•
Commencement of employment: 5 February 2024
•
Remuneration: During the year ended 30 June 2024, Mr Souter was on a total employment cost basis of $350,000 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 2024, the total employment cost basis was increased to $364,000
(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, prorated to the date of commencement of Employment for the first year and the Board's
determination of whether the performance objectives have been achieved will be final and binding on the Employee.
•
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: During the year ended 30 June 2024, Dr Hilt was on a total employment cost basis of USD $220,000 per
annum during the quarter ended 30 September 2023, which increased to USD $300,000 per annum with effect from 1
October 2023 for working a 0.70 full-time equivalent role (plus statutory employment and healthcare contributions and
prorated 14 days annual leave entitlement). With effect from 1 July 2024, the total employment cost basis was increased
to USD $312,000 (plus statutory employment and healthcare contributions).
•
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.
Ms Tamara Miller – Senior Vice President – Product Development
•
Commencement of employment: 21 September 2017 – Cessation of employment: 29 September 2023
•
Remuneration: During the year ended 30 June 2024, Ms Miller was on a total employment cost basis of $346,124 per
annum (inclusive of superannuation guarantee) with four weeks annual leave entitlement, prorated to the date of
termination of employment.
•
Termination: On the 29 September 2023, Ms Miller’s role was made redundant. The Company gave four weeks’ written
notice and paid out termination benefits totalling $155,223.
Actinogen Medical Limited
36
Mr Jeff Carter – Chief Financial Officer
•
Commencement of consultancy: 21 September 2020 – Cessation of consultancy: 30 November 2023
•
During the year ended 30 June 2024, the standard base monthly amount for part time services was $12,320 per month
(plus GST and are exclusive of superannuation)
•
Termination: The Company or Consultant may terminate the contract by giving one month’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.
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
$324,825. 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 $105,416 per annum (plus GST and superannuation guarantee) with effect from 1 July 2023. 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 2024.
Dr George Morstyn – Non-Executive Director - Appointed 1 December 2017
•
Director Fees set at $69,258 per annum (plus GST and exclusive of superannuation) with effect from 1 July 2023. Subject
to annual review, it was determined that these fees increase to $72,029 per annum (plus GST and exclusive of
superannuation guarantee) with effect from 1 July 2024.
Mr. Malcolm McComas – Non-Executive Director- Appointed 4 April 2019
•
Director Fees set at $69,258 per annum (plus GST and exclusive of superannuation) with effect from 1 July 2023. Subject
to annual review, it was determined that these fees increase to $72,029 per annum (plus GST and exclusive of
superannuation guarantee) with effect from 1 July 2024.
Dr Nicki Vasquez – Non-Executive Director- Appointed 1 March 2023
•
Director Fees set at $69,258 per annum with effect from 1 July 2023. Dr Vasquez is US-based therefore GST and
superannuation are not applicable. Subject to annual review, it was determined that these fees increase to $72,029 per
annum with effect from 1 July 2024.
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
37
Directors’ report
Remuneration Report (Audited)
11.7
DISCLOSURES RELATING TO SHARES
The shareholding of KMP as at 30 June 2024 is as follows:
KMP
Balance at
beginning of
year 1/7/2023
Granted as
remuneration
On
exercise
of options
Accounted
for as
options (a)
Net change
other (b)
Balance at end
of year
30/6/2024
Geoffrey Brooke
2,152,223
- - -
2,203,182
4,355,405
Steven Gourlay
18,547,222
- - -
9,685,292
28,232,514
George Morstyn
4,512,223
- - - 1,962,572
6,474,795
Malcolm McComas
822,223
- - -
849,613
1,671,836
Nicki Vasquez
-
- - -
366,667
366,667
William Souter
-
- - -
400,000
400,000
Dana Hilt
-
- - - -
-
Total share holding
26,033,891
- - -
15,467,326
41,501,217
(a)
Loan Shares on issue, although issued ordinary shares that carry voting and divided rights, they 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)(iii)
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, the KMP participated in, and purchased shares, under the Rights Issue in September 2023 and a Non-
renounceable Entitlement Offer in June 2024.
11.8
DISCLOSURES RELATING TO OPTIONS
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. Refer below to table (i) for the
quantity of option holdings held by KMP as at 30 June 2024; and table (ii) for value of options awarded, vested and lapsed
during the financial year.
Actinogen Medical Limited
38
(i)
Option holdings of KMP as at 30 June 2024
KMP
Unit
Price
($)
Grant
Date
Expiry
Date
Balance at
beginning
of year
1 July 2023
Granted as
remuneration
Net change
other
Balance at
end of year
30 June 2024
Vested at
beginning
of year
1 July 2023
Vested
during
the year
Vested at
end of year
30 June 2024
Unvested at
end of year
30 June 2024
G. Brooke
Options
0.10000
24/03/2017
24/03/2025
5,000,000
-
-
5,000,000
5,000,000
-
5,000,000
-
Options
0.08500
28/11/2018
27/11/2023
4,900,000
-
(4,900,000)
-
4,900,000
-
-
-
Loan Shares
0.20000
18/11/2021
18/11/2026
2,500,000
-
-
2,500,000
1,250,000
1,250,000
2,500,000
-
Loan Shares
0.03125
1/12/2023
30/11/2028
-
12,000,000
-
12,000,000
-
-
-
12,000,000
12,400,000
12,000,000
(4,900,000)
19,500,000
11,150,000
1,250,000
7,500,000
12,000,000
S. Gourlay
Loan Shares
0.03500
15/03/2021
15/03/2026
24,181,150
-
-
24,181,150
18,135,864
6,045,286
24,181,150
-
Loan Shares
0.04500
15/03/2021
15/03/2026
24,181,150
-
-
24,181,150
18,135,864
6,045,286
24,181,150
-
Loan Shares
0.03125
1/12/2023
30/11/2028
-
20,000,000
-
20,000,000
-
-
-
20,000,000
48,362,300
20,000,000
- 68,362,300
36,271,728
12,090,572
48,362,300
20,000,000
G. Morstyn
Options
0.08500
28/11/2018
27/11/2023
1,500,000
-
(1,500,000)
-
1,500,000
-
-
-
Loan Shares
0.20000
18/11/2021
18/11/2026
1,000,000
-
-
1,000,000
500,000
500,000
1,000,000
-
Loan Shares
0.03125
1/12/2023
30/11/2028
-
4,500,000
-
4,500,000
-
-
-
4,500,000
2,500,000
4,500,000
(1,500,000)
5,500,000
2,000,000
500,000
1,000,000
4,500,000
M. McComas
Options
0.10000
4/04/2019
4/04/2024
3,000,000
-
(3,000,000)
-
3,000,000
-
-
-
Loan Shares
0.20000
18/11/2021
18/11/2026
1,000,000
-
-
1,000,000
500,000
500,000
1,000,000
-
Loan Shares
0.03125
1/12/2023
30/11/2028
-
4,500,000
-
4,500,000
-
-
-
4,500,000
4,000,000
4,500,000
(3,000,000)
5,500,000
3,500,000
500,000
1,000,000
4,500,000
N. Vasquez
Loan Shares
0.03125
1/12/2023
30/11/2028
-
5,500,000
-
5,500,000
-
-
-
5,500,000
-
5,500,000
- 5,500,000
-
-
-
5,500,000
W. Souter
Loan Shares
0.03800
9/02/2024
8/02/2029
-
18,000,000
-
18,000,000
-
-
-
18,000,000
-
18,000,000
- 18,000,000
-
-
- 18,000,000
D. Hilt
Loan Shares
0.08500
20/03/2023
19/03/2028
10,000,000
-
-
10,000,000
-
4,166,667
4,166,667
5,833,333
Loan Shares
0.02200
8/11/2023
7/11/2028
-
8,000,000
-
8,000,000
-
-
-
8,000,000
10,000,000
8,000,000
- 18,000,000
-
4,166,667
4,166,667
13,833,333
T. Miller
Options
0.08500
12/12/2018
12/12/2023
4,000,000
-
(4,000,000)
-
-
-
-
-
Loan Shares
0.11000
16/09/2021
16/09/2026
5,000,000
-
(1,666,670)
3,333,330
2,656,250
677,080
3,333,330
-
Loan Shares
0.08800
24/05/2022
24/05/2027
5,000,000
-
(2,916,668)
2,083,332
1,406,250
677,082
2,083,332
-
14,000,000
-
(8,583,338)
5,416,662
4,062,500
1,354,162
5,416,662
-
J. Carter
Options
0.04600
28/09/2020
27/09/2025
1,600,000
-
(1,600,000)
-
1,466,664
133,336
1,600,000
-
Loan Shares
0.11000
16/09/2021
16/09/2026
500,000
-
(500,000)
-
265,625
70,313
335,938
-
2,100,000
-
(2,100,000)
-
1,732,289
203,649
1,935,938
-
Total KMP Holding
93,362,300
72,500,000
(20,083,338)
145,778,962
58,716,517
20,065,050
69,381,567
78,333,333
Annual Financial Report
39
(ii) Value of options awarded, vested and lapsed during the financial year
KMP
Unit
Price
($)
Financial
Year
Quantity
Fair value
per option/
loan share
($)
Total
Share-based
payment (SBP)
valuation ($)
Total SBP
expensed
as at
1 July 2023 ($)
Value SBP
recognised
during
the year ($)
Total SBP
expensed
as at
30 June 2024 ($)
Value SBP to be
recognised
in future
years ($)
Remuneration
consisting of
option for the year
(%)
G. Brooke
Options
0.10000
2017
5,000,000
0.04906
245,285
245,285
-
245,285
-
0%
Options
0.08500
2019
4,900,000
0.01420
69,580
69,580
-
69,580
-
0%
Loan Shares
0.20000
2022
2,500,000
0.11881
297,026
252,880
39,754
292,634
4,392
17%
Loan Shares
0.03125
2024
12,000,000
0.01760
211,200
-
77,622
77,622
133,578
33%
24,400,000
823,091
567,745
117,376
685,121
137,970
50%
S. Gourlay
Loan Shares
0.03500
2021
24,181,150
0.01584
383,027
371,253
11,774
383,027
-
3%
Loan Shares
0.04500
2021
24,181,150
0.01451
350,963
340,175
10,788
350,963
-
3%
Loan Shares
0.03125
2024
20,000,000
0.01760
352,000
-
129,370
129,370
222,630
31%
68,362,300
1,085,990
711,428
151,932
863,360
222,630
37%
G. Morstyn
Options
0.08500
2019
1,500,000
0.01420
21,300
21,300
-
21,300
-
0%
Loan Shares
0.20000
2022
1,000,000
0.11881
118,810
101,152
15,901
117,053
1,757
14%
Loan Shares
0.03125
2024
4,500,000
0.01760
79,200
-
29,108
29,108
50,092
25%
7,000,000
219,310
122,452
45,009
167,461
51,849
39%
M. McComas
Options
0.10000
2019
3,000,000
0.01413
42,390
42,390
-
42,390
-
0%
Loan Shares
0.20000
2022
1,000,000
0.11881
118,810
101,152
15,901
117,053
1,757
14%
Loan Shares
0.03125
2024
4,500,000
0.01760
79,200
-
29,108
29,108
50,092
25%
8,500,000
240,400
143,542
45,009
188,551
51,849
39%
N. Vasquez
Loan Shares
0.03125
2024
5,500,000
0.01760
96,800
-
35,576
35,576
61,224
34%
5,500,000
96,800
-
35,576
35,576
61,224
34%
W. Souter
Loan Shares
0.03800
2024
18,000,000
0.02031
365,511
-
96,314
96,314
269,197
45%
18,000,000
365,511
-
96,314
96,314
269,197
45%
D. Hilt
Loan Shares
0.08500
2023
10,000,000
0.04940
494,036
92,888
285,842
378,730
115,306
40%
Loan Shares
0.02200
2024
8,000,000
0.01260
100,800
-
41,055
41,055
59,745
6%
18,000,000
594,836
92,888
326,897
419,785
175,051
46%
T. Miller
Options
0.08500
2019
4,000,000
0.01580
63,200
63,200
-
63,200
-
0%
Loan Shares
0.11000
2022
5,000,000
0.06423
321,175
284,630
12,732
297,362
23,813
5%
Loan Shares
0.08800
2022
5,000,000
0.05170
258,483
178,811
23,069
201,880
56,603
8%
14,000,000
642,858
526,641
35,801
562,442
80,416
13%
J. Carter
Options
0.04600
2021
1,600,000
0.00934
14,948
14,848
100
14,948
-
0%
Loan Shares
0.11000
2022
500,000
0.06423
32,117
28,463
1,469
29,932
2,185
2%
2,100,000
47,065
43,311
1,569
44,880
2,185
2%
Total KMP Holding
165,862,300
4,115,861
2,208,007
855,483
3,063,490
1,052,371
Actinogen Medical Limited
40
Directors’ report
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)(iii) for further information. As at 30 June 2024, 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.
2024
2023
2022
2021
2020
2019
Quoted price of ordinary shares at year end (cents)
6.0
5.0
5.0
12.0
2.2
1.0
Loss per share (cents)
0.60
0.60
0.55
0.28
0.48
0.90
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 $86,336 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 2024 totalled $82,680 (2023: $75,700). Total non-audit
services paid to the external auditor and its associated entities during the year ended 30 June 2024 was $Nil (2023: $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 2024 forms a part of the Directors’ Report and can be found on page 42. Signed in accordance with a resolution of the
Board of Directors.
Dr Steven Gourlay
Managing Director
Sydney, New South Wales
30 August 2024
Annual Financial Report
41
Auditor’s independence declaration
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Ernst & Young
11 Mounts Bay Road
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 2024, 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
30 August 2024
Actinogen Medical Limited
42
Financial report
Statement of comprehensive income
44
Statement of financial position
45
Statement in changes of equity
46
Statement of cash flows
47
Notes to the financial statements
48
1
Corporate information
48
2
Summary of material accounting policies
48
3
Segment information
53
4
Financial risk management
53
5
Critical accounting estimates and judgements
55
6
Other income and expenses
56
7
Income tax
57
8
Cash and cash equivalents
58
9
Other receivables and prepayments
58
10
Property, plant and equipment
59
11
Right-of-use asset & lease liability
59
12
Intangible assets
60
13
Trade and other payables
60
14
Contributed equity
61
15
Reserves
63
16
Remuneration of auditor
63
17
Losses per share
63
18
Commitments and contingencies
63
19
Events subsequent to the end of financial year
64
20
Related party transactions
64
21
Key management personnel disclosures
64
22
Share-based payments
65
Consolidated entity disclosure statement
67
Directors’ declaration
68
Independent auditor’s report
69
Annual Financial Report
43
Statement of comprehensive income
For the year ended 30 June 2024
Full year ended
30/06/2024
Full year ended
30/06/2023
Note
$
$
Interest revenue
291,021
366,654
Other income
9,931,504
4,887,935
Total revenue & other income
6
10,222,525
5,254,589
Research & development costs
6
(15,535,482)
(8,899,947)
Employment costs
(4,195,292)
(3,257,223)
Corporate & administration costs
(1,732,305)
(1,793,660)
Finance costs
(24,292)
(16,599)
Realised (loss) / unrealised gain on foreign currency
(55,189)
(117,172)
Share-based payment expenses
(1,307,416)
(1,516,650)
Amortisation expense
12
(313,602)
(312,746)
Depreciation expense (right-of-use asset)
11
(82,179)
(81,008)
Depreciation expense (office equipment)
10
(21,050)
(11,854)
Total expenses
(23,266,807)
(16,006,859)
Loss before income tax
(13,044,282)
(10,752,270)
Income tax expense
-
-
Loss for the year
(13,044,282)
(10,752,270)
Other comprehensive income
Items that may be reclassified subsequently to profit and loss:
Other comprehensive income
-
-
Total comprehensive loss for the year
(13,044,282)
(10,752,270)
Loss per share for attributable to the ordinary equity
holders of the Company
Basic and diluted loss per share in cents
17
(0.60)
(0.60)
The above Statement of Comprehensive Income should be read in conjunction with the accompanying Notes.
Actinogen Medical Limited
44
Statement of financial position
As at 30 June 2024
As at
30/06/2024
As at
30/06/2023
Note
$
$
Current Assets
Cash and cash equivalents
8
9,450,735
8,460,074
Other receivables and prepayments
9
9,425,548
4,228,311
Total Current Assets
18,876,283
12,688,385
Non-Current Assets
Property, plant and equipment
10
24,389
37,276
Intangible assets
12
2,094,110
2,407,712
Right-of-use assets
11
317,085
75,432
Total Non-Current Assets
2,435,584
2,520,420
TOTAL ASSETS
21,311,867
15,208,805
Current Liabilities
Trade and other payables
13
1,179,426
1,559,470
Provision for employee entitlements
116,873
155,187
Lease liability
11(b)
60,673
86,933
Total Current Liabilities
1,356,972
1,801,590
Non-Current Liabilities
Lease liability
11(b)
258,396
-
Total Non-Current Liabilities
258,396
-
TOTAL LIABILITIES
1,615,368
1,801,590
NET ASSETS
19,696,499
13,407,215
Equity
Contributed equity
14(a)
100,023,653
78,712,128
Reserve shares
14(b)
(10,483,367)
(7,197,992)
Reserves
15
11,892,048
10,584,632
Accumulated losses
(81,735,835)
(68,691,553)
TOTAL EQUITY
19,696,499
13,407,215
The above Statement of Financial Position should be read in conjunction with the accompanying Notes.
Annual Financial Report
45
Statement in changes of equity
For the year ended 30 June 2024
Contributed
Equity
Accumulated
Losses
Option
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
Contributed
Equity
Accumulated
Losses
Option
Reserve
Reserve
Shares
Total
Full year ended 30 June 2023
$
$
$
$
$
Balance as at 1 July 2022
76,942,670
(57,939,283)
9,067,982
(6,331,492)
21,739,877
Loss for the year
-
(10,752,270)
-
-
(10,752,270)
Other comprehensive income
-
-
-
-
-
Total comprehensive loss for the year
-
(10,752,270)
-
-
(10,752,270)
Transactions with equity holders in
their capacity as equity holders:
Shares issued during the year
1,769,458
-
-
(866,500)
902,958
Share-based payments
-
-
1,516,650
-
1,516,650
Balance as at 30 June 2023
78,712,128
(68,691,553)
10,584,632
(7,197,992)
13,407,215
The above Statement of Changes in Equity should be read in conjunction with the accompanying Notes.
Actinogen Medical Limited
46
Statement of cash flows
For the year ended 30 June 2024
Full year ended
Full year ended
30/06/2024
30/06/2023
Note
$
$
Cash Flows from Operating Activities
Interest received
291,021
366,654
Interest paid
11(a)
(20,120)
(17,012)
Payments to suppliers and employees
(5,714,352)
(4,537,191)
Payments for research and development
(16,300,284)
(9,154,875)
Government R&D tax rebate and grants received
4,792,865
4,644,183
Net cash outflow from operating activities
8
(16,950,870)
(8,698,241)
Cash Flows from Investing Activities
Purchase of property, plant and equipment
10
(8,163)
(36,599)
Net cash outflow from investing activities
(8,163)
(36,599)
Cash Flows from Financing Activities
Proceeds from issue of shares
14
18,879,650
902,958
Proceeds from exercise of options
14
226,024
-
Transaction costs associated with issue of shares
14
(1,064,284)
-
Principal repayment on leases
11(a)
(91,696)
(78,337)
Net cash inflow from financing activities
17,949,694
824,621
Net (decrease) / increase in cash and cash equivalents
990,661
(7,910,219)
Cash and cash equivalents at beginning of the year
8,460,074
16,370,283
Effect of movement in exchange rates on cash held
-
10
Cash and cash equivalents at the end of the year
8
9,450,735
8,460,074
The above Statement of Cash Flows should be read in conjunction with the accompanying Notes.
Annual Financial Report
47
Notes to the financial statements
For the year ended 30 June 2024
1. CORPORATE INFORMATION
The financial statements of Actinogen Medical Limited (Actinogen Medical or the Company) for the year ended 30 June 2024
were authorised in accordance with a resolution of Directors on 30 August 2023. 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 2024.
(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 2024, the Company incurred a net loss after tax of $13,044,282 (2023: $10,752,270) and had
net cash outflows from operating activities of $16,950,870 (2023: $8,698,241). As reported, with $9,450,735 cash at bank at
30 June 2024 together with the anticipated research and development tax incentive of $9,022,474 expected to be received
during the quarter ended 31 December 2024, 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 CY2025.
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 CY2025 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 $9,450,735 in cash and cash equivalents as at 30 June 2024. This amount does not include the
proposed claim for the research and development tax incentive which is estimated to lead to a cash refund of $9,022,474
(refer Note 9);
•
The Company is listed on the ASX and therefore has access to the Australian equity capital markets. During the year, the
Company successfully completed a Rights Issue and Shortfall Placement during September 2023, raising approximately
$10 million (before costs) and a Placement and Rights Issue during May and June 2024, raising approximately $8.9 million
(before costs) – refer to Note 14 for additional details.
•
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.
(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.
(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.
Actinogen Medical Limited
48
(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
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.
Annual Financial Report
49
(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.
(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.
Actinogen Medical Limited
50
(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.
(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
Annual Financial Report
51
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) 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 2024
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
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.
The Company has not early adopted any other accounting standard, interpretation or amendment that has been issued
but is not yet effective. The Company is in the process of evaluating the potential impact of adopting these standards,
interpretations, or amendments on its financial position and performance.
Actinogen Medical Limited
52
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 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 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)
Set out below is an overview of the financial instruments held by the Company as at 30 June 2023:
As at 30 June 2023
Cash and
cash equivalents
$
Financial assets / liabilities
at amortised cost
$
Financial assets
Cash and cash equivalents
8,460,074
-
Other receivables and prepayments
- 215,237
Total current assets
8,460,074 215,237
Total financial assets
8,460,074 215,237
Financial liabilities
Trade and other payables
- 1,559,470
Lease liabilities - current
- 86,933
Total current liabilities
- 1,646,403
Lease liabilities - non-current
-
-
Total non-current liabilities
-
-
Total financial liabilities
- 1,646,403
Net exposure
8,460,074 (1,431,166)
Annual Financial Report
53
4. FINANCIAL RISK MANAGEMENT
(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 no
interest-bearing debt and is only exposed to interest rate risk in respect of amounts held in current, interest-bearing bank
accounts and demand deposits. At 30 June 2024, the Company held $9,387,383 (2023: $8,284,194) 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 $93,874 (2023: $82,842).
Sensitivity analysis:
Interest rate risk
-1%
+1%
Carrying amount
Profit/Equity
Profit/Equity
$
$
$
30 June 2024
Financial Assets
Cash and cash equivalents
9,417,297
(94,173)
94,173
30 June 2023
Financial Assets
Cash and cash equivalents
8,284,194
(82,842)
82,842
Variable rate instruments:
As at 30/6/2024
As at 30/6/2023
Weighted average
interest rate
Balance
Weighted average
interest rate
Balance
%
$
%
$
Cash and cash equivalents
4.14
9,417,297
3.81%
8,284,194
(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: A-1+), 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.
Actinogen Medical Limited
54
(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 not have any financing arrangements (2023: None).
(ii)
Maturities of financial liabilities
The Company’s debt relates to trade and other payables, where payments are generally due within 30 days, and lease
liabilities. 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 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
As at 30 June 2023
Trade and other payables
1,559,470
-
-
1,559,470
Lease liabilities
14,706
66,179
-
80,885
1,574,176
66,179
-
1,640,355
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).
Annual Financial Report
55
6. OTHER INCOME AND EXPENSES
Full year ended
Full year ended
30/06/2024
30/06/2023
$
$
Income
Interest income
291,021
366,654
Other income
R&D tax rebate - current year
9,022,474
4,887,935
R&D tax rebate - prior year deferred income (a)
909,030
-
Total other income
9,931,504
4,887,935
Total income
10,222,525
5,254,589
Expenses
Research and development costs:
Laboratory & clinical trial expenses
15,122,815
8,220,347
Regulatory & clinical development consultants
145,785
413,349
Other expenses
266,882
266,251
Total research and development costs
15,535,482
8,899,947
(a)
The R&D tax rebate amount of $909,030 relates to the prior year ended 30 June 2023, this was an additional portion not
recorded as a receivable as at 30 June 2023 but instead was recognised and recorded when received in the current
year.
Actinogen Medical Limited
56
7. INCOME TAX
Full year ended
Full year ended
30/06/2024
30/06/2023
$
$
Reconciliation of operating loss to prima facie income tax
expense
Operating loss before income tax
(13,044,282)
(10,752,270)
Tax benefit at the Australian tax rate of 30% (2023: 30%)
(3,913,284)
(3,225,681)
Tax effect of amounts that are not deductible / taxable in
calculating taxable income:
Non-deductible expenses
3,545
4,399
Share-based payments
418,712
454,995
Research and development
2,601,461
1,498,278
Realised foreign exchange gain/(loss)
- -
Deferred income tax asset not brought to account
889,566
1,268,009
Income tax expense
-
-
Tax losses
Unused tax losses for which no deferred tax asset has been
recognised
25,902,283
22,845,850
Potential tax benefit @ 30% (2023: 30%)
7,770,685
6,853,755
Unrecognised temporary differences
Temporary differences for which deferred tax assets have not
been recognised.
- Provisions and accruals
153,683
184,575
- Intangible assets
2,042,343
1,728,742
- Capital raising costs
850,775
796,977
- Legal expenses
22,084
60,619
- Right of use adjustments
1,984
11,500.00
- Unrealised foreign exchange gain
9,036
7,131.00
- Fixed assets
(24,388)
(37,276)
3,055,517
2,752,267
Unrecognised deferred tax asset relating to the above temporary
differences @ 30% (2023: 30%)
916,655
825,680
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
57
8. CASH AND CASH EQUIVALENTS
As at
As at
30/06/2024
30/06/2023
$
$
Cash at bank and on hand
2,235,135
1,280,160
Short term deposits
7,215,600
7,179,914
Total cash and cash equivalents
9,450,735
8,460,074
During the year ended 30 June 2024, 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 $9,022,474 for eligible expenditure incurred during the year ended 30 June 2024. 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
30/06/2024
30/06/2023
$
$
Loss for the year
(13,044,282)
(10,752,270)
Non cash items:
Depreciation (computer equipment)
21,050
11,854
Depreciation (lease: office rental)
82,179
81,008
Amortisation expense
313,602
312,746
Share-based payment expense
1,307,416
1,516,650
Unrealised foreign currency gain
(15,240)
(10)
Change in assets and liabilities:
Increase in trade and other receivables
(5,197,237)
(181,672)
Increase in trade and other payables
(380,044)
251,089
Increase in provisions
(38,314)
62,364
Net cash outflow used in operating activities
(16,950,870)
(8,698,241)
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)(iii) of the Remuneration Report for further information. There were no other non-cash operating activities that
occurred during the year ended 30 June 2024.
Financing facilities available: As at 30 June 2024, the Company had no financing facilities available (2023: 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.
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
30/06/2024
30/06/2023
$
$
Prepaid insurance
108,829
104,686
Goods and services tax receivable
183,591
129,240
Research and development tax rebate receivable
9,022,474
3,883,834
Other receivables
110,654
110,551
Total other receivables and prepayments
9,425,548
4,228,311
Actinogen Medical Limited
58
10. PROPERTY, PLANT AND EQUIPMENT
As at
As at
30/06/2024
30/06/2023
$
$
At cost
76,646
68,484
Accumulated depreciation
(52,257)
(31,208)
Total property, plant and equipment
24,389
37,276
Movements during the year:
Computer Equipment
Total
$
$
Opening balance at 1 July 2022
12,531
12,531
Acquisitions
36,599
36,599
Depreciation
(11,854)
(11,854)
Closing balance at 30 June 2023
37,276
37,276
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
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 2024:
Full year ended
Full year ended
30/06/2024
30/06/2023
$
$
Depreciation expense on right-of-use asset
82,179
81,008
Interest expense on lease liabilities
5,172
6,790
Rent expense - short-term leases
-
1,560
Total amounts recognised in profit or loss
87,351
89,358
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 2024:
Right-of-use Assets
Leased Premises
Lease Liability
Leased Premises
$
$
As at 1 July 2022
156,440
165,270
Depreciation expense
(81,008)
-
Interest expense
-
6,790
Payments
-
(85,127)
As at 30 June 2023
75,432
86,933
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 (a)
-
5,172
Payments (a)
-
(96,869)
As at 30 June 2024 (b)
317,085
319,069
(a) The lease payments made during the year totalled $96,869 comprising $91,696 which represents the principal component
and $5,172 which represents the interest expense component.
(b) Of the total lease liability amounting to $319,069, the amount of $60,673 is current, and $258,396 is non-current.
Annual Financial Report
59
12. INTANGIBLE ASSETS
As at
As at
30/06/2024
30/06/2023
$
$
At cost
5,756,743
5,756,743
Accumulated amortisation
(3,662,633)
(3,349,031)
Total intangible assets
2,094,110
2,407,712
Movements during the year:
Intellectual
Property
$
Opening balance at 1 July 2022
2,720,458
Amortisation expense
(312,746)
Closing balance at 30 June 2023
2,407,712
Opening balance at 1 July 2023
2,407,712
Amortisation expense
(313,602)
Closing balance at 30 June 2024
2,094,110
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 remaining life of the licence agreement is 8 years. 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 2024, 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
30/06/2024
30/06/2023
$
$
Trade payables
597,236
1,101,471
Accruals and other payables
506,625
404,249
Provision for payroll tax
25,000
-
Employee tax liabilities
50,565
53,750
Total trade and other payables
1,179,426
1,559,470
Trade and other payables are non-interest-bearing liabilities stated at amortised cost and settled within 30 days.
Actinogen Medical Limited
60
14. CONTRIBUTED EQUITY
(a)
Fully paid ordinary shares
As at
As at
30/06/2024
30/06/2023
$
$
Fully paid ordinary shares
106,043,906
83,652,836
Capital raising costs
(6,020,253)
(4,940,708)
Total contributed equity
100,023,653
78,712,128
As at 30 June 2024 there were 2,683,049,308 ordinary shares on issue (of which 200,595,627 are Loan Shares, refer 14(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 2022
1,795,643,817
76,942,670
Issue of employee loan shares
15/07/2022
250,000
0.0660
16,500
Exercise of unlisted options
11/11/2022
1,500,000
0.1000
150,000
Exercise of unlisted options
9/12/2022
8,858,333
0.0850
752,958
Issue of employee loan shares
20/03/2023
10,000,000
0.0850
850,000
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 Employee 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
Annual Financial Report
61
(b)
Reserve shares (“Loan shares”)
Date
Quantity
Unit Price $
Total $
Balance at 30 June 2022
(84,762,300)
(6,331,492)
Issue of employee loan shares
15/07/2022
(250,000)
0.06600
(16,500)
Issue of employee loan shares
20/03/2023
(10,000,000)
0.08500
(850,000)
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 Employee 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)
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)
Reserves 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, 113,000,000 loan shares were issued to Directors,
employees and contractors of the Company; and 7,416,673 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
Exercise Price
Grant Date
Expiry Date
5,000,000 Director Options
$0.1000
24/03/2017
24/03/2025
1,600,000 Employee Options
$0.0460
28/09/2020
27/09/2025
92,901,734 Rights Issue Options
$0.0375
11/09/2024
11/09/2026
(609,643) Exercise of Rights Issue Options
$0.0375
11/09/2024
11/09/2026
107,127,459 Shortfall Options
$0.0375
15/09/2024
15/09/2026
(5,418,203) Exercise of Shortfall Options
$0.0375
15/09/2024
15/09/2026
177,564,221 Placement & Rights Issue Options
$0.0500
14/05/2024
31/05/2027
378,165,568
Total unissued ordinary shares under option
During the year:
•
20,100,000 Director and employee options issued in a prior period expired
•
92,901,734 options were issued under the Rights Issue carried out in September 2023, of which 609,643 were later
exercised during the year
•
107,127,459 options were issued under the Shortfall Issue carried out in September 2023, of which 5,418,203 were
later exercised during the year
•
177,564,221 options were issued under the Placement and Rights Issue carried out in June 2024
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.
Actinogen Medical Limited
62
15. RESERVES
Reserves are made up of the option reserve. The option reserve records items recognised as share-based payment (SBP)
expenses for employee and Director options. Details of the movement in reserves is shown below.
As at
As at
30/06/2024
30/06/2023
$
$
Option reserve
11,892,048
10,584,632
Total reserves
11,892,048
10,584,632
Movements during the year:
Year ended
Year ended
30/06/2024
30/06/2023
$
$
Balance at the beginning of the period
10,584,632
9,067,982
Share-based payment expense on Employee options
100
9,867
Share-based payment expense on Employee loan shares
912,413
1,130,082
Share-based payment expense on Director loan shares
394,903
376,701
Balance at end of period
11,892,048
10,584,632
Total share-based payment expenses recognised during the year amounted to $1,307,416. For further information on share-
based payments refer to Note 22. For further information on loan shares and unissued ordinary shares under option refer to
Note 14.
16. REMUNERATION OF AUDITOR
Full year ended
Full year ended
30/06/2024
30/06/2023
$
$
Amounts paid or payable to Ernst & Young for:
An audit or review of the financial statements of the entity
87,196
75,700
87,196
75,700
17. LOSSES PER SHARE
Full year ended
Full year ended
30/06/2024
30/06/2023
Net loss used in calculating loss per share ($)
(13,044,282)
(10,752,270)
Weighted number of ordinary shares used as the denominator ('000)
2,174,301
1,801,548
Basic and diluted loss per share from continuing operations attributable to
the ordinary shareholders of the Company (cents)
(0.60)
(0.60)
As at 30 June 2024, there were 378,165,568 (2023: 26,700,000) unissued ordinary shares under option and 200,595,627 loan
shares (2023: 95,012,300) 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.
18. COMMITMENTS AND CONTINGENCIES
The Directors are not aware of any material commitments, contingent liabilities or assets that exist at 30 June 2024 (2023:
$Nil).
Annual Financial Report
63
19. EVENTS SUBSEQUENT TO THE END OF FINANCIAL YEAR
Other than what is outlined below, no other 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.
•
5,793,564 Rights Issue Options, were exercised at $0.0375 each
•
20,917,326 Shortfall Options were exercised at $0.0375 each
•
2,018,208 Placement & Rights Issue options were exercised at $0.05 each
•
On 12 August 2024, the Company announced that Xanamem treatment had clinically and statistically significant (p <
0.05) benefits on depression in its phase 2a XanaCIDD trial of Xanamem in patients with cognitive dysfunction and
major depressive disorder (MDD). This outcome indicates potential modification of the underlying biology of
depression as a result of inhibition of tissue cortisol synthesis – a completely novel mechanism for the treatment of
depression. The trial did not meet the primary endpoint of improving the “Attention Composite” in the context of an
unexpectedly large improvement in the placebo group.
•
On 26 August 2024, the Company announced that ongoing analysis of the XanaCIDD phase 2a depression trial data
found a consistent benefit of Xanamem® treatment on symptoms of depression in a variety of different endpoints.
The consistent benefits observed support the conclusion that a 10 mg Xanamem dose is clinically active in controlling
brain cortisol and has clinically significant anti-depressant activity.
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:
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
Ms Tamara Miller
Senior Vice President - Product Development
Resigned
Mr Jeff Carter
Chief Financial Officer
Resigned
Full year ended
Full year ended
30/06/2024
30/06/2023
$
$
Short-term employee benefits
1,672,337
1,420,115
Termination benefits
155,223
-
Post-employment benefits
93,571
71,543
Other benefits
87,389
63,652
Share-based payments
855,483
861,624
2,864,003
2,416,934
The detailed remuneration disclosures and relevant interest of each KMP in fully paid ordinary shares and options of the
Company are provided in the audited Remuneration Report on pages 29 to 41.
Actinogen Medical Limited
64
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 2023
Quantity issued,
(lapsed/forfeited
or expired)
during the year
(a) (b)
Quantity
as at
30 June
2024
Grant Date
Expiry Date
Expected
Volatility
Risk-
free
Interest
Rate
Fair
value
per
option
($)
Total
SBP
valuation
($)
Opening value
SBP expense
as at
1 July 2023
($)
Value
recognised
during the
year
($)
Closing value
of SBP
expense
as at
30 June 2024
($)
Value to be
recognised
in future
years
($)
Value of
unvested
SBP
expense
($) (c)
Options
Director options
5,000,000
-
5,000,000
24/03/2017
24/03/2025
100%
2.61%
0.0491
245,286
245,286
-
245,286
- -
Director options
-
-
-
18/01/2018
1/12/2022
60%
2.44%
0.0129
19,350
19,350
-
19,350
- -
Director options
6,400,000
(6,400,000)
-
28/11/2018
27/11/2023
54%
2.29%
0.0142
215,485
215,485
-
215,485
- -
Employee options
5,700,000
(5,700,000)
-
12/12/2018
12/12/2023
54%
2.15%
0.0158
91,377
91,377
-
91,377
- -
Employee options
5,000,000
(5,000,000)
-
1/02/2019
1/02/2024
54%
1.83%
0.0185
92,500
92,500
-
92,500
- -
Director options
3,000,000
(3,000,000)
-
4/04/2019
4/04/2024
49%
1.50%
0.0141
42,390
42,390
-
42,390
- -
Employee options
1,600,000
-
1,600,000
28/09/2020
27/09/2025
60%
0.32%
0.0093
14,948
14,848
100
14,948
- -
Total
26,700,000
(20,100,000)
6,600,000
721,336
721,242
100
721,336
-
-
Loan Shares
Loan shares
48,362,300
- 48,362,300
15/03/2021
15/03/2026
80%
0.71%
0.0145
733,990
711,428
22,562
733,990
-
-
Loan shares (d)
11,900,000
(4,166,670)
7,733,330
16/09/2021
16/09/2026
100%
0.62%
0.0642
764,395
677,419
45,230
722,649
1,131
40,615
Loan shares
4,500,000
-
4,500,000
18/11/2021
18/11/2026
100%
1.38%
0.1188
534,646
455,184
71,556
526,740
7,906
-
Loan shares (e)
4,000,000
(333,335)
3,666,665
13/01/2022
13/01/2027
100%
1.47%
0.1109
443,577
359,061
69,054
428,115
7,313
8,149
Loan shares (f)
16,000,000
(2,916,668)
13,083,332
24/05/2022
24/05/2027
100%
3.04%
0.0517
827,144
572,193
163,615
735,808
34,734
56,603
Loan shares
250,000
- 250,000
15/07/2022
14/07/2027
95%
3.16%
0.0412
10,299
9,269
66
9,335
964
-
Loan shares
10,000,000
- 10,000,000
20/03/2023
19/03/2028
80%
2.95%
0.0494
494,036
92,888
285,842
378,730
115,306
-
Loan shares
-
39,750,000
39,750,000
23/10/2023
7/11/2028
100%
4.24%
0.0126
500,850
- 203,996
203,996
296,854
-
Loan shares
-
46,500,000
46,500,000
22/11/2023
30/11/2028
100%
4.14%
0.0176
818,400
- 300,785
300,785
517,615
-
Loan shares
-
6,750,000
6,750,000
22/11/2023
30/11/2028
100%
4.14%
0.0176
118,800
- 43,662
43,662
75,138
-
Loan shares
-
18,000,000
18,000,000
9/02/2024
8/02/2024
85%
3.67%
0.0203
365,511
-
96,314
96,314
269,197
-
Loan shares
-
1,000,000
1,000,000
1/04/2024
1/04/2029
85%
3.57%
0.0213
21,253
-
3,977
3,977
17,276
-
Loan shares
-
1,000,000
1,000,000
17/06/2024
16/06/2029
85%
3.77%
0.0196
19,600
- 657
657
18,943
-
Total
95,012,300
105,583,327
200,595,627
5,652,501
2,877,442
1,307,316
4,184,758
1,362,377
105,367
Total SBP
121,712,300
85,483,327
207,195,627
6,373,837
3,598,684
1,307,416
4,906,094
1,362,377
105,367
Annual Financial Report
65
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 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 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 share options 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) 20,100,000 options expired during the year. Refer to Note 14 (c) for further information on options.
(b) 7,416,673 loan shares were cancelled by the Company due to forfeiture by the holders of these loan shares ceasing employment.
Refer to Note 14 (b) for information on loan shares.
(c) $105,367 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.
(d) Included in the Quantity as at 30 June 2024, a portion amounting to 3,333,330 relating to a former employee will expire on 27
October 2024 if the election to purchase all or some of the vested loan shares is not made.
(e) Included in the Quantity as at 30 June 2024, a portion amounting to 666,665 relating to a former employee will expire on 19
February 2025 if the election to purchase all or some of the vested loan shares is not made.
(f)
Included in the Quantity as at 30 June 2024, a portion amounting to 2,083,332 relating to a former employee will expire on 27
October 2024 if the election to purchase all or some of the vested loan shares is not made.
Actinogen Medical Limited
66
Consolidated entity disclosure
statement
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.
Annual Financial Report
67
Directors’ declaration
In the Directors’ opinion:
The Financial Statements and Notes set out on pages 43 to 66, 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 2024 and of its performance for the year
ended on that date,
The remuneration disclosure included in the audited Remuneration Report in the Directors’ Report complies with Section 300A
of the Corporations Act 2001.
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.
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.
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.
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
30 August 2024
Actinogen Medical Limited
68
Independent auditor’s report
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Ernst & Young
11 Mounts Bay Road
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 2024, the statement of comprehensive income,
statement in 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 2024 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 the 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 this matter. 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 matter below, provide the basis for our audit opinion on the
accompanying financial report.
Annual Financial Report
69
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Research and development rebate
Why significant
How our audit addressed the key audit matter
The Company has recognised a rebate receivable of
$9,022,474 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 2024 year.
This amount has been included in other receivables and
prepayments on the statement of financial position as at 30
June 2024 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 2024 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
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.
Actinogen Medical Limited
70
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
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.
►
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.
Annual Financial Report
71
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
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 2024.
In our opinion, the Remuneration Report of Actinogen Medical Limited for the year ended 30 June
2024, 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
30 August 2024
Actinogen Medical Limited
72
Shareholder information
Substantial shareholders:
The following substantial shareholders have lodged notices with the company as at 5 August 2024:
Holders
Shares
Percentage of
Issued Capital
BVF Partners L.P. on its own behalf and on behalf of BVF Inc., Mark N Lampert,
Biotechnology Value Fund, L.P.; and Biotechnology Value Fund II, L.P.
247,334,680
13.77%
Distribution of ordinary shareholders as at 5 August 2024
Range of Holding
Holders
Shares
1-1,000
127
15,286
1,001-5,000
254
931,516
5,001-10,000
593
4,820,819
10,001 - 100,000
2,391
99,715,967
100,001 – over
1,822
2,606,156,295
Total
5,187
2,711,639,883
Shareholders with less than a marketable parcel
508
Voting Rights: Each fully paid ordinary share carries voting rights of one vote per share. No voting rights attach to unlisted
options.
Twenty Largest holders of quoted ordinary shares as at 5 August 2024
Number of
Shares
Percentage of
Issued Capital
HSBC Custody Nominees (Australia) Limited
249,527,468
9.19%
Dr Steven Gourlay
72,677,180
2.68%
Citicorp Nominees Pty Limited
55,901,720
2.06%
JSC Wealth Management Pty Ltd
52,966,360
1.95%
Old College Capital Holdings Limited
48,147,864
1.78%
Mrs Sarah Cameron
35,600,000
1.31%
Precision Opportunities Fund Pty Ltd
35,000,000
1.29%
Garnsworthy Pension Fund Pty Ltd
31,500,000
1.16%
Tisia Nominees Pty Ltd
31,403,330
1.16%
Rickenbacker Capital Investments Pty Ltd
28,100,000
1.04%
Kaleidoscope Holdings Pty Ltd
26,483,275
0.98%
Structure Investments Pty Ltd
24,347,335
0.90%
Mr James Murch & Mrs Catherine Murch
23,971,378
0.88%
Alua Nominees Pty Ltd
22,688,291
0.84%
Mr Guillermo Cesar Orselli & Dr David Matthew Krelle
21,963,421
0.81%
SVE Capital Pty Ltd
21,146,116
0.78%
SG Gourlay Nominees Pty Ltd
20,561,907
0.76%
Peter Kyros Pty Ltd
19,530,676
0.72%
Iral Pty Ltd
19,524,230
0.72%
Mrs Gillian Karen Nes & Mrs Ronald Nes
19,500,000
0.72%
TOTAL
860,270,551
31.73%
Annual Financial Report
73
Unquoted Securities as at 5 August 2024
1.
There were 5,000,000 unlisted options exercisable at $0.10 each and expiring on 24 March 2025 held by one holder,
on issue. Details of the holders holding more than 20% are outlined below:
Number of Options
Percentage
Geoffrey Edward Duncan Brooke
5,000,000
100.00%
2.
There were 86,636,716 unlisted options exercisable at $0.0375 each and expiring on 11 September 2025 held by 614
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 2025 held by 29
holders, on issue, with no one holder holding more than 20%.
4.
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.
5.
There were 175,546,347 unlisted options exercisable at $0.05 each and expiring on 31 May 2027 held by 790
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.
Actinogen Medical Limited
74
Corporate directory
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: 14 November 2024
Meeting time and details to be advised.
Annual Financial Report
75