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FaronAnnual Report
2023
Contents
Contents
Who we are
Highlights
The Xanamem Pipeline
How Xanamem Targets Non-amyloid Disease
Mechanisms via Cortisol in Alzheimer’s Disease
Clinical Trials Program Overview
Chair’s Letter
Chief Executive Officer’s Letter
Vision and Strategy
Operating & Financial Review
Board of Directors
Executive Leadership Team
Directors’ Report
Remuneration Report (Audited)
Auditor’s Independence Declaration
Financial Report
Notes to the Financial Statements
Directors’ Declaration
Independent Auditor’s Report
Shareholder Information
Corporate Directory
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70
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.
Actinogen is a neurotherapeutics
developer realizing a revolutionary
therapy so neurology patients and
their families can live their best lives
1
Annual Financial Report Highlights
The highlight of FY2023 was the strongly positive
clinical biomarker Phase 2a trial data in patients with
mild Alzheimer’s disease
Reported clinically
significant effects
of Xanamem® in
biomarker-positive
patients with mild AD
Confirmed the utility of the
blood biomarker pTau181
to select patients with
progressive AD suitable
for the Phase 2b trial
Identified and started
qualifying sites for
the Phase 2b AD
trial in Australia, US,
UK, Singapore and
South Korea
Completed development
and manufacturing of
the to-be-marketed
tablet formulation
Commenced further scale
up manufacturing activities
for drug substance
Commenced XanaCIDD
trial in patients with
cognitive impairment
and depressive disorder
Appointed esteemed
neurologist Dana Hilt MD1
as Chief Medical Officer
based in Boston, USA
Successfully updated
regulatory documentation
with the FDA for the
Phase 2b AD trial and
new tablet formulation
Appointed experienced
drug developer Nicki
Vasquez PhD as Non-
Executive Director based
in San Francisco, USA
Filed a new manufacturing
patent to protect a key step
in the chemistry process
Conducted the first two
Clinical Trials Science
Fora to share more detailed
scientific information
with shareholders
Dr Hilt gave an oral
presentation on
Xanamem clinical effects
and pTau at the ADPD
conference in Sweden2
® Xanamem is a registered trademark of Actinogen Medical Limited
1 Dr Hilt replaced Dr Rolan, who continues as the Company’s clinical pharmacologist and medical director for the XanaCIDD clinical trial
2 The International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders
2
Actinogen Medical Limited The Xanamem Pipeline
Phase 2 placebo-controlled trials
Outlook
Cognitive impairment in
early Alzheimer’s disease
Phase 2b in patients with early AD
and elevated blood pTau
Depression with
cognitive impairment
Phase 2a in patients with cognitive
impairment and depression
Pivotal trials
examining cognitive
enhancement and
reduced disease
progression
Pivotal trials
assessing effects
on both depression
and cognition
Anxiety, sleep &
behavioural problems
in Fragile X syndrome
Proof-of-concept in adolescent and young adult males
Pending alternative
funding e.g.
partnerships or grants
3
Annual Financial Report Current Phase 1 & 2 datasets
Safety, cognition activity (n>300)
Phase 2
Alzheimer’s Disease
Phase 2
Cognitive Impairment
in Depression
2x Phase 3
Alzheimer’s Disease
2x Phase 3
Cognitive Impairment
in Depression
How Xanamem Targets Non-amyloid
Disease Mechanisms via Cortisol in
Alzheimer’s Disease
Xanamem1 is a unique molecule
that reaches its target in the brain
Xanamem’s novel mechanism of action sets it apart from
other therapies for neurological diseases. It works by
blocking the excess production of intracellular cortisol –
the stress hormone – through the inhibition of the 11β-HSD1
enzyme inside brain cells. The 11β-HSD1 enzyme is highly
concentrated in the hippocampus and frontal cortex, the
areas of the brain associated with cognitive impairment in
neurological diseases, including Alzheimer’s disease (AD).
The Company’s recent XanaMIA Part A trial confirmed
Xanamem’s ability to rapidly enhance attention and working
memory (referred to as cognition – the ability to think and
remember things). These findings replicated the pattern
of improvement seen in the prior XanaHES trial in healthy
older volunteers. In addition, large beneficial clinical effects
were seen in patients with mild AD and elevated blood pTau
protein (to indicate progressive AD). Recent human target
engagement data for the drug in the brain suggests good
activity of doses as low as 5mg daily. Clinical safety data
have been collected from more than 300 individual patients
or volunteers.
The Company is undertaking a Phase 2b placebo-controlled
trial evaluating Xanamem in the treatment of mild to moderate
AD, where some functional impairment (difficulty completing
activities of daily living) is also present and patients have an
elevated level of pTau in the blood to indicate progressive
disease. It is also conducting a Phase 2a placebo-controlled
trial measuring the effects of Xanamem on safety, cognitive
performance and depression in patients who are inadequately
treated by their anti-depressant medication and have both
depressive symptoms and cognitive impairment.
The cortisol hypothesis targets
‘the amyloid gap’
Xanamem was developed in response to a large body of
evidence from non-clinical and human studies implicating
elevated brain cortisol in cognitive decline. Animal non-clinical
studies show 11β-HSD1 inhibition protects against long term
cognitive decline independent of continued amyloid formation.
Recently, newer anti-amyloid intravenous infusions have been
shown to rapidly remove amyloid protein from the brains of
people with AD, resulting in a slowing of clinical progression
by approximately 30% (refer Figure footnote 1 below). More
is needed to halt progression completely and this almost
certainly will come from other approaches such as that of
Xanamem (Figure).
Newer anti-amyloid antibodies shown to slow but not
halt progression of AD1
Ideally patients would
not worsen on treatment
s
h
t
n
o
m
8
1
r
e
v
o
2
B
S
-
R
D
C
g
n
n
e
s
r
o
w
%
i
0
-5
-10
-15
-20
-25
-30
-35
-40
Large area of
unmet need most
likely treatable
by non-amyloid
therapies
lecanemab
donanemab all
donanemab
subgroup
halt
progression
Drugs targeting other mechanisms like Xanamem are needed
1 Lecanemab and donamemab are anti-amyloid antibodies given as an
intravenous infusion every 2 or 4 weeks (van Dyck et al. 2022; DOI:
10.1056/NEJMoa242182 n9=1795 and Sims JR at al.JAMA. Published
online July 17, 2023. doi:10.1001/jama.2023.13239
2 CDR-SB is an 18-point scale measuring functional status and was the
primary endpoint for lecanemab and a secondary endpoint for donanemab
1 Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any other regulatory authority
4
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>300)
Phase 2
Alzheimer’s Disease
Phase 2
Cognitive Impairment
in Depression
2x Phase 3
Alzheimer’s Disease
2x Phase 3
Cognitive Impairment
in Depression
5
Annual Financial Report Chair’s Letter
Actinogen represents a unique opportunity with
near-term Phase 2a data for the XanaCIDD trial
less than 12 months away
Dear Shareholder,
I am pleased to present to you the Actinogen Medical Annual Report
for the financial year ended 30 June 2023.
The Company has again made significant progress in its
clinical pipeline activity focused on the successful
development of our novel, small molecule drug, Xanamem, to
treat illnesses such as Alzheimer’s disease and cognitive
impairment in depression. Reducing excess cortisol inside
brain cells has the powerful potential for positive impact in
the lives of patients and their families suffering from many
neurological and neuropsychiatric conditions where there is
substantial unmet medical need.
In the face of challenging market headwinds this year in the
small cap biotech sector and capital markets in general, we
have delivered positive clinical data and commenced
enrolment in our Phase 2a trial of cognitive impairment in
depressive disorder (CIDD). We continue to be guided by our
strategic objectives of accelerating clinical development in
cognitive impairment, forward planning, and creating value
from partnerships. In so doing we adhere to high quality trial
design and conduct so that we optimize the chances of
success and drive value for shareholders.
Further details on the Company’s strategic priorities for
FY2024 are shown in the Vision and Strategy sections of this
annual report on pages 10 and 11.
Executive leadership
CEO Dr Steven Gourlay has once again provided excellent,
proactive executive leadership of all aspects of the Actinogen
business over the past year. The board was delighted when
he announced positive results from the Phase 2a clinical
biomarker trial in October 2022, which validated Xanamem’s
cortisol mechanism of action and the design of the Xanamem
AD program.
Following the release of those new results, we were able to
recruit renowned neurologist Dr Dana C. Hilt MD to our
executive leadership team in February as the Company’s
Chief Medical Officer (CMO) reporting to Dr Gourlay. US-
based Dr Hilt brings world-leading expertise and experience
to the role as an eminent neurologist and a clinical trial
specialist in Alzheimer’s disease, depression, and other
neurologic and neuropsychiatric diseases.
Dr Gourlay and Dr Hilt now form a powerful senior
management team for presentations and conferences. They
have attended all the important international AD conferences
and key partnering meetings over the past year. I am
confident that Dr Gourlay and Dr Hilt will lead the Company in
’following the science’ with distinction in the coming year with
the help of our other highly experienced staff. We are
66
6 Actinogen Medical Limited
Actinogen Medical Limited
pleased that former CMO, Professor Paul Rolan continues to
provide valuable expert supervision for our clinical
pharmacology and depression programs.
The Company continues to fill vital organisational and
consultant roles to ensure the success of the clinical
development program. Key appointments included a Global
Program Lead based in the USA, along with several clinical
operations team members in Australia.
Board and corporate governance
In March, the Board was pleased to announce the
appointment of US-based Dr Nicki Vasquez PhD as an
independent non-executive director. Dr Vasquez is an
immunologist and biopharmaceutical executive with more
than 25 years of biopharmaceutical discovery research and
development experience. She strengthens the Actinogen
Board with her skills and experience in strategic licensing,
partnering and alliance management as well as a strong
depth of knowledge in clinical development.
Dr Vasquez is currently Chief Portfolio Strategy & Alliance
Officer at Sutro Biopharma, a clinical stage oncology
company in San Francisco where she is responsible for
program management, portfolio strategy, and alliance
management. We welcome Dr Vasquez to the Actinogen
board.
The board seeks continuous improvement in its governance
and management oversight capability. During the past year
we conducted a review of all activities and responsibilities,
including the Board skills matrix to identify gaps and
opportunities for improvement. We updated our diversity
policy to reflect a greater emphasis on inclusion. These and
other corporate governance materials are posted on our
website. We will continue to assess the skills suitable for the
Board and, where appropriate, make changes and/or
additions.
Depression & cognition advisory board appointment
The Company welcomed esteemed Singapore-based clinical
expert in dementia, Associate Professor Christopher Chen
BMBCh, MRCP, FAMS (neurology), FRCPE to the Company’s
Depression & cognition Advisory Board during the year.
Associate Professor Chen is a Senior Clinician-Scientist at the
Departments of Pharmacology and Psychological Medicine,
Yong Loo Lin School of Medicine, National University of
Singapore, and Director of the Memory Aging and Cognition
Centre, National University Healthcare System.
We continue to utilise world-leading advisors to drive our
On 15 August 2023 the Company announced a substantial
strategic initiatives and ensure the success of our clinical
and binding commitment from Defender Asset Management
development programs.
Further details on all Actinogen board, advisory board and
senior executive personnel can be found on the Company’s
offer.
website: https://actinogen.com.au/our-team/
I would like to thank all our dedicated staff, the executive
team, our esteemed advisory boards, and my fellow
corporate board members for their strong contributions to
Pty Ltd and McFarlane Cameron Pty Ltd for $4.56 million in
aggregate if there is a shortfall in funds raised under the
Directors also reserve the right to place any shortfall in
subscriptions for new shares (and corresponding new
options) to qualifying investors for 3 months after the offer
closes on 4 September 2023.
the success of the Company in FY2023.
Actinogen remains in a solid financial position with $8.5
Capital raising
On 2 August 2023 the Company announced a post balance
date non-renounceable pro-rata rights issue offer (also
known as an entitlement offer) to existing shareholders to
million in cash as at 30 June 2023, prior to the addition of net
cash raised in the rights issue. Additional funds of at least
$3.8 million are expected from the R&D tax incentive cash
refund in the coming months.
raise a maximum of approximately $10 million before costs.1
Annual General Meeting
We are pleased to offer this opportunity to our existing
shareholders as we believe that this rights offer, which is still
current as at the date of this annual report, is a highly
attractive investment. In summary, it offers shareholders the
ability to:
• Acquire 1 new share for every 4.54 Shares held at an
issue price of 2.5 cents per new share
•
Receive for no additional payment 1 new unlisted option
(with an exercise price of 3.75 cents and an expiry date
36 months from the date of issue) for every 2 new shares
• Apply for any number of additional shares (and
This year’s Annual General Meeting will return to its
traditional in-person format. It will be held in Sydney on
Friday 17 November 2023, and we invite shareholders to
attend. Details of the meeting time and location will be
announced in due course.
Outlook
Actinogen has completed another year of achievement and
progression of our clinical development pipeline, particularly
with the announcement of the results of the Phase 2a clinical
biomarker trial which validated Xanamem’s cortisol
mechanism of action and allowed us to simulate the next
phase 2b trial in AD.
corresponding new options) if shareholders subscribe for
The board is confident in the Company’s prospects in FY2024
their full pro rata entitlement initially (known as a top up
and beyond with two major clinical readouts in the next 18
issued
offer).
A prospectus was released to the ASX and ASIC on 8 August
and letters were distributed to shareholders on the day the
offer opened, 17 August 2023. I strongly encourage
shareholders to accept the offer prior to the closing time of
7pm AEST on 4 September 2023.
If shareholders have not yet received a letter via email or
mail, please contact the Company’s share registrar, Automic,
to register your email address for urgent delivery of your
personalized offer document and instructions on how to
participate in the offer. Automic’s contact details are shown
in the box below.
months reflecting the hard work and dedication of the
Actinogen team. The XanaCIDD depression trial that is
expected to report results in the first half of calendar 2024,
followed by the interim analysis of the XanaMIA Phase 2b trial
in patients with AD, expected in early 2025.
The board and management team remain committed to
proactive management of all aspects of our business and the
successful execution of our strategic priorities to ensure the
best possible outcomes for shareholders.
On behalf of the Board, I would like to thank you for your
ongoing support, and we look forward to updating you on our
progress during the coming year.
If you have any questions in relation to the current rights
Dr Geoff Brooke
issue or your shareholding in Actinogen, please contact
Chair
Automic at hello@automicgroup.com.au or on 1300 288
30 August 2023
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.
1 Unless stated otherwise, all financial data is in Australian dollars
Annual Financial Report 7
Actinogen Medical Limited Chair’s Letter
Chair’s Letter
Actinogen represents a unique opportunity with
Actinogen represents a unique opportunity with
near-term Phase 2a data for the XanaCIDD trial
near-term Phase 2a data for the XanaCIDD trial
less than 12 months away
less than 12 months away
Dear Shareholder,
Dear Shareholder,
I am pleased to present to you the Actinogen Medical Annual Report
I am pleased to present to you the Actinogen Medical Annual Report
for the financial year ended 30 June 2023.
for the financial year ended 30 June 2023.
The Company has again made significant progress in its
The Company has again made significant progress in its
pleased that former CMO, Professor Paul Rolan continues to
pleased that former CMO, Professor Paul Rolan continues to
clinical pipeline activity focused on the successful
clinical pipeline activity focused on the successful
provide valuable expert supervision for our clinical
provide valuable expert supervision for our clinical
development of our novel, small molecule drug, Xanamem, to
development of our novel, small molecule drug, Xanamem, to
pharmacology and depression programs.
pharmacology and depression programs.
treat illnesses such as Alzheimer’s disease and cognitive
treat illnesses such as Alzheimer’s disease and cognitive
impairment in depression. Reducing excess cortisol inside
impairment in depression. Reducing excess cortisol inside
brain cells has the powerful potential for positive impact in
brain cells has the powerful potential for positive impact in
the lives of patients and their families suffering from many
the lives of patients and their families suffering from many
neurological and neuropsychiatric conditions where there is
neurological and neuropsychiatric conditions where there is
substantial unmet medical need.
substantial unmet medical need.
In the face of challenging market headwinds this year in the
In the face of challenging market headwinds this year in the
small cap biotech sector and capital markets in general, we
small cap biotech sector and capital markets in general, we
have delivered positive clinical data and commenced
have delivered positive clinical data and commenced
enrolment in our Phase 2a trial of cognitive impairment in
enrolment in our Phase 2a trial of cognitive impairment in
depressive disorder (CIDD). We continue to be guided by our
depressive disorder (CIDD). We continue to be guided by our
strategic objectives of accelerating clinical development in
strategic objectives of accelerating clinical development in
cognitive impairment, forward planning, and creating value
cognitive impairment, forward planning, and creating value
from partnerships. In so doing we adhere to high quality trial
from partnerships. In so doing we adhere to high quality trial
design and conduct so that we optimize the chances of
design and conduct so that we optimize the chances of
success and drive value for shareholders.
success and drive value for shareholders.
Further details on the Company’s strategic priorities for
Further details on the Company’s strategic priorities for
FY2024 are shown in the Vision and Strategy sections of this
FY2024 are shown in the Vision and Strategy sections of this
annual report on pages 10 and 11.
annual report on pages 10 and 11.
Executive leadership
Executive leadership
The Company continues to fill vital organisational and
The Company continues to fill vital organisational and
consultant roles to ensure the success of the clinical
consultant roles to ensure the success of the clinical
development program. Key appointments included a Global
development program. Key appointments included a Global
Program Lead based in the USA, along with several clinical
Program Lead based in the USA, along with several clinical
operations team members in Australia.
operations team members in Australia.
Board and corporate governance
Board and corporate governance
In March, the Board was pleased to announce the
In March, the Board was pleased to announce the
appointment of US-based Dr Nicki Vasquez PhD as an
appointment of US-based Dr Nicki Vasquez PhD as an
independent non-executive director. Dr Vasquez is an
independent non-executive director. Dr Vasquez is an
immunologist and biopharmaceutical executive with more
immunologist and biopharmaceutical executive with more
than 25 years of biopharmaceutical discovery research and
than 25 years of biopharmaceutical discovery research and
development experience. She strengthens the Actinogen
development experience. She strengthens the Actinogen
Board with her skills and experience in strategic licensing,
Board with her skills and experience in strategic licensing,
partnering and alliance management as well as a strong
partnering and alliance management as well as a strong
depth of knowledge in clinical development.
depth of knowledge in clinical development.
Dr Vasquez is currently Chief Portfolio Strategy & Alliance
Dr Vasquez is currently Chief Portfolio Strategy & Alliance
Officer at Sutro Biopharma, a clinical stage oncology
Officer at Sutro Biopharma, a clinical stage oncology
company in San Francisco where she is responsible for
company in San Francisco where she is responsible for
program management, portfolio strategy, and alliance
program management, portfolio strategy, and alliance
management. We welcome Dr Vasquez to the Actinogen
management. We welcome Dr Vasquez to the Actinogen
CEO Dr Steven Gourlay has once again provided excellent,
CEO Dr Steven Gourlay has once again provided excellent,
board.
board.
proactive executive leadership of all aspects of the Actinogen
proactive executive leadership of all aspects of the Actinogen
business over the past year. The board was delighted when
business over the past year. The board was delighted when
he announced positive results from the Phase 2a clinical
he announced positive results from the Phase 2a clinical
biomarker trial in October 2022, which validated Xanamem’s
biomarker trial in October 2022, which validated Xanamem’s
cortisol mechanism of action and the design of the Xanamem
cortisol mechanism of action and the design of the Xanamem
AD program.
AD program.
The board seeks continuous improvement in its governance
The board seeks continuous improvement in its governance
and management oversight capability. During the past year
and management oversight capability. During the past year
we conducted a review of all activities and responsibilities,
we conducted a review of all activities and responsibilities,
including the Board skills matrix to identify gaps and
including the Board skills matrix to identify gaps and
opportunities for improvement. We updated our diversity
opportunities for improvement. We updated our diversity
policy to reflect a greater emphasis on inclusion. These and
policy to reflect a greater emphasis on inclusion. These and
Following the release of those new results, we were able to
Following the release of those new results, we were able to
other corporate governance materials are posted on our
other corporate governance materials are posted on our
recruit renowned neurologist Dr Dana C. Hilt MD to our
recruit renowned neurologist Dr Dana C. Hilt MD to our
website. We will continue to assess the skills suitable for the
website. We will continue to assess the skills suitable for the
executive leadership team in February as the Company’s
executive leadership team in February as the Company’s
Board and, where appropriate, make changes and/or
Board and, where appropriate, make changes and/or
Chief Medical Officer (CMO) reporting to Dr Gourlay. US-
Chief Medical Officer (CMO) reporting to Dr Gourlay. US-
additions.
additions.
based Dr Hilt brings world-leading expertise and experience
based Dr Hilt brings world-leading expertise and experience
to the role as an eminent neurologist and a clinical trial
to the role as an eminent neurologist and a clinical trial
specialist in Alzheimer’s disease, depression, and other
specialist in Alzheimer’s disease, depression, and other
neurologic and neuropsychiatric diseases.
neurologic and neuropsychiatric diseases.
Depression & cognition advisory board appointment
Depression & cognition advisory board appointment
The Company welcomed esteemed Singapore-based clinical
The Company welcomed esteemed Singapore-based clinical
expert in dementia, Associate Professor Christopher Chen
expert in dementia, Associate Professor Christopher Chen
BMBCh, MRCP, FAMS (neurology), FRCPE to the Company’s
BMBCh, MRCP, FAMS (neurology), FRCPE to the Company’s
Dr Gourlay and Dr Hilt now form a powerful senior
Dr Gourlay and Dr Hilt now form a powerful senior
Depression & cognition Advisory Board during the year.
Depression & cognition Advisory Board during the year.
management team for presentations and conferences. They
management team for presentations and conferences. They
Associate Professor Chen is a Senior Clinician-Scientist at the
Associate Professor Chen is a Senior Clinician-Scientist at the
have attended all the important international AD conferences
have attended all the important international AD conferences
Departments of Pharmacology and Psychological Medicine,
Departments of Pharmacology and Psychological Medicine,
and key partnering meetings over the past year. I am
and key partnering meetings over the past year. I am
Yong Loo Lin School of Medicine, National University of
Yong Loo Lin School of Medicine, National University of
confident that Dr Gourlay and Dr Hilt will lead the Company in
confident that Dr Gourlay and Dr Hilt will lead the Company in
Singapore, and Director of the Memory Aging and Cognition
Singapore, and Director of the Memory Aging and Cognition
’following the science’ with distinction in the coming year with
’following the science’ with distinction in the coming year with
Centre, National University Healthcare System.
Centre, National University Healthcare System.
the help of our other highly experienced staff. We are
the help of our other highly experienced staff. We are
We continue to utilise world-leading advisors to drive our
We continue to utilise world-leading advisors to drive our
strategic initiatives and ensure the success of our clinical
strategic initiatives and ensure the success of our clinical
development programs.
development programs.
Further details on all Actinogen board, advisory board and
Further details on all Actinogen board, advisory board and
senior executive personnel can be found on the Company’s
senior executive personnel can be found on the Company’s
website: https://actinogen.com.au/our-team/
website: https://actinogen.com.au/our-team/
I would like to thank all our dedicated staff, the executive
I would like to thank all our dedicated staff, the executive
team, our esteemed advisory boards, and my fellow
team, our esteemed advisory boards, and my fellow
corporate board members for their strong contributions to
corporate board members for their strong contributions to
the success of the Company in FY2023.
the success of the Company in FY2023.
Capital raising
Capital raising
On 2 August 2023 the Company announced a post balance
On 2 August 2023 the Company announced a post balance
date non-renounceable pro-rata rights issue offer (also
date non-renounceable pro-rata rights issue offer (also
known as an entitlement offer) to existing shareholders to
known as an entitlement offer) to existing shareholders to
raise a maximum of approximately $10 million before costs.1
raise a maximum of approximately $10 million before costs.1
We are pleased to offer this opportunity to our existing
We are pleased to offer this opportunity to our existing
shareholders as we believe that this rights offer, which is still
shareholders as we believe that this rights offer, which is still
current as at the date of this annual report, is a highly
current as at the date of this annual report, is a highly
attractive investment. In summary, it offers shareholders the
attractive investment. In summary, it offers shareholders the
ability to:
ability to:
• Acquire 1 new share for every 4.54 Shares held at an
• Acquire 1 new share for every 4.54 Shares held at an
•
•
issue price of 2.5 cents per new share
issue price of 2.5 cents per new share
Receive for no additional payment 1 new unlisted option
Receive for no additional payment 1 new unlisted option
(with an exercise price of 3.75 cents and an expiry date
(with an exercise price of 3.75 cents and an expiry date
36 months from the date of issue) for every 2 new shares
36 months from the date of issue) for every 2 new shares
issued
issued
• Apply for any number of additional shares (and
• Apply for any number of additional shares (and
corresponding new options) if shareholders subscribe for
corresponding new options) if shareholders subscribe for
their full pro rata entitlement initially (known as a top up
their full pro rata entitlement initially (known as a top up
offer).
offer).
A prospectus was released to the ASX and ASIC on 8 August
A prospectus was released to the ASX and ASIC on 8 August
and letters were distributed to shareholders on the day the
and letters were distributed to shareholders on the day the
offer opened, 17 August 2023. I strongly encourage
offer opened, 17 August 2023. I strongly encourage
shareholders to accept the offer prior to the closing time of
shareholders to accept the offer prior to the closing time of
7pm AEST on 4 September 2023.
7pm AEST on 4 September 2023.
If shareholders have not yet received a letter via email or
If shareholders have not yet received a letter via email or
mail, please contact the Company’s share registrar, Automic,
mail, please contact the Company’s share registrar, Automic,
to register your email address for urgent delivery of your
to register your email address for urgent delivery of your
personalized offer document and instructions on how to
personalized offer document and instructions on how to
participate in the offer. Automic’s contact details are shown
participate in the offer. Automic’s contact details are shown
in the box below.
in the box below.
If you have any questions in relation to the current rights
If you have any questions in relation to the current rights
issue or your shareholding in Actinogen, please contact
issue or your shareholding in Actinogen, please contact
Automic at hello@automicgroup.com.au or on 1300 288
Automic at hello@automicgroup.com.au or on 1300 288
664 (within Australia) or +61 2 9698 5414 (outside
664 (within Australia) or +61 2 9698 5414 (outside
Australia). Visit the Automic website
Australia). Visit the Automic website
https://investor.automic.com.au/#/home to register as
https://investor.automic.com.au/#/home to register as
an ACW shareholder or log in to your existing account.
an ACW shareholder or log in to your existing account.
1 Unless stated otherwise, all financial data is in Australian dollars
1 Unless stated otherwise, all financial data is in Australian dollars
On 15 August 2023 the Company announced a substantial
On 15 August 2023 the Company announced a substantial
and binding commitment from Defender Asset Management
and binding commitment from Defender Asset Management
Pty Ltd and McFarlane Cameron Pty Ltd for $4.56 million in
Pty Ltd and McFarlane Cameron Pty Ltd for $4.56 million in
aggregate if there is a shortfall in funds raised under the
aggregate if there is a shortfall in funds raised under the
offer.
offer.
Directors also reserve the right to place any shortfall in
Directors also reserve the right to place any shortfall in
subscriptions for new shares (and corresponding new
subscriptions for new shares (and corresponding new
options) to qualifying investors for 3 months after the offer
options) to qualifying investors for 3 months after the offer
closes on 4 September 2023.
closes on 4 September 2023.
Actinogen remains in a solid financial position with $8.5
Actinogen remains in a solid financial position with $8.5
million in cash as at 30 June 2023, prior to the addition of net
million in cash as at 30 June 2023, prior to the addition of net
cash raised in the rights issue. Additional funds of at least
cash raised in the rights issue. Additional funds of at least
$3.8 million are expected from the R&D tax incentive cash
$3.8 million are expected from the R&D tax incentive cash
refund in the coming months.
refund in the coming months.
Annual General Meeting
Annual General Meeting
This year’s Annual General Meeting will return to its
This year’s Annual General Meeting will return to its
traditional in-person format. It will be held in Sydney on
traditional in-person format. It will be held in Sydney on
Friday 17 November 2023, and we invite shareholders to
Friday 17 November 2023, and we invite shareholders to
attend. Details of the meeting time and location will be
attend. Details of the meeting time and location will be
announced in due course.
announced in due course.
Outlook
Outlook
Actinogen has completed another year of achievement and
Actinogen has completed another year of achievement and
progression of our clinical development pipeline, particularly
progression of our clinical development pipeline, particularly
with the announcement of the results of the Phase 2a clinical
with the announcement of the results of the Phase 2a clinical
biomarker trial which validated Xanamem’s cortisol
biomarker trial which validated Xanamem’s cortisol
mechanism of action and allowed us to simulate the next
mechanism of action and allowed us to simulate the next
phase 2b trial in AD.
phase 2b trial in AD.
The board is confident in the Company’s prospects in FY2024
The board is confident in the Company’s prospects in FY2024
and beyond with two major clinical readouts in the next 18
and beyond with two major clinical readouts in the next 18
months reflecting the hard work and dedication of the
months reflecting the hard work and dedication of the
Actinogen team. The XanaCIDD depression trial that is
Actinogen team. The XanaCIDD depression trial that is
expected to report results in the first half of calendar 2024,
expected to report results in the first half of calendar 2024,
followed by the interim analysis of the XanaMIA Phase 2b trial
followed by the interim analysis of the XanaMIA Phase 2b trial
in patients with AD, expected in early 2025.
in patients with AD, expected in early 2025.
The board and management team remain committed to
The board and management team remain committed to
proactive management of all aspects of our business and the
proactive management of all aspects of our business and the
successful execution of our strategic priorities to ensure the
successful execution of our strategic priorities to ensure the
best possible outcomes for shareholders.
best possible outcomes for shareholders.
On behalf of the Board, I would like to thank you for your
On behalf of the Board, I would like to thank you for your
ongoing support, and we look forward to updating you on our
ongoing support, and we look forward to updating you on our
progress during the coming year.
progress during the coming year.
Dr Geoff Brooke
Dr Geoff Brooke
Chair
Chair
30 August 2023
30 August 2023
66 Actinogen Medical Limited
6 Actinogen Medical Limited
Actinogen Medical Limited
Annual Financial Report
77
Annual Financial Report 7
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Annual Financial Report
Chief Executive
Officer’s Letter
Dear Shareholder,
Continuing to ‘follow the science’
As we outlined in our Clinical Trials Science Forum held in
early August 2022, Actinogen’s clinical trials in Alzheimer’s
disease and cognitive impairment in major depressive
disorder are predicated on ensuring that we hit the ‘right’
criteria for successful, precision drug development:2
• Hitting the right target
• Having a drug with the right properties
• Using the right biomarkers and assessments to guide
development
Selecting the right trial participants
•
• Using the right trial design
•
Targeting the right dose
•
Ensuring the right safety profile.
Alzheimer’s disease (AD)
The new clinical data generated during the year was a critical
and important confirmation of the clinical benefit of Xanamem
at the right 10 mg dose level.
The primary finding of the trial, conducted under a pre-
specified double-blind analysis, was that Xanamem 10 mg
produced clinical and cognitive benefit in patients with
elevated blood pTau-181.3 Levels above the median value of
6.74 pg/mL (n=34) or 10.2 pg/mL (n=9) identified patients
who had a clinically significant therapeutic benefit from
Xanamem compared with placebo. The average effect size
was approximately 0.6 to 0.8 points on the CDR-SB scale4,
measuring cognition and function, which is widely used in
modern trials of early-stage AD.
While the trial was not designed to be large enough or long
enough to achieve statistical significance, the clinical effect
size, measured by the Cohen’s d statistic of 0.41, was very
large for the AD field and supports the effectiveness of
Xanamem in this patient population (p = 0.09).
In drug development, clinical safety data is equally important
as efficacy data. Notably, the clinical safety profile of
Xanamem continues to look promising, with no Serious
Our strategy is to complete our
XanaCIDD trial by June 2024 and
repeat and extend our positive clinical
data in a larger and longer Alzheimer’s
disease trial
Adverse Events attributed to the drug in more than 300
people treated for up to 12 weeks.
With the new clinical data in hand to intelligently simulate
and design the next Phase 2b trial, a design was chosen that
enables assessment of Xanamem’s effects on both cognition,
via a series of mental exercises, as well as clinical function,
measured with endpoints like the CDR-SB and activities of
daily living scores.
Thirty-six weeks duration was chosen to enable a long
enough 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.
Results are anticipated by the end of 2025, with an interim
analysis expected in early 2025. In my view, this trial has a
relatively high probability of success given the independent
efficacy observations from three separate trials to date and
our ability to simulate it with prior Phase 2a data.5
Cognitive impairment in depression (CIDD)
There is an extensive database of clinical literature to
suggest that reducing brain cortisol levels is a promising
strategy for the treatment of depression.6 Because
Xanamem achieves good target inhibition in the brain with
doses of 10 mg, our placebo-controlled XanaCIDD Phase 2a
trial should definitively answer the question on whether or
not the cortisol hypothesis is relevant in depression.
Previously, the computerized cognitive testing system used
as the primary endpoint in XanaCIDD showed a Xanamem
treatment benefit
in two independent placebo-controlled
trials of older volunteers.
2 Based on The ‘rights’ of precision drug development for Alzheimer’s disease.
Cummings et al. Alzheimer’s Research & Therapy (2019) 11:76
https://doi.org/10.1186/s13195-019-0529-5
3 P-Tau181 is elevated in patients with AD.
4 CDR-SB is the Clinical Dementia Rating - Sum of Boxes, an FDA approved rating
scale
5 See the biomarker trial data announced 10 October 2022
6 Meta-analysis of prior trials aimed at reducing cortisol, Ding et. al 2021
8
8 Actinogen Medical Limited
Actinogen Medical Limited
Chief Executive
Officer’s Letter
The key highlight of the year was demonstrating a
clinical and cognitive benefit of Xanamem in patients
The key highlight of the year was demonstrating a
The key highlight of the year was demonstrating a
with biomarker-positive, mild Alzheimer’s disease
clinical and cognitive benefit of Xanamem in patients
clinical and cognitive benefit of Xanamem in patients
with biomarker-positive, mild Alzheimer’s disease
with biomarker-positive, mild Alzheimer’s disease
Alzheimer’s disease (AD)
daily living scores.
Dear Shareholder,
Continuing to ‘follow the science’
As we outlined in our Clinical Trials Science Forum held in
early August 2022, Actinogen’s clinical trials in Alzheimer’s
disease and cognitive impairment in major depressive
disorder are predicated on ensuring that we hit the ‘right’
criteria for successful, precision drug development:2
• Hitting the right target
• Having a drug with the right properties
• Using the right biomarkers and assessments to guide
development
•
•
•
Selecting the right trial participants
• Using the right trial design
Targeting the right dose
Ensuring the right safety profile.
The new clinical data generated during the year was a critical
and important confirmation of the clinical benefit of Xanamem
at the right 10 mg dose level.
The primary finding of the trial, conducted under a pre-
specified double-blind analysis, was that Xanamem 10 mg
produced clinical and cognitive benefit in patients with
elevated blood pTau-181.3 Levels above the median value of
6.74 pg/mL (n=34) or 10.2 pg/mL (n=9) identified patients
who had a clinically significant therapeutic benefit from
Xanamem compared with placebo. The average effect size
was approximately 0.6 to 0.8 points on the CDR-SB scale4,
measuring cognition and function, which is widely used in
modern trials of early-stage AD.
While the trial was not designed to be large enough or long
enough to achieve statistical significance, the clinical effect
size, measured by the Cohen’s d statistic of 0.41, was very
large for the AD field and supports the effectiveness of
Xanamem in this patient population (p = 0.09).
In drug development, clinical safety data is equally important
as efficacy data. Notably, the clinical safety profile of
Xanamem continues to look promising, with no Serious
Our strategy is to complete our
XanaCIDD trial by June 2024 and
repeat and extend our positive clinical
data in a larger and longer Alzheimer’s
disease trial
Adverse Events attributed to the drug in more than 300
people treated for up to 12 weeks.
With the new clinical data in hand to intelligently simulate
and design the next Phase 2b trial, a design was chosen that
enables assessment of Xanamem’s effects on both cognition,
via a series of mental exercises, as well as clinical function,
measured with endpoints like the CDR-SB and activities of
Thirty-six weeks duration was chosen to enable a long
enough 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.
Results are anticipated by the end of 2025, with an interim
analysis expected in early 2025. In my view, this trial has a
relatively high probability of success given the independent
efficacy observations from three separate trials to date and
our ability to simulate it with prior Phase 2a data.5
Cognitive impairment in depression (CIDD)
There is an extensive database of clinical literature to
suggest that reducing brain cortisol levels is a promising
strategy for the treatment of depression.6 Because
Xanamem achieves good target inhibition in the brain with
doses of 10 mg, our placebo-controlled XanaCIDD Phase 2a
trial should definitively answer the question on whether or
not the cortisol hypothesis is relevant in depression.
Previously, the computerized cognitive testing system used
as the primary endpoint in XanaCIDD showed a Xanamem
treatment benefit
trials of older volunteers.
in two independent placebo-controlled
2 Based on The ‘rights’ of precision drug development for Alzheimer’s disease.
Cummings et al. Alzheimer’s Research & Therapy (2019) 11:76
scale
4 CDR-SB is the Clinical Dementia Rating - Sum of Boxes, an FDA approved rating
5 See the biomarker trial data announced 10 October 2022
6 Meta-analysis of prior trials aimed at reducing cortisol, Ding et. al 2021
https://doi.org/10.1186/s13195-019-0529-5
3 P-Tau181 is elevated in patients with AD.
8 Actinogen Medical Limited
By the end of July 2023 approximately 25% of the target 160
participants had been enrolled in Australia in the 6-week
treatment protocol and results are expected in Q2 CY 2024.
By the end of July 2023 approximately 25% of the target 160
Unheralded industry-wide delays by the UK regulatory
participants had been enrolled in Australia in the 6-week
By the end of July 2023 approximately 25% of the target 160
authorities slowed our trial expansion. This is being actively
treatment protocol and results are expected in Q2 CY 2024.
participants had been enrolled in Australia in the 6-week
mitigated by opening clinical sites in the US. We have now
Unheralded industry-wide delays by the UK regulatory
treatment protocol and results are expected in Q2 CY 2024.
finally received approval from the UK and will open a number
authorities slowed our trial expansion. This is being actively
Unheralded industry-wide delays by the UK regulatory
of preferred sites there next month.
mitigated by opening clinical sites in the US. We have now
authorities slowed our trial expansion. This is being actively
Business development & partnering
finally received approval from the UK and will open a number
mitigated by opening clinical sites in the US. We have now
of preferred sites there next month.
finally received approval from the UK and will open a number
Business development and partnering remains an ongoing
of preferred sites there next month.
focus for the Company and we continue to see a high level
Business development & partnering
of interest in our programs despite the challenging
Business development & partnering
Business development and partnering remains an ongoing
biopharma market conditions with markedly reduced merger
focus for the Company and we continue to see a high level
Business development and partnering remains an ongoing
and funding activity in the sector.
of interest in our programs despite the challenging
focus for the Company and we continue to see a high level
We attended an increased number of important international
biopharma market conditions with markedly reduced merger
of interest in our programs despite the challenging
conferences during the year in person to enhance
and funding activity in the sector.
biopharma market conditions with markedly reduced merger
Actinogen’s credentials as a Phase 2 clinical-stage company
and funding activity in the sector.
We attended an increased number of important international
and facilitate potential partner engagement and relationship
conferences during the year in person to enhance
We attended an increased number of important international
building.
Actinogen’s credentials as a Phase 2 clinical-stage company
conferences during the year in person to enhance
The highlight presentation of the year was by our CMO, Dr
and facilitate potential partner engagement and relationship
Actinogen’s credentials as a Phase 2 clinical-stage company
Dana Hilt MD, who gave an oral presentation on our new data
building.
and facilitate potential partner engagement and relationship
on Xanamem clinical effects and blood pTau levels at the
building.
The highlight presentation of the year was by our CMO, Dr
March ADPD academic conference in Sweden.7 There is
Dana Hilt MD, who gave an oral presentation on our new data
The highlight presentation of the year was by our CMO, Dr
significant activity and interest in blood biomarkers for the
on Xanamem clinical effects and blood pTau levels at the
Dana Hilt MD, who gave an oral presentation on our new data
diagnosis of AD as they may potentially avoid expensive and
March ADPD academic conference in Sweden.7 There is
on Xanamem clinical effects and blood pTau levels at the
hard-to-access Positron Emission Tomography (PET) scans
March ADPD academic conference in Sweden.7 There is
significant activity and interest in blood biomarkers for the
of the brain. It is likely that several blood tests for pTau will
diagnosis of AD as they may potentially avoid expensive and
significant activity and interest in blood biomarkers for the
support the diagnosis of AD in the future, making diagnostic
hard-to-access Positron Emission Tomography (PET) scans
diagnosis of AD as they may potentially avoid expensive and
testing widely available to general practitioners. Actinogen
of the brain. It is likely that several blood tests for pTau will
hard-to-access Positron Emission Tomography (PET) scans
will partner with a leading diagnostics company for the
support the diagnosis of AD in the future, making diagnostic
of the brain. It is likely that several blood tests for pTau will
upcoming Phase 2b trial.
testing widely available to general practitioners. Actinogen
support the diagnosis of AD in the future, making diagnostic
Other meetings included a CEO presentation at the Sach’s
will partner with a leading diagnostics company for the
testing widely available to general practitioners. Actinogen
Neuroscience meeting and Biopartnering @JPM associated
upcoming Phase 2b trial.
will partner with a leading diagnostics company for the
with the 41st annual JP Morgan HealthCare Conference in
upcoming Phase 2b trial.
Other meetings included a CEO presentation at the Sach’s
San Francisco in January, and the annual BIO International
Neuroscience meeting and Biopartnering @JPM associated
Other meetings included a CEO presentation at the Sach’s
Convention in Boston, USA in June, where Dr Hilt and I
with the 41st annual JP Morgan HealthCare Conference in
Neuroscience meeting and Biopartnering @JPM associated
conducted more than 30 partnering meetings.
San Francisco in January, and the annual BIO International
with the 41st annual JP Morgan HealthCare Conference in
We continue to develop relationships and explore potential
Convention in Boston, USA in June, where Dr Hilt and I
San Francisco in January, and the annual BIO International
business development partnerships in regional areas and
conducted more than 30 partnering meetings.
Convention in Boston, USA in June, where Dr Hilt and I
globally.
conducted more than 30 partnering meetings.
We continue to develop relationships and explore potential
business development partnerships in regional areas and
We continue to develop relationships and explore potential
globally.
business development partnerships in regional areas and
globally.
7 ADPD™ 2023: The International Conference on Alzheimer’s and Parkinson’s
Diseases and related neurological disorders. Data also presented at the Alzheimer’s
Association International Conference (AAIC) in Amsterdam in July
7 ADPD™ 2023: The International Conference on Alzheimer’s and Parkinson’s
Diseases and related neurological disorders. Data also presented at the Alzheimer’s
7 ADPD™ 2023: The International Conference on Alzheimer’s and Parkinson’s
Association International Conference (AAIC) in Amsterdam in July
Diseases and related neurological disorders. Data also presented at the Alzheimer’s
Association International Conference (AAIC) in Amsterdam in July
Good Manufacturing Practice (GMP) manufacturing
The successful manufacturing of Xanamem drug substance
and a to-be-marketed formulation of tablets was a major
Good Manufacturing Practice (GMP) manufacturing
milestone for the Company during the year.
Good Manufacturing Practice (GMP) manufacturing
The successful manufacturing of Xanamem drug substance
This was driven by our expert manufacturing team based in
and a to-be-marketed formulation of tablets was a major
The successful manufacturing of Xanamem drug substance
the San Francisco Bay Area, with drug substance
milestone for the Company during the year.
and a to-be-marketed formulation of tablets was a major
manufactured by Corden Pharma in Switzerland and
milestone for the Company during the year.
This was driven by our expert manufacturing team based in
formulated into tablets by Catalent in the US.
the San Francisco Bay Area, with drug substance
This was driven by our expert manufacturing team based in
Because Xanamem is a low dose drug we are in the fortunate
manufactured by Corden Pharma in Switzerland and
the San Francisco Bay Area, with drug substance
position of needing only modestly sized manufacturing runs
formulated into tablets by Catalent in the US.
manufactured by Corden Pharma in Switzerland and
to complete the clinical trial program. Scale up batches will be
formulated into tablets by Catalent in the US.
Because Xanamem is a low dose drug we are in the fortunate
made in the coming year to further validate the commercially-
position of needing only modestly sized manufacturing runs
Because Xanamem is a low dose drug we are in the fortunate
ready manufacturing process.
to complete the clinical trial program. Scale up batches will be
position of needing only modestly sized manufacturing runs
Xanamem’s data keeps getting stronger
made in the coming year to further validate the commercially-
to complete the clinical trial program. Scale up batches will be
ready manufacturing process.
made in the coming year to further validate the commercially-
Xanamem’s promising story as a breakthrough oral therapy
ready manufacturing process.
for Alzheimer’s disease and many other illnesses continues to
Xanamem’s data keeps getting stronger
mature, with our latest trial analysis showing a large clinical
Xanamem’s data keeps getting stronger
Xanamem’s promising story as a breakthrough oral therapy
effect on CDR-SB in patients with mild AD.
for Alzheimer’s disease and many other illnesses continues to
Xanamem’s promising story as a breakthrough oral therapy
This dataset effectively simulated the Phase 2b clinical trial
mature, with our latest trial analysis showing a large clinical
for Alzheimer’s disease and many other illnesses continues to
using similar patients and the same blood biomarker that
effect on CDR-SB in patients with mild AD.
mature, with our latest trial analysis showing a large clinical
will be used in that trial, giving us increased confidence of a
effect on CDR-SB in patients with mild AD.
This dataset effectively simulated the Phase 2b clinical trial
positive outcome.
using similar patients and the same blood biomarker that
This dataset effectively simulated the Phase 2b clinical trial
We are delighted with our success in the past year, and I would
will be used in that trial, giving us increased confidence of a
using similar patients and the same blood biomarker that
like to extend my thanks to the team for all of their hard work.
positive outcome.
will be used in that trial, giving us increased confidence of a
positive outcome.
Based on the results of our trials conducted in more than 300
We are delighted with our success in the past year, and I would
patients so far, we firmly believe that Xanamem has the
like to extend my thanks to the team for all of their hard work.
We are delighted with our success in the past year, and I would
potential to be a first-in-class drug in the treatment of early
like to extend my thanks to the team for all of their hard work.
Based on the results of our trials conducted in more than 300
stage AD and to be a first-in-class cognitive enhancer for
patients so far, we firmly believe that Xanamem has the
Based on the results of our trials conducted in more than 300
depression, with the added potential to be a successful anti-
potential to be a first-in-class drug in the treatment of early
patients so far, we firmly believe that Xanamem has the
depressant (possible ’dual action‘).
stage AD and to be a first-in-class cognitive enhancer for
potential to be a first-in-class drug in the treatment of early
The Company is now actively implementing an expanded
depression, with the added potential to be a successful anti-
stage AD and to be a first-in-class cognitive enhancer for
Phase 2 program in AD and CIDD and continues to evaluate
depressant (possible ’dual action‘).
depression, with the added potential to be a successful anti-
alternative funding solutions such as partnership and grants to
depressant (possible ’dual action‘).
The Company is now actively implementing an expanded
progress the FXS Phase 2 indication.
Phase 2 program in AD and CIDD and continues to evaluate
The Company is now actively implementing an expanded
Thank you for your ongoing support for Actinogen and we look
alternative funding solutions such as partnership and grants to
Phase 2 program in AD and CIDD and continues to evaluate
forward to updating you on our progress in the near future with
progress the FXS Phase 2 indication.
alternative funding solutions such as partnership and grants to
each successive trial and corporate milestone.
progress the FXS Phase 2 indication.
Thank you for your ongoing support for Actinogen and we look
Yours sincerely,
forward to updating you on our progress in the near future with
Thank you for your ongoing support for Actinogen and we look
each successive trial and corporate milestone.
forward to updating you on our progress in the near future with
Dr Steven Gourlay,
each successive trial and corporate milestone.
CEO & Managing Director
Yours sincerely,
30 August 2023
Yours sincerely,
Dr Steven Gourlay,
CEO & Managing Director
Dr Steven Gourlay,
30 August 2023
CEO & Managing Director
30 August 2023
9
Annual Financial Report 9
Annual Financial Report 9
Annual Financial Report 9
Annual Financial Report
Our Vision
To realize a
revolutionary therapy
so that neurology
patients and their
families can live their
best lives
Vision and Strategy
Our Fundamentals
Quality
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.
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.
10
FY2024 Strategic Priorities
Forward planning
• Complete additional manufacturing
for scale-up and supply of future
clinical trials
• Use to-be-marketed tablet
formulation in all future trials
• Integrate global regulatory
strategic planning to optimize
path to marketing approvals
• Plan and conduct required regulatory
nonclinical studies to the Good
Laboratory Practice standard
• Plan and conduct ancillary clinical
pharmacology studies required for
marketing approvals
Forward
planning
Create value from
partnerships
Create value from
partnerships
• Prioritize high value regional
partnerships in the near term
• Engage with the universe of
potential biopharma partners
who could create synergy for
the Xanamem program
• Maintain close working
relationships with key
regulators such as the US
FDA and the EMA
• Partner with leading clinical
trial implementation providers
• Partner with key community
organizations in Australia
and globally
Accelerate clinical
development in
cognitive
impairment
Accelerate clinical development
in cognitive impairment
• Build on improved attention and
working memory in two independent,
placebo-controlled trials
• Complete Phase 2a trial now
underway in patients with cognitive
impairment and depressive disorder
(XanaCIDD).
• Build on large Xanamem effect
seen in patients with mild AD and
elevated pTau181 protein in the blood
(an indication of progressive AD)
• Initiate Phase 2b trial in patients
with the early stages of Alzheimer’s
disease and elevated pTau
(XanaMIA Part B)
• Leverage ‘hands on’ clinical operations
and management based in Australia to
speed timelines and reduce cost
Actinogen Medical Limited Our Fundamentals
Quality
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.
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
FY2024 Strategic Priorities
Forward planning
• Complete additional manufacturing
for scale-up and supply of future
clinical trials
• Use to-be-marketed tablet
formulation in all future trials
• Integrate global regulatory
strategic planning to optimize
path to marketing approvals
• Plan and conduct required regulatory
nonclinical studies to the Good
Laboratory Practice standard
• Plan and conduct ancillary clinical
pharmacology studies required for
marketing approvals
Create value from
partnerships
Forward
planning
Create value from
partnerships
• Prioritize high value regional
partnerships in the near term
• Engage with the universe of
potential biopharma partners
who could create synergy for
the Xanamem program
• Maintain close working
relationships with key
regulators such as the US
FDA and the EMA
• Partner with leading clinical
trial implementation providers
• Partner with key community
organizations in Australia
and globally
Accelerate clinical
development in
cognitive
impairment
Accelerate clinical development
in cognitive impairment
• Build on improved attention and
working memory in two independent,
placebo-controlled trials
• Complete Phase 2a trial now
underway in patients with cognitive
impairment and depressive disorder
(XanaCIDD).
• Build on large Xanamem effect
seen in patients with mild AD and
elevated pTau181 protein in the blood
(an indication of progressive AD)
• Initiate Phase 2b trial in patients
with the early stages of Alzheimer’s
disease and elevated pTau
(XanaMIA Part B)
• Leverage ‘hands on’ clinical operations
and management based in Australia to
speed timelines and reduce cost
11
Annual Financial Report Operating & Financial Review
1. PRINCIPAL ACTIVITIES
The principal activity of the Company during the year focused on the ongoing development of Xanamem, a unique inhibitor of
the 11β- HSD1 enzyme that achieves target engagement in the central nervous system. 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 disease such as Alzheimer’s disease (AD), neuropsychiatric diseases such
as major depressive disorder (MDD or Depression), and Fragile X syndrome (FXS).
2. OPERATIONS REVIEW
Highlights: ‘Following the Science’
Xanamem program and cortisol target validated by Phase 2a clinical biomarker trial results showing large clinical benefit
on CDR-SB endpoint
Advancing two major Phase 2 clinical trial programs:
•
•
•
Enrolment increasing over the first six months in the XanaCIDD Phase 2a depression clinical trial at Australian sites- UK
and US sites opening soon, and results expected in H1CY24
US Food and Drug Administration (FDA) approval to proceed with XanaMIA Phase 2b Alzheimer’s disease trial - startup
phase progressing well, and final results expected in H2CY25 with an interim analysis in early CY25
Completed development and manufacturing of the new and to-be-marketed tablet formulation for use in the XanaMIA
Phase 2b clinical trial and all future trials.
Strengthened the team:
•
Appointed new independent non-executive director Nicki Vasquez PhD, new CMO Dr Dana Hilt MD, and clinical advisor
A/Professor Christopher Chen
Expanded the operational team by appointing a global project manager in the US and additional clinical trial personnel in
Australia.
•
Completed the Company’s first and second Clinical Trials Science Forum webinars to inform and educate investors on the
science behind Xanamem, anti-amyloid drugs and the Company’s clinical trials program.
Presented at numerous international and Australian AD, investment and partnering meetings.
The 2023 financial year was successfully marked by major milestones and events for Actinogen:
Announced positive AD biomarker Phase 2a trial result - large clinical benefit shown that validates Xanamem program:
•
The Phase 2a clinical biomarker trial was conducted in 72 patients with available blood biomarker samples from the prior
Phase 2a placebo controlled XanADu trial of 185 patients. Patients in the original trial had an unconfirmed, clinical
diagnosis of mild AD, and were treated with Xanamem 10 mg or placebo once daily for 12 weeks
•
•
The positive result announced on 10 October 2022 showed clinically significant effects on key endpoints (CDR-SB and
cognition)8 in patients with biomarker-positive AD. The effects on cognition were consistent with the positive pattern of
improvement in attention and working memory from previous healthy volunteer trials
The analysis validated the design and outcome measures of the upcoming XanaMIA Phase 2b trial in patients with mild
to moderate AD by essentially simulating the trial in a prospectively defined and double-blind analysis of similar patients
(see next page).
Advancing Phase 2 trial programs:
•
XanaCIDD Phase 2a depression clinical trial:
o Commenced the XanaCIDD Phase 2a depression trial in 160 patients with cognitive impairment associated with
persistent major depressive disorder (MDD) in December 2022
o After the expected slower pace of the start-up phase, trial enrolment is now progressing well - Australian sites
are now open for recruitment and actively screening, enrolling, and treating patients, with enrolment at more
than 25%. New sites are being opened in the USA to compensate for industry-wide regulatory delays in the UK9
and to ensure that timelines are maintained. Approval from the UK regulator has just been received. Sites are
expected to open in the UK in September and the USA in October 2023
o
o
Signed contracts with suppliers worth approximately US$3 million to provide clinical development services
Results are anticipated in H1 CY2024.
8 Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) is a measure of patient functional abilities and a composite of cognitive tests of mental abilities considered a measure of
“executive function”
9 Industry-wide delays in The Medicines and Healthcare products Regulatory Agency (MHRA) approval processes has prevented XanaCIDD trial center activation in the UK until 22
August 2023
12
12 Actinogen Medical Limited
Actinogen Medical Limited
Operating & Financial Review
Operating & Financial Review
1. PRINCIPAL ACTIVITIES
1. PRINCIPAL ACTIVITIES
The principal activity of the Company during the year focused on the ongoing development of Xanamem, a unique inhibitor of
The principal activity of the Company during the year focused on the ongoing development of Xanamem, a unique inhibitor of
the 11β- HSD1 enzyme that achieves target engagement in the central nervous system. It is an oral medication for neurological
the 11β- HSD1 enzyme that achieves target engagement in the central nervous system. 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
diseases amenable to its mechanism of lowering cortisol in brain cells. Brain cortisol is associated with a number of
neurological diseases, including neurodegenerative disease such as Alzheimer’s disease (AD), neuropsychiatric diseases such
neurological diseases, including neurodegenerative disease such as Alzheimer’s disease (AD), neuropsychiatric diseases such
as major depressive disorder (MDD or Depression), and Fragile X syndrome (FXS).
as major depressive disorder (MDD or Depression), and Fragile X syndrome (FXS).
2. OPERATIONS REVIEW
2. OPERATIONS REVIEW
Highlights: ‘Following the Science’
Highlights: ‘Following the Science’
on CDR-SB endpoint
on CDR-SB endpoint
Advancing two major Phase 2 clinical trial programs:
Advancing two major Phase 2 clinical trial programs:
Xanamem program and cortisol target validated by Phase 2a clinical biomarker trial results showing large clinical benefit
Xanamem program and cortisol target validated by Phase 2a clinical biomarker trial results showing large clinical benefit
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Enrolment increasing over the first six months in the XanaCIDD Phase 2a depression clinical trial at Australian sites- UK
Enrolment increasing over the first six months in the XanaCIDD Phase 2a depression clinical trial at Australian sites- UK
and US sites opening soon, and results expected in H1CY24
and US sites opening soon, and results expected in H1CY24
US Food and Drug Administration (FDA) approval to proceed with XanaMIA Phase 2b Alzheimer’s disease trial - startup
US Food and Drug Administration (FDA) approval to proceed with XanaMIA Phase 2b Alzheimer’s disease trial - startup
phase progressing well, and final results expected in H2CY25 with an interim analysis in early CY25
phase progressing well, and final results expected in H2CY25 with an interim analysis in early CY25
Completed development and manufacturing of the new and to-be-marketed tablet formulation for use in the XanaMIA
Completed development and manufacturing of the new and to-be-marketed tablet formulation for use in the XanaMIA
Phase 2b clinical trial and all future trials.
Phase 2b clinical trial and all future trials.
Strengthened the team:
Strengthened the team:
A/Professor Christopher Chen
A/Professor Christopher Chen
Australia.
Australia.
Appointed new independent non-executive director Nicki Vasquez PhD, new CMO Dr Dana Hilt MD, and clinical advisor
Appointed new independent non-executive director Nicki Vasquez PhD, new CMO Dr Dana Hilt MD, and clinical advisor
Expanded the operational team by appointing a global project manager in the US and additional clinical trial personnel in
Expanded the operational team by appointing a global project manager in the US and additional clinical trial personnel in
Completed the Company’s first and second Clinical Trials Science Forum webinars to inform and educate investors on the
Completed the Company’s first and second Clinical Trials Science Forum webinars to inform and educate investors on the
science behind Xanamem, anti-amyloid drugs and the Company’s clinical trials program.
science behind Xanamem, anti-amyloid drugs and the Company’s clinical trials program.
Presented at numerous international and Australian AD, investment and partnering meetings.
Presented at numerous international and Australian AD, investment and partnering meetings.
The 2023 financial year was successfully marked by major milestones and events for Actinogen:
The 2023 financial year was successfully marked by major milestones and events for Actinogen:
Announced positive AD biomarker Phase 2a trial result - large clinical benefit shown that validates Xanamem program:
Announced positive AD biomarker Phase 2a trial result - large clinical benefit shown that validates Xanamem program:
The Phase 2a clinical biomarker trial was conducted in 72 patients with available blood biomarker samples from the prior
The Phase 2a clinical biomarker trial was conducted in 72 patients with available blood biomarker samples from the prior
Phase 2a placebo controlled XanADu trial of 185 patients. Patients in the original trial had an unconfirmed, clinical
Phase 2a placebo controlled XanADu trial of 185 patients. Patients in the original trial had an unconfirmed, clinical
diagnosis of mild AD, and were treated with Xanamem 10 mg or placebo once daily for 12 weeks
diagnosis of mild AD, and were treated with Xanamem 10 mg or placebo once daily for 12 weeks
The positive result announced on 10 October 2022 showed clinically significant effects on key endpoints (CDR-SB and
The positive result announced on 10 October 2022 showed clinically significant effects on key endpoints (CDR-SB and
cognition)8 in patients with biomarker-positive AD. The effects on cognition were consistent with the positive pattern of
cognition)8 in patients with biomarker-positive AD. The effects on cognition were consistent with the positive pattern of
improvement in attention and working memory from previous healthy volunteer trials
improvement in attention and working memory from previous healthy volunteer trials
The analysis validated the design and outcome measures of the upcoming XanaMIA Phase 2b trial in patients with mild
The analysis validated the design and outcome measures of the upcoming XanaMIA Phase 2b trial in patients with mild
to moderate AD by essentially simulating the trial in a prospectively defined and double-blind analysis of similar patients
to moderate AD by essentially simulating the trial in a prospectively defined and double-blind analysis of similar patients
(see next page).
(see next page).
Advancing Phase 2 trial programs:
Advancing Phase 2 trial programs:
•
•
XanaCIDD Phase 2a depression clinical trial:
XanaCIDD Phase 2a depression clinical trial:
o Commenced the XanaCIDD Phase 2a depression trial in 160 patients with cognitive impairment associated with
Commenced the XanaCIDD Phase 2a depression trial in 160 patients with cognitive impairment associated with
o
persistent major depressive disorder (MDD) in December 2022
persistent major depressive disorder (MDD) in December 2022
o After the expected slower pace of the start-up phase, trial enrolment is now progressing well - Australian sites
After the expected slower pace of the start-up phase, trial enrolment is now progressing well - Australian sites
o
are now open for recruitment and actively screening, enrolling, and treating patients, with enrolment at more
are now open for recruitment and actively screening, enrolling, and treating patients, with enrolment at more
than 25%. New sites are being opened in the USA to compensate for industry-wide regulatory delays in the UK9
than 25%. New sites are being opened in the USA to compensate for industry-wide regulatory delays in the UK9
and to ensure that timelines are maintained. Approval from the UK regulator has just been received. Sites are
and to ensure that timelines are maintained. Approval from the UK regulator has just been received. Sites are
expected to open in the UK in September and the USA in October 2023
expected to open in the UK in September and the USA in October 2023
Signed contracts with suppliers worth approximately US$3 million to provide clinical development services
Signed contracts with suppliers worth approximately US$3 million to provide clinical development services
Results are anticipated in H1 CY2024.
Results are anticipated in H1 CY2024.
8 Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) is a measure of patient functional abilities and a composite of cognitive tests of mental abilities considered a measure of
8 Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) is a measure of patient functional abilities and a composite of cognitive tests of mental abilities considered a measure of
9 Industry-wide delays in The Medicines and Healthcare products Regulatory Agency (MHRA) approval processes has prevented XanaCIDD trial center activation in the UK until 22
9 Industry-wide delays in The Medicines and Healthcare products Regulatory Agency (MHRA) approval processes has prevented XanaCIDD trial center activation in the UK until 22
o
o
o
o
“executive function”
“executive function”
August 2023
August 2023
12 Actinogen Medical Limited
12 Actinogen Medical Limited
•
XanaMIA Phase 2b Alzheimer’s disease clinical trial:
o
o
o
Site feasibility and other startup activities for the XanaMIA Phase 2b clinical trial of Xanamem in patients with
mild to moderate Alzheimer’s disease continue to progress well with a view to enrolling the first patient before
the end of CY23. Numerous enthusiastic global trial centers for early activation have been identified in Australia,
Canada, the USA, Singapore, and South Korea
On 5 June 2023, the Company submitted updated regulatory documentation to the FDA including the updated
clinical protocol and quality documentation for the new tablet formulation of Xanamem. The 30-day waiting
period for FDA feedback has passed, so the Company may proceed with the trial and new tablets as planned
Results are anticipated in H2 CY2025, with an interim analysis expected in early CY2025.
• Manufacturing milestone:
o
o
Successfully completed development and manufacturing of the new and to-be-marketed tablet formulation for
use in the XanaMIA Phase 2b clinical trial
This is a notable milestone that enables the Company’s planned, rapid expansion of its trial program upon a
positive result from the phase 2a depression trial next year.
Strengthening the team:
•
Appointed US-based highly experienced neurologist and trials expert Dr Dana Hilt MD as CMO effective 1 February
2023
•
•
•
Appointed highly credentialled immunologist and experienced US-based biopharma executive Dr Nicki Vasquez PhD
to the board as an independent non-executive director effective 1 March 2023
Appointed esteemed Singapore-based clinical expert in dementia, Associate Professor Christopher Chen BMBCh,
MRCP, FAMS (neurology), FRCPE to the Company’s Depression & Cognition Advisory Board
Continued to fill vital operational roles to ensure the success of the clinical development program. Appointees included:
o
A Global AD Program Lead based in the USA, along with several clinical operations team members in Australia.
The Actinogen ’hands on’ operational model aims to increase trial quality and decrease cost by using Actinogen
staff to closely supervise the performance of trial centers and other partner organizations.
Clinical Trials Science Forum presentations to investors:
•
Initiated the Actinogen Clinical Trials Science Forum (CTSF) in August 2022 to inform and educate a broad audience,
including those from non-technical backgrounds, on the science behind Xanamem and the Company’s clinical trials
program
•
‘Following the Science’ is fundamental to all Actinogen’s activities and was the foundation for the Company’s second
CTSF presentation titled Alzheimer’s disease: amyloid therapies are only part of the answer. The presentation explained
the science behind targeting amyloid in Alzheimer’s disease and the opportunity for non-amyloid treatments such as
Xanamem.
Presented at key international conferences and industry meetings:
•
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:
o
o
o
o
o
The Spark Plus Australian Equities Day Webinar on 28 July 2022 where Dr Gourlay presented on ACW’s excellent
clinical safety demonstrated in more than 300 people; identical patterns of clinical activity on cognition in two
independent, placebo-controlled clinical trials; and upcoming Phase 2 trials
The Spark Plus and the Bell Potter Healthcare conferences in November 2022 where Dr Gourlay provided
investors with an overview of the Company and its positive Phase 2a AD biomarker trial results that showed a
strong clinical effect from Xanamem and a major validation of the ‘cortisol hypothesis’ for AD
The CTAD10 conference in San Francisco where Dr Gourlay presented an academic poster on the XanaMIA Phase
1b trial results,11 which revealed positive effects on attention and working memory in cognitively normal, older
volunteers at 5 and 10 mg daily doses of Xanamem as well as encouraging safety data
The Sachs Neuroscience Innovation Forum in San Francisco on 8 January 2023 where Dr Gourlay presented the
company’s latest clinical data. Dr Gourlay also participated in industry meetings at conferences that ran
concurrently with the J.P. Morgan Healthcare Conference week
The Spark Plus Biotech Conference in Singapore on 24 March 2023 where Dr Gourlay’s presentation focused on
four main topics including data showing Xanamem activity in four independent trials, and why anti-amyloid
therapies have limited utility and novel therapies are still required for the treatment of AD.
10 The Clinical Trials on Alzheimer’s Disease conference
11 XanaMIA Phase 1b (Part A) trial results announced 27 April 2022
1313
Annual Financial Report
Annual Financial Report 13
Annual Financial Report
Operating and Financial Review (continued)
2. OPERATIONS REVIEW (continued)
o
o
o
ADPD12 2023 on 30 March in Gothenburg, Sweden where CMO Dr Hilt presented Actinogen’s novel Phase 2a
biomarker trial data. The presentation was one of the first to show that the blood p-Tau181 biomarker is a highly
effective method for selection of patients with a progressive form of mild Alzheimer’s disease
The BIO International Convention in Boston, USA on 5 June 2023 where Dr Gourlay and Dr Hilt met with
international investors and prospective biopharma partners
The National Dementia Conference in Melbourne on 21 June 2023 where Dr Gourlay provided a keynote
presentation on the small number of oral therapies in development for AD with credible cognitive data
competing with the Xanamem program.
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.
3. FINANCIAL REVIEW
(a) Financial Performance
The financial performance of the Company during the year ended 30 June 2023 is as follows:
Revenue and other income ($)
Net loss after tax ($)
Loss per share (cents)
Dividend ($)
(b) Financial Position
The financial position of the Company as at 30 June 2023 is as follows:
Cash and cash equivalents
Net assets / Total equity
Contributed equity
Accumulated losses
(c) Post balance date capital raising
Full year ended
Full year ended
30/06/2023
30/06/2022
5,254,589
3,681,154
(10,752,270)
(9,497,370)
(0.60)
-
(0.55)
-
As at
As at
30/06/2023
30/06/2022
$
$
8,460,074
16,370,283
13,407,215
21,739,877
78,712,128
76,942,670
(68,691,553)
(57,939,283)
•
•
•
•
On 2 August 2023 the Company announced a non-renounceable pro-rata rights issue offer to existing shareholders to
raise a maximum of approximately $10 million (before costs)
The offer to eligible shareholders (holding shares at the Record Date of 14 August 2023) is to:
o
o
o
Acquire 1 new share for every 4.54 Shares held at an issue price of 2.5 cents per new share
Receive for no additional payment 1 new unlisted option (with an exercise price of 3.75 cents and an expiry date
36 months from the date of issue) for every 2 new shares issued
Apply for any number of additional shares (and corresponding new options) if shareholders subscribe for their
full pro rata entitlement initially (known as a top up offer).
On 15 August 2023 the Company announced a substantial and binding commitment from Defender Asset
Management Pty Ltd and McFarlane Cameron Pty Ltd for $4.56 million in aggregate of any shortfall that may arise from
the rights issue offer
Directors also reserve the right to place any shortfall in subscriptions for new shares (and corresponding new options)
to qualifying investors for 3 months after the offer closes on 4 September 2023.
12 The International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders
1414
Actinogen Medical Limited
14 Actinogen Medical Limited
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
Actinogen’s future success is dependent on the performance of
Mitigation measures include ‘following the
Development
Actinogen’s lead molecule, Xanamem®, in clinical trials and whether it
science’ of the data generated for
Activities
proves to be a safe and effective treatment. Xanamem is an
Xanamem to date, hiring expert clinical
experimental product in Phase 2 clinical development. Product
development professionals to design,
commercialization resulting in potential product sales revenues are
oversee and analyse the trial program,
likely to be years away without any guarantee that it will be
engagement of leading contract research
successful. It requires additional research and development,
organisations to manage components of
including ongoing clinical evaluation of safety and efficacy in clinical
the trials and drive recruitment as well as
trials and regulatory approval prior to marketing authorization. Until
engagement of well-qualified clinical sites
Actinogen is able to provide further clinical evidence of the ability of
experienced in clinical trial execution and
Xanamem to improve outcomes in patients, the future success of its
in the relevant therapeutic areas.
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.
Regulatory
Actinogen operates within a highly regulated industry, relating to the
Mitigation measures include operating
Approvals
manufacture, distribution and supply of pharmaceutical products.
under a US FDA Investigational New Drug
There is no guarantee that Actinogen will obtain the required
(IND) process, engagement of suitably
approvals, licenses and registrations from relevant regulatory
qualified and experienced persons with
authorities in jurisdictions in which it operates. The commencement
expertise in the regulation of small
of clinical trials may be delayed and Actinogen may incur further
molecule therapies, establishing
costs if the Food and Drug Administration (FDA) and other regulatory
relationships with regulators to facilitate
agencies are tardy or observe deficiencies that require resolution or
feedback and guidance from them, regular
request additional studies be conducted in addition to those that are
review of evolving regulatory requirements
currently planned. A change in regulation may also adversely affect
and analysis of the Company’s activities
Actinogen’s ability to commercialize and manufacture its treatments.
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
Securing rights in technology and patents is an integral part of
Mitigation measures include use of expert
Property
securing potential product value in the outcomes of biotechnology
patent attorneys, regular review of the
research and development. Competition in retaining and sustaining
relevant patent landscape, filing of
protection of technology and the complex nature of technologies can
additional patents and maintenance of
lead to patent disputes. Actinogen’s success depends, in part, on its
patents in a broad geography covering
ability to obtain patents, maintain trade secret protection and
major pharmaceutical markets.
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 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
commercialize 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.
Annual Financial Report 15
Actinogen Medical Limited
Operating and Financial Review (continued)
2. OPERATIONS REVIEW (continued)
ADPD12 2023 on 30 March in Gothenburg, Sweden where CMO Dr Hilt presented Actinogen’s novel Phase 2a
biomarker trial data. The presentation was one of the first to show that the blood p-Tau181 biomarker is a highly
effective method for selection of patients with a progressive form of mild Alzheimer’s disease
The BIO International Convention in Boston, USA on 5 June 2023 where Dr Gourlay and Dr Hilt met with
international investors and prospective biopharma partners
The National Dementia Conference in Melbourne on 21 June 2023 where Dr Gourlay provided a keynote
presentation on the small number of oral therapies in development for AD with credible cognitive data
competing with the Xanamem program.
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.
The financial performance of the Company during the year ended 30 June 2023 is as follows:
The financial position of the Company as at 30 June 2023 is as follows:
Full year ended
Full year ended
30/06/2023
30/06/2022
5,254,589
3,681,154
(10,752,270)
(9,497,370)
(0.60)
-
(0.55)
-
As at
As at
30/06/2023
30/06/2022
$
$
8,460,074
16,370,283
13,407,215
21,739,877
78,712,128
76,942,670
(68,691,553)
(57,939,283)
3. FINANCIAL REVIEW
(a) Financial Performance
Revenue and other income ($)
Net loss after tax ($)
Loss per share (cents)
Dividend ($)
(b) Financial Position
Cash and cash equivalents
Net assets / Total equity
Contributed equity
Accumulated losses
(c) Post balance date capital raising
o
o
o
o
o
o
•
•
•
•
On 2 August 2023 the Company announced a non-renounceable pro-rata rights issue offer to existing shareholders to
raise a maximum of approximately $10 million (before costs)
The offer to eligible shareholders (holding shares at the Record Date of 14 August 2023) is to:
Acquire 1 new share for every 4.54 Shares held at an issue price of 2.5 cents per new share
Receive for no additional payment 1 new unlisted option (with an exercise price of 3.75 cents and an expiry date
36 months from the date of issue) for every 2 new shares issued
Apply for any number of additional shares (and corresponding new options) if shareholders subscribe for their
full pro rata entitlement initially (known as a top up offer).
On 15 August 2023 the Company announced a substantial and binding commitment from Defender Asset
Management Pty Ltd and McFarlane Cameron Pty Ltd for $4.56 million in aggregate of any shortfall that may arise from
the rights issue offer
Directors also reserve the right to place any shortfall in subscriptions for new shares (and corresponding new options)
to qualifying investors for 3 months after the offer closes on 4 September 2023.
12 The International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders
14
14 Actinogen Medical Limited
Actinogen Medical Limited
4. MATERIAL RISKS
4. MATERIAL RISKS
In addition to risks associated with any business there are specific, material risks that, either individually or in combination, may
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
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
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:
of Actinogen, its directors and management. The material risks identified by management are described below:
Risk
Risk
Implication
Implication
Mitigation
Mitigation
Research and
Research and
Development
Development
Actinogen’s future success is dependent on the performance of
Actinogen’s future success is dependent on the performance of
Actinogen’s lead molecule, Xanamem®, in clinical trials and whether it
Actinogen’s lead molecule, Xanamem®, in clinical trials and whether it
Mitigation measures include ‘following the
Mitigation measures include ‘following the
science’ of the data generated for
science’ of the data generated for
Activities
Activities
proves to be a safe and effective treatment. Xanamem is an
proves to be a safe and effective treatment. Xanamem is an
Xanamem to date, hiring expert clinical
Xanamem to date, hiring expert clinical
experimental product in Phase 2 clinical development. Product
experimental product in Phase 2 clinical development. Product
development professionals to design,
development professionals to design,
commercialization resulting in potential product sales revenues are
commercialization resulting in potential product sales revenues are
oversee and analyse the trial program,
oversee and analyse the trial program,
likely to be years away without any guarantee that it will be
likely to be years away without any guarantee that it will be
engagement of leading contract research
engagement of leading contract research
successful. It requires additional research and development,
successful. It requires additional research and development,
organisations to manage components of
organisations to manage components of
including ongoing clinical evaluation of safety and efficacy in clinical
including ongoing clinical evaluation of safety and efficacy in clinical
the trials and drive recruitment as well as
the trials and drive recruitment as well as
trials and regulatory approval prior to marketing authorization. Until
trials and regulatory approval prior to marketing authorization. Until
engagement of well-qualified clinical sites
engagement of well-qualified clinical sites
Actinogen is able to provide further clinical evidence of the ability of
Actinogen is able to provide further clinical evidence of the ability of
experienced in clinical trial execution and
experienced in clinical trial execution and
Xanamem to improve outcomes in patients, the future success of its
Xanamem to improve outcomes in patients, the future success of its
in the relevant therapeutic areas.
in the relevant therapeutic areas.
technology remains speculative. Research and development risks
technology remains speculative. Research and development risks
include uncertainty of the outcome of results, difficulties or delays in
include uncertainty of the outcome of results, difficulties or delays in
development and generally the uncertainty that surrounds the
development and generally the uncertainty that surrounds the
scientific development of pharmaceutical products.
scientific development of pharmaceutical products.
Regulatory
Regulatory
Actinogen operates within a highly regulated industry, relating to the
Actinogen operates within a highly regulated industry, relating to the
Mitigation measures include operating
Mitigation measures include operating
Approvals
Approvals
manufacture, distribution and supply of pharmaceutical products.
manufacture, distribution and supply of pharmaceutical products.
under a US FDA Investigational New Drug
under a US FDA Investigational New Drug
There is no guarantee that Actinogen will obtain the required
There is no guarantee that Actinogen will obtain the required
(IND) process, engagement of suitably
(IND) process, engagement of suitably
approvals, licenses and registrations from relevant regulatory
approvals, licenses and registrations from relevant regulatory
qualified and experienced persons with
qualified and experienced persons with
authorities in jurisdictions in which it operates. The commencement
authorities in jurisdictions in which it operates. The commencement
expertise in the regulation of small
expertise in the regulation of small
of clinical trials may be delayed and Actinogen may incur further
of clinical trials may be delayed and Actinogen may incur further
molecule therapies, establishing
molecule therapies, establishing
costs if the Food and Drug Administration (FDA) and other regulatory
costs if the Food and Drug Administration (FDA) and other regulatory
relationships with regulators to facilitate
relationships with regulators to facilitate
agencies are tardy or observe deficiencies that require resolution or
agencies are tardy or observe deficiencies that require resolution or
feedback and guidance from them, regular
feedback and guidance from them, regular
request additional studies be conducted in addition to those that are
request additional studies be conducted in addition to those that are
review of evolving regulatory requirements
review of evolving regulatory requirements
currently planned. A change in regulation may also adversely affect
currently planned. A change in regulation may also adversely affect
and analysis of the Company’s activities
and analysis of the Company’s activities
Actinogen’s ability to commercialize and manufacture its treatments.
Actinogen’s ability to commercialize and manufacture its treatments.
and plans against regulatory expectations
and plans against regulatory expectations
in key jurisdictions, and ensuring that the
in key jurisdictions, and ensuring that the
expectations and uncertainties related to
expectations and uncertainties related to
regulatory approvals, and the timing of
regulatory approvals, and the timing of
such approvals, are included in business
such approvals, are included in business
plans.
plans.
Intellectual
Intellectual
Securing rights in technology and patents is an integral part of
Securing rights in technology and patents is an integral part of
Mitigation measures include use of expert
Mitigation measures include use of expert
Property
Property
securing potential product value in the outcomes of biotechnology
securing potential product value in the outcomes of biotechnology
patent attorneys, regular review of the
patent attorneys, regular review of the
research and development. Competition in retaining and sustaining
research and development. Competition in retaining and sustaining
relevant patent landscape, filing of
relevant patent landscape, filing of
protection of technology and the complex nature of technologies can
protection of technology and the complex nature of technologies can
additional patents and maintenance of
additional patents and maintenance of
lead to patent disputes. Actinogen’s success depends, in part, on its
lead to patent disputes. Actinogen’s success depends, in part, on its
patents in a broad geography covering
patents in a broad geography covering
ability to obtain patents, maintain trade secret protection and
ability to obtain patents, maintain trade secret protection and
major pharmaceutical markets.
major pharmaceutical markets.
operate without infringing the proprietary rights of third parties.
operate without infringing the proprietary rights of third parties.
Because the patent position of biotechnology companies can be
Because the patent position of biotechnology companies can be
highly uncertain and frequently involves complex legal and factual
highly uncertain and frequently involves complex legal and factual
questions, neither the breadth of claims allowed in biotechnology
questions, neither the breadth of claims allowed in biotechnology
patents nor their enforceability can be predicted. There can be no
patents nor their enforceability can be predicted. There can be no
assurance that any patents which Actinogen may own, access or
assurance that any patents which Actinogen may own, access or
control will afford Actinogen commercially significant protection of its
control will afford Actinogen commercially significant protection of its
technology or its products or have commercial application or that
technology or its products or have commercial application or that
access to these patents will mean that Actinogen will be free to
access to these patents will mean that Actinogen will be free to
commercialize its technology. Competitors may file patents which
commercialize its technology. Competitors may file patents which
could limit the Company's freedom to operate for its technologies.
could limit the Company's freedom to operate for its technologies.
The granting of a patent does not guarantee that the rights of others
The granting of a patent does not guarantee that the rights of others
are not infringed or that competitors will not develop technology or
are not infringed or that competitors will not develop technology or
products to avoid Actinogen's patented technology. Actinogen’s
products to avoid Actinogen's patented technology. Actinogen’s
current patenting strategies do not cover all countries which may
current patenting strategies do not cover all countries which may
lead to generic competition arising in those markets.
lead to generic competition arising in those markets.
15
Annual Financial Report 15
Annual Financial Report 15
Annual Financial Report
•
•
•
•
•
•
•
•
•
In addition to conducting high quality clinical trials there are numerous other important activities for successful drug
development. At Actinogen, we proactively plan and manage all aspects of the Xanamem development plan.
Our key goals under this strategic priority are:
Complete additional manufacturing for scale-up and supply of future clinical trials
Use to-be-marketed tablet formulation in all future trials
Integrate global regulatory strategic planning to optimize path to marketing approvals
Plan and conduct required regulatory nonclinical studies to the Good Laboratory Practice standard
Plan and conduct ancillary clinical pharmacology studies required for marketing approvals.
Create value from partnerships
Our active business development plan maintains and develops relationships with all potential drug development partners, both
large and small, regional and global. We continue to see a high level of interest in our programs despite the challenging
biopharma market conditions with markedly reduced merger and funding activity in the sector.
Strengthened by the addition of Dr Hilt to the team, we attended in person at an increased number of important international
conferences during the year to facilitate relationship building, partner engagement and Actinogen’s presence as a Phase 2
clinical-stage company.
We use our Alzheimer's program as the ‘core’ collaboration with the US FDA covering manufacturing, quality and nonclinical
matters. 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.
Our key goals under this strategic priority are:
Prioritize high value regional partnerships in the near term
Engage with the universe of potential biopharma partners who could create synergy for the Xanamem program
• Maintain close working relationships with key regulators such as the US FDA and EMA
Partner with leading clinical trial implementation providers
Partner with key community organizations in Australia and globally
Our FY2024 strategic priorities are also summarized in the infographic on page 11 of this annual report
Outlook
The Company remains confident about its prospects in FY2024 and beyond. Actinogen is now implementing the XanaCIDD trial
that will report results in H1CY 2024, using a primary endpoint measuring cognition that was validated by demonstrating
Xanamem benefits in two prior volunteer trials. Xanamem effects on depression itself will also be measured.
The second major clinical milestone is the interim analysis of the XanaMIA Phase 2b trial in patients with AD, expected in early
2025. To have two major clinical readouts in the next 18-month period reflects the successful hard work and dedication of the
Actinogen team.
expansion on successful Phase 2 results.
Meanwhile manufacturing, regulatory, clinical pharmacology and nonclinical activities continue in high order to enable rapid
We are committed to proactive management of all aspects of our business to ensure the best possible outcomes for
shareholders. This includes our current clinical trials program, our forward planning for future trials and eventual drug
commercialization, and working closely with existing and potential new partners.
Risk
Implication
Mitigation
Forward planning
Partnership
While undertaking its Phase 2 clinical program the Company is
Mitigation measures employed by the
Model
actively pursuing value-add partnership(s) to expand the trial
Company include: using expert business
program further and secure commercialization pathways in one or
development professionals to build
more territories. This model, which typically involves entering into
relationships with potential partners,
commercial arrangements with other companies by which Actinogen
performing rigorous due diligence;
would license its Xanamem technology to the partner in one or more
ensuring that the commercial terms
indications and/or geographies and the partner assumes some or all
negotiated are fair and utilising expert
responsibility for progressing, and paying for, the clinical trials and
legal advice to ensure that appropriate
eventual commercialization. This strategy involves the risk that the
warranties and commitments are included
Company will lose some or all control of the development timetable
in contracts, and that the contracts reflect
of its products to its commercial partner(s), which may give rise to an
the agreed commercial position.
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.
Manufacturing
The Company’s products are manufactured using a specialised
Mitigation measures include performing
manufacturing process at an expert third party facility, as is the norm
rigorous due diligence on contract
in our industry. An inability of these third party contract
manufacturers, engaging contract
manufacturing organisations to continue to manufacture the
manufacturers with strong track records
Company’s products in a timely, economical and/or consistent
and sufficient capability to meet the
manner, including any scale up of manufacturing processes, or to
Company’s foreseeable needs, employing
maintain legally compliant manufacturing to maintain product supply,
senior managers responsible for managing
could adversely impact on the progress of the Company’s
and monitoring the performance of
development programs and potentially on the financial performance
contract manufacturers, and maintenance
of the Company.
of quality systems and related
documentation.
Fundraising
Actinogen is reliant upon fundraising to fund its operations. Funds
Mitigation measures include filing of
risk
may be available in the future from grants, development and
multiple grant applications, key
commercial partnerships, tax incentives and capital markets but are
management focus on partnership
not guaranteed. Capital market volatility has affected many
relationships, use of specialist advisors in
companies since 2020 and may impact Actinogen’s ability to raise
tax, business development and investor
future funds if it continues to be adverse.
relations, maintaining high quality analyst
coverage, frequent communications to
retail and institutional investors and having
a presence at many scientific and business
conferences.
5. BUSINESS STRATEGY & OUTLOOK
Actinogen’s strategic priorities focus on three key elements:
•
•
•
Accelerate clinical development in cognitive impairment
Forward planning
Create value from partnerships.
Accelerate clinical development in cognitive impairment
The positive results from the Phase 2a clinical biomarker trial strongly supported the feasibility of using both cognitive testing
and the CDR-SB endpoint for our Phase 2b trial. The benefits of Xanamem in the biomarker-positive patients allowed us to
model the design of the next study to increase its chances of success.
Our key goals under this strategic priority are:
•
•
•
•
•
Build on improved attention and working memory in two independent, placebo-controlled trials
Complete Phase 2a trial now underway in patients with cognitive impairment and depressive disorder (XanaCIDD)
Build on the large Xanamem effect seen in patients with mild AD and elevated pTau181 protein in the blood (an indication
of progressive AD)
Initiate Phase 2b trial in patients with the early stages of Alzheimer’s disease and elevated pTau (XanaMIA Part B)
Leverage ‘hands on’ clinical operations and management based in Australia to speed timelines and reduce cost.
1616
Actinogen Medical Limited
16 Actinogen Medical Limited
Annual Financial Report 17
Actinogen Medical Limited Risk
Risk
Implication
Implication
Mitigation
Mitigation
Forward planning
Forward planning
In addition to conducting high quality clinical trials there are numerous other important activities for successful drug
In addition to conducting high quality clinical trials there are numerous other important activities for successful drug
development. At Actinogen, we proactively plan and manage all aspects of the Xanamem development plan.
development. At Actinogen, we proactively plan and manage all aspects of the Xanamem development plan.
Our key goals under this strategic priority are:
Our key goals under this strategic priority are:
•
•
•
•
•
•
•
•
•
•
Complete additional manufacturing for scale-up and supply of future clinical trials
Complete additional manufacturing for scale-up and supply of future clinical trials
Use to-be-marketed tablet formulation in all future trials
Use to-be-marketed tablet formulation in all future trials
Integrate global regulatory strategic planning to optimize path to marketing approvals
Integrate global regulatory strategic planning to optimize path to marketing approvals
Plan and conduct required regulatory nonclinical studies to the Good Laboratory Practice standard
Plan and conduct required regulatory nonclinical studies to the Good Laboratory Practice standard
Plan and conduct ancillary clinical pharmacology studies required for marketing approvals.
Plan and conduct ancillary clinical pharmacology studies required for marketing approvals.
Create value from partnerships
Create value from partnerships
Our active business development plan maintains and develops relationships with all potential drug development partners, both
Our active business development plan maintains and develops relationships with all potential drug development partners, both
large and small, regional and global. We continue to see a high level of interest in our programs despite the challenging
large and small, regional and global. We continue to see a high level of interest in our programs despite the challenging
biopharma market conditions with markedly reduced merger and funding activity in the sector.
biopharma market conditions with markedly reduced merger and funding activity in the sector.
Strengthened by the addition of Dr Hilt to the team, we attended in person at an increased number of important international
Strengthened by the addition of Dr Hilt to the team, we attended in person at an increased number of important international
conferences during the year to facilitate relationship building, partner engagement and Actinogen’s presence as a Phase 2
conferences during the year to facilitate relationship building, partner engagement and Actinogen’s presence as a Phase 2
clinical-stage company.
clinical-stage company.
We use our Alzheimer's program as the ‘core’ collaboration with the US FDA covering manufacturing, quality and nonclinical
We use our Alzheimer's program as the ‘core’ collaboration with the US FDA covering manufacturing, quality and nonclinical
matters. We also aim to build and maintain good working relationships with other global regulators such as the European
matters. 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.
Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency.
Partnership
Partnership
While undertaking its Phase 2 clinical program the Company is
While undertaking its Phase 2 clinical program the Company is
Mitigation measures employed by the
Mitigation measures employed by the
Model
Model
actively pursuing value-add partnership(s) to expand the trial
actively pursuing value-add partnership(s) to expand the trial
Company include: using expert business
Company include: using expert business
program further and secure commercialization pathways in one or
program further and secure commercialization pathways in one or
development professionals to build
development professionals to build
more territories. This model, which typically involves entering into
more territories. This model, which typically involves entering into
relationships with potential partners,
relationships with potential partners,
commercial arrangements with other companies by which Actinogen
commercial arrangements with other companies by which Actinogen
performing rigorous due diligence;
performing rigorous due diligence;
would license its Xanamem technology to the partner in one or more
would license its Xanamem technology to the partner in one or more
ensuring that the commercial terms
ensuring that the commercial terms
indications and/or geographies and the partner assumes some or all
indications and/or geographies and the partner assumes some or all
negotiated are fair and utilising expert
negotiated are fair and utilising expert
responsibility for progressing, and paying for, the clinical trials and
responsibility for progressing, and paying for, the clinical trials and
legal advice to ensure that appropriate
legal advice to ensure that appropriate
eventual commercialization. This strategy involves the risk that the
eventual commercialization. This strategy involves the risk that the
warranties and commitments are included
warranties and commitments are included
Company will lose some or all control of the development timetable
Company will lose some or all control of the development timetable
in contracts, and that the contracts reflect
in contracts, and that the contracts reflect
of its products to its commercial partner(s), which may give rise to an
of its products to its commercial partner(s), which may give rise to an
the agreed commercial position.
the agreed commercial position.
unanticipated delay in any commercial returns. Further, the Company
unanticipated delay in any commercial returns. Further, the Company
may be unable to enter into arrangements with suitable commercial
may be unable to enter into arrangements with suitable commercial
partners in respect of relevant indications. If either of these
partners in respect of relevant indications. If either of these
outcomes occurred, the Company’s business and operations may be
outcomes occurred, the Company’s business and operations may be
adversely affected.
adversely affected.
Manufacturing
Manufacturing
The Company’s products are manufactured using a specialised
The Company’s products are manufactured using a specialised
Mitigation measures include performing
Mitigation measures include performing
manufacturing process at an expert third party facility, as is the norm
manufacturing process at an expert third party facility, as is the norm
rigorous due diligence on contract
rigorous due diligence on contract
in our industry. An inability of these third party contract
in our industry. An inability of these third party contract
manufacturers, engaging contract
manufacturers, engaging contract
manufacturing organisations to continue to manufacture the
manufacturing organisations to continue to manufacture the
manufacturers with strong track records
manufacturers with strong track records
Company’s products in a timely, economical and/or consistent
Company’s products in a timely, economical and/or consistent
and sufficient capability to meet the
and sufficient capability to meet the
manner, including any scale up of manufacturing processes, or to
manner, including any scale up of manufacturing processes, or to
Company’s foreseeable needs, employing
Company’s foreseeable needs, employing
maintain legally compliant manufacturing to maintain product supply,
maintain legally compliant manufacturing to maintain product supply,
senior managers responsible for managing
senior managers responsible for managing
could adversely impact on the progress of the Company’s
could adversely impact on the progress of the Company’s
and monitoring the performance of
and monitoring the performance of
development programs and potentially on the financial performance
development programs and potentially on the financial performance
contract manufacturers, and maintenance
contract manufacturers, and maintenance
of the Company.
of the Company.
of quality systems and related
of quality systems and related
documentation.
documentation.
Fundraising
Fundraising
Actinogen is reliant upon fundraising to fund its operations. Funds
Actinogen is reliant upon fundraising to fund its operations. Funds
Mitigation measures include filing of
Mitigation measures include filing of
risk
risk
may be available in the future from grants, development and
may be available in the future from grants, development and
multiple grant applications, key
multiple grant applications, key
commercial partnerships, tax incentives and capital markets but are
commercial partnerships, tax incentives and capital markets but are
management focus on partnership
management focus on partnership
not guaranteed. Capital market volatility has affected many
not guaranteed. Capital market volatility has affected many
relationships, use of specialist advisors in
relationships, use of specialist advisors in
companies since 2020 and may impact Actinogen’s ability to raise
companies since 2020 and may impact Actinogen’s ability to raise
tax, business development and investor
tax, business development and investor
future funds if it continues to be adverse.
future funds if it continues to be adverse.
relations, maintaining high quality analyst
relations, maintaining high quality analyst
coverage, frequent communications to
coverage, frequent communications to
retail and institutional investors and having
retail and institutional investors and having
a presence at many scientific and business
a presence at many scientific and business
conferences.
conferences.
5. BUSINESS STRATEGY & OUTLOOK
5. BUSINESS STRATEGY & OUTLOOK
Actinogen’s strategic priorities focus on three key elements:
Actinogen’s strategic priorities focus on three key elements:
Accelerate clinical development in cognitive impairment
Accelerate clinical development in cognitive impairment
Forward planning
Forward planning
Create value from partnerships.
Create value from partnerships.
Accelerate clinical development in cognitive impairment
Accelerate clinical development in cognitive impairment
The positive results from the Phase 2a clinical biomarker trial strongly supported the feasibility of using both cognitive testing
The positive results from the Phase 2a clinical biomarker trial strongly supported the feasibility of using both cognitive testing
and the CDR-SB endpoint for our Phase 2b trial. The benefits of Xanamem in the biomarker-positive patients allowed us to
and the CDR-SB endpoint for our Phase 2b trial. The benefits of Xanamem in the biomarker-positive patients allowed us to
model the design of the next study to increase its chances of success.
model the design of the next study to increase its chances of success.
Our key goals under this strategic priority are:
Our key goals under this strategic priority are:
Build on improved attention and working memory in two independent, placebo-controlled trials
Build on improved attention and working memory in two independent, placebo-controlled trials
Complete Phase 2a trial now underway in patients with cognitive impairment and depressive disorder (XanaCIDD)
Complete Phase 2a trial now underway in patients with cognitive impairment and depressive disorder (XanaCIDD)
Build on the large Xanamem effect seen in patients with mild AD and elevated pTau181 protein in the blood (an indication
Build on the large Xanamem effect seen in patients with mild AD and elevated pTau181 protein in the blood (an indication
of progressive AD)
of progressive AD)
Initiate Phase 2b trial in patients with the early stages of Alzheimer’s disease and elevated pTau (XanaMIA Part B)
Initiate Phase 2b trial in patients with the early stages of Alzheimer’s disease and elevated pTau (XanaMIA Part B)
Leverage ‘hands on’ clinical operations and management based in Australia to speed timelines and reduce cost.
Leverage ‘hands on’ clinical operations and management based in Australia to speed timelines and reduce cost.
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Our FY2024 strategic priorities are also summarized in the infographic on page 11 of this annual report
Our FY2024 strategic priorities are also summarized in the infographic on page 11 of this annual report
Outlook
Outlook
The Company remains confident about its prospects in FY2024 and beyond. Actinogen is now implementing the XanaCIDD trial
The Company remains confident about its prospects in FY2024 and beyond. Actinogen is now implementing the XanaCIDD trial
that will report results in H1CY 2024, using a primary endpoint measuring cognition that was validated by demonstrating
that will report results in H1CY 2024, using a primary endpoint measuring cognition that was validated by demonstrating
Xanamem benefits in two prior volunteer trials. Xanamem effects on depression itself will also be measured.
Xanamem benefits in two prior volunteer trials. Xanamem effects on depression itself will also be measured.
The second major clinical milestone is the interim analysis of the XanaMIA Phase 2b trial in patients with AD, expected in early
The second major clinical milestone is the interim analysis of the XanaMIA Phase 2b trial in patients with AD, expected in early
2025. To have two major clinical readouts in the next 18-month period reflects the successful hard work and dedication of the
2025. To have two major clinical readouts in the next 18-month period reflects the successful hard work and dedication of the
Actinogen team.
Actinogen team.
Meanwhile manufacturing, regulatory, clinical pharmacology and nonclinical activities continue in high order to enable rapid
Meanwhile manufacturing, regulatory, clinical pharmacology and nonclinical activities continue in high order to enable rapid
expansion on successful Phase 2 results.
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
We are committed to proactive management of all aspects of our business to ensure the best possible outcomes for
shareholders. This includes our current clinical trials program, our forward planning for future trials and eventual drug
shareholders. This includes our current clinical trials program, our forward planning for future trials and eventual drug
commercialization, and working closely with existing and potential new partners.
commercialization, and working closely with existing and potential new partners.
1616 Actinogen Medical Limited
16 Actinogen Medical Limited
Actinogen Medical Limited
1717
Annual Financial Report
Annual Financial Report 17
Annual Financial Report 17
Our key goals under this strategic priority are:
Our key goals under this strategic priority are:
•
•
•
•
• Maintain close working relationships with key regulators such as the US FDA and EMA
• Maintain close working relationships with key regulators such as the US FDA and EMA
•
•
•
•
Prioritize high value regional partnerships in the near term
Prioritize high value regional partnerships in the near term
Engage with the universe of potential biopharma partners who could create synergy for the Xanamem
program
Engage with the universe of potential biopharma partners who could create synergy for the Xanamem program
Partner with leading clinical trial implementation providers
Partner with leading clinical trial implementation providers
Partner with key community organizations in Australia and globally.
Partner with key community organizations in Australia and globally
Annual Financial Report 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 with a realised value of more than $1.5 billion. Most notably,
Dr Brooke was the 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 holds a Bachelor of Medicine, Bachelor of Surgery (MB,BS) from the University of
Melbourne, a PhD in Medicine from Monash University, an MBA from Macquarie University and is a fellow of the Royal
Australian College of Physicians (FRACP). He is also a specialist physician in general internal medicine.
Dr Gourlay has held no other ASX-listed directorships during the past three years.
Board of Directors (continued)
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) – Current
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
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 is currently Chief Portfolio
Strategy & Alliance Officer at Sutro Biopharma, a clinical stage oncology company in San Francisco where she is 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 has held no other ASX-listed directorships during the past three years.
1818
Actinogen Medical Limited
18 Actinogen Medical Limited
Annual Financial Report 19
Actinogen Medical Limited
Board of Directors
Board of Directors
BOARD OF DIRECTORS
BOARD OF DIRECTORS
Dr Geoffrey Brooke
Dr Geoffrey Brooke
MBBS, MBA
MBBS, MBA
Non-Executive Chair (appointed 1 March 2017)
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
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 with a realised value of more than $1.5 billion. Most notably,
investor and/or Chair/Director of numerous healthcare companies with a realised value of more than $1.5 billion. Most notably,
Dr Brooke was the Managing Director and Founder of leading life sciences venture capital firm, GBS Ventures - one of Asia
Dr Brooke was the 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
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
the region and raised $450 million in venture and private equity funds, focused on biopharmaceuticals, medical devices and
services.
services.
Dr Brooke was also responsible for numerous investments and exits via NASDAQ and ASX public listings and trade sales, as
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
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
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
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,
manufacturer, Johnson & Johnson. Medvest was focused on founding companies based upon healthcare-related technology,
including pharmaceuticals, biotechnology, therapeutic devices, medical services and information systems.
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
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
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.
(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:
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 Director of Acrux Limited (ASX:ACR) – Current
Non-Executive Chair of Cynata Therapeutics Limited (ASX:CYP) – Current
Non-Executive Chair of Cynata Therapeutics Limited (ASX:CYP) –
Current.
Dr Steven Gourlay
Dr Steven Gourlay
MBBS FRACP PhD MBA
MBBS FRACP PhD MBA
Managing Director (appointed 24 March 2021)
Managing Director (appointed 24 March 2021)
Chief Executive Officer (appointed 15 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
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.
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
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,
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
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
successful NASDAQ IPO of Principia Biopharma Inc. in 2018 - subsequently followed by an acquisition by Sanofi for US$3.7
billion in 2020.
billion in 2020.
clinical development.
clinical development.
Prior to Principia Biopharma, Dr Gourlay was a Partner at GBS Venture Partners, the Australian specialist life sciences and
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
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,
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
San Francisco, he held positions of increasing responsibility at Genentech, Inc. in the areas of pharmacoepidemiology and early
Dr Gourlay has significant drug regulatory experience with the US Food and Drug Administration (FDA), European Medicines
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
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.
orphan drug status approvals for his Company's product(s), and completing several biologics license applications.
Dr Gourlay is based in Sydney and holds a Bachelor of Medicine, Bachelor of Surgery (MB,BS) from the University of
Dr Gourlay is based in Sydney and holds a Bachelor of Medicine, Bachelor of Surgery (MB,BS) from the University of
Melbourne, a PhD in Medicine from Monash University, an MBA from Macquarie University and is a fellow of the Royal
Melbourne, a PhD in Medicine from Monash University, an MBA from Macquarie University and is a fellow of the Royal
Australian College of Physicians (FRACP). He is also a specialist physician in general internal medicine.
Australian College of Physicians (FRACP). He is also a specialist physician in general internal medicine.
Dr Gourlay has held no other ASX-listed directorships during the past three years.
Dr Gourlay has held no other ASX-listed directorships during the past three years.
Board of Directors (continued)
Dr George Morstyn
Dr George Morstyn
MBBS FRACP PhD FTSE
MBBS FRACP PhD FTSE
Non-Executive Director (appointed 1 December 2017)
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
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
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
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.
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
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
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.
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.
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,
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
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
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
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
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.
Technological Sciences and Engineering.
Dr Morstyn has held no other ASX-listed directorships during the past three years.
Dr Morstyn has held no other ASX-listed directorships during the past three years.
Mr Malcolm McComas
Mr Malcolm McComas
BEc, LLB (Monash), SFFin, FAIDC
BEc, LLB (Monash), SFFin, FAIDC
Non-Executive Director (appointed 4 April 2019)
Non-Executive Director (appointed 4 April 2019)
Mr McComas is a company director with experience in healthcare including drug development, clinical trials, the regulatory
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
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,
services covering mergers and acquisitions, debt and equity funding across multiple industry sectors including healthcare,
FMCG, resources, financial services and privatisations.
FMCG, resources, financial services and privatisations.
Mr McComas has held leadership roles with Grant Samuel as Director, County NatWest (now Citigroup) as Managing Director
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
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
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
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
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).
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:
During the past three years Mr McComas has served as a Director of the following ASX-listed companies:
•
•
•
•
•
•
Chair of Pharmaxis Limited (ASX:PXS) – Current
Chair of Pharmaxis Limited (ASX:PXS) – Current
Chair of Fitzroy River Corporation Limited (ASX:FZR) – Current
Chair of Fitzroy River Corporation Limited (ASX:FZR) – Current
Non-Executive Director of Core Lithium Limited (ASX:CXO) – Current
Non-Executive Director of Core Lithium Limited (ASX:CXO) –
Current.
Dr Nicki Vasquez (appointed 1 March 2023)
Dr Nicki Vasquez (appointed 1 March 2023)
PhD
PhD
Non-Executive Director (appointed 1 March 2023)
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
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 is currently Chief Portfolio
25 years of biopharmaceutical discovery research and development experience. Dr Vasquez is currently Chief Portfolio
Strategy & Alliance Officer at Sutro Biopharma, a clinical stage oncology company in San Francisco where she is responsible
Strategy & Alliance Officer at Sutro Biopharma, a clinical stage oncology company in San Francisco where she is responsible
for program management, portfolio strategy, and alliance management.
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
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
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
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
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
research, to Vice President Research Operations & Program Management, and Vice President Development Program & Portfolio
Management.
Management.
Dr. Vasquez obtained her doctoral degree in immunology. Dr Vasquez is US-based and strengthens the Actinogen Board with
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
skills and experience in partnering and alliance management, strategic licensing, as well as a strong depth of knowledge in
clinical development. Dr Vasquez has held no other ASX-listed directorships during the past three years.
clinical development. Dr Vasquez has held no other ASX-listed directorships during the past three years.
1818 Actinogen Medical Limited
18 Actinogen Medical Limited
Actinogen Medical Limited
1919
Annual Financial Report
Annual Financial Report 19
Annual Financial Report 19
Annual Financial Report
Executive Leadership Team
Dr Steven Gourlay
MBBS FRACP PhD MBA
Chief Executive Officer (appointed 15 March 2021)
See biography on page 18.
Mr Jeff Carter
Chief Financial Officer
Mr Carter joined Actinogen in September 2020 and has more than 30 years of expertise in professional accounting, investment
banking, corporate finance and commercial / strategic planning roles. He has international experience as Vice President –
Corporate Development and served as a member of the board of a USA based company.
Since the beginning of 2000 Mr Carter has served as Chief Financial Officer and Company Secretary of several publicly listed
healthcare and biotech companies. Prior to his move into the healthcare sector he also held senior positions with Coca Cola
Amatil, Santos, Canadian Imperial Bank of Commerce and Touche Ross.
Mr Carter holds a Bachelor of Financial Administration (UNE) and a Masters of Applied Finance (Macquarie University) and is a
qualified Chartered Accountant.
Ms Tamara Miller
Senior Vice President - Product Development
Ms Miller joined Actinogen in September 2017 and has over 20 years of international clinical operations and product
development experience. Ms Miller holds a Masters and a Bachelor’s Degree in Biomedical Sciences, as well as a Diploma of
Business and Project Management Professional (PMP) certification.
Ms Miller has lived and worked in Australia, the UK, and the US while holding senior positions in product development, clinical
operations, and project management. Her background includes positions within pharmaceutical and biotechnology companies
as well as for CROs, working across a multitude of therapeutic areas, managing all aspects of the drug development life cycle,
and leading cross-functional teams.
As part of the Actinogen team, Ms Miller oversees and manages the overall drug development process and strategy including
pre-clinical, clinical development, clinical operations, CMC & manufacturing, regulatory operations, and R&D budget/finance
operations.
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.
20
20 Actinogen Medical Limited
Actinogen Medical Limited
Executive Leadership Team
Dr Steven Gourlay
MBBS FRACP PhD MBA
Chief Executive Officer (appointed 15 March 2021)
See biography on page 18.
Mr Jeff Carter
Chief Financial Officer
Mr Carter joined Actinogen in September 2020 and has more than 30 years of expertise in professional accounting, investment
banking, corporate finance and commercial / strategic planning roles. He has international experience as Vice President –
Corporate Development and served as a member of the board of a USA based company.
Since the beginning of 2000 Mr Carter has served as Chief Financial Officer and Company Secretary of several publicly listed
healthcare and biotech companies. Prior to his move into the healthcare sector he also held senior positions with Coca Cola
Amatil, Santos, Canadian Imperial Bank of Commerce and Touche Ross.
Mr Carter holds a Bachelor of Financial Administration (UNE) and a Masters of Applied Finance (Macquarie University) and is a
qualified Chartered Accountant.
Ms Tamara Miller
Senior Vice President - Product Development
Ms Miller joined Actinogen in September 2017 and has over 20 years of international clinical operations and product
development experience. Ms Miller holds a Masters and a Bachelor’s Degree in Biomedical Sciences, as well as a Diploma of
Business and Project Management Professional (PMP) certification.
Ms Miller has lived and worked in Australia, the UK, and the US while holding senior positions in product development, clinical
operations, and project management. Her background includes positions within pharmaceutical and biotechnology companies
as well as for CROs, working across a multitude of therapeutic areas, managing all aspects of the drug development life cycle,
and leading cross-functional teams.
As part of the Actinogen team, Ms Miller oversees and manages the overall drug development process and strategy including
pre-clinical, clinical development, clinical operations, CMC & manufacturing, regulatory operations, and R&D budget/finance
operations.
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.
20 Actinogen Medical Limited
Executive Leadership Team (continued)
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.
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.
21
Annual Financial Report 21
Annual Financial Report
Directors’ Report
Your Directors present their report pertaining to Actinogen Medical Limited
(‘Actinogen Medical’ or ‘the Company’) for the year ended 30 June 2023.
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
Dr Geoffrey Brooke
Non-Executive Chairman
Appointed
1/03/2017
Dr Steven Gourlay
Managing Director / Chief Executive Officer
24/03/2021
Dr George Morstyn
Non-Executive Director
Mr Malcolm McComas
Non-Executive Director
Dr Nicki Vasquez
Non-Executive Director
1/12/2017
4/04/2019
1/03/2023
Resigned
Current
Current
Current
Current
Current
Details of Directors qualifications and experience are set out on pages 18 to 19 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
Dr Geoffrey Brooke
Dr Steven Gourlay
Dr George Morstyn
Mr Malcolm McComas
Dr Nicki Vasquez
Total
Fully paid
ordinary shares
2,152,223
18,547,222
4,512,223
822,223
-
Loan shares
(a)
2,500,000
48,362,300
1,000,000
1,000,000
-
Unlisted
options
9,900,000
-
1,500,000
3,000,000
-
26,033,891
52,862,300
14,400,000
(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
Dr Geoffrey Brooke
Dr Steven Gourlay
Dr George Morstyn
Mr Malcolm McComas
Dr Nicki Vasquez
Number of meetings
available to attend
Number of meetings
attended
8
8
8
8
3
8
8
8
8
3
Due to size and scale of the Company, there are no Remuneration, Risk, or Nomination Committees at present. Matters
typically dealt with by these Committees are, for the time being, referred to the Board of Directors. During the prior year, the
Board established an Audit Committee, and in line with best practice corporate governance, the committee comprises
independent non-executive directors.
Audit Committee
Mr Malcolm McComas
Dr Geoffrey Brooke
Dr George Morstyn
22
22
Annual Financial Report
Number of meetings
available to attend
Number of meetings
attended
3
3
3
3
3
3
Actinogen Medical Limited
Directors’ Report
The Audit 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 29 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 the date of this Report, there were 26,700,000 unissued ordinary shares under option:
Quantity
Type of Option
6,400,000
Director Options
5,700,000
Employee Options
5,000,000
Employee Options
3,000,000
Director Options
5,000,000
Director Options
1,600,000
Employee Options
Grant Date
Exercise Price
Expiry Date
28/11/2018
12/12/2018
1/02/2019
4/04/2019
24/03/2017
28/09/2020
$0.085
$0.085
$0.093
$0.100
$0.100
$0.046
27/11/2023
12/12/2023
1/02/2024
4/04/2024
24/03/2025
27/09/2025
26,700,000 Total unissued ordinary shares under option
For further information refer to the Remuneration Report and Note 14(c) Contributed Equity.
(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
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.
26,033,891
52,862,300
14,400,000
6. DIVIDENDS
7. EVENTS SUBSEQUENT TO THE END OF FINANCIAL YEAR
On 2 August 2023 the Company announced a Rights Issue to all eligible shareholders to raise approximately $10 million (before
costs) and issue of approximately 400 million new shares and approximately 200 million new unlisted options The closing date
is 4 September 2023. The non renounceable offer is as follows:
1. One new share for every 4.54 shares held at an issue price of $0.025 (2.5 cents) per new share; and
2. One free unlisted option for every two new shares issued under the offer. The new unlisted options have an exercise
price of $0.0375 (3.75 cents) each and have an expiry date of 36 months after the issue date.
Other than the above, 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.
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.
9. OPERATING AND FINANCIAL REVIEW
Please refer to pages 12 to 17 of this annual report for information on the Company's principal activities, operations,
financial position, material risks and business strategy and outlook, and pages 10 and 11 for a summary of the Company’s vision
and strategy.
10. BUSINESS STRATEGY & OUTLOOK
Please refer to pages 16 to 17 of this annual report for information on the Company's business strategy and outlook. Please
also refer to pages 10 and 11 for a summary of the Company's vision and strategy.
23
Annual Financial Report 23
Your Directors present their report pertaining to Actinogen Medical Limited
(‘Actinogen Medical’ or ‘the Company’) for the year ended 30 June 2023.
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.
Dr Steven Gourlay
Managing Director / Chief Executive Officer
24/03/2021
Name
Position
Dr Geoffrey Brooke
Non-Executive Chairman
Dr George Morstyn
Non-Executive Director
Mr Malcolm McComas
Non-Executive Director
Dr Nicki Vasquez
Non-Executive Director
Appointed
1/03/2017
1/12/2017
4/04/2019
1/03/2023
Resigned
Current
Current
Current
Current
Current
Details of Directors qualifications and experience are set out on pages 18 to 19 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:
Fully paid
ordinary shares
2,152,223
18,547,222
4,512,223
822,223
-
Loan shares
(a)
2,500,000
48,362,300
1,000,000
1,000,000
-
Unlisted
options
9,900,000
1,500,000
3,000,000
-
-
Report for information on these loan shares.
2. DIRECTORS’ MEETINGS
number of meetings attended by each Director.
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
available to attend
Number of meetings
attended
Due to size and scale of the Company, there are no Remuneration, Risk, or Nomination Committees at present. Matters
typically dealt with by these Committees are, for the time being, referred to the Board of Directors. During the prior year, the
Board established an Audit Committee, and in line with best practice corporate governance, the committee comprises
independent non-executive directors.
Number of meetings
available to attend
Number of meetings
attended
8
8
8
8
3
3
3
3
8
8
8
8
3
3
3
3
Director
Dr Geoffrey Brooke
Dr Steven Gourlay
Dr George Morstyn
Mr Malcolm McComas
Dr Nicki Vasquez
Total
Board of Directors
Dr Geoffrey Brooke
Dr Steven Gourlay
Dr George Morstyn
Mr Malcolm McComas
Dr Nicki Vasquez
Audit Committee
Mr Malcolm McComas
Dr Geoffrey Brooke
Dr George Morstyn
Annual Financial Report
22
Annual Financial Report
Directors’ Report (continued)
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
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 FY23
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.
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
Dr Geoffrey Brooke
Dr Steven Gourlay
Dr George Morstyn
Position
Non-Executive Chairman
Managing Director / Chief Executive Officer
Non-Executive Director
Mr Malcolm McComas
Non-Executive Director
Dr Nicki Vasquez
Ms Tamara Miller
Mr Jeff Carter
Prof Paul Rolan
Dr Dana Hilt
Non-Executive Director
Senior Vice President - Product Development
Chief Financial Officer
Chief Medical Officer
Chief Medical Officer
Current / Resigned
Current
Current
Current
Current
Current
Current
Current
Resigned
Current
There were no other changes to KMP after the reporting date and before the date that the financial report was authorised for
issue. All KMP's in the abovementioned table were KMPs for the full year, except for Dr Nicki Vasquez who was appointed as a
Non-Executive Director on 1 March 2023, Dr Dana Hilt who was appointed as Chief Medical Officer on 1 February 2023, and
Professor Rolan who ceased as Chief Medical Officer on 1 February 2023 and has continued on providing pharmacology
consulting services to the Company.
Remuneration Report (Audited) (continued)
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 16 November 2022, Actinogen Medical received 94.89% of votes in favour
of its Remuneration Report for the 2022 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
•
•
•
•
executives and the general pay environment.
(B) Elements of remuneration
fair and responsible rewards to executives having regard to the performance of the Company, the performance of the
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
employees).
Long-term incentive (LTI) component
The STI component is in the form of a cash bonus to executives of the Company (bonuses are also applicable to selected
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.
2424
Actinogen Medical Limited
24 Actinogen Medical Limited
Annual Financial Report 25
Actinogen Medical Limited Directors’ Report (continued)
Directors’ Report (continued)
Remuneration Report (Audited)
Remuneration Report (Audited)
11. REMUNERATION REPORT
11. REMUNERATION REPORT
The information contained in the Remuneration Report has been audited, as required by Section 308(3C) of the Corporations
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:
Act 2001. The Remuneration Report is set out under the following main headings:
11.1
11.1
Introduction
Introduction
11.2
11.2
Remuneration governance
Remuneration governance
11.3
11.3
Remuneration arrangements
Remuneration arrangements
A. Remuneration principles and structures
A. Remuneration principles and structures
B. Elements of remuneration
B. Elements of remuneration
11.5
11.5
Executive employment agreements
Executive employment agreements
11.6
11.6 Non-Executive Director fee arrangements
Non-Executive Director fee arrangements
11.7
11.7
Disclosures relating to options
Disclosures relating to options
11.8
11.8 Disclosures relating to shares
Disclosures relating to shares
C. Details of short-term incentive and long-term incentive plans that existed during FY23
C. Details of short-term incentive and long-term incentive plans that existed during FY23
11.4
11.4
Key Management Personnel remuneration outcomes and performance during the financial year
Key Management Personnel remuneration outcomes and performance during the financial year
11.9
11.9
Loans to Key Management Personnel and their related parties
Loans to Key Management Personnel and their related parties
11.10 Other transactions & balances with 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
11.11 Consequences of performance on shareholder’s wealth.
11.1
11.1
INTRODUCTION
INTRODUCTION
The Remuneration Report details the remuneration arrangements for Key Management Personnel (KMP) who are defined as
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
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
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.
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
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
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:
people considered to be KMP during the financial year were:
Name
Name
Dr Geoffrey Brooke
Dr Geoffrey Brooke
Dr Steven Gourlay
Dr Steven Gourlay
Dr George Morstyn
Dr George Morstyn
Dr Nicki Vasquez
Dr Nicki Vasquez
Ms Tamara Miller
Ms Tamara Miller
Mr Jeff Carter
Mr Jeff Carter
Prof Paul Rolan
Prof Paul Rolan
Dr Dana Hilt
Dr Dana Hilt
Position
Position
Non-Executive Chairman
Non-Executive Chairman
Managing Director / Chief Executive Officer
Managing Director / Chief Executive Officer
Non-Executive Director
Non-Executive Director
Non-Executive Director
Non-Executive Director
Senior Vice President - Product Development
Senior Vice President - Product Development
Chief Financial Officer
Chief Financial Officer
Chief Medical Officer
Chief Medical Officer
Chief Medical Officer
Chief Medical Officer
Current / Resigned
Current / Resigned
Current
Current
Current
Current
Current
Current
Current
Current
Current
Current
Current
Current
Current
Current
Resigned
Resigned
Current
Current
There were no other changes to KMP after the reporting date and before the date that the financial report was authorised for
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 Dr Nicki Vasquez who was appointed as a
issue. All KMP's in the abovementioned table were KMPs for the full year, except for Dr Nicki Vasquez who was appointed as a
Non-Executive Director on 1 March 2023, Dr Dana Hilt who was appointed as Chief Medical Officer on 1 February 2023, and
Non-Executive Director on 1 March 2023, Dr Dana Hilt who was appointed as Chief Medical Officer on 1 February 2023, and
Professor Rolan who ceased as Chief Medical Officer on 1 February 2023 and has continued on providing pharmacology
Professor Rolan who ceased as Chief Medical Officer on 1 February 2023 and has continued on providing pharmacology
consulting services to the Company.
consulting services to the Company.
Remuneration Report (Audited) (continued)
11.2 REMUNERATION GOVERNANCE
11.2 REMUNERATION GOVERNANCE
The Board has not established a separate Remuneration Committee at this point in the Company’s development nor has the
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
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
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 16 November 2022, Actinogen Medical received 94.89% of votes in favour
Annual General Meeting (AGM). At the AGM held on 16 November 2022, Actinogen Medical received 94.89% of votes in favour
of its Remuneration Report for the 2022 financial year. The Company did not receive any specific feedback at the AGM or
of its Remuneration Report for the 2022 financial year. The Company did not receive any specific feedback at the AGM or
throughout the year on its remuneration practices.
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
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
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
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
related party transactions. Refer to the Corporate Governance Statement located on the Company’s website for further
information.
information.
11.3 REMUNERATION ARRANGEMENTS
11.3 REMUNERATION ARRANGEMENTS
(A) Remuneration principles and structures
(A) Remuneration principles and structures
The Company aims to reward executives with a level and mix of remuneration commensurate with their position and
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
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
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.
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:
The main objectives sought when reviewing executive remuneration is that the Company has:
•
•
•
•
•
•
•
•
coherent remuneration policies and practices to attract and retain executives
coherent remuneration policies and practices to attract and retain executives
executives who will create value for shareholders
executives who will create value for shareholders
competitive remuneration offered benchmarked against the external market
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
fair and responsible rewards to executives having regard to the performance of the Company, the performance of the
executives and the general pay environment.
executives and the general pay environment.
(B) Elements of remuneration
(B) Elements of remuneration
The Company aims to reward executives with a level and mix of remuneration appropriate to their position and responsibilities,
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,
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.
short term incentives and long-term incentives as outlined below.
Fixed remuneration component
Fixed remuneration component
Fixed remuneration is represented by total employment cost and comprises base salary, statutory superannuation
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
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
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
considering market data and the performance of the Company against appropriate market comparisons with the comparator
group criteria being market capitalisation.
group criteria being market capitalisation.
Short-term incentive (STI) component
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
The STI component is in the form of a cash bonus to executives of the Company (bonuses are also applicable to selected
employees).
employees).
Mr Malcolm McComas
Mr Malcolm McComas
Non-Executive Director
Non-Executive Director
Long-term incentive (LTI) component
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
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.
with those of the shareholders to maximise shareholder wealth.
24
24 Actinogen Medical Limited
24 Actinogen Medical Limited
Actinogen Medical Limited
Annual Financial Report 2525
Annual Financial Report 25
Annual Financial Report 25
Annual Financial Report Directors’ Report (continued)
Remuneration Report (Audited) (continued)
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?
How is
performance
measured?
The majority of employees have a maximum STI
opportunity of 20% of fixed remuneration. Ms Tamara
Miller (Senior Vice President of Product Development)
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.
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
What happens if
an executive
leaves?
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.
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.
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.
26
26 Actinogen Medical Limited
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.
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.
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.
Actinogen Medical Limited
Directors’ Report (continued)
Remuneration Report (Audited) (continued)
Details of how the STI and LTI is structured is outlined in the table below.
Remuneration Report (Audited) (continued)
11.3
REMUNERATION ARRANGEMENTS (CONTINUED)
(C) Details of short-term incentive and long-term incentive plans that existed during FY23
During the financial year ended 30 June 2023, the Board of Directors had in place various Short-term Incentives and Long-
term Incentives which are outlined below.
Short-Term Incentive (STI)
Long-Term Incentive (LTI)
(a) Short-term Incentives
How is it paid?
Up to 100% of any STI award is paid as a cash bonus
The LTI component is in the form of employee
after the assessment of annual performance and
and Director options and/or loan shares upon
achievement of business goals.
payment of a pre-determined exercise price.
How much can
The majority of employees have a maximum STI
The LTI opportunity is at the discretion of the
executives
opportunity of 20% of fixed remuneration. Ms Tamara
Board. The value of options and/or loan shares
earn?
Miller (Senior Vice President of Product Development)
granted is determined using the fair value at the
and Dr Dana Hilt (Chief Medical Officer) have a
date of grant using a Black Scholes option
maximum STI opportunity of 25% of fixed remuneration.
pricing model, taking into account the terms
Dr Steve Gourlay (Managing Director/CEO) has a
and conditions upon which the options and/or
maximum STI opportunity of 35% of fixed remuneration.
loan shares were granted.
How is
STI awards are determined based the achievement of
LTI's vest according to vesting conditions set at
performance
annual Key Performance Indicator’s (“KPI’s”) and
the date of grant. The performance measures
measured?
individual performance. KPI’s and their relative
are tested at the end of each reporting period
weightings for staff other than the CEO are suggested
where it is determined how many options
by the Executive Leadership Team to the Board for
and/or loan shares have vested according to
approval. KPIs for the CEO are set by the Board. A
the vesting conditions set. Options and/or loan
semi-annual review is conducted with the Board and
shares may lapse if the performance measures
amendments or additions to KPIs are made where
are not met at the end of the performance
appropriate and necessary. KPI’s can include, but are
period.
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.
When is it paid? The STI award is determined after the end of the
Non-cash payment is in the form of vested
financial year following a review of performance over
options and/or loan shares subject to vesting
the year against the STI performance measures by the
conditions being achieved and the terms and
Board (and in the case of the CEO, by the Non-
conditions upon which the options and/or loan
Executive Directors). The Board approves the final STI
shares were granted.
award based on this assessment of performance.
What happens if
If an executive ceases employment during the
If an executive resigns or is terminated for
an executive
performance period by reason of redundancy, ill health,
cause, any unvested LTI awards are forfeited,
leaves?
death, or other circumstances approved by the Board,
unless otherwise determined by the Board. If an
then subject to Board discretion, the executive may be
executive ceases employment during the
entitled to a pro-rata cash payment based on
performance period by reason of redundancy, ill
assessment of performance up to the date of ceasing
health, death, or other circumstances approved
employment for that year.
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
In the event of a change of control, a pro-rata cash
In the event of a change of control, a pro-rata
payment may be made based on assessment of
assessment may be made up to the date of the
performance up to the date of the change of control, at
change of control. Further, under the terms and
there is a
change of
control?
the Board’s discretion.
conditions of the options and/or loan shares any
unvested awards may vest on a change of
control.
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 and regulatory plan. During the 2022 and the 2023 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 $100,131 bonus in connection with performance conditions met and accrued for in the 2022
financial year. A bonus of $63,677, representing 46% of the maximum bonus potential set for Dr Gourlay, has been
accrued for at 30 June 2023 in connection with performance conditions met during the 2023 financial year. This bonus
will be paid during the quarter-end 30 September 2023. Of Dr Gourlay's performance conditions set during the year, 54%
were not met and subsequently forfeited.
• Ms Tamara Miller was paid a $76,250 bonus in connection with performance conditions met and accrued for in the 2022
financial year. A bonus of $60,619, representing 80% of the maximum bonus potential set for Ms Miller, has been accrued
for at 30 June 2023 in connection with performance conditions met during the 2023 financial year. This bonus will be paid
during the quarter-end 30 September 2023. Of Ms Miller's performance conditions set during the year, 20% 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
(i)
(ii)
(iii)
Employee Options
Director Options
5,600,000
14,400,000
Total Options on issue
20,000,000
Loan Shares
76,362,300
6,700,000
-
6,700,000
18,650,000
Total Loan Shares on issue
76,362,300
18,650,000
Total LTIs on issue
96,362,300
25,350,000
Total
12,300,000
14,400,000
26,700,000
95,012,300
95,012,300
121,712,300
(i) Employee Options
During the year, the following KMP held the following options issued under the Employee Option Plan. Specific details, vesting
conditions and a summary of terms and conditions are outlined below:
Employee Options
Employee
Grant Date
Quantity
Exercise Price
Expiry Date
Vesting Conditions:
Tamara Miller
Jeff Carter
12/12/2018
28/09/2020
4,000,000
1,600,000
$0.085
$0.046
12/12/2023
27/09/2025
• Ms Tamara Miller - 4,000,000 options vest quarterly over a period of 3 years from Grant Date, subject to continuous
employment with the Company during the period from the date of grant up to and including the applicable vesting dates.
As at 30 June 2022, these options were fully vested.
• Mr Jeff Carter - 1,600,000 options issued had one-third vest 12 months from grant date with the balance to vest quarterly
over a period of 24 months thereafter. As at 30 June 2023, 1,466,664 have fully vested and 133,336 remain unvested.
Vesting is subject to continuous service to the Company during the period from the date of grant up to and including the
applicable vesting dates.
•
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.
26 Actinogen Medical Limited
27
Annual Financial Report 27
Annual Financial Report
Directors’ Report (continued)
Remuneration Report (Audited) (continued)
Summary Terms & Conditions:
• 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.
•
•
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 2023. 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
Grant Date
Quantity
Exercise Price
Expiry Date
Vesting Conditions:
Geoff Brooke
Geoff Brooke
George Morstyn Malcolm McComas
28/11/2018
24/03/2017
28/11/2018
4,900,000
5,000,000
1,500,000
$0.085
$0.100
$0.085
4/04/2019
3,000,000
$0.100
27/11/2023
24/03/2025
27/11/2023
4/04/2024
As at 30 June 2023, all Director Options outlined above are fully vested. These 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. During the year, Dr Morstyn
exercised 1,500,000 options exercisable at $0.10 each on or before 1 December 2022. 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 2023, 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
Director
Steven Gourlay
Steven Gourlay
Geoff Brooke
George Morstyn Malcolm McComas
Grant Date
Quantity
15/03/2021
15/03/2021
24,181,150
24,181,150
Exercise Price
$0.035
$0.045
18/11/2021
2,500,000
$0.20
18/11/2021
18/11/2021
1,000,000
1,000,000
$0.20
$0.20
Expiry Date
15/03/2026
15/03/2026
18/11/2026
18/11/2026
18/11/2026
28
28 Actinogen Medical Limited
Actinogen Medical Limited
(ii) Director Options
Director Options
Director
Grant Date
Quantity
Exercise Price
Expiry Date
Vesting Conditions:
•
•
•
•
•
Directors’ Report (continued)
Remuneration Report (Audited) (continued)
Summary Terms & Conditions:
discretion of the Board.
• 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
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.
There were no Director Options issued to current Directors during the financial year ended 30 June 2023. 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:
Geoff Brooke
Geoff Brooke
George Morstyn Malcolm McComas
28/11/2018
24/03/2017
28/11/2018
4,900,000
5,000,000
1,500,000
$0.085
$0.100
$0.085
4/04/2019
3,000,000
$0.100
27/11/2023
24/03/2025
27/11/2023
4/04/2024
As at 30 June 2023, all Director Options outlined above are fully vested. These 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. During the year, Dr Morstyn
exercised 1,500,000 options exercisable at $0.10 each on or before 1 December 2022. 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.
As at 30 June 2023, 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
(iii) Loan Shares
outlined below:
Loan Shares
Director
Steven Gourlay
Steven Gourlay
Geoff Brooke
George Morstyn Malcolm McComas
Grant Date
Quantity
15/03/2021
15/03/2021
24,181,150
24,181,150
Exercise Price
$0.035
$0.045
18/11/2021
2,500,000
$0.20
18/11/2021
18/11/2021
1,000,000
1,000,000
$0.20
$0.20
Expiry Date
15/03/2026
15/03/2026
18/11/2026
18/11/2026
18/11/2026
Remuneration Report (Audited) (continued)
11.3
REMUNERATION ARRANGEMENTS (CONTINUED)
(iii) Loan Shares (continued)
Loan Shares
Other KMP
Grant Date
Quantity
Tamara Miller
Tamara Miller
Jeff Carter
Paul Rolan
Dana Hilt
16/09/2021
24/05/2022
16/09/2021
24/05/2022
20/03/2023
5,000,000
5,000,000
500,000
3,000,000
10,000,000
Exercise Price
$0.110
$0.088
$0.110
$0.088
$0.085
Expiry Date
16/09/2026
24/05/2027
16/09/2026
24/05/2027
19/03/2028
Vesting conditions:
Loan Shares were issued with vesting conditions attached whereby 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.
Non-Executive Directors and Dr Dana Hilt:
•
Loan Shares to vest over 3 years, with 1/3 vesting after 12 months from Grant Date and the and the remainder to vest in
equal quarterly increments over the remaining 24 months.
Dr Steven Gourlay:
•
Loan Shares to vest over 3 years, with 1/4 vesting after 12 months from Grant Date and the and the remainder to vest in
equal monthly increments over the remaining 24 months.
Ms Tamara Miller, Mr Jeff Carter and Professor Paul Rolan:
•
Loan Shares to vest over 3 years, with 1/4 vesting after 12 months from Grant Date and the and the remainder to vest in
equal monthly increments over the remaining 24 months.
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 will be interest free, provided that if the loan is not repaid by the repayment date set by the Board, the loan will
incur interest at a default interest rate per annum after that date which will accrue on a daily basis and compounds
annually on the then outstanding loan balance.
by signing and returning a limited recourse loan application, the participant of the Plan acknowledges and agrees that the
Loan Shares will not be transferred, encumbered, otherwise disposed of, or have a security interest granted over it, by or
on behalf of the Participant until the loan is repaid in full to the Company.
the Company has security over the Loan Shares as security for repayment of the loan;
the Outstanding Loan Balance becomes due and payable (unless extended by the Company in its absolute discretion) on
the first to occur of the following:
(a) 90 days after the Continuous Employment (or other permitted engagement) of the Participant ceases for any reason,
(b) by the legal personal representative of the Participant, 120 days after the Participant ceases to be an employee,
officer or director of the Company due to their death, and
(c) the Repayment Date: which is 5 years from the date on which the Company advances the Loan to the Participant.
11.4 KEY MANAGEMENT PERSONNEL REMUNERATION OUTCOMES AND PERFORMANCE
DURING THE FINANCIAL YEAR
During the financial years ended 30 June 2023 and 30 June 2022 (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, post-employment
benefits, other long-term benefits, and share-based payments. All remuneration has been valued at the cost to the Company
and expensed.
28 Actinogen Medical Limited
29
Annual Financial Report 29
Annual Financial Report
Directors’ Report (continued)
Remuneration Report (Audited) (continued)
Table 1: Remuneration of KMP for the year ended 30 June 2023
Key Management
Personnel
Short-term
benefits
Terminatio
n
benefits
Post-
employment
Long-term
benefits
Share-based
payments
Year ended
30 June 2023
Cash,
salary
and fees
$
Cash
Bonus
$ (d)
Terminatio
n
payments
$
Super-
annuation
$
Accrued
leave
benefits
$
Loan shares
& Options
$
Percentage of Total
Total
$
SBP-
related
Perfor-
mance-
related
Geoffrey Brooke (a)
100,877
-
Steven Gourlay
395,508
63,677
George Morstyn (a)
66,276
Malcolm McComas (a)
66,276
Nicki Vasquez (a)(b)
22,092
-
-
-
Tamara Miller
305,000
60,619
Jeff Carter
Paul Rolan (c)
Dana Hilt (c)
130,320
55,500
153,970
-
-
-
Total KMP (e)
1,295,819
124,296
-
-
-
-
-
-
-
-
-
-
54%
31%
44%
44%
10,592
-
130,140
241,609
25,292
29,963
142,448
656,888
54%
22%
-
-
-
-
-
-
52,056
118,332
44%
52,056
118,332
44%
-
22,092
-
-
25,292
23,106
281,377
695,394
40%
-
-
-
-
13,627
143,947
97,032
152,532
10,367
10,583
92,888
267,808
71,543
63,652
861,624 2,416,934
9%
64%
35%
49%
9%
64%
35%
(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.
Table 2: Remuneration of KMP for the year ended 30 June 2022
Key Management
Personnel
Short-term
benefits
Termination
benefits
Post-
employment
Long-term
benefits
Share-based
payments
Year ended
30 June 2022
Cash,
salary
and fees
$
Cash
Bonus
$ (c)
Termination
payments
$
Super-
annuation
$
Accrued
leave
benefits
$
Loan shares
& Options
$
Percentage of Total
Total
$
SBP-
related
Perfor-
mance-
related
Geoffrey Brooke (a)
95,890
-
Steven Gourlay
376,432
100,131
George Morstyn (a)
63,000
Malcolm McComas (a)
63,000
-
-
Tamara Miller
284,825
76,250
Jeff Carter
Paul Rolan (b)
112,800
61,500
-
-
Total KMP (d)
1,057,447 176,381
-
-
-
-
-
-
-
-
9,589
-
134,337
239,816
56%
23,568
28,964
426,071
955,166
45%
-
-
-
-
52,646
115,646
46%
59,695
122,695
49%
23,568
21,916
192,597
599,156
32%
-
-
-
22,080
134,880
10,255
71,755
16%
14%
56,725
50,880
897,681 2,239,114
56%
55%
46%
49%
45%
16%
14%
(a) The total Non-Executive Director fees including superannuation during the year totalled $231,479.
(b) Professor Rolan was appointed as Chief Medical Officer on 15 February 2022.
(c) For further information on short-term incentive cash bonuses, refer to Section 11.3(C)(a).
(d) For detailed information of KMP employment arrangements, refer to Section 11.5 and Section 11.6 of the Remuneration
Report.
For detailed information of KMP employment arrangements, refer to Section 11.5 and Section 11.6 of the Remuneration Report.
30
30 Actinogen Medical Limited
Actinogen Medical Limited
Directors’ Report (continued)
Remuneration Report (Audited) (continued)
Table 1: Remuneration of KMP for the year ended 30 June 2023
Key Management
Personnel
Short-term
benefits
n
Post-
Long-term
Share-based
benefits
employment
benefits
payments
Percentage of Total
Terminatio
Year ended
30 June 2023
Cash,
salary
and fees
$
Cash
Bonus
$ (d)
Terminatio
Accrued
Super-
leave
Loan shares
payments
annuation
benefits
& Options
Total
SBP-
$
$
$
related
Geoffrey Brooke (a)
100,877
-
-
130,140
241,609
Steven Gourlay
395,508
63,677
25,292
29,963
142,448
656,888
52,056
118,332
44%
52,056
118,332
44%
-
22,092
-
-
Perfor-
mance-
related
54%
31%
44%
44%
49%
9%
64%
35%
54%
22%
9%
64%
35%
13,627
143,947
97,032
152,532
10,367
10,583
92,888
267,808
$
10,592
-
-
-
-
-
George Morstyn (a)
66,276
Malcolm McComas (a)
66,276
Nicki Vasquez (a)(b)
22,092
Jeff Carter
Paul Rolan (c)
Dana Hilt (c)
130,320
55,500
153,970
-
-
-
-
-
-
Tamara Miller
305,000
60,619
25,292
23,106
281,377
695,394
40%
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.
Personnel
Year ended
30 June 2022
Table 2: Remuneration of KMP for the year ended 30 June 2022
Key Management
Short-term
Termination
Post-
Long-term
Share-based
benefits
benefits
employment
benefits
payments
Percentage of Total
Cash,
salary
and fees
$
Bonus
$ (c)
Cash
Termination
Super-
leave
Loan shares
payments
annuation
benefits
& Options
Total
SBP-
Accrued
$
9,589
$
$
related
134,337
239,816
56%
Steven Gourlay
376,432
100,131
23,568
28,964
426,071
955,166
45%
-
-
-
-
52,646
115,646
46%
59,695
122,695
49%
22,080
134,880
10,255
71,755
16%
14%
Perfor-
mance-
related
56%
55%
46%
49%
45%
16%
14%
Geoffrey Brooke (a)
95,890
George Morstyn (a)
63,000
Malcolm McComas (a)
63,000
Jeff Carter
Paul Rolan (b)
112,800
61,500
-
-
-
-
-
-
-
-
-
-
$
-
-
-
-
Tamara Miller
284,825
76,250
23,568
21,916
192,597
599,156
32%
n
$
-
-
-
-
-
-
-
-
-
-
$
-
-
-
-
-
-
-
-
Total KMP (d)
1,057,447 176,381
56,725
50,880
897,681 2,239,114
(a) The total Non-Executive Director fees including superannuation during the year totalled $231,479.
(b) Professor Rolan was appointed as Chief Medical Officer on 15 February 2022.
(c) For further information on short-term incentive cash bonuses, refer to Section 11.3(C)(a).
(d) For detailed information of KMP employment arrangements, refer to Section 11.5 and Section 11.6 of the Remuneration
Report.
For detailed information of KMP employment arrangements, refer to Section 11.5 and Section 11.6 of the Remuneration Report.
Remuneration Report (Audited) (continued)
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 package: A total employment cost basis (inclusive of superannuation guarantee) of $420,800 with four
weeks annual leave entitlement. With effect from 1 July 2023, the total employment cost basis was increased to $439,736
(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.
Ms Tamara Miller – Senior Vice President – Product Development
• Commencement of employment: 21 September 2017
•
•
•
•
Remuneration package: During the year ended 30 June 2023, Ms Miller was on a total employment cost basis (inclusive of
superannuation guarantee) of $330,292 with four weeks annual leave entitlement. With effect from 1 July 2023, Ms
Miller’s total employment cost basis was increased to $346,124.
Included within the remuneration package is an STI scheme which is put in place by the Board of Directors for the
achievement of a number of various short-term performance conditions being met.
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 four weeks’ 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 Jeff Carter – Chief Financial Officer
• Commencement of consultancy: 21 September 2020
• During the year ended 30 June 2023, the standard base monthly amount for part time services was increased from
$9,400 to $12,320 per month (plus GST and are exclusive of superannuation) with effect from 1 January 2023.
•
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.
Professor Paul Rolan – Chief Medical Officer
• Commencement of consultancy: 15 February 2022. Ceased fulfilling this role on 1 February 2023
•
•
Remuneration package set at a daily rate of $1,500 (plus GST and exclusive of superannuation). These rates apply for 12
months and should the work continue, then these rates will be subject to Board review. The consultancy services will be
requested on an “as needs” basis, however, it is expected that consultancy services will be required for a maximum of
twelve days per month. Permission to exceed this level of service should be sought in advance.
Termination: The Company or Consultant may terminate the contract by giving seven 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.
Dr Dana Hilt – Chief Medical Officer
• Commencement of employment: 1 February 2023
•
•
Remuneration package: During the year ended 30 June 2023, Dr Hilt was on a total employment cost basis of USD
$220,000 per annum for working a 0.80 full-time equivalent role (plus statutory employment and healthcare contributions
and prorated 16 days annual leave entitlement).
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.
30 Actinogen Medical Limited
31
Annual Financial Report 31
Annual Financial Report
Directors’ Report (continued)
Remuneration Report (Audited) (continued)
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 $266,113.
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 $111,469 per annum (inclusive of superannuation guarantee plus GST) during the year. Subject to
annual review, it was determined that these fees increase to $117,012 per annum (inclusive of superannuation guarantee
plus GST) with effect from 1 July 2023.
Dr George Morstyn – Non-Executive Director - Appointed 1 December 2017
•
Director Fees set at $66,276 per annum (plus GST and exclusive of superannuation) since 1 January 2020. Subject to
annual review, it was determined that these fees increase to $69,258 per annum (plus GST and exclusive of
superannuation) with effect from 1 July 2023.
Mr. Malcolm McComas – Non-Executive Director- Appointed 4 April 2019
•
Director Fees set at $66,276 per annum (plus GST and exclusive of superannuation) since 1 January 2020. Subject to
annual review, it was determined that these fees increase to $69,258 per annum (plus GST and exclusive of
superannuation) with effect from 1 July 2023.
Dr Nicki Vasquez – Non-Executive Director- Appointed 1 March 2023
•
Director Fees set at $66,276 per annum. Dr Vasquez’s fees were prorated from commencement of appointment receiving
$22,092 during the year. In line with the annual review of Non-Executive Director Fees, it was determined that Dr
Vasquez’s fees increase to $69,258 per annum with effect from 1 July 2023. Dr Vasquez is US-based therefore GST and
superannuation are not applicable.
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.
3232
Actinogen Medical Limited
32 Actinogen Medical Limited
Actinogen Medical Limited 3
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Directors’ Report (continued)
Remuneration Report (Audited) (continued)
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 $266,113.
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 $111,469 per annum (inclusive of superannuation guarantee plus GST) during the year. Subject to
annual review, it was determined that these fees increase to $117,012 per annum (inclusive of superannuation guarantee
plus GST) with effect from 1 July 2023.
Dr George Morstyn – Non-Executive Director - Appointed 1 December 2017
•
Director Fees set at $66,276 per annum (plus GST and exclusive of superannuation) since 1 January 2020. Subject to
annual review, it was determined that these fees increase to $69,258 per annum (plus GST and exclusive of
superannuation) with effect from 1 July 2023.
Mr. Malcolm McComas – Non-Executive Director- Appointed 4 April 2019
•
Director Fees set at $66,276 per annum (plus GST and exclusive of superannuation) since 1 January 2020. Subject to
annual review, it was determined that these fees increase to $69,258 per annum (plus GST and exclusive of
superannuation) with effect from 1 July 2023.
Dr Nicki Vasquez – Non-Executive Director- Appointed 1 March 2023
•
Director Fees set at $66,276 per annum. Dr Vasquez’s fees were prorated from commencement of appointment receiving
$22,092 during the year. In line with the annual review of Non-Executive Director Fees, it was determined that Dr
Vasquez’s fees increase to $69,258 per annum with effect from 1 July 2023. Dr Vasquez is US-based therefore GST and
superannuation are not applicable.
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.
32
32 Actinogen Medical Limited
Actinogen Medical Limited
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3
Actinogen Medical Limited
Remuneration Report (Audited) (continued)
11.8 DISCLOSURES RELATING TO SHARES
The shareholding of KMP as at 30 June 2023 is as follows:
KMP
Geoffrey Brooke
Steven Gourlay (a)
George Morstyn (b)
Malcolm McComas
Nicki Vasquez
Tamara Miller
Jeff Carter
Paul Rolan
Dana Hilt
Balance at
beginning of year
1 July 2022
Granted as
remuneration
On exercise
of options
Accounted
for as
options (c)
Net
change
other
Balance at
end of year
30 June 2023
2,152,223
17,797,222
3,012,223
822,223
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298,149
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2,152,223
750,000
18,547,222
1,500,000
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-
-
-
-
-
-
822,223
-
-
298,149
-
-
Total share holding
24,082,040
-
-
- 2,250,000
26,332,040
(a) Dr Gourlay purchased 750,000 fully paid ordinary shares on market during year.
(b) Dr Morstyn exercised 1,500,000 options at $0.10 cents each during the year.
(c) 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.
11.9 LOANS TO KMP AND THEIR RELATED PARTIES
During the year, a 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”. For further
information on these Loan Shares, refer to Section 11.3(C)(b)(iii) within the Remuneration Report. As at 30 June 2023, 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:
Quoted price of ordinary shares at year end (cents)
Loss per share (cents)
Dividends paid
End of Remuneration Report (Audited)
2023
5.00
0.60
2022
5.00
0.55
2021
2020
2019
12.0
0.28
2.2
0.48
-
-
-
-
1.0
0.90
-
35
Annual Financial Report 35
Annual Financial Report
Directors’ Report (continued)
12.
INDEMNIFICATION OF AUDITORS
To the extent permitted by law, the Company has agreed to indemnify its auditors, 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 $86,449 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 auditors and their associated entities for an audit or review of the financial
statements of the Company during the financial year ended 30 June 2023 totalled $75,700 (2022: $69,500).
Total non-audit services paid to the external auditors and their associated entities during the year ended 30 June 2023 was
$Nil (2022: $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 2023 forms a part of the Directors’ Report and can be found on page 37. Signed in accordance with a resolution of the
Board of Directors.
Dr Steven Gourlay
Managing Director
Sydney, New South Wales
30 August 2023
36
36 Actinogen Medical Limited
Actinogen Medical Limited
Directors’ Report (continued)
Auditor’s Independence Declaration
12.
INDEMNIFICATION OF AUDITORS
To the extent permitted by law, the Company has agreed to indemnify its auditors, 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 $86,449 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.
The Company's operations are not subject to significant environmental regulation under the Australian Commonwealth or State
15.
ENVIRONMENTAL REGULATIONS
law.
16.
AUDIT & NON-AUDIT SERVICES
Total amounts paid or payable to the external auditors and their associated entities for an audit or review of the financial
statements of the Company during the financial year ended 30 June 2023 totalled $75,700 (2022: $69,500).
Total non-audit services paid to the external auditors and their associated entities during the year ended 30 June 2023 was
$Nil (2022: $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 2023 forms a part of the Directors’ Report and can be found on page 37. Signed in accordance with a resolution of the
Board of Directors.
Dr Steven Gourlay
Managing Director
Sydney, New South Wales
30 August 2023
36 Actinogen Medical Limited
37
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 2023, 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 inrelation to the audit;b.No contraventions of any applicable code of professional conduct in relation to the audit; andc.No non-audit services provided that contravene any applicable code of professional conduct inrelation to the audit.Ernst & Young Pierre Dreyer Partner 30 August 2023 Annual Financial Report 37 Annual Financial Report
Financial Report
Statement of Comprehensive Income
Statement of Financial Position
Statement in Changes of Equity
Statement of Cash Flows
Notes to the Financial Statements
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
Corporate information
Summary of significant accounting policies
Segment information
Financial risk management
Critical accounting estimates and judgements
Other income and expenses
Income tax
Cash and cash equivalents
Other receivables and prepayments
Property, plant and equipment
Right-of-use asset & lease liability
Intangible assets
Trade and other payables
Contributed equity
Reserves
Remuneration of auditor
Losses per share
Commitments and contingencies
Events subsequent to the end of financial year
Related party transactions
Key management personnel disclosures
Share-based payments
Directors’ Declaration
Independent Auditor’s Report
38
38 Actinogen Medical Limited
39
40
41
42
43
43
43
49
49
52
52
53
53
54
55
55
56
56
57
58
59
59
59
59
59
60
61
63
64
Actinogen Medical Limited
Financial Report
Statement of Comprehensive Income
Statement of Financial Position
Statement in Changes of Equity
Statement of Cash Flows
Notes to the Financial Statements
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
Corporate information
Summary of significant accounting policies
Segment information
Financial risk management
Critical accounting estimates and judgements
Other income and expenses
Income tax
Cash and cash equivalents
Other receivables and prepayments
Property, plant and equipment
Right-of-use asset & lease liability
Intangible assets
Trade and other payables
Contributed equity
Reserves
Remuneration of auditor
Losses per share
Commitments and contingencies
Events subsequent to the end of financial year
Related party transactions
Key management personnel disclosures
Share-based payments
Directors’ Declaration
Independent Auditor’s Report
38 Actinogen Medical Limited
39
40
41
42
43
43
43
49
49
52
52
53
53
54
55
55
56
56
57
58
59
59
59
59
59
60
61
63
64
Statement of Comprehensive Income
For the year ended 30 June 2023
Full year ended
30/06/2023
Full year ended
30/06/2022
Note
$
$
6
6
12
11
10
366,654
4,887,935
5,254,589
41,072
3,640,082
3,681,154
(8,899,947)
(8,214,847)
(3,257,223)
(1,910,085)
(1,793,660)
(1,359,883)
(16,599)
(117,172)
(18,479)
13,394
(1,516,650)
(1,287,955)
(312,746)
(312,746)
(81,008)
(11,854)
(81,008)
(6,915)
(16,006,859)
(13,178,524)
(10,752,270)
(9,497,370)
-
-
(10,752,270)
(9,497,370)
Interest revenue
Other income
Total revenue & other income
Research & development costs
Employment costs
Corporate & administration costs
Finance costs
Realised (loss) / unrealised gain on foreign currency
Share-based payment expenses
Amortisation expense
Depreciation expense (right-of-use asset)
Depreciation expense (office equipment)
Total expenses
Loss before income tax
Income tax expense
Loss for the year
Other comprehensive income
Items that may be reclassified subsequently to profit and loss:
Other comprehensive income
-
-
Total comprehensive loss for the year
(10,752,270)
(9,497,370)
Loss per share for attributable to the ordinary equity
holders of the Company
Basic and diluted loss per share in cents
17
(0.60)
(0.55)
The above Statement of Comprehensive Income should be read in conjunction with the accompanying Notes.
39
Annual Financial Report 39
Annual Financial Report
Statement of Financial Position
As at 30 June 2023
Current Assets
Cash and cash equivalents
Other receivables and prepayments
Total Current Assets
Non-Current Assets
Property, plant and equipment
Intangible assets
Right-of-use assets
Total Non-Current Assets
TOTAL ASSETS
Current Liabilities
Trade and other payables
Provision for employee entitlements
Lease liability
Total Current Liabilities
Non-Current Liabilities
Lease liability
Total Non-Current Liabilities
TOTAL LIABILITIES
NET ASSETS
Equity
Contributed equity
Reserve shares
Reserves
Accumulated losses
TOTAL EQUITY
As at
30/06/2023
As at
30/06/2022
Note
$
$
8
9
10
12
11
8,460,074
16,370,283
4,228,311
4,046,639
12,688,385
20,416,922
37,276
12,531
2,407,712
2,720,458
75,432
156,440
2,520,420
2,889,429
15,208,805
23,306,351
13
1,559,470
1,308,381
11(b)
11(b)
14(a)
14(b)
15
155,187
86,933
92,823
78,337
1,801,590
1,479,541
-
-
86,933
86,933
1,801,590
1,566,474
13,407,215
21,739,877
78,712,128
76,942,670
(7,197,992)
(6,331,492)
10,584,632
9,067,982
(68,691,553)
(57,939,283)
13,407,215
21,739,877
The above Statement of Financial Position should be read in conjunction with the accompanying Notes.
40
40 Actinogen Medical Limited
Actinogen Medical Limited
Statement of Financial Position
Statement of Financial Position
As at 30 June 2023
As at 30 June 2023
Statement in Changes of Equity
For the year ended as at 30 June 2023
As at
As at
30/06/2023
30/06/2023
As at
As at
30/06/2022
30/06/2022
Note
Note
$
$
$
$
Full year ended 30 June 2023
Contributed
Equity
$
Accumulated
Losses
$
Option
Reserve
$
Reserve
Shares
$
Total
$
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
Other comprehensive income
Total comprehensive loss for the
year
Transactions with equity holders in
their capacity as equity holders:
Shares issued during the year
Share-based payments
Balance as at 30 June 2023
Full year ended 30 June 2022
Balance as at 1 July 2021
Loss for the year
Other comprehensive income
Total comprehensive loss for the year
Transactions with equity holders in
their capacity as equity holders:
Shares issued during the year
Capital raising costs
Share-based payments
-
-
-
(10,752,270)
-
(10,752,270)
-
-
-
-
-
-
(10,752,270)
-
(10,752,270)
1,769,458
-
-
-
-
(866,500)
902,958
1,516,650
-
1,516,650
78,712,128
(68,691,553)
10,584,632
(7,197,992)
13,407,215
Contributed
Equity
Accumulated
Losses
$
$
Option
Reserve
$
Reserve
Shares
$
60,054,459
(48,441,913)
7,780,027
Total
$
17,458,081
(9,497,370)
-
(9,497,370)
(1,934,492)
-
-
-
-
-
-
(9,497,370)
-
(9,497,370)
17,719,500
(831,289)
-
-
-
-
1,287,955
(4,397,000)
13,322,500
-
-
(831,289)
1,287,955
-
-
-
-
-
Balance as at 30 June 2022
76,942,670
(57,939,283)
9,067,982
(6,331,492)
21,739,877
The above Statement of Changes in Equity should be read in conjunction with the accompanying Notes.
40 Actinogen Medical Limited
40 Actinogen Medical Limited
Annual Financial Report 4141
Annual Financial Report 41
Current Assets
Current Assets
Cash and cash equivalents
Cash and cash equivalents
Other receivables and prepayments
Other receivables and prepayments
Total Current Assets
Total Current Assets
Non-Current Assets
Non-Current Assets
Property, plant and equipment
Property, plant and equipment
Intangible assets
Intangible assets
Right-of-use assets
Right-of-use assets
Total Non-Current Assets
Total Non-Current Assets
TOTAL ASSETS
TOTAL ASSETS
Current Liabilities
Current Liabilities
Trade and other payables
Trade and other payables
Provision for employee entitlements
Provision for employee entitlements
Lease liability
Lease liability
Total Current Liabilities
Total Current Liabilities
Non-Current Liabilities
Non-Current Liabilities
Lease liability
Lease liability
Total Non-Current Liabilities
Total Non-Current Liabilities
TOTAL LIABILITIES
TOTAL LIABILITIES
NET ASSETS
NET ASSETS
Equity
Equity
Contributed equity
Contributed equity
Reserve shares
Reserve shares
Reserves
Reserves
Accumulated losses
Accumulated losses
TOTAL EQUITY
TOTAL EQUITY
13
13
1,559,470
1,559,470
1,308,381
1,308,381
8
8
9
9
10
10
12
12
11
11
11(b)
11(b)
11(b)
11(b)
14(a)
14(a)
14(b)
14(b)
15
15
8,460,074
8,460,074
16,370,283
16,370,283
4,228,311
4,228,311
4,046,639
4,046,639
12,688,385
12,688,385
20,416,922
20,416,922
37,276
37,276
12,531
12,531
2,407,712
2,407,712
2,720,458
2,720,458
75,432
75,432
156,440
156,440
2,520,420
2,520,420
2,889,429
2,889,429
15,208,805
15,208,805
23,306,351
23,306,351
155,187
155,187
86,933
86,933
92,823
92,823
78,337
78,337
1,801,590
1,801,590
1,479,541
1,479,541
-
-
-
-
86,933
86,933
86,933
86,933
1,801,590
1,801,590
1,566,474
1,566,474
13,407,215
13,407,215
21,739,877
21,739,877
78,712,128
78,712,128
76,942,670
76,942,670
(7,197,992)
(7,197,992)
(6,331,492)
(6,331,492)
10,584,632
10,584,632
9,067,982
9,067,982
(68,691,553)
(68,691,553)
(57,939,283)
(57,939,283)
13,407,215
13,407,215
21,739,877
21,739,877
The above Statement of Financial Position should be read in conjunction with the accompanying Notes.
The above Statement of Financial Position should be read in conjunction with the accompanying Notes.
Annual Financial Report
Statement of Cash Flows
For the year ended 30 June 2023
Cash Flows from Operating Activities
Interest received
Interest paid
Payments to suppliers and employees
Payments for research and development
Government R&D tax rebate and grants received
Net cash outflow from operating activities
Cash Flows from Investing Activities
Purchase of property, plant and equipment
Net cash outflow from investing activities
Cash Flows from Financing Activities
Proceeds from issue of shares
Transaction costs associated with issue of shares
Principal repayment on leases
Net cash inflow from financing activities
Full year ended
30/06/2023
Full year ended
30/06/2022
Note
$
$
11(a)
8
10
14
14
11(a)
366,654
(17,012)
41,072
(10,682)
(4,537,191)
(2,978,470)
(9,154,875)
(8,003,765)
4,644,183
1,434,713
(8,698,241)
(9,517,132)
(36,599)
(36,599)
(2,937)
(2,937)
902,958
13,322,499
-
(831,289)
(78,337)
(71,171)
824,621
12,420,039
Net (decrease) / increase in cash and cash equivalents
(7,910,219)
2,899,970
Cash and cash equivalents at beginning of the year
16,370,283
13,421,653
Reclassify bank guarantee as cash and cash equivalents
Effect of movement in exchange rates on cash held
-
10
35,266
13,394
Cash and cash equivalents at the end of the year
8
8,460,074
16,370,283
The above Statement of Cash Flows should be read in conjunction with the accompanying Notes.
42
42 Actinogen Medical Limited
Actinogen Medical Limited
Cash Flows from Operating Activities
Interest received
Interest paid
Payments to suppliers and employees
Payments for research and development
Government R&D tax rebate and grants received
Cash Flows from Investing Activities
Purchase of property, plant and equipment
Net cash outflow from investing activities
Cash Flows from Financing Activities
Proceeds from issue of shares
Transaction costs associated with issue of shares
Principal repayment on leases
Net cash inflow from financing activities
Full year ended
Full year ended
30/06/2023
30/06/2022
Note
$
$
11(a)
8
10
14
14
11(a)
366,654
(17,012)
41,072
(10,682)
(4,537,191)
(2,978,470)
(9,154,875)
(8,003,765)
4,644,183
1,434,713
(36,599)
(36,599)
(2,937)
(2,937)
902,958
13,322,499
-
(831,289)
(78,337)
(71,171)
824,621
12,420,039
Net (decrease) / increase in cash and cash equivalents
(7,910,219)
2,899,970
Cash and cash equivalents at beginning of the year
16,370,283
13,421,653
Reclassify bank guarantee as cash and cash equivalents
Effect of movement in exchange rates on cash held
-
10
35,266
13,394
Cash and cash equivalents at the end of the year
8
8,460,074
16,370,283
The above Statement of Cash Flows should be read in conjunction with the accompanying Notes.
Statement of Cash Flows
For the year ended 30 June 2023
Notes to the Financial Statements
For the year ended 30 June 2023
Net cash outflow from operating activities
(8,698,241)
(9,517,132)
(a) Basis of preparation
1. CORPORATE INFORMATION
The financial statements of Actinogen Medical Limited (Actinogen Medical or the Company) for the year ended 30 June 2023
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 SIGNIFICANT 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 2023.
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 2023, the Company incurred a net loss after tax of $10,752,270 (2022: $9,497,370) and had
net cash outflows from operating activities of $8,698,241 (2022: $9,517,132). As reported, with $8,460,074 cash at bank at 30
June 2023, the Company is well funded in the short-term in order to fund ongoing research and development activities, as well
as its corporate and administrative requirements. Further funding will be required in order to undertake ongoing research and
development initiatives.
In the Directors’ opinion, there are reasonable grounds to believe that the Company has the ability to raise further funding 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 $8,460,074 in cash and cash equivalents as at 30 June 2023. 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 $3,883,834
(refer Note 9);
The Company is listed on the ASX and therefore has access to the Australian equity capital markets. The Company
announced a Rights Issue on 2 August 2023 to all eligible shareholders to raise approximately $10 million (before costs) –
refer to Note 19 for additional details. Additionally, the Company announced on 15 August 2023 that it had binding
commitments of $4.56 million for any future shortfall in the event that the Rights Issue does not raise the full $10 million;
and
•
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.
As a result of the need to finalise the Rights Issue referred to above or reduce discretionary expenditure if funds are not
forthcoming, there is uncertainty whether the Company will be able to progress with its current research and development
initiatives and continue as a going concern and therefore in this circumstance whether it will be able to realise its assets and
discharge its liabilities in the normal course of business at the amounts stated in the financial statements.
No adjustments have been made relating to the recoverability and classification of recorded asset amounts and the
classification of liabilities that might be necessary should the Company not continue as a going concern.
(c) Compliance with IFRS
The financial statements of the Company also comply with International Financial Reporting Standards (IFRS) as issued by the
International Accounting Standards Board (IASB).
(d) Historical cost convention
These financial statements have been prepared under the historical cost convention.
42 Actinogen Medical Limited
Annual Financial Report 43
43
Annual Financial Report
Notes to the Financial Statements
(continued)
(e) Critical accounting estimates and judgements
The preparation of financial statements requires the use of certain critical accounting estimates. It also requires management
to exercise its judgement in the process of applying the Company’s accounting policies. The areas involving a higher degree of
judgement or complexity, or areas where assumptions and estimates are significant to the financial statements are disclosed in
Note 5.
(f) Plant & equipment
Each asset of plant and equipment is stated at cost, net of accumulated depreciation and impairment losses, if any.
Assets are depreciated from the date the asset is ready for use. Items of plant and equipment are depreciated using
the diminishing value method over their estimated useful lives to the Company. The depreciation rates used for each
class of asset for the current period are as follows, computer equipment rates at 25% to 67%.
An asset is de-recognised upon disposal or when no future economic benefits are expected from its use or disposal.
Any gain or loss arising on de-recognition of the asset (calculated as the difference between the net disposal proceeds
and the carrying amount of the asset) is included in the Statement of Comprehensive Income when the asset is de-
recognised. The assets’ residual values, useful lives and methods of depreciation are reviewed, and adjusted if
appropriate, at each balance date.
(g) Impairment of non-financial assets
At each reporting date, the Company reviews the carrying values of its assets to determine whether there is any
indication that those assets have been impaired. If such an indication exists, the recoverable amount of the asset, being
the higher of the asset’s fair value less costs of disposal and value in use, is compared to the assets carrying value. Any
excess of the assets carrying value over its recoverable amount is expensed to the Statement of Comprehensive
Income. Where it is not possible to estimate the recoverable amount of an individual asset, the Company estimates the
recoverable amount of the cash-generating unit to which the asset belongs. In assessing value in use, the estimated
future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market
assessments of the time value of money and the risks specific to the asset. In determining fair value less cost of
disposal, recent market transactions are taken into account. If no such transactions can be identified, an appropriate
valuation model is used. These calculations are corroborated by valuation multiples, quoted share prices for publicly
traded companies or other available fair value measures.
(h) Intangible assets
Intangible assets acquired separately are measured on initial recognition at cost. The cost of intangible assets acquired
in a business combination is their fair value at the date of acquisition. Following initial recognition, intangible assets are
carried at cost less any accumulated amortisation and accumulated impairment losses. Internally generated intangibles,
excluding capitalised development costs, are not capitalised and the related expenditure is reflected in profit or loss in
the period in which the expenditure is incurred.
The useful lives of intangible assets are assessed as either finite or indefinite. Intangible assets with finite lives are
amortised over the useful economic life and assessed for impairment whenever there is an indication that the intangible
asset may be impaired. The amortisation period and the amortisation method for an intangible asset with a finite useful
life are reviewed at least at the end of each reporting period. Changes in the expected useful life or the expected
pattern of consumption of future economic benefits embodied in the asset are considered to modify the amortisation
period or method, as appropriate, and are treated as changes in accounting estimates and adjusted on a prospective
basis. The amortisation expense on intangible assets with finite lives is recognised in the Statement of Comprehensive
Income. Intangible assets with indefinite useful lives are not amortised, but are tested for impairment annually, and
when indicators of impairment exist, individually or at the cash-generating unit level. The assessment of indefinite life is
reviewed annually, or when indicators of impairment exist, to determine whether the indefinite life continues to be
supportable. If not, the change in useful life from indefinite to finite is made on a prospective basis. Gains or losses
arising from derecognition of an intangible asset are measured as the difference between the net disposal proceeds
and the carrying amount of the asset and are recognised in the Statement of Comprehensive Income when the asset is
derecognised.
(i) Research and development costs
Development expenditure on an individual project is recognised as an intangible asset when the Company can
demonstrate:
•
•
The technical feasibility of completing the intangible asset so that the asset will be available for use or sale
Its intention to complete and its ability to use or sell the asset
44
44 Actinogen Medical Limited
Actinogen Medical Limited Notes to the Financial Statements
Notes to the Financial Statements
(continued)
(continued)
•
•
•
•
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
(e) Critical accounting estimates and judgements
(e) Critical accounting estimates and judgements
The preparation of financial statements requires the use of certain critical accounting estimates. It also requires management
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
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
judgement or complexity, or areas where assumptions and estimates are significant to the financial statements are disclosed in
Note 5.
Note 5.
(f) Plant & equipment
(f) Plant & equipment
Each asset of plant and equipment is stated at cost, net of accumulated depreciation and impairment losses, if any.
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
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
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%.
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.
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
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-
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
recognised. The assets’ residual values, useful lives and methods of depreciation are reviewed, and adjusted if
appropriate, at each balance date.
appropriate, at each balance date.
(g) Impairment of non-financial assets
(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
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
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
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
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
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
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
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
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
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
valuation model is used. These calculations are corroborated by valuation multiples, quoted share prices for publicly
traded companies or other available fair value measures.
traded companies or other available fair value measures.
(h)
(h) Intangible assets
Intangible assets
Intangible assets acquired separately are measured on initial recognition at cost. The cost of intangible assets acquired
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
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,
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
and the carrying amount of the asset and are recognised in the Statement of Comprehensive Income when the asset is
(i) Research and development costs
Research and development costs
(i)
Development expenditure on an individual project is recognised as an intangible asset when the Company can
Development expenditure on an individual project is recognised as an intangible asset when the Company can
The technical feasibility of completing the intangible asset so that the asset will be available for use or sale
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
Its intention to complete and its ability to use or sell the asset
derecognised.
derecognised.
demonstrate:
demonstrate:
•
•
•
•
44 Actinogen Medical Limited
44 Actinogen Medical Limited
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 2023. The Company did not meet this criterion and as a consequence all
research and development costs were expensed to profit and loss for the current year.
(ii)
Intellectual property
The Company’s intangible assets relate to intellectual property for upfront payments to purchase patents and licenses. The
patents and licenses have been granted for a period of 20 years by the relevant government agency with the option of renewal
at the end of this period. As a result, those patents and licenses are amortised on a straight-line basis over the period of the
patents and license. The remaining life of the patents and licenses is 8 years. Refer to Note 12: Intangible Assets.
(i)
Government grants
Research and development tax rebates are treated as a government grant. Government grants are recognised as income
where there is reasonable assurance that the grant will be received, and all attached conditions will be complied with. When
the grant relates to an expense item, it is recognised as income on a systematic basis over the periods that the costs, which it
is intended to compensate, are expensed.
(j)
Income tax
The charge for current income tax expense is based on the result for the year adjusted for any non-assessable or disallowed
items. It is calculated using the tax rates that have been enacted or are substantially enacted by the end of the reporting
period.
Deferred income tax is accounted for using the liability method on temporary differences arising between the tax bases of
assets and liabilities and their carrying amounts in the financial statements. However, the deferred income tax from the initial
recognition of an asset or liability, in a transaction other than a business combination is not accounted for if it arises that at the
time of the transaction and affects neither accounting or taxable profit or loss. Deferred income tax is determined using tax
rates (and laws) that have been enacted or substantially enacted by the end of the reporting period and are expected to apply
when the asset is realised, or liability is settled. Deferred tax assets are recognised for deductible temporary differences and
unused tax losses only if it is probable that future taxable amounts will be available to utilise those temporary differences and
losses.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets and liabilities
and when the deferred tax balances relate to the same taxation authority. Current tax assets and tax liabilities are offset where
the entity has a legally enforceable right to offset and intends either to settle on a net basis, or to realise the asset and settle
the liability simultaneously. Current and deferred tax is recognised in profit or loss, except to the extent that it relates to items
recognised in other comprehensive income or directly in equity. In this case, the tax is also recognised in other comprehensive
income or directly in equity, respectively.
(k)
Employee benefits
Provision is made for the Company’s liability for employee benefits arising from services rendered by employees to balance
date. Employee benefits that are expected to be settled within one year have been measured at the amounts expected to be
paid when the liability is settled, plus related on-costs. Employee benefits payable later than one year have been measured
using the projected unit credit valuation method to estimate future cash outflows to be made for those benefits discounted
using the interest rate on high quality corporate bonds with terms to maturity approximating the terms of the liability.
(l)
Share-based payments
The Company provides benefits to employees (including Directors) and consultants of the Company in the form of share-based
payment transactions, whereby employees and consultants render services in exchange for shares or rights over shares
(‘equity-settled transactions’). The cost of these equity-settled transactions with employees is measured by reference to the
fair value at the date at which they are granted. The fair value is determined by an internal valuation using a Black-Scholes
option pricing model.
The cost of equity-settled transactions is recognised, together with a corresponding increase in equity, over the period in
which the performance conditions are fulfilled, ending on the date on which the relevant employees become fully entitled to
the award (‘vesting date’). The cumulative expense recognised for equity-settled transactions at each reporting date until
vesting date reflects (i) the extent to which the vesting period has expired and (ii) the number of awards that, in the opinion of
the Directors of the Company, will ultimately vest. This opinion is formed based on the best available information at balance
date. No adjustment is made for the likelihood of market performance conditions being met as the effect of these conditions is
included in the determination of fair value at grant date.
Annual Financial Report 4545
Annual Financial Report 45
Annual Financial Report
Notes to the Financial Statements
(continued)
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.
(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
AASB 2021-2
Amendments
The amendments to AASB 108 clarify the definition of an accounting estimate, making it easier
1 January 2023
1 July 2023
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.
4646
Actinogen Medical Limited
46 Actinogen Medical Limited
Annual Financial Report 47
(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.
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.
(u) Segment reporting
(v) Leases
Right-of-use asset:
The Company recognises a right-of-use asset at the commencement date of the lease (i.e., the date the underlying asset is
available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and
adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities
recognised, initial direct costs incurred, and lease payments made at or before the commencement date less any lease
incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease
term, the recognised assets are depreciated on a straight-line basis over the shorter of its estimated useful life and the lease
term. A right-of-use asset is subject to impairment.
Lease liabilities:
At the commencement date of the lease, the Company recognises lease liabilities measured at the present value of lease
payments to be made over the lease term. The lease payments include fixed payments (including in-substance fixed
payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts
expected to be paid under residual value guarantees. The lease payments also include the exercise price of a purchase option
reasonably certain to be exercised by the Company and payments of penalties for terminating a lease, if the lease term reflects
the Company exercising the option to terminate. The variable lease payments that do not depend on an index or a rate are
recognised as expense in the period on which the event or condition that triggers the payment occurs.
In calculating the present value of lease payments, the Company uses the incremental borrowing rate at the lease
commencement date if the interest rate implicit in the lease is not readily determinable. After the commencement date, the
amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition,
the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the in-
substance fixed lease payments or a change in the assessment to purchase the underlying asset.
Short-term leases and leases of low-value assets:
The Company applies the short-term lease recognition exemption to its short-term leases (i.e., those leases that have a lease
term of 12 months or less from the commencement date and do not contain a purchase option). It also applies the lease of low-
value assets recognition exemption to leases of office equipment that are considered of low value (i.e., below USD$5,000).
Lease payments on short-term leases and leases of low-value assets are expensed on a straight-line basis over the lease term.
(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 2023
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
Summary
AASB 2020-1
Amendments
A liability is classified as current if the entity has no right at the end of the reporting period to
1 January 2023
1 July 2023
Application
Application
date of
date for
standard
Company
to AASs –
defer settlement for at least 12 months after the reporting period. The AASB recently issued
Classification
amendments to AASB 101 Presentation of Financial Statements to clarify the requirements for
of Liabilities
classifying liabilities as current or non-current.
as Current or
Non-current
to AASB 108 –
to differentiate it from an accounting policy. The distinction is necessary as their treatment
Definition of
and disclosure requirements are different. Critically, a change in an accounting estimate is
applied prospectively whereas a change in an accounting policy is generally applied
Actinogen Medical Limited Notes to the Financial Statements
(continued)
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.
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
(m) Cash and cash equivalents
risk of changes in value.
(n)
Interest income:
Interest income is recorded using the effective interest rate method (EIR). EIR is the rate that exactly discounts the
estimated future cash payments or receipts over the expected life of the financial instrument, or a shorter period,
where appropriate, to the net carrying amount of the financial asset or liability. Interest income is included in finance
income in the Statement of Comprehensive Income.
(o) Goods and services tax (GST)
Revenues, expenses and assets are recognised net of the amount of GST, except where the amount of GST incurred is
not recoverable from the ATO. In these circumstances the GST is recognised as part of the cost of acquisition of the
asset or as part of the expense. Receivables and payables in the Statement of Financial Position are shown inclusive of
GST. Cash flows are presented in the Statement of Cash Flows on a gross basis, except for the GST component of
investing and financing activities, which are disclosed as operating cash flows.
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
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.
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
(p) Contributed equity
proceeds received.
(q) Trade and other payables
(r) Provisions
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.
(t) Financial assets
(t) Financial assets
Receivables are recognised initially at fair value and subsequently measured at amortised cost using the effect interest
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
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
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
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
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
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
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.
appropriate. Up to the date of this Report, the Board has placed no requirement for collateral on existing debtors.
(u) Segment reporting
(u) Segment reporting
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision
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
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.
operating segments, has been identified as the Board of Directors.
(v) Leases
(v) Leases
Right-of-use asset:
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
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
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
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
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
incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease
term, the recognised assets are depreciated on a straight-line basis over the shorter of its estimated useful life and the lease
term, 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.
term. A right-of-use asset is subject to impairment.
Lease liabilities:
Lease liabilities:
At the commencement date of the lease, the Company recognises lease liabilities measured at the present value of lease
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 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
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
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
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
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.
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
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
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,
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-
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.
substance fixed lease payments or a change in the assessment to purchase the underlying asset.
Short-term leases and leases of low-value assets:
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
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-
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).
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.
Lease payments on short-term leases and leases of low-value assets are expensed on a straight-line basis over the lease term.
(w) New accounting standards and interpretations issued but not yet effective
(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 2023
Certain new accounting standards and interpretations have been published that are not mandatory for 30 June 2023
reporting periods and have not been early adopted by the Company. These new standards and interpretations, and the
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.
status of the Company’s assessment of impact on the Company, are set out below.
Reference
Reference
Title
Title
Summary
Summary
Application
Application
Application
Application
date of
date of
date for
date for
standard
standard
Company
Company
AASB 2020-1
AASB 2020-1
Amendments
Amendments
A liability is classified as current if the entity has no right at the end of the reporting period to
A liability is classified as current if the entity has no right at the end of the reporting period to
1 January 2023
1 January 2023
1 July 2023
1 July 2023
to AASs –
to AASs –
defer settlement for at least 12 months after the reporting period. The AASB recently issued
defer settlement for at least 12 months after the reporting period. The AASB recently issued
Classification
Classification
amendments to AASB 101 Presentation of Financial Statements to clarify the requirements for
amendments to AASB 101 Presentation of Financial Statements to clarify the requirements for
of Liabilities
of Liabilities
classifying liabilities as current or non-current.
classifying liabilities as current or non-current.
as Current or
as Current or
Non-current
Non-current
Diluted loss per share
AASB 2021-2
AASB 2021-2
Amendments
Amendments
The amendments to AASB 108 clarify the definition of an accounting estimate, making it easier
The amendments to AASB 108 clarify the definition of an accounting estimate, making it easier
1 January 2023
1 January 2023
1 July 2023
1 July 2023
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.
to AASB 108 –
to AASB 108 –
to differentiate it from an accounting policy. The distinction is necessary as their treatment
to differentiate it from an accounting policy. The distinction is necessary as their treatment
Definition of
Definition of
and disclosure requirements are different. Critically, a change in an accounting estimate is
and disclosure requirements are different. Critically, a change in an accounting estimate is
applied prospectively whereas a change in an accounting policy is generally applied
applied prospectively whereas a change in an accounting policy is generally applied
46
46 Actinogen Medical Limited
Actinogen Medical Limited
47
Annual Financial Report 47
Annual Financial Report 47
Annual Financial Report
Notes to the Financial Statements
(continued)
Accounting
retrospectively. The new definition provides that ‘Accounting estimates are monetary amounts
Estimates
in financial statements that are subject to measurement uncertainty.’ The amendments explain
that a change in an input or a measurement technique used to develop an accounting
estimate is considered a change in an accounting estimate unless it is correcting a prior
period error.
AASB 2021-28
Amendments
The amendments to AASB 101 require disclosure of material accounting policy information,
1 January 2023
1 July 2023
to AASB 7,
instead of significant accounting policies. Unlike ‘material10’, ‘significant’ was not defined in
AASB 101,
Australian Accounting Standards. Leveraging the existing definition of material with additional
AASB 134
guidance is expected to help preparers make more effective accounting policy disclosures.
Interim
The guidance illustrates circumstances where an entity is likely to consider accounting policy
Financial
information to be material. Entity-specific accounting policy information is emphasised as
Reporting and
being more useful than generic information or summaries of the requirements of Australian
AASB Practice
Accounting Standards. The amendments to AASB Practice Statement 2 supplement the
Statement 2
amendments to AASB 101 by illustrating how the four-step materiality process can identify
Making
material accounting policy information.
Materiality
Judgements–
Disclosure of
Accounting
Policies
AASB 2023-2
Amendments
In response to the Pillar Two Global anti-Base Erosion rules (GloBE Rules)3 , amendments to
1 January 2023
1 July 2023
to AASs –
AASB 112 introduce: A mandatory temporary exception in AASB 112 from recognising and
International
disclosing deferred tax assets and liabilities related to Pillar Two income taxes
Tax Reform
Disclosure requirements for affected entities for the periods before and when the legislation is
Pillar Two
effective The amendments are intended to provide temporary relief, avoid diverse
Model
Rules
interpretations of AASB 12 developing in practice and improve the information provided to
users of financial statements before and after Pillar Two legislation comes into effect. The
amendments do not clarify whether a Pillar Two top-up tax is considered to be an income tax
in the scope of AASB 12, nor do they require all top-up taxes to be treated as income taxes.
Judgement must be applied in determining which top-up taxes are considered to be income
taxes. Earlier application of the amendments is permitted.
AASB 2022-5
Amendments
In a sale and leaseback transaction recognised as a sale under AASB 15 Revenue from
1 January 2024
1 July 2024
to AASs –
Contracts with Customers, AASB 16 requires the seller-lessee to measure the right-of-use
Lease Liability
asset arising from the leaseback at the proportion of the previous carrying amount of the
in a Sale and
asset that relates to the right of use retained by the seller-lessee. The standard, however,
Leaseback
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.
The Company has not early adopted any other accounting standard, interpretation or amendment that has been issued
but is not yet effective. The adoption of these standards, interpretations or amendments is not expected to have a
material impact on the financial position or performance of the Company.
48
48 Actinogen Medical Limited
Actinogen Medical Limited AASB 2023-2
Amendments
In response to the Pillar Two Global anti-Base Erosion rules (GloBE Rules)3 , amendments to
1 January 2023
1 July 2023
Notes to the Financial Statements
(continued)
AASB 2021-28
Amendments
The amendments to AASB 101 require disclosure of material accounting policy information,
1 January 2023
1 July 2023
Accounting
retrospectively. The new definition provides that ‘Accounting estimates are monetary amounts
Estimates
in financial statements that are subject to measurement uncertainty.’ The amendments explain
that a change in an input or a measurement technique used to develop an accounting
estimate is considered a change in an accounting estimate unless it is correcting a prior
period error.
to AASB 7,
instead of significant accounting policies. Unlike ‘material10’, ‘significant’ was not defined in
AASB 101,
Australian Accounting Standards. Leveraging the existing definition of material with additional
AASB 134
guidance is expected to help preparers make more effective accounting policy disclosures.
Interim
The guidance illustrates circumstances where an entity is likely to consider accounting policy
Financial
information to be material. Entity-specific accounting policy information is emphasised as
Reporting and
being more useful than generic information or summaries of the requirements of Australian
AASB Practice
Accounting Standards. The amendments to AASB Practice Statement 2 supplement the
Statement 2
amendments to AASB 101 by illustrating how the four-step materiality process can identify
Making
material accounting policy information.
Materiality
Judgements–
Disclosure of
Accounting
Policies
to AASs –
AASB 112 introduce: A mandatory temporary exception in AASB 112 from recognising and
International
disclosing deferred tax assets and liabilities related to Pillar Two income taxes
Tax Reform
Disclosure requirements for affected entities for the periods before and when the legislation is
Pillar Two
effective The amendments are intended to provide temporary relief, avoid diverse
Model
Rules
interpretations of AASB 12 developing in practice and improve the information provided to
users of financial statements before and after Pillar Two legislation comes into effect. The
amendments do not clarify whether a Pillar Two top-up tax is considered to be an income tax
in the scope of AASB 12, nor do they require all top-up taxes to be treated as income taxes.
Judgement must be applied in determining which top-up taxes are considered to be income
taxes. Earlier application of the amendments is permitted.
to AASs –
Contracts with Customers, AASB 16 requires the seller-lessee to measure the right-of-use
Lease Liability
asset arising from the leaseback at the proportion of the previous carrying amount of the
in a Sale and
asset that relates to the right of use retained by the seller-lessee. The standard, however,
Leaseback
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.
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 2023:
As at 30 June 2023
Financial assets
Cash and cash equivalents
Other receivables and prepayments
Total current assets
Total financial assets
Financial liabilities
Trade and other payables
Lease liabilities - current
Total current liabilities
Lease liabilities - non-current
Total non-current liabilities
Total financial liabilities
Net exposure
Cash and cash
equivalents
$
Financial assets / liabilities
at amortised cost
$
8,460,074
-
8,460,074
8,460,074
-
-
-
-
-
-
8,460,074
-
215,237
215,237
215,237
1,559,470
86,933
1,646,403
-
-
1,646,403
(1,431,166)
AASB 2022-5
Amendments
In a sale and leaseback transaction recognised as a sale under AASB 15 Revenue from
1 January 2024
1 July 2024
Set out below is an overview of the financial instruments held by the Company as at 30 June 2022:
As at 30 June 2022
Financial assets
Cash and cash equivalents
Other receivables and prepayments
Total current assets
Total financial assets
Financial liabilities
Trade and other payables
Lease liabilities - current
Total current liabilities
Lease liabilities - non-current
Total non-current liabilities
Total financial liabilities
Net exposure
Cash and cash
equivalents
$
Financial assets / liabilities
at amortised cost
$
16,370,283
-
16,370,283
16,370,283
-
-
-
-
-
-
-
328,261
328,261
328,261
1,308,381
78,337
1,386,718
86,933
86,933
1,473,651
16,370,283
(1,145,390)
The Company has not early adopted any other accounting standard, interpretation or amendment that has been issued
but is not yet effective. The adoption of these standards, interpretations or amendments is not expected to have a
material impact on the financial position or performance of the Company.
48 Actinogen Medical Limited
49
Annual Financial Report 49
Annual Financial Report
Notes to the Financial Statements
(continued)
4. FINANCIAL RISK MANAGEMENT (CONTINUED)
(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 2023, the Company held $8,284,194 (2022: $15,832,202) 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 $82,842 (2021: $158,322).
Sensitivity analysis:
30 June 2023
Financial Assets
Carrying amount
$
Interest rate risk
-1%
Profit/Equity
$
+1%
Profit/Equity
$
Cash and cash equivalents
8,284,194
(82,842)
82,842
30 June 2022
Financial Assets
Cash and cash equivalents
15,832,202
(158,322)
158,322
Variable rate instruments:
As at 30/6/2023
As at 30/6/2022
Weighted average
interest rate
%
Balance
$
Weighted average
interest rate
%
Balance
$
Cash and cash equivalents
3.89
8,284,194
1.19
15,832,202
(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, 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.
50
50 Actinogen Medical Limited
Actinogen Medical Limited
Notes to the Financial Statements
4. FINANCIAL RISK MANAGEMENT (CONTINUED)
(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 (2022: 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:
As at 30 June 2023
Trade and other payables
Lease liabilities
As at 30 June 2022
Trade and other payables
Lease liabilities
(d) Fair Value Measurements
Less than
3 months
$
1,559,470
14,706
1,574,176
1,308,381
21,211
1,329,592
3 to 12
months
$
-
66,179
66,179
1 to 5
years
$
Total
$
-
-
-
1,559,470
80,885
1,640,355
-
-
1,308,381
63,916
63,916
80,885
80,885
166,012
1,474,393
The fair value of financial assets and financial liabilities must be estimated for recognition and measurement or for disclosure
purposes. Accounting standards require disclosure of fair value measurements by level of the following fair value measurement
hierarchy:
(a) quoted prices (unadjusted) in active markets for identical assets or liabilities (level 1).
(b)
inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (as
prices) or indirectly (derived from prices) (level 2).
(c)
inputs for the asset or liability that are not based on observable market data (unobservable inputs) (level 3).
The carrying value of financial assets and financial liabilities, excluding lease liabilities, approximates their fair value as at 30
June 2023 and 30 June 2022 given the nature of the financial assets and liabilities.
4. FINANCIAL RISK MANAGEMENT (CONTINUED)
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 2023, the Company held $8,284,194 (2022: $15,832,202) in such accounts
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
Carrying amount
Profit/Equity
Profit/Equity
$
Interest rate risk
-1%
$
+1%
$
Cash and cash equivalents
8,284,194
(82,842)
82,842
Cash and cash equivalents
15,832,202
(158,322)
158,322
(continued)
(a) Market Risk
(i) Interest rate risk
and deposits.
by $82,842 (2021: $158,322).
Sensitivity analysis:
30 June 2023
Financial Assets
30 June 2022
Financial Assets
Variable rate instruments:
As at 30/6/2023
As at 30/6/2022
Weighted average
Weighted average
interest rate
Balance
interest rate
Balance
%
$
%
$
Cash and cash equivalents
3.89
8,284,194
1.19
15,832,202
(b) Credit risk
(i) Cash
(ii) Receivables
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:
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, a reputable Australian Banking institution.
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.
50 Actinogen Medical Limited
51
Annual Financial Report 51
Annual Financial Report
Notes to the Financial Statements
(continued)
5. CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS
•
Key estimates: Share-based payments
The Company initially measures the cost of equity-settled transactions with employees by reference to the fair value of the
equity instruments at the date at which they are granted. Estimating fair value for share-based payment transactions requires
determination of the most appropriate valuation model, which is dependent on the terms and conditions of the grant. This
estimate also requires determination of the most appropriate inputs to the valuation model including the expected life of the
share option, volatility and dividend yield and making assumptions about them. The assumptions and models used for
estimating fair value for share-based payment transactions are disclosed in Note 22.
•
Key estimates: Impairment of intangible assets
The Company assesses impairment for intangible assets at each reporting date or when an impairment indicator exists, by
evaluating conditions specific to the Company and to the particular asset that may lead to impairment. These include product,
technology, economic and political environments and future expectations. If an impairment indicator exists, the recoverable
amount of the asset is determined. For further information on intangible assets refer to Note 2(h).
•
Significant judgement: Research and development tax rebate
In line with accounting policy 2(i) research and development tax rebates are treated as government grants and are recognised
as income where there is reasonable assurance that the grant will be received, and all attached conditions will be complied
with. The Company applies judgment in assessing that all attached conditions will be complied with based on the nature of the
expenditure incurred and the activities of the Company undertaken during the year.
•
Significant judgement in determining the lease term of contracts with renewal options:
The Company determines the lease term as the non-cancellable term of the lease, together with any periods covered by an
option to extend the lease if it is reasonably certain to be exercised, or any periods covered by an option to terminate the
lease, if it is reasonably certain not to be exercised. The Company has the option under some of its leases to lease the assets
for additional terms. The Company applies judgement in evaluating whether it is reasonably certain to exercise the option to
renew. That is, it considers all relevant factors that create an economic incentive for it to exercise the renewal. After the
commencement date, the Company reassesses the lease term if there is a significant event or change in circumstances that is
within its control and affects its ability to exercise (or not to exercise) the option to renew and renewal periods (e.g. a change
in business strategy).
6. OTHER INCOME AND EXPENSES
Income
Interest income
Other income
R&D tax rebate (a)
Total other income
Total income
Expenses
Research and development costs:
Laboratory & clinical trial expenses
Regulatory & clinical development consultants
Other expenses
Total research and development costs
Full year ended
30/06/2023
Full year ended
30/06/2022
$
$
366,654
41,072
4,887,935
4,887,935
5,254,589
3,640,082
3,640,082
3,681,154
8,220,347
7,462,503
413,349
266,251
545,496
206,848
8,899,947
8,214,847
(a) The R&D tax rebate comprised an accrual of $3,883,834 relating to the financial year ended 30 June 2023 plus
$1,004,101 relating to the prior year 30 June 2022 R&D tax rebate, which was an additional portion not recorded as a
receivable as at 30 June 2022 but instead was recognised and recorded when received in the current year.
52
52 Actinogen Medical Limited
Actinogen Medical Limited
Notes to the Financial Statements
(continued)
7. INCOME TAX
Reconciliation of operating loss to prima facie income tax expense
Operating loss before income tax
Tax benefit at the Australian tax rate of 30% (2022: 30%)
Tax effect of amounts that are not deductible / taxable in calculating
taxable income:
Non-deductible expenses
Share-based payments
Research and development
Realised foreign exchange gain/(loss)
Deferred income tax asset not brought to account
Income tax expense
Tax losses
Full year ended
30/06/2023
Full year ended
30/06/2022
$
$
(10,752,270)
(3,225,681)
(9,497,370)
(2,849,211)
4,399
454,995
935,991
-
2,925
386,386
1,418,377
115
1,830,296
1,041,408
-
-
Unused tax losses for which no deferred tax asset has been recognised
Potential tax benefit @ 30% (2022: 30%)
24,747,543
19,825,165
7,424,263
5,947,550
Unrecognised temporary differences
Temporary differences for which deferred tax assets have not been
recognised.
- Provisions and accruals
- Intangible assets
- Capital raising costs
- Legal expenses
- Right of use adjustments
- Unrealised foreign exchange gain
- Fixed assets
Unrecognised deferred tax asset relating to the above temporary
differences @ 30% (2022: 30%)
184,575
1,728,742
796,977
60,619
11,500
7,131
140,323
1,415,995
1,118,593
75,683
8,830
(13,428)
(37,276)
(12,531)
2,752,268
2,733,465
825,680
820,040
Full year ended
Full year ended
30/06/2023
30/06/2022
$
$
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.
366,654
41,072
4,887,935
4,887,935
5,254,589
3,640,082
3,640,082
3,681,154
8,220,347
7,462,503
413,349
266,251
545,496
206,848
8,899,947
8,214,847
8. CASH AND CASH EQUIVALENTS
Cash at bank and on hand
Short term deposits
Total cash and cash equivalents
As at
30/06/2023
As at
30/06/2022
$
$
1,280,160
7,179,914
8,460,074
4,270,017
12,100,266
16,370,283
During the year ended 30 June 2023, the Company received interest revenue through holding cash and cash equivalents. The
Company is expecting to receive a research and development tax incentive estimated at $3,883,834 for eligible expenditure
incurred during the year ended 30 June 2023. This has been recognised as a receivable at year end. Refer to Note 9.
5. CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS
•
Key estimates: Share-based payments
The Company initially measures the cost of equity-settled transactions with employees by reference to the fair value of the
equity instruments at the date at which they are granted. Estimating fair value for share-based payment transactions requires
determination of the most appropriate valuation model, which is dependent on the terms and conditions of the grant. This
estimate also requires determination of the most appropriate inputs to the valuation model including the expected life of the
share option, volatility and dividend yield and making assumptions about them. The assumptions and models used for
estimating fair value for share-based payment transactions are disclosed in Note 22.
•
Key estimates: Impairment of intangible assets
The Company assesses impairment for intangible assets at each reporting date or when an impairment indicator exists, by
evaluating conditions specific to the Company and to the particular asset that may lead to impairment. These include product,
technology, economic and political environments and future expectations. If an impairment indicator exists, the recoverable
amount of the asset is determined. For further information on intangible assets refer to Note 2(h).
•
Significant judgement: Research and development tax rebate
In line with accounting policy 2(i) research and development tax rebates are treated as government grants and are recognised
as income where there is reasonable assurance that the grant will be received, and all attached conditions will be complied
with. The Company applies judgment in assessing that all attached conditions will be complied with based on the nature of the
expenditure incurred and the activities of the Company undertaken during the year.
•
Significant judgement in determining the lease term of contracts with renewal options:
The Company determines the lease term as the non-cancellable term of the lease, together with any periods covered by an
option to extend the lease if it is reasonably certain to be exercised, or any periods covered by an option to terminate the
lease, if it is reasonably certain not to be exercised. The Company has the option under some of its leases to lease the assets
for additional terms. The Company applies judgement in evaluating whether it is reasonably certain to exercise the option to
renew. That is, it considers all relevant factors that create an economic incentive for it to exercise the renewal. After the
commencement date, the Company reassesses the lease term if there is a significant event or change in circumstances that is
within its control and affects its ability to exercise (or not to exercise) the option to renew and renewal periods (e.g. a change
in business strategy).
6. OTHER INCOME AND EXPENSES
Income
Interest income
Other income
R&D tax rebate (a)
Total other income
Total income
Expenses
Research and development costs:
Laboratory & clinical trial expenses
Regulatory & clinical development consultants
Other expenses
Total research and development costs
(a) The R&D tax rebate comprised an accrual of $3,883,834 relating to the financial year ended 30 June 2023 plus
$1,004,101 relating to the prior year 30 June 2022 R&D tax rebate, which was an additional portion not recorded as a
receivable as at 30 June 2022 but instead was recognised and recorded when received in the current year.
52 Actinogen Medical Limited
53
Annual Financial Report 53
Annual Financial Report
Notes to the Financial Statements
(continued)
8. CASH AND CASH EQUIVALENTS (CONTINUED)
Reconciliation of net cash flows from operating activities
Loss for the year
Non cash items:
Depreciation (computer equipment)
Depreciation (lease: office rental)
Amortisation expense
Share-based payment expense
Unrealised foreign currency gain
Change in assets and liabilities:
Increase in trade and other receivables
Increase in trade and other payables
Increase in provisions
Net cash outflow used in operating activities
Full year ended
30/06/2023
Full year ended
30/06/2022
$
$
(10,752,270)
(9,497,370)
11,854
81,008
312,746
1,516,650
(10)
6,915
81,008
312,746
1,287,955
(13,394)
(181,672)
(2,412,317)
251,089
62,364
688,809
28,516
(8,698,241)
(9,517,132)
Non-cash financing and investing activities:
During the year, the Company issued 10,250,000 ordinary shares to a employees/contractors 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 financing and investing activities that occurred
during the year ended 30 June 2023.
Financing facilities available:
As at 30 June 2023, the Company had no financing facilities available (2022: 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.
Prepaid insurance
Goods and services tax receivable
Research and development tax rebate receivable
Other receivables
Total other receivables and prepayments
54
54 Actinogen Medical Limited
As at
30/06/2023
As at
30/06/2022
$
$
104,686
129,240
3,883,834
110,551
4,228,311
104,572
78,296
3,640,082
223,689
4,046,639
Actinogen Medical Limited
Notes to the Financial Statements
(continued)
10. PROPERTY, PLANT AND EQUIPMENT
At cost
Accumulated depreciation
Total property, plant and equipment
Movements during the year
Opening balance at 1 July 2021
Acquisitions
Depreciation
Closing balance at 30 June 2022
Opening balance at 1 July 2022
Acquisitions
Depreciation
Closing balance at 30 June 2023
As at
30/06/2023
$
68,484
(31,208)
37,276
As at
30/06/2022
$
31,884
(19,353)
12,531
Computer Equipment
$
16,509
2,937
(6,915)
12,531
12,531
36,599
(11,854)
37,276
Total
$
16,509
2,937
(6,915)
12,531
12,531
36,599
(11,854)
37,276
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 2023:
Depreciation expense on right-of-use asset
Interest expense on lease liabilities
Rent expense - short-term leases
Total amounts recognised in profit or loss
Full year ended
30/06/2023
Full year ended
30/06/2022
$
$
81,008
6,790
1,560
89,358
81,008
10,682
1,560
93,250
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 2023:
As at 1 July 2021
Depreciation expense
Interest expense
Payments
As at 30 June 2022
As at 1 July 2022
Depreciation expense
Interest expense (a)
Payments (a)
As at 30 June 2023 (b)
Right-of-use Assets
Leased Premises
$
Lease Liability
Leased Premises
$
237,448
(81,008)
-
-
156,440
156,440
(81,008)
-
-
75,432
236,441
-
10,682
(81,853)
165,270
165,270
-
6,790
(85,127)
86,933
(a) The lease payments made during the year totalled $85,127 comprising $78,337 which represents the principal component
and $6,790 which represents the interest expense component.
(b) Of the total lease liability amounting to $86,933, the entire amount is current, and $Nil is non-current.
Full year ended
Full year ended
30/06/2023
30/06/2022
$
$
(10,752,270)
(9,497,370)
11,854
81,008
312,746
1,516,650
(10)
6,915
81,008
312,746
1,287,955
(13,394)
(181,672)
(2,412,317)
251,089
62,364
688,809
28,516
(8,698,241)
(9,517,132)
8. CASH AND CASH EQUIVALENTS (CONTINUED)
Reconciliation of net cash flows from operating activities
Loss for the year
Non cash items:
Depreciation (computer equipment)
Depreciation (lease: office rental)
Amortisation expense
Share-based payment expense
Unrealised foreign currency gain
Change in assets and liabilities:
Increase in trade and other receivables
Increase in trade and other payables
Increase in provisions
Net cash outflow used in operating activities
Non-cash financing and investing activities:
during the year ended 30 June 2023.
Financing facilities available:
overdrafts.
During the year, the Company issued 10,250,000 ordinary shares to a employees/contractors 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 financing and investing activities that occurred
As at 30 June 2023, the Company had no financing facilities available (2022: 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
Interest rate risk exposure:
The Company’s exposure to interest rate risk is discussed in Note 4.
Credit risk exposure:
equivalents mentioned above.
The maximum exposure to credit risk at the end of the reporting period is the carrying amount of each class of cash and cash
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.
Prepaid insurance
Goods and services tax receivable
Research and development tax rebate receivable
Other receivables
Total other receivables and prepayments
As at
As at
30/06/2023
30/06/2022
$
$
104,686
129,240
3,883,834
110,551
4,228,311
104,572
78,296
3,640,082
223,689
4,046,639
54 Actinogen Medical Limited
55
Annual Financial Report 55
Annual Financial Report
Notes to the Financial Statements
(continued)
12.
INTANGIBLE ASSETS
At cost
Accumulated amortisation
Total intangible assets
Movements during the year:
Opening balance at 1 July 2021
Amortisation expense
Closing balance at 30 June 2022
Opening balance at 1 July 2022
Amortisation expense
Closing balance at 30 June 2023
Intellectual property
As at
30/06/2023
$
5,756,743
(3,349,031)
2,407,712
As at
30/06/2022
$
5,756,743
(3,036,285)
2,720,458
Intellectual
Property
$
3,033,204
(312,746)
2,720,458
2,720,458
(312,746)
2,407,712
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 2023, 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. However, the above amount for Intangible Assets does not include
subsequent patent applications. During the period, the Company filed a provisional patent application for manufacturing and this
patent has not yet been granted. Costs associated with this filing have been expensed in the current year. 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
Trade payables
Accruals and other payables
Provision for payroll tax
Accrued employee bonuses
Employee tax liabilities
Total trade and other payables
As at
30/06/2023
$
1,101,471
148,199
-
256,050
53,750
As at
30/06/2022
$
898,739
91,395
13,663
264,291
40,293
1,559,470
1,308,381
Trade and other payables are non-interest-bearing liabilities stated at amortised cost and settled within 30 days.
As at
30/06/2023
$
83,652,836
(4,940,708)
78,712,128
As at
30/06/2022
$
81,883,378
(4,940,708)
76,942,670
14. CONTRIBUTED EQUITY
(a)
Fully paid ordinary shares
Fully paid ordinary shares
Capital raising costs
Total contributed equity
Balance at 30 June 2021
Issue of employee loan shares
Institutional Placement
Issue of director loan shares
Share Purchase Plan
Capital raising costs
Issue of employee loan shares
Share Purchase Plan
Balance at 30 June 2022
Issue of employee loan shares
Exercise of unlisted options
Exercise of unlisted options
Issue of employee loan shares
Balance at 30 June 2023
(b)
Reserve shares
As at 30 June 2023 there were 1,816,252,150 ordinary shares on issue. 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.
Of the 1,816,252,150 ordinary shares on issue, 95,012,300 are Loan Shares of which 10,250,000 were issued to an employee
and contractor during the year. Although they are issued ordinary shares that carry voting and divided rights they have been
accounted for as “in-substance options”.
Refer to the Directors’ Report, specifically section 3(C)(b)(iii) of the Remuneration Report for further information on these loan
shares.
Movement of fully paid ordinary shares during the year were as follows:
Date
Quantity
Unit Price $
Issue of employee loan shares
24/05/2022
16,000,000
16/09/2021
1/12/2021
18/11/2021
20/12/2021
1/01/2022
13/01/2022
6/04/2022
15/07/2022
11/11/2022
9/12/2022
20/03/2023
1,660,558,547
11,900,000
88,091,659
4,500,000
9,796,389
4,000,000
797,222
1,795,643,817
250,000
1,500,000
8,858,333
10,000,000
1,816,252,150
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. As at 30 June 2023, the following reserve shares were on issue.
Date
Quantity
Unit Price $
Balance at 30 June 2021
Issue of employee loan shares
Issue of non-executive Director loan shares
Issue of employee loan shares
Issue of employee loan shares
Balance at 30 June 2022
Issue of employee loan shares
Issue of employee loan shares
Balance at 30 June 2023
24/05/2022
(16,000,000)
16/09/2021
18/11/2021
13/01/2022
15/07/2022
20/03/2023
(48,362,300)
(11,900,000)
(4,500,000)
(4,000,000)
(84,762,300)
(250,000)
(10,000,000)
(95,012,300)
Refer to the Directors’ Report, specifically section 11.3(C)(b) of the Remuneration Report for information on these loan shares.
0.110
0.135
0.200
0.135
0.195
0.135
0.088
0.066
0.100
0.085
0.085
0.110
0.200
0.195
0.088
0.066
0.085
Total $
60,054,459
1,309,000
11,892,374
900,000
1,322,501
(831,289)
780,000
107,625
1,408,000
76,942,670
16,500
150,000
752,958
850,000
78,712,128
Total $
(1,934,492)
(1,309,000)
(900,000)
(780,000)
(1,408,000)
(6,331,492)
(16,500)
(850,000)
(7,197,992)
5656
Actinogen Medical Limited
56 Actinogen Medical Limited
Annual Financial Report 57
Actinogen Medical Limited Notes to the Financial Statements
(continued)
12.
INTANGIBLE ASSETS
At cost
Accumulated amortisation
Total intangible assets
Movements during the year:
Opening balance at 1 July 2021
Amortisation expense
Closing balance at 30 June 2022
Opening balance at 1 July 2022
Amortisation expense
Closing balance at 30 June 2023
Intellectual property
As at
30/06/2023
$
5,756,743
(3,349,031)
2,407,712
As at
30/06/2022
$
5,756,743
(3,036,285)
2,720,458
Intellectual
Property
$
3,033,204
(312,746)
2,720,458
2,720,458
(312,746)
2,407,712
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 2023, 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. However, the above amount for Intangible Assets does not include
subsequent patent applications. During the period, the Company filed a provisional patent application for manufacturing and this
patent has not yet been granted. Costs associated with this filing have been expensed in the current year. 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
Trade payables
Accruals and other payables
Provision for payroll tax
Accrued employee bonuses
Employee tax liabilities
Total trade and other payables
As at
30/06/2023
$
1,101,471
148,199
-
256,050
53,750
As at
30/06/2022
$
898,739
91,395
13,663
264,291
40,293
1,559,470
1,308,381
Trade and other payables are non-interest-bearing liabilities stated at amortised cost and settled within 30 days.
14. CONTRIBUTED EQUITY
14. CONTRIBUTED EQUITY
(a) Fully paid ordinary shares
(a)
Fully paid ordinary shares
Fully paid ordinary shares
Fully paid ordinary shares
Capital raising costs
Capital raising costs
Total contributed equity
Total contributed equity
As at
As at
30/06/2023
30/06/2023
$
$
As at
As at
30/06/2022
30/06/2022
$
$
83,652,836
83,652,836
(4,940,708)
(4,940,708)
78,712,128
78,712,128
81,883,378
81,883,378
(4,940,708)
(4,940,708)
76,942,670
76,942,670
As at 30 June 2023 there were 1,816,252,150 ordinary shares on issue. Ordinary shares entitle the holder to participate in
As at 30 June 2023 there were 1,816,252,150 ordinary shares on issue. 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.
dividends and the winding up of the Company in proportion to the number and amount paid on the share held.
Of the 1,816,252,150 ordinary shares on issue, 95,012,300 are Loan Shares of which 10,250,000 were issued to an employee
Of the 1,816,252,150 ordinary shares on issue, 95,012,300 are Loan Shares of which 10,250,000 were issued to an employee
and contractor during the year. Although they are issued ordinary shares that carry voting and divided rights they have been
and contractor during the year. Although they are issued ordinary shares that carry voting and divided rights they have been
accounted for as “in-substance options”.
accounted for as “in-substance options”.
Refer to the Directors’ Report, specifically section 3(C)(b)(iii) of the Remuneration Report for further information on these loan
Refer to the Directors’ Report, specifically section 3(C)(b)(iii) of the Remuneration Report for further information on these loan
shares.
shares.
Movement of fully paid ordinary shares during the year were as follows:
Movement of fully paid ordinary shares during the year were as follows:
Date
Date
Quantity
Quantity
Unit Price $
Unit Price $
Balance at 30 June 2021
Balance at 30 June 2021
Issue of employee loan shares
Issue of employee loan shares
Institutional Placement
Institutional Placement
Issue of director loan shares
Issue of director loan shares
Share Purchase Plan
Share Purchase Plan
Capital raising costs
Capital raising costs
Issue of employee loan shares
Issue of employee loan shares
Share Purchase Plan
Share Purchase Plan
16/09/2021
16/09/2021
1/12/2021
1/12/2021
18/11/2021
18/11/2021
20/12/2021
20/12/2021
1/01/2022
1/01/2022
13/01/2022
13/01/2022
6/04/2022
6/04/2022
1,660,558,547
1,660,558,547
11,900,000
11,900,000
88,091,659
88,091,659
4,500,000
4,500,000
9,796,389
9,796,389
4,000,000
4,000,000
797,222
797,222
Issue of employee loan shares
Issue of employee loan shares
24/05/2022
24/05/2022
16,000,000
16,000,000
Balance at 30 June 2022
Balance at 30 June 2022
Issue of employee loan shares
Issue of employee loan shares
Exercise of unlisted options
Exercise of unlisted options
Exercise of unlisted options
Exercise of unlisted options
15/07/2022
15/07/2022
11/11/2022
11/11/2022
9/12/2022
9/12/2022
1,795,643,817
1,795,643,817
250,000
250,000
1,500,000
1,500,000
8,858,333
8,858,333
Issue of employee loan shares
Issue of employee loan shares
20/03/2023
20/03/2023
10,000,000
10,000,000
Balance at 30 June 2023
Balance at 30 June 2023
1,816,252,150
1,816,252,150
0.110
0.110
0.135
0.135
0.200
0.200
0.135
0.135
0.195
0.195
0.135
0.135
0.088
0.088
0.066
0.066
0.100
0.100
0.085
0.085
0.085
0.085
Total $
Total $
60,054,459
60,054,459
1,309,000
1,309,000
11,892,374
11,892,374
900,000
900,000
1,322,501
1,322,501
(831,289)
(831,289)
780,000
780,000
107,625
107,625
1,408,000
1,408,000
76,942,670
76,942,670
16,500
16,500
150,000
150,000
752,958
752,958
850,000
850,000
78,712,128
78,712,128
(b) Reserve shares
(b)
Reserve shares
Reserves shares (‘Loan shares’) are ordinary shares that have historically been accounted for as “in-substance options”. No
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. As at 30 June 2023, the following reserve shares were on issue.
loan amount is recognised in the financial statements. As at 30 June 2023, the following reserve shares were on issue.
Balance at 30 June 2021
Balance at 30 June 2021
Date
Date
Quantity
Quantity
Unit Price $
Unit Price $
Total $
Total $
(48,362,300)
(48,362,300)
(1,934,492)
(1,934,492)
Issue of employee loan shares
Issue of employee loan shares
16/09/2021
16/09/2021
(11,900,000)
(11,900,000)
0.110
0.110
(1,309,000)
(1,309,000)
Issue of non-executive Director loan shares
Issue of non-executive Director loan shares
Issue of employee loan shares
Issue of employee loan shares
Issue of employee loan shares
Issue of employee loan shares
Balance at 30 June 2022
Balance at 30 June 2022
Issue of employee loan shares
Issue of employee loan shares
Issue of employee loan shares
Issue of employee loan shares
Balance at 30 June 2023
Balance at 30 June 2023
18/11/2021
18/11/2021
13/01/2022
13/01/2022
(4,500,000)
(4,500,000)
0.200
0.200
(4,000,000)
(4,000,000)
0.195
0.195
(900,000)
(900,000)
(780,000)
(780,000)
24/05/2022
24/05/2022
(16,000,000)
(16,000,000)
0.088
0.088
(1,408,000)
(1,408,000)
(84,762,300)
(84,762,300)
15/07/2022
15/07/2022
(250,000)
(250,000)
20/03/2023
20/03/2023
(10,000,000)
(10,000,000)
0.066
0.066
0.085
0.085
(95,012,300)
(95,012,300)
(6,331,492)
(6,331,492)
(16,500)
(16,500)
(850,000)
(850,000)
(7,197,992)
(7,197,992)
Refer to the Directors’ Report, specifically section 11.3(C)(b) of the Remuneration Report for information on these loan shares.
Refer to the Directors’ Report, specifically section 11.3(C)(b) of the Remuneration Report for information on these loan shares.
56
56 Actinogen Medical Limited
Actinogen Medical Limited
57
Annual Financial Report 57
Annual Financial Report 57
Annual Financial Report
Notes to the Financial Statements
(continued)
14. CONTRIBUTED EQUITY (CONTINUED)
(c) Unissued ordinary shares under option
Quantity
Type of Option
6,400,000
Director Options
5,700,000
Employee Options
5,000,000
Employee Options
3,000,000
Director Options
5,000,000
Director Options
1,600,000
Employee Options
Grant Date
Exercise Price
Expiry Date
28/11/2018
12/12/2018
1/02/2019
4/04/2019
24/03/2017
28/09/2020
$0.085
$0.085
$0.093
$0.100
$0.100
$0.046
27/11/2023
12/12/2023
1/02/2024
4/04/2024
24/03/2025
27/09/2025
26,700,000 Total unissued ordinary shares under option
During the year, and up to the date of this Report, no options were issued, expired, lapsed or forfeited. However, during the
year 1,500,000 options were exercised at $0.10 each and 8,858,333 options were exercised at $0.085 each. 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.
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.
Option reserve
Total reserves
Movements during the year:
Balance at the beginning of the period
Share-based payment expense on Director options
Share-based payment expense on Employee options
Share-based payment expense on Employee loan shares
Share-based payment expense on Director loan shares
Balance at end of period
As at
30/06/2023
As at
30/06/2022
$
$
10,584,632
9,067,982
10,584,632
9,067,982
Year ended
30/06/2023
Year ended
30/06/2022
$
$
9,067,982
7,780,027
-
9,867
1,130,082
376,701
25,745
34,459
580,749
647,002
10,584,632
9,067,982
Total share-based payment expenses recognised during the year amounted to $1,516,650. For further information on share-
based payments refer to Note 22. For further information on loan shares and unissued ordinary shares under option refer to
Note 14.
58
58 Actinogen Medical Limited
Actinogen Medical Limited
16. REMUNERATION OF AUDITOR
Amounts paid or payable to Ernst & Young for:
An audit or review of the financial statements of the entity
Grant Date
Exercise Price
Expiry Date
17. LOSSES PER SHARE
Net loss used in calculating loss per share ($)
Full year ended
30/06/2023
$
Full year ended
30/06/2022
$
75,700
75,700
69,500
69,500
Full year ended
30/06/2023
(10,752,270)
Full year ended
30/06/2022
(9,497,370)
Weighted number of ordinary shares used as the denominator ('000)
1,801,548
1,717,092
Basic and diluted loss per share from continuing operations attributable to
the ordinary shareholders of the Company (cents)
(0.60)
(0.55)
As at 30 June 2023, there were 26,700,000 (2022: 37,058,333) unissued ordinary shares under option and 95,012,300 loan
shares (2022: 84,762,300) 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 2023 (2022:
USD$480,000).
19. EVENTS SUBSEQUENT TO THE END OF FINANCIAL YEAR
On 2 August 2023 the Company announced a Rights Issue to all eligible shareholders to raise approximately $10 million (before
costs) and issue of approximately 400 million new shares and approximately 200 million new unlisted options The closing date
is 4 September 2023.
The non renounceable offer is as follows:
1. One new share for every 4.54 shares held at an issue price of $0.025 (2.5 cents) per new share; and
2. One free unlisted option for every two new shares issued under the offer. The new unlisted options have an exercise
price of $0.0375 (3.75 cents) each and have an expiry date of 36 months after the issue date.
Other than the above, 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.
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.
Total share-based payment expenses recognised during the year amounted to $1,516,650. 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
59
Annual Financial Report 59
Notes to the Financial Statements
(continued)
14. CONTRIBUTED EQUITY (CONTINUED)
(c) Unissued ordinary shares under option
Quantity
Type of Option
6,400,000
Director Options
5,700,000
Employee Options
5,000,000
Employee Options
3,000,000
Director Options
5,000,000
Director Options
1,600,000
Employee Options
28/11/2018
12/12/2018
1/02/2019
4/04/2019
24/03/2017
28/09/2020
$0.085
$0.085
$0.093
$0.100
$0.100
$0.046
27/11/2023
12/12/2023
1/02/2024
4/04/2024
24/03/2025
27/09/2025
26,700,000 Total unissued ordinary shares under option
During the year, and up to the date of this Report, no options were issued, expired, lapsed or forfeited. However, during the
year 1,500,000 options were exercised at $0.10 each and 8,858,333 options were exercised at $0.085 each. 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.
At shareholders’ meetings each ordinary share is entitled to one vote when a poll is called, otherwise each shareholder has a
(d) Terms and Conditions of Issued Capital
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.
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.
Option reserve
Total reserves
Movements during the year:
Balance at the beginning of the period
Share-based payment expense on Director options
Share-based payment expense on Employee options
Share-based payment expense on Employee loan shares
Share-based payment expense on Director loan shares
Balance at end of period
Note 14.
58 Actinogen Medical Limited
As at
As at
30/06/2023
30/06/2022
$
$
10,584,632
9,067,982
10,584,632
9,067,982
Year ended
30/06/2023
Year ended
30/06/2022
$
$
9,067,982
7,780,027
-
9,867
1,130,082
376,701
25,745
34,459
580,749
647,002
10,584,632
9,067,982
Annual Financial Report
Notes to the Financial Statements
(continued)
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
Dr Steven Gourlay
Dr George Morstyn
Mr Malcolm McComas
Dr Nicki Vasquez
Ms Tamara Miller
Mr Jeff Carter
Prof Paul Rolan
Dr Dana Hilt
Non-Executive Chairman
Managing Director / Chief Executive Officer
Non-Executive Director
Non-Executive Director
Non-Executive Director
Senior Vice President - Product Development
Chief Financial Officer
Chief Medical Officer
Chief Medical Officer
Current
Current
Current
Current
Current
Current
Current
Resigned
Current
Short-term employee benefits
Termination benefits
Post-employment benefits
Long-term benefits
Share-based payments
Full year ended
30/06/2023
$
1,494,866
-
71,543
63,652
861,624
Full year ended
30/06/2022
$
1,233,828
-
56,725
50,880
897,681
2,491,685
2,239,114
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 24 to 35.
60
60 Actinogen Medical Limited
Actinogen Medical Limited Notes to the Financial Statements
(continued)
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
Dr Steven Gourlay
Dr George Morstyn
Mr Malcolm McComas
Dr Nicki Vasquez
Ms Tamara Miller
Mr Jeff Carter
Prof Paul Rolan
Dr Dana Hilt
Non-Executive Chairman
Managing Director / Chief Executive Officer
Non-Executive Director
Non-Executive Director
Non-Executive Director
Chief Financial Officer
Chief Medical Officer
Chief Medical Officer
Senior Vice President - Product Development
Current
Current
Current
Current
Current
Current
Current
Resigned
Current
Short-term employee benefits
Termination benefits
Post-employment benefits
Long-term benefits
Share-based payments
Full year ended
Full year ended
30/06/2023
30/06/2022
1,494,866
1,233,828
$
-
71,543
63,652
861,624
$
-
56,725
50,880
897,681
2,491,685
2,239,114
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 24 to 35.
60 Actinogen Medical Limited
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Actinogen Medical Limited
Directors’ Declaration
In the Directors’ opinion:
1.
The Financial Statements and Notes set out on pages 39 to 62, are in accordance with the Corporations Act 2001
including:
(a)
(b)
complying with Accounting Standards, the Corporations Regulations 2001 and other mandatory professional
reporting requirements
giving a true and fair view of the Company’s financial position as at 30 June 2023 and of its performance for the year
ended on that date.
2.
3.
4.
5.
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.
This declaration is made in accordance with a resolution of the Directors.
Dr Steven Gourlay
Managing Director
Sydney, New South Wales
30 August 2023
Annual Financial Report 6363
Annual Financial Report 63
Annual Financial Report
Independent Auditor’s Report
64
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 2023, the statement of comprehensive income, statement of changes in equity and statement of cash flows for the year then ended, notes to the financial statements, including a summary of significant accounting policies, 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 2023 and of itsfinancial performance for the year ended on that date; andb.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. Material uncertainty related to going concern We draw attention to Note 2(b) in the financial report, which describes the events or conditions that raise doubt about the Company’s ability to continue as a going concern. These events or conditions indicate that a material uncertainty exists that may cast significant doubt on the Company’s ability to continue as a going concern. Our opinion is not modified in respect of this matter. 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. In addition to the matter described in the Material uncertainty related to going concern section, we have determined the matter described below to be a key audit matter to be communicated in our report. For the matter below, our description of how our audit addressed the matter is provided in that context. Actinogen Medical Limited 65
A member firm of Ernst & Young Global Limited Liability limited by a scheme approved under Professional Standards Legislation 2 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. Research and development rebate Why significant How our audit addressed the key audit matter The Company has recognised a rebate receivable of $3.9 million 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 2023 year. This amount has been included in other receivables and prepayments on the statement of financial position as at 30 June 2023 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 Note 9 to 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 2023 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. Annual Financial Report Independent Auditor’s Report (continued)
66
A member firm of Ernst & Young Global Limited Liability limited by a scheme approved under Professional Standards Legislation 3 Responsibilities of the directors for the financial report The directors of the Company are responsible for the preparation of the financial report that gives a true and fair view in accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal control as the directors determine is necessary to enable the preparation of the financial report that gives a true and fair view and is free from material misstatement, whether due to fraud or error. In preparing the financial report, the directors are responsible for assessing the Company’s ability to continue as a going concern, disclosing, as applicable, matters relating to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the Company or to cease operations, or have no realistic alternative but to do so. Auditor’s responsibilities for the audit of the financial report Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with the Australian Auditing Standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of this financial report. As part of an audit in accordance with the Australian Auditing Standards, we exercise professional judgment and maintain professional scepticism throughout the audit. We also: ►Identify and assess the risks of material misstatement of the financial report, whether due tofraud or error, design and perform audit procedures responsive to those risks, and obtain auditevidence that is sufficient and appropriate to provide a basis for our opinion. The risk of notdetecting a material misstatement resulting from fraud is higher than for one resulting fromerror, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or theoverride of internal control.►Obtain an understanding of internal control relevant to the audit in order to design auditprocedures that are appropriate in the circumstances, but not for the purpose of expressing anopinion on the effectiveness of the Company’s internal control.►Evaluate the appropriateness of accounting policies used and the reasonableness of accountingestimates and related disclosures made by the directors.►Conclude on the appropriateness of the directors’ use of the going concern basis of accountingand, based on the audit evidence obtained, whether a material uncertainty exists related toevents or conditions that may cast significant doubt on the Company’s ability to continue as agoing concern. If we conclude that a material uncertainty exists, we are required to drawattention in our auditor’s report to the related disclosures in the financial report or, if suchdisclosures are inadequate, to modify our opinion. Our conclusions are based on the auditevidence obtained up to the date of our auditor’s report. However, future events or conditionsmay cause the Company to cease to continue as a going concern.►Evaluate the overall presentation, structure and content of the financial report, including thedisclosures, and whether the financial report represents the underlying transactions and eventsin a manner that achieves fair presentation.Actinogen Medical Limited 67
A member firm of Ernst & Young Global Limited Liability limited by a scheme approved under Professional Standards Legislation 4 We communicate with the directors regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. We also provide the directors with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards applied. From the matters communicated to the directors, we determine those matters that were of most significance in the audit of the financial report of the current year and are therefore the key audit matters. We describe these matters in our auditor’s report unless law or regulation precludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication. Report on the audit of the Remuneration Report Opinion on the Remuneration Report We have audited the Remuneration Report included in the directors’ report for the year ended 30 June 2023. In our opinion, the Remuneration Report of Actinogen Medical Limited for the year ended 30 June 2023, 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 Pierre Dreyer Partner Perth 30 August 2023 Annual Financial Report Shareholder Information
Substantial shareholders:
The following substantial shareholders have lodged notices with the company as at 3 August 2023:
Holders
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.
Distribution of ordinary shareholders as at 3 August 2023
Range of Holding
1-1,000
1,001-5,000
5,001-10,000
10,001 - 100,000
100,001 – over
Total
Shares
Percentage of
Issued Capital
247,334,680
13.77%
Holders
119
296
592
2,258
1,456
Shares
14,013
1,102,362
4,825,465
95,349,260
1,714,961,050
4,721
1,816,252,150
Shareholders with less than a marketable parcel
1,455
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 3 August 2023
HSBC Custody Nominees (Australia) Limited
Dr Steven Gourlay
Edinburgh Technology Fund Limited
JSC Wealth Management Pty Ltd
Citicorp Nominees Pty Limited
Tisia Nominees Pty Ltd
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