Annual Report
2022
Contents
Contents
Who we are
Highlights
The Xanamem Pipeline
About Xanamem and Cortisol Diseases
Clinical Trials Program Overview
Chair’s Letter
Chief Executive Officer’s Letter
Vision and Strategy
Operating & Financial Review
Board of Directors and Company Secretary
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
Disclaimer
1
2
3
4
5
6
8
10
12
18
20
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67
69
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
FY2022 was a highly productive year and has set a clear
pathway forward for clinical trials focused on cognition
Reported strongly positive
results for XanaMIA
Part A trial
Prioritized Alzheimer’s
Disease (AD) & Cognitive
Impairment in Depressive
Disorder (CIDD) clinical
trial programs
Announced high level
trial design for
XanaMIA Part B
AD trial and XanaCIDD
Depression trial
Successfully completed a
$13.3m1 capital raising
Reallocated circa
$12m of resources to
cognition-focused clinical
trial programs
Finalized a clinical
protocol for a strategic
collaboration with Oxford
University researchers2
Attended several
significant international
partnering conferences
Continued scale-up
manufacturing & initiated
tablet formulation
Established two new
Xanamem clinical
advisory boards
Appointed highly
credentialled CMO & VP
Clinical Operations
Strengthened IP portfolio
with grant of Brazilian
patent application
Launched new website
and corporate branding
& logo
1 Unless otherwise stated all financial data is quoted in Australian dollars
2 To investigate the therapeutic potential for Xanamem to control the metabolic effects of excessive cortisol in a disease called Mild Autonomous Cortisol
Secretion (MACS)
2
Actinogen Medical Limited The Xanamem® Pipeline
Phase 2 placebo-controlled trials
Outlook
Cognitive impairment in
early Alzheimer’s Disease
Biomarker analysis in patients with mild AD
Cognitive benefit in patients with early stages of AD
Depression with
cognitive impairment
Depression and cognitive impairment
Anxiety, sleep &
behavioural problems
in Fragile X Syndrome
Proof-of-concept in adolescent and young adult males
Pivotal trials
focused on
cognitive
enhancement
Pivotal trials
assessing both
depression and
cognitive impairment
Pending alternative
funding e.g.
partnerships or grants
® Xanamem is a registered trademark of Actinogen Medical Limited.
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
About Xanamem and
Cortisol Diseases
Xanamem1 is a unique molecule
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.
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. Recent human
target engagement data for the drug in the brain suggests
good activity of doses as low as 5mg daily. Clinical safety
data has been collected from more than 300 individual
patients or volunteers.
The Company is undertaking a Phase 2 placebo-controlled
trial evaluating Xanamem in the treatment of Mild Cognitive
Impairment (MCI) or mild AD, where some functional
impairment (difficulty completing activities of daily
living) is also present. It is also conducting a Phase 2
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.
Science & inhibition of
11β-HSD1: the cortisol
hypothesis
Xanamem was developed in response to a large body
of evidence from animals and humans implicating
cortisol, commonly known as the ’stress hormone’,
in cognitive decline. While cortisol is produced in
times of physical and mental stress, this response is
normal if temporary. However, if cortisol levels remain
elevated for long periods of time, it is believed to
negatively affect important areas of the brain and
may contribute to the formation of abnormal proteins
associated with Alzheimer’s Disease such as amyloid
beta and tau. Excess brain cortisol is also linked to
the severity of major depression and small clinical
trials designed to modify brain cortisol action have
shown promise.
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
Dear Shareholder,
I am pleased to present to you the Actinogen Medical Annual Report
for the financial year ended 30 June 2022.
It has been another year of major achievements for the
Company and significant advancement in the clinical
development pipeline.
Not only did we successfully navigate the complexities and
challenges of managing clinical programs at the height of the
global COVID-19 pandemic, but we also met our strategic
objectives centered around operational excellence,
strengthening people and partnerships and forward planning
to optimize timelines to marketing approvals.
Our most significant announcement for the year was in April
where we reported positive results for safety and cognition
from our XanaMIA Part A trial, which replicated the
improvements in working memory and attention seen in the
prior XanaHES trial.
Subsequently, we announced the immediate prioritization of
Alzheimer’s Disease (AD) and Cognitive Impairment in (Major)
Depressive Disorder (CIDD) domestic clinical trial programs,
where cognition is the primary focus, and the suspension of
our more complex and lengthier international Fragile X
Syndrome (FXS) trial program.
That strategic decision allowed us to reallocate circa $12
million of resources from the FXS program to the expedited
AD and CIDD programs.
Readers can find out more details about the Company’s
adjusted strategic objectives for FY2023 in the Vision and
Strategy section of this annual report on pages 10 and 11.
Executive Leadership
Steven Gourlay has continued to excel in the role of CEO,
achieving many milestones with the team throughout the
year. He has brought a broad set of drug development,
people and business development skills to the Company and I
look forward to more great achievements in FY2023.
In February, the Company was pleased to appoint Professor
Paul Rolan as Chief Medical Officer (CMO) reporting to Dr
Gourlay. Professor Rolan is a clinical pharmacologist and
neurology drug development consultant and one of
Australia's most experienced clinical trial investigators and
drug developers.
We also made two further changes of note to the executive
leadership team.
The first was the promotion of Ms Tamara Miller to the
position of Senior Vice President, Product Development. Ms
Miller has been a key driving force behind the Company’s
clinical development program in recent years.
The second was the appointment of Ms Cheryl Townsend to
the newly created role of Vice President, Clinical Operations.
Ms Townsend has extensive experience with clinical trial
operations in the Asia-Pacific region across all phases of
clinical development.
Expanding the advisory and larger team
We were pleased to announce the establishment of two new
Xanamem clinical advisory boards for the Depression and
FXS programs during the year.
The inaugural expert appointments to those boards comprise
five renowned global thought leaders in clinical trials for
Depression and assessment of Cognition, and FXS:
Depression and Cognition Clinical Advisory Board:
Professor John Harrison, PhD, based in the UK
•
• Dr Dana C. Hilt, MD based in the USA
• Dr Christina Kurre Olsen based in Denmark
Fragile X Syndrome Clinical Advisory Board
(currently inactive while FXS program suspended):
• Dr Elizabeth Berry-Kravis, MD, PhD
• Dr Pam Ventola, PhD, both based in the USA
Further details on all Actinogen board, advisory board and
senior executive personnel can be found on the Company’s
recently updated and improved corporate website,
www.actinogen.com.au
We continue to fill vital organisational and technical
consultant roles to drive strategic initiatives and ensure the
success of our clinical development program and other
operational requirements.
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 the success
of the Company in the 2022 financial year.
6 Actinogen Medical Limited
Actinogen represents a unique opportunity
because the clinical trial data on more than 300
people treated with Xanamem is compelling.
Balance sheet strength
Annual General Meeting
Actinogen is in a strong financial position with $16.4 million in
cash as at 30 June 2022 ($13.4 million 30 June 2021), having
successfully raised $13.3 million in December 2021 at an
offer price of 13.5 cents per share. Additional funds of $3.6
million are expected from the R&D tax incentive cash refund
in the coming months.
Shareholders subsequently ratified the issue of new shares
for the December 2021 placement at a general meeting of the
Company in April 2022 including the approval of 797,222
shares issued to Dr Steven Gourlay who subscribed for
shares at the 13.5 cents per share issue price.
Board and corporate governance
The Actinogen Board seeks continuous improvement in its
governance and management oversight capability. During the
past year we conducted our periodic review of all activities
and responsibilities, including the Board skills matrix to
identify gaps and opportunities for improvement. Specific
developments for the Board were:
• First year of operation of the Audit Committee to monitor
and review the integrity of the Company’s financial
reporting
• Development of a refined Key Performance Indicator (KPI)
evaluation processes – KPIs are used for incentivizing
employees and contractors.
We will continue to assess the skills suitable for the Board
and where appropriate make changes and/or additions.
In consideration of the on-going COVID-19 pandemic, this
year’s Annual General Meeting will be in a ‘hybrid’, allowing
both in person and virtual attendance and voting. We will
advise shareholders in due course of the details of the
meeting and voting procedures.
Outlook
Actinogen has completed a busy and valuable year with the
major achievement being the replication and confirmation of
the cognitive enhancing properties of our lead molecule
Xanamem at 5 mg and 10 mg dose levels.
The Board remains confident about the prospects of the
Company in 2023 and beyond. We now enter an exciting
period of Phase 2 clinical data generation, with clinical data
readouts for biomarkers in AD expected before the end of
October 2022, the XanaCIDD trial in late 2023 or 2024 and
the XanaMIA Part B trial in early AD in 2024.
We will continue to proactively manage all aspects of our
program, working closely with existing and potential new
partners, to ensure the best possible outcomes for you, our
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.
Dr Geoff Brooke
Chair
25 August 2022
Annual Financial Report 7
Chief Executive
Officer’s Letter
Dear Shareholder,
Accelerating the clinical development pipeline by ’following the
science’
As we outlined in our recent 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:1
• 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.
During the year we strengthened the team to implement
these principles with new appointments of:
• Professor Paul Rolan as Chief Medical Officer
• Cheryl Townsend as VP Clinical Operations
• Promotion of Tamara Miller to Senior VP Product
Development.
The operational highlight of a highly productive 2022 financial
year was undoubtedly the strongly positive results from the
XanaMIA Part A Alzheimer’s Disease trial that the Company
announced in late April 2022.
The results confirmed Xanamem’s ability to rapidly enhance
attention and working memory (referred to as cognition – the
ability to think and remember things) and replicated the
pattern of improvement seen in the prior XanaHES trial.
Following these highly confirmatory results, we initiated
decisive adjustments to our strategy to prioritize Alzheimer’s
Disease (AD) and Cognitive Impairment in Depressive
Disorder (CIDD) clinical trial programs where cognition is the
primary focus. We are accelerating Xanamem’s clinical
development with a focus on cognitive enhancement to
optimize the path to commercialisation.
Actinogen has the right team
in place driving the right
clinical strategy to create the
greatest value from our highly
promising drug Xanamem.
While the strategy adjustment also prompted the suspension
of our more complex global XanaFX Fragile X Syndrome trial,
the renewed focus on cognitive enhancement allowed us to
re-allocate circa $12 million of resources from that program
to our two cognition-focused programs.2
We were then able to announce the high-level trial design
and commencement of activities and detailed planning for our
next two major trials:
• XanaMIA Part B Phase 2 AD trial - a placebo-
controlled 24-week trial measuring the effects of
Xanamem on safety and cognitive performance in
participants with early stages of AD
• XanaCIDD Phase 2 Depression trial - a placebo-
controlled, 6-week 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.
Early in the 2023 financial year we also provided information
on the timing and design of the Phase 2 biomarker study in
patients with Mild AD. This study is a prospective analysis of
the effects of Xanamem on AD biomarkers using stored blood
samples from the prior placebo-controlled XanADu Phase 2
trial. The result of this analysis is expected to be announced
before the end of October 2022.
1 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
2 The strong scientific rationale for the FXS program has not changed and the
Company will investigate alternative funding, partnership, and implementation
models to study the utility of Xanamem in people with FXS.
8 Actinogen Medical Limited
The operational highlight of a highly productive
2022 financial year was undoubtedly the
strongly positive results from the XanaMIA
Part A Alzheimer’s Disease trial.
Business development & partnering
The outlook is positive
We continued to attend important international conferences
during the year either virtually or in person to facilitate
partner engagement and relationship building.
We are delighted with the success we have had on our
journey to this point, and I would like to extend my thanks to
the team for their hard work in the 2022 financial year.
In January, I attended the Biopartnering @JPM associated
with the 40th annual JP Morgan HealthCare Conference in
San Francisco. While there, I conducted multiple business
development and other stakeholder meetings during the
conference week and presented at the H.C. Wainwright
BioConnect Virtual Conference that runs concurrently with
the JP Morgan conference.
In June 2022, I attended the BIO International Convention in
San Diego with the Company’s Head of Business
Development, Dr Christian Toouli.
Based on the results of our trials conducted in more than 300
patients so far, we firmly believe that Xanamem has the
potential to be a first in class drug in the treatment of early
stage Alzheimers Disease and to be a first-in-class cognitive
enhancer for Depression, with the added potential for being a
successful anti-depressant (possible ’dual action‘).
The Company is now actively commencing an expanded
Phase 2 program in AD and CIDD and continues to evaluate
alternate funding solutions such as partnership and grants to
progress the FXS Phase 2 trial.
The convention is the world’s largest gathering of the
biotechnology industry and an immensely important event in
the meeting calendar.
Thank you for your ongoing support for Actinogen. We look
forward to updating you on our progress in the near future
with each successive trial milestone.
We used the opportunity to conduct approximately thirty
business development and stakeholder meetings to update
potential pharmaceutical and biotech industry partners on the
Company’s clinical development pipeline and its near and
medium-term milestones.
Yours sincerely,
Dr Steven Gourlay
CEO & Managing Director
25 August 2022
Xanamem’s promising story as a breakthrough oral therapy
for Alzheimer’s Disease and many other illnesses continues to
garner great interest.
With a strong cash position of $16.4 million at the end of the
2022 financial year, we can take the appropriate time to
determine if any potential partnerships would create true
synergy and increased value for shareholders.
Annual Financial Report 9
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
� Build on improved attention and working memory in two independent, placebo-controlled trials� Initiate Phase 2 trial in patients with the early stages of Alzheimer’s Disease (XanaMIA Part B)� Initiate Phase 2 trial in patients with Cognitive Impairment and Depressive Disorder (XanaCIDD)� Leverage ‘hands on’ clinical operations and management based in Australia to speed timelines and reduce cost� Defer FXS Phase 2 trial until alternative funding from partnerships or grants availableAccelerate clinical development in cognitive impairmentAccelerate clinical development in cognitive impairmentCreate value from partnerships� Explore high value regional partnerships in the near term� Engage with the universe of potential biopharma partners who could create synergy for the Xanamem program� Ensure 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 globallyCreate value from partnerships� Complete additional manufacturing activities for scale-up and supply of future clinical trials� Complete tablet development for use in Phase 3 trials and subsequent commercial launch� Integrate global regulatory strategic planning to optimize path to marketing approvals� Complete required regulatory nonclinical studies to the Good Laboratory Practice standard� Plan ancillary clinical and nonclinical studies required for marketing approvalsForward planningFY2023 Strategic PrioritiesForward planningActinogen 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
11
� Build on improved attention and working memory in two independent, placebo-controlled trials� Initiate Phase 2 trial in patients with the early stages of Alzheimer’s Disease (XanaMIA Part B)� Initiate Phase 2 trial in patients with Cognitive Impairment and Depressive Disorder (XanaCIDD)� Leverage ‘hands on’ clinical operations and management based in Australia to speed timelines and reduce cost� Defer FXS Phase 2 trial until alternative funding from partnerships or grants availableAccelerate clinical development in cognitive impairmentAccelerate clinical development in cognitive impairmentCreate value from partnerships� Explore high value regional partnerships in the near term� Engage with the universe of potential biopharma partners who could create synergy for the Xanamem program� Ensure 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 globallyCreate value from partnerships� Complete additional manufacturing activities for scale-up and supply of future clinical trials� Complete tablet development for use in Phase 3 trials and subsequent commercial launch� Integrate global regulatory strategic planning to optimize path to marketing approvals� Complete required regulatory nonclinical studies to the Good Laboratory Practice standard� Plan ancillary clinical and nonclinical studies required for marketing approvalsForward planningFY2023 Strategic PrioritiesForward planningAnnual 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 REVIEW3
Highlights
Clinical program
•
•
•
•
•
•
•
Reported strongly positive results for attention and working memory (cognition) in the XanaMIA Part A Phase 2 trial,
confirming the same pattern of improvement seen in the prior XanaHES trial
Initiated strategic adjustments to prioritize AD and Depression clinical trial programs where cognition is the primary
outcome of measurement
Announced high level trial design and commencement of activities for XanaMIA Part B Phase 2 AD trial and the XanaCIDD
Phase 2 Depression trial
Announced that the Phase 2 biomarker trial data will be available by the end of October and that the final sample size will
be approximately 70 participants (post financial year end announcement)
Finalized a clinical protocol for a strategic collaboration with Oxford University researchers to investigate the therapeutic
potential for Xanamem to control the metabolic effects of excessive cortisol in a disease called Mild Autonomous Cortisol
Secretion (MACS)
Established two new Xanamem clinical advisory boards for Depression and FXS programs
Appointed highly credentialled Chief Medical Officer Professor Paul Rolan and VP Clinical Operations Cheryl Townsend,
and continued to expand expertise through appointment of key employees and consultants
Manufacturing
Continued scale-up manufacturing with Corden Pharma
Initiated tablet development with Metrics Contract Services
•
•
Finances
•
•
•
Successfully completed a $13.3 million capital raising in December 2021 to fund the clinical development pipeline
Year-end cash balance of $16.4 million
Reallocated circa $12 million of resources from suspended Fragile X Syndrome program to clinical trial programs where
cognition is the primary focus
Corporate and Business Development
•
Attended and participated in several significant international conferences, events and meetings that facilitated
opportunities for engagement with potential commercial partners
Launched new corporate branding and logo. Launched new and enhanced corporate website
•
Intellectual Property
•
•
•
Received Grant of final composition of matter patent for Xanamem received from Brazilian Patent and Trademark Office
which completes the global patent approvals for that patent family, granting composition of matter protection to 2031 and
beyond in many countries
Published provisional patent for scale up synthesis
Submitted new provisional patent for treatment of Major Depressive Disorder.
The Year in Review
Strongly positive results for XanaMIA Part A Phase 2 Alzheimer’s Disease trial
On 27 April 2022, the Company announced positive XanaMIA Part A trial results which 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.
The XanaMIA Part A trial was established to assess the efficacy of 5 mg and 10 mg Xanamem doses compared to placebo in
107 older healthy patients (aged 50 to 80 years old), over six weeks, to confirm the minimum effective dose needed to improve
cognition. The target dose range was determined by the results of a dose-ranging positron emission tomography (PET) clinical
trial of Xanamem's inhibition of its target in the brain.
3 Unless otherwise stated, all information in this Operations Review relates to the financial year ended 30 June 2022, and all financial data is quoted in Australian dollars.
12 Actinogen Medical Limited
Other key features of the trial and the results were:
•
Assessed cognitive abilities using the internationally recognized Cogstate computerized Cognitive Test Battery (CTB)
supplemented by the International Digit Symbol Substitution Test-Symbols (IDSSTS)
• Met primary safety, pharmacodynamic and efficacy endpoints
• Confirmed Xanamem’s ability to rapidly enhance attention and working memory, with a similar pattern of cognitive test
findings as the prior 20 mg dose trial. No effect was observed for the IDSSTS.
•
Results were consistent with a prior Positron Emission Tomography (PET) dose-ranging study that indicated dose levels of
10 mg daily or lower are likely to be effective.
For further information, please refer to the detailed XanaMIA trial results announcement along with the associated webcast
slide presentation released to the ASX on 27 April 2022. Alternatively, please refer to the ASX announcements section in the
Investor Centre on the Actinogen website www.actinogen.com.au.
Strategic adjustments to prioritize Alzheimer’s Disease and Cognitive Impairment in Depressive Disorder (CIDD) clinical
trial programs
Following the positive and highly confirmatory results for attention and working memory (cognition) from the XanaMIA Part A
trial, the Company conducted a reassessment of its priorities and planned expenditures, resulting in the following strategic
adjustments that it announced in May 2022 to:
•
•
•
•
Prioritize cognitive enhancement, now shown in two independent trials for clinical development and regulatory approvals
Focus on the AD and CIDD clinical programs for Xanamem, where cognition is the primary focus, ahead of the FXS
program where cognition is one of several factors
Expedite the XanaMIA Part B Phase 2 AD trial and the XanaCIDD Phase 2 Depression trial
Suspend clinical trial operations for the more complex, global XanaFX FXS Phase 2 trial and reallocate those resources
(approximately $12 million) to the AD and CIDD programs and investigate alternative funding, partnership and
implementation models to study the utility of Xanamem in people with FXS. The strong scientific rationale for the 11β-HSD1
enzyme as a therapeutic target has not changed.
High level trial design for XanaMIA Part B Phase 2 AD trial and XanaCIDD Phase 2 Depression trial
In June 2022, the Company announced that it had finalised designs for its planned Phase 2 trials in AD and CIDD:
•
•
The XanaMIA Part B AD trial will be a six-month placebo-controlled, dose-ranging, parallel group trial in circa 300
participants measuring the effects of Xanamem on safety and cognitive performance in patients with the early stages of
AD. Participants will have memory impairment alone, called Mild Cognitive Impairment (MCI) or mild AD, where some
functional impairment (difficulty completing activities of daily living) is also present.
The effects of 5mg and 10mg Xanamem dose levels on cognition will be measured by the same CTB used in the XanaMIA
Part A trial, supplemented by a variety of other tests of memory, attention, and executive function. Results are expected in
2024.
The XanaCIDD MDD trial is a six-week proof-of-concept, placebo-controlled, parallel group 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 trial will comprise
approximately 160 patients with persistent Depression and cognitive impairment despite a standard course of anti-
depressant therapy. Xanamem 10 mg daily or placebo will be added to the existing anti-depressant therapy and effects on
both cognition and depression will be assessed. Results are expected in late 2023 or 2024.
Early in the 2023 financial year the Company signed a Letter of Intent (LOI) with Axiom Real-Time Metrics, Inc (Axiom) to
provide clinical research services to help operationalise the XanaCIDD Phase 2 trial. Axiom is the premier provider of
eClinical (trial automation) services to small and medium life sciences organisations.
Axiom’s platform technology will support the internal Actinogen team by providing cost-effective operational solutions to
manage the XanaCIDD trial. The LOI is to initiate work on the trial while a full work order is negotiated, expected in late
August or early September 2022. The LOI value is US$605,195 for a 60-day duration (extendable), and cancellable with
30 days’ notice and subsequent refund of unused funds up to 50% of the LOI value.
Phase 2 Biomarker study in AD
The Company also announced early in the 2023 financial year additional details of the timing and design of its Phase 2
biomarker study in people with Mild AD. This study is a prospective analysis of the effects of Xanamem on AD biomarkers and
a new analysis of efficacy in biomarker positive patients.
This study is analysing stored blood samples from the previously completed XanADu Phase 2 trial that was conducted in 185
patients with mild dementia and a clinical diagnosis consistent with AD in Australia, the USA, and the UK. The XanADu trial used
a 10mg dose versus placebo over 12 weeks and results were first reported in 2019.
Annual Financial Report 13
Operating and Financial Review (continued)
2. OPERATIONS REVIEW (continued)
At the time the trial was originally conducted, blood-based AD biomarker analyses were not available. In this AD biomarker
study, analyses will be ’double-blind‘ and guided by an a priori Statistical Analysis Plan. The main objectives of the study are to
examine 1) the effects on cognition of Xanamem in patients with biomarker-positive AD, and 2) the effects of Xanamem on a
variety of AD biomarkers.
The Company has access to adequate samples from approximately 70 of the original XanADu Phase 2 trial patients,
representing a relatively large sample size for a biomarker study.
The analysis of the samples will be conducted at the University of Gothenburg, Sweden, under the direction of world-leading
AD researcher Professor Kaj Blennow, with statistical analysis to follow. Results are expected to be available before the end of
October 2022.
Successful revision of US Investigational New Drug (IND) dossier for Alzheimer’s Disease with updated information and
opened new FXS IND
In the first two quarters of the financial year, the Actinogen team successfully rewrote and updated many sections of its
existing AD US IND dossier so that a new IND for FXS could be filed and cross-reference the AD information. In doing so, the
US FDA was provided with the latest information on nonclinical, manufacturing and clinical activities for the Xanamem program.
Successful $13.3 million capital raising
In December 2021, Actinogen announced the successful completion of a $13.3 million capital raising, comprising a $12 million
institutional placement of 88,888,881 new, fully paid ordinary shares at an offer price of $0.135 per new share, and a $1.3
million Share Purchase Plan (SPP) of 9,796,389 new, ordinary fully paid shares to existing shareholders at the same $0.135
issue price.
The funds raised are primarily being applied to the clinical development pipeline including the addition of the CIDD program
and the AD biomarker study. Circa $12 million of funding from the suspended XanaFX Phase 2 international trial was re-
allocated to the AD and CIDD trial programs.
The Company held a General Meeting on 5 April 2022 to seek shareholder approval of two resolutions relating to the capital
raising:
1. The issue of 797,222 shares to CEO Dr Steven Gourlay who subscribed for the shares at an issue price of $0.135 per
share in conjunction with, and at the same price as, the placement of 88,091,659 shares to sophisticated investors
2. Ratification of the 88,091,659 shares issued to sophisticated investors on 30 November 2021 under the capital raising
institutional placement.
Both resolutions were approved as set out in an announcement dated 5 April 2022. Dr Gourlay subsequently completed the
$107,625 share subscription payment following shareholder approval of Resolution 1.
Strategic collaboration with Oxford University researchers
The Company announced in December 2021 the finalisation of a clinical protocol as part of its strategic collaboration with
researchers at the Radcliffe Department of Medicine, University of Oxford, to investigate Xanamem and a condition called Mild
Autonomous Cortisol Secretion (MACS). MACS is associated with over-production of the stress hormone cortisol by
noncancerous growths on the adrenal glands.
The placebo-controlled 12-week clinical trial will enrol approximately 40 participants and is designed to investigate the
therapeutic potential for Xanamem in patients with MACS and will evaluate effects of Xanamem on metabolism, bone density,
and cognitive function.
The trial is funded by a Medical Research Council (UK) grant, and Actinogen will supply Xanamem to Oxford free-of-charge and
provide trial design support. Results are anticipated in 2024.
Business development and engagement at international industry conferences
There were several important conferences and events during the year where senior executives attended, presented and/or
conducted meetings either in person or online to update potential pharmaceutical industry partners on the Company’s
expanded clinical development pipeline and its near and medium-term milestones.
These included:
•
The Biopartnering @JPM associated with the 40th annual JP Morgan HealthCare Conference in San Francisco and at the
H.C. Wainwright BioConnect Virtual Conference that ran concurrently with the JP Morgan conference in January 2022.
ACW CEO Dr Steven Gourlay gave presentations and used his time in San Francisco to initiate multiple business
development and other stakeholder meetings
14 Actinogen Medical Limited
•
•
The Sachs 15th Annual European Life Sciences CEO Forum for Partnering & Investment conference in March 2022, which
was conducted entirely online. Dr Gourlay presented and conducted business development meetings
The BIO International Convention in San Diego, USA, which is the world’s largest gathering of the biotechnology industry.
The ACW team comprising Dr Gourlay and the Company’s Head of Business Development, Dr Christian Toouli used the
opportunity to engage in approximately 30 business development and stakeholder meetings.
Continued scale-up manufacturing with Corden Pharma and initiated tablet formulation with Metrics Contract Services
During the year Actinogen continued scale-up manufacturing of Xanamem Active Pharmaceutical Ingredient with Corden
Pharma, based in Switzerland, for use in upcoming clinical trials. In addition, we initiated tablet development with Metrics
Contract Services for the use in larger Phase 2 and 3 trials and commercial launch.
Established two new Xanamem clinical advisory boards for Depression and FXS programs
In December 2021, the Company announced the establishment of two new Xanamem clinical advisory boards for its programs
in Depression and FXS. The inaugural expert appointments to those boards comprised five renowned global thought leaders in
clinical trials for Depression and assessment of Cognition, and FXS:
Depression and Cognition Clinical Advisory Board:
Professor John Harrison, PhD, based in the UK, Dr Dana C. Hilt, MD based in the USA and Dr Christina Kurre Olsen based in
Denmark
Fragile X Syndrome Clinical Advisory Board (currently inactive while FXS program suspended):
Dr Elizabeth Berry-Kravis, MD, PhD and Dr Pam Ventola, PhD, both based in the USA
The expertise and qualifications of all advisory board members can be found on the company’s website.
Senior executive and consultant appointments maintain operational momentum
The Company appointed Professor Paul Rolan as Chief Medical Officer (CMO) effective 15 February 2022. Professor Rolan is a
clinical pharmacologist and neurology drug development consultant and one of Australia's most experienced clinical trial
investigators and drug developers, having taken drugs from first human administration to market. He has extensive expertise
in the development of medicines as principal investigator in more than 750 early phase proof-of-concept, clinical
pharmacology, drug interaction and special patient groups studies.
The Company also made two further changes to its executive leadership team. The first was the promotion of Ms Tamara Miller
to the position of Senior Vice President Product Development. Ms Miller has been a key driving force behind the Company’s
clinical development program in recent years.
Given the expansion of Actinogen’s clinical program to include Cognitive Impairment in Depressive Disorder during the year,
the Company also created the new position of Vice President Clinical Operations and appointed Ms Cheryl Townsend to that
role. Ms Townsend has extensive experience with clinical trial operations in the Asia-Pacific region across all phases of clinical
development.
The Company has also continued to fill vital organisational and technical consultant roles to drive strategic initiatives and
ensure the success of its clinical development program and other operational requirements. Specialists in pivotal fields such as
global regulatory affairs, clinical neurology, clinical pharmacology, pharmacology, biostatistics, toxicology, manufacturing,
quality and medical writing have been appointed as required to maintain operational momentum.
Further details on all Actinogen board, advisory board and senior executive personnel can be found on the Company’s recently
updated and improved corporate website, www.actinogen.com.au
Strengthened intellectual property portfolio
In August 2021 the Company received official notification from the Brazilian Patent and Trademark Office of the grant of its
patent application for Xanamem. The grant of the Brazilian patent completed a key part of Actinogen’s intellectual property (IP)
portfolio, with protection across all major pharmaceutical markets including the USA, UK, EU, Japan, China, Canada and
Australia. The patents provide exclusive rights in these regions and cover the composition of matter of Xanamem and its use in
all diseases.
Globally, this patent encompasses composition of matter protection to 2031 with the possibility to extend by an additional five
years in markets including Australia, USA, EU, Korea, Japan, China and Israel.
More recent patents continued to be progressed, with publication of the provisional patent covering scale up synthesis for
Active Pharmaceutical Ingredient (API) manufacture and a new patent submitted for the treatment of Major Depressive
Disorder.
For a more recent patent covering the use of Xanamem in enhancing cognition in healthy subjects, the Company made
extension filings in 13 key countries.
Annual Financial Report 15
Operating and Financial Review (continued)
2. OPERATIONS REVIEW (continued)
Launched new corporate branding and logo, and new and enhanced corporate website
In April 2022 the Company launched its new corporate website with new and improved sections in all key areas including
streamlined and enhanced scientific/medical focused sections on Xanamem and Clinical Development.
The landing page, Our Company, Investor Centre and News sections have also been improved and expanded.
The website can be accessed at www.actinogen.com.au and features the new corporate branding and logo revealed in last
year’s annual report.
3. FINANCIAL REVIEW
(a) Financial Performance
The financial performance of the Company during the year ended 30 June 2022 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 2022 is as follows:
Cash and cash equivalents
Net assets / Total equity
Contributed equity
Accumulated losses
Full year ended
Full year ended
30/06/2022
30/06/2021
3,681,154
2,011,162
(9,497,370)
(3,915,067)
(0.55)
(0.28)
-
-
As at
As at
30/06/2022
30/06/2021
$
$
16,370,283
13,456,919
21,739,877
17,458,081
76,942,670
60,054,459
(57,939,283)
(48,441,913)
The increase in cash and cash equivalents, and contributed equity balances as at 30 June 2022 were largely attributed to
capital raisings during the year, net of increased research and development expenditure.
4. COVID-19 RISK, FUTURE DEVELOPMENTS, AND EXPECTED RESULTS
In March 2020, the World Health Organisation declared the outbreak of COVID-19 as a pandemic. The Company has recently
completed its XanaMIA Part A trial and will soon commence new trials including the XanaMIA Part B Phase 2 trial in patients
with either Mild Cognitive Impairment or early Alzheimer’s Disease, and its XanaCIDD Phase 2 trial in patients with Depression.
Continued outbreaks of COVID-19 may cause clinical trial disruption. There is uncertainty around the potential consequences
of COVID-19 disruptions and as such the Company is unable to determine if such disruptions would have a material impact on
its future clinical trials.
All material developments in Actinogen’s activities will be disclosed as usual in accordance with the Company’s continuous
disclosure obligations under the ASX Listing Rules.
16 Actinogen Medical Limited
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 strong results from the XanaMIA Part A trial in AD led to the prioritization of the AD and CIDD clinical trials programs where
cognition is the primary focus and the path to commercialization is fastest.
Our key goals under this strategic priority are:
•
•
•
•
•
Build on improved attention and working memory in two independent, placebo-controlled trials
Initiate Phase 2 in patients with the early stages of Alzheimer’s Disease (XanaMIA Part B)
Initiate Phase 2 in patients with Cognitive Impairment and Depressive Disorder (XanaCIDD)
Leverage ‘hands on’ clinical operations and management based in Australia to speed timelines and reduce cost
Defer FXS Phase 2 trial until alternative funding from partnership or grants available
Forward planning
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 activities for scale-up and supply of future clinical trials
Complete tablet development for use in Phase 3 trials and subsequent commercial launch
Integrate global regulatory strategic planning to optimize path to marketing approvals
Complete required regulatory nonclinical studies to the Good Laboratory Practice standard
Plan ancillary clinical and nonclinical 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. With a strong cash balance we are in a position to evaluate potential deals for synergy and increased value for
Actinogen shareholders.
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 and the UK Medicines and Healthcare products Regulatory Agency.
Our key goals under this strategic priority are:
•
•
•
•
•
Explore high value regional partnerships in the near term
Engage with the universe of potential biopharma partners who could create synergy for the Xanamem program
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
The Company remains confident about its prospects in 2023 and beyond. Actinogen is now entering an exciting period of
Phase 2 clinical data generation, with clinical data readouts for biomarkers in AD expected before the end of October 2022, the
XanaCIDD trial in late 2023 or 2024 and the XanaMIA Part B trial in early AD in 2024.
Actinogen has the right team in place driving the right clinical strategy to create the greatest value from our highly promising
drug Xanamem.
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.
Annual Financial Report 17
Board of Directors and Company
Secretary
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 further 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.
18 Actinogen Medical Limited
Board of Directors and Company Secretary (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) Limos Biotech 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
• Non-Executive Director of Royalco Resources Limited (ASX:RCO) – Delisted February 2020
COMPANY SECRETARY
Peter Webse (appointed 10 October 2013)
B.Bus, FGIA, FCPA, MAICD
Mr Webse joined Actinogen in 2013 and has over 28 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), a Fellow of the Chartered Governance Institute (GCI), and a Member of the Australian
Institute of Company Directors (MAICD).
Annual Financial Report 19
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 Master 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.
Professor Paul Rolan
Chief Medical Officer
Professor Rolan joined Actinogen in 2022. Professor Rolan is a clinical pharmacologist, pharmaceutical physician and pain
management physician who has worked in both academia and industry in the UK and Australia.
Professor Rolan holds numerous academic and professional qualifications including a Bachelor of Medicine and Bachelor of
Surgery (MBBS), and a Doctor of Medicine (MD). Professor Rolan also holds fellowships of the Royal Australian College of
Physicians (FRACP), the Faculty of Pharmaceutical Medicine, Royal College of Physicians, (FFPM) and the Faculty of Pain
Medicine, Australian and New Zealand College of Anaesthetists, (FFPMANZCA). Professor Rolan has extensive expertise in the
development of medicines as principal investigator in more than 750 early phase proof-of-concept, clinical pharmacology, drug
interaction and special patient groups studies.
As part of the Actinogen team, Professor Rolan provides expertise as a clinical pharmacologist and drug development
consultant
20 Actinogen Medical Limited
Executive Leadership Team (continued)
Ms Cheryl Townsend
Vice President of Clinical Operations
Ms Townsend joined Actinogen in March 2022 and brings 30 years of international clinical research experience to Actinogen,
including senior positions in clinical operations and medical affairs in pharmaceutical companies and clinical research
organisations. Ms Townsend has worked across many therapeutic spheres ranging from Phase 1 through Phase 4 trials,
including 10 years working in rare diseases. Most recently Ms Townsend held increasingly senior positions in clinical operations
at Alexion Pharmaceuticals Australasia. Ms Townsend is a registered nurse with post graduate degrees in Nursing and Clinical
Research as well as a Master’s degree in Health Law.
As part of the Actinogen team, Ms Townsend is responsible for Actinogen’s clinical operations and the successful delivery of
the company’s clinical trial program.
Ms Therese Russell
Head of People & Infrastructure
Ms Russell joined Actinogen in October 2016 and has over 20 years of experience in the financial services, investment banking
and corporate advisory sectors. Ms Russell has worked in project management, corporate advisory, branding, and corporate
office administration roles with a range of medium to large private companies.
As part of the Actinogen team, Ms Russell is responsible for employee relations, IT infrastructure, social media and internal
communications as well as the management and administration of the corporate head office.
Dr Christian Toouli
Head of Business Development
Dr Toouli joined Actinogen in 2017 to manage the company’s business development program and has more than fifteen years
of experience in business development and strategy, particularly in the biotechnology sector. He also serves as the CEO and
Managing Director of FivepHusion, a private oncology-focused biotech company, and is Executive Director of Bio-Link
Australia, a global business development and strategic advisory company
Dr Toouli has co-founded two biotechnology companies developing cutting-edge therapeutic platform technologies.
Previously, Dr Toouli was a Postdoctoral Fellow in the Discovery Research Department of Schering-Plough Biopharma/DNAX
Research Institute, the biotechnology arm of the Schering-Plough Corporation.
Dr Toouli holds a PhD from the University of Sydney and was awarded a Certificate in Biotechnology Management with
Honours from the University of California, Santa Cruz Extension, and First-Class Honours in Biotechnology from Flinders
University of South Australia. He is also a graduate of the Australian Institute of Company Directors.
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 also
provides investor relations and corporate communications consulting services at Trinity Communications.
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 (FFin).
As part of the Actinogen Leadership Team, Mr Roberts heads the Company's investor relations and corporate communications
function.
Annual Financial Report 21
Directors’ Report
Your Directors present their report pertaining to Actinogen Medical Limited
(‘Actinogen Medical’ or ‘the Company’) for the year ended 30 June 2022.
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
1/12/2017
4/04/2019
Resigned
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
Total
Fully paid
ordinary shares
2,152,223
17,797,222
3,012,223
822,223
23,783,891
Loan shares
(a)
2,500,000
48,362,300
1,000,000
1,000,000
Unlisted
options
9,900,000
-
3,000,000
3,000,000
52,862,300
15,900,000
(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
Number of meetings
available to attend
Number of meetings
attended
8
8
8
8
8
8
8
8
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 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
Number of meetings
available to attend
Number of meetings
attended
1
1
1
1
0
1
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.
22 Actinogen Medical Limited
3. COMPANY SECRETARY
Details of the Company Secretary's qualifications and experience are set out on page 19 of this annual report.
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 37,058,333 unissued ordinary shares under option:
Quantity
Type of Option
Grant Date
Exercise Price
Expiry Date
1,500,000
Director Options
15,175,000
Director Options
5,783,333
Employee Options
5,000,000
Employee Options
3,000,000
Director Options
5,000,000
Director Options
1,600,000
Employee Options
1/12/2017
28/11/2018
12/12/2018
1/02/2019
4/04/2019
24/03/2017
28/09/2020
$0.100
$0.085
$0.085
$0.093
$0.100
$0.100
$0.046
1/12/2022
27/11/2023
12/12/2023
1/02/2024
4/04/2024
24/03/2025
27/09/2025
37,058,333
Total unissued ordinary shares under option
During the year, and up to the date of this Report, no options expired, lapsed or were forfeited.
Loan Shares currently on issue are accounted for as “in-substance options” due to the vesting conditions attached to them,
however, they are in fact issued ordinary shares and therefore, not included in the table above. For further information refer to
Section 11.3C(b)(iii) of the Remuneration Report.
6. DIVIDENDS
No amounts have been paid or declared by way of dividend since the date of incorporation. The Directors recommend that no
final dividend be paid.
7. EVENTS SUBSEQUENT TO THE END OF FINANCIAL YEAR
• On 13 July 2022, Actinogen provided further information on the timing and design of the Company’s upcoming Biomarker
Study in patients with Mild Alzheimer’s Disease (AD). This Study is analysing stored plasma samples from the previously
completed XanADu Phase 2 trial that was conducted in 185 patients with mild dementia and a clinical diagnosis consistent
with AD in Australia, the USA, and the UK.
• On 6 July 2022 Actinogen signed a Letter of Intent (LOI) with Axiom Real-Time Metrics, Inc (Axiom) to provide clinical
research services to help operationalise the XanaCIDD Phase 2 trial. Axiom is the premier provider of eClinical (trial
automation) services and they will support the internal Actinogen team by providing cost-effective operational solutions to
manage the trial. The LOI value of US$605,195 is to initiate work on the trial while a full work order is negotiated.
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 and business strategy and outlook. Please also refer to pages 10 and 11 for a summary of the Company’s
vision and strategy.
10. BUSINESS STRATEGY & OUTLOOK
Please refer to page 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.
Annual Financial Report 23
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
11.2
11.3
11.4
11.5
Introduction
Remuneration governance
Remuneration arrangements
A. Remuneration principles and structures
B. Elements of remuneration
C. Details of STI and LTI incentive plans that existed during FY22
Key Management Personnel remuneration outcomes and performance during the financial year
Executive employment agreements
11.6 Non-Executive Director fee arrangements
11.7
11.8
11.9
Disclosures relating to options
Disclosures relating to shares
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
Ms Tamara Miller
Senior Vice President - Product Development
Mr Jeff Carter
Prof Paul Rolan
Chief Financial Officer
Chief Medical Officer
Current / Resigned
Current
Current
Current
Current
Current
Current
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 Professor Rolan who was a KMP from his
commencement of consultancy with the Company on 15 February 2022.
24 Actinogen Medical Limited
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 10 November 2021, Actinogen Medical received 99.45% of votes in favour
of its Remuneration Report for the 2021 financial year. The Company did not receive any specific feedback at the AGM or
throughout the year on its remuneration practices.
It is considered that the size of the Board, along with the level of activity of the Company, renders having a Remuneration
Committee impractical, and the full Board considers in detail all of the matters for which the Directors are responsible. All
matters of remuneration are performed in accordance with the Corporations Act 2001 requirements, especially in respect of
related party transactions. Refer to the Corporate Governance Statement located on the Company’s website for further
information.
11.3 REMUNERATION ARRANGEMENTS
(A) Remuneration principles and structures
The Company aims to reward executives with a level and mix of remuneration commensurate with their position and
responsibilities within the Company and aligned with market practice. The nature and amount of remuneration of executives is
assessed on a periodic basis by the Board (in the absence of a Remuneration Committee) for their approval, with the overall
objective of ensuring maximum stakeholder benefit from the retention of high performing executives.
The main objectives sought when reviewing executive remuneration is that the Company has:
•
•
•
•
coherent remuneration policies and practices to attract and retain executives
executives who will create value for shareholders
competitive remuneration offered benchmarked against the external market
fair and responsible rewards to executives having regard to the performance of the Company, the performance of the
executives and the general pay environment.
(B) Elements of remuneration
The Company aims to reward executives with a level and mix of remuneration appropriate to their position and responsibilities,
while being market competitive. The Company’s remuneration structure for executives can include a mix of fixed remuneration,
short term incentives and long-term incentives as outlined below.
Fixed remuneration component
Fixed remuneration is represented by total employment cost and comprises base salary, statutory superannuation
contributions (where applicable) and other benefits. It is paid by the Company to compensate fully for all requirements of the
executive’s employment with reference to the market and the individual’s role and experience. It is subject to annual review
considering market data and the performance of the Company against appropriate market comparisons with the comparator
group criteria being market capitalisation.
Short-term incentive (STI) component
The STI component is in the form of a cash bonus to executives of the Company (bonuses are also applicable to selected
employees).
Long-term incentive (LTI) component
The Board is of the opinion that the shares and options currently on issue provide a sufficient LTI to align the goals of the KMP
with those of the shareholders to maximise shareholder wealth.
Annual Financial Report 25
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. During the
year Ms Tamara Miller was promoted to Senior Vice
President of Product Development and her maximum
STI opportunity was increased from 20% to 25% of
fixed remuneration. Dr Steve Gourlay, Managing
Director/CEO, has a maximum STI opportunity of 35%
of fixed remuneration.
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.
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 Actinogen Medical Limited
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.
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.
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.
Remuneration Report (Audited) (continued)
11.3
REMUNERATION ARRANGEMENTS (CONTINUED)
(C) Details of STI and LTI plans that existed during the FY22
During the financial year ended 30 June 2022, the Board of Directors had in place various Short-term Incentives and Long-
term Incentives which are outlined below.
(a) Short-term Incentives
The Board of Directors put in place various STIs that when achieved, a cash bonus is paid. Examples of such short-term
performance conditions include clinical development, pre-clinical development, product development, project analysis, patient
enrolments, studies, planning, regulatory, budgeting, data read-out, executed confidentiality agreements with potential
partners, drug development and regulatory plan. During the 2021 and the 2022 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 - a bonus of $100,131, representing 76% of the maximum bonus potential set for Dr Gourlay, has been
accrued for at 30 June 2022 in connection with performance conditions met during the 2022 financial year. This bonus will
be paid during the quarter-end 30 September 2022. Of Dr Gourlay's performance conditions set during the year, 24%
were not met and subsequently forfeited.
• Ms Tamara Miller was paid a $48,500 bonus in connection with performance conditions met and accrued for in the 2021
financial year. A bonus of $76,250, representing 100% of the maximum bonus potential set for Ms Miller, has been accrued
for at 30 June 2022 in connection with performance conditions met during the 2022 financial year. This bonus will be paid
during the quarter-end 30 September 2022.
(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
15,900,000
6,783,333
8,775,000
Total Options on issue
21,500,000
15,558,333
Loan Shares
66,362,300
18,400,000
Total Loan Shares on issue
66,362,300
18,400,000
Total
12,383,333
24,675,000
37,058,333
84,762,300
84,762,300
Total LTIs on issue
87,862,300
33,958,333
121,820,633
(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 have fully vested.
• Mr Jeff Carter - Of 1,600,000 options issued, 533,333 (one-third) will vest 12 months from date of grant, with the balance
of 1,066,667 (two-thirds) to vest quarterly over a period of 24 months thereafter. 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 21: Share-based Payments for further information.
Annual Financial Report 27
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 2022. 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
Geoff Brooke
Geoff Brooke
George Morstyn
George Morstyn Malcolm McComas
28/11/2018
24/03/2017
28/11/2018
18/01/2018
4,900,000
5,000,000
1,500,000
1,500,000
4/04/2019
3,000,000
$0.100
Exercise Price
$0.085
$0.100
$0.085
$0.100
Expiry Date
27/11/2023
24/03/2025
27/11/2023
1/12/2022
4/04/2024
Vesting Conditions:
As at 30 June 2022, all Director Options outlined above have 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.
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 21: 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
During the year 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 Actinogen Medical Limited
Remuneration Report (Audited) (continued)
11.3
REMUNERATION ARRANGEMENTS (CONTINUED)
(iii) Loan Shares (continued)
Loan Shares
Other KMP
Grant Date
Quantity
Exercise Price
Expiry Date
Vesting conditions:
Tamara Miller
Tamara Miller
Jeff Carter
Paul Rolan
16/09/2021
24/05/2022
16/09/2021
24/05/2022
5,000,000
5,000,000
$0.110
$0.088
500,000
$0.110
3,000,000
$0.088
16/09/2026
24/05/2027
16/09/2026
24/05/2027
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 21: Share-based Payments for further information.
Non-Executive Directors:
•
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.
Other KMP:
•
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 2022 and 30 June 2021 (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.
Annual Financial Report 29
Directors’ Report (continued)
Remuneration Report (Audited) (continued)
Table 1: 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
23,568
28,964
426,071
955,166
-
-
-
-
52,646
115,646
59,695
122,695
23,568
21,916
192,597
599,156
-
-
-
22,080
134,880
10,255
71,755
56,725
50,880
897,681 2,239,114
56%
45%
46%
49%
32%
16%
14%
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.
Table 2: Remuneration of KMP for the year ended 30 June 2021
Key Management
Personnel
Short-term
benefits
Termination
benefits
Post-
employment
Long-term
benefits
Share-based
payments
Year ended
30 June 2021
Cash,
salary
and fees
$
Cash
Bonus
$ (e)
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 (b)
112,395
Bill Ketelbey (c)
210,480
George Morstyn (a)
63,000
Malcolm McComas (a)
63,000
-
-
-
-
-
Tamara Miller
270,000
73,500
Jeff Carter (d)
94,275
-
-
-
9,110
-
23,193
128,193
18%
7,116
8,648
142,909
271,068
53%
238,014
18,900
16,186
41,535
525,115
-
-
-
-
-
-
-
-
7,825
70,825
14,132
77,132
21,694
21,909
21,067
408,170
-
-
7,602
101,877
8%
11%
18%
5%
7%
18%
53%
8%
11%
18%
23%
7%
Total KMP (f)
909,040
73,500
238,014
56,820
46,743
258,263
1,582,380
(a) The total Non-Executive Director fees including superannuation during the year totalled $231,000.
(b) Dr Gourlay commenced full-time employment as Chief Executive Officer of the Company on 15 March 2021.
(c) Dr Ketelbey resigned on 8 February 2021. Termination payments totalling $238,014 comprise: $86,451 covering the three-
month notice period, $35,000 STI bonus fee, $81,116 in unused annual leave accrued up to the date of resignation, and
$35,447 in prorated long service leave benefits for approximately 6 years of service with the Company. Long-term
benefits of $16,186 relate to unused annual leave accrued during the financial year.
(d) Mr Carter was appointed as the Chief Financial Officer of the Company on 21 September 2020.
(e) For information on short-term incentive cash bonuses, refer to Section 11.3(C)(a).
For detailed information of KMP employment arrangements, refer to Section 11.5 and Section 11.6 of the Remuneration Report.
30 Actinogen Medical Limited
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 $400,000 with four
weeks annual leave entitlement. With effect from 1 July 2022, the total employment cost basis was increased to $420,800
(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. For further information on STI’s refer to Section 11.3(C)(a) of the Remuneration Report.
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
•
Role: upon commencement of employment Ms Miller fulfilled the role of Director of Drug Development. On 1 April 2018, Ms
Miller was promoted to Senior Director of Clinical Development and Strategy and later promoted to Vice President of Drug
Development & Strategy on 1 June 2019. During the year Ms Miller was promoted to her current role of Senior Vice
President – Product Development on 1 April 2022.
•
•
•
•
Remuneration package: During the year ended 30 June 2022, Ms Miller was on a total employment cost basis (inclusive of
superannuation guarantee) of $301,668 with four weeks annual leave entitlement. With effect from 1 April 2022, Ms
Miller’s total employment cost basis was increased to $328,568.
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. For further information on STI’s refer to
Section 11.3(C)(a) of the Remuneration Report.
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
•
The standard base monthly amount has been $9,400 (plus GST and exclusive of superannuation) and no additional
charges have been made for excess hours served during the month.
•
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
•
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.
Annual Financial Report 31
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
$231,479.
During the financial year the following Non-Executive Directors were remunerated for their respective roles and were subject
to the following contractual arrangements:
Dr Geoffrey Brooke – Non-Executive Chairman – Appointed 1 March 2017
• Director Fees set at $105,000 per annum (inclusive of superannuation guarantee plus GST) since 1 January 2020. Subject
to annual review, it was determined that these fees increase to $111,471 per annum (inclusive of superannuation
guarantee plus GST) with effect from 1 July 2022.
Dr George Morstyn – Non-Executive Director - Appointed 1 December 2017
• Director Fees set at $63,000 per annum (plus GST and exclusive of superannuation) since 1 January 2020. Subject to
annual review, it was determined that these fees increase to $66,276 per annum (plus GST and exclusive of
superannuation) with effect from 1 July 2022.
Mr. Malcolm McComas – Non-Executive Director- Appointed 4 April 2019
• Director Fees set at $63,000 per annum (plus GST and exclusive of superannuation) since 1 January 2020. Subject to
annual review, it was determined that these fees increase to $66,276 per annum (plus GST and exclusive of
superannuation) with effect from 1 July 2022.
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 Actinogen Medical Limited
Remuneration Report (Audited) (continued)
11.7 DISCLOSURES RELATING TO OPTIONS
At the date of this Report, the unissued ordinary shares of Actinogen Medical under option carry no dividend or voting rights. When exercisable, each option is convertible into one fully paid ordinary
share of the Company. No options lapsed during the year.
(i) Option holdings of KMP as at 30 June 2022:
KMP
Geoffrey Brooke
Options (10c)
Options (8.5c)
Loan Shares (20c)
Steven Gourlay
Loan Shares (3.5c)
Loan Shares (4.5c)
George Morstyn
Options (10c)
Options (8.5c)
Loan Shares (20c)
Malcolm McComas
Options (10c)
Loan Shares (20c)
Tamara Miller
Options (8.5c)
Loan shares (11c)
Loan shares (8.8c)
Jeff Carter
Options (4.6c)
Loan shares (11c)
Paul Rolan
Loan shares (8.8c)
Total KMP Holding
Grant
Date
Expiry
Date
Balance at beginning
of year 1 July 2021
Granted as
remuneration
Net
change other
Balance at end of
year 30 June 2022
Vested during
the year
Vested as at
30 June 2022
Not vested as at
30 June 2022
24/03/2017 24/03/2025
27/11/2023
28/11/2018
18/11/2026
18/11/2021
15/03/2021
15/03/2021
15/03/2026
15/03/2026
18/01/2018
28/11/2018
18/11/2021
1/12/2022
27/11/2023
18/11/2026
4/04/2019
18/11/2021
4/04/2024
18/11/2026
12/12/2023
12/12/2018
16/09/2026
16/09/2021
24/05/2022 24/05/2027
28/09/2020
16/09/2021
27/09/2025
16/09/2026
24/05/2022 24/05/2027
5,000,000
4,900,000
-
9,900,000
-
-
2,500,000
2,500,000
24,181,150
24,181,150
48,362,300
-
-
-
1,500,000
1,500,000
-
3,000,000
-
-
1,000,000
1,000,000
3,000,000
-
3,000,000
-
1,000,000
1,000,000
4,000,000
-
-
4,000,000
-
5,000,000
5,000,000
10,000,000
1,600,000
-
1,600,000
-
500,000
500,000
- 3,000,000
- 3,000,000
18,000,000
69,862,300
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
5,000,000
4,900,000
2,500,000
12,400,000
-
816,667
-
816,667
5,000,000
4,900,000
-
9,900,000
-
-
2,500,000
2,500,000
24,181,150
24,181,150
48,362,300
8,312,271
8,312,271
16,624,542
8,312,271
8,312,271
16,624,542
15,868,879
15,868,879
31,737,758
1,500,000
1,500,000
1,000,000
4,000,000
-
250,000
-
250,000
1,500,000
1,500,000
-
3,000,000
-
-
1,000,000
1,000,000
3,000,000
1,000,000
4,000,000
750,000
-
750,000
3,000,000
-
3,000,000
-
1,000,000
1,000,000
4,000,000
5,000,000
5,000,000
14,000,000
666,667
-
-
666,667
4,000,000
-
-
4,000,000
-
5,000,000
5,000,000
10,000,000
1,600,000
500,000
2,100,000
933,332
-
933,332
933,332
-
933,332
666,668
500,000
1,166,668
3,000,000
3,000,000
87,862,300
-
-
20,041,208
-
-
37,457,874
3,000,000
3,000,000
50,404,426
Annual Financial Report 33
Directors’ Report (continued)
Remuneration Report (Audited) (continued)
11.7 DISCLOSURES RELATING TO OPTIONS (CONTINUED)
(ii) Value of options awarded, vested and lapsed during the financial year
KMP
Geoffrey Brooke
Options (10c)
Options (8.5c)
Loan Shares (20c)
Steven Gourlay (a)
Loan Shares (3.5c)
Loan Shares (4.5c)
George Morstyn
Options (10c)
Options (8.5c)
Loan Shares (20c)
Malcolm McComas
Options (10c)
Loan Shares (20c)
Tamara Miller
Options (8.5c)
Loan shares (11c)
Loan shares (8.8c)
Jeff Carter
Options (4.6c)
Loan shares (11c)
Paul Rolan
Loan shares (8.8c)
Total KMP Holding
Financial
Year
Quantity
Fair value
per option /
loan share
Total Share-
based payment
(SBP) valuation
Value vested
during the
year
Total SBP
expensed as at
1 July 2021
Value
recognised
during the year
Total SBP
expensed as at
30 June 2022
Value to be
recognised
in future years
Remuneration
consisting of
option for the year
2017
2019
2022
2021
2021
2018
2019
2022
2019
2022
2019
2022
2022
2021
2022
2022
5,000,000
4,900,000
2,500,000
12,400,000
24,181,150
24,181,150
48,362,300
1,500,000
1,500,000
1,000,000
4,000,000
3,000,000
1,000,000
4,000,000
4,000,000
5,000,000
5,000,000
14,000,000
1,600,000
500,000
2,100,000
3,000,000
3,000,000
87,862,300
$0.049
$0.014
$0.119
$0.016
$0.015
$0.013
$0.014
$0.119
$0.014
$0.119
$0.016
$0.064
$0.052
$0.009
$0.064
$0.052
$245,286
$69,580
$297,026
$611,892
-
$11,597
-
$ 11,597
$383,027
$350,963
$733,990
$131,666
$120,643
$ 252,309
$19,350
$21,300
$118,810
$159,460
$42,396
$118,810
$161,206
$63,200
$321,175
$258,483
$642,858
$14,948
$32,117
$47,065
-
$3,550
-
$ 3,550
$10,599
-
$10,599
$10,533
-
-
$10,533
$5,583
-
$5,583
$245,286
$57,983
-
$303,269
$74,576
$68,333
$142,909
$19,350
$17,750
-
$37,100
$31,797
-
$31,797
$52,667
-
-
$52,667
$7,602
-
$7,602
-
$11,597
$122,740
$134,337
$222,342
$203,729
$426,071
-
$3,550
$49,096
$52,646
$10,599
$49,096
$59,695
$10,533
$164,972
$17,092
$192,597
$5,583
$16,497
$22,080
$245,286
$69,580
$122,740
$437,606
$296,918
$272,062
$568,980
$19,350
$21,300
$49,096
$89,746
$42,396
$49,096
$91,492
$63,200
$164,972
$17,092
$245,264
$13,185
$16,497
$29,682
-
-
$174,286
$174,286
$86,109
$78,901
$165,010
-
-
$69,714
$69,714
-
$69,714
$69,714
-
$156,203
$241,391
$397,594
$1,763
$15,620
$17,383
$155,090
$155,090
$2,511,561
-
-
$294,171
-
-
$575,344
$10,255
$10,255
$897,681
$10,255
$10,255
$1,473,025
$144,835
$144,835
$1,038,536
0%
5%
51%
56%
29%
26%
55%
0%
3%
43%
46%
9%
40%
49%
3%
38%
4%
45%
4%
12%
16%
14%
14%
34 Actinogen Medical Limited
Remuneration Report (Audited) (continued)
11.8 DISCLOSURES RELATING TO SHARES
The shareholding of KMP as at 30 June 2022 is as follows:
KMP
Balance at
beginning of year
1 July 2021
Granted as
remuneration
On exercise
of options
Accounted
for as
options (f)
Net
change
other
Balance at
end of year
30 June 2022
Geoffrey Brooke (a)
1,590,000
Steven Gourlay (b)
15,000,000
George Morstyn (c)
2,790,000
Malcolm McComas (d)
600,000
Tamara Miller
Jeff Carter (e)
Paul Rolan
-
-
-
Total share holding
19,980,000
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
562,223
2,152,223
2,797,222
17,797,222
222,223
3,012,223
222,223
822,223
-
-
298,149
298,149
-
-
- 4,102,040
24,082,040
(a) Dr Brooke purchased 222,223 fully paid ordinary shares at 13.5 cents each under a share purchase plan and 340,000 on
market.
(b) Dr Gourlay purchased 797,222 fully paid ordinary shares at 13.5 cents each under a share placement approved by
shareholders on 5 April 2022 and 2,000,000 on market.
(c) Dr Morstyn purchased 222,223 fully paid ordinary shares at 13.5 cents each under a share purchase plan.
(d) Mr McComas purchased 222,223 fully paid ordinary shares at 13.5 cents each under a share purchase plan.
(e) Mr Jeff Carter is one of five beneficiaries in Carter Superannuation Fund who purchased 148,149 fully paid ordinary shares
at 13.5 cents under a share purchase plan and 150,000 on market.
(f) 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 2022, 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
2022
2021
2020
2019
2018
5.00
0.55
12.0
0.28
2.2
0.48
-
-
-
1.0
0.90
-
4.8
0.88
-
End of Remuneration Report (Audited)
Annual Financial Report 35
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 $84,000 plus 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 2022 totalled $69,500 (2021: 43,265).
Total non-audit services paid to the external auditors and their associated entities during the year ended 30 June 2022 was
$Nil (2021: $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 2022 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
25 August 2022
36 Actinogen Medical Limited
Auditor’s Independence Declaration
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 2022, I declare to the best of my knowledge and belief, there have been: a) No contraventions of the auditor independence requirements of the Corporations Act 2001 in relation to the audit; b) No contraventions of any applicable code of professional conduct in relation to the audit; and c) No non-audit services provided that contravene any applicable code of professional conduct in relation to the audit. Ernst & Young Pierre Dreyer Partner 25 August 2022 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.
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
Related party transactions
Key management personnel disclosures
Share-based payments
Directors’ Declaration
Independent Auditor’s Report
39
40
41
42
43
43
43
48
49
52
52
53
53
54
55
55
56
56
57
58
59
59
59
59
59
60
62
63
38 Actinogen Medical Limited
Statement of Comprehensive Income
For the year ended 30 June 2022
Interest revenue
Other income
Total revenue & other income
Research & development costs
Employment costs
Corporate & administration costs
Finance costs
Unrealised foreign currency gain
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
Full year ended
30/06/2022
Full year ended
30/06/2021
Note
$
$
6
6
12
11
10
41,072
27,090
3,640,082
1,984,072
3,681,154
2,011,162
(8,214,847)
(2,406,237)
(1,910,085)
(1,704,953)
(1,359,883)
(1,116,744)
(18,479)
(22,318)
13,394
-
(1,287,955)
(289,282)
(312,746)
(312,747)
(81,008)
(65,728)
(6,915)
(8,220)
(13,178,524)
(5,926,229)
(9,497,370)
(3,915,067)
-
-
(9,497,370)
(3,915,067)
Other comprehensive income
Items that may be reclassified subsequently to profit and loss:
Other comprehensive income
-
-
Total comprehensive loss for the year
(9,497,370)
(3,915,067)
Loss per share for attributable to the ordinary equity
holders of the Company
Basic and diluted loss per share in cents
17
(0.55)
(0.28)
The above Statement of Comprehensive Income should be read in conjunction with the accompanying Notes.
Annual Financial Report 39
Statement of Financial Position
As at 30 June 2022
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
As at
30/06/2022
As at
30/06/2021
Note
$
$
8
9
10
12
11
16,370,283
13,456,919
4,046,639
1,634,322
20,416,922
15,091,241
12,531
16,509
2,720,458
3,033,204
156,440
237,448
2,889,429
3,287,161
23,306,351
18,378,402
13
1,308,381
619,573
Provision for employee entitlements
92,823
64,307
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
11(c)
78,337
71,170
1,479,541
755,050
11(c)
86,933
165,271
86,933
165,271
1,566,474
920,321
21,739,877
17,458,081
14(a)
76,942,670
60,054,459
14(b)
(6,331,492)
(1,934,492)
15
9,067,982
7,780,027
(57,939,283)
(48,441,913)
21,739,877
17,458,081
The above Statement of Financial Position should be read in conjunction with the accompanying Notes.
40 Actinogen Medical Limited
Statement in Changes of Equity
For the year ended as at 30 June 2022
Full year ended 30 June 2022
$
$
$
Contributed
Equity
Accumulated
Losses
Option
Reserve
Reserve
Shares
$
Total
$
Balance as at 1 July 2021
60,054,459
(48,441,913)
7,780,027
(1,934,492)
17,458,081
Loss for the year
-
(9,497,370)
-
-
(9,497,370)
Other comprehensive income
-
-
-
-
-
Total comprehensive loss for the year
-
(9,497,370)
-
-
(9,497,370)
Transactions with equity holders in
their capacity as equity holders:
Shares issued during the year
17,719,500
-
-
(4,397,000)
13,322,500
Capital raising costs
(831,289)
-
-
-
(831,289)
Share-based payments
-
-
1,287,955
-
1,287,955
Balance as at 30 June 2022
76,942,670
(57,939,283) 9,067,982
(6,331,492)
21,739,877
Full year ended 30 June 2021
$
$
$
Contributed
Equity
Accumulated
Losses
Option
Reserve
Reserve
Shares
$
Total
$
Balance as at 1 July 2020
47,924,606
(44,526,846)
7,490,745
-
10,888,505
Loss for the year
-
(3,915,067)
-
-
Other comprehensive income
-
-
-
-
(3,915,067)
-
Total comprehensive loss for the year
-
(3,915,067)
-
-
(3,915,067)
Transactions with equity holders in
their capacity as equity holders:
Shares issued during the year
12,845,721
-
-
(1,934,492)
10,911,229
Capital raising costs
(715,868)
-
-
-
(715,868)
Share-based payments
-
-
289,282
-
289,282
Balance as at 30 June 2021
60,054,459
(48,441,913)
7,780,027
(1,934,492)
17,458,081
The above Statement of Changes in Equity should be read in conjunction with the accompanying Notes.
Annual Financial Report 41
Statement of Cash Flows
For the year ended 30 June 2022
Full year ended
30/06/2022
Full year ended
30/06/2021
Note
$
$
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
Net increase in cash and cash equivalents
Cash and cash equivalents at beginning of the year
Reclassify bank guarantee as cash and cash equivalents
Effect of movement in exchange rates on cash held
11(b)
8
10
14
14
11(b)
41,072
(10,682)
27,090
(18,054)
(2,978,470)
(1,290,872)
(8,003,765)
(3,470,266)
1,434,713
3,028,200
(9,517,132)
(1,723,902)
(2,937)
(2,937)
(6,188)
(6,188)
13,322,499
10,911,229
(831,289)
(715,868)
(71,171)
(84,104)
12,420,039
10,111,257
2,899,970
8,381,167
13,421,653
5,040,486
35,266
-
13,394
-
Cash and cash equivalents at the end of the year
8
16,370,283
13,421,653
The above Statement of Cash Flows should be read in conjunction with the accompanying Notes.
42 Actinogen Medical Limited
Notes to the Financial Statements
For the year ended 30 June 2022
1. CORPORATE INFORMATION
The financial statements of Actinogen Medical Limited (Actinogen Medical or the Company) for the year ended 30 June 2022
were authorised in accordance with a resolution of Directors on 25 August 2022. 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 2022.
(a) Basis of preparation
These general-purpose financial statements have been prepared in accordance with Australian Accounting Standards, other
authoritative pronouncements of the Australian Accounting Standards Board, and the Corporations Act 2001. The financial
statements have been prepared on a going concern basis. The financial statements are presented in Australian dollars.
(b) Going concern basis
This financial report has been prepared on the going concern basis after taking into consideration the net loss after tax for the
year ended 30 June 2022 of $9,497,370 and the net cash outflows from operating activities of $9,517,132. The going concern
basis contemplates the continuity of normal business activity and the realisation of assets and settlement of liabilities in the
normal course of business.
In forming this view the Directors have taken into consideration the following:
•
•
The Company has $16,370,283 in cash and cash equivalents as at 30 June 2022. 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
$3,640,082 (refer Note 9: other receivables and prepayments). Further, the Company is listed on the ASX and therefore
has access to the Australian equity capital markets. Accordingly, the Directors consider that the Company maintains a
reasonable expectation of being able to raise funding from the market as and when required, although it cannot determine
in advance the terms upon which it may raise such funding.
The Directors have confidence in the ability of Actinogen Medical to successfully continue development of its lead
molecule, Xanamem, and eventually generate positive cash flows from operations and/or alliances. It will commence future
trials including Part B of the XanaMIA trial in patients with Alzheimer’s Disease and XanaCIDD trial in patients with Major
Depressive Disorder.
(c) COVID-19 pandemic
In March 2020, the World Health Organisation declared the outbreak of COVID-19 as a pandemic. The Company has recently
completed its XanaMIA Part A trial and will soon commence new trials including the XanaMIA Part B Phase 2 trial in patients
with either Mild Cognitive Impairment or early Alzheimer’s Disease, and its XanaCIDD Phase 2 trial in patients with Depression.
Continued outbreaks of COVID-19 may cause clinical trial disruption. There is uncertainty around the potential consequences
of COVID-19 disruptions and as such the Company is unable to determine if such disruptions would have a material impact on
its future clinical trials. All material developments in Actinogen’s activities will be disclosed as usual in accordance with the
Company’s continuous disclosure obligations under the ASX Listing Rules.
(d) 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).
(e) Historical cost convention
These financial statements have been prepared under the historical cost convention.
(f) 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.
43 Actinogen Medical Limited
Notes to the Financial Statements
(continued)
(g) 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 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.
(h) 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.
(i)
Intangible assets
Intangible assets acquired separately are measured on initial recognition at cost. The cost of intangible assets acquired
in a business combination is their fair value at the date of acquisition. Following initial recognition, intangible assets are
carried at cost less any accumulated amortisation and accumulated impairment losses. Internally generated intangibles,
excluding capitalised development costs, are not capitalised and the related expenditure is reflected in profit or loss in
the period in which the expenditure is incurred.
The useful lives of intangible assets are assessed as either finite or indefinite. Intangible assets with finite lives are
amortised over the useful economic life and assessed for impairment whenever there is an indication that the intangible
asset may be impaired. The amortisation period and the amortisation method for an intangible asset with a finite useful
life are reviewed at least at the end of each reporting period. Changes in the expected useful life or the expected
pattern of consumption of future economic benefits embodied in the asset are considered to modify the amortisation
period or method, as appropriate, and are treated as changes in accounting estimates and adjusted on a prospective
basis. The amortisation expense on intangible assets with finite lives is recognised in the Statement of Comprehensive
Income. Intangible assets with indefinite useful lives are not amortised, but are tested for impairment annually, and
when indicators of impairment exist, individually or at the cash-generating unit level. The assessment of indefinite life is
reviewed annually, or when indicators of impairment exist, to determine whether the indefinite life continues to be
supportable. If not, the change in useful life from indefinite to finite is made on a prospective basis. Gains or losses
arising from derecognition of an intangible asset are measured as the difference between the net disposal proceeds
and the carrying amount of the asset and are recognised in the Statement of Comprehensive Income when the asset is
derecognised.
(i) Research and development costs
Development expenditure on an individual project is recognised as an intangible asset when the Company can
demonstrate:
The technical feasibility of completing the intangible asset so that the asset will be available for use or sale
Its intention to complete and its ability to use or sell the asset
•
•
• How the asset will generate future economic benefits
The availability of resources to complete the asset
•
The ability to measure reliably the expenditure during development
•
The ability to use the intangible asset generated
•
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 2022. 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
patent patents and license. The remaining life of the patents and licenses is 9 years. Refer to Note 12: Intangible Assets.
(j) 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.
(k)
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.
(l)
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.
(m) 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 45
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.
(n) 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.
(o) 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.
(p) 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.
(q) 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.
(r) 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.
(s) 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.
(t) 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 earnings per share
Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account
the after-income tax effect of interest and other financing costs associated with dilutive potential ordinary shares and
46 Actinogen Medical Limited
the weighted average number of additional ordinary shares that would have been outstanding assuming the conversion
of all dilutive potential ordinary shares.
(u) 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.
(v) Segment reporting
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision
maker. The chief operating decision maker, who is responsible for allocating resources and assessing performance of the
operating segments, has been identified as the Board of Directors.
(w) 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.
Annual Financial Report 47
Notes to the Financial Statements
(continued)
(x) New accounting standards and interpretations issued but not yet effective
Certain new accounting standards and interpretations have been published that are not mandatory for 30 June 2022
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.
Application date
of standard
Application date
for Company
1 January 2023
1 July 2023
1 January 2023
1 July 2023
1 January 2023
1 July 2023
Reference
Title
Summary
AASB 2020-1
Amendments
to AASs –
Classification
of Liabilities as
Current or
Non-current
A liability is classified as current if the entity has no right
at the end of the reporting period to defer settlement for
at least 12 months after the reporting period. The AASB
recently issued amendments to AASB 101 Presentation of
Financial Statements to clarify the requirements for
classifying liabilities as current or non-current.
AASB 2021-2
Amendments
to AASB 108 –
Definition of
Accounting
Estimates
AASB 2021-28
Amendments
to AASB 7,
AASB 101,
AASB 134
Interim
Financial
Reporting and
AASB Practice
Statement 2
Making
Materiality
Judgements–
Disclosure of
Accounting
Policies
The amendments to AASB 108 clarify the definition of an
accounting estimate, making it easier to differentiate it
from an accounting policy. The distinction is necessary
as their treatment 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 retrospectively. The new
definition provides that ‘Accounting estimates are
monetary amounts 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.
The amendments to AASB 101 require disclosure of
material accounting policy information, instead of
significant accounting policies. Unlike ‘material10’,
‘significant’ was not defined in Australian Accounting
Standards. Leveraging the existing definition of material
with additional guidance is expected to help preparers
make more effective accounting policy disclosures. The
guidance illustrates circumstances where an entity is
likely to consider accounting policy information to be
material. Entity-specific accounting policy information is
emphasised as being more useful than generic
information or summaries of the requirements of
Australian Accounting Standards. The amendments to
AASB Practice Statement 2 supplement the amendments
to AASB 101 by illustrating how the four-step materiality
process can identify material accounting policy
information.
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.
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.
48 Actinogen Medical Limited
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 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
Cash and cash
equivalents
$
Financial assets / liabilities
at amortised cost
$
16,370,283
-
-
16,370,283
328,261
328,261
16,370,283
328,261
-
-
-
-
-
1,308,381
78,337
1,386,718
86,933
86,933
-
1,473,651
Net exposure
16,370,283
(1,145,390)
Set out below is an overview of the financial instruments held by the Company as at 30 June 2021:
As at 30 June 2021
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
Cash and cash
equivalents
$
Financial assets / liabilities
at amortised cost
$
13,456,919
-
-
13,456,919
13,456,919
-
-
-
89,956
89,956
89,956
619,573
71,170
690,743
- 165,271
- 165,271
-
856,014
Net exposure
13,456,919
(766,058)
Annual Financial Report 49
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 2022, the Company held $15,832,202 (2021: $13,265,921) 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 $158,322 (2021: $132,659).
Sensitivity analysis:
30 June 2022
Financial Assets
Carrying amount
$
Interest rate risk
-1%
Profit/Equity
$
+1%
Profit/Equity
$
Cash and cash equivalents
15,832,202
(158,322)
158,322
30 June 2021
Financial Assets
Cash and cash equivalents
13,265,921
(132,659)
132,659
Variable rate instruments:
As at 30/6/2022
As at 30/6/2021
Weighted average
interest rate
%
Balance
$
Weighted average
interest rate
%
Balance
$
Cash and cash equivalents
1.19
15,832,202
0.21
13,265,921
(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 Actinogen Medical Limited
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 (2021: 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 2022
Trade and other payables
Less than
3 months
$
3 to 12
months
$
1 to 5
years
$
Total
$
1,308,381
-
-
1,308,381
Lease liabilities
21,211
63,916
80,885
166,012
1,329,592
63,916
80,885
1,474,393
As at 30 June 2021
Trade and other payables
619,573
-
-
619,573
Lease liabilities
20,394
61,454
166,013
247,861
639,967
61,454
166,013
867,434
(d) Fair Value Measurements
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 2022 and 30 June 2021 given the nature of the financial assets and liabilities.
Annual Financial Report 51
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 21.
•
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(i).
•
Significant judgement: Research and development tax rebate
In line with accounting policy 2(j) 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
Government grants
R&D tax rebate (current year)
R&D tax rebate (prior year deferred income)
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
52 Actinogen Medical Limited
Full year ended
30/06/2022
$
Full year ended
30/06/2021
$
41,072
27,090
-
3,640,082
-
3,640,082
3,681,154
144,656
1,438,571
400,845
1,984,072
2,011,162
7,462,503
545,496
206,848
1,711,142
421,561
273,534
8,214,847
2,406,237
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 25% (2021: 26%)
Tax effect of amounts that are not deductible / taxable in calculating
taxable income:
Non-deductible expenses
ATO interest income
ATO cash flow boost
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
30/06/2022
$
Full year ended
30/06/2021
$
(9,497,370)
(2,374,343)
(3,915,067)
(1,017,917)
2,437
1,598
-
-
-
321,989
1,181,981
13,000
75,213
485,807
96
-
867,840
442,299
-
-
Unused tax losses for which no deferred tax asset has been recognised
Potential tax benefit @ 25% (2021: 26%)
19,825,165
15,692,749
4,956,291
4,080,115
Unrecognised temporary differences
Temporary differences for which deferred tax assets have not been
recognised.
- Provisions and accruals
- Intangible assets
- Capital raising costs
- Patent application fees
- Legal expenses
- Right of use adjustments
- Unrealised foreign exchange gain
- Fixed assets
Unrecognised deferred tax asset relating to the above temporary
differences @ 25% (2021: 26%)
140,323
1,415,995
1,118,593
-
75,683
125,325
1,103,249
889,017
25,990
19,202
8,830
-
(13,428)
-
(12,531)
(16,509)
2,733,465
2,146,274
683,366
558,031
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.
8. CASH AND CASH EQUIVALENTS
Cash at bank and on hand
Short term deposits
Total cash and cash equivalents
As at
30/06/2022
$
4,270,017
12,100,266
16,370,283
As at
30/06/2021
$
6,356,653
7,100,266
13,456,919
During the year ended 30 June 2022, the Company received interest revenue through holding several interest-bearing term
deposit accounts between 30 and 90 day terms. The Company is expecting to receive a research and development tax
incentive estimated at $3,640,082 for eligible expenditure incurred during the year ended 30 June 2022. This has been
recognised as a receivable at year end. Refer to Note 9.
Annual Financial Report 53
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)/decrease in trade and other receivables
Decrease in trade and other payables
(Decrease)/increase in provisions
Full year ended
30/06/2022
$
Full year ended
30/06/2021
$
(9,497,370)
(3,915,067)
6,915
81,008
312,746
1,287,955
(13,394)
8,220
65,728
312,747
289,282
-
(2,412,317)
688,809
28,516
1,489,106
110,298
(84,216)
Net cash outflow from operating activities
(9,517,132)
(1,723,902)
Non-cash financing and investing activities:
During the year, the Company issued 36,650,000 ordinary shares to Non-Executive Directors, employees and 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 2022.
Financing facilities available:
As at 30 June 2022, the Company had no financing facilities available (2021: 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 Actinogen Medical Limited
As at
30/06/2022
As at
30/06/2021
$
$
104,572
78,296
3,640,082
89,956
105,795
1,438,571
223,689
-
4,046,639
1,634,322
10. PROPERTY, PLANT AND EQUIPMENT
At cost
Accumulated depreciation
As at
30/06/2022
$
As at
30/06/2021
$
31,884
28,947
(19,353)
(12,438)
Total property, plant and equipment
12,531
16,509
Movements during the year
Opening balance at 1 July 2020
Acquisitions
Depreciation
Closing balance at 30 June 2021
Opening balance at 1 July 2021
Acquisitions
Depreciation
Computer Equipment
$
Total
$
18,541
18,541
6,188
6,188
(8,220)
(8,220)
16,509
16,509
16,509
16,509
2,937
2,937
(6,915)
(6,915)
Closing balance at 30 June 2022
12,531
12,531
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 2022:
Full year ended
30/06/2022
$
Full year ended
30/06/2021
$
Depreciation expense on right-of-use asset
81,008
93,937
Interest expense on lease liabilities
Rent expense - short-term leases
10,682
18,054
1,560
1,560
Total amounts recognised in profit or loss
93,250
113,551
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 2022:
As at 1 July 2020
Right-of-use Assets
Leased Premises
$
Lease Liability
Leased Premises
$
372,501
389,870
Adjustment to right-of-use asset due to revised lease terms
(69,325)
(69,325)
Depreciation expense (a)
(93,937)
-
Adjustment to depreciation expense due to revised lease terms
28,209
-
Interest expense
Payments
As at 30 June 2021
As at 1 July 2021
Depreciation expense
Interest expense (b)
Payments (b)
As at 30 June 2022 (c)
-
18,054
-
(102,158)
237,448
236,441
237,448
(81,008)
236,441
-
-
10,682
-
(81,853)
156,440
165,270
(a)
In the prior year, the depreciation expense shown on the statement of comprehensive income totals $65,728. This amount
comprises the depreciation expense of ($93,937) plus an adjustment of $28,209 which recognises the new terms that
took effect from 1 June 2021.
(b) The lease payments made during the year totalled $81,853 comprising $71,171 which represents the principal component
and $10,682 which represents the interest expense component.
(c) Of the total lease liability amounting to $165,270, $78,337 is current, and $86,933 is non-current.
Annual Financial Report 55
Notes to the Financial Statements
(continued)
12.
INTANGIBLE ASSETS
At cost
As at
30/06/2022
$
As at
30/06/2021
$
5,756,743
5,756,743
Accumulated amortisation and impairment loss
(3,036,285)
(2,723,539)
Total intangible assets
Movements during the year:
Opening balance at 1 July 2020
Amortisation expense
Closing balance at 30 June 2021
Opening balance at 1 July 2021
Amortisation expense
Closing balance at 30 June 2022
Intellectual property
2,720,458
3,033,204
Intellectual
Property
$
3,345,951
(312,747)
3,033,204
3,033,204
(312,746)
2,720,458
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 9 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 2022, the Company assessed whether any indicators of impairment reversal were present that suggested that
the impairment loss charged in a prior year may require full or partial reversal. The Company determined that an impairment
reversal indicator was present, however after assessing various internal and external indicators, the Company determined that
no impairment reversal was necessary in the current year.
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 year Actinogen did not file any new worldwide non-provisional patent applications
for its lead drug, Xanamem.
13. TRADE AND OTHER PAYABLES
Trade payables
Accruals and other payables
Goods and services tax payable
Provision for payroll tax
Accrued employee bonuses
Employee tax liabilities
Total trade and other payables
As at
30/06/2022
$
898,739
91,395
As at
30/06/2021
$
392,187
54,903
-
1,116
13,663
10,620
264,291
79,040
40,293
81,707
1,308,381
619,573
Trade and other payables are non-interest-bearing liabilities stated at amortised cost and settled within 30 days.
56 Actinogen Medical Limited
14. CONTRIBUTED EQUITY
(a) Fully paid ordinary shares
Fully paid ordinary shares
Capital raising costs
Total contributed equity
As at
30/06/2022
$
81,883,378
(4,940,708)
76,942,670
As at
30/06/2021
$
64,163,878
(4,109,419)
60,054,459
As at 30 June 2022 there were 1,795,643,817 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
1,795,643,817 ordinary shares on issue, 84,762,300 are Loan Shares of which 36,400,000 were issued to various directors,
employees and contractors 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:
Opening balance at 1 July 2020
Proceeds from Placement
Proceeds from Rights Issue
Capital raising costs
Balance as at 31 December 2020
Date
Quantity
Unit Price $
1,116,231,320
22/10/2020
272,727,273
0.022
17/11/2020
61,828,576
0.022
1,450,787,169
Total $
47,924,606
6,000,000
1,360,229
(511,284)
54,773,551
Proceeds from Shortfall Placement
10/02/2021
161,409,078
0.022
3,551,000
Capital raising costs
Loan Shares
Loan Shares
Balance at 30 June 2021
Issue of employee loan shares
Institutional Placement
Issue of director loan shares
Share Purchase Plan
Capital raising costs
15/03/2021
15/03/2021
24,181,150
0.035
24,181,150
0.045
1,660,558,547
(204,584)
846,340
1,088,152
60,054,459
16/09/2021
1/12/2021
18/11/2021
20/12/2021
1/01/2022
11,900,000
0.110
1,309,000
88,091,659
0.135
11,892,374
4,500,000
0.200
9,796,389
0.135
900,000
1,322,501
(831,289)
780,000
107,625
Issue of employee loan shares
13/01/2022
4,000,000
0.195
Share Purchase Plan
6/04/2022
797,222
0.135
Issue of employee loan shares
24/05/2022
16,000,000
0.088
1,408,000
Balance at 30 June 2022
1,795,643,817
76,942,670
(b) Reserve shares
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 2022, the following reserve shares were on issue.
Issue of CEO/Managing Director loan shares
Issue of CEO/Managing Director loan shares
15/03/2021
15/03/2021
(24,181,150)
0.035
(846,340)
(24,181,150)
0.045
(1,088,152)
Balance at 30 June 2021
(48,362,300)
(1,934,492)
Issue of employee loan shares
16/09/2021
(11,900,000)
0.110
(1,309,000)
Date
Quantity
Unit Price $
Total $
Issue of non-executive Director loan shares
18/11/2021
(4,500,000)
0.200
Issue of employee loan shares
Issue of employee loan shares
Balance at 30 June 2022
13/01/2022
(4,000,000)
0.195
24/05/2022
(16,000,000)
0.088
(1,408,000)
(84,762,300)
(6,331,492)
(900,000)
(780,000)
Refer to the Directors’ Report, specifically section 11.3(C)(b) of the Remuneration Report for information on these loan shares.
Annual Financial Report 57
Notes to the Financial Statements
(continued)
14. CONTRIBUTED EQUITY (CONTINUED)
(a) Unissued ordinary shares under option
Quantity
Type of Option
Grant Date
Exercise Price
Expiry Date
1,500,000
Director Options
15,175,000
Director Options
5,783,333
Employee Options
5,000,000
Employee Options
3,000,000
Director Options
5,000,000
Director Options
1,600,000
Employee Options
1/12/2017
28/11/2018
12/12/2018
1/02/2019
4/04/2019
24/03/2017
28/09/2020
$0.100
$0.085
$0.085
$0.093
$0.100
$0.100
$0.046
1/12/2022
27/11/2023
12/12/2023
1/02/2024
4/04/2024
24/03/2025
27/09/2025
37,058,333
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. 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.
(b) 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.
(c) 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
As at
30/06/2022
$
As at
30/06/2021
$
9,067,982
7,780,027
9,067,982
7,780,027
Year ended
30/06/2022
$
Year ended
30/06/2021
$
7,780,027
7,490,745
25,745
34,459
580,749
647,002
86,685
59,688
-
142,909
Balance at end of period
9,067,982
7,780,027
Total share-based payment expenses recognised during the year amounted to $1,287,955. For further information on share-
based payments refer to Note 21. For further information on loan shares and unissued ordinary shares under option refer to
Note 14.
58 Actinogen Medical Limited
16. REMUNERATION OF AUDITOR
Full year ended
30/06/2022
$
Full year ended
30/06/2021
$
Amounts paid or payable to Ernst & Young for:
An audit or review of the financial statements of the entity
69,500
43,265
Other assurance services
17. LOSSES PER SHARE
Net loss used in calculating loss per share ($)
-
-
69,500
43,265
Full year ended
30/06/2022
(9,497,370)
Full year ended
30/06/2021
(3,915,067)
Weighted number of ordinary shares used as the denominator ('000)
1,717,092
1,405,161
Basic and diluted loss per share from continuing operations attributable to
the ordinary shareholders of the Company (cents)
(0.55)
(0.28)
As at 30 June 2022, there were 37,058,333 (2021: 37,058,333) unissued ordinary shares under option and 84,762,300 loan
shares (2021: 48,362,300) 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 2022 other than
what is outlined below.
• Drug product manufacturing contract with as Metrics Contract Services, with the balance remaining (not already included
in “Trade and other payables” within these accounts – refer note 13) to be paid of approximately US$480,000 (2021: Nil).
19. RELATED PARTY TRANSACTIONS
There were no related party transactions that occurred during the year other than transactions with KMP as set out in Note 20.
20. 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
Ms Tamara Miller
Mr Jeff Carter
Prof Paul Rolan
Non-Executive Chairman
Managing Director / Chief Executive Officer
Non-Executive Director
Non-Executive Director
Senior Vice President - Product Development
Chief Financial Officer
Chief Medical Officer
Current
Current
Current
Current
Current
Current
Current
Short-term employee benefits
Termination benefits
Post-employment benefits
Long-term benefits
Share-based payments
Full year ended
30/06/2022
$
1,233,828
-
56,725
50,880
897,681
Full year ended
30/06/2021
$
982,540
238,014
56,820
46,743
258,263
2,239,114
1,582,380
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.
Annual Financial Report 59
21. SHARE-BASED PAYMENTS
The table below summarises movements in share-based payments (SBP) during the year and assumptions used in valuing SBP in prior periods and the current financial year:
Type of SBP
Options
Director options
Director options
Director options
Employee options
Employee options
Director options
Employee options
Total options
Loan shares
Loan shares
Loan shares
Loan shares
Loan shares
Loan shares
Total loan shares
Total SBP on issue
Vesting Criteria:
Vesting
Criteria
Quantity
as at 1 July 2021
Quantity issued or
(lapsed) during the year
Quantity
as at 30 June 2022
Grant Date
Expiry Date
Expected
Volatility
Risk-free
Interest Rate
Fair value
per option
24/03/2017
24/03/2025
100%
(a)
(a)
(a)
(b)
(c)
(a)
(d)
(e)
(f)
(g)
(f)
(f)
5,000,000
1,500,000
15,175,000
5,783,333
5,000,000
3,000,000
1,600,000
37,058,333
48,362,300
-
-
-
-
48,362,300
85,420,633
-
-
-
-
-
-
-
-
-
11,900,000
4,500,000
4,000,000
16,000,000
36,400,000
36,400,000
5,000,000
1,500,000
15,175,000
5,783,333
5,000,000
3,000,000
1,600,000
37,058,333
48,362,300
11,900,000
4,500,000
4,000,000
18/01/2018
28/11/2018
12/12/2018
1/02/2019
4/04/2019
1/12/2022
27/11/2023
12/12/2023
1/02/2024
4/04/2024
28/09/2020
27/09/2025
15/03/2021
16/09/2021
18/11/2021
13/01/2022
15/03/2026
16/09/2026
18/11/2026
13/01/2027
16,000,000
24/05/2022
24/05/2027
84,762,300
121,820,633
60%
54%
54%
54%
49%
60%
80%
100%
100%
100%
100%
2.61%
2.44%
2.29%
2.15%
1.83%
1.50%
0.32%
0.71%
0.62%
1.38%
1.47%
3.04%
$0.049
$0.013
$0.014
$0.016
$0.019
$0.014
$0.009
$0.015
$0.064
$0.119
$0.111
$0.052
(a) Director Options issued outlined above have 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. 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.
(b) Employee options issued under an Employee Option Plan to various employees to 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 have fully vested.
(c) Employee options issued under an Employee Option Plan to a consultant whereby 500,000
options have no vesting conditions attached, 1.5 million options vesting is conditional upon
execution of the first term sheet which is substantially associated with a patterning deal; and
3 million options is conditional upon execution of the first commercial agreement which is
substantially associated with a deal (option, licence, company acquisition or other
arrangement).
(d) Employee options issued under an Employee Option Plan to the Chief Financial Officer
whereby one-third vest 12 months from Grant Date, and the balance vest in equal quarterly
increments over the remaining 24 months.
(e) Loan Shares issued to the Chief Executive Officer whereby one-quarter vest 12 months from
Grant Date and the and the remainder vest in equal monthly increments over the remaining
24 months.
(f) Loan Shares issued to various employees and a consultant whereby one-quarter vest 12
months from Grant Date and the and the remainder vest in equal monthly increments over
the remaining 24 months.
(g) Loan Shares issued to Non-Executive Directors whereby one-third vest 12 months from
Grant Date and the remainder vest in equal quarterly increments over the remaining 24
months.
In all instances, Loan Shares were issued under a Loan Share Plan 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.
60 Actinogen Medical Limited
Notes to the Financial Statements
(continued)
21. SHARE-BASED PAYMENTS (CONTINUED)
Common to all classes of share-based payments on issue are the following factors and assumptions:
•
•
•
•
•
The fair value of options granted have been valued using a Black-Scholes option pricing model, taking into account the terms and conditions upon which the share options were granted. Where
vesting conditions are applicable, they are expensed over the vesting period.
The assumed dividend payable during the term of the Options is deemed to be nil.
A volatility of the share price fluctuation was calculated by considering the historical movement of the share price over a period of time as well factoring market conditions of its competitors to
predict the distribution of relative share performance.
The exercise price of the share options is equal to the market price of the underlying shares on the date of grant.
The Company does not have a past practice of cash settlement or cash settlement alternatives for these awards.
The table below summarises the options on issue, including loan shares that are in substance options, and the movements in share-based payments during the year as at 30 June 2022. There were no
SBP that lapsed during the year.
Quantity
on issue
Total SBP
valuation
Opening value SBP expense
as at 1 July 2021
Value recognised
during the year
Closing value of SBP expense
as at 30 June 2022
Value to be recognised
in future years
5,000,000
1,500,000
15,175,000
5,783,333
5,000,000
3,000,000
1,600,000
37,058,333
48,362,300
11,900,000
4,500,000
4,000,000
16,000,000
84,762,300
121,820,633
$245,286
$19,350
$215,485
$91,377
$92,500
$42,396
$14,948
$721,342
$733,990
$764,395
$534,646
$443,577
$827,144
$3,303,752
$4,025,094
$245,286
$19,350
$200,338
$76,367
$70,429
$31,797
$7,603
$651,170
$142,909
-
-
-
-
$142,909
$794,079
-
-
$15,147
$15,010
$13,866
$10,599
$5,583
$60,205
$426,070
$392,633
$220,932
$133,421
$54,694
$1,227,750
$1,287,955
$245,286
$19,350
$215,485
$91,377
$84,295
$42,396
$13,186
$711,375
$568,980
$392,633
$220,932
$133,421
$54,694
$1,370,659
$2,082,034
-
-
-
-
$8,205
-
$1,762
$9,967
$165,010
$371,762
$313,714
$310,155
$772,450
$1,933,091
$1,943,058
Type of SBP
Options
Director options
Director options
Director options
Employee options
Employee options
Director options
Employee options
Total options
Loan shares
Loan shares
Loan shares
Loan shares
Loan shares
Loan shares
Total loan shares
Total SBP
61 Actinogen Medical Limited
Directors’ Declaration
In the Directors’ opinion:
1.
The Financial Statements and Notes set out on pages 39 to 61, are in accordance with the Corporations Act 2001
including:
(a) complying with Accounting Standards, the Corporations Regulations 2001 and other mandatory professional reporting
requirements,
(b) giving a true and fair view of the Company’s financial position as at 30 June 2022 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.
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
25 August 2022
62 Actinogen Medical Limited
Independent Auditor’s Report
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 2022, 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 2022 and of its
financial performance for the year ended on that date
b)
complying with Australian Accounting Standards and the Corporations Regulations 2001.
Basis for opinion
We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under
those standards are further described in the Auditor’s Responsibilities for the Audit of the Financial
Report section of our report. We are independent of the Company in accordance with the auditor
independence requirements of the Corporations Act 2001 and the ethical requirements of the
Accounting Professional and Ethical Standards Board’s APES 110 Code of Ethics for Professional
Accountants (including Independence Standards) (the Code) that are relevant to our audit of the
financial report in Australia. We have also fulfilled our other ethical responsibilities in accordance with
the Code.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis
for our opinion.
Key audit matters
Key audit matters are those matters that, in our professional judgment, were of most significance in
our audit of the financial report of the current year. These matters were addressed in the context of
our audit of the financial report as a whole, and in forming our opinion thereon, but we do not provide
a separate opinion on these matters. For the matter below, our description of how our audit addressed
the matter is provided in that context. We have determined the matter described below to be the key
audit matter to be communicated in our report.
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
63
Annual Financial Report Independent Auditor’s Report (continued)
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.
1. Research and development rebate
Why significant
How our audit addressed the key audit matter
The Company has recognised a rebate 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.
Included in other receivables and prepayments on the
statement of financial position and in Note 9 of the
financial report is an amount for $3.64 million related
to the R&D rebate calculated as receivable for the year
ended 30 June 2022.
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 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
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
The directors are responsible for the other information. The other information comprises the
information included in the Company’s 2022 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.
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
64
Actinogen Medical Limited
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 to
fraud or error, design and perform audit procedures responsive to those risks, and obtain audit
evidence that is sufficient and appropriate to provide a basis for our opinion. The risk of not
detecting a material misstatement resulting from fraud is higher than for one resulting from
error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the
override of internal control.
• Obtain an understanding of internal control relevant to the audit in order to design audit
procedures that are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control.
•
Evaluate the appropriateness of accounting policies used and the reasonableness of accounting
estimates and related disclosures made by the directors.
• Conclude on the appropriateness of the directors’ use of the going concern basis of accounting
and, based on the audit evidence obtained, whether a material uncertainty exists related to
events or conditions that may cast significant doubt on the Company’s ability to continue as a
going concern. If we conclude that a material uncertainty exists, we are required to draw
attention in our auditor’s report to the related disclosures in the financial report or, if such
disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit
evidence obtained up to the date of our auditor’s report. However, future events or conditions
may cause the Company to cease to continue as a going concern.
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
65
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 4 • Evaluate the overall presentation, structure and content of the financial report, including the disclosures, and whether the financial report represents the underlying transactions and events in a manner that achieves fair presentation. We communicate with the directors regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. We also provide the directors with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards applied. From the matters communicated to the directors, we determine those matters that were of most significance in the audit of the financial report of the current year and are therefore the key audit matters. We describe these matters in our auditor’s report unless law or regulation precludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication. Report on the audit of the remuneration report Opinion on the remuneration report We have audited the Remuneration Report included in the directors' report for the year ended 30 June 2022. In our opinion, the Remuneration Report of the Company for the year ended 30 June 2022, 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 25 August 2022 Actinogen Medical Limited Shareholder Information
Substantial shareholders:
The following substantial shareholders have lodged notices with the company as at 19 August 2022:
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 19 August 2022
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
109
304
582
Shares
13,442
1,129,952
4,787,664
2,342
99,470,871
1,474
1,690,491,888
4,811
1,795,893,817
Shareholders with less than a marketable parcel
545
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 19 August 2022
HSBC Custody Nominees (Australia) Limited
Dr Steven Gourlay
Edinburgh Technology Fund Limited
JSC Wealth Management Pty Ltd
Tisia Nominees Pty Ltd
Citicorp Nominees Pty Limited
Mr James Murch & Mrs Catherine Murch
Garnsworthy Pension Fund Pty Ltd
SG Gourlay Nominees Pty Ltd
Amber Court Nominees Pty Ltd
Iral Pty Ltd
Mrs Gillian Karen Nes & Mrs Ronald Nes
Big Eater Pty Ltd
John Dahlsen Superannuation Fund Pty Ltd
Brazil Farming Pty Ltd
Double Jay Group Holdings Pty Ltd
HSBC Custody Nominees (Australia) Limited – A/C 2
Rickenbacker Capital Investments Pty Ltd
Kaleidoscope Holdings Pty Ltd
Oaktone Nominees Pty Ltd
Number of
Shares
Percentage of
Issued Capital
262,689,970
14.63%
48,362,300
48,147,864
44,655,962
33,440,621
26,916,130
20,500,000
19,000,000
15,797,222
15,023,401
15,000,000
14,700,000
12,999,659
12,200,000
12,000,000
11,475,253
11,466,402
10,840,741
10,800,000
10,500,000
2.69%
2.68%
2.49%
1.86%
1.14%
1.14%
1.06%
0.88%
0.84%
0.84%
0.82%
0.72%
0.68%
0.67%
0.64%
0.64%
0.60%
0.60%
0.58%
TOTAL
656,515,525
36.56%
Annual Financial Report 67
Shareholder Information (continued)
Unquoted Securities as at 19 August 2022
1.
There were 1,500,000 unlisted options exercisable at $0.10 each and expiring on 1 December 2022 held by one
holder, on issue. Details of the holders holding more than 20% are outlined below:
George Morstyn
Number of Options
1,500,000
Percentage
100.00%
2.
There were 15,175,000 unlisted options exercisable at $0.085 each and expiring on 27 November 2023 held by three
holders, on issue. Details of the holders holding more than 20% are outlined below::
John William Ketelbey
Geoffrey Edward Duncan Brooke
Number of Options
Percentage
8,775,000
4,900,000
57.83%
32.29%
There were 5,783,333 unlisted employee share option plan options exercisable at $0.085 each and expiring on 12
December 2023 held by six holders, on issue.
There were 5,000,000 unlisted options exercisable at $0.093 each and expiring on 1 February 2024 held by one
holder, on issue. Details of the holders holding more than 20% are outlined below::
Bio-Link Australia Pty Ltd
Number of Options
5,000,000
Percentage
100.00%
There were 3,000,000 unlisted options exercisable at $0.10 each and expiring on 4 April 2024 held by one holder, on
issue. Details of the holders holding more than 20% are outlined below:
Malcolm John McComas
Number of Options
3,000,000
Percentage
100.00%
There were 5,000,000 unlisted options exercisable at $0.10 each and expiring on 24 March 2025 held by one holder,
on issue. Details of the holders holding more than 20% are outlined below:
Geoffrey Edward Duncan Brooke
Number of Options
5,000,000
Percentage
100.00%
There were 1,600,000 unlisted employee share option plan options exercisable at $0.046 each and expiring on 27
September 2025 held by one holder, on issue.
3.
4.
5.
6.
7.
Restricted Securities
The Company has no securities on issue that are subject to either ASX or voluntary escrow.
On-Market Buy-Back
There is no current on-market buy back in place.
The Corporate Governance Statement is not included as part of this Annual Report but can be referenced via the Company’s
website.
68 Actinogen Medical Limited
Corporate Directory
Board of Directors
Dr Geoffrey Brooke - Non-Executive Chairman
Dr Steven Gourlay - Managing Director & Chief Executive Officer
Dr George Morstyn - Non-Executive Director
Mr Malcolm McComas - Non-Executive Director
Company Secretary
Mr Peter Webse
Investor Relations
Mr Michael Roberts
Principal Place of Business / Registered Office
Suite 901
Level 9
109 Pitt Street
Sydney NSW 2000
Contact Details
Telephone: 02 8964 7401
info@actinogen.com.au
www.actinogen.com.au
ABN 14 086 778 476
Lawyers
K&L Gates
Level 25 South Tower
525 Collins Street
Melbourne VIC 3000
Share Register
Automic Group
Level 5
126 Phillip Street
Sydney NSW 2000
Auditors
Ernst & Young
Australia
Actinogen Medical Limited shares are listed on
the Australian Securities Exchange ('ASX').
ASX Code: ACW
AGM details
Actinogen Medical Limited
ABN: 14 086 778 476
Annual General Meeting
Due to health and safety priorities and the ongoing
COVID‑19 pandemic, this year’s Annual General Meeting
will be in a ‘hybrid’ format, allowing both in person and
virtual attendance and voting.
Date: 16 November 2022
Meeting time and details to be advised.