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TIC DISEASES
2022-2023
Amplia Therapeutics Ltd
ANNUAL REPORT
1
Amplia Therapeutics recognises and respects
First Nations People and welcomes the
work of all those who strive for
health equality in Australia.
2
Contents
Letter from the Chairman .................................................... 4
CEO’s Message ..................................................................... 6
Meet the Team .................................................................. 8
Company Snapshot ........................................................ 10
Review of Operations ..................................................... 13
Clinical Trials - bright minds, steady hands ................. 14
News Flow and Milestones ................................................. 16
Q&A with Dr Chris Burns, MD & CEO .................................... 18
Advancing Amplia’s Preclinical Program ..................................... 20
Our Values .................................................................................................. 22
Financial Report ................................................................................................... 23
Letter from the Chairman
Dear Shareholders,
On behalf of your Board it is my pleasure to share with you the 2023 Annual Report of our Company.
This has been an important year for Amplia. Firstly, and most importantly, with the COVID pandemic largely
behind us we were able to move forward freely with our Phase 1b/2a trial of AMP945 in pancreatic cancer (the
ACCENT trial) and begin dosing patients. As I write this we are well into the dose range-finding stage of the
study with the third cohort completely enrolled. Initially recruitment into the study was slowed through some
delays at clinical sites as they dealt with COVID related staff shortages. Recruitment is now back on track and
we are grateful for the coordinated efforts of sites and the team of people managing the study.
The progress in the ACCENT trial is a credit to both Dr John Lambert, our inaugural CEO, and to Dr Chris Burns,
who was appointed as CEO and Managing Director in December 2022. We had high expectations that this
change of leadership would go very smoothly and those expectations have been justified. We thank John for
his leadership and sterling efforts in building the Company and establishing the clinical program for AMP945.
Chris Burns, as a fellow Board member and co-founder of the Company, was very well placed to takeover
this leadership role. In addition to driving the ACCENT trial, Chris has been active in exploring additional
opportunities for our FAK inhibitors through preclinical studies, and progress from these will be reported in
due course. Dr Terrie-Anne Cock, Head of Translational Biology, also joined the Company in the last year
(see page 21) and brings a wealth of invaluable experience in drug development.
This promising progress for Amplia is taking place in an environment where biotechnology companies
in Australia, and indeed around the world, are facing significant headwinds at present. Market
sentiment is poor, capital markets have shrunk, and as a consequence, deals (collaborations,
partnerships, acquisitions) with pharma and larger biotechs are down compared to historical
norms. Nevertheless, the Company remains confident that our developing dataset, both clinical
and preclinical, for our FAK inhibitors continues to add value to the Company and enhance
shareholder value as well as increase opportunities for commercial deal-making going forward.
Dr Burns is well established in his new role as CEO and making significant contributions to
Amplia. Progress over recent months reflects his leadership of our small, experienced, and
cohesive management team. I am grateful for the significant contributions and guidance
of my fellow Directors. The Board’s collegial approach and ‘roll-up-the sleeves’ attitude has
undoubtedly added to the Company’s success.
In conclusion, Amplia continues to make excellent progress with the ACCENT trial while
exploring additional value-creating opportunities for our FAK inhibitors.
Warwick Tong
Independent Non-Executive Chair
4
“
We are resolutely
focused on ethical drug
development – and the
next 12-18 months will be
a defining chapter in our
journey to improve the
lives of people with
pancreatic cancer.
NON-EXECUTIVE CHAIRMAN,
WARWICK TONG
CEO’s Message
This past year has been a significant one for Amplia as we initiated our first clinical trial in patients.
The ACCENT trial in advanced pancreatic cancer patients was approved by Human Research Ethics Committees
in April and May 2022, and the first patient was dosed in early August 2022. We now have seven sites open
across Melbourne, Sydney and Brisbane and the pace of recruitment has now substantially improved after a
slow start impacted by lingering COVID constraints. This trial is in two stages: the first stage (Phase 1b) is a
dose-range finding stage where increasing doses of AMP945 are tested in cohorts of three patients to assess
safety, tolerability and PK/PD* effects; the second stage (Phase 2a) is directed towards testing the best dose
identified from the Phase 1b portion in up to 50 patients and assessing for signs of clinical efficacy. Over the
course of this financial year, we successfully completed dosing two cohorts in the Phase 1b portion of the trial.
Looking forward, we anticipate completing the Phase 1b portion of the trial in the third quarter of the year and
starting the Phase 2a component of the trial before year end.
In the background the Amplia team have been expanding the formal preclinical work on AMP945 to allow for
regulatory filings with the Korean and US drug regulators to enable expansion of the trial to these countries.
In particular, our goal is to open sites in Korea later this year so that these sites can participate in the Phase 2a
portion of the trial. Also noteworthy is that chemical synthesis of the drug on scale has progressed smoothly,
as has manufacture of the final capsule form for use in the trial.
We have continued to explore additional clinical opportunities for our FAK assets AMP945 and AMP886
across a range of disease indications. Studies undertaken over the year with AMP945 for the debilitating
lung disease idiopathic pulmonary fibrosis (IPF) demonstrated that the compound performs as well
as the current standard-of-care drug nintedanib in a preclinical model of the disease. This result
is extremely promising given that the annual sales for nintedanib are >US$2b despite it being
poorly tolerated by patients. Our IND-enabling studies with AMP945 in IPF are continuing. We
routinely review the scientific literature for research identifying FAK’s role in disease, and where
a FAK inhibitor may be a potential treatment option. A number of preliminary laboratory
studies have been initiated with AMP945 over the year, and findings will be reported once
the studies are complete. In addition, we have trialled our second FAK inhibitor, AMP886,
in specific mouse models of acute myeloid leukemia (AML), a poorly treated blood cancer.
Our data clearly demonstrated that AMP886 reduced disease burden in treated animals
in a dose-dependent manner and further studies are underway to explore the competitive
potential of AMP886 in this indication, compared with opportunities for this compound in
solid tumours.
This year also saw a change of leadership at Amplia Therapeutics, with the departure of
Dr John Lambert and my appointment. I am extremely grateful to the Board for giving me
the opportunity to lead the Company at this exciting time and ensuring that the transition
proceeded smoothly. I would personally like to thank John for his assistance in the transition
and for building such an exceptional group of co-workers at the Company. The team at Amplia
is top-notch and the uninterrupted progress across our manifold activities is testament to this.
Everything we do at Amplia is made possible by the support of our shareholders and investors.
We remain focused on increasing shareholder value by progressing our programs in the most
capital-efficient manner, to address serious unmet medical needs.
Dr Christopher Burns
CEO & MD
*PK/PD = pharmacokinetics and pharmacodynamics
6
“
Our primary goal is to
advance the development
of AMP945 in pancreatic
cancer by completing the
ACCENT trial, and moving
towards registration -
enabling trials in Australia,
the US and Europe.
CEO & MD,
DR CHRISTOPHER BURNS
Meet the Team
Board of Directors
WARWICK TONG MB ChB MPP GAICD
Non-Executive Chairman of the Board
Warwick is a NZ trained physician with more than 25 years’ experience
in the pharmaceutical and biotechnology industry.
Dr Tong was appointed as a Non-Executive Director on 4th of May 2018
and Chairman on 25th May 2018. Dr Tong is also a member of the
Audit Committee.
CHRISTOPHER BURNS B.Sc. (Hons) PhD GAICD
Chief Executive Officer and Managing Director
Chris is an experienced drug discovery leader having worked in various
roles in pharma, biotech and academia for 30 years.
Dr Burns was originally appointed as a Non-Executive Director on
4th May 2018 and was subsequently appointed as Chief Executive
Officer and Managing Director on 5th December 2022.
ROBERT PEACH PhD
Independent Non-Executive Director
Robert has over 25 years of drug discovery and development
experience in the pharmaceutical and biotechnology industry.
Dr Peach was appointed as an Independent Non-Executive Director
on 2nd of September 2015 and is a member of the Remuneration
Committee.
JANE BELL BEc, LLB, LLM (Lond), FAICD
Independent Non-Executive Director
Jane is a banking and finance lawyer and non-executive director with
more than 30 years’ experience in leading law firms, financial services
and corporate treasury operations in Melbourne, London, Toronto,
San Francisco and Brisbane.
Ms Bell was appointed as an Independent Non-Executive Director on
12th April 2021 and is Chair of the Audit and Risk Committee.
8
Meet the Team
Executive Team
Scientific Advisers
CHRISTOPHER BURNS BSc (Hons) PhD, GAICD
PROFESSOR MARGARET FRAME OBE, PhD
Chief Executive Officer and Managing Director
FAK Biology Adviser
RHIANNON JONES BSc (Hons) PhD, GAICD
PROFESSOR PAUL TIMPSON PhD
Chief Operating Officer
FAK Biology Adviser
HAMISH GEORGE CA, BCom, GIA(Cert)
DR MARK DEVLIN BSc (Hons) PhD GradD Drug Dev MBA
Chief Financial Officer
ANDREW J. COOKE LL.B
Company Secretary
CHARLOTTE MULDER BVSc (Hons), MBA
Principal Development Manager
ANTHONY BISHOP BSc, GradDip
Principal Development Manager
TERRIE-ANNE COCK PhD
Head of Translational Biology
ADRIAN SULISTIO B Eng (Hons), B. Com, PhD
CMC Project Manager
NICOLE KRUGER BSc
Clinical Operations Manager
Scientific Adviser
DR JULIE BULLOCK PhD
Clinical Pharmacology Consultant
Clinical Advisers
DR JOSE IGLESIAS MD
Clinical Adviser (Oncology)
DR JASON LICKLITER MBBS, FRACP
Medical Adviser
Company Snapshot
The team is developing two potent, orally-available
inhibitors of Focal Adhesion Kinase (FAK),
which show promise in treating cancer and
fibrotic diseases.
Amplia is a drug
development
company focused
on new treatments
for cancer and
fibrotic diseases.
The lead compound, AMP945, is currently being studied in a Phase 1b/2a
clinical trial for advanced pancreatic cancer, in combination with
standard-of-care chemotherapy gemcitabine and nab-paclitaxel, in Australia.
A Phase 1 clinical trial of AMP945 in healthy volunteers was successfully completed in 2021.
Australian Innovation
Amplia’s lead drug candidates, AMP945 and AMP886, were both discovered in Melbourne, Australia by
researchers at the Cancer Therapeutics CRC – a successful cancer research collaboration between Australia’s
leading research institutes, universities, and biotechnology companies. Recognising the potential of both
molecules, the Company proudly brought this promising technology from the lab, into clinical development.
Following a successful Phase 1 trial in healthy volunteers, the Company is now conducting the ACCENT trial,
a Phase 1b/2a clinical trial of AMP945 in first line pancreatic cancer patients across seven clinical sites in
Melbourne, Sydney and Brisbane.
Targeting Focal Adhesion Kinase
Focal Adhesion Kinase (FAK) inhibitors are a promising area of cancer research. FAK is an increasingly
important target in cancer and particularly cancers that generate a protective fibrotic and immunosuppressive
microenvironment around the tumour cells. At this stage of its development, Amplia is targeting resources on
fibrotic cancers, of which pancreatic cancer is one of the most deadly.
By targeting FAK, we have the potential to disrupt these fibrotic and immunosuppressive pathways and slow
the progression of cancer. Additionally, FAK inhibitors have shown promise in treating other fibrotic diseases,
such as idiopathic pulmonary fibrosis (IPF), which opens up an alternate area of therapeutic potential for
Amplia’s pipeline drugs.
10
AMP945
Lead candidate, AMP945, is a highly selective and potent FAK inhibitor that has shown promising results in
preclinical studies for the treatment of pancreatic cancer.
Pancreatic cancer is a difficult to treat cancer, with a low survival rate – only 3 out of 10 people (35.5%) will
survive one year after diagnosis of pancreatic cancer1. Fibrotic shields protect many solid tumours from
chemotherapy. Amplia’s FAK inhibitors aim to remove this shield, making the tumours more susceptible
to chemotherapy.
In preclinical models of other (non-cancer) fibrotic diseases, the efficacy of AMP945 has been shown to be
similar to or better than current standard-of-care therapies.
FAK
inhibitor
Fibrotic tumour
microenvironment (FAK)
Exposed
tumour
Dead
tumour
Created with BioRender.com
Amplia’s ACCENT trial is a multicentre, open label, two-part study to determine whether AMP945,
when given prior to dosing with gemcitabine and nab-paclitaxel, improves response to
chemotherapy in first-line patients with unresectable or metastatic pancreatic cancer.
Recruitment is now underway.
AMP886
AMP886 is also a highly potent FAK inhibitor, that also inhibits two other validated disease targets. Preclinical
studies suggest AMP886 may have clinical potential in the treatment of acute myeloid leukemia (AML) and
certain solid tumours.
1 Australian Institute of Health and Welfare (2022) https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia
11
Pipeline
Amplia continues to explore the potential of both AMP945 and AMP886 in a range of preclinical models of
cancer and fibrotic disease to identify future development, partnering, and licensing opportunities. The current
development pipeline is strong.
Drug
Indication
Therapy
Preclinical
Phase 1
Phase 2
Phase 3
(approval)
Current Status
Next 12 Months
AMP945
Pancreatic
Cancer
Combination
Therapy
AMP945
Idiopathic
pulmonary
fibrosis (IPF)
Monotherapy
AMP945
Cancers and
fibrotic disease
Combo/
Monotherapies
AMP886
Cancers and
fibrotic disease
Combo/
Monotherapy
Established Networks
Amplia has built strong connections with highly respected clinicians and researchers within the oncology
community – both in Australia and worldwide. These experts provide valuable insight into the development
of its therapies and help guide clinical trial strategies.
In addition, the Company has built a network of respected drug development advisers, contract research
organisations and clinical operations specialists so that our trials are conducted efficiently and to world’s
best practice.
12
Review of Operations
The Road Ahead
Amplia is constantly exploring new ways to collaborate, innovate, and deliver life-changing
outcomes for patients around the world. As a values-driven company, Amplia is motivated to
build a better future for our team, collaborating stakeholders, and the wider community.
Robust plans are in place to safeguard the Company’s long-term growth and sustainability. While
the focus continues to be on advancing Amplia’s lead asset AMP945 through the clinic via the
ACCENT trial in pancreatic cancer, there are clear plans to maximise the potential of the
FAK inhibitor development program in other cancers and fibrotic diseases too. Amplia is also
investing in its team and infrastructure to sustainably support its operations.
Strategic Planning
program. Targeted
The Amplia team is
development processes,
The goal is to position
Amplia for the future
by building a more
sophisticated and
scalable company.
Under the direction of
a highly credentialed
Board, the Company
is underpinned by a
culture of innovation
and excellence –
with planning and
preparation, both
cornerstones of
its success.
2022 represented a year
of increased activity for
Amplia as it progressed
its Phase 1b/2a ACCENT
trial in pancreatic cancer.
Considered forward-
planning was a crucial
part of this, enabling the
team to establish strong
working relationships
with key opinion leading
(KOL) doctors and their
patients, to effectively
recruit for, and
implement the clinical
activities to amplify
highly motivated,
from early research
awareness of,
with deep and varied
to clinical trials and
and engagement
expertise. The Company
commercialisation.
with, the trial has also
has assembled talented
The integration of a
been successful.
individuals with diverse
QMS into Amplia’s
In early 2023, the Amplia
team ran a strategic
planning workshop to
reflect on the Company’s
strengths, to identify
new opportunities, and
set priorities for the
future that are aligned
with clear values and
purpose – a regular
checkpoint, as the
Company grows
and nurtures a
high-achieving
backgrounds and skills
operations will help to
across all areas of
improve efficiencies,
operations, from the lab
ensure compliance with
bench to the clinic. Its
regulatory requirements,
in-house credentials are
and maintain the highest
bolstered by a network
standards of quality
of trusted specialist
across all activities.
advisors too.
Streamlining
Operations
ESG
In line with Amplia’s
values-driven approach,
Amplia is future-
the Company is
proofing its operations
currently exploring
by investing in the
ways to incorporate ESG
culture along the way.
improvement of
(Environment, Society,
Growing The Team
Building a world-
class team is critical
to achieving Amplia’s
systems and processes,
Governance) initiatives
including in areas of
into its operations.
project management,
By adopting a more
cyber-security and
sustainable and socially
quality systems.
responsible approach
mission, so recruiting
In particular, the Quality
and supporting an
Management System
appropriately skilled
(QMS) framework
workforce has been a
will enable the team
primary focus of FY22-23.
to manage drug
13
to business, Amplia
will create long-term
value for its valued
stakeholders and
positively impact the
communities it serves.
Clinical trials -
bright minds, steady hands
Clinical trials are a crucial step in the development of new medical treatments - but it’s no
secret they are complex and demanding, with strict regulatory requirements, ethical
standards, and safety guidelines. Recruiting experienced and steady hands to guide
the process is vital, which is exactly what we have done at Amplia.
The launch of Amplia’s ACCENT trial in 2022 was the culmination of rigorous planning and
collaboration, and signalled a critical milestone in the development of AMP945. Amplia’s
team of experienced clinical trial experts have been integral to its success, leveraging
specialist expertise every step of the way.
“Initiating a Phase 2 clinical trial requires an immense breadth of knowledge of the
operational, regulatory and logistical elements of clinical trial development. Fortunately,
Amplia has assembled an exceptional team of employees and collaborators dedicated
to ensuring that not only are there no gaps in the science, but that the clinical
development process runs as smoothly and successfully as possible,” explains
Amplia’s CEO and MD, Dr Chris Burns.
With regulatory approval and commercialisation the ultimate goals, Amplia must
maintain meticulous documentation of the entire clinical development journey.
This is an administrative responsibility that is not only required for regulatory
compliance, but also safeguards the Company in the event of staffing changes
during the course of the clinical development process.
Amplia’s Clinical Operations Manager, Nicole Kruger, is no stranger to the complexities
of managing clinical research programs. Nicole has been working in the biotechnology
and pharmaceutical sector for three decades, helping biotechnology companies to
implement and manage their clinical research programs and projects.
While planning a clinical trial, and its many moving parts can sound onerous, Nicole says
Amplia’s rigorous processes, including their approach to record-keeping combined with a
specialist team and experienced trial sites, helped to streamline the commencement of the
ACCENT trial.
“It can be complex, but not difficult,” she explained. “The team has worked closely with each of the clinical trial
sites who conduct the trials, to bring together all the necessary documentation and procedures required to ensure
that our clinical protocols are ethical and scientifically sound,” said Nicole.
Nicole’s knowledge and understanding of the regulatory and governance frameworks that underpin the clinical
trials process means that the ACCENT trial remains on track, meeting all necessary checkpoints as they arise
during the trial. As Amplia nears Stage 2 of the trial, preparations are ongoing to ensure that the clinical trial
program continues to meet both clinical and regulatory milestones – on time, and on budget.
“There is a responsibility, as the trial Sponsor, to ensure that we meet our legal and ethical responsibilities, and that
patient wellbeing remains at the heart of our clinical program,” said Dr Burns.
“We are very fortunate to be able to lean on a dynamic and highly-focused team that understands the work that
needs to be done, can navigate the challenges, and believes in our vision to help bring more effective treatments to
pancreatic cancer patients”.
14
Relationship building,
the secret to trial recruitment
Establishing a transparent, supportive and productive
working relationship with the trial sites is vital to support
successful recruitment to a clinical trial.
“Clinical development is as much about logistics and
relationship-building as it is about the science,” explains
Amplia’s Principal Development Manager, Anthony Bishop.
“Once the trial protocol is agreed and approved, we work closely with
the sites to maintain clear, open and timely communication of all data
and developments as they arise.”
Anthony works closely with the trial sites to make sure the recruitment
process is smooth, with a steady stream of patients moving through.
Each site has a clinical trial coordinator who interfaces with the
patients, and Amplia meets regularly with them to ensure that the
site has all the necessary information and documentation in place
to recruit patients.
With over 25 years in pharmaceutical development, Anthony
has been involved in many clinicals trials – from both the
sponsor and the CRO perspective.
“ There are many moving parts and resources that need to
come together, and sensitively navigating the challenges
for both is definitely an advantage to keep things
moving forward.”
Now recruiting
The ACCENT Phase 2 clinical trial
is now recruiting people who
have been diagnosed with
advanced pancreatic cancer,
specifically those patients who have
inoperable pancreatic cancer or
whose cancer has spread to other
parts of the body. Patients will be
initially recruited through treating
doctors at hospitals in Melbourne,
Sydney, and Brisbane.
In total, it is expected that the
trial will recruit approximately
62 participants.
Learn more:
ampliatx.com/accent
News Flow and Milestones
Media Headlines
The launch of Amplia’s ACCENT trial attracted attention from top-tier media outlets and industry
publications. This coverage highlights Amplia’s growing reputation and recognition as a pioneering force in
the biotechnology industry.
Trial launch makes national headlines
In partnership with research collaborators at the Garvan Institute of Medical Research, Amplia launched a
media campaign to support recruitment of pancreatic cancer patients for the ACCENT clinical trial.
The media campaign initially made national headlines with a page 3 feature in The Australian, by Health
Editor Natasha Robinson. The article, titled ‘Drug to tear down pancreatic tumour defences’ explained the
importance of Amplia’s research, and the novel treatment capabilities of FAK inhibitor, AMP945.
The drug, AMP945, has the potential to make chemotherapy much more effective because it breaks
down a fibrous shield that surrounds cancer cells that makes them difficult to penetrate.
The trial was also featured on prime-time television, with Channel 9’s Health Reporter, Gabriella Rogers,
meeting with Amplia’s former CEO, Dr John Lambert, and Garvan Institute’s, Professor Paul Timpson, to discuss
Amplia’s Phase1b/2a clinical trial of AMP945 in people with pancreatic cancer.
16
Northern Exposure: Queensland media embraces ACCENT trial
In February 2023, Amplia opened a trial site in Queensland, bringing the total number of clinical trial
sites to seven across Melbourne, Sydney and Brisbane. The announcement attracted significant
coverage across television, print and radio.
Channel 9 News filmed an interview with clinical trial investigator at Greenslopes Private Hospital,
Dr Warren Joubert. The segment also featured pancreatic cancer patient, Judi Adams, who bravely
shared her own experience with the disease – together with a passionate plea encouraging patient
participation in medical research.
Courier Mail Health Reporter, Jackie Sinnerton, published an article titled “New hope for advanced
pancreatic cancer patients in clinical trials,” highlighting the importance of new therapies in the face of
grim survival statistics for patients.
Amplia CEO and MD, Dr Chris Burns, also spoke with Craig Zonca and Loretta Ryan on ABC Radio Brisbane
Breakfast to discuss the details of the trial, and how patients could get involved.
ASX announcements
April 2022
May 2022
June 2022
Amplia Receives Ethics Clearance for Phase 2 Trial in Pancreatic Cancer Patients
Amplia Receives Second Ethics Clearance for Phase 2 Trial
AMP945 Shows Efficacy in Model of Lung Fibrosis
August 2022
First Patient Recruited to ACCENT Trial in Pancreatic Cancer
August 2022
Amplia receives $1.8m R&D Tax Incentive
September 2022
American Association for Cancer Research (AACR) Conference Presentation
October 2022
AMP886 Activity in Acute Myeloid Leukemia (AML)
November 2022
Amplia appoints Dr Christopher Burns as CEO and Managing Director
November 2022
Enrolment of the first cohort of patients into ACCENT Trial completed
November 2022
Dose Escalation Approved in ACCENT Clinical Trial of AMP945
January 2023
First Patient Recruited to Cohort 2 of ACCENT Trial in Pancreatic Cancer
February 2023
ACCENT clinical trial presentation at the 35th Annual Lorne Cancer Conference
February 2023
February 2023
Amplia’s FAK inhibitor program presented at Next Generation Kinase Inhibitors
Summit in Boston, USA
Enrolment of the second cohort of patients in the ongoing Phase 1b/2a ACCENT
clinical trial completed
17
Q&A
with Dr Chris Burns, CEO & MD
An experienced leader with over 25 years in drug discovery and development, Dr Chris Burns
co-founded Amplia Therapeutics in 2016. He has been a Director on the Amplia Board since 2018,
and in December 2022, was appointed as Chief Executive Officer and Managing Director.
Tell us about your background and how you came to be the CEO of Amplia Therapeutics?
I have worked in drug discovery and development for most of my professional career.
In 2016, a group of like-minded drug developers got together in Melbourne and together we founded Amplia,
with the goal of developing the FAK inhibitors discovered at the Cancer Therapeutics CRC. Once we had
secured the IP, we set about building and financing the Company, ultimately settling on reverse-listing onto the
ASX in 2018.
I became a Director of the Company at that time and have worked closely with the other Board members and
management to help progress the development of the FAK assets. In late 2022, Dr John Lambert announced
his retirement and I stepped into the CEO role in December 2022.
What are the core values and mission of Amplia Therapeutics, and how do they guide the
Company’s direction?
Our core values of Patient Focus, Integrity, Respect, Performance, Innovation, Accountability and Excellence
succinctly describe our approach to our mission of developing innovative drugs for unmet medical needs. We
embrace an open, team-oriented culture to reach our goals in the most capital and time-efficient manner.
Can you speak to Amplia’s approach to drug development and what sets the Company apart from
other biotechnology companies?
Amplia has an experienced team who bring expertise and know-how from their previous roles with local and
international drug development organisations. Additionally, we work with expert advisers, both in Australia and
overseas, who possess specialised knowledge to provide guidance and support as needed.
Our deep understanding of FAK and cancer biology, as well as our adherence to best-practice drug
development, further bolsters our team’s capabilities. To ensure that we achieve success, we operate
within a project and budget plan that encourages all team members to engage and contribute.
Looking ahead, what is Amplia’s vision for the next 5-10 years, and what are some of the key
initiatives to achieve this vision?
Our primary goal is to advance the development of AMP945 in pancreatic cancer by completing the ACCENT
trial, and moving towards registration-enabling trials in Australia, the US and Europe.
In addition, we are conducting targeted laboratory research studies in collaboration with academic institutions
and contract research organisations to investigate the potential of both AMP945 and AMP886 in other
cancer indications.
AMP945 and AMP886 also have potential utility outside of oncology, in fibrotic diseases, and we continue to
explore opportunities to expand the drugs’ application in these indications. Our work in idiopathic pulmonary
fibrosis (IPF), a debilitating lung disease, is well advanced and we anticipate initiating a clinical trial for this
indication in 2024.
18
Can you provide insight into the Company’s valuable partnerships and collaborations?
Our partnership with Professor Paul Timpson at the Garvan Institute in Sydney has been extremely valuable.
Paul’s work on the role of FAK in the tumour microenvironment (TME) laid the groundwork for the ACCENT trial
in pancreatic cancer, and we continue to work with Paul and his team to develop our understanding of the
processes affected by our FAK inhibitors within the TME.
What role do you see patient advocacy groups playing in the development and commercialisation of
cancer therapies, and how does Amplia seek to engage with these groups?
Patient advocacy groups have an ever increasing and important role in the development of new drugs. To best
understand the needs and challenges of a disease, it is critical to sensitively engage with those at the frontline –
patients, their loved ones and support workers.
We have strong relationships with the two main pancreatic cancer patient advocacy groups in Australia and
have supported the annual conference of the Australian Gastrointestinal Trials Group - a multi-disciplinary
collaborative group of medical and research professionals, conducting clinical trials and related biological
research to improve treatments for gastro-intestinal (GI) cancers. We have also initiated similar interactions
with the key pancreatic cancer charities in the US.
Looking to the future, what excites you most about the potential of FAK inhibitors and what future
developments do you anticipate in this field?
The potential for safe and well tolerated FAK inhibitors in the treatment of cancer and fibrotic diseases is hugely
promising. New scientific findings identifying the role of dysregulated FAK activity in cancer and other diseases
are continually being reported, and we monitor these developments closely. In addition to orally dosed FAK
inhibitors, like AMP945 being used in pancreatic cancer, we believe there will be increased interest in topically
applied FAK inhibitors to treat wounds and scarring too.
We have recently begun working with CSIRO to develop a formulation of AMP945 that can be applied to a wound
topically. Based on recent literature studies, we believe
that AMP945 delivered in this way has the
potential to improve wound healing
whilst reducing scar tissue
formation. Our studies are in
the early stages, but should
this be demonstrated,
the potential for such
a product for use
in surgery and
wound treatment
would be
considerable.
Advancing Amplia’s
Preclinical Program
While Amplia’s ACCENT trial investigates the action of FAK-inhibitor AMP945 in pancreatic cancer,
the drug’s potential to treat other fibrotic cancers and diseases, as well as other therapeutic
applications, is being explored in a preclinical program led by Amplia’s Director of Translational
Biology, Dr Terrie-Anne Cock.
Focal adhesion kinase (FAK) is a critical regulator in development of fibrosis through its action within cells
called fibroblasts. Fibroblasts occur in many tissues and are responsible for the deposition and cross-linking
of collagen – the key constituents of fibrotic tissue – in response to cell stress and injury. In disease,
including cancer, this process becomes uncontrolled leading to formation of dense fibrotic tissue, better
known as scar tissue.
Given that fibrosis in all its forms has been reported to contribute to 45% of all deaths, inhibiting the activity of
FAK in fibroblasts could have profound impacts in many different diseases.
To date, Amplia’s focus has been pancreatic cancer, a highly fibrotic cancer. In preclinical studies with Professor
Paul Timpson and colleagues at the Garvan Institute in Sydney, AMP945 dose-dependently inhibits collagen
deposition and cross-linking from fibroblasts, both in vitro (i.e. ‘test tube’) and in vivo, in cancer tissues of mice
dosed with drug. Further, AMP945, when used in combination with the chemotherapies gemcitabine and
nab-paclitaxel, significantly extends the life of mice harbouring pancreatic tumours.
%
l
a
v
i
v
r
u
s
f
o
y
t
i
l
i
b
a
b
o
r
P
100
80
60
40
20
0
AMP945
increases survival
in pancreatic cancer
(KPC) model
0
5
10
20
15
Days Post Injection
25
30
Vehicle
Gemcitabine / nab-paclitaxel
AMP945 / gemcitabine / nab-paclitaxel
P ≤ 0.001
P ≤ 0.05
Pancreatic cancer cells.
Source: National Cancer Institute (https://www.cancer.gov)
There is a huge unmet need in the treatment of these fibrotic cancers, and laboratory studies
with AMP945 will determine whether the drug also has potential to treat these diseases.
20
Outside of cancer, Terrie-Anne is investigating the potential of Amplia’s FAK inhibitors in other fibrotic diseases.
Idiopathic pulmonary fibrosis (IPF) is one such disease, and the company is undertaking formal preclinical
development activities with AMP945 to take this drug into clinical trials in IPF.
Amplia is also planning on testing FAK inhibitors in wound healing.
“There is a growing body of evidence from the scientific literature showing that FAK inhibitors can promote wound
healing and can reduce scar formation at the same time. This has huge medical and commercial potential in that
scars can reduce skin movement and pliability whilst also raising cosmetic concerns,” said Terrie-Anne.
Director of Translational Biology, Dr Terrie-Anne Cock
Dr Terrie-Anne Cock joined the Amplia team in 2022, bringing with her over 18 years’ experience in
pharmaceutical research and development with multinational pharmaceutical companies GlaxoSmithKline and
OSI Pharmaceuticals, and various other Australian biotechnology companies.
Terrie-Anne has a PhD in Medicine from Garvan Institute of Medical Research and University of New South Wales
and was a recipient of the prestigious Marie Curie Postdoctoral Fellowship, which she undertook at the
Institut de Génétique et de Biologie Moléculaire et Cellulaire, in Illkirch, France.
Terrie-Anne has played key roles in the translation of molecules from research, through clinical trials,
and regulatory approvals. She has a deep knowledge of disease biology and discovery, combined with a
thorough understanding of the drug development process - from hit-to-lead research, preclinical and clinical
development, all the way to commercialisation.
Pancreatic cancer cells.
Source: National Cancer Institute (https://www.cancer.gov)
Our Values
Patient Focus
Putting patient health and safety first in the ongoing process of research and development.
Integrity
Doing what is right to achieve our purpose.
Respect
Embracing openness, trust, teamwork, diversity, collaboration and relationships that are
mutually beneficial.
Performance
Pursuing an ethical drug development strategy to generate commercial results.
Innovation
Focusing our efforts on developing new medicines to improve and save lives.
Accountability
Defining and accepting responsibility and delivering on our commitments to both patients
and shareholders.
Excellence
Striving to deliver outcomes using best practice principles in drug development.
22
Financial
Report
23
Contents
Appendix 4E - Preliminary final report .......................... 25
Corporate directory ......................................................... 27
Directors’ report .............................................................. 30
Auditor’s independence declaration ......................... 38
Consolidated statement of profit or loss
and other comprehensive income .............................. 39
Consolidated statement of financial position .............. 40
Consolidated statement of changes in equity .................. 41
Consolidated statement of cash flows ..................................... 42
Notes to the consolidated financial statements ........................... 43
Directors’ declaration ................................................................................... 63
Independent auditor’s report ................................................................................ 64
Shareholder information ................................................................................................... 68
24
Amplia Therapeutics Limited
Appendix 4E
Preliminary final report
1. Company details
Name of entity:
ABN:
Reporting period:
Previous period:
Amplia Therapeutics Limited
16 165 160 841
For the year ended 31 March 2023
For the year ended 31 March 2022
2. Results for announcement to the market
$
Revenues and other income from ordinary activities
down
35% to
1,286,740
Loss from ordinary activities after tax attributable to the owners of
Amplia Therapeutics Limited
up
71%
to
(6,242,435)
Loss for the year attributable to the owners of Amplia
Therapeutics Limited
up
71%
to
(6,242,435)
Dividends
The Directors have resolved that no dividend will be paid during this current financial year.
Comments
The loss for the consolidated entity after providing for income tax amounted to $6,242,435 (31 March 2022:
$3,644,217).
Reporting
period
Cents
Previous
period
Cents
4.1
7.2
3. Net tangible assets
Net tangible assets per ordinary security
4. Control gained over entities
Not applicable.
5. Loss of control over entities
Not applicable.
6. Dividends
Current period
There were no dividends paid, recommended or declared during the current financial period.
Previous period
There were no dividends paid, recommended or declared during the previous financial period.
7. Dividend reinvestment plans
Not applicable.
25
Amplia Therapeutics Limited
Appendix 4E
Preliminary final report
8. Details of associates and joint venture entities
Not applicable.
9. Foreign entities
Details of origin of accounting standards used in compiling the report:
Not applicable.
10. Audit qualification or review
Details of audit/review dispute or qualification (if any):
The financial statements have been audited and an unmodified opinion has been issued.
11. Attachments
Details of attachments (if any):
The Annual Report of Amplia Therapeutics Limited for the year ended 31 March 2023 is attached.
12. Signed
Signed ___________________________
Date: 30 May 2023
Warwick Tong
Non-Executive Chairman
26
Amplia Therapeutics Limited
Corporate directory
31 March 2023
Directors
Dr. Warwick Tong (Non-Executive Chair)
Dr. Robert Peach (Non-Executive Director)
Dr. Christopher Burns (CEO and Managing Director)
Mrs. Jane Bell (Non-Executive Director)
Company secretary
Mr. Andrew J. Cooke
Registered office
Share register
Level 17, 350 Queen Street
Melbourne VIC 3000
Australia
Computershare Investor Services Pty Limited
Level 3, 60 Carrington Street
Sydney NSW 2000
Australia
Telephone: 1300 556 161 (within Australia) + 61 3 9415 4000 (outside
Australia)
Website: www.investorcentre.com/contact
Auditor
Grant Thornton Audit Pty Ltd
Australia
Stock exchange listing
Amplia Therapeutics Limited shares are listed on the Australian Securities
Exchange (ASX code: ATX)
Website
www.ampliatx.com
27
3
Amplia Therapeutics Limited
Directors' report
31 March 2023
Your directors present their report on Amplia Therapeutics Limited (the “Company” or “Amplia”) and its
subsidiaries (together the “Group”) for the year ended 31 March 2023.
Directors
The names of directors in office at any time during or since the financial year are:
Dr. Warwick Tong
Mrs. Jane Bell
Dr. Christopher Burns
Dr. Robert Peach
Dr. John Lambert (Resigned 30 November 2022)
Information on Directors
Details of the directors’ qualifications, experience and responsibilities, for directors as at the date of this report,
are detailed below:
Warwick Tong (MB ChB MPP GAICD) – Independent Non-Executive Director and Chair
Dr. Tong is a NZ trained physician with 30 years’ experience in the Pharmaceutical and Biotechnology industry.
After his early career in General Medical Practice Warwick has held a wide variety of roles in the pharmaceutical
and biotech industry in NZ(Glaxo) Singapore (GlaxoWellcome) London (GSK), Boston (Surface Logix) and
Melbourne (CTx - Cancer Therapeutics CRC). Warwick currently serves as director of Aculeus Therapeutics Pty
Ltd, Clear Scientific Pty Ltd and MyndBio Pty Ltd. He is a member of the Scientific Advisory Board of the Maurice
Wilkins Centre in Auckland NZ and of the CSIRO Manufacturing Business Advisory Committee. Warwick is a
former CEO and director of CTx, director and Chair of the CTx commercialisation company, CTxONE, and
director and Chair of BioMedVic. Warwick graduated in Medicine at the University of Auckland, holds a Master
of Public Policy from Victoria University, Wellington, New Zealand and is a Graduate of the Australian Institute of
Company Directors. Warwick was appointed as a Non-Executive Director on the 4th of May 2018 and Chairman
on 25 May 2018. Warwick is a member of the Audit and Remuneration Committees.
Jane Bell (BEc LLB LLM (Lond) FAICD) – Independent Non-Executive Director
Mrs Bell is a banking and finance lawyer and non-executive director with more than 30 years’ experience in
leading law firms, financial services and corporate treasury operations gained living in Melbourne, London,
Toronto, San Francisco and Brisbane. Jane has been a non-executive director since 2002, serving on 14 boards
including ten health and medical research boards. Jane currently serves as a Director of Mesoblast Limited
(ASX:MSB) (Nasdaq:MESO), Deputy Chair of Monash Health and Director of Jessie McPherson Private Hospital.
Jane is a former Chair of Melbourne Health (Royal Melbourne Hospital), Chair of Biomedical Research Vic,
Deputy Chair of Westernport Water Corporation, Director of UCA Funds Management, WorkSafe Victoria,
Hudson Institute of Medical Research, Queensland Institute of Medical Research Trust, Australian Red Cross
(Qld), Victorian Women’s Housing Association and Tribunal Member of the Administrative Appeals Tribunal. Jane
holds a Master of Laws from Kings College, London, Bachelor of Laws from the University of Melbourne, Bachelor
of Economics from Monash University and is a Fellow of the Australian Institute of Company Directors. Jane was
appointed as a Non-Executive Director on the 12 April 2021 and was simultaneously appointed Chair of the Audit
Committee.
28
4
Amplia Therapeutics Limited
Directors' report
31 March 2023
Christopher Burns (B.Sc. (Hons) PhD FRACI FRSC GAICD) – CEO and Managing Director
Dr Burns is an experienced drug discovery leader having worked in various roles in pharma, biotech and
academia for 25 years. After completing a PhD in Organic Chemistry at the University of Melbourne Chris
undertook post-doctoral studies in the USA before moving to Pfizer UK, where he worked on a variety of drug
discovery projects. After 5 years he returned to Australia as a Research Fellow at the University of Sydney with
the CRC for Molecular Engineering and Technology and after two years joined the biotechnology company Ambri
as Head of Chemistry. Chris then moved to the Melbourne-based biotech Cytopia as Head of Medicinal Chemistry
and later as Research Director. During this time he led teams in the discovery of two anti-cancer drugs that
entered clinical trial, including the drug momelotinib which recently successfully completed Phase III studies.
Chris was recruited to WEHI in Melbourne as a Laboratory Head before taking on executive roles at the biotech
start-ups Metabloq Pharmaceuticals, Certa Therapeutics and MycRx. Dr Burns is the inventor on over 30 patents
and a co-author on over 60 scientific publications. He is a Fellow of the Royal Society of Chemistry (UK) and the
Royal Australian Chemical Institute, and a Graduate of the Australian Institute of Company Directors. Chris was
a co-founder of Amplia Therapeutics and was appointed as a Non-Executive Director on the 4th of May 2018 and
was Chairman of the Audit Committee during the year ended 31 March 2021 resigning as Chair on 12 April 2021.
Chris was also a member of the remuneration committee until he became CEO in December 2022.
Robert Peach (PhD) – Independent Non-Executive Director
Dr Peach has 30 years of drug discovery and development experience in the Pharmaceutical and Biotechnology
industry. In 2009 he co-founded Receptos Limited, becoming Chief Scientific Officer and raising US$59M in
venture capital and US$800M in an IPO and three subsequent follow-on offerings. In August 2015 Receptos was
acquired by Celgene for US$7.8B. Robert held senior executive and scientific positions in other companies
including Apoptos, Biogen Idec, IDEC and Bristol-Myers Squibb, supporting in-licensing, acquisition and venture
investments. His extensive drug discovery and development experience in autoimmune and inflammatory
diseases, and cancer has resulted in multiple drugs entering clinical trials and 3 registered drugs. He is currently
on the Board of Directors of AdAlta Limited (1AD) and Rekover Therapeutics, and serves on the Scientific
Advisory Board of Eclipse Bioinnovations. Robert is the co-author of 70 scientific publications and book chapters,
and 26 patents and patent applications. He was educated at the University of Canterbury and the University of
Otago, New Zealand. He was appointed as a Non-Executive Director on 2 September 2015 and is Chairman of
the Remuneration Committee.
John Lambert (B.Sc. (Hons) PhD GAICD) – CEO & Managing Director (Resigned 30 November 2022)
Dr Lambert was appointed CEO on 24 June 2019 and Managing Director on 6 February 2020 (Resigned 30
November 2022). John has more than 18 years of drug discovery and development experience. His prior
appointments included leadership roles in Drug Development, Operations Management and Drug Discovery
(Biota Pharmaceuticals), primarily working on the development of respiratory antiviral drugs. As a Senior Director
at Medicines Development for Global Health, John was a member of the team that received approval in 2018
from the US FDA for moxidectin as a treatment for river blindness. Prior to working in industry John was an
academic researcher in organic, medicinal and biological chemistry (University of Melbourne, ANU and Harvard
University). John is an experienced manager of both in early and late development of therapeutics and has built
and led multidisciplinary project teams tasked with the objective of delivering clinical proof-of-concept for new
products. As such, his experience spans the entire spectrum of drug development from design of development
strategy through project management, manufacture, formulation, pre-clinical and clinical development and
regulatory affairs.
Meetings of Directors
The number of directors’ meetings (including meetings of committees of directors) and number of meetings
attended by each of the directors of the Company during the financial year are:
Directors' Meetings
Held
Attended
Audit Committee
Held
Attended
Remuneration Committee
Attended
Held
Warwick Tong
Jane Bell
Robert Peach
Christopher Burns
John Lambert1
12
12
12
12
9
12
12
12
12
9
6
29
6
6
-
-
-
6
6
-
-
-
-
-
2
1
-
-
-
2
1
-
Amplia Therapeutics Limited
Directors' report
31 March 2023
1 Dr Lambert resigned on 30 November 2022.
Held: represents the number of meetings held during the time the director held office or was a member of the
relevant committee.
Company secretary
Andrew Cooke (LLB) – Company Secretary
Mr Cooke holds a law degree from Sydney University and has extensive experience in law, corporate finance,
governance and compliance. Andrew has been the Company Secretary since 11 October 2013.
Principal activities
The principal activity of the Company is development of its Focal Adhesion Kinase (FAK) inhibiting drug
candidates AMP886 and AMP945. These assets represent highly attractive compounds for clinical development
possessing excellent potency and drug-like properties, biological selectivity, bioavailability, and manufacturing
scale-up potential. The Company is focused on the development of these drug candidates for potential use in
multiple indications including oncology and chronic fibrosis.
Operating results
The Group total comprehensive loss after tax for the year ended 31 March 2023 was $6,242,435 (2022:
$3,644,217).
Dividends paid or recommended
No dividends were paid or declared during the financial year or after the reporting date.
Review of operations
In April 2022, the Company announced Human Research Ethics Committee (HREC) approval to initiate the
Company’s Phase 2 clinical trial of its FAK inhibitor, AMP945, in first-line patients with advanced pancreatic
cancer for sites in NSW. This approval also covers trial sites in Queensland. In May, we announced a second
HREC approval to conduct the trial at sites in Victoria. In May the company also announced that a pre-IND (Type
B) meeting with the US Food and Drug Administration (US FDA) had been held to discuss the Company’s
proposed development plans and design of the pancreatic cancer trial. The trial design, consisting of a dose-
escalation phase followed by a Simon 2-stage design, was considered acceptable though the FDA recommended
some further pharmacokinetic sampling to more thoroughly interrogate patient exposures to AMP945,
gemcitabine and nab-paclitaxel. These changes were seamlessly implemented into the ACCENT trial.
In August 2022, the first patient in the first cohort of the dose-escalation phase of the ACCENT trial was dosed,
and in November the completion of cohort 1 recruitment was announced. The company announced that dose-
escalation to cohort 2 was approved by the Safety Review Committee and dosing of the first patient in that cohort
began in February 2023, and was completed at the end of that month.
In June 2022, Amplia reported exciting data for AMP945 in a preclinical model of idiopathic pulmonary fibrosis
(IPF). In this challenging model, pulmonary fibrosis was induced in mice and after seven days, AMP945, or the
standard-of-care agent nintedanib (Ofev®), were administered daily for two weeks. Lung fibrosis in the animals
was determined using a standard protocol and showed that AMP945 performed as well as nintedanib, with both
significantly reducing fibrosis in this model. This data was extremely positive given that nintedanib, sales of which
exceed US$2b per year, is poorly tolerated by patients indicating a clear need for better treatments.
In October 2022, preclinical data for Amplia’s second FAK inhibitor, AMP886, was reported. In a preclinical model
of the rare but aggressive blood cancer acute myeloid leukaemia (AML), AMP886 demonstrated robust and dose-
dependent inhibition of the disease. Further, when compared against the drug venetoclax, AMP886 showed
improved activity, while the combination of AMP886 and venetoclax demonstrated a trend of improved overall
survival, compared to the individual agents alone.
As part of our scientific and business development outreach, Amplia has presented data of its preclinical and
clinical studies at various international scientific meetings. Thus, in September 2022 we presented the design
and rationale of the ACCENT clinical trial at the American Association for Cancer Research (AACR) Special
Conference on Pancreatic Cancer. In February 2023, the Company presented a mixture of preclinical and Phase
1 data from our previous healthy volunteer study, at two cancer conferences in Australia and the US.
30
6
Amplia Therapeutics Limited
Directors' report
31 March 2023
The Company completed manufacture of capsules for the dose selection portion of the ACCENT trial across two
batches in the second and fourth calendar quarters of 2022. In July 2022 the Company completed a newly
manufactured batch of the AMP945 active pharmaceutical ingredient (API). This material will provide clinical-
grade material to be used in the clinical trial expansion into phase 2.
The toxicology studies, conducted in two species, were completed in the middle of 2022 and demonstrated safety
in these species over a 90 day period.
The company undertakes continual review of the scientific and patent literature to identify additional opportunities,
and a strategy day to discuss new opportunities and priorities was held in February with the Board and key
advisers.
The Company’s CEO Dr John Lambert announced his retirement from the position in September 2022 and was
replaced by Board Member Dr Chris Burns in December 2022.
Financial position
The Group loss after tax for the year ended 31 March 2023 was $6,242,435 (2022: $3,644,217). This result
included a non-cash share based compensation of $209,090 (2022: $60,953). Since 31 March 2022, the net
assets of the Group have decreased from $21,847,638 to $15,835,526 at 31 March 2023.
Research and development expenses increased to $4,686,887 (2022: $3,772,156). This reflected Amplia’s focus
on progressing lead candidate AMP945 through a Phase II clinical trial.
General and Administration expenses increased to $2,198,433 (2022: $1,636,051). Patent and associated
expenses increased to $307,549 (2022: $154,630).
At balance date the Group held Cash and cash equivalents of $9,256,677 (2022: $14,608,581) and had debt of
$2,106,614 (2022: $2,100,473).
The key intangible asset is the exclusive worldwide license to develop and commercialise the drug candidates
AMP945 and AMP886. This is being carried at the deemed share consideration paid on acquisition
i.e. $7,937,932. The Group continues to believe that the carrying value for these assets at the deemed acquisition
value remains appropriate.
On 1 April 2022 the Company had 193,854,001 shares on issue. During the year 151,535 shares were issued
raising a total of $21,233 through the exercise of options. The number of shares on issue at 31 March 2023 was
194,005,536.
Options
At the date of this report unissued shares of the Group under option are:
Expiry date
Exercise Price ($)
Number as at 31
March 2023
Number
exercised/lapsed
during year ended 31
March 2023
Number
issued/exercised post
reporting date
31-Aug-23
31-Dec-23
10-May-24
24-Jun-24
2-Sep-25
2-Sep-23
2-Sep-25
31-Dec-23
6-Sep-25
7-Oct-25
0.59
0.28
0.43
0.15
0.15
0.20
0.20
0.28
0.26
0.26
960,000
377,166
500,000
1,070,000
720,000
2,000,000
1,000,000
25,439,421
2,355,000
5,626,000
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
The number of shares under option, on the date of this report, was 40,047,587.
31
8
Amplia Therapeutics Limited
Directors' report
31 March 2023
Significant changes in the state of affairs
There has been no significant change in the activities of the Company during the year. Amplia has continued to
be focused on the development of drug candidates AMP886 and AMP945 for application in oncology and chronic
fibrosis indications.
Matters subsequent to the end of the financial year
No matter or circumstance has arisen since 31 March 2023 that has significantly affected, or may significantly
affect the consolidated entity's operations, the results of those operations, or the consolidated entity's state of
affairs in future financial years.
Environmental issues
The Group was in compliance with all the necessary environmental regulations throughout the period and no
related issues have arisen since the end of the financial year to the date of this report.
Future developments
The Company continues to focus on efficient timely execution of the ACCENT cancer trial, and we plan to
complete the Phase 1b portion of the trial in the third quarter of the year. The Phase 2a portion of the trial is
planned to start before year end. We have initiated the regulatory process with the South Korean authorities to
conduct the Phase 2a ACCENT trial in South Korea, as well as Australia. Filing of an Investigational New Drug
(IND) application with the US FDA is planned for the end of this year to also allow trial sites in the US. Significant
background work to support both these filings is underway.
Amplia continues to work with academic researchers to explore the broader therapeutic potential of AMP945.
Additional preclinical studies in pancreatic cancer and in ovarian cancer are currently underway and data will be
reported in due course. Other studies will also be announced as data comes to hand.
As disclosed last year, the Company has applied for a drug name for AMP945. The review process is still ongoing,
however we anticipate announcing the drug name, once approved, some time in the coming months. This is a
small but important step in the commercialization and further development of the compound.
Proceedings on behalf of the company
No person has applied to the Court under section 237 of the Corporations Act 2001 for leave to bring proceedings
on behalf of the company, or to intervene in any proceedings to which the company is a party for the purpose of
taking responsibility on behalf of the company for all or part of those proceedings.
Audit committee
The Audit Committee Charter is available on the Company’s website at http://www.ampliatx.com/site/About-
Us/corporate-governance.
During the reporting period, the Audit Committee consisted of the following Non-executive, Independent
Directors:
Mrs Jane Bell (Chair)
Mr Warwick Tong
The Group’s lead signing and review External Audit Partner, CEO, CFO and selected consultants attend meetings
of the Audit Committee by standing invitation.
Directors' Indemnification
During or since the end of the financial year the company has given an indemnity or entered an agreement to
indemnify, or paid or agreed to pay insurance premiums as follows:
●
●
The Company entered into Deeds of Indemnity, Insurance and Access in favour of all directors.
The Company has paid premiums to ensure all directors of the parent entity and officers of the consolidated
entity against liabilities for costs and expenses incurred by them in defending any legal proceedings arising
out of their conduct while acting in the capacity of director or officer of the Company, other than conduct
involving a wilful breach of duty in relation to the Company.
32
8
Amplia Therapeutics Limited
Directors' report
31 March 2023
Auditor
The lead auditor has provided the Auditor’s Independence Declaration under section 307C of the Corporations
Act 2001 (Cth) for the year ended 31 March 2023 and a copy of this declaration forms part of the Directors’
Report.
Remuneration report
The Directors of the Group present the Remuneration Report for non-executive directors, executive directors and
other key management personnel (“KMP”), prepared in accordance with the Corporations Act 2001 and the
Corporations Regulations 2001.
Directors and KMP disclosed in this report:
Directors
Warwick Tong
John Lambert
Robert Peach
Christopher Burns
Jane Bell
Chairman and Non-Executive Director
Chief Executive Officer & Managing Director (resigned 30 November 2022)
Non-Executive Director
Non-Executive Director until appointment as Chief Executive Officer & Managing
Director on 5 December 2022
Non-Executive Director
Role of the Remuneration Committee
The Remuneration Committee is a committee of the Board. Its primary purpose is to:
●
●
●
Assist the Board in fulfilling its oversight responsibilities relating to the remuneration of officers, directors,
and executives of the Company.
Advise the Board regarding the Company’s remuneration philosophies, practices and procedures.
Advise the Board regarding key senior management succession planning, including recruiting, hiring,
development, and retention, and termination of key senior executives.
The objective of the Committee, currently comprising Directors Dr Robert Peach (Chair), Dr Warwick Tong and
Mrs. Jane Bell is to ensure that remuneration policies and structures are fair and competitive and aligned with
the long-term interests of the Company.
Non-Executive Directors’ remuneration policy
Fees and payments to Non-Executive Directors reflect the demands, which are made on, and the responsibilities
of, the directors. For the financial year ended 31 March 2023, the Board approved an annual base fee of $70,000
for the Chairman and $50,000 for the other Non-Executive Directors (which also covers serving on a committee),
paid six monthly in arrears. Long term incentives are provided through participation in the Employee Share Option
Plan.
Non-Executive Directors’ fees are determined within an aggregate directors’ fee pool limit, which is periodically
recommended for approval by shareholders. The fee pool limit was set at $300,000 at the 2014 Annual General
Meeting.
Executive remuneration policy
The Remuneration Committee is responsible for approving remuneration packages applicable to executive
directors and other KMP of the Group. The Remuneration Committee is to ensure that the remuneration package
properly reflects the person’s duties and responsibilities, and that the remuneration is competitive in attracting,
retaining and motivating people of high quality and standard.
Executive Directors of the Group do not receive director’s fees and are not currently provided with retirement
benefits.
33
9
Amplia Therapeutics Limited
Directors' report
31 March 2023
Executive Directors and KMP are remunerated primarily by means of cash benefits and may receive cash
bonuses based on the achievement of individually set key performance indicators. However, the Group’s need
to preserve cash may result in the cash component of remuneration being insufficient to match that which is
offered by other companies to personnel in comparable positions or with similar skill sets. Accordingly, the Group
may use share options where necessary to mitigate this and to also provide for medium term shareholder and
KMP goal alignment.
Directors’ and other Key Management Personnel Remuneration - 31 March 2023
Details of the nature and amount of each element of the remuneration of each Director and KMP for the year
ended 31 March 2023, are shown in the table below:
Cash
salary and
fees
($)
Cash
bonus
($)
Non-
monetary
benefits
($)
Superannu
ation
($)
Retirement
benefits
($)
2023
Long
service
leave
($)
Share
based
payments
(options)
($)
Total
Directors
Non-Executive
Warwick Tong
Robert Peach
Christopher
Burns
Jane Bell
Total
70,000
50,000
33,712
45,249
198,961
-
-
-
-
-
Executive
John Lambert1
Christopher
Burns2
106,155
Total executive 325,049
218,894
43,892
-
43,892
524,010
43,892
-
-
-
-
-
-
-
-
-
-
-
-
4,751
4,751
18,538
8,431
26,969
31,720
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
27,366
19,520
97,366
69,520
53,232
19,520
69,520
19,520
85,926 289,638
10,935 292,259
-
114,586
10,935 406,845
96,861 696,483
1 John Lambert ceased employment on 30 November 2022. The Board determined that he could retain the
awards made under the employee share option plan. For awards retained, any unamortised fair value was
recognised at that date.
2 Dr Burns was appointed CEO and Managing Director on 5 December 2022, his remuneration as Executive
Director is only from this date.
Directors’ and other Key Management Personnel Remuneration - 31 March 2022
Details of the nature and amount of each element of the remuneration of each Director and KMP for the year
ended 31 March 2022, are shown in the table below:
34
10
Amplia Therapeutics Limited
Directors' report
31 March 2023
Cash
salary &
fees
$
Cash
bonus
$
Non-
monetary
benefits
$
Superannu
ation
$
Retirement
benefits
$
Long
service
leave
$
Share
based
payments
(options) 4
$
Total
$
2022
Directors
Non-Executive
Warwick Tong
Robert Peach
Christopher
Burns
Jane Bell3
Total non-
executive
33,000
22,000
22,000
20,000
97,000
-
-
-
-
-
-
-
-
-
-
-
-
-
2,000
2,000
Executive
John Lambert1
KMP
Jeff Carter2
263,036
68,136
-
23,851
72,047
-
432,083
68,136
-
-
-
25,851
-
-
-
-
-
-
-
-
-
-
-
-
-
-
9,650
33,000
31,650
-
-
22,000
22,000
9,650
108,650
-
24,588 379,611
-
-
-
72,047
34,238 560,308
1 Dr Lambert’s annual salary was increased from $260,000 plus statutory superannuation to $296,432 plus
statutory superannuation in March 2022. During the 2022 financial year two cash bonuses were paid, $59,500
for the year ended 31 March 2021 and $68,136 for the year ended 31 March 2022. No director fees were paid to
Dr Lambert.
2 Jeff Carter provided CFO services to 1 November 2021. CFO services were subsequently provided by Bio101
Financial Advisory Pty Ltd which the Board determined do not meet the definition of a KMP.
3 Jane Bell commenced 12 April 2021.
Options issued as part of remuneration for the year ended 31 March 2023
Options may be issued to executives as part of their remuneration. The options are issued to encourage goal
alignment between Executives, Directors and Shareholders.
2,355,000 stock options were issued to Directors as part of remuneration during the year ended 31 March 2023.
Employment contracts
Christopher Burns - CEO & Managing Director
Dr Burns was appointed CEO and Managing Director on 5 December 2022. His fixed remuneration was $350,000
per annum inclusive of statutory superannuation. Dr Burns has a short-term performance incentive of 25% of
fixed remuneration plus statutory superannuation.
Non-Executive Directors
There are engagement letters in place for all Non-Executive Directors (Refer to 'Non-Executive Directors’
remuneration policy' section above).
Directors and other Key Management Personnel equity holdings
(i)
Options provided as remuneration and shares issued on the exercise of such options are outlined below.
The terms and conditions of the options issued during the year ended 31 March 2023 can be found above
(“Options Issued as part of Remuneration for the year ended 31 March 2023”). There were no options provided
as remuneration during the year ended 31 March 2022.
(ii) The number of unlisted options over ordinary shares in the company held by each director of the company
and other KMP (including related parties) of the Group are set out below including all options that are vested and
exercisable at year end.
35
11
Amplia Therapeutics Limited
Directors' report
31 March 2023
Loans to Directors and Other Key Management Personnel
There were no loans to any directors of the Company or other KMP of the Group during the financial year ended
31 March 2023 (2022: Nil).
Other Transactions with Directors and Other Key Management Personnel
There were no other transactions with directors of the Company or other KMP of the Group during the financial
year.
Consequences of Performance on Shareholder Wealth
In considering the Group’s performance and benefits for shareholder wealth, the Board have regard to the
following indices in respect of the current financial year and the previous four financial years:
Item
2023
2022
2021
2020
2019
EPS (cents)
Dividends (paid)
Net profit/loss ($000)
Share Price - (cents)
Share-based compensation
(3.22)
-
(6,242)
8.50
(2.50)
-
(3,644)
14.50
(2.41)
-
(2,281)
26.00
(4.58)
-
(2,219)
6.00
(4.56)
-
1,870
14.00
Issue of shares
There were no shares issued to directors and other key management personnel as part of compensation during
the year ended 31 March 2023.
Options
There were 2,355,000 stock options granted over ordinary shares granted to directors and other key management
personnel as part of compensation during the year ended 31 March 2023.
The number of options over ordinary shares granted to and vested by directors and other key management
personnel as part of compensation during the year ended 31 March 2023 are set out below:
Non-Executive
Director
Stock Options
Granted
Warwick Tong
Robert Peach
Christopher Burns
Jane Bell
750,000
535,000
535,000
535,000
Grant Date
Expiry Date
25/08/2022
25/08/2022
25/08/2022
25/08/2022
06/09/2025
06/09/2025
06/09/2025
06/09/2025
Exercise
Price
$0.26
$0.26
$0.26
$0.26
Directors' Interests
Particulars of Directors’ interests in shares and options as at the date of this report are as follows:
Warwick Tong
Robert Peach
Christopher Burns
Jane Bell
Ordinary
shares
Options
3,016,247
783,334
1,664,760 1,125,984
553,519
2,527,798
607,590
2,025,474
9,234,279 3,070,427
The above table only includes details for Directors that were Directors at the date of this report. Further
information regarding the above interests and net movements throughout the reporting period is disclosed in note
18 (Related Parties) to the Financial Statements accompanying this Directors’ Report.
36
12
Amplia Therapeutics Limited
Directors' report
31 March 2023
Directors' Benefits
Since 1 April 2022, no director has received or become entitled to receive a benefit because of a contract made
by the Company, or a related body corporate with a director, a firm of which a director is a member or an entity
in which a director has a substantial financial interest.
This statement excludes a benefit included in the aggregate amount of remuneration received or due and
receivable by directors and shown in the company’s accounts, or the fixed salary of a full-time employee of the
parent entity, controlled entity, or related body corporate.
This concludes the remuneration report, which has been audited.
This report is made in accordance with a resolution of directors, pursuant to section 298(2)(a) of the Corporations
Act 2001.
On behalf of the directors
___________________________
Warwick Tong
Non-Executive Chairman
30 May 2023
37
13
Grant Thornton Audit Pty Ltd
Level 22 Tower 5
Collins Square
727 Collins Street
Melbourne VIC 3008
GPO Box 4736
Melbourne VIC 3001
T +61 3 8320 2222
Auditor’s Independence Declaration
To the Directors of Amplia Therapeutics Limited
In accordance with the requirements of section 307C of the Corporations Act 2001, as lead auditor for the audit
of Amplia Therapeutics Limited for the year ending 31 March 2023, I declare that, 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; and
b no contraventions of any applicable code of professional conduct in relation to the audit.
Grant Thornton Audit Pty Ltd
Chartered Accountants
T S Jackman
Partner – Audit & Assurance
Melbourne, 30 May 2023
www.grantthornton.com.au
ACN-130 913 594
Grant Thornton Audit Pty Ltd ACN 130 913 594 a subsidiary or related entity of Grant Thornton Australia Limited ABN 41 127 556 389 ACN 127 556 389.
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38
Amplia Therapeutics Limited
Consolidated statement of profit or loss and other comprehensive income
For the year ended 31 March 2023
Revenue and other income
R&D tax incentive
Interest income
Government grants income
Total revenue and other income
Expenses
Research & development expenses
Patent & associated expenses
Administrative & general expenses
Share based compensation
Depreciation and amortisation expense
Total expenses
Operating deficit before financing costs
Interest expense
Loss before income tax expense
Note
2023
$
2022
$
5
1,148,434 1,983,316
616
-
1,286,740 1,983,932
97,254
41,052
(307,549)
(4,686,887) (3,772,156)
(154,630)
(2,198,433) (1,636,051)
(60,953)
(3,209)
(7,475,327) (5,626,999)
(209,090)
(73,368)
(6,188,587) (3,643,067)
(53,848)
(1,150)
(6,242,435) (3,644,217)
Income tax expense
15
-
-
Loss after income tax expense for the year attributable to the owners
of Amplia Therapeutics Limited
(6,242,435)
(3,644,217)
Other comprehensive income for the year, net of tax
-
-
Total comprehensive loss for the year attributable to the owners of
Amplia Therapeutics Limited
(6,242,435)
(3,644,217)
Cents
Cents
Basic and diluted earnings per share
4
(3.22)
(2.50)
The above consolidated statement of profit or loss and other comprehensive income should be read inconjunction with the accompanying notes
The above consolidated statement of profit or loss and other comprehensive income should be read in
39
conjunction with the accompanying notes
15
Amplia Therapeutics Limited
Consolidated statement of financial position
As at 31 March 2023
Note
2023
$
2022
$
Assets
Current assets
Cash and cash equivalents
R&D tax incentive receivable
Prepayments
Other assets
Total current assets
Non-current assets
Property, plant and equipment
Right-of-use assets
Intangibles
Other assets
Total non-current assets
Total assets
Liabilities
Current liabilities
Accounts payable & accrued liabilities
Borrowings
Lease liabilities
Provisions
Total current liabilities
Non-current liabilities
Borrowings
Lease liabilities
Provisions
Total non-current liabilities
Total liabilities
Net assets
Equity
Issued capital
Reserves
Accumulated losses
Total equity
6
7
8
9
9,256,677 14,608,581
1,148,434 1,843,003
33,586
47,684
10,508,529 16,532,854
36,718
66,700
20,883
163,957
12,915
-
7,937,932 7,937,932
-
8,175,806 7,950,847
53,034
18,684,335 24,483,701
10
11
12
528,501
2,106,614
74,534
40,910
2,750,559
486,176
-
-
44,004
530,180
11
12
94,719
3,531
- 2,100,473
-
5,410
98,250 2,105,883
2,848,809 2,636,063
15,835,526 21,847,638
13
14
151,528,974 151,507,741
(1,041,651)
(134,724,417) (128,618,452)
(969,031)
15,835,526 21,847,638
The above consolidated statement of financial position should be read in conjunction with the accompanying notes
The above consolidated statement of financial position should be read in conjunction with the accompanying notes
16
40
Amplia Therapeutics Limited
Consolidated statement of changes in equity
For the year ended 31 March 2023
Issued
capital
$
Share option
reserve
$
Foreign
currency
translation
reserve
$
Accumulated
losses
$
Total equity
$
Balance at 1 April 2021
136,554,307
811,504
(1,818,617) (125,207,235) 10,339,959
Loss after income tax expense for the year
Other comprehensive income for the year,
net of tax
Total comprehensive loss for the year
Transactions with owners in their capacity
as owners:
Share-based payments
Issue of shares
Issue of shares on exercise of options
Cost of issuing shares
Expiry of options previously recorded as
share-based payments
-
-
-
-
-
-
-
(3,644,217)
(3,644,217)
-
-
-
-
(3,644,217)
(3,644,217)
-
16,201,762
69,122
(1,317,450)
60,953
-
-
137,509
-
(233,000)
-
-
-
-
-
-
60,953
- 16,201,762
-
69,122
-
(1,179,941)
233,000
-
Balance at 31 March 2022
151,507,741
776,966
(1,818,617) (128,618,452) 21,847,638
Issued
capital
$
Share
option
reserve
$
Foreign
currency
translation
reserve
$
Accumulated
losses
$
Total equity
$
Balance at 1 April 2022
151,507,741
776,966
(1,818,617) (128,618,452) 21,847,638
Loss after income tax expense for the year
Other comprehensive income for the year,
net of tax
Total comprehensive loss for the year
Transactions with owners in their capacity
as owners:
Share-based payments
Transfer of share-based payments on
expired options
Issue of shares on exercise of options
-
-
-
-
-
-
-
(6,242,435)
(6,242,435)
-
-
-
-
(6,242,435)
(6,242,435)
-
209,090
-
21,233
(136,470)
-
-
-
-
-
209,090
136,470
-
-
21,233
Balance at 31 March 2023
151,528,974
849,586
(1,818,617) (134,724,417) 15,835,526
The above consolidated statement of changes in equity should be read in conjunction with the accompanying
The above consolidated statement of changes in equity should be read in conjunction with the accompanying notes
notes
18
41
Amplia Therapeutics Limited
Consolidated statement of cash flows
For the year ended 31 March 2023
Cash flows from operating activities
Interest received
Government grants
R&D tax incentive received
Payments to suppliers
Payments to employees
Note
2023
$
2022
$
86,158
41,052
616
-
1,843,004 1,140,313
(6,061,080) (4,588,816)
(954,132)
(1,198,822)
Net cash used in operating activities
16
(5,289,688) (4,402,019)
Cash flows from investing activities
Payments for property, plant and equipment
Payments for security deposits
Proceeds from release of security deposits
Net cash used in investing activities
Cash flows from financing activities
Proceeds from issue of shares
Proceeds from issue of shares from the exercise of options
Capital raising costs
Proceeds from borrowings
Interest and other finance costs paid
Repayment of lease liabilities
Net cash from/(used in) financing activities
Net increase/(decrease) in cash and cash equivalents
Cash and cash equivalents at the beginning of the financial year
Effects of exchange rate changes on cash and cash equivalents
7
(17,631)
(53,034)
12,240
(14,402)
(12,240)
-
(58,425)
(26,642)
13
- 16,201,762
69,122
- (1,181,863)
- 2,100,000
-
-
21,233
(40,804)
(64,646)
(84,217) 17,189,021
(5,432,330) 12,760,360
14,608,581 1,848,408
(187)
80,426
Cash and cash equivalents at the end of the financial year
6
9,256,677 14,608,581
The above consolidated statement of cash flows should be read in conjunction with the accompanying notes
The above consolidated statement of cash flows should be read in conjunction with the accompanying notes
19
42
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 1. Significant accounting policies
(a) Basis of preparation
The financial statements presented are for the entity Amplia Therapeutics Limited and its controlled entities as a
consolidated entity (the “Group”).
The 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.
Compliance with Australian Accounting Standards ensures the consolidated financial statements and notes of
the Group comply with International Financial Reporting Standards (‘IFRS”). Amplia is a for profit entity for the
purposes of reporting under Australian Accounting Standards.
The financial statements have been prepared on an accruals basis and are based on historical costs and do not
take into account changing money values or, except where stated, current valuations of financial assets. Cost is
based on the fair values of the consideration given in exchange for assets. The accounting policies have been
consistently applied, unless otherwise stated.
In applying Australian Accounting Standards management must make judgement regarding carrying values of
assets and liabilities that are not readily apparent from other sources. Assumptions and estimates are based on
historical experience and any other factors that are believed reasonable in light of the relevant circumstances.
These estimates are reviewed on an ongoing basis and revised in those periods to which the revision directly
affects.
All accounting policies are chosen to ensure the resulting financial information satisfies the concepts of relevance
and reliability.
The consolidated entity has adopted all of the new or amended Accounting Standards and Interpretations issued
by the Australian Accounting Standards Board ('AASB') that are mandatory for the current reporting period.
Any new or amended Accounting Standards or Interpretations that are not yet mandatory have not been early
adopted.
(b) Principles of consolidation
The consolidated financial statements are prepared by combining the financial statements of all the entities that
comprise the Group, being the company (the parent entity) and its subsidiaries as defined in Accounting Standard
AASB 10 Consolidated Financial Statements. Consistent accounting policies are employed in the preparation
and presentation of the consolidated financial statements.
The consolidated financial statements include the information and results of each subsidiary from the date on
which the company obtains control and until such time as the company ceases to control such entity. In preparing
the consolidated financial statements, all intercompany balances and transactions, and unrealised profits arising
with the consolidated entity are eliminated in full.
A list of controlled entities is found in note 19 of the Financial Statements.
Intercompany transactions, balances and unrealised gains on transactions between entities in the consolidated
entity are eliminated. Unrealised losses are also eliminated unless the transaction provides evidence of the
impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to
ensure consistency with the policies adopted by the consolidated entity.
The acquisition of subsidiaries is accounted for using the acquisition method of accounting. A change in
ownership interest, without the loss of control, is accounted for as an equity transaction, where the difference
between the consideration transferred and the book value of the share of the non-controlling interest acquired is
recognised directly in equity attributable to the parent.
Where the consolidated entity loses control over a subsidiary, it derecognises the assets including goodwill,
liabilities and non-controlling interest in the subsidiary together with any cumulative translation differences
recognised in equity. The consolidated entity recognises the fair value of the consideration received and the fair
value of any investment retained together with any gain or loss in profit or loss.
43
19
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 1. Significant accounting policies (continued)
(c) Cash and cash equivalents
Cash and cash equivalents comprise of cash on hand, at call deposits with banks or financial institutions, bank
bills and investments in money market instruments where it is easily convertible to a known amount of cash and
subject to an insignificant risk of change in value.
(d) Property, plant and equipment
Property, plant and equipment are measured at cost less accumulated depreciation and impairment losses. Cost
includes expenditure that is directly attributable to the acquisition of the asset. In the event settlement of all or
part of the purchase consideration is deferred, cost is determined by discounting the amounts payable in the
future to their present value as at the date of acquisition.
Depreciation is calculated on a diminishing value basis to expense the cost of the assets over their estimated
useful lives and reflects the pattern of consumption of the future economic benefits of these assets and is as
follows:
Leasehold improvements
Plant and equipment
Office furniture and fittings
4 to 13 years
4 to 11 years
2 to 13 years
Depreciation is charged to profit or loss within the Statement of Profit or Loss and Other Comprehensive Income.
The residual value and useful life of property, plant and equipment is reassessed annually.
Repairs and maintenance and gains or losses on sale or disposal of assets are reflected in profit or loss within
Statement of Profit or Loss and Other Comprehensive Income as incurred. Major renewals and betterments are
capitalised.
(e) Foreign currencies
The functional and presentation currency of the Group is Australian dollars.
Transactions denominated in foreign currencies are converted at the exchange rate current at the transaction
date. Monetary assets and liabilities denominated in foreign currencies at the reporting date are converted at
exchange rates current at reporting date. Foreign exchange gains or losses are included in profit or loss within
the Statement of Profit or Loss and Other Comprehensive Income.
(f) Research and Development
Research expenses include direct and overhead expenses for drug discovery and research, pre-clinical trials
and, more recently, for costs associated with clinical trial activities and drug manufacturing industrialisation.
When a project reaches the stage where it is reasonably certain that future expenditure can be recovered through
the processes or products produced, development expenditure is recognised as a development asset (other
intangible asset).
Government grants, including research and development incentives are recognised at fair value when there is
reasonable assurance that the grant will be received and all grant conditions will be met.
(g) Share capital
Ordinary shares are classified as equity. Costs associated with the issue of raising capital are recognised in
shareholders’ equity as a reduction of the share proceeds received. Other expenses such as legal fees are
charged to profit and loss within the Statement of Profit or Loss and Other Comprehensive Income in the period
the expense is incurred.
(h) Earnings per share
Basic earnings per share
Basic earnings per share is determined by dividing net profit after income tax attributable to members 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.
44
20
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 1. Significant accounting policies (continued)
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 the weighted average number of shares assumed to have been issued for no consideration in relation
to dilutive potential ordinary shares.
(i) Goods & services tax
The Statement of Profit or Loss and Other Comprehensive Income and Statement of Cash Flows have been
prepared so that all components are presented exclusive of GST. All items in the Statement of Financial Position
are presented net of GST, with the exception of receivables and payables, which include GST invoiced.
(j) Income tax
Income tax expense comprises current and deferred tax. Income tax expense is recognised in profit or loss within
the Statement of Profit or Loss and Other Comprehensive Income except to the extent that it relates to items
recognised directly in Other Comprehensive Income, in which case it is recognised in equity.
Current tax is the expected tax payable on the taxable income for the year, using tax rates enacted or
substantively enacted at the reporting date, and any adjustment to tax payable in respect of previous years.
Deferred tax is recognised using the balance sheet method, providing for temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation
purposes. Deferred tax is not recognised for the following temporary differences: the initial recognition of goodwill,
the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects
neither accounting nor taxable profit, and differences relating to investments in subsidiaries and jointly controlled
entities to the extent that they probably will not reverse in the foreseeable future. Deferred tax is measured at the
tax rates that are expected to be applied to the temporary differences when they reverse, based on the laws that
have been enacted or substantively enacted by the reporting date.
A deferred tax asset is recognised to the extent that it is probable that future taxable profits will be available
against which deductible temporary differences or unused tax losses can be utilised. Deferred tax assets are
reviewed at each reporting date and are reduced to the extent that it is no longer probable that the related tax
benefit will be realised.
(k) Other income
Other income is recognised on an accrual basis unless there is significant uncertainty as to the extent and
qualifying criteria for future receipt of such other income. If this condition is not met then other income is
recognised on a cash basis.
(I) Statement of cash flows
The Statement of Cash Flows has been prepared using the direct approach. Cash and cash equivalents are short
term, highly liquid investments that are readily convertible to known amounts of cash and which are subject to an
insignificant risk of changes in value.
Investing activities are those activities relating to the acquisition, holding and disposal of property, plant and
equipment, intangible assets and investments.
Financing activities are those that result in changes in the size and composition of the capital structure. Cash is
considered to be cash on hand and current accounts and demand deposits in banks, net of bank overdrafts.
Operating activities are all transactions and events that are not investing or financing activities.
(m) Share-based compensation
The Group operates equity-settled share-based remuneration plans for its employees. None of the Group’s plans
feature any options for a cash settlement.
45
21
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 1. Significant accounting policies (continued)
All goods and services received in exchange for the grant of any share-based payment are measured at their fair
values. Where employees and directors are rewarded using share-based payments, the fair values of employees’
and directors’ services are determined indirectly by reference to the fair value of the equity instruments granted.
This fair value is appraised at the grant date and excludes the impact of non-market vesting conditions (for
example profitability and sales growth targets and performance conditions).
All share-based remuneration is ultimately recognised as an expense in profit or loss with a corresponding credit
to share option reserve. If vesting periods or other vesting conditions apply, the expense is allocated over the
vesting period, based on the best available estimate of the number of share options expected to vest.
Non-market vesting conditions are included in assumptions about the number of options that are expected to
become exercisable. Estimates are subsequently revised if there is any indication that the number of share
options expected to vest differs from previous estimates. Any cumulative adjustment prior to vesting is recognised
in the current period. No adjustment is made to any expense recognised in prior periods if share options ultimately
exercised are different to that estimated on vesting.
Upon exercise of share options, the proceeds received net of any directly attributable transaction costs are
allocated to share capital.
(n) Finance income and expenses
Finance income
Finance income comprises of interest income. Interest income is recognised as it accrues, using the effective
interest method.
Finance expenses
Finance expenses comprised of interest expense on borrowings. All borrowing costs are recognised in profit and
loss of Statement of Profit or Loss and Other Comprehensive Income using the effective interest method.
(o) Operating expenses
Operating expenses are recognised in profit or loss within the Statement of Profit or Loss and Other
Comprehensive Income upon utilisation of the service or at the date of their origin.
(p) Financial Instruments
Financial assets at amortised cost
Financial assets are measured at amortised cost if the assets meet the following conditions (and are not
designated as FVPL):
●
●
they are held within a business model whose objective is to hold the financial assets and collect its
contractual cash flows.
the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and
interest on the principal amount outstanding.
After initial recognition, these are measured at amortised cost using the effective interest method. Discounting is
omitted where the effect of discounting is immaterial. The Group’s cash and cash equivalents, trade and most
other receivables fall into this category of financial instruments.
Impairment of financial assets
AASB 9’s impairment requirements use more forward looking information to recognize expected credit losses –
the ‘expected credit losses (ECL) model’. Instruments within the scope of the new requirements included loans
and other debt-type financial assets measured at amortised cost and FVOCI, trade receivables, contract assets
recognised and measured under AASB 15 and loan commitments and some financial guarantee contracts (for
the issuer) that are not measured at fair value through profit or loss.
The Group considers a broader range of information when assessing credit risk and measuring expected credit
losses, including past events, current conditions, reasonable and supportable forecasts that affect the expected
collectability of the future cash flows of the instrument.
In applying this forward-looking approach, a distinction is made between:
46
22
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 1. Significant accounting policies (continued)
●
●
financial instruments that have not deteriorated significantly in credit quality since initial recognition or that
have low credit risk (‘Stage 1’), and
financial instruments that have deteriorated significantly in credit quality since initial recognition and whose
credit risk is not low (‘Stage 2’).
‘Stage 3’ would cover financial assets that have objective evidence of impairment at the reporting date. ‘12-month
expected credit losses’ are recognised for the first category while ‘lifetime expected credit losses’ are recognised
for the second category. Measurement of the expected credit losses is determined by a probability-weighted
estimate of credit losses over the expected life of the financial instrument.
Trade and other receivables and contract assets
The Group makes use of a simplified approach in accounting for trade and other receivables as well as contract
assets and records the loss allowance at the amount equal to the expected lifetime credit losses. In using this
practical expedient, the Group uses its historical experience, external indicators and forward-looking information
to calculate the expected credit losses using a provision matrix. The Group assess impairment of trade
receivables on a collective basis as they possess credit risk characteristics based on the days past due.
Financial liabilities
The Group’s financial liabilities include trade and other payables. All financial liabilities are measured
subsequently at amortised cost using the effective interest method.
Trade and other payables represent liabilities for goods and services provided to the Group prior to the end of
the financial year which are unpaid. The amounts are unsecured and are usually paid within 30 days of
recognition.
All derivative financial instruments that are not designated and effective as hedging instruments are accounted
for at fair value through profit or loss.
Derivative financial instruments
At the reporting date the Group did not undertake any form of hedge accounting.
Determination of fair value and fair value hierarchy
The Group uses the following hierarchy for determining and disclosing the fair value of financial instruments:
Level 1:
Level 2:
Level 3:
Quoted prices in active markets for the same instrument (i.e. without modification or repackaging);
Quoted prices in active markets for similar assets or liabilities or other valuation techniques for
which all significant inputs are based on observable market data and yield curve information
provided by the Group’s bankers; and
Valuation techniques for which significant inputs are not based on observable market data.
(q) Post employment benefits and short term employment benefits
The Group does not provide any post employment benefits other than superannuation contributions where
required by statutory obligations. Short term employee benefits are included in current liabilities, measured at the
undiscounted amount that the Group expects to pay as a result of the unused entitlement. There are no long term
employee benefits.
(r) Segment reporting
A segment is a component of the Group entity that earns revenues or incurs expenses whose results are regularly
reviewed by the chief operating decision makers and for which discrete financial information is prepared. The
Group has no operating segments, management review financial information on a consolidated basis. It has
established entities in more than one geographical area, however the activities from these entities comparative
to the Group are considered immaterial for the purposes of segment reporting.
(s) Intangible assets
Intangible assets are carried at cost and are amortised over the life of the intangible asset. The licenses acquired,
by the acquisition of Amplia Therapeutics Pty Ltd, were valued at the deemed acquisition value. The licences are
not yet ready for use and hence, no amortisation has been made for the current year.
47
23
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 1. Significant accounting policies (continued)
(t) Going concern
The financial statements have been prepared on a going concern basis after taking into consideration the net
loss for the year of $6,242,435 and the cash and cash equivalents balance of $9,256,677 and borrowings of
$2,106,614. The going concern basis contemplates continuity of normal business activities and realisation of
assets and settlement of liabilities in the ordinary course of business. The going concern of the Group is
dependent upon it maintaining sufficient funds for its operations and commitments. The Group has prepared
detailed cash flow forecasts and believe that they will have sufficient cash to further research and development
plans for the 12 months from signing the financial report but note to further progress plans the Group may need
to obtain additional capital. The directors also considered the other following matters in their cashflow forecast,
all of which give rise to a material uncertainty regarding going concern:
● The Company can scale down its operations sufficiently (and narrow the scope of its planned activities) should
the above capital raising not occur; and
● The Company may be able to claim the Research & Development tax incentive from the ATO for eligible spend.
Accordingly, the financial statements do not include any adjustments relating to the recoverability or classification
of recorded asset amounts or classification of liabilities that might be necessary should the Group not be able to
continue as a going concern.
The Group has the exclusive worldwide license to develop and commercialise the drug candidates AMP945 and
AMP886. The exploitation of these licenses will require future funding. The Directors believe that they will be able
to raise sufficient capital to fund the Group’s future operations. The Directors continue to monitor these ongoing
funding requirements and are of the opinion that the financial statements have been appropriately prepared on a
going concern basis.
(u) Right-of-use assets
A right-of-use asset is recognised at the commencement date of a lease. The right-of-use asset is measured at
cost, which comprises the initial amount of the lease liability, adjusted for, as applicable, any lease payments
made at or before the commencement date net of any lease incentives received, any initial direct costs incurred,
and, except where included in the cost of inventories, an estimate of costs expected to be incurred for dismantling
and removing the underlying asset, and restoring the site or asset.
Right-of-use assets are depreciated on a straight-line basis over the unexpired period of the lease or the
estimated useful life of the asset, whichever is the shorter. Where the consolidated entity expects to obtain
ownership of the leased asset at the end of the lease term, the depreciation is over its estimated useful life. Right-
of use assets are subject to impairment or adjusted for any remeasurement of lease liabilities.
The consolidated entity has elected not to recognise a right-of-use asset and corresponding lease liability for
short-term leases with terms of 12 months or less and leases of low-value assets. Lease payments on these
assets are expensed to profit or loss as incurred.
(v) Lease liabilities
A lease liability is recognised at the commencement date of a lease. The lease liability is initially recognised at
the present value of the lease payments to be made over the term of the lease, discounted using the interest rate
implicit in the lease or, if that rate cannot be readily determined, the consolidated entity's incremental borrowing
rate. Lease payments comprise of fixed payments less any lease incentives receivable, variable lease payments
that depend on an index or a rate, amounts expected to be paid under residual value guarantees, exercise price
of a purchase option when the exercise of the option is reasonably certain to occur, and any anticipated
termination penalties. The variable lease payments that do not depend on an index or a rate are expensed in the
period in which they are incurred.
Lease liabilities are measured at amortised cost using the effective interest method. The carrying amounts are
remeasured if there is a change in the following: future lease payments arising from a change in an index or a
rate used; residual guarantee; lease term; certainty of a purchase option and termination penalties. When a lease
liability is remeasured, an adjustment is made to the corresponding right-of use asset, or to profit or loss if the
carrying amount of the right-of-use asset is fully written down.
48
24
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 1. Significant accounting policies (continued)
(w) Employee benefits
Short-term employee benefits
Liabilities for wages and salaries, including non-monetary benefits, annual leave and long service leave expected
to be settled wholly within 12 months of the reporting date are measured at the amounts expected to be paid
when the liabilities are settled.
Other long-term employee benefits
The liability for annual leave and long service leave not expected to be settled within 12 months of the reporting
date are measured at the present value of expected future payments to be made in respect of services provided
by employees up to the reporting date using the projected unit credit method. Consideration is given to expected
future wage and salary levels, experience of employee departures and periods of service. Expected future
payments are discounted using market yields at the reporting date on high quality corporate bonds with terms to
maturity and currency that match, as closely as possible, the estimated future cash outflows.
(x) Borrowings
All loans and borrowings are initially recognised at fair value, net of transaction costs incurred. Borrowings are
subsequently measured at amortised cost. Any difference between the proceeds (net of transaction costs) and
the redemption amount is recognised in profit or loss over the year of the loans and borrowings using the effective
interest method.
Borrowings are derecognised from the statement of financial position when the obligation specified in the contract
has been discharged, cancelled or expires. The difference between the carrying amount of the borrowing
derecognised and the consideration paid is recognised in profit or loss as other income or finance costs.
All borrowings are classified as current liabilities unless the Group has an unconditional right to defer settlement
of the liability for at least 12 months after the end of the reporting year.
(y) New or amended Accounting Standards and Interpretations adopted
The company has adopted all of the new or amended Accounting Standards and Interpretations issued by the
Australian Accounting Standards Board (‘AASB’) that are mandatory for the current and prior reporting periods.
New standards adopted did not have a material impact on the financial statements of the Group as they are either
not relevant to the Group’s activities or require accounting which is consistent with the Group’s accounting
policies.
Any new or amended Accounting Standards or Interpretations that are not yet mandatory have not been early
adopted and do not have a material impact on the financial statements of the Group as they are either not relevant
to the Group’s activities or require accounting which is consistent with the Group’s accounting policies.
Note 2. Critical accounting judgements, estimates and assumptions
The preparation of the financial statements requires management to make judgements, estimates and
assumptions that affect the reported amounts in the financial statements. Management continually evaluates its
judgements and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses.
Management bases its judgements, estimates and assumptions on historical experience and on other various
factors, including expectations of future events, management believes to be reasonable under the circumstances.
There are no critical accounting judgements, estimates and assumptions that are likely to affect the current or
future financial years.
Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are
recognised in the period in which the estimate is revised and in any future periods affected.
In particular, information about significant areas of estimation uncertainty and critical judgements in applying
accounting policies that have the most significant effect on the amount recognised in the financial statements are
described in the following notes:
49
25
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 2. Critical accounting judgements, estimates and assumptions (continued)
●
●
●
With the successful track record of the Company in obtaining the Research and Development rebate from
the ATO, an estimated rebate of $1,148,434 has been accrued as income for the year ended 31 March 2023
(31 March 2022: $1,983,316). The company is entitled to claim grant credits from the Australian Government
in recompense for its research and development program expenditure. The program is overseen by
AusIndustry, which is entitled to audit and/or review claims lodged for the past 4 years. In the event of a
negative finding from such an audit or review AusIndustry has the right to rescind and clawback those prior
claims, potentially with penalties. Such a finding may occur in the event that those expenditures do not
appropriately qualify for the grant program. In their estimation, considering also the independent external
expertise they have contracted to draft and claim such expenditures, the directors of the company consider
that such a negative review has a remote likelihood of occur.
The Company assesses the impairment of non-financial assets at each reporting date by evaluating
conditions specific to the Group and to the particular asset that may lead to impairment by comparing the
carrying value to the recoverable amount. The recoverable amount of each individual non-financial asset is
determined using a cost approach, which reflects the amount that would be required currently to replace the
service capacity of an asset less any wastage, obsolescence and costs of disposal.
The Company 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. The fair value is determined by using either
the Black-Scholes model, taking into account the terms and conditions upon which the instruments were
granted. The accounting estimates and assumptions relating to equity-settled share-based payments would
have no impact on the carrying amounts of assets and liabilities within the next annual reporting period but
may impact profit or loss and equity. Refer to note 11 for further information.
Note 3. Segment information
The Group has no operating segments as management review financial information on a consolidated basis.
During the 2023 financial period the Group conducted all its activities in Australia.
Note 4. Earnings per share
2023
$
2022
$
Loss after income tax attributable to the owners of Amplia Therapeutics Limited
(6,242,435) (3,644,217)
Weighted average number of ordinary shares used in calculating basic and diluted
earnings per share
193,975,005
145,548,817
Number
Number
Basic and diluted earnings per share
Cents
Cents
(3.22)
(2.50)
A loss per share cannot be further diluted and therefore the basic loss per share is equal to the diluted loss per
share.
50
27
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 5. R&D tax incentive
R&D tax incentive - year ended 31 March 2021
R&D tax incentive - year ended 31 March 2022
R&D tax incentive - year ended 31 March 2023
2023
$
2022
$
-
140,313
- 1,843,003
-
1,148,434
1,148,434 1,983,316
In the current period, an accrual was made for the potential R&D tax incentive of $1,148,434. The R&D Tax
Incentive income is based on criteria of eligible expenditure set out by AusIndustry. The Company has applied
for an Advanced Overseas Finding for certain overseas expenditure to be eligible for the rebate, at the date of
this report the finding is pending. If successful, the Company estimates a further $1,260,024 of R&D tax incentive
for the year ended 31 March 2023. Due to the uncertain nature of the outcome of the finding any income as a
result of a positive finding will be recognised in the period the finding is granted.
Note 6. Cash and cash equivalents
Cash and cash equivalents consist of the following:
Current assets
Cash at bank
Cash on deposit
2023
$
2022
$
1,273,197 3,984,127
7,983,480 10,624,454
9,256,677 14,608,581
Cash on deposit includes term deposits which have a maturity of less than 3 months. The Group also has the
ability to terminate a term deposit by providing the institution with notice, incurring minor financial penalties and
therefore term deposit is considered cash and cash equivalents.
Note 7. Property, plant and equipment
Non-current assets
Office equipment - at cost
Less: Accumulated depreciation
Balance at 1 April
Additions
Depreciation expense
Reallocations
Balance at 31 March
51
27
2023
$
2022
$
35,531
(14,648)
17,256
(4,341)
20,883
12,915
2023
$
2022
$
12,915
17,631
(10,307)
644
5,471
14,402
(3,208)
(3,750)
20,883
12,915
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 8. Right-of-use assets
Non-current assets
Land and buildings - right-of-use
Less: Accumulated depreciation
2023
$
2022
$
227,018
(63,061)
163,957
-
-
-
Reconciliations
Reconciliations of the written down values at the beginning and end of the current financial year are set out below:
Balance at 1 April
Additions
Depreciation expense
Balance at 31 March
2023
$
2022
$
-
227,018
(63,061)
163,957
-
-
-
-
In the current period, the Company entered a lease agreement for corporate office facilities commencing 1 June
2022, that runs for an initial 3-year period and with an annual rent of $77,575. A security deposit amounting to
$53,034 was paid as security for the facilities. This lease is disclosed in the accounts as a Lease Liability.
Note 9. Intangibles
Non-current assets
Global license - AMP 945 & AMP 886 - at cost
Less: Accumulated amortisation
2023
$
2022
$
7,937,932 7,937,932
-
-
7,937,932 7,937,932
Global license - AMP 945 & AMP 886 represents the cost of the separately acquired intangible assets
representing the worldwide right to drug candidates AMP 945 and AMP 886, expiring in 2032. At reporting date,
the intangible assets representing the drug candidates were tested for impairment. No impairment was calculated.
Note 10. Accounts payable & accrued liabilities
Current liabilities
Accounts payable and accrued liabilities
Other payables
Refer to note 17 for further information on financial instruments.
2023
$
2022
$
347,286
181,215
368,894
117,282
528,501
486,176
52
28
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 11. Borrowings
Current liabilities
Loan - R&D Advance
Accrued interest
Non-current liabilities
Loan - R&D Advance
Accrued interest
2023
$
2022
$
2,100,000
6,614
2,106,614
-
-
-
- 2,100,000
473
-
- 2,100,473
2,106,614 2,100,473
The Company executed a funding facility (Facility) with Treasury Corporation of Victoria (TCV) as part of the
Victorian Government’s R&D Cash Flow Loan Initiative (Initiative) of up to $2,100,000. The Company received
the first tranche of $1,260,000 in December 2021 and the second tranche of $840,000 in February 2022. Interest
on Facility advances is variable at the “TCV 11am” loan interest rate (currently 3.765% (2022: 0.265%). The loan
facility requires the Company to maintain a loan value ratio (LVR) of at least 80% or make partial repayments to
correct LVR. Repayment of the Facility is timed to coincide with receipt of Amplia’s FY2023 RDTI refund, expected
by 30 September 2023, and is recognised as current borrowing during the period. The Facility is secured by the
FY2022 and FY2023 R&D Tax Incentive (RDTI) refunds.
Refer to note 17 for further information on financial instruments.
Note 12. Lease liabilities
Current liabilities
Lease liability
Non-current liabilities
Lease liability
2023
$
2022
$
74,534
94,719
169,253
-
-
-
The company has provided a bank guarantee equivalent to six months rent, as security for the lease.
Refer to note 17 for further information on financial instruments.
Note 13. Issued capital
2023
2022
Shares
Shares
2023
$
2022
$
Ordinary shares - fully paid
194,005,536 193,854,001 151,528,974 151,507,741
At 31 March 2023, 194,005,536 ordinary shares (March 2022: 193,854,001) were issued and fully paid. All
ordinary shares rank equally as to voting, dividends and liquidation. There are no reserved shares of the Group.
The shares have no par value.
53
30
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 13. Issued capital (continued)
Balance brought forward as at 1 April
Issue of shares
Issue of shares from the exercise of options
Transaction costs relating to issue of shares
31 March
2023
31 March
2022
Shares
Shares
31 March
2023
$
31 March
2022
$
193,854,001 107,972,609 151,507,741 136,554,307
- 16,201,762
69,122
(1,317,450)
- 85,402,835
478,557
-
151,535
-
21,233
-
Balance at 31 March
194,005,536 193,854,001 151,528,974 151,507,741
Shares Issued
During the year a total of 151,535 (March 2022: 85,881,392) fully paid Ordinary Shares were issued.
Options
The Company has on issue 40,047,587 share options as at 31 March 2023 (March 2022: 38,010,109). During
the period 7,981,000 (March 2022: 26,316,587) options were issued and 151,535 (March 2022: 478,557) were
exercised. During the year 5,791,987 options that were not exercised expired.
Share Based Compensation
The movement in fair value of employee, director and non-employee share options of $209,090 (March 2022:
$60,953) corresponds with the amount recorded in expenses during the period and represents the fair value of
vested and issued options (refer to note 14).
Share Option Reserve
The share option reserve is used to record the fair value of options as at each reporting date. The values of
options are transferred between equity components as they expire/lapse/are exercised.
Foreign Currency Translation Reserve
The foreign currency translation reserve is used to allow for translation differences on conversion from the
functional currency to the presentational currency.
Note 14. Reserves
Foreign currency reserve
Share option reserve
2023
$
2022
$
(1,818,617) (1,818,617)
776,966
849,586
(969,031) (1,041,651)
Foreign currency reserve
The foreign currency translation reserve is used to allow for translation differences on subsidiary conversion from
the functional currency to the presentational currency.
Share-based payments reserve
The reserve is used to recognise the value of equity benefits provided to employees and directors as part of their
remuneration, and other parties as part of their compensation for services.
54
31
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 14. Reserves (continued)
Reconciliation of movement:
Balance at beginning of period
Share-based payment expenses (recognised in the Profit and Loss statement)
Share-based payment expenses (recognised in Equity as costs of raising capital)
Transfer to accumulated losses due to unexercised option expiry (previously
recognised in the Profit and Loss statement)
Balance at end of period
2023
$
2022
$
776,966
209,090
-
811,504
60,953
137,509
(136,470)
(233,000)
849,586
776,966
The total share-based payment expense amortised for the year ended 31 March 2023 was $209,090 (2022:
$198,462). $136,470 was recognised in retained earnings as a transfer of share-based payment expenses
relating to options that lapsed during the financial year that were previously recognised in the Profit and Loss
statement.
Share based compensation
Options may be issued to external consultants or non-related parties without shareholders’ approval, where the
annual 15% capacity pursuant to ASX Listing Rule 7.1 has not been exceeded. Options cannot be offered to a
director or an associate except where approval is given by shareholders at a general meeting.
Options may be issued to employees in accordance with the Company’s existing ESOP. Options cannot be
offered to a director or an associate except where approval is given by shareholders at a general meeting. Each
option issued converts into one ordinary share of Amplia Therapeutics Limited on exercise. The options carry
neither right to dividends nor voting rights. Options may be exercised at any time from the date of vesting to the
date of their expiry.
Set our below are summaries of options granted to employees, directors and consultants that fall under AASB2
for the year ended 31 March 2023:
Grant date
31/08/2018
31/08/2018
01/10/2019
02/09/2020
02/09/2020
02/09/2020
10/05/2021
20/12/2021
18/01/2022
25/08/20221
09/09/20222
12/09/20222
14/09/20222
Exercise
price
Balance at
start of year
Granted
during year
Expired/exer
cised during
year
Balance at
end of year
Expiry date
960,000
$0.590
$0.590
750,000
$0.155 1,070,000
$0.200 1,000,000
720,000
$0.150
$0.200 2,000,000
$0.428
500,000
$0.280 2,500,000
$0.280
377,166
$0.260
$0.260
$0.260
$0.260
-
-
-
-
-
-
-
-
-
- 2,355,000
- 1,208,000
- 3,693,000
725,000
-
9,877,166 7,981,000
-
(750,000)
960,000 31/08/2023
- 31/08/2022
- 1,070,000 24/06/2024
- 1,000,000 02/09/2025
720,000 02/09/2025
-
- 2,000,000 02/09/2023
-
500,000 10/05/2024
- 2,500,000 31/12/2023
-
377,166 31/12/2023
- 2,355,000 06/09/2025
- 5,626,000 07/10/2025
- 07/10/2025
-
- 07/10/2025
-
(750,000) 17,108,166
Weighted average
exercise price
$0.29
$0.26
$0.59
$0.27
1 2,355,000 options were granted to Non-Executive Directors. The vesting date of the options is the issue date.
2 5,626,000 options were granted to employees. The vesting date of the options is 1/3 annually.
The weighted average remaining contractual life in years is 1.95 (2022: 1.91)
55
32
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 14. Reserves (continued)
The fair value of options granted is estimated using the Black-Scholes option-pricing model. For the options
granted during the current financial year, the valuation model inputs used to determine the fair value at the grant
date are as follows:
Grant date
Expiry date
Share price at
grant date
Exercise price
Expected
volatility
Dividend yield
Risk-free rate
25/08/2022
09/09/2022
12/09/2022
14/09/2022
06/09/2025
07/10/2025
07/10/2025
07/10/2025
$0.115
$0.115
$0.096
$0.100
$0.260
$0.260
$0.260
$0.260
77.95%
79.81%
81.78%
81.90%
0.00%
0.00%
0.00%
0.00%
1.85%
2.35%
2.35%
2.35%
Set out below are summaries of options granted to employees, directors and consultants for the year ended 31
March 2022:
Grant date
31/08/2018
31/08/2018
31/08/2018
1/10/2019
2/09/2020
2/09/2020
2/09/2020
10/05/20211
20/12/20212
18/01/20223
Exercise
price
Balance at
start of year
Granted
during year
Expired/exer
cised during
year
Balance at
end of year
Expiry date
- (1,370,000)
$0.590 1,370,000
-
-
960,000
$0.590
-
-
$0.590
750,000
-
$0.155 1,200,000
-
$0.200 1,000,000
-
$0.150
720,000
-
$0.200 2,000,000
-
$0.428
500,000
- 2,500,000
$0.280
377,166
-
$0.280
- 31/03/2022
960,000 31/08/2023
750,000 31/08/2022
(130,000) 1,070,000 24/06/2024
- 1,000,000 2/09/2025
-
720,000 2/09/2025
- 2,000,000 2/09/2023
-
500,000 10/05/2024
- 2,500,000 31/12/2023
377,166 31/12/2023
-
8,000,000 3,377,166 (1,500,000) 9,877,166
Weighted average
exercise price
$0.34
$0.30
$0.55
$0.29
1 500,000 options were granted to corporate advisors Taylor Collison for services provided in the capital raise in
May 2021. The vesting date of the options is the issue date.
2 2,500,000 options were granted to corporate advisors Taylor Collison for services provided in the capital raise
in December 2021. The vesting date of the options is the issue date.
3 377,166 options were granted to Company Secretary for services provided to the Company. The vesting date
of the options is the issue date.
Note 15. Provision for income tax
In assessing the reliability of deferred tax assets, management considers whether it is probable that all of the
deferred tax asset will be realised. The ultimate realisation of deferred tax assets is dependent upon the
generation of future taxable income and compliance with continuity of ownership requirements.
Based upon the level of projections for future taxable income over the periods in which the temporary differences
are available to reduce income taxes payable, and uncertainties over continuity of ownership having regard to
the Company’s equity raisings, management has established a valuation provision for the full amount of the
deferred tax assets related to the net operating loss carried forward.
The Group is a resident for Australian tax purposes and is subject to the statutory tax rate in Australia applicable
to the size of the Group i.e. 25% (2022: 25%). The recoverability of prior tax losses will be dependent on the
Group meeting either the “continuity of ownership test” or the “continuity of business test”. The Group believes
that it will meet one of these tests but regardless, has not recognised the tax benefit of any tax losses carried
forward.
56
32
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 15. Provision for income tax (continued)
Numerical reconciliation of income tax expense and tax at the statutory rate
Loss before income tax expense
Tax at the statutory tax rate of 25%
2023
$
2022
$
(6,242,435) (3,644,217)
(1,560,609)
(911,054)
Tax effect amounts which are not deductible/(taxable) in calculating taxable income:
Share-based payments
Licence payments
Other non-deductible/(non-assessable) items
Research & development
Unrecognised temporary differences
Unrecognised tax losses
Income tax expense
52,272
35,990
2,192
372,911
(71,000)
1,168,244
15,238
8,458
360
563,368
(60,082)
383,712
-
-
2023
$
2022
$
Deferred tax assets not recognised
Deferred tax assets not recognised comprises temporary differences attributable to:
Provision for holiday pay
Other accruals
Section 40-880 deduction carry forward
Patent application carry forward
Net operating loss to carry forward
Total deferred tax assets not recognised
11,110
21,301
228,690
29,152
12,354
14,007
319,812
31,096
3,068,276 1,900,031
3,358,529 2,277,300
The above potential tax benefit, which excludes tax losses, for deductible temporary differences has not been
recognised in the statement of financial position as the recovery of this benefit is uncertain.
Note 16. Reconciliation of loss after taxation to cash flows from operating activities
Loss after income tax expense for the year
(6,242,435) (3,644,217)
2023
$
2022
$
Adjustments for:
Depreciation
Share based compensation
Right-to-use asset amortisation
Other
Changes in Working Capital
Accounts receivable and prepayments
Accounts payable and accruals
Net cash used in operating activities
10,307
209,090
63,061
675
3,209
60,953
-
(248)
680,342
(10,728)
(825,432)
3,716
(5,289,688) (4,402,019)
57
33
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 17. Financial instruments
Capital management
The Group manages its capital to ensure entities in the Group will be able to continue as going concern while
maximising the return to stakeholders through the optimisation of the debt and equity balance.
The Group’s overall strategy remains unchanged from 31 March 2022.
The Group is not subject to any externally imposed capital requirements.
Given the nature of the business, the Group monitors capital on the basis of current business operations and
cash flow requirements.
Categories of financial instruments, including fair value of financial instruments
The classification of each class of financial assets and liabilities, and their fair values are as follows:
Non-derivative financial assets
Loans and Receivables
(i) Accounts receivable
(ii) Other receivables
Non-derivative financial liabilities
At amortised cost
(i) Accounts payable, accrued liabilities and provisions
(ii) Borrowings
(iii) Lease liabilities
March 2023 March 2023 March 2022 March 2022
Carrying
amounts
$
Carrying
amounts
$
Fair value
$
Fair value
$
-
-
-
-
-
-
-
-
-
-
-
-
569,411
569,411
535,590
2,106,614 2,106,614 2,100,473 2,100,473
-
2,845,278 2,845,278 2,636,063 2,636,063
535,590
169,253
169,253
-
Financial Risks
The financial risks associated with the Group’s financial assets and liabilities include credit risk, interest rate risk,
liquidity risk and currency risk.
Credit Risk – Financial instruments that potentially subject the Group to concentrations of credit risk consist
principally of cash and cash equivalents, investments, loans and receivables. The maximum credit risk is the face
value of these financial instruments. However, the Group considers the risk of non-recovery of these accounts to
be minimal.
Maximum Risk Exposure – The maximum credit risk exposures are the carrying amounts of the financial assets
and financial liabilities listed under the “Categories of Financial Instruments, including Fair Value of Financial
Instruments” table. No financial assets are either past due or impaired. There are no collateral and other credit
enhancements for the financial assets.
Currency Risk – Currency risk is the risk of loss to the Group arising from adverse changes in foreign exchange
rates. The Group has an Australian dollar presentation currency and is exposed to currency risk in respect of
amounts held in foreign currency bank accounts and demand deposits. At 31 March 2023 the Group held NZ$0
(2022: NZ$0) and Euro 50 (2022: Euro 50) in such accounts and deposits. Should exchange rates strengthen by
10% this would have an impact of A$7 (2022: A$7).
58
34
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 17. Financial instruments (continued)
Interest Rate Risk – Interest rate risk is the risk of loss to the Company arising from adverse changes in interest
rates. At 31 March 2023, the Company held $7,983,480 (2022: $10,624,454) in such accounts and deposits. A
50 basis points (0.5%) decrease is used when reporting interest rate risk internally to key management personnel
and represents management’s assessment of the reasonably possible change in interest rates. For each interest
rate movement of 50 basis points lower, assuming all other variables were held constant, the Group’s loss for the
year would increase by $40,000 (2022: $53,000).
At 31 March 2023, the Company had an R&D cash flow loan with the Victorian Government of $2,100,000
(2022: $2,100,000). A 50 basis points (0.5%) increase is used when reporting interest rate risk internally to key
management personnel and represents management’s assessment of the reasonably possible change in interest
rates. For each interest rate movement of 50 basis points higher, assuming all other variables were held constant,
the Group’s loss for the year would increase by $10,500 (2022: $10,500).
Liquidity Risk - Liquidity risk is the risk that the Group will encounter difficulty in raising funds at short notice to
meet commitments associated with financial instruments. The Group’s non-derivative and derivative financial
liabilities have contractual maturities as summarised below:
Carrying
amount
Contractual
cash flows
Within 6
months
6 to 12
months
1 to 5 years
Later than 5
years
2023 March
Accounts payable and
accrued liabilities
Borrowings
2022 March
Accounts payable and
accrued liabilities
Borrowings
Note 18. Related parties
528,501
528,501
2,106,614 2,106,614
2,635,115 2,635,115
528,501
-
- 2,106,614
528,501 2,106,614
-
-
-
486,476
486,176
2,100,473 2,100,473
2,586,949 2,586,649
486,176
-
486,176
-
-
- 2,100,473
- 2,100,473
-
-
-
-
-
-
(a) Parent entity
The immediate parent and ultimate controlling party of the Group is Amplia Therapeutics Limited. Interests in
subsidiaries are set out in note 19.
(b) Directors & other key management personnel remuneration
The total compensation to directors and other key management personnel during the year was:
Short-term benefits (including performance bonuses)
Post-employment benefits
Share based payments
2023
2022
567,902
31,720
96,861
500,219
25,851
34,238
696,483
560,308
59
36
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 19. Interests in subsidiaries
The consolidated financial statements incorporate the assets, liabilities and results of the following subsidiary
with non-controlling interests in accordance with the accounting policy described in note 1:
Principal place of
business /
Country of
incorporation
Principal activities
Parent
Ownership
interest
2023
%
Ownership
interest
2022
%
Australia
Licence holding company
100.00%
100.00%
Name
ACN 612 556 948 Pty Ltd
(formerly Amplia
Therapeutics Pty Ltd)
Note 20. Parent entity information
Set out below is the supplementary information about the parent entity.
Statement of profit or loss and other comprehensive income
Loss after income tax
Total comprehensive loss
Statement of financial position
Total current assets
Total assets
Total current liabilities
Total liabilities
Equity
Issued capital
Foreign currency reserve
Share option reserve
Accumulated losses
Total equity
Parent
2023
$
2022
$
(6,242,434) (3,644,217)
(6,242,434) (3,644,217)
Parent
2023
$
March 2022
$
10,508,529 16,532,854
18,684,335 24,483,701
2,750,559
530,180
2,848,809
2,636,063
151,528,974 151,507,741
(1,818,617)
776,966
(134,724,417) (128,618,452)
(1,818,617)
849,586
15,835,526 21,847,638
Significant accounting policies
The accounting policies of the parent entity are consistent with those of the consolidated entity, as disclosed in
note 1, except for the following:
●
●
●
Investments in subsidiaries are accounted for at cost, less any impairment, in the parent entity.
Investments in associates are accounted for at cost, less any impairment, in the parent entity.
Dividends received from subsidiaries are recognised as other income by the parent entity and its receipt may
be an indicator of an impairment of the investment.
60
37
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 20. Parent entity information (continued)
Significant accounting policies
The accounting policies of the parent entity are consistent with those of the consolidated entity, as disclosed in
note 1, except for the following:
●
●
●
Investments in subsidiaries are accounted for at cost, less any impairment, in the parent entity.
Investments in associates are accounted for at cost, less any impairment, in the parent entity.
Dividends received from subsidiaries are recognised as other income by the parent entity and its receipt may
be an indicator of an impairment of the investment.
Note 21. Remuneration of auditors
Audit and review of financial statements
Grant Thornton - Australia
Other services
Grant Thornton - Australia
Taxation compliance
Total auditor's remuneration
Note 22. Commitments and contingencies
March 2023 March 2022
$
$
66,500
53,000
-
7,500
66,500
60,500
Licenses (AMP945 & AMP886)
Under the in-licence agreement with Cancer Research Technology Limited (“CRT”) signed in March 2018, the
Company was required to use commercially reasonable efforts to develop AMP945 by filing an Investigational
New Drug (“IND”) application or commence a Phase 1 trial within two years. This obligation was met in October
2020 when the Company initiated a Phase 1 trial of AMP945.
For AMP886, the Company agreed to file an IND or commence a Phase 1 trial within three years. In November
2021, CRT agreed to extend the deadline for filing an IND or commencing a Phase 1 trial of AMP886 until 31
December 2023. Under the license agreement there is an annual maintenance fee of between US$15,000 and
US$20,000 per annum. Additionally, under this agreement there are various milestone payments under the
license agreement totalling US$50,000 for the commencement of a further Phase 1 clinical trial and US$150,000
for the allowance of the two IND’s.
Upon commencement of the first Phase 2 trial of either AMP886 or AMP945, a milestone payment of US$250,000
is due to CRT. Further milestone payments would only become due and payable upon commencing additional
Phase 2 and 3 studies, regulatory approvals and ultimately commercialisation.
Intellectual Property Royalties on the Use of MIS416 – Vendors
The Company must pay to the original Vendors 3.25% of net revenues on any product sales and licence revenues
arising from the use of MIS416 to treat radiation injury, as described in a number of granted patents and patent
applications having a priority date in 2009, expiring at the end of the respective patent periods.
Collaborations
The Group has entered a collaborative arrangement with the Garvan Institute of Medical Research (Garvan) for
work being done to develop FAK inhibitor AMP945 in combination with gemcitabine and nab-paclitaxel. Upon
first dosing of a patient in an Amplia-sponsored clinical trial in pancreatic cancer a milestone payment of
AU$100,000 was paid to Garvan. Further milestone payments would only become due and payable upon
commencing additional Phase 2 and 3 studies, regulatory approvals and ultimately commercialisation.
61
37
Amplia Therapeutics Limited
Notes to the consolidated financial statements
31 March 2023
Note 22. Commitments and contingencies (continued)
Research and development
The Group has entered into an agreement with IQVIA related to research and development activities for the
Phase 2 AMP945 clinical trial, the total estimated value of the agreement is $3.97 million, a combination of
professional fees and pass through spanning through to 2026. When certain milestones in the trial are satisfied,
the Group will need to settle advanced payments. At balance date, $0.68 million of the agreement has been
settled.
Note 23. Events after the reporting period
No matter or circumstance has arisen since 31 March 2023 that has significantly affected, or may significantly
affect the consolidated entity's operations, the results of those operations, or the consolidated entity's state of
affairs in future financial years.
62
38
Amplia Therapeutics Limited
Directors' declaration
31 March 2023
In the directors' opinion:
●
●
●
●
the attached financial statements and notes comply with the Corporations Act 2001, the Accounting
Standards, the Corporations Regulations 2001 and other mandatory professional reporting requirements;
the attached financial statements and notes comply with International Financial Reporting Standards as
issued by the International Accounting Standards Board as described in note 1 to the financial statements;
the attached financial statements and notes give a true and fair view of the consolidated entity's financial
position as at 31 March 2023 and of its performance for the financial year ended on that date; and
there are reasonable grounds to believe that the company will be able to pay its debts as and when they
become due and payable.
The directors have been given the declarations required by section 295A of the Corporations Act 2001.
Signed in accordance with a resolution of directors made pursuant to section 295(5)(a) of the Corporations Act
2001.
On behalf of the directors
___________________________
Warwick Tong
Non-Executive Chairman
30 May 2023
63
39
Grant Thornton Audit Pty Ltd
Level 22 Tower 5
Collins Square
727 Collins Street
Melbourne VIC 3008
GPO Box 4736
Melbourne VIC 3001
T +61 3 8320 2222
Independent Auditor’s Report
To the Members of Amplia Therapeutics Limited
Report on the audit of the financial report
Opinion
We have audited the financial report of Amplia Therapeutics Limited (the Company) and its subsidiaries
(the Group), which comprises the consolidated statement of financial position as at 31 March 2023, the
consolidated statement of profit or loss and other comprehensive income, consolidated statement of
changes in equity and consolidated statement of cash flows for the year then ended, and notes to the
consolidated financial statements, including a summary of significant accounting policies, and the Directors’
declaration.
In our opinion, the accompanying financial report of the Group is in accordance with the Corporations Act
2001, including:
a
b
giving a true and fair view of the Group’s financial position as at 31 March 2023 and of its
performance for the year ended on that date; and
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 Group 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.
www.grantthornton.com.au
ACN-130 913 594
Grant Thornton Audit Pty Ltd ACN 130 913 594 a subsidiary or related entity of Grant Thornton Australia Limited ABN 41 127 556 389 ACN 127 556 389.
‘Grant Thornton’ refers to the brand under which the Grant Thornton member firms provide assurance, tax and advisory services to their clients and/or
refers to one or more member firms, as the context requires. Grant Thornton Australia Limited is a member firm of Grant Thornton International Ltd (GTIL).
GTIL and the member firms are not a worldwide partnership. GTIL and each member firm is a separate legal entity. Services are delivered by the member
firms. GTIL does not provide services to clients. GTIL and its member firms are not agents of, and do not obligate one another and are not liable for one
another’s acts or omissions. In the Australian context only, the use of the term ‘Grant Thornton’ may refer to Grant Thornton Australia Limited ABN 41 127
556 389 ACN 127 556 389 and its Australian subsidiaries and related entities. Liability limited by a scheme approved under Professional Standards
Legislation.
64
w
Material uncertainty related to going concern
We draw attention to Note 1 in the financial statements, which indicates that the Group incurred a net loss of
$6,242,435 during the year ended 31 March 2023. As stated in Note 1, these events or conditions, along with
other matters as set forth in Note 1, indicate that a material uncertainty exists that may cast doubt on the Group’s
ability to continue as a going concern. Our opinion is not modified in respect of this matter.
Key audit matters
Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of
the financial report of the current period. These matters were addressed in the context of our audit of the financial
report as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these
matters.
In addition to the matter described in the Material uncertainty related to going concern section, we have
determined the matters described below to be the key audit matters to be communicated in our report.
Key audit matter
How our audit addressed the key audit matter
Intangible assets (Note 9 and Note 2)
At 31 March 2023, the Group has intangible assets with a
carrying amount of $7,937,932 relating to AMP886 and
AMP945 (the drug candidates).
There is a risk the recoverable amount of the drug
candidates is lower than their carrying amount in which
case impairment should be recognised.
As these intangible assets are not ready for use, the drug
candidates are tested at least annually for impairment in
accordance with AASB 136 Impairment of Assets.
This area is a key audit matter due to the significant
judgments involved in assessing management’s
determination of the recoverable amount of the drug
candidates and whether the drug candidates are impaired
at year end.
R&D incentives (Note 5)
The Group receives a 43.5% refundable tax offset of
eligible expenditure under the Research and Development
(R&D) Tax Incentive scheme if its turnover is less than
$20 million per annum, provided it is not controlled by
income tax-exempt entities.
Management has performed a detailed review of the
Group’s total research and development expenditure to
determine the potential claim under the R&D tax incentive
legislation.
The process of calculating the R&D tax rebate requires
judgment and specialised knowledge in identifying eligible
expenditures, which gives rise to anticipated R&D tax
incentives. Balances in relation to R&D tax incentives are
therefore considered a key audit matter.
Our procedures included, amongst others:
• Obtaining management’s impairment memorandum
describing the basis for determining the recoverable
amount and challenging and testing the underlying
inputs and assumptions;
• Assessing the determination of the recoverable amount
has been made in accordance with AASB 136
Impairment of Assets and AASB 13 Fair Value.
• Obtaining and evaluating management’s calculation of
the recoverable amount, ensuring the inputs and
assumptions are appropriate;
• Considering other qualitative considerations (e.g.
recent clinical trial results, capital raising activities and
other public information available or press releases);
and
• Assessing disclosures in the financial statements for
adequacy.
Our procedures included, amongst others:
• Obtaining FY23 R&D rebate calculations and
performing the following procedures;
• Developing an understanding of the calculation,
identifying and assessing key assumptions in the
calculation;
• Verifying included expenses agree to the
underlying supporting documents;
• Testing the mathematical accuracy of the accrual;
• Testing a sample of claimed expenditure to source
documentation and verifying the expenses are
eligible; and
• For labour costs included in the calculation,
reviewing the percentage relating to R&D activities
for appropriateness and the underlying salary of
the employee.
65
Grant Thornton Audit Pty Ltd
Key audit matter
How our audit addressed the key audit matter
R&D incentives (Note 5) (Cont.)
• Obtaining the assessment made by Management’s
experts in relation to R&D rebate calculation;
• Comparing the estimated R&D accrual made in the
prior year to the amount of cash received after
lodgement of the R&D tax claim;
• Consulting with internal tax specialists to verify the
accuracy and eligibility of the claimed expenditure in
the calculation; and
Reviewing the disclosures in the financial statements to
ensure adequacy.
Information other than the financial report and auditor’s report thereon
The Directors are responsible for the other information. The other information comprises the information included
in the Group’s annual report for the year ended 31 March 2023, 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 we do not express any form of
assurance conclusion thereon.
In connection with our audit of the financial report, our responsibility is to read the other information and, in doing
so, consider whether the other information is materially inconsistent with the financial report or our knowledge
obtained in the audit or otherwise appears to be materially misstated.
If, based on the work we have performed, we conclude that there is a material misstatement of this other
information, we are required to report that fact. We have nothing to report in this regard.
Responsibilities of the Directors’ for the financial report
The Directors of the Company are responsible for the preparation of the financial report 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 Group’s ability to continue as a
going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of
accounting unless the Directors either intend to liquidate the Group 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.
A further description of our responsibilities for the audit of the financial report is located at the Auditing and
Assurance Standards Board website at: http://www.auasb.gov.au/auditors_responsibilities/ar1_2020.pdf.This
description forms part of our auditor’s report.
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Grant Thornton Audit Pty Ltd
Report on the remuneration report
Opinion on the remuneration report
We have audited the Remuneration Report included in pages 33 to 37 of the Directors’ report for the year
ended 31 March 2023.
In our opinion, the Remuneration Report of Amplia Therapeutics Limited, for the year ended 31 March 2023
complies with section 300A of the Corporations Act 2001.
Responsibilities
The Directors of the Company are responsible for the preparation and presentation of the Remuneration Report
in accordance with section 300A of the Corporations Act 2001. Our responsibility is to express an opinion on the
Remuneration Report, based on our audit conducted in accordance with Australian Auditing Standards.
Grant Thornton Audit Pty Ltd
Chartered Accountants
T S Jackman
Partner – Audit & Assurance
Melbourne, 30 May 2023
67
Grant Thornton Audit Pty Ltd
Amplia Therapeutics Limited
Shareholder information
31 March 2023
The shareholder information set out below was applicable as at 9 May 2023.
(a) Number of ATX shareholders
(b) Total shares issued
(c) Percentage of total holdings by or on behalf on the 20 largest shareholders
1,554
194,005,536
53.09%
(d) Distribution schedule of fully paid ordinary shares
Range
1-1,000
1,001-5000
5,001-10,000
10,001-100,000
100,001 and over
Total
Holders
Units
% of Total
Units
148
42,510
316
1,121,609
282
2,181,234
609 22,872,318
199 167,787,865
0.02%
0.58%
1.12%
11.79%
86.49%
1,554 194,005,536
(e) The number of holders holding less than a marketable parcel of ordinary fully paid shares: 393
Top 20 holders of ordinary fully paid shares
Ordinary shares
% of total
shares
Number
held
issued
HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED
BOND STREET CUSTODIANS LIMITED (LAM1 - D08047 A/C)
BNP PARIBAS NOMS PTY LTD
J P MORGAN NOMINEES AUSTRALIA PTY LIMITED
CITICORP NOMINEES PTY LIMITED
UBS NOMINEES PTY LTD
CTXT PTY LTD
ELK RIVER HOLDINGS PTY LTD
WARWICK TONG
CHRISTOPHER JOHN BURNS
GP SECURITIES PTY LTD
34TH AVENUE PTY LTD (DEVLIN FAMILY A/C)
HEH ENTREPRISES PTY LTD (HEH ENTREPRISES INVEST A/C)
MRS JANE CATHERINE JOCELYN BELL + MR GEOFFREY ARTHUR BELL
(SCHOONER SUPER FUND A/C)
MR ANDREW PODOLAK
MR ANTHONY HAMILTON MARTIN
ROBERT JAMES PEACH + COFACTOR LLC
MR MARK SULLIVAN
CITICORP NOMINEES PTY LIMITED (DPSL A/C)
SWANMARK SUPER PTY LTD RC (SWAN SUPER FUND A/C)
36,892,524
13,472,500
6,690,878
6,052,184
5,678,561
4,024,411
3,940,579
3,067,142
3,016,247
2,527,798
2,412,500
2,215,237
2,050,000
2,025,474
1,925,000
1,822,539
1,664,760
1,661,428
1,537,327
1,500,000
19.02
6.94
3.45
3.12
2.93
2.07
2.03
1.58
1.55
1.30
1.24
1.14
1.06
1.04
0.99
0.94
0.86
0.86
0.79
0.77
104,177,089
53.68
Other quoted securities
Options Expiring 31 December 2023 with Exercise Price of $0.28: 25,439,421.
Unquoted equity securities
Options Expiring various dates with various exercise prices: 14,608,166.
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Amplia Therapeutics Limited
Shareholder information
31 March 2023
Substantial holders
Substantial holders in the company are set out below:
Ordinary shares
% of total
shares
Number
held
issued
PLATINUM INVESTMENT MANAGEMENT LIMITED
BLUEFLAG HOLDINGS PTY LTD AS TRUSTEE FOR THE BLUEFLAG TRUST
ACORN CAPITAL LTD
34,813,002
13,472,500
10,071,620
17.94
6.94
5.19
Voting rights
The voting rights attached to ordinary shares are set out below:
Ordinary shares
On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a
poll each share shall have one vote.
There is no current on-market buy back of any equity securities.
Corporate Governance
The Company's Annual Corporate Governance Statement and Corporate Government policies can be found on
the Company's website at: https://www.ampliatx.com/site/About-Us/corporate-governance
69
43
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