ANNUAL
REPORT
2022
CONTENTS
Corporate Highlights ................................................................................ 1
Market Highlights ....................................................................................... 2
Achievements .............................................................................................. 3
Chairman’s Letter ...................................................................................... 4
Directors’ Report ........................................................................................ 8
Auditor’s Independence Declaration .............................................. 20
Consolidated Statement of Profit or Loss
and Other Comprehensive Income ................................................... 21
Consolidated Statement of Financial Position ........................... 22
Consolidated Statement of Changes in Equity .......................... 23
Consolidated Statement of Cash Flows ......................................... 24
Notes to the Financial Statements ................................................... 25
Directors’ Declaration ........................................................................... 43
Independent Auditor’s Report .......................................................... 44
Corporate Governance Statement ................................................... 47
ASX Additional Information ................................................................ 48
Corporate Directory ................................................................................. 51
COMPONENTS FOR INVEX’S SUCCESS
MANUFACTURING
Exclusive Agreement with
Peptron, Inc. for 1x per week
Presendin™ clinical and
commercial supply.
REGULATORY
AU registration via TGA,
UK registration via MHRA,
European registration via EMA,
U.S. clinical sites via FDA
CLINICAL
Single Phase III clinical
trial designed with
expert input.
FUNDING
$29.3 million cash –
fully funds Phase III
trial to registration.
ii
INVEX THERAPEUTICS LTD.
CORPORATE HIGHLIGHTS
$29.3
million
cash
$3.4m
FY22
Operating
Cash Burn
$4.0m
Net Loss
after Tax
$0.90m $2.6
Annual Corporate
Investment
into R&D
overhead (excluding
R&D and share-based
compensation)
18%
Directors and
Management
share ownership
million
>20
8
Core Invex team
Consultants and
delivering on Presendin™
advisors assisting Invex
clinical and commercial
in delivering Presendin™
pathways
Phase III clinical trial
ANNUAL REPORT 2022
1
MARKET HIGHLIGHTS
$1.6 billion
total annual addressable market for IIH
in the EU, the UK and the US
IIH Patients Report:
82%
severe impact of
headache on daily life1
3.4%
annual growth in IIH incidence
77%
24k
Annual number
16k
Annual number
frequent visual problems1
of newly diagnosed
of newly diagnosed
IIH patients (EU & UK)
IIH patients (US)
49%
felt their daily life was
often severely impacted1
1. Witry, M., Kindler, C., Weller, J. et al. The
patients’ perspective on the burden of idio-
pathic intracranial hypertension. J Headache
Pain 22, 67 (2021).
700+
neuro-ophthalmologists in key Invex
target markets (US, AU, UK, EU)
2
INVEX THERAPEUTICS LTD.
ACHIEVEMENTS
IIH EVOLVE single Phase III clinical trial in Idiopathic Intracranial Hypertension (IIH)
to meet regulatory requirements of the EMA, TGA and MHRA
Peptron signed commercial agreement in
September 2021
IIH EVOLVE the Phase III registration
trial for Presendin™ in IIH
Professor Michael Wall leading IIH key
opinion leader and Trial Steering Group
Chairperson for the IIH EVOLVE Phase III
Clinical Trial
Presendin™ the once per week sustained-
release Exenatide formulation for clinical
and commercial sale
12,000 patient doses per month at
Peptron’s existing manufacturing facility
in Osong, Korea
Best Abstract 2022 NANOS
Annual Meeting for Phase II
PRESSURE trial
WHAT IS IIH EVOLVE?
Phase III Schematic
1 week
screening
24 weeks
Placebo,
s.c.,
1x weekly
Presendin™,
s.c.,
1x weekly
Study unblinded - Analysis of Primary,
Secondary Endpoints
IIH Evolve is a randomised, double-blind,
placebo-controlled, multicentre clinical
trial to determine the safety and efficacy
of Presendin™ in the treatment of IIH.
Change in Intracranial
Pressure (ICP) from baseline
at 24 weeks
Change in Perimetric Mean
Deviation (PMD) from
baseline over 24 weeks
Change in Optical Coherence
Tomography (OCT) measures
over 24 weeks
Change in Monthly Headache
Days (MHD) from baseline
over 24 weeks
Primary
Endpoint
Secondary
Endpoint
Secondary
Endpoint
Secondary
Endpoint
Safety
Quality
of Life
Adverse events rate,
anti-drug antibodies, PK and
general lab measures
4 week
safety
follow-up
No
Treatment
Patient reported outcomes
(SF-36, ED-5D-5L, VFQ-25),
monthly patient diary
End of Trial
s.c. means sub-cutaneous (under the skin)
ANNUAL REPORT 2022
3
CHAIRMAN’S LETTER
Dear Shareholders,
On behalf of the Board of Invex Therapeutics Ltd
(Invex, the Company) and its controlled entity
(Group), I am pleased to present the Invex Annual
Report to shareholders for the year ended 30 June
2022 (FY22).
During FY22 Invex has been very focussed on
completing the necessary clinical, regulatory and
manufacturing requirements in order to commence
a single Phase III clinical trial (IIH EVOLVE) of a once
per week formulation of Exenatide – Presendin™ – for
the treatment of Idiopathic Intracranial Hypertension
(IIH). We have made excellent progress during FY22
and will be in a position to recruit patients across
the United Kingdom (UK), Australia, the United
States (US), Europe, New Zealand and Israel in FY23.
Our aim is to secure initial regulatory approval for
Presendin™ in the major markets of European Union
(EU), the UK and Australia.
IIH is a chronic condition that develops
predominately in obese women of child bearing
age, where intracranial pressure (ICP) in the brain
elevates siginficantly, resulting in disabling daily
headaches and in some cases permanent vision loss.
There are currently no European Medicines Agency
(EMA) and US Food and Drug Adminsitration (FDA)
treatments approved for IIH. Hence, there is an
urgent need to develop new drug treatments for
these patients, who suffer from significant quality of
life effects with IIH patients often requring multiple
hospital admissions, representing a large cost to the
healthcare system.
The economic cost of IIH is very significant. For
example, the annual cost of IIH to the health system
in England has been calculated to be almost £500
million by 2030. In Scotland, the incidence of IIH has
increased to approximately 40 per 100,000 in obese
females. Invex estimates the IIH annual addressable
market in the US and EU/UK to be around A$1.6
billion, with a treatable patient population of
approximately 92,000 patients (based on prevalence
of the disease). Our approach seeks to ameliorate
elevated ICP and therefore prevent the downstream
impacts on these patients’ vision and headaches.
Long Term Manufacturing Partner
Secured – Peptron
In September 2021, Invex signed an exclusive long-
term Collaboration and Manufacturing Agreement
with Peptron, Inc. a biopharmaceutical company
developing sustained-release peptide-based
medicines based in Daejeon, Korea. Under the
terms of the agreement, Peptron will provide Invex
with access to its intellectual property, including
an extensive preclinical and clinical data package,
and GMP grade Presendin™ for all of its clinical
trials in IIH as well as for commercial use, once
Presendin™ is approved. The Agreement provides
a defined price per dose for the global supply of
Presendin™ for clinical studies and for the first ten
years following the first commercial sale. In addition,
Invex has granted Peptron an exclusive license to
commercialise Presendin™ for IIH in Korea.
In December, Invex successfully completed an
independent Qualified Person (QP) Audit of
Peptron’s manufacturing facility. A satisfactory
QP Audit and the subsequent certification of
manufactured batches of drug product by a QP
is a requirement under European Union (EU) and
UK law prior to importation of manufactured drug
product into the EU and or the UK for clinical
or commercial purposes. The completion of the
QP Audit of Peptron and one of Peptron’s key
suppliers of manufacturing material will facilitate the
importation of Presendin™ and placebo doses into
clinical sites in Europe and the UK participating in
Invex’s IIH EVOLVE Phase III clinical trial. Following
the successful QP audit, Invex placed an initial
purchase order with Peptron for supply of a clinical
batch of Presendin™ and placebo drug product for
the IIH EVOLVE Phase III clinical trial.
Completion of Clinical and Regulatory Strategy
Following multiple interactions with global regulators
and consultation with clinical advisory groups
Invex announced a strategy aimed at bringing
Presendin™ to market as quickly as possible
by focusing on meeting the requirements for
registration of Presendin™ in the EU, the UK and
Australia utilising a trial design based on advice
received from the European Medicines Agency
4
INVEX THERAPEUTICS LTD.
(EMA), the UK Medicines and Healthcare products
Regulatory Agency (MHRA) and US FDA. Data
from IIH EVOLVE will then be used to further
inform discussions with the US FDA regarding the
regulatory pathway for registration of Presendin™
in the US market. Accordingly, the Group’s
regulatory strategy will be sequential in nature in
order to maximise the commercial opportunity and
regulatory certainty.
Regulatory Submissions Seeking Approval
to Commence IIH EVOLVE Filed and Several
Approved
In December, Professor Michael Wall, MD was
appointed as the Trial Steering Group Chairperson
for the IIH EVOLVE Phase III clinical trial. Dr Wall
is a Professor of Ophthalmology and Neurology
at the University of Iowa College of Medicine and
Director of the Iowa Visual Field Reading Center. He
is a global key opinion leader in IIH having made a
significant contribution to the clinical and scientific
literature pertaining to the diagnosis, treatment and
management of this disease and has led a significant
number of important clinical trials in IIH.
IIH EVOLVE is a placebo-controlled, double-blind
trial that will randomise 240 patients with newly
diagnosed IIH to determine the efficacy and safety
of Presendin™ versus placebo, administered once
weekly over 24 weeks. The primary endpoint of
the trial is the change in intracranial pressure from
baseline with key secondary endpoints related to
vision and headache outcome measures. Invex
intends to open up to 40 clinical sites globally.
Information on the trial is available at clinicaltrials.
gov under Identifier NCT05347147.
In December 2021 Invex filed the first Human
Research Ethics Committee (HREC) dossier in
Australia seeking authorisation from an HREC
representing several private hospitals in Australia. In
parallel, Invex submitted a Clinical Trial Notification
(CTN) to the Therapeutic Goods Administration
(TGA). In early July, the Group secured HREC and
TGA approvals. Associate Professor Celia Chen,
Director at Vision SA, Consultant Ophthalmologist
at Flinders Medical Centre will be a Principal
Investigator for IIH EVOLVE in Australia.
“We have made excellent
progress during FY22
and will be in a position
to recruit patients across
the United Kingdom (UK),
Australia, the United States
(US), Europe, New Zealand
and Israel in FY23. Our aim
is to secure initial regulatory
approval for Presendin™
in the major markets of
European Union (EU), the
UK and Australia.”
Invex has commenced the initiation of Australian
IIH EVOLVE clinical trial sites and remains on track
to commence patient recruitment once separate
institutional authorisations are completed and study
drug/placebo is available on-site. Additionally, Invex
filed an additional separate HREC application for a
single public hospital in Australia.
During the year, the Group made the necessary
regulatory submissions to the UK MHRA through a
Clinical Trial Authorisation (CTA). In late June 2022,
Invex received notification the MHRA had approved
the Group’s CTA to commence the IIH EVOLVE
Phase III clinical trial in the UK, for patients with IIH. In
addition, Invex received a favourable ethical opinion
from a Research Ethics Committee (REC), which is
also a requirement prior to commencing the trial.
Invex also submitted its Investigational New Drug
(IND) Application to the US FDA with the IND
subsequently granted as announced to ASX on
19 August 2022.
Invex has now received approvals to proceed
with the IIH EVOLVE study from a number of key
regulatory agencies and while this has been a major
undertaking for the Group during the last financial
year, Invex is now in a strong position to commence
patient recruitment in the second half of the 2022
calendar year.
5
ANNUAL REPORT 2022 “The Group is effectively
structured utilising a global
virtual business model, with
a small number of highly
experienced executives and
employees based in the UK
utilising additional expertise
from clinical, regulatory and
manufacturing consultants,
as required, to progress our
clinical program in Australia,
the UK, Europe and the
United States.”
Intellectual Property
Intellectual Property (IP) is key to Invex’s business.
Our orphan drug designations for Exenatide in IIH in
both the US and Europe provides Invex with seven
and ten years market exclusivity, respectively, upon
regulatory clearance being granted. These orphan
designations were secured from the FDA and EMA
in 2017. Invex continued to make solid progress in
expanding its patent and other intellectual property
protection for Exenatide in pressure related
disorders of the brain, including IIH, as well as the
Company’s trademark, Presendin™.
During the year, the European Patent Office notified
Invex on the intention to grant the Company a
European patent, designated patent number
EP3188747 and titled “Elevated Intracranial Pressure
Treatment.” The patent was subsequently published
on 8 September 2021. As with the Company’s
issued US patent, this additional European patent
covers the use of GLP-1 receptor agonists, including
Exenatide, in reducing elevated ICP associated with
IIH, with the patent providing protection until at least
August 2035. The granting of this patent for Europe,
alongside the Company’s issued patents in other
major markets including the US and Japan provides
broad IP protection as Invex progresses its clinical
development plans for Presendin™.
6
COVID-19
The Coronavirus (COVID-19) pandemic continued
to persist throughout the 2022 financial year,
particularly in the first half, although country-wide
lockdowns were avoided in the United Kingdom and
elsewhere during the year. COVID-19 did not exhibit
any significant adverse impact on the Group during
the 2022 financial year, although, the Company did
note some delays in completing a number of lead-in
activities related to the IIH EVOLVE clinical trial as
they related to manufacturing, assay development
and regulatory turnaround times. The pandemic has
also affected the Group’s ability to hold in-person
negotiations with the Group’s manufacturing partner
Peptron Inc. and limited travel for Group consultants
and staff, which has been largely mitigated through
the use of virtual meeting platforms.
Financials
The Group recorded a net loss after tax of $3.950
million for the year ended 30 June 2022 (FY22), an
increase of 73% on the prior corresponding period
(pcp). This was largely due to higher R&D costs
of $2.642 million (FY21: $1.139 million), reflecting
the necessary regulatory and clinical expenditure
required to commence the IIH EVOLVE study, along
with product manfuacturing costs of $0.327 million
(FY21: NIL) associated with the purchase of drug
product (Presendin™) and placebo from Peptron. In
addition share-based payment expenses of $0.352
million (FY21: $0.562 million). The Group continued
to prudently manage its cash reserves during the
year, with an overall cash burn from operations for
the 2022 financial year of $3.377 million (FY21: $1.678
million), including corporate and administrative
overheads of $0.9 million (FY21: $0.74 million).
Importantly, the Group is effectively structured utilising
a global virtual business model, with a small number
of highly experienced executives and employees
based in the UK utilising additional expertise from
clinical, regulatory and manufacturing consultants,
as required, to progress our clinical program in
Australia, the UK, Europe and the United States.
INVEX THERAPEUTICS LTD. The Group remains in a strong financial position with
cash and cash equivalents of $29.339 million as at 30
June 2022 (FY21: $32.777 million), which is sufficient
to complete a Phase III pivotal trial for Presendin™ for
registration purposes in IIH.
Corporate Governance & Diversity
There were no changes to the Board composition
during the year. We were pleased to complete new
agreements for Executive Directors, which included
Professor Sinclair increasing her time commitment
to the Group as a part-time employee. Professor
Sinclair continues to provide expert input into the
execution of the Group’s Phase III clinical trial and in
the assessment of potential new clinical indications
by leveraging Invex’s core strength in the treatment
of pressure-related brain disorders with GLP-1
receptor agonists such as Presendin™ with academic
centres of excellence.
During the year, the Board updated its Skills Matrix,
which highlighted the Board currently has most of
the appropriate skills and knowledge, experience
and diversity required for a company of its size.
In addition, the Board undertook a performance
evaluation review relating to the scope and structure
of Board meetings, compliance, risk management
and strategy. The review has provided the Board with
some areas for improvement; however, there were no
notable areas of material concern for the Board.
Invex makes a significant commitment to diversity,
by understanding all people are created differently
and by accepting and respecting different points of
views and leveraging them to learn from one another.
Our small team has demonstrated an exceptional
willingness to collaborate, engage and execute. Female
representation at the Board level was 40%. Excluding
the Executive Directors, 100% of Invex employees
are female. Inclusive of Executive Directors, the
representation is 83% female and 17% male.
Concluding Remarks
On behalf of the Board I would like to thank our
employees, advisors and consultants for their
significant efforts in advancing the IIH EVOLVE
study and in particular for achieving approvals from
key regulatory bodies such as the FDA, MHRA and
TGA as well as for the overall solid progress we have
made during the year. As Chairman, I fully appreciate
that timelines in the drug development sector can
seem long and arduous; however, we certainly
thank shareholders for their support of the Group
to date. Our aim is to build significant value for all
shareholders, through careful clinical planning and
execution to provide Presendin™ with every chance
of clinical and commercial success.
We are certainly excited by what the 2023 financial
year holds for Invex shareholders and we look
forward to keeping you apprised of our progress.
Dr Jason Loveridge
Non-Executive Chairman
7
ANNUAL REPORT 2022
Your Directors present their report together with the consolidated financial statements of the Invex
Therapeutics Ltd (Invex or Company) and its controlled entity (Group) for the financial year ended
30 June 2022.
DIRECTORS
The name of the Directors in office for the year ended 30 June 2022 until the date of this report are as
follows. All Directors were in office for the entire year unless otherwise stated.
Dr Jason Loveridge
Non-executive Chairman
Appointed 8 March 2019
Dr Loveridge is a founder of Invex Therapeutics and also CEO of 4SC AG, a German publicly listed oncology
company. He has more than 30 years of international experience across Europe, Asia and the US in senior
management positions in life sciences companies and as an investment professional dealing in both
privately held and publicly traded companies. Additionally, he has substantial transactional experience in
the sale and partnering of biotechnology assets.
Dr Loveridge graduated in Biochemistry and Microbiology from the University of New South Wales,
Australia, and holds a Ph.D. in Biochemistry from the University of Adelaide, Australia. He is also a fellow of
the Royal Society of Medicine. Dr Loveridge is not considered an independent Director.
Current Directorships – Member of the Management Board of 4SC AG.
Former Directorships in last three years - Director of Actinogen Medical Ltd.
Interests in shares and options – 3,374,462 shares and 800,000 unlisted options.
Professor Alexandra Sinclair
Executive Director – Chief Scientific Officer
Appointed 28 June 2019
Prof Alexandra Sinclair is a founder of Invex Therapeutics and a Clinician Scientist and practicing Neurology
Consultant running the Translational Brain Science Group at the Institute of Metabolism and Systems
Research, College of Medical and Dental Sciences, University of Birmingham, UK. She runs the Headache
service and Idiopathic Intracranial Hypertension Service at University Hospital Birmingham NHS Foundation
Trust.
Prof Sinclair pioneered the pre-clinical work identifying GLP-1RA’s as a novel therapeutic approach
to reduce brain pressure which she then progressed into a successful phase 2 clinical trial. She runs a
translational research group focussed on developing novel therapeutics with forward translation to improve
patient care. She is a member of the British Medical Association, UK, the Association of British Neurologists
(ABN), UK and a Fellow of the Royal College of Physicians, London. Professor Sinclair is a member of the
board for the European Headache Federation and is on the scientific committees for the North American
Neuro-Ophthalmology Society (NANOS). She is also a council member for the British Association for the
Study of Headache (BASH). Professor Sinclair has served on the MRC Neuroscience and Mental Health
Board and the Midland Neuroscience Teaching and Research Fund Board, as well as being Chair of the Brain
Research UK Scientific Advisory Board. Previously, she was an elected board member of the IHS. She was
on the research committee for the Association for British Neurologists and was also the previous patron of
the patient charity IIH UK.
Current directorships – None.
Former directorships held in last three years – None.
Interests in shares and options - 2,500,000 shares and 800,000 unlisted options.
8
INVEX THERAPEUTICS LTD. DIRECTORS’ REPORT Dr Thomas Duthy
Executive Director
Appointed 1 October 2020
Dr Duthy has over 18 years of direct financial markets experience having worked in sell-side equity research,
and senior executive roles across investor relations and corporate development. Dr Duthy is the Founder
and CEO of Nemean Group Pty Ltd, a boutique corporate advisory and investor relations firm specialising
in delivering value-added services across the life sciences, medical devices, healthcare, technology and
emerging company sectors.
Prior to establishing Nemean Group in October 2018, Dr Duthy was the Global Head of Investor Relations
& Corporate Development at Sirtex Medical Limited (ASX:SRX), which was sold to CDH Investments in
September 2018 for A$1.9 billion and remains the largest medical device transaction in Australian corporate
history. Prior to Sirtex, Tom spent ten years as a leading sell-side Healthcare & Biotechnology analyst at
Taylor Collison Limited, focused mainly on small cap companies. He is a Member of the Australian Institute
of Company Directors (MAICD).
Current directorships – None.
Former directorships held in last three years – Respiri Limited.
Interests in shares and options – 106,923 shares and 800,000 unlisted options.
Dr Megan Baldwin
Non-executive Director
Appointed 16 February 2021
Dr Baldwin is CEO and Managing Director of Opthea Limited (ASX:OPT; NASDAQ:OPT), a late-stage
biopharmaceutical company developing a novel therapy, OPT-302, to address the unmet need in the
treatment of retinal eye diseases, including wet age-related macular degeneration (wet AMD). Under
Dr Baldwin’s leadership, Opthea has rapidly advanced its ophthalmology program through Phase I
and Phase II clinical development and in October 2020 completed a $180 million IPO and listing
on the US NASDAQ exchange to progress two pivotal Phase III studies in wet AMD. Dr Baldwin is
currently over-seeing the expansion of the company’s management team in the U.S. and preparing for
commercialization of OPT-302.
Dr Baldwin is an experienced biotechnology executive, having over 20 years’ experience working on
therapeutic drug development programs for cancer and ophthalmic indications. Prior to Opthea, Dr Baldwin
was employed at Genentech (now Roche) as a postdoctoral researcher before moving to Genentech’s
commercial division. Dr Baldwin also serves on the Board of Ausbiotech as Deputy Chair. Dr Baldwin is
considered an independent Director.
Current directorships – Opthea Limited., Ausbiotech.
Former directorships held in last three years – None.
Interests in shares and options - 400,000 unlisted options.
Mr David McAuliffe
Non-executive Director
Appointed 8 March 2019
Mr McAuliffe is an experienced company director and entrepreneur who has had over twenty years’
experience, mostly in the international biotechnology field. During that time, he was involved in numerous
capital raisings and in-licensing of technologies. He is a founder of several companies in Australia, France
and the United Kingdom, many of which have become public companies. Mr McAuliffe has an Honours
degree in Law, a Bachelor of Pharmacy degree and is the President of the Dyslexia – Speld Foundation WA
(Inc). Mr McAuliffe is considered an independent Director.
Current directorships - 4DS Memory Limited.
Former directorships held in last three years – None.
Interests in shares and options - 3,350,001 shares and 200,000 unlisted options.
9
ANNUAL REPORT 2022DIRECTORS’ REPORT (CONT.) Ms Narelle Warren
Company Secretary
Ms Warren is a Chartered Accountant with over twenty years of corporate advisory, financial management
and company secretarial experience. Ms Warren has coordinated and assisted in numerous corporate
transactions, including acquisitions, divestments and raising funds via private and public equity markets.
She holds both a Bachelor of Laws and Bachelor of Commerce.
PRINCIPAL ACTIVITY
Invex is a biopharmaceutical Group focused on the repurposing of an already approved drug, Exenatide,
for efficacious treatment of neurological conditions derived from or involving raised intracranial pressure
(ICP). The Group’s primary focus is Idiopathic Intracranial Hypertension (IIH), a severe condition of
predominately overweight women of childbearing age, which can lead to disabling headaches and in some
patients, permanent vision loss. The Group’s lead program is the development of Presendin™ for IIH, which
is currently at Phase III clinical stage.
Presendin™ is a once per week, subcutaneous, sustained-release (SR) Exenatide microsphere formulation
originally developed by Peptron, Inc. (KOSDAQ: 087010). Invex completed a Phase II trial in 2020 and
expects to commence a single, Phase III clinical trial (“IIH EVOLVE”) designed to meet the requirements for
market approval of Presendin™ for the treatment of IIH in the European Union (EU), United Kingdom (UK)
and Australia during 2022.
Presendin™ is the Group’s filed (and granted) trademark name for reformulated Exenatide.
The principal activity of the Group during the period has been to plan and prepare to commence the
Phase III IIH EVOLVE clinical trial.
OPERATING RESULTS
The result of the Group for the year ended 30 June 2022 was a loss of $3,950,183 (2021: $2,288,595 loss).
The net loss of the Group predominantly related to Research & Development costs of $2,962,596 associated
with the planning of the Phase III clinical trial, intellectual property prosecution, manufacturing costs and
regulatory advice, administration and corporate costs of $900,286 and non-cash items; notably share-
based payments of $352,390.
REVIEW OF OPERATIONS
The Group is well funded to meet its medium-term objectives, including the completion of a Phase III trial
for Presendin™ in IIH, with the associated drug manufacture and supply for the Phase III trial. In addition, the
Group may consider the commencement of a small Phase II study for Presendin™ in a second patient group.
FY22 highlights include:
• Granted key European patent for Exenatide
• Execution of an exclusive long-term Collaboration and Manufacturing Agreement with Peptron, Inc
• Completion of regulatory and clinical reviews – targeting single Phase III clinical trial for Presendin™
• Scientific presentations at leading neuro ophthalmology conferences in Europe and the US
• Successful completion of Qualified Person (QP) audit of Peptron
• First commercial order of Presendin™ for clinical trial purposes from Peptron
• Regulatory submissions for IIH EVOLVE clinical trial in Australia, UK, US and Europe completed
LIKELY DEVELOPMENTS
The Group has undertaken a significant amount of clinical and regulatory preparative work during FY22 and
anticipates the commencement of the Phase III IIH EVOLVE clinical trial across a number of countries in the
second half of the 2022 calendar year.
10
INVEX THERAPEUTICS LTD. DIRECTORS’ REPORT (CONT.) DIVIDENDS
No dividends were paid or recommended by the Directors since the commencement of the year.
SIGNIFICANT CHANGES IN STATE OF AFFAIRS
Other than as outlined above, there were no significant changes in the Group’s state of affairs during the
year.
MATTERS SUBSEQUENT TO THE END OF THE FINANCIAL YEAR
On 1 July 2022, Carol Parish was appointed Chief Operating Officer (COO) at the Group. Until 30 June 2022,
Carol held the role as Head of Clinical Operations. Carol has been a pharmaceutical professional for over
33 years within the Pharmaceutical/Biotech industry, where she has been accountable for all Phases of
drug development in multiple therapy areas. Prior to joining Invex, Carol was the Global Clinical Operations
Lead at Intercept Pharmaceuticals (NASDAQ: ICPT) and has held various senior clinical positions at Stiefel
Laboratories (acquired by GlaxoSmithKline in 2009) including Senior Director, Global Clinical Development
for a new drug product, including collaborating with GSK Japan and China. Additionally, Carol spent over
20 years at Merck & Co (NYSE:MRK) and Johnson & Johnson (NYSE:JNJ).
No other significant events occurred after balance date which may affect either the Group’s operations or
results of those operations or the Group’s state of affairs.
MEETINGS OF DIRECTORS
During the year the following Director meetings were held.
Director
Dr Jason Loveridge
Prof Alexandra Sinclair
Dr Thomas Duthy
Mr David McAuliffe
Dr Megan Baldwin
Board Meetings
Number Eligible
to Attend Number Attended
8
8
8
8
8
8
7
8
8
8
ENVIRONMENTAL REGULATIONS
The Group is not subject to significant environmental regulation in respect of its research and development
activities.
UNISSUED SHARES UNDER OPTION
Unissued ordinary shares of Invex Therapeutics Ltd under option at the date of this report are as follows:
Date Options Granted
Expiry Date
Exercise Price
22 November 2019
22 November 2023
21 January 2020
9 April 2020
20 October 2020
21 January 2023
9 April 2023
20 October 2023
18 November 2020
18 November 2023
8 April 2021
Total
8 April 2024
$0.60
$1.00
$0.60
$1.30
$1.30
$1.10
Number Under
Option
2,200,000
750,000
60,000
400,000
800,000
400,000
4,610,000
11
ANNUAL REPORT 2022DIRECTORS’ REPORT (CONT.) INSURANCE OF OFFICERS AND INDEMNITIES
Invex paid a premium to insure the directors and secretary of the Group.
The liabilities insured are legal costs that may be incurred in defending civil or criminal proceedings that
may be brought against the officers in their capacity as officers of entities in the Group, and any other
payments arising from liabilities incurred by the officers in connection with such proceedings. This does
not include such liabilities that arise from conduct involving a wilful breach of duty by the officers or the
improper use by the officers of their position or of information to gain advantage for them or someone else
or to cause detriment to the Group. It is not possible to apportion the premium between amounts relating
to the insurance against legal costs and those relating to other liabilities.
PROCEEDINGS ON BEHALF OF THE GROUP
No person has applied to the Court under section 237 of the Corporations Act 2001 for leave to bring
proceedings on behalf of the Group, or to intervene in any proceedings to which the Group is a party, for
the purpose of taking responsibility on behalf of the Group for all or part of those proceedings.
No proceedings have been brought or intervened in on behalf of the Group with leave of the Court under
section 237 of the Corporations Act 2001.
NON-AUDIT SERVICES
The Group may decide to employ its auditor on assignments additional to their statutory audit duties where
the auditor’s expertise and experience with the Group is important.
During the year, other services were performed in addition to their statutory duties. The details of the
amount paid are disclosed in Note 20 of the consolidated financial report.
AUDITOR’S INDEPENDENCE DECLARATION
A copy of the auditors’ independence declaration as required under section 307C of the Corporations
Act 2001 is set out on the page following this Directors’ Report.
ADDITIONAL INFORMATION
The earnings of the consolidated entity to 30 June 2022 are summarised below:
Sales revenue
EBITDA
EBIT
Loss after income tax
2022
$
—
2021
$
—
(3,950,183)
(2,282,320)
(3,950,183)
(3,950,183)
(2,282,320)
(2,282,320)
REMUNERATION REPORT - AUDITED
The remuneration report outlines the remuneration arrangements which were in place during the year and
remain in place as at the date of this report, for the Directors and Key Management Personnel of the Group.
The information provided in this remuneration has been audited as required by section 308(3C) of the
Corporations Act 2001.
12
INVEX THERAPEUTICS LTD. DIRECTORS’ REPORT (CONT.) KEY MANAGEMENT PERSONNEL
Key Management Personnel are those persons who are responsible for directing and controlling the
activities of the Group. The Board has determined that the key management personnel of the Group are
the Non-executive Directors and Executives of Invex, whose details are set out below. The following Key
Management Personnel during the period unless otherwise stated:
Director
Date of appointment/resignation
Role
Dr Jason Loveridge
Appointed 8 March 2019
Prof Alexandra Sinclair
Appointed 28 June 2019
Appointed 1 October 2020
Non-executive Chair
Executive Director
Executive Director
Dr Thomas Duthy
Dr Megan Baldwin
David McAuliffe
Narelle Warren
Carol Parish
Appointed 16 February 2021
Non-executive Director
Appointed 8 March 2019
Appointed 8 March 2019
Appointed 1 July 2022
Non-executive Director
CFO & Company Secretary
Chief Operating Officer
REMUNERATION POLICIES
The Board has not elected to establish a remuneration committee. Given the size of the current Board
remuneration matters will be considered and approved by the full Board.
The following items will be considered and discussed as deemed necessary at the Board meetings:
• recommend the terms and conditions of employment for the Executive Directors and Senior Officers;
• undertake a review of the Executive Directors’ performance, at least annually, including setting with the
Executive Directors goals for the coming year and reviewing progress in achieving those goals;
• consider and report on the recommendations of the Executive Directors on the remuneration of all direct
reports; and
• develop and facilitate a process for Board and Director evaluation.
Non-executive Director’s remuneration
The compensation of Non-executive Directors is based on market practice, Director’s duties and the level of
accountability. The compensation policy is designed to attract and retain competent and suitably qualified
Non-executive Directors and aims to align Director’s interests with interests of shareholders. Non-executive
Directors fees are paid a set fee plus statutory superannuation where appropriate, and are reimbursed for
out-of-pocket expenses.
The Chair’s fees are determined independently to the fees of Non-executive Directors based on
comparative roles in the external market.
The base fees are reviewed annually and were last reviewed at a recent Board meeting. Non-executive
Directors’ fees are determined within an aggregate directors’ fee pool limit, which is periodically
recommended for approval by shareholders. The current limit stands at $400,000 per annum and was
approved by shareholders at its Annual General Meeting of shareholders in November 2021.
A Director may also be paid fees or other amounts as the Directors determine if a Director performs special
duties or otherwise performs services outside the scope of the ordinary duties of a Director.
Executive remuneration
In determining executive remuneration, the Board aims to ensure that remuneration practices are:
• competitive and reasonable, enabling the company to attract and retain key talent;
• aligned to the company’s strategic and business objectives and the creation of shareholder value;
• transparent; and
• acceptable to shareholders.
13
ANNUAL REPORT 2022DIRECTORS’ REPORT (CONT.) The executive remuneration framework has three components:
•
fixed annual compensation comprising salary or fees and benefits, including superannuation;
• short-term performance incentives; and
•
long-term incentives through participation in the Invex Employee Share Option Plan.
Fixed annual compensation
Executives receive their base salary/fees and benefits structured as a total employment cost (TEC) package
which may be delivered as a combination of cash and prescribed non-financial benefits at the executives’
discretion.
Executives are offered a competitive base pay that comprises the fixed component of pay and rewards.
Independent remuneration consultants provide analysis and advice to ensure base pay is set to reflect the
market for a comparable role.
Base pay for executives is reviewed annually to ensure the executive’s pay is competitive with the market.
An executive’s pay is also reviewed on promotion.
There are no guaranteed base pay increases included in any executives’ contracts.
There are no short-term incentives outstanding.
No benefits other than noted above are paid to Directors or management except as incurred in normal
operations of the business.
Short term incentives
No benefits other than remuneration disclosed in the remuneration report are paid to Directors or
management except as incurred in normal operations of the business.
Long term incentives
The Group’s current Employee Share Incentive Plan (ESIP) is designed to provide medium and long term
incentives for all employees (including Non-executive and Executive Directors) and to attract and retain
experienced Employees, Board Members and Executive Officers and provide motivation to make the Group
more successful.
As incentive securities granted to Directors and Employees are considered to represent the value of the
services received over the vesting period of the incentive security, the assessed value of the options are
recognised and expensed over the vesting period. Incentive securities vesting during the period of issue are
fully expensed under the accounting standards.
Other than incentive securities disclosed in the remuneration report there have been no options issued to
Directors at the date of this financial report.
Voting and comments made at the Company’s 2021 Annual General Meeting (AGM)
At the 2021 AGM, 96.8% of the votes received supported the adoption of the remuneration report for the
year ended 30 June 2021. The Company did not receive any specific feedback at the AGM regarding its
remuneration practices.
Remuneration consultants
The Group did not engage any remuneration consultants during the year.
The Group may engage independent remuneration consultants should it look to make any changes to
director fee levels to ensure they are in line with market conditions and any decisions are made free from
undue influence from members of the Group’s Key Management Personnel (KMP’s).
Service agreements
During the year the Company entered into revised agreements with Executives. Prof. Alexandra Sinclair
entered into an employment agreement on the 27 January 2022, commencing 1 March 2022. Dr Thomas
14
INVEX THERAPEUTICS LTD. DIRECTORS’ REPORT (CONT.) Duthy entered into a deed of variation with the Company effective 1 April 2022. The details of the key terms
of the revised agreements are set out below:
Name
Executive Directors
Term of
agreement
Prof Alexandra Sinclair Open
Remuneration
Termination benefit
£145,000
plus statutory
pension duties
Relevant notice periods apply, being
1 months’ notice with reason or
3 months without reason.
Dr Thomas Duthy –
appointed 1 October
2020
Open
$180,000
Relevant notice periods apply, being
1 months’ notice with reason or
3 months without reason.
The relative proportions of remuneration that are linked to performance and those that are fixed are as
follows:
Name
Executive Directors
Prof Alexandra Sinclair
Dr Thomas Duthy
Non-executive Directors
Fixed
remuneration
2022
Performance
based
remuneration (%)
2022
$315,373
$138,750
7.67
47.42
On appointment to the Board, all Non-executive Directors enter into a service agreement with the Company
in the form of a letter of appointment. The letter summarises the Board’s policies and terms, including
compensation, relevant to the director, and among other things:
• the terms of the directors appointment, including governance, compliance with the Company’s
Constitution, committee appointments, and re-election;
• the directors duties, including disclosure obligations, exercising powers, use of office, attendance at
meetings and commitment levels;
• the fees payable, in line with shareholder approval, any other terms, timing of payments and
entitlements to reimbursements;
•
insurance and indemnity;
• disclosure obligations; and
• confidentiality.
Dr Jason Loveridge entered into a new Consultancy Agreement effective 1 February 2022. The Non-
executive Director fees paid during the year:
Name
Non-Executive Directors
Dr Jason Loveridge –
Consultancy
Dr Jason Loveridge -
Non-executive
Chairman fee
Term of
agreement
Remuneration
Termination benefit
Open
£110,000
Relevant notice periods apply, being
3 months’ notice without reason.
Shareholder
Approval by rotation
$60,000
Nil
Dr Megan Baldwin -
Non-executive fee
Shareholder
Approval by rotation
$50,000
David McAuliffe -
Non-executive fee
Shareholder Approval
by rotation
$50,000
Nil
Nil
15
ANNUAL REPORT 2022DIRECTORS’ REPORT (CONT.) -
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17
ANNUAL REPORT 2022DIRECTORS’ REPORT (CONT.)
SHARE-BASED COMPENSATION
Incentive Securities
The Company’s current Employee Incentive Plan (ESIP) was approved by Shareholders on 25 November
2021 and the previous Employee Incentive Option Plan (ESOP) was approved by the Board of Directors
on 20 May 2019. The Incentive Plans are designed to provide medium and long term incentives for all
employees (including Non-executive and Executive Directors) and to attract and retain experienced
employees, board members and executive officers and provide motivation to make the Company more
successful.
Under the ESIP, participants have not yet been granted incentive securities. Incentive securities only vest
if certain milestones are met. Participation in the plan is at the Board’s discretion and no individual has a
contractual right to participate in the plan or to receive any guaranteed benefit.
Any option may only be exercised after the option has vested and other conditions imposed by the Board
have been satisfied. Options were granted under the ESOP for no consideration. Options granted under
the ESOP carry no dividend or voting rights. When exercisable, shares allotted pursuant to the exercise of
options will be allotted following receipt of relevant documentation and payments will rank equally with all
other shares.
As options granted to employees are considered to represent the value of the services received over
the vesting period of the options, the assessed value of the options is recognised and expensed over
the vesting period. Options vesting during the period of issue are fully expensed under the accounting
standards.
During the year 30 June 2022 no incentive securities were granted, no options were cancelled and no
options were forfeited.
Details of the share-based component issued during the year included in the remuneration are set out
below.
EQUITY INSTRUMENTS HELD BY KEY MANAGEMENT PERSONNEL
Shareholdings
The numbers of shares in the Company held during the year by each director or key management personnel
of Invex, including their personally related parties are set out below. There were no shares granted during
the reporting year as compensation.
2022
Name
Directors
Dr Jason Loveridge
Prof. Alexandra Sinclair
Dr Thomas Duthy
David McAuliffe
Dr Megan Baldwin
Narelle Warren
Total
Balance at
the start of
the year
3,374,426
2,500,000
106,923
3,350,001
—
200,000
9,531,350
Capital
Raising
shares
subscribed
for
On Market
Purchases/
On
appointment
Balance at
the end of
the year
Disposals
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
3,374,426
2,500,000
106,923
3,350,001
—
200,000
9,531,350
18
INVEX THERAPEUTICS LTD. DIRECTORS’ REPORT (CONT.) Option holdings
The number of options over ordinary shares in the Company held during the year by each director and KMP
of Invex Therapeutics Ltd, including their personally related parties, are set out below.
Balance at
the start of
the year
Granted as
compensation
Exercised/
Expired
Balance at
end of the
year
Vested and
exercisable Un-vested
Fair value
at grant
date
2022
Name
Directors and
KMP’s
Dr Jason
Loveridge
Prof Alexandra
Sinclair
Dr Thomas
Duthy
800,000
800,000
800,000
David McAuliffe
200,000
Dr Megan
Baldwin
400,000
Narelle Warren
400,000
Total
3,400,000
—
—
—
—
—
—
—
—
—
—
—
—
—
800,000
800,000
800,000
800,000
—
—
800,000
400,000 400,000
200,000
200,000
—
400,000
200,000 200,000
400,000
400,000
—
— 3,400,000 2,800,000 600,000
$0.42
$0.42
$0.32
$0.42
$0.33
$0.42
LOANS WITH KEY MANAGEMENT PERSONNEL
There were no loans to or from key management personnel during the year ended 30 June 2022.
OTHER TRANSACTIONS WITH KEY MANAGEMENT PERSONNEL
There were no other services provided with key management personnel which are not disclosed.
This is the end of the Remuneration Report.
Signed in accordance with a resolution of the Board of Directors.
David McAuliffe
Non-executive Director
Perth, Western Australia, 19 August 2022
19
ANNUAL REPORT 2022DIRECTORS’ REPORT (CONT.) AUDITORS’ INDEPENDENCE
DECLARATION
Tel: +61 8 6382 4600
Fax: +61 8 6382 4601
www.bdo.com.au
Level 9, Mia Yellagonga Tower 2
5 Spring Street
Perth WA 6000
PO Box 700 West Perth WA 6872
Australia
DECLARATION OF INDEPENDENCE BY JARRAD PRUE TO THE DIRECTORS OF INVEX THERAPEUTICS
LTD
As lead auditor of Invex Therapeutics Ltd for the year ended 30 June 2022, I declare that, to the best
of my knowledge and belief, there have been:
1. No contraventions of the auditor independence requirements of the Corporations Act 2001 in
relation to the audit; and
2. No contraventions of any applicable code of professional conduct in relation to the audit.
This declaration is in respect of Invex Therapeutics Ltd and the entity it controlled during the period.
Jarrad Prue
Director
BDO Audit (WA) Pty Ltd
Perth
19 August 2022
BDO Audit (WA) Pty Ltd ABN 79 112 284 787 is a member of a national association of independent entities which are all members of
BDO Australia Ltd ABN 77 050 110 275, an Australian company limited by guarantee. BDO Audit (WA) Pty Ltd and BDO Australia Ltd are
members of BDO International Ltd, a UK company limited by guarantee, and form part of the international BDO network of
independent member firms. Liability limited by a scheme approved under Professional Standards Legislation.
20
INVEX THERAPEUTICS LTD. CONSOLIDATED STATEMENT OF
PROFIT OR LOSS AND OTHER
COMPREHENSIVE INCOME
FOR THE YEAR ENDED 30 JUNE 2022
Other income
Research and development expenditure
Finance, compliance and administration expenses
Share-based payment expenses
Loss before income tax from continuing operations
Income tax expense/benefit
Note
2022
$
2021
$
4
5
5
17
6
262,132
158,785
(2,962,596)
(1,139,222)
(900,286)
(740,752)
(352,390)
(562,723)
(3,953,140)
(2,283,911)
—
—
Loss for the year from continuing operations
(3,953,140)
(2,283,911)
Other comprehensive income for the year, net of tax
Items that may be reclassified subsequently to profit or loss
Exchange differences on translation of foreign operations,
net of tax
Total other comprehensive income for the year, net of tax
attributable to members of the Group
Loss for the year is attributable to:
Owners of Invex Therapeutics Ltd
—
2,957
—
1,591
(3,950,183)
(2,282,320)
(3,950,183)
(2,282,320)
Total comprehensive income for the year is attributable to:
Owners of Invex Therapeutics Ltd
(3,950,183)
(2,282,320)
Loss per share (cents)
11
(5.26)
(3.04)
The above Consolidated Statement of Profit or Loss and Other Comprehensive Income should be read in
conjunction with the accompanying notes.
21
ANNUAL REPORT 2022 CONSOLIDATED STATEMENT OF
FINANCIAL POSITION
AS AT 30 JUNE 2022
ASSETS
Current Assets
Cash and cash equivalents
7
29,339,382
32,716,091
Note
2022
$
2021
$
Other receivables
Total Current Assets
TOTAL ASSETS
LIABILITIES
Current Liabilities
Trade and other payables
Total Current Liabilities
TOTAL LIABILITIES
NET ASSETS
EQUITY
Contributed equity
Reserves
Accumulated losses
TOTAL EQUITY
145,715
21,199
29,485,097
32,737,290
29,485,097
32,737,290
8
1,004,214
1,004,214
1,004,214
658,614
658,614
658,614
28,480,883
32,078,676
9
10
11
36,413,432
36,413,432
1,896,903
1,541,556
(9,829,452)
(5,876,312)
28,480,883
32,078,676
The above Consolidated Statement of Financial Position should be read in conjunction with the
accompanying notes.
22
INVEX THERAPEUTICS LTD. CONSOLIDATED STATEMENT OF
CHANGES IN EQUITY
FOR THE YEAR ENDED 30 JUNE 2022
Contributed
Equity
$
Accumulated
Losses
$
Reserves
Total
Equity
$
Balance as at 1 July 2021
36,413,432
(5,876,312)
1,541,556
32,078,676
(Loss) for the year
Other comprehensive income for the year
Fx reserve movement
Total comprehensive (loss) for the year
Share-based payment reserve movement
Transactions with owners in their capacity as
owners:
Issue of share capital, net of transaction costs
—
—
—
—
—
—
(3,953,140)
—
—
(3,953,140)
—
—
—
—
—
2,957
2,957
(3,953,140)
—
2,957
(3,950,183)
352,390
352,390
—
—
—
—
Balance as at 30 June 2022
36,413,432
(9,829,452)
1,896,903
28,480,883
Contributed
Equity
$
Accumulated
Losses
$
Reserves
Total
Equity
$
Balance as at 1 July 2020
27,017,127
(3,592,401)
977,242
24,401,968
(Loss) for the year
Other comprehensive income for the year
Fx reserve movement
Total comprehensive (loss) for the year
Share-based payment reserve movement
Transactions with owners in their capacity as
owners:
—
—
—
—
—
—
Issue of share capital, net of transaction costs
9,396,305
(2,283,911)
—
—
—
—
1,591
(2,283,911)
—
1,591
(2,283,911)
1,591
(2,282,320)
—
—
—
562,723
562,723
—
—
—
9,396,305
Balance as at 30 June 2021
36,413,432
(5,876,312)
1,541,556
32,078,676
The above Consolidated Statement of Changes in Equity should be read in conjunction with the
accompanying notes.
23
ANNUAL REPORT 2022 CONSOLIDATED STATEMENT OF
CASH FLOWS
FOR THE YEAR ENDED 30 JUNE 2022
CASH FLOWS FROM OPERATING ACTIVITIES
Payments to suppliers and employees
R&D Tax rebate
Interest received
Net cash outflow from operating activities
CASH FLOWS FROM FINANCING ACTIVITIES
Subscription proceeds received for ordinary shares
Placement capital raising costs
Net cash inflow from financing activities
Note
2022
$
2021
$
(3,638,841)
(1,837,030)
182,251
79,881
—
158,785
(3,376,709)
(1,678,245)
—
—
—
8,647,547
(553,670)
8,093,877
Net increase/(decrease) in cash and cash equivalents held
Cash and cash equivalents at the beginning of the year
(3,376,709)
6,415,632
32,716,091
26,300,459
Cash and cash equivalents at end of financial year
7
29,339,382
32,716,091
The above Consolidated Statement of Cash Flows should be read in conjunction with accompanying the
notes.
24
INVEX THERAPEUTICS LTD. 1. BASIS OF PREPARATION
The financial report is a general purpose financial report that has been prepared in accordance
with Australian Accounting Standards, Australian Accounting Interpretations, other authoritative
pronouncements of the Australian Accounting Standards Board and the Corporations Act 2001.
Invex Therapeutics Ltd is a listed public company, incorporated and domiciled in Australia and is the parent
entity. Invex Therapeutics Ltd is a for-profit entity for the purpose of preparing the financial statements.
These consolidated financial statements comprise the Company and its controlled entity at the end of,
or during the year (together referred to as ‘the Group’) and were authorised for issue by the Board of
Directors.
Australian Accounting Standards set out accounting policies that the AASB has concluded would result in
a financial report containing relevant and reliable information about transactions, events and conditions.
Compliance with Australian Accounting Standards ensures that the financial statements and notes also
comply with International Financial Reporting Standards as issued by the IASB. Material accounting policies
adopted in the preparation of this financial report are presented below and have been consistently applied
unless otherwise stated.
The financial report has been prepared on an accruals basis and is based on historical costs, modified,
where applicable, by the measurement at fair value of selected non-current assets, financial assets and
financial liabilities.
2. NEW AND AMENDED ACCOUNTING STANDARDS AND INTERPRETATIONS
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.
3. SUMMARY OF ACCOUNTING POLICIES
The following material accounting policies adopted by the Group in the preparation of the financial report,
have been consistently applied unless otherwise stated.
(a) Parent entity information
In accordance with the Corporations Act 2001, these financial statements present the results of the
consolidated entity only. Supplementary information about the parent entity is disclosed in note 19.
(b) Principles of consolidation
The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Invex
Therapeutics Ltd (Company or Invex) as at 30 June 2022 and the results of all subsidiaries for the year then
ended. Invex Therapeutics Ltd and its subsidiary together are referred to in these financial statements as
the 'consolidated entity’.
Subsidiaries are all those entities over which the consolidated entity has control. The consolidated entity
controls an entity when the consolidated entity is exposed to, or has rights to, variable returns from its
involvement with the entity and has the ability to affect those returns through its power to direct the
activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to
the consolidated entity. They are de-consolidated from the date that control ceases.
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.
25
ANNUAL REPORT 2022NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (c) Foreign currency translation
The financial statements are presented in Australian dollars, which is Invex's functional and presentation
currency.
Foreign currency transactions
Foreign currency transactions are translated into Australian dollars using the exchange rates prevailing
at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such
transactions and from the translation at financial year-end exchange rates of monetary assets and liabilities
denominated in foreign currencies are recognised in profit or loss.
Foreign operations
The assets and liabilities of foreign operations are translated into Australian dollars using the exchange rates
at the reporting date. The revenues and expenses of foreign operations are translated into Australian dollars
using the average exchange rates, which approximate the rates at the dates of the transactions, for the
period. All resulting foreign exchange differences are recognised in other comprehensive income through
the foreign currency reserve in equity.
The foreign currency reserve is recognised in profit or loss when the foreign operation or net investment is
disposed of.
(d) Operating segments
Operating segments are presented using the 'management approach', where the information presented is
on the same basis as the internal reports provided to the Chief Operating Decision Makers ('CODM'). The
CODM is responsible for the allocation of resources to operating segments and assessing their performance.
(e) Revenue recognition
Revenue is recognised when or as the Group transfers control of goods or services to a customer at the
amount at which the Group expects to be entitled. The following specific recognition criteria must also be
met before revenue is recognised:
Interest income
Revenue is recognised as the interest accrues (using the effective interest method), which is the rate that
exactly discounts estimated future cash receipts through the expected life of the financial instrument to the
net carrying amount of the financial asset.
(f) Loans and Receivables
Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not
quoted in an active market and are stated at amortised cost using the effective interest rate method.
At each reporting date, the Group assesses whether there is objective evidence that a financial instrument
has been impaired.
(g) Cash and Cash Equivalents
Cash and short-term deposits in the Statement of Financial Position comprise cash at bank and on hand
and short-term deposits.
(h) Right-of-use asset
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.
26
INVEX THERAPEUTICS LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 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.
(i) Lease liability
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.
(j) Goods and Services Tax (GST)
Revenues, expenses and assets are recognised net of the amount of GST, except where the amount of GST
incurred is not recoverable from the Tax Office. In these circumstances the GST is recognised as part of
the cost of acquisition of the asset or as part of an item of the expense. Receivables and payables in the
statement of financial position are shown inclusive of GST.
Cash flows are presented in the statement of cash flows on a gross basis, except for the GST components of
investing and financing activities, which are disclosed as operating cash flows.
(k) Trade and Other Receivables
Trade receivables, which generally have 30-90 day terms, are recognised and initially at fair value and
subsequently measured at amortised cost using the effective interest rate method, less loss allowance.
The Group applies the AASB 9 simplified approach to measure expected credit losses which uses lifetime
expected loss allowance for trade receivables. Bad debts are written off when identified.
(l) Trade and other Payables
Trade and other payables represent liabilities for goods and services provided to the Group prior to the
period end and which are unpaid. These amounts are unsecured, have 30-60 day payment terms and are
measured at amortised cost.
(m) Share-based payments
Equity-settled and cash-settled share-based compensation benefits are provided to employees.
Equity-settled transactions are awards of shares, or options over shares, that are provided to employees in
exchange for the rendering of services. Cash-settled transactions are awards of cash for the exchange of
services, where the amount of cash is determined by reference to the share price.
The cost of equity-settled transactions are measured at fair value on grant date. Fair value is independently
determined using either the Binomial or Black-Scholes option pricing model that takes into account the
exercise price, the term of the option, the impact of dilution, the share price at grant date and expected
price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the
term of the option, together with non-vesting conditions that do not determine whether the consolidated
entity receives the services that entitle the employees to receive payment. No account is taken of any other
vesting conditions.
27
ANNUAL REPORT 2022NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) The cost of equity-settled transactions are recognised as an expense with a corresponding increase in
equity over the vesting period. The cumulative charge to profit or loss is calculated based on the grant date
fair value of the award, the best estimate of the number of awards that are likely to vest and the expired
portion of the vesting period. The amount recognised in profit or loss for the period is the cumulative
amount calculated at each reporting date less amounts already recognised in previous periods.
The cost of cash-settled transactions is initially, and at each reporting date until vested, determined by
applying either the Binomial or Black-Scholes option pricing model, taking into consideration the terms and
conditions on which the award was granted. The cumulative charge to profit or loss until settlement of the
liability is calculated as follows:
• during the vesting period, the liability at each reporting date is the fair value of the award at that date
multiplied by the expired portion of the vesting period.
•
from the end of the vesting period until settlement of the award, the liability is the full fair value of the
liability at the reporting date.
All changes in the liability are recognised in profit or loss. The ultimate cost of cash-settled transactions is
the cash paid to settle the liability.
(n) Equity, reserves and dividend payments
Share capital represents the fair value of shares that have been issued. Any transaction costs associated
with the issuing of shares are deducted from share capital, net of any related income tax benefits.
Dividend distributions payable to equity shareholders are included in other liabilities when the dividends
have been approved in a General Meeting prior to the reporting date.
All transactions with owners of the parent are recorded separately within equity.
(o) Research and Development
Research expenditure is recognised as an expense is incurred.
Costs incurred on developments projects (relating to the development and testing of new or improved
products) are recognised as intangible assets when it is probable that the project will, after considering
its commercial and technical feasibility, be completed and generate future economic benefits and its costs
can be measured reliably. The expenditure capitalized comprises all directly attributable costs, including
costs of materials, services, direct labour and an appropriate proportion of overheads. Other development
expenditures that do not meet these criteria are recognized as an expense as incurred. Development costs
previously recognised as an expense are not recognized as an asset in a subsequent period. Capitalised
development costs are recorded as intangible assets and amortised from the point at which the asset is
ready for use.
(p) Income Tax
Tax expense recognised in profit or loss comprises the sum of deferred tax and current tax not recognised
in other comprehensive income or directly in equity.
Current income tax assets and/or liabilities comprise those obligations to, or claims from, the Australian
Taxation Office (ATO) and other fiscal authorities relating to the current or prior reporting periods that are
unpaid at the reporting date. Current tax is payable on taxable profit, which differs from profit or loss in the
financial statements. Calculation of current tax is based on tax rates and tax laws that have been enacted or
substantively enacted by the end of the reporting period.
Deferred income taxes are calculated using the full liability method on temporary differences between
the carrying amounts of assets and liabilities and their tax bases. However, deferred tax is not provided
on the initial recognition of goodwill or on the initial recognition of an asset or liability unless the related
transaction is a business combination or affects tax or accounting profit. Deferred tax on temporary
differences associated with investments in subsidiaries and joint ventures is not provided if reversal of these
temporary differences can be controlled by the Group and it is probable that reversal will not occur in the
foreseeable future.
28
INVEX THERAPEUTICS LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) Deferred tax assets and liabilities are calculated, without discounting, at tax rates that are expected to
apply to their respective period of realisation, provided they are enacted or substantively enacted by the
end of the reporting period.
Deferred tax assets are recognised to the extent that it is probable that they will be able to be utilised
against future taxable income, based on the Group’s forecast of future operating results which is adjusted
for significant non-taxable income and expenses and specific limits to the use of any unused tax loss or
credit. Deferred tax liabilities are always provided for in full.
Deferred tax assets and liabilities are offset only when the Group has a right and intention to set off current
tax assets and liabilities from the same taxation authority.
Changes in deferred tax assets or liabilities are recognised as a component of tax income or expense in
profit or loss, except where they relate to items that are recognised in other comprehensive income (such
as the revaluation of land) or directly in equity, in which case the related deferred tax is also recognised in
other comprehensive income or equity, respectively.
(q) Impairment of assets
Non-financial assets
At the end of each reporting period, non-financial assets are reviewed for impairment whenever events or
changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is
recognised for the amount by which the asset’s carrying amount exceeds its recoverable amount.
Recoverable amount is the higher of an asset’s fair value less costs of disposal and value-in-use. The value-
in-use is the present value of the estimated future cash flows relating to the asset using a pre-tax discount
rate specific to the asset or cash-generating unit to which the asset belongs. Assets that do not have
independent cash flows are grouped together to form a cash-generating unit.
Financial assets
At the end of each reporting period, the Group assesses whether there is objective evidence that a financial
asset has been impaired. For financial assets measured at fair value, gains or losses will be recorded in profit
or loss, or through Other Comprehensive Income (FVTOCI) if the Group has made an irrevocable election at
the time of initial recognition to account for equity instruments through OCI.
(r) Critical Accounting Estimates and Judgments Required
The directors evaluate estimates and judgments incorporated into the financial report based on historical
knowledge and best available current information. Estimates assume a reasonable expectation of future
events and are based on current trends and economic data, obtained both externally and within the Group.
Coronavirus (COVID-19) pandemic
Judgement has been exercised in considering the impacts that the Coronavirus (COVID-19) pandemic has
had, or may have, on the consolidated entity based on known information. This consideration extends to
the nature of the products and services offered, customers, supply chain, staffing and geographic regions in
which the consolidated entity operates. Other than as addressed in specific notes, there does not currently
appear to be either any significant impact upon the financial statements or any significant uncertainties
with respect to events or conditions which may impact the consolidated entity unfavourably as at the
reporting date or subsequently as a result of the Coronavirus (COVID-19) pandemic.
Research and development expenditure
Distinguishing the research and development phases of a new customized project and determining whether
the recognition requirements for the capitalization of development costs are met requires judgement. The
Group has expensed all costs relating to research and development expenditure to date on the basis that
the capitalisation requirements have not been met.
The Group’s consideration of whether its internal projects to develop drugs are in a research phase or
development phase involves significant judgement.
29
ANNUAL REPORT 2022NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) The Group considers a project to be in a development phase when the following can be demonstrated:
• The technical feasibility of completing the intangible asset so that it will be available for use or sale;
• There is intention to complete the project;
• The existence of a market to be able to sell output resulting from the project;
• How the intangible asset will generate probable future economic benefits;
• There is adequate technical, financial and other resources available to complete the development and to
use or sell the intangible asset; and
• Expenditure attributable to the project can be reliably measured.
Share-based payment transactions
The Group measures the cost of equity-settled transactions by reference to the fair value of the equity
instruments at the date at which they are granted. The fair value is determined using a Black-Scholes model.
30
INVEX THERAPEUTICS LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 4. OTHER INCOME
R&D Tax rebate
Interest income
2022
$
182,251
79,881
262,132
2021
$
—
158,785
158,785
5. LOSS FOR THE YEAR
The loss for the year before income tax includes the following specific expenses:
(a) Research and development expenses
Manufacturing expenses
Reformulation
Phase II Clinical Trial
Phase III Clinical Trial
Employee costs
Regulatory advice
Consultants
Scientific Advisory Board/Committees
CSO - Executive director fees
Patent expenses
Total
(b) Administration expenses
Accounting and company secretarial fees
ASX, ASIC and bank fees
Executive Director’s fees
Non-executive Director’s fees
Legal fees
Rent and office expenses
Audit, corporate advice and tax fees
Travel and entertainment
Insurance
Investor relations and PR expenses
Share registry and shareholder meetings
Other general expenses
Unrealised fx gain
Website and IT expenses
Total
2022
$
2021
$
326,498
—
—
762,449
509,892
189,548
714,836
1,094
315,373
142,907
—
106,828
15,779
106,073
395,097
—
247,908
2,652
150,000
114,886
2,962,596
1,139,222
131,759
69,597
138,750
160,000
109,240
20,980
68,100
30,891
92,004
51,116
20,122
13,703
(26,408)
20,432
900,286
131,703
89,462
93,750
128,750
25,896
31,626
63,025
(11,430)
68,575
55,152
30,785
22,202
—
11,256
740,752
31
ANNUAL REPORT 2022NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 6. INCOME TAX
(a) The components of tax expense comprise:
Current tax
Deferred tax expense
Total income tax expense from continuing operations
Deferred income tax expense included in income tax expense
comprises:
Decrease/(increase) in deferred tax assets
Decrease/(increase) in deferred tax liabilities
(b) The prima facie tax on profit from ordinary activities before
income tax is reconciliation of income tax expense to prima
facie tax payable:
2022
$
2021
$
—
—
—
—
—
—
—
—
—
—
Loss before income tax
(3,953,140)
(2,283,911)
Prima facie tax benefit on loss from ordinary activities before
income tax at 30% (2021: 30%)
(1,185,942)
(685,173)
Tax effect of:
– share-based payments
– intellectual property costs
– entertainment
– other
– tax differential rate
Tax losses and temporary differences not recognised
Income tax expense/(benefit)
The applicable weighted average effective tax rate are as
follows:
(c) Amounts recognised directly in equity
Aggregate current and deferred tax arising in the reporting
period and not recognised in net loss or other comprehensive
income but directly debited or credited to equity.
Current tax
Net deferred tax
32
105,717
42,872
587
—
232,932
804,374
—
0%
168,187
34,446
422
127
77,448
403,894
—
0%
—
166,109
INVEX THERAPEUTICS LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) (d) Deferred tax assets
Patents
Accruals
Business related costs
Australian tax losses
Unrealised fx losses
Foreign tax losses
Capital raising costs in equity
7. CASH AND CASH EQUIVALENTS
Cash at bank and on hand
8. TRADE AND OTHER PAYABLES
Trade payables
Accruals and other payables
2022
$
34,576
7,500
28,112
1,748,686
(7,922)
207,379
264,422
2,282,753
2021
$
29,801
7,200
37,413
1,175,857
4,734
211,221
408,202
1,874,427
2022
$
29,339,382
29,339,382
2021
$
32,716,091
32,716,091
2022
$
138,778
865,436
1,004,214
2021
$
11,333
647,281
658,614
Trade payables are non-interest bearing and are normally settled on 30-day terms.
9. CONTRIBUTED EQUITY
2022
$
2022
Number
of shares
2021
$
2021
Number
of shares
Ordinary shares on issue – fully paid
36,413,432
75,153,848
36,413,432
75,153,848
36,413,432
75,153,848
36,413,432
75,153,848
Holders of ordinary shares are entitled to receive dividends as declared from time to time and are entitled
to one vote per share at shareholders meetings. In the event of winding up of the Company ordinary
shareholders rank after creditors and are fully entitled to any proceeds of liquidation in proportion to the
number and amount paid on the shares held.
Movement in fully paid ordinary
shares on issue
Balance at beginning of financial
period
Placement (May 20 and July 20)
Cost of capital raising
2022
$
2022
Number
of shares
2021
$
2021
Number
of shares
36,413,432
75,153,848
27,017,127
67,500,001
—
—
—
—
9,949,975
7,653,847
(553,670)
—
Balance at end of financial year
36,413,432
75,153,848
36,413,432
75,153,848
33
ANNUAL REPORT 2022NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 10. RESERVES
Share-based payment reserve
Foreign currency translation reserve
Nature and Purpose of Reserve
2022
$
2021
$
1,898,630
1,546,240
(1,727)
(4,684)
1,896,903
1,541,556
The share-based payment reserve records the value of options, performance rights and performance shares
issued to the Group’s directors, employees, and third parties. The value of the amount disclosed during the
period reflects the value of options, performance rights and performance shares issued by the Group.
The Foreign currency translation reserve records exchange differences arising on translation of foreign
controlled entities.
Options outstanding at 30 June 2022
The following options over ordinary shares of the Company were granted at reporting date:
Grant Date
Expiry Date
Exercise
Price
Balance
at start of
year
Granted
during
the year
Exercised
during the
year
Forfeited
during the
year
Balance at
year end
Vested and
exercisable
at year end
22 Nov 2019 22 Nov 2023
$0.60 2,200,000
21 Jan 2020 21 Jan 2023
$1.00 750,000
9 April 2020 9 April 2023
$0.60
60,000
20 Oct 2020 20 Oct 2023
$1.30 400,000
18 Nov 2020 18 Nov 2023
$1.30 800,000
8 April 2021 8 April 2024
$1.10 400,000
4,610,000
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Reconciliation of movement in Share-based payment reserve:
Opening Balance - 1 July 2021
— 2,200,000 2,200,000
— 750,000
750,000
—
60,000
60,000
— 400,000
200,000
— 800,000
400,000
— 400,000
200,000
— 4,610,000
3,810,000
Number of
Options
Value
$
1,546,240
Share-based payment expense in respect to Director options on issue at
30 June 2022
2,200,000
72,032
Share-based payment expense in respect to employee options on issue at
30 June 2022
Share-based payment expense in respect to employee options on issue at
30 June 2022
Share-based payment expense in respect to Director options on issue at
30 June 2022
Share-based payment expense in respect to Director options on issue at
30 June 2022
Closing Balance – 30 June 2022
60,000
6,214
400,000
64,681
800,000
125,114
400,000
84,169
4,610,000
1,898,630
34
INVEX THERAPEUTICS LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 11. LOSS PER SHARE
Basic and Diluted (Loss) per Share – cents
Total basic and diluted loss per share – cents
2022
$
(5.26)
2021
$
(3.04)
Basic and diluted loss per share is calculated by dividing the loss for the year attributable to ordinary equity
holders of the parent by the weighted average number of ordinary shares outstanding during the year.
The following table reflects the loss and share data used in the basic and diluted loss per share:
Net loss attributable to members of the Group
(3,953,140)
(2,283,911)
Earnings used in calculating basic and diluted earnings per share
from continuing operations
(3,953,140)
(2,283,911)
2022
$
2021
$
2022
Number of
shares
2021
Number of
shares
Weighted average number of Ordinary Shares used in calculating
basic and diluted earnings per share
75,153,848
75,132,821
Dilutive Potential Ordinary Shares
As at balance date, there were no dilutive options on issue.
Conversions, Calls, Subscriptions or Issues after 30 June 2022
Subsequent to year end there have not been any conversions, calls, subscriptions or issues of securities.
12. ACCUMULATED LOSSES
Accumulated losses at the beginning of the financial period
Net loss attributable to members of the Group
Accumulated losses at the end of the financial year
2022
$
2021
$
(5,876,312)
(3,953,140)
(3,592,401)
(2,283,911)
(9,829,452)
(5,876,312)
35
ANNUAL REPORT 2022NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 13. RECONCILIATION OF NET CASH FLOWS OPERATING ACTIVITIES TO
OPERATING (LOSS) AFTER TAX
2022
$
2021
$
(3,953,140)
(2,283,911)
352,390
2,957
562,723
1,591
(124,517)
345,601
95,682
(54,330)
(3,376,709)
(1,678,245)
Loss (after income tax) for the year
Non-cash items included in profit or loss:
Share-based payment expenses
Unrealised fx reserve movements
Net changes in working capital:
Decrease/(increase) in trade and other receivables
Increase/(decrease) in trade and other payables
Net cash used in operating activities
Non-cash investing and financing activities disclosed in other notes are:
Share-based payment expense (refer Note 17).
FX reserve movements (refer Note 10).
14. FINANCIAL RISK MANAGEMENT
The Group’s principal financial instruments comprise cash, short-term deposits and trade payables.
The Group does not have any derivative instruments at 30 June 2022 and does not speculate in any
financial instruments.
Financial Risks
The activities of the Group expose it primarily to the financial risks of interest rate risk, liquidity risk, foreign
exchange risk and credit risk. The Board of Directors is responsible for monitoring and managing the
financial risks of the Group. The Company Secretary/CFO monitors these risks by the review and analysis of
monthly management accounts and other financial data.
Interest Rate Risk
The Group’s main interest rate risk arises from cash held on deposit by Australian Financial Institutions.
Cash held in term deposits is subject to prevailing variable interest rates and expose the Group to cash flow
interest rate risk.
The following table summarises interest rate risk for the Group.
2022
Interest-bearing financial instruments
Cash and cash equivalents
Fixed Interest
Rate Maturing
Floating
Interest
Rate
$
1 Year or
Less
$
1 to 5 Years
$
Non-
Interest
Bearing
$
Total
$
29,339,382
29,339,382
—
—
—
—
— 29, 339,382
— 29,339,382
36
INVEX THERAPEUTICS LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 2021
Interest-bearing financial instruments
Cash and cash equivalents
Fixed Interest
Rate Maturing
Floating
Interest
Rate
$
1 Year or
Less
$
1 to 5 Years
$
Non-
Interest
Bearing
$
Total
$
32,716,091
32,716,091
—
—
—
—
—
32,716,091
— 32,716,091
The Group does not rely on the generation of interest on cash at bank to provide working capital and does
not consider the exposure to be material to the Group and have therefore not undertaken any further
analysis of exposure.
Liquidity Risk
Liquidity risk is the risk that the Group will not be able to meet its financial obligations as they fall due. The
Board of Directors manage liquidity risk by continually monitoring cash reserves and cashflow forecasts to
ensure that financial commitments can be met as and when they fall due.
The Group’s objective is to maintain a balance between continuity of funding and flexibility through the use
of equity funding.
The following table details the expected contractual maturity for its non-derivative financial liabilities.
2022
Financial liabilities due
Trade and other payables
2021
Financial liabilities due
Trade and other payables
Credit Risk Exposure
Total
$
1 year or
less
$
1 – 5 years
$
5+ years
$
138,778
138,778
138,778
138,778
—
—
—
—
Total
$
11,333
11,333
1 year or
less
$
11,333
11,333
1 – 5 years
$
5+ years
$
—
—
—
—
Credit risk is the risk of financial loss to the Group if a customer or counterparty to a financial instrument
fails to meet its contractual obligations and arises principally from the Group’s cash at bank. The carrying
amount of the financial assets on the Statement of Financial Position represents the maximum credit
exposure.
All cash and cash equivalents are held with large reputable financial institutions within Australia and
therefore credit risk is considered minimal.
Cash and cash equivalents:
AA rated
2022
$
2021
$
29,339,382
32,716,091
37
ANNUAL REPORT 2022NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) Foreign currency risk
The consolidated entity undertakes certain transactions denominated in foreign currency and is exposed to
foreign currency risk through foreign exchange rate fluctuations.
Foreign exchange risk arises from future commercial transactions and recognised financial assets and
financial liabilities denominated in a currency that is not the entity’s functional currency. The risk is
measured using sensitivity analysis and cash flow forecasting.
15. RELATED PARTY TRANSACTIONS
Key Management Personnel
There were no key management personnel, other than the directors and the CFO/Company Secretary,
during the year ended 30 June 2022.
The names of each person holding the position of director of the Company during the financial year are set
out below:
• Dr Jason Loveridge
• Prof. Alexandra Sinclair
• Dr Thomas Duthy
• Dr Megan Baldwin
• Mr David McAuliffe
• Ms Narelle Warren
Transactions with key management personnel
(i) Total key management personnel remuneration is as follows:
Short Term Benefits
Other non-cash Benefits
Post-Employment Benefits
Share-based payments
2022
$
2021
$
966,468
590,873
—
467
—
1,626
281,315
508,922
1,248,250
1,101,421
(ii) Nil loans were payable to or receivable from KMPs during or at the end of the financial year.
Unless otherwise stated, none of the transactions incorporate special terms and conditions and no
guarantees were given or received.
16. INTERESTS IN SUBSIDIARY
The consolidated financial statements incorporate the assets, liabilities and results of the following wholly-
owned subsidiary in accordance with the accounting policy described in note 3:
Name
Principal place of business /
Country of incorporation
Invex Therapeutics Ltd
United Kingdom
Ownership interest
2022
%
100
2021
%
100
38
INVEX THERAPEUTICS LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 17. SHARE-BASED PAYMENTS
Share-based payments made during the year ended 30 June 2022 are summarised below.
Recognised Share-based payment expense
Options granted to Directors as incentive
Options granted to Advisers as incentive
Options granted to Employees as incentive
2022
$
2021
$
281,315
508,922
—
(32,228)
71,075
86,029
352,390
562,723
Options granted to Directors and Employees for services
The Group’s current Employee Share Option Plan (ESIP) was approved by Shareholders on 25 November
2021. The previous Employee Share Option Plan (ESOP) was approved by the Board of Directors on
20 May 2019 (Incentive Plans). The Incentive Plans are designed to provide medium and long term
incentives for all employees (including Non-executive and Executive Directors) and to attract and retain
experienced Employees, Board Members and Executive Officers and provide motivation to make the Group
more successful.
Under the previous ESOP, participants have been granted options which only vest if certain milestones
are met. Participation in the plan is at the board’s discretion and no individual has a contractual right to
participate in the plan or to receive any guaranteed benefit.
Any option may only be exercised after the option has vested and other conditions imposed by the board
have been satisfied. Options are granted under the ESOP for no consideration. Options granted under the
ESOP carry no dividend or voting rights. When exercisable, shares allotted pursuant to the exercise of
options will be allotted following receipt of relevant documentation and payments will rank equally with all
other shares.
As options granted to employees and directors are considered to represent the value of the services
received over the vesting period of the options, the assessed value of the options are recognised and
expensed over the vesting period. Options vesting during the year of issue are fully expensed under the
accounting standards. There were no new incentive securities granted during the financial year. The total
Directors and Employee Options expense for the period is outlined below.
Valuation
Tranche
Date Expiry Date
Exercise
Price
Balance at
start of year
Granted
during the
year
Vested at
year end
22 Nov 2019 22 Nov 2023
$0.60
2,200,000
— 2,200,000
9 April 2020 9 April 2023
$0.60
60,000
20 Oct 2020 20 Oct 2023
18 Nov 2020 18 Nov 2023
8 April 2021 8 April 2024
$1.30
$1.30
$1.10
400,000
800,000
400,000
—
—
—
—
60,000
200,000
400,000
200,000
1
3
4
5
6
Total
Total
Share-based
payment
expense for
the year $
72,032
6,214
64,681
125,114
84,169
3,860,000
— 3,060,000
352,210
39
ANNUAL REPORT 2022NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) Appropriate values for the options using the Black Scholes Model applying the following inputs.
Tranche
Exercise price
Expected volatility
Expiry date (years)
Expected dividends
Risk free rate
Value per option
1
3
$0.60
$0.60
75%
4.00
Nil
0.77%
$0.42
75%
3.00
Nil
0.77%
$0.55
4
$1.30
80%
3.00
Nil
0.77%
$0.35
5
$1.30
80%
3.00
Nil
0.87%
$0.32
6
$1.10
80%
3.00
Nil
0.77%
$0.33
The vesting conditions attached to the Tranche 1, 3, 4, 5 and 6 Director and Employee Options are as
follows:
• 50% of the Options will vest and become exercisable upon completion of 12 months continuous service
from date of issue; and
• 50% of the Options vest and become exercisable upon completion of 24 months continuous service
from date of issue.
The weighted average remaining contractual life of options outstanding at the end of the year was 1.04
years.
18. MATTERS SUBSEQUENT TO END OF FINANCIAL YEAR
On 1 July 2022, Carol Parish was appointed Chief Operating Officer (COO) at the Group. Until 30 June 2022,
Carol held the role as Head of Clinical Operations. Carol has been a pharmaceutical professional for over
33 years within the Pharmaceutical/Biotech industry, where she has been accountable for all Phases of
drug development in multiple therapy areas. Prior to joining Invex, Carol was the Global Clinical Operations
Lead at Intercept Pharmaceuticals (NASDAQ: ICPT) and has held various senior clinical positions at Stiefel
Laboratories (acquired by GlaxoSmithKline in 2009) including Senior Director, Global Clinical Development
for a new drug product, including collaborating with GSK Japan and China. Additionally, Carol spent over
20 years at Merck & Co (NYSE:MRK) and Johnson & Johnson (NYSE:JNJ).
Other than as disclosed above, no matters or events have arisen since the end of the financial period
which significantly affected or may significantly affect the operations of the company, the results of those
operations or the state of affairs of the company in subsequent financial periods.
40
INVEX THERAPEUTICS LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 19. 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 income
Statement of financial position
Total current assets
Total non-current assets
Total current liabilities
Total liabilities
Equity
Issued capital
Reserves
Accumulated losses
Total equity
20. AUDITOR’S REMUNERATION
Amounts paid or payable to BDO for:
Audit services
– an audit or review of the financial report of the entity
Total audit services
Corporate advisory services
Taxation services
Total other services
Parent
2022
$
2021
$
(4,692,091)
(1,579,841)
(4,692,091)
(1,579,841)
Parent
2022
$
2021
$
29,225,668
32,667,047
—
901,054
642,157
655,521
642,157
655,521
36,413,432
36,413,432
1,898,630
1,541,556
(9,728,551)
(5,036,460)
28,583,511
32,918,528
2022
$
2021
$
37,376
37,376
2,000
5,658
7,658
35,126
35,126
—
2,500
2,500
41
ANNUAL REPORT 2022NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) 21. DIVIDENDS
There are no dividends paid or payable at 30 June 2022.
22. COMMITMENTS
There are no other commitments which require disclosure as at 30 June 2022 (30 June 2021: nil).
23. SEGMENT REPORTING
The Group has identified its operating segments based on the internal reports that are reviewed and used
by the Board of Directors in assessing performance and determining the allocation of resources.
The Group is managed primarily on the basis of its research and development activities. Operating
segments are therefore determined on the same basis.
Reportable segments disclosed are based on aggregating operating segments where the segments are
considered to have similar economic characteristics.
The Group operated in one segment which is research and development activities within Australia. The
Company is domiciled in Australia.
24. CONTINGENT LIABILITIES AND CONTINGENT ASSETS
The Directors are not aware of any contingent liabilities or contingent assets which require disclosure as at
30 June 2022 (30 June 2021 : nil).
42
INVEX THERAPEUTICS LTD. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (CONT.) DIRECTORS’ DECLARATION
In the Directors’ opinion:
(a) the financial statements and notes are in accordance with the Corporations Act 2001, and:
(i) complying with Accounting Standards, the Corporations Regulations 2001 and other mandatory
professional reporting requirements; and
(ii) give a true and fair view of the financial position as at 30 June 2022 and of the performance for the
year ended on that date of the Group.
(iii) are in accordance with International Financial Reporting Standards issued by the International
Accounting Standards Board, as stated in note 1 to the financial statements; and
(b) In the Directors’ opinion, there are reasonable grounds to believe that the Group will be able to pay its
debts as and when they become due and payable; and
(c) The Directors have been given the declarations by the Executive Director as required by section 295A, of
the Corporations Act 2001.
This declaration is made in accordance with a resolution of the Board of Directors and is signed for and on
behalf of the directors by;
David McAuliffe
Non-executive Director
Perth, Western Australia, 19 August 2022
43
ANNUAL REPORT 2022 INDEPENDENT AUDITOR’S REPORT
Tel: +61 8 6382 4600
Fax: +61 8 6382 4601
www.bdo.com.au
Level 9, Mia Yellagonga Tower 2
5 Spring Street
Perth WA 6000
PO Box 700 West Perth WA 6872
Australia
INDEPENDENT AUDITOR’S REPORT
To the members of Invex Therapeutics Ltd
Report on the Audit of the Financial Report
Opinion
We have audited the financial report of Invex Therapeutics Ltd (the Company) and its subsidiary (the
Group), which comprises the consolidated statement of financial position as at 30 June 2022, the
consolidated statement of profit or loss and other comprehensive income, the consolidated statement
of changes in equity and the consolidated statement of cash flows for the year then ended, and notes
to the financial report, 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:
(i)
Giving a true and fair view of the Group’s financial position as at 30 June 2022 and of its
financial performance for the year ended on that date; and
(ii)
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 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 confirm that the independence declaration required by the Corporations Act 2001, which has been
given to the directors of the Company, would be in the same terms if given to the directors as at the
time of this auditor’s report.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis
for our opinion.
BDO Audit (WA) Pty Ltd ABN 79 112 284 787 is a member of a national association of independent entities which are all members of BDO Australia
Ltd ABN 77 050 110 275, an Australian company limited by guarantee. BDO Audit (WA) Pty Ltd and BDO Australia Ltd are members of BDO
International Ltd, a UK company limited by guarantee, and form part of the international BDO network of independent member firms. Liability
limited by a scheme approved under Professional Standards Legislation
44
INVEX THERAPEUTICS LTD. INDEPENDENT AUDITOR’S REPORT (CONT.)
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.
We have not identified any key audit matters for Invex Therapeutics Ltd.
Other information
The directors are responsible for the other information. The other information comprises the
information in the Group’s annual report for the year ended 30 June 2022, but does not include the
financial report and the 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 ability of the group 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 has 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.
45
ANNUAL REPORT 2022 INDEPENDENT AUDITOR’S REPORT (CONT.)
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 (http://www.auasb.gov.au/Home.aspx) at:
https://www.auasb.gov.au/admin/file/content102/c3/ar1_2020.pdf
This description forms part of our auditor’s report.
Report on the Remuneration Report
Opinion on the Remuneration Report
We have audited the Remuneration Report included in pages 12 to 19 of the directors’ report for the
year ended 30 June 2022.
In our opinion, the Remuneration Report of Invex Therapeutics Ltd, for the year ended 30 June 2022,
complies with section 300A of the Corporations Act 2001.
Responsibilities
The directors of the Company are responsible for the preparation and presentation of the
Remuneration Report in accordance with section 300A of the Corporations Act 2001. Our responsibility
is to express an opinion on the Remuneration Report, based on our audit conducted in accordance with
Australian Auditing Standards.
BDO Audit (WA) Pty Ltd
Jarrad Prue
Director
Perth, 19 August 2022
46
INVEX THERAPEUTICS LTD. CORPORATE GOVERNANCE STATEMENT
In fulfilling its obligations and responsibilities to its various stakeholders, the Board is a strong advocate
of corporate governance. This statement outlines the principal corporate governance procedures of Invex
Therapeutics Ltd (Group). The Board of Directors (Board) supports a system of corporate governance to
ensure that the management of Invex Therapeutics Ltd is conducted to maximise shareholder wealth in a
proper and ethical manner.
ASX CORPORATE GOVERNANCE COUNCIL RECOMMENDATIONS
The Board has adopted corporate governance policies and practices consistent with the ASX Corporate
Governance Council's Principles of Good Corporate Governance and Best Practice Recommendations ("ASX
Principles and Recommendations 4th Edition") where considered appropriate for Invex Therapeutics Ltd
size and nature. Such policies include, but are not limited to the Board Charter, Board Committee Charters,
Code of Conduct, Trading in Securities, Continuous Disclosure, Shareholder Communication and Risk
Management Policies.
Further details in respect to the Group’s corporate governance practises and copies of the Group’s
corporate governance policies and the 2022 Corporate Governance Statement, approved by the Board and
applicable as at 30 June 2022 are available of the Group’s website:
https://invextherapeutics.com/corporate-governance/
47
ANNUAL REPORT 2022 ASX ADDITIONAL INFORMATION
Additional information required by the ASX Limited Listing Rules not disclosed elsewhere in this Annual
Report is set out below.
1. SHAREHOLDINGS
The issued capital of the Company as at 1 August 2022 is 75,153,848 ordinary fully paid shares. All issued
ordinary fully paid shares carry one vote per share.
Ordinary Shares
Shares Range
1-1,000
1,001-5,000
5,001-10,000
10,001-100,000
100,001 and above
Total
Unmarketable parcels
Holders
233
483
240
438
Units
143,116
1,331,649
1,921,496
15,102,038
91
56,655,549
%
0.19
1.77
2.56
20.09
75.39
1,485
75,153,848
100.00
There were 178 holders of less than a marketable parcel of ordinary shares representing a total of 88,383 shares.
2. TOP 20 SHAREHOLDERS AS AT 1 AUGUST 2022
Name
1 TATTARANG
2 TISIA NOMINEES PTY LTD
3 DR JASON LOVERIDGE
4 MR DAVID JERIMIAH MCAULIFFE
5 JK NOMINEES PTY LTD
6 ANTHONY GRIST
7 ALEXANDRA JEAN SINCLAIR
8 MRS KATHRYN SALKILLD
9 THE UNIVERSITY OF BIRMINGHAM
10 CITICORP NOMINEES PTY LIMITED
Number of
shares
8,846,154
4,000,000
3,374,462
3,350,001
3,000,000
2,749,000
2,500,000
2,293,000
2,000,000
1,954,956
11 BANNABY INVESTMENTS PTY LIMITED
1,625,000
12 SUNSET CAPITAL MANAGEMENT PTY LTD
1,448,175
13 CITYSCAPE ASSET PTY LTD
14 CABLETIME PTY LTD
15 SANDHURST TRUSTEES LTD
16 NETWEALTH INVESTMENTS LIMITED
17 PETER KYROS PTY LTD
18 PALLA NOMINEES PTY LTD
19 HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED
20 MAGAURITE PTY LTD
TOP 20 TOTAL
TOTAL REMAINING HOLDERS BALANCE
TOTAL
48
%
11.77
5.32
4.49
4.46
3.99
3.66
3.33
3.05
2.66
2.60
2.16
1.93
1.66
1.49
1.44
0.88
0.78
0.77
0.77
0.75
1,250,000
1,120,000
1,081,924
658,751
588,616
580,000
578,184
560,000
43,558,223
31,595,625
57.96
42.04
75,153,848
100.00
INVEX THERAPEUTICS LTD. ASX ADDITIONAL INFORMATION (CONT.)
3. UNQUOTED SECURITIES
The unlisted options over shares in the Company as at 1 August 2022 are as follows:
Holder
DR JASON LOVERIDGE
ALEXANDRA JEAN SINCLAIR
CIPA INVESTMENTS PTY LTD
WACC PTY LTD
DR MEGAN BALDWIN
CAROL PARISH
PHILUCHNA PTY LTD
DAVID JERIMIAH MCAULIFFE
EMMA HILTON
Total
4. VOTING RIGHTS
See note 12 of the financial statements.
Number of
options held
% of issued
capital held
800,000
800,000
800,000
750,000
400,000
400,000
400,000
200,000
60,000
17.35
17.35
17.35
16.27
8.68
8.68
8.68
4.34
1.30
4,610,000
100.00
5. SUBSTANTIAL SHAREHOLDERS AS AT 1 AUGUST 2022
Holder
TATTARANG
TISIA NOMINEES PTY LTD
Number of
shares held
% of issued
capital held
8,846,154
4,000,000
11.77
5.32
6. RESTRICTED SECURITIES SUBJECT TO ESCROW PERIOD
There are no restricted securities.
7. ON-MARKET BUYBACK
There is currently no on-market buyback program for any of Invex’s listed securities.
8. COMPANY CASH AND ASSETS
In accordance with Listing Rule 4.10.19, the Company confirms that it has been using the cash and assets it
had acquired at the time of admission and for the year ended 30 June 2022 in a way that is consistent with
its business objective and strategy.
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ANNUAL REPORT 2022 This page has been left blank intentionally.
50
INVEX THERAPEUTICS LTD. CORPORATE DIRECTORY
This financial report includes the consolidated
financial statements and notes of the Group
consisting of Invex Therapeutics Ltd and its
controlled entity (Invex Therapeutics UK).
The Group’s functional and presentation currency
is Australian Dollars ($).
A description of the Group’s operations and
principal activity is included in the review of
operations and activities in the Directors’ report
on pages 8 to 19. The Directors’ Report is not part
of the Consolidated Financial Report.
Directors:
Dr Jason Loveridge
Professor Alexandra Sinclair
Dr Thomas Duthy
Dr Megan Baldwin
Mr David McAuliffe
Company Secretary:
Ms Narelle Warren
Registered Office & Principal Place of Business:
Level 2, 38 Rowland St
Subiaco WA 6008
Tel: +61 8 6382 0137
Website: www.invextherapeutics.com
Auditors:
BDO
Level 9
Mia Yellagonga Tower 2
5 Spring Street
Perth WA 6000
Bankers:
Westpac Banking Corporation
Level 4 Tower 2 Brookfield Place
123 St Georges Terrace
Perth WA 6000
Solicitors:
Steinepreis Paganin
Level 4, The Read Buildings
16 Milligan St
Perth WA 6000
Share Registry:
Automic Registry Services
Telephone: 1300 288 664
International: +61 2 9698 5414
Website: www.automicgroup.com.au
ASX code: IXC
ideate
Co.
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ANNUAL REPORT 2022