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AdAlta

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FY2021 Annual Report · AdAlta
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ANNUAL 
REPORT
FOR THE YEAR ENDED  
30 JUNE 2021
ADALTA LTD
ABN 92 120 332 925

CONTENTS 

CORPORATE DIRECTORY ������������������������������������������������������� 3

CHAIR’S LETTER ��������������������������������������������������������������������� 5

CEO AND MANAGING DIRECTOR’S LETTER ��������������������������� 6

DIRECTORS’ REPORT �������������������������������������������������������������� 7

AUDITOR’S INDEPENDENCE DECLARATION ������������������������� 27

STATEMENT OF PROFIT OR LOSS AND OTHER 

COMPREHENSIVE INCOME �������������������������������������������������� 28

STATEMENT OF FINANCIAL POSITION ��������������������������������� 29

STATEMENT OF CHANGES IN EQUITY ��������������������������������� 30

STATEMENT OF CASH FLOWS ��������������������������������������������� 31

NOTES TO THE FINANCIAL STATEMENTS ����������������������������� 32

DIRECTORS’ DECLARATION ������������������������������������������������� 48

INDEPENDENT AUDITOR’S REPORT TO 
THE MEMBERS OF ADALTA LIMITED �������������������������������������� 49

SHAREHOLDER INFORMATION �������������������������������������������� 54

AdAlta Limited Annual Report 2021  ABN 92 120 332 925

2

CORPORATE DIRECTORY

DIRECTORS

Dr Paul MacLeman

Dr Timothy Oldham

Ms Elizabeth McCall

Dr Robert Peach

SHARE REGISTRY

Automic Registry Services
Level 5
126 Phillip Street
Sydney, NSW 2000

Tel: 1300 288 664

Dr David Fuller (appointed 22 July 2020)

Dr James Williams (alternate to Elizabeth McCall)

STOCK EXCHANGE LISTING
Adalta Limited shares are listed on the Australian 
Securities Exchange.

COMPANY SECRETARY

Mr Cameron Jones

REGISTERED OFFICE
Unit 15 / 2 Park Drive
Bundoora Vic 3083

AUDITOR

Butler Settineri (Audit) Pty Ltd
Unit 16, First Floor,
100 Railway Road
Subiaco, Western Australia 6008

ASX CODE

1AD

WEBSITE

www.adalta.com.au

AdAlta Limited Annual Report 2021  ABN 92 120 332 925

3

AdAlta Limited Annual Report 2021  ABN 92 120 332 925

4

CHAIR’S LETTER

In FY2021 we have continued to make substantial progress 
in progressing our i-body enabled assets and expanding 
our pipeline.

Our lead asset, AD-214, has now successfully completed 
a Phase I clinical trial, demonstrating an excellent safety 
profile in single and multiple intravenous doses in healthy 
volunteers. We also successfully developed a radio-labelled 
version of AD-214 for PET imaging, with pre-clinical studies 
demonstrating the value of this asset as a translational 
research tool. We now have a clear pathway to clinical trials 
in Idiopathic Pulmomary Fibrosis (IPF) patients using a patient 
preferred, inhaled formulation of AD-214. Despite some 
unexpected results in pre-clinical imaging, we continue to 
believe that AD-214 could offer an important new option for 
sufferers of debilitating fibrotic diseases.

Our commercial collaboration with GE Healthcare moved 
to the next phase, following the successful identification 
of multiple i-bodies to be advanced into pre-clinical 
development for use as a potential PET diagnostic imaging 
agent. Delivering on our strategic agenda to expand our 
pipeline, we also entered a collaboration with Carina 
Biotech Pty Ltd (Carina) to develop precision engineered, 
i-body enabled, CAR-T cells with potential to make these 
breakthrough therapies available to a wider range of 
patients with cancer. Both these collaborations provide 
commercial validation of our platform.

AdAlta is now in the middle - or expansion - phase of the 
growth strategy we outlined in 2020. Our near-term strategic 
priorities remain:

1.   Continue AD-214 progression through clinical 

value inflection points. 

Clinical studies in patients are planned upon resupply of 
clinical AD-214 drug product in mid-2023 and our aim is to 
develop a patient preferred, inhaled formulation of AD-214 
for these studies. Formulation and pre-clinical distribution and 
efficacy studies will be conducted during FY22.

2.   Add additional assets to our internal 

pipeline. 

We are in the final stages of selecting two new GPCR targets 
in the fields of fibrosis, inflammation and oncology and 
anticipate commencing discovery research by the end  
of 2021.

3.   Progress multiple collaborations through our 

external pipeline.

Our collaboration with GE Healthcare has now progressed 
into pre-clinical development and we continue to assist 
with manufacturing process development. Further updates 
are expected in the first half of CY2022. The PET imaging 
agents that GE Healthcare is developing could generate 
royalty revenue for AdAlta much earlier than AD-214. In 
FY22 we also anticipate first experimental results from our 
new collaboration with Carina and we are continuing our 
business development efforts to add further collaborations to 
our external pipeline.

4.  Continue to invest in our i-body platform. 

It is important that we invest to keep our platform technology 
at the forefront of drug discovery technologies. Early results 
show great promise that we can improve the efficiency and 
intellectual property protection of our i-body platform.

I would like to acknowledge and thank you, our 
shareholders, who supported us last year with $8.1 million 
new funds under a placement and entitlement issue to 
progress AD214 though Phase I trials and for your continued 
support and encouragement of our strategy.  

Finally, the COVID-19 pandemic has continued to disrupt 
individuals, companies and economies in unprecedented 
ways in 2021. AdAlta is in the fortunate position that our 
laboratories, collaborators and clinical trial sites have 
generally been able to remain open and our programs 
suffered only minor delays as a result. Our thoughts are with 
all those less fortunate than us, and particularly with the 
survivors of COVID-19 infection who it would appear may 
be at greater risk of developing lung fibrosis. This highlights 
even more the importance of the work we are doing to bring 
AD-214 to the lung fibrosis patients who so desperately need 
new therapeutic options.

Paul MacLeman
Chair

AdAlta Limited Annual Report 2021  ABN 92 120 332 925

5

CEO AND MANAGING 
DIRECTOR’S LETTER

AdAlta’s purpose is to generate a broad portfolio of i-body 
enabled drugs which can treat diseases that are challenging 
for traditional antibody technologies. Our strategy to do 
this is clear: progress our existing assets and develop an 
internal pipeline of wholly owned assets that we discover 
and develop through early clinical trials before partnering 
(i.e. more assets like AD-214), while also progressing an 
external pipeline of assets co-developed with partners who 
provide the target (i.e. more collaborations like that with 
GE Healthcare).

During the past year our asset advancement and pipeline 
expansion initiatives gained strong momentum. This was 
exemplified by the successful completion of a Phase I 
clinical trial for AD-214, the progress we made through the 
collaboration with GE Healthcare which passed its first major 
milestone, then moved into preclinical development; as well 
as the establishment of our next collaboration with Carina 
(announced after year end). The Company is on track to 
achieve its goal of five active programs by the end of 2021. 
We are well into the expansion phase of the growth strategy 
outlined in March 2020.

Drug development is rarely a straight line and unexpected 
results do occur. Our success will ultimately be determined 
by how we adapt to and incorporate these results as they 
occur. The unexpected result for FY2021 was of course the 
finding, through PET imaging, that a large proportion of the 
administered intravenous dose of AD-214 rapidly distributed 
to the liver of mice and non-human primates. This finding 
appropriately raised a number of important questions and 
I am proud of the way our team and collaborators worked 
through these questions quickly and systematically so that 
we now have a clear pathway and plan towards our next 
clinical trial of AD-214, planned to be with a preferred, 
inhaled formulation. The value of PET imaging as a 
translational research tool has now proven its worth.

AD-214 has been developed to date for intravenous 
administration. I have always believed that a more 
convenient route of administration would be preferred for 
chronic treatment of Idiopathic Pulmonary Fibrosis (IPF), 
the lead indication for AD-214, however intravenous 
administration was the simplest, and potentially fastest, way 
to obtain safety and initial efficacy data. After evaluating the 
current status of inhalation technology for biologic drugs, we 
determined that an inhaled formulation of AD-214 is feasible 
and clearly offers greater patient convenience, reduced cost 
of goods and also the potential to partner AD-214 separately 
for each fibrosis indication. We chose to lock in resupply 
of clinical AD-214 prior to the end of the Phase I program, 
setting an earliest possible date for our next clinical trial in 
mid-2023. We have also determined that it is feasible to 
develop an inhaled formulation of AD-214 prior to this using 
the drug substance we have on hand. 

So we will now move into our next clinical trials, which will 
be designed to test efficacy as well as safety, with a patient 
preferred formulation that brings significant additional 
advantages – such as improved cost of goods and ease 
of delivery. We have concluded the Phase I intravenous 
safety studies early as they have achieved their objective 
and demonstrated an excellent safety profile for the AD-
214 molecule. We have also decided not to proceed with 
the planned Phase Ib study of AD-214 in patients with PET 
imaging. Due to the pre-clinical PET imaging results, we 
now know the Phase Ib study would be unlikely to enable us 
to confirm distribution of AD-214 to tissues of interest. We 
believe we will be able to obtain this information with further 
pre-clinical imaging during inhaled formulation development. 

It is also important to note several other findings. First, the 
rapid liver distribution appears to be linked to AD-214 only 
and has not been observed with other i-bodies imaged to 
date. Other programs have not been disrupted or impacted. 
Secondly, we are continuing to work on other indications for 
AD-214 that do not require systemic administration such as 
eye fibrosis. Thirdly, we also continue to work on improved 
intravenous formulations of AD-214 that may reduce or 
eliminate liver localisation, opening up further possible 
indications for AD-214.

We look back proudly upon a year which included 
significant successes. Completing our first ever clinical trial 
and demonstrating the safety of AD-214 is a significant 
milestone. Our collaboration with GE Healthcare deepened 
and we have entered an exciting new collaboration with 
Carina. These are all significantly value driving events for 
shareholders and we look forward to seeing progress under 
each arm of our strategy play out further in FY22.

The market need for new anti-fibrotic products, the potential 
patient benefits and early royalty revenue potential from 
our GE collaboration and the enormous interest in next 
generation CAR-T products for solid tumours combine to 
provide great confidence in the potential of the i-body 
platform to create valuable assets that will generate demand 
from potential partners and returns for shareholders.

I would like to thank the whole AdAlta team and the board 
for their contributions through this transformational year, 
the volunteers who participated in our clinical trials, our 
collaborators and our shareholders for their continued 
encouragement.

Tim Oldham
CEO and Managing Director

6

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT

The Directors of AdAlta Limited (“AdAlta” or “the Company”) submit herewith the Annual Report of the Company for the financial 
year ended 30 June 2021. In order to comply with the provisions of the Corporations Act 2001, the Directors report as follows:

Information about the Directors
The names and particulars of the Directors of the Company during or since the end of the financial year are:

Dr Paul MacLeman  
MBA, BVSc, Grad Dip Tech, Grad Cert Eng, GAICD

Joined the Board and was appointed as Chair on 16 April 
2015. Dr MacLeman has over 25 years’ experience across 
all phases of the life sciences sector. With a career-spanning 
veterinary practice, pharmaceutical development and 
manufacturing, biotechnology, diagnostics and finance, 
Dr MacLeman has expertise in capital raising, business 
development, technology commercialisation and sales & 
marketing globally. Dr MacLeman has launched products 
using both in-house and outsourced sales staff in Australia and 
the US. He has founded life sciences start-ups in the biologics 
area and worked in investment banking focusing on the 
analysis and financing of technology companies.  
Dr MacLeman has previously served as Chairman, Director 
or Managing Director/CEO of several VC funded, ASX, 
NASDAQ, CSE and TSX listed companies. Dr MacLeman 
is currently Executive Chairman of Island Pharmaceuticals 
Limited, Chairman of SuperTrans Medical Limited and 
nonexecutive director of Upkara Inc. and Upkara Asia 
Pacific Pty Ltd. Dr MacLeman Chairs the Industry Review 
Committee for the Pharmaceutical Manufacturing National 
Training Package for the AISC. He is an expert advisor 
to PharmaVentures (Oxford, UK) and Mind Medicine. Dr 
MacLeman also serves on a number of other NFP and 
government advisory groups. Dr MacLeman holds a degree 
in veterinary science, post-graduate engineering and 
governance qualifications, and an MBA from MGSM.

Dr Timothy Oldham  
BSc(Hons), LLB (Hons), PhD

Managing Director and CEO, joined the Board on 8 October 
2019. Tim has almost 20 years of life sciences business 
development, alliance management, portfolio and product 
development, and commercialisation experience in Europe, 
Asia and Australia, with a particular focus on biologics, 
cell and gene therapies and pharmaceutical product. 
Immediately prior to this, he was Executive Leader of Tijan 
Ventures, an advisory business focussed on growing life 
sciences companies through strategic advisory and interim 
CEO, executive and non-executive leadership services, with 
a particular focus on biologics, cell and gene therapies and 
immunotherapy. Previous roles include CEO and Managing 
Director of Cell Therapies Pty Ltd, a leading contract 
manufacturer and distributor cellular therapies in Asia Pacific, 
President of Asia Pacific for Hospira, Inc., and a variety of 

senior management roles with Mayne Pharma Ltd prior to its 
acquisition by Hospira. Prior to this, Tim was an engagement 
manager with McKinsey & Company. Industry leadership 
roles include currently serving as a Director of BioMelbourne 
Network Inc and terms as Chair of the European Generic 
Medicines Association Biosimilars and Biotechnology 
Committee, a Director of the Alliance for Regenerative 
Medicine and a Director of the Generic Medicines Industry 
Association. He is a Non-executive Director at Acrux Ltd 
(ASX:ACR).

Ms Elizabeth (Liddy) McCall  
LLB., B.Juris,B.Com (Hons), GDipApFin (SIA), GAICD

Non-Executive Director, joined the Board 16 December 
2010. Liddy is co-founder of 3 biotechnology companies 
successfully achieving 3 FDA drug registrations and 1 FDA/ 
CE Mark medical device approval. She is an inventor on 
patents granted in major jurisdictions translating novel 
G-protein coupled pharmacology into a therapeutic drug 
treatment currently in multiple Phase 3 clinical trials. Liddy 
co-founded IIF venture capital fund, Yuuwa Capital LP, which 
is responsible for a portfolio of 6 companies commercializing 
biotechnology and IT innovation. Liddy has over 25 years of 
experience in senior Board and management roles including 
iCeutica Inc group (acquired in 2011), Dimerix Bioscience Pty 
Ltd (now Dimerix Limited ASX:DXB), AdAlta Limited (ASX:1AD) 
and iCetana Pty Ltd (now iCetana Limited ASX:ICE). Liddy 
was an Associate Director in the Corporate Advisory Group 
of Macquarie Bank and prior to that worked as a lawyer 
with a leading Australian law firm. She has qualifications in 
law and finance. Liddy is a Non-Executive Director of the not-
for-profit Ear Science Institute Australia and also of Argenica 
Therapeutics Ltd (ASX:AGN), Agworld Pty Ltd, Nexgen Plants 
Pty Ltd and The Tailor Made Spirits Company Limited.

7

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Dr Robert Peach  
BSc, MSc, PhD

Dr James Williams  
BSc (Hons), MBA, PhD, GAICD

Non-Executive Director, appointed 14 November 2016. 
Robert has 30 years of drug discovery and development 
experience in the Pharmaceutical and Biotechnology 
industry. In 2009 he co-founded Receptos, becoming 
Chief Scientific Officer and raising US$59M in venture 
capital and US$800M in an IPO and three subsequent 
follow-on offerings. In August 2015 Receptos was acquired 
by Celgene for $7.8B. Robert held senior executive and 
scientific positions in other companies including Apoptos, 
Biogen Idec, IDEC and Bristol- Myers Squibb, supporting in-
licensing, acquisition and venture investments. His extensive 
drug discovery and development experience in autoimmune 
and inflammatory diseases, and cancer has resulted in 
multiple drugs entering clinical trials and 4 registered drugs. 
He currently serves on the Board of Directors of Amplia 
Therapeutics, Rekover Therapeutics and is a Scientific 
Advisory Board member of Eclipse Bioinnovations. Robert is 
the co-author of 75 scientific publications and book chapters, 
and 17 patents. He was educated at the University of 
Canterbury and the University of Otago, New Zealand.

Dr David Fuller  
MBBS, BPharm 
Appointed 22 July 2020.

Non-Executive Director, appointed 22 July 2020. David 
has over 30 years’ experience in pre-clinical, clinical 
development, medical and regulatory affairs with 
specialisations in early phase development and oncology. 
He has led five product approvals in the United States (US) 
and European Union (EU) for orphan and major market 
products, together with multiple Regulatory Agency (US/
EU) interactions including Investigational New Drug (IND) 
applications. David has designed and executed multiple 
Phase I – III studies in US, EU and Asia across multiple 
therapeutic areas. David is currently Chief Medical Officer 
for ASX listed Race Oncology and is also a Non-Executive 
Director at EpiAxis Therapeutics Pty Ltd. Previously David 
was Senior Vice President, Oncology, Syneos Health, a 
Non-Executive Director of Linear Clinical Research Ltd – a 
Perth based clinical trials facility – and a former Chair of 
Dimerix Ltd (ASX:DXB). David holds Bachelor of Medicine/
Bachelor of Surgery and Bachelor of Pharmacy degrees from 
University of Sydney.

Alternate Director to Liddy McCall. James is a co-founder 
and Investment Director of Yuuwa Capital LP, a venture 
capital firm based in Western Australia. Prior to Yuuwa 
Capital, he was Managing Director of two medical device 
companies, ASX-listed Resonance Health Ltd and Argus 
Biomedical Pty Ltd, both of which secured regulatory 
approvals under his leadership. He conceived, co-founded 
and is a former CTO and Director of iCeutica, Inc., a 
clinical stage nano drug delivery company. iCeutica was 
acquired by Philadelphia-based Iroko Pharmaceuticals in 
2011. Iroko received FDA approval for the first three iCeutica 
formulations between 2013 and 2015. James is Chairman 
of ASX-listed clinical stage drug discovery and development 
company Dimerix Ltd (ASX:DXB) and Director of Yuuwa 
investee company PolyActiva Pty Ltd. He is a member of the 
“Panel of Experts” for the University of Western Australia’s 
Pathfinder Fund and a member of the Australian Federal 
Government’s Entrepreneur Program Committee.

The above-named Directors held office during the whole of 
the financial year and since the end of the financial year, 
unless otherwise indicated.

Company Secretary
The name and particulars of the Company Secretary of the 
Company during or since the end of the financial year are:

Cameron Jones  
B.Bus, CA

Cameron is the Managing Director of Bio101, a financial 
services firm providing accounting, tax and company 
secretarial services specialising in the healthcare and life 
science sectors. A qualified Chartered Accountant and 
registered tax agent, Cameron acts as CFO and Company 
Secretary for a number of ASX listed life science companies 
and Venture Capital investee companies. In his role at Bio101 
Cameron has assisted clients in the IPO process and fills the 
role and acts as Australian Resident Director.

8

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Directors’ shareholdings as at the date of this report
The following table sets out each Director’s relevant interest in shares, debentures and rights or options in shares or debentures of 
the Company as at the date of this report:

Directors

Fully paid ordinary shares

Options under ESOP

Dr Paul MacLeman  

Dr Timothy Oldham

Ms Elizabeth McCall1

Dr Robert Peach

Dr David Fuller

Dr James Williams1

(Number)

472,970

211,000

166,668

1,295,999

187,260

253,334

(Number)

30,000

4,929,060

-

200,000

-

-

1James Williams and Elizabeth McCall’s interests do not include 54,059,848 ordinary shares beneficially owned by the limited partners of Yuuwa 
Capital LP, a venture capital fund. Yuuwa Capital Management Pty Ltd which is associated with James Williams and Elizabeth McCall provides 
investment management services to Yuuwa Capital LP.

Dividends
There were no dividends paid, recommended or declared during the current or previous financial year.

Shares under option

Number of shares under option

Class of shares

Exercise price of option

Expiry date of options

400,000

130,000

100,000

100,000

620,535

600,000

1,000,000

4,929,060

Ordinary

Ordinary

Ordinary

Ordinary

Ordinary

Ordinary

Ordinary 

Ordinary

$0.2485

$0.4985

$0.7485

$0.9985

$0.2385

$0.085

$0.175

$0.2485

14 November 2021

14 November 2021

14 November 2021

14 November 2021

27 February 2022

20 March 2023

15 March 2025

26 November 2025

During the year 1,000,000 options were issued to employees (2020: 4,929,060). No share options were exercised by key 
management personnel during the year (2020:Nil).

A total of 23,345,078 listed options expired unexercised on 30 June 2021. The listed options had an exercise price of $0.2485.

On 2 July 2021 a total of 3,725 ordinary shares were issued on exercise of listed options for gross proceeds to the Company 
of $925. 

The holders of these options do not have the right to participate in any share issue of the Company without first exercising the 
options in accordance with the terms of any such share issue.

9

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Indemnity and insurance of officers and auditors
During the financial year, the Company paid a premium in respect of a contract that insures the Directors of the Company (as 
named above), the company secretary and all executive officers of the Company and of any related body corporate against 
a liability incurred as such a Director, secretary or executive officer to the extent permitted by the Corporations Act 2001. The 
contract of insurance prohibits disclosure of the nature of the liability and the amount of the premium.

The Company has not otherwise, during or since the end of the financial year, except to the extent permitted by law, indemnified 
or agreed to indemnify an officer or auditor of the Company or of any related body corporate against a liability incurred as such 
an officer or auditor.

Meetings of Directors
The number of meetings of the company’s Board of Directors (‘the Board’) and of each Board committee held during the year 
ended 30 June 2021, and the number of meetings attended by each Director were:

Full Board

Remuneration and 
Nomination Committee

Audit and  
Risk Committee

Attended

Held

Attended

Held

Attended

Held

Dr Paul MacLeman

Dr Timothy Oldham 

Ms Elizabeth McCall  

Dr Robert Peach 

Mr David Fuller

7

7

7

7

7

7

7

7

7

7

1

-

1

1

-

1

-

1

1

-

2

-

2

2

-

Held: represents the number of meetings held during the time the Director held office or was a member of the relevant committee.

No person has applied for leave of Court to bring proceedings on behalf of the Company or intervene in any proceedings 
to which the Company is a party for the purpose of taking responsibility on behalf of the Company for all or any part of 
those proceedings.

Auditor’s independence declaration
A copy of the auditor’s independence declaration as required under section 307C of the Corporations Act 2001 is set out 
immediately after this Directors’ report.

2

-

2

2

-

10

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Operating and Financial Review 

Summary of principal activities
AdAlta Ltd (AdAlta or the Company) is a clinical 
stage drug discovery and development company listed on 
the Australian Securities Exchange (ASX:1AD). AdAlta’s 
purpose is to use its i-body technology platform to generate 
a broad portfolio of i-body enabled drugs against drug 
targets that challenge traditional antibody technologies 
and in doing so create novel therapies for high unmet need 
medical conditions.

i-bodies are a new class of small, targeted, fully human 
proteins modelled on the single domain antibodies found 
in the shark immune system. They have been engineered 
to mimic many of the characteristics of naturally occurring 
antibodies and their unique properties (small size, stability 
and long, flexible binding domain) make them ideally 
suited for addressing drug targets considered challenging 
or ‘undruggable’ by traditional antibody therapies, offering 
the potential for new drugs against substantial unmet 
medical needs. 

Figure 1 illustrates some of the many ways that i-bodies can 
be used to generate novel pharmaceutical products.

i-bodies can be used directly as therapeutic agents, where 
the i-body engages a target receptor and modifies its 
signalling or pharmacology to treat disease. The i-bodies 
may be modified to enhance their pharmaceutical properties 
such as half-life (a measure of the time a drug stays in 
the body) in multiple ways. AdAlta’s first internal product 
candidate, AD-214, is an example. AD-214 is a first-in-class 
product (meaning it works by blocking a novel target) being 
developed to treat fibrotic diseases, with an initial focus on 
degenerative Interstitial Lung Disease (ILD) including the 
orphan (rare) disease Idiopathic Pulmonary Fibrosis (IPF).

i-bodies may also be used to deliver a therapeutic or 
diagnostic cargo. Here, the i-body provides a direction-
finding function to deliver an attached cargo precisely 
to the location required for therapeutic or diagnostic 
effect. AdAlta’s collaboration with GE Healthcare Inc (GE 
Healthcare) is an example. AdAlta is discovering i-bodies 
that bind to molecule called granzyme B (GZMB) secreted 
by the immune system when it attacks a pathogen or cancer. 
By attaching the i-bodies to GE Healthcare’s PET imaging 
molecules, the resulting PET imaging agents could be used 
to determine whether a patient’s immune system has been 
activated by immuno-oncology (I/O) drugs. These imaging 
agents could shorten the time required to get patients onto 
the right I/O drug and avoid treatments that do not work.

AdAlta has a second collaboration with Carina Biotech 
Pty Ltd (Carina) to develop precision engineered, i-body 
enabled chimeric antigen receptor T cell (CAR-T cell) 
therapies that provide new hope for patients with cancer. 
AdAlta’s i-bodies will be used in the antigen binding region 
of Carina’s CAR-T cells. In this application, the i-body 
provides targeting capability for the T cell cargo.

A third application of i-bodies is to combine them to create 
multi-functional antibodies. Combining two i-bodies binding 
to different targets can result in novel therapeutic outcomes. 
For example, one of the objectives of the collaboration 
with Carina will be the creation of bi-specific CAR-T cells to 
improve targeting of solid tumours and reduce damage to 
healthy tissue. 

Figure 1: Applications of i-bodies

The primary focus of the FY2021 year was to progress  
Phase I clinical trials of AdAlta’s lead i-body enabled 
candidate, AD-214; complete the discovery of i-bodies 
suitable for pre-clinical development under our collaboration 
with GE Healthcare; and to prepare for expansion of our 
pipeline.

11

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Company strategy
AdAlta’s purpose is to develop multiple i-body enabled 
products that utilise the unique i-body features to address 
challenging drug targets and treat diseases with high unmet 
need. External collaborations provide important commercial 
validation of the attractiveness of the i-body platform while 
also extending the reach and application of the i-body 
platform beyond programs that AdAlta could develop in-
house. The completion of a Phase I clinical trial of  
AD-214 demonstrates that AdAlta can develop i-body 
enabled products from discovery to clinical trials. The GE 
Healthcare and Carina collaborations demonstrate the 
conviction other biopharmaceutical companies have in the 
ability of the i-body platform to deliver unique therapeutic 
and diagnostic products.

Figure 2 illustrates the two core strategies AdAlta is using to 
generate value and returns from the i-body platform.

•  Internal pipeline products: these are AdAlta owned 
products that will be developed to a commercially 
attractive point, then out-licensed to a partner for further 
development and commercialisation

•  External pipeline products: these are co-development 

programs with third parties addressing targets and using 
complimentary platform technologies supplied by the third 
party and partially or wholly funded by the third party.

Internal pipeline assets

Internal pipeline assets are AdAlta owned projects 
addressing targets that AdAlta selects. These targets will 
initially be focussed on a class of biological receptors found 
in cell membranes called G-protein coupled receptors 
(GPCRs). GPCRs are one of the largest families of drug 
targets and also one of the most difficult to target successfully 
with antibodies, making them ideal candidates for i-body 
enabled drugs. Therapeutic areas of primary focus will be 
fibrotic and inflammatory diseases and cancer. 

Internal product candidates are intended to be developed 
from discovery through pre-clinical development and initial 
clinical development (Phase I or Phase II) prior to out-
licensing to larger biopharmaceutical companies to complete 
clinical development and obtain regulatory approval, 
reimbursement and commercial launch. AdAlta anticipates 
receiving upfront and development milestones and royalties 
on commercial success.

AD-214 is the first example of this strategy and AdAlta 
has set a goal to add up to five new internal development 
candidates to the pipeline by 2023, with discovery to 
commence on the next two prior to the end of 2021.

Figure 2: AdAlta’s business model to create value from the i-body platform

12

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

External pipeline assets

Strategic priorities

AdAlta will enter co-development collaborations with 
other companies to discover and develop i-body enabled 
therapeutics. These programs will address targets, and/or 
use complimentary platform technologies that are supplied 
by the other company and so the resulting products are 
known as external pipeline assets. AdAlta and the other 
company will generally jointly own these external pipeline 
assets and discovery and development will usually be 
partially or wholly funded or supported by the third party.

The know-how provided by the other company means that 
external pipeline assets can be developed against a much 
wider range of targets and diseases than is possible with 
wholly internal programs.

The Company’s collaborations with GE Healthcare and 
Carina are examples of this type of relationship, providing 
AdAlta with access to PET imaging technology and CAR-T 
technology respectively. AdAlta has set the goal of adding 
2-4 additional collaborations by 2023.

AdAlta’s growth requires continued execution of existing 
projects while scaling resources and investment as each 
new target opportunity and pipeline asset is added. The 
immediate strategic priorities are:

1.  AD-214: develop a more patient convenient inhaled 
formulation for inclusion in next clinical trial of AD-214 in IPF; 
continue to generate pre-clinical data and develop suitable 
formulations for other fibrotic indications; continue to build a 
pipeline of potential commercialisation partners.

2.  Internal pipeline assets: progress development 
projects against two new targets. 

3.  External pipeline assets: support i-body 
manufacturing development as GE Healthcare progresses 
pre-clinical development of an i-body enabled PET imaging 
agent for immuno-oncology; conduct discovery and 
selection of i-bodies against first two targets under Carina 
collaboration; further expand the range of collaborations in 
the Company’s external pipeline.

4.  i-body platform: invest in continuous improvement, 
extending AdAlta’s intellectual property protection to ensure 
that the i-body platform remains at the forefront of tools 
available to address the drug targets that most challenge the 
biopharmaceutical industry today.

Pipeline
Figure 3 summarises AdAlta’s pipeline today and its anticipated evolution.

Figure 3: AdAlta’s asset pipeline 

13

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

AD-214

AdAlta’s most advanced asset, AD-214, is a first-in-class 
product being developed to treat fibrotic diseases, with an 
initial focus on degenerative Interstitial Lung Disease (ILD) 
including the orphan (rare) disease Idiopathic Pulmonary 
Fibrosis (IPF). IPF is a debilitating, progressive and ultimately 
fatal respiratory disease with a median survival from 
diagnosis of less than four years. The two marketed drugs for 
IPF are not curative and merely slow progression of disease. 
They are also accompanied by such severe side effects that 
many patients are unable to tolerate therapy long term. 
Improved therapeutic options are desperately needed.

The US Food and Drug Administration (FDA) has granted 
Orphan Drug Designation for AD-214 for use in IPF, 
conferring significant regulatory support and financial 
incentives on ultimate commercialisation that will be valuable 
to potential commercialisation partners for this asset.

AD-214 has completed a Phase I clinical trial in healthy 
volunteers at single doses up to 20 mg/kg and multiple doses 
at two-week intervals at 5 mg/kg. AD-214 demonstrated 
an excellent safety profile via the intravenous route of 
administration and clear evidence that it functionally engages 
its target receptor, the GPCR known as CXCR4. Significantly, 
AD-214 occupied the CXCR4 receptor on immune cells at 
high levels for much longer than the circulating time in the 
blood, supporting an extended pharmacodynamic effect 
and enabling longer duration between doses. Multiple dose 
study results were consistent with those of single dose studies 
except for mild infusion related reactions in some participants 
that were attributed to the formulation rather than the AD-214 
drug substance.

A radio-labelled version of AD-214 has been developed to 
enable in vivo PET imaging of AD-214 distribution to CXCR4 
receptors and tissues other than the blood and immune 
system. Initial pre-clinical imaging studies in mice and non-
human primates showed that a significant proportion of the 
AD-214 administered intravenously was distributed rapidly to 
the liver where it is not available for therapeutic effect. This 
has not been associated with any adverse safety signals. 

AdAlta is now progressing development of a more patient 
convenient inhaled version of AD-214 for future clinical 
studies in IPF patients. This is anticipated to be completed 
for deployment in the next clinical trial of AD-214 which is 
scheduled to commence upon resupply of clinical AD-214 
material, secured for mid-2023. An inhaled formulation offers 
greater patient convenience, increased dosing flexibility, 
lower cost of goods and the potential to select different 
partners for AD-214 for IPF and other indications. AdAlta is 
also continuing to evaluate other formulations of AD-214 that 
are more suitable for intravenous administration and/or other 

1P Sharma, et al, Cell 168(4) 707 (2017) 

fibrotic indications that do not require systemic administration 
such as eye fibrosis. 

Granzyme B PET imaging for immuno-oncology (I/O)

AdAlta’s first external product candidate is being developed 
through a co-development collaboration with GE Healthcare 
that commenced in 2019. GE Healthcare is one of the 
world’s leading diagnostic imaging companies.

I/O drugs, including a class of drugs known as check-point 
inhibitors, work by reactivating a patient’s own immune 
system to fight cancer. While these drugs have revolutionised 
cancer outcomes in some indications, they only work in 20-
40% of patients1. Today there is no simple way to determine 
if any given patient is responding to a particular check-point 
inhibitor. Granzyme B is an enzyme secreted by activated 
immune cells and serves to kill the target pathogen or cell. 
Detecting increases in granzyme B following treatment with 
a check-point inhibitor may therefore be useful in identifying 
responders early, reducing the time taken to find the correct 
therapy for any patient and reducing the cost and side effect 
burden of therapies that are not working.

AdAlta’s collaboration with GE Healthcare is seeking to 
discover i-bodies that bind to granzyme B and can be coupled 
to GE Healthcare’s radio-isotopes to create PET imaging agents 
for use as diagnostic agents for patients receiving I/O drugs. 
Our commercial collaboration with GE Healthcare moved to 
the next phase, following the successful identification of multiple 
i-bodies to be advanced into pre-clinical development. 
AdAlta is providing ongoing manufacturing and in vitro 
assay support for which it continues to earn research fees.

i-body enabled, precision engineered CAR-T cells

The objective of AdAlta’s second external product collaboration 
with Carina, which commenced in 2021, is to develop precision 
engineered, i-body enabled CAR-T cell therapies that provide 
new hope for patients with cancer. CAR-T cell therapies are 
living medicines. A patient’s T cells (a type of immune cell) 
are collected and engineered in a laboratory to express a 
new, chimeric antigen receptor (CAR) that enables the T cell 
to recognise cancer. The CAR-T cells are readministered to 
the patient where they can now locate and kill cancer cells.

Under this collaboration, AdAlta and Carina will develop 
CAR-T cell products against up to 5 solid tumour antigens. 
AdAlta will discover i-bodies against the tumour antigen 
targets. Carina will then incorporate them into their CAR-T 
platform for in vitro and in vivo evaluation. Carina and 
AdAlta will jointly own the products emerging from in vivo 
proof of concept and may continue to co-develop these 
products, choose one party to continue development or 
out-license to a third party. The collaboration will have a 
particular focus on solid tumour targets and bi-specific or 
dual specific CAR-Ts.

14

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Figure 3: Recent licensing deals in IPF

i-bodies are ideally suited for use in CAR-T cells. i-bodies 
can be utilised as the binding domain of a CAR receptor 
that engages the tumour antigen. The small size and unique 
targeting capabilities of i-bodies may provide access to a 
wider range of targets than the binding domains used in other 
CAR-T cells. The small size also provides greater flexibility 
and design options for CAR-T cells. This makes it ideally 
suited to the production of bi-specific CARs, dual CARs and 
multifunctional CARs where it can be incorporated with other 
technologies, such as Carina’s Chemokine Platform, to yield 
CAR-T cells with increased precision and efficacy. Bi-specific 
and dual CARs can engage two different tumour antigens. This 
may solve the two problems: firstly, that not all tumour cells 
express the same antigens (so may “escape” mono-specific 
CAR-T cells) and secondly, that not all tumour antigens are 
specific to the tumour, therefore engaging a second antigen 
can reduce damage to healthy tissue.

Carina is able to incorporate CARs in a very high proportion 
of patient T cells and expand these to a patient dose in just 
nine days, in line with or better than industry best practice. 
These capabilities, combined with Carina’s Chemokine 
Receptor Platform that incorporates GPCRs known as 
chemokines into CAR-T cells ensures that the CAR-T cells 
exhibit higher potency and less “aging” and are better 
placed to overcome both barriers to solid tumour access and 
the immunosuppressive environment within the tumour.

2GlobalData Dec 2019
3PM George, AU Wells, RG Jenkins, “Pulmonary fibrosis and 
COVID-19: the potential role for antifibrotic therapy”, Lancet 
published online May 15, 2020 https://doi.org/10.1016/S2213-
2600(20)30225-3
4GlobalData 2019

Commercial opportunity

IPF and fibrosis – AD-214

The two marketed IPF drugs, pirfenidone and nintedanib, 
generated estimated sales of US$2.9 billion in 2019 
including US$1.74 billion in US, the five largest EU markets 
and Japan2, despite modest efficacy and significant 
side effects. If successfully developed, AD-214 would be 
anticipated to take a share of this market and potentially 
increase the market should it offer improved efficacy or 
reduced side effects.

AdAlta aims to partner with a larger biopharmaceutical 
company to progress the development and commercialisation 
of AD-214. Partnering is most likely to occur just prior to 
or after the completion of Phase II clinical trials, currently 
planned to commence in mid-2023. Examples of the 
attractive licensing deals that may be possible in IPF are 
shown in Figure 3.

In addition, it has been reported that the burden of fibrotic 
lung disease following SARS-CoV-2 infection is likely to be 
high, and suggested that antifibrotic therapies could have 
value in preventing severe COVID-19 in IPF patients and 
preventing or treating fibrosis after SARS-CoV-2 infection3, 
further expanding the market potential for AD-214 in 
lung fibrosis.

Further, the market for fibrotic indications in other organs, 
which may also represent applications for AD-214, is 
potentially even larger, with the market for chronic kidney 
disease estimated at US$10 billion per year and the market 
for wet age-related macular degeneration estimated at 
US$16 billion per year4. Fibrotic diseases were identified 

15

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Figure 4: US approved CAR-T cell therapies and related transactions13

as one of the top three therapeutic areas of the future at 
the 2020 JPMorgan Healthcare Conference. In addition, 
antibodies against AD-214’s biological target, CXCR4, are 
now being developed against some of the 23 or more cancers 
with which CXCR4 is associated. 

The market for PET imaging agents is estimated to reach 
US$6.4 billion by 20275, with the largest products 
generating sales in excess of US$400 million in 20076. The 
market for I/O drugs is forecast to reach US$95 billion by 
20267 and if just 1-2% is spent on imaging agents, the I/O 
biomarker PET imaging market could be US$1-2 billion8.

Granzyme B PET imaging in immuno-oncology 
(I/O)

CAR-T products

AdAlta’s collaboration with GE Healthcare is already 
generating revenue. GE Healthcare paid an initial milestone to 
access the i-body technology, funded i-body discovery activities, 
and is now funding additional AdAlta support for manufacturing 
development. In addition, AdAlta will earn development and 
commercialisation milestones and royalty revenue on GE 
Healthcare sales should the granzyme B PET imaging agent 
currently in development, be successfully progressed.

The development timeline for PET imaging agents is 
significantly shorter than for therapeutics, and revenue 
can be generated from clinical research use even before 
general marketing authorisations are obtained. If successfully 
developed, a granzyme B PET imaging agent could generate 
royalty income for AdAlta ahead of AD-214.

5Global Industry Analysts, Imaging Agents: Global Market Trajectory 
and Analytics, April 2021
6AD Nunn, J Nucl Med (2007) 169
7ResearchandMarkets.com, Immuno-Oncology - Market Analysis, 
Trends, Opportunities and Unmet Needs - Thematic Research, March 
2021
8Pitt Street Research, GE Collaboration Bodes Well, 1 July 2021
9Carina Biotech analysis
10Grandview Research, T-cell Therapy Market Size, Share & Trends 
Analysis Report 2021 – 2028, Feb 2021
11Polaris Market Research, CAR-T Cell Therapy Market Share, Size, 
Trends, Industry Analysis Report 2021 – 2028, June 2021

The market for CAR-T therapy is emerging rapidly. CAR-T 
therapy was named by the American Society of Clinical 
Oncology (ASCO) as its Advance of the Year in 2018. After 
the first approvals in 2018, there are now five approved 
CAR-T therapies available in the US today (see Figure 4). 
Single doses are generating transformational outcomes 
for patients that have failed multiple prior lines of therapy. 
Current therapies treat a small number of blood cancers and 
due to the results they have yielded for patients, command 
prices in excess of US$300,000 per treatment. Sales of the 
first two approved products exceeded US$1 billion in 20209.

Even with these limited early applications, the market is 
forecast to grow at 20.2% per year, and to be worth $20.3 
billion by 202710. Revenues from solid tumour CAR-T cell 
therapies are forecast to exceed revenues from blood cancer 
CAR-T cell therapies by 203011.

AdAlta and Carina will jointly own products that achieve 
in vivo proof of concept. Each product may be further 
developed and commercialised in one of three ways: 
continuing to co-develop the products together; selecting 
one company to continue development alone (key cross 
licensing terms including development and commercialisation 
milestones and royalties have been pre-agreed); or out-
license immediately to third parties. In the first two cases, 
either or both parties will incur additional costs prior to a 
subsequent on-licensing to a commercialisation partner. 

16

ManufacturerDrug nameStatus FDA approvedNotable CAR-T transactionsUS$ revenue 2020August 2017 (acute lymphoblastic leukemia, large B cell lymphoma)UPenn and Novartis Alliance Aug 2012US$474mOctober 2017 (large B cell lymphoma)Gilead acquired Kite Aug 2017 US$11.9bUS$569mJuly 2020 (mante cell lymphoma)Gilead acquired Kite Aug 2017 US$11.9bUS$44mFebruary 2021 (large B cell lymphoma)Celgene acquired Juno Jan 2018 US$9b; BMS acquired Celgene Jan 2019 US$74bN/AMarch 2021 (multiple myeloma)Celgene acquired Juno Jan 2018 US$9b; BMS acquired Celgene Jan 2019 US$74bN/AAdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

There is a very active deal making environment for CAR-T 
cell products at all stages of development. CAR-T companies 
have raised more than US$3.7 billion between September 
2017 and February 2021 and five CAR-T company 
acquisitions over the same period were valued at US$96 
billion in aggregate12. Big pharma are actively participating, 
with Novartis, Gilead, Astellas, Janssen, BMS, Bayer, AbbVie 
and Celgene all completing deals in the past 4 years.

Platform technologies – i-bodies

AdAlta’s i-body technology is applicable in the global 
antibody market, worth US$131 billion in 201914. i-bodies 
are a member of the single domain antibody segment. 
The first single domain antibody product, caplacizumab, 
was approved by the US Food and Drug Administration 
in February 2019. Caplacizumab was discovered and 
developed by Ablynx whose single domain antibody 
platform was derived from camelid (llamas, camels, etc) 
immune systems. Ablynx was acquired by Sanofi in January 
2018, ten years after its first product commenced clinical 
trials, for €3.8 billion.

GPCRs are the largest human membrane protein family 
and regulate large numbers of diverse physiological 
processes and so are of significant interest as drug targets. 
Approximately one third of all approved drugs target a 
GPCR and these drugs had aggregate sales of US$890 
billion from 2011-201515. Of the 400 known GPCRs 
(excluding those associated with the sense of smell), only 
108 are acted on by approved drugs (and even then not 
optimally) with only 66 more the subject of clinical trials, 
leaving nearly two thirds of GPCRs as untapped therapeutic 
potential. There are very few GPCR targeted monoclonal 
antibodies approved or in late clinical development, 
highlighting the challenges of drugging these targets using 
standard technologies.

There is significant potential to create valuable assets and 
pipelines applying i-bodies to GPCRs.

There is no guarantee that AdAlta will be able to execute 
transactions of the type or value of those listed above.

12BioInformant, CAR-T funding brief – financing rounds, acquisitions 
and IPOs, 2021
13https://www.businesswire.com/news/home/20210204006011/
en/Gilead-Sciences-Announces-Fourth-Quarter-and-Full-Year-142020-
Financial-Results; https://www.novartis.com; https://www.celgene.
com/newsroom/cellular-immunotherapies/celgene-corporation-to-
acquire-juno-therapeutics-inc/
14MarketData Forecast, Global Antibodies Market Size, Share, 
Trends and Growth Analysis Report Forecast 2019 to 2024, August 
2019
15AS Hauser et al, Nature Reviews Drug Discovery, 2017 (16) 829

Significant milestones achieved 
during the reporting period 

AD-214

First ever Phase I clinical trial results establish 
excellent safety profile for AD-214

During the year ended 30 June 2021, AdAlta commenced 
and completed dosing of 50 healthy volunteer participants 
in the Company’s first ever clinical trial. 42 participants 
received single doses of AD-214 up to 20 mg/kg or 
placebo and 8 received three doses of AD-214 at 5 mg/
kg or placebo intravenously every two weeks. Single dose 
results were announced in March 2021 and preliminary 
multiple dose results were announced after the end of the 
reporting period.

This Phase I program achieved its objective, establishing 
an excellent safety profile for AD-214 via intravenous 
administration and providing clear evidence that AD-214 
engages the CXCR4 receptor on white blood cells. From a 
safety perspective there were no dose limiting toxicities or 
adverse events of clinical concern, no concerning clinical 
laboratory or organ function results and no concerning 
immune responses. There were no differences between 
participants receiving single and multiple doses except for 
moderate infusion related reactions in some participants 
receiving both placebo and active drug that was attributed 
to the formulation. The supervising Human Research Ethics 
Committee approved further dose escalation in the multi-dose 
program prior to the Company electing to conclude the study.

The pharmacokinetic profile of AD-214 (concentration in 
the blood) increased linearly with dose and demonstrated 
rapid serum clearance. AD-214 was shown to bind to 
and occupy the CXCR4 receptors on white blood cells 
well beyond the clearance from circulation, supporting a 
potential pharmacodynamic and therapeutic effect that is 
not dependent on circulating drug concentration. The level 
and duration of receptor occupancy increased with dose, 
with more than 60% receptor occupancy observed at three 
weeks following a single dose at 20 mg/kg, supporting 
extended dosing. Biomarkers of CXCR4 engagement include 
circulating white blood cell and blood stem cell counts and 
serum concentrations of SDF-1, the natural ligand of AD-
214. All showed the expected transient and dose dependent 
increases following administration of AD-214. Multiple 
dose pharmacokinetic and pharmacodynamic results were 
consistent with single dose results and there was no evidence 
of drug tolerance or drug accumulation across multiple doses.

17

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

PET tracer development informs development of 
inhaled formulation for next clinical studies

In December 2019, the Company announced the award of 
A$1 million over two years from the Australian Government’s 
Medical Research Future Fund (MRFF) through the 
Biomedical Translation Bridge (BTB) program to develop and 
clinically evaluate a radiolabeled version of AD-214 (RL-
AD-214) for imaging of the cell surface receptor CXCR4 (the 
target of AD-214) in IPF patients.

During the year ended 30 June 2021, the development and 
pre-clinical evaluation of RL-AD-214 was completed. Pre-
clinical imaging in healthy mice and non-human primates 
conducted during the period and reported post period end 
demonstrated the value of this technique. These studies 
showed that, in addition to localizing in tissues containing 
high concentrations of CXCR4 expressing immune cells, more 
than half the administered dose of AD-214 rapidly distributed 
to the liver where it is unavailable for therapeutic effect. This 
rapid liver distribution appears to be unique to AD-214 (it 
has not been observed for other i-bodies tested to date) and 
has not been associated with any adverse events or changes 
in liver function in pre-clinical toxicology or human clinical 
studies to date.

This program has thus achieved its near-term objective early, 
enabling visualization of AD-214 distribution and informing 
optimal dosing and route of administration. AdAlta will 
now progress an inhaled form of AD-214 into future clinical 
studies for IPF while continuing to explore improvements to 
the intravenous formulation for other indications.

Regulatory and intellectual property 
portfolio advances

On 24 February 2021, AdAlta announced that the US 
Food and Drug Administration (FDA) had granted an 
Orphan Drug Designation to AD-214 for IPF. Orphan Drug 
Designation is designed to encourage and provide special 
incentives to biopharmaceutical companies that undertake 
the development of promising potential treatments for rare or 
‘orphan’ diseases that affect fewer than 200,000 people in 
the United States.

Orphan Drug Designation entitles AD-214 to certain benefits 
during development for IPF including eligibility for seven years 
market exclusivity post approval, tax credits of 50% of qualified 
clinical drug testing costs awarded upon approval, additional 
protocol assistance, reduced review times and waiver of certain 
marketing authorisation application fees. In addition to bringing 
novel therapies to sufferers of rare diseases more rapidly, 
these benefits add additional economic value to AD-214 for 
AdAlta and its eventual commercialisation partners.

On 19 May 2021, AdAlta announced that Japan Patent 
Number 6863897 entitled “CXCR4 binding molecules and 

methods of use thereof” was granted by the Japanese Patent 
Office with an expiration date of 8 January 2036. This 
patent includes the composition of AD-214 and its use in 
therapeutic and diagnostic applications, including IPF. 

Pre-clinical studies for indication extension

AdAlta continues to evaluate AD-214 in multiple pre-clinical 
models of fibrosis and cancer.

Granzyme B PET imaging agent 
progresses to preclinical development

In September 2019, AdAlta announced a co-discovery and 
development collaboration with GE Healthcare to discover 
i-bodies that bind to granzyme B for use as an imaging 
agent in cancer diagnostics.

During the period ended 30 June 2021, AdAlta successfully 
completed the i-body discovery phase and GE Healthcare 
exercised its option to progress a panel of i-bodies binding 
granzyme B into pre-clinical development. The companies 
also extended the scope of their collaboration, with AdAlta 
now providing additional support for i-body manufacturing 
development and in vitro testing.

GE Healthcare paid AdAlta A$763,190 in research fees 
related to the discovery stage of the collaboration during the 
financial year, bringing the total fees and milestones paid 
to date under the collaboration to A$1,379,009. Additional 
research fees will be paid in future for AdAlta support during 
pre-clinical and manufacturing development. 

Business development
During the year AdAlta continued to develop relationships 
with potential licensing partners for AD-214 and i-body 
co-development partners. The Company now anticipates 
that the first significant partnering opportunity for AD-214 
will open prior to commencement of the next clinical trial 
once pre-clinical data on the efficacy and distribution of the 
inhaled formulation of AD-214 is available. The Company 
is also pleased with the pipeline of potential i-body co-
development partners with several under confidentiality 
agreement or evaluating the i-body technology under 
material transfer agreements.

COVID-19 response
The Company is fortunate that to date its major programs 
have not been materially affected by the COVID-19 
environment. A comprehensive risk assessment and 
contingency plan is in place and continuously evaluated.

AdAlta’s laboratories at La Trobe University have remained 

18

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

continuously open though out 2020 and 2021, with remote 
working where possible and modified work practices 
implemented. The Phase I trial was conducted at CMAX 
Clinical Research in Adelaide and Scientia Clinical Research 
in Sydney to mitigate risks to healthy volunteer recruitment.

product is now anticipated to be available for these trials 
in mid-2023. There may be longer term impacts on the 
state of affairs of the Company or the environment within 
which it operates, the extent of which the Company cannot 
currently estimate.

AdAlta is observing increases in lead times and supply 
shortages for some laboratory consumables, manufacturing 
raw materials, and contract manufacturing capacity. In 
particular, lead times for contract manufacturing of biologics 
are extending significantly. To mitigate this impact, AdAlta 
has now secured a manufacturing slot for the next batch of 
clinical grade AD-214 to support future clinical trials. Drug 

The Company continues to actively monitor literature 
reporting a likely significantly increased burden of lung 
fibrosis in patients recovering from COVID-19 infection and 
clinical studies exploring the long-term progression of this 
fibrosis. This enables the potential of AD-214 to contribute 
to the long-term care of these recovering patients to 
be assessed.

Financial results
The loss for the company after providing for income tax amounted to $5,628,355 (30 June 2020: $6,006,456).

The year ended 30 June 2021 operating results included the following:

License and collaboration Income

R&D tax incentive

Other revenue

Research and development expenses (external)

Corporate administration expenses

Share based payment expenses

Employee benefit expense

Financial liquidity and 
capital resources
The Company began the year with $3.37 million cash 
at bank.

On 11 August 2021, the Company completed a Placement 
of 40,000,000 ordinary shares and on 7 September 2021, 
the Company completed a fully allocated Entitlement Issue 
of 40,986,403 ordinary shares and a further placement 
of 243,837 ordinary shares, raising $8.12 million of new 
funding before costs. Almost 70% of funds raised were from 
existing shareholders.

On 25 June 2021, AdAlta announced a loan facility with 
Radium Capital providing the Company with immediate 
access to up to 80% of its estimated accrued RDTI rebate for 
the three quarters to 31 March 2021. As at 30 June 2020, 
the Company had drawn funds of $1.68 million under this 
facility which is secured against the FY2021 RDTI refund.

On 2 July 2021, the Company announced the issuance of 
3,275 ordinary shares following exercise of listed options, 
raising $926 in new funding before costs. 23,345,078 listed 
options expired unexercised on 30 June 2021.

2021

$

848,190 

2,854,818 

281,365 

(6,233,515)

(1,333,098)

(517,065)

(1,088,689)

2020

$

615,819 

3,143,912 

68,000 

(7,012,240)

(1,036,613)

(590,458)

(816,152)

Net cash flow from operations, including RDTI refund of 
$3.14million (prior year: $3.50million), was an outflow of 
$4.78million (prior year: $5.89million).

The Company ended the year with $5.79 million cash at 
bank on 30 June 2021.

AdAlta manages its research expenditure as a series of 
projects that can be commenced, accelerated, slowed or 
halted to manage overall cash reserves.

As a result, the Directors believe the Company is in a strong 
and stable financial position.

Leadership
On 22 July 2020, the Company appointed Dr. David Fuller 
as a Non-Executive Director.

Events after the reporting period
On 1 July 2021, AdAlta announced that it had accepted an 
AD-214 clinical material resupply proposal under a master 
services agreement with its contract manufacturing partner, 
KBI Biopharmaceuticals Inc. The scheduled production of 

19

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

bulk AD-214 will mean clinical drug product is available for 
the commencement of clinical trials in patients in the first half 
of 2023.

On 2 July 2021 a total of 3,725 ordinary shares were 
issued on exercise of listed options for gross proceeds to the 
Company of $925. 

On 19 July 2021, the Company announced the preliminary 
results of multi-dose intravenous studies of AD-214 in healthy 
volunteers and the results of pre-clinical development of RL-
AD-214 for PET imaging. Taking the totality of these results 
and the next available clinical supplies of AD-214, AdAlta 
has elected to advance the development of an inhaled 
formulation of AD-214. An inhaled formulation will offer 
greater patient convenience, more flexible dose scheduling 
and lower cost of goods. Importantly, AdAlta anticipates that 
the development of an inhaled formulation can occur within 
the time available prior to the commencement of the next 
clinical studies of AD-214 in patients, resulting in no delay in 
the timelines to efficacy data. PET imaging using RL-AD-214 
will continue to inform pre-clinical development of the inhaled 
formulation. The Phase I program in healthy volunteers has 
been concluded and a planned Phase Ib protocol using 
RL-AD-214 in patients to assess distribution and lung tissue 
receptor occupancy will not proceed. AdAlta will continue to 
explore improvements to the AD-214 intravenous formulation 
for potential use in other fibrotic indications.

On 24 August 2021, AdAlta and Carina Biotech Pty Ltd 
announced a collaboration to develop unique, precision 
engineered, i-body enabled CAR-T cell therapeutics to 
provide new hope for patients with cancer. 

Under the collaboration the parties will work together on 
up to 5 tumour antigen targets, commencing in a staged 
fashion over the next two years. The first two targets have 
been selected but not disclosed. AdAlta’s role is to discover 
i-bodies against these targets. Carina’s roll is to then engineer 
them into CAR-T cells and test them in vitro and then in vivo 
to demonstrate proof of concept and select optimal CAR 
constructs to progress as CAR-T cell therapeutics. Targets 
may be combined to create bi-specific CAR-Ts. AdAlta and 
Carina will jointly own the collaboration intellectual property 
and products to proof-of-concept stage. Following proof of 
concept, the parties may elect to continue to co-develop the 
products together, choose one party to continue development 
independently, or out-license immediately to third parties to 
continue development.

Other than outlined above or elsewhere in this report, 
there has not been any matter or circumstance that has 
arisen subsequent to the end of the financial year that 
has significantly affected, or may significantly affect, the 
operations of the Company, the results of those operations, or 
the state of affairs of the Company in future financial years.

Future developments, prospects 
and business strategies
During FY2022 the Company’s focus is on:

•  Preparing for clinical studies of AD-214 in patients by 

developing an inhaled formulation of AD-214;

•  Continuing pre-clinical studies of AD-214 in other fibrotic 

indications and cancer;

•  Supporting manufacturing process development for 
granzyme B binding i-bodies with GE Healthcare;

•  Initiating discovery and optimisation of i-bodies against the 

first two targets selected for the Carina collaboration;

•  Initiating i-body discovery on two new GPCR targets for 

AdAlta’s internal pipeline; and

•  Progressing i-body platform continuous 

improvement initiatives.

The Company anticipates completing initial inhalation 
formulation feasibility studies before the end of 2021, and 
to demonstrate efficacy and dose optimisation in relevant 
animal models of IPF during the first half of 2022. These 
studies will include imaging to demonstrate biodistribution. 
Inhaled toxicology studies are planned to commence in the 
second half of 2022. Additional pre-clinical data in other 
indications is also expected during the last half of 2021.

AdAlta anticipates being able to provide an update on the 
progress of preclinical development of granzyme B i-body 
enabled PET imaging agents by GE Healthcare in the first 
half of 2022.

Evaluation of new GPCR targets for AdAlta’s internal pipeline 
is on track to enable discovery research to commence on two 
new targets by the end of 2021.

The next steps under the collaboration with Carina are to 
finalise research program outlines for the first two targets 
during the remainder of 2021. First experimental results are 
expected during the first half of 2022.

AdAlta’s pipeline advancement and expansion gained 
significant momentum during the year to 30 June 2021 as 
exemplified by the successful completion of a Phase I clinical 
trial for AD-214, progression of the collaboration with GE 
Healthcare through the first major milestone to preclinical 
development and the establishment of our next collaboration 
with Carina. The Company is on track to achieve its goal of 
five active programs by the end of 2021.

20

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Likely developments and 
expected results of operations
Information on likely developments in the operations of the 
company and the expected results of operations have not been 
included in this report because the Directors believe it would be 
likely to result in unreasonable prejudice to the company.

Environmental regulation
The Company laboratories are located within the La 
Trobe Institute for Molecular Sciences, La Trobe University, 
Victoria, Australia and adopt the environmental policies and 
procedures of La Trobe University. The Company’s operations 
are not subject to significant environmental regulation under 
the Australian Commonwealth or State Law.

21

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Remuneration report (audited)
This remuneration report, which forms part of the Directors’ 
report, sets out information about the remuneration of AdAlta 
Limited’s key management personnel for the financial year 
ended 30 June 2021 in accordance with the requirements of 
the Corporations Act 2001 and its Regulations.

indirectly, including any Director (whether executive or 
otherwise) of the Company.

The prescribed details for each person covered by this report 
are detailed below under the following headings:

•  key management personnel

•  details of remuneration 

•  remuneration policy

•  additional disclosures 

The term ‘key management personnel’ refers to those persons 
having authority and responsibility for planning, directing 
and controlling the activities of the Company, directly or 

•  relationship between the 
remuneration policy and 
Company performance

relating to key management 
personnel

Key management personnel
The Directors and other key management personnel of the Company during the financial year were:

Non-Executive Directors

Dr Paul MacLeman

Ms Elizabeth McCall

Dr Robert Peach

Dr David Fuller (appointed 22 July 2020)

Dr James Williams

Executive Directors

Dr Timothy Oldham

Position

Non-Executive Chairman

Non-Executive Director

Non-Executive Director

Non-Executive Director

Alternate Director to Elizabeth McCall

Position

Chief Executive Officer and Managing Director

The named persons held their current position for the whole of the financial year and since the end of the financial year unless 
otherwise indicated.

Remuneration policy
The Remuneration and Nominations Committee is currently 
responsible for determining and reviewing compensation 
arrangements for key management personnel. All 
recommendations of the Remuneration and Nominations 
Committee require Board approval for adoption. The 
Company has a Remuneration Committee, which consists of 
Paul MacLeman (Chair of Remuneration Committee), Robert 
Peach and Liddy McCall. The remuneration policy, which is 
set out below, is designed to promote superior performance 
and long-term commitment to the Company.

Non-Executive Director remuneration

Non-Executive Directors are remunerated by way of fees, 
in the form of cash, non-cash benefits, superannuation 
contributions or salary sacrifice into equity. Non-Executive 
Directors are also eligible to receive equity grants as 
a component of fees under share and option schemes 
generally made in accordance with thresholds and on terms 
set in plans approved by shareholders.

Board fees were suspended from 1 April 2020 to 1 
September 2020 as part of the Company’s COVID-19 risk 
and management plan.

Shareholders’ approval must be obtained in relation to the 
overall limit set for the Non-Executive Directors’ fees. The 
maximum aggregate remuneration approved by shareholders 
for Non-Executive Directors is $350,000 per annum. The 
Directors set the individual Non-Executive Director fees within 
the limit approved by shareholders. Non-executive Directors 
are not provided with retirement benefits.

Executive Director and Executive remuneration

Executive Directors and Executives receive a base 
remuneration, which is at market rates, and may be entitled 
to performance based remuneration, which is determined on 
an annual basis. Overall remuneration policies are subject 
to the discretion of the Board and can be changed to reflect 
competitive and business conditions where it is in the interests 
of the Company and shareholders to do so. Executive 
remuneration and other terms of employment are reviewed 
annually by the Board having regard to performance, 
relevant comparative information and expert advice.

The Board’s ‘remuneration policy reflects its obligation to 
align executive remuneration with shareholders’ interests 
and to retain appropriately qualified executive talent for the 
benefit of the Company. The main principles are:

22

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

(a)  remuneration reflects the competitive market in which the 

Company operates;

(b)  individual remuneration should be linked to performance 

criteria if appropriate; and

(c)  executives should be rewarded for both financial and non-

financial performance.

The total remuneration of executives consists of the following:

(a) Salary – executives receive a fixed sum payable monthly 
in cash plus superannuation at 9.5% of salary in FY2021 
(increasing to 10% in FY2022) on salary up to the statutory 
maximum superannuation contribution base;

(b) Cash at risk component (short term incentive) – executives 
may receive a variable cash sum up to a maximum 
percentage of salary that is payable annually at the end 
of each financial year on the basis of performance against 
goals set at the beginning of each financial year (as 
assessed by the Board);

(c) Equity component (long term incentive) – executives 
may participate, at the discretion of the board, in share 
and option schemes generally made in accordance 
with thresholds and on terms set in plans approved by 
shareholders and otherwise at the discretion of the Board. 
In exceptional circumstances the Board may, subject to any 
necessary shareholder approval, issue shares and options to 
executives outside of approved schemes. Long term incentive 
awards are typically time limited and are made on a case by 
case basis having regard to the overall number, value and 
remaining term of unexpired incentive securities held by the 
executive, benchmarking and performance; and

(d) Other benefits – executives may, if deemed appropriate 
by the Board, be provided with a fully expensed mobile 
phone and other forms of remuneration.

The Board has not formally engaged the services of a 
remuneration consultant to provide recommendations when 
setting the remuneration received by Directors or other key 
management personnel during the financial year.

Relationship between the 
remuneration policy and 
Company performance
The Board considers that at this time, evaluation of the 
Company’s financial performance using generally accepted 
measures such as profitability, total shareholder return or 
per Company comparison are not relevant due to the early 
stage of development of the Company’s assets as outlined 
in the Directors’ report. Remuneration is structured to align 
short term incentives with the achievement of operational 
objectives that meaningfully progress the development of 
the Company’s assets each year and to align long term 
incentives with increasing shareholder value as a result of 
developing and increasing those assets over the mid-term.

Details of remuneration
Remuneration is reported as Earned Remuneration and 
Realised Remuneration.

Earned Remuneration is the accounting value of remuneration 
awarded in a period as recorded in the financial statements 
of the Company. This includes cash payments during the 
period plus the value of long term incentives awarded and 
expensed during the period which have an accounting value 
that may not be immediately realisable by the recipient, 
for example because options have an exercise price that is 
equal to or below the current share price.

Realised option value is the value of remuneration realised or 
becoming realisable by the recipient during the period. This 
includes cash payments during the period plus the value of 
long term incentive payments from the current or any prior 
period that have become immediately realisable by the 
recipient during the period. This will include, for example, 
the value of shares issued on the exercise of options less the 
exercise price (as measured at the time of exercise)

Amounts of remuneration

Details of the remuneration of key management personnel of 
the company are set out in the following tables.

23

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Short-term  
benefits

Cash salary 
and fees

$

Other

58,980
40,000
40,000
40,000
-

Post-
employment 
benefits

Super-
annuation

Total cash 
payments

Share-based 
payments

Total earned 
remuneration 

Realised 
option value

Equity-settled

$

$

$

-
-
-
-
-

$

$

5,603
-
-
-
-

64,583
40,000
40,000
40,000
-

$

-
-
-
-
-

64,583
40,000
40,000
40,000
-

2021

Non-Executive Directors:2
Dr Paul MacLeman
Ms Elizabeth McCall3
Dr Robert Peach
Dr David Fuller1
Dr James Williams3 (Alternate)

Executive Directors:
Dr Timothy Oldham

300,000
478,980

29,750
29,750

21,694
27,297

351,444
536,027

147,906
147,906

499,350
683,933

1David Fuller was appointed on 22 July 2020.
2Non-Executive Director fees were suspended effective 1 April 2020 under the Company’s COVID-19 risk management plan and were not 
reinstated until 1 September 2020. Paul MacLeman continued to receive 50% of his fee as Chair during this period. As of 1 January 2021 
Director fees were increased $10,000 per annum for Non-Executive Chair and $5,000 per annum for Non-Executive Directors.
3Liddy McCall is contracted under a service agreement with Yuuwa Capital LP. Fees are paid directly to Yuuwa Capital LP. Yuuwa Capital LP is 
a venture capital fund that is managed by its General Partner, Yuuwa Management LP/Yuuwa Capital Management Pty Ltd which is associated 
with James Williams and Liddy McCall. James Williams resigned as a Director on 27 March 2020 and transitioned to an alternate director to 
Liddy McCall on the same day. 

Short-term  
benefits

Cash salary 
and fees

Other

Post-
employment 
benefits

Super-
annuation

Total cash 
payments

Share-based 
payments

Total earned  
remuneration

Realised 
option value

Equity-settled

$

$

$

$

$

$

2020
Non-Executive Directors:7
Dr Paul MacLeman1
Dr James Williams2
Ms Elizabeth McCall2
John Chiplin3
Dr Robert Peach
Rosalind Wilson4

Executive Directors:
Samantha Cobb5
Timothy Oldham6

71,198
33,750
33,750
22,500
33,750
27,397

160,376
209,987
592,708

-
-
-
-
-
-

-
-
-

6,764
-
-
-
-
2,603

77,962
33,750
33,750
22,500
33,750
30,000

$

-
-
-
-
-
-

77,962
33,750
33,750
22,500
33,750
30,000

9,491
15,079
33,937

169,867
225,066
626,645

12,423
167,712
180,135

182,290
392,778
806,780

1Paul MacLeman filled the role as Executive Director during the transition of outgoing CEO and Managing Director Samantha Cobb and 
incoming CEO and Managing Director Timothy Oldham. During this time Paul MacLeman was remunerated $21,086 in addition to the Non-
Executive Chair fees.
2Liddy McCall and James Williams are contracted under a service agreement with Yuuwa Capital LP. Fees are paid directly to Yuuwa Capital LP. 
Yuuwa Capital LP is a venture capital fund that is managed by its General Partner, Yuuwa Management LP/Yuuwa Capital Management Pty Ltd 
which is associated with James Williams and Liddy McCall. James Williams resigned as a Director on 27 March 2020 and transitioned to an 
alternate director to Liddy McCall on the same day. Fees paid to Yuuwa Capital LP for James Williams are only for the time James was a Director 
of the Company. No fees are paid while James is acting as an Alternate Director.
3John Chiplin resigned as a Director of the Company on 3 January 2020.
4Rosalind Wilson was appointed on 1 August 2019 and resigned as a Director of the Company on 27 March 2020.
5Samantha Cobb resigned as CEO on 12 August 2019 and as a Director of the Company on 25 August 2019.
6Timothy Oldham was appointed CEO and Managing Director on 8 October 2020.
7Non-Executive Director fees were suspended effective 1 April 2020 under the Company’s COVID-19 risk management plan and were not 
reinstated prior to 30 June 2020. Paul MacLeman continued to receive 50% of his fee as Chair during this period.

24

-
-
-
-
-

-
-

-
-
-
-
-
-

-
-
-

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Arrangements with Directors

Position

Non-Executive Chair
Non-Executive Directors

Annual salary  

(to 31 December 2020)
$65,000
$45,000

Annual Salary

(effective 1 January 2021)
$75,000
$50,000

Payment of Non-Executive Director fees were suspended from 1 April 2020 and reinstated on 1 September 2020 as part of the 
Company’s COVID-19 risk and management plan. Board Chair, Paul MacLeman received 50% of his fee as Chair during this period.

The Company has entered into consulting agreements with all Directors. Under the terms of these consulting agreement, the 
agreements can be terminated by either party by giving one months’ notice. Further, continuation of appointment is subject to re-
election at a forthcoming AGM.

Elizabeth McCall is appointed as the nominated Director of Yuuwa Capital LP, with James Williams as Ms McCall’s Alternate 
Director. Director fees are not payable to Alternate Directors. The director fees in respect of Ms McCall are paid to Yuuwa Capital 
LP and not to the direct benefit of Ms McCall or Dr Williams.

No additional fees are payable to Directors for their involvement in Board committees.

On appointment to the Board, all Non-Executive Directors are required to sign a letter of appointment with the Company. The 
letter of appointment summarises the Board policies and terms, including compensation relevant to the office or Director.

Additional disclosures relating to key management personnel 
Fully paid ordinary shares of AdAlta Limited

2021
Dr Timothy Oldham
Dr Paul MacLeman
Dr James Williams (Alternate)1
Ms Elizabeth McCall1
Dr Robert Peach
Dr David Fuller2

Balance at  
1 July

Received on 
exercise of options

Number
120,000
472,970
233,334
133,334
1,295,999
-

Number
-
-
-
-
-
-

Net other  
change

Number
-
-
-
-
-
149,808

Additions

Number
91,000
-
20,000
33,334
-
37,452

Balance at  
30 June

Number
211,000
472,970
253,334
166,668
1,295,999
187,260

1 James Williams and Elizabeth McCall’s interests do not include 54,059,848 ordinary shares beneficially owned by the limited partners of 
Yuuwa Capital LP, a venture capital fund. Yuuwa Capital Management Pty Ltd which is associated with James Williams and Elizabeth McCall 
provides investment management services to Yuuwa Capital LP.
2 David Fuller held 149,808 shares on appointment as Director on 22 July 2020.

2020
Dr Timothy Oldham
Dr Paul MacLeman
Dr James Williams3
Ms Elizabeth McCall3
Dr Robert Peach
Samantha Cobb1
John Chiplin2
Rosalind Wilson

Balance at 1 July

Received on 
exercise of options

Number
-
439,636
100,000
100,000
333,333
1,443,843
1,000,000
-

Number
-
-
-
-
-
-
-
-

Net other  
change

Number
-
-
-
-
-
(1,443,843)
(1,000,000)
-

Additions

Number
120,000
33,334
133,334
33,334
962,666
-
-
-

Balance at  
30 June

Number
120,000
472,970
233,334
133,334
1,295,999
-
-
-

1Samantha Cobb held 1,443,843 shares on resignation as Director on 27 March 2020.
2John Chiplin held 1,000,000 shares on resignation as Director on 3 January 2020.
3James Williams and Elizabeth McCall’s interests do not include 54,059,848 ordinary shares beneficially owned by the limited partners of 
Yuuwa Capital LP, a venture capital fund. Yuuwa Capital Management Pty Ltd which is associated with James Williams and Elizabeth McCall 
provides investment management services to Yuuwa Capital LP.

25

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ REPORT (Continued)

Share Options of AdAlta Limited

Balance at  
1 July

Granted as 
compensation

Cancelled

Net other 
change

Balance at 
30 June

Vested and 
exercisable

Options vested 
during year

2021

Number

Number

Number

Number

Number

Number

Number

Dr Timothy Oldham

4,929,060

Dr Paul MacLeman

Dr James Williams (Alternate)

Ms Elizabeth McCall

Dr Robert Peach

Dr David Fuller

46,667

66,667

16,667

681,333

-

-

-

-

-

-

-

-

(16,667)

(66,667)

(16,667)

(481,333)

-

-

-

-

-

-

-

4,929,060

1,971,624

1,478,718

30,000

30,000

-

-

-

-

-

-

-

200,000

200,000

100,000

-

-

-

Balance at  
1 July

Granted as 
compensation

Cancelled

Net other 
change

Balance at 
30 June

Vested and 
exercisable

Options vested 
during year

2020

Dr Timothy Oldham

Dr Paul MacLeman

Dr James Williams

Ms Elizabeth McCall

Dr Robert Peach

Samantha Cobb1

John Chiplin1

Number

Number

Number

Number

Number

Number

-

4,929,060

30,000

-

-

200,000

1,750,000

20,000

-

-

-

-

-

-

-

4,929,060

492,906

16,667

66,667

16,667

46,667

66,667

16,667

46,667

66,667

16,667

-

-

-

-

-

481,333

681,333

481,333

381,333

(1,750,000)

(20,000)

-

-

-

-

-

-

-

-

Number

492,906

-

-

-

1Balance of options held at date of resignation as a Director.
2Listed options issued under the Prospectus dated 23 May 2019.

Voting and comments made at the company’s 2020 Annual 
General Meeting (AGM)
At the Company’s 2020 Annual General Meeting (AGM), a resolution to adopt the 2020 Remuneration Report was put to the vote 
and greater than 75% of the votes cast were cast in favour of the resolution.

No comments were made at the AGM by shareholders in relation to the Remuneration Report.

This Directors’ report, incorporating the remuneration report, is signed in accordance with a resolution made pursuant to s.298(2) 
of the Corporations Act 2001.

This concludes the remuneration report, which has been audited.
This report is made in accordance with a resolution of Directors, pursuant to section 298(2)(a) of the Corporations Act 2001.

On behalf of the Directors

Paul MacLeman
Chairman

26 August 2021 
Melbourne

26

AdAlta Limited Annual Report 2021 ABN 92 120 332 925AUDITOR’S INDEPENDENCE DECLARATION 

As lead auditor for the audit of AdAlta Limited for the year ended 30 June 2021, I 
declare that, to the best of my knowledge and belief, there have been: 

a) No  contraventions  of  the  auditor  independence  requirements  of  the 

Corporations Act 2001 in relation to the audit; and 

b) No contraventions of any applicable code of professional conduct in relation 

to the audit. 

BUTLER SETTINERI (AUDIT) PTY LTD 

ROBERT HALL 
Director 

Perth 
Date:   26 August 2021 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STATEMENT OF PROFIT OR LOSS AND 
OTHER COMPREHENSIVE INCOME

FOR THE YEAR ENDED 30 JUNE 2021

Revenue

License and collaboration Income

Interest received

Other revenue

Total revenue

Expenses

Research and development expenses (external)

Corporate administration expenses

Share based payment expenses

Net foreign exchange (loss) / gain

Patent and legal costs

Depreciation and amortisation expense

Employee benefit expense

Finance costs

Total expenses

Note

2021

$

2020

$

848,190 

615,819 

2,942 

19,149 

3

3,136,183 

3,211,912 

3,987,315 

3,846,880 

(6,233,515)

(7,012,240)

(1,333,098)

(1,036,613)

16

(517,065)

(590,458)

(115,362)

(70,205)

(201,224)

(170,289)

9

(29,079)

(41,833)

(1,088,689)

(816,152)

(97,638)

(115,546)

(9,615,670)

(9,853,336)

Loss before income tax expense

(5,628,355)

(6,006,456)

Income tax expense

4

-  

-  

Loss after income tax expense for the year attributable to the owners of AdAlta Limited

(5,628,355)

(6,006,456)

Other comprehensive income for the year, net of tax

-  

-  

Total comprehensive income for the year attributable to the owners of AdAlta Limited

(5,628,355)

(6,006,456)

Basic earnings per share

Diluted earnings per share

5

5

Cents

(2.40)

(2.40)

Cents

(3.66)

(3.66)

The above statement of profit or loss and other comprehensive income should be read in conjunction with the accompanying notes.

28

AdAlta Limited Annual Report 2021 ABN 92 120 332 925STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2021

Current assets

Cash and cash equivalents

Trade and other receivables

Other current assets

Total current assets

Non-current assets

Property, plant and equipment

Other non-current assets

Total non-current assets

Total assets

Liabilities

Current liabilities

Trade and other payables

Borrowings

Provisions

Other current liabilities

Total current liabilities

Total liabilities

Net assets

Equity

Issued capital

Reserves

Accumulated losses

Total equity

Note

2021

$

2020

$

6

7

8

9

10

11

12

13

14

15

16

5,791,389 

3,366,503 

3,108,386 

3,364,391 

77,918 

-  

8,977,693 

6,730,894 

71,689 

-  

98,648 

77,918 

71,689 

176,566 

9,049,382 

6,907,460 

865,740 

829,858 

1,687,491 

2,191,327 

70,952 

38,849 

30,487 

153,702 

2,663,032 

3,205,374 

2,663,032 

3,205,374 

6,386,350 

3,702,086 

36,232,030 

28,436,476 

1,381,087 

864,022 

(31,226,767)

(25,598,412)

6,386,350 

3,702,086 

The above statement of financial position should be read in conjunction with the accompanying notes. 

29

AdAlta Limited Annual Report 2021 ABN 92 120 332 925STATEMENT OF CHANGES IN EQUITY

FOR THE YEAR ENDED 30 JUNE 2021

Issued capital

Reserves

Unissued  
share reserve

Retained profits

Total equity

$

$

$

$

$

Balance at 1 July 2019

26,529,233

273,564

280,267

(19,591,956)

7,491,108

Loss after income tax expense for the year

Other comprehensive income for the 
year, net of tax

Total comprehensive income for the year

Transactions with owners in their capacity 
as owners:

Share-based payments 

Issue of ordinary shares

Share issue costs

Cash received requiring shareholder 
approval to issue Ordinary shares

-

-

-

-

2,059,887

(152,644)

-

-

-

-

590,458

-

-

-

-

-

-

-

-

-

(280,267)

(6,006,456)

(6,006,456)

-

-

(6,006,456)

(6,006,456)

-

-

-

-

590,458

2,059,887

(152,644)

(280,267)

Balance at 30 June 2020

28,436,476

864,022

-

(25,598,412)

3,702,086

Issued capital

Reserves

Unissued 
share reserve

Retained profits

Total equity

$

$

$

$

$

Balance at 1 July 2020

28,436,476

864,022

Loss after income tax expense for the year

Other comprehensive income for the 
year, net of tax

Total comprehensive income for the year

Transactions with owners in their capacity 
as owners:

Share-based payments 

Issue of ordinary shares

Share issue costs

-

-

-

-

8,123,024

(327,470)

-

-

-

517,065

-

-

Balance at 30 June 2021

36,232,030

1,381,087

-

-

-

-

-

-

-

-

(25,598,412)

3,702,086

(5,628,355)

(5,628,355)

-

-

(5,628,355)

(5,628,355)

-

-

-

517,065

8,123,024

(327,470)

(31,226,767)

6,386,350

The above statement of changes in equity should be read in conjunction with the accompanying notes.

30

AdAlta Limited Annual Report 2021 ABN 92 120 332 925STATEMENT OF CASH FLOWS

FOR THE YEAR ENDED 30 JUNE 2021

Cash flows from operating activities

Receipts from customers 

Payments to suppliers and employees

R & D tax incentive 

Cash receipts from other operating activities

Interest received 

Note

2021

$

2020

$

1,038,030 

615,819 

(9,162,138)

(10,091,262)

3,143,923 

3,498,774 

195,501 

2,942 

68,000 

19,457 

Net cash used in operating activities

21

(4,781,742)

(5,889,212)

Cash flows from investing activities

Payments for property, plant and equipment

Net cash used in investing activities

Cash flows from financing activities

Proceeds from issue of shares

Payment of share issue costs

Repayment of borrowings

Proceeds from borrowings

Net cash from financing activities

Net increase/(decrease) in cash and cash equivalents

Cash and cash equivalents at the beginning of the financial year

Effects of exchange rate changes on cash and cash equivalents

(2,121)

(2,121)

(2,376)

(2,376)

8,123,024 

1,779,620 

(327,471)

(153,185)

(2,284,363)

-  

1,682,890 

2,075,781 

7,194,080 

3,702,216 

2,410,217 

(2,189,372)

3,366,503 

5,555,875 

14,669 

-  

Cash and cash equivalents at the end of the financial year

6

5,791,389 

3,366,503 

The above statement of cash flows should be read in conjunction with the accompanying notes. 

31

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS

30 JUNE 2021

1. General information
The financial statements cover Adalta Limited as an 
individual entity. The financial statements are presented in 
Australian dollars, which is Adalta Limited’s functional and 
presentation currency.

Adalta Limited is a listed public company limited by shares, 
incorporated and domiciled in Australia. Its registered office 
and principal place of business is:

Unit 15 / 2 Park Drive
Bundoora VIC 3083
Australia

A description of the nature of the company’s operations and 
its principal activities are included in the Directors’ report, 
which is not part of the financial statements. 

The financial statements were authorised for issue, in 
accordance with a resolution of Directors, on 26 August 
2021. The Directors have the power to amend and reissue 
the financial statements.

2. Significant accounting policies

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 (AASB) and 
the Corporations Act 2001. The Company is a for-profit 
entity for financial reporting purposes under Australian 
Accounting Standards.

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 to 
which they apply. Material accounting policies adopted 
in the preparation of this financial report are presented 
below. They have been consistently applied unless 
otherwise stated.

Except for cash flow information, 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.

Going concern

These financial statements have been prepared on the going 
concern basis, which contemplates the continuity of normal 
business activities and the realisation of assets and settlement 
of liabilities in the normal course of business.

As disclosed in the financial statements, the Company 
incurred losses of $5,628,355 (2020: $6,006,456) 
and the Company had net cash outflows from operating 
activities of $4,781,742 (2020: $5,889,212). As at balance 
date, the Company had net current assets of $6,386,350 
(2020: $3,702,086).

The Directors believe that it is reasonably foreseeable that 
the Company will continue as a going concern and that 
it is appropriate to adopt the going concern basis in the 
preparation of the financial report.

Revenue recognition

AASB15 Revenue from contracts with customers

The Company has adopted AASB 15 from 1 July 2018. 
The standard provides a single comprehensive model for 
revenue recognition. The core principle of the standard is 
that an entity shall recognise revenue to depict the transfer 
of promised goods or services to customers at an amount 
that reflects the consideration to which the entity expects 
to be entitled in exchange for those goods or services. 
The standard introduced a new contract-based revenue 
recognition model with a measurement approach that is 
based on an application of the transaction price. This is 
described further in the accounting policies below. Credit 
risk is presented separately as an expense rather than 
adjusted against revenue. Contracts with customers are 
presented in an entity’s statement of financial position 
as a contract liability, a contract asset, or a receivable, 
depending on the relationship between the entity’s 
performance and the customer’s payment. Customer 
acquisition costs and costs to fulfil a contract can, 
subject to certain criteria, be capitalised as an asset and 
amortised over the contract period.

Interest

Interest revenue is recognised as interest accrues using the 
effective interest method. This is a method of calculating 
the amortised cost of a financial asset and allocating the 
interest income over the relevant period using the effective 
interest rate, which is the rate that exactly discounts 
estimated future cash receipts through the expected life 
of the financial asset to the net carrying amount of the 
financial asset.

Research and Development Tax Incentive

Accounted for in line with AASB 120 Government Grants 
on an accruals basis when the following recognition criteria 
have been met:

(a)  the entity reasonably expects it will comply with the 

conditions attaching to the grant; and

(b) the grant will be received.

32

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

Significant accounting policies (continued)

Income tax

The income tax expense (revenue) for the year comprises 
current income tax expense (income) and deferred tax 
expense (income).

Current income tax expense charged to profit or loss is the 
tax payable on taxable income calculated using applicable 
income tax rates enacted, or substantially enacted, as at 
reporting date. Current tax liabilities (assets) are therefore 
measured at the amounts expected to be paid to (recovered 
from) the relevant taxation authority.

Deferred income tax expense reflects movements in deferred 
tax asset and deferred tax liability balances during the year 
as well unused tax losses.

Current and deferred income tax expense (income) is 
charged or credited outside profit or loss when the tax 
relates to items that are recognised outside profit or loss.

Deferred tax assets and liabilities are calculated at the tax 
rates that are expected to apply to the period when the asset 
is realised or the liability is settled and their measurement 
also reflects the manner in which management expects to 
recover or settle the carrying amount of the related asset 
or liability.

Deferred tax assets relating to temporary differences and 
unused tax losses are recognised only to the extent that it is 
probable that future taxable profit will be available against 
which the benefits of the deferred tax asset can be utilised.

Fair value measurement

Fair value is the price the Company would receive to sell 
an asset or would have to pay to transfer a liability in an 
orderly (i.e. unforced) transaction between independent, 
knowledgeable and willing market participants at the 
measurement date.

As fair value is a market-based measure, the closest 
equivalent observable market pricing information is used 
to determine fair value. Adjustments to market values may 
be made having regard to the characteristics of the specific 
asset or liability. The fair values of assets and liabilities that 
are not traded in an active market are determined using one 
or more valuation techniques. These valuation techniques 
maximise, to the extent possible, the use of observable 
market data.

For non-financial assets, the fair value measurement also 
takes into account a market participant’s ability to use 
the asset in its highest and best use or to sell it to another 
market participant that would use the asset in its highest and 
best use.

The fair value of liabilities and the entity’s own equity 
instruments (excluding those related to share-based payment 
arrangements) may be valued, where there is no observable 
market price in relation to the transfer of such financial 
instrument, by reference to observable market information 
where such instruments are held as assets. Where this 
information is not available, other valuation techniques 
are adopted and, where significant, are detailed in the 
respective note to the financial statements.

Cash and cash equivalents

Cash and cash equivalents include cash on hand, deposits 
available on demand with banks, other short-term highly 
liquid investments with original maturities of 12 months or 
less, and bank overdrafts. Bank overdrafts are reported 
within short-term borrowings in current liabilities in the 
statement of financial position.

Trade and other receivables

Trade and other receivables include amounts due from 
customers for goods sold and services performed in the 
ordinary course of business. Receivables expected to be 
collected within 12 months of the end of the reporting period 
are classified as current assets. All other receivables are 
classified as non-current assets.

Property, plant and equipment

Each class of plant and equipment is carried at cost or fair 
value as indicated less, where applicable, any accumulated 
depreciation and impairment losses.

Plant and equipment are measured on the cost basis and 
are therefore carried at cost less accumulated depreciation 
and any accumulated impairment losses. In the event the 
carrying amount of plant and equipment is greater than its 
estimated recoverable amount, the carrying amount is written 
down immediately to its estimated recoverable amount and 
impairment losses recognised either in profit or loss or as 
a revaluation decrease if the impairment losses relate to a 
revalued asset.

Depreciation

The depreciable amount of all fixed assets is depreciated on 
a diminishing value basis over the asset’s useful life to the 
Company commencing from the time the asset is held ready 
for use.

33

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

Significant accounting policies (continued)

The depreciation rates used for each class of depreciable assets are:

Depreciation rate

Notes

Class of Fixed Asset

Computer software

Office equipment

Office equipment

Plant and Equipment

13.17%

17.31%

100.00%

28.57%

The assets’ residual values and useful lives are reviewed, and 
adjusted if appropriate, at the end of each reporting period. 
An asset’s carrying amount is written down immediately to its 
recoverable amount if the asset’s carrying amount is greater 
than its estimated recoverable amount.

Gains and losses on disposals are determined by comparing 
proceeds with the carrying amount. These gains or losses are 
recognised in profit or loss when the item is derecognised. 
When revalued assets are sold, amounts included in the 
revaluation reserve relating to that asset are transferred to 
retained earnings.

Financial instruments

Recognition, initial measurement and 
derecognition 

Financial assets and financial liabilities are recognised when 
the Company becomes a party to the contractual provisions 
of the financial instrument. Financial instruments (except for 
trade receivables)are measured initially at fair value adjusted 
by transactions costs, except for those carried “at fair value 
through profit or loss”, in which case transaction costs are 
expensed to profit or loss. Where available, quoted prices 
in an active market are used to determine the fair value. 
In other circumstances, valuation techniques are adopted. 
Subsequent measurement of financial assets and financial 
liabilities are described below.

Trade receivables are initially measured at the transaction 
price if the receivables do not contain a significant financing 
component in accordance with AASB 15.

Financial assets are derecognised when the contractual rights 
to the cash flows from the financial asset expire, or when 
the financial asset and all substantial risks and rewards are 
transferred. A financial liability is derecognised when it is 
extinguished, discharged, cancelled or expires.

Impairment

Assets acquired pre 31 December 2016

Assets acquired post 31 December 2016

events (a ‘loss event’) having occurred, which has an impact 
on the estimated future cash flows of the financial asset(s).

Impairment losses are recognised in profit or loss 
immediately. Also, any cumulative decline in fair value 
previously recognised in other comprehensive income is 
reclassified into profit or loss at this point.

Impairment of assets

At the end of each reporting period, the Company assesses 
whether there is any indication that an asset may be 
impaired. The assessment will include considering external 
sources of information and internal sources of information, 
including dividends received from subsidiaries, associates or 
joint ventures deemed to be out of pre-acquisition profits. If 
such an indication exists, an impairment test is carried out on 
the asset by comparing the recoverable amount of the asset, 
being the higher of the asset’s fair value less costs to sell 
and value in use to the asset’s carrying amount. Any excess 
of the asset’s carrying amount over its recoverable amount 
is recognised immediately in profit or loss, unless the asset 
is carried at a revalued amount in accordance with another 
Standard (e.g. in accordance with the revaluation model in 
AASB 116: Property, Plant and Equipment). Any impairment 
loss of are valued asset is treated as a revaluation decrease 
in accordance with that other Standard.

Where it is not possible to estimate the recoverable 
amount of an individual asset, the Company estimates the 
recoverable amount of the cash-generating unit to which the 
asset belongs. Impairment testing is performed annually for 
goodwill and intangible assets with indefinite lives.

Trade and other payables

Trade and other payables represent the liabilities for goods 
and services received by the Company that remain unpaid at 
the end of the reporting period. The balance is recognised as 
a current liability with the amounts normally paid within 30 
days of recognition of the liability.

At the end of each reporting period, the Company assesses 
whether there is objective evidence that a financial asset 
has been impaired. A financial asset (or a group of financial 
assets) is deemed to be impaired if, and only if, there is 
objective evidence of impairment as a result of one or more 

Provisions

Provisions are recognised when the Company has a legal or 
constructive obligation, as a result of past events, for which it 
is probable that an outflow of economic benefits will result, 
and that outflow can be reliably measured.

34

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

Significant accounting policies (continued)

Provisions are measured using the best estimate of the 
amounts required to settle the obligation at the end of the 
reporting period.

Employee benefits

Short-term employee benefits

Liabilities for wages and salaries, including non-monetary 
benefits, annual leave and long service leave expected to be 
settled within 12 months of the reporting date are recognised 
in current liabilities in respect of employees’ services up 
to the reporting date and are measured at the amounts 
expected to be paid when the liabilities are settled.

The Company’s obligations for short-term employee benefits 
such as wages, salaries and sick leave are recognised as a 
part of current trade and other payables in the statement of 
financial position.

Long-term employee benefits

The liability for annual leave and long service leave not 
expected to be settled within 12 months of the reporting 
date are recognised in non-current liabilities, provided there 
is an unconditional right to defer settlement of the liability. 
The liability is measured as the present value of expected 
future payments to be made in respect of services provided 
by employees up to the reporting date using the projected 
unit credit method. Consideration is given to expected 
future wage and salary levels, experience of employee 
departures and periods of service. Expected future payments 
are discounted using market yields at the reporting date 
on national government bonds with terms to maturity and 
currency that match, as closely as possible, the estimated 
future cash outflows.

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.

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.

Market conditions are taken into consideration in determining 
fair value. Therefore any awards subject to market conditions 
are considered to vest irrespective of whether or not that 
market condition has been met, provided all other conditions 
are satisfied.

If equity-settled awards are modified, as a minimum an 
expense is recognised as if the modification has not been 
made. An additional expense is recognised, over the 
remaining vesting period, for any modification that increases 
the total fair value of the share-based compensation benefit 
as at the date of modification.

If the non-vesting condition is within the control of the 
consolidated entity or employee, the failure to satisfy the 
condition is treated as a cancellation. If the condition is not 
within the control of the consolidated entity or employee 
and is not satisfied during the vesting period, any remaining 
expense for the award is recognised over the remaining 
vesting period, unless the award is forfeited.

35

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

Significant accounting policies (continued)

If equity-settled awards are cancelled, it is treated as if it 
has vested on the date of cancellation, and any remaining 
expense is recognised immediately. If a new replacement 
award is substituted for the cancelled award, the cancelled 
and new award is treated as if they were a modification.

Foreign exchange gains/losses

Transactions in foreign currencies are translated at the 
foreign exchange rate ruling at the date of the transaction. 
Monetary assets and liabilities denominated in foreign 
currencies at the reporting date are translated to Australian 
dollars at the foreign exchange rate at that date. Foreign 
exchange differences arising on translation are recognised in 
the income statement.

Non-monetary assets and liabilities that are measured in 
terms of historical cost in a foreign currency are retranslated 
to Australian dollars using the foreign exchange rate at the 
date of the transaction. Non-monetary assets and liabilities 
denominated in foreign currencies that are measured at fair 
value are retranslated to Australian dollars at the exchange 
rate at the date that the fair value was determined.

Goods and Services Tax (‘GST’) and other 
similar taxes

Revenues, expenses and assets are recognised net of 
the amount of associated GST, unless the GST incurred 
is not recoverable from the tax authority. In this case it is 
recognised as part of the cost of the acquisition of the asset 
or as part of the expense.

Receivables and payables are stated inclusive of the amount 
of GST receivable or payable. The net amount of GST 
recoverable from, or payable to, the tax authority is included 
in other receivables or other payables in the statement of 
financial position.

Cash flows are presented on a gross basis. The GST 
components of cash flows arising from investing or financing 
activities which are recoverable from, or payable to the tax 
authority, are presented as operating cash flows.

Comparative figures

When required by Accounting Standards, comparative 
figures have been adjusted to conform to changes in 
presentation for the current financial year.

Critical accounting estimates and 
judgements

The Directors evaluate estimates and judgements 
incorporated into the financial statements 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 Company.

Key estimates:

(i) Environmental Issues

Balances disclosed in the financial statements and notes 
thereto are not adjusted for any pending or enacted 
environmental legislation, and the Directors understanding 
thereof. At the current stage of the Company’s development 
and its current environmental impact the Directors believe 
such treatment is reasonable and appropriate.

(ii) Taxation

Balances disclosed in the financial statements and the notes 
hereto, related to taxation are based on the best estimates 
of Directors. These estimates take into account both the 
financial performance and position of the Company as they 
pertain to current income tax legislation and the Directors 
understanding thereof. No adjustment has been made for 
pending or future tax legislation. The current income tax 
position represents that Directors’ best estimate, pending an 
assessment by the Australian Taxation Office.

New Accounting Standards and 
Interpretations not yet mandatory or early 
adopted

Australian Accounting Standards and Interpretations that 
have recently been issued or amended but are not yet 
mandatory, have not been early adopted by the company 
for the annual reporting period ended 30 June 2021. The 
company has not yet assessed the impact of these new or 
amended Accounting Standards and Interpretations.

36

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

3. Other revenue

R&D tax incentive

Other revenue

4. Income tax expense

Income tax expense

Current tax

Deferred tax

Aggregate income tax expense

2021

$

2020

$

2,854,818 

3,143,912 

281,365 

68,000 

3,136,183 

3,211,912 

2021

$

2020

$

-  

-  

-  

-  

-  

-  

Numerical reconciliation of income tax expense and tax at the statutory rate

Loss before income tax expense

(5,628,355)

(6,006,456)

Tax at the statutory tax rate of 26% (2020: 27.5%)

(1,463,372)

(1,651,775)

Tax effect amounts which are not deductible/(taxable) in calculating taxable income:

  Non deductible expenses

  Non assessable income

Temporary differences

Benefits of tax losses not brought into account

Income tax expense

1,750,018 

2,193,451 

(759,150)

(158,533)

631,037 

(878,326)

(79,222)

415,872 

-  

-  

The Company has revenue losses of approximately $7,712,314 for which no deferred tax asset has been recognised.

The Company has no franking credits currently available for future offset.

37

AdAlta Limited Annual Report 2021 ABN 92 120 332 925 
 
 
NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

5. Loss per share

2021

$

2020

$

Loss after income tax attributable to the owners of Adalta Limited

(5,628,355)

(6,006,456)

Number

Number

Weighted average number of ordinary shares used in calculating basic earnings per share

234,255,299

164,030,499

Weighted average number of ordinary shares used in calculating diluted earnings per share1

234,255,299

164,030,499

Basic earnings per share

Diluted earnings per share

1The 7,879,595 options (2020: 31,062,870) are not considered to be dilutive.

6. Cash and cash equivalents

Cheque accounts

Cash reserve accounts

7. Trade and other receivables

Other receivables

Goods and services tax

Prepaid expenses

Sundry receivable - R&D tax incentive

Cents

(2.40)

(2.40)

2021

$

Cents

(3.66)

(3.66)

2020

$

876,521 

4,914,868 

25,240 

3,341,263 

5,791,389 

3,366,503 

2021

$

-  

122,401 

131,178 

2020

$

90,000 

76,981 

53,498 

2,854,807 

3,143,912 

3,108,386 

3,364,391 

38

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

8. Other current assets

Security Deposits

9. Property, plant and equipment

Plant and equipment - at cost

Less: Accumulated depreciation

Office equipment - at cost

Less: Accumulated depreciation

Movements in the carrying amounts for each class of

Plant and equipment 

Balance at beginning of year

Additions

Disposals

Loss on sale

Depreciation expense

Balance at end of year

Office equipment

Balance at beginning of year

Additions

Depreciation

Balance at end of year

10. Other non-current assets

Security deposits

2021

$

2020

$

77,918 

-  

2021

$

167,233 

(96,770)

70,463 

17,915 

(16,689)

1,226 

71,689 

2020

$

167,234 

(68,586)

98,648 

15,794 

(15,794)

-  

98,648 

98,648

138,105

-

-

-

-

-

-

(28,185)

(39,457)

70,463

98,648

-

2,121

(895)

1,226

2021

$

-  

-

13,418

(13,418)

-

2020

$

77,918 

39

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

11. Trade and other payables

Trade payables

Accrued expenses

PAYG payable

Superannuation payable

12. Borrowings

2021

$

215,722 

612,865 

31,519 

5,634 

2020

$

540,832 

268,005 

21,021 

-  

865,740 

829,858 

 20211

$

20202

$

Loan – R&D Advance

1,687,491 

2,191,327 

1The loan facility entered into on 15 June 2021 was with Innovation Structured Finance Co., LLC serviced via Radium Capital and was an 
advance on 80% of the Company’s estimated R&D tax Incentive (RDTI) for the financial year ending 30 June 2021. The interest rate for the loan 
facility is 14% per annum. 

2The loan facility entered into on 20 December 2019 was with Innovation Structured Finance Co., LLC serviced via Radium Capital and was an 
advance on 80% of the Company’s estimated R&D tax Incentive (RDTI) for the financial year ending 30 June 2020. The interest rate for the loan 
facility was 15% per annum. Full settlement of the loan facility was made on 13 October 2020, upon receipt of the 2020FY RDTI refund.

13. Provisions

2021

$

2020

$

Annual leave

70,952 

30,487 

14. Other current liabilities

20211

$

20202

$

Forward exchange contract

38,849 

153,702 

1On 6 July 2020 the company entered into a Forward Exchange contract to buy USD at a rate of 1AUD = 0.7035USD maturing on the 14 
January 2022. As at 30 June 2021 there is a balance on the Forward Exchange contact of $444,117 USD. The amount disclosed at 30 June 
2021 is the unrealised loss on the forward exchange contract.  

2On 23 March 2020 the Company entered into a Forward Exchange contract to buy $520,000 USD at a rate of 1AUD = 0.5702USD, maturing 
on 31 December 2020. The amount disclosed at 30 June 2020 was the unrealised loss on the forward exchange contract.

40

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

15. Issued capital

2021

Shares

2020

Shares

2021

$

2020

$

Ordinary shares - fully paid

245,175,853

163,945,613

36,232,030 

28,436,476 

Ordinary shares

Ordinary shares entitle the holder to participate in dividends and the proceeds on winding up of the Company in proportion to 
the number of and amounts paid on the shares held. On a show of hands, every holder of ordinary shares present at a meeting 
in person or by proxy is entitled to one vote, and upon a poll each share is entitled to one vote. Incremental costs directly 
attributable to the issue of the new shares or options are shown in equity as a deduction, net of tax, from the proceeds.

2021

Shares

2020

Shares

2021

$

2020

$

Balance at beginning of the reporting period

163,945,613

150,569,426

28,436,476

26,529,233

Issue of ordinary shares

81,230,240

13,732,581

8,123,024

2,059,887

Cancellation of ordinary shares

Capital raising costs

-

-

(356,394)

-

-

-

(327,470)

(152,644)

245,175,853

163,945,613

36,232,030

28,436,476

Options on issue

Expiry date 

14 November 2021

14 November 2021

14 November 2021

14 November 2021

27 February 2022

20 March 2023

15 March 2025

26 November 2025

Number of options

Exercise price

400,000

130,000

100,000

100,000

620,535

600,000

1,000,000

4,929,060

$0.2485

$0.4985

$0.7485

$0.9985

$0.2385

$0.085

$0.175

$0.2485

41

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

16. Reserves

2021

$

2020

$

Share-based payments reserve

1,381,087 

864,022 

Share-based payments reserve

The reserve is used to recognise the value of equity benefits provided to employees and Directors as part of their remuneration, 
and other parties as part of their compensation for services. In the period under review there were no change to inputs on  
option valuation. 

At beginning of reporting period

Recognised during the period

At end of reporting period

2021

$

864,022

517,065

2020

$

273,564

590,458

1,381,087

864,022

Balance at  
start of year

Number

Granted  
in year

Number

Exercised

Number

Expired / 
cancelled

Number

Balance at  
end of year

Number

Expiry 

Date

01/11/2020

16/10/2020

14/11/2021

14/11/2021

14/11/2021

14/11/2021

27/02/2022

30/06/2021

30/06/2021

26/11/2025

26/11/2025

26/11/2025

26/11/2025

20/03/2023

20/03/2023

20/03/2023

20/03/2023

15/03/2025

15/03/2025

$0.2485 

16,482,513

Exercise

Price

$0.1685 

$0.1685 

$0.2485 

$0.4985 

$0.7485 

$0.9985 

$0.2385 

$0.2485 

$0.2485 

$0.2485 

$0.2485 

$0.2485 

$0.0850 

$0.0850 

$0.0850 

$0.0850 

$0.1750 

$0.1750 

234,472

600,000

400,000

130,000

100,000

100,000

620,535

6,866,290

492,906

1,478,718

1,478,718

1,478,718

100,000

100,000

200,000

200,000

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

(234,472)

(600,000)

-

-

-

-

-

(3,725)

(16,478,788)

-

-

-

-

-

-

-

-

-

-

-

(6,866,290)

-

-

-

-

-

-

-

-

-

-

-

-

400,000

130,000

100,000

100,000

620,535

-

-

492,906

1,478,718

1,478,718

1,478,718

100,000

100,000

200,000

200,000

500,000

500,000

-

-

500,000

500,000

Weighted average exercise price at 30 June 2021 $0.2453(30 June 2020: $0.25)

31,062,870

1,000,000

(3,725)

(24,179,550)

7,879,595

42

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

Note 16. Reserves (continued)

For the options granted during the current financial year, the valuation model inputs used to determine the fair value at the grant 
date are as follows:

Grant  
date

Expiry  
date

Share price at 
grant date

Exercise  
price

Expected  
volatility

Dividend  
yield

Risk-free  
rate

15/3/2021

15/03/2025

$0.175

$0.175

112.66%

0%

0.10%

17. Related party transactions

Related parties 

The Company’s main related parties are as follows:

Non-Executive Directors

Dr Paul MacLeman

Ms Elizabeth McCall 

Dr Robert Peach

Dr David Fuller

Dr James Williams

Executive Directors

Dr Timothy Oldham

Position

Non-Executive Chair

Non-Executive Director

Non-Executive Director

Non-Executive Director

Alternate Director to Ms Elizabeth McCall

Position

Chief Executive Officer and Managing Director

Transactions with related parties

Aside from the amounts previously disclosed in the Remuneration Report, there were no other transactions with related parties 
during the current and previous financial year.

18. Contingent liabilities and contingent assets
The Directors are not aware of any matters or circumstances which may give rise to a contingent liability or asset.

19. Commitments
Lease commitments
The Company has no lease commitments.

Capital commitments
The Company has no capital commitments.

Other commitments
The Company has significant expenditure expected to be incurred in relation to manufacturing costs for its Phase I human study.

43

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

20. Financial risk management
The Company does not have any complex financial instruments or derivatives.

Term, conditions and accounting policies

The Company’s accounting policies, including the terms and conditions of each class of financial asset, financial liability and 
equity instrument, both recognised and unrecognised at the reporting date, are as follows:

Recognised 
Financial Instruments

Statement of 
Financial Position 
Notes

Accounting  
Policies

Terms and  
Conditions

i) Financial assets

Cheque account

Cash reserve

R & D tax incentive

Trade receivables

Goods & services 
tax paid

ii) Financial liabilities

Trade and other 
creditors

Other liabilities

Borrowings

6

6

7

7

7

11

14

12

iii) Equity

Ordinary shares

15

Carried at face value.

Carried at face value.

Recognised on an accrual basis.

The cheque account is at call with an interest 
rate of 0.00% (2020: 0.00%).

The cash reserve account is at call with an 
interest rate of 0.01% (2020: 0.05%).

The incentive is claimed annually under 
an Australia Taxation Office mechanism 
which designed to promote research 
and development.

Recognised on an accrual basis.

Normal invoice terms are 14-60 days.

Recognised on an accrual basis.

Business activity statements are lodged on a 
quarterly basis.

Liabilities are recognised for amounts 
to be paid in the future for goods and 
services received, whether or not billed to 
the company.

The majority of costs are invoiced on a 
quarterly basis and hence liabilities accrue 
for up to 90 days. Trade liabilities are 
normally settled on 14-30 day terms.

Carried at face value.

Carried at face value.

Forward exchange contract is entered into 
on specific terms as agreed by the Foreign 
Exchange intermediary and the Company.

The Loan was a Secured Loan, with an 
interest rate of 14% per annum (2020: 15% 
per annum). The Security was the R&D Tax 
Incentive refund for the financial year ending 
30 June 2021.

Ordinary share capital is recognised at the 
fair value of the consideration received by 
the company.

Details of the shares issued and the terms and 
conditions of the options outstanding over 
ordinary shares at balance date are set out 
in note 15.

Carrying value 

The carrying value of financial assets and liabilities approximates their fair value.

Financial risk management 

The Company’s activities expose it to a variety of financial risks; market risk (fair value interest rate risk and price risk), credit risk, 
liquidity risk and cash flow interest rate risk. The Company’s overall risk management program focuses on the unpredictability of 
financial markets and seeks to minimise potential adverse effects on the financial performance of the Company.

44

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

Note 20. Financial risk management (continued)

i) Market risk

The Company is not exposed to either equity securities price risk or commodity price risk.

The Company has an exposure to foreign currency risk because several contracts relating to cost of services are denominated in 
foreign currencies. When the service agreement is signed the Company seeks to lock-in a foreign exchange rate to minimise the 
risks associated with fluctuating currency markets.

ii) Credit risk

The maximum credit risk is total current assets of which the vast majority is either in the form of cash or amounts receivable from 
the Australian Taxation Office in the form of the Research and Development tax incentive and GST refundable.

iii) Liquidity risk

Prudent liquidity risk management implies maintaining sufficient cash and short-term assets to enable the Company to settle 
its liabilities.

The contractual undiscounted cash flows of the Company’s borrowing commitments is set out in the table below. Balances due 
within 12 months equal their carrying amounts as the impact of discounting is not significant.

Contractual 
maturities

Loan - R&D advance - 2021

Loan - R&D advance - 2020

iv) Interest Rate Risk

<1 year 

$

1,687,491

2,191,327

>1 year  
<5 years

>5 years

$

-

-

$

-

-

Total 

$

Carrying  
amount

$

1,687,491

2,191,327

1,687,491

2,191,327

The main interest rate risk arises from cash and cash equivalents with variable interest rates which expose the Company to cash 
flow interest rate risk. Excess cash and cash equivalents are invested in fixed interest term reserve accounts which do not expose 
the Company to cash flow interest rate risk. Cash and cash equivalents required for working capital are held in variable and non-
interest bearing accounts.

Weighted  
average

%

0.01% 

0.05% 

Balance

$

5,791,389

3,366,503

Fixed interest  
rate exposure

Variable interest  
rate exposure

$

4,914,843

3,341,263

$

876,546

25,240

Cash and cash Equivalents - 2021

Cash and cash Equivalents - 2020

v) Cash flow and fair value interest rate risk

As the Company has no interest-bearing liabilities, cash out flows are not exposed to changes in market interest rates.

The Company maintains a current cheque account balance sufficient to meet day to day expenses with the balance of cash held 
in accounts designed to maximise interest income.

vi) Foreign exchange risk

The Company has contracts denominated in foreign currencies, predominantly in US dollars , Euros and Great Britain Pounds and 
may enter into forward exchange contracts where appropriate in light of anticipated future purchases and sales, conditions in 
foreign markets, commitments with suppliers and customers and past experience and in accordance with Board-approved limits.

45

AdAlta Limited Annual Report 2021 ABN 92 120 332 925NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

21. Reconciliation of loss after income tax to net cash used in 
operating activities
Reconciliation of cash flow from operations with profit after income tax

2021

$

2020

$

Loss after income tax expense for the year

(5,628,355)

(6,006,456)

Adjustments for:

Depreciation and amortisation

Share-based payments

Adjustments for:

Cost of issuing shares

Interest expense and borrowing costs

Change in operating assets and liabilities:

(Increase) / decrease in receivables

(Increase) / decrease in non-current assets

(Increase) / decrease in current assets

Increase / (decrease) in payables

Increase / (decrease) in provisions

Increase / (decrease) in other current liabilities

29,079 

517,065 

41,833 

590,457 

-  

542 

97,636 

115,546 

256,006 

249,050 

77,918 

(77,918)

21,215 

40,465 

(114,853)

-  

(75,319)

(910,253)

(48,314)

153,702 

Net cash used in operating activities

(4,781,742)

(5,889,212)

22. Dividends
There were no dividends paid, recommended or declared during the current or previous financial year.

23. Remuneration of auditors
During the financial year the following fees were paid or payable for services provided by Butler Settineri (Audit) Pty Ltd, the 
auditor of the company:

Audit services - Butler Settineri (Audit) Pty Ltd

Audit and review of the financial statements

2021

$

2020

$

24,238 

14,148 

46

AdAlta Limited Annual Report 2021 ABN 92 120 332 925 
 
 
 
 
 
NOTES TO THE FINANCIAL STATEMENTS 
30 JUNE 2021 (Continued)

24. Significant changes in the 
state of affairs
The Company is fortunate that to date its major programs 
have not been materially affected by the COVID-19 
environment. A comprehensive risk assessment and 
contingency plan is in place and continuously evaluated.

AdAlta’s laboratories at La Trobe University have remained 
continuously open though out 2020 and 2021, with remote 
working where possible and modified work practices 
implemented. The Phase I trial was conducted at CMAX 
Clinical Research in Adelaide and Scientia Clinical Research 
in Sydney to mitigate risks to healthy volunteer recruitment.

AdAlta is observing increases in lead times and supply 
shortages for some laboratory consumables, manufacturing 
raw materials, and contract manufacturing capacity. In 
particular, lead times for contract manufacturing of biologics 
are extending significantly. To mitigate this impact, AdAlta 
has now secured a manufacturing slot for the next batch of 
clinical grade AD-214 to support future clinical trials. Drug 
product is now anticipated to be available for these trials 
in mid-2023. There may be longer term impacts on the 
state of affairs of the Company or the environment within 
which it operates, the extent of which the Company cannot 
currently estimate. 

The Company continues to actively monitor literature 
reporting a likely significantly increased burden of lung 
fibrosis in patients recovering from COVID-19 infection and 
clinical studies exploring the long-term progression of this 
fibrosis. This enables the potential of AD-214 to contribute 
to the long-term care of these recovering patients to 
be assessed.

25. Events after the 
reporting period
On 1 July 2021, AdAlta announced that it had accepted an 
AD-214 clinical material resupply proposal under a master 
services agreement with its contract manufacturing partner, 
KBI Biopharmaceuticals Inc. The scheduled production of 
bulk AD-214 will mean clinical drug product is available for 
the commencement of clinical trials in patients in the first half 
of 2023.

On 2 July 2021 a total of 3,725 ordinary shares were 
issued on exercise of listed options for gross proceeds to the 
Company of $925. 

On 19 July 2021, the Company announced the preliminary 
results of multi-dose intravenous studies of AD-214 in healthy 
volunteers and the results of pre-clinical development of RL-
AD-214 for PET imaging. Taking the totality of these results 
and the next available clinical supplies of AD-214, AdAlta 
has elected to advance the development of an inhaled 
formulation of AD-214. An inhaled formulation will offer 
greater patient convenience, more flexible dose scheduling 
and lower cost of goods. Importantly, AdAlta anticipates that 
the development of an inhaled formulation can occur within 
the time available prior to the commencement of the next 
clinical studies of AD-214 in patients, resulting in no delay in 
the timelines to efficacy data. PET imaging using RL-AD-214 
will continue to inform pre-clinical development of the inhaled 
formulation. The Phase I program in healthy volunteers has 
been concluded and a planned Phase Ib protocol using 
RL-AD-214 in patients to assess distribution and lung tissue 
receptor occupancy will not proceed. AdAlta will continue to 
explore improvements to the AD-214 intravenous formulation 
for potential use in other fibrotic indications.

On 24 August 2021, AdAlta and Carina Biotech Pty Ltd 
announced a collaboration to develop unique, precision 
engineered, i-body enabled CAR-T cell therapeutics to 
provide new hope for patients with cancer.

Under the collaboration the parties will work together on 
up to 5 tumour antigen targets, commencing in a staged 
fashion over the next two years. The first two targets 
have been selected but not disclosed. AdAlta’s role is to 
discover i-bodies against these targets. Carina’s roll is to 
then engineer them into CAR-T cells and test them in vitro 
and then in vivo to demonstrate proof of concept and 
select optimal CAR constructs to progress as CAR-T cell 
therapeutics. Targets may be combined to create bi-specific 
CAR-Ts. AdAlta and Carina will jointly own the collaboration 
intellectual property and products to proof-of-concept 
stage. Following proof of concept, the parties may elect to 
continue to co-develop the products together, choose one 
party to continue development independently, or out-license 
immediately to third parties to continue development.

Other than outlined above or elsewhere in this report, 
there has not been any matter or circumstance that has 
arisen subsequent to the end of the financial year that 
has significantly affected, or may significantly affect, the 
operations of the Company, the results of those operations, or 
the state of affairs of the Company in future financial years.

47

AdAlta Limited Annual Report 2021 ABN 92 120 332 925DIRECTORS’ DECLARATION

30 JUNE 2021

In the Directors’ opinion:

•  the attached financial statements and notes comply with the Corporations Act 2001, the Accounting Standards, the 

Corporations Regulations 2001 and other mandatory professional reporting requirements;

•  the attached financial statements and notes comply with International Financial Reporting Standards as issued by the 

International Accounting Standards Board as described in note 2 to the financial statements;

•  the attached financial statements and notes give a true and fair view of the company’s financial position as at 30 June 2021 

and of its performance for the financial year ended on that date; and

•  there are reasonable grounds to believe that the company will be able to pay its debts as and when they become due 

and payable.

The Directors have been given the declarations required by section 295A of the Corporations Act 2001.

Signed in accordance with a resolution of Directors made pursuant to section 295(5)(a) of the Corporations Act 2001.

On behalf of the Directors

Paul MacLeman
Chairman

26 August 2021
Melbourne

48

AdAlta Limited Annual Report 2021 ABN 92 120 332 925INDEPENDENT AUDITOR’S REPORT 
TO THE MEMBERS OF ADALTA LIMITED 

Report on the Financial Report 

Opinion 

We  have  audited  the  financial  report  of  AdAlta  Limited  (the  Company),  which  comprises  the 
statement  of financial  position  as  at  30  June  2021, the  statement  of profit  and  loss  and  other 
comprehensive income, the statement of changes in equity and the statement of cash flows for 
the year then ended, and notes to the financial statements, including a summary of significant 
accounting policies, and the directors’ declaration. 

In our opinion, the accompanying financial report of AdAlta Limited, is in accordance with the 
Corporations Act 2001, including: 

i)  giving a true and fair view of the Company’s financial position as at 30 June 2021 

and of its financial performance for the year then ended; and 

ii)  complying  with  Australian  Accounting  Standards  and 

the  Corporations 

Regulations 2001. 

Basis for Opinion 

We  have  conducted  our  audit  in  accordance  with  Australian  Auditing  Standards.    Our 
responsibilities under those Standards are further described in the Auditor’s Responsibilities for 
the Audit of the Financial Report section of our report. 

We  are  independent  of  the  Company  in  accordance  with  the  auditor  independence 
requirements  of  the  Corporations  Act  2001  and  the  ethical  requirements  of  the  Accounting 
Professional  and  Ethical  Standards  Board’s  APES  110  Code  of  Ethics  for  Professional 
Accountants (including  Independence  Standards) (the Code) that are relevant to our audit of 
the financial report in Australia.  We have also fulfilled our ethical requirements 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 date 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. 

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. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Key Audit Matter 

Intellectual  Property  Rights  and 
Obligations  arising  from  Research 
and Development  Agreements 

How our audit addressed the key 
audit matter 

with 

research 

The  Company  has  in  place  multiple 
and 
agreements 
development  providers  whereby  certain 
services  and  facilities  are  supplied  in 
exchange  for  payment.  To  enable  the 
delivery  of  these  services  and  facilities, 
the  Company’s  intellectual  property  is 
made  available  to  the  research  and 
development providers. 

into 

Management  have  written  specific 
clauses 
the  Research  and 
Development Agreements to protect the 
Company’s  intellectual  property  rights 
and  also  exercise  their  judgment  in 
interpreting  the  agreements  and  the 
recognition  of  any  potential  liabilities 
and/or commitments arising therefrom. 

Equity and Capital Structure 
Refer note 15  

the 

year, 

During 
the  Company 
successfully  issued  fully  paid  ordinary 
shares  as  well  as  various  options  of 
which some have been exercised. 

Research  and  Development  Tax 
Incentive 
Refer notes 3 and 7 

Management  utilise  key  assumptions, 
in 
judgements 
determining 
Incentive 
disclosed  in  note  3  and  7  which  is 
material to the financial statements. 

the  R&D  Tax 

estimates 

and 

them 

Our  audit  procedures  included  obtaining 
copies  of  major  agreements  and 
reviewing 
if  any 
commitments,  provisions  or  payables 
needed 
for  and 
to  be  accounted 
disclosed  in  line  with  the  applicable 
Australian Accounting Standards.  

to  determine 

we 

Furthermore, 
the 
agreements  to  ensure  clauses  were 
present 
intellectual 
to  protect 
property rights of AdAlta Limited. 

reviewed 

the 

Our  audit  procedures 
included  an 
examination  of  each  issue  of,  fully  paid 
ordinary  shares  during 
the  year  as 
shown  in  note  15.  We  also  assessed 
whether  or  not  share-based  payments 
should  have been recognised  in relation 
to  the  Employee  Share  Option  Plan. 
Further,  we  reconciled  the  third  party 
share  registry  to  information  announced 
to the public. 

of 

the 

included  an 
Our  audit  procedures 
evaluation 
assumptions, 
methodologies  and conclusions  used  by 
management’s  expert  in  preparing  the 
R&D  Tax  Incentive  application. We  also 
focused  on  the  adequacy  of  financial 
report  disclosures 
these 
assumptions as disclosed at note 1. 

regarding 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Key Audit Matter 

Deferred Taxation 
Refer note 3 

How  our  audit  addressed  the  key 
audit matter 

Management  utilise  key  assumptions, 
judgements and estimates in calculating 
the  deferred  tax  disclosed  in  note  1 
which  are  material 
financial 
statements. 

the 

to 

of 

the 

included  an 
Our  audit  procedures 
assumptions, 
evaluation 
methodologies  and conclusions  used  by 
the  company  in  preparing  their  estimate 
of  deferred  taxes.  We  also  focused  on 
report 
the  adequacy  of 
disclosures regarding these assumptions 
as disclosed at note 1. 

financial 

Revenue Recognition 
Refer note 3 

During the year, the company continued 
a  revenue  contract  with  a  customer  for 
the  use  of  research  and  development 
information and intellectual property. 

We  assessed  the  contract  and  revenue 
recognition and determined that revenue 
has been recognised in accordance with 
AASB 15 Contracts with Customers.  

Other information 

The  directors  are  responsible  for  the  other  information.    The  other  information  comprises  the 
information  in  the  Company’s  annual  report  for  the  year  ended  30  June  2021,  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 accordingly 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  the  Australian  Accounting  Standards  and  the 
Corporations Act 2001 and for such internal control as the directors determine is necessary to 
enable  the  preparation  of  the  financial  report  that  gives  a  true  and  fair  view  and  is  free  from 
material misstatement, whether due to fraud or error. 

In  preparing  the  financial  report,  the  directors  are  responsible  for  assessing  the  Company’s 
ability  to  continue  as  a  going  concern,  disclosing,  as  applicable,  matters  related  to  going 
concern and using the going concern basis of accounting unless the directors either intend to 
liquidate the Company or to cease operations, or have no realistic alternative but to do so. 

Auditor’s Responsibilities for the Audit of the Financial Report 

Our objectives are to obtain reasonable assurance about whether the financial report as a whole 
is  free  from  material  misstatement,  whether  due  to  fraud  or  error,  and  to  issue  an  auditor’s 
report that includes our opinion. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reasonable  assurance  is  a  high  level  of  assurance,  but  is  not  a  guarantee  that  an  audit 
conducted  in  accordance  with  the  Australian  Auditing  Standards  will  always  detect  a  material 
misstatement when it exists.  Misstatements can arise from fraud or error and are considered 
material if, individually or in the aggregate, they could reasonably be expected to influence the 
economic decisions of users taken on the basis of the financial report. 

As  part  of  an  audit  in  accordance  with  the  Australian  Auditing  Standards,  we  exercise 
professional judgement and maintain professional scepticism throughout the audit.  We also: 

 

Identify  and  assess  risks  of  material  misstatement  of  the  financial  report,  whether  due  to 
fraud or error, design and perform audit procedures responsive to those risks, and obtain 
audit evidence that is sufficient and appropriate to provide a basis for our opinion.  The risk 
of not detecting a material misstatement resulting from fraud is higher than for one resulting 
from  error,  as 
intentional  omissions, 
involve  collusion, 
fraud  may 
misrepresentations, or the override of internal control. 

forgery, 

  Obtain  and  understanding  of  internal control relevant to the audit in order to design audit 
procedures that are appropriate in the circumstances, but not for the purpose of expressing 
an opinion on the effectiveness of the Company’s internal control. 

  Evaluate  the  appropriateness  of  accounting  policies  used  and  the  reasonableness  of 

accounting estimates and related disclosures made by the directors. 

  Conclude  on  the  appropriateness  of  the  directors’  use  of  the  going  concern  basis  of 
accounting  and,  based  on  the  audit  evidence  obtained,  whether  a  material  uncertainty 
exists  related  to  events  or  conditions  that  may  cast  significant  doubt  on  the  Company’s 
ability to continue as a going concern.  If we conclude that a material uncertainty exists, we 
are  required  to  draw  attention  in  our  auditor’s  report  to  the  related  disclosures  in  the 
financial  report  or,  if  such  disclosures  are  inadequate,  to  modify  our  opinion.    Our 
conclusions are based on the audit evidence obtained up to the date of our auditor’s report.  
However, future events or conditions may cause the Company to cease to continue as a 
going concern. 

  Evaluate the overall presentation, structure and content of the financial report, including the 
disclosures,  and  whether  the  financial  report  represents  the  underlying  transactions  and 
events in a manner that achieves fair presentation. 

We  communicate  with  the  directors  regarding,  among  other  matters,  the  planned  scope  and 
timing of the audit and significant audit findings, including any significant deficiencies in internal 
control that we identify during our audit. 

We  also  provide  the  directors  with  a  statement  that  we  have  complied  with  relevant  ethical 
requirements  regarding  independence,  and  to  communicate  with  them  all  relationships  and 
other  matters  that  may  reasonably  be  thought  to  bear  on  our  independence,  and  where 
applicable, actions taken to eliminate threats or safeguards applied.  

From  the  matters  communicated  with  the  directors,  we  determine  those  matters  that  were  of 
most significance in the audit of the financial report of the current period and are therefore key 
audit  matters.    We  describe  these  matters  in  our  auditor’s  report  unless  law  or  regulation 
precludes  public  disclosure  about  the  matter  or  when,  in  extremely  rare  circumstances,  we 
determine  that  a  matter  should  not  be  communicated  in  our  report  because  the  adverse 
consequences of doing so would reasonably be expected to outweigh public interest benefits of 
such communication. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Report on the Remuneration Report 

Opinion on the Remuneration Report 

We  have  audited  the  Remuneration  Report  included  on  pages  22  to  26  of  the  directors’ 
report for the year ended 30 June 2021. 

In  our  opinion,  the  Remuneration  Report  of  AdAlta  Limited,  for  the  year  ended  30  June 
2021, 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. 

BUTLER SETTINERI (AUDIT) PTY LTD 

ROBERT HALL 
Director 

Perth 
Date:   26 August 2021      

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SHAREHOLDER INFORMATION

30 JUNE 2021

The shareholder information set out below was applicable as at 16 August 2021.

(a) Distribution of equitable securities

Analysis of number of equitable security holders by size of holding:

Ordinary Shares

1 to 1,000

1,001 to 5,000

5,001 to 10,000

10,001 to 100,000

100,001 and over

# of holders

# of units

% Issued share

38

193

280

768

262

4,312

700,607

2,246,951

30,367,710

211,859,998

1,541

245,179,578

-

-

0.3% 

12.4% 

84.6% 

The number of shareholders holding less than a marketable parcel of shares are 238.

(b) Voting rights

Ordinary shares

On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a poll each share 
shall have one vote.

The names of the twenty largest holders of quoted ordinary shares are:

Position 

Holder name

Holding

 IC

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

YUUWA CAPITAL LP

HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED

MEURS HOLDINGS PTY LTD - P&M MEURS SUPERANNUATION A/C

RADIATA SUPER PTY LTD - R & E SYPKES FAMILY SF A/C

SACAVIC PTY LTD - MORRIS SUPER FUND A/C

CITYCASTLE PTY LTD

LA TROBE UNIVERSITY

JAGEN PTY LTD

NATIONAL NOMINEES LIMITED

MR ROBIN BEAUMONT & MS HELEN SHINGLER

SKIPTAN PTY LTD - P&M MEURS FAMILY A/C

CITICORP NOMINEES PTY LIMITED

BAULDIA PTY LTD - BONAVENTURE SUPER FUND A/C

SCINTILLA STRATEGIC INVESTMENTS LIMITED

MRS GWEN MURRAY PFLEGER - PFLEGER FAMILY A/C 

MR ALISTAIR DAVID STRONG

ROBERT PEACH

BARE SUPER PTY LTD - BALLARD READ SF A/C

RUI LONG INTERNATIONAL PTY LTD - RUI LONG FAMILY A/C

MR IAIN ROSS

Total

Total issued capital 

54,059,848

28,993,114

17,887,693

7,689,999

4,444,407

4,302,320

3,041,330

2,500,000

2,101,000

2,075,000

2,072,000

2,001,388

1,825,409

1,424,972

1,395,000

1,300,000

1,295,999

1,277,358

1,200,000

1,150,000

22.05%

11.83%

7.30%

3.14%

1.81%

1.75%

1.24%

1.02%

0.86%

0.85%

0.85%

0.82%

0.74%

0.58%

0.57%

0.53%

0.53%

0.52%

0.49%

0.47%

142,036,837

245,179,578

57.93%

100.00%

54

AdAlta Limited Annual Report 2021 ABN 92 120 332 925SHAREHOLDER INFORMATION 
30 JUNE 2021 (Continued)

(c) Substantial shareholders

The names of substantial shareholders in accordance with section 671B of the Corporations Act 2001 are:

Position

Shareholder

Holding

% IC

1

2

3

YUUWA CAPITAL LP

PLATINUM INVESTMENT MANAGEMENT LTD 

MEURS HOLDINGS PTY LTD - P&M MEURS

54,059,848

28,993,114

17,887,693

22.05%

11.83%

7.30%

(d) Unquoted securities

Details of substantial holders:

Number

Number of holders

Class

Holders of more than 20%

7,879,595

11

Options expiring various dates and 
various prices

Timothy Oldham 62.55% (4,929,060)

(e) Use of funds

Since admission the Company has used its cash in a way consistent with its business objectives.

55

AdAlta Limited Annual Report 2021 ABN 92 120 332 925