ADALTA LIMITED — AGM Information 2021

Nov 28, 2021

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29 November 2021

ASX Announcement

AGM: CHAIR ADDRESS, CEO PRESENTATION AND FIRST i-CAR-T DATA

MELBOURNE Australia, 29 November 2021: AdAlta Limited (ASX:1AD), the clinical stage drug discovery company developing novel therapeutic products from its i-body platform is pleased to release presentations to be made its Annual General Meeting today by Chair, Dr Paul MacLeman and CEO and Managing Director, Dr Tim Oldham.

Highlights of the presentations include:

• Progress report against 2021 milestones set at the 2020 AGM

• Milestones for 2022 calendar year

• Proof of principle data showing i-bodies can be incorporated into Carina’s CAR-T cells and achieve targeted cell killing.

AdAlta and Carina Biotech (Carina) announced a collaboration to develop precision engineered, i-body enabled chimeric antigen receptor T (CAR-T) cells as cancer therapeutics on 24 August 2021. Under the collaboration, AdAlta will discover i-bodies for up to five solid tumour targets (antigens) that Carina Biotech will then use with its proprietary CAR-T technologies to develop CAR-T cell therapy products. The i-body enabled CAR-T cell is expected to bring improved targeting, better penetration and treatment persistence when used to treat solid tumours.

In preliminary proof of principle studies, an AdAlta i-body binding to an undisclosed target was incorporated into three different CAR designs and successfully engineered into T cells using Carina technology to create three different CAR-T cells. The ability of these CAR-T cells to kill target cells expressing the target antigen were assessed.

Key findings of these proof of principle experiments were:

• 97% of T cells in culture incorporated the i-body CAR to become i-CAR-T cells which then expanded during manufacturing at the rates expected;

• i-body enabled CAR-T cells were capable of in vitro killing a cell line engineered to overexpress the i-body’s target, but did not kill the original cells; and

• i-body enabled CAR-T cells were capable of in vitro killing of two colorectal cancer cell lines and (less effectively) a glioblastoma (brain) cancer cell line known to express the i-body’s target. Illustrative data is shown in the attached presentation.

Managing Director and CEO, Dr Tim Oldham commented: “We are very pleased to share the proof of principle data that so excited us about the potential of this collaboration. We look forward to first experimental results on agreed targets under the collaboration in the first half of next year.”

The Company also notes the issuance of a first Singapore Patent 11201705583X and a second Australian Patent 2019203511 protecting the i-body sequence used in AdAlta’s lead product, AD-214, sequences similar to this, and pharmaceutical compositions containing these i-body sequences and their uses in therapeutic and diagnostic applications, including Idiopathic Pulmonary Fibrosis (IPF), the lead indication for which

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AD-214 is being developed. These patents expire on 8 January 2036. This adds to patent protection already obtained in Australia (2017), USA (2020 and 2021) and Japan (2021), with additional applications pending in Europe, China, India and other markets.

Authorised for lodgement by:

Tim Oldham CEO and Managing Director November 2021

Notes to editor

About AdAlta

AdAlta Limited is a clinical stage drug development company headquartered in Melbourne, Australia. The Company is using its proprietary i-body technology platform to solve challenging drug targeting problems and generate a promising new class of single domain antibody protein therapeutics with the potential to treat some of today’s most challenging medical conditions.

The i-body technology mimics the shape and properties of a unique and versatile antigen binding domain that was discovered initially in sharks and then developed as a human protein. The result is a range of unique proteins capable of interacting with high selectivity, specificity and affinity with previously difficult to access targets such as G-protein coupled receptors (GPCRs) that are implicated in many serious diseases. i-bodies are the first fully human single domain antibody scaffold and the first based on the shark motif to reach clinical trials.

AdAlta has completed Phase I clinical studies for its lead i-body candidate, AD-214, that is being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other human fibrotic diseases for which current therapies are sub-optimal and there is a high unmet medical need. A second target implicated in fibrosis is in discovery research.

The Company is also entering collaborative partnerships to advance the development of its i-body platform. It has a revenue generating agreement with GE Healthcare to codevelop i-bodies as diagnostic imaging agents against Granzyme B, a biomarker of response to immuno-oncology drugs, a program now in preclinical development. It also has a collaboration with Carina Biotech to co-develop precision engineered, i-body enabled CAR-T cell therapies to bring new hope to patients with cancer.

AdAlta’s strategy is to maximise the products developed using its next generation i-body platform by internally discovering and developing selected i-body enabled product candidates against GPCRs implicated in fibrosis, inflammation and cancer and partnering with other biopharmaceutical companies to develop product candidates against other classes of receptor, in other indications, and in other product formats.

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Further information can be found at: https://adalta.com.au

For more information, please contact:

Investors

Media

Tim Oldham, CEO & Managing Director IR Department Tel: +61 403 446 665 Tel: +61 411 117 774 E: t.oldham@adalta.com.au E: jane.lowe@irdepartment.com.au

CHAIR’S ADDRESS

Ladies and gentlemen,

I am pleased to welcome you to AdAlta’s 2021 Annual General Meeting. This AGM is being conducted in a fully virtual environment to enable participation of all those around the world affected by the ongoing pandemic. Wherever you’re joining us from today, I thank you for your participation.

Looking back, it is appropriate to characterise FY2021 as one of substantial progress for AdAlta – where we advanced our existing i-body enabled assets and expanded our pipeline.

Our lead asset, AD-214 which is being investigated for Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, completed a Phase I clinical trial, demonstrating that it was very well tolerated 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. This showed that, although we could progress to Phase II with the current formulation of AD-214, this would not be the optimal formulation from a cost or patient convenience perspective. The time to availability of our next clinical batch of AD-214 affords us the opportunity to develop both inhaled and iv formulations. Importantly, we now have a clear pathway to clinical trials in Idiopathic Pulmonary Fibrosis (IPF) patients using an inhaled formulation of AD-214, which we think will be preferred by both patients and clinicians. Despite the pre-clinical imaging results not being exactly as expected, our pre-clinical efficacy data remains valid and we continue to be confident 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. GE Healthcare are leading pre-clinical development and AdAlta continue to earn revenue from this collaboration as we support preclinical and manufacturing development.

We also entered a collaboration with Carina Biotech Pty Ltd (Carina) to develop precisionengineered, i-body enabled, CAR-T cells with potential to make these breakthrough therapies available to a wider range of patients with solid cancers. Both the GE and Carina collaborations contribute to our strategy to expand our pipeline and 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 the following, which Tim Oldham will expand upon through his CEO’s presentation.

Firstly, we will continue to progress AD-214 through clinical value inflection points following successful completion of Phase I clinical studies.

Secondly, we will continue to add additional assets to our internal pipeline.

Thirdly, we will progress multiple collaborations in our external pipeline. The PET imaging agents that GE Healthcare is developing could generate royalty revenue for AdAlta much earlier than AD-214 and in FY22 we also anticipate first experimental results from our new collaboration with Carina.

Fourthly, we will continue to invest in our drug discovery and development platform to continue to improve its efficiency and intellectual property protection.

I would like to acknowledge and thank you, our shareholders, who supported us last year with $8.1 million in new funds and for your continued support and encouragement of our strategy.

I'd like to express my gratitude to our management team and Board for all the significant effort deployed throughout FY21.

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, with the most significant impact being the previously announced extended lead time for our next AD-214clinical material.

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.

We will now progress to the formal business of the meeting, after which our CEO and Managing Director, Dr Tim Oldham to deliver his report and provide opportunities for questions.

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Building momentum, remaining agile

Tim Oldham PhD, CEO and Managing Director Annual General Meeting, 29 November 2021

AGM PRESENTATION – NOVEMBER 2021

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AdAlta today

AdAlta is building significant growth momentum while retaining agility to respond and adapt to data and opportunities

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• i-body platform : can create therapeutics addressing targets underserved by traditional antibodies

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• Fibrosis/inflammation: lead asset AD-214 preparing for Phase II clinical trial • US$3b IPF market today,[1] multiple US$b indication potential

• Second target in discovery

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• Immuno-oncology: two co-development collaborations

• GZMB PET imaging agent with GE Healthcare : US$6.4b PET imaging agent market[2]

• • i-body enabled CAR-T with Carina Biotech : US$20b market by 2028[3]

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• Continuing to build out pipeline with additional internal and external programs: targeting 10 by 2023

• GlobalData, Idiopathic Pulmonary Fibrosis Opportunity Analysis and Forecasts to 2029, November 2020 2. 2027 forecast by Global Industry Analysts, Imaging Agents: Global Market Trajectory and Analytics, April 2021 3. 2028 forecast by Grandview Research, “T-cell Therapy Market Size, Share & Trends Analysis” Feb 2021

AGM PRESENTATION – NOVEMBER 2021

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AGM PRESENTATION – NOVEMBER 2021

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Progress against calendar 2021 goals (per 2020 AGM)

2021 goals were achieved or modified in direct response to new data or emerging near term opportunities with greater value

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AD-214 clinical

• ü Phase I single and multi-dose safety: successfully completed, AD-214 well tolerated with clear evidence of long duration CXCR4 engagement

• ü Safety studies in patients: replaced with health volunteers to generate safety data for Phase II more rapidly

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AD-214 PET imaging

ü Pre-clinical development of RL-AD-214 for PET imaging: successfully completed

• × 1st images in patients: deferred based on pre-clinical studies until improved formulation available

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Partnerships

• ü GE Healthcare commence pre-clinical development of GZMB i-body PET agent: AdAlta engagement extended; $1.5m revenue to date

• ü 2[nd] external collaboration: multi-target CAR-T collaboration with Carina Biotech – 1[st] target commencing discovery

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Internal pipeline and platform development

• ü 2 new targets into discovery: 1[st] commenced; 2[nd] from Carina collaboration; nearer term formulation development

• i-body2.0: program commenced, scope now expanded to include bi-specifics, manufacturing (GE collaboration) & formulation improvements

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Other achievements

• Orphan Drug Designation for AD-214

• Four new patents granted covering AD-214 (Japan, Singapore and second US and Australian patents)

• $4m Vic Government RDTI low interest loan facility & $0.7m BTB Grant amendment to support inhalation development

AGM PRESENTATION – NOVEMBER 2021

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AdAlta has successfully transitioned to the expansion phase of our growth plan Achievements in 2021 have laid the foundation for acceleration of our growth

Accelerate (from ~mid-2021)

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Maximise catalysts from current funded base (2020)

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Expand (~mid 2020 to late 2021)

Now here

Preparing for acceleration

From…

Via…

Towards 2023…

• i-body platform in clinic for difficult drug targets

• Clinical and commercial validation: AD-214 Phase I trial and GE partnership

• Laying the foundations for growth

• AD-214 progressing through clinical and commercial development

• Building internal and external pipeline

• Continuous platform improvement

• Multi-product, multi-partner platform company

• AD-214 partnering, new indications

• ~5 internal GPCR programs

• 3-5 co-development partnerships

• Fully leveraging our platform, discovery, preclinical and clinical capabilities

AGM PRESENTATION – NOVEMBER 2021

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AdAlta assets and business model

AdAlta’s pipeline is expanding to plan. The i-body platform is creating wholly owned or co-developed assets. Our team is building skills in fibrosis/inflammation and immuno-oncology.

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Co- Precision engineered, i-body enabled CAR-T Immuno-oncology developed Granzyme B i-body enabled PET imaging cells potentially providing new hope for theme assets agents for use in immuno-oncology patients with cancer Pre-clinical Discovery One more target to be added in early 2022 Wholly Lead candidate: AD-214 Undisclosed target: GPCR for Fibrosis and owned First in class anti-fibrotic targeting CXCR4 fibrotic disease inflammation assets Discovery theme Phase I Orphan Drug Designation for IPF Platform Patented, diverse i-body discovery platform: 20 billion different i-bodies for drugging undruggable targets

AGM PRESENTATION – NOVEMBER 2021

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Four needs AdAlta is addressing today AdAlta’s platform and pipeline is already offering the potential to address four major opportunities in our industry

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Antibodies cannot do everything!
AdAlta’s i-bodies are a new drug discovery platforms for challenging targets
Idiopathic pulmonary fibrosis: degenerative, fatal
AdAlta’s AD-214 could meet a desperate need for new approaches for a debilitating
disease
Immuno-oncology drugs revolutionising cancer treatment … for some
AdAlta and GE Healthcare’s GZMB PET imaging could identify responders early
CAR-T cell therapy providing new hope for blood cancer patients
AdAlta and Carina’s i-body CAR-T cells could offer same hope for patients with solid tumours
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AGM PRESENTATION – NOVEMBER 2021

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An immensely powerful drug discovery platform i-body technology can enable a wide range of therapeutic and diagnostic products

Wide range of target classes

Wide range of product formats

CAR-T

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Targeting agents
Chemokine
That deliver
therapeutic cargos
more precisely
G-Protein Coupled
Lysophos-
>25 targets to which pholipid Receptors GZMB
Other i-body binders have i-bodies
been found
Neurotensin
Acetylcholine Direct therapeutics
Prostanoid For challenging targets,
Ion channel such as GCPRs
AD-214
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Bi-specifics and multi-specifics

To improve targeting and selectivity

For challenging targets, such as GCPRs

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AD-214
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Phase I clinical and PET imaging inform Phase II dosing and route of administration

Intravenous AD-214 is well tolerated in Phase I studies; PET imaging with radiolabelled AD-214 supports early transition to inhaled route of administration

Phase I clinical study successfully completed[1]

• Intravenous AD-214 is well tolerated in single and multiple doses

Direct lung delivery (inhalation) of AD ⁃ 214: a superior format for IPF

• Target (CXCR4) binding observed with extended duration

Improved intravenous formulation for other indications, derisks IPF

Resupply of AD-214 clinical material secured[2]

• Defines timeline for Ph II clinical study

Phase II studies in IPF scheduled for 2H 2023 with superior formulation

Pre-clinical intravenous studies inform optimal administration[3]

• PET imaging shows rapid liver distribution (reduced bioavailability)

• Preclinical animal data supports potential iv safety, efficacy profile

• ASX Releases 10 Mar 2021 and 19 Jul 2021

• ASX Release 1 July 2021

• ASX Release 19 July 2021

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Key milestones progressively de-risk AD-214 development: IPF Phase II 2023

Quarterly milestones to de-risk formulation; extensive use of pre-clinical imaging; AD-214 partnering window from late 2022

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Key data readouts
2021 2022 2023 2024
INHALATION
PROGRAM
Aerosol stability and formulation
Pre-clinical efficacy, dose optimisation
Distribution, PK + imaging: correlated with efficacy
INTRAVENOUS
IV reformulation
PROGRAM
TOXICOLOGY
Multi-dose toxicology
PROGRAM
CLINICAL
PROGRAM Clinical: healthy volunteer bridging safety Bridging safety, PK
Clinical: patient Phase IIa/b
Patient imaging
CLINICAL
RESUPPLY Manufacturing (clinical resupply)
(SECURED)
PARTNERING Likely next AD-214 partnering window
PROGRAM
Calendar years
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Immuno-oncology (I/O) PET imaging

US$6.4b PET imaging market: could help identify the 20-40% of patients who will respond to revolutionary I/O drugs faster

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Immuno-oncology (I/O) drugs reactivate the patient’s own immune system to fight cancer

Granzyme B (GZMB) is produced by immune cells to kill cancer

Potential biomarker of immune system activated by I/O drugs

PET imaging agents have short development time

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

US$95 billion I/O market[1]

Only 20-40% of patients respond to I/O drugs[2]

PET imaging GZMB can help identify responders early

US$6.4 billion PET imaging agent market[3] Largest products >US$400m[4]

1. 2027 forecast by Global Industry Analysts, Imaging Agents: Global Market Trajectory and Analytics, April 2021 4. AD Nunn, J Nucl Med (2007) 169

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CAR-T therapies are revolutionising cancer treatment

Reprogramming a patient’s own immune system to fight cancer is a fast-growing market at the cutting edge of medicine

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CAR engineeredchemokine
receptor
step 1 step 2
T cells T cells genetically
isolated from a modified to express
patient’s blood both the CAR molecule
+ chemokine receptor/s
Immune cells are removed from blood and re-
engineered so they “see” cancer as a pathogen
step 4 step 3
CAR-T cells Newly created
infused back CAR-T cells
into patient expanded
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US$20.3b
revenue forecast for 2028 [1]
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50%
solid tumour share of
revenues by 2030 [2]
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1. Grandview Research, “T-cell Therapy Market Size, Share & Trends Analysis” Feb 2021

2. Polaris Market Research, "CAR-T Cell Therapy Market Share, Size Trends, Industry Analysis Report", June 2021

AGM PRESENTATION – NOVEMBER 2021

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Advantages of i-body enabled CAR-T

i-body enabled CAR-T cells may demonstrate improved precision, performance and persistence, particularly in bi-specific and dual CAR-T cells[1]

• Specifically designed for antigens considered difficult or intractable for traditional approaches

• Half the size of the traditional CAR binding domain

• Enables greater flexibility in CAR design

i-body enabled mono / dual CAR i-body enabled bi-specific CAR engineered engineered chemokine chemokine receptor receptor

• Ideally suited to dual and bispecific CARs

• Target 2 antigens on cancer cells

• Less likely for tumour cells to be missed

• Reduces chance of damaging healthy tissue

• In vitro proof of principle established

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1. ASX Release 24 Aug 2021

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Building the first i-CAR-T cell therapy: proof of principle results

i-body enabled CAR-T cells have been successfully generated by Carina and demonstrate in vitro cell killing (lysis)[1]

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Experimental details

• LOVO and LIM1215 are colorectal cancer cell lines; U87 is a glioblastoma cell line

• 3 different Carina CAR-T constructs incorporating i-body against a single target “X” (CNA4002/CNA4003/CNA4004)

• UT is an unmodified T-cell that does not result in significant killing (lysis) of these cell lines

• i-CAR-T cells manufactured with 97% transduction (i-body CAR insertion) efficiency

• i-CAR-T cells included 60-70% CD4+ (helper) and 20-30% CD8+ (cytotoxic – killer) T cells

CONFIDENTIAL

1. 210921 Carina iBody Datapack SB (2021) – previously unpublished data

AGM PRESENTATION – NOVEMBER 2021

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Current approved CAR-T products

Five FDA approved CAR-T products for blood cancers generate strong revenues and are in high demand

	Manufacturer
	Product
	Notable CAR-T transactions	UPenn and Novartis Alliance Aug 20122	Gilead acquired Kite Aug 2017 US$11.9b1	Gilead acquired Kite Aug 2017 US$11.9b1	Celgene acquired Juno Jan 2018 US$9b; BMS acquired Celgene Jan 2019 US$74b3	Celgene acquired Juno Jan 2018 US$9b; BMS acquired Celgene Jan 2019 US$74b3
	FDA approval	August 2017 (acute lymphoblastic leukemia, large B cell lymphoma)	October 2017 (large B cell lymphoma)	July 2020 (mantle cell lymphoma)	February 2021 (large B cell lymphoma)	March 2021 (multiple myeloma)
Revenue 20204	Revenue 20204	US$474m	US$563m	US$44m	N/A	N/A

1. https://www.businesswire.com/news/home/20210204006011/en/Gilead-Sciences-Announces-Fourth-Quarter-and-Full-Year-2020-Financial-Results 2. https://www.novartis.com/

2. https://www.celgene.com/newsroom/cellular-immunotherapies/celgene-corporation-to-acquire-juno-therapeutics-inc/

3. businesswire.com/news/home/20210204006011/en/Gilead-Sciences-Announces-Fourth-Quarter-and-Full-Year-2020-Financial-Results, novartis.com, celgene.com/newsroom/cellular-immunotherapies/celgenecorporation-to-acquire-juno-therapeutics-inc/

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An expanding pipeline of i-body enabled products

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----- Start of picture text -----

IND
PROGRAM PARTNER PRODUCT/ DISCOVERY PRECLINICAL, ENABLING PHASE I PHASE II
INDICATION PRODUCT
STUDIES
DEV
CXCR4 AD-214: Idiopathic Inhaled
Pulmonary Fibrosis Intravenous
AD-214: Indication 2
Target 2 Not disclosed
Target 3 Not disclosed
Target 4 TBC
Target 5 TBC
GZMB PET imaging I/O
5 targets – i-body enabled, bi-specific
not disclosed and next-gen CAR-Ts
TBC Partner #3
TBC Partner #4
2020 Current End ‘21/early ‘22 End 2023 (aim)
INTERNAL PIPELINE
EXTERNAL PIPELINE
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• Target #3 may be replaced by second Carina target, delivering shorter time to proof of concept

AGM PRESENTATION – NOVEMBER 2021

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Calendar 2022 goals

Significant progress anticipated on both existing core programs and further pipeline expansion

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AD-214 – first in class anti-fibrotic

• Inhaled formulation development: nebulisation feasibility, efficacy in animal model of IPF (Q1); lung distribution imaging in healthy and disease model animals (Q1); dose finding and clinical formulation (Q2)

• Intravenous formulation development (Q3)

• GLP toxicology with inhaled formulation (commences 2H22)

• Continuning partnering discussions (Q1); selection of next indication

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GE Healthcare – GZMB PET imaging

• Pre-clinical proof of concept – milestone payment (mid-22)

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Carina Biotech – i-body enabled CAR-T cells

• 1st experimental results on Target #1

• Commence i-body discovery on Target #2

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Internal pipeline and platform development

• Initial functional data on i-body binders against internal Target #2 (2H22)

• i-body2.0: new intellectual property filed (end’22)

• 7 programs in pipeline (end’22)

• Additional patent filings, grants on individual i-body enabled products

AGM PRESENTATION – NOVEMBER 2021

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Industry experienced leadership and advisors

Team with experience from discovery through manufacturing, clinical and commercialisation

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Board Dr Paul MacLeman Chair

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Liddy McCall Director (alt: Dr James Williams)

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Tim Oldham, PhD CEO & Managing Director

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Dr Robert Peach Independent Director

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Dr David Fuller Independent Director

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Executive Tim Oldham, PhD CEO & Managing Director Dallas Hartman, PhD Chief Operating Officer

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Claudia Gregorio-King, PhD VP Clinical Product Development

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Mick Foley, PhD Founding Chief Scientist

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Michael Rasmussen Consultant Medical Expert

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Scientific Advisory Board Brian Richardson Drug discovery and development expert

Steve Felstead Clinical development

John Westwick

Pulmonary drug discovery and development Development team

10 staff (9 PhD’s)

Skills in protein chemistry, i-body discovery, product development, pre-clinical development, clinical development

AGM PRESENTATION – NOVEMBER 2021

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Investment proposition

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i-body platform to create value

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Clear vision for growth

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Fibrosis/inflammation Lead asset advancing to Phase II >$3b market potential in first indication[1]

Discovery initiated on 2[nd] target

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Leading expertise

Immuno-oncology 2 x co-development collaborations to leverage platform

ü GE Healthcare: $6b PET market[2] ü Carina Biotech: $20b CAR-T market[3]

Regular near-term news flow

1. GlobalData, Idiopathic Pulmonary Fibrosis Opportunity Analysis and Forecasts to 2029, November 2020 2. 2027 forecast by Global Industry Analysts, Imaging Agents: Global Market Trajectory and Analytics, April 2021 3. 2028 forecast by Grandview Research, “T-cell Therapy Market Size, Share & Trends Analysis” Feb 2021

Contact:

Tim Oldham, CEO and Managing Director enquiries@adalta.com.au www.adalta.com.au

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