ADALTA LIMITED — Investor Presentation 2021

Oct 21, 2021

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22 October 2021

ASX Announcement

ADALTA PRESENTATIONS AT AUSBIOTECH INVEST AND BIO-EUROPE

MELBOURNE Australia, 22 October 2021: AdAlta Limited (ASX:1AD), the clinical stage drug discovery company developing novel therapeutic products from its i-body platform is pleased to announce that CEO and Managing Director, Dr Tim Oldham, will present at the upcoming AusBiotech Invest and BIO-Europe Digital conferences taking place virtually from 25-29 October 2021.

Dr Oldham’s presentations will draw on AdAlta’s corporate overview (attached), incorporating results from most recent quarterly report. The presentations focus on AdAlta’s wholly owned fibrosis/inflammation pipeline and co-developed immunooncology pipeline that demonstrate the power of the i-body platform for drug discovery. The video presentations will be available on demand throughout the conferences. The AusBiotech Invest presentation can also be found on the Company’s website at: https://adalta.com.au/investors/presentations/.

Potential investors or partners attending either conference are invited to make contact to arrange 1:1 discussions on AdAlta’s i-body platform, its fibrosis or oncology assets, or for a company introduction. Contact information for Dr Tim Oldham is available at the bottom of this announcement.

About the conferences

AusBiotech Invest 2021

AusBiotech is the leading Australian industry body representing and advocating for organisations doing business in and with the global life sciences economy. AusBiotech Invest is the largest life sciences conference in Australia. Networking and one-to-one meetings for the global life science network are available via this forum. In 2021 AusBiotech Invest will be held virtually from 25-29 October. https://www.ausbiotechnc.org/

BIO-Europe Digital

BIO-Europe Digital is one of the largest biotech partnering conference in Europe. BIOEurope Digital plays a pivotal role in bringing global biopharma and investment leaders together, to build partnerships that facilitate innovation and medical breakthroughs. In 2021 BIO-Europe will be held digitally from 25-28 October. https://informaconnect.com/bioeurope/.

Authorised for lodgement by:

Tim Oldham CEO and Managing Director October 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 stability of a unique and versatile antigenbinding 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.

The Company is also entering collaborative partnerships to advance the development of its i-body platform. It has an agreement with GE Healthcare to co-develop i-bodies as diagnostic imaging agents against Granzyme B, a biomarker of response to immunooncology 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.

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

Corporate overview October 2021

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INVESTOR PRESENTATION – OCTOBER 2021 2

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Disclaimer

Investment in AdAlta is subject to investment risk, including possible loss of income and capital invested. AdAlta does not guarantee any particular rate of return or performance, nor do they guarantee the repayment of capital.

This presentation is not an offer or invitation for subscription or purchase of or a recommendation of securities. It does not take into account the investment objectives, financial situation and particular needs of the investor. Before making any investment in AdAlta, the investor or prospective investor should consider whether such an investment is appropriate to their particular investment needs, objectives and financial circumstances and consult an investment advisor if necessary.

This presentation may contain forwardlooking statements regarding the potential of the Company’s projects and interests and the development and therapeutic potential of the company’s research and development. Any statement describing a goal, expectation, intention or belief of the company is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercialising drugs that are safe and effective for use as human therapeutics and the financing of such activities.

There is no guarantee that the Company’s research and development projects and interests (where applicable) will receive regulatory approvals or prove to be commercially successful in the future. Actual results of further research could differ from those projected or detailed in this presentation. As a result, you are cautioned not to rely on forward-looking statements. Consideration should be given to these and other risks concerning research and development programs referred to in this presentation.

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AdAlta today

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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

• US$3b IPF market today, multiple 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

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

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

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What is the i-body advantage?

All the selectivity and specificity of antibodies with greater versatility and tunability

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Accessing
challenging
targets
Small Molecule Antibody i-body
Diverse
applications
Naked PEGylation Fc-fusion Bi-specific Payload CAR cell
i-body targeting therapy
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Small size, flexible binding domain Confers unique binding capability for targets challenging traditional antibodies; enables modular drug design across diverse applications

Minimising off-target side effects

Unique binding capability potentially allows greater selectivity and specificity, tunable affinity

Multiple drug administration routes

Amenable to multiple administration routes (e.g. injection, inhalation and topical)

Robust

Resilient to pH and temperature cycling

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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

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CAR-T
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Bi-specifics and
Targeting agents
multi-specifics
That deliver
To improve targeting
therapeutic cargos
and selectivity
more precisely
GZMB
i-bodies
Direct therapeutics
For challenging targets,
such as GCPRs
AD-214
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Idiopathic Pulmonary Fibrosis (IPF)

AdAlta’s first target, already a $3b market, is a degenerative, fatal disease in dire need of improved treatment options: i-bodies have been designed to target a novel mode of action to address this medical need

In IPF, scarring and stiffening 3.8 years of the lungs progressively and median survival after diagnosis irreversibly reduces lung function

Despite being poorly tolerated and having difficult side effects, the two current therapies sell $3b per year

>300,000 people living with IPF, It is irreversible

40,000 people die from IPF every year

Burden of fibrotic lung disease following COVID-19 likely to be high.* “Long COVID” is a developing issue – potentially further increasing the need for better anti-fibrotic drugs.

• PM George, et al, “Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy”, Lancet published online May 15, 2020.

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AD-214: first in class treatment for fibrosis

AD-214’s initial focus is IPF

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First-in-class (novel mode Human
of action) treatment
Lung
Tissue
Brown stain shows
increased amount of
Targets a receptor called CXCR4 in fibrotic
CXCR4 lung tissue
Normal Diseased
Initial focus is Idiopathic
Pulmonary Fibrosis
(IPF) , one of a group
Mouse
of Interstitial Lung
model of
Diseases (ILDs)
lung Purple stain
fibrosis shows amount
of collagen
(fibrosis)
Blocking CXCR4
reduces fibrosis in animal
models
Normal mouse IPF mouse lung tissue IPF mouse lung tissue
lung tissue + AD-214
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• IPF tissue images taken 21 days after bleomycin (BLM) was administered to induce fibrosis; mouse treated with AD-214 received 10 mg/kg AD-214 every 4 days from day 8 after bleomycin administration.

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Phase I clinical and PET imaging inform dosing and route of administration

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

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

• Phase I healthy volunteers: 42 single dose participants to 20 mg/kg; 8 multiple dose participants at 5 mg/kg

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No concerning immune responses, clinical sign or organ function results

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Target (CXCR4) binding observed with extended duration

• Clear markers of CXCR4 engagement observed (Phase I and PET imaging) Receptor occupancy sustained at high levels for extended periods

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Direct lung delivery (inhalation) of AD ⁃ 214 could achieve a therapeutic dose at lower levels than intravenous delivery

Alternate intravenous formulations to be evaluated for other indications

Rapid liver distribution and clearance reduces bioavailability

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• Consistent with pharmacokinetics and a first pass clearance mechanism More than half administered dose not available at target site of action

Liver distribution does not appear to affect safety, efficacy profile

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• Consistent with lack of localization to hepatocytes, observed changes in liver function or toxicity in toxicology and clinical studies

Consistent with observed bleomycin mouse efficacy data

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Phase II planned with inhaled formulation

Delivery of AD-214 by inhalation has potential to improve bioavailability, be more convenient for patients, be more cost effective, and improve partnering flexibility

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• AD-214 delivered direct to fibrotic areas

• • First pass liver clearance avoided

• Improved bioavailability • Dosing schedule flexibility to optimise receptor coverage

• • Self administration (no scheduled clinic

• Greater patient convenience visits; freedom of movement) • Less invasive • Lower drug dose means lower cost of goods

• Enhanced cost effectiveness • Lower healthcare costs for administration

• • Potential to partner AD-214 by indication using different routes of

• Diversified partnering options administration - broadens potential long term options

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Key milestones to de-risk AD-214 development

Quarterly milestones to de-risk asset; extensive use of pre-clinical imaging; AD-214 partnering window from FY23

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Key data readouts
FY22 FY23 FY24
INHALATION PROGRAM MILESTONES
Aerosol stability and formulation
Pre-clinical efficacy, dose
optimisation
Distribution, PK + imaging:
correlated with efficacy
Multi-dose toxicology
Clinical: healthy volunteer bridging safety Bridging safety, PK
Clinical: patient Phase IIa/b
Patient imaging
CLINICAL RESUPPLY (SECURED)
Manufacturing (clinical resupply)
Likely next AD-214 partnering window
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AD-214: multiple indication extension options

Each additional indication could address multiple markets with U$ billion potential

Data in tissue and animal models show that AD-214 may improve fibrosis across a range of fibrotic diseases and cancer:

multiple indication extension potential

Indication specific formulations and routes of administration may enhance partnering potential

• LUNG (lead indication - inhaled): Idiopathic Pulmonary Fibrosis with natural extension to Interstitial Lung Disease

• EYE (intravitreal injection): Wet-Age Related Macular Degeneration

• CANCER : 23 different cancers, enhancement of I/O drugs*

• KIDNEY : Chronic kidney disease*

• LIVER: NASH*

• SKIN (topical, local injection) : Hypertrophic scars

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Lung Eye Cancer
IPF/ILD Wet-AMD 23 different cancers, I/O
>US$3b >$15b >$1b ea
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Liver Skin
Kidney
NASH & CIRRHOSIS SCLERODERMA
RENAL FIBROSIS
>US$10b
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• Subject to development of a satisfactory, improved intravenous formulation.

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IPF partnering: valuable options as early as Phase I

IPF assets have recently yielded attractive deal terms at early stages of development – first partnering window for AD-214 in FY2023

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Feb-21: License by Graviton Jul-19 license by Boehringer Ingelheim Phase I Phase I US$517.5m milestones €45m upfront + €1.1b milestones Nov-20: Galapagos collaboration Nov-19 acquired by Roche – Phase II Phase II ready US$390m upfront + US$1b milestones €320m milestones [Aug-15 BMS option to buy US$150m upfront + US$1.25b milestones] Aug-20: License by AstraZeneca Jan-20 platform license by Boehringer Ingelheim Preclinical Preclinical Upfront US$17m + milestones US$360m upfront undisclosed + US$1b milestones

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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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US$95 billion I/O market[1]

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

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

Granzyme B (GZMB) is produced by immune cells to kill cancer PET imaging GZMB can help identify responders early Potential biomarker of immune system activated by I/O drugs

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

PET imaging agents have short development time

1. 2026 forecast by ResearchandMarkets.com, Immuno-Oncology - Market Analysis, Trends, Opportunities and Unmet Needs - Thematic Research, March 2021 2. P Sharma, et al, Cell 168(4) 707 (2017)

2. 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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GZMB i-body asset: GE Healthcare co-development collaboration

Second asset in pre-clinical development; and could generate royalty revenue sooner than a therapeutic due to shorter diagnostic development timelines

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Pipeline asset at no financial cost to AdAlta

• i-body discovery

Unique i-body platform

• AdAlta earns research fees, development and sales milestone payments and royalties on product sales

• Manufacturing process development

• A$1.5 million revenue (milestones and research fees) earned to June 2021

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October 2021 status

• Panel of GZMB specific i-bodies identified

Leading global supplier of PET imaging equipment and tracers

• 18F chemistry, final product manufacture

• Pre-clinical proof of concept studies underway

• Manufacturing development underway

• Pre-clinical, clinical proof of concept

• Commercialisation

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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
step 2 receptor
T cells genetically
modified to express
both the CAR molecule
+ chemokine receptor/s
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step 1 T cells isolated from a patient’s blood

• ü Takes advantage of the body’s natural immune response to pathogens

• ü Immune cells removed from blood and reengineered so they “see” cancer as a pathogen

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step 3 Newly created CAR-T cells expanded

step 4 CAR-T cells infused back into patient

earned by CAR-T therapy products in 2020[3]

US$1b

addressable patient 2m population within next 10 years[1]

US$20.3b revenue forecast for 2028[1]

solid tumour share of revenues by 2030[2]

50%

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

3. Yescarta and Kymriah market size estimates calculated from various publicly available sources. Estimates vary and different analyses may give different results.

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i-body enabled CAR-T assets: Carina collaboration

Third program entering discovery to generate precision engineered CAR-T products providing new hope for patients with cancer

World-leading proprietary CAR-T technologies for superior access, potency and persistence

Unique i-body platform for exceptional reach and targeting capability

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To develop precision engineered, i-body enabled, CAR-T therapies, including bi-specific and dual CAR-T products, that provide new hope for patients with cancer

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Carina collaboration details

AdAlta and Carina will jointly develop up to 5 targets to create CAR-T, bi-specific CAR-T and dual CAR-T cell therapy products

Up to 5 targets

Significant new, shared IP

• Proof of principle already achieved ( in vitro )

• Targets not yet disclosed

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• Share costs, research to in vivo proof of concept

• AdAlta + Carina will jointly own collaboration IP

• Combine targets for bi-specific and dual-targeted CARs

Post proof of concept commercialisation options

Attractive deal space

• Can continue to develop products together, progress independently or out license

• Products emerge from the collaboration at proof of concept

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• Biotech and immuno-oncology segment: very attractive deal space

• Large biotech and pharma companies are actively sourcing CAR-T products

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AdAlta assets and business model

Current strategy is based on leveraging the i-body platform to create i-body enabled assets that are wholly owned or codeveloped. The pipeline is expanding to plan

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Co- Precision engineered, i-body enabled CAR-T Immuno-oncology developed Granzyme B i-body enabled PET imaging cells providing new hope for patients with theme assets agents for use in immuno-oncology cancer Pre-clinical Discovery 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 One more target to be added in 2021 Platform Patented, diverse i-body discovery platform: 20 billion different i-bodies for drugging undruggable targets

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An expanding pipeline of i-body enabled products

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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
Current End 2021 End 2023 (aim)
INTERNAL PIPELINE
EXTERNAL PIPELINE
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The potential of our strategy: Ablynx case study

Multiple internal and external assets drive value, attract partners

GPCR platform exits

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Acquisition
US$5B
IPO
US$182m
+US$83m
+US$112m
+US$57m
+US$40m
+US$70m
IPO
US$121m
Global Data 2019
AdAlta is embarking on
a similar journey
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Feb-15 acquired by Sosei Phase Ib + 7 preclinical leads US$400m Jul-15 acquired by Celgene Ph II/III + GPCR platform US$7.8b Feb-18 acquired by Sanofi 8 clinical, 37 preclinical candidates €3.9b

Source: Platinum Asset Management, AdAlta analysis

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Milestones for remainder of FY2022

Milestones extended through end of FY2022

	AD-214	Other Assets
H1 2021	ü Orphan Drug Designation for AD-214 in IPF ü Results of Phase I single dose studies in healthy volunteers ü Phase I multi-dose studies in healthy volunteers commence ü Japanese patent covering AD-214 granted ü PET tracer pre-clinical development results	ü Progressing the GE Healthcare collaboration from discovery to pre- clinical development
H2 2021	ü Top line results of multi-dose studies in healthy volunteers ü Pre-clinical data in additional indications • Preliminary stability of AD-214 following nebulisation	ü Entering a second collaboration agreement (Carina Biotech) • Finalise research project outlines for initial Carina targets • Commencing development of two new i-body enabled internal pipeline assets (one commenced, one to go)
H1 2022	• Initial efficacy of inhaled AD-214 in IPF animal model • Imaging inhaled AD-214 in the lungs of healthy and fibrotic disease model animals • Inhaled dose and dose scheduling optimisation	• New i-body 2.0 IP filed • GE Healthcare preclinical update • First experimental results from Carina collaboration

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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 Liddy McCall Director (alt: Dr James Williams) Tim Oldham, PhD CEO & Managing Director 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 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

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Corporate snapshot

Key financial details (18 Oct 2021)

	Key financial details (18 Oct 2021)
	ASX code	1AD
	Market capitalisation	A$21.33m
	Share price (12 month closing range)	A$0.087 ($0.081 - 0.195)
	12 month return Ordinary Shares (daily volume) Unlisted Options Cash(30 Sep 2021)	(33)% 245,179,578 (497,778) 7,514,067 A$6.77m

Major shareholders (18 Oct 2021)	%
Yuuwa Capital LP	22.0
Platinum Asset Management Meurs Holdings Pty Ltd	11.6 7.3
Radiata Super Pty Ltd	3.1
Sacavic Pty Ltd	1.8
Other (1,567 total holders)	54.2
Total	100%

Analyst Coverage

Edison Pitt Street Research Securities Vault

Share price performance (last 12 months)

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0.25 7.0
6.0
0.20
5.0
0.15 4.0
3.0
0.10
2.0
0.05
1.0
0.00 0.0
19-Oct-20 19-Dec-20 19-Feb-21 19-Apr-21 19-Jun-21 19-Aug-21
Price Volume
Quarterly cash flows (A$ million)
Net inflows Net outflows Cash at end of quarter
12
10
8
6
4
2
0
(2)
(4)
(6)
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
FY19 FY19 FY19 FY19 FY20 FY20 FY20 FY20 FY21 FY21 FY21 FY21 FY22
Volume (m)
Share price (A$)
Cash (A$ milion)
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Quarterly cash flows (A$ million)

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Investment proposition

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i-body platform to create value

Patented, validated i-body platform for asset creation: designed for “difficult” targets, multiple modalities

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Fibrosis/inflammation

Lead asset advancing to Phase II

AD-214: first-in-class, multiple indications Phase I complete; clear path to Phase II in IPF >$3b market potential in first indication

Immuno-oncology

2 x co-development collaborations to leverage platform

• ü GE Healthcare: PET imaging in I/O $6b market

• ü Carina Biotech: CAR-T $20b market

Discovery initiated on 2[nd] target

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Clear vision for growth

Build on existing clinical and commercial validation of platform and therapeutic knowledge to add internal programs, expand collaborations

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Leading expertise

Experienced drug development team in place

Regular near-term news flow

AdAlta substantially undervalued relative to peers Regular near milestones advance and derisk pipeline

Contact:

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

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