ADALTA LIMITED — Investor Presentation 2021

Jun 2, 2021

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3 June 2021

ASX Announcement

ADALTA PRESENTS AT SHARE CAFÉ HIDDEN GEMS AND BIO DIGITAL

MELBOURNE Australia, 3 June 2021: AdAlta Limited (ASX:1AD), the clinical stage biotechnology company developing novel therapeutic products from its i-body platform, is pleased to provide investors with a copy of its latest investor presentation, highlights from which are to be presented by CEO, Dr Tim Oldham at the upcoming Share Café Hidden Gems investor webinar and BIO Digital conference.

The Share Café Hidden Gems investor webinar will be held tomorrow, Friday 4 June from 12:30pm AEST / 9:30am AWST and is able to be viewed live via Zoom. To access further details of the event and to register (at no charge), please copy and paste the following link into your internet browser: https://us02web.zoom.us/webinar/register/5416151767246/WN_J9qXooSqQLW1evtXH QtTmg

The BIO Digital conference, one of the largest annual industry partnering conferences, will be held virtually on 10-11 and 14-18 June, 2021 . To access further details of the event, please copy and paste the following link into your internet browser: - https://www.bio.org/events/bio digital.The video of Dr Oldham’s presentation will be made available on AdAlta’s website.

AdAlta is pleased to be able to provide investors and shareholders these additional forums to learn about the Company’s progress.

Authorised for lodgement by:

Tim Oldham CEO and Managing Director June 2021

Notes to Editors

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.

AdAlta is conducting Phase 1 clinical studies for its lead i-body candidate, AD-214. AD-214 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 discover i-bodies as

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diagnostic imaging agents against Granzyme B, a biomarker of response to immunooncology drugs.

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 - AdAlta Media - AdAlta Tim Oldham, CEO & Managing Director IR Department Tel: +61 403 446 665 Tel: +61 411 364 382 E: t.oldham@adalta.com.au E: gabriella.hold@irdepartment.com.au

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Corporate overview June 2021

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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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Idiopathic Pulmonary Fibrosis (IPF) AdAlta’s first target, already a $3b market, is a degenerative, fatal disease in dire need of improved treatment options

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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Why invest in AdAlta now?

Very near-term catalysts across two programs, multiple expansion opportunities

i-body platform Lead asset AD-214: to create products unique, needed and valuable Enables creation of Unique mode of action therapeutics for multi-billion dollar markets Phase I: underserved by single doses well tolerated traditional antibodies US$3b market for IPF IPF assets earn high, early milestones Clear vision AD-214: for growth grow and de-risk Poised to expand pipeline: Further Phase I data 2 products today Further pre-clinical data supporting AD-214 use in multiple indications 5 by end 2021 First partnering window ~10 by end 2023 in Q4 CY21

Lead asset AD-214: unique, needed and valuable Unique mode of action

Phase I: single doses well tolerated US$3b market for IPF IPF assets earn high, early milestones

Asset 2 GZMB: early revenue, fully funded

PET imaging agent to identify responders to immunotherapy Pre-clinical

Fully funded by GE Healthcare: A$1.4m revenue to date

US$6.4b PET imaging market

Other assets: progress, diversify GZMB asset progress to pre-clinical development Second co-development collaboration mid-2021 Two further internal programs in 2021

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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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Unique
binding
capability
Small Molecule Antibody
Flexible
modular
formats
Naked i-body PEGylation Fc-fusion Bi-specific Payload targeting
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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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Diverse applications of i-bodies i-body technology can enable a wide range of applications

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Bi-specifics and
Targeting agents
multi-specifics
That deliver
To improve targeting
therapeutic payloads
and selectivity
more precisely
GZMBGZMB
i-bodies
Direct therapeutics
For challenging targets,
such as GCPRs
AD-214
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AD-214: first in class treatment for fibrosis

AD-214’s initial focus is the US$3b IPF market

First-in-class (novel mode of action) treatment for fibrotic diseases, which can affect almost every organ

Targets a receptor called CXCR4: a critical player in the development of fibrosis in many organs and the progression of many cancers

Initial focus is Idiopathic Pulmonary Fibrosis (IPF) , one of a group of Interstitial Lung Diseases (ILDs). CXCR4 is highly expressed in IPF and other ILDs

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Brown stain
shows amount
of CXCR4
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Human Lung Tissue Normal Diseased

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Mouse
model of
lung fibrosis
Purple stain
shows amount
of collagen
(fibrosis)
Normal mouse IPF mouse lung tissue IPF mouse lung tissue + AD-214
lung tissue (21 days after (21 days after BLM; AD-214 at
bleomycin [BLM]) 10mg/kg every 4 days from day 8)
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AD-214 Phase 1 clinical program

The Phase 1 program is evaluating safety and distribution of AD-214 in healthy volunteers and patients

Phase 1 protocol in healthy volunteers

Part A

Part B (Commenced Q2 2021)

(Completed)

Single dose, Multiple ascending dose, healthy volunteers (HV SAD) healthy volunteers (HV MAD) 42 patients in 7 cohorts 12 – 24 patients in 3 cohorts 0.01-20 mg/kg dose 5-15 mg/kg every 2 weeks

Objectives of Phase 1 Part A and B:

• Top-line safety data by end 2021

• Explore optimal dosing intervals

• Supports Phase II, FDA IND application in all CXCR4 indications

Phase 1b protocol in IPF and ILD (and other fibrotic disease) patients*

Arm 1 Arm 2

PET screening of fibrotic diseases

Multi-dose in IPF/ILD

Open label with standard of care** ~12 patients (~6 IPF/ILD) + PET

Open label with standard of care** ~6 patients, max 6 doses over 18 weeks +/- PET imaging

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Objectives of Phase 1b:

• Safety in IPF/ILD in combination with standard of care**

• Effect of elevated lung CXCR4 on distribution and receptor engagement of AD-214 in IPF and ILD patients

• Explore change in CXCR4 expression over time as potential biomarker

• Supported by a Biomedical Translational Bridge grant from Medical Research Future Fund and MTPConnect. ** Includes pirfenidone, nintedanib or non-pharmacologic intervention.

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AD-214 – Phase 1 trial: results to date

Single doses well tolerated, AD-214 clearly engages CXCR4 target for extended duration

Results from single dose studies (Part A)

AD-214 has an excellent safety profile

• No dose limiting toxicities or adverse events of clinical concern

• No concerning clinical laboratory results

• No concerning immune responses or clinical symptoms

• Consistent with Non-Human Primate (NHP) toxicology studies

AD-214 engages the CXCR4 receptor

• Clear markers of target (CXCR4) engagement observed

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Lung
IPF/ILD
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Receptor occupancy sustained at high levels for extended periods

• Supportive of longer dosing interval than projected from NHP if replicated in patients

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IPF late-stage clinical landscape: a narrow development field

AdAlta’s novel mode of action expected to be attractive to partners as an alternative to, and in combination with other therapies

Company	Drug	Mode of action	Phase	Orphan Drug Designation
	PRM-151	Endogenous human protein that directs the immune cells called macrophages to turn off and reverse fibrotic processes	Phase 3 (Mono or combination therapy)	YES
	Pamrevlumab	Human monoclonal antibody (mAb) that inhibits the activity of connective tissue growth factor (CTGF) to inhibit myofibroblast activation, collagen deposition and other pro-fibrotic factors	Phase 3 (Monotherapy)	YES
	Inhaled Treprostinil	Small molecule analogue of prostacyclin that reduces pulmonary artery pressure through direct vasodilation of the pulmonary and systemic arterial vascular beds	Phase 3 (Supportive care/ symptom reduction)	YES
	AD-214	i-body-Fc fusion protein blocking CXCR4 to inhibit inflammatory cell migration, epithelial to mesenchymal transition and fibrotic growth factor production, and deposition of collagen	Phase I	YES

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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 can improve fibrosis across a range of fibrotic diseases and may improve cancer –

multiple indication extension potential

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

• EYE: Wet-Age Related Macular Degeneration

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

• KIDNEY : Chronic kidney disease

• LIVER: NASH

• SKIN : Hypertrophic scars

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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IPF partnering: valuable early options

IPF assets have recently yielded attractive deal terms at early stages of development

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Feb-21: License by Graviton up to US$517.5m - Phase I

Jul-19 license by Boehringer Ingelheim €45m + €1.1b – Phase I

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Nov-20: Galapagos collaboration + license €320m - Phase 2 ready

Nov-19 acquired by Roche $390m + $1b – Phase II Aug-15 BMS option to buy $150m + $1.25b milestones

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Aug-20: License by AstraZeneca US$17m + US$360m – Preclinical

Jan-20 platform license by Boehringer Ingelheim upfront undisclosed + $1b milestones – Preclinical

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Immuno-oncology (I/O) imaging

I/O drugs revolutionising cancer treatment, but only work in 20-40% of patients. PET imaging identifies them faster

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Immuno-oncology (I/O) drugs reactivate the patient’s own immune system to fight cancer US$95 billion I/O market[1]

PET imaging biomarkers of an activated immune system can help identify responders early: reduces cost, improves choice of therapy, accelerates drug development

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

PET imaging agents have substantially shorter development time than therapeutics

US$6.4 billion

PET imaging agent market[3] (largest products >US$400m[4] )

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 poised to enter pre-clinical development; and could generate royalty revenue sooner than a therapeutic

AdAlta and GE Healthcare are co-developing a PET imaging agent against granzyme B (GZMB)

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Granzyme B can be used as a biomarker to show whether cancer immunotherapies, such as checkpoint inhibitors, are working effectively

This would significantly improve therapy selection/patient outcomes and reduce cost

GE Healthcare funded discovery at AdAlta, and will now progress GZMB i-bodies through pre-clinical and clinical development and commercialisation

Total development time substantially shorter than therapeutics

May 2021 status

• Panel of GZMB i-bodies identified, now progressing to pre-clinical development

• A$1.4 million revenue earned to date (milestones and research fees). AdAlta will generate additional research fees assisting with pre-clinical and manufacturing development

• Further milestones and royalties to be earned on development and commercialisation success: pipeline asset added at no financial cost to AdAlta

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Business model

Two key commercialisation pathways for platform

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External assets

Collaborations with pharma and biotech to further leverage the i-body platform GE Healthcare deal: Granzyme B

One new collaboration forecast in 2021

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Internal assets

In-house pipeline of drug candidates: license to pharma for major upfronts, milestones and royalties Lead candidate: AD-214

Two more targets to be added in 2021

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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|
|PRODUCT/|PRECLINICAL,|
|TARGET|PARTNER|DISCOVERY|ENABLING|PHASE I|PHASE II|
|INDICATION|PRODUCT|
|STUDIES|
|DEV|
|CXCR4|AD-214:|Idiopathic|
|Pulmonary Fibrosis|
|AD-214: Indication 2|
|AD-214: Indication 3|
|Target 2|Not disclosed|
|Target 3|Not disclosed|
|Target 4|TBC|
|Target 5|TBC|
|GZMB|PET imaging I/O|
|TBC|Partner #2|
|TBC|Partner #3|
|TBC|Partner #4|
|End 2019|End 2020|End 2021 (est)|End 2023 (aim)|

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The potential of our strategy: Ablynx case study

Multiple internal and external assets drive value, attract partners

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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 here
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Corporate landscape: leveraging platforms

Creating multiple internal and partnered assets drives value creation for platform companies

AdAlta value

Micro-antibody platforms April-16 license by Abbvie

$40m upfront + $645m milestones & royalties

GPCR platforms

Feb-15 acquired by Sosei $400m Phase Ib asset + 7 pre-clinical leads

AD-214 value

External partnerships

Feb-18 collaboration with Seattle Genetics (3 targets)

$30m upfront + $1.2b milestones & royalties

Jul-15 acquired by Celgene $7.8b Ph III, Ph II and GPCR platform

Platform value

April-16 license with Boehringer Feb-18 acquired by Sanofi €8m + €125m milestones €3.9b Phase I GPCR nanobody

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Milestones for remainder of 2021

News-flow rich period for remainder of CY2021

AD-214

ü Orphan Drug Designation for AD-214 in IP ü Results of Phase I single dose studies in healthy volunteers ü Phase I multi-dose studies in healthy volunteers commence Phase I multi-dose studies in healthy volunteers commence

• ü Phase I multi-dose studies in healthy volunteers commence Phase I multi-dose studies in healthy volunteers commence

Other Assets

  - ü Progression of the GEHC collaboration from discovery to pre-clinical development

  - Entering a second collaboration agreement

• PET tracer pre-clinical development results

• Phase 1b commences: First studies in IPF patients, generating safety data in patients and in combination with standard of care.

• First PET images to visualise distribution of AD-214 in the lungs of IPF patients

• 1st partnering window opens

• Commencing development of two new i-body enabled internal pipeline assets

• New i-body 2.0 IP filed

• Top line results of multi-dose studies in healthy volunteers

• Additional indications pre-clinical data

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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 (alt: Dr James Williams) Director

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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

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Mick Foley, PhD Chief Scientific Officer

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Dallas Hartman, PhD Chief Operating Officer

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Claudia Gregorio-King, PhD VP Clinical Product Development

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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 (21 May)

	ASX code 1AD	1AD
	Market capitalisation	A$31.87m
	Share price (12 month range) Ordinary Shares (daily volume) Listed Options Unlisted Options	A$0.135 ($0.069 - 0.265) 245,175,853 (629,809) 23,348,803 7,514,067
	Cash(31 Mar 2021)	A$6.05m
	Major shareholders (19 Apr) %
	Yuuwa Capital LP	22.0
	Platinum Asset Management Meurs Holdings Pty Ltd	11.6 7.3
	Radiata Super Pty Ltd	2.4
	Sacavic Pty Ltd	1.8
	Other (1,399 total holders)	54.9
	Total	100%

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
21-May-20 21-Aug-20 21-Nov-20 21-Feb-21 21-May-21
Price Volume
Volume (m)
Share price (A$)
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Quarterly cash flows (A$ million)

Analyst Coverage

Edison Pitt Street Research Securities Vault BioShares

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Investment proposition

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Platform to create value

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

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Clear vision for growth

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

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Lead asset has multiple indications

AD-214: first-in-class asset for multiple fibrotic indications and cancer

$3b market potential in first indication

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Leading expertise

Experienced drug development team in place

GZMB asset: GEHC partnership

Solving the challenge of identifying I/O drug responders

PET imaging agent market worth US$6.4b

Several near-term growth catalysts

AdAlta substantially undervalued relative to peers, with near term and mid-term value drivers.

Contact:

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

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Appendix: Strategy

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AdAlta has successfully transitioned to the expansion phase of our growth plan

Accelerate (from ~mid-2021)

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Expand (~mid 2020 to late 2021)

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Maximise catalysts from current funded base (2020)

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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

• Progress AD-214

• Build 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

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Our strategy

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A
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i-body technology platform and library Proof of Principle against > 25 targets

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B
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In-house pipeline of drug candidates Usually GPCRs in fibrosis, inflammation, oncology Invest to value inflection (typically Phase I or II)

Licence to pharma Major upfronts + milestones and royalties

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Select novel, challenging drug targets where the i-body structure is most advantaged

Pharma, biotech partnerships Partner-led target selection and development Partner-enabled complex formats eg bivalent drugs

Co-develop with pharma, biotech Research fees + milestones and royalties

Multiple i-body drugs and diagnostics New drug class Potential in multiple disease indications

Appendix: AD-214

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AD-214: road to the clinic

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Validated target Novel mode of GMP NHP GLP NHP GLP action, IP manufacturing toxicology toxicology

• CXCR4

• Player in inflammatory, fibrotic processes

• Biomarker, prognostic indicator

• Patented CXCR4 i-body antagonist

• CXCR4 expressed on diverse cell types

• Inhibition of fibrotic cell migration

• Fc-fusion format

• CDMO: KBI Biopharma

• IND-ready CMC package

• Very clean tox • Bleomycin profile mouse model of IPF

• Half-life supports IPF weekly dosing • Ashcroft Score,

• • Sustained gene expression, receptor collagen occupancy • Eye, kidney, liver cancer PoC

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Panel of pre-clinical studies “generally sufficient” to support an Investigational New Drug application The Phase I trial design is “reasonable” Specific guidance readily incorporated into Phase I protocol and ongoing development plans

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AD-214 inhibits key features of the fibrogenic pathway with novel MOA

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Block fibrocyte recruitment Inhibit epithelial cell secretion of
into the damaged tissue pro-fibrotic factors and epithelial to
mesenchymal transition
Injury Entry
Entry
Inflammatory
mediators Neutrophil BM fibrocyte Resident fibroblast
EMT
Platelet Fibrosis Excess deposition
activation IL-1β of ECM
Macrophage
TGF-β
IL-13
TNF
Epithelial cell T cell Myofibroblast Wound
ECM repair
1 Clotting and 2 Inflammatory 3 Fibroblast migration, 4 Tissue remodeling
coagulation cell migration proliferation and activation and/or resolution Wound contraction
Modulate aspects of
inflammation Inhibit fibroblast migration Reduce ECM deposition
and differentiation during tissue remodeling
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AD-214 induced reduction in progression of fibrosis in mouse bleomycin model

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Ashcroft Score
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Day 8 bleomycin (start of treatment)

AD-214 reduced Ashcroft Score with statistical significance compared to bleomycin treated mice at:

• 1-30mg/kg every second day

• 10-30mg/kg every fourth day

Wide range of dosing regimens can be used to test efficacy

• 10mg/kg every second day exhibited

• effectiveness by most study parameters

• Human equivalent dose: 1mg/kg (estimated)

AD-214 efficacy demonstrated in gold standard IPF disease model

Supportive of potential human therapeutic window beginning as low as 1mg/kg

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NHP GLP toxicology: AD-214 safe

3 non-human primate studies completed Good Laboratory Practice (GLP) study to evaluate safety and toxicology

• 10mg/kg, 30mg/kg and 100mg/kg multiple doses over four weeks plus recovery (human equivalent dose 32mg/kg)

AD-214 well tolerated with no deaths, no AD-214-related clinical signs, no changes in a panel of clinical observations:

• neurological function

• body weight

• ophthalmoscopy

• • blood pressure

• coagulation

• urinalysis

• electrocardiography

• • respiratory function

• organ weight

• • macroscopic and microscopic findings

Minor, transient, completely reversible increase in total white cell and circulating CD34+ cells

Small, transient, completely reversible decrease in serum total protein and albumin at highest dose only (100 mg/kg)

ToxTox study results were in line with expectations and in keeping with previous studiesstudy results were in line with expectations and in keeping with previous studies

No major organ toxicity has been observed on repeat dosing at high doses No major organ toxicity has been observed on repeat dosing at high doses No suggestion of off-target toxicities No suggestion of off-target toxicities

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Non-human primate GLP toxicology: Phase I dose justification

Pharmacokinetics

• Elimination half-life 22-29h

• Human equivalent: ~71h (estimate)

• AD-214vailable for >3 days

Pharmacodynamics

• 60% receptor occupancy* for 72h at >30mg/kg

• Human equivalent: ~10mg/kg (estimate)

• High receptor binding for >3 days

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Supportive of human therapeutic dose window including 10mg/kg intravenously, weekly or every second week Supportive of human therapeutic dose window including 10mg/kg intravenously, weekly or every second week

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AD-214 Phase I Part A design detail*

Protocol: A Phase I dose-escalating study of the safety, tolerability, PK and PD of single and repeat doses of AD-214 in healthy volunteers (HVs) and patients with interstitial lung disease (ILD)

Part A: Single ascending dose in healthy volunteers Patient numbers by cohort Total n=42 (31 active, 11 placebo, blinded)

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Primary

• Safety, tolerability of AD-214

• adverse events, physical examinations, vital signs, ECG

• clinical laboratory tests (hematology, chemistry, coagulation, cytokines)

Secondary

• PK, RO of AD-214

• Immunogenicity of AD-214

Exploratory

• PD markers (SDF-1, CD34+)

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AD-214 pharmacokinetics increase proportionally with dose (single doses)

• Maximum exposure, Cmax, increases in a dose proportional manner

• Total exposure, AUC0-inf, increases in a more than dose proportional manner

• Elimination half-life t1/2 ~40h

AD-214 plasma concentrations (log and linear scale) Maximum and total plasma exposure

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Transient white blood cell and blood stem cell increases indicate CXCR4 engagement

Observed in Phase I HV SAD* Transient, dose dependent, increase in WCC and CD34+ counts at 4-12 hours consistent with CXCR4 blockade

WCC counts

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WCC counts at 4h CD34+ cell counts

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Transient increase in SDF-1 (natural ligand of CXCR4) consistent with CXCR4 engagement

Transient increases in SDF-1 levels at 4 hours in some participants, returning to baseline at 24h consistent with CXCR4 blockade

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Sustained high levels of CXCR4 receptor occupancy on T cells

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White blood cells naturally express CXCR4 in healthy individuals, providing an accessible surrogate for AD-214 target engagement or receptor occupancy (RO)

Understanding duration of RO is critical to inform dosing

Primary

• 70% CXCR4 RO at 7 days after 5-10 mg/kg infusion • >60% CXCR4 RO at 21 days after 20 mg/kg infusion*

• Duration of RO is considerably longer than PK profile

If replicated on CXCR4 receptors in fibrotic tissues, result supports extended dosing intervals despite relatively rapid clearance from circulation

• Receptor occupancy was monitored for one week at all dose levels except 20 mg/kg (4 weeks)

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A clinician’s perspective on AD-214 results so far

• Un-met need in IPF/ILD remains – need to progress new therapies

• Research at The Alfred suggests if targeting CXCR4 works in IPF it may work in other ILD’s

• AD-214 is well tolerated and ready to move forward into multi-dose studies in healthy volunteers and patients

• The data is supportive of extending dosing interval to two weekly at least

• AdAlta approach is methodical and appropriate

• PET imaging strategy is particularly important as an innovative way to explore target engagement and mode of action in diseased tissue

• Key insights anticipated from multidose and early patient studies (in addition to safety):

Prof Glen Westall leading respiratory and lung fibrosis specialist

• CXCR4 receptor engagement in tissue

• Nature of the anti-drug antibodies that are expected with a biologic

AdAlta Investor Briefing 10 March 2021

• Further characterisation of biomarker responses: CD34+, white cells, SDF-1a

Appendix: i-bodies

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i-bodies: next generation antibodies

i-bodies are human proteins that belong to the class of next-generation antibodies

Generation of the i-body

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1
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Shark antibody binding domain with unique long loop

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Two long loops are engineered onto
2
the human protein. These enable
tight binding to the drug target
and have a therapeutic effect
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A human protein that is the same shape as the shark antibody is the backbone or scaffold protein of the i-body

3 Each unique i-body has different binding loops. The i-body library has 20 billion unique i-bodies

i-body is the combination of a human protein that mimics the shape of the shark antibody with unique long loop binding sites

The long loops of the i-body have exceptional targeting and binding properties, providing therapeutic access to drug targets that have evaded traditional monoclonal antibodies

Drug targets include G-protein-coupled receptors (GPCRs), currently the most heavily investigated class of drug targets in the body, and CXCR4 which is present in IPF

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An immensely powerful drug development platform

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i-body platform capability

• G-protein coupled receptors (GPCRs)

• Fibrosis, inflammation, oncology

• Diagnostics (PET tracers; cancer imaging)

GPCRs are the most heavily investigated class of drug today and 80% of GPCR targets are yet to be effectively exploited

**Includes both i-body and VNAR/IgNAR formats