ADALTA LIMITED — Investor Presentation 2021

Mar 9, 2021

==> picture [537 x 74] intentionally omitted <==

10 March 2021

ASX Announcement

AD-214 Phase I study: positive data expands opportunities for AdAlta

MELBOURNE Australia, 10 March 2021: AdAlta Limited (ASX:1AD), a clinical stage biopharmaceutical discovery and development company using i-body technology to address challenging drug targets is hosting an investor briefing at 1100 AEDT today to discuss top line results from Part A of its Phase I clinical program studying single ascending doses (SAD) of lead asset AD-214 in healthy volunteers (HVs).

Highlights of the briefing include:

• Part A of the AD-214 Phase I program (HV SAD) has been successfully completed

• AD-214 is very well tolerated in single doses up to 20 mg/kg in healthy volunteers

• • AD-214 engages its target receptor, CXCR4, and sustains higher levels of receptor occupancy for longer than predicted

• These results enable a more efficient program for the remainder of Phase I, generating more data more rapidly for the same cost

• Part B will now be a multiple ascending dose study in HVs, enabling a safety package supportive of a Phase II US FDA Investigational New Drug (IND) application to be obtained by end of 2021

• A longer dosing interval will be explored for clinical convenience

• Patient studies will be conducted under a separate Phase Ib protocol incorporating a radio-labelled version of AD-214 for PET imaging. This achieves the originally planned exploration of the effect of elevated CXCR4 in Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF) patients on AD-214 safety, pharmacokinetics and receptor occupancy. In addition, this protocol may also explore distribution of AD-214 in other fibrotic indications, the effect of AD-214 when administered over 18 weeks, and the safety of AD-214 when used in combination with standard of care therapies. This data could support expansion into additional indications.

• This clinical validation of the i-body platform is anticipated to increase partner interest in both AD-214 and co-development opportunities, contributing significantly to the acceleration of AdAlta’s asset creation strategy. The Company aims to have 9 products in discovery research through to Phase II by the end of 2023.

The presentation to be discussed at the briefing is attached. A limited number of online seats to the briefing are still available: register to receive a link to the briefing via lauren.byrne@irdepartment.com.au.

Authorised for lodgement by:

Tim Oldham CEO and Managing Director February 2021

==> picture [596 x 81] intentionally omitted <==

==> picture [537 x 74] intentionally omitted <==

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. The i-body technology mimics the shape and stability 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 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 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

Media

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

==> picture [596 x 81] intentionally omitted <==

==> picture [116 x 89] intentionally omitted <==

AD-214 Phase I study: positive data expands opportunity Investor Briefing 10 March 2021

AdAlta Limited (ASX:1AD) enquiries@adalta.com.au

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 forward-looking 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.

==> picture [720 x 35] intentionally omitted <==

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

2
----- End of picture text -----

Agenda today

==> picture [61 x 61] intentionally omitted <==

==> picture [61 x 61] intentionally omitted <==

Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Oldham, CEO and Managing Director

3

Today’s highlights

• ü Single ascending dose (SAD) healthy volunteer (HV) study successfully completed

• ü AD-214 is very well tolerated in single doses to 20 mg/kg in healthy volunteers

• ü AD-214 engages its target receptor, CXCR4, and sustains high levels of receptor occupancy

• Ø Results enable more efficient program for remainder of Phase I including:

• Extended dosing interval for patient/clinician convenience

• Phase I safety dosing to complete by end 2021

• Delivers safety package supportive of Phase II US FDA Investigational New Drug (IND) application in any CXCR4 mediated indication

• Parallel Phase Ib patient studies to explore effect of fibrotic disease on safety, PK, distribution and receptor occupancy of AD-214

Initial clinical validation i-body platform strengthens AdAlta’s asset creation options

4

Agenda today

==> picture [61 x 61] intentionally omitted <==

==> picture [61 x 61] intentionally omitted <==

Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Oldham, CEO and Managing Director

5

AdAlta is rapidly transforming to a multi-asset company

==> picture [660 x 307] intentionally omitted <==

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

4
Executing growth: creating multiple i-body-enabled assets
•
$8m $8.1 million raised Sep 2020 in placement and rights issue
• Progressing new internal product ideas: 2 programs to start 2021
• Encouraging business development pipeline
• One new co-development program forecast for 2021
3
Lead external asset: GE Healthcare target in lead optimisation
•
$1.15 million milestones and research fees received to 31 Dec 2020
• Lead optimization stage completes Q1 2021
2
Lead internal asset: AD-214 a first in class anti-fibrotic in Phase I clinical trial
• US FDA pre-IND meeting, Orphan Drug Designation
• Phase I: excellent safety profile, sustained high receptor occupancy (single dose, healthy subject)
1
Patented i-body discovery platform: unique, validated capabilities against difficult targets
• First fully human single domain antibody platform; first based on shark motif to reach the clinic
• Now clinically and commercially validated
Interim data
----- End of picture text -----

• Next generation improvements in development to maintain technology leadership

6

AdAlta has two strategies to create valuable assets from the i-body platform

==> picture [656 x 300] intentionally omitted <==

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

A In-house pipeline of
Licence to pharma
drug candidates
Major upfronts + milestones
Usually GPCRs in fibrosis, & royalties
inflammation, oncology
Invest to value inflection
(typically Phase I or II)
i-body Multiple i-body
technology drugs and
Select novel, challenging drug
platform and diagnostics
targets where the i-body
library New drug class
structure is most advantaged
Proof of principle Potential in multiple
against >25 targets disease indications
B Pharma, biotech
Co-develop with
partnerships
pharma, biotech
Partner-led target selection
Research fees +
and development
milestones & royalties
Partner enabled complex
formats eg bivalent drugs
----- End of picture text -----

7

Near term strategic priorities set March 2020

Create value inflections for lead asset AD-214

• Clinical development in IPF/ILD

• Expand indications, create licensing options

Add 2 assets to internal pipeline in our “sweet spot”

• G-protein coupled receptors (GPCRs)

• Fibrosis, inflammation, cancer

Add to external pipeline through a new partnership

• Earlier revenue; access to additional target expertise

Continuous i-body platform and AD-214 product improvement

• Ensures continued technology leadership, competitive advantage

8

Strategic priorities: progress to March 2021

March 2021 status

Create value inflections for lead asset AD-214

• Phase I clinical program started: top-line single dose results today

• • Pre-IND meeting and Orphan Drug Designation secured from FDA

• • Pre-clinical data in kidney fibrosis; studies in eye, cancer underway

• • On track to confirm next two indications for AD-214 • Partnering pipeline developing well

• Add 2 assets to internal • Developed selection process •

• pipeline in our “sweet spot” Screened existing targets, now extending to other GPCRs* • On track to commence discovery research on two targets in H2 2021

• Add to external pipeline • GEHC progressed to lead optimisation •

• through a new partnership Co-development partnering pipeline developing well • On track to execute second collaboration by mid 2021

Continuous i-body platform • and AD-214 product Encouraging progress made on i-body2.0, manufacturing and high improvement throughput discovery methods

9

Major milestones achieved since March 2020

==> picture [652 x 353] intentionally omitted <==

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

Mar ‘21
Safety, PK, RO FDA pre-IND Ph I Part A Ph I part A
in NHP advice safety update top line safety
Efficacy in BLM Ph I Part A FDA ODD
mouse commenced in IPF
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2020 2021
Growth $8.1m
strategy placement,
investor rights issue
update
GE progress to GE progress to
Stage 3 lead optimisation
AD-214
Other assets
----- End of picture text -----

==> picture [720 x 35] intentionally omitted <==

FDA engagement: AD-214

• Pre-IND meeting June 2020 Orphan Drug Designation granted for AD-214 in IPF February 2021

• • Pre-clinical studies “generally sufficient” to support an IND application

• • Phase I trial design is “reasonable”

• • Minor feedback readily incorporated into clinical trial design and ongoing preclinical and CMC studies

==> picture [70 x 53] intentionally omitted <==

11

Agenda today

==> picture [61 x 61] intentionally omitted <==

==> picture [61 x 61] intentionally omitted <==

Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Oldham, CEO and Managing Director

12

Preliminary healthy volunteer single dose results

AD-214 has an excellent safety profile

• No dose limiting toxicities or adverse events of clinical concern

• No concerning clinical laboratory results

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

AD-214 engages the CXCR4 receptor

• Clear markers of target (CXCR4) engagement observed

Receptor occupancy sustained at high levels for extended periods

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

Enables redesign of remainder of Phase I program to:

• Explore more clinically convenient dosing interval

• Deliver Phase II IND ready safety for multiple indications

• • Explore multiple doses in patients over longer period

13

AD-214 Phase I Part A design detail*

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)

==> picture [346 x 245] intentionally omitted <==

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

20 mg/kg
10 mg/kg
5 mg/kg
1 mg/kg
0.5 mg/kg
0.02 mg/kg
0.01 mg/kg Active Placebo
0 1 2 3 4 5 6
----- End of picture text -----

Objectives

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+)

14

• https://clinicaltrials.gov/ct2/show/NCT04415671?term=adalta&draw=2&rank=1

Single dose of AD-214 is well tolerated

Adverse events (unblinded data)

Immune response*

• No dose limiting adverse events

• No serious adverse events

• Isolated incidences of minor cytokine elevation - Transient and primarily low level elevation of IL-6 and IL-8 in some participants (including placebos)

• No concerning clinical laboratory results

• No clinically significant cytokine release

• Dose escalation steps completed without concern

  • Antidrug antibodies: detected in 11 participant - Predominantly low titre

    • Characterisation pending

• Adverse events were non-concerning

• Predominantly mild

• No clinical symptoms related to immune response observed

• Three Grade 2 (moderate) adverse events

• Based on unblinded data, active drug participants assumed to be those for whom pharmacokinetic Cmax was determined

15

AD-214 pharmacokinetics increase proportionally with dose

Observed in NHP GLP toxicology study

• Maximum exposure, Cmax, increases in a dose

• proportional manner

==> picture [6 x 7] intentionally omitted <==

Observed in Phase I HV SAD

• Maximum exposure, Cmax, increases in a dose

• proportional manner

==> picture [6 x 7] intentionally omitted <==

==> picture [6 x 7] intentionally omitted <==

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

• proportional manner

==> picture [6 x 7] intentionally omitted <==

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

• proportional manner

==> picture [6 x 7] intentionally omitted <==

• Elimination half-life t1/2 22-29 h

==> picture [6 x 7] intentionally omitted <==

• Elimination half-life t1/2 = 44±15 h

AD-214 plasma concentrations (log and linear scale)

Maximum and total plasma exposure

==> picture [626 x 195] intentionally omitted <==

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

450
1,000.00 400 600 3000
350 Cmax (ug/mL)
300 500 AUC0-inf (hug/mL) 2500
100.00 250
Linear (Cmax (ug/mL))
200
150 400 Poly. (AUC0-inf (hug/mL)) 2000
10.00 100
50
0 300 1500
0 15 30 45 60 75
1.00 Time from start of infusion (h)
200 1000
0.10 0.1 mg/kg 100 500
1 mg/kg
0.01 5 mg/kg 0 0
0 15 30 45 60 75 10 mg/kg 0 5 10 15 20
Time from start of infusion (h) 20 mg/kg Dose (mg/kg)
(ug/mL)
AD-214 plasma concentration
(hug/mL)
Total AD-214 exposure AUC0-inf
Peak AD-214 exposure Cmax (ug/mL)
AD-214 plasma concentration (ug/mL)
----- End of picture text -----*

==> picture [720 x 35] intentionally omitted <==

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

16
----- End of picture text -----

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

Observed in NHP GLP toxicology

• Transient increase in white cell counts (WCC) and

• blood stem cell (CD34+) cell counts

==> picture [6 x 7] intentionally omitted <==

Observed in Phase I HV SAD*

• Transient, dose dependent, increase in WCC and

• CD34+ counts at 4-12 hours consistent with CXCR4 blockade

==> picture [6 x 7] intentionally omitted <==

==> picture [646 x 231] intentionally omitted <==

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

WCC counts WCC counts at 4h CD34+ cell counts
30 Placebo 30
Placebo
0.01mg/kg 30
25 0.02mg/kg 25 0.01mg/kg
0.02mg/kg
0.1mg/kg
20 1.0mg/kg 20 20 0.1mg/kg
1.0mg/kg
5.0mg/kg
15 10mg/kg 15 5.0mg/kg
10mg/kg
20mg/kg
10 10 10 20mg/kg
5
5
0
0
0
0 50 100
0 50 100 Time after start of infusion (h)
Time after start of infusion (h)
Placebo0.1mg/kg1.0mg/kg5.0mg/kg10mg/kg20mg/kg
Mean white cell count (X10^9/L) Mean viable cell count (cells/uL)
Mean white cell counts (x10^9/L)
----- End of picture text -----

==> picture [720 x 35] intentionally omitted <==

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

17 * Based on unblinded data, CD34+ incudes only participants for whom pharmacokinetics Cmax was determined
----- End of picture text -----

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

Expected from literature and prior studies

Observed in Phase I HV SAD*

==> picture [6 x 7] intentionally omitted <==

• Transient increases in SDF-1 levels in response to

• CXCR4 blockade, high participant to participant variability

==> picture [6 x 8] intentionally omitted <==

• Transient increases in SDF-1 levels at 4 hours in

• some participants, returning to baseline at 24h consistent with CXCR4 blockade

==> picture [217 x 214] intentionally omitted <==

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

SDF-1 levels
7,000 Placebo
0.01mg/kg
6,000
0.02mg/kg
5,000 0.1mg/kg
1.0mg/kg
4,000
5.0mg/kg
10mg/kg
3,000
20mg/kg
2,000
1,000
0
0 50 100
Time after start of infusion (h)
SDF-1 plasma concentratrion (pg/mL)
----- End of picture text -----

==> picture [178 x 198] intentionally omitted <==

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

SDF-1
10000
8000
6000
4000
2000
0
Placebo0.1mg/kg1.0mg/kg5.0mg/kg10mg/kg20mg/kg
SDF-1 plasma concen tration (pg/mL)
----- End of picture text -----

==> picture [720 x 35] intentionally omitted <==

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

18 * Based on unblinded data, includes only participants for whom pharmacokinetic Cmax was determined
----- End of picture text -----

Sustained high levels of CXCR4 receptor occupancy on T cells

==> picture [286 x 304] intentionally omitted <==

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

Mean occupancy of T cell CXCR4 receptors by
AD-214
120 0.01mg/kg
0.02mg/kg
0.1mg/kg
100 1mg/kg
5mg/kg
80 10mg/kg
20mg/kg
LLOQ
60
40
20
0
0 200 400 600
Time since end of infusion (h)
Percent receptor occupancy
----- End of picture text -----

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

Observed in NHP GLP toxicology

• 50% CXCR4 receptor occupancy (RO) on T cells at four

• days after infusion of 10-20 mg/kg

==> picture [6 x 8] intentionally omitted <==

Observed*

• Dose dependent level and duration of RO

==> picture [6 x 8] intentionally omitted <==

• 70% CXCR4 RO at 7 days after 5-10 mg/kg infusion

==> picture [6 x 8] intentionally omitted <==

• 60% CXCR4 RO at 21 days after 20 mg/kg infusion**

==> picture [6 x 8] intentionally omitted <==

• Duration of RO is considerably longer than PK profile

==> picture [6 x 8] intentionally omitted <==

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

• Based on unblinded data, incudes participants for whom PK Cmax was determined, placebo excluded ** Receptor occupancy was monitored for one week at all dose levels except 20 mg/kg (4 weeks)

19

More efficient design for remainder of Phase I

Current approved Phase 1 protocol

Part A: HV SAD Blinded/placebo controlled 7 cohorts ✓ Up to 44 pts

Part B: IPF/ILD SAD Part C: IPF/ILD MAD Unblinded/no placebo Unblinded/no placebo 5 cohorts 4 cohorts / once weekly dosing 15 – 30 pts 12 – 24 pts

Planned more efficient next steps

Protocol amendment submitted*

• Treatment complete end 2021

• Safety data supports Phase II in all AD-214 indications (iv route)

Part B: HV MAD Blinded/ Placebo controlled 5-15 mg/kg every 2 weeks 3 cohorts, 12 – 24 pts

New exploratory Phase Ib protocol in preparation*

• Anticipated commence Q3 2021

• Demonstrates AD-214 distribution and CXCR4 receptor occupancy in tissue in a range of indications

• • Determines impact of disease on AD-214 PK parameters

Arm 1: PET screening of fibrotic diseases Open label with SoC 1-2 PET-CT sequences ~12 patients (~6 IPF/ILD) CXCR4 disease Arm 2: Multi-dose in IPF/ILD Open label with SoC Max 6 doses, 5-10mg/kg over 18 weeks ~6 patients +/- PET imaging

• Supported by Safety Management Committee, subject to HREC approval ** Standard of Care (includes pirfenidone, nintadanib or non-pharmacologic intervention)

20

Agenda today

==> picture [61 x 61] intentionally omitted <==

==> picture [61 x 61] intentionally omitted <==

Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Oldham, CEO and Managing Director

21

Lead indication IPF: $3b market, poor options

Idiopathic Pulmonary Fibrosis (IPF) is irreversible, unpredictable, incurable >300,000 people living with IPF 40,000 people die from IPF every year

3.8 years median survival after diagnosis Current treatments come with safety, efficacy limitations

==> picture [405 x 293] intentionally omitted <==

Burden of fibrotic lung disease following COVID-19 likely to be high “Antifibrotic therapies could have value preventing severe COVID-19 in IPF patients and preventing fibrosis after SARS-CoV-2 infection”*

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

Limited (and decreasing) new options for patients

==> picture [641 x 334] intentionally omitted <==

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

|||||
|---|---|---|---|
|FDA Fast|FDA Orphan|
|Phase II|Phase III|Track|Drug|
|ISABELA 1&2:|TERMINATED|
|12 weeks, 23 subjects|✓|
|GLPG1690|52 weeks, 1500 subjects|
|ZEPHYRUS - ACTIVE|
|48 weeks, 103 subjects|✓|✓|
|Pamrevlumab|52 weeks, 565 subjects|
|NO PROGRESS SINCE 2018|
|PBI-4050|12 weeks, 40 subjects|✓|✓|
|Phase III initiated in 658|
|24 weeks, 116 subjects|✓|✓|
|PRM-151|subjects - acquired by Roche|
|NOT PROGRESSING|
|24 weeks, 76 subjects|✓|
|KD025|Focusing on other indications|
|New therapies and combination therapies|
|addressing multiple modes of action are required|

----- End of picture text -----

23

CXCR4 plays a role in IPF

CXCR4 is upregulated in IPF lung tissue

Very limited expression in normal or non-diseased tissues

==> picture [137 x 148] intentionally omitted <==

==> picture [137 x 148] intentionally omitted <==

==> picture [561 x 129] intentionally omitted <==

Brown stain shows amount of CXCR4

==> picture [720 x 35] intentionally omitted <==

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

24
----- End of picture text -----

CXCR4 is expressed in both IPF and ILD patient lung tissue and in multiple cell types

==> picture [396 x 169] intentionally omitted <==

• CXCR4 was abundantly expressed in both IPF and ILF donors compared with non-diseased controls

==> picture [6 x 8] intentionally omitted <==

• CXCR4 is expressed on circulating immune cells and we have demonstrated that in patients with IPF and other fibrotic ILDs, CXCR4 is significantly upregulated in fibrotic airway epithelial cells and myeloid cells in fibrotic loci

==> picture [6 x 8] intentionally omitted <==

==> picture [209 x 275] intentionally omitted <==

CXCR4 stained brown

==> picture [720 x 35] intentionally omitted <==

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

25 Source: Jaffar et al, Respiratory Research (2020) 21: 221
----- End of picture text -----

Why targeting CXCR4 could improve IPF/ILD outcomes

Observation

Significance

==> picture [7 x 9] intentionally omitted <==

CXCR4 is up-regulated in ILD patients as well as IPF patients

==> picture [7 x 9] intentionally omitted <==

If AD-214 works in IPF it is more likely to work in ILD as well … and there are at least as many non-IPF ILD patients as IPF patients

==> picture [7 x 9] intentionally omitted <==

• CXCR4 is upregulated in epithelial and

• myeloid cells in fibrotic tissue

==> picture [7 x 9] intentionally omitted <==

• Epithelial cells trigger the fibrosis cascade:

• blocking CXCR4 could have a broader effect than simply shutting down collagen deposition

==> picture [7 x 9] intentionally omitted <==

CXCR4 also mediates migration of fibroblasts and inflammatory cells such as macrophages in a disease specific way

==> picture [7 x 9] intentionally omitted <==

• Blocking CXCR4 may also have an immune

• modulation effect and inhibit immune/ inflammatory cell infiltration to the lungs

==> picture [720 x 35] intentionally omitted <==

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

26
----- End of picture text -----

Implications for AD-214: a clinician’s perspective

==> picture [7 x 9] intentionally omitted <==

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

==> picture [7 x 9] intentionally omitted <==

• Research at The Alfred suggests that if targeting CXCR4 works in IPF it may also work in other

• ILD’s

==> picture [7 x 9] intentionally omitted <==

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

• volunteers and patients

==> picture [7 x 9] intentionally omitted <==

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

==> picture [7 x 9] intentionally omitted <==

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

==> picture [7 x 9] intentionally omitted <==

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

• CXCR4 receptor engagement in tissue

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

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

==> picture [47 x 46] intentionally omitted <==

==> picture [720 x 35] intentionally omitted <==

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

27
----- End of picture text -----

Agenda today

==> picture [61 x 61] intentionally omitted <==

==> picture [61 x 61] intentionally omitted <==

Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Oldham, CEO and Managing Director

28

Advantages of amended Phase I design

• Early data on effect of elevated CXCR4 on AD-214 distribution and receptor occupancy in Preserves diseased tissue remains on track for Q3 2021 original • Explores potential for longer dosing intervals objectives • Provides insight to mode of action • Full Phase II IND ready HV safety package by end 2021 , independent of IPF/ILD recruitment Speed • IPF/ILD patient study is easier to recruit , more flexible • Parallel design enables shorter total Phase I program

• HV safety package suitable for all intravenous indications New • IPF/ILD patient study generates preliminary safety data in combination with SoC options • 6 doses over 18 weeks in IPF/ILD study may provide initial indication of efficacy created • IPF/ILD study may demonstrate distribution, target engagement in other CXCR4 indications Cost • No material impact on overall study cost or 2021 cash requirements impact

29

Clinical validation of i-body platform unlocks pipeline expansion opportunities

November 2019

November 2020

==> picture [50 x 15] intentionally omitted <==

End 2021 (est) End 2023 (aim)

Preclinical, IND Class of Partner Product/ Indication Discovery product enabling Phase I Phase II Target Target dev studies Internal pipeline AD-214 : Idiopathic CXCR4 GPCR Pulmonary Fibrosis AD-214 : Indication 2 AD-214 : Indication 3 Target 2 GPCR Not disclosed Target 3 GPCR Not disclosed Target 4 GPCR TBC Target 5 GPCR TBC External pipeline Serine GZMB PET imaging I/O protease TBC TBC Partner #2 TBC TBC Partner #3 TBC TBC Partner #4

30

Milestones for remainder of 2021

==> picture [672 x 353] intentionally omitted <==

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

Mar ‘21
Phase Ib
Safety, PK, RO FDA pre-IND Ph I Part A Ph I HV SAD commences 1 [st] partnering
in NHP advice safety update top line safety 1 [st] PET images window opens
Efficacy in BLM Ph I Part A FDA ODD PET tracer Ph I HV MAD Ph I HV MAD
mouse commenced in IPF pre-clinical commences top line results
Jan Apr Jul Oct Jan Apr Jul Oct
2020 2021
Growth $8.1m 2 [nd] external 2 new internal i-body2.0
strategy placement, partnership targets in complete
update rights issue discovery
GE progress to GE progress to GE commence pre-
Stage 3 lead optimisation clinical development
AD-214
Other assets
----- End of picture text -----

==> picture [720 x 35] intentionally omitted <==

AdAlta (ASX:1AD) investment proposition

==> picture [7 x 9] intentionally omitted <==

==> picture [7 x 9] intentionally omitted <==

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

• Unique structure, properties addresses targets that challenge traditional antibodies

AD-214: clinical stage first-in-class asset for fibrosis

==> picture [32 x 48] intentionally omitted <==

• Orphan Drug Designation for US$3 billion idiopathic pulmonary fibrosis (IPF) market

• Excellent safety profile and sustained high receptor occupancy in Phase I single dose studies

• Multi-dose studies commencing; PET images in patients Q3-2021; partnering window end of 2021

• Pre-clinical data available and emerging in multiple fibrotic indications and cancer

==> picture [48 x 36] intentionally omitted <==

==> picture [7 x 9] intentionally omitted <==

==> picture [7 x 9] intentionally omitted <==

GE Healthcare: commercial validation of platform

• Partner funded discovery program in I/O imaging; progressed to lead optimisation

Clear vision for growing existing assets and adding more; A$8m cash balance

==> picture [69 x 27] intentionally omitted <==

• AD-214: Phase I patient data, expand indications, partner

• Internal pipeline: GPCRs in fibrotic, inflammatory disease and cancer (2 new assets by end 2021)

• External pipeline: partner selected and funded targets: 2[nd] partnership by mid-2021

• Platform leadership: continuous improvements to i-body platform, formulation and manufacturing

==> picture [94 x 54] intentionally omitted <==

==> picture [7 x 9] intentionally omitted <==

Experienced drug development team driving strategic focus

==> picture [7 x 9] intentionally omitted <==

Unique investment opportunity: validated platform, cash runway, beginning to realize expansion potential

==> picture [720 x 35] intentionally omitted <==

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

34
----- End of picture text -----

==> picture [268 x 59] intentionally omitted <==

Contacts for more information: Tim Oldham, CEO and Managing Director enquiries@adalta.com.au www.adalta.com.au

==> picture [33 x 34] intentionally omitted <==

==> picture [34 x 34] intentionally omitted <==

==> picture [259 x 446] intentionally omitted <==