ADALTA LIMITED — AGM Information 2020

Nov 24, 2020

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Building a pipeline of i-body enabled therapeutics AGM Presentation Nov 2020

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AdAlta Limited (ASX:1AD) Tim Oldham, CEO and Managing Director enquiries@adalta.com.au

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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 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.

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2020 has been a transformational year

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Grow by building multiple i-body-enabled assets
$8m • Progress and partner AD-214; progress GE Healthcare asset
• Add 5 internal assets and 3-5 external partnerships
•
$8.1 million raised in fully subscribed placement and rights issue
to accelerate growth trajectory
3
Lead external asset: GE Healthcare target in lead optimisation
•
$1.15 million milestones and research fees earned to 30 Sept
• Lead optimization stage completes Q1’21
2
Lead internal asset: AD-214 a first in class anti-fibrotic in Phase I
• Pre-clinical efficacy, safety; BTB grant for PET tracer; US FDA pre-IND meeting
• Phase I clinical trial commenced; 4 of 7 dose levels in healthy subjects complete; safety data Q1’21
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
• Evaluating the >20 targets already hit to select next internal candidates; expanding business development pipeline
RECRUITING
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AD-214: road to the clinic

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120100 Receptor Occupancy - All animals Vehicle10 mg/kg30 mg/kg100 mg/kg 54 ns Statistical significance ns ns ns * [#] to 21d bleomycin * ** **
80 3
60
40 2
20 1
0 0
-20
Pre-Dose 2 hours 48 hours 72 hours Pre-Dose 2 hours 48 hours 72 hours
post-SOI post-SOI post-SOI post-SOI post-SOI post-SOI
Normal Diseased i-body Fc-fusion Day 1 Day 25 Bleomycin alone Every 2 days Every 4 days
AD-114 AD-214 AD-214
Validated Novel mode of GMP NHP GLP
✓ ✓ ✓ ✓ ✓ In vivo efficacy
target action, IP manufacturing toxicology
CXCR4 Patented Fc-fusion Very clean Bleomycin
CXCR4 format tox profile mouse
i-body model of
antagonist IPF
Player in CDMO: KBI Half-life
inflammatory, CXCR4 Biopharma supports Ashcroft
fibrotic expressed weekly Score, gene
processes on diverse dosing expression,
cell types collagen
IND-ready Sustained
Biomarker, Inhibition of CMC receptor Eye, kidney,
prognostic fibrotic cell package occupancy liver cancer
indicator migration PoC
Percent receptor occupancy Ashcroft Score
Naïve 21 day 30 mg/kg 30 mg/kg 60 mg/kg 0.01 mg/kg 1 mg/kg 10 mg/kg 30 mg/kg 10 mg/kg 30 mg/kg
Control i- body Pirfenidone daily Nintedanib daily
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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”

Pre-IND meeting Specific guidance readily incorporated into Phase I protocol and ongoing development plans

4

Phase I clinical trial is progressing well

• Part A Part B Part C (Results early 2021) (early 2021 to late 2021) (late 2021 to mid-2022) Single dose, healthy Single dose, ILD/IPF Multiple dose, ILD/IPF volunteers patients patients (HV SAD) (Pax SAD) (Pax MAD)

• • Up to 44 subjects • ~15-30 subjects • ~12-24 subjects

• November ‘20 status November ‘20 status • • 28 participants received AD-214 or placebo (~3:1) Fine tuning design with Part A results

• • 5 cohorts complete from 0.01-5 mg/kg • AD-214 PET tracer development on track to show ⁃ No safety findings of clinical concern distribution and receptor occupancy in patients

• • ⁃ First participants in 10 mg/kg cohort treated A$1m BTB grant funding ⁃ ⁃ No adverse events of note reported to date Agreement with Telix

• • Maximum planned dose: 20 mg/kg Pharmaceuticals to secure • Second site (Scientia) opened to mitigate leading chelation technology recruitment risk

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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

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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”*

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

Multiple options in play for AD-214

Phase I data

• Safety

• PK

• Receptor occupancy

• Receptor distribution

Early partnering options

Indication extension options

• IPF/ILD Phase II and other fibrotic indications

• Active early stage partnering landscape

• Metastatic cancer, I/O combinations

• Novel mode of action expected to be attractive

• First partnering window end of Phase I

• Animal data in >5 additional indications

• Markets worth US$2-15 billion each

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Jul-19 license by Boehringer
Ingelheim €45m + €1.1b
Phase I
Lung Eye Liver
IPF Wet-AMD & PVR NASH & CIRRHOSIS
Nov-19 acquired by Roche
$390m + $1b – Phase II
Aug-15 BMS option to buy
$150m + $1.25b milestones
Jan-20 platform license by
Boehringer Ingelheim Kidney Skin Heart
$?m + $1b milestones RENAL FIBROSIS SCLERODERMA CARDIAC FIBROSIS
Preclinical
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External pipeline: multi-national GE Healthcare

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i-body Target:
October ‘20 status
platform granzyme B • Panel of i-bodies identified
•
Lead optimization underway (6 mo)
•
A$1.15 million milestones and
research fees earned to date
Discovery
Development
Further milestones and royalties to be
earned on development and
commercialization success:
pipeline asset at no financial risk to
Commercialisation AdAlta
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Opportunity: PET imaging GZMB

• US$100 billion immuno-oncology market by 2025

• ~30% patients respond; granzyme B (GZMB) a biomarker for responders

• PET imaging GZMB could significantly improve therapy selection, outcomes

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

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A In-house pipeline
Licence to pharma
of 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 targets where the i-body diagnostics
library structure is most advantaged New drug class
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
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Single domain antibody platform potential: Ablynx case study

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Ablynx strategy (2007) A. Leverage platform to rapidly identify potential drug candidates B. Drive lead product candidate through clinical development

C. Selectively partner to maximize market opportunity D. Maintain and expand technology and IP position

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Comparator position: year first product reaches clinic Opportunity : using first clinical trial as catalyst for acceleration

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Source: Ablynx Euronext IPO prospectus, NASDAQ prospectus and press releases; AdAlta analysis

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

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C
Accelerate
(from ~mid-2021)
B
Expand
A
(~mid 2020 to late 2021)
Maximise catalysts from
current funded base (2020)
$8m
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From …

Via …

Towards 2023 …

• i-body platform in clinic for difficult drug targets

• Laying the foundations for growth

• Multi-product, multi-partner platform company

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

• Progress AD-214

• Build internal and external pipeline

• Continuous platform improvement

• AD-214 partnering, new indications

• ~5 internal GPCR programs

• 3-5 co-development partnerships

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AdAlta pipeline target of five assets by end 2021

November 2019 November 2020 End 2021 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 Target 2 GPCR TBD Target 3 TBD TBD External pipeline Serine GZMB PET imaging I/O protease 2023 target: Partner • 5 internal pipeline candidates TBC TBC #2 • 3-5 external pipeline partnerships

• May be GPCR or, if sourced from existing portfolio of hits, an alternate target class

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Major milestones achieved; more in year ahead

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Nov ‘20
Safety, PK, RO FDA pre-IND Ph I part A Ph I part A 1 [st] PET images 1 [st] partnering
in NHP advice safety update top line safety in patients window opens
Efficacy in BLM Ph I part A PET tracer Ph I part B Ph I part C
mouse commenced pre-clinical commences commences
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2020 2021
Growth $8.1m 2 [nd] external 2 new internal i-body2.0
strategy placement, partnership targets in complete
rights issue discovery
GE progress to GE progress to GE commence pre-
Stage 3 lead optimisation clinical development
AD-214
Other assets
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Industry experienced leadership and advisors

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Board Dr Paul MacLeman Tim Oldham, PhD Chair CEO & Managing Director Liddy McCall Dr Robert Peach (alt: Dr James Williams) Independent Director Director Dr David Fuller Independent Director

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Scientific Advisory Board
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Brian Richardson Drug discovery and development expert

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Steve Felstead Clinical development

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John Westwick Pulmonary drug discovery and development

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Executive
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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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Mick Foley, PhD Chief Scientific Officer

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Kevin Lynch, MD Consultant Medical Expert

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Healthy cash position, supportive shareholders

	Key financial details(23 Nov)
	ASX code	1AD
	Market capitalisation	A$28.2m
	Share price_(12 month range) Ordinary Shares(daily volume)_	A$0.115_($0.04-0.16) 245,175,853(488,961)_
	Listed Options	23,348,803
	Unlisted Options	7,514,067
	Cash(30 Sep 2020)	A$10.03m

	Major shareholders(23 Nov)	%
	Yuuwa Capital LP	22.0
	Platinum Asset Management	11.6
	Meurs Holdings Pty Ltd	7.3
	CS Third Nominees Pty Ltd	2.6
	Radiata Super Pty Ltd	1.9
	Other(1,399 total holders)	54.6
	Total	100%

Share price performance (last 12 months)

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0.18 7
0.16
6
0.14
5
0.12
0.10 4
0.08 3
0.06
2
0.04
1
0.02
0.00 0
Volume (m) Share Price (A$)
25-Nov-19 25-Dec-19 25-Jan-20 25-Feb-20 25-Mar-20 25-Apr-20 25-May-20 25-Jun-20 25-Jul-20 25-Aug-20 25-Sep-20 25-Oct-20
Volume (m)
Shaer price (A$)
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Quarterly cash flows (A$ million)

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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
FY19 FY19 FY19 FY19 FY20 FY20 FY20 FY20 FY21
A$8.1m capital raise, 69% from existing register
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AdAlta: clinical stage drug discovery company entering expansion phase

4 Grow by building multiple i-body-enabled assets Build pipeline of assets with validated technology:

✓ Continue to add value to AD-214 and GE Healthcare assets

✓ Add internal pipeline assets in AdAlta sweet spot

✓ Add external pipeline assets: partner target, funding plus i-body

3 Lead external asset: GE Healthcare target - commercial validation i-body enabled PET imaging agent to identify responders in $100 billion immuno-oncology market

2 Lead internal asset: AD-214 anti-fibrotic product in Phase I - clinically validates platform

First-in-class, clinical stage for $3 billion Idiopathic Pulmonary Fibrosis (IPF) market and other fibrotic diseases

Patented i-body platform: unique asset creation capability

Unique single domain antibody-like platform design for drug discovery against targets that challenge traditional antibodies

1

16

AdAlta (ASX:1AD) investment ~~proposition~~

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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

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• Phase I trial underway in US$3 billion orphan disease idiopathic pulmonary fibrosis (IPF)

• Part A top line safety data Q1 2021 + Part B PET images in patients mid-2021

• Partnering window opening towards end of 2021

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

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GE Healthcare: commercial validation of platform

• Partner funded discovery program; progressed to lead optimisation

Clear vision for growing existing assets and adding more; A$10m cash balance

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

• Internal pipeline: GPCRs in fibrotic, inflammatory disease and cancer (2-3 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

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Experienced drug development team driving strategic focus

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

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

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APPENDIX: DETAIL

i-bodies: designed for “difficult to drug” targets

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CDR3 CDR3
CDR1 CDR1
Shark
Human
Human
Human NCAM i-body
Shark VNAR Ribbon overlay
Domain 1 library
scaffold
scaffold (billions)
First fully human single domain Advantaged over traditional antibodies:
antibody scaffold unique target access and binding, many
possible formats
First shark motif scaffold in clinical >25 targets “hit”: GPCRs, ion channels,
trials enzymes, ligands, protein interfaces
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• Known as an IgNAR when coupled to a fibronectin scaffold

Lead asset AD-214: first-in-class anti-fibrotic

CXCR4 receptor is critical player in development of fibrosis in many organs

AD-214 is first in class: the only CXCR4 antagonist being developed for fibrosis

Normal Diseased Brown stain shows amount of CXCR4

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Potential in multiple fibrotic and cancer indications

AD-214 specifically designed for fibrosis Novel pharmacology Granted patents expire 2036

Efficacy demonstrated in gold standard Idiopathic Pulmonary Fibrosis (IPF) mouse model

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Normal mouse lung tissue

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IPF mouse lung tissue (21 days after bleomycin [BLM])

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IPF mouse lung tissue + AD-214 (21 days after BLM; AD-214 at 10mg/kg every 4 days from day 8)

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AD-214 induced reduction in progression of fibrosis in mouse bleomycin model

fibrosis in mouse bleomyci	fibrosis in mouse bleomyci	fibrosis in mouse bleomyci	fibrosis in mouse bleomyci	fibrosis in mouse bleomyci	fibrosis in mouse bleomyci	fibrosis in mouse bleomyci	fibrosis in mouse bleomyci
0 1 2 3 4 5 6 Naïve 21 day 30 mg/kg 30 mg/kg 60 mg/kg 0.01 mg/kg 1 mg/kg 10 mg/kg 30 mg/kg 10 mg/kg 30 mg/kg Ashcroft Score Bleomycin alone AD-214 Control i- body Pirfenidone daily Nintedanib daily ns ns ns ns Statistical significance# to 21d bleomycin Every 4 days Every 2 days**
		Naïve 21 day 30 mg/kg 30 mg/kg 60 mg/kg 0.01 mg/kg 1 mg/kg 10 mg/kg 30 mg/kg 10 mg/kg 30 mg/kg Bleomycin l ol i- ody one aily nib aily ns ns ns ns Statistical significance# to 21d bleomycin Every 4 d Every 2 d**
		aone	Contr b	Pirfenid d	Ninteda d	AD-214 ays ays

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• 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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Statistical significance assessed using ANOVA and post-hoc Dunnett’s test; ns (not significant) = p >0.05, * = p<0.05, ** = p < 0.01
22 relative to 21-day bleomycin vehicle; negative control is an i-body that does not bind specifically to CXCR4; error bars are standard error
of the mean
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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

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

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

• § body weight § electrocardiography § coagulation § macroscopic and microscopic

• § ophthalmoscopy § respiratory function § urinalysis findings

• § blood pressure § neurological § organ weight function

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

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

Tox study 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 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-214 available 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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Day 1 Male
mg/kg
mg/kg
mg/kg
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Receptor Occupancy - All animals Vehicle
120 10 mg/kg
30 mg/kg
100 100 mg/kg
80
60
40
20
0
-20
Pre-Dose 2 hours 48 hours 72 hours Pre-Dose 2 hours 48 hours 72 hours
post-SOI post-SOI post-SOI post-SOI post-SOI post-SOI
Day 1 Day 25
Percent receptor occupancy
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Supportive of human therapeutic dose window including 10mg/kg intravenously, weekly or every second week

• On peripheral blood mononuclear cells (white blood cells)

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Source: GLP NHP Toxicology Report; external expert pharmacological modelling; error bars are standard deviations (n=6-10 animals per group)

Phase I design detail*

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

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Part A Part B Part C Objectives
(Ongoing to early 2021) (early 2021 to late 2021) (late 2021 to mid-2022)
Single dose, Primary
healthy Single dose, Multiple dose, • Safety, tolerability of AD-214
volunteers ILD/IPF patients ILD/IPF patients
(Pax SAD) (Pax MAD)
(HV SAD) Secondary
•
PK, PD of AD-214
• Up to 44 subjects • ~15-30 subjects • ~12-24 subjects • Immunogenicity of AD-214
• 0.01-20 mg/kg iv • 0.1-20 mg/kg iv • iv weekly, 4 weeks
• 2 sites • 2-3 sites • 2-3 sites
Exploratory
• Effect of AD-214 on
respiratory function
Includes AD-214 PET tracer for distribution • Localisation/distribution of
and receptor occupancy 89Zr-AD-214 by PET-CT
Contracted vendors Partners in development and clinical validation of PET tracer for Parts B and C
RECRUITING
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** Standard 3 + 3 safety design: up to 3 additional ILD pts will be recruited into any dose group if required to provide additional safety

*** Subject to successful development and subsequent ethics approval of[89] Zr-AD-214

• https://clinicaltrials.gov/ct2/show/NCT04415671?term=adalta&draw=2&rank=1; Part A is fully funded

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Pipeline: diverse target capability supports internal and external pipeline assets

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i-body platform capability Commercial validation
GPCRs
Chemokine
• i-body libraries, IP • Target
Brings
>20 targets to
•
Other which i-body Lysophos- • Discovery, Does Pre-clinical, clinical
binders have pholipid validation development
Enzymes been found
Protein binding
interfaces Neurotensin
Ligand binding sites • Milestones Receives • Binder IP
Acetylcholine • Research fees • Commercialisation
Prostanoid • Royalties rights
Ion channel
Successfully progressed to Stage 4 (lead
optimization) following 10 month discovery program
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Internal pipeline asset creation

• G-protein coupled receptors

• • Fibrosis, inflammation, oncology

External pipeline asset creation

• Multiple co-development partnerships

• New target biology, non-dilutive funding

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• Includes both i-body and VNAR/IgNAR formats

Near term strategic priorities: expansion phase

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

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Market benchmarks: reaching for the stars!

Fibrosis pipelines	Jul-19 license by Boehringer Ingelheim €45m + €1.1b	Nov-19 acquired by Roche $390m + $1b – Phase II Aug-15 BMS option to buy	Jan-20 platform license by Boehringer Ingelheim $?m + $1b milestones
	Phase I	$150m + $1.25b milestones	Preclinical
Micro- antibody platforms	April-16 license by Abbvie $40m upfront + $645m milestones & royalties	Feb-18 collaboration with Seattle Genetics (3 targets) $30m upfront + $1.2b milestones & royalties	Feb-18 acquired by Sanofi €3.9b
GPCR platforms	Feb-15 acquired by Sosei $400m Phase Ib asset + 7 pre-	Jul-15 acquired by Celgene $7.8b Ph III, Ph II and GPCR	April-16 license with Boehringer €8m + €125m milestones
	clinical leads	platform	Phase I GPCR nanobody

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