Investor presentation
Released
Released
Announcement PDF
Building our clinical pipeline
AdAlta Limited (ASX:1AD)
A modern targeting system for next generation drugs
Investor Overview
20 May 2024
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.
2
AdAlta (ASX:1AD): unique discovery platform, expanding business model
Purpose: i-body® targeting for next generation therapeutics
Going where antibodies can't to produce high-value, next generation protein and cell therapies for debilitating diseases
Discovery business
i-body® “inventory” of high value product
candidates for development or licensing
AdCella
Product development
businesses
Fibrosis/inflammation
Cellular immunotherapy
Product candidates progressing through
value-adding development milestones for
out-licensing or co-development
Larger biopharma companies
Out-licensing and co-development
3
Near-term momentum and opportunities for shareholders
Attractive current valuation and fundamentals
Share price performance (ASX:1AD) (12 months)
v Enterprise value ~A$10.6m* (Market capitalisation A$13.3m)
v Strong and supportive institutional register
v $3.7m flexible financing facility secured to progress
transactions (Apr’24)
Momentum accelerating towards return on AD-214
investment - AdSolis
v Phase I extension study clinical data achieves critical
milestone for partnering and Phase II readiness (Mar’24)
Largest shareholders (13 May 2024)**
%
Platinum International Healthcare Fund
16.5
Meurs Group
12.5
Sacavic Group
FMI Pty Ltd atf Commonwealth of Australia
6.5
Radiata Foundation
3.9
Other (~1,480 total holders)
Total
5.1
56.5
100%
v Multiple partnering strategies in play to fund Phase II: IPF
assets commanding upfront license payments of more than
US$45 million
“East to west” cellular immunotherapy strategy in place for
near term clinical pipeline – AdCella (Apr’24)
v Collaboration with SYNBV to launch AdCella: pathway for
Asian cellular therapy innovation to global markets
v Appointment of Cell Therapies as preferred manufacturer
*Market capitalization A$13.3m at 13 May 2024 less 31 Mar 2024 cash $1.51m and first $1.2m from NLSC/Meurs Group financing announced 29 April 2024
**Based on 533.2m issued ordinary shares; does not include effect of 173.0m 1ADOA listed options and 13.8m unlisted options
4
AdAlta’s core strategies each have opportunities for growth
Current status
1. Realise the value of lead asset AD-214
2. Progress i-CAR and i-PET discovery
3. Invest in i-body® platform and pipeline
Partnering discussions advancing via
AdSolis for:
v Out-licensing; or
v Co-development/asset financing
v 3 active i-CAR-T discovery programs
(Carina Biotech)
v i-PET imaging discovery program
(GE Healthcare)
v 2 new i-CAR discovery programs
commencing
Focus for direct investment narrowed to
cellular immunotherapy via AdCella
v MoU with SYNBV enables faster and
more capital efficient progress
v Platform available for sponsored
research in other areas
v Platform renewal making limited
progress
5
AD-214: new hope for fibrotic disease patients
Bill van Nierop: IPF survivor speaks to challenge of living with IPF
“… sadly I am one of a few who can actually
relate to the lived experience with and without PF
…”
“You see our symptoms are basically an
ongoing internal struggle to breathe freely …
and it’s invisible to all, including family, friends
and the general community.”
“I talked with a 60 something grandmother, who really enjoyed days looking after
grandkids, but as disease progressed she found sometimes she needed to reduce
the time a bit. You won’t believe that her daughter in law suggested she would just
bring them around less, ‘you’re always tired but you look really well’, so I won’t
bother you as much. Shattering to the poor woman obviously, but again
demonstrates the absolute lack of understanding of this debilitating disease. Looks
well, so can’t be too ill, except she’s struggling to breathe and is on a journey
with an inevitable end.”
Source: Bill van Nierop, https://www.facebook.com/kayakforlungs 28 September 2023
https://www.lonagkayakforlungs.com.au/
7
The need: Better outcomes for Idiopathic Pulmonary Fibrosis (IPF) and other
fibrotic diseases
45% of developed world deaths
IPF prevalence
>490,000 worldwide
have a chronic fibrosis component
72,000
78,000
Europe
USA
14,000
Japan
159,000
China
6,000
Australia
3-5
Slow, but do not halt progression. Serious side effects
limit compliance, tolerability
$5.1b
$4.3b
• Lung
(US$4b)
• Kidney
(US$10b)
• Eye
(US$15b)
• Cancer
(US$1b each)3
New drivers of incidence
• “Long COVID”1
• Re-emergence of silicosis
>100,000 pa
2022
2029
Source: GlobalData,2 company financial
reports, AdAlta analysis
1 PM George, et al, “Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy”, Lancet published online May 15, 2020.
2 GlobalData, Idiopathic Pulmonary Fibrosis: Competitive Landscape, April 2023
3
GlobaData, disease analysis reports
8
AdSolis’ solution: AD-214 has a compelling value proposition
A$45m investment to date has built strong value
proposition
AD-214 is competitively well positioned in Phase II and
beyond pipeline*
First in class molecule targeting established mode of action in
fibrotic disease
ü Competitively positioned as only antibody-like therapeutic
entering late-stage development pipeline
Pre-clinical efficacy in multiple animal models of fibrotic
disease – derisks clinical studies
ü Led by Idiopathic Pulmonary Fibrosis (IPF): TAM US$4.3b
ü Multiple US$b indication potential: kidney, eye, cancer
AD-214 poised to enter Phase II as the only product
offering antibody-like precision – and one of only
three products targeting a novel but validated disease
modifying pathway with no prior failures
Pirfenidone or
nintedanib analogues –
uncertain mode of
action, tolerability risks
Phase I successfully completed
ü Well tolerated, evidence of target binding
ü Addresses partner questions
Target IV product profile verified; enhanced SC product profile
identified – supports clinical adoption
ü Intravenous (IV) every 2 weeks; subcutaneous (SC) every week
2
Targeting novel
pathways with no
clinical failure to date
3
6
9
7
Targeting novel
pathways where there
have been prior
clinical failures
Products designed to
manage symptoms –
not disease modifying
Strong intellectual property, regulatory position
ü Patents protecting asset to 2036 and beyond
ü US FDA Orphan Drug Designation for IPF
ü 10-12 years market exclusivity (US, EU)
* As at October 2023; excludes 11 studies categorized as Phase I/II, institution led or with <25 patients per arm which are unlikely to be powered to show efficacy
Source: GlobalData, clinicaltrials.gov, company press releases, AdAlta analysis
9
Phase I extension study achieves critical partnering and Phase II readiness
milestones
Phase I extension study finding
Significance
1.
Multiple doses of 10 mg/kg IV AD-214 are well
tolerated, no dose limiting toxicity, only “mild” adverse
events
ü Establishes safety profile necessary to advance this
dose to Phase II
2.
PK (maximum and total exposure) and PD (white cell
and receptor occupancy*) profiles are consistent
across multiple doses and multiple patients; in line
with model predictions
ü Supports potential efficacy of selected Phase II dose
3.
Antidrug antibodies present at low levels only; no
evidence of effect on PK and PD parameters
ü ADAs (or other immune responses) are unlikely to
detract from clinical safety or efficacy
4.
Larger biopharmaceutical licensing partners want to
know that the target Phase II dose is safe, has potential
to be effective and that any immune response will not
detract from this
ü Results comprehensively address pharma company
clinical questions received to date
* RO profile after fourth dose remains under evaluation
10
AD-214 development plan
Phase I extension study
• AD-214 well tolerated at target Phase II dose; PK/PD as predicted, consistent across doses; no evidence of negative ADA effects
• Results comprehensively address pharma company clinical questions received to date
Phase II financing strategy
Co-development in
AdSolis …
• AD-214 licensed to AdSolis
subsidiary; new strategic or
financial investors invest
• AdAlta leads Phase II
• AdAlta receives management
fees, retains substantial
equity ownership
• AdAlta benefits from value
uplift of any Phase II success
… and/or out-licensing
from AdSolis to larger
biopharmaceutical
company
• AD-214 licensed to global or
regional company
• Partner responsible for
funding, executing Phase II
• AdAlta receives upfront
payment, development
milestones and royalties on
any future commercial sales
• AdAlta return is fixed now
Phase I extension study data being shared
with short list of partners to enable them
to complete their evaluation of AD-214
Objective is a near term transaction
Product development strategy
Target intravenous (IV)
product profile
Potential subcutaneous
(SC) product profile
• IV in clinic
• Patient self administration at
home (like diabetes, arthritis)
• Two weeks minimum
between infusions
• Weekly or daily injections
• Fastest, cheapest to clinical
proof of concept
• Enhanced market share,
reduced COGS
• Progress to Phase II
• Develop formulation,
progress to Phase I
Choice of formulation to take through to
Phase III
Based on relative success of each
development
11
The value: Pharma companies are actively licensing IPF assets for
significant value
Upfront payment to
licensor
Contingent milestones
Clinical Phase at
transaction
Feb 23
Acquisition#
US$294m
N/A
2
Jan 23
China only license
US$76m^
US$336m
2
Aug-22
License
US$80m
US$620m
2
Apr-20
Acquisition*
US$45m
Not disclosed
2
Nov-19
License
US$390m
US$1,000m
2
Nov-21
Acquisition#
US$254m
N/A
2 (Ready)
Nov-20
License
€25m
€320m
2 (Ready)
Sep-21
License
US$152m
US$602m
2 (Ready)
Feb-21
License
Not disclosed
US$517.5m
1
Jul-19
License
€45m
€1,100m
1
Oct-22
Acquisition
US$255m
Not disclosed
Pre-clinical
(+ platform)
Licensor/target
Licensee/acquirer
Source: Company press releases; * Lead indication was diffuse cutaneous systemic sclerosis which usually evolves into IPF; # Did not complete; ^ Includes development milestones
AD-214 almost
Phase II ready
Transaction
Date
12
AdCella
AdAlta’s “east to west” cellular
immunotherapy strategy
Cellular immunotherapies are transforming cancer outcomes
New, multifunctional therapies are needed to address solid cancers
Therapy involves re-engineering patient’s own immune cells to
“see” cancer – living drug, single dose, potentially curative
6 FDA-approved CAR-T therapies since 2017 transforming outcomes:
Complete response rates: 83% r/r pALL, 51-65% r/r LBCL, 78% r/r MM4
… but so far only for blood cancers
CAR-T: >US$2.6 billion earned in 2022,3 US$20.3 billion forecast for 20281
>50% of CAR-T revenues from solid tumours by 20302
90% of cancers are solid tumours: harder to target, harder to access, immune suppressive
Need new, multifunctional, cellular therapies
2024: FDA approved 1st cellular immunotherapy (non-CAR-T) for solid cancer (melanoma)5
1.
2.
3.
4.
5.
Grandview Research, “T-cell Therapy Market Size, Share & Trends Analysis” Feb 2021
Polaris Market Research, "CAR-T Cell Therapy Market Share, Size Trends, Industry Analysis Report", June 2021
Company websites and financial filings
Kymriah, Yescarta and Carvytki prescribing information; r/r = relapsed/refractory; pAML – paediatric acute lymphoblastic leukemia, LBCL = large B cell lymphoma, MM = multiple myeloma
https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/amtagvi
14
Why AdAlta should develop a cell therapy company (AdCella)
Cellular immunotherapy for solid
tumours is a large, fast
growing market
Highly differentiated
competitive position:
• Eastern
hemisphere
innovation
• Australia’s
experienced and
cost effective
delivery ecosystem
• i-body® technology
Rich pipeline of
differentiated product
candidates, many
with initial patient
data, that could be in
western regulated
clinical trials in near
term
Scalable business
model allowing for
multiple programs
that can be pursued
cost effectively with
speed to market
Strong team and
partnership with
SYNBV and CTPL;
complemented by
other known networks
15
The value: cell and gene therapy up front deal values 3.5x higher than other
biologic drugs with potential to partner early
Pre-clinical proof of concept cell therapy transactions
Asset in-licensing terms
Median upfront (cash and equity) payments (US$
million)
Cell & gene therapy
Biologics
120
No. of
assets
Upfront/
target
(US$m)
Deal value/
target
(US$m)
Jun-22
2
30
730
Jul-20
1
20
988
Feb-20
2
25
300
Nov-19
1
10
304
Oct-18
1
45
1702
25
730
Date
100
80
60
40
20
Licensee
Licensor
0
2018
2019
2020
2021
2022
2023
H1
Median value
Source: JPMorgan, Q2 2023 Biopharma Licensing and Venture Report, July 2023 (“Biologics” includes biologics, mAbs, ADC, proteins, DNA, RNA, etc); GlobalData, company press releases, AdAlta analysis
16
Three insights support AdAlta and AdCella’s vision and opportunity in
cellular immunotherapy
Asia is global epicentre of innovation in
cellular immunotherapy; supportive
regulatory system enables early clinical
data to derisk assets
AdAlta’s i-body® technology is ideally
suited to multifunctional products;
supported by operating capability, access
to capital and Australian ecosystem
Australian manufacturing and
clinical ecosystem is experienced,
western regulated and cost advantaged
even before R&D tax incentive
17
Eastern hemisphere has the richest cellular immunotherapy
development pipeline in the world
Cellular immunotherapy developers 20231
Cellular immunotherapy clinical trials 20242
n = 1,104
n = 1804
1108
Other
South Korea
Japan
Australia
449
11 28
47
50
439
583
185
Asia Pacific
North America
Europe
31
RoW
China
49
Canada
574
USA
972
• 41% of developers, 61% of clinical trials in Asia Pacific
• Dominance of China in clinical trials reflects efficiency of
Investigator Initiated Trials (IITs) to generate early clinical
proof of concept
• Number of newly identified CAR-T therapies from Chinese
developers has doubled every year since 2014
1.
2.
162
Asia Pacific
North America
Europe
41
RoW
Alliance for Regenerative Medicine, Developer Data Report Q3 2023. Includes all companies developing gene modified cell therapies and cell-based immuno-oncology products by headquarter region
GlobalData, Pharma Intelligence Centre, Clinical Trials Database (accessed 5 April 2024). Includes all adoptive cell therapies (T cell immunotherapies, NK cell immunotherapies and tumour infiltrating lymphocytes. Includes
all ongoing clinical trials. Multinational trials are included in each country in which they are conducted
18
Australia has a well-developed cell therapy delivery ecosystem1
Clinical delivery capability
• 138 cell and gene therapy trials to date
• 55 institutions treating patients with cell and gene therapies
• 25 sites approved for commercial CAR-T delivery
• 3 commercial approvals for CAR-T products
• Clinical trial costs 25-50% cheaper than US
Manufacturing and supply chain capability
• Several cGMP cell therapy manufacturing facilities
• Cell Therapies Pty Ltd approved for commercial CAR-T
supply by TGA and Japan PMDA
• Viral Vector Manufacturing Facility Pty Ltd being established
• Plasmid DNA (vector starting material) CDMO
Innovation and translation
• >20 companies developing advanced therapeutics
• Cell and Gene Catalyst to drive ecosystem
• R&D Tax Incentive to further leverage cost advantages
1.
Adapted from Heather Main, Hoya Consulting (unpublished analysis); company/institution websites
19
AdAlta’s solution: i-bodies enable superior CAR constructs (i-CARs) and
other advanced therapies when combined with partner platforms
i-CAR-T example
TINY i-body® needs LESS room in inserted gene,
enabling MORE engineered function
i-body applications
Tumor cell
Produces superior, multifunctional advanced therapy
products
i-body targeting domain
Tumor
antigen
Chimeric antigen receptor (CAR)
v Improved targeting
§ Novel tumor antigens, dual and bi-specific CARs
v Persistence and performance
§ Overcome immune suppression “checkpoints”,
enhanced trafficking, reduced exhaustion
v Payload
§ Higher payload for vectorized antibody therapeutics
(mRNA, in vivo CAR-T, etc)
Cell killing
molecules
Secreted i-body
immune
checkpoint
inhibitors
Immune cell
Collaboration with Carina Biotech – 3 targets in discovery
Significant industry interest from potential additional partners
Value could be realized at preclinical PoC
20
AdCella business model
1.
3.
In-license market
leading assets from
Asia
Establish global manufacturing network
and on-license to commercialization
partners
AdCella
2.
Build value by establishing western
regulated manufacturing, obtaining first
western regulated clinical data
Source: F Bray et al, Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, CA Cancer J Clin 2024:1-35. doi:10.3322/caac.21834
21
SYNthesis BioVentures (SYNBV) is partnering with AdAlta to develop next
generation cellular immunotherapies for solid cancers
Memorandum of Understanding
6-12 months initial collaboration
•
•
•
•
•
i-body platform: building blocks for
next generation cell therapies
Clinical development capabilities
Access to public capital
Access to Australian cell therapy
ecosystem
Pipeline of potential cellular
immunotherapy partners
AdCella
Connecting Asia innovation, Australian
manufacturing and clinical execution and
AdAlta’s i-body technology to deliver next
generation cellular immunotherapies for solid
tumours into western regulated markets
•
•
•
•
Deep China experience
Cross border transaction capability
Access to private capital
Venture capital disciplines in due
diligence, asset selection, drug
development
Challenges solved
Identifying (selectively) cancer
Navigating to cancer
Surviving and thriving
22
Key terms of AdAlta-SYNBV collaboration
Success = AdCella
Ownership:
75% AdAlta 25% SYNBV
before financing of initial assets (so may
change over time)
License:
to ex-Asia rights for near to clinic novel
cellular immunotherapies for solid
cancers
Financing:
to progress initial asset or assets through
first western regulated clinical proof of
concept trial
AdCella
Secure licensing
agreements for
initial assets
Complete
establishment of
AdCella
Raise capital for
first western
regulated clinical
proof of concept
studies in
Australia
No obligation to
incur any specific
costs; deploy
specific
resources; or
establish AdCella
Review, expand,
and complete
due diligence on
pipeline of
potential assets
6 + 6 month Memorandum of Understanding (MoU)
period to secure building blocks
Parties have right to each invest $7.5m in
first financing, right of first refusal on
subsequent financings
Option:
to license AdAlta’s i-body platform and
other cellular immunotherapy assets
Management:
services agreement with AdAlta
23
Cell Therapies Pty Ltd (CTPL) collaboration brings world class
manufacturing and product development capabilities to AdCella
1AD – CTPL Master Services Agreement
Relationship: CTPL is AdAlta’s preferred
manufacturer of cellular
immunotherapies
Services:
Process development, technology
transfer, analytical testing, clinical
product manufacturing and
supply, regulatory support,
executed under work orders
Standards:
Service standards, including
cGMP compliance where
relevant, and governance model
defined
Next steps:
Technical feasibility assessment
of initial AdCella pipeline
candidates
24
Unlocking value in i-body pipeline
Upcoming milestones and objectives in 2024
1. Realise the value of AD-214
ü Complete Phase I extension study
ü
v Finance AD-214 Phase II (AdSolis)
Phase II dose well tolerated, PK/PD profile supportive of
potential efficacy, no concerning immune response
v GPCR Therapeutics (Korea) collaboration
§
§
§
§
Out-license or project finance
Finances Phase II clinical studies without using 1AD
equity
Unlocks value and financing for other strategy pillars
Results of GPCR Tx evaluation of CXCR4 i-bodies
2. Progress i-CAR and i-PET discovery
v Progress Carina Biotech i-CAR-T cell therapy collaboration
§
§
A-i-CAR-T in vivo proof of concept: go/no go for further development
Complete i-body discovery on targets B and C: go/no go for in vitro cell cytotoxicity
v Commencing discovery on two new “catalogue” targets suitable for multiple i-CAR collaborations
v Continue GE Healthcare collaboration for GZMB-i-PET imaging agent
§
Milestones dependent on GE Healthcare
3. Invest in i-body® platform and pipeline
ü AdCella: Delivering Asian innovation in next generation cellular immunotherapies for solid
tumours into global markets
ü
ü
§
SYNBV collaboration to launch and co-finance
CTPL engaged as preferred manufacturer
Securing first clinical stage in-licensing candidates and i-body® co-developments
v i-body®2.0 program and i-body® “inventory” build
ü World first discovery of high potency, pan-species inhibitor of malaria parasite invasion
26
AdAlta’s portfolio: High value therapeutics addressing challenging diseases in
fibrosis and immuno-oncology and a platform grow further
AdSolis for fibrosis: degenerative, progressive, fatal
AdAlta’s AD-214 could meet a desperate need for new approaches for debilitating diseases of the lung (US$4.3b), kidney
(US$10b) and eye (US$15b)
Comparator licensing transactions: >US$45m up front;
US$320-1,000m milestones
AdCella for “east to west” cellular immunotherapies
Bringing Asian innovation to global patients and i-body enhancement; rapidly scalable business
Comparator licensing transactions: >US$10m up front;
>US$300m milestones
CAR-T cell therapy providing new hope… for blood cancer patients so far
AdAlta and Carina’s i-CAR-T cells could offer the same hope for solid tumour patients (US$20b by end of decade)
Comparator licensing transactions: >US$10m up front;
>US$300m milestones
Immuno-oncology drugs revolutionising cancer treatment… for some
AdAlta and GE Healthcare’s GZMB i-PET imaging agent could identify responders early (US$6b)
Comparator product revenue potential: >US$400m pa
Traditional antibodies can’t do everything!
AdAlta’s i-bodies are a differentiated drug discovery platform partners can leverage for difficult diseases
27
New investment provides access to up to $3.7 million additional funds
New Life Sciences Capital LLC (NLSC)
A US-based healthcare focused fund
A$ million
First Investment
Meurs Group
AdAlta’s second largest (and one of its longest standing)
shareholders
Second Investment
$0.7m
Third Investment
Total
Up to $0.8m
Up to $3m
NLSC
$0.8m
$0.7m
Meurs Group
$0.4m
$0.3m
Total
$1.2m
$1.0m
$0.7m
Up to $0.8m
When
Immediately (May’24)
Within 6 months
Within 12 months
Within 12 months
Key conditions1
None (NLSC)
Definitive
agreements (Meurs)
$0.7m
At AdAlta’s option (with NLSC’s consent as
to second $0.7m)
Up to $3.7m
By mutual agreement
1. Other customary conditions apply to the second and subsequent investments as detailed in ASX release of 29 April 2024 (https://investorhub.adalta.com.au/announcements/6310002).
These include continued compliance with the terms of investment agreements, solvency, minimum share price and market capitalization requirements and available placement capacity
28
Benefits of new investment
Certainty
Funds support growth initiatives
§ Accelerate progress of cellular
immunotherapy collaboration with
SYNthesis BioVentures
§ Progress internal i-body® programs
• Can progress growth initiatives independently of availability of funds from
ongoing partnering initiatives for AD-214
Flexibility
• Only need to draw down funds needed
• Can repay investment rather than issue shares if cash is available
Competitive terms
• Issue price determined by share price at time of issue, not share price today
• Floor price protection
• Pricing and fees compare favourably with discounted placements
• No options coverage
29
Experienced in-house team
Executing from discovery through product development
BOARD
SCIENTIFIC ADVISORY BOARD
EXECUTIVE
Paul MacLeman, DVM
Angus Tester, PhD
CHAIR
SENIOR MANAGER,
PROJECTS AND PROGRAMS
Tim Oldham, PhD
Janette Dixon, DBA
CEO & MANAGING DIRECTOR
HEAD OF BUSINESS
DEVELOPMENT
Robert Peach, PhD
INDEPENDENT DIRECTOR
Dr. David Fuller
Darryn Bampton
DIRECTOR, CLINICAL AND
REGULATORY
OPERATIONS
Michael Rasmussen
INDEPENDENT DIRECTOR
CONSULTANT MEDICAL
EXPERT
Mick Foley, PhD
FOUNDING CHIEF
SCIENTIST
Brian Richardson
DRUG DISCOVERY &
DEVELOPMENT EXPERT
Steve Felstead
CLINICAL DEVELOPMENT
John Westwick
PULMONARY DRUG DISCOVERY
& DEVELOPMENT
PARTNERS AND KEY CONTRACTORS
Joseph Tyler
CONSULTANT CMC EXPERT
IN-HOUSE DISCOVERY &
DEVELOPMENT TEAM
8 PhD/MSc Staff + La Trobe Uni location
Skills in protein chemistry, i-body discovery,
product development, pre-clinical development
30
AdAlta’s foundations in place for transaction driven growth
Lead asset AD-214 heading to Phase II (US$4.3b IPF market plus other indications), substantially derisked by Phase I extension study clinical readouts
AD-214 partnering window open with multiple options in play: active market with comparator
valuations >US$45m upfront with US$0.3-1b milestones
AdCella: “east to west” cellular immunotherapy strategy leveraging regional and i-body® advantages
in high value, high growth sector; enabled by SYNthesis BioVentures and CTPL collaborations
Experienced team and network; differentiated discovery platform; established partnerships and
pipeline
Strong and supportive institutional and large shareholder register, flexible financing
Attractive valuation relative to commercial potential of pipeline
31
A modern targeting system for next generation drugs
AdAlta Ltd (ASX:1AD)
Investor Presentation
May 2024
For more information please contact:
Tim Oldham
CEO & Managing Director
+61 403 446 665
t.oldham@adalta.com.au
Investor Relations
The Capital Network
Russell Katz
+61 2 8999 3699
russell@thecapitalnetwork.com.au
www.adalta.com.au
AD-214: new hope for fibrotic disease patients
AD-214 is now ready to move into Phase II clinical studies for IPF
Recent data
✓
✓
Validated target
• CXCR4
• Player in
inflammatory,
fibrotic processes
• Biomarker,
prognostic
indicator
Novel mode of
action, IP
GMP
manufacturing
Pre-clinical
efficacy
• Patented i-body®
antagonist
• Fc-fusion format
• Target found on
diverse cell types
• Inhibition of fibrotic
cell migration,
collagen
deposition, fibrotic
markers
• CDMO: KBI
Biopharma
• IND-ready CMC
package
• IV, SC routes of
administration
likely feasible
(inhaled and IVT
also possible)
NHP GLP
toxicology
Phase I clinical
trials (IV)
• Bleomycin mouse
model of IPF
• Very clean tox
profile
• Very well tolerated
in two studies
• FA and UUO
model of kidney
fibrosis
• Half-life supports
weekly+ dosing
• High, extended
target engagement
consistent across
multiple doses
• Laser CNV model
of eye fibrosis
• Combination
oncology pending
• Sustained receptor
occupancy
• Dose simulations
support efficacy of
commercially
feasible IV and SC
regimens
Pre-IND meeting:
Panel of pre-clinical studies “generally sufficient” to support an Investigational New Drug application
The Phase I trial design is “reasonable”
Orphan Drug Designation: granted (US)
34
Phase 1 clinical studies completed in 58 participants covering planned
Phase II doses
Phase 1, randomized, blinded and placebo controlled dose-escalating studies of the safety, tolerability, and pharmacokinetics of single
and repeat doses of AD-214 when administered intravenously to healthy volunteers1
Phase 1 protocol in healthy volunteers
Part B
Extension – Aug ‘23-Feb’24
Single ascending dose
Multiple dose
Multiple dose
§ 42 participants in 7 cohorts (31 active: 11
placebo)
§ 8 participants in 1 cohort (6 active: 2 placebo)
§ 8 participants in 1 cohort (6 active: 2
placebo)
§ AD-214 administered IV at 0.01-20 mg/kg
§ AD-214 administered IV at 5 mg/kg IV (3 doses
two weeks apart)
§ A
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