Investor Presentation
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
Updated AdAlta Investor Presentation
MELBOURNE Australia, 3 May, 2017: AdAlta Limited (ASX:1AD), the biotechnology
Company advancing its lead i-body candidate towards clinical development today
announced an updated investor presentation that Chief Executive Officer Sam Cobb will
present at the Canary Networks Stocks to Watch Roadshow and various investor meetings.
The updated AdAlta Investor presentation will comprise a Company update including
progression of lead compound, AD-114, towards the clinic for idiopathic pulmonary fibrosis
(refer to recently released Idiopathic Pulmonary Fibrosis document for a disease overview).
The Stocks to Watch Roadshow provides the opportunity for investors and industry leaders
to hear live presentations from some of Australia’s most exciting small-cap companies. The
roadshow is held in Melbourne on Wednesday May 3 and in Sydney on Thursday May 4.
A copy of the presentation will be released to the ASX and is also available on the
Company’s website.
Notes to Editors
About AdAlta
AdAlta Limited is an Australian based drug development company headquartered in
Melbourne. The Company is focused on using its proprietary technology platform to
generate i-bodies, a new class of protein therapeutics, with applications as
therapeutic drugs to treat disease.
I-bodies are a promising, novel class of drugs that offer a new and more effective
approach to treating a wide range of human diseases. They are identified and
developed using our proprietary technology platform.
We have pioneered a technology that mimics the shape and stability of a crucial
antigen-binding domain, that was discovered initially in sharks and then developed
as a human protein. The result is a range of unique compounds, now known as ibodies, for use in treating serious diseases.
AdAlta is developing its lead i-body candidate, AD-114, 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 also plans to continue further drug discovery and development
directed towards other drug targets and diseases with its i-body technology platform.
Further information can be found at: www.adalta.com.au.
For more information, please contact:
AdAlta Limited
Sam Cobb, CEO
Tel: +61 (0)3 9479 5159
E: s.cobb@adalta.com.au
Media (Australia)
Andrew Geddes
Tel: +61 (0)408 677 734
E: adalta@instinctif.com
Media (International)
Sue Charles / Daniel Gooch
Tel: +44 (0)20 7866 7905
E: adalta@instinctif.com
i-bodies – a new class of protein therapeutics to
treat human disease
May 2017
Sam Cobb, CEO and Managing Director
AdAlta Limited (ASX:1AD)
s.cobb@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.
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Corporate and investment summary
A drug discovery and development company
using its powerful technology platform to
generate a promising new class of protein
therapeutics, known as i-bodies, for treating a
wide range of human diseases.
Investment highlights
Initial focus on treating fibrosis – high unmet medical
need
Advanced lead fibrosis drug candidate AD-114 with
significant pre-clinical validation
Fully funded for phase 1 development of lead
fibrosis drug and i-body pipeline
Orphan drug designation USA FDA
Early commercialisation potential
Experienced team with strong track record of drug
development and ability to deliver
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Capital structure
ASX code
Shares on issue*
Share price (1 May)
Market capitalisation
Current cash
Trading Range
1AD
101,110,890
AU$0.27
AU$27.3m
AU$7.47m
AU$0.31 to $0.165
* 24.1m shares escrowed for 24 months from listing
Major Shareholders
%
Yuuwa Capital LP
Platinum Asset Management
Citycastle Pty Ltd
La Trobe University
Robin Beaumont
Other shareholders
53.5
7.91
5.25
3.01
1.87
28.46
Total
100%
i-body technology
Long loop that
enables access to
novel drug targets
AdAlta is developing a new technology platform that produces
unique proteins known as i-bodies, that mimics the shape and
stability of a crucial antigen-binding domain, that was discovered
initially in sharks and then developed as a human protein.
An i-body is a unique human protein that combines the
advantages of small molecules (for stability) and antibodies (with
a high affinity and specificity for treating certain illnesses) in one
powerful treatment.
Advantages of i-bodies
i-body human
protein scaffold
High target specificity and high affinity for their target
Small proteins; 10% the size of a typical human antibody
Highly stable to proteases, high temperatures and low pH
Long loop that can bind to a diverse range of therapeutically
relevant targets including those that are difficult for current
antibody therapies
Human protein – reduced risk of immune response
4
Human Antibody
Shark Antibody
Fibrosis: unmet medical need with
multiple indications
Developing i-bodies as improved therapies for
the treatment of fibrosis
– a condition that is prevalent in
45-50% of all diseases
Fibrosis can occur in many tissues of the body
as a result of inflammation or damage
Lung
Eye
Liver
IPF
Wet-AMD & PVR
NASH & CIRRHOSIS
Kidney
Skin
Heart
RENAL FIBROSIS
SCLERODERMA
CARDIAC FIBROSIS
– it can result in scarring of vital organs causing
irreparable damage and eventual organ failure
AdAlta’s initial focus is on lung fibrosis
Collectively fibrosis represents
a large unmet clinical need
5
AD-114 lead program in Idiopathic Pulmonary
Fibrosis (IPF)
AD-114 is lead i-body
candidate in pre-clinical
development
– Demonstrates both antifibrotic and anti-inflammatory
activity in the lung
– Important for arresting and
modifying the disease and
tackling the treatment of
idiopathic pulmonary fibrosis
(IPF); this is the first
indication
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AD-114 prevents lung fibrosis in disease
models
Extensive pre-clinical AD-114 studies have demonstrated positive
in vitro (in the lab) and in vivo (in animals) data
Normal
lung tissue
IPF lung tissue
(lung disease mouse model)
IPF lung tissue + AD-114
dosed for 21 days
(lung disease mouse model)
AD-114 reduces collagen content and inflammatory cell infiltration and demonstrates a
similar architecture to that of the normal lung in the Bleomycin mouse model
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AD-114 key advantages compared to existing
IPF treatments
No effect
on normal
tissue
Effect on
diseased /
IPF tissue
i-body AD-114
✔
✔
Nintedanib (Boehringer)
✗
✔
Pirfenidone (Roche)
✔
✗
Other CXCR4 drug
(Sanofi)
✔
✗
Human tissue
In vitro activity
AD-114 has greater in vitro efficacy compared to the only
approved therapies Nintedanib and Pirfenidone for IPF
treatment
– Existing IPF treatments have limited efficacy; either
no effect or slow down disease progression i.e. no
cure
Novel mechanism of action compared to other drugs
targeting the GPCR chemokine receptor CXCR4
Very specific for diseased tissue and no effects on
normal tissue
AD-114 has both anti-fibrotic and anti-inflammatory
effects
Novel mechanism of action for
fibrosis treatment enabling a “first in
class” therapy
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Orphan drug status US FDA, allows for R&D tax credits,
new drug application fee waivers and a seven year
period of market exclusivity
Global market interest in fibrosis treatments
Recent transactions confirm that big pharma are actively acquiring fibrosis assets at
an early stage – typically based on Phase I results
Date
Company
Target
Acquired by
Deal value (US$)
Deal commentary
Sep-15
Adheron
Therapeutics
SDP051
Roche
$105M upfront, plus
$475M in milestones
SDP-51 at end of Phase I for IPF
Aug-15
Promedior
PRM-151
BMS
$150m upfront + $1.25B
Phase II IPF and myelofibrosis
Nov-14
Galecto
Biotech AB
TD139
BMS
$444M
Option to acquire at end of clinical
POC (no later than 60 days
following Ph 1b for IPF completion)
Aug-14
Intermune
Esbriet /
Pirfenidone
Roche
$8.3B
Approval in Europe / Japan, phase
III in the US
Jun-13
MicroDose
Therapeutx
MMI0100
Teva
Pharmaceuticals
$40M upfront
$125M milestones
MMI0100 was in pre-clinical
development
Mar-12
Stromedix
STX100
Biogen Idec
$75M upfront
$487.5M milestones
End of phase I for IPF
Jul-11
Amira / BMS
BMS-986020
BMS
$325M upfront
$150M milestones
End of phase I for IPF
Source: Medtrack Pharma Intelligence, Informa (all IPF deals since 2011)
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AD-114 broad application for treatment of
fibrosis
Wet-AMD
AMD is the leading cause of blindness in people over the age of 50 years in the
developed world, >1m in AU and 2m in USA
Despite anti-VEGF therapy (US$8 billion sales 2016), 30% of people don’t respond
and 50% of people loose vision after 3 years of treatment
Eye
Wet-AMD & PVR
AD-114 is able to significantly reduce fibrosis, leakage, lesion size and fibrosis
gene expression in a mouse model of wet-AMD
NASH
About 3-5% of adults in the USA have NASH
Sales of drugs for the treatment of fibrosis caused by NASH are estimated to be USA
$1.6 billion by 2020
Liver
NASH & CIRRHOSIS
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AD-114 significantly reduces hepatocellular ballooning and possess hepatoprotective and anti-NASH effects in a mouse model of NASH
AD-114 development: key milestones
CY2017
Q1
Q2
CY2018
Q3
Q4
Manufacturing
Toxicology studies
Q1
Q2
Partnering of lead
candidate
based on other
benchmark deals
Orphan designation
Phase I
Publication of data
Other fibrosis indications
BD and partnerships
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Recent achievements and near term milestones
Q3 & Q4 2016
H1 2017
ü
Commence manufacturing of material for toxicology testing with FujiFilm Diosynth
Biotechnologies
ü
Additional AD-114 IPF fibrosis data
ü
Completion of evaluation of AD-114 with IPF clinicians Alfred Hospital
ü
Completion of AD-114 NASH animal study
ü
Orphan Drug Designation (US FDA)
ü
Hypertrophic scarring animal results for AD-114
Manufactured material for toxicology testing available
H2 2017
Eye fibrosis additional data, funded by NHMRC development grant
Completion of other pre-clinical study animal models of AD-114
AD-114 toxicology results
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AdAlta business model – strategy to
create value
Pharma &
biotech
partnerships
i-body
technology
platform and
library
Revenues: Upfronts,
FTEs, milestones &
royalties
In-house
pipeline of
drug
candidates
Invest up to key
value inflection point
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i-bodies new
drug class
Licence to
pharma
Revenues: major
upfronts + milestones
& royalties
Potential in multiple
disease indications
Market benchmarks
Fibrosis
lead AD-114
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa asset
Nov-14 acquired by BMS
$444m
phase I asset
April-16 with Abbvie
$40m upfront + $645m
milestones & royalties
Dec -15 with Roche
$6.4m upfront + $410m
milestones & royalties
Nov-15 with Novo-Nordisk
€9m upfront + €182m
milestones & royalties)
Acquired by Celgene July-15
$8b Ph III, Ph II and GPCR
platform
April-16 with Boehringer
€8m payment for Ph1 GPCR
nanobody (€125m milestones
& royalties)
Next gen
antibodies
From: Heptares Therapeutics Ltd news@heptares.com
Subject: Sosei Acquires Heptares Therapeutics for up to USD 400 million
Date: 23 February 2015 8:00 pm
To: s.cobb@adalta.com.au
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View it in your browser.
GPCRs
Sosei Acquires Heptares Therapeutics for up to USD 400 million
Acquired Feb-15 by Sosei
$400m Phase Ib asset + 7 preclinical leads
Combination Creates a Leading Global Biopharmaceutical Company with a Major Drug Discovery and
Development Hub in the UK
Tokyo, Japan and London, UK – 23 February 2015: Sosei Group Corporation (the “Group” or “Sosei” - 4565,
Tokyo Stock Exchange MOTHERS index), a leading Japanese biopharmaceutical company with operations in
Japan and the UK, announces that it has acquired Heptares Therapeutics Limited (“Heptares”), a clinical-stage
private UK-based biotechnology company focused on creating novel medicines targeting G protein-coupled
receptors (“GPCRs”).
The combination will create a leading global biopharmaceutical group with:
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sustainable, proven and highly successful drug discovery and clinical development capabilities for
generating innovative medicines;
a broad and balanced pipeline with strong growth prospects, including products with blockbuster potential;
access to global pharmaceutical markets;
regulatory expertise across the EU, US and Japan; and
a significant cash balance.
These strengths will enable the Group to sustain its pipeline and revenue stream on a long-term basis. Heptares
will become a wholly owned subsidiary of the Group, with its existing R&D operations continuing in the UK.
Management and Board in place to
deliver strategy
Sam Cobb: Founding CEO and Director
Dr John Chiplin: Independent Director
Extensive experience in raising equity, contract and
grant funding
CEO of investment Company NewStar Ventures
15 years of commercialisation and
management experience
Dr Paul MacLeman: Chairman
Managing Director of a ASX listed IDT Australia
Ltd
Founded biologics companies, experienced ASX
listed executive
Liddy McCall & Dr James Williams:
Yuuwa Capital Directors
Founders and investment Directors of
Yuuwa Capital
Founders of iCeutica Inc (acquired 2011) and
Dimerix Limited
Dr Robert Peach
Directors of several Australian biotech and Agritech
companies
Founder and CSO of Receptos Inc, acquired by
Celgene Corporation in 2015 for US$7.8bn
Multiple FDA, CE Mark and TGA approvals
Deep experience in research and drug
development
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Managing Director of acquired antibody company
Arana Therapeutics
Scientific Advisory Board
Internationally recognised with proven track record of drug development
Dr Mick Foley, AdAlta CSO
Expert in phage display
John Westwick: pulmonary drug
discovery and development
NIH, NHMRC, ARC, Gates funding and over 70
scientific publications
Over 14 years experience at Novartis, head of
respiratory drug discovery
Five product launches and 13 positive proof of
concepts in respiratory, including a number of
antibodies which are now in phase III.
Brian Richardson: drug discovery
and development expert
David McGibney: pre-clinical and
clinical advisor
Ex-Sandoz and Novartis (40+ years), including
Head of Pre-clinical Research
20 years with Pfizer, including Head of
European R&D
Over 60 original peer reviewed research papers
Ex Pfizer Ltd board member
Developed Viagra, and 10+ blockbuster drugs
Steve Felstead: clinical advisor
Ex-Pfizer (25 years), including Head of Clinical
Research, Pharmatherapeutics Division
Developed Zithromax, Vfend, Celsentri, Viagra
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AdAlta investment summary
Powerful proprietary technology platform to develop a pipeline of i-bodies for the treatment
of a wide range of human diseases
Initial focus on treating Idiopathic Pulmonary Fibrosis and other fibrotic diseases - high
unmet clinical need
Advanced lead candidate with significant pre-clinical validation of AD-114 demonstrating
anti-fibrotic and anti-inflammatory effects
Early commercialisation opportunity
Experienced management and Board to drive AD-114 development and secure technology
platform partnerships and product licensing deals
IPO August 2016 raised $10M to meet major milestones: Phase I clinical trials of AD-114 in
lung fibrosis and development of i-body pipeline
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