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ADALTA LIMITED AGM Information 2016

Nov 13, 2016

64247_rns_2016-11-13_d1ae3262-090f-48e8-bed6-9764e8b669f9.pdf

AGM Information

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i-bodies – a new class of protein therapeutics to treat human disease

AGM November 2016 Sam Cobb, CEO and Managing Director AdAlta Limited (ASX:1AD) [email protected]

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

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A drug discovery and development company focused on using its proprietary technology platform to generate a 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

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Capital structure
ASX code 1AD
Shares on issue* 101,037,617
Shareprice(13November) AU$0.22
Market capitalisation AU$22m
Current cash $9m
TradingRange AU$0.31 to$0.18
  • 50.9m shares escrowed for 6-24 months from listing

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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
Early commercialisation potential
Experienced team with strong track record of drug
development and ability to deliver
Major Shareholders %
Yuuwa Capital LP 53.5
Platinum Asset Management 7.97
Citycastle PtyLtd 5.26
La Trobe University 3.01
Robin Beaumont 1.82
Other shareholders 28.44
Total 100%

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Recent updates

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Manufacturing AD-114

  • FujiFilm Diosynth Biotechnologies currently completing process development, formulation and manufacture of AdAlta’s lead i-body molecule AD-114

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Orphan Drug Designation

  • Additional pre-clinical data for AD-114 required by FDA

  • Allowing for a standard 120-day review and response time, AdAlta expects to receive a response from the FDA within Q2 2017

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Collaboration with XL Proteins

  • A long-acting form of AD-114 that has a significantly extended plasma half-life would allow less frequent administration and lower dosing, making it ideal for treating chronic indications such as IPF

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License to Crossbeta

  • License to three beta-amyloid oligomer (AßO)-specific shark antibodies

  • All ongoing research and development (R&D) as well as commercialisation will be managed by Crossbeta

  • AdAlta will receive royalties on future revenues from successful commercialization

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Financials

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The Company remains in a solid cash position with ~$10 million cash in the bank as at 30 September 2016

  • Closed IPO in August 2016, with oversubscribed offer, raising $10m to advance the lead i-body candidate AD-114 to the clinic for the treatment of IPF

  • Receipt of $738,208 R&D Tax Incentive and an Innovation Connections Grant

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This is sufficient to see the development of AD-114 into the clinic

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R&D expenditure for the September quarter was $482K, an increase of 25% from the previous quarter and will increase to $1,605K before the end of December 2016 due to the manufacturing of AD-114

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Operationally all other expenses remain similar to the previous quarter (excluding listing costs)

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AD-114 development: key milestones

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CY2016 CY2017 CY2018
Q4 Q1 Q2 Q3 Q4 Q1 Q2
Partnering of lead
Manufacturing AD-114
candidate
based on other
Toxicology studies benchmark deals
Orphan designation
Phase I
Publication of data
Other fibrosis indications
BD and partnerships
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Expected newsflow next 12 months

Q3 2016 ü Commence manufacturing of material for toxicology testing with FujiFilm Diosynth Biotechnologies

Q3 2016 Q3 2016 ü
Commence manufacturing of material for toxicology testing with FujiFilm Diosynth
Biotechnologies
ü
Commence manufacturing of material for toxicology testing with FujiFilm Diosynth
Biotechnologies
Q4 2016 Additional AD-114 IPF fibrosis data
Hypertrophic scarring animal results for AD-114
Completion of evaluation of AD-114 with IPF clinicians Alfred Hospital
Q4 2016 Additional AD-114 IPF fibrosis data
Hypertrophic scarring animal results for AD-114
Completion of evaluation of AD-114 with IPF clinicians Alfred Hospital
H1 2017 Orphan Drug Designation (US FDA)
Presentation at Biotech Showcase, San Francisco
Data available from AD-114 NASH animal studies
Manufactured material for toxicology testing available
H2 2017 H2 2017 Eye fibrosis additional data, funded by NHMRC development grant
Completion of other pre-clinical study animal models of AD-114
Initial Kidney/Heart data available for AD-114
AD-114 toxicology results

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AdAlta business model – strategy to create value

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Pharma &
biotech
partnerships
Revenues: Upfronts,
i-body FTEs, milestones & i-bodies new
royalties
technology drug class
platform and Potential in multiple
In-house disease indications
library Licence to
pipeline of
pharma
drug
Revenues: major
candidates upfronts + milestones
& royalties
Invest up to key
value inflection point
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Market benchmarks

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)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa 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)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa 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)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa 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)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa 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)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa 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)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa asset
Nov-14 acquired by BMS
$444m
phase I asset
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)
GPCRs Acquired Feb-15 by So
$400m Phase Ib asset + 7
clinical leads

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Management and Board in place to deliver strategy

Sam Cobb: Founding CEO and Director

Dr John Chiplin: Independent Director

Managing Director of acquired antibody company Arana Therapeutics

Extensive experience in raising equity and commercialisation of technology

Liddy McCall & Dr James Williams : Yuuwa Capital Directors

Dr Mick Foley: Founding CSO

Expert in phage display for screening of the i-body library

Founders and investment Directors of Yuuwa Capital

Founders of iCeutica Inc (acquired 2011) and Dimerix Limited

Dr Paul MacLeman: Chairman

Managing Director of a ASX listed IDT Australia Ltd

Directors of several Australian biotech and Agritech companies Multiple FDA, CE Mark and TGA approvals

Founded biologics companies, experienced ASX listed executive

Internationally recognised SAB with proven track record of drug development

David McGibney: pre-clinical and clinical advisor

20 years with Pfizer, including Head of European R&D, developed 10+ blockbuster drugs

Brian Richardson: drug discovery and development expert

Ex-Sandoz and Novartis (40+ years), including Head of Pre-clinical Research

John Westwick: pulmonary drug discovery and development

Over 14 years experience at Novartis, head of respiratory drug discovery, with five product launches and 13 products currently in the clinic

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AdAlta investment summary

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Powerful proprietary technology platform to develop a pipeline of i-bodies for the treatment of a wide range of human diseases

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Initial focus on treating Idiopathic Pulmonary Fibrosis and other fibrotic diseases - high unmet clinical need

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Advanced lead candidate with significant pre-clinical validation of AD-114 demonstrating anti-fibrotic and anti-inflammatory effects

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Early commercialisation opportunity

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Experienced management and Board to drive AD-114 development and secure technology platform partnerships and product licensing deals

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IPO August 2016 raised $10M to meet major milestones: clinical trials of AD-114 in fibrosis and development of i-body pipeline

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