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ADALTA LIMITED — AGM Information 2017
Nov 13, 2017
64247_rns_2017-11-13_43f60be6-4c73-4b23-b395-9cd3e6f1bf4a.pdf
AGM Information
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i-bodies – a new class of protein therapeutics to treat human disease
AGM November 2017 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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ADALTA 2017 AGM AGENDA
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Chairman introduction AGM formal proceedings CEO presentation
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Corporate and investment summary
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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.
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Investment highlights
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- Initial focus on treating fibrosis – high unmet medical need
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- Advanced lead fibrosis drug candidate AD-114 with significant pre-clinical validation
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- Fully funded for phase 1 development of lead fibrosis drug and i-body pipeline
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- Orphan drug designation USA FDA
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- Early commercialisation potential
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- Experienced team with strong track record of drug development and ability to deliver
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Financial position
| Key Financial Details | ||
|---|---|---|
| ASX code | 1AD | |
| Share price (10 November 2017) | AU$0.20 | |
| Market capitalisation | AU$20.3m | |
| Shares on issue* | 101,257,434 | |
| Escrowed shares (August 2018) | 24,000,000 | |
| Options on issue | 969,427 | |
| Current cash (30 September 17) | AU$6.87m | |
| Trading range (since listing) | AU$0.325 to $0.165 | |
| Average daily volume | 12,311 | |
| Major Shareholders | % | |
| Yuuwa Capital LP | 53.39 | |
| Platinum Asset Management | 8.05 | |
| Citycastle Pty Ltd | 5.25 | |
| La Trobe University | 3.00 | |
| National Nominees Limited | 2.14 | |
| Other shareholders | 28.17 | |
| Total | 100% |
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AD-114 efficacy and safety
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Safety
Efficacy
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NHP studies:
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Lung: IPF
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PK: IV and SC
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Animal models
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Dose range finder
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Human IPF tissue
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Multi dosing studies
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Biomarker assessments (Alfred Health & others)
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PK-PD assays developed demonstrating target engagement
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Broad fibrotic application with demonstration in other animal models and human tissues
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Cytokine analysis (20 human blood donors)
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Eye: wet-AMD
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Liver: NASH
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Kidney: CKD
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Skin: HT Scarring
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Achievements over last 12 months
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Manufacturing agreement of AD-114 kicked off with Fuji
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Innovation Connection Grant with Alfred Health; a collaboration with local IPF clinicians to evaluate AD-114 as a biomarker
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Presented at a number of international conferences including Discovery on Target, Bio Europe, Biotech Showcase (JPMorgan), ARVO, Bioshares, IPF Summit Strengthened Board and SAB
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Orphan Drug Designation IPF USA FDA
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XL protein collaboration for half life extension technology for AD-114 Crossbeta license deal of shark antibody for Alzheimer's treatment SIEF Grant for i-body pipeline development
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Fibrosis Symposium February 2017 bringing clinicians and investors together
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Some of our FY17 media and analyst coverage
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“Patersons readies ASX-hopeful, AdAlta”
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“AdAlta hopes to take a bite out of fibrosis market with shark-based drug”
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“Breakthrough for local biotech as influential backer emerges”
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“I-bodies continue to make progress”
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“AdAlta on track for fibrosis treatment”
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“‘Shark antibody’ biotech AdAlta seeks $7.5M IPO for fibrosis candidate”
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“AdAlta presenting data on therapy candidate, AD-114 at inaugural IPF summit”
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“Investigational IPF Drug Inspired by Shark Antibodies”
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“Ticking the right boxes on the way to the clinic”
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“2017 Fibrosis Symposium”
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Initiatives that drove awareness and engagement
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Fibrosis Symposium in February 2017 was well attended by investors and analysts, with follow up investor/analyst reports from Partersons, NDF Research and Bioshares
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Integrated campaigns for IPF awareness month across AdAlta’s social channels (Twitter and LinkedIn) drove additional engagement around AD-114 and IPF
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New visitors to AdAlta website grew consistently throughout the period and LinkedIn channel grew significantly as driver of traffic to www.adalta.com.au
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Financial operating results
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The Company reported a loss for the year ended 30 June 2017, after accounting for
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income tax benefit, of ($2,832,517) (30 June 2016: ($1,163,056)).
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The Company remains in a solid cash position with ~$6.87 million cash in the bank as at
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30 September 2017
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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
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Receipt of $ 1,777,030 R&D Tax Incentive 2017 ($738,208 2016), two Innovation Connections Grants for $100K, SIEF Grant $210K
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Cost of services expense of $3,598,678 (30 June 2016: $1,413,975)
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Employment benefit expense of $404,669 (30 June 2016: $224,620)
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The Company is in a strong and stable financial position to take AD-114 through to the end of Phase 1 trials in IPF
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Management and Board in place to deliver strategy
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Sam Cobb: Founding CEO and Director
Extensive experience in raising equity, contract and grant funding
15 years of commercialisation and management experience
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Dr John Chiplin: Independent Director
CEO of investment Company NewStar Ventures
Managing Director of acquired antibody company Arana Therapeutics (acquired by Cephalon Inc. for US$200 million)
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Dr Paul MacLeman: Chairman
Director of CMAX Clinical Research Pty Ltd and Protec Groupe
Founded biologics companies, experienced ASX listed executive
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Liddy McCall & Dr James Williams : Yuuwa Capital Directors
Founders and investment Directors of Yuuwa Capital
Founders of iCeutica Inc (acquired 2011) and Dimerix Limited
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Dr Robert Peach
Founder and CSO of Receptos Inc, acquired by Celgene Corporation in 2015 for US$7.8bn
Deep experience in research and drug development
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Directors of several Australian biotech and Agritech companies
Multiple FDA, CE Mark and TGA approvals
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Scientific Advisory Board
Internationally recognised with proven track record of drug development
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Dr Mick Foley, AdAlta CSO
Expert in phage display
NIH, NHMRC, ARC, Gates funding and over 70 scientific publications
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John Westwick: pulmonary drug discovery and development
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.
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Brian Richardson: drug discovery and development expert
Ex-Sandoz and Novartis (40+ years), including Head of Pre-clinical Research
Over 60 original peer reviewed research papers
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David McGibney: pre-clinical and clinical advisor
20 years with Pfizer, including Head of European R&D
Ex Pfizer Ltd board member
Developed Viagra, and 10+ blockbuster drugs
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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 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 &
Invest up to key
royalties
value inflection point
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Market benchmarks
| April-16 with Abbvie $40m upfront + $645m milestones & royalties May -17 with AZ $58m upfront + $2.1b milestones & royalties July-17 with Sanofi €31m upfront + €2.4b 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 May -17 with AZ $58m upfront + $2.1b milestones & royalties July-17 with Sanofi €31m upfront + €2.4b 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 May -17 with AZ $58m upfront + $2.1b milestones & royalties July-17 with Sanofi €31m upfront + €2.4b 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 May -17 with AZ $58m upfront + $2.1b milestones & royalties July-17 with Sanofi €31m upfront + €2.4b 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 May -17 with AZ $58m upfront + $2.1b milestones & royalties July-17 with Sanofi €31m upfront + €2.4b 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 May -17 with AZ $58m upfront + $2.1b milestones & royalties July-17 with Sanofi €31m upfront + €2.4b 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 |
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| GPCRs | Acquired Feb-15 by Sos $400m Phase Ib asset + 7 clinical leads |
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IPF Phase II readouts generate $1.4billion market value
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(NASDAQ:FGEN)
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$869 million added to its market cap on announcement (7 August 2017) of meeting primary endpoint in Phase IIb study Pamrevlumab (FG-3019) 103 patients 48 weeks
(Euronext:GLPG; NASDAQ:GLPG)
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$555 million added to market cap on announcement (9
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August 2017) exploratory Phase IIa data
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FLORA trial had 23 IPF patients:17 drug, 6 placebo for 12 weeks
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AD-114 development: key milestones
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FY2018 FY2019
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Partnering of lead
Manufacturing
candidate
based on other
Toxicology
studies benchmark deals
Phase I
Publication of data
BD and partnerships
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Expected newsflow next 12 months
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H1 2017 ü Orphan Drug Designation (US FDA)
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ü Presentation at partnering meetings including Biotech Showcase 2017, San Francisco ü Data available from AD-114 NASH animal studies
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ü Manufactured material for toxicology testing available
| H2 | 2017 | ü | Strengthened eye fibrosis, funded by NHMRC Development Grant with Melbourne University, |
|---|---|---|---|
| and lung data, funded by Innovation Connection Grant with Alfred Health | |||
| ü | Completion of additional pre-clinical animal models in diseased of the lung, kidney, skin; | ||
| strengthening broad anti-fibrotic data package of AD-114 | |||
| ü | AD-114 pharmacokinetics (half life) and toxicology results in 3 non-human primate studies | ||
| ü | Presentation of AD-114 data at multiple fibrosis conferences | ||
| H1 | 2018 | Update on manufacturing | |
| 4 week NHP toxicology study | |||
| Publication of lung data and other key data with AD-114 | |||
| H2 | 2018 | Phase I study with AD-114 |
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AdAlta summary
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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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Initial focus on treating Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases - high unmet clinical need
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AD-114 has significant pre-clinical validation demonstrating broad anti-fibrotic and antiinflammatory effects as well as safety
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AD-114 orphan drug designation with FDA for treatment of IPF
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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
Early commercialisation opportunity, with experienced management and Board to drive AD-114 development and secure technology platform partnerships / product licensing deals
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