Adalta Ltd. · ASX:1AD
Adalta — Investor Presentation (January 2019)
123 slides from Adalta's investor presentation, Jan 31, 2019
Slide 1: ASX Release: AdAlta investor and analyst briefing presentation material
ASX Release AdAlta investor and analyst briefing presentation material For personal use only MELBOURNE Australia, 31 January 2019: AdAlta Limited (ASX: 1AD), the biotechnology company advancing its lead i-body candidate towards clinical development, is pleased to release material to be presented in
Slide 2: ASX release speakers and topics (continued)
• Glen Westall, IPF Clinician, Alfred Health o An IPF clinician’s perspective: Glen will provide an overview of what IPF is, how it is treated and an update on his recent findings as a clinician. For personal use only • Bill Van Nierop, IPF patient o An IPF patient’s perspective: Bill will discuss w
Slide 3: Notes to editors
Notes to editors 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, For personal use only with applications as therapeutic drugs to t
Slide 4: Analyst and investor briefing: The pathway to the clinic
For personal use only Analyst and investor briefing The pathway to the clinic January 2019 ASX: 1AD
Slide 5: Analyst & Investor Briefing
Analyst & Investor Briefing For personal use only AdAlta’s 2019 Special Investor/Analyst Briefing will focus on the drug development process and getting to the clinic. Hugh MacNally will kick off the day with an overview of what it takes to invest in Biotech. Manufacturing of antibodies is a major h
Slide 6: Analyst & Investor Briefing
Analyst & Investor Briefing For personal use only Idiopathic Pulmonary Fibrosis (IPF) represents a large unmet clinical need globally – No current clinically satisfactory approach to treatment. – IPF landscape is evolving with a number of Phase II clinical trials completed in the last 12 months. – W
Slide 7: Agenda
or email: e.fietz@adalta.com.au 00am Arrival and registration pecial Investor/ 30am genda Investing in Biotech, what does it take? Agenda Hugh MacNally, Chairman and Founder of Private Portfolio Managers Hugh MacNally is Chair and the founder of PPM. He has been the CIO since the company was founded
Slide 8: Agenda
ursday 31 January 2019, Melbourne I N V I TAT I O N Agenda 0:30am The IPF landscape PANEL What doesAdvisorya good drug look like? For personal use only Dr Steve Felstead, Clinician and Member of Scientific Board Steve retired from the position of Vice President, Head of Clinical Research, Pharmather
Slide 9: Investing in Biotech, what does it take?
For personal use only Investing in Biotech, what does it take? Hugh McNally Private Portfolio Managers
Slide 10: Hugh MacNally and speaker agenda
00am Arrival and registration 30am Investing in Biotech, what does it take? Hugh MacNally, Chairman and Founder of Private Portfolio Managers Hugh MacNally is Chair and the founder of PPM. He has been the CIO since the company was founded in 1995 and Hugh MacNally is responsible for management of bo
Slide 11: Therapeutic Fc Fusion Proteins
For personal use only Therapeutic Fc Fusion Proteins Robert Peach AdAlta Non-Executive Director
Slide 12: Robert Peach
Robert Peach For personal use only Dr Peach has over 25 years of drug discovery and development experience in the pharmaceutical and biotechnology industry. In 2009 he co-founded Receptos, becoming Chief Scientific Officer and raising US$59M in venture capital and US$800M in an IPO and three subsequ
Slide 13: Presentation overview
PRESENTATION OVERVIEW For personal use only What is an Fc Fusion protein? Why utilize the Fc construct as a therapeutic modality? – Extend circulatory half-life – Dial in/out effector functions – Ease of manufacture Personal experience with Fc Fusion proteins – Abatacept, Belatacept Marketed therape
Slide 14: Typical IgG Antibody Structure
Typical IgG Antibody Structure For personal use only 11
Slide 15: What is an Fc Fusion Protein?
What is an Fc Fusion Protein? For personal use only 12
Slide 16: Fc Fusion Protein Structure and Function
Fc Fusion Protein Structure and Function For personal use only 13
Slide 17: AdAlta's lead i-body AD-214 is an Fc-Fusion Protein
AdAlta’s lead i-body AD-214 is an Fc-Fusion Protein For personal use only AD-214 is a superior drug candidate 14
Slide 18: Binding to FcRn Extends Half-life
Binding to FcRn Extends Half-life For personal use only The neonatal Fc receptor for IgG (FcRn) is expressed by endothelial cells and circulating monocytes. These cells internalize serum IgG, which binds to FcRn in an acidic endosomal compartment. FcRn hen recycles IgG back into circulation, thus ex
Slide 19: Fc Region Effector Functions
Fc Region Effector Functions For personal use only 16
Slide 20: T Lymphocyte Activation
T Lymphocyte Activation For personal use only 17
Slide 21: CTLA4Ig: An Fc Fusion Protein Construct
CTLA4Ig: An Fc Fusion Protein Construct For personal use only 18
Slide 22: CTLA4Ig: A Therapeutic Fc Fusion Protein
CTLA4Ig: A Therapeutic Fc Fusion Protein For personal use only Also called Abatacept and marketed as Orencia – T1/2 ~14 days in humans (5-7 days in monkeys) Indicated to treat: – Moderate to severe rheumatoid arthritis • USA 2005; Europe 2007 – Juvenile idiopathic arthritis • USA 2008, Europe 2010 2
Slide 23: Ongoing Orencia Clinical Studies
Ongoing Orencia Clinical Studies For personal use only – Relapsing-remitting multiple sclerosis – Scleroderma – Ulcerative colitis, Crohn’s disease – Polymyositis, Dermatomyositis – SLE, lupus nephritis – ANCA-associated vasculitis – Uveitis – Type 1 diabetes mellitus – Psoriatic arthritis – Ankylos
Slide 24: LEA29Y
For personal use only 21 LEA29Y L104 A29
Slide 25: Primate Allogeneic Renal Transplantation
Primate Allogeneic Renal Transplantation For personal use only CTLA4Ig LEA29Y MMF/Pred LEA29Y/MMF/Pred Anti-IL2R LEA29Y/Anti-IL2R 22
Slide 26: LEA29Y (Nulojix): A Therapeutic Fc Fusion Protein
LEA29Y (Nulojix): A Therapeutic Fc Fusion Protein For personal use only Indicated to treat adult patients receiving kidney transplants – USA and Europe, 2011 T1/2 ~8-10 days in humans (5.6-9 days in monkeys) 23
Slide 27: 2017 Sales of Marketed Fc Fusion Proteins
2017 Sales of Marketed Fc Fusion Proteins For personal use only Enbrel Orencia Arcalyst (TNFRII), 1998, Amevive (CTLA-4), 2005, (IL-1R/accessory rheumatoid arthritis (LFA-3), 2003, plaque rheumatoid arthritis protein), 2008, plaque psoriasis $8.25B $2.6B psoriasis Nplate Eylea Nulojix Zaltrap (TPO p
Slide 28: Manufacturing of AD-214
For personal use only Manufacturing of AD-214 January 2019 Dallas Hartman AdAlta Chief Operating Officer 25
Slide 29: Dallas Hartman
Dallas Hartman For personal use only Over 15 years experience in the biotechnology industry Previously Vice President of Product Development at Nexvet where he was responsible for scalable bioprocess development, formulation, stability, analytical characterisation and cell line development Worked at
Slide 30: Disclaimer
Disclaimer For personal use only 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 in
Slide 31: Why is manufacturing so important?
Why is manufacturing so important? Regulatory For personal use only – Materials that are going to be given to humans as potential treatments need to meet certain standards set by government regulatory agencies – The process for manufacturing biologics defines the final product – The pathway for the
Slide 32: Manufacturing biologics
Manufacturing biologics Small Molecules Biologics For personal use only Produced by chemical synthesis Produced by living host cells Low molecular weight High molecular weight Single molecular entity Heterogeneous mix of similar molecules Well defined modifications Many modifications possible Stable
Slide 33: What is an Fc-Fusion?
What is an Fc-Fusion? For personal use only AdAlta’s lead i-body AD-214 is an Fc-Fusion AD-214 is a superior drug candidate 30
Slide 34: Developing AD-214 manufacturing process
Developing AD-214 manufacturing process For personal use only Cell Line Cell Line Purification Formulation Development Expression Process Parameters such The components Several techniques as pH, oxygen, that make up the DNA is are evaluated to temperature, AD-214 introduced into determine the best p
Slide 35: Why Selexis?
Why Selexis? R&D & Clinical Pipeline Based on the SUREtechnologyTM Platform For personal use only 32
Slide 36: Why KBI?
Why KBI? Mammalian Process Development: >90 Projects For personal use only Product Type mAb* Bispecific AB Vaccine Glycoprotein FC-Fusion, Fusion Protein PEGylated Enzyme/Protein Recombinant Protein Growth factor Enzyme Recombinant Enzyme 0 10 20 30 40 50 60 * 9 biosimilars 50+ programs & 12 client
Slide 37: Selexis & KBI together
Selexis & KBI together KBI has performed Process and Analytical Development using over 20 For personal use only Selexis cell lines Type of Clone Titer Range Project Molecule stage (g/L) A mAb Final clone 4.5 - 8.5* B Bispecific mAb Final clone 3.5 - 4.5 C Fusion protein Lead clones 2.2 - 2.8 D Bispe
Slide 38: What is a clone?
Cell+DNA =Clone =Clone Cell+DNA What What What isclone? is a a isclone? a clone? What is a clone? What What What is a isclone? is a clone? a clone? Select Select cells cells with with AD-214 AD-214 DNA DNA Separate Separate individual indiv Ce AD-214 AD-214 AD-214Host cellHost Clones Clones and cell
Slide 39: Cell line development (Selexis)
Cell line development (Selexis) For personal use only Selexis completed the following cell line development activities: – Generated research cell banks (RCB) for the four lead AD-214 clones – Confirmed sequences of all lead clones – Determined copy number for all lead clones – Demonstrated monoclona
Slide 40: Cell line expression (KBI)
Cell line expression (KBI) Performed for clone selection and process optimization For personal use only Process optimization focused on product levels and quality Small-scale bioreactor Process optimization performed in scalable mini bioreactors Examine nutrient, media feed strategies, temperature s
Slide 41: Product purification (KBI)
Product purification (KBI) Cell culture media contains the product plus contaminants that need to be For personal use only removed Product is purified by chromatography Add cell culture media which includes i- body AD-214, host cell proteins and other contaminants Collect purified i- body AD-214 A s
Slide 42: Product formulation (KBI)
Product formulation (KBI) For personal use only Proteins can be very sensitive to their environment AD-214 need to be in a solution that keeps it stable and active over long periods of time Screen different additives (excipients) to determine most appropriate formulation solution Early screening of
Slide 43: AD-214 manufacturing progress
AD-214 manufacturing progress For personal use only Cell Line Cell Line Purification Formulation Development Expression Process Commenced Commenced Commenced Commenced June 2018 October 2018 November 2018 December 2018 Final cell line Expected Expected Expected selected by completion completion comp
Slide 44: Manufacturing Milestones
Manufacturing Milestones For personal use only Milestone Expected Date Cell line development February 2019 ✓ Optimisation of process March 2019 development and formulation AD-214 material available for June 2019 toxicity studies AD-214 material available for December 2019 Phase I clinical study 41
Slide 45: AD-214 development: key milestones
AD-214 development: key milestones For personal use only 2019 2020 Q1 Q2 Q3 Q4 Q1 Q2 Manufacturing Dosing and Toxicology PK studies studies Phase I Publication of data Development of i-body pipeline BD and partnerships 42
Slide 46: AD-214 manufacturing summary
AD-214 manufacturing summary For personal use only AD-214 has significant pre-clinical validation demonstrating broad anti-fibrotic and anti-inflammatory effects as well as safety Cell line development results are now ahead of expectations at 3 grams per litre (3g/L), up from the 1g/L reported in Oc
Slide 47: Pulmonary fibrosis: current state of play in IPF
For personal use only Pulmonary fibrosis – current state of play in Idiopathic Pulmonary Fibrosis A/Prof Glen Westall Lung Fibrosis Service, Alfred Hospital NHMRC Centre of Research Excellence: Lung Fibrosis
Slide 48: Glen Westall
Glen Westall For personal use only Completed undergraduate medical training at King’s College Medical School in London, UK, before Training in general and respiratory medicine at the Royal Brompton Hospital in London and the Alfred Hospital in Melbourne. Clinical interests include advanced lung dise
Slide 49: Lung fibrosis
• o Lungs • o Lungs become stiffbecome stiff • o Lungs Lung • o Lungs shrink Fibrosis shrink in size in size For personal use only Scaring of the Lung Lungs become stiff Lungs shrink in size Normal CXR Normal CXR Lung Fibrosis Lu 46
Slide 50: Interstitial lung disease classification
Interstitial lung disease (ILD) classification Interstitial lung disease classification For personal use only Interstitial lung disease Diseases of Idiopathic Granulomatous known cause interstitial lung diseases Other pneumonias Multiple subtypes – over 200 types of disorder in total! 47
Slide 51: Idiopathic Pulmonary Fibrosis (IPF)
diopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF) For personal use only Represents 50% of all Fibrotic Lung Conditions Male:Female 1.5:1 Age of Presentation 66 yrs Smoking history 70% Australian IPF Cases 5000-10,000 Diagnosed by MDT Meeting 48
Slide 52: Lungs deteriorate over time
Lungs deteriorate over time For personal use only 100% 80% 60% Lung Function 40% 20% Age (yrs) 49
Slide 53: IPF Diagnosis: Multi-Disciplinary Team meeting
IPF Diagnosis: Multi-Disciplinary Team (MDT) meeting For personal use only • Communication between clinician, radiologist and when appropriate pathologist • Clinical data • Presentation, Exposures, Smoking status, Associated disease, Lung function and Radiologic findings 50
Slide 54: Traditional Therapy for IPF: historical view
Traditional Therapy for IPF: historical view Historical View For personal use only • Uncontrolled Chronic Inflammation • Corticosteroids • Cyclophosphamide • Azathioprine • N-acetylcysteine (NAC) 51
Slide 55: 2011 Evidence Based Guidelines: Treatment recommendations
2011 Evidence Based Guidelines: Treatment recommendations For personal use only Agent For Against Corticosteroids Strong + Colchicine Strong + Cyclosporine A Strong + Corticosteroid and imm-mod Strong ++ Interferon gamma Strong ++++ Bosentan Strong +++ Etanercept Strong +++ NAC, predisolone, Weak ++
Slide 56: 2011 Evidence Based Guidelines: Treatment recommendations
2011 Evidence Based Guidelines: Treatment recommendations For personal use only Agent Agent For For Against Against Corticosteroids Corticosteroids Strong++ Strong Colchicine Colchicine Strong++ Strong CyclosporineAA Cyclosporine Strong++ Strong Corticosteroidand Corticosteroid andimm-mod imm-mod St
Slide 57: 2014: A big year for lung fibrosis (pirfenidone)
2014: A big year for lung fibrosis! NEJM 2014; 370: 2083 For personal use only Pirfenidone approved by FDA Reduction in mortality and decreased FVC Adverse Events Adverse Events 47% reduction in proportion of patients with a decline in FVC Pooled data: Ascend & Capacity studies All cause mortality Ð
Slide 58: 2014: A big year for lung fibrosis (nintedanib)
Intracellular inhibitor of multiple tyrosine kinases 2014: A big year for lung fibrosis! For personal use only Nintedanib approved by FDA Reduction in mortality and decreased FVC Adverse Events Adverse Events Intracellular inhibitor of multiple tyrosine NB: Not curative kinases Study drug 2° end-poi
Slide 59: Treatment era for IPF
Treatment era for IPF For personal use only Anti-fibrotics approved in 2014 by FDA Change in FVC does not equate to improved quality of life (QOL) or survival No IPF studies will be powered to show survival advantage QOL important as 61.5% develop diarrhoea with Nintedanib and 36% develop nausea wit
Slide 60: Clinical Trials in IPF in the Posttreatment Era
Clinical Trials in Idiopathic Pulmonary Fibrosis in the “Posttreatment Era” Kevin F. Gibson, MD: Daniel 1 Kass, MD ‘The “treatment era” for idiopathic pulmonary fibrosis (IPF) in the United States and other countries was inaugurated in November 2014 following the Food and Drug Administra- tion's (FD
Slide 61: Clinically meaningful endpoints
• Survival • Hospitalisation For personal use only • (acute exacerbation) • (functional status – 6MWT) AJRCCM 2012 Clinical meaningful endpoints – reflect how a patient feels, functions or survives 58
Slide 62: Unmet clinical need: drugs in development
Dysregulated repair following epithelial injury Unmet clinical need: drugs in development Current drugs have limited efficacy and For personal use only substantial side effects Other anti-fibrotic and anti-angiogenic agents currently in development with multiple targets – Inhaled Pirfenidone – WNT s
Slide 63: Clinical trials
For personal use only 60 Clinical trials
Slide 64: Drug Discovery and translational research
Drug Discovery and translational research Translational Research For personal use only In-vitro science Animal model Clinical Trials Human IPF Tissue Assessment of human IPF tissue provides additional evidence of efficacy prior to clinical trials 61
Slide 65: Alfred Tissue Bank
• Alfred Tissue Bank National Resource For personal use only • Collaborations Alfred Lung(Academic & Commercial Tissue Bank entity) National resource • Creation of pilot Resource Collaborations • National data (Academic and Commercial entity) Creation of pilot data • Collaborations (Academic & Comme
Slide 66: CXCR4 Role in IPF
CXCR4: CXCR4 Role in IPFRole in IPF For personal use only Very limited expression in normal or non- diseased tissues Normal lung histology CXCR4 is upregulated in IPF tissue 63
Slide 67: CXCR4 abundantly expressed in IPF and ILD lung tissue
CXCR4 abundantly expressed in both IPF and ILD patient lung tissue For personal use only Lung tissue was sampled from lung apex (∆) and lung bases (•) of patients with IPF, ILD and donors with no lung disease (NDC) and stained immunohistochemically for CXCR4 expression CXCR4 was abundantly expressed
Slide 68: CXCR4 expressed in honeycomb cysts, vessels and distal airways
CXCR4 is expressed in honeycomb cysts, vessels and distal airways For personal use only CXCR4 expressed in distal airways, Normal lung tissue IPF lung tissue small vessels and honeycombing Immunostaining of serial sections of lung tissue for CXCR4 and SDF-1 demonstrated heterogeneity in the expressi
Slide 69: Summary
Summary • Lung Fibrosis: For personal use only • Increasing understanding of the pathophysiology • Treatments (albeit limited) • Many Lung Fibrosis services/clinics Need better therapies for a terminal disease!! 66
Slide 70: The IPF Landscape
For personal use only The IPF Landscape Dr Steve Felstead Clinician and Member of AdAlta Scientific Advisory Board
Slide 71: Steve Felstead
0:30am The IPF landscape Dr Steve Felstead, Clinician and Member of Scientific Advisory Board Steve retired from the position of Vice President, Head of Clinical Research, Pharmatherapeutics Division, Pfizer Inc in Steve Felstead April 2014. He joined Pfizer in 1989, having qualified in Medicine at
Slide 72: Current Targeted Pharmacotherapy for IPF
Current Targeted Pharmacotherapy for IPF For personal use only Pirfenidone (Esbriet) • US Approval October 15th 2014 – previous rejection in 2010 (albeit positive advisory committee vote) with FDA requiring an additional study. • Sales 1st 9 months of 2018 CHF739MM approximately same in US$ • 16% in
Slide 73: Pirfenidone Background
Pirfenidone Background For personal use only Long regulatory history, approval in Japan and then EU, pre-dating US approval. Three efficacy studies were eventually required for FDA. The mechanism of action of pirfenidone is described as unknown in the Package Insert (PI). Publications suggest that t
Slide 74: Pirfenidone Efficacy
Pirfenidone Efficacy Placebo Nintedanib % of patients Patients had confirmed IPF by HRCT, and had For personal use only FVC (lung capacity) measurements >50% of predicted but less than 90%. (Note NICE have supported the use of pirfenidone in IPF patients with FVC 50%-80% predicted, treatment may con
Slide 75: Pirfenidone Safety
Pirfenidone Safety Key safety issues identified are: For personal use only – Drug Induced Liver Injury – Hy’s law cases noted within the program, but no deaths or liver transplants reported • Liver function test monitoring is recommended monthly for 6 months then 3 monthly. Dose suspension or discon
Slide 76: Nintedanib Background
Nintedanib Background For personal use only Nintedanib had a conventional development pathway. A dose response study over 52 weeks to determine optimal dose (and provide supportive efficacy data) followed by 2 Phase 3 studies. The mechanism of action is known – a multiple receptor tyrosine kinase in
Slide 77: Nintedanib Efficacy
Nintedanib Efficacy Efficacy based upon a Phase 2 dose ranging, Placebo For personal use only Nintedanib % of patients followed by 2 phase 3 studies. Studies enrolled patients with FVC > 50% predicted in much the same way as pirfenidone. (Note that NICE recommends the use of nintedanib for the same
Slide 78: Nintedanib Safety
Nintedanib Safety For personal use only Key safety issues identified are: – Liver related adverse events. Elevated ALT/AST were seen in 3-4% of patients, but no Hy’s law cases were defined. • Liver function test monitoring is required monthly for 3 months and then 3 monthly. • Note: drug-induced liv
Slide 79: Combination Therapy?
Combination Therapy? INJOURNEY Phase 4 trial compared nintedanib + For personal use only pirfenidone vs nintedanib alone in 104 patients over 12 weeks. Described as a safety and PK trial. Open label, no formal statistical analysis of efficacy. – Primary endpoint GI toleration over 8 weeks. + – Combi
Slide 80: What's next?
What’s next? Pamrevlumab PRM-151 GLPG-1690 PBI-4050 KD025 For personal use only Molecule Recombinant Monoclonal Antibody Small molecule to Small Molecule to Small molecule to Type Protein, Serum to CTGF Autotaxin CTGF ROCK2 Amyloid A Phase II 103 patients 116 patients 23 patients 41 patients 39 pati
Slide 81: Conclusions
Conclusions 1 For personal use only Landmark decade for treatments for IPF, approval of pirfenidone and nintedanib Definite effects on FVC and other lung function biomarkers maybe a trend to improved mortality Can/should we use in combination? – as yet unknown Neither are optimal therapies, the dise
Slide 82: Conclusions
Conclusions 2 The approval of nintedanib and pirfenidone has led to greater confidence in the For personal use only development of drugs for IPF The Phase 3 pathway and database is reasonably established (2 studies FVC based 52 weeks, 600 on drug) Phase 2 pathway more varied, but dose response work
Slide 83: An IPF patient's perspective
For personal use only An IPF patient’s perspective Bill Van Nierop IPF patient and advocate
Slide 84: Bill Van Nierop
in Melbourne. His clinical interests include advanced lung disease including Idiopathic Pulmonary Disease (IPF), bronchoscopy and lung transplantation. He is physician-incharge of the Paediatric Lung Transplant program at the Alfred. 10am An IPF patient’s perspective Bill Van Nierop, IPF patient Bil
Slide 85: When you can't breathe, nothing else matters
For personal use only WHEN YOU CAN’T BREATHE, NOTHING ELSE MATTERS.
Slide 86: Today
For personal use only Today IPF- Diagnosis that changed my life Early days - A ‘Private Strategy’ Living with IPF Why do what I do? The future 83
Slide 87: For personal use only
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Slide 88: For personal use only
For personal use only 85
Slide 89: For personal use only
For personal use only 86
Slide 90: Long Kayak for Lungs
Lung bo l* LONG KAYAK @)) Foundation —Km>=1 NGS Australia 7 ING. when you can't breathe... nothing else matters”
Slide 91: Long Kayak for Lungs
Lung bo LONG KAYAK Foundation ear By UNG@< etic =e) ELUI IGS when you can't breathe... nothing else matters”
Slide 92: For personal use only
For personal use only 89
Slide 93: The Long Kayak for Lungs
L 5—7HE LONG KAYAK dd Foundation Kk sLUNGS Australia when you can't breathe... nothing else matters”
Slide 94: The Long Kayak for Lungs
4\ Lung S—THE_LONG KAYAK Foundation Ss V YV Australia when you can’t breathe... nothing else matters®
Slide 95: Albury, NSW
ALBURY, NSW _ INSPIRATIONAL STORMfor _PADDLING FOR A CAUSE
Slide 96: For personal use only
For personal use only 93
Slide 97: Live your Life
For personal use only Live your Life Remember, when it gets a bit tough: “Don’t wait for the storm to pass, learn to dance in the rain” 94
Slide 98: I have IPF - I'm up for the fight!
For personal use only I have IPF- I’m up for the fight! Bill Van Nierop My Journey with IPF 95
Slide 99: Panel Discussion: What does a good drug look like?
For personal use only Panel Discussion: What does a good drug look like? Dr Steve Felstead Dr Brian Richardson Dr John Westwick Dr Robert Peach
Slide 100: Panel members
10:30am The IPF landscape Dr Steve Felstead, Clinician and Member of Scientific Advisory Steve retired from the position of Vice President, Head of Clinical Resea April 2014. He joined Pfizer in 1989, having qualified in Medicine at L appointed Head of Clinical Research in January 2009 responsible f
Slide 101: For personal use only
1 150mg Te. aie cemene = Ez th Novartis me CERTICAN” 0,5 mg O5mg 2 Eee . Yy ce) - \ “Orenciy’ VIAGRA (abatacept) CONNECT a > azithromycin r Phen) la Ce XOlair | Omalizumab 200mg Seen ssreueanst
Slide 102: What does a good drug look like?
What does a good drug look like? For personal use only What drugs have you specifically been involved in developing? What does a good drug look like and how do you know you have one? What do Pharma look for when partnering? Is it the same criteria? 99
Slide 103: AD-214: a novel treatment for IPF
For personal use only AD-214: a novel treatment for IPF January 2019 Sam Cobb, CEO and Managing Director AdAlta Limited (ASX:1AD) s.cobb@adalta.com.au
Slide 104: Sam Cobb
Sam Cobb For personal use only Sam is the founding CEO of AdAlta and has over fifteen years’ experience in business development and commercialisation of early-stage scientific technologies. Prior to AdAlta, Sam was the Business Development Director at the Co-operative Research Centre for Diagnostics
Slide 105: Disclaimer
Disclaimer For personal use only 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 in
Slide 106: AdAlta (1AD) investment summary
AdAlta (1AD) investment summary For personal use only AdAlta Limited (ASX:1AD) is an Australian listed 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 disea
Slide 107: Financial position
Financial position For personal use only Key financial details Share price performance (last 12-month Share Price12 months) Performance ASX code 1AD 0.40 1.0 Share price (29 January 2019) AU$0.27 0.36 0.8 Market capitalisation AU$31.75m Share Price ($) Volume (’000) 0.32 0.6 Shares on issue 117,604,
Slide 108: Extensive support from institutional investors and HNWs
Extensive support from institutional investors and HNWs For personal use only Top 20 shareholders ~80% 60% institutional shareholders Australian-based venture capital $40m fund 12% HNWs with >500K shares each $27b under management, global 4% founding academic institutions equities investor 3.5% Boar
Slide 109: Management and Board in place to deliver strategy
Management and Board in place to deliver strategy For personal use only Sam Cobb: Founding CEO and Director Dr John Chiplin: Independent Director Extensive experience in raising equity, contract and CEO of investment company, NewStar Ventures grant funding Managing Director of acquired antibody comp
Slide 110: Scientific Advisory Board
Scientific Advisory Board Internationally recognised with proven track record of drug development For personal use only Dr Mick Foley, AdAlta CSO John Westwick: pulmonary drug Expert in phage display discovery and development NIH, NHMRC, ARC, Gates funding and over 70 Over 14 years experience at Nov
Slide 111: Market opportunity for IPF
Market opportunity for IPF For personal use only Idiopathic Pulmonary Fibrosis (IPF) is an irreversible, unpredictable and incurable disease THE STATISTICS People living with IPF 300,000 People die from IPF every year 40,000 Median length of survival after IPF diagnosis 3.8 years 108
Slide 112: CXCR4 novel target for treatment of IPF
CXCR4 novel target for treatment of IPF For personal use only Significant literature to support hypothesis CXCR4 of Normal human Diseased IPF the involvement of CXCR4 in fibrosis lung tissue lung tissue IPF diseased lung tissue has increased CXCR4 expression compared with normal lung tissues AD-214
Slide 113: AD-214 novel treatment for fibrosis
AD-214 novel treatment for fibrosis For personal use only AdAlta’s lead i-body has demonstrated in vivo activity in the Bleomycin mouse model AdAlta’s i-body reduces collagen content and inflammatory cell infiltration and demonstrates a similar architecture to that of the normal lung Normal IPF lung
Slide 114: AD-214 has broad application in treating fibrosis
AD-214 has broad application in treating fibrosis For personal use only AdAlta data shows that AD-214 can improve fibrosis across a range of fibrotic diseases LUNG: Idiopathic Pulmonary Fibrosis EYE: Wet-Age Related Macular Degeneration Lung Eye Liver LIVER: NASH IPF Wet-AMD & PVR NASH & CIRRHOSIS S
Slide 115: Global market interest in fibrosis treatments
Global market interest in fibrosis treatments Fibrosis assets acquired at an early stage – typically based on Phase I results For personal use only Date Company Target Acquired by Deal value (US$) Deal commentary Sep-18 Samumed SM04646 United $10m upfront, plus Undergoing Phase I, USA rights Therape
Slide 116: AD-214 manufacturing progress
AD-214 manufacturing progress For personal use only Cell Line Cell Line Purification Formulation Development Expression Process Commenced Commenced Commenced Commenced June 2018 October 2018 November 2018 December 2018 Final cell line Expected Expected Expected selected by completion completion comp
Slide 117: AD-214 development: key milestones
AD-214 development: key milestones For personal use only 2019 2020 Q1 Q2 Q3 Q4 Q1 Q2 Manufacturing Dosing and Toxicology PK studies studies Phase I Publication of data Development of i-body pipeline BD and partnerships 114
Slide 118: 2018: significant achievements
2018: significant achievements For personal use only ✓ Orphan Drug Designation (US FDA) of AdAlta i-body for treatment of IPF ✓ Completion of additional pre-clinical animal models in diseases of the lung, kidney, skin; strengthening broad anti-fibrotic data package of anti-CXCR4 i- body ✓ Publicatio
Slide 119: AdAlta business model: strategy to create value
AdAlta business model – strategy to create value For personal use only Pharma & biotech partnerships Revenues: Upfronts, i-body FTEs, milestones & royalties i-bodies: new technology drug class platform and Potential in multiple library In-house disease indications Licence to pipeline of pharma drug
Slide 120: Market benchmarks
Market benchmarks For personal use only Fibrosis Sep-15 acquired by Roche Aug-15 acquired by BMS Nov-14 acquired by BMS lead AD-214 $105m + $475m milestones $150m + $1.25b milestones $444m phase I asset phase IIa asset phase I asset Next-gen April-16 with Abbvie May -17 with AZ July-17 with Sanofi a
Slide 121: Expected news flow
Expected news flow For personal use only H1 2018 ✓ Publication of AD-114 data in Scientific Reports demonstrating i-body application of pulmonary fibrosis with human tissue and animal model data ✓ Investor and analyst briefing detailing application of the i-body for the undruggable targets such as G
Slide 122: AdAlta Limited (ASX:1AD) summary
AdAlta Limited (ASX:1AD) summary For personal use only December 2018 cash position of $5.3m with strong support from existing institutional investors AD-214 has significant pre-clinical validation demonstrating broad anti-fibrotic and anti-inflammatory effects as well as safety Initial focus on trea
Slide 123: AdAlta Limited contact
For personal use only AdAlta Limited ASX: 1AD Sam Cobb, CEO and Managing Director s.cobb@adalta.com.au www.adalta.com.au