Adalta Ltd. · ASX:1AD
Adalta — Investor Presentation (February 2020)
30 slides from Adalta's investor presentation, Feb 10, 2020
Slide 1: i-body: a unique drug discovery platform
For personal use only i-body: a unique drug discovery platform February 2020 AdAlta Limited (ASX:1AD) Tim Oldham, CEO and Managing Director [email protected]
Slide 2: 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 3: AdAlta's purpose
AdAlta’s purpose For personal use only AdAlta Limited (ASX:1AD) is a late pre-clinical stage biotechnology company using a promising new class of single domain antibodies, known as i-bodies, to discover and develop novel therapeutics for treating a wide range of human diseases 3
Slide 4: AdAlta summary
AdAlta summary For personal use only i-body platform for generating multiple products against “difficult” targets – Novel structure (small scaffold, long binding loops) provides new way to access unique epitopes on tough biological targets such as GPCRs and ion channels that can be difficult to acce
Slide 5: AdAlta strategy and business model to create value
AdAlta strategy and business model to create value For personal use only Strategy 1. In- Licence to pharma house pipeline of Revenues: major upfronts + drug candidates milestones & royalties AD-214 Invest up to key value inflection point A B G Multiple i-body i-body drugs and technology Long loop th
Slide 6: i-bodies: human single domain antibodies
i-bodies: human single domain antibodies CDR3 For personal use only CDR3 CDR1 CDR1 Shark Human Human Shark VNAR* Ribbon overlay hNCAM Domain 1 i-body library Basic research on … led to discovery of … leading to choice … and invention and unique shark human proteins with of human NCAM-1 patenting of
Slide 7: i-bodies: targeting "difficult to drug" targets
i-bodies: targeting “difficult to drug” targets Small size, long loop of i-body can access unique epitopes For personal use only GPCRs Ligand binding Can we select i-bodies that bind to GPCRs? sites MCP-1 cytokine &&&&&&ApplicaDons:& Drug'discovery'tool' Assist'with'coLcrystalliza,on' Therapeu,c'lea
Slide 8: Many potential "difficult to drug" targets: GPCR example
Many potential “difficult to drug” targets: G- protein coupled receptor (GPCR) example For personal use only • 34% (475) of FDA • 224 GPCRs with approved drugs target “broad, untapped 108 GPCRs therapeutic potential” 108 Total GPCRs with potential to be implicated in 224 disease • ~130 GPCRs are ~40
Slide 9: AdAlta pipeline
AdAlta pipeline IND For personal use only Product/ Class of Manufact- Partner Discovery Preclinical enabling Phase I Indication Target Target uring studies AD-214: Idiopathic CXCR4 GPCR Orphan Drug Designation Pulmonary Fibrosis AD-214: Other fibrotic indications CXCR4 GPCR (kidney, eye, liver, skin
Slide 10: Fibrosis: significant unmet medical need
Fibrosis: significant unmet medical need For personal use only Fibrosis is the build-up of connective issue Results from repeated inflammation and uncontrolled wound healing Causes scarring of vital organs such as the lung, liver, skin, eye, heart and kidney Leads to irreparable damage and eventual
Slide 11: Market opportunity for IPF (lung fibrosis)
Market opportunity for IPF (lung fibrosis) 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 11
Slide 12: AD-214 targets CXCR4, a GPCR involved in fibrosis and other disease states
AD-214 targets CXCR4, a GPCR involved in fibrosis and other disease states For personal use only CXCR4 is important in maintaining stem cells in bone marrow HIV-1 uses CXCR4 as a co-receptor for viral entry into host cells Mozobil (plerixafor or AMD3100)* CXCR4 has been associated with more than 23
Slide 13: AD-114 specifically reduced migration/invasion with IPF lung fibroblasts in vitro
AD-114* specifically reduced migration/invasion with IPF lung fibroblasts in vitro For personal use only AD-114 Specifically inhibited migration of fibroblasts from Normal fibroblasts slow and rapidly progressing IPF patients but did not affect fibroblasts from normal subjects Has greater in vitro e
Slide 14: AD-114 in vivo activity in Bleomycin-induced mouse model of lung fibrosis
AD-114* in vivo activity in Bleomycin-induced mouse model of lung fibrosis For personal use only Prophylaxis setting AD-114 has demonstrated in vivo activity (reduced collagen content, reduced inflammatory cell infiltration, improved tissue architecture) in a bleomycin-induced mouse model of lung fi
Slide 15: AD-114 prevents fibrosis in 21-day bleomycin-induced mouse lung fibrosis model
AD-114* prevents fibrosis in 21-day bleomycin-induced mouse lung fibrosis model For personal use only Prophylactic setting Ashcroft score Fibrotic gene expression Col1A1 Fold Change as Compared To Naive Col3A1 Fold Change as Compared To 25 30 Naive 20 25 20 15 15 10 10 5 5 0 0 Naïve Isotype Day 8 AD
Slide 16: From single domain antibody to AD-214
From single domain antibody to AD-214 For personal use only When combined, the i-body and Fc fragment create a superior drug, which will be better for patients and for potential commercial partners Monoclonal Antibody AD-214 i-body binds to CXCR4 to have anti- fibrotic activity AD-114 Fc Fragment Fc
Slide 17: AD-214 safe in 4-week toxicology study
AD-214 safe in 4-week toxicology study For personal use only RECENT DATA 3 non-human primate studies completed Most recent: a Good Laboratory Practice (GLP) study to evaluate safety and toxicology prior to initial human studies – 10mg/kg, 30mg/kg and 100mg/kg multiple doses over four weeks plus reco
Slide 18: AD-214 radio-labelled PET tracer to enhance clinical development
AD-214 radio-labelled PET tracer to enhance clinical development For personal use only Challenge Solution Benefits • No good biomarker for • Radio-label AD-214 so it • Confirm binding of AD-214 CXCR4 blocking in patients can be detected by PET to CXCR4 in patients • Difficult to confirm AD-214 imagi
Slide 19: AD-214 development: key milestones
AD-214 development: key milestones For personal use only 2019 2020 Q3 Q4 Q1 Q2 Q3 Q4 Toxicology studies GMP manufacturing: bulk drug and vialing PET tracer development Pre-clinical dose ranging disease model study Trial protocol and ethics submission Phase I program: healthy volunteer SAD, patient S
Slide 20: AD-214 has broad application in treating fibrosis
AD-214 has broad application in treating fibrosis For personal use only AdAlta data suggests that AD-214 can improve fibrosis across a range of fibrotic diseases LUNG: Idiopathic Pulmonary Fibrosis KIDNEY: Chronic kidney disease Lung Eye Liver EYE: Wet-Age Related Macular Degeneration IPF Wet-AMD &
Slide 21: GE Healthcare licensing deal: i-body platform
GE Healthcare licensing deal: i-body platform For personal use only Overview: Agreement with global medical technology and diagnostics firm, GE Healthcare AdAlta will screen its novel i-body library on a number of targets in order to identify i-bodies that GE can use as imaging agents, starting with
Slide 22: Financial position
Financial position For personal use only Key financial details Share price performance (last 12 months) ASX code 1AD Share price (3 February 2020) AUD$0.10 Market capitalisation AUD$16.39m Ordinary Shares 163,945,613 Listed Options 23,348,803 Unlisted Options 7,514,067 Current cash (31 December 2019
Slide 23: Financial results: funded into Phase I
Financial results: funded into Phase I AUD million For personal use only Financial year cash flows Quarterly cash flows FY20 H1 Net inflows* Cash FY18 FY19 Net outflows** (AUD (AUD (AUD 10 Cash at end of quarter million) million) million) 8 Operating inflows 1.86 2.11 3.88 6 4 Operating/investing (5
Slide 24: Market benchmarks
Market benchmarks Breaking: Jan-20 Boehringer Ingelheim and Enleofen ink $1 Billion+ fibrosis deal For personal use only Fibrosis Nov-19 acquired by Roche Sep-15 acquired by Roche Jul-19 license by Boehringer $390m + $1b – Phase II lead AD-214 $105m + $475m milestones Ingelheim €45m + €1.1b Aug-15 B
Slide 25: Significant 2019 achievements
Significant 2019 achievements AD-214 For personal use only ✓ Successfully completed AD-214 cell-line and manufacturing process development; completed manufacturing of clinical AD-214 bulk drug substance ✓ Completed Phase I-enabling non-human primate toxicity (safety) studies (pharmacology data pendi
Slide 26: FY20 news flow
FY20 news flow For personal use only H2 2019 ü Partnership announcement – GE partnership September 2019 ü Publication of key i-body data in well recognised, peer reviewed scientific journal, mAbs ü 4-week NHP toxicology study – completed October 2019 (plus GMP production of AD214 bulk for Phase I st
Slide 27: Management focused on milestone delivery
Management focused on milestone delivery For personal use only Tim Oldham, PhD CEO & Managing Director Appointed October 2019, Tim brings >20 years of life sciences business development, alliance management, portfolio and product development, and commercialisation experience in Europe, Asia and Aust
Slide 28: International Board, Scientific Advisory Board
International Board, Scientific Advisory Board Extensive track record of drug, antibody development, capital raising and exits For personal use only Board Scientific Advisory Board Dr Paul MacLeman Dr Mick Foley Chair AdAlta CSO Expert in phage display Liddy McCall Director Brian Richardson Drug dis
Slide 29: AdAlta Limited (ASX:1AD) Summary
AdAlta Limited (ASX:1AD) Summary For personal use only i-body platform technology for multiple products against “difficult” targets First in class lead internal program AD-214 to commence Phase I clinical trial mid-2020 – Has significant pre-clinical validation demonstrating broad anti-fibrotic and
Slide 30: Contact us
For personal use only Contact us: Tim Oldham, CEO and Managing Director [email protected] www.adalta.com.au