Adalta Ltd. · ASX:1AD
Adalta — Investor Presentation (October 2020)
30 slides from Adalta's investor presentation, Oct 9, 2020
Slide 1: AdAlta to present at BIO Investor Forum Digital Conference
9 October 2020 ASX Announcement ADALTA TO PRESENT AT BIO INVESTOR FORUM DIGITAL CONFERENCE MELBOURNE Australia, 9 October 2020: AdAlta Limited (ASX:1AD), a clinical stage biopharmaceutical discovery and development company using i-body technology to address challenging drug targets advises that CEO
Slide 2: About AdAlta and contact details
diagnostic imaging agents against Granzyme B, a biomarker of response to immuno- oncology drugs. AdAlta’s strategy is to maximise the products developed using its next generation i-body platform by internally discovering and developing selected i-body enabled product candidates against GPCRs implica
Slide 3: i-bodies: next generation protein therapeutics for difficult targets
i-bodies: next generation protein therapeutics for difficult targets Investor Presentation Oct 2020 AdAlta Limited (ASX:1AD) Tim Oldham, CEO and Managing Director t.oldham@adalta.com.au
Slide 4: Disclaimer
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 subscript
Slide 5: AdAlta: clinical stage discovery company, platform poised for growth
AdAlta: clinical stage discovery company, platform poised for growth 4 Grow by building multiple i-body-enabled assets Build pipeline of assets with validated technology: ✓ Continue to add value to AD-214 and GE Healthcare assets ✓ Add internal pipeline assets in AdAlta sweet spot ✓ Add external pip
Slide 6: 2020 achievements
2020 achievements 4 Grow by creating and advancing i-body-enabled assets $8m • Growth strategy and internal discovery “sweet spot” defined • $8.1 million raised in fully subscribed placement and rights issue to accelerate growth trajectory 3 Lead external asset: GE Healthcare target - commercial val
Slide 7: i-bodies: designed for "difficult to drug" targets
i-bodies: designed for “difficult to drug” targets CDR3 CDR3 CDR1 Shark CDR1 Human Human Human NCAM i-body Shark VNAR* Ribbon overlay Domain 1 library scaffold scaffold (billions) First fully human single domain Advantaged over traditional antibodies: antibody scaffold unique target access and bindi
Slide 8: Lead asset AD-214: first-in-class anti-fibrotic
Lead asset AD-214: first-in-class anti-fibrotic CXCR4 receptor is critical player in AD-214 specifically designed for fibrosis development of fibrosis in many organs Novel pharmacology CXCR4 Normal Diseased Granted patents expire 2036 Human lung tissue Brown stain AD-214 is first in class: the only
Slide 9: Lead indication IPF: $3b market, poor options
Lead indication IPF: $3b market, poor options Idiopathic Pulmonary Fibrosis (IPF) is irreversible, unpredictable, incurable >300,000 people living with IPF 40,000 people die from IPF every year 3.8 years median survival after diagnosis Current treatments come with safety, efficacy limitations Burden
Slide 10: Current phase I clinical trial
correlates with GAP Index and Treatment Effects in IPF Current phase I clinical trial Antje Prasse1, Danny Jonigk2, Tobias Welte1, Benedikt Jäger1, Frank Bengel3, Thorsten Derlin3 1Pneumology, Hannover Medical School; Fraunhofer ITEM, DZL BREATH September 2Pathology, Hannover Medical ‘20 status Scho
Slide 11: Multiple options in play for AD-214
Multiple options in play for AD-214 Phase I data • Safety • PK • Receptor occupancy • Receptor distribution Early partnering options Indication extension options • Active early stage partnering landscape • IPF/ILD and other fibrotic indications • Novel mode of action expected to be attractive • Meta
Slide 12: External pipeline: multi-national GE Healthcare
External pipeline: multi-national GE Healthcare i-body Target: platform granzyme B September ‘20 status • Panel of i-bodies identified • Lead optimization underway (6 mo) • A$1.15 million milestones and research fees earned to date Discovery Development Further milestones and royalties to be earned
Slide 13: AdAlta's twin strategies to create valuable assets from the i-body platform
AdAlta’s twin strategies to create valuable assets from the i-body platform A In-house pipeline Licence to pharma of drug candidates Major upfronts + milestones Usually GPCRs in fibrosis, & royalties inflammation, oncology Invest to value inflection (typically Phase I or II) i-body Multiple i-body t
Slide 14: Single domain antibody platform potential: Ablynx case study
Single domain antibody platform potential: Ablynx case study Ablynx strategy (2007) A. Leverage platform to rapidly identify potential drug candidates B. Drive lead product candidate through clinical development C. Selectively partner to maximize market opportunity D. Maintain and expand technology
Slide 15: AdAlta pipeline to expand through 2021
AdAlta pipeline to expand through 2021 October 2020 End 2021 Preclinical, IND Class of Partner Product/ Indication Discovery product enabling Phase I Phase II Target Target dev studies Internal pipeline AD-214: Idiopathic CXCR4 GPCR Pulmonary Fibrosis AD-214: Indication 2 Target 2 GPCR* TBD Target 3
Slide 16: Key execution milestones
Key execution milestones Strategic 2020 YTD achievements H2 2020 H1 2021 H2 2021 priority US patent Phase I Part A (HV) Phase I Part A (HV): top Phase I Part C (ILD) interim drug safety line safety, PK/PD first patient multi-dose Pre-clinical efficacy, committee findings* results* PK/PD First partne
Slide 17: Industry experienced leadership and advisors
Industry experienced leadership and advisors Board Scientific Advisory Board Dr Paul MacLeman Tim Oldham, PhD Brian Richardson Chair CEO & Managing Director Drug discovery and development expert Liddy McCall Dr Robert Peach Steve Felstead (alt: Dr James Williams) Independent Director Clinical develo
Slide 18: Financial position
Financial position Share price performance (last 12 months) Key financial details (11 Sep) 0.18 5.00 ASX code 1AD 0.16 4.50 4.00 0.14 Market capitalisation A$24.52m 3.50 0.12 Share Price (A$) Share price (12 month range) A$0.10 ($0.04-0.16) 3.00 Volume (m) 0.10 2.50 Ordinary Shares (daily volume) 24
Slide 19: AdAlta (ASX:1AD) Investment proposition
Molecular Imaging with CXCR4-Gallium-68-Pentixa correlates with GAP Index and Treatment Effects i AdAlta (ASX:1AD) Investment proposition Antje Prasse1, Danny Jonigk2, Tobias Welte1, Benedikt Jäger1, Frank B 1Pneumology, Hannover Medical School; Fraunhofer ITEM, DZL BREAT 2Pathology, Hannover Medica
Slide 20: Contacts for more information
Contacts for more information: Tim Oldham, CEO and Managing Director t.oldham@adalta.com.au www.adalta.com.au
Slide 21: APPENDIX: DETAIL
M AdAlta next generation protein therapeutics APPENDIX: DETAIL
Slide 22: Growth trajectory to build value
Growth trajectory to build value C Accelerate (from ~mid-2021) B Expand A (~mid 2020 to late 2021) Maximise catalysts from current funded base (2020) Market Cap: A$25 million $8m (11 Sep 2020) From … Via … Towards 2023 … • i-body platform in clinic for difficult • Laying the foundations for growth •
Slide 23: Near term strategic priorities (expansion phase)
Near term strategic priorities (expansion phase) Create value inflections for lead asset AD-214 • Clinical development in IPF/ILD • Expand indications, create licensing options Add 2 assets to internal pipeline in our “sweet spot” • G-protein coupled receptors (GPCRs) • Fibrosis, inflammation, cance
Slide 24: Market benchmarks: reaching for the stars!
Market benchmarks: reaching for the stars! Fibrosis Nov-19 acquired by Roche Jan-20 platform license by Jul-19 license by Boehringer $390m + $1b – Phase II Boehringer Ingelheim pipelines Ingelheim €45m + €1.1b Aug-15 BMS option to buy $?m + $1b milestones Phase I $150m + $1.25b milestones Preclinica
Slide 25: Pipeline: diverse target capability supports internal and external pipeline assets
Pipeline: diverse target capability supports internal and external pipeline assets i-body platform capability Commercial validation GPCRs Chemokine • i-body libraries, IP • Target Brings >20 targets to which i-body • Discovery, • Pre-clinical, clinical Other binders* have Lysophos- Does development
Slide 26: AD-214: road to the clinic
AD-214: road to the clinic CXCR4 6 Statistical significance# to 21d bleomycin Receptor Occupancy - All animals Vehicle 5 120 10 mg/kg 30 mg/kg ns ns ns ns 100 mg/kg 100 4 Ashcroft Score Percent receptor occupancy 80 * * ** ** ** 3 60 2 40 20 1 0 0 Naïve 21 day 30 mg/kg 30 mg/kg 60 mg/kg 0.01 mg/kg 1
Slide 27: NHP GLP toxicology: AD-214 safe
NHP GLP toxicology: AD-214 safe 3 non-human primate studies completed Good Laboratory Practice (GLP) study to evaluate safety and toxicology 10mg/kg, 30mg/kg and 100mg/kg multiple doses over four weeks plus recovery (human equivalent dose 32mg/kg) AD-214 well tolerated with no deaths, no AD-214-rela
Slide 28: Non-human primate GLP toxicology: Phase I dose justification
Non-human primate GLP toxicology: Phase I dose justification Pharmacokinetics Pharmacodynamics • Elimination half-life 22-29h • >60% receptor occupancy* for 72h at >30mg/kg • Human equivalent: ~71h (estimate) • Human equivalent: ~10mg/kg (estimate) • AD-214 available for >3 days • High receptor bind
Slide 29: AD-214 induced reduction in progression of fibrosis in mouse bleomycin model
AD-214 induced reduction in progression of fibrosis in mouse bleomycin model 6 AD-214 reduced Ashcroft Score with statistical significance compared to bleomycin treated Statistical significance# to 21d bleomycin mice at: 5 ns ns ns ns – 1-30mg/kg every second day 4 – 10-30mg/kg every fourth day Ashc
Slide 30: Phase I design detail
Phase I design detail* Phase I, dose-escalating study of the safety, tolerability, PK & PD of single and repeat doses of AD-214 in healthy volunteers (HVs) and patients with interstitial lung disease (ILD) Part A Molecular Part B Imaging with CXCR4-Gallium-68-Pentixafor PET Part C Objectives (Ongoin