Adalta Ltd. · ASX:1AD
Adalta — Shareholder Meeting (November 2020)
28 slides from Adalta's shareholder meeting presentation, Nov 25, 2020
Slide 1: Building a pipeline of i-body enabled therapeutics
Building a pipeline of i-body enabled therapeutics AGM Presentation Nov 2020 AdAlta Limited (ASX:1AD) Tim Oldham, CEO and Managing Director enquiries@adalta.com.au
Slide 2: 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 3: 2020 has been a transformational year
2020 has been a transformational year 4 Grow by building multiple i-body-enabled assets $8m • Progress and partner AD-214; progress GE Healthcare asset • Add 5 internal assets and 3-5 external partnerships • $8.1 million raised in fully subscribed placement and rights issue to accelerate growth traj
Slide 4: 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 5: Phase I clinical trial is progressing well
Molecular Imaging with CXCR4-Gallium-68-Pentixa correlates with GAP Index and Treatment Effects in Phase I clinical trial is progressing well Antje Prasse1, Danny Jonigk2, Tobias Welte1, Benedikt Jäger1, Frank B Part A Part B Part C 1Pneumology, Hannover Medical School; Fraunhofer ITEM, DZL BREAT 2P
Slide 6: 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 7: 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 Phase II and other fibrotic indications • Novel mode of action expected to be attracti
Slide 8: External pipeline: multi-national GE Healthcare
External pipeline: multi-national GE Healthcare i-body Target: platform granzyme B October ‘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 on
Slide 9: AdAlta has two strategies to create valuable assets from the i-body platform
AdAlta has two 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 A B G Invest to value inflection (typically Phase I or II) i-body Multiple i
Slide 10: 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 11: AdAlta has successfully transitioned to the expansion phase of our growth plan
AdAlta has successfully transitioned to the expansion phase of our growth plan C Accelerate (from ~mid-2021) B Expand A (~mid 2020 to late 2021) Maximise catalysts from current funded base (2020) $8m From … Via … Towards 2023 … • i-body platform in clinic for difficult • Laying the foundations for g
Slide 12: AdAlta pipeline target of five assets by end 2021
AdAlta pipeline target of five assets by end 2021 November 2019 November 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 T
Slide 13: Major milestones achieved; more in year ahead
Major milestones achieved; more in year ahead Nov ‘20 Safety, PK, RO FDA pre-IND Ph I part A Ph I part A 1st PET images 1st partnering in NHP advice safety update top line safety in patients window opens AD-214 Efficacy in BLM Ph I part A PET tracer Ph I part B Ph I part C mouse commenced pre-clinic
Slide 14: 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 15: Healthy cash position, supportive shareholders
Healthy cash position, supportive shareholders Key financial details (23 Nov) Major shareholders (23 Nov) % ASX code 1AD Yuuwa Capital LP 22.0 Market capitalisation A$28.2m Platinum Asset Management 11.6 Meurs Holdings Pty Ltd 7.3 Share price (12 month range) A$0.115 ($0.04-0.16) CS Third Nominees P
Slide 16: AdAlta: clinical stage drug discovery company entering expansion phase
AdAlta: clinical stage drug discovery company entering expansion phase 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 p
Slide 17: 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 18: Contacts for more information
Contacts for more information: Tim Oldham, CEO and Managing Director t.oldham@adalta.com.au www.adalta.com.au
Slide 19: APPENDIX: DETAIL
M AdAlta next generation protein therapeutics APPENDIX: DETAIL
Slide 20: 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 21: 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 is first in class: the only CXCR4 development of fibrosis in many organs antagonist being developed for fibrosis CXCR4 Potential in multiple fibrotic and cancer indications Normal Diseased Human lung tissue B
Slide 22: 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 23: 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 24: 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 25: 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
Slide 26: 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 27: 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, cancer
Slide 28: 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