Adalta Ltd. · ASX:1AD
Adalta — Inaugural PAC Partners Healthcare Conference 2022
67 slides from Adalta's conference presentation, Apr 5, 2022
Slide 1: AdAlta to Present at Inaugural PAC Partners Healthcare Conference
5 April 2022 ASX Announcement ADALTA TO PRESENT AT INAUGURAL PAC PARTNERS HEALTHCARE CONFERENCE MELBOURNE Australia, 5 April 2022: AdAlta Limited (ASX:1AD) the clinical stage biotechnology company developing novel therapeutic products from its i-body platform is pleased to be presenting at the Inaug
Slide 2: About AdAlta
Notes to Editors About AdAlta AdAlta Limited is a clinical stage drug development company headquartered in Melbourne, Australia. The Company is using its proprietary i-body technology platform to solve challenging drug targeting problems and generate a promising new class of single domain antibody p
Slide 3: Developing High Value Drugs for Challenging Diseases
Developing high value drugs for challenging diseases Tim Oldham PhD, CEO and Managing Director Inaugural PAC Partners Healthcare Conference, 6 April 2022
Slide 4: Disclaimer
INVESTOR PRESENTATION – APRIL 2022 2 Disclaimer Investment in AdAlta is subject to This presentation may contain forward- There is no guarantee that the investment risk, including possible loss looking statements regarding the Company’s research and development of income and capital invested. AdAlta
Slide 5: AdAlta at a Glance
INVESTOR PRESENTATION – APRIL 2022 3 AdAlta at a glance AdAlta’s i-body platform is enabling a high-value product pipeline in two therapeutic areas of significant unmet medical need A wholly owned fibrosis and A co-developed immuno-oncology inflammation pipeline pipeline
Slide 6: Four Human Health Needs AdAlta Is Addressing Today
INVESTOR PRESENTATION – APRIL 2022 4 Four human health needs AdAlta is addressing today Antibodies cannot do everything! AdAlta’s i-bodies are a differentiated drug discovery platform for difficult diseases Idiopathic Pulmonary Fibrosis: degenerative, fatal AdAlta’s AD-214 could meet a desperate nee
Slide 7: Lead Program: AD-214
Lead program: AD-214 5
Slide 8: About Idiopathic Pulmonary Fibrosis
INVESTOR PRESENTATION – APRIL 2022 4 About | Idiopathic Pulmonary Fibrosis (IPF) Scarring and stiffening of the lungs progressively and irreversibly reduces lung function >300,000 people living with IPF; 40,000 people die from IPF every year Only 3.8 years median survival after diagnosis Two current
Slide 9: AD-214 Completed Phase I, Preparing Inhalation Format
INVESTOR PRESENTATION – APRIL 2022 7 AD-214 | Completed Phase I, preparing superior inhalation format for Phase II Phase I intravenous (iv) clinical study successfully completed1 Drug substance manufacturing secured for • AD-214 (iv) is well tolerated in single and multiple doses next clinical studi
Slide 10: Inhaled AD-214 Milestones and Opportunities in 2022
INVESTOR PRESENTATION – APRIL 2022 8 Inhaled AD-214 | Milestones and opportunities in 2022 June 2022 Through mid CY 2022 September 2022 quarter December 2022 quarter quarter • Antifibrotic effects in cultured human lung • Preparation for inhalation tissue • Efficacy in bleomycin toxicology studies •
Slide 11: Valuable IPF Partnering Options as Early as Phase I
INVESTOR PRESENTATION – APRIL 2022 9 AD-214 | Valuable IPF partnering options as early as Phase I Date Licensee Licensor Transaction Terms Clinical Phase Nov-21 US$254m Upfront 2 (Ready) Nov-21 €320m Milestones 2 (Ready) US$152m Upfront Sep-21 2 (Ready) +US$602m Milestones US$390m Upfront Nov-19 2 +
Slide 12: Multiple Indication Extension Options in Other Forms of Fibrosis
INVESTOR PRESENTATION – APRIL 2022 10 AD-214 | Multiple indication extension options in other forms of fibrosis • Preclinical tissue and animal models show that AD-214 may improve fibrosis across a range of fibrotic diseases and cancer Lung Eye Cancer IPF/ILD Wet-AMD 23 different cancers, I/O >US$3b
Slide 13: Co-Developed Immuno-Oncology Assets
Co-developed immuno-oncology assets 11
Slide 14: About Immuno-Oncology PET Imaging
INVESTOR PRESENTATION – APRIL 2022 12 About | Immuno-oncology (I/O) PET imaging Immuno-oncology (I/O) drug market is worth US$95 billion1 … … but only 20-40% of patients respond2 to therapy Granzyme B (GZMB) is produced by immune cells to kill cancer: potential biomarker of I/O drug activation of th
Slide 15: GE Healthcare Co-Development Collaboration
INVESTOR PRESENTATION – APRIL 2022 13 GZMB iPET imaging asset | GE Healthcare co-development collaboration AdAlta and GE are co-developing a GZMB i-body PET imaging (iPET) asset to evaluate the effectiveness of immuno-oncology drugs Revenue generative pipeline asset • AdAlta earns research fees, dev
Slide 16: About CAR-T Therapies
INVESTOR PRESENTATION – APRIL 2022 14 About | CAR-T therapies CAR-T therapies are providing new hope for patients with cancer who have failed all other options Therapy involves removing immune cells from blood and re-engineering them so they “see” cancer as a pathogen Already 6 FDA-approved CAR-T th
Slide 17: Carina Co-Development Collaboration
INVESTOR PRESENTATION – APRIL 2022 15 iCAR-T assets | Carina co-development collaboration AdAlta and Carina are combining i-bodies and a world class CAR-T platform to create iCAR-Ts that could offer improved precision, performance and persistence Further expands AdAlta’s pipeline in an attractive de
Slide 18: I/O Assets Milestones and Opportunities in 2022
INVESTOR PRESENTATION – APRIL 2022 16 I/O assets | Milestones and opportunities in 2022 Through mid CY Through mid CY September 2022 December 2022 2022 2022 quarter quarter iCAR-T Target A • Initial in vitro • in vitro cancer • GZMB iPET cell killing cancer cell killing imaging agent • iCAR-T target
Slide 19: Corporate Snapshot
INVESTOR PRESENTATION – APRIL 2022 17 Corporate snapshot Key financial details (31 March 2022) Share price performance (last 12 months) ASX code 1AD 0.20 4.0 0.18 3.5 Market capitalisation A$22.94m 0.16 Share price (12 month closing range) A$0.073 ($0.071 - 0.183) 3.0 0.14 12 month return (52)% Shar
Slide 20: Investment Proposition
INVESTOR PRESENTATION – APRIL 2022 18 Investment proposition Fibrosis/inflammation Immuno-oncology Lead asset advancing to Phase II 2 x co-development collaborations to i-body platform to create value >$3b market potential in first indication1 leverage platform ü GE Healthcare: $6b PET market2 Disco
Slide 21: Contact
Contact: Tim Oldham, CEO and Managing Director enquiries@adalta.com.au www.adalta.com.au
Slide 22: Appendix: Company Overview
Appendix: Company overview
Slide 23: Industry Experienced Leadership and Advisors
INVESTOR PRESENTATION – APRIL 2022 21 Industry experienced leadership and advisors Team with experience from discovery through manufacturing, clinical and commercialisation Board Executive Scientific Advisory Board Dr Paul MacLeman Tim Oldham, PhD Brian Richardson Chair CEO & Managing Director Drug
Slide 24: Our Strategy
INVESTOR PRESENTATION – APRIL 2022 39 Our strategy In-house pipeline of drug candidates Licence to Usually GPCRs in fibrosis, pharma inflammation, oncology Major upfronts + milestones A Invest to value inflection and royalties (typically Phase I or II) Multiple i-body drugs i-body technology Select
Slide 25: Growth Plan Expansion Phase
INVESTOR PRESENTATION – APRIL 2022 38 AdAlta has successfully transitioned to the expansion phase of our growth plan* Accelerate (from ~mid-2021) Expand (~mid 2020 to late 2021) Maximise catalysts from current funded base (2020) From… Via… Towards 2023… • i-body platform in clinic for difficult • La
Slide 26: Summary: Our Platform and Programs
INVESTOR PRESENTATION – APRIL 2022 24 Summary: our platform and programs Building out pipeline with additional internal and external programs: targeting 10 by 2023 Immuno-oncology: two co-development collaborations 1. GZMB PET imaging agent with GE Healthcare: US$6.4b PET imaging agent market 2. i-b
Slide 27: An Expanding Pipeline of i-Body Enabled Products
INVESTOR PRESENTATION – APRIL 2022 25 An expanding pipeline of i-body enabled products IND PRODUCT/ PRECLINICAL, PROGRAM PARTNER DISCOVERY ENABLING PHASE I PHASE II INDICATION PRODUCT STUDIES DEV CXCR4 AD-214: Idiopathic Inhaled Pulmonary Fibrosis Intravenous AD-214: Indication 2 INTERNAL PIPELINE T
Slide 28: Appendix: i-bodies
Appendix: i-bodies
Slide 29: i-bodies: Next Generation Protein Therapeutics
INVESTOR PRESENTATION – APRIL 2022 41 i-bodies: next generation protein therapeutics i-bodies are built on human protein scaffolds to mimic the properties of single domain antibodies Generation of the i-body 1 2 Two binding loops are engineered onto the human protein. These enable 3 Each unique i-bo
Slide 30: What Is the i-body Advantage?
INVESTOR PRESENTATION – APRIL 2022 28 What is the i-body advantage? All the selectivity and specificity of antibodies with greater versatility and tunability Small size, flexible binding domain Confers unique binding capability for targets challenging traditional Accessing antibodies; enables modula
Slide 31: An Immensely Powerful Drug Development Platform
INVESTOR PRESENTATION – APRIL 2022 42 An immensely powerful drug development platform Demonstrated i-body platform capability • G-protein coupled receptors (GPCRs) • Fibrosis, inflammation, oncology • Diagnostics (PET tracers; cancer imaging) • Chimeric antigen receptor (CAR) cell therapy GPCRs are
Slide 32: Appendix: AD-214
Appendix: AD-214
Slide 33: AD-214: Development Summary
INVESTOR PRESENTATION – APRIL 2022 31 AD-214: development summary ✓ ✓ ✓ ✓ ✓ ✓ Validated target Novel mode of GMP Pre-clinical NHP GLP Phase I clinical action, IP manufacturing efficacy toxicology trial • CXCR4 • Patented • Fc-fusion format • Bleomycin • Very clean tox • Very well • Player in CXCR4 i
Slide 34: AD-214 Inhibits Key Features of the Fibrogenic Pathway
INVESTOR PRESENTATION – APRIL 2022 32 AD-214 inhibits key features of the fibrogenic pathway with novel MOA Block fibrocyte recruitment Inhibit epithelial cell secretion of into the damaged tissue pro-fibrotic factors and epithelial to mesenchymal transition Injury Entry Entry Inflammatory mediators
Slide 35: AD-214: First in Class Treatment for Fibrosis
INVESTOR PRESENTATION – APRIL 2022 33 AD-214: first in class treatment for fibrosis AD-214’s initial focus is IPF CXCR4 First-in-class (novel mode Human of action) treatment Lung Tissue Brown stain shows increased amount of Targets a receptor called CXCR4 in fibrotic CXCR4 lung tissue Normal AD214 1
Slide 36: AD-214 Reduced Fibrosis in Mouse Model
INVESTOR PRESENTATION – APRIL 2022 34 AD-214 induced reduction in progression of fibrosis in mouse bleomycin model AD-214 reduced Ashcroft Score with statistical significance compared to bleomycin treated mice at: • 1-30mg/kg every second day Ashcroft Score • 10-30mg/kg every fourth day Day 8 bleomy
Slide 37: AD-214 Attenuates Renal Damage
INVESTOR PRESENTATION – APRIL 2022 35 AD-214 attenuates renal damage induced by unilateral ureteral obstruction UUO induces an increase in Fibronectin, Col1 and Col3 gene expression and protein deposition in murine kidneys. 1 and 5mg/kg AD-214 by intraperitoneal injection every two days for 14 days
Slide 38: NHP GLP Toxicology: AD-214 Safe
INVESTOR PRESENTATION – APRIL 2022 29 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 AD-214 well tolerated with no deaths, no AD-214-related Minor, transient, Small, transient, and 100mg/kg
Slide 39: Non-Human Primate GLP Toxicology: Phase I Dose Justification
INVESTOR PRESENTATION – APRIL 2022 30 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-214vaila
Slide 40: Intravenous AD-214 Phase 1 Clinical and Pre-Clinical Imaging Programs
INVESTOR PRESENTATION – APRIL 2022 38 Intravenous AD-214 Phase 1 clinical and pre-clinical imaging programs The Phase 1 program has demonstrated the safety and target engagement of intravenous AD-214 in healthy volunteers Phase 1 protocol in healthy volunteers - COMPLETE Part A Part B Objectives of
Slide 41: Intravenous AD-214 Phase I Healthy Volunteer Results
INVESTOR PRESENTATION – APRIL 2022 39 Intravenous AD-214 Phase I healthy volunteer results Intravenous AD-214 is well tolerated in single doses to 20 mg/kg and multiple doses to 5 mg/kg* AD-214 molecule is well tolerated in single and multiple iv doses (see Appendix for more detail)* • No dose limit
Slide 42: Intravenous AD-214 Phase I Safety Findings
INVESTOR PRESENTATION – APRIL 2022 40 Intravenous AD-214 Phase I healthy volunteer study: safety findings Single iv doses to 20 mg/kg (42 participants) Multiple iv doses 5 mg/kg (8 participants) • No dose limiting adverse events • No dose limiting adverse events • No serious adverse events • Safety
Slide 43: Intravenous AD-214 Immune Response Findings
INVESTOR PRESENTATION – APRIL 2022 41 Intravenous AD-214 Phase I healthy volunteer study: immune response findings Single iv doses to 20 mg/kg (42 participants) Multiple iv doses 5 mg/kg (8 participants) • Isolated instances of minor cytokine elevation • Sporadic and primarily low level elevation of
Slide 44: Intravenous AD-214 Pharmacokinetics Increase Proportionally
INVESTOR PRESENTATION – APRIL 2022 32 Intravenous AD-214 pharmacokinetics increase proportionally with dose (single doses) • Maximum exposure, Cmax, increases in a dose proportional manner • Total exposure, AUC0-inf, increases in a more than dose proportional manner • Elimination half-life t1/2 ~40h
Slide 45: Intravenous AD-214 Pharmacokinetics
INVESTOR PRESENTATION – APRIL 2022 32 Intravenous AD-214 pharmacokinetics Maximum exposure, Cmax, and total exposure, AUC0-inf, increase in a dose proportionate manner and are consistent across multiple doses of AD-214 at 5 mg/kg, supporting absence of drug induced tolerance or clearance Maximum and
Slide 46: Transient White Blood Cell and Stem Cell Increases
INVESTOR PRESENTATION – APRIL 2022 33 Transient white blood cell and blood stem cell increases indicate CXCR4 engagement Observed in Phase I HV SAD* Transient, dose dependent, increase in WCC and CD34+ counts at 4-12 hours consistent with CXCR4 blockade WCC counts WCC counts at 4h CD34+ cell counts
Slide 47: Transient Increase in SDF-1 Consistent With CXCR4 Engagement
INVESTOR PRESENTATION – APRIL 2022 34 Transient increase in SDF-1 (natural ligand of CXCR4) consistent with CXCR4 engagement Transient increases in SDF-1 levels at 4 hours in some participants, returning to baseline at 24h consistent with CXCR4 blockade * Single ascending dose data presented as mean
Slide 48: Biomarkers of CXCR4 Receptor Engagement
INVESTOR PRESENTATION – APRIL 2022 33 Biomarkers of CXCR4 receptor engagement at 5 mg/kg Transient increases in blood biomarkers demonstrate consistent engagement of the target receptor, CXCR4 across multiple AD-214 doses 16 CD34+ cells Biomarker data confirm single dose findings, consistent across
Slide 49: Sustained High Levels of CXCR4 Receptor Occupancy
INVESTOR PRESENTATION – APRIL 2022 35 Sustained high levels of CXCR4 receptor occupancy on T cells White blood cells naturally express CXCR4 in healthy individuals, providing an accessible surrogate for AD-214 target engagement or receptor occupancy (RO) Understanding duration of RO is critical to i
Slide 50: PET Imaging Studies Inform Dosing and Route of Administration
INVESTOR PRESENTATION – APRIL 2022 48 PET imaging studies* inform dosing and route of administration PET imaging with radiolabelled AD-214 supports early transition to inhaled route of administration Rapid liver distribution and clearance reduces bioavailability Consistent with pharmacokinetic profi
Slide 51: Phase II Planned With Inhaled Formulation
INVESTOR PRESENTATION – APRIL 2022 49 Phase II planned with inhaled formulation Delivery of AD-214 by inhalation has potential to improve bioavailability, be more convenient for patients, be more cost effective, and improve partnering flexibility* • AD-214 delivered direct to fibrotic areas • First
Slide 52: Inhalation in IPF
INVESTOR PRESENTATION – APRIL 2022 50 Inhalation in IPF Numerous drugs have been formulated for inhalation in IPF and respiratory disease, a substantial number of biologics are in development for inhalation and off-the-shelf devices are available for rapid translation from intravenous route Inhalati
Slide 53: Predicted Regional Deposition of AD-214 in Human Lungs
INVESTOR PRESENTATION – APRIL 2022 51 Predicted regional deposition of AD-214 in human lungs The ICRP661 model predicts that 17-46% of AD-214 delivered from commercial nebulisers will be delivered to the smallest (alveolar/interstitial) airways of the lungs where most IPF is found Device A Device B
Slide 54: A Clinician's Perspective on AD-214 Results So Far
INVESTOR PRESENTATION – APRIL 2022 36 A clinician’s perspective on AD-214 results so far • Un-met need in IPF/ILD remains – need to progress new therapies • Research at The Alfred suggests if targeting CXCR4 works in IPF it may work in other ILD’s • AD-214 is well tolerated and ready to move forward
Slide 55: IPF Late-Stage Clinical Landscape
INVESTOR PRESENTATION – APRIL 2022 53 IPF late-stage clinical landscape: a narrow development field AdAlta’s novel mode of action and Orphan Drug Designation expected to be attractive to partners as an alternative to, and in combination with other therapies Orphan Drug Company Drug Mode of action Ph
Slide 56: Current IPF Clinical Development Landscape
INVESTOR PRESENTATION – APRIL 2022 Current IPF clinical development landscape: a narrow development field AdAlta’s novel mode of action expected to be attractive to partners ORPHAN CURRENT COMPANY DRUG MODE OF ACTION DRUG PHASE DESIGNATION Inhaled Reduction in pulmonary artery pressure through direc
Slide 57: IPF Partnering: Valuable Options as Early as Phase I
INVESTOR PRESENTATION – APRIL 2022 55 IPF partnering: valuable options as early as Phase I IPF assets have recently yielded attractive deal terms at early stages of development Date Licensee Licensor Transaction Terms Asset/Mode of Action Clinical Phase Additional Comments SPAC merger; Deal includes
Slide 58: IPF Partnering: Valuable Options as Early as Phase I
INVESTOR PRESENTATION – APRIL 2022 56 IPF partnering: valuable options as early as Phase I IPF assets have recently yielded attractive deal terms at early stages of development Additional Date Licensee Licensor Transaction Terms Asset/Mode of Action Clinical Phase Comments US$0.4m upfront BBT-301 Op
Slide 59: Appendix: CAR-T
Appendix: CAR-T
Slide 60: CAR-T Therapies Are Revolutionising Cancer Treatment
INVESTOR PRESENTATION – APRIL 2022 58 CAR-T therapies are revolutionising cancer treatment Reprogramming a patient’s own immune system to fight cancer is a fast growing market at the cutting edge of medicine earned by CAR-T therapy step 1 CAR engineered chemokine >US$1b products in 20203 step 2 rece
Slide 61: Current Approved CAR-T Products
INVESTOR PRESENTATION – APRIL 2022 59 Current approved CAR-T products Six FDA approved CAR-T products for blood cancers generate strong revenues and are in high demand Manufacturer Product Notable CAR-T UPenn and Novartis Gilead acquired Kite Celgene acquired Juno Janssen – Legend Biotech transactio
Slide 62: Advantages of CAR-T Therapy
INVESTOR PRESENTATION – APRIL 2022 60 Advantages of CAR-T therapy For patients, CAR-T therapies offer a potentially curative, single shot therapy that is precision engineered to find and kill cancer Can be curative Long lasting Highly targeted Even in patients whose Living therapy: a single Precisio
Slide 63: i-bodies in CAR-T Format
INVESTOR PRESENTATION – APRIL 2022 61 i-bodies in CAR-T format • i-bodies are approximately half the size of the traditional CAR binding domain • Enables greater flexibility in CAR design • Ideally suited to bispecific CARs • i-bodies are specifically designed to target antigens considered difficult
Slide 64: Advantages of i-body Enabled CAR-T
INVESTOR PRESENTATION – APRIL 2022 62 Advantages of i-body enabled CAR-T i-body enabled CAR-T cells may demonstrate improved precision, performance and persistence, particularly in bi-specific and dual CAR-T cells i-body enabled mono / dual CAR i-body enabled Delivering precision to difficult bi-spe
Slide 65: Carina Collaboration Details
INVESTOR PRESENTATION – APRIL 2022 63 Carina collaboration details AdAlta and Carina will jointly develop up to 5 targets to create CAR-T, bi-specific CAR-T and dual CAR-T cell therapy products Up to 5 targets Significant new, shared IP – Proof of principle already achieved - Share costs, research t
Slide 66: Collaboration Synergies
INVESTOR PRESENTATION – APRIL 2022 64 Collaboration synergies By joining forces, AdAlta and Carina access complimentary expertise to create a toolbox to address three main challenges facing solid tumour CAR-T therapies. AdAlta expands its pipeline and further validates the i-body platform Precision
Slide 67: Building the First iCAR-T Cell Therapy: Proof of Principle Results
INVESTOR PRESENTATION – APRIL 2022 65 Building the first iCAR-T cell therapy: proof of principle results i-body enabled CAR-T (iCAR-T) cells have been successfully generated by Carina and demonstrate in vitro cell killing (lysis)1 Experimental details • LOVO and LIM1215 are colorectal cancer cell li
Adalta — Inaugural PAC Partners Healthcare Conference 2022 on 6ix