Adalta Ltd. · ASX:1AD
Adalta — Corporate Update (July 2021)
28 slides from Adalta's corporate update, Jul 19, 2021
Slide 1: Webinar to discuss AD-214 results and strategy
19 July 2021 ASX Announcement WEBINAR TO DISCUSS AD-214 RESULTS AND STRATEGY MELBOURNE Australia, 19 July 2021: AdAlta Limited (ASX:1AD), the clinical stage biotechnology company developing novel therapeutic products from its i-body platform will hold a webinar to discuss the results of Phase I tria
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: AD-214 strategy update
AD-214 strategy update AdAlta Investor Presentation, 19 July 2021
Slide 4: Disclaimer
INVESTOR PRESENTATION – JULY 2021 2 Disclaimer Investment in AdAlta is subject to This presentation may contain forward- There is no guarantee that the Company’s investment risk, including possible loss of looking statements regarding the potential of research and development projects and income and
Slide 5: Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF
INVESTOR PRESENTATION – JULY 2021 3 Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF Invaluable findings from AD-214 clinical study and separate radiolabelled AD-214 preclinical studies map a pathway to conducting next clinical trials in patients with a preferre
Slide 6: Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF
INVESTOR PRESENTATION – JULY 2021 4 Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF Invaluable findings from AD-214 clinical study and separate radiolabelled AD-214 preclinical studies map a pathway to conducting next clinical trials in patients with a preferre
Slide 7: AD-214 Phase 1 clinical program
INVESTOR PRESENTATION – JULY 2021 5 AD-214 Phase 1 clinical program The Phase 1 program is evaluating safety and distribution of AD-214 in healthy volunteers and patients Phase 1 protocol in healthy volunteers Part A Part B Objectives of Phase 1 Part A and B: Single dose, Multiple ascending dose, •
Slide 8: AD-214 Phase I healthy volunteer results to date
INVESTOR PRESENTATION – JULY 2021 6 AD-214 Phase I healthy volunteer results to date AD-214 has an excellent safety profile in single doses to 20 mg/kg and multiple doses to 5 mg/kg* AD-214 molecule has an excellent safety profile in single and multiple doses (see Appendix for more detail)* • No dos
Slide 9: Biomarkers of CXCR4 receptor engagement at 5 mg/kg
INVESTOR PRESENTATION – JULY 2021 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 P
Slide 10: AD-214 pharmacokinetics
INVESTOR PRESENTATION – JULY 2021 32 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 total plasma
Slide 11: Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF
INVESTOR PRESENTATION – JULY 2021 9 Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF Invaluable findings from AD-214 clinical study and separate radiolabelled AD-214 preclinical studies map a pathway to conducting next clinical trials in patients with a preferre
Slide 12: AD-214 distribution by PET imaging
INVESTOR PRESENTATION – JULY 2021 10 AD-214 distribution by PET imaging Pre-clinical PET imaging shows that while AD-214 distributes to tissues containing CXCR4 expressing cells, more than half the administered dose rapidly distributes to, or is cleared via, the liver. This is not seen with other i-
Slide 13: PET imaging studies inform dosing and route of administration
INVESTOR PRESENTATION – JULY 2021 11 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 profile
Slide 14: Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF
INVESTOR PRESENTATION – JULY 2021 12 Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF Invaluable findings from AD-214 clinical study and separate radiolabelled AD-214 preclinical studies map a pathway to conducting next clinical trials in patients with a preferr
Slide 15: Benefits of inhalation
INVESTOR PRESENTATION – JULY 2021 13 Benefits of inhalation 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 pass liver clearance
Slide 16: Inhalation in IPF
INVESTOR PRESENTATION – JULY 2021 14 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 Inhalatio
Slide 17: Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF
INVESTOR PRESENTATION – JULY 2021 15 Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF Invaluable findings from AD-214 clinical study and separate radiolabelled AD-214 preclinical studies map a pathway to conducting next clinical trials in patients with a preferr
Slide 18: Pathway to clinical studies in patients
INVESTOR PRESENTATION – JULY 2021 16 Pathway to clinical studies in patients Timeline to clinical efficacy in IPF patients largely unchanged; imaging remains a key development tool Key data readouts FY22 FY23 FY24 INHALATION PROGRAM Optimise iv formulation for nebulization/inhalation Pre-clinical ef
Slide 19: Key milestones
INVESTOR PRESENTATION – JULY 2021 17 Key milestones Numerous new milestones to demonstrate progress, pre-clinical imaging more comprehensive that patient imaging and key for dosimetry, AD-214 partnering window now most likely to open in FY23 Key data readouts FY22 FY23 FY24 INHALATION PROGRAM Optimi
Slide 20: Idiopathic Pulmonary Fibrosis (IPF)
INVESTOR PRESENTATION – JULY 2021 4 Idiopathic Pulmonary Fibrosis (IPF) AD-214 remains a first in class opportunity in a $3b market for a degenerative, fatal disease in dire need of improved treatment options In IPF, scarring and stiffening 3.8 years of the lungs progressively and median survival af
Slide 21: Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF
INVESTOR PRESENTATION – JULY 2021 19 Key points: AdAlta to progress inhaled version of AD-214 into efficacy studies for IPF Invaluable findings from AD-214 clinical study and separate radiolabelled AD-214 preclinical studies map a pathway to conducting next clinical trials in patients with a preferr
Slide 22: Milestones for remainder of FY2022
INVESTOR PRESENTATION – JULY 2021 20 Milestones for remainder of FY2022 Milestones extended through end of FY2022 AD-214 Other Assets ü Orphan Drug Designation for AD-214 in IPF ü Progressing the GE Healthcare collaboration from discovery to pre- H1 2021 ü Results of Phase I single dose studies in h
Slide 23: An expanding pipeline of i-body enabled products
INVESTOR PRESENTATION – JULY 2021 21 An expanding pipeline of i-body enabled products IND PRODUCT/ PRECLINICAL, TARGET 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 AD-
Slide 24: Corporate snapshot
INVESTOR PRESENTATION – JULY 2021 22 Corporate snapshot Key financial details (16 Jul 2021) Share price performance (last 12 months) 0.25 7.0 ASX code 1AD 6.0 Market capitalisation A$33.1m 0.20 Share price (12 month range) A$0.135 ($0.091 - 0.265) 5.0 Share price (A$) 12 month return 43% 0.15 Volume
Slide 25: Investment proposition
INVESTOR PRESENTATION – JULY 2021 23 Investment proposition Platform to create value Lead asset has multiple indications GZMB asset: GEHC partnership Patented, validated i-body platform AD-214: first-in-class asset for multiple Solving the challenge of identifying for asset creation: designed fibrot
Slide 26: Contact
Contact: Tim Oldham, CEO and Managing Director enquiries@adalta.com.au www.adalta.com.au
Slide 27: AD-214 Phase I healthy volunteer study: safety findings
INVESTOR PRESENTATION – JULY 2021 25 AD-214 Phase I healthy volunteer study: safety findings Single doses to 20 mg/kg (42 participants) Multiple doses 5 mg/kg (8 participants) • No dose limiting adverse events • No dose limiting adverse events • No serious adverse events • Safety Management Committe
Slide 28: AD-214 Phase I healthy volunteer study: immune response findings
INVESTOR PRESENTATION – JULY 2021 26 AD-214 Phase I healthy volunteer study: immune response findings Single doses to 20 mg/kg (42 participants) Multiple doses 5 mg/kg (8 participants) • Isolated instances of minor cytokine elevation • Sporadic and primarily low level elevation of cytokines • Transi