Adalta Ltd. · ASX:1AD
Adalta — Investor Presentation (June 2021)
44 slides from Adalta's investor presentation, Jun 3, 2021
Slide 1: AdAlta presents at Share Café Hidden Gems and BIO Digital
3 June 2021 ASX Announcement ADALTA PRESENTS AT SHARE CAFÉ HIDDEN GEMS AND BIO DIGITAL For personal use only MELBOURNE Australia, 3 June 2021: AdAlta Limited (ASX:1AD), the clinical stage biotechnology company developing novel therapeutic products from its i-body platform, is pleased to provide inve
Slide 2: About AdAlta and contacts
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: Corporate overview, June 2021
For personal use only Corporate overview June 2021
Slide 4: Disclaimer
INVESTOR PRESENTATION – JUNE 2021 2 Disclaimer For personal use only 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 p
Slide 5: AdAlta's purpose
INVESTOR PRESENTATION – JUNE 2021 3 For personal use only AdAlta’s purpose To use our unique i-body technology to create multiple novel therapeutics for debilitating diseases that have proven difficult to drug with traditional antibodies
Slide 6: Idiopathic Pulmonary Fibrosis (IPF)
INVESTOR PRESENTATION – JUNE 2021 4 Idiopathic Pulmonary Fibrosis (IPF) AdAlta’s first target, already a $3b market, is a degenerative, fatal disease in dire need of improved treatment options For personal use only In IPF, scarring and stiffening 3.8 years of the lungs progressively and median survi
Slide 7: Why invest in AdAlta now?
INVESTOR PRESENTATION – JUNE 2021 5 Why invest in AdAlta now? Very near-term catalysts across two programs, multiple expansion opportunities For personal use only i-body platform Lead asset AD-214: Asset 2 GZMB: to create products unique, needed and valuable early revenue, fully funded Enables creat
Slide 8: What is the i-body advantage?
INVESTOR PRESENTATION – JUNE 2021 6 What is the i-body advantage? All the selectivity and specificity of antibodies with greater versatility and tunability For personal use only Minimising off-target side effects Unique binding capability potentially Unique allows greater selectivity and specificity
Slide 9: Diverse applications of i-bodies
INVESTOR PRESENTATION – JUNE 2021 7 Diverse applications of i-bodies i-body technology can enable a wide range of applications For personal use only Targeting agents Bi-specifics and multi-specifics That deliver To improve targeting therapeutic payloads and selectivity more precisely GZMB GZMB i-bod
Slide 10: AD-214: first in class treatment for fibrosis
INVESTOR PRESENTATION – JUNE 2021 8 AD-214: first in class treatment for fibrosis AD-214’s initial focus is the US$3b IPF market For personal use only CXCR4 First-in-class (novel mode Human of action) treatment for Lung Tissue fibrotic diseases, which can affect almost every Brown stain shows amount
Slide 11: AD-214 Phase I clinical program
INVESTOR PRESENTATION – JUNE 2021 9 AD-214 Phase 1 clinical program The Phase 1 program is evaluating safety and distribution of AD-214 in healthy volunteers and patients For personal use only Phase 1 protocol in healthy volunteers Objectives of Phase 1 Part A and B: Part A Part B (Completed) (Comme
Slide 12: AD-214 Phase I trial: results to date
INVESTOR PRESENTATION – JUNE 2021 10 AD-214 – Phase 1 trial: results to date Single doses well tolerated, AD-214 clearly engages CXCR4 target for extended duration For personal use only Results from single dose studies (Part A) AD-214 has an excellent safety profile • No dose limiting toxicities or
Slide 13: IPF late-stage clinical landscape: a narrow development field
INVESTOR PRESENTATION – JUNE 2021 11 IPF late-stage clinical landscape: a narrow development field For personal use only AdAlta’s novel mode of action expected to be attractive to partners as an alternative to, and in combination with other therapies Orphan Drug Company Drug Mode of action Phase Des
Slide 14: AD-214: multiple indication extension options
INVESTOR PRESENTATION – JUNE 2021 12 AD-214: multiple indication extension options For personal use only Each additional indication could address multiple markets with U$ billion potential Data in tissue and animal models show that AD-214 can improve fibrosis across a range of fibrotic diseases and
Slide 15: IPF partnering: valuable early options
INVESTOR PRESENTATION – JUNE 2021 13 IPF partnering: valuable early options For personal use only IPF assets have recently yielded attractive deal terms at early stages of development Feb-21: License by Graviton Jul-19 license by Boehringer Ingelheim up to US$517.5m - Phase I €45m + €1.1b – Phase I
Slide 16: Immuno-oncology (I/O) imaging
INVESTOR PRESENTATION – JUNE 2021 14 Immuno-oncology (I/O) imaging I/O drugs revolutionising cancer treatment, but only work in 20-40% of patients. PET imaging identifies them faster For personal use only Immuno-oncology (I/O) drugs reactivate the Only 20-40% of patients patient’s own immune respond
Slide 17: GZMB i-body asset: GE Healthcare co-development collaboration
INVESTOR PRESENTATION – JUNE 2021 15 GZMB i-body asset: GE Healthcare co-development collaboration For personal use only Second asset poised to enter pre-clinical development; and could generate royalty revenue sooner than a therapeutic Granzyme B can be used as a GE Healthcare funded discovery at A
Slide 18: Business model
INVESTOR PRESENTATION – JUNE 2021 16 Business model For personal use only Two key commercialisation pathways for platform External assets Collaborations with pharma and biotech to further leverage the i-body platform GE Healthcare deal: Granzyme B One new collaboration forecast in 2021 Internal asse
Slide 19: An expanding pipeline of i-body enabled products
INVESTOR PRESENTATION – JUNE 2021 17 An expanding pipeline of i-body enabled products For personal use only IND PRODUCT/ PRECLINICAL, TARGET PARTNER DISCOVERY ENABLING PHASE I PHASE II INDICATION PRODUCT STUDIES DEV CXCR4 AD-214: Idiopathic Pulmonary Fibrosis AD-214: Indication 2 INTERNAL PIPELINE A
Slide 20: The potential of our strategy: Ablynx case study
INVESTOR PRESENTATION – JUNE 2021 18 The potential of our strategy: Ablynx case study Multiple internal and external assets drive value, attract partners For personal use only Acquisition US$5B IPO US$182m +US$83m +US$112m +US$57m +US$40m +US$70m IPO US$121m Global Data 2019 AdAlta is here
Slide 21: Corporate landscape: leveraging platforms
INVESTOR PRESENTATION – JUNE 2021 19 Corporate landscape: leveraging platforms For personal use only Creating multiple internal and partnered assets drives value creation for platform companies Micro-antibody GPCR platforms platforms AdAlta value April-16 license by Abbvie Feb-15 acquired by Sosei $
Slide 22: Milestones for remainder of 2021
INVESTOR PRESENTATION – JUNE 2021 20 Milestones for remainder of 2021 For personal use only News-flow rich period for remainder of CY2021 AD-214 Other Assets ü Orphan Drug Designation for AD-214 in IP ü Progression of the GEHC collaboration from discovery to pre-clinical H1 2021 ü Results of Phase I
Slide 23: Industry experienced leadership and advisors
INVESTOR PRESENTATION – JUNE 2021 21 Industry experienced leadership and advisors For personal use only 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 & Ma
Slide 24: Corporate snapshot
INVESTOR PRESENTATION – JUNE 2021 22 Corporate snapshot For personal use only Key financial details (21 May) Share price performance (last 12 months) 0.25 7.0 ASX code 1AD 1AD 6.0 Market capitalisation A$31.87m 0.20 Share price (12 month range) A$0.135 ($0.069 - 0.265) 5.0 Share price (A$) Volume (m
Slide 25: Investment proposition
INVESTOR PRESENTATION – JUNE 2021 23 Investment proposition For personal use only 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 cre
Slide 26: Contact
For personal use only Contact: Tim Oldham, CEO and Managing Director [email protected] www.adalta.com.au
Slide 27: Appendix: Strategy
For personal use only Appendix: Strategy
Slide 28: AdAlta has transitioned to the expansion phase of our growth plan
INVESTOR PRESENTATION – JUNE 2021 38 AdAlta has successfully transitioned to the expansion phase of our growth plan For personal use only 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 clini
Slide 29: Our strategy
INVESTOR PRESENTATION – JUNE 2021 39 Our strategy For personal use only 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-bo
Slide 30: Appendix: AD-214
For personal use only Appendix: AD-214
Slide 31: AD-214: road to the clinic
INVESTOR PRESENTATION – JUNE 2021 29 AD-214: road to the clinic For personal use only Validated target Novel mode of GMP NHP GLP NHP GLP action, IP manufacturing toxicology toxicology • CXCR4 • Patented CXCR4 • Fc-fusion format • Very clean tox • Bleomycin • Player in i-body antagonist • CDMO: KBI p
Slide 32: AD-214 inhibits key features of the fibrogenic pathway
INVESTOR PRESENTATION – JUNE 2021 30 AD-214 inhibits key features of the fibrogenic pathway with novel MOA For personal use only Block fibrocyte recruitment Inhibit epithelial cell secretion of into the damaged tissue pro-fibrotic factors and epithelial to mesenchymal transition Injury Entry Entry I
Slide 33: AD-214 reduction in progression of fibrosis in mouse bleomycin model
INVESTOR PRESENTATION – JUNE 2021 31 AD-214 induced reduction in progression of fibrosis in mouse bleomycin model For personal use only 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 fo
Slide 34: NHP GLP toxicology: AD-214 safe
INVESTOR PRESENTATION – JUNE 2021 29 NHP GLP toxicology: AD-214 safe For personal use only 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, tr
Slide 35: Non-human primate GLP toxicology: Phase I dose justification
INVESTOR PRESENTATION – JUNE 2021 30 Non-human primate GLP toxicology: Phase I dose justification For personal use only Pharmacokinetics Pharmacodynamics • Elimination half-life 22-29h • >60% receptor occupancy* for 72h at >30mg/kg • Human equivalent: ~71h (estimate) • Human equivalent: ~10mg/kg (es
Slide 36: AD-214 Phase I Part A design detail
INVESTOR PRESENTATION – JUNE 2021 31 AD-214 Phase I Part A design detail* For personal use only Protocol: A Phase I dose-escalating study of the safety, tolerability, PK and PD of single and repeat doses of AD-214 in healthy volunteers (HVs) and patients with interstitial lung disease (ILD) Part A:
Slide 37: AD-214 pharmacokinetics increase proportionally with dose
INVESTOR PRESENTATION – JUNE 2021 32 AD-214 pharmacokinetics increase proportionally with dose (single doses) For personal use only • Maximum exposure, Cmax, increases in a dose proportional manner • Total exposure, AUC0-inf, increases in a more than dose proportional manner • Elimination half-life
Slide 38: Transient white blood cell and blood stem cell increases indicate CXCR4 engagement
INVESTOR PRESENTATION – JUNE 2021 33 Transient white blood cell and blood stem cell increases indicate CXCR4 engagement For personal use only 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
Slide 39: Transient increase in SDF-1 consistent with CXCR4 engagement
INVESTOR PRESENTATION – JUNE 2021 34 Transient increase in SDF-1 (natural ligand of CXCR4) consistent with CXCR4 engagement For personal use only Transient increases in SDF-1 levels at 4 hours in some participants, returning to baseline at 24h consistent with CXCR4 blockade
Slide 40: Sustained high levels of CXCR4 receptor occupancy on T cells
INVESTOR PRESENTATION – JUNE 2021 35 Sustained high levels of CXCR4 receptor occupancy on T cells For personal use only White blood cells naturally express CXCR4 in healthy individuals, providing an accessible surrogate for AD-214 target engagement or receptor occupancy (RO) Understanding duration o
Slide 41: A clinician's perspective on AD-214 results so far
INVESTOR PRESENTATION – JUNE 2021 36 A clinician’s perspective on AD-214 results so far For personal use only • 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
Slide 42: Appendix: i-bodies
For personal use only Appendix: i-bodies
Slide 43: i-bodies: next generation antibodies
INVESTOR PRESENTATION – JUNE 2021 41 i-bodies: next generation antibodies i-bodies are human proteins that belong to the class of next-generation antibodies For personal use only Generation of the i-body 1 2 Two long loops are engineered onto the human protein. These enable 3 Each unique i-body has
Slide 44: An immensely powerful drug development platform
INVESTOR PRESENTATION – JUNE 2021 42 An immensely powerful drug development platform For personal use only i-body platform capability • G-protein coupled receptors (GPCRs) • Fibrosis, inflammation, oncology • Diagnostics (PET tracers; cancer imaging) GPCRs are the most heavily investigated class of