Adalta Ltd. · ASX:1AD
Adalta — Investor Presentation (December 2021)
68 slides from Adalta's investor presentation, Dec 15, 2021
Slide 1: Cash position, Carina news and corporate presentation
15 December 2021 ASX Announcement CASH POSITION, CARINA NEWS AND CORPORATE PRESENTATION For personal use only Key points: • Cash position of A$6.46 million at 30 November 2021 (excluding A$3.75 million Placement proceeds) • Research plan agreed for first target in Carina collaboration • Corporate pr
Slide 2: About AdAlta
Authorised for lodgement by: Tim Oldham CEO and Managing Director 15 December 2021 For personal use only Notes 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 chal
Slide 3: Further information and contacts
that any forward-looking statements will be realised. AdAlta Limited does not make any representation or give any warranty as to the likelihood of achievement or reasonableness of any forward-looking statements. Further information can be found at: https://adalta.com.au For personal use only For mor
Slide 4: Corporate overview
For personal use only Corporate overview December 2021
Slide 5: Disclaimer
INVESTOR PRESENTATION – DECEMBER 2021 2 Disclaimer For personal use only 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
Slide 6: AdAlta's purpose
INVESTOR PRESENTATION – DECEMBER 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 7: AdAlta today
INVESTOR PRESENTATION – DECEMBER 2021 4 AdAlta today AdAlta is building significant growth momentum while retaining agility to respond and adapt to data and opportunities For personal use only • i-body platform: can create therapeutics addressing targets underserved by traditional antibodies • Fibro
Slide 8: Four human health needs AdAlta is addressing today
INVESTOR PRESENTATION – DECEMBER 2021 5 Four human health needs AdAlta is addressing today For personal use only Antibodies cannot do everything! AdAlta’s i-bodies are a new drug discovery platforms for challenging targets Idiopathic Pulmonary Fibrosis: degenerative, fatal AdAlta’s AD-214 could meet
Slide 9: What is the i-body advantage?
INVESTOR PRESENTATION – DECEMBER 2021 6 What is the i-body advantage? All the selectivity and specificity of antibodies with greater versatility and tunability For personal use only Small size, flexible binding domain Confers unique binding capability for targets challenging traditional Accessing an
Slide 10: An immensely powerful drug discovery platform
INVESTOR PRESENTATION – DECEMBER 2021 7 An immensely powerful drug discovery platform i-body technology can enable a wide range of therapeutic and diagnostic products For personal use only Wide range of target classes Wide range of product formats CAR-T Targeting agents Bi-specifics and Chemokine mu
Slide 11: AD-214: first in class treatment for fibrosis
INVESTOR PRESENTATION – DECEMBER 2021 8 AD-214: first in class treatment for fibrosis AD-214’s initial focus is IPF For personal use only 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 lu
Slide 12: AD-214: multiple indication extension options
INVESTOR PRESENTATION – DECEMBER 2021 9 AD-214: multiple indication extension options For personal use only Each additional indication could address multiple markets with US$ billion potential Data in tissue and animal models show that AD-214 may improve fibrosis across a range of fibrotic diseases
Slide 13: Idiopathic Pulmonary Fibrosis (IPF)
INVESTOR PRESENTATION – DECEMBER 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 i-bodies have been designed to target a novel mode of action to address this med
Slide 14: Phase I clinical and PET imaging inform dosing and route
INVESTOR PRESENTATION – DECEMBER 2021 11 Phase I clinical and PET imaging inform dosing and route of administration Intravenous AD-214 is well tolerated in Phase I studies; PET imaging with radiolabelled AD-214 supports early transition to inhaled route For personal use only of administration Phase
Slide 15: Key milestones progressively de-risk AD-214 development
INVESTOR PRESENTATION – DECEMBER 2021 12 Key milestones progressively de-risk AD-214 development: IPF Phase II 2023 For personal use only Quarterly milestones to de-risk formulation; extensive use of pre-clinical imaging; AD-214 partnering window from late 2022 Key data readouts 2021* 2022 2023 2024
Slide 16: Predicted regional deposition of AD-214 in human lungs
INVESTOR PRESENTATION – DECEMBER 2021 13 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 For personal use only (alveolar/interstitial) airways of the lungs where most IPF is
Slide 17: IPF partnering: valuable options as early as Phase I
INVESTOR PRESENTATION – DECEMBER 2021 14 IPF partnering: valuable options as early as Phase I For personal use only 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 S
Slide 18: Immuno-oncology (I/O) PET imaging
INVESTOR PRESENTATION – DECEMBER 2021 15 Immuno-oncology (I/O) PET imaging For personal use only US$6.4b PET imaging market: could help identify the 20-40% of patients who will respond to revolutionary I/O drugs faster Immuno-oncology (I/O) drugs US$95 billion I/O market1 reactivate the patient’s ow
Slide 19: GZMB i-body asset: GE Healthcare co-development collaboration
INVESTOR PRESENTATION – DECEMBER 2021 16 GZMB i-body asset: GE Healthcare co-development collaboration Second asset in pre-clinical development; and could generate royalty revenue sooner than a therapeutic due to shorter diagnostic For personal use only development timelines Pipeline asset generatin
Slide 20: CAR-T therapies are revolutionising cancer treatment
INVESTOR PRESENTATION – DECEMBER 2021 17 CAR-T therapies are revolutionising cancer treatment For personal use only 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 prod
Slide 21: i-body enabled CAR-T assets: Carina collaboration
INVESTOR PRESENTATION – DECEMBER 2021 18 i-body enabled CAR-T assets: Carina collaboration For personal use only Third program entering discovery to generate precision engineered CAR-T products, providing new hope for patients with cancer World-leading proprietary CAR-T technologies for superior acc
Slide 22: Building the first iCAR-T cell therapy: proof of principle results
INVESTOR PRESENTATION – DECEMBER 2021 19 Building the first iCAR-T cell therapy: proof of principle results For personal use only 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
Slide 23: Carina collaboration details
INVESTOR PRESENTATION – DECEMBER 2021 20 Carina collaboration details For personal use only 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
Slide 24: AdAlta assets and business model
INVESTOR PRESENTATION – DECEMBER 2021 21 AdAlta assets and business model AdAlta’s pipeline is expanding to plan. The i-body platform is creating wholly owned or co-developed assets. Our team is For personal use only building skills in fibrosis/inflammation and immuno-oncology. Co- Precision enginee
Slide 25: An expanding pipeline of i-body enabled products
INVESTOR PRESENTATION – DECEMBER 2021 22 An expanding pipeline of i-body enabled products For personal use only 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: Indicat
Slide 26: The potential of our strategy: Ablynx case study
INVESTOR PRESENTATION – DECEMBER 2021 23 The potential of our strategy: Ablynx case study Multiple internal and external assets drive value, attract partners For personal use only GPCR platform exits Acquisition US$5B Feb-15 acquired by Sosei IPO Phase Ib + 7 preclinical leads US$182m US$400m +US$83
Slide 27: Calendar 2022 goals
INVESTOR PRESENTATION – DECEMBER 2021 24 Calendar 2022 goals For personal use only Significant progress anticipated on both existing core programs and further pipeline expansion AD-214 – first in class anti-fibrotic • Inhaled formulation development: nebulisation feasibility, efficacy in animal mode
Slide 28: Industry experienced leadership and advisors
INVESTOR PRESENTATION – DECEMBER 2021 25 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
Slide 29: Corporate snapshot
INVESTOR PRESENTATION – DECEMBER 2021 22 Corporate snapshot For personal use only Key financial details (15 Dec 2021 – proforma*) Share price performance (last 12 months) ASX code 1AD 0.25 7.0 Market capitalisation A$23.65m 6.0 0.20 Share price (12 month closing range) A$0.081 ($0.074 - 0.195) 5.0 1
Slide 30: Investment proposition
INVESTOR PRESENTATION – DECEMBER 2021 27 Investment proposition For personal use only 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 Healthca
Slide 31: Contact
For personal use only Contact: Tim Oldham, CEO and Managing Director [email protected] www.adalta.com.au
Slide 32: Appendix: Strategy
For personal use only Appendix: Strategy
Slide 33: Our strategy
INVESTOR PRESENTATION – DECEMBER 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
Slide 34: Transition to the expansion phase of our growth plan
INVESTOR PRESENTATION – DECEMBER 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 c
Slide 35: Appendix: i-bodies
For personal use only Appendix: i-bodies
Slide 36: i-bodies: next generation protein therapeutics
INVESTOR PRESENTATION – DECEMBER 2021 41 i-bodies: next generation protein therapeutics For personal use only 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
Slide 37: An immensely powerful drug development platform
INVESTOR PRESENTATION – DECEMBER 2021 42 An immensely powerful drug development platform For personal use only Demonstrated i-body platform capability • G-protein coupled receptors (GPCRs) • Fibrosis, inflammation, oncology • Diagnostics (PET tracers; cancer imaging) • Chimeric antigen receptor (CAR
Slide 38: Appendix: AD-214
For personal use only Appendix: AD-214
Slide 39: AD-214: development summary
INVESTOR PRESENTATION – DECEMBER 2021 36 AD-214: development summary For personal use only ✓ ✓ ✓ ✓ ✓ ✓ 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
Slide 40: AD-214 inhibits key features of the fibrogenic pathway
INVESTOR PRESENTATION – DECEMBER 2021 37 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 Ent
Slide 41: AD-214 reduction in fibrosis progression in mouse bleomycin model
INVESTOR PRESENTATION – DECEMBER 2021 38 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 ever
Slide 42: AD-214 attenuates renal damage induced by ureteral obstruction
INVESTOR PRESENTATION – DECEMBER 2021 39 AD-214 attenuates renal damage induced by unilateral ureteral obstruction For personal use only 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 ev
Slide 43: NHP GLP toxicology: AD-214 safe
INVESTOR PRESENTATION – DECEMBER 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
Slide 44: Non-human primate GLP toxicology: Phase I dose justification
INVESTOR PRESENTATION – DECEMBER 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
Slide 45: Intravenous AD-214 Phase I and pre-clinical imaging programs
INVESTOR PRESENTATION – DECEMBER 2021 42 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 For personal use only Phase 1 protocol in healthy volunteers - COMPLETE Par
Slide 46: Intravenous AD-214 Phase I healthy volunteer results
INVESTOR PRESENTATION – DECEMBER 2021 43 Intravenous AD-214 Phase I healthy volunteer results For personal use only 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
Slide 47: Phase I healthy volunteer study: safety findings
INVESTOR PRESENTATION – DECEMBER 2021 44 Intravenous AD-214 Phase I healthy volunteer study: safety findings For personal use only 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
Slide 48: Phase I healthy volunteer study: immune response findings
INVESTOR PRESENTATION – DECEMBER 2021 45 Intravenous AD-214 Phase I healthy volunteer study: immune response findings For personal use only 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 primari
Slide 49: Intravenous AD-214 pharmacokinetics increase proportionally with dose
INVESTOR PRESENTATION – DECEMBER 2021 32 Intravenous 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 • Elimin
Slide 50: Intravenous AD-214 pharmacokinetics
INVESTOR PRESENTATION – DECEMBER 2021 32 Intravenous AD-214 pharmacokinetics For personal use only 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
Slide 51: Transient white blood cell and blood stem cell increases
INVESTOR PRESENTATION – DECEMBER 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
Slide 52: Transient increase in SDF-1 consistent with CXCR4 engagement
INVESTOR PRESENTATION – DECEMBER 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 * Single ascending do
Slide 53: Biomarkers of CXCR4 receptor engagement at 5 mg/kg
INVESTOR PRESENTATION – DECEMBER 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 For personal use only AD-214 doses 16 CD34+ cells Biomarker data confirm single dose fin
Slide 54: Sustained high levels of CXCR4 receptor occupancy on T cells
INVESTOR PRESENTATION – DECEMBER 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 durati
Slide 55: PET imaging studies inform dosing and route of administration
INVESTOR PRESENTATION – DECEMBER 2021 52 PET imaging studies inform dosing and route of administration For personal use only PET imaging with radiolabelled AD-214 supports early transition to inhaled route of administration Rapid liver distribution and clearance reduces bioavailability Consistent wi
Slide 56: Phase II planned with inhaled formulation
INVESTOR PRESENTATION – DECEMBER 2021 53 Phase II planned with inhaled formulation For personal use only 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
Slide 57: Inhalation in IPF
INVESTOR PRESENTATION – DECEMBER 2021 54 Inhalation in IPF For personal use only 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 i
Slide 58: A clinician's perspective on AD-214 results so far
INVESTOR PRESENTATION – DECEMBER 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
Slide 59: IPF late-stage clinical landscape: a narrow development field
INVESTOR PRESENTATION – DECEMBER 2021 56 IPF late-stage clinical landscape: a narrow development field For personal use only 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 Compa
Slide 60: IPF clinical development landscape: narrow and narrowing
INVESTOR PRESENTATION – OCTOBER 2021 43 IPF clinical development landscape: narrow and narrowing development field AdAlta’s novel mode of action expected to be attractive to partners For personal use only ORPHAN COMPANY DRUG MODE OF ACTION PHASE DRUG DESIGNATION Inhaled Reduction in pulmonary artery
Slide 61: IPF partnering: pre-clinical assets have attracted partnerships
INVESTOR PRESENTATION – DECEMBER 2021 58 IPF partnering: pre-clinical assets have attracted partnerships For personal use only 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
Slide 62: Appendix: CAR-T
For personal use only Appendix: CAR-T
Slide 63: Advantages of CAR-T therapy
INVESTOR PRESENTATION – DECEMBER 2021 60 Advantages of CAR-T therapy For personal use only 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 t
Slide 64: CAR-T market opportunity
INVESTOR PRESENTATION – DECEMBER 2021 61 CAR-T market opportunity For personal use only The CAR-T market formed in 2017, has already reached US$1b and is forecast to reach US$20b by 2028 Sales and market share growth for CAR-T products3 ü >$US1 billion earned by CAR-T therapy products in 2020 ü Reve
Slide 65: Current approved CAR-T products
INVESTOR PRESENTATION – DECEMBER 2021 62 Current approved CAR-T products For personal use only Five 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 Gilead acquired Kite Celgene ac
Slide 66: Collaboration synergies
INVESTOR PRESENTATION – DECEMBER 2021 63 Collaboration synergies For personal use only 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
Slide 67: i-bodies in CAR-T format
INVESTOR PRESENTATION – DECEMBER 2021 64 i-bodies in CAR-T format For personal use only • 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 anti
Slide 68: Advantages of i-body enabled CAR-T
INVESTOR PRESENTATION – DECEMBER 2021 65 Advantages of i-body enabled CAR-T For personal use only 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 prec