Adalta Ltd. · ASX:1AD
Adalta — Investor Presentation (August 2024)
47 slides from Adalta's investor presentation, Aug 21, 2024
Slide 1: Upcoming AdAlta Event Presentations
ASX Release | 21 August 2024 AdAlta Limited (ASX:1AD) UPCOMING ADALTA EVENT PRESENTATIONS Opportunities to learn about the momentum building behind the transactions enabling expansion of AdAlta’s clinical stage pipeline For personal use only AdAlta Limited (ASX:1AD) (“AdAlta” or “the Company”), deve
Slide 2: For personal use only
He will be providing an update of the Company’s progress towards transactions via its AdSolis and AdCella units that could unlock the value of lead asset AD-214 as a whole new approach to IPF and expand its clinical stage pipeline by providing Asian innovation in cellular immunotherapies with a path
Slide 3: For personal use only
The i-body® technology creates a range of unique proteins capable of interacting with high selectivity, specificity and affinity with previously difficult to access targets such as G-protein coupled receptors (GPCRs) that are implicated in many serious diseases. i-bodies are the first fully human si
Slide 4: Building our clinical pipeline
For personal use only Building our clinical pipeline AdAlta Limited (ASX:1AD) A modern targeting system for next generation drugs Investor Presentation August 2024
Slide 5: 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. For personal use only This presentation is not an offer or in
Slide 6: Unique discovery platform, expanding business model
AdAlta (ASX:1AD): unique discovery platform, expanding business model For personal use only A new approach to fibrotic disease Larger biopharma companies Out-licensing and co-development AdCella East to west cellular immunotherapies Discovery business Product development businesses i-body® “inventor
Slide 7: Near-term momentum and opportunities for shareholders
Near-term momentum and opportunities for shareholders Attractive current valuation and fundamentals Share price performance (ASX:1AD) (12 months) 0.04 16.0 ▪ Enterprise value ~A$12.4m* (Market capitalisation A$15.5m) For personal use only 0.03 12.0 ▪ Strong and supportive institutional register Shar
Slide 8: Core strategies each have opportunities for growth
AdAlta’s core strategies each have opportunities for growth Current status Seeking to realise the value of lead asset AD-214 by partnering For personal use only 1. AdSolis: a new approach to fibrotic disease (out-licensing or co-development/asset financing discussions advancing) to: ▪ Progress IV AD
Slide 9: AD-214: new hope for fibrotic disease patients
For personal use only AD-214: new hope for fibrotic disease patients
Slide 10: The need: living with IPF
3 The need: Bill van Nierop, IPF survivor speaks to challenge of living with IPF 1 AD-214 was inspired by people like Bill van Nierop, one of the 500,000 For personal use only patients affected by Idiopathic Pulmonary Fibrosis (IPF) around the world today. He received the gift of a double lung trans
Slide 11: The solution: AD-214 momentum and development strategy
11 The solution: AD-214 momentum and development strategy A$45m investment to date has built strong value proposition Product development strategy Progress and momentum First in class molecule targeting established mode of action in For personal use only fibrotic disease Target intravenous (IV) Pote
Slide 12: Phase 1 clinical studies completed covering planned Phase II doses
11 Phase 1 clinical studies completed in 58 participants covering planned Phase II doses 1 Phase 1, randomized, blinded and placebo controlled dose-escalating studies of the safety, tolerability, and pharmacokinetics of Progress and momentum single and repeat doses of AD-214 when administered intrav
Slide 13: Phase I extension study achieves partnering and Phase II readiness milestones
11 Phase I extension study achieves critical partnering and Phase II readiness milestones 1 Progress and momentum Phase I extension study finding Significance For personal use only 1. Multiple doses of 10 mg/kg IV AD-214 are well ✓ Establishes safety profile necessary to advance this tolerated, no d
Slide 14: The value: pharma companies licensing IPF assets
13 The value: Pharma companies are actively licensing IPF assets for significant value Upfront payment to Clinical Phase at Date Licensor/target Licensee/acquirer Transaction Contingent milestones licensor^^ transaction For personal use only Aug-22 License US$100m US$600m 2 complete Apr-20 Acquisiti
Slide 15: AdCella
AdCella For personal use only AdAlta’s “east to west” cellular immunotherapy strategy
Slide 16: Cellular immunotherapies are transforming cancer outcomes
Cellular immunotherapies are transforming cancer outcomes New, multifunctional therapies are needed to address solid cancers Therapy involves re-engineering patient’s own immune cells to “see” cancer – living drug, single dose, potentially curative For personal use only 6 FDA-approved CAR-T therapie
Slide 17: Why AdAlta should develop a cellular immunotherapy company
Why AdAlta should develop a cellular immunotherapy company (AdCella) For personal use only Cellular immuno- Highly differentiated Rich pipeline of Scalable business Strong team and therapy for solid competitive position: differentiated product model allowing for partnership with tumours is a large,
Slide 18: Cell and gene therapy upfront deal values higher than other biologics
The value: cell and gene therapy up front deal values 3.5x higher than other biologic drugs with potential to partner early Asset in-licensing terms Proof of concept cell therapy transactions For personal use only Cell & gene therapy Biologics Upfront/ Deal value/ No. of 120 Date Licensee Licensor t
Slide 19: Three insights supporting AdCella's vision
Three insights support AdAlta and AdCella’s vision and opportunity in cellular immunotherapy For personal use only Asia is global epicentre of innovation in cellular immunotherapy; supportive regulatory system enables early clinical data to derisk assets AdAlta’s i-body® technology is ideally suited
Slide 20: Eastern hemisphere has richest cellular immunotherapy pipeline
Eastern hemisphere has the richest cellular immunotherapy development pipeline in the world Cellular immunotherapy developers 20231 Cellular immunotherapy clinical trials 2024 2 n = 1,104 n = 1804 For personal use only 1108 Other South Korea 11 28 47 Japan 50 Australia 449 439 583 185 49 Canada Chin
Slide 21: Australia has a well-developed cell therapy delivery ecosystem
Australia has a well-developed cell therapy delivery ecosystem1 Clinical delivery capability • 138 cell and gene therapy trials to date For personal use only • 55 institutions treating patients with cell and gene therapies • 25 sites approved for commercial CAR-T delivery • 3 commercial approvals fo
Slide 22: i-bodies enable superior CAR constructs
AdAlta’s i-bodies enable superior CAR constructs (i-CARs) and other advanced therapies when combined with partner platforms For personal use only TINY i-body® needs LESS room in inserted gene, i-CAR-T example i-body enabling MORE engineered function i-body targeting domain Produces superior, multifu
Slide 23: AdCella business model
AdCella business model For personal use only 1. In-license market leading assets from Asia 3. Establish global manufacturing network and on-license to commercialization partners AdCella 2. Build value by establishing western regulated manufacturing, obtaining first western regulated clinical data 20
Slide 24: Building blocks for a globally competitive immunotherapy company
AdCella has assembled the building blocks for a globally competitive immunotherapy company Clinic ready assets People Evaluation process For personal use only High calibre team from developed to secure best-in- AdAlta, complemented by class assets from Asia network Approach to manufacturing Investme
Slide 25: SYNthesis BioVentures partnering with AdAlta
SYNthesis BioVentures (SYNBV) is partnering with AdAlta to develop next generation cellular immunotherapies for solid cancers Memorandum of Understanding 6-12 months initial collaboration For personal use only • i-body platform: building blocks for • Deep China experience next generation cell therap
Slide 26: CTPL collaboration brings manufacturing capabilities to AdCella
Cell Therapies Pty Ltd (CTPL) collaboration brings world class manufacturing and product development capabilities to AdCella 1AD – CTPL Master Services Agreement For personal use only Relationship: CTPL is AdAlta’s preferred manufacturer of cellular immunotherapies Services: Process development, tec
Slide 27: Unlocking value in i-body pipeline
For personal use only Unlocking value in i-body pipeline
Slide 28: Near term milestones and objectives
Near term milestones and objectives Near term milestones ▪ Out-licensing or co-development/asset financing to provide For personal use only 1. AdSolis: a new approach to fibrotic disease capital for further development of AD-214, crystalize the value of AD-214 to AdAlta Multiple term sheets being ne
Slide 29: AdAlta's portfolio of high value therapeutics
AdAlta’s portfolio: High value therapeutics addressing challenging diseases in fibrosis and immuno-oncology and a platform grow further AdSolis for fibrosis: degenerative, progressive, fatal For personal use only AdAlta’s AD-214 could meet a desperate need for new approaches for debilitating disease
Slide 30: Experienced in-house team
Experienced in-house team Executing from discovery through product development BOARD EXECUTIVE SCIENTIFIC ADVISORY BOARD For personal use only Paul MacLeman, DVM Angus Tester, PhD Mick Foley, PhD CHAIR SENIOR MANAGER, FOUNDING CHIEF PROJECTS AND PROGRAMS SCIENTIST Tim Oldham, PhD Janette Dixon, DBA
Slide 31: Foundations in place for transaction driven growth
AdAlta’s foundations in place for transaction driven growth AdSolis: Lead asset AD-214 heading to Phase II (US$4.3b IPF market plus other indications), substantially de-risked by Phase I extension study clinical readouts For personal use only AdSolis: AD-214 partnering window open with multiple opti
Slide 32: A modern targeting system for next generation drugs
A modern targeting system for next generation drugs For personal use only AdAlta Ltd (ASX:1AD) Investor Presentation August 2024 For more information please contact: Tim Oldham CEO & Managing Director +61 403 446 665 t.oldham@adalta.com.au Investor Relations The Capital Network Julia Maguire +61 2 7
Slide 33: Technical Appendix
For personal use only Technical Appendix
Slide 34: AD-214: new hope for fibrotic disease patients
For personal use only AD-214: new hope for fibrotic disease patients
Slide 35: AD-214 is ready to move into Phase II studies for IPF
AD-214 is now ready to move into Phase II clinical studies for IPF Recent data ✓ For personal use only ✓ Validated target Novel mode of GMP Pre-clinical NHP GLP Phase I clinical action, IP manufacturing efficacy toxicology trials (IV) • CXCR4 • Patented i-body® • Fc-fusion format • Bleomycin mouse •
Slide 36: PK profile consistent between doses and independent of ADA response
PK profile was consistent between dose 1 and dose 4 and independent of ADA response for all extension study participants* 10 mg/kg IV For personal use only Cmax AUC 300000 50000 Dose 1 Dose 1 Dose 4 40000 Dose 4 AUC (ng/mL*day) Cmax (ng/mL) 200000 30000 20000 100000 10000 0 0 S002 S007 S008 S011 S01
Slide 37: White blood cell counts consistent across participants and doses
White blood cell counts (a PD marker) were consistent across all participants and all doses in extension study Participant WBC_unblinded White blood 1st and 4th cell (WBC) dose count S002 For personal use only 25 S007 S008 20 S011 WBC (x109/L) 15 S013 S015 10 S001 (P) S010 (P) 5 0 0 1 2 3 4 5 112 11
Slide 38: Phase I study supports extended duration of CXCR4 engagement
Phase 1 clinical study supports extended duration of AD-214 CXCR4 engagement Sustained high levels of CXCR4 receptor occupancy (RO) by AD-214 on T cells observed across single and multiple For personal use only doses of AD-214 ▪ >70% CXCR4 RO at 7 days after 10 mg/kg infusion ▪ > 60% CXCR4 at 21 day
Slide 39: Dosing regimens achieve target receptor occupancy
Two weekly IV and potentially weekly SC dosing regimens achieve target receptor occupancy For personal use only A. Dosing every two weeks B. Dosing every week 10 mg/kg 1 mg/kg 3 mg/kg Days Days IV administration Maximal inhibition of fibrotic process SC administration Meaningful inhibition of fibrot
Slide 40: AdCella
AdCella For personal use only AdAlta’s “east to west” cellular immunotherapy strategy
Slide 41: AdCella: connecting Asia innovation, Australian ecosystem and i-body technology
AdCella: Connecting Asia innovation, Australian ecosystem and i-body technology to deliver next generation cellular immunotherapies For personal use only World class advanced therapies clinical trial and translational research Product innovation and clinical CAR-T trials ~25-50% lower cost validatio
Slide 42: i-bodies enable superior CAR constructs and advanced therapies
AdAlta’s solution: i-bodies enable superior CAR constructs (i-CARs) and other advanced therapies when combined with partner platforms For personal use only TINY i-body® needs LESS room in inserted gene, i-CAR-T example i-body applications enabling MORE engineered function Tumor cell i-body targeting
Slide 43: Key terms of AdAlta-SYNBV collaboration
Key terms of AdAlta-SYNBV collaboration Success = AdCella For personal use only Ownership: 75% AdAlta 25% SYNBV AdCella before financing of initial assets (so may change over time) License: to ex-Asia rights for near to clinic novel Raise capital for cellular immunotherapies for solid first western
Slide 44: AdCella is evaluating a pipeline of de-risked assets
AdCella is evaluating a pipeline of substantially de-risked assets: examples Project: Tamworth Project: Jiansgu Project: Seoul For personal use only Origin: China Origin: China Origin: South Korea Target: Known class, unusual peptide Target: Known, superior specificity Target: Novel Format: TCR-T ce
Slide 45: Unlocking value in i-body pipeline
For personal use only Unlocking value in i-body pipeline
Slide 46: i-bodies are a powerful drug discovery tool
i-bodies are a powerful drug discovery tool to engage targets that traditional antibodies can’t Small Molecules Antibodies i-bodies Flexible, modular formats For personal use only Current pipeline focus CAR cell therapy ADC/ radiotherapeutic Bi-specific Unique binding Fc-fusion Avoid off-target ~10%
Slide 47: AdAlta's pipeline so far
AdAlta’s pipeline so far: Five active assets plus growing i-body® inventory Discovery Non-clinical Clinical Target Product Indication Partner Lead Discovery Preclinical IND enabling Phase I Phase II optimisation For personal use only Lung, kidney IV Available fibrosis SC to license AD-214 Product di