Adalta Ltd. · ASX:1AD
Adalta — Investor Presentation (November 2024)
49 slides from Adalta's investor presentation, Nov 21, 2024
Slide 1: 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 November 2024
Slide 2: 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 3: AdAlta: 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 Next generation protein and cell therapeutics AdCella East to west cellular immunotherapies Discovery business Pr
Slide 4: 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$8.5m* (Market capitalisation A$11.0m, $2.5m pro forma cash) For personal use only 0.03 12.0 ▪ Strong and supportive instit
Slide 5: AdAlta's core strategies each have opportunities for growth
AdAlta’s core strategies each have opportunities for growth Current status Advancing out-licensing and co-development/asset financing For personal use only 1. AdSolis: a new approach to fibrotic disease partnerships for first-in-class molecule AD-214 (several term sheets in negotiation) to: ▪ Genera
Slide 6: AD-214: new hope for fibrotic disease patients
For personal use only AD-214: new hope for fibrotic disease patients
Slide 7: The need: fibrotic diseases including IPF have no good outcomes today
7 The need: fibrotic diseases including Idiopathic Pulmonary Fibrosis (IPF) have no good outcomes today IPF market is underserved today Current IPF treatments Many other fibrosis market opportunities • Two existing therapies generated US$4.3b in 2022 Every organ vulnerable: • They slow but do not ha
Slide 8: The need: Bill van Nierop, IPF survivor speaks to challenge of 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 9: 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 priorities Progress and momentum First in class molecule targeting established mode of action in For personal use only fibrotic disease 1. Generate clinical proof
Slide 10: Phase I 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 11: 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 12: AD-214 offers a competitive and differentiated product profile
8 AD-214 offers a competitive and differentiated product profile compared with leading disease modifying candidates 1 Product Attributes AD-214 BI-1015550 BMS-986278 Bexotegrast For personal use only Sponsor AD-214 difference: Development stage Phase I/II Phase III Phase III Phase II/III • Novel mod
Slide 13: The value: Pharma companies are actively 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 14: The global advisory team: Experienced team to execute
9 The global advisory team: Experienced team to execute CONSULTANTS CLINICAL ADVISORY BOARD 1 Prof Tamera Corte Prof Toby Maher Royal Prince Alfred Hospital Keck School of Medicine CONSULTANT CHIEF MEDICAL OFFICER University of Sydney USC For personal use only 30y pulmonary clinical practice 20y res
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: 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 18: AdCella business model: force multiplier for Asian partners
AdCella business model: force multiplier for Asian partners 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 fir
Slide 19: AdCella has assembled the building blocks for a globally competitive company
AdCella has assembled the building blocks for a globally competitive immunotherapy company Clinic ready assets People Evaluation process developed to For personal use only High calibre team from AdAlta secure first/best-in-class assets (service agreement), from Asia complemented by network Approach
Slide 20: Strong and experienced management team available to AdCella
Strong and experienced management team available to AdCella Tim Oldham, PhD David Fuller, MD Kevin Lynch, MD CEO & MANAGING NON-EXECUTIVE DIRECTOR – CHIEF MEDICAL OFFICER – ADCELLA DIRECTOR Clinical Advisor For personal use only • 25 years industry physician experience across • 10 years cell and gen
Slide 21: Asset selection criteria
Asset selection criteria For personal use only ❑ Solid cancer indication – no hyper competitive blood cancer indications ❑ Target validated by clinical development programs in cell therapy or other modalities – reduces target risk ❑ US FDA IND ready – amend to add AdCella’s preferred CDMO; some asse
Slide 22: AdCella's rich pipeline
AdCella’s rich pipeline Screening Competitive position Term sheet negotiation Term sheet and market validation executed For personal use only Armored Target D CAR-T • Best in class Target G Target F potential CAR-T CAR-T • HCC Target C CAR-T Armored Target Target A CAR-T • IIT n = 4 patients • Novel
Slide 23: Deal comparators at AdCella exit: Phase I CAR-T cell therapy transactions
Deal comparators at AdCella exit: Phase I CAR-T cell therapy transactions Total value Upfront Date Drug(s) Licensor Licensee Deal stage Lead indications (US$m) (US$m) For personal use only DLL3 targeting Phase 1 Nov-23 autologous CAR-T cell Legend Biotech Novartis SCLC, LCNEC 1110 100 (ongoing; US)
Slide 24: Why invest in AdCella
Why invest in AdCella - a future powerhouse in cellular immunotherapy Large, rapidly growing market for cellular immunotherapies for solid cancers For personal use only Unique business model enables low cost asset acquisition: AdCella ”buys in” by allocating capital to develop assets and sharing ups
Slide 25: Unlocking value in i-body pipeline
For personal use only Unlocking value in i-body pipeline
Slide 26: 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 27: AdAlta's portfolio: High value therapeutics in fibrosis and immuno-oncology
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 28: Experienced in-house team
Experienced in-house team Executing from discovery through product development BOARD EXECUTIVE IN-HOUSE DISCOVERY & DEVELOPMENT TEAM For personal use only Paul MacLeman, DVM Angus Tester, PhD 8 PhD/MSc Staff + La Trobe Uni location CHAIR SENIOR MANAGER, PROJECTS AND PROGRAMS Skills in protein chemis
Slide 29: AdAlta's 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 30: 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 November 2024 For more information please contact: Tim Oldham CEO & Managing Director +61 403 446 665 [email protected] Investor Relations The Capital Network Julia Maguire +61 2
Slide 31: Technical Appendix
For personal use only Technical Appendix
Slide 32: AD-214: new hope for fibrotic disease patients
For personal use only AD-214: new hope for fibrotic disease patients
Slide 33: AD-214 is now ready to move into Phase II clinical studies for IPF
AD-214 is now ready to move into Phase II clinical studies for IPF ✓ 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 • Very clean
Slide 34: PK profile was consistent between dose 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 35: White blood cell counts were consistent across all 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 36: Phase I study supports extended duration of AD-214 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 37: 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 38: AdCella
AdCella For personal use only AdAlta’s “east to west” cellular immunotherapy strategy
Slide 39: Cell and gene therapy up front deal values 3.5x higher than other biologics
Cell and gene therapy up front deal values 3.5x higher than other biologic drugs with early partnering potential For personal use only Asset in-licensing terms Cell & gene therapy Biologics 120 Median upfront (cash and equity) payments (US$ 100 80 million) 60 40 20 0 2018 2019 2020 2021 2022 2023 H1
Slide 40: Three insights support AdAlta and AdCella's vision and opportunity
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 41: Eastern hemisphere has the richest cellular immunotherapy development 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 42: 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 43: i-bodies enable superior CAR constructs (i-CARs) and other 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 44: SYNthesis BioVentures is partnering with AdAlta to develop cellular immunotherapies
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 45: 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 46: Cell Therapies Pty Ltd (CTPL) collaboration brings manufacturing capabilities
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 47: Unlocking value in i-body pipeline
For personal use only Unlocking value in i-body pipeline
Slide 48: i-bodies are a powerful drug discovery tool to engage targets antibodies can't
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 49: AdAlta's pipeline so far: Five active assets plus growing i-body inventory
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