Adalta Ltd. · ASX:1AD
Adalta — Investor Presentation (May 2024)
47 slides from Adalta's investor presentation, May 20, 2024
Slide 1: Building our clinical pipeline: Investor Overview
For personal use only Building our clinical pipeline AdAlta Limited (ASX:1AD) A modern targeting system for next generation drugs Investor Overview 20 May 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: Unique discovery platform, expanding business model
AdAlta (ASX:1AD): unique discovery platform, expanding business model Purpose: i-body® targeting for next generation therapeutics Going where antibodies can't to produce high-value, next generation protein and cell therapies for debilitating diseases For personal use only Discovery business i-body®
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) v Enterprise value ~A$10.6m* (Market capitalisation A$13.3m) For personal use only v Strong and supportive institutional register v $3.7m flexible financi
Slide 5: Core strategies each have opportunities for growth
AdAlta’s core strategies each have opportunities for growth Current status For personal use only Partnering discussions advancing via 1. Realise the value of lead asset AD-214 AdSolis for: v Out-licensing; or v Co-development/asset financing v 3 active i-CAR-T discovery programs (Carina Biotech) 2.
Slide 6: AD-214: new hope for fibrotic disease patients
For personal use only AD-214: new hope for fibrotic disease patients
Slide 7: Bill van Nierop: IPF survivor speaks to challenge of living with IPF
Bill van Nierop: IPF survivor speaks to challenge of living with IPF For personal use only “… sadly I am one of a few who can actually “I talked with a 60 something grandmother, who really enjoyed days looking after relate to the lived experience with and without PF grandkids, but as disease progres
Slide 8: The need: Better outcomes for IPF and other fibrotic diseases
The need: Better outcomes for Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases 45% of developed world deaths IPF prevalence >490,000 worldwide have a chronic fibrosis component For personal use only 72,000 78,000 Europe • Lung (US$4b) USA 14,000 Japan • Kidney (US$10b) 159,000 China 6
Slide 9: AdSolis' solution: AD-214 value proposition
AdSolis’ solution: AD-214 has a compelling value proposition A$45m investment to date has built strong value AD-214 is competitively well positioned in Phase II and proposition beyond pipeline* For personal use only First in class molecule targeting established mode of action in fibrotic disease AD-
Slide 10: Phase I extension study achieves partnering and Phase II readiness milestones
Phase I extension study achieves critical partnering and Phase II readiness milestones Phase I extension study finding Significance For personal use only 1. Multiple doses of 10 mg/kg IV AD-214 are well ü Establishes safety profile necessary to advance this tolerated, no dose limiting toxicity, only
Slide 11: AD-214 development plan
AD-214 development plan Phase I extension study • AD-214 well tolerated at target Phase II dose; PK/PD as predicted, consistent across doses; no evidence of negative ADA effects • Results comprehensively address pharma company clinical questions received to date Phase II financing strategy Product d
Slide 12: Pharma companies are actively licensing IPF assets for significant value
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 Feb 23 Acquisition# US$294m N/A 2 Jan 23 China only license US$
Slide 13: AdCella: east to west cellular immunotherapy strategy
AdCella For personal use only AdAlta’s “east to west” cellular immunotherapy strategy
Slide 14: 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 15: Why AdAlta should develop a cell therapy company (AdCella)
Why AdAlta should develop a cell therapy 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, fast • Eas
Slide 16: 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 Pre-clinical proof of concept cell therapy transactions For personal use only Cell & gene therapy Biologics Upfront/ Deal value/ 120 No. of Date Licens
Slide 17: Three insights supporting the vision in cellular immunotherapy
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 18: 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 20242 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 China
Slide 19: 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 20: i-bodies enable superior CAR constructs (i-CARs)
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 21: 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 21
Slide 22: SYNBV partnering with AdAlta on 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 23: 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 cellular immunotherapies for solid Raise capital for cancers first
Slide 24: CTPL collaboration brings manufacturing and development 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 25: Unlocking value in i-body pipeline
For personal use only Unlocking value in i-body pipeline
Slide 26: Upcoming milestones and objectives in 2024
Upcoming milestones and objectives in 2024 1. Realise the value of AD-214 ü Complete Phase I extension study v Finance AD-214 Phase II (AdSolis) ü Phase II dose well tolerated, PK/PD profile supportive of § Out-license or project finance For personal use only potential efficacy, no concerning immune
Slide 27: 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 28: New investment provides access to up to $3.7 million
New investment provides access to up to $3.7 million additional funds New Life Sciences Capital LLC (NLSC) Meurs Group A US-based healthcare focused fund AdAlta’s second largest (and one of its longest standing) shareholders For personal use only A$ million First Investment Second Investment Third I
Slide 29: Benefits of new investment
Benefits of new investment Certainty For personal use only • Can progress growth initiatives independently of availability of funds from ongoing partnering initiatives for AD-214 Funds support growth initiatives § Accelerate progress of cellular immunotherapy collaboration with Flexibility SYNthesis
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 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 AD-214 partnering window open with multiple options in play: acti
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 May 2024 For more information please contact: Tim Oldham CEO & Managing Director +61 403 446 665 [email protected] Investor Relations The Capital Network Russell Katz +61 2 8999
Slide 33: AD-214: new hope for fibrotic disease patients
For personal use only AD-214: new hope for fibrotic disease patients
Slide 34: AD-214 is now ready to move into Phase II 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 35: Phase I studies completed covering planned Phase II doses
Phase 1 clinical studies completed in 58 participants covering planned Phase II doses Phase 1, randomized, blinded and placebo controlled dose-escalating studies of the safety, tolerability, and pharmacokinetics of single For personal use only and repeat doses of AD-214 when administered intravenous
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: east to west cellular immunotherapy strategy
AdCella For personal use only AdAlta’s “east to west” cellular immunotherapy strategy
Slide 41: Three targets in development with Carina Biotech
Three targets in development with Carina Biotech using repeatable partnering model For personal use only i-body® platform cell therapy platform i-body® enabled CAR-T (i-CAR-T) cells have i-CAR-Ts for solid tumor patients ü successfully demonstrated in vitro cancer cell line killing (lysis) Target A:
Slide 42: 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 43: 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 44: Unlocking value in i-body pipeline
For personal use only Unlocking value in i-body pipeline
Slide 45: 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 46: 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 Available
Slide 47: Other NLSC investment terms
Other NLSC investment terms Key investment terms – NLSC investment For personal use only § AdAlta to issue Placement Shares worth 109% of the 1st and 2nd investment amounts (100% of the 3rd investment) • Placement Shares to be issued over up to 36 months, if requested by NLSC § Purchase Price: $0.06