Slide 1: Closing in on clinical and partnering milestones
Closing in on clinical and partnering milestones AdAlta Limited (ASX:1AD) A modern targeting system for next generation drugs Investor Overview 8 March 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. This presentation is not an offer or invitation for subscript
Slide 3: AdAlta (ASX:1AD): a modern targeting system for next generation drugs
AdAlta (ASX:1AD): a modern targeting system for next generation drugs 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 Discovery business Product development business i
Slide 4: Near-term momentum and opportunities for shareholders
Near-term momentum and opportunities for shareholders Share price performance (ASX:1AD) (12 months) Attractive current valuation and fundamentals 0.05 5.0 0.04 4.5 0.04 4.0 v Enterprise value ~A$11.6m* (Market capitalisation A$15.2m) 3.5 0.03 Share price (A$) 3.0 v Strong and supportive institutiona
Slide 5: Three core strategies, all with near term partnering potential
Three core strategies, all with near term partnering potential Near term partnering opportunities v Out-licensing; or 1. Realise the value of lead asset AD-214 v Co-development/asset financing v Co-development collaborations in 2. Progress i-CAR and i-PET programs core i-body® application areas v Sp
Slide 6: AD-214: new hope for fibrotic disease patients
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 “… 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 progressed she found sometime
Slide 8: The need: Better outcomes for Idiopathic Pulmonary Fibrosis (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 72,000 78,000 Europe • Lung (US$4b) USA 14,000 Japan • Kidney (US$10b) 159,000 China 6,000 Slow, but do not
Slide 9: AdAlta's solution: AD-214 has a compelling value proposition
AdAlta’s 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* First in class molecule targeting established mode of action in fibrotic disease AD-214 poised to enter Ph
Slide 10: 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 Breaking: new data ✓ ✓ 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 tox
Slide 11: Phase I clinical 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 and repeat doses of AD-214 when administered intravenously to healthy voluntee
Slide 12: Phase I extension study achieves critical partnering and Phase II readiness milestones
Phase I extension study achieves critical partnering and Phase II readiness milestones Phase I extension study finding Significance 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 “mild” adverse dose t
Slide 13: 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 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 S013 S015 S002 S007 S008
Slide 14: 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 25 S007 S008 20 S011 WBC (x109/L) 15 S013 S015 10 S001 (P) S010 (P) 5 0 0 1 2 3 4 5 112 113 114 115 116 Study da
Slide 15: The development plan
The development plan Phase II financing strategy Product development strategy Either co-development in Or out-licensing to larger Target intravenous (IV) Potential subcutaneous asset specific entity biopharmaceutical product profile (SC) product profile company • AD-214 licensed to AdAlta • IV admin
Slide 16: The value: 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 Feb 23 Acquisition# US$294m N/A 2 Jan 23 China only license US$76m^ US$336m 2 Aug-22
Slide 17: Co-developed immuno-oncology programs: i-CAR-cell and other advanced therapies
Co-developed immuno-oncology programs: i-CAR-cell and other advanced therapies
Slide 18: The need: Multifunctional CAR-cell therapies
The need: Multifunctional CAR-cell therapies Therapy involves re-engineering patient’s own immune cells to “see” cancer – living drug, single dose, potentially curative 6 FDA-approved CAR-T therapies since 2017 transforming outcomes: Complete response rates: 83% r/r pALL, 51-65% r/r LBCL, 78% r/r MM
Slide 19: AdAlta's solution: 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 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 domain Produces super
Slide 20: Three targets in development with Carina Biotech using repeatable partnering model
Three targets in development with Carina Biotech using repeatable partnering model 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: 3 A-i-CAR-T cells pro
Slide 21: The value: Cell & gene therapy up front deal values 3.5x higher than other biologics
The value: Cell & 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 Cell & gene therapy Biologics Upfront/ Deal value/ 120 No. of Date Licensee Licensor target targe
Slide 22: Unlocking value in i-body pipeline
Unlocking value in i-body pipeline
Slide 23: AdAlta's portfolio: High value therapeutics addressing challenging diseases
AdAlta’s portfolio: High value therapeutics addressing challenging diseases in fibrosis and immuno-oncology and a platform grow further Fibrosis: degenerative, progressive, fatal AdAlta’s AD-214 could meet a desperate need for new approaches for debilitating diseases of the lung (US$4.3b), kidney (U
Slide 24: Partnering momentum increasing to unlock asset value and build pipeline
Partnering momentum increasing to unlock asset value and build pipeline • Illustrative recent progress Out-licensing or co-investment for Phase II development Generating return on investment to date • 21 active licensee evaluations post BIO2023 AD-214 Phase II • One party testing AD-214 in own assay
Slide 25: 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 pathway to Phase II clinical studies ü Phase II dose well tolerated, PK/PD profile supportive of § Out-license or project finance potential efficacy, no concerning immune res
Slide 26: Experienced in-house team
Experienced in-house team Executing from discovery through product development BOARD EXECUTIVE SCIENTIFIC ADVISORY BOARD Paul MacLeman, DVM Angus Tester, PhD Mick Foley, PhD CHAIR SENIOR MANAGER, FOUNDING CHIEF PROJECTS AND PROGRAMS SCIENTIST Tim Oldham, PhD Janette Dixon, DBA Brian Richardson CEO &
Slide 27: AdAlta's foundations in place for growth
AdAlta’s foundations in place for growth Lead asset AD-214 heading to Phase II (US$4.3b IPF market plus other indications), substantially de- risked by Phase I extension study clinical readouts AD-214 partnering window open with multiple options in play: active market with comparator valuations >US$
Slide 28: www.adalta.com.au
A modern targeting system for next generation drugs AdAlta Ltd (ASX:1AD) Investor Presentation October 2023 For more information please contact: Tim Oldham CEO & Managing Director +61 403 446 665 t.oldham@adalta.com.au Investor Relations The Capital Network Russell Katz +61 2 8999 3699 russell@theca
Slide 29: i-bodies are a powerful drug discovery tool to engage targets that traditional 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 Current pipeline focus CAR cell therapy ADC/ radiotherapeutic Bi-specific Unique binding Fc-fusion Avoid off-target ~10% the size of capabili
Slide 30: 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 Lung, kidney IV Available fibrosis SC to license AD-214 Available CXCR4 Eye fibrosis IVT