Adalta Ltd. · ASX:1AD
Adalta — Investor Presentation (October 2023)
39 slides from Adalta's investor presentation, Oct 27, 2023
Slide 1: Next generation protein and cell therapies: solutions to debilitating diseases
For personal use only Next generation protein and cell therapies: solutions to debilitating diseases Tim Oldham PhD, CEO and Managing Director, AdAlta (ASX:1AD) Overview for investors, 26 October 2023
Slide 2: Disclaimer
Investor presentation – October 2023 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 3: AdAlta (ASX:1AD) business and focus
Investor presentation – October 2023 3 AdAlta (ASX:1AD) business and focus For personal use only 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 Pro
Slide 4: AdAlta's portfolio: high value therapeutics and a platform
Investor presentation – October 2023 4 AdAlta’s portfolio: high value therapeutics and a platform to help other companies address challenging diseases in fibrosis and immuno-oncology For personal use only Fibrosis: degenerative, progressive, fatal AdAlta’s AD-214 could meet a desperate need for new
Slide 5: AD-214: new hope for fibrotic disease patients
For personal use only AD-214: new hope for fibrotic disease patients 5
Slide 6: The need: better outcomes for IPF and other fibrotic diseases
Investor presentation – October 2023 6 The need: better outcomes for Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases For personal use only 45% of developed world IPF prevalence >490,000 deaths have a chronic 72,000 worldwide 78,000 fibrosis component Europe USA 14,000 159,000 Japan E
Slide 7: Bill van Nierop: IPF survivor on the challenge of living with IPF
Investor presentation – October 2023 7 Bill van Nierop: IPF survivor on the challenge of living with IPF For personal use only “I talked with a 60 something grandmother, who really enjoyed days “… sadly I am one of a few who can actually looking after grandkids, but as disease progressed she found r
Slide 8: AdAlta's solution: AD-214 readied for Phase II and partnering
Investor presentation – October 2023 8 AdAlta’s solution: AD-214 is being readied for Phase II clinical studies and partnering For personal use only A$45m investment to date has built strong value Next steps to realise value proposition First in class molecule targeting validated mode of action in f
Slide 9: Recent achievements #1: Potential IV efficacy verified; potential SC product identified
Investor presentation – October 2023 9 Recent achievements #1: Potential IV efficacy verified at clinical dosing regimens; potential SC product identified For personal use only A. AD-214 has demonstrated efficacy in multiple animal models of fibrotic disease B. In humans, AD-214 was able to maintain
Slide 10: Recent achievements #2: Phase I extension study
Investor presentation – October 2023 10 Recent achievements #2: Phase I extension study supporting partnering and Phase II For personal use only AD-214 multidose Phase I extension clinical study Establishes safety of AD-214 at likely maximum dose to be used in Phase II studies ü 3x10 mg/kg doses wel
Slide 11: Competitive positioning: AD-214 differentiated approach to fibrotic disease
Investor presentation – October 2023 Competitive positioning: AD-214 takes a much needed, differentiated approach to fibrotic disease For personal use only AD-214 poised to enter Phase II as one of only three products targeting a novel but 18 active product candidates in Phase II or beyond* validate
Slide 12: The value: pharma companies license fibrosis assets for significant prices
Investor presentation – October 2023 12 The value: pharma companies license fibrosis assets for significant prices: IPF examples Upfront payment Contingent Clinical Phase Date Licensor/target Licensee/acquirer Transaction For personal use only to licensor milestones at transaction Feb 23 Acquisition
Slide 13: Co-developed immuno-oncology programs: i-CAR-cell therapies
For personal use only Co-developed immuno-oncology programs: i-CAR-cell therapies 13
Slide 14: The need: multifunctional CAR-cell therapies
Investor presentation – October 2023 14 The need: multifunctional CAR-cell therapies For personal use only Therapy involves re-engineering patient’s own immune cells to “see” cancer – living drug, single dose, potentially curative >US$2.6 billion earned in 20223 US$20.3 billion CAR-T market forecast
Slide 15: i-bodies enable superior CAR constructs (i-CARs)
Investor presentation – October 2023 15 AdAlta’s solution: i-bodies enable superior CAR constructs (i-CARs) For personal use only when combined with partner platforms Tiny i-bodies take up LESS room in inserted gene, enabling TWICE the engineered i-body targeting Tumor cell domain functionality Tumo
Slide 16: i-CAR-T: Valuable cell therapy partnering potential at pre-clinical proof of concept
Investor presentation – October 2023 16 i-CAR-T: Valuable cell therapy partnering potential at pre-clinical proof of concept For personal use only AdAlta i-bodies + Carina cell therapy platform i-body® enabled CAR-T (i-CAR-T) cells have ü successfully demonstrated in vitro cancer cell line killing (
Slide 17: The value: cell therapy up front deal value higher than other protein therapeutics
Investor presentation – October 2023 17 The value: cell therapy up front deal value higher than other protein therapeutics For personal use only Source: JPMorgan, Q2 2023 Biopharma Licensing and Venture Report, July 2023
Slide 18: Co-developed immuno-oncology programs: i-PET imaging
For personal use only Co-developed immuno-oncology programs: i-PET imaging 18
Slide 19: The need: Immuno-oncology imaging
Investor presentation – October 2023 19 The need: Immuno-oncology (I/O) imaging For personal use only Immuno-oncology (I/O) drug market is worth US$95 billion1 … … but only 20-40% of patients respond2 to therapy Granzyme B (GZMB) is produced by immune cells to kill cancer: potential biomarker of I/O
Slide 20: Funded discovery, shorter timeline to royalties for GZMB i-PET imaging asset
Investor presentation – October 2023 20 AdAlta’s solution: funded discovery, shorter timeline to royalties for GZMB i-PET imaging asset For personal use only AdAlta i-bodies + GE PET technology = GZMB i-PET asset to evaluate the effectiveness of immuno-oncology drugs ü Fully funded discovery program
Slide 21: The investment opportunity
For personal use only The investment opportunity 21
Slide 22: i-bodies are a powerful drug discovery tool
Investor presentation – October 2023 22 i-bodies are a powerful drug discovery tool to engage targets that traditional antibodies can’t For personal use only Small Antibodies i-bodies™ Flexible, modular formats Molecules Current pipeline focus CAR cell therapy ADC/ radiotherapeutic Bi-specific Fc-fu
Slide 23: AdAlta's pipeline so far: five active assets plus growing inventory
Investor presentation – October 2023 23 AdAlta’s pipeline so far: five active assets plus growing i-body® inventory For personal use only Discovery Non-clinical Clinical Target Product Indication Partner Lead IND Discovery Preclinical Phase I Phase II optimisation enabling Lung, kidney IV Available
Slide 24: Partnering momentum increasing to unlock asset value and reduce risk
Investor presentation – October 2023 24 Partnering momentum increasing to unlock asset value and reduce risk For personal use only • Illustrative recent progress Out-licensing or co- investment for Phase II development Generating return on investment to date • 21 active evaluations post BIO2023 AD-2
Slide 25: Upcoming FY24 milestones
Investor presentation – October 2023 25 Upcoming FY24 milestones: AD-214 and i-CAR-T data + potential multiple transaction upside For personal use only Strategy Milestone Impact ü HREC approval, 1st participant Phase I extension (Q3 23) Realise Generates new data for partnering, shortens Phase II st
Slide 26: Corporate snapshot
Investor presentation – October 2023 26 Corporate snapshot For personal use only Key financial details (23 Oct 2023) Share price performance (ASX:1AD) (last 12 months) 0.06 6.0 HQ and operations Melbourne, Australia Market capitalisation A$10.63m 0.05 5.0 Share price (12 month closing range) A$0.024
Slide 27: Experienced, in-house team to execute from discovery through product development
Investor presentation – October 2023 27 Experienced, in-house team to execute from discovery through product development BOARD EXECUTIVE SCIENTIFIC ADVISORY BOARD For personal use only Paul MacLeman Angus Tester, PhD Mick Foley, PhD CHAIR SENIOR MANAGER, FOUNDING CHIEF PROJECTS AND SCIENTIST PROGRAM
Slide 28: Investment proposition
Investor presentation – October 2023 28 Investment proposition For personal use only Fibrosis/inflammation Immuno-oncology i-body platform to create value AD-214: Phase II and partnering in $4.3b 2 co-development collaborations market1 (4 programs) in $20b2 and $6b3 markets Strategy: invest to maint
Slide 29: Contact
For personal use only Contact: Tim Oldham, CEO and Managing Director [email protected] www.adalta.com.au
Slide 30: The market opportunity: US dominates value, unmet needs in China
Investor presentation – October 2023 The market opportunity: US market dominates value today, with significant unmet patient needs in China For personal use only IPF: diagnosed prevalence Global market value Global prevalence: 2-3 per 100,000 600 559 6 Diagnosed prevalent patients (‘000) 495 CAGR CA
Slide 31: AD-214 is a first in class CXCR4 antagonist designed for fibrotic disease
Investor presentation – October 2023 31 AD-214 is a first in class CXCR4 antagonist designed specifically for fibrotic disease For personal use only Product Profile: AD-214 Product development strategy Disease Area Fibrosis Target intravenous (IV) product Potential subcutaneous (SC) Molecule class P
Slide 32: AD-214 offers a superior safety profile compared with marketed products
Investor presentation – October 2023 AD-214 offers a superior safety profile and potential efficacy compared with marketed products For personal use only Product attributes AD-214 Ofev (nintedanib) Esbriet (pirfenidone) Sponsor Development stage Phase I/IIa Marketed Marketed More specific, targeted
Slide 33: AD-214 competitive and differentiated profile versus leading disease modifying products
Investor presentation – October 2023 AD-214 offers a competitive and differentiated product profile compared with leading disease modifying products For personal use only Product attributes AD-214 BI-1015550 BMS-986278 Bexotegrast Sponsor Development stage Phase I/II Phase III Phase III Phase II Ant
Slide 34: AD-214: efficacy validated in IPF mouse model; safety and target engagement in Phase I
Investor presentation – October 2023 34 AD-214: efficacy validated in IPF mouse model; safety and target engagement in Phase I For personal use only AD-214 inhibited development of lung fibrosis in a mouse AD-214 was well tolerated in Phase I clinical trials and model at a wide range of doses and do
Slide 35: Two weekly IV dosing regimens maintain sufficient receptor occupancy
Investor presentation – October 2023 35 Two weekly IV dosing regimens can maintain sufficient receptor occupancy to meaningfully inhibit fibrotic processes For personal use only 1. Ex vivo cell migration is a model fibrotic process and inhibition of migration is a model of efficacy • Maximum efficac
Slide 36: Two weekly IV and weekly SC dosing regimens achieve target receptor occupancy
Investor presentation – October 2023 36 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 admini
Slide 37: i-body-like sdAb CAR-T therapies are an emerging, validated approach
Investor presentation – October 2023 37 i-body-like sdAb CAR-T therapies are an emerging, validated approach For personal use only GROUP YEAR STAGE SDAB CAR TARGET AVAILABLE RESULTS Proof of principle AdAlta Ltd/Carina Biotech 2022 Undisclosed (in vitro) P3 results for n=97 patients Johnson and John
Slide 38: Building the first iCAR-T cell therapy: proof of principle results
Investor presentation – October 2023 38 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 c
Slide 39: i-CAR-T: Valuable cell therapy partnering potential at pre-clinical proof of concept
Investor presentation – October 2023 39 i-CAR-T: Valuable cell therapy partnering potential at pre-clinical proof of concept For personal use only No. of Upfront/target Deal value/target Date Licensee Licensor assets (US$m) (US$m) Jun-22 2 30 730 Jul-20 1 20 988 Feb-20 2 25 300 Nov-19 1 10 304 Oct-1