Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (December 2021)
27 slides from Amplia Therapeutics's investor presentation, Dec 16, 2021
Slide 1: Amplia Provides Updated Investor Presentation
ABN 16 165 160 841 ASX RELEASE 16th December 2021 Amplia Provides Updated Investor Presentation Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) today released a new investor presentation (attached) which outlines the Company’s technology, plans for growth during 2022 and reviews s
Slide 2: Growth plans for 2022 and 2021 Year In Review
Amplia Therapeutics Growth plans for 2022 and 2021 Year In Review December 2021 Amplia Therapeutics Limited
Slide 3: Disclaimer
Disclaimer The information contained in the presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Amplia Therapeutics Limited (“Amplia”) in any jurisdiction. No representation or warranty, express or implied, is made in relation to the a
Slide 4: Company & Technology Snapshot
Company & Technology Snapshot 3
Slide 5: Why is FAK a good target for drug development?
Why is FAK a good target for drug development? Focal Adhesion Kinase (FAK) Indication FIBROTIC DISEASES SOLID CANCERS Opportunities Monotherapy Combination Therapy • Lung fibrosis • Pancreatic cancer • Liver fibrosis (NASH) • Ovarian cancer • Renal fibrosis • Breast cancer • Wound healing • Hepatoce
Slide 6: Targeting cancer's defence mechanisms
Targeting cancer’s defence mechanisms Fibrosis FAK helps establish and maintain the dense, fibrotic tissue around cancers FAK is involved in many cancer defence mechanisms that reduce the effectiveness of cancer drugs Immune response Amplia is investigating the use of FAK FAK triggers the release of
Slide 7: Amplia's target indications
Amplia’s target indications Pancreatic Cancer Idiopathic Pulmonary Fibrosis (IPF) • 60,000 new diagnoses and 48,000 deaths from • Affects 130,000 in the US and ~3M people pancreatic cancer in the US each year worldwide • Difficult-to-treat cancer that is often surrounded • Devastating, progressive d
Slide 8: Recent deals for anti-fibrotic and pancreatic cancer drugs
Recent deals for anti-fibrotic and pancreatic cancer drugs US$1,300M Total disclosed upfront and milestones payments; excludes potential royalty payments US$870M US$785M US$20M + US$380M US$80M + milestones R&D US$235M Year 2021 2020 2020 2019 2019 2019 2019 Deal Licensing/R&D License License Licens
Slide 9: Amplia's pipeline
Amplia’s pipeline DRUG INDICATION THERAPY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 & APPROVAL AMP945 Pancreatic cancer Combination therapy AMP945 Idiopathic pulmonary Monotherapy fibrosis (IPF) AMP945 Other cancers & Combo/Mono fibrotic diseases therapies AMP886 Cancers & Monotherapy fibrotic disease Cur
Slide 10: Amplia's Growth Plans for 2022
Amplia’s Growth Plans for 2022 9
Slide 11: Key objectives for 2022
Key objectives for 2022 Recruit patients in two Phase 2 trials of AMP945 Pancreatic cancer Report early results Pulmonary fibrosis Expand pipeline by progression of AMP886 into early development Continue to build momentum by hitting key development and corporate milestones 10
Slide 12: Phase 2 trials planned in 2022
Phase 2 trials planned in 2022 • Phase 2 pancreatic cancer clinical trial • Protocol and design work completed • Funded through recent capital raise • Drug manufacture nearing completion • Dosing expected to commence in Q1 CY2022 • Phase 2 pulmonary fibrosis clinical trial • Vendors, designs and sch
Slide 13: Clinical schedule
Clinical schedule CY2021 CY2022 CY2023 CY2024 Activity Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pancreatic Cancer HREC Filing Decision Point Pre-IND Patient Recruitment Interim Analysis Pulmonary Fibrosis Toxicology Patient Recruitment HREC: Human Research Ethics Committee IND: Investigational New
Slide 14: Performance track record
Performance track record “Am plia’s team has built a solid track record for delivery against our key objectives. W e ex pect this to continue in 2022 as w e progress AM P945 into Phase 2 trials.” Dr John Lambert, Amplia CEO. Major achievements in 2021 • Completed successful Phase 1 trial of AMP945 s
Slide 15: Corporate & Company Milestones in 2021
Corporate & Company Milestones in 2021 14
Slide 16: Human capital
Human capital Ex pansion of team , capabilities and ex perience reflecting the grow th and m aturation of Am plia • Jane Bell appointed as Independent Director in April 2021: • 30 years experience as banking and finance lawyer • Extensive experience as a Director on health and medical research Board
Slide 17: Financial capital
Financial capital Secured investm ent and accessed additional funding sources to support initiation of Phase 2 program • Strong support from investors resulting in $16.2 million in new capital in two rounds: • $3.8 million raised in May 2021 via Share Placement • $12.4 million raised in December 202
Slide 18: Clinical Development Milestones in 2021
Clinical Development Milestones in 2021 17
Slide 19: Completed Phase 1 trial of AMP945 in May 2021
Completed Phase 1 trial of AMP945 in May 2021 • Trial execution: • Commenced in October 2020 - completed May 2021 • Recruited 56 healthy volunteers aged 18 - 65 • Single site in Melbourne, Australia • Summary of Outcomes • Safe and well-tolerated at all doses tested • Inhibition of FAK demonstrated
Slide 20: Significance of data from Phase 1 clinical trial
Significance of data from Phase 1 clinical trial • Inhibition of FAK in skin biopsies confirms target engagement • AMP945 inhibits human FAK in human volunteers • ‘Target engagement’ is a prerequisite for clinical efficacy • AMP945’s safety profile supports dosing in patients • Pancreatic cancer pat
Slide 21: Research Achievements & Developments in 2021
Research Achievements & Developments in 2021 20
Slide 22: Amplia's FAK inhibitors reduce key disease markers in liver fibrosis model
Amplia’s FAK inhibitors reduce key disease markers in liver fibrosis model Fibroblast marker Fibroblast activation NASH symptoms Fibrosis ns Not significant * P ≤ 0.05 ** P ≤ 0.01 *** P ≤ 0.001 ****P ≤ 0.0001 21
Slide 23: Formalised collaboration with the Garvan Institute
Formalised collaboration with the Garvan Institute • Garvan and Amplia collaboration agreement signed June 2021: • Work program seeks to expand on therapeutic opportunities for AMP945 • Collaboration builds on existing knowledge and taps clinician network • Collaboration has already shown that: • AM
Slide 24: Garvan data supports rationale for Phase 2 trial
Garvan data supports rationale for Phase 2 trial • Recent publications highlight potential synergy of FAK inhibition with current standards of care Key findings • Priming with FAK inhibitor before treatment with gemcitabine/Abraxane® • Increases survival in KPC pancreatic cancer model • Reduces meta
Slide 25: AMP945 improves survival in pancreatic cancer model
AMP945 improves survival in pancreatic cancer model • 25% improvement in survival when added to standard of care (p ≤ 0.001) • KPC* is a highly aggressive animal model of human pancreatic cancer • Demonstrates pharmaceutical activity of AMP945 translates into survival benefit “A 25% improvement in s
Slide 26: Summary of growth plans for 2022
Summary of growth plans for 2022 • Over the last 18-months, Amplia has progressed from a pre-clinical stage company to being a Phase 2-ready company • In 2022, Amplia will continue to build on its track record for delivery • Key value drivers for the company will be • Initiation of two Phase 2 clini
Slide 27: Amplia Therapeutics Limited
Amplia Therapeutics Limited ABN 16 165160 841 Contact: ASX: ATX John Lambert info@ampliatx.com Chief Executive Officer www.ampliatx.com john@ampliatx.com
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