Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Shareholder Meeting (August 2024)
30 slides from Amplia Therapeutics's shareholder meeting presentation, Aug 23, 2024
Slide 1: ASX Release: CEO & Managing Director's Presentation to AGM
ASX RELEASE 23 August 2024 CEO & Managing Director’s Presentation to Annual General Meeting Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) is pleased to release the CEO & Managing Director’s presentation to the Company’s Annual General Meeting (YE 31 March 2
Slide 2: Annual General Meeting
For personal use only Annual General Meeting 23 August 2024 Dr Chris Burns CEO and MD ampliatx.com | @ampliatx
Slide 3: Disclaimer
DISCLAIMER This presentation (Presentation) contains summary information about Amplia Therapeutics market, regulatory and other relevant environments that will exist and affect Amplia’s business and Limited ACN 165 160 841 and its subsidiaries (the Company or Amplia) which is current as at 30 Jun op
Slide 4: Snapshot
SNAPSHOT Amplia is developing a pipeline of small molecule inhibitors of Focal Adhesion Kinase (FAK) - a validated target in cancer For personal use only Amplia’s lead compound narmafotinib is the best-in-class FAK inhibitor in development Amplia’s ongoing trial of narmafotinib in advanced pancreati
Slide 5: Development Highlights
DEVELOPMENT HIGHLIGHTS Phase 2a clinical trial in advanced Orphan Drug Designation from US pancreatic cancer underway FDA for pancreatic cancer and IPF* Well tolerated 7 years market exclusivity in US For personal use only Promising signs of efficacy Assistance with development planning Interim read
Slide 6: Narmafotinib positioned as preferred agent to enhance solid tumour drugs
Narmafotinib is being positioned as the preferred For personal use only agent to enhance activity of drugs for solid tumours
Slide 7: Corporate Summary
CORPORATE SUMMARY ASX:ATX 12 month share price chart Share price A$0.13 (22-Aug-24) For personal use only Shares on 274.21m issue Market cap A$35.65m (22-Aug-24) Cash at hand A$6.3m on a pro forma basis* (30-Jun-2024) Platinum Investment Substantial Management Ltd Shareholders Blueflag Holdings Pty
Slide 8: Experienced Board
EXPERIENCED BOARD BOARD For personal use only Warwick Tong Robert Peach Jane Bell Chris Burns MB ChB MPP GAICD PhD LLB, LLM (Lond), FAICD PhD GAICD Chair Director Director CEO and MD 7
Slide 9: Experienced Management
EXPERIENCED MANAGEMENT SENIOR TEAM For personal use only Rhiannon Jones Terrie-Anne Cock Charlotte Mulder Adrian Sulistio PhD GAICD PhD BVSc (Hons) MBA B Eng (Hons), B Com, PhD COO Director Translational Science Director Early Clinical Development Manager Product Development 8
Slide 10: Amplia's drugs inhibit the enzyme Focal Adhesion Kinase (FAK)
Amplia’s drugs inhibit the enzyme Focal For personal use only Adhesion Kinase (FAK)
Slide 11: Focal Adhesion Kinase (FAK)
FOCAL ADHESION KINASE (FAK) FAK is a critical protein in cancer growth and spread, and in formation of fibrotic (scar) tissue For personal use only Broad clinical potential Amplia’s drugs potently and selectively block Cancer Fibrosis Scarring the activity of the FAK protein 10
Slide 12: FAK Inhibitors in Development
FAK INHIBITORS IN DEVELOPMENT Only 3 companies with bona fide FAK inhibitors in development For personal use only Verastem Inxmed Good Good PK Selectivity DDI Clinical Notes Stage profile profile Amplia Narmafotinib Safe and well Ph 2a (Amplia) tolerated Defactinib Promising data in Narmafotinib has
Slide 13: Narmafotinib
NARMAFOTINIB Drug-like small molecule Highly potent and selective For personal use only Excellent PK; once-a-day dosing FAK Activity Highly potent FAK inhibitor Minimal DDI* risk when combining with other drugs Biochemical assays Selectivity IC 50 2.2 nM Highly selective for FAK K 29 pM Narmafotinib
Slide 14: Narmafotinib in Cancer
NARMAFOTINIB IN CANCER Multi-action of narmafotinib Extensive preclinical data showing narmafotinib activity in cancer models Anti-proliferative Synergy with For personal use only Reduces cell’s ability chemotherapies to proliferate Enhances activity of and migrate drugs and other Early signals of e
Slide 15: Broad Potential for FAK Inhibitors in Cancer
BROAD POTENTIAL FOR FAK INHIBITORS IN CANCER FAK inhibitors can enhance effects of existing therapeutic For personal use only approaches in solid tumours Chemotherapy Radiotherapy ... but can also enhance newer targeted treatments Kinase Inhibitors Immune Checkpoint Inhibitors Antibodies and ADCs* C
Slide 16: Clinical studies of narmafotinib in pancreatic cancer
Clinical studies of narmafotinib For personal use only in pancreatic cancer
Slide 17: Pancreatic Cancer: An Unmet Need
PANCREATIC CANCER An unmet need For personal use only 13% Increasing Prevalence 5 year Market size survival Estimated 66,000 diagnoses Global treatment market and 50,000 deaths in Difficult-to-treat: estimated over US$6 billon US this year* typically detected late in in 2023 disease progression** 4,
Slide 18: Pancreatic Cancer: Role of FAK in Disease Progression
PANCREATIC CANCER Undisputed role of FAK in disease progression Over-expression FAK activity correlates Beneficial preclinical efficacy and increased FAK activity with worse outcome with FAK inhibition For personal use only Narmafotinib decreases tumour Low levels active FAK = better survival fibros
Slide 19: Clinical data indicates narmafotinib safe and well tolerated
Clinical data indicates narmafotinib safe and For personal use only well tolerated with preliminary signs of efficacy
Slide 20: ACCENT Trial Design
ACCENT TRIAL DESIGN Phase 1b Dose Phase 2a Interim Phase 2a (cont) (Australia) Selected (Australia and South Korea) Analysis (Australia and South Korea) For personal use only ≥6 PR 14 patients 26 patients 24 patients 400 mg* 200 mg 100 mg COMPLETED RECRUITED *Dose selected for Phase 2 19
Slide 21: ACCENT Phase 1b: Key trial read-outs
ACCENT PHASE 1b Key trial read-outs following industry standard criteria Primary Endpoint: Objective Response Rate For personal use only Secondary Endpoint: Duration on Trial Objective Response Rate categorised as: Complete Response (CR) - Disappearance of all tumour lesions; no new lesions Partial
Slide 22: ACCENT Phase 1b: Combination with Gemcitabine and Abraxane
ACCENT PHASE 1b Narmafotinib in combination with standard of care gemcitabine and Abraxane® Orally-dosed narmafotinib in the days preceding weekly chemotherapy For personal use only 3 Cohorts (100 mg, 200 mg, 400 mg) Orally-dosed (capsules) Once-a-day Safe and well tolerated All patients elected to
Slide 23: ACCENT Phase 1b: Preliminary signs of efficacy
ACCENT PHASE 1b Preliminary signs of efficacy observed Best Response (all patients) Improved response rate (PR and SD) compared to For personal use only ACCENT Historical Best Overall Best Overall historical gemcitabine/Abraxane alone Classification Response* Response** n=14 (n=431) Comparison to pi
Slide 24: ACCENT Phase 1b: Tumour Reduction
ACCENT PHASE 1b Tumour Reduction Preliminary signs of efficacy observed (% change from baseline) Improved response rate (PR and SD) compared to For personal use only historical gemcitabine/Abraxane alone (individual patients) Comparison to pivotal trial (2013)** Better objective response (tumour red
Slide 25: ACCENT Phase 1b: Duration on trial
ACCENT PHASE 1b Preliminary signs of efficacy observed Duration on trial Improved response rate (PR and SD) compared to For personal use only historical gemcitabine/Abraxane alone Comparison to pivotal trial (2013)** Better objective response (tumour reduction) at higher doses 4 of 6 PRs with top do
Slide 26: ACCENT Phase 2a Preliminary Data
ACCENT PHASE 2a PRELIMINARY DATA Require 6 or more PRs to progress to 50 patient total enrolment For personal use only By 21 August, 5 confirmed PRs have been observed at 4 month timepoint >30% reduction in tumour lesion size sustained over 2 months No new lesions In addition, 6 SDs also observed at
Slide 27: Summary
For personal use only Summary
Slide 28: Clinical Focus and Opportunity
CLINICAL FOCUS AND OPPORTUNITY For personal use only Combinations in Combinations in Preclinical evidence - pancreatic cancer ovarian cancer other solid cancers Gemcitabine and Abraxane Platinum resistant disease Bile duct, oesophageal, head (ACCENT trial) - and neck cancer - Maintenance therapy pos
Slide 29: Recent and Planned Milestones
RECENT AND PLANNED MILESTONES For personal use only 2H 2023 / 1H 2024 2H 2024 1H 2025 Completion enrolment 50 pts ACCENT trial - Complete Phase 1b ACCENT trial - October 26 Patients recruited ACCENT trial - July March Korean regulatory approval - November 6 Confirmed PRs - September Initiation ovari
Slide 30: Chris Burns, CEO and MD
For personal use only Chris Burns PhD GAICD CEO and MD chris@ampliatx.com ampliatx.com | @ampliatx
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