Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (February 2022)
30 slides from Amplia Therapeutics's investor presentation, Feb 1, 2022
Slide 1: Amplia Investor Presentation - February 2022 (ASX release)
ABN 16 165 160 841 ASX RELEASE 1 February 2022 For personal use only Amplia Investor Presentation - February 2022 Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) today released a new investor presentation (attached) which outlines the Company’s technology and plans for growth duri
Slide 2: Investor Presentation February 2022
For personal use only ampliatx.com Investor Presentation February 2022
Slide 3: Disclaimer
Disclaimer The information contained in the presentation is not intended to be an offer for subscription, invitation or For personal use only recommendation with respect to shares of Amplia Therapeutics Limited (“Amplia”) in any jurisdiction. No representation or warranty, express or implied, is mad
Slide 4: Section One: Company and Technology Snapshot
Section One For personal use only Company and Technology Snapshot Amplia is a clinical-stage company developing small molecule inhibitors of Focal Adhesion Kinase (FAK) for the treatment of cancer and fibrotic diseases. Next Page
Slide 5: Company Snapshot
Company Snapshot For personal use only ATX Price and volume – 6 monthsto 28 Jan 2022 SHARES | 194m MARKET CAP | $31m CASH | $16.2m LAST QUARTER BURN | $0.94m INSTITUTIONS | Platinum Inv. Management 17.5%; PRICE | $0.16 Blueflag Holdings 7.0%; 12-MONTH HIGH | $0.35 Acorn Capital 6.5%. AV DAILY VOLUM
Slide 6: Amplia Board
Amplia Board For personal use only Warwick Tong John Lambert Jane Bell Robert Peach Chris Burns MB, ChB, MPP, GAICD PhD, GAICD LLM, LLB, BEc PhD PhD, FRSC, GAICD Non-Executive Independent Managing Director & CEO Non-Executive Non-Executive Non-Executive Director & Chair Independent Director Independ
Slide 7: Investment Highlights
Two Phase 2 clinical trials of lead asset AMP945 scheduled to start in 2022. For personal use only First results expected mid-2023 with early data reports likely beforehand Fully funded to achieve major value inflections Initial efficacy assessment in pancreatic cancer trial Regulatory approval to
Slide 8: Amplia's Pipeline
Amplia’s Pipeline Current Status Next 12- months For personal use only Drug Indication Therapy Preclinical Phase 1 Phase 2 Phase 3 (approval) AMP945 Pancreatic Combination Cancer Therapy Idiopathic AMP945 pulmonary Monotherapy fibrosis (IPF) Other cancers AMP945 & fibrotic Combo/ diseases Monothera
Slide 9: Amplia's Therapeutic Opportunities
Amplia’s Therapeutic Opportunities For personal use only Melanoma Lung Fibrosis Breast cancer Liver Fibrosis Pancreatic cancer Kidney Fibrosis Ovarian cancer Colorectal cancer 8
Slide 10: Amplia's Current Focus
Amplia’s Current Focus For personal use only Pancreatic Cancer Idiopathic Pulmonary Fibrosis (IPF) 60,000 new diagnoses and 48,000 deaths from pancreatic cancer in the US each year* Affects ~3M people worldwide** Difficult-to-treat cancer Devastating, progressive disease caused by Less than 20%
Slide 11: Why Focus on Pancreatic Cancer and Pulmonary Fibrosis?
Why Focus on Pancreatic Cancer and Pulmonary Fibrosis? For personal use only Pancreatic Cancer Pulmonary Fibrosis Unmet need AMP945 Orphan Drug Designation (US FDA) Preclinical data supports rationale for clinical assessment Available clinical safety data supports proposed trial Gateway to other i
Slide 12: Section Two: Targeting FAK in Cancer and Fibrosis
Section Two For personal use only Targeting FAK in Cancer and Fibrosis Fibrotic shields protect many solid tumours from chemotherapy- Amplia’s FAK inhibitors aim to remove the shield. Next Page
Slide 13: Amplia's Drug Target | Focal Adhesion Kinase
Amplia’s Drug Target | Focal Adhesion Kinase For personal use only Fibrotic Diseases Solid Cancers Promotes fibrosis Shields tumours from chemotherapy Focal Adhesion Fibrotic tissue Fibrotic Tissue Kinase (FAK) surrounding a tumour 12
Slide 14: Amplia's Hypothesis | Enhancing Chemotherapy
Amplia's Hypothesis | Enhancing Chemotherapy For personal use only Fibrotic shields protect many solid tumours from chemotherapy Amplia’s FAK inhibitors aim to remove the shield FAK inhibitor Exposed tumour Dead tumour Fibrotic tissue surrounding a tumour 13
Slide 15: Rationale for Phase 2 Pancreatic Cancer Trial
Rationale for Phase 2 Pancreatic Cancer Trial For personal use only Preclinical evidence highlights potential synergy of FAK inhibition with current standards of care Key findings: Priming with FAK inhibitor before treatment with gemcitabine/Abraxane® Increases survival in pancreatic cancer mod
Slide 16: AMP945 Improves Survival in Pancreatic Cancer Model
AMP945 Improves Survival in Pancreatic Cancer Model For personal use only 25% improvement in survival when added to standard of care (p ≤ 0.001) KPC* is a highly aggressive animal model of pancreatic cancer FAK inhibition by AMP945 translates into survival benefit A 25% improvement in survival i
Slide 17: AMP945 Inhibits Deposition and Crosslinking of Collagen
AMP945 Inhibits Deposition and Crosslinking of Collagen For personal use only Total collagen decreases Cross-linked collagen is a key component of fibrotic tissues Cross-linked collagen decreases AMP945 inhibits collagen formation and collagen cross-linking in a dose- dependent manner Increasing AM
Slide 18: AMP945 in Lung Fibrosis
AMP945 in Lung Fibrosis Control: healthy lung For personal use only Bleomycin animal model of lung fibrosis Prevention Treatment AMP945 administered Bleomycin: fibrotic lung AMP945 administered after before onset of fibrosis onset of fibrosis Evaluating ability of Evaluating ability of AMP945 A
Slide 19: Section Three: Clinical Development
Section Three For personal use only Clinical Development Amplia’s clinical scheduleprovides multiple potential value inflections within the next 12-months. Next Page
Slide 20: Phase 2 Trials Planned in 2022
Phase 2 Trials Planned in 2022 For personal use only Phase 2 pancreatic cancer Phase 2 pulmonary fibrosis clinical trial clinical trial Protocol and design work completed Vendors, designs and schedules for Funded through recent capital raise preliminary toxicology locked in Drug manufacture comp
Slide 21: Phase 2 Study of AMP945 in Pancreatic Cancer
Phase 2 Study of AMP945 in Pancreatic Cancer For personal use only Key trial elements First-line therapy - Largest patient cohort - Healthier patients - Aims to position AMP945 as a first-line treatment option Patients with non-resectable or metastatic pancreatic cancer Intermittent dosing of
Slide 22: Pancreatic Cancer Priming Dose Regimen
Pancreatic Cancer Priming Dose Regimen AMP945 priming doses For personal use only Chemotherapy Normal chemotherapy treatment cycle dose: gemcitabine and Abraxane® Day 1 Day 8 Day 15 Day 22 Amplia’s investigational chemotherapy treatment cycle Day 1 Day 8 Day 15 Day 22 21
Slide 23: Phase 2 Pancreatic Cancer Trial Summary
Phase 2 Pancreatic Cancer Trial Summary For personal use only Patients with Stage III or IV pancreatic cancer First line therapy Population ECOG status ≤ 1 Life expectancy of >3 month Phase 1b/2a open label, single arm study to Design evaluate safety, PK, PD and efficacy of AMP945 in combinatio
Slide 24: Phase 2 Trial Overview and Decision Tree
Phase 2 Trial Overview and Decision Tree For personal use only Stage 1 Stage 2 Detailed regulatory interactions + 26 patients >> 19% responders(>> 5/26) Randomised efficacy trial > 30% > 19% responders(> 5/26) responders ~12 Interim (> 15/50) patients Analysis dose escalation Evaluate a furt
Slide 25: Clinical trial supplies
Clinical trial supplies For personal use only Manufacture of 2kg batch scale of AMP945 drug substance Improved process Increased scale GMP Manufacture of AMP945 drug product (capsules) Machine filling of capsule - supports commercial development Supplies pancreatic cancer trial GMP 24
Slide 26: Amplia's Clinical Schedule
Amplia’s Clinical Schedule HREC: Human Research Ethics Committee IND: Investigational New Drug Complete CY2022 CY2023 CY2024 For personal use only Activity Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pancreatic Cancer Protocol Drug product Decision Vendor contracts Point HREC approval Pre-IND/IND Patien
Slide 27: Section Four: Growth Plans for 2022
Section Four For personal use only Growth Plans for 2022 Amplia will continue to build momentum by hitting key development and corporate milestones this year. Next Page
Slide 28: Performance Track Record
Performance Track Record For personal use only Major Achievements in 2021 Completed successful Phase 1 trial of AMP945 supporting progression into Phase 2 trials in two indications Phase 2 trial design work led to inclusion of first-line patients in final trial design New preclinical data furthe
Slide 29: Top Line Objectives for 2022
Top Line Objectives for 2022 For personal use only Initiate recruitment of patients in two Phase 2 trials of AMP945 Pancreatic cancer Report early results Pulmonary fibrosis Regulatory engagement to refine development plans Expand therapeutic opportunities for AMP945 Cancer Fibrosis Expand pip
Slide 30: Thank You.
Thank You. For personal use only Amplia Therapeutics Limited ABN 16 165160 841 ASX: ATX info@ampliatx.com ampliatx.com John Lambert Chief Executive Officer john@ampliatx.com
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