Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Shareholder Meeting (August 2022)
30 slides from Amplia Therapeutics's shareholder meeting presentation, Aug 25, 2022
Slide 1: CEO & Managing Director's Presentation to Annual General Meeting
ABN 16 165 160 841 ASX RELEASE 25 August 2022 CEO & Managing Director’s Presentation to Annual General Meeting 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 2022
Slide 2: Annual General Meeting
ampliatx.com Annual General Meeting 25 August 2022
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: Agenda
Agenda Company overview and the year in 1 review 2 Technology 3 ACCENT trial - 1st line pancreatic cancer 4 Plans for FY2023 3
Slide 5: Company and Year in Review
Company and Year in Review
Slide 6: Our values
Our values Patients first Integrity Respect Performance Innovation Accountability Excellence 5
Slide 7: Our people
Our people Rhiannon Jones Terrie-Anne Cock Anthony Bishop Charlotte Mulder Chief Operating Officer Head of Translational Biology Principal Development Manager Principal Development Manager Nicole Kruger Adrian Sulistio Hamish George Andrew Cooke Clinical Operations Manager CMC Project Manager Chief
Slide 8: Amplia's year in review | Focus areas
Amplia's year in review | Focus areas Establishment of AMP945 clinical trial in patients with pancreatic cancer - ACCENT Toxicology studies in preparation for extended dosing of AMP945 in patients with pulmonary fibrosis Improvement of AMP945 manufacturing methods in readiness for commercialisation
Slide 9: Cash position
Cash position 15,000 $14.6m* $12.7m** 10,000 Cash burn rate will be substantially driven by rate of recruitment into ACCENT trial R&D Tax Rebates forecast as 5,000 income in FY2022 and FY2023 $1.85m* 0 March 2021 March 2022 FQ1 2023 ** Amplia Therapeutics 2022 Annual Report ** Amplia Therapeutics Ju
Slide 10: Capital efficiency
Capital efficiency FY22 expenditure | $5.63m Salaries & Superannuation 13% Corporate & Business Development 18% FY2022 Cost breakdown Drug Development Operations Patents & License Fees 66% 3% 9
Slide 11: Amplia's year in review | Outcomes
Amplia's year in review | Outcomes 10
Slide 12: Technology
Technology
Slide 13: Developing inhibitors of Focal Adhesion Kinase (FAK)
Developing inhibitors of Focal Adhesion Kinase (FAK) Small molecule Orally bioavailable Potent and selective Indications Oncology Fibrosis Clinical stage First-line advanced pancreatic cancer Pulmonary fibrosis 12
Slide 14: Amplia's drug target | Focal adhesion kinase
Amplia’s drug target | Focal adhesion kinase Fibrosis: Fibrosis Collagen deposition Immunosupression Collagen crosslinking Focal Adhesion Fibrotic tumour Fibrotic Tissue Kinase (FAK) microenvironment Fibrotic Diseases Solid Cancers 13
Slide 15: Amplia's pipeline
Amplia’s pipeline Current Status Next 12- months Drug Indication Therapy Preclinical Phase 1 Phase 2 Phase 3 (approval) AMP945 Pancreatic Combination Cancer Therapy Idiopathic AMP945 pulmonary Monotherapy fibrosis (IPF) AMP945 Cancers & Combo/ fibrotic disease Monotherapies AMP886 Cancers & Combo/
Slide 16: Amplia's hypothesis | Enhancing chemotherapy
Amplia's hypothesis | Enhancing chemotherapy Fibrotic shields protect many solid tumours from chemotherapy Amplia’s FAK inhibitors aim to remove the shield Unshielded tumours should be more susceptible to chemotherapy FAK inhibitor Exposed tumour Dead tumour Fibrotic tumour microenvironment 15
Slide 17: AMP945 improves survival in pancreatic cancer models
AMP945 improves survival in pancreatic cancer models KPC Model Vehicle P ≤ 0.001 gemcitabine / nab-paclitaxel P ≤ 0.05 AMP945 / gemcitabine / nab-paclitaxel Days post tumour implantation TKCC-10-LO Orthotopic Model Vehicle P ≤ 0.0001 gemcitabine / nab-paclitaxel P ≤ 0.05 AMP945 / gemcitabine / nab-
Slide 18: Amplia's hypothesis | Treating fibrosis
Amplia's hypothesis | Treating fibrosis Idiopathic pulmonary fibrosis (IPF) is a dangerous progressive disease with poor treatment options FAK plays a key role in establishment of fibrotic tissue Preclinical studies in models of lung fibrosis show that AMP945 reduces lung fibrosis AMP945's clinical
Slide 19: AMP945 inhibits fibrosis
AMP945 inhibits fibrosis 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 AMP945 18
Slide 20: AMP945 Clinical Development
AMP945 Clinical Development ACCENT: Proof of Concept Trial in First Line Pancreatic Cancer Patients
Slide 21: ACCENT: Clinical study of AMP945 in people with pancreatic cancer
ACCENT: Clinical study of AMP945 in people with pancreatic cancer First-line patients with advanced pancreatic cancer Open label AMP945 added to gemcitabine/nab-paclitaxel standard of care Not previously treated with gemcitabine and/or nab-paclitaxel Primary endpoint: Objective Response One protoco
Slide 22: ACCENT trial startup
ACCENT trial startup HREC 1 (NSW) April '22 Contract Site Initiation Visits Recruit HREC 2 (Victoria) May '22 negotiations (SIV) Initial Company forecasts were for recruitment to commence in CQ1 2022 Following HREC approvals, site contract discussions were straightforward but slower than forecast Kn
Slide 23: ACCENT | Regulatory and recruitment strategy
ACCENT | Regulatory and recruitment strategy HREC Pre- CTN IND IND IND Interim Analysis PART A DOSE PART B: STAGE 1 PART B: STAGE 2 SELECTION Underway ~ 12 patients 26 patients 24 patients Australia (4-8 sites) South Korea (5 sites) USA (# sites TBD) 22
Slide 24: ACCENT | Recruitment forecast
ACCENT | Recruitment forecast Interim Analysis 9 months 10 months PART A DOSE PART B: STAGE 1 PART B: STAGE 2 SELECTION ~ 12 patients 26 patients 24 patients Australia (4-8 sites) South Korea (5 sites) USA (# sites TBD) 23
Slide 25: ACCENT | Decision points
ACCENT | Decision points Optimal Interim Have we found dose? Analysis >15 responders? Escalate dose? PART A DOSE PART B: STAGE 1 PART B: STAGE 2 SELECTION Have we found No >5 responders? Yes ~ 12 patients 26 patients 24 patients Australia (4-8 sites) South Korea (5 sites) USA (# sites TBD) 24
Slide 26: ACCENT | Australian sites
ACCENT | Australian sites Follow on sites - Part B and Part A contingency Recruiting Westmead Hospital Royal North Shore Hospital Epworth Hospital Western Health Monash Medical Centre 25
Slide 27: ACCENT | Part A, dose escalation
ACCENT | Part A, dose escalation Select Part B Dose Cycle 1 Cycle 1 Safety, PD and Safety, PD and PK Review PK Review Dose Level 4 Cycle 1 3 patients Safety, PD and PK Review Dose Level 3 Cycle 1 3 patients Safety, PD and PK Review Dose Level 2 3 patients Outcomes Dose Level 1 Safety and tolerabilit
Slide 28: Plans for FY2023
4molia Plans for FY2023
Slide 29: Value drivers
Value drivers Clinical milestones Pancreatic cancer ACCENT results Pulmonary fibrosistrial Regulatory engagement US and Korean INDs Expand therapeutic opportunities for AMP945 Cancer Fibrosis Expand pipeline by progression of AMP886 28
Slide 30: Thank You.
Thank You. Amplia Therapeutics Limited ABN 16 165 160 841 ASX: ATX info@ampliatx.com ampliatx.com Dr John Lambert Chief Executive Officer john@ampliatx.com
Amplia Therapeutics — Shareholder Meeting (August 2022) on 6ix