Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Corporate Update (July 2021)
29 slides from Amplia Therapeutics's corporate update, Jul 28, 2021
Slide 1: Quarterly Activities and Cash Flow Reports
ASX RELEASE 28 July 2021 QUARTERLY ACTIVITIES AND CASH FLOW REPORTS Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), a company developing new approaches for the treatment for cancer and fibrosis, is pleased to announce further progress across its small molec
Slide 2: Operations and financial update (continued)
to support a Phase 2 clinical trial of AMP945 in patients with IPF which is currently scheduled to start in mid-2022. In June, Amplia finalised the commercial terms and executed its Research Collaboration Agreement with the Garvan Institute of Medical Research (the “Garvan”) in Sydney. This collabor
Slide 3: About Amplia and FAK
field of cancer immunology and Amplia has a particular development focus in pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF).
Slide 4: Appendix 4C Quarterly cash flow report
Rule 4.7B Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Name of entity Amplia Therapeutics Limited ABN Quarter ended (“current quarter”) 16 165 160 841 30 June 2021 Consolidated statement of cash flows Current quarter Year to date $A’000 (3 months) $A’000 1. Cash f
Slide 5: Consolidated statement of cash flows
Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Consolidated statement of cash flows Current quarter Year to date $A’000 (3 months) $A’000 (e) intellectual property (f) other non-current assets 2.2 Proceeds from disposal of: (a) entities (b) businesses (c) property,
Slide 6: Consolidated statement of cash flows
Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Consolidated statement of cash flows Current quarter Year to date $A’000 (3 months) $A’000 4.3 Net cash from / (used in) investing activities <4> <4> (item 2.6 above) 4.4 Net cash from / (used in) financing activities 3
Slide 7: Financing facilities
Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B 7. Financing facilities Total facility Amount drawn at Note: the term “facility’ includes all forms of financing amount at quarter quarter end arrangements available to the entity. end $A’000 Add notes as necessary for
Slide 8: Compliance statement
Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Compliance statement 1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A. 2 This statement gives a true and fair view of the matters disclosed. D
Slide 9: Amplia Therapeutics Shareholder Update - July 2021
Amplia Therapeutics Shareholder Update - July 2021 Amplia Therapeutics Limited
Slide 10: 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 11: Focal Adhesion Kinase – one drug target, two applications
Focal Adhesion Kinase – one drug target, two applications Focal Adhesion Kinase (FAK) Indication FIBROTIC DISEASES SOLID CANCERS • Collagen accumulation • Cell migration and metastasis Biology • Collagen crosslinking • Collagen accumulation • Fibronectin production • Local regulation of immune respo
Slide 12: Amplia’s target indications
Amplia’s target indications Pancreatic Cancer Idiopathic Pulmonary Fibrosis (IPF) • 60,000 new diagnosis 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 detected • Devastating, progressive dis
Slide 13: 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 & Combo/Mono fibrotic disease ther
Slide 14: Amplia – highlights from the June 2021 quarter
Amplia – highlights from the June 2021 quarter • Finalised and executed Collaboration Agreement with the Garvan Institute for Medical Research in Sydney • Preclinical data supports advancing AMP945 in Phase 2 clinical trials in patients with pancreatic cancer: • Inhibits formation of new fibrotic ti
Slide 15: Garvan Collaboration
Garvan Collaboration
Slide 16: Amplia’s collaboration with the Garvan Institute
Amplia’s collaboration with the Garvan Institute • Garvan and Amplia collaboration agreement signed June 2021: • Prof. Timpson’s group studying FAK in pancreatic cancer for >6 years • Professor Timpson joined Amplia’s Scientific Advisory Board in Feb 2020 • Collaboration builds on existing knowledge
Slide 17: Garvan collaboration
Garvan collaboration • Amplia receives • Access to Garvan know-how • First right to arising IP • Garvan receives • Research funding • Translational opportunities for science • Amplia collaboration promoted in Garvan’s June Seminar The Power of Personalized Medicine 9
Slide 18: Preclinical Data
Preclinical Data
Slide 19: AMP945 inhibits deposition of collagen
AMP945 inhibits deposition of collagen Picosirius red staining for total collagen Decreasing collagen Vehicle 5 nM 10 nM 20 nM 50 nM 100 nM *** P ≤ 0.001 • Fibroblasts lay down new collagen • Collagen is a key component of fibrotic tissue Increasing AMP945 • AMP945 inhibits fibroblasts, causing less
Slide 20: AMP945 has positive impact on key tumour markers
AMP945 has positive impact on key tumour markers AMP945 priming strategy – pretreatment to make Marker of cell death increases Marker of cell proliferation tumours more responsive to standard of care (Caspase 3) decreases (Ki67) AMP945 Gem/Abraxane 0 2 4 6 Treatment Day Establish tumors Harvest * P
Slide 21: AMP945 improves survival in pancreatic cancer model
AMP945 improves survival in pancreatic cancer model • 25% improvement in median survival when added to standard of care (p ≤ 0.001) • KPC is a highly aggressive animal model of Median survival human pancreatic cancer • Demonstrates pharmaceutical activity of AMP945 translates into survival benefit “
Slide 22: Phase 1 Clinical Trial
Phase 1 Clinical Trial
Slide 23: Phase 1 trial of AMP945 – design and execution
Phase 1 trial of AMP945 – design and execution Oct-20 Nov-20 Dec-20 Jan-21 Feb-21 Mar-21 Apr-21 A Single Ascending Dose Study (4 cohorts) C Multiple Ascending Dose Study (3 cohorts) B Food Effect A/B/C Pharmacokinetic study Pharmacodynamic study Exploratory Metabolite study 15
Slide 24: Data from successful Phase 1 clinical trial of AMP945
Data from successful Phase 1 clinical trial of AMP945 Data on AMP945 from Phase 1 clinical trial • Safe and well-tolerated at all doses tested: − Single ascending doses – up to 125mg − Multiple ascending dose (up to 100mg for 7 days) • No serious adverse events (SAEs) or withdrawals and no identifie
Slide 25: Inhibitory concentration of AMP945 achieved
Inhibitory concentration of AMP945 achieved AMP945 Day 7 (steady state) Median AMP945 Concentration • Concentrations of AMP945 that inhibit FAK were rapidly achieved in the blood of human volunteers Inhibitory concentration of AMP945 • These levels were maintained in the steady state concentrations
Slide 26: Significance of Phase 1 results
Significance of Phase 1 results Current status Phase 2 clinical trial at advanced Phase 2 trial in planning stage. pancreatic cancer Target Q4 2021 Preclinical safety Phase 1 trial in and manufacture healthy volunteers Large-scale manufacture underway Phase 2 trial in for extended toxicology pro
Slide 27: Raised $3.8M to support preparation for Phase 2
Raised $3.8M to support preparation for Phase 2 • In May 2021, Amplia successfully completed a $3.8M capital raising at $0.23 / share • Total of 16.6M new shares issued • New institutional shareholder: Acorn Capital • Supported by existing institutional shareholders: Platinum and Blueflag • New capi
Slide 28: Summary
Summary Outcomes for the quarter • Phase 1 completion • Successful implementation of clinical strategy so-far • Opens up opportunities in cancer and fibrosis • Garvan Collaboration • Supports current plans • Prospects for further opportunities Coming Up • Disclosure of pancreatic cancer trial design
Slide 29: ampliatx.com
lasmoplia Exposing cancer. Enhancing treatment. ampliatx.com