Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (June 2020)
32 slides from Amplia Therapeutics's investor presentation, Jun 2, 2020
Slide 1: Amplia Provides Updated Investor Presentation (ASX Release)
ABN 16 165 160 841 ASX RELEASE 2nd June 2020 For personal use only Amplia Provides Updated Investor Presentation Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) today released a new investor slide deck which provides an update on the Company’s technology and its near-term and mid-
Slide 2: About Amplia Therapeutics Limited
ABN 16 165 160 841 About Amplia Therapeutics Limited Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal For personal use only Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer immuno
Slide 3: Investor Presentation June 2020
For personal use only Investor Presentation June 2020 Amplia Therapeutics Limited
Slide 4: Disclaimer
Disclaimer For personal use only 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 mad
Slide 5: Company Highlights
Company Highlights For personal use only Developing small molecule drugs against Focal Adhesion Kinase (FAK) for two, significant disease areas: • cancer – combo therapy in hard-to-treat solid tumours • fibrosis – prevention and treatment Orphan Drug Designations for both pancreatic cancer and idiop
Slide 6: Company snapshot
Company snapshot1 For personal use only Shares 66.5M ATX Price and Volume – 6 months Market cap $9.3M Options 9.3M Cash 2 $1.1M Last qtr burn 2 ($0.6M) Listed May 2018 (RTO) Headquarters Melbourne Board Warwick Tong (Chair) John Lambert (MD) Robert Peach (NED) Chris Burns (NED) Substantial instituti
Slide 7: Board of Directors
Board of Directors For personal use only Warwick Tong John Lambert Robert Peach Chris Burns MB, ChB, MPP, GAICD PhD, GAICD PhD PhD, FRSC, GAICD Non-Executive Chairman MD & CEO Non-Executive Non-Executive Director Independent Director • GSK (NZ, London, Singapore) • Biota (Drug Discovery, Drug • co-f
Slide 8: Amplia's Scientific Advisors
Amplia’s Scientific Advisors For personal use only Prof. Margaret Frame Prof. Paul Timpson Assoc Prof. Lara Lipton Prof. Phil Hansbro OBE, PhD PhD MBBS, PhD, FRACP PhD Science Director and Chair of Laboratory Head - Invasion and Medical oncologist and clinical Director, Centenary UTS Centre Cancer B
Slide 9: Technology overview
For personal use only Technology overview
Slide 10: Focal Adhesion Kinase – dual purpose drug target
Focal Adhesion Kinase – dual purpose drug target For personal use only Focal Adhesion Kinase (FAK) Cancer defence mechanisms Fibrotic disease treatments • cell migration and metastasis • central role in fibrosis • tumour microenvironment (TME) • collagen accumulation • local regulation of immune res
Slide 11: Amplia is developing two FAK inhibitors
Amplia is developing two FAK inhibitors Amplia has exclusive, worldwide licenses to two proprietary, FAK inhibitors: For personal use only • AMP945 – highly potent, highly selective, orally bioavailable – only blocks the FAK protein • AMP886 – orally bioavailable, potent blocker of the FAK protein a
Slide 12: Cancer treatments
For personal use only Cancer treatments
Slide 13: Why cancer drugs often do not work
Why cancer drugs often do not work For personal use only Pharmaceutical strategies to treat cancer: 1. cytotoxic drugs: target rapidly dividing cancer cells 2. targeted drugs: block specific proteins elevated in cancer cells 3. anti-angiogenic drugs: block new blood vessels which feed the cancer 4.
Slide 14: Targeting cancer's defence mechanisms
Targeting cancer’s defence mechanisms For personal use only Fibrosis • elevated levels of FAK in cancers are FAK helps establish and associated with poor outcomes maintain the dense, fibrotic tissue around cancers • increased FAK activity is found in many, difficult-to-treat, solid cancers Immune ac
Slide 15: FAK inhibition – pancreatic cancer
FAK inhibition – pancreatic cancer For personal use only Pancreatic cancer is a deadly and difficult to treat disease with most patients dying within 6-12 months FAKi allows pancreatic cancer to respond to I-O drugs Pancreatic cancer is unresponsive to cancer drugs: • surrounded by a dense, fibrotic
Slide 16: AMP945 – potential to enhance cancer treatments
AMP945 – potential to enhance cancer treatments For personal use only Reduced Reduced Improved immunosuppression angiogenesis efficacy tumour tumour CD8 eff tumour response to chemotherapy macrophages suppressor cells T-cells endothelial cells drugs 4 0.8 0.4 0.20 800 * * ** * pancreatic tumour grow
Slide 17: AMP945 – treatment of solid tumours
AMP945 – treatment of solid tumours For personal use only Pancreatic cancer • FDA Orphan Drug Designation for AMP945 in the treatment of pancreatic cancer received in March 2020 • Collaboration with Prof. Paul Timpson at the Garvan Institute to assess novel dosing regimes and combination therapies f
Slide 18: Fibrosis treatments
For personal use only Fibrosis treatments
Slide 19: FAK in Idiopathic Pulmonary Fibrosis
FAK in Idiopathic Pulmonary Fibrosis For personal use only Idiopathic Pulmonary Fibrosis (IPF) is a devastating, progressive disease caused by the build-up of fibrotic tissue in the lung which affects 3M people worldwide, including 130,000 in the US Left untreated, the median survival time is 2-3 ye
Slide 20: AMP945 – prevention and treatment of fibrosis
AMP945 – prevention and treatment of fibrosis For personal use only Prevention Treatment Lung Fibrosis control – healthy lung • FDA Orphan Drug Designation for AMP945 in the treatment of idiopathic pulmonary fibrosis received in May 2020 Preclinical study of AMP945 using the industry-standard bleomy
Slide 21: Business Plan
For personal use only Business Plan
Slide 22: Amplia's FAKi's provide a promising opportunity set
Amplia’s FAKi’s provide a promising opportunity set For personal use only AMP945 and AMP886 provide Amplia with several commercial opportunities Amplia is taking three approaches realize these opportunities: 1. take AMP945 into clinical development for pancreatic cancer and idiopathic lung fibrosis
Slide 23: Readiness for Phase 1 Trial of AMP945
Readiness for Phase 1 Trial of AMP945 For personal use only First clinical trial of AMP945 planned to commence in 2H 2020: • GMP clinical manufacture complete (kg scale) • Dosing in preclinical toxicology studies complete • CRO selected Phase 1 safety trial of orally administered AMP945 in healthy v
Slide 24: Design of Planned Phase 1 Trial of AMP945
Design of Planned Phase 1 Trial of AMP945 For personal use only Part A: Single Ascending Dose (SAD) • 5 cohorts of 8 volunteers • Single doses • Safety and pharmacokinetics following a single dose of AMP945 Part B: Food Effects (Single dose) • 1 cohort of 8 volunteers • Single dose • Safety and phar
Slide 25: Targeted Outcomes from Phase 1 Trial of AMP945
Targeted Outcomes from Phase 1 Trial of AMP945 For personal use only Safety • Establish tolerable doses in healthy volunteers • Identify safety signals for monitoring in expected later clinical trials Pharmacokinetics (PK) • Identify rate of drug clearance and informs optimal dosing frequency • Esta
Slide 26: Parallel Preclinical Studies
Parallel Preclinical Studies For personal use only • In parallel with conducting the Phase 1 clinical trial of AMP945 in healthy volunteers, Amplia plans to evaluate AMP945 in multiple preclinical models • Drug combinations in animal models of human cancers: − each combination/tumour model relativel
Slide 27: AMP886 – age-related macular degeneration
AMP886 – age-related macular degeneration For personal use only Age-related macular degeneration (AMD) affects 1 in 7 Australians >50yrs1: • 17% experience vision impairment • 15% people >80yrs have vision loss or blindness due to AMD Antibody drugs that target vascular endothelial growth factor (VE
Slide 28: AMP945 – 18-month development plan
AMP945 – 18-month development plan For personal use only CY2020 CY2021 Activity Q2 Q3 Q4 Q1 Q2 Q3 Q4 preclinical studies Phase 1 – healthy volunteers Phase 1 – data IND filing preclinical testing Phase 2 planning Phase 2 – cancer & IPF 26
Slide 29: Upcoming targeted milestones
Upcoming targeted milestones For personal use only • June 2020 - final report of preclinical toxicology studies • July 2020 - ethics clearance to commence Phase 1 trial in healthy volunteers • Q3 2020 - initiate Phase 1 clinical trial • Q2 2021 - selection of first indication for Phase 2 based on pr
Slide 30: Appendix
For personal use only Appendix
Slide 31: Competitive landscape
Competitive landscape For personal use only Competitor FAKi status & comments Verastem defactinib • in Phase 2 clinical trials for pancreatic cancer in combination with Keytruda • initiating Phase 1 clinical trials in combination with in-licensed Mek/Raf inhibitor InxMed IN10018 • Shanghai-based com
Slide 32: ampliatx.com
For personal use only ampliatx.com
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