Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (July 2020)
35 slides from Amplia Therapeutics's investor presentation, Jul 1, 2020
Slide 1: Investor Presentation
Investor Presentation July 2020 Amplia Therapeutics Limited
Slide 2: Disclaimer
Disclaimer This investor presentation (Presentation) has been prepared by Amplia Therapeutics Limited ACN 165 Past performance 160 841 (Amplia or the Company) and is dated 1 July 2020. This Presentation has been prepared in Past performance information, including past share price performance, should
Slide 3: Contents
Contents 1. Program and Company Overview 2. Technology Overview 3. Details of Capital Raising 4. Key Risks 5. Summary of Underwriting Agreement 3
Slide 4: Program and Company Overview
Program and Company Overview
Slide 5: AMP945: Initiation of Clinical Development
AMP945: Initiation of Clinical Development In January 2020, Amplia raised $0.93M to fund the completion of toxicology studies for AMP945, the Company’s lead FAK inhibitor The toxicology studies were conducted under a Good Laboratory Practice (GLP) quality framework and included repeat-dose administr
Slide 6: Summary
Summary Capital raising Undertaking a fully underwritten 3 for 5, pro rata accelerated non-renounceable entitlement offer at an offer price of $0.10 per share to raise approximately $4.0 million Company highlights • Amplia is developing small molecule drugs against Focal Adhesion Kinase (FAK) for tw
Slide 7: Amplia’s FAKi’s provide a promising opportunity set
Amplia’s FAKi’s provide a promising opportunity set 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 (both granted Orphan D
Slide 8: Readiness for Phase 1 Trial of AMP945
Readiness for Phase 1 Trial of AMP945 First clinical trial of AMP945 planned to commence in 2H 2020: • GMP clinical manufacture complete (kg scale) • Phase 1 site selected Phase 1 safety trial of orally administered AMP945 in healthy volunteers: • Single Australian site • 64 volunteers, cost of ~$2M
Slide 9: Targeted Outcomes from Phase 1 Trial of AMP945
Targeted Outcomes from Phase 1 Trial of AMP945 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 • Establish relationship bet
Slide 10: AMP945 – 18-month development plan
AMP945 – 18-month development plan CY2020 CY2021 Activity Q2 Q3 Q4 Q1 Q2 Q3 Q4 preclinical safety studies Phase 1 – healthy volunteers Phase 1 – data IND filing preclinical testing Phase 2 planning Phase 2 – cancer & IPF 10
Slide 11: Upcoming targeted milestones
Upcoming targeted milestones • July 2020 - report of preclinical toxicology studies (preliminary data received) • July 2020 - ethics clearance to commence Phase 1 trial in healthy volunteers • Q3 2020 - initiate Phase 1 clinical trial • Q2 2021 - select of first indication for Phase 2 based on precl
Slide 12: Company snapshot
Company snapshot1 Shares 66.5M $0.18 ATX Price and Volume – 6 months 4,000 Market cap $8.3M $0.16 3,500 Options 10.4M $0.14 3,000 $0.12 Cash (31 March 2020) $1.1M 2,500 $0.10 Expected qtr burn ($0.5M) 2,000 $0.08 Anticipated cash $0.6M 1,500 30 June 2020 (ex Offer) $0.06 1,000 $0.04 Headquarters Mel
Slide 13: Board of Directors
Board of Directors 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-founder Receptos (acqui
Slide 14: Amplia’s Scientific Advisors
Amplia’s Scientific Advisors 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 Biology, University of
Slide 15: Technology Overview
Technology Overview
Slide 16: Focal Adhesion Kinase – dual purpose drug target
Focal Adhesion Kinase – dual purpose drug target 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 response • fibronectin pr
Slide 17: Amplia is developing two FAK inhibitors
Amplia is developing two FAK inhibitors Amplia has exclusive, worldwide licenses to two proprietary, FAK inhibitors: • AMP945 – highly potent, highly selective, orally bioavailable – only blocks the FAK protein • AMP886 – orally bioavailable, potent blocker of the FAK protein and other cancer drug t
Slide 18: Targeting cancer’s defence mechanisms
Targeting cancer’s defence mechanisms 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 activity • FAK is involv
Slide 19: AMP945 – potential to enhance cancer treatments
AMP945 – potential to enhance cancer treatments 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 growth 3 0.6 0.3 0.15 600
Slide 20: AMP945 – treatment of solid tumours
AMP945 – treatment of solid tumours 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 for pancreatic cancer •
Slide 21: FAK in Idiopathic Pulmonary Fibrosis
FAK in Idiopathic Pulmonary Fibrosis 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 years, with lung transpl
Slide 22: AMP945 – prevention and treatment of fibrosis
AMP945 – prevention and treatment of fibrosis 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 bleomycin model of lung fibr
Slide 23: AMP886 – age-related macular degeneration
AMP886 – age-related macular degeneration 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 (VEGF) have improved the
Slide 24: Capital Raising Details
Capital Raising Details
Slide 25: Key details of Entitlement Offer
Key details of Entitlement Offer Structure and size • Underwritten 3 for 5 pro rata accelerated non-renounceable entitlement offer to raise gross proceeds of approximately $4.0 million, comprising: • accelerated offer to eligible institutional shareholders (Institutional Entitlement Offer) • offer t
Slide 26: Near term plan and capital requirements
Near term plan and capital requirements Amplia is raising capital to undertake: • a Phase 1 clinical trial of Amplia’s Focal Adhesion Kinase (FAK) inhibitor drug AMP945 in healthy volunteers • enabling preclinical efficacy studies in multiple indications Results from the Phase 1 clinical trial: • ar
Slide 27: Use of funds
Use of funds Use Amount Pre-clinical studies (cancer) $250k Pre-clinical studies (other indications) $150k Phase 1 clinical trial $2,200k Drug capsule manufacture $100k Patent & licence fees $350k Cash costs of the offer $300k Working capital $650k TOTAL $4,000k 27
Slide 28: Offer Timetable
Offer Timetable Event Date Trading halt and announcement of Entitlement Offer Wednesday, 1 July 2020 Institutional Entitlement Offer opens Wednesday, 1 July 2020 Institutional Entitlement Offer closes Thursday, 2 July 2020 Announcement of results of Institutional Entitlement Offer Friday, 3 July 202
Slide 29: Key Risks
Key Risks
Slide 30: Key risks
Key risks Company risks Risk Description COVID-19 and global health risks Global health risks or the potential for these events could have a negative impact on the Company. Since early 2020 the coronavirus pandemic, now known as COVID- 19, has spread rapidly to many countries globally. The impact of
Slide 31: Key risks (cont.)
Key risks (cont.) Company risks Risk Description Commercialisation of products and potential The Company has not yet commercialised any products and as yet has no revenues. The Company is also dependent on commercially attractive markets remaining market failure available to it during the commercial
Slide 32: Key risks (cont.)
Key risks (cont.) General risks Risk Description Economic General economic conditions, movements in interest and inflation rates and currency exchange rates may have an adverse effect on the Company's business and production activities, as well as on its ability to fund those activities. Market cond
Slide 33: Underwriting Agreement
Underwriting Agreement
Slide 34: Underwriting agreement
Underwriting agreement Taylor Collison Limited (Taylor Collison) is acting as underwriter pursuant to an Underwriting Agreement between Taylor Collison and the Company dated 1 July 2020 (Agreement). The Agreement contains representations and warranties, undertakings and indemnities in favour of Tayl
Slide 35: ampliatx.com
VANaatelite! Exposing cancer. Enhancing treatment. ampliatx.com
Amplia Therapeutics — Investor Presentation (July 2020) on 6ix