Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (November 2021)
41 slides from Amplia Therapeutics's investor presentation, Nov 8, 2021
Slide 1: Amplia Entitlement Offer Investor Presentation
ABN 16 165 160 841 ASX RELEASE 8 November 2021 Amplia Entitlement Offer Investor Presentation Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) has today announced a capital raising consisting of: - a Placement to institutional and sophisticated investors to raise $5.4m; and - a 1 f
Slide 2: Amplia Therapeutics Investor Slide Deck
Amplia Therapeutics Investor Slide Deck 8 November 2021 Amplia Therapeutics Limited
Slide 3: Disclaimer
Disclaimer This investor presentation (Presentation) has been prepared by Amplia Therapeutics Limited ACN 165 160 Past performance 841 (Amplia or the Company) and is dated 8 November 2021. This Presentation has been prepared in Past performance information, including past share price performance, sh
Slide 4: Contents
Contents 1. Overview 2. About focal adhesion kinase (FAK) 3. Rationale for Phase 2 clinical trial of AMP945 4. Phase 2 clinical trial overview 5. Capital Raising Summary, Use of Funds, Proforma Financial Information and Timetable 6. Key Risks 3
Slide 5: Overview
Overview 4
Slide 6: Investment highlights
Investment highlights • Two Focal Adhesion Kinase (FAK) inhibitors with activity profiles supporting multiple therapeutic opportunities • Origins in Cancer Therapeutics Cooperative Research Centre • Clear differentiation from other FAK inhibitors in development • AMP945 has completed a Phase 1 trial
Slide 7: Board of Directors
Board of Directors 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 MD & CEO Non-Executive Non-Executive Non-Executive Independent Chairman Independent Independent Independent Director Director Director • GSK
Slide 8: 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 & Monotherapy fibrotic disease Cur
Slide 9: About focal adhesion kinase (FAK)
About focal adhesion kinase (FAK)
Slide 10: FAK: a drug target with multiple therapeutic opportunities
FAK: a drug target with multiple therapeutic opportunities Focal Adhesion Kinase (FAK) Indication FIBROTIC DISEASES SOLID CANCERS Opportunities Monotherapy Combination Therapy • Lung fibrosis • Pancreatic cancer • Liver fibrosis (NASH) • Ovarian cancer • Renal fibrosis • Breast cancer • Wound healin
Slide 11: Inhibiting FAK targets cancer's defence mechanisms
Inhibiting FAK targets cancer’s defence mechanisms Fibrosis FAK helps establish and maintain the dense, fibrotic tissue around cancers FAK is involved in many cancer defence mechanisms that reduce the effectiveness of cancer drugs Immune response Amplia is investigating the use of FAK FAK triggers t
Slide 12: Amplia's target indications
Amplia’s target indications Pancreatic Cancer Idiopathic Pulmonary Fibrosis (IPF) • 60,000 new diagnoses 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 surrounded • Devastating, progressiv
Slide 13: Why target pancreatic cancer and pulmonary fibrosis?
Why target pancreatic cancer and pulmonary fibrosis? Pancreatic Cancer Pulmonary Fibrosis Preclinical data provides rationale for clinical study in this disease AMP945 enhances the efficacy of standard of care in AMP945 reduces fibrosis in the bleomycin model of lung pancreatic cancer models fibrosi
Slide 14: Product differentiation
Product differentiation Pancreatic Cancer Fibrosis FAK Company FAKi First Line Combo with Selectivity Amplia AMP945 Gemcitabine/Abraxane® Verastem defactinib Pembrolizumab Pembrolizumab InxMed IN10018 KN046 Amplia’s AMP945 is differentiated from its competitors by 1. Exquisite F
Slide 15: Rationale for Phase 2 clinical trials of AMP945
Rationale for Phase 2 clinical trials of AMP945 14
Slide 16: AMP945 inhibits deposition of collagen in vitro
AMP945 inhibits deposition of collagen in vitro 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, cau
Slide 17: AMP945 blocks collagen cross-linking in vitro
AMP945 blocks collagen cross-linking in vitro Decreasing crosslinking • Crosslinking of collagen is required for the formation of fibrotic tissues ** P ≤ 0.01 *** P ≤ 0.001 • AMP945 inhibits collagen cross-linking in a dose-dependent manner Increasing AMP945 Vehicle 5 nM 10 nM 20 nM 50 nM 100 nM Stu
Slide 18: AMP945 treats and prevents lung fibrosis
AMP945 treats and prevents lung fibrosis Bleomycin animal model of lung fibrosis control – healthy lung PREVENTION TREATMENT • AMP945 administered before • AMP945 administered after onset of fibrosis onset of fibrosis • Evaluating ability of AMP945 to • Evaluating ability of AMP945 to bleomycin – fi
Slide 19: Peer-reviewed preclinical rationale for Phase 2 trial
Peer-reviewed preclinical rationale for Phase 2 trial • Recent publications highlight potential synergy of FAK inhibition with current standards of care Key findings • Priming with FAK inhibitor before treatment with gemcitabine/Abraxane® • Increases survival in KPC pancreatic cancer model • Reduces
Slide 20: AMP945 improves survival in an aggressive pancreatic cancer model
AMP945 improves survival in an aggressive pancreatic cancer model • 25% improvement in survival when added to standard of care (p ≤ 0.001) • KPC is a highly aggressive animal model of human pancreatic cancer • Demonstrates pharmaceutical activity of AMP945 translates into survival benefit “A 25% imp
Slide 21: Phase 1 trial of AMP945 completed in May 2021
Phase 1 trial of AMP945 completed in May 2021 • Trial execution: • Commenced in October 2020 - completed May 2021 • Recruited in 56 healthy volunteers aged 18 - 65 • Single site in Melbourne Australia • Summary of Outcomes • Safe and well-tolerated at all doses tested • No serious adverse events (SA
Slide 22: AMP945's excellent clinical safety profile
AMP945’s excellent clinical safety profile Summary of Treatment Emergent Adverse Events from Amplia’s Phase 1 trial of AMP945 Single Dose Multiple Dose Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 1 Cohort 2 Cohort 3 Pooled Pooled AMP945 AMP945 AMP945 AMP945 AMP945 AMP945 AMP945 Placebo Placebo 15 mg
Slide 23: Phase 2 Clinical Trial Overview
Phase 2 Clinical Trial Overview 22
Slide 24: Objectives of the Offer
Objectives of the Offer • The funds raised by the Offer will support the conduct of a Phase 1b/2a clinical trial of AMP945 in patients with pancreatic cancer • The trial has been designed in two parts • Stage 1: Dose selection in approximately 12 pancreatic cancer patients and initial assessment of
Slide 25: Phase 2 study of AMP945 in pancreatic cancer
Phase 2 study of AMP945 in pancreatic cancer Key Trial Elements • Patients with non-resectable or metastatic pancreatic cancer • First-line therapy • Largest patient cohort • Healthier patients • Aims to position AMP945 as a first-line treatment option • Intermittent dosing of AMP945 between normal
Slide 26: AMP945 will be integrated into first-line therapy in the trial
AMP945 will be integrated into first-line therapy in the trial Pancreatic Cancer AMP945 + gemcitabine/ Abraxane ≥ 70% 5%-10% 10%-20% Non-resectable/ 1st line metastatic Borderline Resectable surgery chemotherapy 2nd line therapy Maintenance Recurrence Maintenance Gilbert, J. W., Wolpin, B., et al.,
Slide 27: Phase 2 trial efficacy endpoints
Phase 2 trial efficacy endpoints • Primary Endpoint – Objective Response Rate (ORR) • Widely used in single-arm trials • Able to support Accelerated Approvals • Sensitive endpoint • Secondary Endpoints – Safety, DoR, PFS, OS, CR, Symptoms, Pharmacokinetics • Alternate measures of efficacy • Initial
Slide 28: Phase 2 trial design
Phase 2 trial design Stage 1 Stage 2 • Select the optimal dose of AMP945 • Adapt trial based on Stage 1 results • Minimal dose giving maximum effect on pFAK • Recruit additional patients • Safety and tissue sampling guides dose • Increase confidence in efficacy results to selection support randomise
Slide 29: Phase 2 trial summary
Phase 2 trial summary Population Design Treatment Endpoints Dose escalation • Fixed doses of G/A, escalating Dose Escalation Patients with Stage III or IV doses of AMP945 Safety, PK, RP2D pancreatic cancer Phase 1b/2a open label, single • 4 cohorts of 3-6 pts. 1 month arm study to evaluate safety, P
Slide 30: Phase 2 trial overview and decision tree
Phase 2 trial overview and decision tree Stage 1 Stage 2 Detailed regulatory interactions Randomised trial >> 19% responders (>> 5/26) > 19% responders > 30% responders (> 5/26) (> 15/50) Interim Analysis ≤ 19% responders Evaluate a further 24 Patients (≤ 5/26) ~12 patients dose escalation + 26 pati
Slide 31: Amplia's planned clinical schedule
Amplia’s planned clinical schedule CY2021 CY2022 CY2023 CY2024 Activity Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pancreatic Cancer Drug Product Development Drug Interaction Studies HREC Filing Decision Point IND filing Patient Recruitment Interim Analysis Pulmonary Fibrosis Extended Toxicology Pati
Slide 32: Capital Raising Summary
Capital Raising Summary
Slide 33: Key details of Capital Raising
Key details of Capital Raising Structure and size • Placement to institutional investors to raise gross proceeds of approximately $5.4m, via the issue of 30.1 million New Shares utilising the Company’s existing placement capacity under ASX Listing Rule 7.1 and 7.1A. New Shares issued under the Place
Slide 34: Source and application of funds
Source and application of funds Source Amount Application Amount Cash as at 30 September 2021 $3.2m AMP945 Phase 1b/2a clinical trial costs $7.0m R&D rebate received $1.1m AMP945 manufacturing costs $2.9m Placement $5.4m IPF Toxicology and non-clinical POC studies $1.25m Entitlement Offer $7.0m Pate
Slide 35: Pro forma balance sheet
Pro forma balance sheet Jun. & Sept. Pro-forma 31 March 2021 Placement & Quarter Appendix Adj. Statement (audited) Entitlement Offer $AUD 4C (unaudited) Current Assets Cash and cash equivalents 1,848,408 1,322,573 1,140,352(a) 12,387,210(b) 16,698,543 Trade and other receivables 1,000,000 - (1,000,0
Slide 36: Offer Timetable
Offer Timetable Event Date (2021) Trading halt lifted Monday, 8 November Capital Raising announced, Prospectus lodged, trading halt lifted Monday, 8 November Settlement of the Placement Thursday, 11 November Issue of New Shares under the Placement Friday, 12 November Record Date for Entitlement Offe
Slide 37: Key risks
Key risks
Slide 38: Key risks
Key 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 COVID-19 has l
Slide 39: 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 40: 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 41: Amplia Therapeutics Limited
Amplia Therapeutics Limited ABN 16 165160 841 Contact: ASX: ATX John Lambert info@ampliatx.com Chief Executive Officer www.ampliatx.com john@ampliatx.com
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