Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (October 2021)
35 slides from Amplia Therapeutics's investor presentation, Oct 19, 2021
Slide 1: Amplia Provides Updated Investor Presentation (ASX release)
ABN 16 165 160 841 ASX RELEASE 19th October 2021 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 further information on the Company’s technology and its plan
Slide 2: Amplia Therapeutics
For personal use only Amplia Therapeutics October 2021 Amplia Therapeutics Limited
Slide 3: 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 4: Amplia Therapeutics is developing new treatments for cancer and fibrosis
For personal use only Amplia Therapeutics is developing new treatments for cancer and fibrosis 3
Slide 5: Investment highlights
Investment highlights For personal use only • Two Focal Adhesion Kinase (FAK) inhibitors with activity profiles supporting multiple therapeutic opportunities • Clear differentiation from other FAK inhibitors in development • AMP945 has completed a Phase 1 trial in 56 volunteers and was shown to have
Slide 6: Company snapshot
Company snapshot1 For personal use only Shares on issue 124.8M ATX Price and Volume – 12 months Market capitalization $24.3M Options on issue 13.9M Cash 2 $4.1M Headquarters Melbourne Board Warwick Tong (Chair) Jane Bell (NED) Chris Burns (NED) John Lambert (MD) Robert Peach (NED) Institutional hold
Slide 7: Amplia's pipeline
Amplia’s pipeline For personal use only 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 & Monotherap
Slide 8: Why is FAK a good target for drug development?
Why is FAK a good target for drug development? For personal use only 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 • Wo
Slide 9: Targeting cancer's defence mechanisms
Targeting cancer’s defence mechanisms For personal use only 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 activity Amplia is investigating the use of FAK FAK t
Slide 10: Amplia's target indications
Amplia’s target indications For personal use only 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 • Deva
Slide 11: Why target pancreatic cancer and pulmonary fibrosis?
Why target pancreatic cancer and pulmonary fibrosis? For personal use only 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
Slide 12: Recent deals for anti-fibrotic and pancreatic cancer drugs
Recent deals for anti-fibrotic and pancreatic cancer drugs For personal use only US$1,300M Total disclosed upfront and milestones payments; excludes potential royalty payments US$870M US$785M US$20M + US$380M US$80M + milestones R&D US$235M Year 2021 2020 2020 2019 2019 2019 2019 Deal Licensing/R&D
Slide 13: Product differentiation
Product differentiation For personal use only Pancreatic Cancer Fibrosis FAK Company FAKi First Line Combo with Selectivity Amplia AMP945 Gem/nab-paclitaxel Verastem defactinib Pembrolizumab Pembrolizumab InxMed IN10018 KN046 Amplia’s AMP945 is differentiated from its competitor
Slide 14: AMP945 is primed for Phase 2 clinical trials
For personal use only AMP945 is primed for Phase 2 clinical trials 13
Slide 15: AMP945 is the most selective FAK inhibitor in clinical development
AMP945 is the most selective FAK inhibitor currently in clinical development For personal use only Non-specific kinase inhibition often leads to clinical side effects AMP945 is currently the most selective FAK inhibitor in clinical development AMP945 Defactinib Number of kinases targeted in addition
Slide 16: AMP945 inhibits deposition of collagen
AMP945 inhibits deposition of collagen For personal use only 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 fib
Slide 17: AMP945 blocks collagen cross-linking
AMP945 blocks collagen cross-linking For personal use only Decreasing crosslinking • Crosslinking of collagen is required for the formation 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
Slide 18: AMP945 treats and prevents lung fibrosis
AMP945 treats and prevents lung fibrosis For personal use only 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 AM
Slide 19: Peer-reviewed preclinical rationale for Phase 2 trial
Peer-reviewed preclinical rationale for Phase 2 trial For personal use only • Recent publication by Amplia’s Garvan collaborators highlights potential of FAK inhibition in pancreatic cancer Key findings • Priming with FAK inhibitor before treatment with gemcitabine/Abraxane® • Increases survival in
Slide 20: AMP945 drives same effects in Garvan models
AMP945 drives same effects in Garvan models For personal use only AMP945 increases survival in aggressive AMP945 impacts key markers KPC model of pancreatic cancer of tumour growth 19
Slide 21: Phase 1 trial of AMP945 completed in May 2021
Phase 1 trial of AMP945 completed in May 2021 For personal use only • Trial execution: • Commenced in October 2020 - completed May 2021 • Recruited in 56 healthy volunteers aged 18 - 65 • Single site in Melbourne Australia, Nucleus Network • Phase 1 trial components: • Single Ascending Doses • Multi
Slide 22: AMP945's excellent clinical safety profile
AMP945’s excellent clinical safety profile For personal use only 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
Slide 23: AMP945 Phase 1 data supports further development
AMP945 phase 1 data supports further development For personal use only • Summary of Outcomes • Safe and well-tolerated at all doses tested • No serious adverse events (SAEs) or withdrawals and no identified safety trends • Single ascending doses up to 125mg • Multiple ascending dose (100mg QD for 7
Slide 24: Phase 2 Clinical Trial in Pancreatic Cancer Patients
For personal use only Phase 2 Clinical Trial in Pancreatic Cancer Patients 23
Slide 25: Questions Amplia's Phase 2 study aims to answer
Questions Amplia's Phase 2 study aims to answer For personal use only • Does AMP945 enhance the efficacy of gemcitabine and Abraxane® in patients with advanced pancreatic cancer? • If AMP945 does enhance the efficacy of gemcitabine and Abraxane®, how does this manifest clinically? • What is the opti
Slide 26: Phase 2 study of AMP945 in pancreatic cancer
Phase 2 study of AMP945 in pancreatic cancer For personal use only Key Trial Elements • Patients with non-resectable or metastatic pancreatic cancer • First-line therapy • Largest patient cohort • Healthier patients • Positions AMP945 as a first-line treatment option • Intermittent dosing of AMP945
Slide 27: AMP945 will be integrated into first-line therapy
AMP945 will be integrated into first-line therapy For personal use only US: 60,000 patients per year Pancreatic Cancer WW: 450,000 patients per year AMP945 + gemcitabine/ nab-paclitaxel ≥ 70% 5%-10% 10%-20% Non-resectable/ 1st line metastatic Borderline Resectable surgery chemotherapy 2nd line thera
Slide 28: Benefits of developing AMP945 as 1st line therapy
Benefits of developing AMP945 as 1st line therapy For personal use only Largest patient population: >70% newly diagnosed patients “With the exception of two targeted • Largest addressable market opportunity agents, which exhibited minimal or no overall survival benefit (erlotinib and • Large patient
Slide 29: Efficacy endpoints
Efficacy endpoints For personal use only • 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 •
Slide 30: Phase 2 trial design
Phase 2 trial design For personal use only Stage 1 Stage 2 • Select the optimal dose of AMP945 • Adapt trial based on Stage 1 results • Minimal dose giving maximum effect on • Recruit additional patients pFAK • Increase confidence in efficacy results to • Tissue sampling to guide dose selection supp
Slide 31: AMP945-202 trial summary
AMP945-202 trial summary For personal use only 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 st
Slide 32: Trial overview and decision tree
Trial overview and decision tree For personal use only Detailed regulatory interactions Randomised trial >> 19% responders (>> 5/26) Stage 1 Stage 2 > 19% responders > 30% responders (> 5/26) (> 15/50) Interim Analysis ≤ 19% responders Evaluate a further 24 Patients (≤ 5/26) ~12 patients dose escala
Slide 33: Schedule
Schedule For personal use only 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 Patient
Slide 34: Expected newsflow
Expected newsflow For personal use only Stage 1: Dose escalation and Expansion Part 1 Garvan Agreement Signed Positive data in NASH Model Pancreatic cancer model data Dose escalation complete Garvan FAK publication IND Jul '20 Oct '20 Jan '21 Apr '21 Jul '21 Oct '21 Jan '22 Apr '22 Jul '22 Oct '22 J
Slide 35: Amplia Therapeutics Limited
For personal use only Amplia Therapeutics Limited ABN 16 165160 841 Contact: ASX: ATX John Lambert info@ampliatx.com Chief Executive Officer www.ampliatx.com john@ampliatx.com
Amplia Therapeutics — Investor Presentation (October 2021) on 6ix