Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Bioshares Conference 2024
30 slides from Amplia Therapeutics's conference presentation, Jul 12, 2024
Slide 1: Bioshares Conference Presentation (ASX Release)
ABN 16 165 160 841 ASX RELEASE 12 July 2024 BIOSHARES CONFERENCE PRESENTATION Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”) is pleased to announce that Amplia’s CEO and MD Dr Chris Burns is presenting today at the annual Bioshares conference, being held in
Slide 2: BioShares Presentation
For personal use only BioShares Presentation 12 July 2024 ampliatx.com | @ampliatx
Slide 3: Disclaimer
DISCLAIMER This presentation (Presentation) contains summary information about Amplia Therapeutics market, regulatory and other relevant environments that will exist and affect Amplia’s business and Limited ACN 165 160 841 and its subsidiaries (the Company or Amplia) which is current as at 31 operat
Slide 4: Snapshot
SNAPSHOT Amplia is developing a pipeline of small molecule inhibitors of Focal Adhesion Kinase (FAK) - a validated target in cancer For personal use only Amplia’s drugs were discovered at the Cancer Therapeutics CRC, in collaboration with Australia’s premier Medical Research Institutes (WEHI, Peter
Slide 5: Development Highlights
DEVELOPMENT HIGHLIGHTS Phase 2a clinical trial in advanced Orphan Drug Designation from pancreatic cancer underway US FDA for pancreatic cancer Well tolerated and IPF For personal use only Preliminary signs of efficacy Interim readout planned for Q3 2024 Compelling preclinical data in disease models
Slide 6: Corporate Summary
CORPORATE SUMMARY ASX:ATX 12 month share price chart Share price A$0.063 (9-Jul-24) For personal use only Shares on 271.9m issue Market cap A$16.8m (9-Jul-24) Platinum Investment Management Ltd Substantial Blueflag Holdings Pty Ltd Shareholders Acorn Capital Ltd Pengana 5
Slide 7: Experienced Board and Management: Board
EXPERIENCED BOARD AND MANAGEMENT BOARD For personal use only Warwick Tong Robert Peach Jane Bell Chris Burns MB ChB MPP GAICD PhD LLB, LLM (Lond), FAICD PhD GAICD Chair Director Director CEO and MD 6
Slide 8: Experienced Board and Management: Senior Team
EXPERIENCED BOARD AND MANAGEMENT SENIOR TEAM For personal use only Rhiannon Jones Terrie-Anne Cock Charlotte Mulder Adrian Sulistio PhD GAICD PhD BVSc (Hons) MBA B Eng (Hons), B Com, PhD COO Director Translational Science Director Early Clinical Development Manager Product Development 7
Slide 9: Amplia's drugs inhibit the enzyme Focal Adhesion Kinase (FAK)
Amplia’s drugs inhibit the enzyme Focal For personal use only Adhesion Kinase (FAK)
Slide 10: Focal Adhesion Kinase (FAK)
FOCAL ADHESION KINASE (FAK) FAK is a critical protein in cancer growth and spread, and in formation of fibrotic (scar) tissue For personal use only Broad clinical potential Amplia’s drugs potently and selectively block Cancer Fibrosis Scarring the activity of the FAK protein 9
Slide 11: FAK Inhibitors in Development
FAK INHIBITORS IN DEVELOPMENT Only 3 companies with bona fide FAK inhibitors in development For personal use only Verastem Inxmed Good Good PK Selectivity DDI Clinical Notes Stage profile profile Amplia Narmafotinib Safe and well Ph 2a (Amplia) tolerated Defactinib Promising data in Narmafotinib has
Slide 12: Narmafotinib
NARMAFOTINIB Drug-like small molecule Highly potent and selective For personal use only Excellent PK; once-a-day dosing FAK Activity Highly potent FAK inhibitor Minimal DDI* risk when combining with other drugs Biochemical assays Selectivity IC 50 2.2 nM Highly selective for FAK K 29 pM Narmafotinib
Slide 13: Narmafotinib in Cancer
NARMAFOTINIB IN CANCER Multi-action of narmafotinib Extensive preclinical data showing narmafotinib activity in cancer models Anti-proliferative Synergy with For personal use only Reduces cell’s ability chemotherapies to proliferate Enhances activity of and migrate drugs and other Early signals of e
Slide 14: Broad Potential for FAK Inhibitors in Cancer
BROAD POTENTIAL FOR FAK INHIBITORS IN CANCER FAK inhibitors can enhance effects of existing therapeutic For personal use only approaches in solid tumours Chemotherapy Radiotherapy ... but also newer targeted treatments Kinase Inhibitors Immune Checkpoint Inhibitors Antibodies and ADCs kRas Inhibitor
Slide 15: Clinical studies of narmafotinib in pancreatic cancer
Clinical studies of narmafotinib For personal use only in pancreatic cancer
Slide 16: Pancreatic Cancer: An Unmet Need
PANCREATIC CANCER An unmet need For personal use only 13% Increasing Prevalence 5 year Market size survival Estimated 66,000 diagnoses Global treatment market and 50,000 deaths in Difficult-to-treat: estimated over US$6 billon US this year* typically detected late in in 2023 disease progression** 4,
Slide 17: Pancreatic Cancer: Undisputed Role of FAK in Disease Progression
PANCREATIC CANCER Undisputed role of FAK in disease progression Over-expression FAK activity correlates Beneficial preclinical efficacy and increased FAK activity with worse outcome with FAK inhibition For personal use only Narmafotinib decreases tumour Low levels active FAK = better survival fibros
Slide 18: Clinical data indicates narmafotinib safe and well tolerated
Clinical data indicates narmafotinib safe and For personal use only well tolerated with preliminary signs of efficacy
Slide 19: ACCENT Trial Design
ACCENT TRIAL DESIGN Narmafotinib in combination with standard-of-care gemcitabine and Abraxane Orally-dosed narmafotinib in the days preceding weekly chemotherapy For personal use only Dose Interim Phase 1b Selected Phase 2a Analysis Phase 2a (cont) 14 patients (400 mg) 26 patients >6 PR’s 24 patien
Slide 20: ACCENT Phase 1b Cohorts
ACCENT PHASE 1b 3 Cohorts (100 mg, 200 mg, 400 mg) Orally dosed (capsules) For personal use only Once-a-day Safe and well tolerated All patients elected to stay on drug post cycle 1 One DLT*: uncontrolled nausea Fatigue (Grade 3 or below) in more than 1 patient likely drug related *DLT = Dose Limiti
Slide 21: ACCENT Phase 1b: Preliminary Signs of Efficacy
ACCENT PHASE 1b Preliminary signs of efficacy observed Best Response (all patients) Improved response rate (PR and SD) compared to For personal use only ACCENT Historical Best Overall Best Overall historical gemcitabine/Abraxane alone Classification Response* Response** n=14 (n=431) Comparison to pi
Slide 22: ACCENT Phase 1b: Tumour Reduction
ACCENT PHASE 1b Tumour Reduction Preliminary signs of efficacy observed (% change from baseline) Improved response rate (PR and SD) compared to For personal use only historical gemcitabine/Abraxane alone (individual patients) Comparison to pivotal trial (2013)** Better objective response (tumour red
Slide 23: ACCENT Phase 1b: Duration on Trial
ACCENT PHASE 1b Preliminary signs of efficacy observed Duration on trial Improved response rate (PR and SD) compared to For personal use only historical gemcitabine/Abraxane alone Comparison to pivotal trial (2013)** Better objective response (tumour reduction) at higher doses 4 of 6 PRs with top do
Slide 24: Positioning narmafotinib as the preferred agent for solid tumours
Positioning narmafotinib as the preferred agent For personal use only to enhance activity of drugs for solid tumours
Slide 25: Clinical Focus and Opportunity
CLINICAL FOCUS AND OPPORTUNITY For personal use only Combinations in Combinations in Preclinical evidence - pancreatic cancer ovarian cancer other solid cancers Gemcitabine and Abraxane Platinum resistant disease Bile duct, oesophageal, head (ACCENT trial) - and neck cancer - Maintenance therapy pos
Slide 26: Recent and Planned Milestones
RECENT AND PLANNED MILESTONES For personal use only 2H 2023 / 1H 2024 2H 2024 1H 2025 Completion enrolment 50 pts ACCENT trial - Complete Phase 1b ACCENT trial - October 26 Patients recruited ACCENT trial - July March Korean regulatory approval - November Interim ACCENT trial data - October Initiati
Slide 27: Valuations of Similar Small Molecule Oncology Companies
VALUATIONS OF SIMILAR SMALL MOLECULE ONCOLOGY COMPANIES For personal use only Company Lead Asset Lead Indication Current Status Market Cap (US$) Positive Phase 2 results in Verastem Defactinib / Avutometinib LGSOC 74.5M KRAS mutant cancers Ikena Oncology IK-595 RAS & RAF mutant cancers Ongoing Phase
Slide 28: Oncology Licensing Deals
ONCOLOGY LICENSING DEALS Company Buyer Nature of Deal Year Indication Asset Stage Value (USD) Joyo Exclusive license (excl RAS and KRAS small 12.5M upfront; For personal use only Erasca May 2024 Preclin Pharmatech mainland China) mutant tumours molecule 176M in milestones Medshine RAS and KRAS small
Slide 29: Oncology M&A
PHASE 2 ONCOLOGY M&A Company Buyer Nature of Deal Year Indication Lead Asset Value (USD) For personal use only Profound Bio Genmab Acquisition May 2024 Ovarian Cancer ADC 1.8B AnHeart Nuvation Bio Acquisition Mar 2024 NSCLC small molecule undisclosed Therapeutics radio- Fusion Pharma AstraZeneca Acq
Slide 30: Chris Burns, CEO and MD
For personal use only Chris Burns PhD GAICD CEO and MD chris@ampliatx.com ampliatx.com | @ampliatx