Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (February 2025)
35 slides from Amplia Therapeutics's investor presentation, February 2025
Slide 1: Targeting Cancer and Fibrosis
Targeting Cancer and Fibrosis February 2025 ampliatx.com ampliatx.com | @ampliatx | @ampliatx
Slide 2: Disclaimer
DISCLAIMER This presentation (Presentation) contains summary information about Amplia Therapeutics Limited ACN from statements in this Presentation. Forward-looking statements are based on the Company’s good faith 165 160 841 and its subsidiaries (the Company or Amplia) which is current as at 31 Dec
Slide 3: Executive Summary
EXECUTIVE SUMMARY Developing a pipeline of small molecule inhibitors of FAK – a validated cancer target Lead drug narmafotinib is the best-in-class FAK inhibitor in development Phase 2a ACCENT clinical trial in pancreatic cancer underway and fully recruited, with positive interim data Preparing for
Slide 4: Investment Highlights
Investment Highlights Experience Optionality Near Term Value Potential Strong Engagement Inflection Points for non-oncology / and endorsement An experienced Board Other cancers fibrosis indications from KOLs and Management Initiation US team with strong track Other co-meds pancreatic trial record To
Slide 5: Corporate Overview
Corporate Overview ampliatx.com | @ampliatx
Slide 6: Company Summary
COMPANY SUMMARY ASX: ATX Founded in 2016 Burns, Behrenbruch, Tong, Sullivan, Devlin Reverse-listed onto ASX in 2018 Developing assets discovered at Australian industry - academic partnership ç CRC for Cancer Therapeutics Based in Melbourne, Australia 8 local staff Worldwide network of collaborators,
Slide 7: Company Summary
COMPANY SUMMARY ASX: ATX Share price A$0.08-0.09 (Feb 2025) Shares on issue 388m Market cap ~A$33m (Feb 2025) ç Platinum Investment Management Ltd Blueflag Holdings Pty Ltd Acorn Capital Ltd Significant Pengana Capital Shareholders Frazis Capital Partners Regal Funds Management Board + Management
Slide 8: Corporate Timeline
CORPORATE TIMELINE 2016 2018 2019 2020 Founding of Reverse Listing Dr John Lambert Orphan Drug Company onto ASX appointed CEO Designation Phase 1 and Managing Granted in Trial Director pancreatic cancer and IPF Demonstrated safety and tolerability in healthy volunteers 2023 2022 2021 Dr Chris Burns
Slide 9: Experienced Board + Management
EXPERIENCED BOARD + MANAGEMENT BOARD MANAGEMENT Rhiannon Jones PhD GAICD COO Warwick Tong Robert Peach Jane Bell Chris Burns* LLB, LLM (Lond), FAICD PhD GAICD FAHMS Terrie-Anne Cock MB ChB MPP GAICD PhD Chair Director Director CEO and MD PhD Director Translational Science Charlotte Mulder BVSc (Hons
Slide 10: Cancer Therapeutics CRC
CANCER THERAPEUTICS CRC WORLD CLASS DRUG DISCOVERY Top Universities Including Top MRIs Including Top Drug Developers Select Biotech Partners Australia’s National Science Agency
Slide 11: Cancer Therapeutics CRC
CANCER THERAPEUTICS CRC WORLD CLASS DRUG DISCOVERY Top Universities Including Project 1 Top MRIs Including Project 2 Top Drug Developers Select Biotech Partners Project 3 Australia’s National Science Agency Project 4
Slide 12: Focal Adhesion Kinase as a Target
Focal Adhesion Kinase as a Target ampliatx.com | @ampliatx
Slide 13: 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 Broad clinical potential Amplia’s drugs potently and selectively block Cancer Fibrosis Scarring the activity of the FAK protein 8
Slide 14: FAK Inhibition in Cancer
FAK INHIBITION IN CANCER Over-expression and increased FAK activity FAK is over-expressed and over- active in many cancers Higher FAK levels correlate with worse FAK gene Alteration frequency patient outcomes ovarian pancreatic Narmafotinib potently inhibits FAK and thereby reduces cancer growth Wit
Slide 15: FAK Inhibition in Cancer
FAK INHIBITION IN CANCER FAK activity correlates with worse outcome FAK is over-expressed and over-active in many cancers Low levels active FAK = better survival High levels active FAK = worse survival Higher FAK levels correlate with worse patient outcomes Narmafotinib potently inhibits FAK and the
Slide 16: FAK Inhibition in Cancer
FAK INHIBITION IN CANCER Multi-action of Narmafotinib FAK is over-expressed and over-active Anti-proliferative Synergy with in many cancers Reduces cells’ ability to proliferate chemotherapies Enhances activity of and migrate drugs and other therapies Higher FAK levels correlate with worse patient o
Slide 17: Narmafotinib
Narmafotinib ampliatx.com | @ampliatx
Slide 18: Pipeline
PIPELINE Drug Target Indication Preclinical IND enabling Phase 1 Phase 2 Late Phase Status ONCOLOGY Narmafotinib (AMP945) FAK Pancreatic Cancer Active; Fully (Gemcitabine/Abraxane) ACCENT Recruited Pancreatic Cancer Open IND (Folfirinox combination) Ovarian Cancer In planning Other solid tumours AMP
Slide 19: Preclinical Data
PRECLINICAL DATA Preclinical profile of Narmafotinib Narmafotinib displays excellent potency Biochemical/biophysical assays Cellular assays and selectivity IC50 2.2 nM Ovarian cancer cells (OVCAR 5) K 29 pM Narmafotinib improves survival in pancreatic D 0.1 cancer models when dosed in combination Na
Slide 20: Preclinical Data
PRECLINICAL DATA Efficacy with FAK inhibition in preclinical studies Narmafotinib displays excellent potency and selectivity Narmafotinib improves survival in pancreatic cancer models when dosed in combination with standard of care therapies Narmafotinib reduces collagen deposition and cross-linking
Slide 21: Preclinical Data
PRECLINICAL DATA Anti-fibrotic effects of Narmafotinib Narmafotinib displays excellent potency and selectivity Narmafotinib improves survival in pancreatic cancer models when dosed in combination with standard of care therapies TIFs treated with Narmafotinib, 7 days Picrosirius red staining for tota
Slide 22: Preclinical Data
PRECLINICAL DATA Anti-fibrotic effects of Narmafotinib Narmafotinib displays excellent potency and selectivity Narmafotinib improves survival in pancreatic cancer models when dosed in combination with standard of care therapies Narmafotinib reduces collagen deposition and cross-linking in vitro and
Slide 23: Narmafotinib in the Clinic
Narmafotinib in the Clinic ampliatx.com | @ampliatx
Slide 24: Early Development Results
EARLY DEVELOPMENT RESULTS Circulating Narmafotinib levels and FAK inhibition Healthy volunteer study demonstrated excellent clinical profile Safety and tolerability Once a day dosing No food effect No accumulation Target engagement in skin-punch Circulating levels of Narmafotinib show dose dependenc
Slide 25: ACCENT Trial Design
ACCENT TRIAL DESIGN An open-label trial of Narmafotinib in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer Trial Read-outs: Safety and Tolerabilty; Efficacy Phase 2 dose Interim Data Analysis identified analysis 400 mg oral dose Required 6 or more Saf
Slide 26: ACCENT Phase 1b Summary
ACCENT PHASE 1b SUMMARY Narmafotinib safe and well tolerated Duration on trial All 14 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 Three dose levels examined, with 400 mg dose (oral, once-a-day) in d
Slide 27: ACCENT Phase 2a Interim Data
ACCENT PHASE 2a Interim Data 26 patients Narmafotinib continues to be generally well tolerated 10 confirmed PRs observed by mid December 2024 >30% reduction in tumour lesion size sustained over 2 months No new lesions Duration on trial continues to far out-perform gemcitabine-Abraxane alone Jan 2025
Slide 28: ACCENT Phase 2a Interim Data
ACCENT PHASE 2a Interim Data Collated data of ‘best response’ at any scan Best Response (evaluable patients)* indicates promising activity 19 patients have recorded a decrease in tumor size 12 patients have recorded a decrease in tumor size >30% *Based on data available in trial database on Sep 27 2
Slide 29: Opportunities and Future Plans
Opportunities and Future Plans ampliatx.com | @ampliatx
Slide 30: Pancreatic Cancer Treatments
PANCREATIC CANCER TREATMENTS (Global Data 2019) Folfirinox Gemcitabine+Abraxane Gemcitabine Other 100 Stage IV Metastatic Pancreatic Cancer Patients with Stage III Unresectable / 80 60 40 20 0 a * ce n K n SA ly y in lia an ai U pa Ita an U Ch Sp ra m Ja Fr st er Au G *2022; Metastatic patients only
Slide 31: Future Milestones
FUTURE MILESTONES Pancreatic Cancer ACCENT Recruitment Topline Mature Trial TRIAL completed data data completion 2025 2026 FOLFIRINOX Trial Sites First patient Complete dose Initiate 2 dose Complete 2 dose TRIAL Engagement dosed escalation comparison comparison
Slide 32: Opportunities
OPPORTUNITIES Evidence for FAK involvement in ovarian cancer Opportunities in Ovarian Low Grade Serous Ovarian Cancer Cancer Platinum Resistant Disease Maintenance Therapy Evidence that FAK enhances the effect of other targeted agents Opportunities in various cancers for combinations with, for e.g.
Slide 33: Opportunities
OPPORTUNITIES Co-development Partner with biotech or pharma to develop combination therapies partnership Co-fund trials with pharma or biotech who may take option to license Regional licensing deal for pharma/biotech to have the rights to develop and Licensing market Narmafotinib in single region, s
Slide 34: FAK Inhibitors in Development
FAK INHIBITORS IN DEVELOPMENT Only 3 companies with bona fide FAK inhibitors in development Verastem (VSTM.NASDAQ, Mkt Cap ~US$260m) Co-development with a second drug (avutometinib) Promising data in low-grade serous ovarian cancer (~10% patients) Completed Phase 2 trials; Confirmatory Phase 3 under
Slide 35: Amplia Therapeutics Limited
Amplia Therapeutics Limited ABN 16 165 160 841 ASX: ATX [email protected] ampliatx.com
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