Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (July 2025)
52 slides from Amplia Therapeutics's investor presentation, Jul 23, 2025
Slide 1: Capital Raising Presentation
Capital Raising Presentation July 2025 ampliatx.com | @ampliatx
Slide 2: Important Information
IMPORTANT INFORMATION This presentation (Presentation) has been prepared by Amplia Therapeutics Limited ACN 165 160 841 (the Company or Amplia) and is dated Forward-looking statements, opinions and estimates provided in this Presentation are based on assumptions and contingencies which are subject t
Slide 3: Executive Summary
EXECUTIVE SUMMARY Developing a pipeline of small molecule inhibitors of FAK – a validated cancer target • Lead compound Narmafotinib is the best-in-class Focal Adhesion Kinase (FAK) inhibitor in development • Promising clinical safety and tolerability positions Narmafotinib as the preferred agent to
Slide 4: Experienced Board + Management
EXPERIENCED BOARD + MANAGEMENT Combined >120 years of drug development experience bringing 4 FDA approved drugs to market BOARD SENIOR MANAGEMENT Rhiannon Jones PhD GAICD COO Warwick Tong Robert Peach Jane Bell AM Chris Burns* MB ChB MPP GAICD PhD LLB, LLM (Lond), FAICD PhD GAICD FAHMS Chair Directo
Slide 5: Background on pancreatic cancer and Focal Adhesion Kinase (FAK)
Background on pancreatic cancer and Focal Adhesion Kinase (FAK)
Slide 6: Pancreatic Cancer
PANCREATIC CANCER Increasing prevalence with limited innovation or new therapies approved beyond traditional chemotherapy in recent decades Increasing 5 year Market Prevalence survival size (advanced disease) Estimated 67,440 diagnoses Difficult-to-treat: Global treatment market and 51,980 deaths in
Slide 7: Current Standard of Care
CURRENT STANDARD OF CARE Current standard-of-care for advanced pancreatic cancer remains chemotherapy. Amplia aims to demonstrate that addition of Narmafotinib will enhance durability of response Chemotherapy mPFS‡ mOS‡ Comments • Regarded as better tolerated (lower adverse events), Gemcitabine and
Slide 8: Focal Adhesion Kinase (FAK)
FOCAL ADHESION KINASE (FAK) FAK is a key driver of cancer progression and fibrosis, offering broad clinical potential across multiple therapeutic areas FAK is a critical protein in cancer growth and spread, and in formation of fibrotic (scar) tissue Potential applications extend beyond pancreatic ca
Slide 9: FAK Inhibition in Cancer
FAK INHIBITION IN CANCER FAK overactivation is driving poor patient outcomes — Narmafotinib delivers an effective targeted response Multi-action of Narmafotinib FAK over-expressed and over-active in many cancers Anti-proliferative Synergy with Reduces cells’ ability chemotherapies to proliferate Enh
Slide 10: Limited Competing FAK Inhibitors
LIMITED COMPETING FAK INHIBITORS Amplia is one of only 3 companies with bona fide FAK inhibitors in development VSTM.NASDAQ, Mkt Cap ~US$260m • Co-development with a second drug (avutometinib) • Targeting low-grade serous ovarian cancer (LGSOC) (~10% patients) • Accelerated FDA approval obtained in
Slide 11: ACCENT Trial in Advanced Pancreatic Cancer
ACCENT Trial in Advanced Pancreatic Cancer
Slide 12: Phase 1b/2a Trial Design
PHASE 1B/2A TRIAL DESIGN Fully recruited with top-line data expected in late July/early August 2025 An open-label trial of Narmafotinib in combination with gemcitabine + nab-paclitaxel in first-line patients with advanced pancreatic cancer Trial Read-outs: Safety and Tolerabilty; Preliminary efficac
Slide 13: Phase 1b – October 2023
PHASE 1B – OCTOBER 2023 Excellent safety profile established, allowing highest dose to be selected for Phase 2A and positive efficacy signals Duration on trial Release October 2023 - Narmafotinib safe and well tolerated • All 14 patients elected to stay on drug post cycle 1 • One DLT*: uncontrolled
Slide 14: Phase 2a Interim Data – March 2025
PHASE 2A INTERIM DATA – MARCH 2025 Released in March 2025. Showed longer duration and median survival than chemotherapy alone and no serious adverse events Duration on Trial* High-level data (first 26 patients)* • Duration on trial average ~7 months (208 days) ⚬ Historical median duration of treatme
Slide 15: Phase 2a Interim Data – March 2025
PHASE 2A INTERIM DATA – MARCH 2025 38% response rate compares favourably to other historical trials at 23% Best Response (evaluable patients)* Collated data of ‘best response’ at any scan indicates promising activity • 26 evaluable patients • 15 patients recorded decrease in tumor size >30% • 11 as
Slide 16: Phase 2a Interim Data – March 2025
PHASE 2A INTERIM DATA – MARCH 2025 Combination with gem + Abraxane leads to faster and more sustained response. If approved as a combination therapy by FDA, it has the potential for Narmafotinib combination to become far more appealing Comparison with historical gemcitabine+ Response over time (all
Slide 17: Phase 2a Update – June/July 2025
PHASE 2A UPDATE – JUNE/JULY 2025 17 Partial Responses, including 2 Complete Responses, from 55 patients* with 20 patients remaining on trial and awaiting results Response rate sufficient to demonstrate superiority of Narmafotinib combination over gem/Nab-P alone • 17/55 patients (31%) better than 23
Slide 18: Patient Case Study
PATIENT CASE STUDY Rare pathological Complete Response in ACCENT study Patient diagnosed with stage 4 pancreatic cancer and joined ACCENT study Most patients who are diagnosed at this stage will not survive 12 months After 12 months, patient’s pancreatic tumour and liver metastases reduced in size •
Slide 19: Top-Line Data Preview
TOP-LINE DATA PREVIEW Data comparison with previous gem/nab-P data from prior MPACT and NAPOLI-3 trials Full data expected to be available end of MPACT (n=431) NAPOLI (n=383) July / early August 2025 Overall survival (mo) 8.5 9.2 Progression free survival (mo) 5.5 5.6 Aiming to see: DOT (days) 117 1
Slide 20: Potential Regulatory Pathway
Potential regulatory pathway Potential for Narmafotinib to receive accelerated approval following a pivotal Phase 2b/3 clinical trial • Amplia’s Narmafotinib has potential for an accelerated path to market in in advanced pancreatic cancer following a Phase 2b/3 pivotal trial – as per Verastem, Inc •
Slide 21: Additional Opportunities
ADDITIONAL alls: OPPORTUNITIES [vim
Slide 22: Amplicity Trial
AMPLICITY TRIAL Combining Narmafotinib with most common chemotherapy for advanced pancreatic cancer in US Phase 2 clinical study of Narmafotinib in Protocol design combination with FOLFIRINOX Part A: • Strong pre-clinical evidence - BOIN design; estimate 20-27 patients 600 mg • FDA has cleared IND -
Slide 23: kRAS Inhibitor Combinations
kRAS Inhibitor Combinations Narmafotinib to be explored with selected kRAS inhibitor in pancreatic cancer trial FAK inhibition enhances kRAS inhibitors represent exciting new drug efficacy of kRAS inhibitor class for pancreatic, lung and colorectal cancer • Highly competitive - multiple drugs in cli
Slide 24: Ovarian Cancer
OVARIAN CANCER IIT’s for clinical study of Narmafotinib plus standard-of-care therapy in ovarian cancer submitted for funding and in discussion Opportunities in: • First-line therapy as a chemo-sensitiser in platinum-resistant cancer (neoadjuvant) • In recurrence and acquired resistance • In sub-typ
Slide 25: Outlook & catalysts
Outlook & catalysts
Slide 26: Partnering Opportunities
PARTNERING OPPORTUNITIES Significant new partnering interest following highly prospective ACCENT clinical trial data • Amplia’s partnering interest from global pharmaceutical companies has materially increased following recent interim data and patient updates in the ACCENT clinical trial • Heightene
Slide 27: Upcoming Catalysts
UPCOMING CATALYSTS Significant pipeline of expected news flow with key catalysts imminent • Q3 2025 ✓ ACCENT top-line data including progression free survival (Late July/early August 2025) ✓ ACCENT request FDA type C meeting to discuss Phase 2b/3 pivotal trial design ✓ Amplicity first patient dosed
Slide 28: Capital raising overview
lAsmplia THERAPEUTICS Capital raising overview
Slide 29: Capital Raising Overview
CAPITAL RAISING OVERVIEW Amplia is undertaking a capital raising of $27.5m via a placement and share purchase plan • Amplia is undertaking a capital raising (the “Offer”) of approximately $27.5 million comprising: - an institutional placement (“Tranche 1 Placement”) to raise approximately $22.3 mill
Slide 30: Sources and Use of Funds
SOURCES AND USE OF FUNDS Following the capital raising, Amplia will be funded into 2027 SOURCES OF FUNDS AUD ($m) PURPOSE AUD ($m) Cash Balance (at 30 June 25) 1 $7.0 ACCENT trial • Completion of Phase 2a $6.0 • Foundational work for Phase 2b/3 trial Expected FY25 and FY26 R&D $8.2 Amplicity trial T
Slide 31: Offer Timetable
OFFER TIMETABLE Record Date for SPP 7.00pm (AEST), Tuesday, 22 July 2025 Trading resumes, Announcement of Capital Raising Wednesday, 23 July 2025 Settlement of New Shares under Placement Monday, 28 July 2025 Allotment of New Shares under Placement Tuesday, 29 July 2025 SPP Opens Friday, 1 August 202
Slide 32: Amplia Therapeutics Limited
Amplia Therapeutics Limited ABN 16 165 160 841 ASX: ATX info@ampliatx.com 32 ampliatx.com
Slide 33: Appendix
Appendix
Slide 34: Company Summary (ASX:ATX)
COMPANY SUMMARY (ASX:ATX) Founded in 2016 Share price • Reverse-listed onto ASX in 2018 A$0.285 (as at 18/07/25) Developing assets discovered at Australian industry - academic collaboration • CRC for Cancer Therapeutic Based in Melbourne, Australia Shares on issue 388.7m • 8 local staff • Worldwide
Slide 35: FAK Inhibition in Cancer
FAK INHIBITION IN CANCER Over-expression and increased FAK activity FAK is over-expressed and over- active in many cancers FAK gene Alteration frequency ovarian pancreatic 35
Slide 36: FAK Inhibition in Cancer
FAK INHIBITION IN CANCER FAK activity correlates with worse outcome Higher FAK levels correlate with worse patient outcomes Low levels active FAK = better survival High levels active FAK = worse survival EMBO Mol Med 2020, 12, e12010 36
Slide 37: 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 effect of food on drug absorption ⚬ No accumulation Circulating levels of Narmafotinib show dose dependence,
Slide 38: Potential for Combination with Other Therapeutic Approaches
POTENTIAL FOR COMBINATION WITH OTHER THERAPEUTIC APPROACHES Evidence for synergistic or additive combinations with: • Raf/Mek and kRas inhibitors • Wnt inhibitors • Hippo Pathway inhibitors • I/O agents ⚬ anti PD-1 and PD-L1 ⚬ anti-TIGIT Also: • Antibody-Drug Conjugates • Radiation and radiopharmace
Slide 39: Background on Narmafotinib (AMP945)
Background on Narmafotinib (AMP945)
Slide 40: Preclinical Data
PRECLINICAL DATA Preclinical profile of Narmafotinib Narmafotinib displays excellent potency and selectivity Biochemical/biophysical assays Cellular assays Ovarian cancer cells IC 5 2.2 nM (OVCAR 5) 0 KD 29 pM 0.1 Narmafotinib conc. (nM) FAK Red circles show inhibition of additional kinases. Size of
Slide 41: Preclinical Data
PRECLINICAL DATA Efficacy with FAK inhibition in preclinical studies Narmafotinib improves survival in pancreatic cancer models when dosed in combination with standard of care therapies Survival plot from mouse model of human pancreatic cancer, comparing three groups of mice: (i) vehicle (orange), (
Slide 42: Preclinical Data
PRECLINICAL DATA Anti-fibrotic effects of Narmafotinib Narmafotinib reduces collagen deposition and cross-linking in vitro and in vivo • No toxicity to fibroblasts • Correlates with decreased pFAK • Shorter collagen fibers Fibroblasts treated with Narmafotinib, 7 days Picrosirius red staining for to
Slide 43: Narmafotinib IP Position
Narmafotinib IP POSITION FDA Orphan Drug Designation for pancreatic cancer and idiopathic pulmonary fibrosis Status Filing Date Composition of Matter Granted 2012 Salt Form Granted (JP, EU) 2020 Method of Use (IPF) Filed 2021 Method of Use (PC) Filed 2023 Additional Filings Ongoing 43
Slide 44: Extended Pipeline
EXTENDED PIPELINE Extensive pipeline, with lead asset in pancreatic cancer potentially heading towards a Phase 2 registrational trial ONCOLOGY ACCENT AMPLICITY FIBROTIC DISEASE Expected developments over the next 12 months 44
Slide 45: Key Risks
lAsmplia THERAPEUTICS Key Risks
Slide 46: Key Risks
KEY RISKS RISK DESCRIPTION Risks associated with the The Offer is not underwritten. Accordingly, the amount that will be raised under the Offer is uncertain and as such could be insufficient to meet all of the objectives outlined in the “Sources and Uses of Funds” slide above. If the Offer raises le
Slide 47: Key Risks
KEY RISKS RISK DESCRIPTION Chemistry, manufacturing The ACCENT clinical trial currently underway requires supply of Narmafotinib drug product (capsules). There are risks to production of drug substance in a timely manner should supply chains be affected. There are also risks associated with shipment
Slide 48: Key Risks
KEY RISKS RISK DESCRIPTION Growth There is a risk that the Company may be unable to manage its future growth successfully. The ability to hire and retain skilled personnel as outlined above may be a significant obstacle to growth. Commercial partners The Company’s growth strategy may be impacted if
Slide 49: General Risks
GENERAL RISKS RISK DESCRIPTION Economic General economic conditions, movements in financial markets, 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 con
Slide 50: International Selling Restrictions
International Selling Restrictions 50
Slide 51: International Selling Restrictions
INTERNATIONAL SELLING RESTRICTIONS This document does not constitute an offer of New Shares in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares and Attaching Options may not be offered or sold, in any country outsid
Slide 52: International Selling Restrictions
INTERNATIONAL SELLING RESTRICTIONS Singapore This document and any other materials relating to the New Shares have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, this document and any other document or materials in
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