Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (October 2024)
48 slides from Amplia Therapeutics's investor presentation, Oct 30, 2024
Slide 1: Capital Raising Presentation
Not for release to US Wire Services or distribution in the United States Capital Raising Presentation October 2024 ampliatx.com | @ampliatx 1
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 Future performance and forward-looking statements: This Presentation contains certain references to forecasts, estimates, assumptions and is dated 30 Oc
Slide 3: Executive Summary
EXECUTIVE SUMMARY Best-in-class FAK inhibitor in development with near term clinical milestones 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 cli
Slide 4: Company Summary
COMPANY SUMMARY ASX:ATX 12 month share price chart $0.20 12 Share price Millions A$0.135 (29-Oct-2024) 10 $0.16 Shares on issue 274.8m 8 $0.12 Market cap 6 A$37.1M (29-Oct-2024) $0.08 4 Cash A$4.6M $0.04 (30-Sep-2024) 2 • Platinum Investment $- 0 Management Ltd (12.9%) Oct23 Dec23 Feb24 Apr24 Jun24
Slide 5: Experienced Board + Management
EXPERIENCED BOARD + MANAGEMENT BOARD MANAGEMENT Rhiannon Jones PhD GAICD COO Warwick Tong Robert Peach Jane Bell Chris Burns* MB ChB MPP GAICD PhD LLB, LLM (Lond), FAICD PhD GAICD Terrie-Anne Cock Director CEO and MD PhD Chair Director Director Translational Science Charlotte Mulder BVSc (Hons) MBA
Slide 6: Pipeline
PIPELINE lAxmplia THERAPEUTICS Drug Target Indication Preclinical IND enabling Phase 1 Phase 2 Late Phase Status Narmafotinib (AMP945) FAK (ACCENT) Enrolling (Folfirinox combination) IND approved Other solid tumours AMP886 FAK/VEGFR3/FLT3 — Solid tumours yp > Ca ss es es es [eee Idiopathic Pulmonary
Slide 7: Amplia's drugs inhibit the enzyme Focal Adhesion Kinase
Amplia’s drugs inhibit the enzyme Focal Adhesion Kinase (FAK) 7
Slide 8: 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 9: FAK Inhibition in Cancer
FAK INHIBITION IN CANCER Multi-action of narmafotinib FAK over-expressed and over-active in many cancers Anti-proliferative Synergy with Reduces cells’ ability chemotherapies to proliferate Enhances activity of Higher FAK levels correlate with worse and migrate drugs and other therapies patient outc
Slide 10: FAK Inhibitors in Development
FAK INHIBITORS IN DEVELOPMENT Only 3 companies with bona fide FAK inhibitors in development Verastem (VSTM.NASDAQ, Mkt Cap US$136m (A$207m)) • Co-development with a second drug (avutometinib) • Promising data in low-grade serous ovarian cancer (~10% patients) • New Drug Application (NDA) with FDA re
Slide 11: Clinical studies of narmafotinib in pancreatic cancer
Clinical studies of narmafotinib in pancreatic cancer 11
Slide 12: Pancreatic Cancer
PANCREATIC CANCER 13% Increasing 5 year Market Prevalence survival size Estimated 66,440 diagnoses Difficult-to-treat: Global treatment market and 51,750 deaths in typically detected late in estimated at ~US$2.5 billon US this year* disease progression** in 2024 † ~4,506 diagnoses in AU Projected to
Slide 13: ACCENT Pancreatic Trial
ACCENT PANCREATIC TRIAL Background FAK activity correlates Efficacy with FAK inhibition in with worse outcome preclinical studies • Fibrosis features within TME,‡ consistent with • Narmafotinib decreases tumour fibrosis activated FAK , correlate with worse patient (collagen) outcome • Narmafotinib t
Slide 14: ACCENT Pancreatic Trial: FDA Interactions
ACCENT PANCREATIC TRIAL FDA Interactions Orphan Drug Designation* granted Clearance of Investigational New Drug • Assistance with development planning application • Tax credits for clinical costs • Clinical study of narmafotinib in combination • Exemptions from certain fees with FOLFIRINOX chemother
Slide 15: ACCENT Pancreatic Trial: Healthy Volunteer Data
ACCENT PANCREATIC TRIAL Background 2021 Healthy Volunteer trial demonstrated excellent clinical profile Narmafotinib circulating Narmafotinib safe and well tolerated levels over time • No withdrawals or safety trends Excellent Pharmacokinetics • Once-a-day oral dosing • No impact of food on drug abs
Slide 16: 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: Phase 1b: Primary endpoint – Safety and Tolerability; Secondary endpoint – PK and preliminary efficacy Phase 2a: Primary endpoi
Slide 17: Phase 1b data indicates narmafotinib well tolerated with preliminary signs of efficacy
Phase 1b data indicates narmafotinib well tolerated with preliminary signs of efficacy 17
Slide 18: ACCENT Phase 1b Summary
ACCENT PHASE 1b SUMMARY Narmafotinib safe and well tolerated • All 14 patients elected to stay on drug post cycle 1 • One DLT*: nausea >72 hours • 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 days preceding c
Slide 19: Preliminary Phase 2a data also positive
Preliminary Phase 2a data also positive 19
Slide 20: ACCENT Phase 2a Preliminary Data
ACCENT PHASE 2a Preliminary Data Narmafotinib continues to be generally well tolerated in this patient group with no dose reductions 6 confirmed PRs observed at 4 month timepoint by end Sep 2024 • >30% reduction in tumour lesion size sustained over 2 months • No new lesions Developing data-set suffi
Slide 21: ACCENT Phase 2a Preliminary Data: Duration on Trial
ACCENT PHASE 2a Preliminary Data Duration on Trial* High-level data as of 27 September 2024* Trial is ongoing - dataset is developing • 15 patients remain on study • 6 confirmed PRs (= PR sustained over 2 or more months) Individual patients • 4 PRs yet to be confirmed • 7 SDs for 2 or more months •
Slide 22: ACCENT Phase 2a Preliminary Data: Best Response
ACCENT PHASE 2a Preliminary Data Best Response (evaluable patients)* Collated data of ‘best response’ at any scan indicates promising activity • 19 patients have recorded a decrease in tumour size • 12 patients have recorded a decrease in tumour size >30% Partial Response Stable Disease Progressive
Slide 23: ACCENT Phase 2a Preliminary Data: Historical Comparison
ACCENT PHASE 2a Preliminary Data Comparison with historical gemcitabine/ ACCENT Phase 2a Historical Abraxane data indicates promising response Part A* MPACT Trial trends, noting Best Overall Response Best Response Response** • Different data-set sizes Classification (n=26) (n=431) • ACCENT trial sti
Slide 24: ACCENT Phase 2a Preliminary Data: Response Over Time
ACCENT PHASE 2a Preliminary Data Comparison with historical gemcitabine/ Abraxane data suggests combination with ACCENT Phase 2a Response over time (all lesions)* narmafotinib leads to: • Faster response Mean % Change from Baseline ± 95% CI • Longer/sustained response (all target lesions) Historical
Slide 25: Positioning narmafotinib as the preferred agent
Positioning narmafotinib as the preferred agent to enhance activity of drugs for solid tumours 25
Slide 26: FOLFIRINOX Combination Study
FOLFIRINOX COMBINATION STUDY Narmafotinib + FOLFIRINOX in advanced pancreatic cancer Daily dosing of narmafotinib + fortnightly mFOLFIRINOX* Part A • First-line therapy/newly diagnosed patients Stage (i): • Cleared IND from FDA for US-based trial - 3+3 or BOIN design; Dose 4 estimate ~20 patients •
Slide 27: Ovarian Cancer Opportunity
OVARIAN CANCER OPPORTUNITY Narmafotinib + SOC* therapy in resistant ovarian cancer Tumour Burden Strong FAK involvement in ovarian cancer • FAK is overexpressed in ovarian cancer • FAK levels increase post-chemotherapy • FAK activity drives tumour growth and resistance to therapies Promising preclin
Slide 28: Future Milestones
FUTURE MILESTONES 2024 2025 ACCENT Commence ACCENT ACCENT Pancreatic Interim FOLFIRINOX Trial Fully Topline Cancer Analysis Trial in US Recruited Data Commence Ovarian Clinical Trial Cancer (subject to funding) Regional Licensing Partnering Deal 28
Slide 29: Opportunity Summary
OPPORTUNITY SUMMARY Combinations in Combinations in Preclinical evidence in pancreatic cancer ovarian cancer other solid tumors Gemcitabine and Abraxane Platinum resistant disease Bile duct, oesophageal, head (ACCENT trial) - and neck cancer - Maintenance therapy post - FOLFIRINOX (US trial with sur
Slide 30: Capital Raising Overview
lnsmnplia THERAPEUTICS Capital Raising Overview
Slide 31: Capital Raising Overview
CAPITAL RAISING OVERVIEW • Amplia is undertaking a capital raising (the “Offer”) of up to approximately A$13.0m comprising: - a 1 for 6.45 pro-rata accelerated non-renounceable entitlement offer to eligible Amplia shareholders to raise up to approximately A$4.9 million (“Entitlement Offer”); Offer S
Slide 32: Sources and Use of Funds
SOURCES AND USE OF FUNDS SOURCES OF FUNDS AMOUNT (A$M) PURPOSE AMOUNT (A$M) ACCENT Cash Balance 1 $4.6 $5.9 • Trial Costs Anticipated R&D Rebate 2 $4.0 FOLFIRINOX • Trial Costs $6.3 • Shipping 3 • PK/PD Capital Raising Proceeds $13.0 CMC (Follow-on studies) $1.9 Total Sources $21.6 Operations, Pre-c
Slide 33: Offer Timetable
OFFER TIMETABLE The timetable is indicative only and dates and times are subject to change without notice. Trading halt and announcement of Offer Wednesday, 30 October 2024 Prospectus lodged with ASIC and released to ASX Placement & Institutional Entitlement Offer opens Wednesday, 30 October 2024 Pl
Slide 34: Appendix
lnsmnplia THERAPEUTICS Appendix
Slide 35: ACCENT Phase 1b Trial
ACCENT PHASE 1b TRIAL Key trial read-outs following industry standard criteria • Primary endpoint – Safety and Tolerability • Secondary endpoint – PK and preliminary efficacy Objective Response Rate categorised as: • Complete Response (CR) - Disappearance of all tumour lesions; no new lesions • Part
Slide 36: ACCENT Phase 1b Data
ACCENT PHASE 1b DATA Narmafotinib in combination with standard of care gemcitabine and Abraxane® • Orally-dosed narmafotinib in the days preceding weekly chemotherapy 3 Cohorts (100 mg, 200 mg, 400 mg) • Orally-dosed (capsules) • Once-a-day Safe and well tolerated • All patients elected to stay on d
Slide 37: ACCENT Phase 1b Data: Best Response
ACCENT PHASE 1b DATA Best Response Preliminary signs of efficacy observed (all patients) Improved response rate (PR and SD) compared to Historical ACCENT Best Overall historical gemcitabine/Abraxane alone Classification Best Response* Response** (n=14) • Comparison to pivotal trial (2013)** (n=431)
Slide 38: ACCENT Phase 1b Data: Tumour Reduction
ACCENT PHASE 1b DATA Preliminary signs of efficacy observed Tumour Reduction (% change from baseline) Improved response rate (PR and SD) compared to historical gemcitabine/Abraxane alone (individual patients) • Comparison to pivotal trial (2013)** Better objective response (tumour reduction) at high
Slide 39: ACCENT Phase 1b Data: Duration on Trial
ACCENT PHASE 1b DATA Preliminary signs of efficacy observed Duration on trial Improved response rate (PR and SD) compared to historical gemcitabine/Abraxane alone • Comparison to pivotal trial (2013)** Better objective response (tumour reduction) at higher doses • 4 of 6 PRs with top dose narmafotin
Slide 40: Key Risks
lnsmnplia THERAPEUTICS Key Risks
Slide 41: Key Risks
KEY RISKS RISK DESCRIPTION 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 Risks associated with the objectives outlined in the “Sources and Uses of Funds” slide above. If the Offer raises le
Slide 42: Key Risks
KEY RISKS RISK DESCRIPTION The research, development, manufacture, marketing and sale of products developed by the Company are subject to varying degrees of regulation by a number Regulatory and of government authorities in Australia and overseas. Pharmaceutical products under development, such as d
Slide 43: Key Risks
KEY RISKS RISK DESCRIPTION The Company is currently entitled to receive an R&D rebate on part of its expenditure in research and development. There is a risk that the Australian Research & Development Government may make material changes to the rebate scheme, which may adversely impact the funding a
Slide 44: 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 45: International Selling Restrictions
International Selling Restrictions 45
Slide 46: International Selling Restrictions
INTERNATIONAL SELLING RESTRICTIONS This document does not constitute an offer of New Shares and Attaching Options 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,
Slide 47: International Selling Restrictions
INTERNATIONAL SELLING RESTRICTIONS Singapore This document and any other materials relating to the New Shares and Attaching Options 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 doc
Slide 48: ampliatx.com
Amplia Therapeutics Limited Chris Burns PhD GAICD CEO and MD ABN 16 165 160 841 ASX: ATX chris@ampliatx.com info@ampliatx.com ampliatx.com 48
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