Amplia Therapeutics Ltd. · ASX:ATX
Amplia Therapeutics — Investor Presentation (April 2024)
45 slides from Amplia Therapeutics's investor presentation, Apr 16, 2024
Slide 1: Investor Slide Deck April 2024
ismplio Vie RAPE Vies Investor Slide Deck April 2024 ampliatx.com | @ampliatx 2 " RS 0 EN . k
Slide 2: Disclaimer
DISCLAIMER This presentation (Presentation) has been prepared by Amplia Therapeutics Limited ACN 165 160 841 (the Company or Future performance and forward-looking statements: This Presentation contains certain references to forecasts, estimates, Amplia) and is dated 16 April 2024. This Presentation
Slide 3: Snapshot
For personal use only SNAPSHOT Amplia is developing a pipeline of small molecule inhibitors of Focal Adhesion Kinase (FAK) - a clinically validated target in cancer Promising clinical safety and tolerability data positions narmafotinib as the preferred agent to enhance the activity of drugs that are
Slide 4: Highlights
For personal use only HIGHLIGHTS © & Clinical trial in advanced pancreatic cancer underway e Interim readout planned for mid- 2024 ¢ Preliminary signs of efficacy Lean, experienced drug development team e Network of experienced consultants and contractors lAxmplia THERAPEUTICS Open IND* for narmafot
Slide 5: Company Summary
For personal use only COMPANY SUMMARY “Axmplia ASX:ATX Share price (11-Apr-2024) Shares on issue Market cap (11-Apr-24) Cash (pro forma) (31-Mar-24) Substantial Shareholders THERAPEUTICS 12 month share price chart $0.12 mm Market Volume | — Close Price ner A$0.085 $0.10 mo $0.08 194.0m ai $0.06 150
Slide 6: For personal use only
For personal use only
Slide 7: Focal Adhesion Kinase (FAK)
For personal use only FOCAL ADHESION KINASE (FAK) “Xxmplia FAK is a critical protein in cancer development and formation of fibrotic (scar) tissue. Amplia’s drugs block the activity of the FAK protein and are highly potent and selective. Clinical potential in: ¢ Cancer ¢ Fibrotic diseases ¢ Scar Red
Slide 8: FAK Inhibitors in Development
For personal use only FAK INHIBITORS IN DEVELOPMENT “Axmplia THERAPEUTICS Only 3 companies with bona fide FAK inhibitors in development Verastem .. Good Selectivity Sondre DDI Clinical Notes Stage \ P profile Amplia Safe and well Ea Defactinib Recent success in (Verastem) ? Phase 2 LGSOC EDI a High
Slide 9: FAK Inhibition in Cancer
For personal use only FAK INHIBITION IN CANCER FAK activity promotes cancer growth ¢ within cancer cell ¢ in tumour microenvironment FAK over-expressed and over-active in many cancers Higher FAK levels correlate with worse patient outcomes FAK inhibitors target multiple drivers of cancer growth lasm
Slide 10: Clinical Validation of FAK
For personal use only CLINICAL VALIDATION OF FAK Activity of defactinib in low grade serous ovarian cancer US biotech Verastem developing first- generation FAK inhibitor defactinib In combination with second drug, avutometinib Verastem share price rose >100% on the back of this data Verastem surges
Slide 11: Clinical Validation of FAK: Verastem data
CLINICAL VALIDATION OF FAK Verastem data - ASCO Jun 2023 2 ee 6.2 7 og o Si °y as C64 ro) a o8 Za of — £ Og LL g 60} g 804 De kraswt BH krasmt 100+ % Still on treatment Avutometinib Minimal response with avutometinib alone Add FAK inhibitor — 1004 Best Response (% Change from Baseline) 2079 -804 lAs
Slide 12: Clinical studies of narmafotinib in pancreatic cancer
Clinical studies fo} mat-laaatclioltialle in pancreatic cancer
Slide 13: Pancreatic Cancer
For personal use only PANCREATIC CANCER Increasing Prevalence Estimated 66,000 diagnoses and 50,000 deaths in US this year* 4,500 diagnoses in AU in 2023** * American Cancer Society (link) *™ Cancer Australia (link) 5 year survival Difficult-to-treat: typically detected late in disease progression**
Slide 14: ACCENT Pancreatic Trial: Background
For personal use only ACCENT PANCREATIC TRIAL “Axmplia Background FDA Orphan Drug Designation granted by US FDA* e Assistance with development planning ¢ Tax credits for clinical costs ¢ Exemptions from certain fees e Seven years of post-approval marketing exclusivity *www.fda.gov/industry/medical-p
Slide 15: ACCENT Pancreatic Trial: Background
For personal use only ACCENT PANCREATIC TRIAL “Axmplia THERAPEUTICS Background 2021 Healthy Volunteer trial demonstrated excellent clinical profile hiarmafosinib Geouiating Narmafotinib safe and well tolerated levels over time © No withdrawals or safety trends 8 Oral Dose 4 > 125mg = 60mg > 30mg -~
Slide 16: ACCENT Trial Design
For personal use only ACCENT PANCREATIC TRIAL “Axmplia ACCENT Trial Design Ano com pen-label trial of narmafotinib in bination with gemcitabine and Abraxane® in patients with advanced pancreatic cancer e Metastatic, or on-resectable Conducted in two stages: °P °P hase 1b - dose selection (completed)
Slide 17: Clinical data indicate narmafotinib safe, well tolerated, preliminary signs of efficacy
Clinical data ind narmafotinib sa well tolerated preliminary sign of efficacy
Slide 18: ACCENT Pancreatic Trial: Phase 1b
For personal use only ACCENT PANCREATIC TRIAL Phase 1b (complete) Increasing doses of narmafotinib in combination with standard-of-care gemcitabine and Abraxane® Identified 400 mg once-a-day as safe and appropriate dose for Phase 2 lAsmplia THERAPEUTICS ( >) = 3 Cohorts (100 mg, 200 mg, 400 mg) stoe
Slide 19: Preliminary signs of efficacy observed
For personal use only ACCENT PANCREATIC TRIAL “axmplia Preliminary signs of efficacy observed Improved response rate (Partial Response and Stable Disease) compared to historical gemcitabine/Abraxane alone © Comparison to pivotal trial (2013)** Analysis includes patients on all three doses ¢ Includin
Slide 20: Patient Duration on ACCENT trial
For personal use only ACCENT PANCREATIC TRIAL Patient Duration on ACCENT trial (as at 20 Mar 2024) Phase 1b Continuing Stable Disease Partial response Pre-assessment Phase 2a 150 709 Days on trial c=) wo 0 Change from baseline (%) lasmplia THERAPEUTICS Best response (as at 14 Mar 2024) 20- 100mg aH
Slide 21: ACCENT Trial Design: Phase 2a
For personal use only ACCENT TRIAL DESIGN Phase 2a Recruitment increases anticipated in Australia ¢ 6 sites open from Phase 1b e Single dose - 400 mg e Cohort recruiting continuously ¢ More attractive to patients - reduced blood sampling and site interaction Introduced 5 sites in South Korea RECRUIT
Slide 22: Positioning narmafotinib as the preferred agent to enhance activity of drugs for solid tumours
Positioning nar as the preferred to enhance acti of drugs for sol tumours THERAPEUTICS
Slide 23: New Pancreatic Cancer Opportunity
For personal use only NEW PANCREATIC CANCER OPPORTUNITY Narmafotinib + FOLFIRINOX in pancreatic cancer FOLFIRINOX chemotherapy is preferred treatment option for pancreatic cancer in US and most of EU Recent data indicates improved response compared to gemcitabine + nab-paclitaxel Narmafotinib improv
Slide 24: Ovarian Cancer Opportunity
For personal use only OVARIAN CANCER OPPORTUNITY Narmafotinib + SOC therapy in resistant ovarian cancer High FAK overexpression in ovarian cancer FAK levels increase after standard of care FAK activity drives tumour growth and resistance to therapies in ovarian cancer Total flux (p/s) Tumour Burden
Slide 25: Opportunity Summary
For personal use only OPPORTUNITY SUMMARY Combinations in pancreatic cancer Combinations in ovarian cancer lAsmoplia THERAPEUTICS Preclinical evidence in other solid tumors Gemcitabine and Abraxane (ACCENT trial) FOLFIRINOX (US trial with open IND) Platinum resistant disease Maintenance therapy post
Slide 26: Future Milestones
FUTURE MILESTONES “Asmplia THERAPEUTICS For personal use only Pp ti Commence ancreatic ACCENT FOLFIRINOX ACCENT Phase 2b/3 Cancer Interim Analysis Trial in US Trial Complete Planning Ovarian Cancer Commence Clinical Trial Partnering pte Licensing Deal 26
Slide 27: Pipeline
PIPELINE Drug Target lAsmoplia THERAPEUTICS Indication IND enabling Phase1 Phase 2 Late Phase Status Narmafotinib (AMP945) FAK AMP886 FAK/VEGFR3/FLT3 For personal use only Narmafotinib (AMP945) = FAK re p> oa Pancreatic Cancer Ovarian Cancer C1 > In planning Other solid tumours >>> Solid tumours FIB
Slide 28: Capital Raising Details
lwmnplia WEAN ete alc ag oy ak Aan Se TET yl [ol Capital Raising Details
Slide 29: Key Details of Entitlement Offer
KEY DETAILS OF ENTITLEMENT OFFER • A fully underwritten non-renounceable rights issue on a two (2) for five (5) basis raising ~$4.27 million via the issue of 77.6 million shares (New Shares) (Entitlement Offer or the Offer). Structure • The Entitlement Offer will be offered to eligible shareholders
Slide 30: Near Term Plan & Capital Requirements
NEAR TERM PLAN & CAPITAL REQUIREMENTS Amplia is raising capital to: • Provide sufficient funding to undertake the Interim Analysis for ongoing Phase 2a ACCENT trial • Undertake production of additional narmafotinib, and manufacture a further batch of 25,000 capsules • Support a pilot Investigator In
Slide 31: Use of Funds
For personal use only USE OF FUNDS PURPOSE AMOUNT (A$M) cae Phase 1 (Pilot Investigator Initiated) clinical trial - Ovarian Cancer $0.15 Cash costs of the Entitlement Offer $0.33 *The Company expects future R&D Tax incentive inflows in relation to FY2024 which are not included in the use of funds st
Slide 32: Timetable
TIMETABLE Company in trading halt 9am Friday, 12 April 2024 For personal use only Company announces Entitlement Offer and resumes trading Tuesday, 16 April 2024 Ex date Thursday, 18 April 2024 Record Date Friday, 19 April 2024 Entitlement Offer opens & booklet despatched Wednesday, 24 April 2024 Ent
Slide 33: Key Risks
lwmplia WEN ih Wests ec ago akl aan oe TEL yl [ol er Key Risks
Slide 34: Key Risks
KEY RISKS RISK DESCRIPTION Clinical development risk The nature of clinical drug development has inherent risks, with many drug candidates entering clinical trial failing to be successfully developed into marketable products. The Company is currently undertaking a clinical trial with its lead drug n
Slide 35: Key Risks
KEY RISKS RISK DESCRIPTION Commercialisation of products and The Company has not yet commercialised any products and as yet has no revenues. The Company is also dependent on commercially attractive markets remaining available to it during the commercialisation phase and there is a risk that, once de
Slide 36: 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. For personal use only Commercial partners The Company’s growth strate
Slide 37: General Risks
GENERAL RISKS RISK DESCRIPTION General economic conditions, movements in interest and inflation rates and currency exchange rates may have an adverse effect on the Economic Company's business and production activities, as well as on its ability to fund those activities. For personal use only Share m
Slide 38: General Risks
GENERAL RISKS RISK DESCRIPTION The Company's capital requirements depend on numerous factors. The Company may require further financing in addition to amounts Additional requirements for capital raised under the capital raising. Any additional equity financing will dilute shareholdings, and debt fin
Slide 39: Appendix A - Underwriting Agreement
la~mplia TTS eet tig eke ME Rh Pe tere Appendix A - Underwriting Agreement
Slide 40: Underwriting Agreement
UNDERWRITING AGREEMENT Taylor Collison Limited (Lead Manager) is acting as lead manager, underwriter and bookrunner of the Entitlement Offer. Amplia has entered into an underwriting agreement with the Lead Manager in respect of the Entitlement Offer (Underwriting Agreement). The Underwriting Agreeme
Slide 41: Underwriting Agreement
UNDERWRITING AGREEMENT j) ASIC: (i) applies for an order under Part 9.5 of the Corporations Act in relation to the Entitlement Offer, the issue of the New Shares or any document lodged with ASX on the Announcement Date (Information Document); (ii) holds, or gives notice of intention to hold, a heari
Slide 42: Underwriting Agreement
UNDERWRITING AGREEMENT In addition, the Lead Manager may, in certain circumstances, terminate its obligations under the Underwriting Agreement if any of the following termination events occur: • had or could be expected to have, individually or in aggregate with a separate termination event, a mater
Slide 43: Underwriting Agreement
UNDERWRITING AGREEMENT k) the Company: (i) issues an Information Document without the prior approval of the Lead Manager (such approval not to be unreasonably withheld); or (ii) varies or withdraws an existing Information Document without the prior approval of the Lead Manager (such approval not to
Slide 44: Underwriting Agreement
UNDERWRITING AGREEMENT Sub-underwriting arrangements with Dr Robert Peach The Company has entered into a sub-underwriting commitment letter with Dr Robert Peach (RP Sub-underwriting Letter), which is stated to be for the benefit of the Company and the Lead Manager, by which Dr Peach agrees to sub-un
Slide 45: Contact
LAM Mplio Tob EeRwAR PSE TGS: Chris Burns PhD GAICD Amplia Therapeutics Limited CEO and MD ABN 16 165160 841 ASX: ATX chris@ampliatx.com info@ampliatx.com ihe ampliatx.com
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