Island Pharmaceuticals Ltd · ASX:ILA
Island Pharmaceuticals — Investor Presentation (February 2022)
29 slides from Island Pharmaceuticals's investor presentation, Feb 10, 2022
Slide 1: Updated investor presentation and webinar invitation
10 February 2022 For personal use only ASX Announcement Updated investor presentation and webinar invitation MELBOURNE Australia, 10 February 2022: Australian mid-clinical stage antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; “Island”; “the Company”) is pleased to release a
Slide 2: Priority Review Voucher and paperless registration
If ISLA-101 achieves FDA approval, and certain other criteria are met, Island may be eligible to obtain a "Priority Review Voucher" at the time of FDA approval. This means that as well as getting approval to manufacture and sell ISLA-101, the Priority Review Voucher (PRV) could permit Island to expe
Slide 3: Solving Urgent Viral Disease Threats
For personal use only SOLVING URGENT VIRAL DISEASE THREATS (ASX: ILA) Investor update – February 2022 ISLAND PHARMACEUTICALS LIMITED 1 Investor INVESTOR Presentation PRESENTATION – October 2022 – FEBRUARY 2021
Slide 4: Disclaimer
DISCLAIMER This presentation has been prepared by Island Pharmaceuticals Limited views on its future performance or condition. Actual results could differ No representation, warranty or assurance (express or implied) is given or For personal use only (ABN 641 183 842) (Company or Island Pharmaceutic
Slide 5: Island at a Glance
ISLAND AT A GLANCE For personal use only Island Pharmaceuticals (ASX: ILA) is a mid clinical-stage drug repurposing company, focused on the rapid development of antiviral therapeutics for infectious diseases Island’s drug Island repurposing Initial focus is Pharmaceuticals strategy enables on mosqui
Slide 6: The Benefits of Drug Repurposing
THE BENEFITS OF DRUG REPURPOSING For personal use only ISLAND PHARMACEUTICALS LIMITED 4 Investor INVESTOR Presentation PRESENTATION – October 2022 – FEBRUARY 2021
Slide 7: The Challenge
For personal use only THE CHALLENGE ISLAND PHARMACEUTICALS LIMITED 5 Investor INVESTOR Presentation PRESENTATION – October 2022 – FEBRUARY 2021
Slide 8: Why Dengue as a First Target for ISLA-101?
WHY DENGUE AS A FIRST TARGET FOR ISLA-101? SIGNIFICANT UNMET NEED FOR DISEASE WITH INCREASING INCIDENCE For personal use only Significant unmet need (3.9 billion people at risk) Increasing spread to US, EU and Australia ISLA-101 has both therapeutic and prophylactic potential Strong animal and human
Slide 9: Communities Hit by Two Viruses at Once
COMMUNITIES HIT BY TWO VIRUSES AT ONCE For personal use only Dec 1, 2021 Nov 23, 2021 Nov 17, 2021 The researchers found 2.4 times the rate of arbovirosis as originally reported, including coinfections, suggesting underestimation of the incidence of the three viruses. However, future research is nee
Slide 10: Dengue Is a Widespread Issue
DENGUE IS A WIDESPREAD ISSUE For personal use only Dengue outbreaks occurred in many countries of the world in the Americas, Africa, the Middle East, Asia, and the Pacific Islands. ISLAND PHARMACEUTICALS LIMITED https://www.healthmap.org/dengue/en/ 8 Investor INVESTOR Presentation PRESENTATION – Oct
Slide 11: Dengue in 2050 – A Global Disease
DENGUE IN 2050 – A GLOBAL DISEASE For personal use only Prediction based on projections of future temperatures, rainfall, and mosquito populations (NASA Earth Observatory map by Lauren Dauphin based on data from Janey Messina, University of Oxford.) ISLAND PHARMACEUTICALS LIMITED https://earthobserv
Slide 12: Limited Available Solutions
LIMITED AVAILABLE SOLUTIONS HIGHLY PREVALENT DISEASES WITH UNMET MEDICAL NEED For personal use only Deformities in babies from mothers with Zika Dengue Zika Yellow Japanese West Nile fever Virus fever Encephalitis Viral diseases are a Worldwide 390 Up to n/a 130,000 70,000 leading cause of prevalenc
Slide 13: ISLA-101
For personal use only ILSA 101 ISLAND PHARMACEUTICALS LIMITED 11 Investor INVESTOR Presentation PRESENTATION – October 2022 – FEBRUARY 2021
Slide 14: ISLA-101 Broad Activity Evident
ISLA-101 BROAD ACTIVITY EVIDENT DEMONSTRATED ACTIVITY AGAINST FLAVIVIRUSES (A SUBGROUP OF ARBOVIRUSES) IN MULTIPLE MODELS OF INFECTION For personal use only • In in-vitro models using fresh human cells, Dengue 1-4 ISLA-101 has demonstrated broad anti-viral activity • In animal models, ISLA-101 is pr
Slide 15: Safety Profile of Drug Established
SAFETY PROFILE OF DRUG ESTABLISHED 45 HUMAN CLINICAL STUDIES OF ISLA-101 COMPLETED IN OTHER INDICATIONS For personal use only 4 2 Canada EU Verified as safe in 1 humans by multiple 1 Asia 39 regulators in other Middle US East clinical indications 3 Australia & NZ ISLAND PHARMACEUTICALS LIMITED 13 In
Slide 16: Nearing IND Submission
NEARING IND SUBMISSION IND IS A CRITICAL REGULATORY MILESTONE, ENABLING PEACH STUDY COMMENCEMENT For personal use only Sponsor information (complete) Drug manufacturing Summary of existing (almost complete) human data (complete) ✓ Drug substance (API) ✓ ~45 previous clinical • Drug product trials ✓
Slide 17: World Class Team in Place
WORLD CLASS TEAM IN PLACE TEAM ASSEMBLED WITH DOMAIN EXPERTISE IN CLINICAL TRIALS AND MANUFACTURING For personal use only Sponsor Key Island people overseeing the ISLA-101 PEACH study Teresa Byrne, Vice President Larry Norder, CMC Consultant Clinical Product Development. Overseeing clinical developm
Slide 18: Pathway / Timing to Clinical Trials
PATHWAY / TIMING TO CLINICAL TRIALS MULTIPLE WORKSTREAMS WILL TAKE US TO FDA REVIEW OF OUR IND For personal use only 1. Manufacturing of clinical product 2. Finalization of CMC section of IND IND Mandatory Island trial submitted 30-day review commences!* 3. Completion of Protocol period at FDA ISLAN
Slide 19: Phase II Dengue (PEACH) Trial Study in Detail
PHASE II DENGUE (PEACH) TRIAL STUDY IN DETAIL “PEACH" STUDY- A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY FOR THE PROPHYLACTIC EXAMINATION OF AN ANTIVIRAL IN A DENGUE CHALLENGE MODEL For personal use only Administer ISLA-101 daily Phase II trial protocol Up to 4 cohorts/4 arms Incl
Slide 20: The Commercial Opportunity
For personal use only THE COMMERCIAL OPPORTUNITY ISLAND PHARMACEUTICALS LIMITED 18 Investor INVESTOR Presentation PRESENTATION – October 2022 – FEBRUARY 2021
Slide 21: Commercial Opportunity
COMMERCIAL OPPORTUNITY For personal use only Prophylactic for National Government Priority Review travelers Military outbreaks Stockpiles Voucher Tropical area travellers opportunity: Military opportunity: Endemic area opportunity: • Comparable to malaria market – • Isla is partnering with army (CRA
Slide 22: Priority Review Voucher Eligibility
PRIORITY REVIEW VOUCHER ELIGIBILITY For personal use only The last 10 PRV acquisitions • ISLA-101 is eligible for Neglected Tropical Date Acquired by Value Disease designation for the treatment of Q3 2019 Astra Zeneca US$95m dengue fever Q4 2019 Confidential US$95m • This designation means ISLA-101
Slide 23: Platform Strategy: Multiple Shots on Goal
PLATFORM STRATEGY: MULTIPLE SHOTS ON GOAL For personal use only TARGETS • Tropical diseases with no existing therapies • Prophylactic or therapeutic trial potential ISLAND PHARMACEUTICALS LIMITED 21 Investor INVESTOR Presentation PRESENTATION – October 2022 – FEBRUARY 2021
Slide 24: Drug Development Pipeline
DRUG DEVELOPMENT PIPELINE For personal use only Stage of Development Program Indication Preclinical Phase I Phase 2 Phase 3 FDA Review Dengue (PEACH) To be initiated ISLA-101 Other mosquito (or vector) borne diseases Monash TBD Collaboration Griffith TBD Collaboration ISLAND PHARMACEUTICALS LIMITED
Slide 25: Key Collaborations & Alliances
KEY COLLABORATIONS & ALLIANCES SUPPORTING FUTURE PIPELINE DEVELOPMENT For personal use only Research Collaboration Agreement to screen thousands of known molecules against host targets building upon the Fenretinide (ISLA-101) discovery sourced from these laboratories that the Company has licensed fo
Slide 26: Board, Management & Scientific Board
BOARD, MANAGEMENT & SCIENTIFIC BOARD ISLAND IS LED BY A HIGHLY CAPABLE, EXPERIENCED MANAGEMENT TEAM, BOARD OF DIRECTORS AND SCIENTIFIC ADVISORY BOARD WITH EXTENSIVE EXPERTISE IN DRUG REPURPOSING AND For personal use only DEVELOPMENT, INFECTIOUS DISEASES AND EXECUTING SUCCESSFUL COMMER CIAL TRANSACTI
Slide 27: Upcoming Milestones
UPCOMING MILESTONES For personal use only H1 FY 2022 H2 FY 2022 H1 FY 2023 ✓ Sign SUNY CTA • Drug product manufactured • Advance through PEACH ✓ Announce Principal • File IND cohorts Investigator • Open IND • Trial read out • Screening subjects for • Meeting with FDA ✓ Engaged CRO • Identify lead mo
Slide 28: Key Strengths
KEY STRENGTHS For personal use only Initially targeting Drug repurposing Phase II Commercial Pipeline Highly dengue diseases strategy ready asset upside expansion experienced with unmet need strategy team Targeting diseases, Repurposing can Lead compound, Potential ‘platform Research Experienced Boa
Slide 29: Contact
For personal use only David Foster Chief Executive Officer & Executive Director david@islapharma.com Authorized for release by Paul MacLeman, Executive Chairman Island Pharmaceuticals www.islapharma.com Limited Registered office: Suite 201, ISLAND PHARMACEUTICALS 697 Burke Rd, Camberwell VIC 3124, A
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