Island Pharmaceuticals Ltd · ASX:ILA
Island Pharmaceuticals — Pitt Street Research Life Sciences Conference 2024
24 slides from Island Pharmaceuticals's conference presentation, Sep 19, 2024
Slide 1: ASX Announcement: Island Pharmaceuticals presentation for Pitt Street Research Conference
19 September 2024 ASX Announcement Island Pharmaceuticals presentation for Pitt Street Research Life Sciences Conference 2024 MELBOURNE Australia, 19 September 2024: Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to provide a co
Slide 2: Announcement continued: Priority Review Voucher and shareholder information
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 expedite the FDA approval process for a new drug or sell the PRV in a secondary ma
Slide 3: Targeting Viral Threats, Developing Lifesaving Countermeasures
TARGETING VIRAL THREATS, DEVELOPING LIFESAVING COUNTERMEASURES For personal use only Dr PAUL MacLEMAN, EXECUTIVE CHAIR PITT STREET RESEARCH LIFE SCIENCES CONFERENCE (ASX: ILA) SEPTEMBER 2024 ISLAND PHARMACEUTICALS 1 SEPTEMBER 2024
Slide 4: Disclaimer
DISCLAIMER For personal use only This presentation has been prepared by Island Pharmaceuticals Limited (ABN 641 183 842) (Company or Future performance Island Pharmaceuticals). This presentation contains certain "forward-looking statements". The words "expect", "anticipate", Not an offer or financia
Slide 5: Rapid Paths to Market
For personal use only ASSETS: - Known small molecules with clinical history - Mid/late stage clinical or other abbreviated routes - Open USFDA INDs - Validated US Govt/military funding support - Priority Review Voucher eligible RAPID PATHS TO MARKET PITT STREET RESEARCH LIFE SCIENCES (ASX: ILA) CONF
Slide 6: Strategic Checklist
STRATEGIC CHECKLIST For personal use only Clinical history Small molecule Proven preclinical anti-viral activity Eligible for Priority Review Vouchers National and military preparedness need Probable/confirmed non-dilutive funding to support: military, civilian, NGO Fit for our managem
Slide 7: Strategic Connectivity Between Assets: ISLA-101 and Galidesivir
STRATEGIC CONNECTIVITY BETWEEN ASSETS: ISLA-101 (FENRETINIDE) AND GALIDESIVIR For personal use only Both assets: • Have completed Phase I or later human clinical trials • Have open Investigational New Drug applications with FDA • Are antivirals, therefore fast to develop and potential for early lice
Slide 8: About ISLA-101
For personal use only About ISLA-101 ISLAND PHARMACEUTICALS 6 SEPTEMBER 2024
Slide 9: WHO: Half of world population at risk of dengue
For personal use only “About half of the world's population is now at risk of dengue with an estimated 100–400 million infections occurring each year” World Health Organisation, 30 May 2024 ISLAND PHARMACEUTICALS 7 SEPTEMBER 2024
Slide 10: Targeting Known or Re-purposable Drugs with Reduced Time to Market: ISLA-101
TARGETING KNOWN OR RE-PURPOSABLE DRUGS WITH REDUCED TIME TO MARKET For personal use only ISLA-101 – dengue, Zika, Yellow Fever, Chikungunya, other arboviruses • 45+ human trials of ISLA-101 completed in other indications • Island’s recent Single Ascending Dose study reinforced safety and established
Slide 11: Dengue in 2050 – A Global Disease
DENGUE IN 2050 – A GLOBAL DISEASE WHO prediction based on projections of future temperatures, rainfall, For personal use only and mosquito populations Europe USA Australia NASA Earth Observatory map by Lauren Dauphin based on data from Janey Messina, University of Oxford - https://earthobservatory.n
Slide 12: Phase 2a/b Dengue (PROTECT) Trial Study
PHASE 2a/b DENGUE (PROTECT) TRIAL STUDY For personal use only “PROTECT" study- A Phase 2a/b, Randomized, Double Phase 2a/b trial protocol: 2 cohorts blind, Placebo-controlled Dengue Challenge Study – a 1. Prophylactic Cohort- 2A: 4 subjects randomized 3:1 PROphylactic and TrEatment Challenge Trial 2
Slide 13: Phase 2a/b Clinical Trial Design
PHASE 2a/b CLINICAL TRIAL DESIGN For personal use only Phase 2a/b trial protocol: 2 cohorts Key near-term milestones: 1. Prophylactic Cohort- 2a (left): 4 subjects randomized 3:1 • Ethics approval received in August 2024, patient 2. Therapeutic Cohort: 2b (right): 10 subjects randomized 8:2 screenin
Slide 14: US Army CRADA Provides Control Group for PROTECT
US ARMY CRADA* PROVIDES CONTROL GROUP FOR PROTECT For personal use only Phase 1 challenge study conducted by Walter Reed Army Institute of Research and SUNY provides ILA’s Phase 2a/b study control data, and enables unprecedented ability to monitor dengue symptoms, including: • Abdominal & eye pain •
Slide 15: Pipeline Build, Opportunities and Milestones
For personal use only PIPELINE BUILD, OPPORTUNITIES AND MILESTONES ISLAND PHARMACEUTICALS 13 SEPTEMBER 2024
Slide 16: Targeting Known or Re-purposable Drugs: Galidesivir
TARGETING KNOWN OR RE-PURPOSABLE DRUGS WITH REDUCED TIME TO MARKET For personal use only GALIDESIVIR – Ebola, Marburg, Zika & and many other RNA viruses • 12 month, binding Letter of Intent signed 11 September 2024 (AU) • Substantial Phase I human safety data • Proven protective efficacy in a number
Slide 17: Commercial Opportunities
COMMERCIAL OPPORTUNITIES BOTH candidates have prophylactic and therapeutic potential For personal use only Travellers Military National Outbreaks Malaria is also a mosquito borne Relationship with US Army in Millions of patients in Latin disease and therefore a proxy for place (CRADA, ISLA101). Will
Slide 18: Corporate Snapshot
CORPORATE SNAPSHOT Key data Recent ILA trading history For personal use only Share price (AUD1) $0.079 Market cap1 $10.1m Shares on issue1 126,782,904 Listed Options2 32,506,360 Cash3 $1.7m Board of Directors Substantial shareholders Ownership breakdown • Top 201: 72.3% Dr Paul MacLeman, Executive C
Slide 19: Key Milestones
KEY MILESTONES** For personal use only H1 FY 2025 H1 FY 2024 (Jul – Dec 2023) H2 FY 2024 (Jan – Jun 2024) H2 FY 2025 (Jan – Jun 2025) (Jul – Dec 2024) • Key US and Australian • Dose final Single • Obtain ethics approval • Subjects dosed in patents granted for Ascending Dose for Phase 2 trial Phase 2
Slide 20: Island Pharmaceuticals contact details
For personal use only Island Pharmaceuticals (ASX: ILA) islandpharmaceuticals.com @IslandPharma Island Pharmaceuticals pmacleman@islandpharmaceuticals.com +61 419 401 445 ISLAND PHARMACEUTICALS 18 SEPTEMBER 2024
Slide 21: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD For personal use only Dr Leigh Farrell Prof Stephen Thomas MD Dr Amy Patick Leigh has over 30 years’ experience in the US WRAIR – SUNY Upstate BMS – Mayo Clinic biotechnology and pharmaceutical industry and is Professor Stephen Thomas, MD has an international Amy Patick is
Slide 22: ISLA-101 Prevents Viral Replication
ISLA-101 PREVENTS VIRAL REPLICATION For personal use only Mechanism of action (how it works) ISLA-101 reduces viral load1 ISLA-101 inhibits propagation of flaviviruses Above: dose response showing ISLA-101’s ability to protect against dengue infection • To replicate, the virus needs to hijack the nu
Slide 23: Galidesivir Prevents Viral Replication
GALIDESIVIR PREVENTS VIRAL REPLICATION For personal use only Galidesivir inhibits propagation of RNA viruses • RNA-dependent RNA polymerase (RdRp) is crucial in viral replication and transcription • Catalyses viral RNA synthesis and is the therapeutic target of Galidesivir https://link.springer.com/
Slide 24: Players in the Medical Countermeasures Space
PLAYERS IN THE MEDICAL COUNTERMEASURES SPACE For personal use only Programs backed by BARDA and/or NIAID • BioFactura • BioFire Defense • Certara • Emergent BioSolutions • Evotec SE • IDbyDNA (DIGET program) • Juxtopia • DARPA Panacea Program • ARMR • JnJ Blue Knight Consortium https://globalbiodefe
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