Island Pharmaceuticals Ltd · ASX:ILA
Island Pharmaceuticals — Investor Presentation (July 2025)
39 slides from Island Pharmaceuticals's investor presentation, Jul 28, 2025
Slide 1: ASX Announcement: Presentation and Australian investor roadshow
28 July 2025 ASX Announcement Presentation and Australian investor roadshow MELBOURNE Australia, 28 July 2025: Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to provide the attached copy of the Company’s investor presentation, w
Slide 2: ASX Announcement (continued)
expedite the FDA approval process for a new drug or sell the PRV in a secondary market. Island encourages all current investors to go paperless by registering their details with the Company's share registry, Automic Registry Services, whose contact info is housed on the Shareholder Services page of
Slide 3: Combatting Urgent Viral Disease Threats
For personal use only COMBATTING URGENT VIRAL DISEASE THREATS Investor Presentation Dr David Foster, CEO & Managing Director ASX: ILA July 2025
Slide 4: Disclaimer
DISCLAIMER This presentation has been prepared by Island Pharmaceuticals Limited (ABN 641 183 842) (Company or Island Pharmaceuticals). Not an offer or financial product advice The Company is not licensed to provide financial product advice. This presentation is not and should not be considered, and
Slide 5: Island Pharmaceuticals is an antiviral therapeutics company
Island Pharmaceuticals (ASX: ILA) is an antiviral therapeutics For personal use only company targeting infectious diseases Phase 2a/b PROTECT clinical trial in dengue Two, well advanced clinical stage programs complete Major market potential via both programs Positive results in aggressive models Bo
Slide 6: Corporate Overview
CORPORATE OVERVIEW Share on issue¹: 247,235,095 Substantial shareholders Price per share¹: $0.15 Dr William James Garner³ 16.86% Market capitalisation¹: $37.1m Jason Alan Carroll⁴ 12.58% For personal use only Cash at bank (30 June 2025)²: $7.25m MWP Partners Limited⁵ 7.79% DoD grant funding to direc
Slide 7: Company Overview
COMPANY OVERVIEW • Two clinical stage assets – Galidesivir and ISLA-101 - both with Priority Review Voucher potential based on approval For personal use only • Galidesivir: • Small molecule with broad antiviral activity against numerous high-priority threats • Robust development history with over US
Slide 8: Benefits of Drug Repurposing
BENEFITS OF DRUG REPURPOSING De Novo Drug Discovery and Development For personal use only 4~8 YEARS 5~7 YEARS 1~2 YEARS Basic Drug Experiment Experiment Phase 1 in Phase 2 in Phase 3 in Drug study design in vitro in vivo clinical trials clinical trials clinical trials Registration De Novo Drug Disco
Slide 9: Increased Likelihood of Success
INCREASED LIKELIHOOD OF SUCCESS For personal use only • Treatments for infectious disease have a statistically higher likelihood of overall success in clinical trials • Anti-infective treatments sit at the low end of the drug development cost curve across therapeutics • JAMA research shows that anti
Slide 10: Clinical Development – Multiple Studies Already Done
CLINICAL DEVELOPMENT – MULTIPLE STUDIES ALREADY DONE ISLA-101 has promising Phase 2a/b clinical trial data in dengue fever Galidesivir has successful Phase 1 clinical trials - with plans to advance an an animal efficacy study in Marburg. For personal use only ASSET TARGET ANIMAL EFFICACY STUDY PHASE
Slide 11: Galidesivir Program Summary
For personal use only GALIDESIVIR PROGRAM SUMMARY
Slide 12: Galidesivir Unlocks Another Major Market
GALIDESIVIR UNLOCKS ANOTHER MAJOR MARKET For personal use only 1 2 3 Demonstrated activity Activity against potential Potential markets: against 20+ viruses – bioterror threats ⚬ Government stockpile programs many with no available ⚬ Numerous antiviral programs treatment ⚬ Ripe potential for partner
Slide 13: Broad Spectrum Activity Demonstrated
BROAD SPECTRUM ACTIVITY DEMONSTRATED Data highlights activity in vitro against multiple RNA viruses from diverse families Virus Family Virus Strain/Variant Virus Family Virus Strain/Variant For personal use only Marburg Musoke Nipah virus Malaysia Paramyxo HRS A2 Marburg Ci67 Filoviridae Measles Chi
Slide 14: Multiple Phase Human Safety Clinical Studies
MULTIPLE PHASE 1 HUMAN SAFETY CLINICAL STUDIES Key Terms Phase1 HV – SAD Single Ascending Dose SAD: Highest Dose: 10 mg/kg For personal use only SAD / MAD IM COMPLETED MAD: Highest Dose: 10 mg/kg 7 days MAD Multiple Ascending Dose Study 101 Cohort 1: 5 mg/kg Phase1 HV – SAD IV Cohort 2: 10 mg/kg COM
Slide 15: Demonstrated In Vivo Antiviral Effects
DEMONSTRATED IN VIVO ANTIVIRAL EFFECTS Impact achieved with delayed dosing across a broad range of viruses Animal Species Virus Dose Regimen Key Results For personal use only 100% survival initial dose 3dpi, 80% survival initial dose Hamsters Yellow Fever 100 mg/kg BID 7 days 4dpiᵃ; 12.5% survival c
Slide 16: Efficacy in NHPs Infected with MARV
EFFICACY IN NHPS INFECTED WITH MARV For personal use only FIGURE A: SURVIVAL Animals (n=6/group) were challenged with MARV by SC injection, and Galidesivir (15mg/kg BID) or vehicle was administered IM beginning 1 hr (RED) 24 hr (BLUE) or 48 hr (GREEN) after challenge. Vehicle control (WHITE). Key Te
Slide 17: Suppression of Marburg Virus Proliferation in Infected NHPs
SUPPRESSION OF MARBURG VIRUS PROLIFERATION IN INFECTED NHPS For personal use only FIGURE B: VIRAL LOAD Serum viral RNA load was determined in animals (n=6 per group) treated IM beginning 1 hr (RED) 24 hr (BLUE) or 48 hr (GREEN) after challenge. Vehicle control (WHITE). *P<0.05 for comparison of trea
Slide 18: Potential Regulatory Path
POTENTIAL REGULATORY PATH 4~8 YEARS 4~6 YEARS 1 YEAR In vivo Basic Drug Experiment experiments Phase 1 Phase 2 Phase 3 NDA For personal use only study design in vitro (animal clinical trials clinical trials clinical trials studies) In vivo Basic Drug Experiment experiments Phase 1 Animal Rule NDA st
Slide 19: Potential Regulatory Fast Track
Galidesivir transaction POTENTIAL REGULATORY Due diligence with BioCryst Pharmaceuticals, FAST TRACK Inc. (Nasdaq: BCRX) completed and asset purchase agreement executed Existing Galidesivir data package and FDA Animal Rule unlock quicker approval path ILA’s maiden animal study Aim to complete within
Slide 20: Galidesivir WIP - Significant Pipeline Opportunity
GALIDESIVIR WIP - SIGNIFICANT PIPELINE OPPORTUNITY GALIDESIVIR – POTENTIAL TO TACKLE EBOLA, MARBURG, ZIKA & OTHER RNA VIRUSES For personal use only • Small molecule, re-purposable with reduced timeframe to market • Substantial Phase 1 human safety data • Demonstrated efficacy in multiple lethal anim
Slide 21: ISLA-101
For personal use only ISLA-101
Slide 22: Dengue - Infection Leads to Lethal Outcomes
DENGUE - INFECTION LEADS TO LETHAL OUTCOMES For personal use only • Dengue is a viral infection transmitted to humans through the bite of infected mosquitoes • Directly impacts white blood cell count and platelets - vital for body protective mechanisms • Moderate to severe symptoms include fever, mu
Slide 23: Half of the world's population at risk of dengue
About half of the world's population For personal use only is now at risk of dengue with an estimated 100 – 400 million infections occurring each year WORLD HEALTH ORGANISATION, 30 MAY 2024 Island Pharmaceuticals Limited 21
Slide 24: Dengue - Common and Spreading
DENGUE - COMMON AND SPREADING Global cases of dengue fever rose steeply in 2024 HealthMap: Recent reports of local or imported Monthly global cases, millions dengue cases (July 2025) For personal use only US$8.9B estimated impact to the economy from dengue fever Island Pharmaceuticals Limited 22
Slide 25: Dengue by 2050 Is More Prevalent
DENGUE BY 2050 IS MORE PREVALENT DRIVEN BY: For personal use only Warmer temperatures • Accelerating development • Increases activity of female mosquitoes • Reduces incubation time for mosquito to become infectious • Allow mosquitoes to survive longer through winter High humidity • Improves mosquito
Slide 26: Multi-Billion Dollar Opportunity
MULTI-BILLION DOLLAR OPPORTUNITY • There is no specific treatment for dengue – providing ILA with a For personal use only first to market opportunity • Takeda Pharmaceuticals project global sales (ex-USA) of its Qdenga dengue vaccine at up to US$2bn by 2030¹ • Qdenga is a preventative measure – ISLA
Slide 27: ISLA-101 – Broad Activity Evident
ISLA-101 – BROAD ACTIVITY EVIDENT 1 DENGUE 1- 4 • ISLA-101 has demonstrated broad anti-viral activity in in- For personal use only vitro models 2 ZIKA • Demonstrated potent anti dengue-1 activity in in-vitro models using fresh human cells • Protective in dengue fever and Zika in animal models 3 WEST
Slide 28: Preventing Animal Deaths from Lethal Dengue and Protective Against Zika
PREVENTING ANIMAL DEATHS FROM LETHAL DENGUE AND PROTECTIVE AGAINST ZIKA For personal use only Two daily doses of Isla101 prevent 70% of deaths by otherwise lethal dengue Survival curve showing protection from lethal dengue change by Increasing dose of ISLA101 (mouse model). Island Pharmaceuticals Li
Slide 29: Phase 2a/b (PROTECT) Study Overview
PHASE 2A/B (PROTECT) STUDY OVERVIEW Randomised, double blind, placebo-controlled dengue challenge study – prophylactic and treatment challenge: For personal use only • Study include a prophylactic (Phase 2a) and therapeutic (Phase 2b) arm • Prophylactic Cohort- 2a: 4 subjects randomized 3:1 • Therap
Slide 30: Phase 2a/b (PROTECT) Design
PHASE 2A/B (PROTECT) DESIGN Phase 2A: Prophylactic (preventative) cohort High-level, unblinded results obtained • Phase 1 (completed April 2024) achieved all study outcomes For personal use only relating to safety and dosing, demonstrating benefit of Challenge study approach • Phase 2a (prophylactic
Slide 31: Positive Phase 2a/b Top-line Results
POSITIVE PHASE 2A/B TOP-LINE RESULTS: For personal use only • Highly encouraging top-line results advocate for ongoing clinical development of ISLA-101 in dengue • ISLA-101 delivered meaningful reduction in viremia (viral load) and symptoms in preventative cohort • Treatment cohort demonstrated sign
Slide 32: Duration of Viral Load - RNAemia
DURATION OF VIRAL LOAD- RNAEMIA ISLA-101 treated subjects exhibited shorter For personal use only exposure to virus • Control subjects had detectable viral RNA for ~10.5 days • Both treatment and preventative cohorts exhibited detectable viral RNA for ~8.5 days – two days shorter than control Island
Slide 33: Evidence of Anti-Dengue Activity
EVIDENCE OF ANTI-DENGUE ACTIVITY • Using two measures of viral load, a clear reduction in viral load was witnessed in the preventative arm and trend towards viral load reduction in the treatment arm • Mean peak virus level (RNA) detected a reduction of 10-15 times For personal use only Area Under th
Slide 34: Evidence of Reduced Viral Load
EVIDENCE OF REDUCED VIRAL LOAD *Lowest ISLA-101 Peak viral load reduced in ISLA-101 treated blood concentration subjects For personal use only • Viral RNA substantially reduced in preventative arm compared to internal control (blue) and historical controls (J9 in grey) • Active virus reduced in prev
Slide 35: Summary of Signs/Symptoms
SUMMARY OF SIGNS/SYMPTOMS For personal use only Reported symptoms 1: Control- 21/33 reported symptoms (63.6%) 2: Prophylaxis- 11/33 reported symptoms (33.3%) 3: Delayed treatment- 54/88 reported symptoms (61.4%) Island Pharmaceuticals Limited 33
Slide 36: Select Symptoms and Lab Abnormalities
SELECT SYMPTOMS AND LAB ABNORMALITIES For personal use only Island Pharmaceuticals Limited 34
Slide 37: Clinical Trial and Regulatory Pathway
CLINICAL TRIAL AND REGULATORY PATHWAY A defined clinical and regulatory route based on Phase 2a/b study results • Two likely pathways depending on Phase 2a/b results • Discussions advancing with multiple potential strategic partners for additional phase 2 and 3 clinical trials For personal use only
Slide 38: Near Term Milestones
NEAR TERM MILESTONES A number of value catalysts pending over the coming months Milestone Timeframe For personal use only Completion of Galidesivir transaction August 2025 Submission of documents and meeting request to FDA regarding Galidesivir August 2025 Completion of Phase 2/3 clinical trial pipe
Slide 39: Island Pharmaceuticals
For personal use only Island Pharmaceuticals ASX: ILA info@islandpharmaceuticals.com islandpharmaceuticals.com @IslandPharma Island Pharmaceuticals
Island Pharmaceuticals — Investor Presentation (July 2025) on 6ix