Island Pharmaceuticals Ltd · ASX:ILA
Island Pharmaceuticals — Investor Presentation (February 2026)
26 slides from Island Pharmaceuticals's investor presentation, Feb 5, 2026
Slide 1: Combatting Urgent Viral Disease Threats
For personal use only COMBATTING URGENT VIRAL DISEASE THREATS Dr David Foster, CEO & Managing Director February 2026 ASX: ILA
Slide 2: Disclaimer
DISCLAIMER Important Information This disclaimer applies to this presentation and the information contained in it (Presentation). By reading this disclaimer you agree to be bound by it. The Presentation has been prepared by Island Pharmaceuticals Limited and all related bodies corporate (Company). C
Slide 3: Two Programs Targeting Infectious Diseases
ISLAND PHARMACEUTICALS (ASX: ILA) TWO PROGRAMS TARGETING INFECTIOUS DISEASES For personal use only Phase 2a/b PROTECT clinical trial in dengue Two, well advanced clinical stage programs complete Positive FDA feedback on Animal Rule Major market potential via both programs regulatory path Multiple ne
Slide 4: Corporate Overview
CORPORATE OVERVIEW Shares on issue¹: 269,052,397 Substantial shareholders Price per share¹: $0.43 Dr William James Garner³ 15.50% Market capitalisation¹: $115.7m Cash at bank (31 December 2025)²: $6.87m Jason Alan Carroll³ 11.92% For personal use only Potential additional capital from vested options
Slide 5: 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 6: An Urgent Threat: Lethal Filoviruses & Global Security
AN URGENT THREAT: LETHAL FILOVIRUSES & GLOBAL SECURITY For personal use only UNTAMED KILLERS HUMAN & ECONOMIC IMPACT • High Fatality Rates: Marburg up to 88%, Ebola up to 90% & Sudan up to 47% • Systemic organ failure • Limited defenses: No widely approved antivirals or • Hemorrhaging vaccines for M
Slide 7: Galidesivir Program Overview
GALIDESIVIR PROGRAM OVERVIEW • Small molecule with broad antiviral activity against numerous high-priority threats • Robust development history with over US$70m in funding to-date from US government • Confirmed regulatory pathway under the FDA’s Animal Rule • Qualifies for a Priority Review Voucher
Slide 8: FDA Response Significantly De-Risks Regulatory Pathway
FDA RESPONSE SIGNIFICANTLY DE-RISKS REGULATORY PATHWAY Island has the potential to become to first Australian company to gain drug approval via the FDA’s Animal Rule For personal use only FDA confirmed the Clear guidance FDA advised that Island intends to Animal Rule provided on clinical Galidesivir
Slide 9: 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 10: Galidesivir Provides Unprecedented Speed to Market
GALIDESIVIR PROVIDES UNPRECEDENTED SPEED TO MARKET The FDA has a number of paths for acceleration of pharmaceutical compounds to approval: - Fast Track Designation - Breakthrough Therapy Designation For personal use only - Accelerated Approval Pathway - Priority Review - Animal Rule Pathway (Special
Slide 11: 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 12: High Efficacy in Marburg Non-Human Primate Study
HIGH EFFICACY IN MARBURG NON-HUMAN PRIMATE STUDY Treated non-human primates showed an overall survival rate of 94% during trial For personal use only Island Pharmaceuticals Limited 11
Slide 13: Animal Rule Is a Proven Path for Bioterror Threat Countermeasures
ANIMAL RULE IS A PROVEN PATH FOR BIOTERROR THREAT COUNTERMEASURES Since 2012, the FDA’s Animal Rule approval has For personal use only led to 8 bioterror countermeasures joining the US Strategic National Stockpile (SNS) In 7 out of 8 cases, these medical countermeasures continue to remain under SNS
Slide 14: Galidesivir Is Designed to Protect the Backbone of National Resilience
GALIDESIVIR IS DESIGNED TO PROTECT THE BACKBONE OF NATIONAL RESILIENCE For personal use only ILA’s stockpile strategy ensures full treatment coverage for the 10,000+ individuals critical to outbreak containment and continuity of government – from POTUS + Cabinet to Essential Infrastructure Leaders.
Slide 15: Multiple Shots on Goal for Galidesivir
MULTIPLE SHOTS ON GOAL FOR GALIDESIVIR For personal use only Non-human PRV Eligible for Animal Rule Strategic National Virus Cell culture data Animal data primate efficacy first indication Potential Stockpile Potential Marburg Ebola Sudan Zika Chikungunya Island Pharmaceuticals Limited 14
Slide 16: PRV Prices Continue to Increase
PRV PRICES CONTINUE TO INCREASE FDA Priority Review Voucher (PRV) Sale Prices (2022-2026) For personal use only • Following expiration of two forms of PRVs the price has dramatically increased over the last 18 months. • With two programs that are currently PRV eligible, Island is in rare company wit
Slide 17: Galidesivir FDA Feedback & Next Steps
For personal use only Galidesivir FDA Feedback & Next Steps
Slide 18: FDA Feedback – Key Takeaways
FDA FEEDBACK – KEY TAKEAWAYS For personal use only Core Animal Model Elements Confirmed FDA requests and pathway stage-gates are clearly defined and actionable Normal step in Animal Rule development – this is the same path taken by the last 6 Animal Rule countermeasure approvals Expert Team and stra
Slide 19: What the FDA Has Confirmed
WHAT THE FDA HAS CONFIRMED For personal use only Cynomolgus Angola Marburg Challenge dose Single animal macaque = Strain = (1,000 PFU) = species approach appropriate appropriate appropriate may be species challenge virus challenge dose acceptable Island Pharmaceuticals Limited 18
Slide 20: What the FDA Has Requested
WHAT THE FDA HAS REQUESTED For personal use only Complete natural history dataset (Island Additional justification for model has access to this data) parameters Analysis and generation of Toxicology and Refinements to NHP Study design and Pharmacokinetic (PK) data identification of lowest efficaciou
Slide 21: Clear FDA Approval Path Defined
CLEAR FDA APPROVAL PATH DEFINED PHASE 1 PHASE 2 PHASE 3 PHASE 4 FOUNDATION & STUDY DESIGN REFINEMENT APPROVAL ENABLING REGULATORY INTEGRATION ALIGNMENT & DATA INTEGRATION EFFICACY PACKAGE & SUBMISSION [Q1 CY26] [Q2-Q3 CY26] [Q4 CY26] [Q1 CY27] For personal use only ACTION ACTION ACTION ACTION ACTION
Slide 22: Our Response Plan
OUR RESPONSE PLAN For personal use only 1 2 3 4 Provide natural Refine study and Complete Continue close history dataset dose design to requested Tox/PK engagement with the meet FDA analysis FDA for alignment on requirements Pivotal Study Island Pharmaceuticals Limited 21
Slide 23: Our Team and Partners
OUR TEAM AND PARTNERS For personal use only Deep antiviral and Strong US Government Access to world-class Animal Rule experience collaborators BSL-4 facilities - team has demonstrated expertise in 14 Animal Rule approvals Island Pharmaceuticals Limited 22
Slide 24: We Are Confident of Success
WE ARE CONFIDENT OF SUCCESS For personal use only FDA alignment on all core fundamentals to be the first Australian company to proceed through the FDA approval process via the Animal Rule pathway Absolute clarity on the roadmap to progress – we know exactly what is required Highly experienced team o
Slide 25: Near Term Milestones
NEAR TERM MILESTONES A number of value catalysts pending over the coming months for Galidesivir Galidesivir specific milestones Timeframe* For personal use only Commence strategic appointments to establish Galidesivir Advisory Committee Ongoing FDA feedback on protocol clarifying questions Received
Slide 26: Island Pharmaceuticals
For personal use only Island Pharmaceuticals ASX: ILA dfoster@islandpharmaceuticals.com islandpharmaceuticals.com @IslandPharma Island Pharmaceuticals
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