Island Pharmaceuticals Ltd · ASX:ILA

Island Pharmaceuticals — Third Annual Dengue Endgame Summit 2025

25 slides from Island Pharmaceuticals's conference presentation, Aug 14, 2025

  1. Slide 1: Presentation to the Third Annual Dengue Endgame Summit

    14 August 2025 ASX Announcement Presentation to the Third Annual Dengue Endgame Summit MELBOURNE Australia, 14 August 2025: Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to provide the following presentation, which was presente

  2. Slide 2: About Island Pharmaceuticals

    Approved for release to the ASX by: David Foster (CEO and Managing Director) Island Pharmaceuticals Limited info@islandpharmaceuticals.com Investors and media, for further information, please contact: Henry Jordan Six Degrees Investor Relations +61 (0) 431 271 538 henry.jordan@sdir.com.au About Isla

  3. Slide 3: Results of a Phase 2 Placebo-controlled Study of ISLA-101

    For personal use only Results of a Phase 2 Placebo-controlled Study of ISLA-101 using DENV-1-LVHC 45AZ5 Challenge Session 7. Advanced stage countermeasure update: therapeutics Third Annual Dengue Endgame Summit

  4. Slide 4: Conflicts of Interest

    Conflicts of Interest For personal use only • Bert Slade MD FAAAAI • Consultant, Chisholm Clinical Research Services • Medical Monitor for the study • No conflicts to declare

  5. Slide 5: Clinical Study Design

    Clinical Study Design  ISLA-101 (fenretinide, 4-HPR) For personal use only  Interferes with NS5 transport to the nucleus  NS5 is 70% conserved across serotypes  Prophylactic [Cohort 1] 24 days of BID dosing, inoculation on Day 4 (after the 7th dose)  Therapeutic [Cohort 2] 14 days of BID dosing

  6. Slide 6: Study Design

    Study Design For personal use only -90 -45 Week Week Week Week Week Week Week Week Week Week SCR1 SCR2 Wk1 Wk2 Wk3 Wk4 Wk5 Wk6 Wk13 Wk15 Wk18 Wk19 Innoculate x1 ¨d4 ISLA101 bid d1 d24 COHORT 1 PK d1 d2 d24 Viremia d4 d7 d9 d11 d12 d14 d16 d18 d21 d23 d26 d28 d32 d36 d94 d124 Safety labs SCR d1 d4 d7

  7. Slide 7: CONSORT

    For personal use only CONSORT

  8. Slide 8: Demographics

    For personal use only Demographics

  9. Slide 9: Dosing: In Vitro inhibition

    Dosing In Vitro inhibition For personal use only EC50 EC90 Huh-7 cells PBMC THP-1 cells + Vero ADE DENV-1 2.6 µM 0.81 µM 0.78 µM DENV-2 2.1 µM 2.0 µM DENV-3 1.4 µM DENV-4 2.1 µM

  10. Slide 10: Dosing: PK modeling

    For personal use only Dosing PK modeling

  11. Slide 11: Drug Levels

    Drug Levels Levels achieved @ 300 mg/m2 q12h plus high fat, high calorie meal For personal use only Cohort 2, Day 2 Dose 3 2000 5 1800 1600 4 1400 Concentration (ng/mL) mM concentration 1200 3 1000 800 2 600 400 1 200 0 0 0 1 2 3 4 5 6 Time (hours)

  12. Slide 12: Drug Levels

    Drug Levels Levels achieved @ 300 mg/m2 q12h plus high fat, high calorie meal For personal use only Cohort 1, D24 Cohort 2 Day 21 2400 2400 2200 2200 2000 2000 1800 1800 Concentration (ng/mL) Concentration (ng/mL) 1600 1600 1400 1400 1200 1200 1000 1000 800 800 600 600 400 400 200 200 0 0 0 2 4 6 8

  13. Slide 13: Effect on Virus: Time to clear

    Effect on Virus Time to clear For personal use only

  14. Slide 14: Effect on Virus

    Effect on Virus RNA GE/mL, Virus PFU/mL Peak Area Under the Curve For personal use only 1e+9 1e+9 100 90 80 70 1e+8 1e+8 60 50 Exponent (common log) 1e+7 1e+7 40 30 1e+6 1e+6 20 1e+5 1e+5 1e+4 1e+4 10 9 1e+3 1e+3 8 Placebo Therapeutic Prophylaxis Placebo Therapeutic Prophylaxis Group Group Group vs

  15. Slide 15: Effect on Virus: Prophylactic group vs. all controls

    Effect on Virus Prophylactic group vs. all 3 controls For personal use only

  16. Slide 16: Effect on Virus: NS1 antigen

    Effect on Virus NS1 antigen For personal use only

  17. Slide 17: Clinical Observations

    Clinical Observations Signs & symptoms of Dengue infection (solicited AEs) For personal use only Grade 2 nausea and/or vomiting was seen only among controls.

  18. Slide 18: Clinical Lab Observations: Hematology - WBC

    Clinical Lab Observations Hematology - WBC SID SCR2 V1 V4 V7 V11 V14 V18 V21 V25 V28 For personal use only 01-002 2.73 2.89 2.77 2.28 0.88 2.26 2.98 1.2 - 4.0 = normal range, lymphocytes 01-004 1.09 1.16 1.58 1.26 0.82 0.83 0.82 CTCAE lymphocytes 01-019 2.81 2.57 2.63 2.14 1.15 2.00 2.54 GR1 GR2 GR3

  19. Slide 19: Clinical Lab Observations: Hematology - WBC

    Clinical Lab Observations Hematology - WBC SID SCR2 V1 V4 V7 V11 V14 V18 V21 V25 V28 For personal use only 01-002 2.73 2.89 2.77 2.28 0.88 2.26 2.98 1.2 - 4.0 = normal range, lymphocytes Grade 1 01-004 1.09 1.16 1.58 1.26 0.82 0.83 0.82 CTCAE lymphocytes 01-019 2.81 2.57 2.63 2.14 1.15 2.00 2.54 GR1

  20. Slide 20: Clinical Lab Observations: Hematology - platelets

    Clinical Lab Observations Hematology - platelets SCR2 V1 V4 V7 V11 V14 V18 V21 V25 V28 For personal use only 01-002 346 386 367 336 299 230 370 150-400 Normal range, platelets 01-004 222 209 218 205 214 160 232 GR1 GR2 GR3 GR4 01-019 326 384 373 375 335 268 410 <LLN - 75 <75.0 - 50 <50.0 - 25 <25 01

  21. Slide 21: Clinical Lab Observations: Chemistry - Hepatic Enzymes

    Clinical Lab Observations Chemistry – Hepatic Enzymes SID SCR2 V1 V4 V7 V11 V14 V18 V21 V25 V28 For personal use only 01-002 37 37 45 50 49 55 56 <41 = normal range, alanine aminotransferase 01-004 --- 40 43 32 30 35 31 CTCAE ALT 01-019 53 20 5 17 27 27 26 GR1 01-008 34 46 39 35 126 124 91 US >ULN -

  22. Slide 22: Adverse Events (unsolicited)

    Adverse Events (unsolicited) Prophylactic subjects For personal use only • GI disorders (3/4, 75%) • Nervous system disorders (2/4, 50%) • Skin and subcutaneous tissue disorders (2/4, 50%) • Grade 2 drug rash led to discontinuation of 1 subject Treatment subjects • Eye disorders (2/8, 25%) • GI diso

  23. Slide 23: Conclusions

    Conclusions For personal use only • Drug levels were in the targeted zone for 50% inhibition • Drug effect on virus was seen with both prophylactic and therapeutic use • Prophylactic use showed more profound effects • 48 doses vs 28 • Drug on board at inoculation • ISLA-101 was associated with rash,

  24. Slide 24: Discussion

    Discussion For personal use only • The chosen dose was at the low end of doses found to be safe in Ph1 single ascending dose (300, 600, 900 mg/m2 tested); higher doses are possible • Reported EC50 were in vitro, with constant drug level • No subject dropped out due to drug effects • Impact on virus

  25. Slide 25: Acknowledgments

    Acknowledgments Kris Paolino MD For personal use only Stephen Thomas MD Adam Waickman PhD SUNY Study Team Michelle Klick BreAnn Burnette Lisa Ware Island Study Team David Foster PhD JD Nick McCoy (McCoy Clinical Consulting) Mari Heghinian PhD (Seran LLC) H.B.Slade MD (Chisholm Clinical Research Serv

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