Opthea Limited · ASX:OPT

Opthea — Corporate Update (August 2025)

31 slides from Opthea's corporate update, Aug 20, 2025

  1. Slide 1: Corporate Update Investor Call – 20 August 2025

    CORPORATE UPDATE INVESTOR CALL – 20 August 2025 Dr Jeremy Levin – Chairman of the Board Fred Guerard – Chief Executive Officer Tom Reilly – Chief Financial Officer

  2. Slide 2: Disclaimer

    This investor presentation (Presentation) is dated August 19th, 2025 and has been prepared by Opthea Limited (ASX:OTP) (Opthea or the Company). SUMMARY INFORMATION This Presentation contains summary information about the current activities of Opthea and its subsidiaries (the Opthea Group or Group) w

  3. Slide 3: Agenda – Corporate Update

    Introduction – Dr Jeremy Levin, Chairman of the Board Results of Sozinibercept Phase 3 Trials (COAST and ShORe) – Fred Guerard, CEO Update on Development Funding Agreement Negotiations – Tom Reilly, CFO Current state of the company – Dr Jeremy Levin, Chairman of the Board The path forward – Dr Jerem

  4. Slide 4: Introduction

    Introduction Dr Jeremy Levin

  5. Slide 5: Introduction

    The results of our Phase 3 program did not meet their primary endpoints and were deeply disappointing Thanks to our CEO’s and CFO's efforts, we have now completed negotiations with the Development Funding Agreement investors, gaining clarity on available resources and outcomes for shareholders The p

  6. Slide 6: Results of Sozinibercept Phase 3 Trials in Neovascular AMD

    Results of Sozinibercept Phase 3 Trials in Participants with Neovascular Age-related Macular Degeneration: COAST (Sozinibercept in Combination with Aflibercept) and ShORe (Sozinibercept in Combination with Ranibizumab) Fred Guerard

  7. Slide 7: Sozinibercept Phase 3 Trials Design

    Primary Efficacy Endpoint Week 52 Primary Efficacy Endpoint Week 52 Safety Follow-up Week 100 Safety Follow-up Week 100 Sozinibercept Phase 3 Trials Design Standard of care administered according to approved dosing schedule: aflibercept (2 mg IVT q8w after 3 loading doses) and ranibizumab (0.5 mg IV

  8. Slide 8: Baseline Characteristics Were Well Balanced Across Arms

    Baseline Characteristics Were Well Balanced Across Arms COAST Baseline Characteristics Demographic/Baseline Disease Characteristic, Overall Population sham q4w + aflibercept q8w (n=330) sozinibercept q4w + aflibercept q8w (n=333) sozinibercept q8w + aflibercept q8w (n=330) Mean Age – years ± SD 75.2

  9. Slide 9: COAST Did Not Achieve Primary Endpoint (Minimally Classic and Occult)

    Similar Visual Outcomes Across All Treatment Arms COAST Phase 3 Trial Did Not Achieve Primary Endpoint sham q4w + aflibercept q8w (n=299) sozinibercept q4w + aflibercept q8w (n=296) sozinibercept q8w + aflibercept q8w (n=297) ∆ = -0.57 (p=0.59) ∆ = -0.52 (p=0.62) Mean BCVA Change from Baseline to We

  10. Slide 10: COAST Did Not Achieve Primary Endpoint (Overall Population)

    Similar Visual Outcomes Across All Treatment Arms COAST Phase 3 Trial Did Not Achieve Primary Endpoint sham q4w + aflibercept q8w (n=330) sozinibercept q4w + aflibercept q8w (n=333) sozinibercept q8w + aflibercept q8w (n=330) ∆ = -0.18 (p=0.86) ∆ = -0.84 (p=0.42) Mean BCVA Change from Baseline to We

  11. Slide 11: Similar Results Across Secondary Visual Acuity Endpoints

    Similar Results Observed Across Secondary Visual Acuity Endpoints % Gaining ≥ 15 Letters from Baseline to Week 52, Overall Population % Gaining ≥ 10 Letters from Baseline to Week 52, Overall Population sham q4w + aflibercept q8w (n=330) sozinibercept q4w + aflibercept q8w (n=333) sozinibercept q8w +

  12. Slide 12: Similar Reductions in CST Observed in All Treatment Arms

    Similar Reductions in CST Observed in All Treatment Arms CST: central subfield thickness Mean CST Change from Baseline Over Time, Overall Population -155.29 µm (-170.03, -140.55) sham q4w + aflibercept q8w sozinibercept q4w + aflibercept q8w sozinibercept q8w + aflibercept q8w -152.79 µm (-167.65, -

  13. Slide 13: No Significant Difference in CNV Regression Across Arms

    No Statistically Significant Difference in CNV Regression Across Treatment Arms CNV: choroidal neovascularization Mixed Model for Repeated Measures (MMRM) Analysis LS Mean Change in CNV Area from Baseline to Week 52, Overall Population sham q4w + aflibercept q8w (n=330) sozinibercept q4w + afliberce

  14. Slide 14: Similar Safety Profile to Aflibercept: Treatment Emergent Adverse Events

    Sozinibercept Combination Therapy Demonstrated Similar Safety Profile to Aflibercept Treatment Emergent Adverse Events sham q4w + aflibercept q8w (n=330) sozinibercept q4w + aflibercept q8w (n=333) sozinibercept q8w + aflibercept q8w (n=330) TEAEs, n (%) 256 (77.6%) 260 (78.1%) 255 (77.3%) Ocular in

  15. Slide 15: Similar Safety Profile: Serious Ocular TEAEs

    Sozinibercept Combination Therapy Demonstrated Similar Safety Profile to Aflibercept Serious Ocular TEAEs Serious ocular TEAEs in study eye, n (%) sham q4w + aflibercept q8w (n=330) sozinibercept q4w + aflibercept q8w (n=333) sozinibercept q8w + aflibercept q8w (n=330) Visual acuity reduced 1 (0.3)

  16. Slide 16: Low Rates of Intraocular Inflammation

    Low Rates of IOI, Majority of Cases Observed in Sozinibercept Combination Arms Cases of Intraocular Inflammation in the Study Eye sham q4w + aflibercept q8w (n=330) sozinibercept q4w + aflibercept q8w (n=333) sozinibercept q8w + aflibercept q8w (n=330) Intraocular Inflammation 0 10 (3.0) 6 (1.8) Uve

  17. Slide 17: ShORe Did Not Achieve Primary Endpoint (Minimally Classic and Occult)

    ShORe (Sozinibercept in Combination with Ranibizumab) Unmasked Early Following COAST Results ShORe Phase 3 Trial Did Not Achieve Primary Endpoint sham q4w + ranibizumab q4w (n=299) sozinibercept q4w + ranibizumab q4w (n=301) sozinibercept q8w + ranibizumab q4w (n=301) ∆ = -1.09 (p=0.30) ∆ = -1.55 (p

  18. Slide 18: ShORe Did Not Achieve Primary Endpoint (Overall Population)

    ShORe (Sozinibercept in Combination with Ranibizumab) Unmasked Early Following COAST Results ShORe Phase 3 Trial Did Not Achieve Primary Endpoint sham q4w + ranibizumab q4w (n=331) sozinibercept q4w + ranibizumab q4w (n=328) sozinibercept q8w + ranibizumab q4w (n=326) ∆ = -1.10 (p=0.28) ∆ = -1.88 (p

  19. Slide 19: ShORe Trial: CST Reductions Observed in All Treatment Arms

    ShORe Trial: CST Reductions Observed in All Treatment Arms CST: central subfield thickness ShORe trial unmasked early following negative COAST results. ShORe CST results are not validated, 95% CI not available. Mean CST Change from Baseline Over Time, Overall Population -143.41 µm -156.68 µm -161.16

  20. Slide 20: COAST and ShORe Trials Key Takeaways

    The COAST and ShORe Phase 3 trials did not meet the primary endpoint of superiority in vision improvement from baseline to week 52 No statistically significant differences in key anatomical outcomes were observed between treatment arms Sozinibercept combination therapy was well tolerated In this lar

  21. Slide 21: Update on Development Funding Agreement (DFA) Negotiations

    Update on Development Funding Agreement (DFA) Negotiations Tom Reilly

  22. Slide 22: Original Terms of the DFA

    In August 2022, Opthea entered into a Development Funding Agreement (DFA) with Ocelot SPV LP which provided USD$120M of funding to support our development of sozinibercept for the treatment of wet AMD In December 2023, Opthea entered into an Amended and Restated DFA with Ocelot as collateral agent,

  23. Slide 23: DFA Discussions and Termination of the Sozinibercept Program

    Following the negative topline data of the COAST trial, Opthea’s management and Board of Directors began discussions with the DFA investors related to the next steps of the Sozinibercept Wet AMD program In consultation with the DFA investors, Opthea determined the most appropriate course of action f

  24. Slide 24: Current State of the Company

    Current State of the Company Dr Jeremy Levin

  25. Slide 25: DFA Settled, Removing Financial Uncertainty; Retained Assets

    Opthea settled arrangements with the DFA investors removing financial uncertainty Opthea retains meaningful assets: Significant cash position No debt No lien on any asset (1) Dual-listing on ASX and NASDAQ. Trading in Opthea's listed securities remains suspended by ASX under ASX Listing Rule 17.3. O

  26. Slide 26: The Path Forward

    The Path Forward Dr Jeremy Levin

  27. Slide 27: Leadership and Governance

    Board of Directors: • Dr. Jeremy Levin • Kathy Connell • Lawrence Gozlan • Sujal Shah, who will step down as of September 15th, 2025 Planned Executive Departures: • Fred Guerard, CEO – stepping down effective September 1st, 2025 • Tom Reilly, CFO – stepping down effective September 15th, 2025 • Kare

  28. Slide 28: Strategy To Maximize Shareholder Return

    The Board will continue to focus on maximizing shareholder value and will assess the following: Full strategic review over the next six months Targeted internal development Strategic partnerships or potential BD/licensing, where appropriate Return of capital to shareholders, where appropriate Strate

  29. Slide 29: Strategic Transition: Clear Priorities, Steady Progress

    Strategic Transition: Clear Priorities, Steady Progress A comprehensive business and asset review is actively underway The Board Is focused on delivering long-term shareholder value Will provide additional support to the company during these transitional stages Expects to provide shareholders with a

  30. Slide 30: Q&A

    OPTHEA testihier tives, Q&A

  31. Slide 31: Thank you

    Thank you

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