Opthea Limited · ASX:OPT
Opthea — Investor Presentation (January 2024)
19 slides from Opthea's investor presentation, Jan 11, 2024
Slide 1: Sozinibercept (OPT-302) for Wet AMD Corporate Presentation
Sozinibercept (OPT-302) for Wet AMD Transforming Patient Outcomes by Improving Vision Corporate Presentation | January 2024 OPTHEA.COM | @OptheaLimited | NASDAQ (OPT); ASX (OPT.AX) Exhibit 99.1
Slide 2: Disclaimer
Disclaimer This presentation includes general background information about the activities of Opthea Limited (ABN 32 006 340 567) (“Opthea” or “Company”) and its affiliates and subsidiaries (together, the “Opthea Group”). The information contained in this presentation is in summary form and does not
Slide 3: Developing sozinibercept, a first-in-class VEGF-C/D trap
We are developing sozinibercept, a first-in-class VEGF-C/D ‘trap’, to be used in combination with standard of care anti-VEGF-A therapies Potential to be the first therapy to demonstrate visual acuity superiority in combination over standard of care in wet AMD Sozinibercept has the potential to impro
Slide 4: Better Vision Gains is an Unmet Medical Need in Wet AMD
Better Vision Gains is an Unmet Medical Need in Wet AMD >45% >60% 25% Do not achieve significant vision gains Will have persisting macular fluid Will have further vision loss at 12 months & beyond Wet AMD is the leading cause of irreversible blindness: Impacts ~3.5M patients1 ~1.6M patients in the U
Slide 5: Sozinibercept Potential Next Transformative Step in Treatment of Wet AMD
Sozinibercept has the Potential to be the Next Transformative Step in the Treatment of Wet AMD THE PROBLEM THE SOLUTION Wet AMD is a multi-factorial disease. VEGF-C and VEGF-D activate validated wet AMD disease pathways, driving angiogenesis and vascular permeability. When used in combination with a
Slide 6: Wet AMD Potential Addressable Market
Wet AMD Potential Addressable Market Wet AMD Total Global Revenue Large & Growing Market Opportunity in Wet AMD Sozinibercept could be combined with any anti-VEGF-A ~US$8B+ Off-label use Implied Total Addressable Market for Sozinibercept Captures Lucentis, Eylea, Vabysmo, and Avastin or biosimilar-t
Slide 7: Near-term Focus is on Sozinibercept Phase Execution
Near-term Focus is on Sozinibercept Phase 3 Execution BLA preparations and pre-commercial activities continue ShORe Phase 3 wet AMD (n=~990) Comparator Ranibizumab (Lucentis®) once every month COAST Phase 3 wet AMD (n=~990) Comparator Aflibercept (Eylea®) once every two months after three monthly do
Slide 8: Phase 2b Trial
Phase 2b Trial Screening Treatment naïve patients with neovascular AMD Key Exclusion Criteria Subfoveal fibrosis or >25% of total lesion Haemorrhage >50% total lesion Other clinically significant ocular disease Key Inclusion Criteria Active CNV >50% lesion, classic / minimally classic / occult BCVA
Slide 9: Phase 2b Demographics and Baseline Characteristics
Phase 2b Demographics and Baseline Characteristics Demographic/Baseline Disease Characteristic Sham + ranibizumab n=121 0.5 mg OPT-302 + ranibizumab n=122 2.0 mg OPT-302 + ranibizumab n=123 Mean Age – years ± SD 76.1 ± 9.48 78.8 ± 8.16 77.8 ± 8.82 Sex – n (%) Male 48 (39.7%) 49 (40.2%) 45 (36.6%) Fe
Slide 10: Combination Therapy: Superiority in Visual Acuity over Ranibizumab
Sozinibercept (2 mg) Combination Therapy: Superiority in Visual Acuity over Ranibizumab Phase 2b primary endpoint achieved Mean Change in Best Corrected Visual Acuity Baseline to Week 24 mITT; BCVA – Best Corrected Visual Acuity Left: Difference in Least Square Means, using Model for Repeated Measur
Slide 11: Better Visual Outcomes Relative to Previous VEGF-A Inhibitor Trials
OPT-302 2 mg in Combination Delivered Better Visual Outcomes Relative to Previous VEGF-A Inhibitor Trials BCVA at 6 months is typically maintained or greater at 12 months in Phase 3 trials with VEGF-A inhibitors 121 119 240 140 304 291 301 306 360 370 6-month data 12-month data MARINA Min. classic &
Slide 12: Neovascular Wet AMD Lesion Types Differ
Neovascular Wet AMD Lesion Types Differ in vessel location, leakiness, and responsiveness to VEGF-A inhibitors LEAST RESPONSIVE to VEGF-A inhibition MODERATELY RESPONSIVE to VEGF-A inhibition HIGHLY RESPONSIVE to VEGF-A inhibition Predominantly Classic MINIMALLY CLASSIC OCCULT 65-80% of wet AMD pati
Slide 13: Primary Analysis on Best Responding Sub-Population
Primary Analysis in Pivotal Trials to Be Performed on Best Responding Sub-Population to Maximize Probability of Success Minimally Classic & Occult Lesions Sham + 0.5 mg ranibizumab N = 87 2.0 mg OPT-302 + 0.5 mg ranibizumab N = 88 +10.3 +16.1 Δ = 5.7 *p = 0.0002 * Unadjusted p-value. Patients with m
Slide 14: Reduced Retinal Thickness and Better Retinal Drying
Reduced Retinal Thickness and Better Retinal Drying In Combination Therapy in Min. Classic & Occult, RAP Absent Patients Mean Change in CST Baseline to Week 24 Sham + 0.5 mg ranibizumab 2.0 mg OPT-302 + 0.5 mg ranibizumab % of Participants with IR Cysts at Week 24 % of Participants with SRF at Week
Slide 15: Reduced the Total Lesion Area in Combination
Reduced the Total Lesion Area In Combination at Week 24 in Min. Classic, Occult, and RAP Absent Patients mITT; as observed; top of bar – statistic, bottom of bar – n. CNV: Choroidal Neovascular. Mean Change in Total Lesion Area at Week 24 Mean Change in CNV Area at Week 24 -6 -4 -2 0 81 -4.4 80 -3.5
Slide 16: Pooled Safety for Completed OPT-302 Trials
Pooled Safety for Completed OPT-302 Trials Combination therapy well-tolerated and comparable to standard of care monotherapy N Participants (%) OPT-302 Any dose* N=399 (N=1,842 injections) OPT-302 2.0 mg N=263 (N=1,121 injections) Sham + anti-VEGF-A control N=169 (N=854 injections) Ocular TEAEs - St
Slide 17: Phase 3 Pivotal Program Enrollment Completion Anticipated in 1H CY24
Phase 3 Pivotal Program Enrollment Completion Anticipated in 1H CY24 Sample size: 330 patients per arm, 990 per trial Primary Objective: Mean change from Baseline in BCVA at Wk 52 Design: Multi-centre, double-masked, randomised (1:1:1), sham control Regulatory quality: 90% power, 5% type I error rat
Slide 18: Sozinibercept is a Potential Multibillion Dollar Drug
Sozinibercept is a Potential Multibillion Dollar Drug Strong Phase 2b Data Superior vision gains of OPT-302 combination therapy over standard of care Consistent improvement across anatomical endpoints Safety profile similar to standard of care in our trials to date Pivotal Phase 3 Trials Ongoing; En
Slide 19: Financial Snapshot & Corporate Activities
Financial Snapshot & Corporate Activities Cash and cash equivalents at Fiscal Year End 6/30/2023 of US$89.2M Completed an Australian rights equity offering and placement in September 2023, raising A$90 million (~US$58M) Received remaining US$35M funding under Development Funding Agreement (DFA), as