Opthea Limited · ASX:OPT
Opthea — Investor Presentation (November 2024)
30 slides from Opthea's investor presentation, Nov 19, 2024
Slide 1: Transforming Patient Outcomes with Superior Vision Gains: Corporate Overview
Transforming Patient Outcomes with Superior Vision Gains Corporate Overview | November 2024 NASDAQ (OPT); ASX (OPT.AX) Exhibit 99.1
Slide 2: Disclaimer and Forward-looking Statements
Disclaimer and Forward-looking Statements 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 i
Slide 3: Sozinibercept Has the Potential to Be the First Product in 20 Years to Improve Visual Outcomes
First-in-class VEGF-C/D ‘trap’ inhibitor intended for combination with standard of care anti-VEGF-A therapies Composition of Matter and Methods of Use Patents through 2034; opportunities to extend beyond 2034* Sozinibercept Has the Potential to Be the First Product in 20 Years to Improve Visual Outc
Slide 4: ~$15bn Global Market and Growing
~$15bn Global Market and Growing Sozinibercept Designed to Improve Visual Outcomes in Combo with VEGF-A Inhibitors; Potential to Create New Multi-Billion Dollar Class Beovu Avastin Eylea $9.4bn Vabysmo $2.8bn Lucentis ~$2.0bn Potential value proposition: Targeting Improved Visual Function Critical f
Slide 5: Experienced Leadership Team
Experienced Leadership Team Expertise and Track Record to Make a Positive Impact on the Retinal Community Fred Guerard, PharmD, MS Chief Executive Officer Tom Reilly Chief Financial Officer Parisa Zamiri, MD, PhD Chief Medical Officer Megan Baldwin, PhD, MAICD Founder, Chief Innovation Officer Mike
Slide 6: Improving Vision Now the Largest Unmet Need in Wet AMD for Retina Specialists
Improving Vision Now the Largest Unmet Need in Wet AMD for Retina Specialists Which factors are more important to you when selecting an anti-VEGF agent? n=1,021 ASRS PAT Survey 2024 What are the greatest unmet needs in treating wet AMD and DME? n=1,012 ASRS PAT Survey 2023 Ability to improve vision
Slide 7: Majority of Patients Achieve Suboptimal Vision Outcomes Despite Standard of Care Anti-VEGF-A Therapies
do not achieve significant vision gains 25% Despite Treatment with Standard of Care Anti-VEGF-A Therapies, the Majority of Patients Achieve Suboptimal Vision Outcomes Despite treatment with anti-VEGF-A therapy* will have further vision loss at 12+ months will have persisting macular fluid >60% >45%
Slide 8: Every Letter Counts When Loss of Vision Potentially Leads to Increased Mortality Risk
Hazard for All-cause Mortality1 Higher in People with Vision Impairment Every Letter Counts When Loss of Vision Potentially Leads to Increased Mortality Risk IADL – Instrumental activities of daily living; ETDRS – Early Treatment Diabetic Retinopathy Study chart 1Ehrlich JR et al. “Association betwe
Slide 9: Sozinibercept Has Demonstrated Improvement in Vision Gains and Reduction in Vision Loss
Sozinibercept Has Demonstrated Improvement in Vision Gains and Reduction in Vision Loss Visual Acuity Lucentis remains the standard of care for visual improvements LUCENTIS AVASTIN (OFF LABEL) EYLEA BEOVU VABYSMO EYLEA HD OTX-TKI CLS-ASX EYP-1901 RGX-314 ADVM-022 4D-150 Tyrosine Kinase Inhibitors Ge
Slide 10: Sozinibercept Has the Potential to Address the Limitations of Anti-VEGF-A Therapies
Sozinibercept, a Proprietary VEGF-C/D “Trap” Inhibitor, Has the Potential to Address the Limitations of Anti-VEGF-A Therapies The Problem The Solution Wet AMD is a multi-factorial disease. Treatment with VEGF-A inhibitors upregulates VEGF-C/D, driving angiogenesis and vascular permeability. When use
Slide 11: Published Evidence Supports Broader VEGF Pathway Inhibition with Sozinibercept
Published Evidence Supports Broader VEGF Pathway Inhibition with Sozinibercept VEGF-A and VEGF-C Induce Vascular Leakage/permeability# VEGF-A VEGF-C VEGF-C Stimulates Retinal Angiogenesis^ Circulating VEGF-C Levels Significantly Elevated in AMD Patients ⍭ Elevated VEGF-C in Aqueous Humor Following A
Slide 12: Sozinibercept Is Designed to Integrate into Current Anti-VEGF-A Clinical Practice
Sozinibercept Is Designed to Integrate into Current Anti-VEGF-A Clinical Practice Superior visual outcomes meaningfully improves patients’ lives Intended to be administered at same anti-VEGF-A visit Patients Better vision outcomes is a high unmet medical need Designed to be agnostic to anti-VEGF-A t
Slide 13: Physicians Willing to Administer Second Injection to up to 1% of Their Patients
Physicians Willing to Administer Second Injection to up to 41% of Their Patients for Additional BCVA Improvement What percentage of your Wet AMD patients would you use a second injection (anti-VEGF C/D) immediately after an anti-VEGF-A injection at various levels of BCVA improvement of the combinati
Slide 14: Development Programs and Anticipated Milestones
PROGRAM DEVELOPMENT PHASE ANTICIPATED MILESTONES PROGRAM RESEARCH / PRECLINICAL PHASE 1 PHASE 2 PHASE 3 ANTICIPATED MILESTONES Wet Age-Related Macular Degeneration (Wet AMD) Sozinibercept For use in combination with anti-VEGF-A therapies Topline data: COAST (in early 2Q CY2025) ShORe (in mid-CY2025)
Slide 15: Advancing Therapeutic Innovations to Transform Patient Outcomes with Superior Vision Gains
Advancing Therapeutic Innovations to Transform Patient Outcomes with Superior Vision Gains We are dedicated to advancing sozinibercept to improve patients’ visual outcomes Clinical Milestones Manufacturing Scale-up Regulatory Preparations Commercial Readiness Phase 3 program enrolled 1,984 patients
Slide 16: Robust Phase 2b Trial in Wet AMD Demonstrated Superiority in Visual Outcome
Robust Phase 2b Trial in Wet AMD Demonstrated Superiority in Visual Outcome 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%
Slide 17: Phase 2b Primary and Secondary Endpoints; Select Pre-specified Subgroups
Phase 2b Primary and Secondary Endpoints Select Pre-specified Subgroups Primary Endpoint Key Secondary Endpoints Mean change from baseline in BCVA at week 24 Proportion of patients gaining ≥15 letters from baseline at week 24 Change in central subfield thickness (CST) from baseline at week 24 Change
Slide 18: Demographic/Baseline Disease Characteristics
Demographic/Baseline Disease Characteristic 2 mg sozinibercept + 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%) Female 73 (60.3%) 73 (59.8%) 78 (63.4%) Caucasian Race – n (%) 117 (99.2%) 119 (99.2%) 117 (97.5%) Mean Visua
Slide 19: Combination Therapy Demonstrated Superiority in Visual Acuity over Ranibizumab Monotherapy
Sozinibercept 2 mg Combination Therapy Demonstrated Superiority in Visual Acuity over Ranibizumab Monotherapy Sham + 0.5 mg ranibizumab (n=119) 2 mg sozinibercept + 0.5 mg ranibizumab (n=121) 0.5 mg sozinibercept + 0.5 mg ranibizumab (n=122) Mean Change in BCVA (SEM) (Letters) Δ = +3.4 (p=0.0107) 20
Slide 20: Best Responding Phase 2b Patients Represent Primary Analysis Population in Phase 3
0 4 8 12 16 20 24 0 5 10 15 20 Weeks M e a n c h a n g e i n B C V A ( S E M ) ( l e t t e r s ) To Maximize Probability of Success, Best Responding Phase 2b Patients Represents Primary Analysis Population in the Pivotal Phase 3 Trials Sham + 0.5 mg ranibizumab (n=87) 2 mg sozinibercept + 0.5 mg ran
Slide 21: A Greater Proportion of Sozinibercept Patients Gained Substantial Vision and Fewer Experienced Vision Loss
In a Disease Where Every Letter Counts, a Greater Proportion of Sozinibercept Patients Gained Substantial Vision and Fewer Experienced Vision Loss ≥15 Loss 10-14 Loss 5-9 Loss 1-4 Loss +0-5 Gain +6-10 Gain +11-15 Gain +16-20 Gain +21-25 Gain +26-30 Gain + >30 Gain Legend (ETDRS Letter Change from Ba
Slide 22: Sozinibercept Reduced Retinal Thickness and Dried the Retina Better
Sozinibercept Reduced Retinal Thickness and Dried the Retina Better With Combination Therapy in Occult & Minimally Classic (RAP Absent) Patients Mean Change in CST Baseline to Week 24 Sham + 0.5 mg ranibizumab 2 mg sozinibercept + 0.5 mg ranibizumab % of Participants with IR Cysts at Week 24 % of Pa
Slide 23: Greater CNV and Lesion Regression With Combination Therapy
Sozinibercept Demonstrated Greater CNV and Lesion Regression With Combination Therapy in Occult & Minimally Classic (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 W
Slide 24: Superior Vision Gains in Pre-Specified Subgroup of Hard-To-Treat PCV Lesion Patients
Sozinibercept Demonstrated Superior Vision Gains in a Pre-Specified Subgroup of Hard-To-Treat PCV Lesion Patients Sham + 0.5 mg ranibizumab (n=20) 2 mg sozinibercept + 0.5 mg ranibizumab (n=22) Δ +6.7 p = 0.0253* 0 5 10 15 20 22 13.5 20 6.9 Mean Change in BCVA (SEM) (Letters) Polypoidal Choroidal Va
Slide 25: Pooled Safety for Completed Sozinibercept Trials
Pooled Safety for Completed Sozinibercept Trials Combination Therapy Well Tolerated and Comparable to Standard of Care Monotherapy N Participants (%) Sozinibercept Any dose* N=399 (N=1,842 injections) Sozinibercept 2 mg N=263 (N=1,121 injections) Sham + anti-VEGF-A control N=170 (N=854 injections) O
Slide 26: Intraocular Inflammation Observed in Combination Therapy Across Completed Trials
N Participants (%) Sozinibercept Any dose* N=399 (N=1,842 injections) Sozinibercept 2 mg N=263 (N=1,121 injections) Sham + anti-VEGF-A control N=170 (N=854 injections) Intraocular Inflammation1 7 (1.8%) 3 (1.1%) 3 (1.8%) OPT-302-1001 (Phase 1/2a wet AMD) 2 0 0 Uveitis with anterior chamber cell 1+ 1
Slide 27: Phase 3 Clinical Program Is Informed by Phase 2b Results and Optimized for Success
Phase 3 Clinical Program Is Informed by Phase 2b Results and Optimized for Success Hierarchical primary analysis first conducted in the high-responding occult and minimally classic population (+5.7 letters in Phase 2b) followed by total patient population Two robust pivotal trials studying soziniber
Slide 28: Phase 3 Wet AMD Trials COAST and ShORe Are Well Advanced
Phase 3 Wet AMD Trials COAST and ShORe Are Well Advanced Phase 3 Trial Design Supports Potential Broad Label for Use With Any Anti-VEGF-A Therapy Ranibizumab q4w + Sozinibercept q4w Ranibizumab q4w + Sham q4w Ranibizumab q4w + Sozinibercept q8w Aflibercept q8w + Sozinibercept q4w Aflibercept q8w + S
Slide 29: Recent Financings Anticipated to Provide Cash Runway Through Both Pivotal Topline Data Readouts
Recent Financings Anticipated to Provide Cash Runway Through Both Pivotal Topline Data Readouts Financial Overview Ticker OPT (ASX/NASDAQ) Shares Outstanding1 Ordinary Shares: 1,231.1M ADS equivalents: 153.9M Cash/Cash Equivalents2 US$167.5M Offices Melbourne, Australia Princeton, NJ Development Fun
Slide 30: Addressing Unmet Medical Need in Large Wet AMD Patient Population in a Potential ~$15B Market
Addressing unmet medical need of improved efficacy in large wet AMD patient population in a potential ~$15B market 1 Sozinibercept Will Not Compete Head-to-Head with Anti-VEGF-A Differentiated Combination Approach Targeting Better Visual Outcomes Drives Commercial Value First and only therapy to hav