Opthea Limited · ASX:OPT
Opthea — Investor Presentation (June 2024)
60 slides from Opthea's investor presentation, Jun 12, 2024
Slide 1: Equity Raising Presentation
Equity Raising Presentation Institutional Placement and Accelerated Non-Renounceable Entitlement Offer (“ANREO”) June 2024 NASDAQ (OPT); ASX (OPT.AX) Exhibit 99.1
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer IMPORTANT: You must read the following before continuing or making use of the information contained in this presentation. By attending an investor presentation, or accepting or viewing this presentation you represent and warrant that you are entitled to receive or acc
Slide 3: Important Notice and Disclaimer
Important Notice and Disclaimer Financial data All dollar values are in United States dollars ($ or US$) unless stated otherwise. This presentation includes pro forma financial information which is provided for illustrative purposes only and is not represented as being indicative of the Company’s (o
Slide 4: Important Notice and Disclaimer
Important Notice and Disclaimer Diagram, charts, graphs and tables Any diagrams, charts, graphs and tables appearing in this presentation are illustrative only and may not be drawn to scale. Investment risk An investment in New Shares and New Options is subject to investment and other known and unkn
Slide 5: Table of Contents
Table of Contents Content Page Opthea Business Snapshot 6 Opthea Update 7 Equity Raising Overview 8 Sources & Uses of Funds 9 Pro Forma Unaudited Condensed Capitalization 10 Equity Raising Timetable 11 Sozinibercept Overview 12 Wet AMD Unmet Medical Needs and Market Opportunity 13 Opthea Development
Slide 6: Opthea Business Snapshot
Opthea Business Snapshot Opthea Ltd Public company listed on ASX (ASX:OPT; Nasdaq:OPT) developing sozinibercept (OPT-302) for wet Age-related Macular Degeneration (“AMD”) Sozinibercept has the potential to be the first product in more than 15 years to improve visual outcomes for wet AMD patients Mar
Slide 7: Opthea Update
Opthea Update Development Funding Agreement (“DFA”) with Carlyle/Abingworth Signed in August 2022 and amended in December 2023 and fully drawn for a total funding of US$170 million Provided non-equity funding for the development of sozinibercept for wet AMD Amounts repaid capped at 4x following rece
Slide 8: Equity Raising Overview
Equity Raising Overview Offering Structure and Size Opthea is seeking to raise up to approximately A$227.3 million (US$150.0 million1) via the issue of up to approximately 568.3 million new fully paid ordinary shares (“New Shares”): An institutional Placement to raise up to approximately A$10.0 mill
Slide 9: Sources and Uses of Funds
Sources of funds (000s) A$ US$ Gross proceeds from Placement and ANREO1 $227,314 $150,027 Commissions, fees, and other estimated offering expenses (17,839) (11,773) Net proceeds $209,475 $138,254 General note: Figures should be considered indicative estimates only and reflect Opthea’s current expect
Slide 10: Pro Forma Unaudited Condensed Capitalization
Pro Forma Unaudited Condensed Capitalization Unaudited balance sheet at: March 31, 2024 December 31, 2023 The pro forma balance sheet gives effect to the proposed offering on the assumption that proposed ANREO and Placement are fully subscribed and provide net proceeds of US$138.3 million (after ded
Slide 11: Equity Raising Timetable
Equity Raising Timetable Item Date Trading Halt (Pre-market) Friday, 7 June 2024 Trading Halt (Pre-market) Announcement of Offer Wednesday, 12 June 2024 Prospectus lodged with ASIC and released on ASX prior to 12 noon Wednesday, 12 June 2024 Institutional Offer Opens (10:00am AEST) Wednesday, 12 Jun
Slide 12: Sozinibercept: First-in-class VEGF-C/D Trap
First-in-class VEGF-C/D Trap 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 More Than 15 Years to Improve Visual Outcom
Slide 13: ~$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 14: 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 Peter Lang Chief Financial Officer Megan Baldwin, PhD, MAICD Founder, Chief Innovation Officer & Executive Director Judith Robertson Chief Commer
Slide 15: Majority of Patients Achieve Suboptimal Vision Outcomes
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 16: Unmet Needs in the Treatment of Wet AMD
Unmet Needs in the Treatment of Wet AMD *Proportion averaged over Weeks 40, 44, and 48; †proportion at Week 48. BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; nAMD, neovascular age-related macular degeneration; PRN, pro re nata (as needed); VEGF, vascular endo
Slide 17: Improved Vision Is One of the Greatest Unmet Needs
Improved Vision Is One of the Greatest Unmet Needs AMD, age-related macular degeneration; DME, diabetic macular edema; Intl, international; US, United States of America; VEGF, vascular endothelial growth factor What are the greatest unmet needs in treating wet AMD and DME? US 1.5% Intl 0.4% Greater
Slide 18: Relative Importance of Treatment Attributes for Patients
Relative Importance of Treatment Attributes for Patients Receiving Anti-VEGF-A Monotherapy n=300
Slide 19: Emerging Treatments for Wet AMD
Better Durability Better Vision Outcomes Emerging Treatments for Wet AMD: Better Vision Outcomes or Durability Sozinibercept (OPT-302) Sozinibercept is the only late-stage drug in development targeting better vision outcomes OTX-TKI CLS-AX EYP-1901 RGX-314 ADVM-022 4D-150 Tyrosine Kinase Inhibitors
Slide 20: Sozinibercept, a VEGF-C/D Trap Inhibitor
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 21: Published Evidence Supports Broader VEGF Pathway Inhibition
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 22: Novel MOA Targeting VEGF-C/D
Novel MOA targeting VEGF-C/D Sozinibercept Targets VEGF-A, VEGF-B, & PlGF Targets VEGF-A, & Ang-2 Targets all isoforms of VEGF-A Sozinibercept Has the Potential to Be the First Therapy in More Than 15 Years to Improve Visual Outcomes in Patients with Wet AMD Targets VEGF-A, VEGF-B, & PlGF Targets al
Slide 23: Designed to Integrate into Current Anti-VEGF-A Clinical Practice
Sozinibercept 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 trea
Slide 24: Opthea Development Pipeline
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-CY 2025
Slide 25: Near-term Focus Is on Sozinibercept Phase Execution
Near-term Focus Is on Sozinibercept Phase 3 Execution Pivotal Program Design Informed by Phase 2b and Optimized for Success Ranibizumab (Lucentis®); Aflibercept (Eylea®) COAST Phase 3 - wet AMD (treatment naïve) n=998 Comparator: Aflibercept (Eylea®) once every two months after three monthly doses S
Slide 26: Phase 2b Wet AMD Trial Overview
Phase 2b Wet AMD Trial Overview 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 / occul
Slide 27: Phase 2b Primary and Secondary Endpoints
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 28: Phase 2b Baseline Demographics
Demographic/Baseline Disease Characteristic 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%) Female 73 (60.3%) 73 (59.8%) 78 (63.4%) Caucasian Race – n (%) 117 (99.2%) 119 (99.2%) 117 (97.5%) Mean Visual Ac
Slide 29: Combination Therapy Demonstrated Superiority in Visual Acuity
Sozinibercept 2.0 mg Combination Therapy Demonstrated Superiority in Visual Acuity over Ranibizumab Monotherapy Sham + 0.5 mg ranibizumab (n=119) 2.0 mg OPT-302 + 0.5 mg ranibizumab (n=121) 0.5 mg OPT-302 + 0.5 mg ranibizumab (n=122) Mean Change in BCVA (SEM) (Letters) Δ = +3.4 (p=0.0107) 20 15 10 5
Slide 30: Best Responding Phase 2b Patients
Best Responding Phase 2b Patients Represents Primary Analysis Population in the Pivotal Phase 3 Trials to Maximize Probability of Success 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* Occult & Minimally Classic Lesions (RAP Absent) *Unad
Slide 31: Control Arm Overperformed MARINA Trial
Trial: Treatment: Number of Patients: 88 87 240 Baseline BCVA in Letters: 50.5 50.5 53.7 Control Arm in Phase 2b Overperformed MARINA Trial at Week 24 in in Similar Lesion Type Patient Population OPT PHASE 2B +Ran 0.5 q4w +Ran 0.5 q4w Ran 0.5 q4w OPT-302 + Ranibizumab Ranibizumab OPT PHASE 2B MARINA
Slide 32: Wet AMD Lesion Types Differ in Responsiveness
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 ~75% of Wet AMD Patients Have Occu
Slide 33: Reduced Retinal Thickness and Better Retinal Drying
Reduced Retinal Thickness and Better Retinal Drying With Combination Therapy in Occult & Minimally Classic (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
Slide 34: Greater CNV and Lesion Regression
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 Week 24 -6 -4 -2 0 81 -4.4 8
Slide 35: Superior Vision Gains in PCV Lesion Patients
Sozinibercept Further Demonstrated Superior Vision Gains in a Pre-Specified Subgroup of PCV Lesion Patients Sham + 0.5 mg ranibizumab (n=20) 2.0 mg OPT-302 + 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 Vasculopathy
Slide 36: 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=170 (N=854 injections) Ocular TEAEs - St
Slide 37: Very Low Intraocular Inflammation Observed
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=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 0 0 Uveit
Slide 38: Phase 3 Clinical Program Informed by Phase 2b Results
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 (RAP absent), followed by total patient population Two robust pivotal trials studying sozinibercept in combi
Slide 39: Phase 3 Trials COAST and ShORe Well Advanced
Phase 3 Wet AMD Trials COAST and ShORe Are Well Advanced 1,984 Patients Enrolled in Phase 3 Program | Topline Data for COAST (anticipated in early 2Q CY 2025) and for ShORe (anticipated in mid-CY2025) Design Multi-center, double-masked, randomized (1:1:1), sham control Treatment naïve wet AMD patien
Slide 40: Phase 3 Primary and Secondary Endpoints
Phase 3 Primary and Secondary Endpoints Primary Efficacy Endpoint at Week 52 to Support BLA Submission Primary Endpoint Key Secondary Endpoints (Baseline to Week 52) Mean change from baseline in BCVA at week 52 Proportion of participants gaining ≥15 letters Proportion of participants gaining ≥10 let
Slide 41: Phase 3 Trial Design Supports Broad Label
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 + Sham q4w Aflibercept q8w + Sozinibercept q8w Safety Follow
Slide 42: Advancing Therapeutic Innovations: Next Steps
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 43: Financial Snapshot & Corporate Activities
Financial Snapshot & Corporate Activities Financial Overview Ticker OPT (ASX/NASDAQ) Shares Outstanding1 662.8M (Ordinary)/ 82.9M (ADSs equivalents) Cash/Cash Equivalents1 US$101.6M Offices Melbourne, Australia Princeton, NJ Development Funding Agreement (DFA) Total funding drawn under DFA: US$170M2
Slide 44: Addressing unmet medical need in a potential ~$15B market
Addressing unmet medical need of improved efficacy in large wet AMD patient population in a potential ~$15B market 1 Sozinibercept Will Not Compete Head-to-Head with Anti-VEGF-A Differentiated Combination Approach Targeting Better Visual Outcomes Drives Commercial Value First and only therapy to hav
Slide 45: Key Risks
Key Risks 48 Future capital requirements Opthea’s activities will require substantial expenditures. Opthea’s losses from operations, including from clinical trial activities, and negative cash flows, raise substantial doubt about the ability for Opthea to continue as a going concern without addition
Slide 46: Going concern
Going concern For the half year ended 31 December 2023, Opthea incurred a loss after income tax of US$ 96.2 million and had net cash outflows from operating activities of $69.4 million. At 31 December 2023, Opthea had cash and cash equivalents of US$157.1 million and was in a net liability position
Slide 47: Access to capital
Access to capital The Opthea business model requires ongoing re-investment into clinical trials with no revenues currently contracted. As such, Opthea will continue to rely upon cash, raised through equity or debt, on acceptable terms, to fund the business as an on-going concern, including in respec
Slide 48: Regulatory approval
50 Regulatory approval Opthea operates within a highly regulated industry, relating to the manufacture, distribution and supply of pharmaceutical products. There is no guarantee that Opthea will obtain or maintain the required approvals, licenses and registrations from all relevant regulatory author
Slide 49: Commercialization
51 Commercialization Sozinibercept has not been approved for commercial sale, and Opthea does not expect commercial sales to occur until some time in the future, if ever. If sozinibercept is approved for commercial sale, Opthea’s commercialization expenses will increase significantly as it establish
Slide 50: Information technology
Information technology Opthea relies on effective information technology, software, data centres and communication systems. There is a risk that these systems may be adversely affected by disruption, failure, service outages or data corruption that could occur as a result of computer viruses, “bugs”
Slide 51: Offer and General Risks
Offer and General Risks Key Risks – Offer and General Risks Effects of Offer on control Regal has informed the Company that its current voting power in the Company is 23.56% (constituted by holdings of 132,902,835 ordinary shares and 2,907,403 ADSs). Regal will have a pro rata entitlement under the
Slide 52: Offer and General Risks: Share price fluctuations
Offer and General Risks Key Risks – Offer and General Risks Share price fluctuations (continued) adverse regulatory decisions, including failure to receive regulatory approval for any of our product candidates; the termination of a strategic alliance or the inability to establish additional strategi
Slide 53: New Options
53 New Options Opthea has applied or will apply for quotation of the New Options within seven days of the Prospectus being lodged with ASIC. ASX requires Opthea to meet certain conditions for quotation of New Options as a new class on ASX. There is a risk that Opthea may not be able to meet those re
Slide 54: Economic risks
Economic risks Opthea is exposed to economic factors in the ordinary course of business. A number of economic factors and conditions, both Australian and global, affect the performance of financial markets generally, which could affect the price at which Opthea shares and ADSs trade on ASX and Nasda
Slide 55: Forward-looking statements
Forward-looking statements There can be no guarantee that the assumptions and contingencies on which the forward-looking statements, opinions and estimates are based will ultimately prove to be valid or accurate. The forward-looking statements, opinions and estimates included in this presentation de
Slide 56: Summary of Underwriting Agreement
Summary of Underwriting Agreement A summary of the events which may trigger termination of the underwriting agreement include (but are not limited to) the following: (misleading disclosure) a statement contained in the Offer materials is or becomes misleading or deceptive or likely to mislead or dec
Slide 57: Summary of Underwriting Agreement (cont'd)
Summary of Underwriting Agreement (cont’d) (applications) an application is made by ASIC for an order under Part 9.5 of the Corporations Act in relation to the Offer materials or the Offer or ASIC commences, or gives notice of an intention to hold, any investigation or hearing in relation to the Off
Slide 58: Summary of Underwriting Agreement (cont'd)
Summary of Underwriting Agreement (cont’d) (compliance): a contravention by Opthea or any member of the Opthea group of the Corporations Act, the Constitution, Listing Rules, any applicable laws, or a requirement, order or request made by or on behalf of the ASIC, ASX or any other government agency
Slide 59: Foreign Selling Restrictions
Foreign Selling Restrictions This document does not constitute an offer of New Shares and New Options in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares and New Options may not be offered or sold, in any country ou
Slide 60: Foreign Selling Restrictions (cont'd)
Foreign Selling Restrictions (cont’d) Singapore This document and any other materials relating to the New Shares and New Options have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, this document and any other docume