Opthea Limited · ASX:OPT
Opthea — Investor Presentation (August 2023)
43 slides from Opthea's investor presentation, Aug 24, 2023
Slide 1: Equity Raising Presentation
Equity Raising Presentation Institutional Placement and Accelerated Non-Renounceable Entitlement Offer (“ANREO”) August 2023 OPTHEA.COM | @OptheaLimited | ASX (OPT.AX); NASDAQ: OPT
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 Equity Raising Timetable 10 Proforma Balance Sheet – June 30, 2023 11 Investment Highlights 12 Market Opportunity 13 Phase 2b wet AMD Trial Data 16 Phase 3 Pivotal Program 29
Slide 6: Opthea Business Snapshot
Opthea Business Snapshot • Public company listed on ASX (ASX:OPT; Nasdaq:OPT) developing sozinibercept (OPT-302) for wet Age-related Macular Degeneration (“AMD”) Opthea Limited • Market capitalization prior to capital raise of approximately A$280M at 23 August 2023 and cash on hand of US$89M at 30 J
Slide 7: Opthea Update
Opthea Update • Completed in August 2022, total capacity US$170 million, with US$120 million committed at signing with the ability to provide an additional US$50 million • Provides non-equity funding for the development of OPT-302 for wet AMD • Amounts received from Carlyle and Abingworth repaid at
Slide 8: Equity Raising Overview
Equity Raising Overview Opthea is seeking to raise up to approximately A$80.0 million (US$51.2 million1) via the issue of up to approximately 173.9 million new fully paid ordinary shares (“New Shares”) • An institutional Placement to raise up to approximately A$10.0 million (US$6.4) million1 (“Place
Slide 9: Sources and Uses of Funds
Sources and Uses of Funds Sources of funds (m) A$/US$ Gross proceeds from Placement and ANREO1 80/51.2 Commission and fees (6.8)/(4.3) Net proceeds 73.2/46.9 Uses of funds (m) US$ To continue advancing the clinical development of OPT-302 for the 46.9 treatment of wet AMD, including to progress the P
Slide 10: Equity Raising Timetable
Equity Raising Timetable Item Date Trading Halt and announcement of the Equity Raising, lodgement of Offer Documents, including Thursday, August 24, 2023 Prospectus with ASIC Institutional Placement and Institutional Entitlement Offer opens Thursday, August 24, 2023 Institutional Placement and Insti
Slide 11: June 30, 2023 Proforma Preliminary Unaudited Balance Sheet
June 30, 2023 Proforma Preliminary Unaudited Balance Sheet Proforma June 30, Funding June 30, • Unaudited balance sheet at June 30, 2023 2023 2023 2023 Unaudited • The pro forma balance sheet gives effect to the following assumptions: US$ US$ US$ Assets Current assets: • US$46.9 million is received
Slide 12: Investment Highlights
Investment Highlights • Wet AMD is the leading cause of vision loss in the elderly, impacting 3.5 million patients in the US and Europe • Revenues for current standard-of-care VEGF-A inhibitors for wet AMD are >US$8 billion/year • OPT-302 is: • a unique and proprietary* biologic with a novel mechani
Slide 13: The Unmet Medical Need for wet AMD
The Unmet Medical Need for wet AMD • Wet AMD is the leading cause of irreversible blindness Despite treatment with anti-VEGF-A therapy2: • Currently: • Impacts 3.5M patients1 >45% Do not achieve significant vision gains • 1.6M patients in U.S.A. Wet AMD • 200,000 new patients each year >60% Will hav
Slide 14: Large and Growing Market Opportunity in Wet AMD
Large and Growing Market Opportunity in Wet AMD OPT-302 is Anti-VEGF-A and Durability Agnostic New entrant trending to $2B* in revenues shows willingness to >$16B switch and impact of commercial investment ~50% treated patients receive Avastin ® Potential Addressable >US$8B Off-label use Wet AMD Mar
Slide 15: OPT-302 Combination Therapy Achieves Broad Blockade of the Validated Pathway in Wet AMD
OPT-302 Combination Therapy Achieves Broad Blockade of the Validated Pathway in Wet AMD Used in combination with any VEGF-A inhibitor, OPT-302 blocks# VEGF-C Ranibizumab VEGFR-2 and VEGFR-3 signaling, (Lucentis®) VEGF-A VEGF-D VEGF-A inhibiting the most important OPT-302 pathways driving angiogenesi
Slide 16: OPT-302 Combination Therapy Clinical Program
OPT-302 Combination Therapy Clinical Program Now Recruiting Completed Completed Completed ShORe COAST Phase 1/2a Phase 1b/2a Phase 2b Phase 3 Phase 3 wet AMD DME wet AMD wet AMD wet AMD (n=51) (n=153) (n=366) (n=990) (n=990) Comparator Comparator Comparator Comparator Comparator Ranibizumab Afliberc
Slide 17: Phase 2b Study Overview
Phase 2b Study Overview Treatment naïve patients Key Inclusion Criteria with neovascular AMD Key Exclusion Criteria • Active CNV >50% lesion, classic / • Subfoveal fibrosis or >25% of total lesion Screening minimally classic / occult • Haemorrhage >50% total lesion • BCVA ≥ 25 and ≤ 60 letters • Oth
Slide 18: Phase 2b Study Demographics and Baseline Characteristics
Phase 2b Study Demographics and Baseline Characteristics Sham + 0.5 mg OPT-302 + 2.0 mg OPT-302 + Demographic/Baseline Disease Characteristic ranibizumab ranibizumab ranibizumab n=121 n=122 n=123 Mean Age – years ± SD 76.1 ± 9.48 78.8 ± 8.16 77.8 ± 8.82 Male 48 (39.7%) 49 (40.2%) 45 (36.6%) Sex – n
Slide 19: Superiority in Visual Acuity over Ranibizumab Monotherapy
OPT-302 (2.0 mg) Combination Therapy Demonstrated Superiority in Visual Acuity over Ranibizumab Monotherapy • Phase 2b primary Mean Change in Best Corrected Visual Acuity Baseline to Week 24 endpoint achieved 20 All Comers Mean change in BCVA (SEM) 15 +14.2 Δ = +3.4 (letters) (p=0.0107) 10 +10.8 5 0
Slide 20: Mean Visual Acuity Higher Relative to Previous VEGF-A Inhibitor Trials
OPT-302 Combination Therapy Mean Visual Acuity Higher 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 20 OPT Phase 2b Min. classic & Occult lesions only OPT-302 + Ranibizumab OPT Phase 2b 16.1 BCVA
Slide 21: Neovascular (Wet) AMD Lesion Types
Neovascular (Wet) AMD Lesion Types Differ in Vessel Location, Leakiness, and Responsiveness to VEGF-A Inhibitors PREDOMINANTLY OCCULT MINIMALLY CLASSIC CLASSIC LEAST RESPONSIVE MODERATELY RESPONSIVE HIGHLY RESPONSIVE to VEGF-A inhibition to VEGF-A inhibition to VEGF-A inhibition A majority of wet AM
Slide 22: Patients with Minimally Classic and Occult Lesions Responded Best in Phase 2b
Patients with Minimally Classic and Occult Lesions (RAP Absent) Responded Best in Phase 2b Minimally Classic and Occult • Achieved greatest vision benefit 20 • Represents primary analysis Mean Change in BCVA (SEM) population in OPT-302 +16.1 Phase 3 program 15 Δ = 5.7 *p = 0.0002 (Letters) 10 +10.3
Slide 23: BCVA (Snellen Equivalent) at Week 24
BCVA (Snellen Equivalent) at Week 24 (Min.Classic & Occult, RAP Absent) Higher Proportion of Patients with 20/40 Vision or Better in OPT-302 Combination Group 80 42% relative increase in % of patients with 20/40 vision at week 24 compared to ranibizumab control 60 % Participants 48.9 40 34.5 20 0 ≥7
Slide 24: Reduced Retinal Thickness and Better 'Retinal Drying'
Reduced Retinal Thickness and Better ‘Retinal Drying’ With OPT-302 Combination Therapy in Min.Classic & Occult, RAP Absent Patients Mean Change in CST % of Participants with % of Participants with IR Baseline to Week 24 SRF at Week 24 Cysts at Week 24 -60 40 40 85 86 Mean Change in CST (SEM) % Parti
Slide 25: Greater Reduction in Total Lesion Area in OPT-302 2.0 mg Combination Group
Total Lesion Area at Week 24 (Min.Classic Occult, RAP Absent) Greater Reduction in Total Lesion Area in OPT-302 2.0 mg Combination Group Mean Change in Total Lesion Mean Change in CNV Area Area at Week 24 at Week 24 0 0 80 81 80 81 Total Lesion Area (SEM) Mean Change in -2 -2 CNV Area (SEM) Mean Cha
Slide 26: Potential to Improve Vision Outcomes in Patients with PCV Lesions
OPT-302 Combination Therapy: Demonstrated potential to improve vision outcomes in patients with PCV lesions 20 Polypoidal Choroidal Vasculopathy Δ = 6.7 (PCV) is a difficult-to-treat wet AMD *p = 0.0253 subtype with a large unmet need Mean Change in BCVA (SEM) 15 In Phase 2b, OPT-302 combination the
Slide 27: 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 OPT-302 Sham + anti-VEGF-A Any dose* 2.0 mg control N=399 N=263 N=169 (N=1,842 injections) (N=1,121 injections) (N=854 injections) Ocular TEAEs - St
Slide 28: OPT-302 Phase 3 Pivotal Program
OPT-302 Phase 3 Pivotal Program Topline Primary Data Analysis at Week 52 • Opthea intends to submit Biologics License Application (BLA) and Marketing Authorization Application (MAA) with the FDA and EMA, respectively, following completion of the primary efficacy phase of the trials Efficacy Phase Sa
Slide 29: Current Focus is on Phase 3 Recruitment
Current Focus is on Phase 3 Recruitment BLA preparation and pre-commercial activities continue Key Dates • Expect to complete patient recruitment Timeline Phase 3 Execution • COAST Q1 CY 2024 • Topline data results to follow • ShORe Q2 CY 2024 data cleaning and database lock • Two trials concurrentl
Slide 30: Summary
Opthea Limited and OPT-302 for Wet AMD Positioned for Clinical and Commercial Success ✓ Differentiated MOA to improve efficacy • OPT-302 is a biologic VEGF-C/D “trap” with no viable threat in competitive pipelines • The first therapy directly targeting VEGF-C & VEGF-D inhibiting angiogenic signaling
Slide 31: Key Risks
Key Risks This section outlines some of the key risks associated with an investment in Opthea, together with the risks relating to participation in the Offer. Opthea’s business is subject to a number of risk factors both specific to its business and of a general nature which may impact on its future
Slide 32: Key Risks – Business Risks
Key Risks – Business Risks (cont’d) Development Funding Agreement We are highly reliant on the funding under the DFA including the third tranche of $35 million expected before December 31, 2023, and the potential increase in funding of US$50 million by a new co-investor of Carlyle and Abingworth (se
Slide 33: Key Risks – Business Risks
Key Risks – Business Risks (cont’d) Opthea’s future success is dependent on the performance of OPT-302 in clinical trials and whether it proves to be a safe and effective treatment. OPT-302 is an experimental product in clinical development and product commercialisation resulting in potential produc
Slide 34: Key Risks – Business Risks
Key Risks – Business Risks (cont’d) The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change, in Australia, the United States and elsewhere, and there are no guarantees about Opthea’s ability to successfully compete. Opthea's
Slide 35: Key Risks – Business Risks
Key Risks – Business Risks (cont’d) Joint venture parties, Opthea is unable to predict the risk of financial failure or default by a participant in any joint venture to which Opthea may become a party or the insolvency or managerial failure by any agents, suppliers, of the contractors used by Opthea
Slide 36: Key Risks – Offer and General Risks
Key Risks – Offer and General Risks Offer and General Risks The market price of Opthea shares will fluctuate due to various factors, many of which are non-specific to Opthea and beyond the control of Opthea, including recommendations by Share price fluctuations brokers and analysts, Australian and i
Slide 37: Key Risks – Offer and General Risks
Key Risks – Offer and General Risks (cont’d) Opthea prepares its general purpose financial statements in accordance with Australian International Financial Reporting Standards (AIFRS) and the Corporations Act 2001 (Cth), which Accounting standards may differ significantly from the accounting standar
Slide 38: 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 d
Slide 39: Summary of underwriting agreement
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
Slide 40: Summary of underwriting agreement
Summary of underwriting agreement (cont’d) (compliance): − a contravention by Opthea or any member of the 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 or
Slide 41: 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 42: Foreign Selling Restrictions
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
Slide 43: Megan Baldwin, PhD and Timothy Morris contact details
Megan Baldwin, PhD Timothy Morris CEO and Managing Director CFO Opthea Limited Opthea Limited Level 4, 650 Chapel Street 103 Carnegie Center, Suite 300 South Yarra 3141 Princeton, New Jersey, Victoria, Australia 08540 U.S.A. P: +61 9826 0399 M: +61 447 788 674 M: +1 650 400 6874 E: megan.baldwin@opt