Full Press Release Details
Equity Raising Presentation
Institutional Placement and Accelerated Non-Renounceable Entitlement Offer ("ANREO") August 2023 OPTHEA.COM | @OptheaLimited | ASX (OPT.AX); NASDAQ: OPT Exhibit 99.1
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 access the presentation in accordance with the restrictions below and agree to be bound by the limitations contained within it. This presentation is dated 24 August 2023 and has been prepared by Opthea Limited (ABN32 006 340
567) ("Company" or "Opthea") in relation to: a placement of new fully paid ordinary shares in the Company ("New Shares") to certain eligible institutional investors ("Placement"); and an accelerated
non-renounceable entitlement offer of New Shares to be made to existing eligible shareholders of Opthea ("Entitlement Offer"), the Placement and Entitlement Offer together, the "Offer". For every two (2) New Shares issued
under the Offer, one (1) option will be issued. The option will have an exercise price of A$0.80 and an expiry date of 31 August 2025 ("New Options"). Application will be made for the options to be quoted on ASX. The Company reserves the
right to withdraw, or vary the timetable for, the Offer without notice. Summary information This presentation contains summary information about the Company and its activities and is current as at the date of this presentation. The information in
this presentation is of a general nature and does not purport to be complete nor does it provide or contain all the information that would be required in a prospectus or other disclosure document prepared in accordance with the requirements of the
Corporations Act 2001 (Cth) ("Corporations Act"), or that an investor should consider when making an investment decision. No representation or warranty, express or implied, is provided in relation to the accuracy or completeness of the
information. Statements in this presentation are made only as of the date of this presentation unless otherwise stated and the information in this presentation remains subject to change without notice. The Company is not responsible for updating,
nor undertakes to update, this presentation. It should be read in conjunction with the Company's other periodic and continuous disclosure announcements lodged with the Australian Securities Exchange ("ASX"), which are available at
www.asx.com.au, and with the U.S. Securities and Exchange Commission (the "SEC"), which are available at www.sec.gov. The Company has also prepared a target market determination in respect of the New Options which is available on the
Company's website at https://opthea.com/. This presentation may also include information derived from public or third-party sources, including public filings, research, surveys or studies conducted by third parties, including industry or
general publications and other publicly available information, that has not been independently verified. Neither Opthea nor any of its subsidiaries or any of the respective directors, officers, employees, representatives, agents or advisers of
Opthea or its subsidiaries ("Opthea Related Persons") makes any representation or warranty with respect to the fairness, accuracy, completeness or adequacy of such information. Not financial product advice This presentation is for
information purposes only and is not a prospectus, product disclosure statement or other offer document under Australian law or the law of any other jurisdiction. This presentation has not been, nor will it be, lodged with the Australian Securities
and Investments Commission ("ASIC"). This presentation is not a financial product or investment advice, a recommendation to acquire New Shares, New Options or accounting, legal or tax advice. It has been prepared without taking into
account the objectives, financial or tax situation or needs of individuals. Any references to, or explanations of, legislation, regulatory issues or any other legal commentary (if any) are indicative only, do not summarize all relevant issues and
are not intended to be a full explanation of a particular matter. You are solely responsible for forming your own opinions and conclusions on such matters and the market, and for making your own independent assessment of the information in this
presentation. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial and tax situation and needs, and seek legal, taxation and other
professional advice appropriate to their circumstances. The Company is not licensed to provide financial product advice in respect of its securities. Cooling off rights do not apply to the acquisition of New Shares or New Options. Effect of rounding
A number of figures, amounts, percentages, estimates, calculations of value and fractions in this presentation are subject to the effect of rounding. Accordingly, the actual calculation of these figures may differ from the figures set out in this
presentation. Past performance Information relating to past performance and activities included in this presentation is given for illustrative purposes only and should not be relied upon as (and is not) an indication of the Company's views on
its future performance or condition. Investors should note that past performance, including the past share price performance of Opthea, cannot be relied upon as an indicator of (and provides no guidance as to) future performance, including future
share price performance. The historical information included in this presentation is, or is based on, information that has previously been released to the market and is not represented as being indicative of Opthea's views on its future
financial condition and/or performance. Trademarks and trade names This presentation may contain trademarks and trade names of third parties, which are the property of their respective owners. Third party trademarks and trade names used in this
presentation belong to the relevant owners and use is not intended to represent sponsorship, approval or association by or with any of Opthea or the Extended Parties (defined below). 2
Important Notice and Disclaimer
Financial data All dollar values are in United States dollars ($ or US$) unless stated otherwise. This presentation includes pro forma financial information which is provided for illustrative purposes only and is not represented as being indicative
of the Company's (or anyone else's) views on the Company's future financial position or performance. The pro-forma financial information included in this presentation is for illustrative purposes and does not purport to be in compliance
with Article 11 of Regulation S-X of the rules and regulations of the U.S. Securities and Exchange Commission. Any conversion of amounts in US$ to amounts in A$ has been conducted at the exchange rate of 0.64. Preliminary Financial Information
Throughout this presentation, we have presented certain preliminary estimated unaudited financial results and other data as of and for the fiscal year ended June 30, 2023, including preliminary estimated cash and cash equivalent amounts as of June
30, 2023. The estimated results are not a comprehensive statement of our results as of and for the fiscal year ended June 30, 2023, and our actual results may differ materially from these preliminary estimated results. Our actual results remain
subject to the completion of management's and our audit and risk committee's reviews and our other financial closing processes. During the course of the preparation of our consolidated financial statements and related notes and the
completion of the audit for the fiscal year ended June 30, 2023, additional adjustments to the preliminary estimated financial information presented in this presentation may be identified, and our final results for these periods may vary from these
preliminary estimates. The preliminary estimated unaudited financial and other data contained in this presentation have been prepared in good faith by, and are the responsibility of, management based upon our internal reporting as of and for the
fiscal year ended June 30, 2023. Deloitte Touche Tohmatsu, our independent registered public accounting firm, has not audited, reviewed, compiled or performed any procedures with respect to such preliminary data. Accordingly, Deloitte Touche
Tohmatsu does not express an opinion or any other form of assurance with respect thereto. Future performance / forward-looking statements This presentation contains certain forward-looking statements. The words "expect", "anticipate", "estimate",
"intend", "believe", "guidance", "should", "could", "may", "will", "predict", "plan" and other similar expressions are intended to identify forward-looking statements. Indications of, and guidance on, future financial position and performance
including the preliminary estimated unaudited financial information and pro forma data, are also forward-looking statements. Forward-looking statements in this presentation include statements regarding the timetable, conduct and outcome of the Offer
and the use of the proceeds thereof, the therapeutic and commercial potential and size of estimated market opportunity of the Company's product in development, the viability of future opportunities, future market supply and demand, the
expected receipt of payments (including the additional potential increase of US$50 million of funding under the Development Funding Agreement ("DFA")) and the timing of such payments, the expected cash runway, the expected timing of
completion of patient enrollment under the clinical trials and timing of top-line data, expectations about topline data based on masked pooled data, the financial condition, results of operations and businesses of Opthea, certain plans, objectives
and strategies of the management of Opthea, including with respect to the current and planned clinical trials of its product candidate, and the future performance of Opthea. Forward-looking statements, opinions and estimates provided in this
presentation are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements, including
projections, guidance on the future financial position of the Company including the preliminary estimated unaudited financial information and pro forma data, are provided as a general guide only and should not be relied upon as an indication or
guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment
and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to the risks described in this
presentation under "Key Risks", including risks associated with: the availability of funding, the receipt of funding under the DFA (including the additional potential increase of US$50 million of funding under the DFA), future capital
requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate OPT-302 safety, tolerability and therapeutic efficacy,
additional analysis of data from Opthea's Phase 3 clinical trials once unmasked, timing of completion of Phase 3 clinical trial patient enrollment and CRO and labor costs, intellectual property protections, the successful completion of the
Offer, completion of management's and the Company's audit and risk committee's review and the Company's other closing processes, and other factors that are of a general nature which may affect the future operating and
financial performance of the Company. No representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking statement by any person (including the Company and Opthea Related Persons). In particular, no
representation, warranty or assurance (express or implied) is given that the occurrence of the events expressed or implied in any forward-looking statements in this presentation will actually occur. Actual results, performance or achievement may
vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. The forward-looking statements in this presentation speak only as of the date of this presentation. Subject to any
continuing obligations under applicable law or any relevant ASX listing rules, the Company and Opthea Related Persons disclaim any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this presentation
to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based. Nothing in this presentation will create an implication that there has
been no change in the affairs of Opthea since the date of this presentation.
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 unknown risks, many of which are beyond the control of Opthea. Opthea does not guarantee any particular rate of return on the New Shares, New Options or their respective performance, nor does it guarantee any particular tax
treatment. In considering an investment in New Shares and New Options, investors should have regard to (among other things) the risks and disclosures outlined in this presentation, including the "Key Risks" section of this presentation,
before making an investment decision, and should consult their professional adviser(s) if they are in any doubt about what to do. Not an offer This presentation is not a disclosure document and should not be considered as investment advice. This
presentation is for information purposes only and should not be considered an offer or an invitation to acquire, or a solicitation or recommendation in relation to the subscription, purchase or sale of Company securities (including the New Shares
and New Options to be offered and sold in the Offer) or any other financial products and does not and will not form any part of any contract for the acquisition of New Shares or New Options. This presentation does not constitute an offer to sell, or
the solicitation of an offer to buy, any securities in the United States or any other jurisdiction in which such an offer would be illegal or impermissible. The New Shares and New Options to be issued in the Offer have not been, and will not be,
registered under the U.S. Securities Act of 1933, as amended (the "Securities Act") or the securities laws of any state or other jurisdiction of the United States. The New Shares and New Options to be issued in the Offer may not be
offered and sold to, directly or indirectly, any person in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act and applicable U.S. state securities
laws. The release, publication or distribution of this presentation (including an electronic copy) in other jurisdictions outside Australia may also be restricted by law and any such restrictions should be observed. If you come into possession of
this presentation, you should observe such restrictions and should seek your own advice on such restrictions. Any failure to comply with such restrictions may constitute a violation of applicable securities laws. Refer to the "Foreign Selling
Restrictions" section of this presentation for more information. By accepting this presentation you represent and warrant that you are entitled to receive such presentation in accordance with the above restrictions and agree to be bound by the
limitations contained herein. Disclaimer The lead manager and underwriter of the Offer ("Lead Manager"), nor any of the Company's advisers or any of their respective affiliates, related bodies corporate, directors, officers,
partners, employees, agents and associates, have authorised, permitted or caused the issue, submission, dispatch or provision of this presentation and, except to the extent referred to in this presentation, none of them makes or purports to make any
statement in this presentation and there is no statement in this presentation which is based on any statement by any of them. To the maximum extent permitted by law, the Company, the Lead Manager, and their respective affiliates, related bodies
corporate, directors, officers, partners, employees, agents and advisers (the "Extended Parties"): (i) exclude and disclaim all liability, for any expenses, losses, damages or costs incurred by you as a result of your participation in
any offer of the New Shares and New Options and the information in this presentation being inaccurate or incomplete in any way for any reason, whether by negligence or otherwise; and (ii) make no representation or warranty, express or implied, as to
the currency, accuracy, reliability, timeliness or completeness of information in this presentation, or likelihood of fulfilment of any forward-looking statement or any event or results expressed or implied in any forward-looking statement. Pursuant
to ASX Listing Rule 7.2, the directors of the Company give notice that they reserve the right to issue any New Shares (and New Options) not issued in the Entitlement Offer ("Shortfall Shares") to new investors or existing shareholders
within 3 months of the close of the offer at a price no less than the Offer Price. The allocation of Shortfall Shares will be within the complete discretion of the Company, having regard to factors such as the Company's desire for an informed
and active trading market, its desire to establish a wide spread of shareholders, the size and type of funds under management of particular investors, the likelihood that particular investors will be long-term shareholders, and any other factors the
Company considers appropriate. You acknowledge and agree that determination of eligibility of investors for the purposes of the Offer is determined by reference to a number of matters, including legal requirements and the discretion of the Company
and the Lead Manager and each of the Company and the Lead Manager (and their respective Extended Parties) disclaim any duty or liability (including for negligence) in respect of the exercise or otherwise of that discretion, to the maximum extent
permitted by law. Further, you acknowledge and agree that any allocation of New Shares (and New Options) (other than pursuant to an entitlement under the Entitlement Offer) is at the sole discretion of the Company and the Lead Manager and each of
the Company and the Lead Manager (and their respective Extended Parties) disclaim any duty or liability (including for negligence) in respect of the exercise or otherwise of that discretion, to the maximum extent permitted by law. The Company and
the Lead Manager reserve the right to change the timetable in their absolute discretion including by closing the Offer early, withdrawing the Offer entirely or extending the Offer closing time (generally or for particular investor(s)) in their
absolute discretion (but have no obligation to do so), without recourse to them or notice to you. Acceptance By attending a presentation or briefing, or accepting, accessing or reviewing this presentation, you acknowledge and agree to the terms set
out in this important notice and disclaimer, including any modifications to them.
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 Current Corporate Focus 29 Key Risks 31 Summary of underwriting agreement 38 Foreign Selling Restrictions 41
Opthea Business Snapshot Opthea
Limited Public company listed on ASX (ASX:OPT; Nasdaq:OPT) developing sozinibercept (OPT-302) for wet Age-related Macular Degeneration ("AMD") Market capitalization prior to capital raise of approximately A$280M at 23 August 2023 and
cash on hand of US$89M at 30 June 2023 (unaudited) OPT-302 has a novel mechanism of action OPT-302 is a trap' inhibitor of VEGF-C and VEGF-D designed specifically for the eye In combination with anti-VEGF-A therapies, blocks VEGFR-2 and
VEGFR-3 activity Targets mechanisms of resistance and sub-optimal clinical response to existing therapies Large commercial potential Current and growing market opportunity estimated at >US$8B+ worldwide for wet AMD OPT-302 being developed for use
in combination with any of the existing anti-VEGF-A agents, biosimilars or novel therapies in development for wet AMD A novel approach seeking to provide additional visual acuity benefit over standard of care Potential future extension to Diabetic
Macular Edema ("DME"), Retinal Vein Occlusion ("RVO") and other retinal clinical pathologies Primary endpoint met in Phase 2b study of OPT-302 in wet AMD OPT-302 combination therapy demonstrated superiority in visual acuity
over ranibizumab (Lucentis ) alone at 24 weeks in an international, randomized, controlled, double-masked trial of 366 patients Secondary endpoint results also supportive of primary outcome Pre-specified sub-group analyses suggest greater
activity of OPT-302 in lesion-types considered more difficult to treat with anti-VEGF-A therapy and highest unmet need Intellectual property covering OPT-302 to 2034 Granted patents in the USA (2), Europe (validated in all countries), Australia,