Full Press Release Details
ASX and Media Release
Opthea Receives A$6.6 m
Melbourne, Australia; 24 January 2022 Opthea Limited (ASX:OPT; Nasdaq:OPT), a clinical stage
biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced that it has received a A$6.6 million (US$4.9 million) research and development (R&D) tax credit from the
Australian Taxation Office. The cash incentive is for research and development costs incurred in the 2020/2021 financial year, and represents the amount disclosed in the company s audited financial statements at 30 June 2021.
The R&D tax incentive credit relates to both Australian and eligible overseas expenditure for the development of Opthea s lead candidate OPT-302. The R&D Tax Incentive is as an Australian Federal Government program under which companies can receive cash incentives for 43.5% of eligible research and development expenditure.
Dr Megan Baldwin, CEO & Managing Director of Opthea, commented, This R&D tax incentive credit of A$6.6 million further strengthens our
balance sheet as Opthea continues global patient recruitment in our pivotal Phase 3 ShORe and COAST clinical trials of OPT-302 in wet AMD.
Opthea (ASX:OPT; Nasdaq:OPT) is a
biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD)
and diabetic macular edema (DME). Opthea s lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with
anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone.
Inherent risks of Investment in Biotechnology Companies
There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is
designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent
applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea
are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and
manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.
Forward-looking statements
Certain statements in this
announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking
statement and should be considered an at-risk statement, including, but not limited to, the advancement of Opthea s Phase 3 registrational program and commercialization efforts for OPT-302 and Opthea s goal of building out a substantial presence in the United States. Such statements are based on Opthea s current plans, objectives, estimates, expectations, and intentions and are
subject to certain risks and uncertainties,
Street, South Yarra, Victoria 3141 Australia T +61 (3) 9826 0399 F +61 (3) 9824 0083
www.opthea.com ABN 32 006 340 567
including risks and uncertainties associated with clinical trials and product development and the impact of general economic, industry or political conditions in Australia, the United States or
internationally. These and other risks and uncertainties are described more fully in the section titled Risk Factors in Opthea s Annual Report on Form 20-F filed with the SEC on
October 28, 2021. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue
reliance on these forward-looking statements as predictions of future events, which statements apply only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement.
Authorized for release to ASX by Megan Baldwin, CEO & Managing Director
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Street, South Yarra, Victoria 3141 Australia T +61 (3) 9826 0399 F +61 (3) 9824 0083
www.opthea.com ABN 32 006 340 567