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Opthea Receives A$6.6 m R&D Tax Incentive

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Opthea Limited (ASX:OPT; Nasdaq:OPT) announced a A$6.6 million (US$4.9 million) research and development tax credit from the Australian Taxation Office. This credit pertains to R&D costs from the 2020/2021 financial year and strengthens the company's financial position as it advances global patient recruitment for its pivotal Phase 3 trials of OPT-302 in treating wet AMD. The R&D incentive supports both domestic and overseas expenditures, reflecting the company’s commitment to addressing retinal diseases.

Positive
  • Received A$6.6 million (US$4.9 million) R&D tax credit, strengthening balance sheet.
  • Supports development of lead candidate OPT-302 for wet AMD.
  • Highlights eligibility for 43.5% cash incentive on R&D expenditure.
Negative
  • Investment in drug development is highly speculative with inherent risks.
  • Clinical trials may fail to meet safety and efficacy criteria.

MELBOURNE, Australia, Jan. 24, 2022 (GLOBE NEWSWIRE) -- 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.”

About Opthea

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, 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

Company & Media Enquiries:Join our email database to receive program updates:
U.S.A. & International:
Sam Martin
Argot Partners
Tel: +1 212-600-1902
opthea@argotpartners.com

Australia:
Rudi Michelson
Monsoon Communications
Tel: +61 (0) 3 9620 3333
Tel: +61 (0) 3 9826 0399
info@opthea.com
www.opthea.com
  

FAQ

What is the recent R&D tax credit amount received by Opthea Limited?

Opthea Limited received a A$6.6 million (US$4.9 million) R&D tax credit.

How does the R&D tax credit impact Opthea's financial position?

The R&D tax credit strengthens Opthea's balance sheet, providing additional funds for clinical trials.

What is the purpose of the OPT-302 clinical trials?

The OPT-302 clinical trials aim to treat wet AMD in combination with anti-VEGF-A therapies.

What are the risks associated with investing in Opthea Limited?

Investing in Opthea is highly speculative, with risks including potential clinical trial failures and uncertain patent protections.

What percentage of R&D expenditures does the Australian government reimburse?

The Australian government reimburses 43.5% of eligible research and development expenditures.

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