Opthea Limited , a clinical-stage biopharmaceutical company pioneering treatments for retinal diseases, has announced the receipt of an A$15.9 million (US$10.4 million) research and development (R&D) tax incentive from the Australian Taxation Office. The incentive, for expenses incurred during the 2023/2024 financial year, strengthens Opthea’s cash reserves as it progresses its Phase 3 clinical trials for sozinibercept.

Significant Tax Incentive Supports Phase 3 Clinical Advancements

The R&D tax credit covers both Australian and eligible overseas expenditures related to sozinibercept, Opthea’s lead candidate. This funding comes under the Australian Federal Government’s R&D Tax Incentive program, offering a 43.5% reimbursement of qualified R&D spending. The reimbursement was previously disclosed in Opthea’s financial statements as a tax receivable at June 30, 2024.

CEO Highlights Financial and Clinical Progress

Frederic Guerard, PharmD, Opthea’s CEO, commented:
“The A$15.9 million R&D tax incentive significantly enhances our financial position as we continue advancing pivotal Phase 3 clinical trials. We remain on track to deliver topline results for the COAST trial in early Q2 2025 and the ShORe trial by mid-2025, driving our commitment to developing transformative therapies for wet AMD.”

Advancing Therapies for Retinal Diseases

Opthea’s lead product, sozinibercept, is under evaluation in two fully enrolled Phase 3 trials—COAST and ShORe—designed to improve treatment efficacy when combined with standard anti-VEGF therapies. These trials target improved visual outcomes for patients suffering from wet AMD, a prevalent and progressive retinal disease.

Strategic Focus Amid Inherent Challenges

While Opthea celebrates its financial and clinical advancements, it remains aware of the inherent risks in biotechnology, including the uncertainties of clinical trial success, regulatory approvals, and intellectual property protections. The company advises investors to consider these risks and seek professional guidance.

Looking Ahead: A Transformative Year for Opthea

With key clinical milestones approaching, including topline data from two pivotal trials, Opthea is poised to advance its vision of revolutionizing retinal disease treatment. The R&D tax incentive reinforces the company’s ability to achieve these goals while preparing for regulatory submissions and commercial readiness.