Opthea's Half-Year Financial Results and Business Updates

Opthea Limited (ASX: $OPT), a clinical-stage biopharmaceutical company, announced its half-year financial results for the six months ended December 31, 2023. The company reported cash and cash equivalents of $157.1 million as of December 31, 2023. Opthea also highlighted the completion of enrollment in its first pivotal Phase 3 trial (COAST) for sozinibercept, a potential treatment for wet age-related macular degeneration (wet AMD), in combination with EYLEAR (aflibercept). The company anticipates the enrollment completion of the second Phase 3 pivotal ShORe trial in the second quarter of CY 2024, with top-line Phase 3 results from the COAST and ShORe trials expected by mid-CY 2025.

Executive Commentary on Opthea's Progress

It is a transformative time for Opthea. We substantially advanced the development of sozinibercept, our lead product candidate for the treatment of wet age-related macular degeneration (wet AMD), expanded our U.S. leadership team, strengthened our clinical and regulatory organization, and received US$143 million in funding. We recently announced the completion of enrollment in our first pivotal Phase 3 trial (COAST), in combination with EYLEAR (aflibercept). We believe that sozinibercept has the potential to deliver superior vision gains for millions of people with wet AMD based on our Phase 2b trial results which demonstrated superior and statistically significant improvements in visual acuity for patients treated with sozinibercept in combination with LUCENTIS (ranibizumab). Sozinibercept therefore has the potential to be the first product in more than 15 years to improve the standard of care in wet AMD and make a tangible difference in the lives of patients. We are excited about Opthea's progress. Looking ahead, we expect to complete enrollment in our second Phase 3 trial (ShORe), in combination with the standard of care ranibizumab, in the second quarter of CY 2024. In addition, we intend to report the top-line data on the COAST and ShORe trials in mid-CY 2025. We are encouraged by the positive momentum in the sozinibercept program.

Summary of Opthea's Announcement

Opthea reported its half-year financial results and highlighted the completion of enrollment in its first pivotal Phase 3 trial (COAST) for sozinibercept, a potential treatment for wet age-related macular degeneration (wet AMD). The company also expanded its U.S. leadership team and received significant funding. Opthea anticipates completing enrollment in the second Phase 3 pivotal ShORe trial in the second quarter of CY 2024, with top-line Phase 3 results from the COAST and ShORe trials expected by mid-CY 2025. The company believes that sozinibercept has the potential to deliver superior vision gains for patients with wet AMD and aims to improve the standard of care in this area. Opthea's progress and anticipated milestones indicate a positive momentum in the development of sozinibercept, reflecting the company's ambitions and goals in addressing unmet needs in the treatment of retinal diseases.