Opthea (OPT) H2 2024 earnings summary

Executive summary

• Advanced lead candidate sozinibercept (OPT-302) for wet AMD, completing enrollment in two pivotal Phase 3 trials (COAST and ShORe) with 1,984 patients globally.

• Raised nearly US$300 million through equity and non-dilutive financing to fund operations through topline Phase 3 data readouts and BLA preparations.

• Strengthened US-based leadership and Board, including new CEO, CFO, and Chief Medical Advisor appointments.

• Focused on commercial readiness, manufacturing scale-up, and regulatory preparations for potential FDA approval.

Financial highlights

• Revenue from ordinary activities: US$3.52 million, up 5.5% year-over-year.

• Net loss after tax: US$220.2 million, up 54.5% from prior year (2023: US$142.5 million).

• R&D expenditure: US$176.3 million (2023: US$128.8 million).

• Cash and cash equivalents at June 30, 2024: US$172.5 million (2023: US$89.2 million).

• Net tangible asset backing per share: (US$0.07) (2023: (US$0.01)).

Outlook and guidance

• Topline data from COAST expected in early Q2 2025 and from ShORe by mid-2025.

• Sufficient funding to support operations through topline data readouts; additional funds required for full trial completion, BLA filing, and commercialization.

• Focus on progressing CMC activities, BLA preparations, and building commercial infrastructure.