Opthea axes wet AMD program, slashes workforce after trial failures

Opthea Limited has ceased development of sozinibercept for wet AMD following the failure of its two pivotal Phase 3 clinical trials, COAST and ShORe, to meet primary and secondary endpoints in March 2025. This decision, made in consultation with Development Funding Agreement (DFA) investors, led to immediate cash preservation measures including an 80% workforce reduction and a 50% decrease in its Board of Directors. The company also renegotiated its DFA, agreeing to a settlement of $20 million cash payment and 9.99% equity stake (136,661,003 ordinary shares) to DFA Investors, releasing all liens and obligations.

The company recorded a net loss of $162,791 for the year ended June 30, 2025, and a net current liability of $201,069, with cash balances reduced to $48,443. Opthea plans to undertake a full strategic review, focusing on reformulating its anti-VEGF compounds to treat other VEGF-C/D and R3 mediated diseases, with estimated costs for the initial phase up to $10 million and a second phase ranging from $5 to $8 million.

The strategic review and potential future clinical trials introduce material uncertainty regarding Opthea’s ability to continue as a going concern, despite having estimated cash reserves sufficient to fund operations into the fourth calendar quarter of 2026.