Opthea Limited (OPT), a biopharmaceutical firm, has decided to discontinue its Phase 3 clinical program for sozinibercept in treating wet age-related macular degeneration (wet AMD). This decision follows the failure of the COAST trial, announced earlier, and accelerated topline results from the ShORe trial, which also did not meet its primary endpoint. The ShORe trial evaluated sozinibercept in combination with ranibizumab but failed to demonstrate a significant improvement in visual acuity compared to ranibizumab alone.
The company and its Development Funding Agreement (DFA) investors have agreed to terminate both the COAST and ShORe trials with immediate effect. This decision does not trigger a termination event under the DFA, meaning Opthea does not immediately owe a payment. However, uncertainty remains regarding Opthea’s financial obligations under the DFA and its ability to continue as a going concern.
Opthea estimates its cash and cash equivalents at US$100 million as of the end of March 2025. Despite this, the company is actively discussing options with DFA investors to navigate its financial future. There remains a possibility that, under certain circumstances following a DFA termination, Opthea could be required to pay a multiple of the funded amount, which would materially impact the company’s solvency.
Trading of Opthea’s securities has been suspended by the ASX until further clarification on the company’s financial position and the outcome of discussions with DFA investors is provided. Opthea is currently relying on ‘safe harbour’ provisions under the Corporations Act 2001 (Cth).
Frederic Guerard, CEO of Opthea, expressed disappointment with the trial results and acknowledged the contributions of patients and clinical investigators. The company will continue discussions with DFA investors to determine the best path forward for Opthea and its shareholders.
