Summary of Opthea Limited (OPT) Corporate Update Webcast Company Overview - **Company**: Opthea Limited (OPT) - **Date of Update**: August 19, 2025 - **Context**: The call discusses the results of phase three clinical trials and the company's future direction following disappointing trial outcomes. Key Points Industry and Clinical Trials - **Phase Three Trials**: The company conducted two pivotal trials, COAST and SHORE, comparing its drug sosinibrocept with existing treatments aflibercept (Eylea) and Lucentis [6][10] - **Primary Endpoint Failure**: Both trials did not meet their primary endpoint of demonstrating superior visual acuity improvement at week 52 compared to the control arms [21][22] - **Patient Population**: Approximately 300 patients were enrolled per arm, with baseline characteristics well balanced across different treatment groups [12][13] - **Results**: The control arm showed a 13.75 letter improvement, while the combination therapy with sosinibrocept did not show statistically significant improvement [14][20] - **Safety Profile**: Sosinibrocept was well tolerated, with similar adverse event rates compared to aflibercept and Lucentis, although there was a slight trend for increased inflammation with higher doses of sosinibrocept [18][22] Financial and Development Funding Agreement (DFA) - **DFA Overview**: In August 2022, the company entered a DFA with OSCELET, initially securing $120 million, later amended to a total of $170 million [24][25] - **Settlement with Investors**: Following negative trial results, the company negotiated a settlement with DFA investors, paying $20 million in cash and providing a 9.99% equity stake, terminating the DFA [27][28] - **Current Cash Position**: As of the update, the company has approximately $20 million in cash on hand and no debt [28][32] Future Strategy and Governance - **Streamlining Operations**: The company has reduced its workforce by over 80% and the board of directors by 50% to align with its current scale [26][33] - **Strategic Review**: A comprehensive strategic review will be undertaken over the next several months to assess internal capabilities and potential partnerships [36][62] - **Focus on Shareholder Return**: The board emphasizes maximizing shareholder return as a primary objective in future decisions [36][64] Additional Insights - **Clinical Trial Insights**: The duration of the trials and patient selection may have impacted outcomes, with suggestions that the phase 2b trial's shorter duration might not have fully informed the phase 3 results [43][44] - **Future Opportunities**: The company is exploring potential therapeutic areas beyond ophthalmology, leveraging its scientific knowledge and assets [48][50] - **R&D Tax Credit**: The company plans to submit for an R&D tax credit, which has not yet been received [55] Conclusion - **Outlook**: The company is positioned to navigate its challenges with a focus on governance, operational efficiency, and strategic partnerships, aiming to enhance shareholder value moving forward [36][39][74]