Opthea(US:OPT)2025-08-20 00:00Summary 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]