Opthea(OPT) Newsfilter·2025-03-24 04:01Core Viewpoint - Opthea Limited's Phase 3 clinical trial COAST for treating wet age-related macular degeneration (wet AMD) failed to meet its primary endpoint, raising concerns about the company's future and obligations under its Development Funding Agreement [1][2][5]. Group 1: Trial Results - The COAST trial evaluated the efficacy and safety of sozinibercept in combination with aflibercept, but did not achieve the primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52 [2]. - In patients with minimally classic and occult lesions, the mean change in BCVA was 13.2 letters for both dosing regimens (every four weeks and every eight weeks) compared to 13.8 letters for aflibercept monotherapy [3]. - The overall population showed a mean change in BCVA of 13.5 letters for the four-week regimen and 12.8 letters for the eight-week regimen, versus 13.7 letters for aflibercept monotherapy [3]. Group 2: Financial and Operational Impact - Following the negative trial results, Opthea is assessing its rights and obligations under the Development Funding Agreement, which may require significant payments to investors, potentially impacting the company's solvency [5][9]. - The potential repayment amounts under the DFA could range from US680 million, depending on various termination triggers [5]. - Opthea's management is in discussions with DFA Investors to explore options for the clinical trial program and to identify a favorable outcome for the company and its shareholders [6]. Group 3: Current Financial Status - As of February 28, 2025, Opthea reported an unaudited cash and cash equivalents balance of US$113.8 million [8]. - The company has requested a suspension of trading in its securities on both ASX and Nasdaq until further clarity on its situation can be provided [10].