Opthea Limited has warned investors that it may face solvency issues after one of its key clinical trials for a macular degeneration treatment failed, potentially triggering repayment obligations of more than US$1 billion.
The biotechnology company, 30% owned by Regal Funds Management, is running two Phase 3 trials of its lead drug, sozinibercept, for treating wet age-related macular degeneration.
The first to report results, the Coast trial, tested the drug alongside aflibercept over one year.
Last week, Opthea requested a trading halt. On Monday, it stated: “The trial did not meet its primary endpoint of mean change in best-corrected visual acuity from baseline to week 52.
“Following the receipt of these results, Opthea has undertaken a thorough review of the data to ensure both its accuracy and integrity,” the company said.
“No anomalies were identified through this process that would cause the board to adopt an alternative view on the data outlined above.”
The result places pressure on the company’s financial position, given the terms of its funding agreements.