Opthea (ASX:OPT) has reported negative outcomes from its pivotal Phase 3 clinical trial involving the combination of its sozinibercept with Bayer's EYLEA (aflibercept) for treating wet age-related macular degeneration.
The company said the combination did not meet the trial's primary endpoint of mean change in best-corrected visual acuity from baseline to week 52, compared to EYLEA monotherapy. It said there was no numerical difference observed in the key secondary endpoints.
Opthea, which remains in a trading halt, said it has undertaken a thorough review of the data to ensure its accuracy and integrity.
"No anomalies were identified through this process that would cause the Board to adopt an alternative view on the data outlined above," it said.
The company, led by former Medicines Australia board member Fred Guerard, has been assessing its rights and obligations under its Development Funding Agreement (DFA) with investors.
"In light of these updates, it is possible that under the DFA, Opthea could become required to pay amounts to the DFA Investors that would have a material adverse impact on the solvency of the company. As previously disclosed, certain instances and events may result upon the termination of the DFA, and upon such termination, Opthea will be obligated to pay the DFA Investors up to four multiples of the amounts paid to the Company under the DFA," it said.
"It should also be noted that the DFA Investors have security over the assets of Opthea in the form of an 'all assets' lien. As a result, Opthea is unable to incur further non-equity funding or dispose of its material assets without the prior consent of the DFA Investors," said the company.
The company said that while it has a cash equivalents balance of US$113.8 million, "In light of these matters, there remains material uncertainty as to Opthea's ability to continue as a going concern. As noted above, discussions with the DFA Investors are ongoing and Opthea cannot be certain as to the outcome of those discussions or when that outcome may become known."