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It mightn’t be too surprising Opthea (ASX:OPT) applied for a voluntary suspension last week ahead of Monday’s Phase 3 trial results – they throw the future of the company into question.
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“[The] COAST Phase 3 trial failed to meet primary endpoint of mean change … from baseline,” the company wrote of its retinal disease trial.
The problem is, with a Development Funding Agreement backed by investors, the company is now unsure whether or not it has a future at all. Phase 3 trials are the be-all-end-all study that typically precedes an FDA approval.
Of course, they can precede an FDA rejection, too – and it’s looking like that’s what’s going to happen, given Opthea’s study combining its drug OPT-302, in conjunction with Afilbercept, hasn’t done anything good for people with wet age-related macular degeneration (‘wet AMD’).
“In light of these matters, there remains material uncertainty as to Opthea’s ability to continue as a going concern,” Opthea wrote on Monday.
“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.”
Dual-listed on the ASX and the NASDAQ, one can be sure that when trades start trading again, there’ll be a most-probably-dramatic price decline.
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Opthea is on the cusp of just dropping its wet AMD COAST trial together and then going back to square one. What that square one may be isn’t exactly clear.
That’s probably what they’re discussing with DFA Investors.
As for the FDA?
“Opthea’s Management and Board of Directors have been in active discussions with the DFA Investors, pursuant to and as required under the DFA, to explore possible options for Opthea in respect of its clinical trial program and with a view to identifying whether there is a pathway that represents the best outcome for the company and its shareholders,” Opthea clarified on Monday.
Typically, the U.S. health regulator isn’t known for investor relations advice, but here we are.
OPT last traded at 60cps.
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