Opthea has completed the production of three consecutive commercial-scale drug substance batches required for the validation of the manufacturing process of sozinibercept. This is a step forward for a potential biologics license application (BLA) filing of sozinibercept in wet AMD. Recent weakness after a huge run-up in the shares seems to be a good entry point.
SUMMARY
Opthea Ltd (OPT AU) completed enrollment in two Phase 3 trials for sozinibercept in wet AMD. Topline data from these trials are expected by mid-2025.
During FY24, Opthea raised $295M to extend runway through topline data readouts of Phase 3 clinical trials. Further, in July, Opthea raised $38M through retail entitlement offer.
Although Opthea is well-funded through mid-2025, any fund requirement beyond that period will be easier to meet amid lower interest rate scenario.
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