Skye Bioscience, Inc. has been advised by its contract manufacturer of its Phase 1 clinical trial material that a now-resolved cyber-attack on the CMO's computer systems as well as a planned annual maintenance shutdown will result in a delay in completing production of Skye's Phase 1 drug to the beginning of September. Skye now expects to initiate enrollment of its Phase 1 clinical study in Fourth Quarter 2022, report preliminary topline data in early First Quarter 2023, and report final data in Second Quarter 2023. Skye's SBI-100 Ophthalmic Emulsion had most recently been scheduled for production and fill in the first week of July.

While the CMO has sufficiently recovered from the recent cyber-attack, planned annual facility maintenance could not be rescheduled. The maintenance schedule has been accelerated and will be conducted through August 30. Skye's SBI-100 product is now planned to be produced and filled in the first week of September, with required drug quality testing completed by the first half of October.