60 Degrees Pharma withdraws COVID Phase IIB IND after FDA comments; will resubmit pending feasibility

60 DEGREES PHARMACEUTICALS, INC.

Withdrew IND for ACLR8-LR Phase IIB study of tafenoquine for COVID-19 due to FDA comments on study design.
Plans to submit revised IND in Q4 2023 pending assessment of feasibility to meet FDA expectations.
Paused start-up activities for the trial, decreasing short-term burn rate and improving cash position.
Will continue commercialization of ARAKODA (tafenoquine) for malaria and prepare IND for babesiosis.
Q2 2023 ARAKODA sales increased 150% YoY.

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