Financial StabilityCash of $48.9M, along with an upcoming $24M development milestone payment from GSK, should provide coverage for operational expenses.
Regulatory ApprovalThe FDA has indicated that positive results from PIVOT-PO and prior clinical trials would be sufficient to approve tebi for cUTI and limited use in acute pyelonephritis.
Trial ProgressThe Phase 3 trial of tebipenem in cUTI is ongoing, with potential for early trial completion if interim outcomes are favorable.