Clinical TrialsThe Phase 3 trial of tebipenem in cUTI met its primary endpoint and was stopped early for efficacy.
Financial MilestonesSPRO will receive up to $351 million in additional development, sales, and commercial milestones, along with royalties on net product sales.
Operational ExpensesCash reserves, along with milestone payments from GSK, should provide operational expense coverage into 2028.
Regulatory ApprovalThe FDA has indicated that positive results from the PIVOT-PO trial, along with data from prior clinical trials, would be sufficient for approval of tebipenem in cUTI.