Tebipenem HBr (cUTI) - Tebipenem HBr is in Phase 3 clinical trials for complicated urinary tract infections (cUTI)[3] - The Phase 3 trial met its primary endpoint following a pre-specified interim analysis (IA) of data from 1,690 enrolled patients[18] - Approximately 2.9 million annual cUTI treatment episodes are attributed to $6+ billion in US healthcare costs[16] - Spero granted GSK an exclusive license for Tebipenem HBr (ex-Asia) and received $66 million upfront and $9 million in common stock investment[32] - Spero is eligible to receive up to $400 million in additional potential regulatory, commercial, and sales milestone payments, as well as royalties from GSK[32] - Spero qualified to receive $95 million in development milestones, with $23.75 million to be received in 2H 2025[33] SPR720 (NTM-PD) - The company has suspended its current development program for SPR720[6, 34] - An interim analysis of a Phase 2a oral study did not show sufficient separation from placebo, highlighting potential oral dose-limiting safety issues in subjects dosed at 1,000 mg orally once daily[37] Financial Foundation - Spero received $30 million upon SPA agreement with the FDA[33] - Spero to receive tiered low-single digit to low-double digit (if sales exceed $1 billion) tiered royalties on net product sales of Tebipenem HBr[33]
Spero Therapeutics (SPRO) Earnings Call Presentation