Sparks - Basilea Pharmaceutica

Basilea Pharmaceutica has received a second $6m non-dilutive BARDA R&D tranche to support the advancement of its oral beta-lactam/beta-lactamase inhibitor candidate, ceftibuten–ledaborbactam (CTB-LEDA), into Phase III for complicated urinary tract infections, including pyelonephritis. This forms part of the $159m BARDA agreement signed in September 2025 by Basilea (novating the original BARDA deal with the licensor Venatorx), designed to fund Phase III regulatory activities and pre-launch preparation. Following the initial $6m recognised in FY25, up to $147m remains available, which can be secured on achieving certain predefined milestones. Phase III initiation is guided for Q127, with top-line data expected in early 2029. Management indicates the BARDA contract should fully cover late-stage development, materially reducing internal cash requirements and execution risk.

CTB-LEDA targets multi-drug-resistant Enterobacterales, a setting with no effective oral therapies, supporting its positioning as a potential carbapenem step-down option with attractive stewardship and commercial dynamics. With  Qualified Infectious Drug Product and Fast Track designations from the FDA and late-stage preparations underway, we view the programme as an increasingly important long-term value driver, alongside Zevtera and fosmanogepix.