Spero Therapeutics Announces Fourth Quarter and Full Year 2025 Operating Results and Provides a Business Update

Core Viewpoint - Spero Therapeutics reported significant financial progress in 2025, highlighted by the resubmission of the New Drug Application (NDA) for tebipenem HBr, an investigational oral antibiotic for complicated urinary tract infections (cUTI), with a decision from the FDA expected by June 18, 2026 [2][5][6]. Financial Results - For Q4 2025, Spero reported a net income of $31.5 million, a turnaround from a net loss of $20.9 million in Q4 2024, resulting in a diluted net income per share of $0.53 compared to a diluted net loss per share of $(0.38) in the previous year [6][19]. - Total revenue for Q4 2025 was $41.3 million, up from $15.0 million in Q4 2024, primarily driven by increased collaboration revenue from agreements with GSK and Pfizer [6][7]. - For the full year 2025, total revenue reached $66.8 million, compared to $48.0 million in 2024, again largely due to collaboration revenue [7]. Research and Development - Research and development expenses for Q4 2025 were $5.6 million, significantly lower than $28.8 million in Q4 2024, with full-year expenses at $38.5 million compared to $96.8 million in 2024, reflecting decreased clinical trial activity [13]. - General and administrative expenses for Q4 2025 were $4.3 million, down from $7.1 million in Q4 2024, with full-year expenses at $21.2 million compared to $23.7 million in 2024, attributed to reduced legal and personnel costs [13]. Cash Position - As of December 31, 2025, Spero had cash and cash equivalents of $40.3 million, which are estimated to be sufficient to fund operations into 2028 [5][13]. - In Q1 2026, Spero received a $25 million milestone payment from GSK related to the NDA resubmission for tebipenem HBr [13]. Tebipenem HBr Program Update - Tebipenem HBr is being developed as an oral alternative to intravenous carbapenems for treating cUTI, including pyelonephritis, with GSK holding the exclusive license for commercialization in most territories [3][6]. - The NDA resubmission is supported by positive results from the Phase 3 PIVOT-PO trial, which demonstrated non-inferiority to intravenous imipenem-cilastatin [6].