Spero Reports $31.5M Q4 Net Income and Resubmits tebipenem HBr NDA for June Decision
Spero reported Q4 net income of $31.5M versus $20.9M loss a year earlier and full-year net income of $8.6M versus $68.6M loss, driven by $41.3M in Q4 collaboration revenue. The company resubmitted tebipenem HBr NDA with a June 18 PDUFA date and holds $40.3M cash runway into 2028.
1. Financial Results
In Q4 2025 Spero reported net income of $31.5 million compared to a $20.9 million loss in Q4 2024, with revenue increasing to $41.3 million from collaboration agreements. For the full year, Spero posted net income of $8.6 million versus a $68.6 million loss, driven by reduced R&D and G&A expenses.
2. NDA Resubmission and PDUFA Update
Spero and partner GSK resubmitted the tebipenem HBr NDA in December 2025 for treating complicated urinary tract infections, with the FDA setting a PDUFA date of June 18, 2026. This submission follows a Phase 3 PIVOT-PO trial that demonstrated non-inferiority to IV imipenem-cilastatin and showed a favorable safety profile.
3. Cash Position and Outlook
As of December 31, 2025, Spero held $40.3 million in cash and cash equivalents, sufficient to fund operations into 2028. In Q1 2026, the company received a $25 million milestone payment from GSK, reflecting progress under the licensing agreement.