Spero Therapeutics’ Q1 Loss Narrows to $7.2M as PDUFA Date Set June 18
Spero reported a Q1 net loss of $7.2 million, down from $13.9 million a year earlier, on $0.3 million revenue while R&D expenses fell to $2.9 million. Its NDA for oral carbapenem tebipenem HBr is under FDA review with a June 18 PDUFA date, and its cash runway extends into 2028.
1. Q1 Financial Results
Spero reported a first-quarter net loss of $7.2 million, or $0.13 per share, compared with a $13.9 million loss, or $0.25 per share, in Q1 2025. Revenue was $0.3 million, while R&D expenses declined to $2.9 million and general and administrative expenses decreased to $4.9 million.
2. Tebipenem HBr NDA Review
GSK submitted the NDA for oral tebipenem HBr in December 2025 for cUTI and pyelonephritis, with the FDA setting a PDUFA action date of June 18, 2026. The Phase 3 PIVOT-PO trial was halted early for efficacy, demonstrating non‐inferiority to IV imipenem‐cilastatin and a safety profile consistent with the carbapenem class.
3. Cash Position and Runway
As of March 31, 2026, Spero held $56.1 million in cash and cash equivalents, providing funding for operations into 2028 based on current spending forecasts.
4. Business Outlook
Spero plans to leverage GSK’s anti-infectives expertise if tebipenem HBr gains approval and is exploring opportunities to expand its clinical-stage pipeline with additional product candidates.