Spero Therapeutics Inc (SPRO) Q2 2025 Earnings Call Highlights: Tepipenem HBR Trial Success and ...

Yahoo

a day ago

Release Date: August 12, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
The phase 3 Pivot PO trial for tepipenem HBR in complicated urinary tract infections (CUTIs) met its primary endpoint and was stopped early for efficacy.
Tepipenem HBR demonstrated non-inferiority to intravenous imipenem cilastatin in hospitalized adult patients with CUTIs, including pyelonephritis.
The trial's early stopping for efficacy resulted in meaningful cost savings, extending Spero Therapeutics Inc (NASDAQ:SPRO)'s cash runway into 2028.
Spero Therapeutics Inc (NASDAQ:SPRO) reported an increase in total revenue for Q2 2025 to $14.2 million, up from $10.2 million in Q2 2024, primarily due to collaboration revenue from GSK.
The company achieved a significant reduction in R&D expenses, from $23.7 million in Q2 2024 to $10.7 million in Q2 2025, due to reduced clinical expenses related to the Pivot PO study.
Negative Points
The SPR 720 program did not meet its primary endpoint in a phase 2A proof of concept study for non-tuberculous mycobacterial pulmonary disease.
Potential dose-limiting safety signals were observed in the SPR 720 study, including cases of reversible grade 3 hepatotoxicity.
Spero Therapeutics Inc (NASDAQ:SPRO) reported a net loss of $1.7 million for Q2 2025, although this was an improvement from a $17.9 million loss in Q2 2024.
General and administrative expenses increased to $5.9 million in Q2 2025 from $5.5 million in Q2 2024, primarily due to increased personnel and professional services expenses.
The FDA action on the regulatory filing for tepipenem HBR is not expected until the second half of 2026, indicating a lengthy approval process.
Q & A Highlights
Warning! GuruFocus has detected 3 Warning Signs with SPRO.
Q: How is Spero Therapeutics planning to allocate capital moving forward? Will the focus be on business development or pipeline expansion? A: (Unidentified_6) Our primary objective is to ensure that Tepipenem HBR gets through the regulatory process and achieves approval, as this will be the main value driver. Our current financial runway is designed to support this goal. Once we have a clearer path to approval, we will make further decisions regarding capital allocation.
Q: Can you provide more details on the financial impact of the Pivot PO trial's early conclusion? A: (Esther Rajavello, CEO and CFO) The early conclusion of the Pivot PO trial for efficacy has resulted in significant cost savings, which we anticipate will extend our cash runway into 2028. This is primarily due to reduced clinical expenses as fewer patients were enrolled than initially planned.
Q: What are the next steps for SPR 720 following the phase 2A trial results? A: (Tim Kreutzer, COO) The phase 2A trial for SPR 720 did not meet its primary endpoint, and we observed potential dose-limiting safety signals. We have completed the assessment of the full data set and are currently determining the next steps for the program.
Q: What is the expected timeline for FDA action on Tepipenem HBR? A: (Esther Rajavello, CEO and CFO) We plan to work with GSK to include the Pivot PO data in an FDA filing by the end of 2025. We currently anticipate FDA action in the second half of 2026.
Q: How does Spero Therapeutics view the market potential for Tepipenem HBR? A: (Tim Kreutzer, COO) We believe Tepipenem HBR has the potential to significantly impact the treatment landscape for complicated urinary tract infections (CUTIs) by offering an oral alternative to the standard IV carbapenem therapy. This could represent a major clinical advance and provide economic benefits to the healthcare system.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.