Spero Therapeutics ((SPRO)) has held its Q2 earnings call. Read on for the main highlights of the call.
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Spero Therapeutics’ recent earnings call painted a generally positive picture, highlighting significant progress in their clinical trials and strategic partnerships. The company reported a successful Phase III trial for Tebipenem HBr and a robust collaboration with GSK, although they faced a setback with the SPR720 program.
Successful Phase III PIVOT-PO Trial for Tebipenem HBr
The Phase III PIVOT-PO trial for Tebipenem HBr, aimed at treating complicated urinary tract infections (cUTIs), was a major highlight of the earnings call. The trial was stopped early due to efficacy, having met its primary endpoint and demonstrating non-inferiority to intravenous imipenem-cilastatin. This success underscores the potential of Tebipenem HBr as a viable oral treatment option for cUTIs.
Regulatory and Commercialization Plans with GSK
Spero Therapeutics and its partner GSK are gearing up to submit the PIVOT-PO trial results to the FDA by the end of 2025. This submission could lead to FDA action in the second half of 2026. The collaboration with GSK could also bring in up to $351 million in contingent milestones, marking a significant financial opportunity for Spero.
Extended Cash Runway
The early stopping of the PIVOT-PO trial has resulted in cost savings, extending Spero’s cash runway into 2028. This financial stability is crucial for the company as it continues to advance its clinical programs and pursue regulatory approvals.
Increased Revenue with Reduced Net Loss
Spero reported a revenue increase to $14.2 million in Q2 2025, up from $10.2 million in Q2 2024. Additionally, the net loss decreased significantly to $1.7 million from $17.9 million in the same period last year. This improvement is largely attributed to collaboration revenue from GSK.
SPR720 Trial Did Not Meet Primary Endpoint
The earnings call also addressed the setback in the SPR720 program. The Phase IIa proof-of-concept study did not meet its primary endpoint, with potential dose-limiting safety signals observed, including reversible grade 3 hepatotoxicity in the high-dose cohort. This presents a challenge that Spero will need to navigate carefully.
Forward-Looking Guidance
Looking ahead, Spero Therapeutics remains optimistic about their lead clinical program, Tebipenem HBr. The company plans to present the full results of the PIVOT-PO trial at a scientific conference, with GSK preparing for an FDA submission by the end of 2025. Financially, Spero is in a strong position with a cash runway extended into 2028, bolstered by collaboration revenue and milestone payments from GSK.
In summary, Spero Therapeutics’ earnings call reflected a positive outlook, driven by the successful Phase III trial for Tebipenem HBr and strategic collaboration with GSK. Despite challenges with the SPR720 program, the company is well-positioned financially and strategically to advance its clinical programs and achieve regulatory milestones.