Spero Therapeuti Stock Price, News & Analysis

Spero Therapeutics (NASDAQ: SPRO) reported third-quarter 2025 results and a business update on Nov 13, 2025. Key items: Phase 3 PIVOT-PO results for tebipenem HBr showed non-inferiority versus IV imipenem-cilastatin (58.5% vs 60.2% overall success; adjusted difference 1.3%; 95% CI: 7.5%, 4.8%). GSK plans an FDA submission in Q4 2025 with an anticipated regulatory decision in 2H 2026. The company discontinued the SPR720 program in Q3 2025. Financials: Q3 net loss $7.4M vs $17.1M year-ago; revenue $5.4M vs $13.5M; cash and cash equivalents $48.6M, expected to fund operations into 2028.

Spero Therapeutics (Nasdaq: SPRO) said it will report its third quarter 2025 financial results and provide a business update on Thursday, November 13, 2025 after the market close. The company noted it does not intend to host a conference call.

Spero is a clinical-stage biopharmaceutical company focused on novel treatments for rare diseases and multi-drug resistant bacterial infections.

Spero Therapeutics (NASDAQ: SPRO) and GSK reported positive Phase 3 PIVOT-PO results for oral tebipenem HBr in complicated urinary tract infections (cUTI), presented Oct 20, 2025 at IDWeek. The trial was stopped early for efficacy in May 2025 and met the primary endpoint of non-inferiority versus IV imipenem-cilastatin: overall success 58.5% (261/446) vs 60.2% (291/483); adjusted difference −1.3% (95% CI −7.5%, 4.8%). Clinical cure was 93.5% vs 95.2%; microbiological response ~60% in both arms. GSK plans to include data in a US filing in Q4 2025.

Spero Therapeutics (Nasdaq: SPRO) announced presentations on oral tebipenem Hbr at IDWeek, Oct 19–22, 2025 in Atlanta.

Company and partner GSK will present late-breaking Phase 3 PIVOT-PO results for tebipenem Hbr in complicated urinary tract infection (cUTI), including pyelonephritis. An oral presentation by David K. Hong is scheduled for Oct 20, 2025, 1:45–3:00 PM ET (Session: Late Breaking Trial Results). Two posters on tebipenem antibacterial activity vs Enterobacterales will be shown on Oct 21, 2025, 12:15–1:30 PM in Poster Hall B4–B5.

Spero Therapeutics (Nasdaq: SPRO) reported significant Q2 2025 developments, highlighted by the early termination of the PIVOT-PO Phase 3 trial for tebipenem HBr due to meeting efficacy endpoints in complicated urinary tract infection (cUTI) treatment. The trial demonstrated non-inferiority compared to intravenous treatment, with plans for FDA submission in H2 2025 alongside partner GSK.

The company reported Q2 2025 financial results with a reduced net loss of $1.7M (vs $17.9M in Q2 2024), revenue of $14.2M (up from $10.2M), and cash position of $31.2M. With GSK milestone payments, including $23.8M received in August 2025, Spero projects runway into 2028.

However, their SPR720 program for NTM-PD was suspended in Q4 2024 after failing to meet primary endpoints in Phase 2a trials. The company also announced leadership changes with Esther Rajavelu appointed as CEO in May 2025.

Spero Therapeutics (NASDAQ:SPRO), a clinical-stage biopharmaceutical company specializing in rare diseases and multi-drug resistant bacterial infections treatments, has scheduled its second quarter 2025 financial results conference call and webcast for Tuesday, August 12, 2025, at 4:30 p.m. ET.

During the call, management will present Q2 2025 financial results and provide a business update. Investors can access the call via phone (1-844-825-9789 domestic, 1-412-317-5180 international) using conference ID 10200686, or through the live audio webcast available on Spero's investor relations website.

Spero Therapeutics (NASDAQ: SPRO) and GSK announced the early termination of their Phase 3 PIVOT-PO trial for tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), due to meeting efficacy endpoints. The trial demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients. The study's safety profile aligned with previous findings, with diarrhea and headache as primary adverse events. If approved, tebipenem HBr would become the first oral carbapenem antibiotic for US cUTI patients. With an estimated 2.9 million cUTI cases annually in the US, contributing to over $6 billion in yearly healthcare costs, GSK plans to submit FDA filing in 2H 2025.

Spero Therapeutics (NASDAQ: SPRO) reported Q1 2025 financial results and provided key updates. The company posted a net loss of $13.9 million ($0.25 per share) compared to $12.7 million loss in Q1 2024. Total revenue decreased to $5.9 million from $9.3 million year-over-year. The company's lead candidate, tebipenem HBr, an oral carbapenem antibiotic for complicated urinary tract infections, is progressing with a pre-specified interim analysis of Phase 3 PIVOT-PO trial expected in Q2 2025. The company appointed Esther Rajavelu as President and CEO effective May 2, 2025. Spero ended Q1 with $48.9 million in cash, which, combined with $23.75M in upcoming GSK milestone payments, is expected to fund operations into Q2 2026. The SPR720 program for NTM-PD was suspended in Q4 2024 after failing to meet primary endpoints in Phase 2a study.

Spero Therapeutics (NASDAQ: SPRO), a clinical-stage biopharmaceutical company specializing in rare diseases and multi-drug resistant bacterial infections treatments, will release its first quarter 2025 financial results after market close on Tuesday, May 13, 2025. The company will also provide a business update but has stated it will not host a conference call for this earnings announcement.