SPRO

New Drug Application (NDA) for tebipenem HBr for complicated urinary tract infections (cUTI), including pyelonephritis, is under review at the FDA, with PDUFA date of June 18, 2026 Spero maintains its cash runway guidance into 2028 CAMBRIDGE, Mass., May 13, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced financial results for the first quarter ended March 31, 2026, and provided a business update. “We continue to make solid progress on the tebipenem HBr program alongside our licensing partner, GSK, as we prepare for the FDA’s decision expected in June,” said Esther Rajavelu, President and CEO of Spero Therapeutics. “With GSK's leadership in anti-infectives, tebipenem HBr, if approved, has the potential to meaningfully improve treatment options for cUTI patients. Looking ahead, we are positioning the company for the next phase by advancing other corporate activities, including exploring opportunities to grow our portfolio of clinical-stage product candidates.” Program Update Tebipenem HBr Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI, including pyelonephritis, to provide an effective oral therapeutic alternative to IV carbapenems. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories where Meiji holds development and commercialization rights. In February 2026, GSK announced that the U.S. Food and Drug Association (FDA) set the Prescription Drug User Fee Act (PDUFA) date to complete the review of the tebipenem HBr NDA as June 18, 2026. The NDA was submitted by GSK in December 2025, supported by results from the Phase 3 PIVOT-PO trial. The trial was stopped early for efficacy in May 2025, demonstrating non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized patients with cUTI, including pyelonephritis, based on the overall response (composite of clinical cure plus microbiological eradication of the bacteria causing the infection) at the test of cure visit. The safety and tolerability profile of tebipenem HBr in PIVOT-PO was consistent with results reported in other studies with tebipenem and in line with that of the ca...

CAMBRIDGE, Mass., May 05, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced that it will report its financial results for the first quarter ended March 31, 2026, and provide a business update on Wednesday, May 13, 2026, after market close. The Company does not intend to host a conference call. About Spero Therapeutics Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need. For more information, visit www.sperotherapeutics.com. Investor Relations Contact: Shai Biran, PhD Spero Therapeutics [email protected] Media Inquiries: [email protected]

Spero announced the resubmission of tebipenem HBr New Drug Application (NDA) to the FDA for complicated urinary tract infections (cUTI), including pyelonephritis in December 2025 In February, Spero’s licensing partner, GSK announced the FDA had set the PDUFA date as June 18, 2026 Spero estimates cash and cash equivalents as of December 31, 2025 are sufficient to fund current operations into 2028 CAMBRIDGE, Mass., March 26, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “2025 was marked by important progress across the tebipenem HBr program in cUTI, including completion of the global Phase 3 trial and resubmission of the NDA,” said Esther Rajavelu, President and CEO of Spero. “With our licensing partner GSK’s global leadership in anti-infectives, tebipenem HBr, if approved, has the potential to address an important need and meaningfully improve treatment options for patients with cUTI. We look forward to the FDA’s decision in late June as we continue to execute our business strategy to deliver innovative therapies.” Spero remains focused on completing its obligations under its License Agreement with GSK while advancing other corporate activities, including exploring opportunities to expand its portfolio of clinical-stage product candidates. Program Update Tebipenem HBr Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI, including pyelonephritis, to provide an effective oral therapeutic alternative to IV carbapenems. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories where Meiji holds development and commercialization rights. In December 2025, GSK resubmitted the tebipenem HBr NDA to the FDA. In February 2026, GSK announced that the FDA set the Prescription Drug User Fee Act (“PDUFA”) date as June 18, 2026. The NDA is supported by results from the successful Phase 3 PIVOT-PO trial that evaluated tebipenem HBr. The trial, which was stopped early for efficacy in May 2025, demonstrated non-inferiority of tebipenem HBr compared to intravenous imipe...

CAMBRIDGE, Mass., March 18, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2025, and provide a business update on Thursday, March 26, 2026, after market close. The Company does not intend to host a conference call. About Spero Therapeutics Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need. For more information, visit www.sperotherapeutics.com. Investor Relations Contact: Shai Biran, PhD Spero Therapeutics [email protected] Media Inquiries: [email protected]

Results from PIVOT-PO Phase 3 trial evaluating tebipenem HBr in complicated urinary tract infection (cUTI) presented as IDWeek late-breaker in October 2025 Spero’s development partner, GSK, plans to submit data from the PIVOT-PO trial as part of a planned US Food and Drug Administration (FDA) filing in 4Q 2025 Company expects current cash and cash equivalents to fund operations into 2028 CAMBRIDGE, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the third quarter ended September 30, 2025, and provided a business update. “We are pleased to have shared the Phase 3 PIVOT-PO study results for tebipenem HBr with the medical community at this year’s IDWeek conference in October,” said Esther Rajavelu, Chief Executive Officer of Spero. “We are working alongside our partner, GSK, to enable them to submit the FDA filing this quarter and we anticipate regulatory decision in 2H 2026. If approved, tebipenem HBr as an oral option could provide an important alternative to IV carbapenem therapies for complicated urinary tract infections, with the potential to shorten hospital stays and improve treatment burden for patients.” Pipeline Update Tebipenem HBr Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI, including pyelonephritis, to provide an effective oral therapeutic taken outside a hospital setting. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories where Meiji holds development and commercialization rights. In October 2025, results from the Phase 3 PIVOT-PO trial evaluating tebipenem HBr, were presented in a late-breaking oral abstract session at IDWeek 2025. The trial, which was stopped early for efficacy in May 2025, demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized patients with cUTI, including pyelonephritis, based on the overall response (composite of clinical cure plus microbiological eradication of the bacteria causing the infection) at the test of cure visit. Tebipenem HBr (oral, 600 mg) achieved a 58.5% overall success rate (261/446 participan...

CAMBRIDGE, Mass., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it will report its third quarter 2025 financial results and provide a business update on Thursday, November 13, after the market close. The Company does not intend to host a conference call. About Spero Therapeutics Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com Spero Investor Relations Contact: Shai Biran, PhD Spero Therapeutics [email protected] Spero Media Inquiries: [email protected]

PIVOT-PO Phase 3 trial evaluating tebipenem Hbr in complicated urinary tract infection (cUTI) patients stopped early for efficacy following review by independent data monitoring committee (IDMC) Spero, along with its development partner, GSK, plans to submit data from the PIVOT-PO trial as part of a planned US Food and Drug Administration (FDA) filing in 2H 2025 Existing cash and earned and non-contingent development milestone payments from GSK provide anticipated runway to fund the Company’s current operating expenses and capital expenditures into 2028 CAMBRIDGE, Mass., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. “During the second quarter, we announced that the tebipenem Phase 3 PIVOT-PO trial met its primary endpoint, marking a significant milestone for this program. We look forward to working with GSK on next steps for this program which include completion of the Phase 3 data analysis and submission of the data package to the FDA,” said Esther Rajavelu, Chief Executive Officer and Chief Financial Officer of Spero. “There remains a critical unmet need for an oral carbapenem to treat complicated urinary tract infections, including pyelonephritis. If approved, we believe tebipenem HBr could set a new standard of care for these infections, with the potential to shorten hospital stays, improve patient outcomes, and reduce pressure on healthcare resources.” Pipeline Update Tebipenem HBr Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI, including pyelonephritis, to help patients potentially reduce the duration of in-patient therapy. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories where Meiji holds development and commercialization rights. In May 2025, Spero and its development partner GSK announced that the Phase 3 PIVOT-PO trial met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis, on overall response (composit...

Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. 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. 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. 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...

CAMBRIDGE, Mass., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) a clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that management will host a conference call and live audio webcast on Tuesday August 12th, 2025 at 4:30 p.m. ET to report financial results for second quarter 2025 and provide a business update. To access the call, please dial 1-844-825-9789 (domestic) or 1-412-317-5180 (international) and refer to conference ID 10200686, or click on this link and request a return call with passcode 0605709. The audio webcast can be accessed live on this link and also on the “Investor Relations” page of the Spero Corporate Website at https://www.sperotherapeutics.com/. The archived webcast will also be available on Spero’s website for 30 days following the call. About Spero Therapeutics Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com Spero Investor Relations Contact: Shai Biran, PhD Spero Therapeutics [email protected] Spero Media Inquiries: [email protected]

Pre-specified interim analysis of the ongoing Phase 3 PIVOT-PO clinical trial of tebipenem HBr in complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), on track to be completed in Q2 2025 Existing cash, together with earned development milestones from GSK, provide runway to fund operating expenses and capital expenditures into Q2 2026 CAMBRIDGE, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the first quarter ended March 31, 2025, and provided a business update. "At Spero, our top priority remains the successful execution of the tebipenem HBr clinical program as we prepare for the pre-specified interim analysis of the PIVOT-PO trial during the second quarter,” said Esther Rajavelu, President and Chief Executive Officer. “We are developing tebipenem HBr to address the significant unmet need for an oral carbapenem option in the treatment of complicated urinary tract infections. We believe that, if approved, tebipenem HBr could deliver meaningful clinical and economic benefits, by improving patient outcomes and reducing the need for hospital stays.” Pipeline Update Tebipenem HBr Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI, including AP, to help patients potentially reduce duration of in-patient therapy. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories where Meiji holds development and commercialization rights. Together with GSK, we are conducting a pre-specified interim analysis of the Phase 3 PIVOT-PO clinical trial of tebipenem HBr. This pre-specified interim analysis is expected in Q2 2025. This randomized, double-blind clinical trial compares oral tebipenem HBr with intravenous imipenem-cilastatin, in hospitalized adult patients with cUTI/AP. The primary endpoint is overall response (a combination of clinical cure and favorable microbiological response) at the Test-of-Cure (TOC) visit. For more information on our PIVOT-PO trial, please refer to ClinicalTrials.gov ID NCT06059846. SPR720 SPR720 is an investigational, chemically stable phosphate ester prodrug that...

Spero Therapeutics Inc (NASDAQ:SPRO) is set to release its Q1 2025 earnings on May 13, 2025. The consensus estimate for Q1 2025 revenue is $11.00 million, and the earnings are expected to come in at -$0.55 per share. The full-year 2025 revenue is expected to be $30.00 million and the earnings are expected to be -$1.25 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 4 Warning Signs with SPRO. Revenue estimates for Spero Therapeutics Inc (NASDAQ:SPRO) have remained flat at $30.00 million for the full year 2025 and $1.00 million for 2026 over the past 90 days. Earnings estimates have declined from -$0.98 per share to -$1.25 per share for the full year 2025 and have increased from -$1.47 per share to -$0.13 per share for 2026 over the past 90 days. In the previous quarter of 2024-12-31, Spero Therapeutics Inc's (NASDAQ:SPRO) actual revenue was $15.04 million, which beat analysts' revenue expectations of $6.20 million by 142.65%. Spero Therapeutics Inc's (NASDAQ:SPRO) actual earnings were -$0.38 per share, which missed analysts' earnings expectations of -$0.31 per share by -22.58%. After releasing the results, Spero Therapeutics Inc (NASDAQ:SPRO) was down by -10.88% in one day. Based on the one-year price targets offered by 2 analysts, the average target price for Spero Therapeutics Inc (NASDAQ:SPRO) is $5.00 with a high estimate of $5.00 and a low estimate of $5.00. The average target implies an upside of 706.45% from the current price of $0.62. Based on GuruFocus estimates, the estimated GF Value for Spero Therapeutics Inc (NASDAQ:SPRO) in one year is $0.90, suggesting an upside of 45.16% from the current price of $0.62. Based on the consensus recommendation from 3 brokerage firms, Spero Therapeutics Inc's (NASDAQ:SPRO) average brokerage recommendation is currently 2.7, indicating a "Hold" status. The rating scale ranges from 1 to 5, where 1 signifies strong buy, and 5 denotes sell. This article, generated by GuruFocus, is designed to provide general insights and is not tailored financial advice. Our commentary is rooted in historical data and analyst projections, utilizing an impartial methodology, and is not intended to serve as specific investment guidance. It does not formulate a recommendation to purchase or divest any stock and does not consider individual investment objectives or financial circums...