Financial Performance - Spero reported a net loss of $7.4 million for Q3 2025, a significant improvement compared to a net loss of $17.1 million in Q3 2024, resulting in a diluted net loss per share of $0.13 versus $0.32[13]. - Total revenue for Q3 2025 was $5.4 million, down from $13.5 million in Q3 2024, primarily due to decreased collaboration revenue with GSK and a decline in grant revenue[13]. - General and administrative expenses for Q3 2025 were $4.2 million, down from $5.2 million in Q3 2024, mainly due to reduced personnel-related costs[13]. - Total operating expenses for Q3 2025 were $13.4 million, compared to $32.1 million in Q3 2024, reflecting a significant reduction in costs[19]. Research and Development - Research and development expenses decreased to $8.6 million in Q3 2025 from $26.9 million in Q3 2024, attributed to reduced clinical expenses related to the PIVOT-PO trial and lower costs for the SPR720 program[13]. - Spero has discontinued the SPR720 program in Q3 2025 after reviewing data from Phase 2a and Phase 1 trials[4]. Clinical Trials - The Phase 3 PIVOT-PO trial for tebipenem HBr demonstrated a 58.5% overall success rate compared to 60.2% for intravenous imipenem-cilastatin, indicating non-inferiority[6]. - The PIVOT-PO trial was stopped early for efficacy in May 2025, highlighting the promising results of tebipenem HBr[6]. - Tebipenem HBr is being developed as an oral treatment for complicated urinary tract infections (cUTI) and could provide an alternative to IV therapies, with a potential FDA filing planned for Q4 2025[2][5]. Cash Position - As of September 30, 2025, Spero had cash and cash equivalents of $48.6 million, which is expected to fund operations into 2028[13].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38266 SPERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 46-4590683 (State or other j ...

Results from PIVOT-PO Phase 3 trial evaluating tebipenem HBr in complicated urinary tract infection (cUTI) presented as IDWeek late-breaker in October 2025Spero’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 biopharmaceu ...

Core Viewpoint - Spero Therapeutics, Inc. is set to report its third quarter 2025 financial results and provide a business update on November 13, 2025, after market close, and will not host a conference call [1]. Company Overview - Spero Therapeutics is a clinical-stage biopharmaceutical company based in Cambridge, Massachusetts, focused on developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections with significant unmet medical needs [2].

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - AlphaVest Acquisition Corp (ATMV) is up 71% at $14.24 [3] - BranchOut Food Inc. (BOF) is up 44% at $3.04 [3] - rYojbaba Co., Ltd. (RYOJ) is up 35% at $5.14 [3] - GSI Technology, Inc. (GSIT) is up 25% at $16.24 [3] - Jowell Global Ltd. (JWEL) is up 18% at $2.02 [3] - General Motors Company (GM) is up 9% at $63.68 [3] - Crown Holdings, Inc. (CCK) is up 8% at $103.00 [3] - Spero Therapeutics, Inc. (SPRO) is up 8% at $2.49 [3] - Sunrun Inc. (RUN) is up 6% at $21.90 [3] - Foxx Development Holdings Inc. (FOXX) is up 5% at $4.50 [3] Premarket Losers - Neuphoria Therapeutics Inc. (NEUP) is down 66% at $5.19 [4] - New Era Energy & Digital, Inc. (NUAI) is down 9% at $5.09 [4] - Odyssey Marine Exploration, Inc. (OMEX) is down 8% at $3.28 [4] - Carbon Revolution Public Limited Company (CREV) is down 7% at $4.86 [4] - Coeur Mining, Inc. (CDE) is down 7% at $20.38 [4] - Hecla Mining Company (HL) is down 6% at $13.50 [4] - Verrica Pharmaceuticals Inc. (VRCA) is down 6% at $4.12 [4] - Sensei Biotherapeutics, Inc. (SNSE) is down 5% at $10.06 [4] - Whitehawk Therapeutics, Inc. (WHWK) is down 5% at $2.52 [4] - Greenidge Generation Holdings Inc. (GREE) is down 5% at $2.07 [4]

Core Insights - Spero Therapeutics and GSK announced positive results from the pivotal phase 3 PIVOT-PO trial for tebipenem HBr, an oral treatment for complicated urinary tract infections (cUTIs) [1][5] Industry Overview - Complicated UTIs are a significant health issue, with approximately 2.9 million cases treated annually in the U.S., leading to over $6 billion in healthcare costs each year [2] - These infections are often caused by multidrug-resistant pathogens, resulting in serious health risks such as organ failure and sepsis [2] Trial Results - The PIVOT-PO trial demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin, with an overall success rate of 58.5% for tebipenem HBr versus 60.2% for imipenem-cilastatin [3][6] - Clinical cure rates were 93.5% for tebipenem HBr compared to 95.2% for imipenem-cilastatin, while microbiological response rates were 60.3% and 61.3%, respectively [6] Regulatory and Market Implications - GSK plans to submit data to U.S. regulatory authorities in Q4 2025, aiming for tebipenem HBr to become the first oral carbapenem antibiotic for cUTIs in the U.S. [7] - The development of tebipenem HBr is supported by federal funds from the U.S. Department of Health and Human Services [8] Company Collaboration - Spero Therapeutics has licensed tebipenem HBr to GSK for development and commercialization, with GSK responsible for regulatory filings [7][9] - The collaboration aims to address the challenges of antimicrobial resistance and expand GSK's anti-infectives portfolio [7]

Core Insights - Spero Therapeutics is set to present results from the successful Phase 3 PIVOT-PO trial for tebipenem HBr, an investigational oral carbapenem antibiotic for complicated urinary tract infections (cUTI) at the IDWeek annual meeting in October 2025 [1][4] Group 1: Trial Results and Presentations - The Phase 3 PIVOT-PO trial demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis [4] - An oral presentation titled "Oral Tebipenem Pivoxil Hydrobromide versus Intravenous Imipenem-Cilastatin in Patients with Complicated Urinary Tract Infections or Acute Pyelonephritis" will be given by David K. Hong on October 20, 2025 [2] - Additional posters will cover the in vitro antibacterial spectrum and activity of tebipenem against Enterobacterales clinical isolates causing urinary tract and bloodstream infections [3] Group 2: Product Development and Licensing - Tebipenem HBr is being developed to potentially reduce the duration of inpatient therapy for cUTI [4] - Spero has granted GSK an exclusive license to commercialize tebipenem HBr in most territories, with certain Asian territories licensed to Meiji [4] - The FDA has granted tebipenem HBr Qualified Infectious Disease Product (QIDP) and Fast Track designations, with GSK planning to file for regulatory approval in Q4 2025 [4] Group 3: Company Overview - Spero Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases and multi-drug resistant bacterial infections [7] - The company is headquartered in Cambridge, Massachusetts, and aims to address high unmet medical needs in its therapeutic areas [7]

Core Viewpoint - Spero Therapeutics, Inc. (SPRO) has experienced a significant downtrend with a 17.7% decline over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to improved earnings expectations from analysts [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold conditions, with a reading below 30 typically indicating that a stock is oversold [2]. - SPRO's current RSI reading is 27.97, indicating that the heavy selling pressure may be exhausting, which could lead to a price rebound as the stock seeks to return to its previous equilibrium [5]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts regarding SPRO, with earnings estimates for the current year being raised by 44.8% over the last 30 days, suggesting a positive outlook for price appreciation [7]. - SPRO holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a near-term turnaround [8].

Financial Data and Key Metrics Changes - Total revenue for 2025 was $14.2 million, compared to $10.2 million for 2024, indicating a year-over-year increase [16] - R&D expenses for 2025 were $10.7 million, down from $23.7 million in 2024, primarily due to reduced clinical expenses related to the PIVOT PO study [17] - The company reported a net loss of $1.7 million for 2025, significantly improved from a net loss of $17.9 million in 2024, with diluted net loss per share of $0.03 compared to $0.33 for the previous year [18] Business Line Data and Key Metrics Changes - The PIVOT PO trial for tebipenem HBr successfully met its primary endpoint and was stopped early for efficacy, which is expected to lead to cost savings and extend the cash runway into 2028 [6][10] - The positive outcome from the PIVOT PO trial supports the potential of tebipenem HBr as an oral alternative to IV carbapenem therapy for complicated urinary tract infections (CUTIs) [7][8] Market Data and Key Metrics Changes - There are approximately 2.9 million episodes of complicated urinary tract infections annually in the United States, contributing to over $6 billion in healthcare costs [11][12] - The current standard of care for many infections caused by multi-drug resistant (MDR) gram-negative bacteria is IV carbapenem antibiotics, highlighting a significant gap for effective oral alternatives [12][13] Company Strategy and Development Direction - The company aims to ensure that tebipenem HBr reaches the regulatory process and approval, which is seen as a key value driver for future growth [22] - The agreement with GSK allows for potential contingent milestones of up to $351 million, including $25 million upon GSK's submission of the U.S. regulatory filing [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the positive results from the PIVOT PO trial, believing it brings tebipenem HBr closer to becoming the first commercial product from the company's pipeline [18] - The company is currently assessing the next steps for SPR720 after the phase 2A study did not meet its primary endpoint, indicating a cautious approach to future development [14] Other Important Information - The company had cash and cash equivalents of $31.2 million as of June 30, 2025, with additional milestone payments expected to fund operations into 2028 [15] - The trial's early stopping for efficacy has resulted in meaningful cost savings, which is a primary driver for the extended cash runway [10][15] Q&A Session Summary Question: Capital allocation strategy - The company indicated that the primary objective is to ensure tebipenem HBr reaches the regulatory process and approval, with future capital allocation decisions to be made once there is clarity on approval [21][22]