CAMBRIDGE, Mass., Dec. 19, 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 its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of co ...

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].

Clinical Development - Tebipenem HBr completed a Phase 3 trial, meeting its primary endpoint and was stopped early for efficacy, with results presented at IDWeek on October 20, 2025 [201][208]. - The company plans to prioritize finalizing Phase 3 clinical trial activities for tebipenem HBr under the GSK License Agreement, with cash runway sufficient to fund operations into 2028 [203]. - The company ceased development of SPR206 and SPR720, focusing on completing obligations under the GSK License Agreement and other corporate activities [202][212]. Financial Performance - As of September 30, 2025, the company had an accumulated deficit of $482.6 million and cash and cash equivalents of $48.6 million, expecting to incur significant expenses and operating losses for at least the next year [203]. - Total revenues for the three months ended September 30, 2025, were $5,442,000, a decrease of $8,027,000 (approximately 59.6%) compared to $13,469,000 in 2024 [232]. - Grant revenue decreased to $2,394,000 in Q3 2025 from $5,650,000 in Q3 2024, a decline of $3,256,000 (approximately 57.5%) primarily due to a reduction in BARDA contract revenue [232]. - Collaboration revenue from GSK fell to $3,048,000 in Q3 2025 from $7,754,000 in Q3 2024, a decrease of $4,706,000 (approximately 60.6%) [233]. - For the nine months ended September 30, 2025, total revenues were $25,505,000, a decrease of $7,428,000 (approximately 22.5%) from $32,933,000 in 2024 [246]. - Collaboration revenue for the nine months ended September 30, 2025, increased to $19,961,000 from $18,040,000 in 2024, an increase of $1,921,000 (approximately 10.7%) driven by GSK [248]. Expenses and Losses - Total operating expenses for Q3 2025 were $13,358,000, down $18,704,000 (approximately 58.3%) from $32,062,000 in Q3 2024 [232]. - Research and development expenses decreased to $8,597,000 in Q3 2025 from $26,864,000 in Q3 2024, a reduction of $18,267,000 (approximately 68.1%) [236]. - The net loss for Q3 2025 was $7,382,000, an improvement of $10,055,000 (approximately 57.6%) compared to a net loss of $17,437,000 in Q3 2024 [232]. - Direct research and development expenses for the nine months ended September 30, 2025, were $32,875,000, down $35,046,000 (approximately 51.6%) from $67,921,000 in 2024 [249]. - Personnel-related costs for the nine months ended September 30, 2025, were $9.8 million, a slight increase of $0.1 million from $9.7 million in 2024, primarily due to retention bonuses and executive severance expenses [253]. - Total general and administrative expenses for the nine months ended September 30, 2025, were $16.9 million, an increase of $0.2 million from $16.6 million in 2024 [253]. Impairment and Other Charges - An impairment charge of $0.6 million was recorded in Q3 2025 related to the right-of-use asset due to a real estate lease evaluation [224]. - The company recognized $1.1 million in expenses related to a strategic restructuring initiative implemented in October 2024, with no further charges expected [225]. - Impairment charges of $587,000 were recognized in Q3 2025, compared to no charges in Q3 2024 [244]. - Impairment charges related to the right of use asset were $0.6 million for the nine months ended September 30, 2025, compared to no charges in the same period of 2024 [257]. Cash Flow and Funding - Cash and cash equivalents as of September 30, 2025, were $48.6 million, providing a runway to fund operating expenses for at least 12 months [259]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $4.3 million, primarily due to a net loss of $22.9 million [262]. - The company did not undertake any investing or financing activities during the nine months ended September 30, 2025 [266][267]. - The company plans to mitigate funding risks through raising additional capital, potential collaborations, and reducing cash expenditures [269]. Revenue Generation and Future Outlook - The company has not generated any revenue from product sales to date, with future revenue dependent on successful regulatory approval of product candidates [214]. - The company anticipates a portion of future revenue will derive from government awards and collaborations with Pfizer and GSK [215][216]. - The company has not yet commercialized any product candidates and may not generate revenue from sales in the near future [259]. Currency Exposure - The company is exposed to foreign currency exchange rate fluctuations, primarily the Euro, British Pound, and Australian Dollar against the U.S. dollar [277].

Core Insights - Spero Therapeutics reported financial results for Q3 2025, highlighting a net loss of $7.4 million, a significant reduction from a net loss of $17.1 million in Q3 2024, indicating improved financial performance [8] - The company is advancing its investigational oral antibiotic, tebipenem HBr, with plans for FDA submission in Q4 2025, potentially offering a new treatment option for complicated urinary tract infections [2][6] Financial Performance - 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 [8] - Research and development expenses decreased to $8.6 million in Q3 2025 from $26.9 million in the same period in 2024, attributed to reduced clinical expenses related to the PIVOT-PO trial and lower costs associated with the SPR720 program [8] - General and administrative expenses were $4.2 million in Q3 2025, down from $5.2 million in Q3 2024, mainly due to reduced personnel-related costs [14] Pipeline Developments - Tebipenem HBr is being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and has shown non-inferiority to intravenous imipenem-cilastatin in the PIVOT-PO trial [3][7] - The PIVOT-PO trial results indicated an overall success rate of 58.5% for tebipenem HBr compared to 60.2% for imipenem-cilastatin, with a safety profile consistent with other carbapenem antibiotics [7] - The SPR720 program for nontuberculous mycobacterium pulmonary disease has been discontinued following a review of Phase 2a and Phase 1 trial data [4] 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 [14]

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]

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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].