Spero Therapeutics(US:SPRO)2025-11-13 21:10Clinical 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].