Spero Therapeutics(SPRO) - 2025 Q1 - Quarterly Results

Spero Therapeutics First Quarter 2025 Operating Results Business Overview and Highlights Spero Therapeutics reported Q1 2025 results, highlighting the successful execution of the tebipenem HBr clinical program with an interim analysis of the Phase 3 PIVOT-PO trial expected in Q2 2025, and confirmed financial runway into Q2 2026 with existing cash and GSK milestone payments - The company's top priority is the execution of the tebipenem HBr clinical program, which aims to provide an oral carbapenem option for complicated urinary tract infections (cUTI) to reduce hospital stays[2] - A pre-specified interim analysis of the ongoing Phase 3 PIVOT-PO clinical trial of tebipenem HBr is on track for completion in Q2 2025[5][6] - Spero projects its existing cash, combined with earned development milestones from GSK, will fund operating expenses and capital expenditures into Q2 2026[5] Pipeline Update The company's pipeline focuses on the lead candidate tebipenem HBr for cUTI, advancing in a Phase 3 trial with GSK, while the SPR720 program for NTM-PD was suspended in late 2024 after its Phase 2a study failed to meet its primary endpoint Tebipenem HBr Tebipenem HBr is an investigational oral carbapenem antibiotic for cUTI and AP, currently in a Phase 3 PIVOT-PO trial comparing it to intravenous imipenem-cilastatin, with commercialization rights licensed to GSK for most territories - Tebipenem HBr is being developed as an oral treatment for cUTI and AP, potentially reducing the duration of in-patient therapy[3] - The Phase 3 PIVOT-PO trial's primary endpoint is a combination of clinical cure and favorable microbiological response at the Test-of-Cure (TOC) visit[6] - GSK holds an exclusive license to commercialize tebipenem HBr in all territories except for certain Asian territories retained by Meiji[3] SPR720 SPR720, an investigational oral prodrug for NTM-PD, had its development program suspended in Q4 2024 after a Phase 2a study's interim analysis did not meet its primary endpoint, with full data analysis underway to determine future steps - SPR720 targets the ATPase site of DNA gyrase B in mycobacteria, a mechanism distinct from other antibiotics used for NTM-PD[4] - The oral development program in NTM-PD was suspended in Q4 2024 after a Phase 2a study's interim analysis of 16 patients did not meet its primary endpoint[11] - Spero is completing the analysis of data from all 25 patients dosed in the Phase 2a study to decide on the future of the program[11] Corporate Update Spero announced the appointment of Esther Rajavelu as President and Chief Executive Officer, effective May 2, 2025, who will also continue as Chief Financial Officer and Treasurer and has been nominated for the Board of Directors - Esther Rajavelu was appointed President and Chief Executive Officer, effective May 2, 2025[7] - Ms. Rajavelu will continue to hold her roles as Chief Financial Officer and Treasurer and has been nominated for election to the Board of Directors[7] First Quarter 2025 Financial Results Spero Therapeutics reported a net loss of $13.9 million for Q1 2025, an increase from $12.7 million in Q1 2024, with total revenues decreasing to $5.9 million from $9.3 million primarily due to lower grant revenue, ending the quarter with $48.9 million in cash and cash equivalents Financial Performance Summary For Q1 2025, Spero's revenue declined to $5.9 million from $9.3 million in Q1 2024 primarily due to reduced grant revenue, leading to a net loss of $13.9 million or $(0.25) per share, despite decreased R&D expenses and increased G&A expenses Q1 2025 vs Q1 2024 Key Financials | Metric | Q1 2025 ($M) | Q1 2024 ($M) | | :--- | :--- | :--- | | Total Revenue | $5.9M | $9.3M | | R&D Expenses | $13.6M | $17.3M | | G&A Expenses | $6.8M | $5.9M | | Net Loss | $(13.9)M | $(12.7)M | | Net Loss Per Share | $(0.25) | $(0.24) | - The decrease in revenue was primarily due to a decrease in grant revenue, partially offset by higher collaboration revenue related to the GSK agreement[11] - The decrease in R&D expenses was primarily due to lower expenditure on the SPR720 clinical program[11] Condensed Consolidated Balance Sheet As of March 31, 2025, Spero's total assets decreased to $77.7 million from $110.5 million at year-end 2024, with cash and cash equivalents at $48.9 million and total liabilities decreasing to $43.9 million from $64.4 million Balance Sheet Data (in thousands) | Account | March 31, 2025 (USD Thousands) | December 31, 2024 (USD Thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $48,887 | $52,889 | | Total assets | $77,709 | $110,543 | | Total liabilities | $43,895 | $64,420 | | Total stockholder's equity | $33,814 | $46,123 | Condensed Consolidated Statements of Operations For Q1 2025, Spero reported total revenues of $5.9 million, down from $9.3 million in Q1 2024, resulting in an increased net loss of $13.9 million or $(0.25) per share, compared to a net loss of $12.7 million or $(0.24) per share in the prior-year period, despite reduced total operating expenses Statement of Operations for the Three Months Ended March 31 (in thousands) | Account | 2025 (USD Thousands) | 2024 (USD Thousands) | | :--- | :--- | :--- | | Total revenues | $5,874 | $9,267 | | Research and development | $13,606 | $17,332 | | General and administrative | $6,824 | $5,917 | | Loss from operations | $(14,731) | $(13,982) | | Net loss | $(13,866) | $(12,669) | | Net loss per share, diluted | $(0.25) | $(0.24) |