Spero Therapeutics(SPRO) - 2025 Q2 - Quarterly Results

Executive Summary Spero Therapeutics reported Q2 2025 results, highlighting the tebipenem Phase 3 PIVOT-PO trial's primary endpoint success for cUTI treatment Second Quarter 2025 Highlights The tebipenem Phase 3 PIVOT-PO trial met its primary endpoint, addressing a critical unmet need for oral carbapenems in cUTI - The tebipenem Phase 3 PIVOT-PO trial met its primary endpoint, marking a significant milestone for this program[2] - There remains a critical unmet need for an oral carbapenem to treat complicated urinary tract infections (cUTI), including pyelonephritis[2] - If approved, 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[2] Business Update Spero Therapeutics updated on pipeline programs, with Tebipenem HBr achieving Phase 3 success and SPR720's NTM-PD program suspended Pipeline Update Key pipeline updates include Tebipenem HBr's successful Phase 3 trial and planned FDA filing, while the SPR720 program was suspended Tebipenem HBr Tebipenem HBr, an investigational oral carbapenem, achieved its primary endpoint in the Phase 3 PIVOT-PO trial for cUTI, with an FDA filing planned for 2H 2025 - Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI, including pyelonephritis[3] - The PIVOT-PO Phase 3 trial evaluating tebipenem HBr in cUTI patients was stopped early for efficacy following review by an independent data monitoring committee (IDMC)[4] - 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[5] - 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[4][5] SPR720 The SPR720 oral development program for NTM-PD was suspended in Q4 2024 after failing to meet its primary endpoint in a Phase 2a trial - SPR720 is an investigational prodrug that converts to SPR719, targeting the ATPase site of DNA gyrase B in mycobacteria for nontuberculous mycobacterium pulmonary disease (NTM-PD)[6] - The oral development program in NTM-PD was suspended in 4Q 2024 after a planned interim analysis of the Phase 2a trial demonstrated it did not meet its primary endpoint[11] Corporate Developments Spero Therapeutics announced new leadership, projected funding into 2028, and adjusted potential commercial milestone payments from GSK - Esther Rajavelu was appointed as Spero's President and Chief Executive Officer, effective May 2, 2025, and continues to serve as the Company's Chief Financial Officer and Treasurer[11] - Existing cash and cash equivalents, together with earned and non-contingent development milestone payments from GSK (including a final $23.8 million payment received in August 2025), are estimated to be sufficient to fund operating expenses and capital expenditures into 2028[4][11] - Pursuant to the GSK License Agreement, aggregate potential commercial milestone payments contingent upon first sales were adjusted from up to $150.0 million to up to $101.0 million after PIVOT-PO was stopped early for efficacy, reducing overall costs to Spero[11] Financial Results Spero Therapeutics reported Q2 2025 financial results, showing a reduced net loss driven by increased collaboration revenue and lower R&D expenses Second Quarter 2025 Financial Overview Spero Therapeutics reported a reduced net loss for Q2 2025, driven by increased GSK collaboration revenue and significantly lower R&D expenses Key Financials (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :-------------------------- | :--------------------- | :--------------------- | :----------- | | Net Loss | $(1,700) | $(17,862) | $(16,162) decrease | | Diluted Net Loss per Share | $(0.03) | $(0.33) | $(0.30) decrease | | Total Revenue | $14,189 | $10,197 | $3,992 increase | | R&D Expenses | $10,672 | $23,725 | $(13,053) decrease | | G&A Expenses | $5,878 | $5,533 | $345 increase | - The revenue increase for the second quarter of 2025 was primarily due to collaboration revenue from GSK[11] - The decrease in research and development expenses compared with the prior year period was primarily due to reduced clinical expense related to the PIVOT-PO trial[11] - The increase in general and administrative expenses compared with the prior year-period was primarily due to increased personnel and professional service expense[11] Condensed Consolidated Balance Sheet Data The balance sheet shows decreases in cash, total assets, liabilities, and equity as of June 30, 2025, compared to December 31, 2024 Condensed Consolidated Balance Sheet Data | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $31,194 | $52,889 | | Other assets | $30,925 | $57,654 | | Total assets | $62,119 | $110,543 | | Total liabilities | $29,291 | $64,420 | | Total stockholder's equity | $32,828 | $46,123 | | Total liabilities and stockholders' equity | $62,119 | $110,543 | Condensed Consolidated Statements of Operations Statements of operations detail Q2 2025 revenues and expenses, showing increased collaboration revenue and decreased R&D, leading to a lower net loss Condensed Consolidated Statements of Operations | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Grant revenue | $2,387 | $4,180 | $3,150 | $9,243 | | Collaboration revenue - related party | $11,802 | $5,903 | $16,901 | $9,967 | | Collaboration revenue | $— | $114 | $12 | $254 | | Total revenues | $14,189 | $10,197 | $20,063 | $19,464 | | Research and development | $10,672 | $23,725 | $24,278 | $41,057 | | General and administrative | $5,878 | $5,533 | $12,702 | $11,450 | | Restructuring | $83 | $— | $258 | $— | | Total operating expenses | $16,633 | $29,258 | $37,238 | $52,507 | | Loss from operations | $(2,444) | $(19,061) | $(17,175) | $(33,043) | | Total other income, net | $744 | $1,199 | $1,609 | $2,512 | | Net loss | $(1,700) | $(17,862) | $(15,566) | $(30,531) | | Net loss per share, basic and diluted | $(0.03) | $(0.33) | $(0.28) | $(0.57) | | Weighted average shares outstanding | 56,026,767 | 53,957,766 | 55,703,275 | 53,740,901 | Additional Information This section provides details on the Q2 2025 conference call, research support, company overview, forward-looking statements, and contact information Conference Call and Webcast Spero management hosted a conference call and webcast on August 12, 2025, to discuss Q2 financial results and provide a business update - Spero management hosted a conference call and live audio webcast at 4:30 p.m. ET on August 12, 2025, to discuss the second quarter financial results and provide a business update[10] - Access to the call was available via dial-in (domestic: 1-844-825-9789, international: 1-412-317-5180, conference ID 10200686) or a webcast link on the 'Investor Relations' page of the Spero Corporate Website[12] Research Support Certain tebipenem HBr studies received federal funding from the Department of Health and Human Services and BARDA - Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; and Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201800015C[14] About Spero Therapeutics Spero Therapeutics is a clinical-stage biopharmaceutical company focused on novel treatments for rare diseases and MDR bacterial infections - Spero Therapeutics 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[15] Forward-Looking Statements This section outlines risks and uncertainties that could cause actual results to differ materially from forward-looking projections - Forward-looking statements are subject to important risks, uncertainties, and other factors that may cause actual results to differ materially, including those related to the timing, progress, and results of Spero's Phase 3 PIVOT-PO trial[16] - Risks include whether tebipenem HBr will advance through clinical development, warrant FDA submission, receive approval, achieve successful commercial launch, and market acceptance[16] - Other factors include Spero's reliance on third parties (e.g., GSK) to manufacture, develop, and commercialize product candidates, the need for additional funding, ability to retain key personnel, leadership transitions, and sufficiency of cash resources[16][17] Contacts Contact information is provided for investor relations and media inquiries - Investor Relations Contact: Shai Biran, PhD, Spero Therapeutics, IR@Sperotherapeutics.com[18] - Media Inquiries: media@sperotherapeutics.com[18]