Keros Therapeutics(KROS) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Financial Results and Business Update Keros Therapeutics reported Q2 2025 financial results, outlining strategic pipeline advancements, financial performance, and liquidity position Company Highlights and Strategic Direction Keros Therapeutics announced Q2 2025 financial results after a strategic review, reaffirming focus on pipeline advancement with KER-065 progressing to Phase 2 for Duchenne muscular dystrophy in Q1 2026 - Keros' Board completed a comprehensive strategic review, reaffirming focus on creating long-term value through pipeline advancement[2] - The lead asset, KER-065, is progressing towards initiation of a Phase 2 clinical trial in patients with Duchenne muscular dystrophy in the first quarter of 2026[2] Financial Performance Summary Keros reported a net loss of $30.7 million in Q2 2025, a $14.6 million decrease from Q2 2024, primarily due to Takeda license revenue partially offset by increased R&D and G&A expenses Second Quarter Financial Highlights (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :---------------------- | :------ | :------ | :------- | | Net Loss | $(30.7) | $(45.3) | $(14.6) decrease | | Research and development expenses | $43.5 | $40.5 | $3.0 increase | | General and administrative expenses | $14.5 | $10.0 | $4.5 increase | - The decrease in net loss was largely due to revenue recognized related to Keros' license agreement with Takeda Pharmaceuticals U.S.A., Inc[3] - Increased research and development efforts and additional investments to support clinical and corporate goals partially offset the net loss improvement[3][4] Liquidity and Capital Resources Keros' cash and cash equivalents significantly increased to $690.2 million by June 30, 2025, with a projected cash runway into the first half of 2028, even after returning $375.0 million to stockholders Cash and Cash Equivalents (in millions) | Metric | June 30, 2025 | December 31, 2024 | Change | | :----------------------- | :------------ | :---------------- | :------- | | Cash and cash equivalents | $690.2 | $559.9 | $130.3 increase | - Keros expects to return $375.0 million of excess capital to stockholders[5] - Based on current operating assumptions, Keros expects its cash and cash equivalents to fund operating expenses and capital expenditure requirements into the first half of 2028[5] Company Profile Keros Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for TGF-ß family protein signaling disorders Business Overview and Pipeline Keros Therapeutics is a clinical-stage biopharmaceutical company developing novel therapeutics for TGF-ß family protein signaling disorders, with lead candidates KER-065 for neuromuscular diseases and elritercept for cytopenias - Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics for disorders linked to dysfunctional TGF-ß family protein signaling[6] - Keros' lead product candidate, KER-065, is being developed for the treatment of neuromuscular diseases, with an initial focus on Duchenne muscular dystrophy[6] - Keros' most advanced product candidate, elritercept, is being developed for the treatment of cytopenias in patients with myelodysplastic syndrome and myelofibrosis[6] Condensed Consolidated Financial Statements This section presents Keros Therapeutics' condensed consolidated statements of operations and balance sheets for recent periods Statements of Operations For Q2 2025, Keros reported $18.168 million in revenue and a $30.696 million net loss, while the six months ended June 30, 2025, saw $229.414 million in revenue and a $117.755 million net income, driven by license revenue Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | 6M 2025 | 6M 2024 | | :------------------------------------------ | :------ | :------ | :------ | :------ | | Total revenue | 18,168 | 37 | 229,414 | 120 | | Research and development | (43,503) | (40,515) | (92,212) | (78,773) | | General and administrative | (14,482) | (9,961) | (24,979) | (20,269) | | Net income (loss) | (30,696) | (45,257) | 117,755 | (88,371) | | Net income (loss) per share — basic | (0.76) | (1.25) | 2.90 | (2.46) | | Net income (loss) per share — diluted | (0.76) | (1.25) | 2.86 | (2.46) | - License revenue of $195,355 thousand was a key contributor to the net income for the six months ended June 30, 2025[12] - Operating expenses, including R&D and G&A, increased year-over-year for both the three-month and six-month periods, reflecting ongoing development and operational investments[12] Balance Sheets As of June 30, 2025, Keros' total assets increased to $757.165 million, and total stockholders' equity rose to $706.734 million, primarily due to higher cash and receivables Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Cash and cash equivalents | 690,215 | 559,931 | | Accounts receivable | 15,816 | 2,742 | | Total current assets | 732,808 | 588,893 | | Total assets | 757,165 | 615,886 | | Total current liabilities | 34,707 | 27,450 | | Total liabilities | 50,431 | 44,333 | | Total stockholders' equity | 706,734 | 571,553 | - The accumulated deficit decreased from $(568,779) thousand at December 31, 2024, to $(451,024) thousand at June 30, 2025, indicating a positive shift in retained earnings due to the six-month period's net income[14] - Deferred revenue of $925 thousand was reported as a current liability as of June 30, 2025, compared to none at December 31, 2024[14] Legal Disclosures and Contacts This section provides cautionary notes on forward-looking statements and essential company contact information Cautionary Note Regarding Forward-Looking Statements This section provides a standard disclaimer for forward-looking statements, noting that actual results may differ due to risks such as limited operating history, funding needs, product candidate dependence, clinical trial delays, competition, and reliance on third parties - Statements regarding matters that are not historical facts are 'forward-looking statements' subject to risks and uncertainties, meaning actual results may differ materially[8] - Identified risks include Keros' limited operating history, ability to raise additional funding, dependence on product candidates, potential delays in clinical trials, competition, intellectual property, and reliance on third parties[8] - Keros undertakes no obligation to update such statements to reflect events or circumstances after the date on which they were made, except as required by law[9] Company Contacts This section provides contact information for investor relations and media inquiries for Keros Therapeutics - Investor Contact: Justin Frantz, jfrantz@kerostx.com, 617-221-6042[10] - Media Contact: Mahmoud Siddig / Adam Pollack / Viveca Tress, Joele Frank, Wilkinson Brimmer Katcher, 212-355-4449[10]