PART I. FINANCIAL INFORMATION Financial Statements This section presents Tourmaline Bio, Inc.'s unaudited condensed consolidated financial statements for the quarter ended March 31, 2025, including balance sheets, statements of operations, stockholders' equity, and cash flows, with notes on business and accounting policies Condensed Consolidated Balance Sheet Highlights (unaudited) | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $35,330 | $30,506 | | Short-term investments | $213,976 | $227,797 | | Total assets | $287,498 | $309,001 | | Liabilities and Stockholders' Equity | | | | Total liabilities | $7,635 | $8,949 | | Total stockholders' equity | $279,863 | $300,052 | Condensed Consolidated Statements of Operations (unaudited) | (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $20,258 | $11,376 | | General and administrative | $5,973 | $6,141 | | Loss from operations | ($26,231) | ($17,517) | | Other income, net | $3,261 | $4,206 | | Net loss | ($22,970) | ($13,311) | | Net loss per share, basic and diluted | ($0.89) | ($0.55) | - The company is a late-stage clinical biotechnology firm developing pacibekitug for immune and inflammatory diseases, facing typical industry risks like financing and regulatory approval needs2324 - Under the Pfizer License Agreement, the company may owe up to $128.0 million in development and regulatory milestones and $525.0 million in sales milestones for pacibekitug, with no payments made as of March 31, 2025454647 - In January 2024, a public offering generated net proceeds of approximately $161.4 million5455 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial results, detailing pacibekitug's clinical trial progress for ASCVD and TED, analyzing increased operating expenses, and outlining liquidity, capital resources, and funding requirements, with current cash projected to last into the second half of 2027 - The lead product candidate, pacibekitug, is a long-acting anti-IL-6 antibody developed for cardiovascular inflammation (ASCVD) and Thyroid Eye Disease (TED)8788 - Key clinical trial updates include TRANQUILITY (ASCVD) Phase 2 trial, which completed over-enrollment in December 2024 with topline data expected in Q2 2025, and spiriTED (TED) pivotal Phase 2b trial, initiated in September 2023 with topline data expected in H2 2025909193 Comparison of Operating Results (Q1 2025 vs Q1 2024) | (in thousands) | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $20,258 | $11,376 | +$8,882 | | General and administrative | $5,973 | $6,141 | -$168 | | Net loss | ($22,970) | ($13,311) | (-$9,659) | - The $8.9 million increase in R&D expenses was primarily due to a $3.8 million rise in clinical trial costs for TRANQUILITY and spiriTED trials, and a $2.7 million increase in payroll-related costs from higher headcount125127 - As of March 31, 2025, the company held $275.3 million in cash, cash equivalents, and investments, projected to fund operations into the second half of 2027130 Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Tourmaline Bio is exempt from providing quantitative and qualitative disclosures regarding market risk - Tourmaline Bio is exempt from providing quantitative and qualitative disclosures about market risk as a smaller reporting company151 Controls and Procedures Management, including the CEO and CFO, concluded the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025153 - No material changes in internal control over financial reporting occurred during the quarter154 PART II. OTHER INFORMATION Legal Proceedings The company is not currently involved in any pending legal proceedings expected to materially adversely affect its financial position, results of operations, or cash flows - As of the report date, the company is not subject to any pending legal proceedings that could materially adversely affect its business157 Risk Factors This section outlines substantial investment risks, including dependence on pacibekitug's success, limited operating history, ongoing net losses, need for additional capital, reliance on CDMOs, inherent clinical trial uncertainties, potential competition, and regulatory challenges - The company's business is highly dependent on the success of its sole product candidate, pacibekitug; any development, approval, or commercialization failure would materially harm the business170 - The company has a history of net losses, anticipates significant operating losses, and will require substantial additional capital to fund future development and operations164175 - Complete reliance on CDMOs for pacibekitug manufacturing exposes the company to risks of supply disruption, quality control issues, and regulatory compliance failures189 - Clinical trials face significant risks, including delays, failure to demonstrate safety and efficacy, and patient enrollment difficulties, potentially preventing or delaying regulatory approval235238243 - Dependence on license agreements with Pfizer and Lonza means their termination could halt pacibekitug development and commercialization357 Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Securities This section details the company's repurchase of 2,600 unvested common stock shares from a former employee during the three months ended March 31, 2025, noting no formal share repurchase program was in place Issuer Purchases of Equity Securities | Period | Total Number of Shares Purchased | Average Price Paid Per Share | | :--- | :--- | :--- | | January 2025 | — | $— | | February 2025 | — | $— | | March 2025 | 2,600 | $2.76 | - The 2,600 shares were repurchased from a former employee at the original exercise price because they were unvested upon separation389 Defaults Upon Senior Securities This item is not applicable as the company has no defaults on senior securities to report Mine Safety Disclosures This item is not applicable to the company Other Information The company reports no other information for this period Exhibits This section lists exhibits filed with the Form 10-Q, including amended corporate documents and required officer certifications under the Sarbanes-Oxley Act - Exhibits filed include key corporate governance documents and required officer certifications (Sections 302 and 906 of Sarbanes-Oxley)394
TALARIS THERAPEU(TALS) - 2025 Q1 - Quarterly Report