Tourmaline Bio(TRML) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights The company reported positive Phase 2 trial results for pacibekitug and outlined its future clinical development strategy Q2 2025 Business Highlights The company announced positive Phase 2 trial results for pacibekitug and provided an update on its cash runway - Positive topline results from the Phase 2 TRANQUILITY trial of pacibekitug showed rapid, deep, and durable reductions in high-sensitivity C-reactive protein (hs-CRP) with quarterly dosing[1] - Additional data from the TRANQUILITY trial will be presented at the European Society of Cardiology Congress in August 2025[1] - The company is on track to initiate a Phase 2 proof-of-concept trial in abdominal aortic aneurysm (AAA) in the second half of 2025[4] - Planning is underway for a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease (ASCVD)[4] Cash Position as of June 30, 2025 | Metric | Amount (Millions USD) | | :----- | :-------------------- | | Cash, cash equivalents, and investments | $256.4 | | Expected cash runway | Into H2 2027 | CEO Commentary The CEO highlighted pacibekitug's best-in-class potential following positive Phase 2 data and outlined plans for further development - Q2 2025 was a transformative period for Tourmaline with the first data readout for pacibekitug[2] - Topline results from the Phase 2 TRANQUILITY trial unlocked pacibekitug's best-in-class potential by demonstrating the viability of quarterly subcutaneous administration[2] - The company plans to advance pacibekitug into the next stage of development within cardiovascular inflammation, including a planned Phase 2 trial in AAA in H2 2025[2] Clinical Development Updates The company provided updates on its cardiovascular inflammation and Thyroid Eye Disease programs for pacibekitug Cardiovascular Inflammation Program The pacibekitug program advanced with positive Phase 2 results and plans for Phase 3 trials in cardiovascular diseases TRANQUILITY Phase 2 Trial Topline Results The Phase 2 trial demonstrated statistically significant hs-CRP reductions with quarterly dosing and a favorable safety profile - Positive topline results from the ongoing Phase 2 TRANQUILITY trial were announced on May 20, 2025[5] - Rapid, deep, and durable reductions in hs-CRP through Day 90 were achieved across all pacibekitug arms with high statistical significance (p<0.0001) compared to placebo[5] - Pacibekitug is the first and only IL-6 inhibitor known to demonstrate deep hs-CRP reductions with quarterly dosing in a clinical trial, achieving >85% reduction from baseline[5] - The overall incidence rates of adverse events were comparable to placebo[5][6] Ongoing Development Activities The company is progressing with plans for a Phase 3 ASCVD trial and a Phase 2 AAA trial for pacibekitug - The TRANQUILITY trial serves as the starting point for pacibekitug's clinical development program for ASCVD and other inflammation-driven cardiovascular diseases[11] - Planning for a Phase 3 cardiovascular outcomes trial in ASCVD is progressing[11] - A successful pre-IND interaction with the FDA was completed for a Phase 2 proof-of-concept trial in AAA, with initiation on track for H2 2025[11] Presentations and Publications Additional trial data will be presented at an upcoming cardiology congress, and the company contributed to a relevant publication - Additional data from the TRANQUILITY trial will be presented at the European Society of Cardiology (ESC) Congress on August 31, 2025[11] - Company representatives co-authored a review manuscript on IL-6 signaling in cardiovascular disease published in Circulation: Genomic and Precision Medicine[11] Thyroid Eye Disease (TED) Program The Phase 2b spiriTED trial is ongoing with topline data expected in early 2026 - The Phase 2b spiriTED trial for pacibekitug in TED remains ongoing[11] - Topline data from the spiriTED trial is expected in early 2026[11] - Tourmaline presented a poster on the prevalence of TED in the United States at the ARVO Annual Conference in May 2025[11] - Future development plans in TED will be determined after a review of the Phase 2b spiriTED trial data[11] Second Quarter 2025 Financial Results The company reported a higher net loss driven by increased operating expenses, while maintaining a cash runway into H2 2027 Cash Position and Runway Cash and investments totaled $256.4 million, providing a projected operational runway into the second half of 2027 Cash, Cash Equivalents, and Investments | Metric | June 30, 2025 (Millions USD) | December 31, 2024 (Millions USD) | Change (Millions USD) | | :----- | :--------------------------- | :------------------------------- | :-------------------- | | Cash, cash equivalents, and investments | $256.4 | $294.9 | -$38.5 | - Current cash, cash equivalents, and investments are anticipated to provide a cash runway into the second half of 2027[10][12] Operating Expenses Total operating expenses rose to $26.0 million, primarily due to increased research and development activities Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 (Thousands USD) | Q2 2024 (Thousands USD) | YoY Change (Thousands USD) | YoY Change (%) | | :--------------- | :---------------------- | :---------------------- | :------------------------- | :------------- | | Research and development | $19,634 | $15,734 | $3,900 | 24.8% | | General and administrative | $6,340 | $6,237 | $103 | 1.6% | | Total operating expenses | $25,974 | $21,971 | $4,003 | 18.2% | - The increase in research and development expenses was primarily driven by increased clinical trial expenses and employee compensation costs[17] - The slight increase in general and administrative expenses was primarily driven by increased employee compensation costs[17] Net Loss The net loss for the quarter increased to $23.1 million, or $0.90 per share, reflecting higher operational spending Net Loss (Three Months Ended June 30) | Metric | Q2 2025 (Thousands USD) | Q2 2024 (Thousands USD) | YoY Change (Thousands USD) | YoY Change (%) | | :----- | :---------------------- | :---------------------- | :------------------------- | :------------- | | Net loss | $(23,092)$ | $(17,487)$ | $(5,605)$ | 32.0% | | Net loss per share, basic and diluted | $(0.90)$ | $(0.68)$ | $(0.22)$ | 32.4% | - The increase in net loss was attributable to increased operating expenses and the company's overall growth[17] Condensed Consolidated Statements of Operations The statement details a Q2 2025 net loss of $23.1 million, an increase from $17.5 million in the prior-year period Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :---------------------------------- | :---------- | :---------- | :---------- | :---------- | | (amounts in thousands) | 2025 | 2024 | 2025 | 2024 | | Research and development | $19,634 | $15,734 | $39,892 | $27,110 | | General and administrative | $6,340 | $6,237 | $12,313 | $12,378 | | Total operating expenses | $25,974 | $21,971 | $52,205 | $39,488 | | Loss from operations | $(25,974)$ | $(21,971)$ | $(52,205)$ | $(39,488)$ | | Other income, net | $2,882 | $4,484 | $6,143 | $8,690 | | Net loss | $(23,092)$ | $(17,487)$ | $(46,062)$ | $(30,798)$ | | Net loss per share, basic and diluted | $(0.90)$ | $(0.68)$ | $(1.79)$ | $(1.24)$ | | Weighted-average common shares outstanding, basic and diluted | 25,755 | 25,724 | 25,723 | 24,908 | Selected Condensed Consolidated Balance Sheet Data The balance sheet shows cash and investments of $256.4 million and total assets of $269.3 million as of June 30, 2025 Selected Condensed Consolidated Balance Sheet Data (Unaudited) | | June 30, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :------------------------------ | :------------------------------ | :-------------------------------- | | Cash, cash equivalents and investments | $256,418 | $294,936 | | Working capital | $239,006 | $259,933 | | Total assets | $269,295 | $309,001 | | Total stockholders' equity | $259,192 | $300,052 | Company and Product Information This section provides an overview of Tourmaline Bio's mission and its lead asset, pacibekitug About Tourmaline Bio Tourmaline Bio is a late-stage clinical biotechnology company developing medicines for immune and inflammatory diseases - Tourmaline is a late-stage clinical biotechnology company[14] - Its mission is to develop transformative medicines for patients with life-altering immune and inflammatory diseases[14] - Pacibekitug is Tourmaline's lead asset[14] About Pacibekitug Pacibekitug is a long-acting, anti-IL-6 monoclonal antibody being developed for cardiovascular and thyroid eye diseases - Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential[15] - Differentiated properties include a naturally long half-life, low immunogenicity, and high binding affinity to IL-6[15] - The product has been studied in approximately 450 participants across six completed clinical trials[15] - Pacibekitug is currently being developed for atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED), with plans to expand into other diseases[15] Legal and Contact Information This section contains the forward-looking statements disclaimer and contact details for inquiries Cautionary Note Regarding Forward-Looking Statements This note outlines the risks and uncertainties associated with forward-looking statements in the report - Statements in this press release that do not describe historical facts may constitute forward-looking statements[16] - These statements involve risks and uncertainties that could cause actual results to differ materially from projections[18] - Risks include those inherent in therapeutic product development, clinical trial delays, and changes in the regulatory environment[18] - Tourmaline assumes no obligation to update any forward-looking statements[18] Contacts This section provides contact information for media and investor relations - Media Contact: Sarah Mishek at Scient PR (SMishek@ScientPR.com)[21] - Investor Contact: Lee M. Stern at Meru Advisors (lstern@meruadvisors.com)[21]