Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q _____________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40384 __________________________________________________________ TOURMALINE BIO, ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) Tourmaline Bio reported Q2 2025 financial results and positive Phase 2 TRANQUILITY trial data for pacibekitug, demonstrating rapid, deep, and durable hs-CRP reductions with quarterly dosing [Second Quarter 2025 Overview](index=1&type=section&id=Second%20Quarter%202025%20Overview) Tourmaline Bio reported its Q2 2025 financial results and highlighted positive topline data from the Phase 2 TRANQUILITY trial of pacibekitug, demonstrating rapid, deep, and durable reductions in hs-CRP with quarterly dosing - Tourmaline Bio reported positive topline results from the ongoing Phase 2 TRANQUILITY trial of pacibekitug in May 2025, showing rapid, deep, and durable reductions in high-sensitivity C-reactive protein (hs-CRP) with quarterly dosing[1](index=1&type=chunk) - The CEO, Sandeep Kulkarni, stated that the second quarter of 2025 was a 'transformative period' due to the first data readout for pacibekitug, which demonstrated the viability of quarterly subcutaneous administration and unlocked its best-in-class potential[2](index=2&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) Tourmaline Bio announced positive Phase 2 TRANQUILITY trial results for pacibekitug in cardiovascular inflammation and continues development for AAA and ASCVD, while the TED trial progresses [Cardiovascular Inflammation Highlights](index=1&type=section&id=Cardiovascular%20Inflammation%20Highlights) Tourmaline Bio announced positive topline results from the Phase 2 TRANQUILITY trial for pacibekitug, showing significant hs-CRP reductions with quarterly dosing, and is progressing with Phase 2 AAA and Phase 3 ASCVD trials [TRANQUILITY Topline Results](index=1&type=section&id=TRANQUILITY%20Topline%20Results) - Positive topline results from the Phase 2 TRANQUILITY trial were announced on May 20, 2025, evaluating quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated hs-CRP and chronic kidney disease[5](index=5&type=chunk) - 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](index=5&type=chunk) - Pacibekitug is the first and only IL-6 inhibitor known to demonstrate deep hs-CRP reductions with quarterly dosing, achieving **>85% hs-CRP reductions** from baseline in the 50 mg quarterly arm after a single dose[5](index=5&type=chunk) - The overall incidence rates of adverse events and serious adverse events in the pacibekitug groups were comparable to placebo through April 23, 2025[5](index=5&type=chunk)[6](index=6&type=chunk) [Ongoing Development Activities](index=2&type=section&id=Ongoing%20Development%20Activities) - Tourmaline continues to plan for a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease (ASCVD)[4](index=4&type=chunk)[11](index=11&type=chunk) - The company completed a successful pre-IND interaction with the FDA and is on track to initiate a Phase 2 proof-of-concept trial in abdominal aortic aneurysm (AAA) in the second half of 2025[4](index=4&type=chunk)[11](index=11&type=chunk) [Presentations and Publications](index=2&type=section&id=Presentations%20and%20Publications) - Additional data from the TRANQUILITY trial will be presented at the European Society of Cardiology (ESC) Congress on August 31, 2025[4](index=4&type=chunk)[11](index=11&type=chunk) - Tourmaline's SVP of Medical Research and VP, Head of Medical Affairs, were contributing authors on a review manuscript entitled 'Human Genetics Informing Drug Development in Cardiovascular Disease: Interleukin-6 Signaling as a Case Study' published in August 2025[11](index=11&type=chunk) [Thyroid Eye Disease (TED) Highlights](index=2&type=section&id=Thyroid%20Eye%20Disease%20%28TED%29%20Highlights) The Phase 2b spiriTED trial for pacibekitug in Thyroid Eye Disease (TED) is ongoing, with topline data expected in early 2026 - The Phase 2b spiriTED trial for TED remains ongoing[11](index=11&type=chunk) - Topline data from the spiriTED trial is expected in early 2026[11](index=11&type=chunk) - Tourmaline expects to provide additional information on future development plans in TED after reviewing spiriTED trial data[11](index=11&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Tourmaline Bio reported a net loss of **$23.1 million** for Q2 2025, driven by increased operating expenses, and maintains a cash runway into the second half of 2027 [Financial Overview](index=2&type=section&id=Financial%20Overview) Tourmaline Bio reported a net loss of **$23.1 million** for Q2 2025, an increase from Q2 2024, primarily due to higher operating expenses driven by increased clinical trial activities and headcount [Cash Position](index=2&type=section&id=Cash%20Position) Cash, Cash Equivalents, and Investments | Metric | June 30, 2025 (Millions USD) | December 31, 2024 (Millions USD) | | :-------------------------------- | :-------------------------- | :------------------------------ | | Cash, cash equivalents, and investments | $256.4 | $294.9 | - Current cash, cash equivalents, and investments are anticipated to provide a cash runway into the second half of 2027, funding operations through key pacibekitug data readouts and development activities[4](index=4&type=chunk)[10](index=10&type=chunk)[12](index=12&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Operating Expenses (Q2 2025 vs Q2 2024) | Expense Category | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change (Millions USD) | YoY Change (%) | | :------------------------ | :-------------------- | :-------------------- | :-------------------- | :------------- | | Research and development | $19.6 | $15.7 | +$3.9 | +24.8% | | General and administrative | $6.3 | $6.2 | +$0.1 | +1.6% | | **Total operating expenses** | **$26.0** | **$22.0** | **+$4.0** | **+18.2%** | - The increase in R&D expenses was primarily driven by increased clinical trial expenses (TRANQUILITY and spiriTED), routine toxicology study expenses, additional headcount, and consulting expenses, partially offset by decreased chemistry, manufacturing, and controls expenses[17](index=17&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) Net Loss (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change (Millions USD) | YoY Change (%) | | :------------------------ | :-------------------- | :-------------------- | :-------------------- | :------------- | | Net loss | $(23.1) | $(17.5) | $(5.6) | +32.0% | | Net loss per share, basic and diluted | $(0.90) | $(0.68) | $(0.22) | +32.4% | - The increase in both net loss and net loss per share was attributable to increased operating expenses and Tourmaline's overall growth from 2024 to 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statements of operations show a net loss of **$23.092 million** for the three months ended June 30, 2025, and **$46.062 million** for the six months ended June 30, 2025, reflecting increased operating expenses year-over-year Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended June 30, | | Six Months Ended June 30, | | | :------------------------------------------ | :---------- | :---------- | :---------- | :---------- | | | **2025 (Thousands USD)** | **2024 (Thousands USD)** | **2025 (Thousands USD)** | **2024 (Thousands USD)** | | Operating expenses: | | | | | | 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](index=5&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, Tourmaline Bio reported cash, cash equivalents, and investments of **$256.4 million**, a decrease from December 31, 2024 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 Information](index=3&type=section&id=Company%20Information) Tourmaline Bio is a late-stage clinical biotechnology company focused on developing transformative medicines for immune and inflammatory diseases, with pacibekitug as its lead asset [About Tourmaline Bio](index=3&type=section&id=About%20Tourmaline%20Bio) Tourmaline Bio is a late-stage clinical biotechnology company focused on developing transformative medicines for immune and inflammatory diseases, with pacibekitug as its lead asset - Tourmaline Bio is a late-stage clinical biotechnology company developing transformative medicines for life-altering immune and inflammatory diseases[14](index=14&type=chunk) - Pacibekitug is Tourmaline's lead asset[14](index=14&type=chunk) [About Pacibekitug](index=3&type=section&id=About%20Pacibekitug) Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential, currently being developed for ASCVD and TED, with plans to expand into AAA and other indications - Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential, featuring a naturally long half-life, low immunogenicity, and high binding affinity to IL-6[15](index=15&type=chunk) - Excluding ongoing trials, pacibekitug was previously studied in approximately **450 participants** across six completed clinical trials for autoimmune disorders[15](index=15&type=chunk) - Tourmaline is currently developing pacibekitug for atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases[15](index=15&type=chunk) [Legal and Contact Information](index=3&type=section&id=Legal%20and%20Contact%20Information) This section provides cautionary notes regarding forward-looking statements, outlining inherent risks and uncertainties, and lists contact information for media and investors [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section outlines that statements not describing historical facts are forward-looking and involve risks and uncertainties that could cause actual results to differ materially - Statements in the press release that do not describe historical facts are forward-looking statements, identified by words like 'believe,' 'expect,' 'may,' 'plan,' 'potential,' and 'will'[16](index=16&type=chunk) - These statements involve risks and uncertainties that could cause actual results to differ materially, including risks related to product development, clinical trial delays, replication of prior results, safety/efficacy profiles, financial estimates, competition, regulatory environment, and macroeconomic conditions[18](index=18&type=chunk) - Tourmaline assumes no obligation to update any forward-looking statements[18](index=18&type=chunk) [Contacts](index=6&type=section&id=Contacts) Contact information for media and investor relations is provided - Media Contact: Scient PR, Sarah Mishek (SMishek@ScientPR.com)[21](index=21&type=chunk) - Investor Contact: Meru Advisors, Lee M. Stern (lstern@meruadvisors.com)[21](index=21&type=chunk)

PART I. FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) 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 needs[23](index=23&type=chunk)[24](index=24&type=chunk) - 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, 2025[45](index=45&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk) - In January 2024, a public offering generated net proceeds of approximately **$161.4 million**[54](index=54&type=chunk)[55](index=55&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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)[87](index=87&type=chunk)[88](index=88&type=chunk) - 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 2025[90](index=90&type=chunk)[91](index=91&type=chunk)[93](index=93&type=chunk) 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 headcount[125](index=125&type=chunk)[127](index=127&type=chunk) - 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 2027[130](index=130&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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 company[151](index=151&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) 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, 2025[153](index=153&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter[154](index=154&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) 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 business[157](index=157&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) 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 business[170](index=170&type=chunk) - The company has a history of net losses, anticipates significant operating losses, and will require substantial additional capital to fund future development and operations[164](index=164&type=chunk)[175](index=175&type=chunk) - Complete reliance on CDMOs for **pacibekitug** manufacturing exposes the company to risks of supply disruption, quality control issues, and regulatory compliance failures[189](index=189&type=chunk) - Clinical trials face significant risks, including delays, failure to demonstrate safety and efficacy, and patient enrollment difficulties, potentially preventing or delaying regulatory approval[235](index=235&type=chunk)[238](index=238&type=chunk)[243](index=243&type=chunk) - Dependence on license agreements with Pfizer and Lonza means their termination could halt **pacibekitug** development and commercialization[357](index=357&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Securities](index=84&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Securities) 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 separation[389](index=389&type=chunk) [Defaults Upon Senior Securities](index=84&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable as the company has no defaults on senior securities to report [Mine Safety Disclosures](index=84&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company [Other Information](index=84&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this period [Exhibits](index=85&type=section&id=Item%206.%20Exhibits) 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](index=394&type=chunk)

Financial Performance - Cash, cash equivalents, and investments were $275.3 million as of March 31, 2025, down from $294.9 million as of December 31, 2024, providing a cash runway into the second half of 2027[10] - Net loss for Q1 2025 was $23.0 million, resulting in a basic and diluted net loss per share of $0.89, compared to a net loss of $13.3 million and a net loss per share of $0.55 in Q1 2024[14] - Total operating expenses for Q1 2025 were $26.2 million, compared to $17.5 million for Q1 2024[19] - General and administrative expenses decreased slightly to $6.0 million in Q1 2025 from $6.1 million in Q1 2024, mainly due to reduced consulting expenses[14] - Tourmaline's total assets decreased to $287.5 million as of March 31, 2025, from $309.0 million as of December 31, 2024[20] Research and Development - Research and development expenses increased to $20.3 million for Q1 2025, compared to $11.4 million for Q1 2024, primarily due to increased clinical trial expenses[14] - The Phase 2 TRANQUILITY trial has enrolled 143 participants, exceeding the initial target of 120, with topline data expected in Q2 2025[7] - Tourmaline plans to provide further details on the clinical development plan for pacibekitug in cardiovascular inflammation alongside the TRANQUILITY topline data[6] - Tourmaline expects to report topline data from the Phase 2b spiriTED trial in the second half of 2025[5] - The company anticipates additional information on future development plans in Thyroid Eye Disease (TED) after reviewing data from the spiriTED trial[8]

Product Development and Trials - Pacibekitug, a fully human monoclonal antibody targeting IL-6, has the potential to establish new standards of care in autoimmune and inflammatory diseases[19]. - The Phase 2 TRANQUILITY trial for pacibekitug commenced in April 2024, with topline data expected in Q2 2025[22]. - The spiriTED trial for thyroid eye disease (TED) was initiated in September 2023, with topline results anticipated in the second half of 2025[24]. - The FDA has cleared INDs for both the TRANQUILITY and spiriTED trials, facilitating the advancement of pacibekitug in clinical development[41]. - The Phase 2 TRANQUILITY trial for pacibekitug commenced in April 2024, focusing on hs-CRP reduction, with topline data expected in Q2 2025[64]. - A Phase 2 proof of concept trial for pacibekitug is planned, with topline results from the TRANQUILITY trial expected in Q2 2025[71]. - The spiriTED trial is a Phase 2b study enrolling approximately 81 participants with specific inclusion criteria, including a baseline proptosis of at least 3 mm greater than normal[92]. - The primary endpoint of the spiriTED trial is the proptosis response rate at Week 20, defined as a ≥2 mm reduction in proptosis from baseline[93]. - Topline results for the spiriTED trial's Primary Efficacy Period are expected in the second half of 2025, with a Phase 3 trial contingent on these results[95]. - Previous studies by Pfizer involved approximately 450 participants treated with pacibekitug across six clinical trials, including Phase 2 studies in other conditions[99]. Market Potential and Demand - The anti-IL-6 class generated over $3.5 billion in global sales in 2024, indicating a strong market demand for IL-6 inhibitors[19]. - Cardiovascular disease (CVD) accounted for an estimated 20 million deaths worldwide in 2021, indicating a significant unmet need for effective treatments[45]. - Atherosclerosis contributes to approximately 80% of all cardiovascular deaths, highlighting the critical need for targeted therapies[47]. - Pacibekitug is expected to be dosed once every three months, offering a differentiated product profile for treating cardiovascular inflammation[21]. - Pacibekitug offers a quarterly dosing regimen, potentially improving patient adherence compared to competitors that require monthly administration[61]. - The company estimates that 15,000 to 20,000 patients in the U.S. have moderate to severe, active, inflammatory TED suitable for advanced therapy like pacibekitug[91]. Safety and Efficacy - Pacibekitug has demonstrated a terminal half-life of 47 to 58 days, allowing for deep and sustained suppression of the IL-6 pathway[42]. - Pacibekitug has shown low immunogenicity, with only 0.4% of patients developing treatment-emergent anti-drug antibodies in Phase 1 and Phase 2 studies[43]. - Safety data indicated that pacibekitug was generally well-tolerated, with no dose-limiting adverse effects reported in doses up to 500 mg[102]. - The most frequently reported treatment-related adverse events were infections and gastrointestinal disorders, with a higher incidence in pacibekitug groups compared to placebo[102]. - Pacibekitug demonstrated >80% mean percent reduction in serum CRP levels in higher dose groups compared to placebo from Day 7 to Day 84[104]. - In the Phase 2 SLE trial, the 10 mg pacibekitug group showed a 60% response rate on SLE Responder Index compared to 40% in the placebo group (p=0.076) but did not meet the primary endpoint[113]. - The CDAI-70 response rate for the 50 mg pacibekitug arm was 49.3% at Week 8 and 47.4% at Week 12, significantly greater than placebo (30.6% and 28.6%, respectively, one-sided p <0.05)[120]. - Median percent change in serum hs-CRP at Week 12 was -12.3%, -66.4%, -86.3%, and -95.5% for placebo, 10 mg, 50 mg, and 200 mg treatment groups, respectively[119]. Regulatory and Compliance - The FDA has cleared the IND for the ASCVD clinical development program related to pacibekitug, indicating regulatory support for its advancement[64]. - The FDA approval process requires substantial time and financial resources, with various stages including preclinical tests, IND submission, and clinical trials[158]. - The FDA has 60 days to review a Biologics License Application (BLA) to determine if it is substantially complete for a substantive review[168]. - The FDA aims to complete its initial review of a standard BLA within 10 months and a priority BLA within 6 months from acceptance of filing[168]. - The FDA may withdraw approval if compliance with regulatory requirements is not maintained after the product reaches the market[184]. - The company is subject to various federal, state, and local regulations, including those from the FDA and CMS, impacting clinical research and marketing activities[191]. Financial and Strategic Partnerships - The company entered into a license agreement with Pfizer in May 2022 for the development and commercialization of pacibekitug[123]. - The company paid Pfizer an upfront payment of $5.0 million and granted 7,125,000 Series A preferred units, equivalent to 15% of capital stock on a fully-diluted basis[125]. - The company is obligated to pay Pfizer up to $128.0 million upon achieving specific development and regulatory milestones and up to $525.0 million upon achieving specific sales milestones[126]. - The company raised $75.0 million in a private placement prior to the Reverse Merger, issuing 4,092,035 shares of common stock[134]. - The company does not currently have its own marketing, sales, or distribution capabilities and may seek strategic collaborations for commercialization[138]. Competitive Landscape - The company faces competition from four FDA-approved IL-6 inhibitors and multiple products in active clinical development targeting similar indications[142]. - The company is pursuing a layered intellectual property strategy, including patents and trademarks, to protect its pacibekitug platform[146]. - The patent portfolio includes eight U.S. provisional applications and four pending PCT applications, with non-provisional applications projected to expire in 2043 or 2044[153]. Healthcare Policy and Market Access - Coverage and reimbursement for products depend on third-party payors, including federal and state healthcare programs, which are critical for new product acceptance[204]. - Obtaining reimbursement approval is a time-consuming process that may require extensive clinical and cost-effectiveness data[209]. - The Inflation Reduction Act of 2022 (IRA) allows HHS to negotiate prices for certain high-expenditure biologics after 11 years on the market, impacting potential revenue[213]. - The ACA has increased Medicaid rebates and required manufacturers to offer significant discounts during coverage gaps, impacting overall revenue from government programs[214]. - Changes in coverage policies and reimbursement rates by third-party payors could adversely impact the marketability of approved products[211].

Financial Performance - Cash, cash equivalents, and investments totaled $294.9 million as of December 31, 2024, up from $203.0 million as of December 31, 2023, providing a cash runway into the second half of 2027[5] - Net loss for Q4 2024 was $22.2 million, resulting in a basic and diluted net loss per share of $0.86, compared to a net loss of $12.9 million and a loss per share of $0.81 in Q4 2023[12] - Tourmaline's total operating expenses for the full year 2024 were $89.7 million, compared to $45.4 million in 2023[16] - The increase in net loss for both periods was primarily due to increased operating expenses and overall growth during 2024[12] Research and Development - Research and development expenses for Q4 2024 were $20.5 million, compared to $8.0 million in Q4 2023, and for the full year 2024, they were $67.0 million, up from $32.4 million in 2023[12] - The Phase 2 TRANQUILITY trial has over-enrolled to 143 participants, exceeding the initial target of 120, with topline data expected in Q2 2025[3] - The company anticipates topline data from the Phase 2b spiriTED trial in the second half of 2025, focusing on thyroid eye disease[6] - Tourmaline plans to provide additional details on a Phase 2 proof-of-concept trial for abdominal aortic aneurysm after the TRANQUILITY trial results[3] Company Growth and Assets - Tourmaline's total assets increased to $309.0 million as of December 31, 2024, from $210.3 million in 2023[18] - The company has strengthened its Cardiovascular Scientific Advisory Board with the addition of prominent experts in the field[6]

Financial Performance - The company reported net losses of $51.0 million and $29.2 million for the nine months ended September 30, 2024 and 2023, respectively, with an accumulated deficit of $113.0 million as of September 30, 2024[98]. - As of September 30, 2024, the company has not generated any revenue since inception and does not expect to do so in the near future[117]. - The net loss for the nine months ended September 30, 2024, was $51.0 million, compared to a net loss of $29.2 million for the same period in 2023[139]. - The company has an accumulated deficit of $113.0 million as of September 30, 2024, indicating significant ongoing financial challenges[139]. - Other income, net increased by $11.7 million from $1.3 million for the nine months ended September 30, 2023, to $13.0 million for the same period in 2024, driven by higher investment and interest income[137]. Cash and Investments - The company has total cash, cash equivalents, and investments of $314.4 million as of September 30, 2024[97]. - The company had $314.4 million in cash, cash equivalents, and investments as of September 30, 2024, which is expected to fund operations into 2027[140]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $56.4 million, an increase of $37.6 million compared to $18.7 million for the same period in 2023[148]. - Net cash used in investing activities for the nine months ended September 30, 2024 was $210.7 million, a significant increase from less than $0.1 million in the same period in 2023[149]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $161.4 million, compared to $88.6 million for the same period in 2023[150]. Research and Development - Pacibekitug, the company's lead product candidate, is currently being evaluated in a pivotal Phase 2b trial for thyroid eye disease (TED), with topline data expected in the second half of 2025[93]. - The company initiated a Phase 2 trial of pacibekitug in patients with chronic kidney disease and elevated hs-CRP in April 2024, with topline data expected in the first half of 2025[95]. - The company has reached alignment with the FDA on the ASCVD clinical development program, including a Phase 2 trial evaluating hs-CRP reduction[94]. - The company is exploring additional indication opportunities for pacibekitug and evaluating new in-licensing and acquisition opportunities[96]. - Research and development expenses increased by $15.6 million from $3.8 million in Q3 2023 to $19.3 million in Q3 2024, primarily due to increased clinical trial expenses and employee compensation costs[131]. - Research and development expenses for the nine months ended September 30, 2024, totaled $46.4 million, an increase of $22.1 million from $24.4 million in the same period in 2023[134]. Operating Expenses - For the nine months ended September 30, 2024, total operating expenses were $63.9 million, up $33.4 million from $30.5 million in the same period in 2023[133]. - General and administrative expenses rose by $2.2 million from $2.9 million in Q3 2023 to $5.1 million in Q3 2024, reflecting increased operational costs[132]. Future Capital Requirements - Future capital requirements will be necessary as the company does not expect to generate meaningful product revenue until regulatory approval and commercialization of its product candidates[141]. - The company expects to require substantial additional capital to develop product candidates and fund operations, with potential dilution of stockholder ownership if raised through equity financing[143]. - Future funding requirements will depend on various factors, including the costs of clinical trials and regulatory reviews for product candidates[144]. - The company may need to pay Pfizer up to $128.0 million upon achieving specific development and regulatory milestones and up to $525.0 million upon achieving specific sales milestones[146]. Risks and Obligations - The company is subject to risks associated with the development of new biopharmaceutical products, which may lead to unforeseen expenses and delays[143]. - The company has an obligation to pay Pfizer up to $128.0 million upon achieving specific development and regulatory milestones related to pacibekitug[106]. - The company has entered into a License Agreement with Lonza, obligating it to pay royalties in the low-single digits on net sales of pacibekitug for ten years following the first commercial sale[112]. - The company has entered into agreements with vendors for manufacturing and clinical trial services, which may include cancellation or termination obligations[152]. Company Status - The company remains an emerging growth company and a smaller reporting company, allowing it to take advantage of certain regulatory exemptions[157][159]. - The company cannot assure that it will ever generate positive cash flow from operating activities[143].

Financial Performance - Cash, cash equivalents, and investments totaled $314.4 million as of September 30, 2024, up from $203.0 million as of December 31, 2023, providing a cash runway into 2027[7] - Net loss for Q3 2024 was $20.2 million, compared to a net loss of $5.6 million for Q3 2023, resulting in a basic and diluted net loss per share of $0.78[12] - Total operating expenses for Q3 2024 were $24.4 million, compared to $6.6 million for Q3 2023[15] - Total assets increased to $328.4 million as of September 30, 2024, from $210.3 million as of December 31, 2023[16] Research and Development - Research and development expenses increased to $19.3 million for Q3 2024, compared to $3.8 million for Q3 2023, primarily due to higher employee compensation and clinical trial costs[12] - The pivotal spiriTED Phase 2b trial is ongoing, with topline data expected in the second half of 2025[11] - The Phase 2 TRANQUILITY trial is ongoing, with topline data anticipated in the first half of 2025[6] - Tourmaline is on track to initiate a pivotal Phase 3 trial for pacibekitug in TED in the second half of 2024, with topline data expected in 2026[11] Administrative Expenses - General and administrative expenses rose to $5.1 million for Q3 2024, up from $2.9 million for Q3 2023, driven by increased headcount and professional service fees[12] - Tourmaline formed a Cardiovascular Scientific Advisory Board in October 2024 to guide its cardiovascular program[4]

Financial Performance - The company reported net losses of $30.8 million and $23.6 million for the six months ended June 30, 2024 and 2023, respectively, with an accumulated deficit of $92.8 million as of June 30, 2024[96]. - As of June 30, 2024, the company has not generated any revenue since inception and does not expect to do so in the near future[115]. - For the six months ended June 30, 2024, total operating expenses were $39.5 million, up from $23.9 million in the same period in 2023, marking an increase of $15.6 million[133]. - The net loss for the six months ended June 30, 2024, was $30.8 million, compared to a net loss of $23.6 million for the same period in 2023, an increase of $7.2 million[138]. - Other income, net increased by $8.4 million from $0.2 million for the six months ended June 30, 2023, to $8.7 million for the same period in 2024, primarily due to increased investment and interest income[138]. - The company had $334.4 million in cash, cash equivalents, and investments as of June 30, 2024, and expects this to fund operations into 2027[141]. - Net cash used in operating activities for the six months ended June 30, 2024 was $32.9 million, an increase of $19.6 million from $13.3 million in the same period in 2023[150]. - Net cash used in investing activities for the six months ended June 30, 2024 was $199.0 million, a significant increase from less than $0.1 million in the same period in 2023[151]. - Net cash provided by financing activities for the six months ended June 30, 2024 was $161.4 million, compared to $92.2 million in the same period in 2023[152]. - As of June 30, 2024, the company has raised approximately $359.7 million in outside capital, with net losses of $30.8 million and $23.6 million for the six months ended June 30, 2024 and 2023, respectively[140]. Research and Development - The initial product candidate, pacibekitug, is a fully human monoclonal antibody targeting IL-6, with the anti-IL-6 class generating over $3.5 billion in global sales in 2023[88]. - The pivotal Phase 2b trial for pacibekitug in thyroid eye disease (TED) was initiated in September 2023, with topline data expected in 2025[91]. - The company expects to commence a pivotal Phase 3 trial of pacibekitug in first-line TED in the second half of 2024, with topline data anticipated in 2026[91]. - The FDA cleared the Investigational New Drug application for the ASCVD clinical development program in March 2024, with a Phase 2 trial initiated in April 2024[93]. - Research and development expenses increased by $1.3 million from $14.5 million in Q2 2023 to $15.7 million in Q2 2024, primarily due to increased employee compensation and clinical trial expenses[129]. - The company expects significant increases in research and development and general and administrative costs as it advances clinical development and prepares for potential commercialization[139]. - The company recognized $8.8 million in research and development expenses in the first half of 2023 related to the issuance of additional shares to Pfizer, with no such expense recognized in the first half of 2024[137]. Capital and Funding - The company raised net proceeds of $161.4 million from the public offering of 5,307,691 shares at a price of $32.50 per share in January 2024[97]. - The company anticipates needing additional capital to fund operations, which may be obtained through equity or debt financings, collaborations, or licensing arrangements[139]. - The company is obligated to pay Pfizer up to $128.0 million upon achieving specific development and regulatory milestones related to pacibekitug[105]. - The company may be required to pay Pfizer up to $128.0 million upon achieving specific development and regulatory milestones, and up to $525.0 million upon achieving specific sales milestones[148]. Operational Expenses - General and administrative expenses rose by $4.3 million from $1.9 million in Q2 2023 to $6.2 million in Q2 2024, reflecting increased operational costs[132]. - Operating expenses increased by $3.3 million due to higher employee compensation costs, including $1.2 million in stock-based compensation[143]. Market and Economic Conditions - Macroeconomic conditions, including inflation and global geopolitical conflicts, may impact the company's financial condition and results of operations in the future[113]. - The company is subject to risks associated with the development of new biopharmaceutical products, which may lead to unforeseen expenses and delays[144]. - Future funding requirements will depend on various factors, including the costs of clinical trials and regulatory reviews for its product candidates[146].

Financial Position - The company has $350.3 million in cash, cash equivalents, and investments as of March 31, 2024, following a public offering that raised net proceeds of $161.3 million[95][97]. - As of March 31, 2024, the company has not generated any revenue since inception and does not expect to do so in the near future[115]. - The accumulated deficit as of March 31, 2024, was $75.4 million, reflecting significant recurring losses since inception[132]. - The company has raised approximately $359.7 million in gross proceeds since inception, primarily from outside capital sources[132]. - Future capital requirements will necessitate additional funding through equity or debt financings, collaborations, or licensing arrangements[136]. - Future funding requirements will depend on various factors, including the costs and outcomes of clinical trials for TOUR006 and other product candidates[138]. - The company remains classified as an "emerging growth company" and a "smaller reporting company," with annual revenue below $100.0 million and market value of stock held by non-affiliates below $700.0 million[151]. Operational Performance - Net losses for the three months ended March 31, 2024, were $13.3 million, compared to $7.5 million for the same period in 2023, with an accumulated deficit of $75.4 million[96]. - Research and development expenses increased by $5.2 million from $6.1 million in Q1 2023 to $11.4 million in Q1 2024, primarily due to increased employee compensation and clinical trial expenses[129]. - General and administrative expenses rose by $4.8 million from $1.4 million in Q1 2023 to $6.1 million in Q1 2024, driven by increased compensation and consulting expenses[130]. - The company anticipates substantial increases in research and development and general and administrative costs as it advances clinical development and prepares for potential commercialization[134]. - Net cash used in operating activities for Q1 2024 was $14.9 million, an increase of $11.1 million compared to $3.8 million in Q1 2023[141]. - The increase in cash used in operating activities is primarily due to overall growth in operations, including headcount[141]. Clinical Development - TOUR006, a fully human monoclonal antibody targeting IL-6, has the potential to establish new standards of care in autoimmune and inflammatory diseases, with over $3.5 billion in global sales generated by similar antibodies in 2023[88]. - The spiriTED trial for TOUR006 in first-line thyroid eye disease (TED) was initiated in September 2023, with topline data expected in 2025, and a Phase 3 trial planned for the second half of 2024[91]. - The FDA cleared the Investigational New Drug application for TOUR006 related to atherosclerotic cardiovascular disease (ASCVD), with a Phase 2 trial initiated in April 2024 and topline data expected in the first half of 2025[93]. - The company has identified thyroid eye disease as a key indication for its FcRn+ strategy, leveraging existing clinical observations of IL-6 pathway inhibitors[90]. - The company is pursuing additional indication opportunities for TOUR006 and evaluating new in-licensing and acquisition opportunities for transformative assets in immune and inflammatory diseases[94]. Licensing and Agreements - The Pfizer License Agreement includes potential milestone payments of up to $128 million for development and regulatory achievements, and up to $525 million for sales milestones[105]. - The Lonza License Agreement obligates the company to pay low-single digit royalties on net sales of TOUR006 for ten years following the first commercial sale[110]. - The company may owe Pfizer up to $128.0 million upon achieving specific development and regulatory milestones and up to $525.0 million upon reaching specific sales milestones[139]. - The company is obligated to pay royalties on product sales to Pfizer and Lonza upon commercialization of TOUR006[139]. Mergers and Acquisitions - The Reverse Merger with Talaris Therapeutics was completed on October 19, 2023, resulting in approximately 20,336,741 shares of common stock being issued and outstanding[101]. - The company has entered into agreements with vendors for manufacturing and clinical trial services, which may include purchase and termination obligations[144]. Future Outlook - The successful development of product candidates, including TOUR006, remains highly uncertain, with significant costs and timing risks associated with regulatory approval[120]. - The company’s operating plans may change, potentially requiring additional capital to meet future operational needs[138].