TALARIS THERAPEU(TALS) - 2025 Q2 - Quarterly Results

Executive Summary 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 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] - 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] Recent Business Highlights 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 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 - 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] - 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, achieving >85% hs-CRP reductions from baseline in the 50 mg quarterly arm after a single dose[5] - The overall incidence rates of adverse events and serious adverse events in the pacibekitug groups were comparable to placebo through April 23, 2025[5][6] Ongoing Development Activities - Tourmaline continues to plan for a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease (ASCVD)[4][11] - 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][11] Presentations and Publications - Additional data from the TRANQUILITY trial will be presented at the European Society of Cardiology (ESC) Congress on August 31, 2025[4][11] - 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] Thyroid Eye Disease (TED) Highlights 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] - Topline data from the spiriTED trial is expected in early 2026[11] - Tourmaline expects to provide additional information on future development plans in TED after reviewing spiriTED trial data[11] Second Quarter 2025 Financial Results 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 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 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][10][12] Operating Expenses 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] Net Loss 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] Condensed Consolidated Statements of Operations 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 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 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 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] - Pacibekitug is Tourmaline's lead asset[14] About Pacibekitug 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] - Excluding ongoing trials, pacibekitug was previously studied in approximately 450 participants across six completed clinical trials for autoimmune disorders[15] - 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] Legal and Contact Information 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 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] - 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] - Tourmaline assumes no obligation to update any forward-looking statements[18] Contacts Contact information for media and investor relations is provided - Media Contact: Scient PR, Sarah Mishek (SMishek@ScientPR.com)[21] - Investor Contact: Meru Advisors, Lee M. Stern (lstern@meruadvisors.com)[21]