Tourmaline Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights

-- Phase 2 TRANQUILITY trial in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease over-enrolled to 143 total participants, on track to report topline data in the second quarter of 2025 --

-- Cardiovascular Scientific Advisory Board strengthened with recent appointments of Drs. Deepak L. Bhatt, Dipender Gill, Paul M. Ridker, and Tabassome Simon --

-- Cash, cash equivalents, and investments of $294.9 million as of December 31, 2024, providing expected cash runway into the second half of 2027 --

NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced its financial results for the fourth quarter and year ended December 31, 2024 and outlined recent business highlights.

"2024 was an important year of execution as it relates to our clinical development programs in cardiovascular inflammation and thyroid eye disease," said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. "We are now transitioning into a potentially transformative year of data in 2025, leading off with topline data from our Phase 2 TRANQUILITY trial expected in the second quarter. Complemented by our strong balance sheet and with the support of our world-class team, we look forward to sharing our first data readouts this year and making further progress towards realizing the enormous standard-of-care changing potential of pacibekitug."

Clinical Highlights and Upcoming Milestones:

Cardiovascular Inflammation

   -- In December 2024, Tourmaline announced the over-enrollment of its Phase 2 
      TRANQUILITY trial, which evaluates quarterly and monthly subcutaneous 
      dosing of pacibekitug in patients with elevated high-sensitivity 
      C-reactive protein and chronic kidney disease. A total of 143 
      participants have been enrolled in the Phase 2 TRANQUILITY trial, as 
      compared to 120 participants originally anticipated. Tourmaline remains 
      on track to report topline data from the TRANQUILITY trial in the second 
      quarter of 2025. 
 
   -- The TRANQUILITY trial is the starting point of Tourmaline's clinical 
      development program for pacibekitug for the potential treatment of 
      atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular 
      diseases. If successful, results from the TRANQUILITY trial are expected 
      to position pacibekitug to be Phase 3-ready for ASCVD. 
 
   -- At its Investor Day in December 2024, Tourmaline announced the nomination 
      of abdominal aortic aneurysm $(AAA)$ as an additional indication within its 
      cardiovascular inflammation disease focus for pacibekitug. 
 
   -- Tourmaline expects to provide additional details on a planned Phase 2 
      proof-of-concept trial in AAA after topline results from the TRANQUILITY 
      trial are reported in the second quarter of 2025. 

Thyroid Eye Disease (TED)

   -- The Phase 2b spiriTED trial remains ongoing, and Tourmaline continues to 
      expect topline data from this trial in the second half of 2025. 
 
   -- Tourmaline expects to provide additional information on its future 
      development plans in TED after review of data from the Phase 2b spiriTED 
      trial. 

Other Corporate Highlights:

   -- Tourmaline has continued to bolster its world-class Cardiovascular 
      Scientific Advisory Board (CV SAB), which is providing invaluable 
      strategic guidance toward the expected future development of pacibekitug 
      to reduce inflammation in cardiovascular diseases. 
 
          -- In December 2024, Tourmaline announced that Deepak L. Bhatt, MD, 
             MPH, MBA, FACC, FAHA, FESC, MSCAI and Dipender Gill, MD, PhD had 
             joined the CV SAB. Dr. Bhatt is the Director of the Mount Sinai 
             Fuster Heart Hospital and the Dr. Valentin Fuster Professor of 
             Cardiovascular Medicine at the Icahn School of Medicine at Mount 
             Sinai in New York City. Dr. Gill is the CEO and Founder of Sequoia 
             Genetics. 
 
          -- In January 2025, Tourmaline announced that Paul M. Ridker, MD, MPH 
             had joined the CV SAB. Dr. Ridker is the Eugene Braunwald 
             Professor of Medicine at the Harvard Medical School and Director 
             of the Center for Cardiovascular Disease Prevention at Brigham and 
             Women's Hospital. 
 
          -- Additionally, Tourmaline is announcing today that Tabassome Simon, 
             MD, PhD has joined the CV SAB. Dr. Simon is a Professor of 
             Medicine and Clinical Pharmacology in the Department of 
             Pharmacology at Assistance Publique-Hôpitaux de Paris (AP-HP, 
             Saint-Antoine Hospital) and Sorbonne Université. Dr. Simon's 
             primary research focuses on the impact of therapeutics on 
             secondary prevention in cardiology and emergency care. She is 
             currently the scientific coordinator of ongoing multi-center 
             trials including studies in myocardial infarction, a member of 
             several Executive Committees and Data Safety Monitoring Boards in 
             national and international trials and has published more than 340 
             articles in international peer-reviewed journals, including The 
             New England Journal of Medicine, The Lancet, JAMA, and Annals of 
             Internal Medicine. 
 
   -- In November 2024, Tourmaline hosted an expert webinar on the human 
      genetic validation for IL-6 inhibition in cardiovascular disease with Dr. 
      Gill. A replay of this webinar can be accessed here. 
 
   -- In December 2024, Tourmaline hosted its first Investor Day, highlighting 
      its focus on cardiovascular inflammation and featuring Dr. Marc Bonaca, 
      Executive Director of CPC Clinical Research and Professor of Medicine and 
      William R. Hiatt Endowed Chair in Cardiovascular Research at the 
      University of Colorado Anschutz. Dr. Bonaca is also a member of 
      Tourmaline's CV SAB. A replay of Investor Day can be accessed here. 

Fourth Quarter and Full Year 2024 Financial Results:

Cash Position

   -- Cash, cash equivalents and investments were $294.9 million as of 
      December 31, 2024, as compared to $203.0 million as of December 31, 2023. 
      Tourmaline anticipates that its current cash, cash equivalents, and 
      investments will provide cash runway into the second half of 2027, 
      funding its operations through key pacibekitug data readouts in 
      cardiovascular inflammation and TED as well as other pacibekitug 
      development activities. 

Research and Development Expenses

   -- Research and development expenses were $20.5 million for the fourth 
      quarter of 2024, as compared to $8.0 million for the fourth quarter of 
      2023. 
 
   -- Research and development expenses were $67.0 million for the full year 
      ended December 31, 2024, as compared to $32.4 million for the full year 
      ended December 31, 2023. 
 
   -- The increase in research and development expenses for both periods was 
      primarily driven by increased employee compensation costs attributable to 
      additional headcount, increased clinical trial expenses directly related 
      to the TRANQUILITY and spiriTED trials, increased drug manufacturing 
      expenses, and increased medical affairs costs. 

General and Administrative Expenses

   -- General and administrative expenses were $5.3 million for the fourth 
      quarter of 2024, as compared to $6.9 million for the fourth quarter of 
      2023. 
 
   -- General and administrative expenses were $22.7 million for the full year 
      ended December 31, 2024, as compared to $13.0 million for the full year 
      ended December 31, 2023. 
 
   -- The decrease in general and administrative expenses from the fourth 
      quarter of 2023 to the fourth quarter of 2024 was primarily driven by 
      decreased stock-based compensation expense. The increase in general and 
      administrative expenses from the full year ended December 31, 2023 to the 
      full year ended December 31, 2024 was primarily driven by employee 
      compensation costs attributable to increased headcount, increased 
      professional services fees, and increased insurance expenses associated 
      with being a public company. 

Net Loss

   -- Net loss was $22.2 million for the fourth quarter of 2024 and $12.9 
      million for the fourth quarter of 2023, resulting in basic and diluted 
      net loss per share of $0.86 and $0.81, respectively. 
 
   -- Net loss was $73.2 million for the full year ended December 31, 2024 and 
      $42.1 million for the full year ended December 31, 2023, resulting in 
      basic and diluted net loss per share of $2.89 and $8.87, respectively. 
 
   -- The increase in net loss for both periods and the increase in net loss 
      per share from the fourth quarter of 2023 to the fourth quarter of 2024 
      was attributable to increased operating expenses and Tourmaline's overall 
      growth during 2024. The decrease in net loss per share from the full year 
      ended December 31, 2023 to the full year ended December 31, 2024 was 
      attributable to the issuance of additional shares of common stock in 
      conjunction with Tourmaline's reverse merger and private placement 
      completed in October 2023 and the underwritten follow-on public offering 
      completed by Tourmaline in January 2024. 

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March 13, 2025 07:30 ET (11:30 GMT)