Tourmaline Bio Reports First Quarter 2024 Financial Results and Recent Business Highlights

Tourmaline Bio, Inc.
Tourmaline Bio, Inc.

In This Article:

– Initiated Phase 2 TRANQUILITY trial in April 2024 following U.S. FDA clearance of Investigational New Drug application (IND) for clinical development program in Atherosclerotic Cardiovascular Disease (ASCVD) –

– Expanded Thyroid Eye Disease (TED) clinical development plan, including accelerating the planned initiation of a pivotal Phase 3 trial into 2024 –

– Completed underwritten follow-on public offering in January 2024, raising gross proceeds of $172.5 million –

– Ended the quarter with $350.3 million of cash, cash equivalents and investments, providing cash runway into 2027 –

NEW YORK, May 13, 2024 (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 first quarter ended March 31, 2024 and outlined recent business highlights.

“During the first quarter of 2024, we continued to execute on our two strategic paths for TOUR006, including the initiation of our Phase 2 TRANQUILITY trial in patients with elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease (CKD). We believe TOUR006 offers multiple pipelines in a single product with the potential to address significant unmet medical needs in TED, ASCVD, and other autoantibody and inflammation-driven diseases,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “We are excited about the ongoing progress of our clinical programs as well as the opportunity to expand into additional indications in 2024 and beyond.”

Clinical Highlights and Upcoming Milestones:

Tourmaline is currently pursuing the development of TOUR006 in two areas of high unmet need: FcRn+ and cardiovascular inflammation.

FcRn+

  • Tourmaline believes that TOUR006, a long-acting, fully-human, anti-IL-6 monoclonal antibody, can potentially deliver substantial therapeutic benefit to address a wide range of autoantibody-driven disorders, including by providing a more durable response and patient-friendly administration compared to therapies currently on the market or in clinical development.

  • The pivotal spiriTED Phase 2b trial in TED is currently enrolling, and Tourmaline expects topline data in 2025.

  • Tourmaline plans to initiate a pivotal Phase 3 trial evaluating TOUR006 delivered subcutaneously every 8 weeks as first-line treatment for TED in the second half of 2024, with topline data expected in 2026.

Cardiovascular Inflammation

  • In 2023, Tourmaline reached alignment with the U.S. Food and Drug Administration (FDA) on the clinical development program of TOUR006 in ASCVD, and Tourmaline received clearance for the related IND in March 2024.

  • In April 2024, Tourmaline initiated the Phase 2 TRANQUILITY trial, which evaluates quarterly subcutaneous dosing of TOUR006 in patients with elevated hs-CRP and CKD. Topline data from this trial are expected in the first half of 2025.

  • If successful, results from the Phase 2 TRANQUILITY trial are expected to position Tourmaline to be Phase 3-ready in 2025 for TOUR006 in cardiovascular disease.