Tourmaline Bio (TRML) Investor Day 2024 summary

Strategic vision and pipeline progress

• Focused on advancing pacibartug/pacibekitug, a long-acting anti-IL-6 monoclonal antibody, in cardiovascular inflammation (ASCVD), thyroid eye disease (TED), and abdominal aortic aneurysm (AAA), with two pivotal phase II readouts (TRANQUILITY and SPIRITED/spiriTED) expected in 2025.

• TRANQUILITY trial in ASCVD surpassed enrollment targets with 143 patients; top-line data expected Q2 2025, aiming for phase III readiness.

• SPIRITED/spiriTED phase II-b trial in TED is ongoing, with top-line data anticipated in H2 2025; phase III TED trial initiation will depend on these results.

• Announced expansion into AAA, with a phase II proof-of-concept study to start after TRANQUILITY data, leveraging genetic and epidemiological support for IL-6 inhibition.

• Strategic prioritization of cardiovascular inflammation, sequencing late-stage trials and preserving financial flexibility and optionality for partnerships or financing post-2025 data readouts.

Scientific rationale and market opportunity

• IL-6 inhibition is supported by robust genetic, epidemiological, and clinical data as a key driver of residual inflammatory risk in cardiovascular disease and AAA.

• Pacibartug/pacibekitug offers quarterly subcutaneous dosing, rapid and durable hsCRP reduction, and a favorable safety profile, differentiating it from competitors.

• Cardiovascular inflammation represents a multi-billion-dollar opportunity, with over 20 million U.S. patients having residual inflammatory risk; ASCVD alone has a 14 million patient addressable market.

• AAA is a high unmet need with no FDA-approved therapies; IL-6 inhibition shows strong genetic and experimental support for slowing aneurysm progression.

• TED market research highlights significant dissatisfaction with current therapies, with pacibartug/pacibekitug's profile capturing leading market share in surveys among U.S. specialists.

Clinical development and differentiation strategy

• TRANQUILITY trial is designed to demonstrate rapid, robust hsCRP reduction and confirm quarterly dosing, with safety and PK/PD data to support phase III transition.

• AAA phase II study will use advanced imaging to assess aneurysm growth, with trial design informed by TRANQUILITY data and regulatory engagement.

• Differentiation strategy includes quarterly dosing, targeting high-risk populations not addressed by competitors, and leveraging learnings from first-to-market brands.

• TED program leverages strong KOL engagement and market research, with phase II-b SPIRITED/spiriTED trial focusing on proptosis response and holistic disease impact.

• Financial discipline maintained by sequencing late-stage trials and preserving optionality for partnerships or financing post-2025 data readouts.