Kailera Therapeutics (KLRA) investor relations material

Market opportunity and strategy

• Obesity affects more than 1B people globally, while treatment rates remain in the high-single to low-double digits; the global market is projected to exceed $200B by 2030.

• Dual GLP-1/GIP therapies represent more than 85% of the market, but penetration remains in the high single digits to ~10%; oral access and international expansion are among the growth drivers.

• Four clinical-stage programs span oral and injectable formats and single, dual, and triple agonists, targeting needs for greater weight loss, tolerability, and tailored treatment.

• More than 60M U.S. adults with obesity are projected to have BMI ≥35 by 2030; management cited continued unmet need for greater weight loss in this population.

Pipeline and milestones

• Ribupatide injectable phase III and high-dose phase II-B trials are fully enrolled; phase II-B data are expected mid-2027 and KaiNETIC phase III data mid-2028.

• KaiNETIC comprises three global trials with nearly 5,000 participants across 11 countries and more than 200 sites; KaiNETIC 3 focuses on BMI ≥35 without type 2 diabetes and includes open-label semaglutide as a comparator.

• Oral ribupatide phase III is planned to start in H1 2027, evaluating doses up to 25 mg over 60 weeks; the FDA end-of-phase II meeting is complete.

• Safiglipron phase II is fully enrolled, with data expected mid-2027; KAI-4729 has an active FDA IND, with phase I planned by end-2026 and data expected in 2027.

• 2027 catalysts include oral ribupatide phase III initiation and data from ribupatide phase II-B, safiglipron phase II, and KAI-4729 phase I.

Clinical evidence

• Ribupatide 8 mg produced 21.1% placebo-adjusted weight loss at 12 weeks at the top dose; mean loss was 23.6% at 36 weeks, including 12 weeks at the top dose, with no plateau reported.

• In a China phase II study, oral ribupatide 25 mg delivered 12.1% weight loss at 26 weeks with no plateau; nausea was ≤22.7% and vomiting ≤11.4%.

• Hengrui's China phase III safiglipron study showed 11.1% weight loss with 180 mg at 50 weeks; no liver safety signal was observed among more than 2,400 patients dosed.

• In an early 12-week phase I study, KAI-4729 12 mg showed 16% mean weight loss and a 67.3% reduction in liver fat; nonclinical studies showed greater weight loss than retatrutide at the same dose level.