Kailera reports Q2 2026 results, oral IND active, Phase 2b fully enrolled

Kailera Therapeutics reported second quarter 2026 results on August 12, 2026, alongside a set of pipeline updates. The company's Investigational New Drug application for oral ribupatide (KAI-9531-T) is now active with the FDA, and Kailera says it remains on schedule to start global Phase 3 obesity trials for the oral formulation in the first half of 2027.¹

For the injectable formulation, the Phase 2b high-dose obesity trial (NCT07458269), which enrolled 264 U.S. participants with a BMI of 35 or greater and no type 2 diabetes, is fully enrolled; it is testing once-weekly doses of 10 mg, 13 mg, 16 mg, and 20 mg over 48 weeks, with data expected in mid-2027.¹ Separately, the global Phase 3 KaiNETIC program for injectable ribupatide, comprising three trials enrolling more than 4,700 participants and testing doses up to 10 mg weekly over 76 weeks, remains on track, with data expected in 2028.¹

For KAI-4729, an injectable GLP-1/GIP/glucagon tri-agonist, Kailera says it is on track to begin a Phase 1 trial before the end of 2026, with data expected in 2027.¹ A Phase 2 trial of KAI-7535, an oral small molecule GLP-1 agonist, is already underway in the U.S. and Australia and started in April 2026, with data expected in 2027.¹

On financing, the company held $1,171.8 million in cash, cash equivalents and marketable securities as of June 30, 2026, which it says is enough to fund operations into mid-2028.¹ Net loss for the quarter was $111.3 million, compared to $28.9 million in the same period of 2025.¹

Kailera also was added to the Russell 2000 Index effective June 29, as part of the first 2026 Russell indexes reconstitution.¹