This is a paid press release. Contact the press release distributor directly with any inquiries.
Kailera Reports Second Quarter 2026 Financial Results and Provides Business Updates
Kailera Therapeutics, Inc.
Thu, August 13, 2026 at 1:35 AM GMT+5:30
14 min read
- KLRA
-1.48%
IND for ribupatide oral active with U.S. FDA, initiation of global Phase 3 obesity trials planned for the first half of 2027
Ribupatide injection Phase 2b high-dose trial in obesity fully enrolled, data anticipated in mid-2027
Expanded executive team to strengthen technical operations capabilities and corporate affairs leadership
Cash, cash equivalents, and marketable securities expected to support execution of multiple clinical milestones with runway into mid-2028
WALTHAM, Mass., Aug. 12, 2026 (GLOBE NEWSWIRE) — Kailera Therapeutics, Inc. (Nasdaq: KLRA) (Kailera), a clinical-stage biotechnology company focused on elevating the next era of obesity care, today reported financial results for the second quarter ended June 30, 2026, and provided a summary of recent business highlights
Kailera is advancing a diversified GLP-1-based pipeline of clinical-stage therapeutic candidates for the treatment of obesity. The company’s approach seeks to improve upon currently available treatments by bringing forward product candidates that have the potential to maximize weight loss, improve tolerability, and address other critical needs in the current therapeutic landscape. The Kailera portfolio includes single-, dual-, and triple-agonist mechanisms and both oral and injectable formulations.
“Our second quarter marked another period of strong execution across the Kailera portfolio. We advanced our global Phase 3 KaiNETIC program for ribupatide injection, completed enrollment in our U.S. Phase 2b high-dose ribupatide injection trial with data expected in mid-2027, and opened our ribupatide oral IND, with initiation of our global Phase 3 obesity program planned for the first half of 2027,” said Ron Renaud, President and Chief Executive Officer of Kailera. “With a strong balance sheet and multiple clinical milestones expected over the next 18 months, we believe Kailera is well positioned to deliver differentiated treatment options to people living with obesity.”
Second Quarter Business Highlights and Recent Developments
Ribupatide Injection (KAI-9531), GLP-1/GIP Receptor Dual Agonist
Enrollment on track in global Phase 3 KaiNETIC program with data anticipated in 2028: The program encompasses three global, double-blind, randomized, placebo-controlled Phase 3 trials (KaiNETIC-1, NCT07284875; KaiNETIC-2, NCT07284901; KaiNETIC-3, NCT07284979) enrolling more than 4,700 participants. The program is evaluating once-weekly ribupatide injection doses of up to 10 mg over 76 weeks in adults living with obesity or overweight. Data are anticipated in 2028
Phase 2b high-dose clinical trial in obesity fully enrolled: The Phase 2b trial (NCT07458269) enrolled 264 participants in the U.S. with a BMI of 35 or greater with no type 2 diabetes (T2D). The trial is evaluating once-weekly ribupatide injection doses of 10 mg, 13 mg, 16 mg, and 20 mg over 48 weeks. Data are anticipated in mid-2027
Phase 1 ribupatide injection site trial data to be presented at the 2026 European Association for the Study of Diabetes Annual Meeting (EASD):The oral presentation titled “Effect of Injection Site on the Relative Bioavailability and Safety of Ribupatide, a Novel Dual GLP-1/GIP Receptor Agonist: Phase 1, Randomized, Single-Dose Crossover Study Results,” will detail Kailera’s Phase 1 injection site trial, which supported the ongoing global Phase 3 KaiNETIC clinical program
Phase 1 datapresentedat the 86th Scientific Sessions of the American Diabetes Association (ADA 2026): Results from Kailera’s Phase 1 single ascending dose trial, the first ribupatide injection clinical data generated outside of China, were presented at ADA 2026. The trial demonstrated similar exposure, tolerability, and weight reduction in participants of Asian and non-Asian descent, which supported the ongoing global Phase 3 KaiNETIC clinical program
Positive topline data from Hengrui-conducted trials in indications beyond obesity further strengthen the growing body of clinical evidence supporting ribupatide:
Two Phase 3 trials in T2D:In Hengrui’s Phase 3 trial in T2D patients with inadequate glycemic control despite diet and exercise interventions (NCT06650007), once-weekly ribupatide injection (4 mg and 2 mg) vs. placebo showed significant reductions in HbA1c from baseline, with a maximum mean reduction of 2.67%, based on the efficacy estimand1. In an additional Phase 3 trial in adults with T2D with inadequate glycemic control after metformin monotherapy or combination therapy with an SGLT2 inhibitor (NCT06649344), the mean HbA1c reductions in the ribupatide injection 4 mg and 2 mg groups reached 2.78% and 2.34%, respectively, compared to 2.29% in the semaglutide injection 1 mg group, with the primary endpoint achieving non-inferiority in both dose groups at Week 36, based on the efficacy estimand2. In addition, ribupatide injection 4 mg demonstrated statistically significant superior HbA1c reduction compared to semaglutide 1 mg. In both trials, safety and tolerability data were consistent with other GLP-1-based treatments, with most treatment-emergent adverse events (TEAEs) being mild to moderate and gastrointestinal-related. Hengrui plans to present additional data from these trials at upcoming medical congresses.
Phase 2 trial in obesity with polyendocrine metabolic ovarian syndrome (PMOS): In Hengrui’s Phase 2 trial in adults with obesity and PMOS (NCT06595797), once-weekly ribupatide injection (4 mg, 2 mg, or 1 mg) vs. placebo demonstrated a mean weight loss of up to 21.2% based on the efficacy estimand3 with no plateau at Week 32. Additionally, the mean change from baseline in the number of menstrual cycles reported by participants taking ribupatide injection 4 mg increased by 0.9 cycles during the final 12 weeks of treatment. Safety and tolerability data were consistent with other GLP-1-based treatments, with most TEAEs being mild and gastrointestinal-related. Hengrui plans to present additional data from this trial at EASD 2026.
