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2026
Q2

Q2 2026 Earnings

8-K

Aug 12, 2026

0001193125-26-346919

EX-99.1

2 ck0002096997-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Kailera Reports Second Quarter 2026 Financial Results and Provides Business Updates

• 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. – August 12, 2026 – 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

Pipeline Highlights

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 data presented at 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:

o 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 est

2026
Q1

Q1 2026 Earnings

8-K

May 26, 2026

0001193125-26-239362

EX-99.1

2 ck0002096997-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Kailera Reports First Quarter 2026 Financial Results and Provides Clinical Data Updates

• Important progress across four clinical-stage programs demonstrating depth and breadth of obesity pipeline

• Initiated five late-stage global clinical trials in obesity, including the ribupatide injection KaiNETIC Phase 3 program

• Reported positive topline clinical data from three trials conducted by our partner Hengrui in China, including new topline data from Phase 3 trial of oral small molecule GLP-1 receptor agonist HRS-7535 (KAI-7535) in type 2 diabetes, and first-in-human topline data from Phase 1 trial for injectable tri-agonist HRS-4729 (KAI-4729)

• Cash on hand, including IPO proceeds, is expected to fund operations into mid-2028

WALTHAM, Mass. – May 26, 2026 – 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 first quarter ended March 31, 2026, and provided a summary of recent business highlights.

“During the quarter, we continued to build meaningful momentum and made significant progress advancing our clinical portfolio, including initiating several clinical trials and reporting important data readouts that further underscore the breadth, depth, and potential of our pipeline,” said Ron Renaud, President and Chief Executive Officer of Kailera. “Importantly, our ribupatide franchise continues to demonstrate category-leading potential among obesity management medications, highlighted by the initiation of the global KaiNETIC Phase 3 program for ribupatide injection and positive Phase 2 data for ribupatide oral in China. We are also pleased to announce new topline data for HRS-7535 (KAI-7535) and HRS-4729 (KAI-4729) that reflect the shared commitment with our partner to advance a diverse portfolio with multiple mechanisms and injectable and oral modalities to help address the diverse and evolving needs of people living with obesity.”

Renaud, continued, “These achievements, combined with our successful IPO, have positioned us with the capital and operational strength to continue advancing multiple programs in parallel. We are focused on maintaining this momentum and executing across our clinical programs as we work to deliver differentiated therapies for the treatment of obesity.”

First Quarter Business Highlights and Recent Developments

Pipeline Highlights

• Ribupatide injection (KAI-9531), GLP-1/GIP receptor dual agonist:

o Initiated global Phase 3 KaiNETIC program: The program encompasses three double-blind, randomized, placebo-controlled Phase 3 trials (KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3) evaluating once-weekly ribupatide injection doses of up to 10 mg over 76 weeks in adults living with obesity or overweight. Data is anticipated in 2028.

o Initiated U.S. Phase 2b high dose obesity clinical trial to evaluate the potential to achieve even greater weight loss with higher doses of ribupatide injection: The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 250 participants with a BMI of 35 or greater and no type 2 diabetes (T2D). Participants will receive either placebo or doses up to 20 mg of ribupatide injection administered over a period of 48 weeks. Data is anticipated in 2027.

o Announced data presentation at the 86th Scientific Sessions of the American Diabetes Association (ADA 2026): Poster presentation will cover Kailera’s Phase 1 single ascending dose bridging study of ribupatide injection in participants of non‑Asian and Asian descent, which supported the initiation of the ongoing global Phase 3 KaiNETIC clinical program.

• Ribupatide oral (KAI-9531-T), GLP-1/GIP receptor dual agonist:

o Reported positive topline data from Hengrui’s Phase 2 obesity trial: Participants taking ribupatide oral achieved a mean weight loss of up to 12.1% with no observed plateau at Week 26, and up to 38.6% of participants taking ribupatide oral achieved at least 15% weight loss. Results demonstrated a potentially highly differentiated tolerability profile with low rates of gastrointestinal adverse events observed. The full data will be presented in a poster presentation at ADA 2026.

o Subject to discussions with the FDA and other regulatory agencies, Kailera plans to initiate Phase 3 global trials as early as the first half of 2027.

• KAI-7535, oral small molecule GLP-1 receptor agonist:

o Initiated global Phase 2 obesity trial: The double-blind, randomized, placebo-controlled trial is expected to enroll approximately 320 participants with a BMI of 30+ or a BMI of 27+ with at least one co-morbidity, which may include T2D. Participants will receive either placebo or doses up to 360 mg of KAI-7535 administered over a period of 44 weeks. Data is anticipated in 2027.

o Reported positive topline data from OUTSTAND-1, Hengrui’s Phase 3 T2D clinical trial (NCT06672172): OUTSTA

About Kailera Therapeutics Inc. Common Stock (KLRA) Earnings

This page provides Kailera Therapeutics Inc. Common Stock (KLRA) earnings call transcripts from SEC 8-K filings along with AI-powered predictions for post-earnings price movements. Our machine learning models analyze historical earnings data, pre-earnings price patterns, volume changes, and volatility to predict 1-day, 5-day, and 20-day returns after each earnings release.

Earnings transcripts are sourced directly from SEC EDGAR filings. Predictions are generated using gradient boosting models trained on KLRA's historical earnings reactions. All predicted returns are shown as percentages, and predicted prices are calculated from the closing price at the time of prediction. Past performance does not guarantee future results.

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