Kailera Therapeutics executives say their lead drug candidate could become best in a category of obesity drugs currently led by a blockbuster Eli Lilly product, and the biotech has secured $600 million for the Phase 3 clinical trials to prove it.
The Series A financing announced Tuesday comes about a year after Kailera, based in Waltham, Massachusetts, and San Diego, emerged from stealth with four metabolic disorder drug candidates licensed from Jiangsu Hengrui Pharmaceuticals. The most advanced of them, KAI-9531, is a peptide engineered to activate the GLP-1 and GIP receptors — the same targets hit by the Lilly obesity drug Zepbound.
China-based Hengrui retains rights to KAI-9531 in its home country, where it is being developed under the code name HRS9531. In July, Kailera and Hengrui reported preliminary results from Phase 3 tests in China showing that patients who received the once-weekly injectable medication achieved an average 19.2% weight loss compared to placebo. Those results were for the 6 mg dose, the highest of three doses tested. There was no plateau for the weight loss measured at 48 weeks, suggesting patients would lose more weight with continued dosing.
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No data on discontinuations were disclosed from the Phase 3 program in China, which is important because gastrointestinal side effects are one of the top reasons that patients stop taking obesity drugs. The companies said only that the gastrointestinal treatment emergent adverse events in the study were mild to moderate and consistent with the drug’s safety and tolerability profile in Phase 2 testing.
Cross-trial comparisons come with caveats due to differences such as clinical trial design and patient population. In Zepbound’s Phase 3 test, which enrolled patients with obesity and overweight but without type 2 diabetes, patients who received the 15 mg high dose achieved an average 17.8% placebo-adjusted weight loss measured at 72 weeks. In the study that evaluated the drug in patients with type 2 diabetes, results showed an average 11.6% placebo-adjusted weight loss at 72 weeks. The discontinuation rate for the high dose across both studies was 6.7%; most discontinuations were within the first few months of treatment due to gastrointestinal side effects.
For KAI-9531, Kailera plans two global Phase 3 studies enrolling adults with obesity or overweight, with and without type 2 diabetes. The company also plans a third study enrolling adults living with a body mass index of 35 or higher. A BMI of 30 or higher is considered the benchmark for obesity. Kailera plans to begin these studies by the end of this year.
“With an increasing global population affected by obesity and limited options for those living with higher BMIs, the need for effective treatment options has never been greater,” Kailera President and CEO Ron Renaud said in a prepared statement. “With this funding, we will accelerate the advancement of our pipeline, including our lead program KAI-9531 that has the potential to deliver substantial weight loss for people living with obesity.”
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Kailera’s new financing, a Series B round, will also support global clinical tests of KAI-7535, an oral small molecule GLP-1 receptor agonist in mid-stage development for obesity and type 2 diabetes. In addition, the capital will support other programs licensed from Hengrui. KAI-4729, an injectable drug designed to activate three targets — the GLP-1, GIP, and glucagon receptors — is in early clinical development for obesity and type 2 diabetes. KAI-9531, an oral small molecule designed to activate the GLP-1 and GIP receptors, is in mid-stage clinical development for obesity and type 2 diabetes. Beyond its current pipeline, Kailera said it has certain rights to new formulations of licensed products and rights of first refusal for selected assets in Hengrui’s metabolic disease portfolio.
Metabolic disorder drugs continue to be hot targets for dealmaking. Last month, Pfizer agreed to pay $4.9 billion to acquire Metsera, a clinical-stage biotech developing injectable obesity drugs that could be dosed at monthly intervals or longer. Last week, Novo Nordisk reached a $4.7 billion deal to buy Akero Therapeutics, whose lead drug candidate has the potential to treat patients in the most severe stage of the fatty liver disease MASH.
Kailera’s latest financing was led by new investor Bain Capital Private Equity. Other new investors include Adage Capital Management LP, Canada Pension Plan Investment Board, Invus, Janus Henderson Investors, Perseverance Capital, Qatar Investment Authority (QIA), Royalty Pharma, Surveyor Capital (a Citadel company), accounts advised by T. Rowe Price Associates, Inc., and an undisclosed large mutual fund. Kailera’s earlier investors, Atlas Venture, Bain Capital Life Sciences, RTW Investments, and Sirona Capital, also participated in the Series B round.
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