Just a year after emerging from stealth with a nearly half a billion dollars, Kailera Therapeutics has reached another financing goal, raising $600m to fund a Phase III trial of its promising weight loss drug.
Kailera, one of the industry’s most closely watched private biotechs, secured the funds as part of a Series B financing round led by new investor Bain Capital.
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The US firm is hoping to seize a share of the lucrative cardiometabolic market with its lead candidate KAI-9531, an injectable dual GLP-1/GIP receptor agonist.
The drug recently emerged successfully from Phase II trials in which it demonstrated it could stand up to the efficacy of Eli Lilly’s Zepbound (tirzepatide).
In the trial conducted with Chinese partner Jiangsu Hengrui Pharmaceuticals, KAI-9531 led to a 22.8% mean weight loss in overweight or obese patients after 36 weeks. For comparison, Zepbound previously demonstrated a 20.9% weight loss across 36 weeks of treatment. There was no plateau in KAI-9531’s treatment window, suggesting the injectable could have a high efficacy ceiling.
With data in hand and a $600m raise secured, Kailera is focusing on the next stage of development for its lead product. The biotech has completed end-of-phase II meetings with the US Food and Drug Administration (FDA) and plans to initiate its global Phase III programme by the end of 2025.
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By GlobalDataThe programme, which will include three trials, will enrol adults living with obesity or overweight with comorbidities, with and without type 2 diabetes, and finally adults living with a BMI of 35 or higher.
“With this funding, we will accelerate the advancement of our pipeline, including our lead programme KAI-9531 that has the potential to deliver substantial weight loss for people living with obesity,” said Kailera’s CEO Ron Renaud.
“We look forward to starting our global Phase 3 trials of KAI-9531 by the end of this year—marking a pivotal step in our mission to deliver therapies that empower people with obesity to transform their health and live fuller, healthier lives,” Renaud added.
KAI-7535, an oral small molecule GLP-1 receptor agonist in Kailera’s pipeline, also stands to benefit from the Series B tranche with clinical advancement.
Kailera’s pipeline also includes KAI-4729, an injectable GLP-1/GIP/glucagon receptor tri-agonist, and KAI-9531 formulated as a once-daily oral tablet, both pre-clinical assets. More candidates could come from Hengrui’s metabolic disease portfolio, of which Kailera has right of first refusal.
KAI-9531 itself was originally discovered and developed by Hengrui, which licensed it out to Kailera when the biotech launched in October 2024.
The Series B round caps a rapid first year for Kailera. The biotech raised $400m in Series A funding upon its launch, marking one of the largest financing debuts in the biotech sector in recent years.
GLP-1RA focused Verdiva Bio launched with $410m in January this year, highlighting how obesity-focused pipelines are emerging as a clear path through the recent lull in early-stage biotech investment. The UK-based biotech is developing a suite of weight loss therapies, licensed from China’s Sciwind Biosciences in a similar model to Kailera.
It has been a difficult few years for the biotech sector, with the tide changing toward more favourable conditions seemingly a distant likelihood. Analysis by GlobalData identified a 20.2% decline in venture financing in the pharma industry in Q1 2025. Investment reached $6.5bn, down from the $8.1bn raised in Q1 2024.
