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¡ªmarking 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. ÍøÆØÃÅ 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.
