The obesity drugs currently available address a broad swath of patients who struggle to manage their weight. While Aardvark Therapeutics is interested in serving this market, first it wants to validate its approach by treating patients whose excessive eating is rooted in a rare genetic disorder. Aardvark’s lead program is in pivotal testing and the biotech now has $94.2 million in IPO cash for clinical research.
Aardvark late Wednesday priced 5.88 million shares at $16 each, which was the low end of the price range set in preliminary IPO terms last week. Those shares will trade on the Nasdaq under the stock symbol “AARD.”
The rare disease that Aardvark aims to treat is Prader-Willi syndrome (PWS), a genetic disorder that manifests as hyperphagia, a constant feeling of hunger that can’t be satisfied by any amount of food. Excessive eating leads to obesity-related complications. So far, there are no FDA-approved therapies for this disorder.
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San Diego-based Aardvark is developing oral small molecules that target bitter taste (TAS2) receptors. Found in the tongue, these receptors sense bitter taste in food. Aardvark’s lead program, ARD-101, is designed to target and activate TAS2 receptors in the gut, which in turn sparks secretion of the gut-peptide hormones GLP-1 and CCK to suppress feelings of hunger. In the IPO filing, Aardvark notes that other CCK research efforts were stymied by toxic effects caused by hitting receptors throughout the body. Aardvark’s aims to avoid this problem with a drug design that restricts ARD-101’s effects to the gut.
In a Phase 2 test of ARD-101 in Prader-Willi patients, Aardvark reported its twice-daily drug led to reduction in hunger and body weight over the course of 28-days. The company also reported the drug was well tolerated by study participants. In December, Aardvark began a Phase 3 study enrolling patients age 13 and older with hyperphagia that is associated with Prader-Willi syndrome. Preliminary data are expected in early 2026.
Hyperphagia can also stem from damage to the hypothalamus, the region of the brain whose roles include regulating feeding behavior. This damage can happen after surgery or radiation to treat tumors in the pituitary gland or hypothalamus. Aardvark aims to see whether ARD-101 can treat the resulting hypothalamic obesity (HO).
“The anatomical and phenotypical presentations of both HO and PWS are similar in many ways, including impaired hypothalamic function, impaired neuronal pathways, altered neurotransmitter activity and hyperphagia,” Aardvark said in the filing. “Additionally, both conditions do not currently have approved pharmacological interventions for the treatment of hyperphagia. This lack of sufficient therapeutic response underscores the distinction of these disorders from other forms of obesity, as PWS and HO are primarily driven by hunger signaling.”
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A second Aardvark program, ARD-201, takes a combination approach. This drug candidate pairs ARD-101 and a DPP-4 inhibitor, a type of drug that inhibits degradation of gut hormones such as GLP-1. Using a DPP-4 inhibitor to allow endogenous levels of gut hormones to increase in the body could offer a synergistic effect with its TAS2 receptor activating drug, Aardvark said in the filing. The company adds that this approach could address some limitation of currently available GLP-1 drugs, including regaining weight after stopping treatment, gastrointestinal side effects, and muscle loss. A Phase 2 study exploring ARD-201 in obesity and obesity-related conditions is expected to start in the second half of this year.
Prader-Willi has been a tough disease target. Zafgen and Millendo Therapeutics encountered clinical trial setbacks with their respective drugs. A Prader-Willi drug developed by Levos Therapeutics advanced as far as an FDA submission, but the agency rejected it in 2022. Acadia Pharmaceuticals acquired Levos in 2022; the Prader-Willi program, now named ACP-101, is in Phase 3 development.
Soleno Therapeutics aims to treat Prader-Willi with an extended-release tablet whose main pharmaceutical ingredient is diazoxide choline. The company says this drug acts on signs and symptoms of the disease in a variety of ways, including stimulating hormones that affect appetite and satiety. Soleno’s drug has been under FDA review; a regulatory decision is expected by March 27.
Aardvark is led by CEO Tien-Li Lee. Prior to founding the company in 2017, Lee was the chief strategy officer of cancer immunotherapy company NantKwest. Since its inception, Aardvark said it had raised $129.1 million prior to the IPO. The company’s most recent financing was an $85 million Series C round last May led by Decheng Capital. That firm is Aardvarks’ largest shareholder, owning a 12.5% post-IPO stake, according to the prospectus.
As of the end of the 2024, the Aardvark reported its cash position was $73.7 million. That capital, combined with the IPO proceeds, will finance clinical development of its two obesity drug candidates. About $63.4 million is budgeted for completing the Phase 3 test of ARD-101 in Prader-Willi patients and for starting and completing a Phase 2 test of the drug in hyperphagia associated with hypothalamic obesity. The company also plans to spend about $24.4 million on starting and completing a Phase 2 test of ARD-201 in obesity and obesity-related conditions. Aardvark estimates its capital will be enough to fund operations into 2027.
