**Aardvark Therapeutics, Inc. Announces Voluntary Pause of Clinical Trials in 10-K Filing**
Aardvark Therapeutics, Inc., a clinical-stage biopharmaceutical company, reported a net loss of $57.6 million for the year ended December 31, 2025, compared to a net loss of $20.6 million for the previous year. The increase in net loss was primarily attributed to a $31.6 million rise in research and development expenses, driven by increased external costs for CMC, clinical, and toxicology studies related to ARD-101, as well as a $7.7 million increase in personnel-related costs due to increased headcount and bonuses. General and administrative expenses also increased to $13.8 million from $5.3 million, reflecting higher personnel costs, professional service fees, and insurance expenses.
The company's 10-K filing revealed that as of December 31, 2025, Aardvark Therapeutics had cash, cash equivalents, and short-term investments totaling $110.0 million. The company estimates that these funds will be sufficient to finance operations into the second quarter of 2027. The company's primary focus remains on the development of ARD-101, an oral gut-restricted small-molecule agonist of certain TAS2Rs, for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS).
A significant development disclosed in the filing was the voluntary pause of enrollment and dosing in the Phase 3 HERO trial and its open-label extension (OLE), as well as the POWER and STRENGTH clinical trials for ARD-201. This decision followed the identification of reversible cardiac observations in a healthy volunteer study of ARD-101. The company is currently reviewing the data and collaborating with the FDA to determine the next steps for the ARD-101 program. As a result, the company no longer anticipates topline data from the HERO trial in the third quarter of 2026 and expects to provide further guidance in the second quarter of 2026.
Aardvark Therapeutics is also advancing ARD-201, a fixed-dose combination of ARD-101 and a DPP-4 inhibitor, for obesity and obesity-related conditions. The company is assessing the potential implications of the voluntary pause of the HERO trial on the ARD-201 program. The company's strategy includes advancing the clinical development of ARD-101, continuing internal drug-discovery efforts, and selectively evaluating strategic collaborations. As of February 28, 2026, the company had 40 full-time employees, with 25 engaged in research and development activities.
About Aardvark Therapeutics, Inc.
Aardvark Therapeutics is a clinical-stage biopharmaceutical company developing small-molecule therapies targeting gut-based receptors, specifically TAS2Rs, to treat metabolic diseases like hyperphagia and obesity. Its lead candidate, ARD-101, aims to regulate hunger via gut-brain signaling, with potential applications for rare disorders such as Prader-Willi Syndrome and hypothalamic obesity. The company focuses on innovative, gut-restricted compounds to improve efficacy and safety in metabolic health management.
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