SAN DIEGO, May 7, 2026 — Leads & Copy — Aardvark Therapeutics, Inc. (Nasdaq: AARD), a biopharmaceutical company focused on developing small-molecule therapeutics for metabolic diseases, reported its first-quarter financial results and provided pipeline updates.
The company’s cash, cash equivalents, and short-term investments totaled $91.2 million as of March 31, 2026. Aardvark believes this will fund projected operations into mid-2027.
Aardvark has been working with the FDA to evaluate data following cardiac observations in a healthy volunteer trial. The company expects to provide further guidance in the second quarter of 2026 regarding its ARD-101 program. Enrollment and dosing in the Phase 3 HERO and open-label extension (OLE) trials evaluating ARD-101 for hyperphagia in individuals with Prader-Willi Syndrome (PWS) were voluntarily paused in February 2026 after unexpected cardiac observations in a separate healthy volunteer trial. No cardiac signals were observed in prior Phase 1 or Phase 2 trials, and preclinical studies did not predict cardiac safety issues.
The company also voluntarily paused development of ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor for obesity and related conditions, in March 2026. Further guidance on this program is also expected in the second quarter of 2026.
Clinical and preclinical data from the ARD-101 program were published in Molecular Metabolism in March 2026. The publication detailed findings from a Phase 2 study demonstrating that ARD-101 reduced self-reported hunger compared to placebo at Day 28. The published manuscript also included data from a double-blind study in fasted healthy participants, where ARD-101 increased post-dose peptide YY (PYY) and glucagon-like peptide-1 (GLP-1).
First quarter 2026 financial results showed research and development expenses were $16.6 million, compared to $7.8 million for the first quarter of 2025. General and administrative expenses were $5.9 million, compared to $2.7 million for the first quarter of 2025. Aardvark reported a net loss of $21.6 million for the first quarter of 2026, compared to a net loss of $9.3 million for the first quarter of 2025.
“We have been working closely with the FDA to comprehensively evaluate the data following the reversible cardiac observations in the healthy volunteer trial and are committed to determining the best path forward for our programs, patients and the broader PWS community,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark.
“We remain focused on establishing a clear path forward for the Phase 3 HERO trial evaluating ARD-101 in PWS, our lead program, and look forward to providing an update in the second quarter.”
Aardvark is a clinical-stage biopharmaceutical company developing small-molecule therapeutics to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Its lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS. Aardvark is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for obesity and obesity-related conditions.
Source: Aardvark Therapeutics, Inc.
