Aardvark Therapeutics, Inc.(AARD), a clinical-stage biopharmaceutical company, reported fourth-quarter and full-year 2025 financial results reflecting a wider net loss. In addition it provided pipeline and business updates for it's investigational drugs ARD-101 and ARD-201.
Company Profile
Aardvark Therapeutics focuses on developing small-molecule therapeutics to activate innate homeostatic pathways to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases.
The firm's lead compound ARD-101 is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterised by insatiable hunger.
Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a dipeptidyl peptidase-4(DPP-4) inhibitor, to address some of the limitations of currently marketed GLP-1 therapies for obesity and obesity-related conditions.
Fourth Quarter Results
For the fourth quarter of 2025, Aardvark's net loss expanded to $17.60 million or $0.81 per share from $8.78 million or $2.16 per share in the last year.
FY25 Results
For the full year 2025, Aardvark reported a wider net loss of $57.59 million or $2.93 per share from a net loss of $20.59 million or $5.15 per share in the year-ago period.
As of December 31, 2025, Aardvark had cash, cash equivalents, and short-term investments of $110.0 million, and the firm believes these funds are sufficient to fund projected operations into the second quarter of 2027.
Pipeline Update
In February 2026, the company announced a voluntary pause in enrollment and dosing in the Phase 3 Hunger Elimination or Reduction Objective (HERO) and open-label extension (OLE) trials evaluating ARD-101 for the treatment of hyperphagia in individuals with PWS following unexpected reversible cardiac observations in a separate healthy volunteer trial.
Aardvark is conducting a comprehensive review of the data and is working closely with the U.S. Food and Drug Administration (FDA) to determine next steps for ARD-101.
Further guidance on the paused program is expected in the second quarter of 2026.
With pending next steps for ARD-101, the firm has also voluntarily paused the ARD-201 trials, including the Phase 2 POWER and Phase 2 STRENGTH trials and expects to provide further guidance on the programs in the second quarter of 2026.
Phase 2 POWER (Prevention of Weight Regain) trial evaluates ARD-101 and a DPP-4 inhibitor for the treatment of obesity and prevention of weight regain among patients who have successfully lost approximately 15% of body weight on GLP-1RA therapy.
Phase 2 Sitagliptin and TAS2R for Weight Reduction with Exercise, Nutrition, and GLP-1RA Trial and Hunger Assessment (STRENGTH) trial evaluates placebo-adjusted weight loss and the additive effects of ARD-201 combined with GLP-1RA.
Conclusion
"We hope to resume the PWS development program in a timely manner and expect to provide further guidance", said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark.
AARD has traded between $4.01 and $17.94 in the last year. The stock closed Monday's trade at $4.06, down 0.12%.
AARD is further down by 1.60% at $4 in the overnight market.
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