Aardvark Therapeutics, Inc.

What they do

The company is developing novel small-molecule therapeutics designed to suppress hunger by activating innate homeostatic pathways, for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Its lead program, ARD-101, was being evaluated for hyperphagia in patients with PWS in the Phase 3 HERO trial and the Phase 3 OLE trial. All clinical studies under the ARD-101 IND have been stopped.

Revenue drivers

• ARD-101 for PWS — The lead product candidate for hyperphagia in Prader-Willi Syndrome, which was the primary focus of clinical development; no product revenue has been generated.
• Metabolic disease programs — Small-molecule therapeutics targeting hunger-associated indications and potential complementary uses with anti-appetite treatments; all programs remain preclinical or clinical-stage with no revenue.
• No commercial revenue — The company reported $0.00 annual revenue for 2025 and $0.00 for the quarters ended March 31, 2026 and 2025.

Recent performance

For the second quarter of 2026, Aardvark reported a net loss of $14.4 million, unchanged from the second quarter of 2025. R&D expenses were $10.5 million, down $2.7 million year over year, primarily due to lower external spending on CMC, clinical and toxicology studies after the voluntary pause and subsequent clinical hold on ARD-101. G&A expenses were $4.6 million, up $1.9 million year over year, reflecting public company costs, higher headcount-related costs, bonuses, and $0.5 million in severance expense. Cash, cash equivalents and short-term investments were $73.9 million as of June 30, 2026, compared to $91.2 million as of March 31, 2026.

Strategy

The company is assessing unblinded Phase 3 HERO and OLE data for ARD-101 in PWS during the third quarter of 2026 to determine next steps. In June 2026, it terminated the HERO and OLE trials and does not currently intend to resume them as previously designed. It remains in active discussions with the FDA regarding resolution of the full clinical hold on the ARD-101 IND, which was imposed in May 2026. Management states that projected operations are funded into late 2027.

Risks

• Clinical hold on ARD-101 — The FDA placed a full clinical hold on the ARD-101 IND in May 2026, halting all previously ongoing clinical studies including the Phase 3 HERO and OLE trials.
• Trial termination — In June 2026, the company terminated the HERO and OLE trials and does not currently intend to resume them as previously designed, leaving the PWS program without an active trial.
• No revenue and recurring losses — The company reported $0.00 revenue for 2025 and net losses of $57.6 million in 2025 and $20.6 million in 2024, with no approved products.
• Cash burn and funding needs — Operating cash flow was negative $54.2 million in 2025 and cash, cash equivalents and short-term investments were $73.9 million as of June 30, 2026, with management expecting funding into late 2027.

Outlook

Management is assessing unblinded HERO and OLE data in the third quarter of 2026 to support an informed determination of next steps for the ARD-101 program in PWS. The company remains in active discussions with the FDA to resolve the clinical hold on the ARD-101 IND. Based on current operating plans, it believes existing cash, cash equivalents and short-term investments will be sufficient to fund projected operations into late 2027.