Aardvark Therapeutics, Inc. Q4 2025 earnings summary — revenue, EPS & margin

What went well

Published ARD-101 clinical and preclinical data in the peer-reviewed journal Molecular Metabolism, showing a statistically significant reduction in self-reported hunger (Control of Eating Questionnaire) versus placebo at Day 28 and engagement of gut-brain hunger pathways, including increased post-dose PYY and GLP-1.
Management reaffirmed confidence in ARD-101, citing prior positive clinical data, an encouraging historical safety profile, and a newly characterized exposure-response relationship indicating that lower doses (e.g., 200 mg twice daily) yield plasma concentrations well below the threshold at which the QRS effect was observed.
Ended 2025 with $110.0 million in cash, cash equivalents and short-term investments (up from $73.7 million a year earlier following the IPO), sufficient to fund operations into the second quarter of 2027.

What went wrong

In February 2026 Aardvark voluntarily paused enrollment and dosing in the Phase 3 HERO and open-label extension trials of ARD-101 for PWS after unexpected reversible cardiac observations (QRS prolongation) in a separate healthy-volunteer cardiac-safety study, where participants were dosed at twice the HERO target dose without dose escalation.
The company also voluntarily paused its entire ARD-201 obesity program, including the POWER and STRENGTH trials, pending next steps on ARD-101, and deferred further guidance on all programs to the second quarter of 2026.
Losses accelerated sharply: full-year net loss rose to $57.6 million from $20.6 million (fourth-quarter net loss of $17.6 million vs. $8.8 million), with full-year R&D up to $48.9 million from $17.4 million and full-year G&A up to $13.8 million from $5.3 million.

Guidance Changes

Metric	Period	Current guidance
Cash runway	As of December 31, 2025	$110.0M in cash, equivalents and short-term investments; funds projected operations into Q2 2027
ARD-101 (PWS) program next steps	Q2 2026	Further guidance expected in the second quarter of 2026 following FDA engagement
ARD-201 (obesity) program next steps	Q2 2026	Program voluntarily paused; further guidance expected in the second quarter of 2026
ARD-101 HERO Phase 3 topline	Under review	Previously guided to Q3 2026; timing under review following the voluntary pause

Metric	YoY	Note
Full-year R&D expense	$48.9M (vs $17.4M)	$31.6M increase, including $23.4M more external spend on ARD-101 development and $7.7M more personnel costs.
Full-year G&A expense	$13.8M (vs $5.3M)	$8.5M increase from higher personnel, professional-services, facilities and insurance costs as a public company.
Full-year net loss	$57.6M (vs $20.6M)	Driven by higher R&D and G&A spend across the year.
Fourth-quarter net loss	$17.6M (vs $8.8M)	Higher clinical development and G&A spend in the quarter.
Cash, equivalents & short-term investments	$110.0M	Down from $126.4M at Q3 2025; funds operations into Q2 2027.
Fourth-quarter diluted net loss per share	$(0.81)	Q4 loss per share; full-year loss per share was $(2.93).

Topic	Previous mention	Current period	Trend
ARD-101 in PWS (HERO)	FDA-aligned and enrolling with OLE	Voluntarily paused (February 2026) after a reversible cardiac QRS signal; FDA engagement underway	Down
ARD-201 obesity program	Two Phase 2 trials initiating	Voluntarily paused pending ARD-101 next steps	Down
ARD-101 evidence base	ObesityWeek 2025 data	Peer-reviewed Molecular Metabolism publication supporting hunger-signal effects	Up
Cash runway	$126.4M into 2027	$110.0M into Q2 2027	Steady