Aardvark Therapeutics, Inc. Q3 2025 earnings summary — revenue, EPS & margin

What went well

Reached alignment with the FDA on a protocol amendment lowering the minimum age of eligibility in the Phase 3 HERO trial of ARD-101 from 13 to 10 years, further broadening the eligible Prader-Willi syndrome population and potential target market.
Commenced enrollment in the HERO open-label extension (OLE) trial and activated its first clinical trial sites in Australia.
Presented new ARD-201 preclinical data at ObesityWeek 2025 showing preserved lean body mass and glucose control comparable to high-dose tirzepatide, alongside supportive ARD-101 Phase 2A obesity data demonstrating weight control, reduced hunger and good tolerability with no serious adverse events.
Ended September 30, 2025 with $126.4 million in cash, cash equivalents and short-term investments, still sufficient to fund operations into 2027.

What went wrong

Net loss widened to $16.3 million from $4.2 million a year earlier, on higher research and development expense ($13.7 million vs. $4.1 million) and general and administrative expense ($4.0 million vs. $1.0 million) as clinical and public-company costs scaled.
Cash, equivalents and short-term investments declined roughly $15 million sequentially (from $141.8 million at June 30 to $126.4 million), reflecting the accelerating clinical burn ahead of key 2026 readouts.

Guidance Changes

Metric	Period	Current guidance
Cash runway	As of September 30, 2025	$126.4M in cash, equivalents and short-term investments; funds projected operations into 2027
ARD-101 HERO Phase 3 topline (PWS)	Q3 2026	Topline data expected in the third quarter of 2026
ARD-201 POWER Phase 2 preliminary/interim data	2H 2026	Preliminary or interim data anticipated in the second half of 2026

Metric	YoY	Note
Research & development expense	$13.7M (vs $4.1M)	$9.7M increase from higher ARD-101 development costs and personnel-related expenses.
General & administrative expense	$4.0M (vs $1.0M)	Higher personnel, facilities and professional-fee costs, partly related to operating as a public company.
Net loss	$16.3M (vs $4.2M)	Driven by increased R&D and G&A spend.
Cash, equivalents & short-term investments	$126.4M	Down from $141.8M at Q2 2025; still funds operations into 2027.
Diluted net loss per share	$(0.75)	Loss per share on 21.7M weighted-average shares outstanding.

Topic	Previous mention	Current period	Trend
ARD-101 in PWS (HERO)	Planned expansion to under-13	FDA-aligned minimum age lowered to 10; OLE enrollment begun; first Australia sites live	Up
ARD-201 obesity program	Two Phase 2 trials planned	ObesityWeek 2025 preclinical data on glucose control and lean-mass preservation	Up
Cash runway	$141.8M into 2027	$126.4M into 2027	Steady