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 |
Performance Breakdown
| 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. |
Earnings Call Themes & Trends
| 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 |
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