What went well
- Continued close engagement with the FDA to comprehensively evaluate the healthy-volunteer cardiac data and to establish a clear path forward for the Phase 3 HERO trial of ARD-101, its lead program, with an update targeted for the second quarter of 2026.
- Reiterated the peer-reviewed Molecular Metabolism publication supporting ARD-101's effect on hunger (Control of Eating Questionnaire) and its engagement of gut-hormone pathways (increased PYY and GLP-1).
- Held $91.2 million in cash, cash equivalents and short-term investments as of March 31, 2026, sufficient to fund operations into mid-2027.
What went wrong
- Both clinical programs remained on voluntary pause through the quarter, with ARD-101 (HERO/OLE) and ARD-201 (obesity) not actively dosing and further guidance still pending until the second quarter of 2026.
- Net loss widened to $21.6 million from $9.3 million a year earlier, with R&D rising to $16.6 million (from $7.8 million) and G&A to $5.9 million (from $2.7 million); cash, equivalents and short-term investments fell roughly $19 million sequentially to $91.2 million.
Guidance Changes
| Metric | Period | Current guidance |
|---|---|---|
| Cash runway | As of March 31, 2026 | $91.2M in cash, equivalents and short-term investments; funds projected operations into mid-2027 |
| ARD-101 (PWS / HERO) program next steps | Q2 2026 | Further guidance expected in the second quarter of 2026 after FDA engagement |
| ARD-201 (obesity) program next steps | Q2 2026 | Program voluntarily paused; further guidance expected in the second quarter of 2026 |
Performance Breakdown
| Metric | YoY | Note |
|---|---|---|
| Research & development expense | $16.6M (vs $7.8M) | $8.8M increase, including $7.1M more external ARD-101 development spend and $1.7M more personnel costs. |
| General & administrative expense | $5.9M (vs $2.7M) | $3.2M increase from higher personnel, professional-services and facilities costs as a public company. |
| Net loss | $21.6M (vs $9.3M) | Driven by higher R&D and G&A spend. |
| Cash, equivalents & short-term investments | $91.2M | Down from $110.0M at year-end 2025; funds operations into mid-2027. |
| Diluted net loss per share | $(0.99) | Loss per share on 21.8M weighted-average shares outstanding. |
Earnings Call Themes & Trends
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| ARD-101 in PWS (HERO) | Paused February 2026 | Remains paused; FDA engagement to define the HERO path, with an update due Q2 2026 | Steady |
| ARD-201 obesity program | Paused March 2026 | Remains paused pending ARD-101 next steps | Steady |
| Cash runway | $110.0M into Q2 2027 | $91.2M into mid-2027 | Steady |
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