The positive FULCRUM-VT data is a major derisking event for ADGM's vCLAS PMA submission. Expect stock to react favorably, but monitor cash runway and potential near-term capital raise given ~$12.9M cash. Next catalyst: PMA submission timeline and FDA acceptance.
Price Chart
Executive Summary
Adagio Medical reported Q1 2026 net loss of $7.0M ($0.31/share), beating the Street consensus of $0.36/share loss, with no revenue. The key catalyst is the positive FULCRUM-VT pivotal trial data presented at HRS 2026, showing 84% freedom from ICD shock and a favorable safety profile, advancing the PMA submission. Cash stands at $12.9M, with potential for $31M additional warrant proceeds.
Key Financial Metrics
Key Facts
- Q1 2026 net loss of $7.0M vs $7.7M a year ago; EPS of $0.31 beat consensus of $0.36 loss
- Zero revenue; pre-revenue clinical-stage medtech
- FULCRUM-VT pivotal trial results: 84% freedom from ICD shock at 6 months, 2.4% major adverse events
- FDA IDE approval for next-gen vCLAS Ultra catheter trial
- Cash and equivalents $12.9M as of March 31, 2026, down from $17.1M at year-end
- Potential $31M additional gross proceeds from milestone-based warrant exercises
Financial Impact
Net loss improved 9.3% YoY to $7.0M; EPS beat by 13.9% vs consensus; cash burn ~$4.2M per quarter
Risk Factors
- Pre-revenue with no approved products in the US; reliance on successful PMA and commercialization
- Cash burn rate may require dilutive financing within 2-3 quarters
- Clinical data still subject to FDA review; potential for regulatory setbacks
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-059026 |
| Document: tm2614299d1_8k.htm | 0001104659-26-059026 |
| Document: 0001104659-26-059026-index-headers.html | 0001104659-26-059026 |
| Document: 0001104659-26-059026-index.html | 0001104659-26-059026 |
| Document: 0001104659-26-059026.txt | 0001104659-26-059026 |
| 8-K Data (Synthetic) | 0001104659-26-059026 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 13, 2026 13d ago | DEF 14A | $0.1253 $0.1208 | ▼ −3.59% | ▼ −2.44% | $0.1030 (−17.80%) |
Oct 1, 2026 25d ago | 8-K | $0.1531 $0.1300 | ▲ +15.09% | ▲ +16.25% | $0.1030 (+32.72%) |
Sep 23, 2026 4w ago | 8-K | $0.2280 $0.1530 | ▲ +32.89% | ▲ +32.22% | $0.1030 (+54.82%) |
Aug 11, 2026 10w ago | 8-K | $0.7190 $0.6460 | ▲ +10.15% | ▲ +9.75% | $0.1030 (+85.67%) |
Jul 13, 2026 15w ago | 10-K/A | $0.5710 $0.5300 | ▼ −7.18% | ▼ −6.40% | $0.1030 (−81.96%) |
May 21, 2026 22w ago | 8-K | $0.8410 $0.7699 | ▼ −8.45% | ▼ −10.13% | $0.1030 (−87.75%) |
May 12, 2026 23w ago | 8-K | $0.9230 $0.8830 | ▼ −4.33% | ▼ −4.41% | $0.1030 (−88.84%) |
Apr 27, 2026 26w ago | 8-K | $1.15 $0.9410 | ▼ −18.17% | ▼ −18.57% | $0.1030 (−91.04%) |
Apr 8, 2026 28w ago | 8-K | $1.41 $1.43 | ▲ +1.42% | ▼ −2.10% | $0.1030 (−92.70%) |
Apr 6, 2026 29w ago | EFFECT | $1.25 $1.33 | ▼ −6.40% | ▼ −2.27% | $0.1030 (+91.76%) |
US Market Status
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