Adagio Medical Reports Second Quarter 2026 Results
Adagio Medical Holdings, Inc. (ADGM) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Adagio Medical Reports Second Quarter 2026 Results LAGUNA HILLS, CA, August 11, 2026 – Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today anno
How this was made
The 30-second read
Why it matters
Traders can use the filing to update near-term expectations for FDA review momentum (PMA submission supported by FULCRUM-VT IDE trial) while also reassessing liquidity and burn rate based on Q2 results.
Market read
The combination of Q2 financials and newly disclosed FDA-facing milestones (PMA submission support, first vCLAS Ultra patient) is likely to drive ADGM-specific sentiment and positioning.
What to watch
Cash and cash equivalents are only $7.7M as of June 30, 2026, and cost of revenue is nil due to a Europe commercial activity pause, both of which can dominate near-term valuation and financing expectations.
Adagio Medical Reports Second Quarter 2026 Results
The Company reported no revenue, a larger net loss, and cash and cash equivalents of $7.7 million as of June 30, 2026, while advancing its PMA application and next-generation vCLAS Ultra clinical program.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| RevenueGAAP | $ — | – | – |
| Cost of revenueGAAP | nil | – | – |
| Research and development expensesGAAP | $2.5M | – | – |
| Selling, general and administrative expensesGAAP | $2.5M | – | – |
| Total cost of revenue and operating expensesGAAP | 4.93M | – | – |
| Loss from operationsGAAP | −4.93M | – | – |
| Convertible notes fair value adjustmentGAAP | −1.16M | – | – |
| Warrant liabilities fair value adjustmentGAAP | 181K | – | – |
| Interest expenseGAAP | −805K | – | – |
| Interest incomeGAAP | 72K | – | – |
| Other (expense) income, netGAAP | −69K | – | – |
| Total other (expense) income, netGAAP | −1.78M | – | – |
| Net lossGAAP | $6.7M | – | – |
| Other comprehensive loss: Foreign currency translation adjustmentGAAP | 153K | – | – |
| Comprehensive lossGAAP | −6.56M | – | – |
| Basic net loss per shareGAAP | $(0.30) per share (Basic) | – | – |
| Diluted net loss per shareGAAP | $(0.30) | – | – |
| Weighted-average shares outstanding – basic and dilutedGAAP | 22,210,459 | – | – |
| Cash and cash equivalentsother | $7.7M | – | – |
| Total assetsother | 33.88M | – | – |
| Total liabilitiesother | 34.30M | – | – |
| Total stockholders’ (deficit) equityother | −415K | – | – |
Amounts quoted below without a unit are in thousands, as in the filing’s tables. Per-share figures are as printed.
What drove it
- The Company did not generate revenue during the three months ended June 30, 2026.
- Cost of revenue decreased primarily due to the pause in commercial activity in Europe.
- Research and development expense increased primarily due to higher product development costs, including consulting and prototyping expenses, and higher operational costs, partially offset by lower clinical trial expenses.
- Selling, general and administrative expense increased primarily due to higher stock-based compensation expenses, partially offset by lower professional services expenses.
- The Company submitted a PMA application to the FDA for the vCLAS Ventricular Ablation System, supported by the FULCRUM-VT pivotal IDE trial.
- FULCRUM-VT enrolled 209 patients, with 2.4% protocol-defined Major Adverse Events, 84% freedom from ICD shock at six months, and 78% discontinuation or reduced dose of antiarrhythmic drugs.
Concerns
- Revenue was $ — for both the three months ended June 30, 2026 and 2025, and the Company cited a pause in commercial activity in Europe.
- Net loss was $6.7 million, compared with a net loss of $3.9 million for the three months ended June 30, 2025.
- Total other (expense) income, net was (1,783) (in thousands), compared with 770 (in thousands), including a convertible notes fair value adjustment of (1,162) (in thousands).
- Total stockholders’ (deficit) equity was (415) (in thousands) as of June 30, 2026.
- The vCLAS Ventricular Ablation System is limited to investigational use in the United States.
What to watch
- FDA review of the PMA application for the vCLAS Ventricular Ablation System.
- Evaluation of the next-generation vCLAS Ultra catheter under the expanded IDE approval.
- The expected timing and results of the Company’s clinical trials, including reproducibility of favorable FULCRUM-VT pivotal data.
- Commercial activity in Europe and any resumption of revenue generation.
- Cash and cash equivalents of $7.7 million as of June 30, 2026.
Balance sheet and cash flow
- Cash and cash equivalents were $7.7 million as of June 30, 2026.
- Cash and cash equivalents were $ 7,740 (in thousands) as of June 30, 2026, compared to $ 17,105 (in thousands) as of December 31, 2025.
- Total assets were 33,884 (in thousands) as of June 30, 2026, compared to 43,253 (in thousands) as of December 31, 2025.
- Total liabilities were 34,299 (in thousands) as of June 30, 2026, compared to 30,851 (in thousands) as of December 31, 2025.
- Total stockholders’ (deficit) equity was (415) (in thousands) as of June 30, 2026, compared to 12,402 (in thousands) as of December 31, 2025.
Analysis
Adagio reported no revenue for the second quarter ended June 30, 2026. The release attributes the absence of revenue to the lack of revenue generation during the period, while cost of revenue was nil compared with $0.3 million in the prior-year period due primarily to the pause in commercial activity in Europe. The operating profile remained development-focused, with research and development expenses of $2.5 million and selling, general and administrative expenses of $2.5 million.
Loss from operations was (4,934) (in thousands), compared with (4,717) (in thousands) in the prior-year period. Research and development expense increased due to higher product development, consulting, prototyping, and operational costs, including depreciation expense related to consoles loaned to customers. The release notes that this depreciation was classified in research and development because the Company did not generate revenue. Higher stock-based compensation drove the increase in selling, general and administrative expense, partly offset by lower professional services expense.
The net loss widened to $6.7 million from $3.9 million. Beyond operating costs, total other (expense) income, net shifted to (1,783) (in thousands) from 770 (in thousands), including a convertible notes fair value adjustment of (1,162) (in thousands), interest expense of (805) (in thousands), and a warrant liabilities fair value adjustment of 181 (in thousands). Basic net loss per share was $(0.30) per share (Basic), versus $(0.26) per share (Basic), with weighted-average shares outstanding of 22,210,459.
The balance sheet reported cash and cash equivalents of $7.7 million as of June 30, 2026. Total liabilities were 34,299 (in thousands), while total stockholders’ (deficit) equity was (415) (in thousands). The filing did not report operating cash flow, free cash flow, debt balances, or capital-return activity, limiting assessment of quarterly cash consumption and financing capacity from this release alone.
Operationally, the quarter centered on regulatory and clinical milestones. Adagio submitted its PMA application for the vCLAS Ventricular Ablation System and highlighted FULCRUM-VT results from 209 patients, including 2.4% protocol-defined Major Adverse Events, 84% freedom from ICD shock at six months, and 78% discontinuation or reduced dose of antiarrhythmic drugs. The Company also reported the first treatment using the next-generation vCLAS Ultra catheter under FDA Expanded Access authorization. No financial guidance or operational outlook was provided, so the key disclosed watch items are the PMA process, the expanded IDE evaluation of vCLAS Ultra, clinical-data reproducibility, and commercial activity in Europe.
Management, verbatim
This quarter marked an inflection point for Adagio as our team continues to execute and deliver on our critical milestones. The enthusiastic physician reception of our FULCRUM-VT late-breaking data at HRS reinforced what we have long believed about the potential for this technology, and the successful treatment of the first patient with vCLAS Ultra — a particularly complex case — was a powerful proof point for our next-generation system.
Todd Usen, Chief Executive Officer of Adagio Medical
We believe our progress – combined with the breadth of our clinical evidence for both ischemic and non-ischemic patients - positions our fully-endocardial ULTA platform as a uniquely differentiated solution capable of treating the entire spectrum of cases in an addressable market that has long needed a purpose-built solution. We remain focused on executing against the milestones ahead as we work to bring our proprietary technology to the many patients who suffer from VT.
Todd Usen, Chief Executive Officer of Adagio Medical
Not in the filing
stated, not guessed- Gross margin and gross profit.
- Non-GAAP financial measures, including non-GAAP operating income, net income, and EPS.
- Prior-quarter comparisons for reported financial metrics.
- Operating cash flow and free cash flow.
- Capital expenditures.
- Debt balance and debt maturities.
- Share repurchases, dividends, and other capital-return activity.
- Forward financial guidance and operational guidance.
- Revenue by reportable segment or geography.
- A prior-quarter outlook for comparison.
AlphAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
This SEC 8-K (Item 2.02) reports Adagio’s Q2 2026 financials and highlights clinical/regulatory progress for its vCLAS ventricular ablation platform and next-generation vCLAS Ultra catheter.
Ticker impact
Adagio filed an 8-K with Q2 2026 results plus clinical and regulatory updates, including FULCRUM-VT data and a vCLAS PMA submission to the FDA.
Moderate upside bias on any market optimism around PMA progress, offset by cash burn and continued pre-revenue status.
The article discloses new operational milestones (first vCLAS Ultra patient under FDA expanded access, FULCRUM-VT pivotal IDE support for PMA) alongside Q2 financial deterioration (higher R&D, larger net loss, $7.7M cash). That mix typically supports biotech-style momentum but keeps downside risk from liquidity.
Market effects
Reinforces investor focus on FDA PMA pathways and ULTA/cryoblation differentiation in cardiac arrhythmia devices.
Europe commercial activity pause is cited as a driver of lower cost of revenue, highlighting regional execution risk.
Could marginally affect sentiment toward cardiac ablation device peers if PMA progress is viewed as de-risking the modality.
Counterpoint
Despite the PMA submission and positive trial metrics, the company remains pre-revenue in the US and reports a widening net loss with limited cash, so the market may discount clinical optimism.
Key entities
- companyAdagio Medical Holdings, Inc.
Nasdaq-listed medical device company reporting Q2 2026 results and FDA-related milestones for its vCLAS/ULTA catheter ablation technology.
- productvCLAS Ventricular Ablation System
CE Marked ventricular ablation system; Adagio submitted a PMA application to the FDA supported by FULCRUM-VT.
- productvCLAS Ultra Ultra-Low temperature ablation catheter (ULTA)
Next-generation catheter; first patient treated under FDA expanded access and evaluated under expanded IDE.
- clinical_trialFULCRUM-VT trial
209-patient pivotal IDE trial; late-breaking HRS 2026 presentation with reported safety and 6-month effectiveness metrics.
- regulatorU.S. Food and Drug Administration (FDA)
Granted IDE expansion and expanded access authorization referenced in the filing, supporting the PMA pathway.
