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ADGM Positive Sentiment Score: 70/100

Adagio Medical Reports Third Quarter 2025 Results Continued Momentum Toward PMA Submission of ULTC Technologies Recent Financing Positions Company to Execute Growth Strategy LAGUNA HILLS, CA, November 12 , 2025 - Adagio

Key Takeaway: Adagio Medical Holdings, Inc. has reported positive financial results for the third quarter of 2025, demonstrating significant progress towards a premarket approval (PMA) submission for its vCLAS System. The successful completion of recent financing not only positions the company to advance its PMA submission but also reflects strong investor confidence. However, despite promising developments, Adagio reported an increasing net loss and significant liabilities, raising concerns about its financial stability.

Market Sentiment Analysis

POSITIVE FACTORS

  • Adagio reported strong clinical momentum toward PMA submission.
  • The company secured financing, indicating investor confidence in its strategy.
  • The proprietary ULTC technology has the potential to treat a broad population of patients.

CONCERNS & RISKS

  • Net loss increased to $10.1 million compared to $4.6 million in the previous year.
  • Total liabilities exceeded assets, leading to a stockholders' deficit equity.

Full Press Release Details

Adagio Medical Reports Third Quarter 2025 Results
Continued Momentum Toward PMA Submission of ULTC Technologies
Recent Financing Positions Company to Execute Growth Strategy
LAGUNA HILLS, CA, November 12, 2025 - Adagio Medical Holdings, Inc (Nasdaq: ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the third quarter ended September 30, 2025.
Recent Business Highlights:
"Adagio made exceptional progress this quarter, with strong clinical momentum, a clear regulatory path and a solid pipeline." said Todd Usen, Chief Executive Officer of Adagio. "The successful completion of our financing provides the resources to advance our PMA submission for the vCLAS System and prepare for commercialization. This financing also reflects the confidence leading healthcare investors have in our strategy and the potentially transformational impact of our proprietary ULTC technology to treat one of the broadest populations of patients with ventricular arrhythmias."
Third Quarter 2025 Financial Results
Cost of revenue was $31 thousand for the three months ended September 30, 2025, compared to $0.6 million for the three months ended September 30, 2024.
Research and development expenses were $2.8 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024.
Selling, general and administrative expenses were $2.9 million for the three months ended September 30, 2025, compared to $7.8 million for the three months ended September 30, 2024.
Net loss for the three months ended September 30, 2025 was $10.1 million, compared to a net loss of $4.6 million for the three months ended September 30, 2024.
Reported cash and cash equivalents of $4.7 million as of September 30, 2025.
About Adagio Medical Holdings, Inc.
Adagio is a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias utilizing its novel, proprietary, catheter-based Ultra-Low Temperature Cryoablation (ULTC) technology. ULTC is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue. The Company is currently focused on the treatment of ventricular arrhythmias with its purpose-built vCLAS Cryoablation System, which is CE Marked and is currently under evaluation in the Company's FULCRUM-VT U.S. Pivotal IDE Trial.
FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm trial, enrolling 209 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines. The results of the study will be used to apply for FDA premarket approval (PMA) for Adagio's vCLAS Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.
Adagio's vCLAS Cryoablation System is commercially available for the treatment of monomorphic VT in Europe and select other geographies but is limited to investigational use in the United States.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the receipt of additional gross proceeds from the private placement if the issued warrants are exercised in full; Adagio's intended use of the proceeds from the private placement; Adagio's strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management; the reproducibility of any favorable results initially seen in Adagio's preliminary FULCRUM-VT acute data; and the potential for FDA approval of Adagio's product candidates. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio's business are described in detail in Adagio's Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, which are available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law.
Chief Financial Officer and Chief Business Officer
Adagio Medical Holdings, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
Successor Predecessor
As of 9/30/2025 As of 12/31/2024
Cash and cash equivalents $ 4,673 $ 20,586
Total assets 31,546 48,448
Total liabilities 32,858 28,536
Total stockholders' (deficit) equity (1,312) 19,912
Condensed Statements of Operations
(in thousands, except share and per share data)
Three Months Ended September 30,
2025 2024
Successor Successor Predecessor
July 31 to September 30 July 1 to July 30
Revenue $ - $ 132 $ 53
Cost of revenue 31 414 157
Research and development 2,774 1,217 1,251
Selling, general, and administrative 2,916 2,926 4,851
Total cost of revenue and operating expenses 5,721 4,557 6,259
Loss from operations (5,721) (4,425) (6,206)
Other (expense) income:
Convertible notes fair value adjustment (3,508) 3,255 (1,907)
Warrant liabilities fair value adjustment (231) 4,973 177
Interest expense (749) (435) (304)
Interest income 79 166 -
Other (expense) income, net 12 72 5
Total other (loss) income, net (4,397) 8,031 (2,029)
Net (loss) income $ (10,118) $ 3,606 $ (8,235)
Basic net (loss) income per share $ (0.66) $ 0.18 $ (8.34)
Diluted net (loss) income per share $ (0.66) $ 0.02 $ (8.34)
Weighted-average shares outstanding - Basic 15,381,565 14,057,636 987,810
Weighted-average shares outstanding - Diluted 15,381,565 16,057,636 987,810
Nine Months Ended September 30,
2025 2024
Successor Successor Predecessor
July 31 to September 30 January 1 to July 30
Revenue $ - $ 132 $ 333
Cost of revenue 626 414 1,381
Research and development 8,404 1,217 7,585
Selling, general, and administrative 8,892 2,926 13,047
Total cost of revenue and operating expenses 17,922 4,557 22,013
Loss from operations (17,922) (4,425) (21,680)
Other (expense) income:
Convertible notes fair value adjustment (1,891) 3,255 2,059
Warrant liabilities fair value adjustment (334) 4,973 191
Interest expense (2,131) (435) (1,818)
Interest income 345 166 3
Other (expense) income, net 155 72 (33)
Total other (loss) income, net (3,856) 8,031 402
Net (loss) income $ (21,778) $ 3,606 $ (21,278)
Basic net (loss) income per share $ (1.42) $ 0.18 $ (26.08)
Diluted net (loss) income per share $ (1.42) $ 0.02 $ (26.08)
Weighted-average shares outstanding - Basic 15,378,543 14,057,636 815,854
Weighted-average shares outstanding - Diluted 15,378,543 16,057,636 815,854

Frequently Asked Questions

What are Adagio Medical's Q3 2025 financial results?

For Q3 2025, Adagio reported a net loss of $10.1 million and revenues of $0.

What is the vCLAS System by Adagio Medical?

The vCLAS System is a cryoablation technology designed for treating ventricular arrhythmias.

How much cash did Adagio have as of September 30, 2025?

Adagio reported cash and cash equivalents of $4.7 million as of September 30, 2025.

What financing did Adagio recently complete?

Adagio completed financing to support its PMA submission for the vCLAS System.

What is the focus of FULCRUM-VT trial?

FULCRUM-VT trials the vCLAS system for ablation in drug-refractory ventricular tachycardia.

Last updated: Nov 12, 2025