Continued Momentum Toward PMA Submission of ULTC Technologies
Recent Financing Positions Company to Execute Growth Strategy
LAGUNA HILLS, Calif.--(BUSINESS WIRE)--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:
-- Closed a private placement on October 20, 2025, with gross proceeds of
up to $50 million, led by a syndicate of healthcare-dedicated
institutional investors; upfront proceeds of approximately $19 million
expected to fund FDA submission activities and ongoing next generation
catheter development, with potential for up to $31 million in additional
gross proceeds
-- Completed enrollment of the 209-patient FULCRUM-VT Pivotal FDA
Investigational Device Exemption ("IDE") trial intended to support the
premarket approval ("PMA") application for the vCLAS$(TM)$ System for
ablation of ventricular tachycardia ("VT")
-- Announced preliminary results from the FULCRUM-VT trial demonstrating
97% acute effectiveness and a favorable safety profile with the Company's
proprietary ultralow temperature technology
-- Strengthened executive leadership team with the appointment of Deborah
Kaster as Chief Financial Officer, adding to her role as Chief Business
Officer
"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(TM) Cryoablation System, which is CE Marked and is currently under evaluation in the Company's FULCRUM-VT U.S. Pivotal IDE Trial.
About FULCRUM VT
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(TM) Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.
Adagio's vCLAS(TM) 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.
Adagio Medical Holdings, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
Successor Predecessor
------------ -------------
As of As of
9/30/2025 12/31/2024
------------ -------------
Cash and cash equivalents $ 4,673 $ 20,586
Total asset 31,547 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 2024
-------------- --------------- --------------
Successor Successor Predecessor
-------------- --------------- --------------
July 31 to July 1 to
September 30 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 (income)
expenses:
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 2024
-------------- --------------- --------------
Successor Successor Predecessor
-------------- --------------- --------------
July 31 to January 1 to
September 30 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 (income)
expenses:
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20251112929137/en/
CONTACT: Debbie Kaster
Chief Financial Officer and Chief Business Officer
dkaster@adagiomedical.com
(END) Dow Jones Newswires
November 12, 2025 16:05 ET (21:05 GMT)
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