Adagio Medical Reports First Quarter 2025 Results

Adagio Medical Reports First Quarter 2025 Results

LAGUNA HILLS, CA, May 15, 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 first quarter ended March 31,

Recent Business Highlights:

"This has been a defining

quarter for Adagio Medical and for our progress across the company. The FDA's Breakthrough Device Designation, multiple

impactful presentations at leading industry conferences, the introduction of our optimized smaller, faster next generation ULTC

technology in development and the continued momentum in enrolling patients in our FULCRUM-VT trial all underscore the clinical

promise and growing validation of our proprietary ULTC platform technology," said Todd Usen, Chief Executive Officer of

Adagio. "I am so proud of the Adagio team's accomplishments as we remain resolute in our mission to transform patient

treatment and outcomes with our purpose-built solution for the large, underserved population of patients suffering from ventricular

First Quarter 2025 Financial Results

$0.3 million for the three months ended March 31, 2025, compared to $0.5 million for the three months ended

development expenses were $3.7 million for the three months ended March 31, 2025, compared to $3.5 million for the

three months ended March 31, 2024.

Selling, general and

administrative expenses were $3.5 million for the three months ended March 31, 2025, compared to $4.8 million for

the three months ended March 31, 2024.

Net loss for the three months

ended, March 31, 2025 was $7.7 million, or $(0.50) per share, compared to a net loss of $8.0 million, or $(10.28) per share, for

the three months ended, March 31, 2024.

Reported cash and cash equivalents

of $13.0 million as of March 31, 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 tachycardia (VT) with its purpose-built vCLAS

Cryoablation System which is CE Marked and is currently under evaluation in the Company's FULCRUM-VT U.S. IDE Pivotal Study.

(Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label,

single-arm study, enrolling 206 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.

vCLAS Cryoablation System is commercially available for the treatment of monomorphic ventricular tachycardia 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 potential of our vCLAS Cryoablation System; our

research, development and regulatory plans for our product candidates, including the timing of initiating additional trials and

reporting data from our trials; the regulatory pathway for our vCLAS Cryoablation

System and the potential impacts of the Breakthrough Device Designation; the

potential for our product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies; and our

current cash resources and the impacts of our corporate prioritization initiative and realignment of resources. 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 our business are described in detail in our Securities and Exchange

Commission ("SEC") filings, including in our Annual Report on Form 10-K for the full-year ended December 31,

2024, which is available on the SEC's website at www.sec.gov. Additional information will be made available in other filings

that we make from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and we disclaim any

obligation to update these statements except as may be required by law.

Chief Business Officer

Caroline Corner, PhD

Adagio Medical Holdings Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

Adagio Medical Holdings Inc.

Condensed Consolidated Statements of Operations

and Comprehensive Loss

(in thousands, except share and per share data)