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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
May 12, 2026
ADAGIO MEDICAL HOLDINGS, INC.
(Exact name of registrant as specified in its
charter)
| Delaware |
001-42199 |
99-1151466 |
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
|
26051 Merit Circle, Suite 102
Laguna Hills, CA |
|
92653 |
| (Address of principal executive offices) |
|
(Zip Code) |
(949) 348-1188
(Registrant’s telephone number, including
area code)
Not Applicable
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of
the Act:
| Title of each class |
Trading
Symbol(s) |
Name of each exchange
on which registered |
| Common Stock, par value $0.0001 per share |
ADGM |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange
Act of 1934.
Emerging growth
company x
If an emerging growth
company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. Results of Operations and Financial Condition.
On May 12, 2026, Adagio Medical Holdings, Inc.
issued a press release announcing financial results for the quarter ended March 31, 2026, and providing a business update. A copy
of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The information furnished with this Item 2.02,
including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated
by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release, dated May 12, 2026 |
| |
|
|
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Dated: May 12, 2026
| |
Adagio Medical Holdings, Inc. |
| |
|
| |
By: |
/s/ Deborah Kaster |
| |
Name: |
Deborah Kaster |
| |
Title: |
Chief Financial Officer and
Chief Business Officer |
Exhibit 99.1
Adagio Medical Reports First Quarter 2026 Results
and Meaningful Clinical Progress
Advancing Toward Submission for PMA Approval Following Late-Breaking
FULCRUM-VT Data
LAGUNA HILLS, CA, May 12, 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 announced financial results for the first quarter ended March 31,
2026.
Recent Business Highlights:
| ● | Pivotal results from the FULCRUM-VT trial
presented in late-breaking session at Heart Rhythm Society 2026 – the first large-scale, rigorously executed pivotal trial in
patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator
(“ICD”) shock at six months, a promising safety profile with 2.4% protocol-defined Major Adverse Events, and a 72% discontinuation
or reduced dose of antiarrhythmic drugs, as well as equivalent results across both ischemic and non-ischemic cardiomyopathy patients with
the Company's proprietary Ultra-Low Temperature Ablation (“ULTA”) technology |
| ● | Received Food and Drug Administration (“FDA”)
Investigational Device Exemption (“IDE”) approval to expand the FULCRUM-VT trial to evaluate the safety and effectiveness
of the next-generation vCLAS Ultra System, which is designed to be faster, colder and deeper, with improved usability, compared to the
first generation vCLAS catheter, underscoring the depth and durability of the Company's ULTA platform for the treatment of Sustained Monomorphic
Ventricular Tachycardia |
| ● | Featured in over a dozen well-attended events,
presentations, and posters at Heart Rhythm Society's 47th Annual Scientific Sessions—Heart Rhythm 2026—highlighting ULTA
as a purpose-built endocardial solution for ventricular tachycardia (“VT”) |
| ● | Announced the publication of pre-clinical
results of the Company’s next generation ULTA technology in the Journal of Cardiovascular Electrophysiology, which describe
titratable lesion depth exceeding 10 millimeters as well as significant functional improvements in catheter performance compared to first-generation
ULTA, including improved handling characteristics, better compatibility with standard laboratory practices and the potential for 50-75%
reduction in ablation time |
| ● | Successfully completed 13 cases under FDA
Expanded Access using the vCLAS System in patients with recurrent VT and premature ventricular contractions who had previously failed
conventional and experimental ablation therapies, including radio frequency (RF)and pulsed field ablation (PFA), demonstrating real-world
applicability and versatility of the ULTA platform |
| ● | Reported cash and cash equivalents of $12.9
million as of March 31, 2026, with potential for up to an additional $31 million of aggregate gross proceeds that may be received
upon the cash exercise in full of milestone-based warrants |
“The first quarter of 2026 was a landmark
period for Adagio during which we made exceptional progress advancing our Ultra-Low Temperature Ablation platform across both clinical
development and real-world use,” said Todd Usen, Chief Executive Officer of Adagio Medical. “The late-breaking results from
the FULCRUM-VT trial represent a defining milestone for our endocardial-only ULTA platform, demonstrating best-in-class safety, 84% freedom
from ICD shock at six months, meaningful reductions in antiarrhythmic drug use, and consistent results across both ischemic and non-ischemic
cardiomyopathy patients—the broadest patient population studied in any VT ablation trial. The enthusiasm from physicians on the
podium was remarkable, with leading electrophysiologists highlighting ULTA as a potentially transformative solution for ventricular tachycardia.
As we look ahead, we have multiple additional meaningful milestones expected this year across our platform of technologies and we are
more confident than ever in our mission to fundamentally change the treatment of VT with a safe, effective solution for a broad group
of patients who suffer from this dangerous arrhythmia."
First Quarter 2026 Financial Results
Cost of revenue was nil for the three months ended
March 31, 2026, compared to $0.3 million for the three months ended March 31, 2025. The decrease was primarily attributable
to the pause in commercial activity in Europe. Depreciation expense related to consoles loaned to customers is generally classified within
cost of revenue; however, because the Company did not generate revenue during the three months ended March 31, 2026, such depreciation
expense is now reflected within research and development expenses for the period.
Research and development expenses were $2.7 million
for the three months ended March 31, 2026, compared to $3.7 million for the three months ended March 31, 2025. The decrease
was primarily attributable to lower clinical trial expenses and lower product development costs, including consulting, prototyping, and
project-related support, partially offset by higher operational costs, including the aforementioned depreciation expense.
Selling, general and administrative expenses were
$2.5 million for the three months ended March 31, 2026, compared to $3.5 million for the three months ended March 31, 2025.
Selling, general and administrative expenses decreased primarily due to lower professional services expenses, regulatory
reporting expenses, and payroll and personnel expenses.
Net loss for the three months ended March 31,
2026 was $7.0 million, compared to a net loss of $7.7 million for the three months ended March 31, 2025.
22,210,459 weighted average shares of common stock outstanding, basic
and diluted, as of March 31, 2026. The Company's fully diluted share count includes all outstanding warrants; however, for purposes
of calculating net loss per share, warrants and certain other potentially dilutive securities are excluded as their inclusion would be
anti-dilutive.
Reported cash and cash equivalents of $12.9 million as of March 31,
2026.
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.
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™ 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 potential 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
FULCRUM-VT pivotal 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,
2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, 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.
Contact
Debbie Kaster
Chief Financial Officer and Chief Business Officer
dkaster@adagiomedical.com
Adagio Medical Holdings Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| | |
March 31, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| | |
(Unaudited) | | |
(Audited) | |
| Cash and cash equivalents | |
$ | 12,909 | | |
$ | 17,105 | |
| Total assets | |
| 39,308 | | |
| 43,253 | |
| Total liabilities | |
| 33,583 | | |
| 30,851 | |
| Total stockholders’ equity | |
| 5,725 | | |
| 12,402 | |
Adagio Medical Holdings Inc.
Condensed Consolidated Statements of Operations
and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
| | |
Three Months Ended
March 31, | |
| | |
2026 | | |
2025 | |
| Revenue | |
$ | — | | |
$ | — | |
| Cost of revenue and operating expenses: | |
| | | |
| | |
| Cost of revenue | |
| — | | |
| 253 | |
| Research and development | |
| 2,741 | | |
| 3,659 | |
| Selling, general, and administrative | |
| 2,459 | | |
| 3,485 | |
| Total cost of revenue and operating expenses | |
| 5,200 | | |
| 7,397 | |
| Loss from operations | |
| (5,200 | ) | |
| (7,397 | ) |
| Other income (expense): | |
| | | |
| | |
| Convertible notes fair value adjustment | |
| (1,063 | ) | |
| 190 | |
| Warrant liabilities fair value adjustment | |
| (131 | ) | |
| 38 | |
| Interest expense | |
| (778 | ) | |
| (662 | ) |
| Interest income | |
| 107 | | |
| 164 | |
| Other income (expense), net | |
| 70 | | |
| (46 | ) |
| Total other loss, net | |
| (1,795 | ) | |
| (316 | ) |
| Net loss | |
$ | (6,995 | ) | |
$ | (7,713 | ) |
| Other comprehensive loss: | |
| | | |
| | |
| Foreign currency translation adjustment | |
| (44 | ) | |
| (61 | ) |
| Comprehensive loss | |
$ | (7,039 | ) | |
$ | (7,774 | ) |
| | |
| | | |
| | |
| Basic net loss per share | |
$ | (0.31 | ) | |
$ | (0.50 | ) |
| Diluted net loss per share | |
$ | (0.31 | ) | |
$ | (0.51 | ) |
| Weighted-average shares outstanding – basic and diluted | |
| 22,210,459 | | |
| 15,375,521 | |
