# EDGAR Filing Document

**Accession Number:** 0002006986
**File Stem:** 0001104659-25-110336
**Filing Date:** 2025-11
**Character Count:** 15386
**Document Hash:** 7df139ba07366af41abea29b6433922b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-110336.hdr.sgml**: 20251112

**ACCESSION NUMBER**: 0001104659-25-110336

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251112

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251112

**DATE AS OF CHANGE**: 20251112

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Adagio Medical Holdings, Inc.
- **CENTRAL INDEX KEY:** 0002006986
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42199
- **FILM NUMBER:** 251472600

**BUSINESS ADDRESS:**
- **STREET 1:** 26051 MERIT CIRCLE
- **STREET 2:** SUITE 102
- **CITY:** LAGUNA HILLS
- **STATE:** CA
- **ZIP:** 92653
- **BUSINESS PHONE:** (949) 348-1188

**MAIL ADDRESS:**
- **STREET 1:** 26051 MERIT CIRCLE
- **STREET 2:** SUITE 102
- **CITY:** LAGUNA HILLS
- **STATE:** CA
- **ZIP:** 92653

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Aja Holdco, Inc.
- **DATE OF NAME CHANGE:** 20240104

?xml version='1.0' encoding='ASCII'? ADAGIO MEDICAL HOLDINGS, INC._November 12, 2025

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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): November 12, 2025**

## ADAGIO MEDICAL HOLDINGS, INC.
**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-42199** | **99-1151466** |
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |

---

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| | |
|:---|:---|
| **26051 Merit Circle, Suite 102**<br>**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:

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| | |
|:---|:---|
| **Title of each class** | **Name of each exchange**<br>**on which registered** |
| Common Stock, par value $0.0001 per share<br> 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 ☒

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. ☐

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**Item 2.02. Results of Operations and Financial Condition.**

On November 12, 2025, Adagio Medical Holdings, Inc. (the "Company"), issued a press release announcing the Company's financial results for the quarter ended September 30, 2025, 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.

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press Release, dated November 12, 2025](adgm-20251112xex99d1.htm) |
| 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: November 12, 2025

---

| | |
|:---|:---|
| **Adagio Medical Holdings, Inc.** | **Adagio Medical Holdings, Inc.** |
| By: | /s/ Deborah Kaster |
| Name: | Deborah Kaster |
| Title: | Chief Financial Officer and Chief Business Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**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:
● 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 <sup>TM</sup> 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.

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#### 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 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.**

#### Contact
Debbie Kaster

Chief Financial Officer and Chief Business Officer

dkaster@adagiomedical.com

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**Adagio Medical Holdings, Inc.**

**Condensed Balance Sheets**

**(in thousands, except share and per share data)**

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| | | |
|:---|:---|:---|
|  | **Successor**  | **Predecessor** |
|  | **As of** <br>**9/30/2025**  | **As of** <br>**12/31/2024**  |
| &nbsp;&nbsp;&nbsp;Cash and cash equivalents | $4673 | $20586 |
| &nbsp;&nbsp;&nbsp;Total assets | 31546 | 48448 |
| &nbsp;&nbsp;&nbsp;Total liabilities | 32858 | 28536 |
| &nbsp;&nbsp;&nbsp;Total stockholders' (deficit) equity | (1312) | 19912 |

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**Condensed Statements of Operations**

**(in thousands, except share and per share data)**

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| | | | |
|:---|:---|:---|:---|
|  | **Three Months Ended September 30,**  | **Three Months Ended September 30,**  | **Three Months Ended September 30,**  |
|  | **2025** | **2024** | **2024** |
|  | **Successor** | **Successor** | **Predecessor** |
|  |  | **July 31 to September 30** | **July 1 to July 30** |
| Revenue | $— | $132 | $53 |
| &nbsp;&nbsp;&nbsp;&nbsp;Cost of revenue | 31 | 414 | 157 |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 2774 | 1217 | 1251 |
| &nbsp;&nbsp;&nbsp;&nbsp;Selling, general, and administrative | 2916 | 2926 | 4851 |
| Total cost of revenue and operating expenses | 5721 | 4557 | 6259 |
| Loss from operations | (5721) | (4425) | (6206) |
| Other (expense) income: |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Convertible notes fair value adjustment | (3508) | 3255 | (1907) |
| &nbsp;&nbsp;&nbsp;&nbsp;Warrant liabilities fair value adjustment | (231) | 4973 | 177 |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest expense | (749) | (435) | (304) |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest income | 79 | 166 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Other (expense) income, net | 12 | 72 | 5 |
| Total other (loss) income, net | (4397) | 8031 | (2029) |
| Net (loss) income | $(10118) | $3606 | $(8235) |
| **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 | 15381565 | 14057636 | 987810 |
| Weighted-average shares outstanding – Diluted | 15381565 | 16057636 | 987810 |

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| | | | |
|:---|:---|:---|:---|
|  | <br>**Nine Months Ended September 30,**  | <br>**Nine Months Ended September 30,**  | <br>**Nine Months Ended September 30,**  |
|  | **2025** | **2024** | **2024** |
|  | **Successor** | **Successor** | **Predecessor** |
|  |  | **July 31 to September 30** | **January 1 to July 30** |
| Revenue | $— | $132 | $333 |
| &nbsp;&nbsp;&nbsp;&nbsp;Cost of revenue | 626 | 414 | 1381 |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 8404 | 1217 | 7585 |
| &nbsp;&nbsp;&nbsp;&nbsp;Selling, general, and administrative | 8892 | 2926 | 13047 |
| Total cost of revenue and operating expenses | 17922 | 4557 | 22013 |
| Loss from operations | (17922) | (4425) | (21680) |
| Other (expense) income: |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Convertible notes fair value adjustment | (1891) | 3255 | 2059 |
| &nbsp;&nbsp;&nbsp;&nbsp;Warrant liabilities fair value adjustment | (334) | 4973 | 191 |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest expense | (2131) | (435) | (1818) |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest income | 345 | 166 | 3 |
| &nbsp;&nbsp;&nbsp;&nbsp;Other (expense) income, net | 155 | 72 | (33) |
| Total other (loss) income, net | (3856) | 8031 | 402 |
| Net (loss) income | $(21778) | $3606 | $(21278) |
| **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 | 15378543 | 14057636 | 815854 |
| Weighted-average shares outstanding – Diluted | 15378543 | 16057636 | 815854 |

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