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Adagio Medical Holdings, Inc.

For the period ended Sep 30, 2025. Filed Nov 12, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 12, 2025

ADGM$0.06+6.4%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-14.

0001558370-25-011420

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-12.

0001104659-25-110345

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 185 previous paragraphs and 195 current paragraphs.

134 unchanged; 32 reworded; 27 added; 19 removed; 0 previous and 2 current paragraphs rearranged.

Tables are not compared: 24 previous and 25 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (27)

Current report

We are also currently developing a next generation ULTC technology for VT. This catheter, which requires only a single freeze, is being designed to improve customer usability and integration with the existing ablation laboratory workflow. The next-generation catheter features a more flexible, smaller diameter shaft that is compatible with the industry-standard 8.5 Fr sheaths, and is designed to operate at lower ablation temperatures resulting in the shorter, single-freeze ablation protocol. We are currently in the design phase with this device.

Current report

On October 14, 2025, we entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain accredited healthcare investors (the “Purchasers”) pursuant to which we issued and sold to the Purchasers in a private placement (the “Private Placement”): (i) 9,792,506 shares (the “Shares”) of our common stock, par value $0.0001 per share (the “Common Stock”), or pre-funded warrants (the “Pre-Funded Warrants”) to purchase shares of Common Stock in lieu thereof, and (ii) accompanying (a) Tranche A Warrants to purchase an aggregate of 6,012,943 shares of Common Stock (or pre-funded warrants in lieu thereof) (the “Tranche A Warrants”), Tranche B Warrants to purchase an aggregate of 6,012,943 shares of Common Stock (or pre-funded warrants in lieu thereof) (the “Tranche B Warrants”) and Tranche C Warrants to purchase an aggregate of 6,012,943 shares of Common Stock (or pre-funded warrants in lieu thereof) (the “Tranche C Warrants” and, together with the Tranche A and Tranche B Warrants, the “Milestone Warrants”), for aggregate gross proceeds of approximately $19 million (excluding up to approximately $31 million of aggregate gross proceeds that may be received in the future upon the cash exercise in full of the Milestone Warrants issued in the Private Placement), before deducting placement agent fees and other expenses payable by us. Each Share and each Pre-Funded Warrant sold pursuant to the Securities Purchase Agreement was accompanied by one Tranche A Warrant, one Tranche B Warrant and one Tranche C Warrant. The combined purchase price of each Share and accompanying Milestone Warrants is $1.9403 and (which includes $0.2303 for the Milestone Warrants sold with each Share in accordance with the rules and regulations of The Nasdaq Stock Market LLC). The combined purchase price of each Pre-Funded Warrant and accompanying Milestone Warrant is $1.9402 (equal to the combined purchase price per Share and accompanying Milestone Warrants, minus $0.001). Entities affiliated with Perceptive Advisors LLC, an affiliate of the Company, purchased Pre-Funded Warrants and Milestone Warrants for an aggregate purchase price of $4,250,000.

Current report

Each Milestone Warrant is exercisable for one share of Common Stock at an exercise price of $1.71 per share. The Milestone Warrants will expire upon the earlier of (i) five years from the date of issuance or (ii) (a) for the Tranche A Warrants, the date that is thirty (30) days following our announcement of results from our FULCRUM-VT IDE pivotal clinical trial, (b) for the Tranche B Warrants, the date that is thirty (30) days following our announcement of FDA approval of our vCLAS Cryoablation System, and (c) for the Tranche C Warrants, the date that is thirty (30) days following our announcement of FDA approval of our second generation vCLAS catheter system. The Pre-Funded Warrants are exercisable for one share of Common Stock at an exercise price of $0.0001 per share. The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full.

Current report

A holder (together with its affiliates) of the Pre-Funded Warrants or Milestone Warrants, as the case may be, may not exercise any portion of the Pre-Funded Warrants or Milestone Warrants to the extent that the holder would own more than 4.99% (or, at the holder’s option upon issuance, 9.99%) of our outstanding Common Stock immediately after exercise, which percentage may be changed at the holder’s election to a lower or higher percentage not in excess of 19.99% upon 61 days’ notice to us subject to the terms of the Pre-Funded Warrants or the Milestone Warrants. In lieu of making the cash payment otherwise contemplated to be made to us upon exercise of a Milestone Warrant, after the deadline for effectiveness of the registration statement to be filed pursuant to the Registration Rights Agreement, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of Common Stock determined according to a formula set forth in the Milestone Warrants, provided that such cashless exercise shall only be permitted if, at the time of such exercise, there is no effective registration statement registering the resale of shares of Common Stock underlying the Milestone Warrants or if the prospectus contained in such registration statement is not available for the resale of shares of Common Stock underlying the Milestone Warrants by the Milestone Warrant holder.

Current report

In lieu of making the cash payment otherwise contemplated to be made to us upon exercise of a Pre-Funded Warrant in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of Common Stock determined according to a formula set forth in the Pre-Funded Warrants.

Current report

In October 2025, we announced a private placement of our common stock (or pre-funded warrants to purchase common stock in lieu thereof) and accompanying warrants to purchase shares of common stock, for aggregate gross proceeds of approximately $19 million (excluding up to $31 million of additional potential gross proceeds from the cash exercise of the common stock warrants) (the “Private Placement”).

Current report

Comparison for the three and nine months ended September 30, 2025 (Successor) to the periods from January 1, 2024 to July 30, 2024 (Predecessor), from July 31, 2024 to September 30, 2024 (Successor), from July 1, 2024 to July 30, 2024 (Predecessor), and from July 31, 2024 to September 30, 2024 (Successor)

Current report

Cost of revenue was $31.0 thousand for the three months ended September 30, 2025 (Successor), compared to $0.4 million and $0.2 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from July 1, 2024 to July 30, 2024 (Predecessor), respectively, representing a decrease of $0.5 million, or 94.6%. The decrease was primarily attributable to a pause in commercial activity in Europe during 2025 and the related impact of an inventory buyback conducted in connection with the pause.

Current report

Research and development expenses were $2.8 million for the three months ended September 30, 2025 (Successor), compared to $1.2 million and $1.3 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from July 1, 2024 to July 30, 2024 (Predecessor), respectively, representing an increase of $0.3 million, or 12.4%. The increase was primarily driven by a $0.5 million increase in clinical trial costs, partially offset by a $0.2 million decrease in quality assurance costs.

Current report

Research and development expenses were $8.4 million for the nine months ended September 30, 2025 (Successor), compared to $1.2 million and $7.6 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively, representing a decrease of $0.4 million, or 4.5%. This decrease was primarily driven by a $1.4 million decrease in quality assurance, operations, and other research and development costs, partially offset by a $1.0 million increase in clinical trials costs.

Current report

The change in convertible notes fair value resulted in a loss of $3.5 million and $1.9 million for the three and nine months ended September 30, 2025 (Successor) respectively. The change in convertible notes fair value resulted in a gain of $3.3 million and a loss of $1.9 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from July 1, 2024 to July 30, 2024 (Predecessor), respectively. The change in convertible notes fair value resulted in a gain of $3.3 million and $2.1 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively.

Current report

On October 20, 2025, we announced the closing of the Private Placement which resulted in up front, aggregate gross proceeds of approximately $19 million. After deducting estimated offering expenses, the net proceeds from the Private Placement are expected to provide us with additional liquidity to fund planned operations and working capital needs. For more information see “—Recent Developments” above.

Current report

We believe that our existing cash and cash equivalents, including the anticipated net proceeds from the Private Placement, will enable us to fund our ongoing development and submission activities to support FDA evaluation of our first and next generation ULTC products. We will require additional capital to fund continued clinical activities for our next generation product, to fund our manufacturing activities, to fund precommercial activities of our programs and for working capital and general corporate purposes. The assessment of our ability to meet our future obligations is inherently judgmental, subjective and susceptible to change. Based on our current forecast, we believe that we will have sufficient cash to maintain our planned operations for the next twelve months following the issuance of these condensed consolidated financial statements.

Current report

Because of the numerous risks and uncertainties associated with research, development and commercialization of medical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

Current report

Upon the consummation of the Business Combination, the April 2023 Convertible Notes automatically converted into shares of Company common stock that were issued in the 2024 PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the 2024 PIPE Financing.

Current report

Upon the consummation of the Business Combination, the November 2023 Convertible Notes automatically converted into shares of Company common stock that were issued in the 2024 PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the 2024 PIPE Financing.

Current report

Upon the consummation of the Business Combination, the May 2024 Convertible Notes automatically converted into shares of Company common stock that were issued in the 2024 PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the 2024 PIPE Financing.

Current report

Upon the consummation of the Business Combination, the June 2024 Convertible Notes automatically converted into shares of Company common stock that were issued in the 2024 PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the 2024 PIPE Financing.

Current report

Upon the consummation of the Business Combination, the July 2024 Convertible Notes automatically converted into shares of Company common stock that were issued in the 2024 PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the 2024 PIPE Financing.

Current report

Comparison of the Nine Months Ended September 30, 2025 (Successor) to the Periods from January 1, 2024 to July 30, 2024 (Predecessor) and from July 31, 2024 to September 30, 2024 (Successor)

Current report

Net cash used in operating activities for the period from July 31, 2024 to September 30, 2024 (Successor) was $6.4 million, consisting primarily of net income of $3.6 million, adjusted by non-cash items of $7.9 million, and net changes in our operating assets and liabilities of $2.1 million. Non-cash items primarily consisted of $0.3 million in depreciation and amortization; offset by a gain of $3.3 million from the change in fair value of convertible notes payable and a gain of $5.0 million from the change in fair value of warrant liabilities. Changes in our net operating assets and liabilities were primarily due to a $0.3 million increase in other accrued liabilities which was primarily driven by interest payable on the convertible note; offset by $1.3 million increase in prepaid expenses and other current assets, $0.4 million decrease in accounts payable, and a $0.7 million decrease in accrued liabilities.

Current report

Net cash used in operating activities for the period from January 1, 2024 to July 30, 2024 (Predecessor) was $16.0 million consisting primarily of a net loss of $21.3 million, adjusted by non-cash items of $0.8 million, and net changes in our operating assets and liabilities of $6.1 million. Non-cash items primarily consisted of $0.6 million in depreciation and amortization, $0.6 million in stock-based compensation, noncash operating lease expense of $0.1 million, and loss on disposal of property and equipment of $0.1 million; offset by a gain of $2.1 million from the change in fair value of convertible notes payable, and a gain of $0.2 million from the change in fair value of warrant liabilities. Changes in our net operating assets and liabilities were primarily due to a $7.4 million increase in accrued transaction costs, the increase in accrued liabilities of $0.5 million and a $1.7 million increase in other accrued liabilities, which were primarily driven by the increase in transaction costs related to the Business Combination, the increase in accrued variable compensation related to the Business Combination, and the increase in interest related the convertible notes; offset by a $2.6 million decrease in accounts payable, $0.8 million increase in inventory, which were primarily driven by the payment of accounts payable related to the Business combination and an increase in inventory purchases.

Current report

Net cash provided by financing activities for the period from January 1, 2024 to July 30, 2024 (Predecessor) was $15.6 million, primarily due to proceeds of $16.5 million from the issuance of the $7.0 million 2024 Bridge Financing Note, the $3.0 million May 2024 Convertible Notes, the $2.5 million June 2024 Convertible Notes, the $1.0 million July 2024 Convertible Notes, and the $3.0 million draw under the November 2023 Convertible Notes, partially offset by a $0.9 million repayment of the SVB Term Loan.
Removed paragraphs (19)

Previous report

•expand our sales force across key markets to increase physician awareness;

Previous report

Comparison for the three and six months ended June 30, 2025 (Successor) to the three and six months ended June 30, 2024 (Predecessor)

Previous report

Research and development expenses were $2.0 million for the three months ended June 30, 2025 (Successor), compared to $2.9 million for the three months ended June 30, 2024 (Predecessor), representing a decrease of $0.9 million, or 31%. The decrease was primarily driven by a $0.5 million reduction in quality assurance and operations costs due to lower production activity, a $0.4 million reduction in product development expenses, including consulting, prototyping, and project-related support, and lower payroll and personnel costs resulting from our corporate prioritization initiative.

Previous report

Research and development expenses were $5.6 million for the six months ended June 30, 2025 (Successor), compared to $6.3 million for the six months ended June 30, 2024 (Predecessor), representing a decrease of $0.7 million, or 11%. This decrease was primarily driven by a $0.7 million decrease in quality assurance and operations costs due to reduced production activity in the current period, and a reduction in payroll and personnel expenses resulting from a corporate prioritization initiative implemented during the six months ended June 30, 2025.

Previous report

The change in convertible notes fair value resulted in a gain of $1.4 million and $1.6 million for the three months ended June 30, 2025 (Successor) and 2024 (Predecessor), respectively, and $1.6 million and $4.0 million for the six months ended June 30, 2025 (Successor) and 2024 (Predecessor), respectively.

Previous report

We do not require significant cash reserve to meet short term and long-term obligations with a balance of approximately $1.3 million for accounts payable and $3.4 million for accrued liabilities as of June 30, 2025 (Successor). We have a balance of $8.2 million in cash as of June 30, 2025, and we do not believe our current cash and cash equivalents are sufficient to fund operations for at least the next 12 months from the issuance date of the condensed consolidated financial statements. We believe that this raises substantial doubt about our ability to continue as a going concern. See “—Going Concern and Operating Outlook.”

Previous report

We intend to mitigate the conditions and events that raise substantial doubt about our ability to continue as a going concern entity by (i) negotiating other cash equity or debt financing in the short-term, (ii) continuing to pursue the necessary regulatory approvals to launch commercially in the U.S. market, and (iii) executing cost-cutting measures to manage cash burn. However, there can be no assurances that the current plans will generate any liquidity to us or be available on terms acceptable to us.

Previous report

Our future liquidity and capital funding requirements will depend on numerous factors, including:

Previous report

Upon the consummation of the Business Combination, the April 2023 Convertible Notes automatically converted into shares of Company common stock that were issued in the PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the PIPE Financing.

Previous report

Upon the consummation of the Business Combination, the November 2023 Convertible Notes automatically converted into shares of Company common stock that were issued in the PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the PIPE Financing.

Previous report

Upon the consummation of the Business Combination, the May 2024 Convertible Notes automatically converted into shares of Company common stock that were issued in the PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the PIPE Financing.

Previous report

Upon the consummation of the Business Combination, the June 2024 Convertible Notes automatically converted into shares of Company common stock that were issued in the PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the PIPE Financing.

Previous report

Upon the consummation of the Business Combination, the July 2024 Convertible Notes automatically converted into shares of Company common stock that were issued in the PIPE Financing in an amount equal to the principal amount and any accrued and unpaid interest, divided by the effective price of the securities sold in the PIPE Financing.

Previous report

Comparison for the six months ended June 30, 2025 (Successor) to the six months ended June 30, 2024 (Predecessor)

Previous report

Net cash used in operating activities for the six months ended June 30, 2025 (Successor) was $11.9 million, consisting primarily of a net loss of $11.7 million, adjusted by non-cash items of $0.5 million and net changes in operating assets and liabilities of $0.3 million. Non-cash items primarily consisted of $0.5 million in depreciation and amortization, $0.5 million in stock-based compensation, partially offset by a $1.6 million net gain from the change in fair value of convertible notes payable. Changes in operating assets and liabilities included a $1.5 million decrease in accounts payable and a $0.4 million decrease in accrued liabilities, partially offset by a $0.8 million decrease in inventory and a $1.4 million increase in other accrued liabilities.

Previous report

Net cash provided by financing activities for the six months ended June 30, 2024 (Predecessor) was $14.6 million, primarily due to receiving $15.5 million from the issuance of convertible notes payable, offset by a decrease of $0.9 million repayment of SVB Term Loan.
Reworded paragraphs (32)

Previous wording

We are a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias with our novel, proprietary, catheter-based Ultra-Low Temperature Cryoablation (“ULTC”) technology. Our initial focus is on the treatment of ventricular tachycardia (“VT”). VT is a rapid, abnormal heart rhythm, or arrhythmia, that originates in the heart's lower chambers, or ventricles, potentially leading to blood flow issues and, if sustained, VT can be fatal. VT is strongly associated with coronary artery disease, with an estimated 15% of patients with coronary artery disease found to have VT, and sudden cardiac death (“SCD”) caused by VT accounts for approximately half of the deaths related to cardiac causes. Radio Frequency (“RF”) ablation catheters currently used to treat VT were primarily designed and approved for the treatment of atrial fibrillation (“AF”) and are therefore not designed to optimally treat the specifics of the ventricular anatomy and disease. As a result, VT procedures performed with current devices can be overly complex, with sub-optimal outcomes, potentially leading to limited growth in the market for VT ablations.

Current wording

We are a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias with our novel, proprietary, catheter-based Ultra-Low Temperature Cryoablation (“ULTC”) technology. Our initial focus is on the treatment of ventricular tachycardia (“VT”). VT is a rapid, abnormal heart rhythm, or arrhythmia, that originates in the heart's lower chambers, or ventricles, potentially leading to impaired blood flow and, if sustained, VT can be fatal. VT-associated sudden cardiac death (“SCD”) accounts for approximately 300,000 deaths each year in the U.S. Radio Frequency (“RF”) ablation catheters currently used to treat VT were primarily designed and approved for the treatment of atrial fibrillation (“AF”) and are therefore not designed to optimally treat the specifics of the ventricular anatomy and disease. As a result, VT procedures performed with current devices can be overly complex and can lead to sub-optimal outcomes, factors that have potentially led to the limited growth in the market for VT ablations.

Previous wording

Our clinically tested ULTC products are purpose-built to treat patients with VT. Our highly differentiated catheters are designed for large, durable, deep lesions within the ventricle through an endocardial approach. Our ULTC approach is built on the hypothesis that large and durable lesions extending through the depth of both diseased and healthy muscular tissue of the ventricle of the heart (ventricular myocardium) is a foundation for improving the effectiveness of VT ablations and patient outcomes. In April 2025, we received Breakthrough Device designation from the FDA for our vCLASTM Cryoablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease.

Current wording

Our clinically tested, proprietary ULTC products are purpose-built to treat patients with VT and are designed to address the unique anatomy of the ventricle and the specific needs of the VT patient. Our ULTC approach is built on the hypothesis that large and durable lesions extending through the depth of both diseased and healthy muscular tissue of the ventricle of the heart (ventricular myocardium) is a foundation for improving the effectiveness of VT ablations and patient outcomes. Our differentiated catheters are designed for large, durable, deep lesions within the ventricle through an endocardial approach with no required irrigation. In October 2025, we announced completion of enrollment in our FULCRUM-VT Pivotal U.S. Food and Drug Administration (“FDA”) Investigational Device Exemption (“IDE”) study evaluating the vCLASTM Cryoablation System for ablation of monomorphic ventricular tachycardia (MMVT) in patients with both ischemic and nonischemic cardiomyopathy. The vCLAS System, which was granted Breakthrough Device Designation by the FDA in April 2025, is built on the Company’s proprietary ULTC technology platform.

Previous wording

We have established a robust cadence of clinical data designed to evaluate our technology and gain regulatory approvals of our product portfolio. Preliminary data suggest that our approach to treating VT offers a favorable combination of safety, acute and chronic effectiveness, compared to the current standard of care, including ablations performed using RF energy. Our first-in-human CRYOCURE-VT trial included 64 patients in nine centers in the E.U. and Canada. The outcomes of this trial, which were used to support CE Mark approval, include a 0% rate of major adverse events, 94% acute procedural success, 60% freedom from sustained VT and 81% freedom from implantable cardioverter defibrillator (“ICD”) shock at six months. Our vCLASTM. Cryoablation System for VT has obtained European CE Mark approval. In the U.S., our 206-patient FULCRUM-VT IDE pivotal clinical trial is currently enrolling patients across twenty (20) centers in the U.S. and Canada. Upon completion, which we anticipate in the second half of 2025, we expect to submit the results of this trial to support U.S. Food and Drug Administration (“FDA”) approval of our vCLASTM Cryoablation System.

Current wording

We have established a robust cadence of clinical data designed to evaluate our technology and gain regulatory approvals of our product portfolio. Preliminary data suggest that our approach to treating VT offers a favorable combination of safety, acute and chronic effectiveness, compared to the current standard of care, including ablations performed using radiofrequency (“RF”) and pulsed field ablation (“PFA”) energy. Our first-in-human CRYOCURE-VT trial included 64 patients in nine centers in the European Union and Canada. The outcomes of this trial, which were used to support CE Mark approval, include a 0% rate of major adverse events, 94% acute procedural success, 60% freedom from sustained VT and 81% freedom from implantable cardioverter defibrillator (“ICD”) shock at six months. Our vCLASTM. Cryoablation System for VT has obtained European CE Mark approval. In the United States, our 209-patient FULCRUM-VT IDE pivotal clinical trial completed enrollment in October 2025 across nineteen (19) centers in the United States and Canada. The study includes patients with both ischemic (“ICM”) and non-ischemic (“NICM”) cardiomyopathies (LVEF=35+/-10%, 33% NICM, 75% with congestive heart failure). In our preliminary acute safety and efficacy results, acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was 97.4%, with all clinically-relevant VTs eliminated in 96.7% of patients tested by post-ablation programmed electrical stimulation. Key safety findings included a 2.5% rate of major adverse events including four (1.9%) peri-procedural deaths, of which one (0.5%) was adjudicated by an independent clinical events committee as definitely related to the investigational device. We plan to submit the results of this trial to support our application for U.S. Food and Drug Administration (“FDA”) approval of our vCLASTM Cryoablation System in the first half of 2026, and to share our six-month primary efficacy endpoint results of the FULCRUM-VT trial in April 2026 at the Heart Rhythm 2026 Conference.

Previous wording

We have also developed a technology that utilizes ULTC in combination with Pulsed Field Ablation, which we call Pulsed Field Cryoablation (“PFCA”). Early demonstration of PFCA technology has been performed in the European PARALELL trial in patients with persistent atrial fibrillation and in preclinical studies targeting VT ablations.

Current wording

We have also developed a technology that utilizes ULTC in combination with PFA, which we call Pulsed Field Cryoablation (“PFCA”). Early demonstration of PFCA technology has been performed in the European PARALELL trial in patients with persistent atrial fibrillation and in preclinical studies targeting VT ablations.

Previous wording

We have incurred net losses each year since our inception in 2011. As of June 30, 2025, and December 31, 2024, we had an accumulated deficit of $82.2 million and $70.6 million, respectively. Our net loss was $3.9 million and $5.7 million for the three months ended June 30, 2025 (Successor) and June 30, 2024 (Predecessor), respectively. Our net loss was $11.7 million and $13.0 million for the six months ended June 30, 2025 (Successor) and June 30, 2024 (Predecessor), respectively. The net cash used in operating activities was $11.9 million for the six months ended June 30, 2025 (Successor) and $13.7 million for the six months ended June 30, 2024 (Predecessor), respectively. Substantially all of our accumulated deficit has resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. As of June 30, 2025, and December 31, 2024, we had cash of $8.2 million and $20.6 million, respectively.

Current wording

We have incurred net losses each year since our inception in 2011. As of September 30, 2025, and December 31, 2024, we had an accumulated deficit of $92.3 million and $70.6 million, respectively. For the three and nine months ended September 30, 2025 (Successor), and for the periods from July 31, 2024 to September 30, 2024 (Successor), and January 1, 2024 to July 30, 2024 (Predecessor), net (loss) income was $(10.1) million, $(21.8) million, $3.6 million, and $(21.3) million, respectively. The net cash used in operating activities was $14.9 million, $6.4 million, and $16.0 million respectively. Substantially all of our accumulated deficit has resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. As of September 30, 2025, and December 31, 2024, we had cash of $4.7 million and $20.6 million, respectively.

Previous wording

The accompanying condensed consolidated financial statements have been prepared on a basis that assumes we will continue as a going concern, which contemplate the realization of assets and liabilities in the normal course of business. We have limited revenue and have experienced recurring operating losses and negative cash flows from operations since our inception and anticipate that we will continue to do so for at least the next several years. In February 2025, in an effort to extend our capital resources, we implemented a corporate prioritization initiative focusing all resources on the FULCRUM-VT clinical trial activities and our new product design optimization program, which has been designed to advance faster innovation and iteration to meet market demands. We incurred one-time expenses related to these events during the six months ended June 30, 2025. Based on our current research and development plans, we expect to have sufficient resources to fund our planned operations into the fourth quarter of 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than expected. We will require additional capital in order to complete clinical development of our vCLASTM Cryoablation System.

Current wording

The accompanying condensed consolidated financial statements have been prepared on a basis that assumes we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We have limited revenue and have experienced recurring operating losses and negative cash flows from operations since our inception and anticipate that we will continue to do so for at least the next several years.

Previous wording

These factors raise substantial doubt about our ability to continue as a going concern for the twelve-month period from the date of this filing with the SEC. Refer toNote 1 - Organization and Description of Businessin our condensed consolidated financial statements for additional information on the going concern assessment.

Current wording

As of the report date, we believe our existing cash and cash equivalents, including the proceeds received from the Private Placement, are sufficient to fund our operating and capital expenditure requirements for at least 12 months from the date of issuance of the unaudited interim condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. If our available cash and cash equivalents are insufficient to satisfy our liquidity requirements, we may need to raise additional capital to fund our operations. No assurance can be given as to whether additional needed financing will be available on terms acceptable to us, if at all. If sufficient funds on acceptable terms are not available when needed, we may be required to suspend or forego certain planned activities. Failure to manage discretionary spending or raise additional financing, as needed, would adversely impact our ability to achieve our intended business objectives and have an adverse effect on our results of operations and future prospects. Refer toNote 1 - Organization and Description of Businessin our condensed consolidated financial statements for additional information on the going concern assessment.

Previous wording

The need for additional capital will depend in part on the scope and costs of our development and clinical activities. To date, we have not generated significant revenue from the sale of commercialized products. Once we conduct a full commercial launch, our ability to generate product revenue will depend on the successful commercialization of our products. Until such time, if ever, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, or through potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. See the section of this Report titled “Risk Factors” for additional information.

Current wording

The need for additional capital in the future will depend in part on the scope and costs of our development and clinical activities. To date, we have not generated significant revenue from the sale of commercialized products. Once we conduct a full commercial launch, our ability to generate product revenue will depend on the successful commercialization of our products. Until such time, if ever, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, or through potential collaborations, other strategic transactions, or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend, or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results, and financial condition. See the section of this Report titled “Risk Factors” for additional information.

Previous wording

Pursuant to the subscription agreements, the PIPE Investors committed financing valued at $64.5 million (the “PIPE Financing”).

Current wording

Pursuant to the subscription agreements, the PIPE Investors committed financing valued at $64.5 million (the “2024 PIPE Financing”).

Previous wording

We accounted for certain common stock warrants outstanding as warrant liabilities at fair value, determined using the Black-Scholes-Merton option pricing model. The liability is subject to remeasurement at each reporting period and any change in fair value is recognized as warrant liabilities fair value adjustment in the condensed consolidated statements of operations and comprehensive loss.

Current wording

We accounted for certain common stock warrants outstanding as warrant liabilities at fair value, determined using the Black-Scholes-Merton option pricing model. The liability is subject to remeasurement at each reporting period and any change in fair value is recognized as warrant liabilities fair value adjustment in the condensed consolidated statements of operations and comprehensive loss (income).

Previous wording

The following table sets forth a summary of our results of operations (in thousands). This information should be read together with our condensed consolidated financial statements and related notes.

Current wording

The following tables set forth a summary of our results of operations (in thousands). This information should be read together with our condensed consolidated financial statements and related notes.

Previous wording

Revenue was nil for both the three and six months ended June 30, 2025 (Successor), compared to $0.3 million for both the three and six months ended June 30, 2024 (Predecessor), representing a decrease of $0.3 million in each period. The decrease was primarily due to the repurchase of previously sold inventory during the three and six months ended June 30, 2025 (Successor), which offset gross sales. This inventory buyback was undertaken in connection with our pause in commercial activity in Europe during the quarter and the first half of 2025.

Current wording

Revenue was nil for the three months ended September 30, 2025 (Successor), compared to $0.1 million and $53.0 thousand for the periods from July 31, 2024 to September 30, 2024 (Successor) and from July 1, 2024 to July 30, 2024 (Predecessor), respectively, representing a decrease of $0.2 million. The decrease was primarily due to the repurchase of previously sold inventory during the three months ended September 30, 2025 (Successor), which offset gross sales. This inventory buyback was undertaken in connection with our pause in commercial activity in Europe.

Previous wording

Cost of revenue was $0.3 million and $0.6 million for the three and six months ended June 30, 2025 (Successor), respectively, compared to $0.7 million and $1.2 million for the three and six months ended June 30, 2024 (Predecessor), respectively, representing decreases of $0.4 million, or 50%, and $0.6 million, or 51%, respectively. The decreases were primarily attributable to a pause in commercial activity in Europe during the second quarter of 2025 and the related impact of an inventory buyback conducted in connection with the pause.

Current wording

Cost of revenue was $0.6 million for the nine months ended September 30, 2025 (Successor), compared to $0.4 million and $1.4 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively, representing a decrease of $1.2 million, or 65.1%. The decrease was primarily attributable to a pause in commercial activity in Europe during 2025 and the related impact of an inventory buyback conducted in connection with the pause.

Previous wording

Our clinical trial expenses relate to trials for our iCLAS atrial ULTC catheter and system (CYROCURE-2), iCLAS atrial ULTC catheter and system ((iCLAS for persistent atrial fibrillation (“PsAF”)), vCLAS ventricular ULTC catheter (CYROCURE-VT), vCLAS ventricular ULTC catheter (FULCRUM-VT), and PFCA catheter. Clinical trial costs include the expenses spent on clinical trial studies and other related expenses. Quality assurance includes regulatory fees and third-party service fees. Pre-clinical trial costs and other research and development costs include the expenses resulting from professional fees, prototypes, and animal testing. Operational costs include the expenses spent on product manufacturing.

Current wording

Our clinical trial expenses relate to trials for our iCLAS atrial ULTC catheter and system (CYROCURE-2), iCLAS atrial ULTC catheter and system (iCLAS for persistent atrial fibrillation), vCLAS ventricular ULTC catheter (CYROCURE-VT), vCLAS ventricular ULTC catheter (FULCRUM-VT), and PFCA catheter. Clinical trial costs include the expenses spent on clinical trial studies and other related expenses. Quality assurance includes regulatory fees and third-party service fees. Pre-clinical trial costs and other research and development costs include the expenses resulting from professional fees, prototypes, and animal testing. Operational costs include the expenses spent on product manufacturing.

Previous wording

Selling, general and administrative expenses were $2.4 million for the three months ended June 30, 2025 (Successor) and $3.4 million for the three months ended June 30, 2024 (Predecessor). The decrease in selling, general and administrative expenses of $1.0 million, or 29%, was primarily due to a decrease in payroll and personnel expense related to lower headcount during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024.

Current wording

Selling, general and administrative expenses were $2.9 million for the three months ended September 30, 2025 (Successor) and $2.9 million and $4.9 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from July 1, 2024 to July 30, 2024 (Predecessor), respectively. The decrease in selling, general and administrative expenses of $4.9 million, or 62.5%, was primarily due to a decrease in payroll and personnel expense related to lower headcount during the three months ended September 30, 2025, as compared to the prior periods.

Previous wording

Selling, general and administrative expenses were $6.0 million for the six months ended June 30, 2025 (Successor) and $8.2 million for the six months ended June 30, 2024 (Predecessor). The decrease in selling, general and administrative expenses of $2.2 million, or 27%, was primarily due to a decrease in payroll and personnel expense related to lower headcount during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. Additionally, we changed our estimate of the useful life of our consoles from five years to three years and recognized a catch-up in January 2024, which increased depreciation expense in the first half of 2024.

Current wording

Selling, general and administrative expenses were $8.9 million for the nine months ended September 30, 2025 (Successor) and $2.9 million and $13.0 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively. The decrease in selling, general and administrative expenses of $7.1 million, or 44.3%, was primarily due to a decrease in payroll and personnel expense related to lower headcount during the nine months ended September 30, 2025, as compared to the prior year periods. Additionally, we changed our estimate of the useful life of our consoles from five years to three years and recognized a catch-up in January 2024, which increased depreciation expense in 2024.

Previous wording

The change in fair value of warrant liabilities resulted in a loss of $141 thousand for the three months ended June 30, 2025, compared to a gain of $94 thousand for the three months ended June 30, 2024.

Current wording

The change in fair value of warrant liabilities resulted in a loss of $0.2 million for the three months ended September 30, 2025, compared to a gain of $5.0 million and $0.2 million for the periods from July 31, 2024 to September 30, 2024 (Successor) and from July 1, 2024 to July 30, 2024 (Predecessor), respectively.

Previous wording

The change in fair value of warrant liabilities resulted in a loss of $103 thousand for the six months ended June 30, 2025, compared to a gain of $14 thousand for the six months ended June 30, 2024.

Current wording

The change in fair value of warrant liabilities resulted in a loss of $0.3 million for the nine months ended September 30, 2025, compared to a gain of $5.0 million and $0.2 million for the periods from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively.

Previous wording

Interest expense was $0.7 million and $0.8 million for the three months ended June 30, 2025 (Successor) and 2024 (Predecessor), respectively. The decrease of $0.1 million, or 5%, was related to interest incurred from the convertible promissory notes issued in April 2023, November 2023, February 2024, May 2024, June 2024, July 2024 Notes, and the Convertible Securities Notes.

Current wording

Interest expense was $0.7 million for the three months ended September 30, 2025 (Successor) and $0.4 million and $0.3 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from July 1, 2024 to July 30, 2024 (Predecessor), respectively. The increase of $10 thousand, or 1.4%, was related to interest incurred from the convertible promissory notes issued in April 2023, November 2023, February 2024, May 2024, June 2024, July 2024 Notes, and the Convertible Securities Notes.

Previous wording

Interest expense was $1.4 million and $1.5 million for the six months ended June 30, 2025 (Successor) and 2024 (Predecessor), respectively. The decrease of $0.1 million, or 9%, was related to interest incurred from the convertible promissory notes issued in April 2023, November 2023, February 2024, May 2024, June 2024, July 2024 Notes, and the Convertible Securities Notes.

Current wording

Interest expense was $2.1 million for the nine months ended September 30, 2025 (Successor) and $0.4 million and $1.8 million for the period from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively. The decrease of $0.1 million, or 5.4%, was related to interest incurred from the convertible promissory notes issued in April 2023, November 2023, February 2024, May 2024, June 2024, July 2024 Notes, and the Convertible Securities Notes.

Previous wording

Interest income was $102 thousand and $2 thousand for the three months ended June 30, 2025 (Successor) and 2024 (Predecessor), respectively. The increase in interest income of $100 thousand was primarily due to the increase of cash balances in an asset management account.

Current wording

Interest income was $79.0 thousand for the three months ended September 30, 2025 (Successor) and $0.2 million and nil for the period from July 31, 2024 to September 30, 2024 (Successor) and from July 1, 2024 to July 30, 2024 (Predecessor), respectively. The decrease in interest income of $87.0 thousand was primarily due to the decrease of cash balances in an asset management account.

Previous wording

Interest income was $266 thousand and $3 thousand for the six months ended June 30, 2025 (Successor) and 2024 (Predecessor), respectively. The increase in interest income of $263 thousand was primarily due to the increase of cash balances in an asset management account.

Current wording

Interest income was $0.3 million for the nine months ended September 30, 2025 (Successor) and $0.2 million and $3.0 thousand for the period from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively. The increase in interest income of $0.2 million was primarily due to the increase of cash balances in an asset management account.

Previous wording

Other income, net was $102 thousand and $5 thousand for the three months ended June 30, 2025 (Successor) and 2024 (Predecessor), respectively. This net increase in other income of $102 thousand was primarily attributable to foreign currency unrealized and realized gain.

Current wording

Other income, net was $12.0 thousand for the three months ended September 30, 2025 (Successor) and other income was $72.0 thousand and $5.0 thousand for the period from July 31, 2024 to September 30, 2024 (Successor) and from July 1, 2024 to July 30, 2024 (Predecessor), respectively. This net decrease in other income of $0.1 million was primarily attributable to foreign currency unrealized and realized loss.

Previous wording

Other income, net was $143 thousand and other expense was $38 thousand for the six months ended June 30, 2025 (Successor) and 2024 (Predecessor), respectively. This net increase in other income of $181 thousand was primarily attributable to foreign currency unrealized and realized gain.

Current wording

Other income, net was $0.2 million for the nine months ended September 30, 2025 (Successor) and other income was $72.0 thousand and other expense was $33.0 thousand for the period from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively. This net increase in other income of $0.1 million was primarily attributable to foreign currency unrealized and realized gain.

Previous wording

To date, we have financed our operations primarily through the sale of equity securities, convertible promissory notes and the SVB Term Loan. Since inception we have incurred operating losses and negative cash flows and anticipate continuing to do so for at least the next several years.

Current wording

To date, we have financed our operations primarily through the sale of equity securities, convertible promissory notes and the SVB Term Loan (as defined below). In connection with the closing of the Business Combination on July 31, 2024, we received net proceeds of $84.2 million. Since inception we have incurred operating losses and negative cash flows and anticipate continuing to do so for at least the next several years.

Previous wording

As of June 30, 2025, and December 31, 2024, the Successor had cash and cash equivalents of $8.2 million and $20.6 million, respectively. For the three months ended June 30, 2025 (Successor) and 2024 (Predecessor), net losses were $3.9 million and $5.7 million, respectively. For the six months ended June 30, 2025 (Successor) and 2024 (Predecessor), net losses were $11.7 million and $13.0 million, respectively. For the six months ended June 30, 2025 (Successor) and 2024 (Predecessor) net cash used in operating activities was $11.9 million and $13.7 million, respectively.

Current wording

As of September 30, 2025, and December 31, 2024, the Company had cash and cash equivalents of $4.7 million and $20.6 million, respectively. For the nine months ended September 30, 2025 (Successor), net losses were ($21.8) million. For the period from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), net income (losses) were $3.6 million and $(21.3) million, respectively. For the nine months ended September 30, 2025 (Successor) and the period from July 31, 2024 to September 30, 2024 (Successor) and the period from January 1, 2024 to July 30, 2024 (Predecessor), net cash used in operating activities was $14.9 million, $6.4 million, and $16.0 million, respectively.

Previous wording

Our primary uses of capital are, and we expect will continue to be, investment in our commercial organization and related expenses, clinical research and development services, and related supplies, legal and other regulatory expenses, general administrative costs and working capital.

Current wording

Our primary uses of capital are, and we expect will continue to be, investment in clinical research and development, and related supplies, marketing and physician education, legal and other regulatory expenses, commercial activities, general administrative costs and working capital.

Previous wording

In November 2023 and February 2024, the October 2022 Convertible Notes were further amended to also subordinate the November 2023 Convertible Notes and the 2024 Bridge Financing Note. Upon the consummation of the Business Combination, all principal and accrued interest in respect of the October 2022 Convertible Notes were converted into shares of Legacy Adagio common stock when multiplied by the exchange ratio applicable to the Legacy Adagio common stock in the Business Combination, which entitled the holder of this note to receive a number of shares of the same class of common stock that were issued in the PIPE Financing equal to the then outstanding principal amount and any accrued and unpaid interest under this note, divided by 75% of the effective price of each share of common stock sold in the PIPE Financing. Further, on the Closing Date, Legacy Adagio common stocks were converted to the Company’s common stock based on the exchange ratio set forth in the Business Combination Agreement.

Current wording

In November 2023 and February 2024, the October 2022 Convertible Notes were further amended to also subordinate the November 2023 Convertible Notes and the 2024 Bridge Financing Note. Upon the consummation of the Business Combination, all principal and accrued interest in respect of the October 2022 Convertible Notes were converted into shares of Legacy Adagio common stock when multiplied by the exchange ratio applicable to the Legacy Adagio common stock in the Business Combination, which entitled the holder of this note to receive a number of shares of the same class of common stock that were issued in the 2024 PIPE Financing equal to the then outstanding principal amount and any accrued and unpaid interest under this note, divided by 75% of the effective price of each share of common stock sold in the 2024 PIPE Financing. Further, on the Closing Date, Legacy Adagio common stocks were converted to the Company’s common stock based on the exchange ratio set forth in the Business Combination Agreement.

Previous wording

Pursuant to the Business Combination Agreement, the outstanding $29.5 million principal along with the accrued but unpaid interest of the Bridge Financing Notes, was converted in exchange for 4,372,607 shares of the Company’s common stock and 3,540,000 Base Warrants as part of the PIPE Financing.

Current wording

Pursuant to the Business Combination Agreement, the outstanding $29.5 million principal along with the accrued but unpaid interest of the Bridge Financing Notes, was converted in exchange for 4,372,607 shares of the Company’s common stock and 3,540,000 Base Warrants as part of the 2024 PIPE Financing.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024 (Predecessor) was $13.7 million, consisting primarily of a net loss of $13.0 million, adjusted by non-cash items of $3.0 million, and net cash provided by changes in operating assets and liabilities of $2.3 million. Non-cash items primarily consisted of $0.6 million in depreciation and amortization, $0.2 million in stock-based compensation, and $0.1 million in non-cash lease expense, partially offset by a $4.0 million gain from the change in fair value of convertible notes payable. Changes in operating assets and liabilities were primarily driven by a $1.8 million increase in accounts payable, a $0.4 million increase in accrued liabilities, and a $1.4 million increase in other accrued liabilities, partially offset by a $0.8 million increase in inventory, and a $0.3 million decrease in accrued transaction costs.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 (Successor) was $14.9 million, consisting primarily of a net loss of $21.8 million, adjusted by non-cash items of $4.0 million and net changes in operating assets and liabilities of $2.9 million. Non-cash items primarily consisted of $0.7 million in depreciation, $0.6 million in stock-based compensation, a loss on disposal of property and equipment of $0.5 million, a change in fair value of convertible notes payable of $1.9 million, and a change in fair value of warrant liabilities of $0.3 million. Changes in operating assets and liabilities were primarily driven by a $4.8 million increase in accrued liabilities, a $2.1 million increase in other accrued liabilities, a $1.1 million decrease in inventory, and a $0.3 million decrease in prepaid expenses and other current assets, partially offset by a $3.6 million decrease in other long-term liabilities and a $1.8 million decrease in accounts payable.

Previous wording

Net cash used in investing activities for each of the six months ended June 30, 2025 (Successor) and the six months ended June 30, 2024 (Predecessor) was $0.3 million. The cash used in investing activities was due to purchases of property and equipment.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2025 (Successor) was $0.9 million. Net cash used in investing activities for the periods from July 31, 2024 to September 30, 2024 (Successor) and January 1, 2024 to July 30, 2024 (Predecessor) was $0.6 million and $0.4 million, respectively. The increase was primarily due to higher purchases of property and equipment during the period.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 (Successor) was nil.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 (Successor) was nil.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Revenue was nil for the nine months ended September 30, 2025 (Successor), compared to $0.1 million and $0.3 million for the periods from July 31, 2024 to September 30, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively, representing a decrease of $0.5 million. The decrease was primarily due to the repurchase of previously sold inventory during the nine months ended September 30, 2025 (Successor), which offset gross sales. This inventory buyback was undertaken in connection with our pause in commercial activity in Europe.

Current report — wording carried from elsewhere

Cost of revenue and operating expenses