Adagio Medical Holdings, Inc.

Previous wording

The following discussion and analysis of financial condition and results of operations should be read together with the condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (this “Report”). Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” in this Report. Unless the context otherwise requires, references in this section of the Report to “we,” “us,” “Adagio,” and “the Company” refer to the business and operations of Adagio Medical Holdings, Inc. and its consolidated subsidiaries. References to our “management” or our “management team” refer to our officers and directors.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read together with the condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (this “Report”). Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” in this Report. Unless the context otherwise requires, references in this section of the Report to “we,” “us,” “Adagio,” and “the Company” refer to the business and operations of Adagio Medical Holdings, Inc. and its consolidated subsidiaries. References to our “management” or our “management team” refer to our officers and directors.

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 Ablation (“ULTA”) 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.

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 Ablation (“ULTA”) platform 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 United States. Radio Frequency (“RF”) ablation catheters currently approved 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 of VT ablation procedures, and the consequential unmet need in the large population of patients suffering from VT.

Previous wording

Our clinically tested, proprietary ULTA 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 ULTA 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 Ventricular Ablation System for treatment 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 ULTA technology platform.

Current wording

Our clinically tested, proprietary ULTA products are purpose-built to treat VT and are designed to address the unique anatomy of the ventricle and the specific needs of the VT patient. Our ULTA 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 to create large, durable, deep, titratable lesions within the ventricle, all through an endocardial approach and 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 our first generation vCLAS Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (“SMVT”) in patients with both ischemic and nonischemic cardiomyopathy, and in May 2026 we announced the submission of our Premarket Approval (“PMA”) application to the FDA for the vCLAS Ventricular Ablation System. The vCLAS System was granted Breakthrough Device Designation by the FDA in April 2025.

Previous wording

We are also currently developing a next generation ULTA technology for VT. We received IDE approval from the FDA in April 2026 to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of our next-generation vCLAS ULTA Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (“SMVT”). The next-generation 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.

Current wording

We have also developed a faster, smaller next-generation vCLASUltra Ventricular Ablation System, which is designed to improve customer usability and integration with the existing ablation laboratory workflow. vCLASUltra features a more flexible, smaller diameter shaft that is compatible with the industry-standard 8.5 Fr sheaths and operates at lower ablation temperatures resulting in the shorter, single-freeze ablations. In April 2026 we received IDE approval from the FDA to evaluate the safety and effectiveness of our vCLASUltra Ventricular Ablation System for the treatment of SMVT.

Previous wording

We believe that our purpose-built solution has the potential to drive additional market growth in ablative treatment of the large, underserved VT patient population.

Current wording

We believe that our purpose-built solutions have the potential to drive additional market growth in the ablative treatment of the large, underserved VT patient population.

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 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. Ventricular Ablation System for VT obtained European CE Mark approval in March 2024. 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 FDA approval of our vCLASTM Ventricular Ablation 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.

Current wording

We have established a robust cadence of clinical data designed to evaluate our ULTA technology and support 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 ablation performed using radio frequency (“RF”) and/or pulsed field ablation (“PFA”) energy sources. The outcomes of our first-in-human CRYOCURE-VT trial, which included 64 patients in nine centers in the European Union and Canada were used to support the March 2024 Conformité Européenne (“CE Mark”) approval of our vCLAS. Ventricular Ablation System for VT. Our 209-patient FULCRUM-VT IDE pivotal clinical trial completed enrollment in October 2025 across 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, which we shared in October 2025, 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 2.4% 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. In April 2026, we announced preliminary 6-month results from our FULCRUM-VT Pivotal IDE clinical trial, which demonstrated 84.3% six-month freedom from ICD shock and a 78% reduction or elimination of amiodarone use. Importantly, vCLAS demonstrated equivalent clinical effectiveness in both ischemic and non-ischemic cardiomyopathy, addressing the largest unmet need in VT ablation. In May 2026, we submitted a PMA application to the FDA for the approval of the vCLAS Ventricular Ablation System.

Previous wording

We have also developed a technology that utilizes ULTA 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.

Current wording

We have also developed a proprietary dual-therapy ablation technology which we call Pulsed Field Cryoablation (“PFCA”), that combines PFA with our ULTA technology. 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 March 31, 2026, and December 31, 2025, we had an accumulated deficit of $102.6 million and $95.6 million, respectively. For the three months ended March 31, 2026, and March 31, 2025, net loss was $7.0 million and $7.7 million, respectively. The net cash used in operating activities was $4.1 million and $7.2 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 March 31, 2026, and December 31, 2025, we had cash of $12.9 million and $17.1 million, respectively.

Current wording

We have incurred net losses each year since our inception in 2011. As of June 30, 2026, and December 31, 2025, we had an accumulated deficit of $109.4 million and $95.6 million, respectively. For the three and six months ended June 30, 2026 and June 30, 2025, our net loss was $6.7 million, $13.7 million, $3.9 million and $11.7 million, respectively. The net cash used in operating activities was $9.4 million and $11.9 million, for the six months ended June 30, 2026 and June 30, 2025, 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, 2026, and December 31, 2025, we had cash of $7.7 million and $17.1 million, respectively.

Previous wording

As of the report date, we do not believe our existing cash and cash equivalents are sufficient to fund our operating and capital expenditure requirements for at least 12 months from the date of issuance of the audited consolidated financial statements included in this Report. Based on our current research and development plans, we expect to have sufficient resources to fund our planned operations into the third quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than expected. 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, could adversely impact our ability to achieve our intended business objectives and may have an adverse effect on our results of operations and future prospects. 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 - Description of Organization and Business Operations in our condensed consolidated financial statements for additional information on the going concern assessment.

Current wording

As of the report date, we do not believe our existing cash and cash equivalents are sufficient to fund our operating and capital expenditure requirements for at least 12 months from the date of issuance of the audited consolidated financial statements included in this Report. Based on our current research and development plans, we expect to have sufficient resources to fund our planned operations into the fourth quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than expected. 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, could adversely impact our ability to achieve our intended business objectives and may have an adverse effect on our results of operations and future prospects. 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 - Description of Organization and Business Operations in our condensed consolidated financial statements for additional information on the going concern assessment.

Previous wording

In February 2025, we announced a strategic realignment of resources to prioritize the completion of our FULCRUM-VT U.S. pivotal IDE clinical trial and our product design optimization program. As part of this realignment, we paused the limited European launch of our vCLAS™ catheter and significantly reduced commercial activities. As a result, we did not generate revenue during the period ended March 31, 2026.

Current wording

In February 2025, we announced a strategic realignment of resources to prioritize the completion of our FULCRUM-VT U.S. pivotal IDE clinical trial and our product design optimization program. As part of this realignment, we paused the limited European launch of our vCLAS™ catheter and significantly reduced commercial activities. As a result, we did not generate revenue during the three and six months ended June 30, 2026 and June 30, 2025.

Previous wording

Other income (expense) income, net primarily consists of foreign currency unrealized and realized gain/loss, and other income related to our research and development (“R&D”) tax credit.

Current wording

Other income (expense) income, net primarily consists of foreign currency unrealized and realized gain/loss, and other income related to our research and development tax credit.

Previous wording

Comparison for the three months ended March 31, 2026 to the three months ended March 31, 2025

Current wording

Comparison for the three and six months ended June 30, 2026 to the three and six months ended June 30, 2025

Previous wording

Revenue was nil for each of the three months ended March 31, 2026 and March 31, 2025, due to our pause in commercial activity in Europe.

Current wording

Revenue was nil for each of the three and six months ended June 30, 2026 and June 30, 2025, due to our pause in commercial activity in Europe.

Previous wording

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, representing a decrease of $0.3 million, or 100%. 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 we 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.

Current wording

Cost of revenue was nil for the three months ended June 30, 2026, compared to $0.3 million for the three months ended June 30, 2025, representing a decrease of $0.3 million, or 100%. The decrease was primarily attributable to the pause in commercial activity in Europe.

Previous wording

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, representing a decrease of $1.0 million, or 25%. 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.

Current wording

Research and development expenses were $5.2 million for the six months ended June 30, 2026, compared to $5.6 million for the six months ended June 30, 2025, representing a decrease of $0.4 million, or 8%. 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.

Previous wording

Our clinical trial expenses relate to trials for our iCLAS atrial ULTA catheter and system (CYROCURE-2), iCLAS atrial ULTA catheter and system (iCLAS for persistent atrial fibrillation), vCLAS ventricular ULTA catheter (CYROCURE-VT), vCLAS ventricular ULTA catheter (FULCRUM-VT), and PFCA catheter. Clinical trial costs include the expenses related to 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 expenses related to product manufacturing.

Current wording

Our clinical trial expenses relate to trials for our vCLAS Ventricular Ablation Catheter (FULCRUM-VT) and vCLASUltra catheter (FULCRUM-VT). Clinical trial costs include the expenses related to 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 expenses related to product manufacturing.

Previous wording

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, representing a decrease of $1.0 million, or 29%. The decrease was primarily due to lower professional services expenses, regulatory reporting expenses, and payroll and personnel expenses during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025.

Current wording

Selling, general, and administrative expenses were $4.9 million for the six months ended June 30, 2026, compared to $6.0 million for the six months ended June 30, 2025, representing a decrease of $1.1 million, or 17%. The decrease was primarily due to lower professional services expenses, regulatory reporting expenses, and payroll and personnel expenses during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.

Previous wording

The change in convertible notes fair value resulted in a loss of $1.1 million for the three months ended March 31, 2026, compared to a gain of $0.2 million for the three months ended March 31, 2025.

Current wording

The change in convertible notes fair value resulted in a loss of $1.2 million for the three months ended June 30, 2026, compared to a gain of $1.4 million for the three months ended June 30, 2025.

Previous wording

The change in fair value of warrant liabilities resulted in a loss of $131 thousand for the three months ended March 31, 2026, compared to a gain of $38 thousand for the three months ended March 31, 2025.

Current wording

The change in fair value of warrant liabilities resulted in a gain of $181 thousand for the three months ended June 30, 2026, compared to a loss of $141 thousand for the three months ended June 30, 2025.

Previous wording

Interest expense was $0.8 million for the three months ended March 31, 2026, compared to $0.7 million for the three months ended March 31, 2025, representing an increase of $0.1 million, or 18%. The increase was related to interest incurred from the Convertible Securities Notes.

Current wording

Interest expense was $0.8 million for the three months ended June 30, 2026, compared to $0.7 million for the three months ended June 30, 2025, representing an increase of $0.1 million, or 12%. The increase was related to interest incurred from the Convertible Securities Notes.

Previous wording

Interest income was $107 thousand for the three months ended March 31, 2026, compared to $164 thousand for the three months ended March 31, 2025, representing a decrease of $57 thousand, or 35%. The decrease was due to interest income on cash balances in an asset management account.

Current wording

Interest income was $72 thousand for the three months ended June 30, 2026, compared to $102 thousand for the three months ended June 30, 2025, representing a decrease of $30 thousand, or 29%. The decrease was due to interest income on cash balances in an asset management account.

Previous wording

Other income, net was $70.0 thousand for the three months ended March 31, 2026, compared to other expense, net of $46.0 thousand for the three months ended March 31, 2025, representing an increase of $0.1 million. The net increase in other income of $0.1 million was primarily attributable to foreign currency unrealized and realized loss.

Current wording

Other expense, net was $69 thousand for the three months ended June 30, 2026, compared to other income, net of $102 thousand for the three months ended June 30, 2025, representing a decrease of $171 thousand. The decrease in other income was primarily attributable to foreign currency unrealized and realized loss.

Previous wording

To date, we have financed our operations primarily through the sale of equity securities, convertible promissory notes and an initial term loan advance of $3.0 million and a right to borrow a subsequent term loan advance of $2.0 million with Silicon Valley Bank (the “SVB Term Loan”). 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.

Current wording

To date, we have financed our operations primarily through the sale of equity securities, convertible promissory notes and an initial term loan advance of $3.0 million and a right to borrow a subsequent term loan advance of $2.0 million with Silicon Valley Bank (the “SVB Term Loan”). The loan with SVB was repaid in full in 2024. 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 March 31, 2026, and December 31, 2025, we had cash and cash equivalents of $12.9 million and $17.1 million, respectively, and current obligations consisting primarily of $1.2 million and $1.1 million of accounts payable, respectively, and $7.1 million and $7.0 million of accrued liabilities, respectively. For the three months ended March 31, 2026, net losses were $7.0 million. For the three months ended March 31, 2025, net losses were $7.7 million. For the three months ended March 31, 2026 and March 31, 2025, net cash used in operating activities was $4.1 million, and $7.2 million, respectively. We do not believe our existing cash and cash equivalents will be sufficient to fund operations for at least the next twelve months from the issuance date of the consolidated financial statements included elsewhere in this Quarterly Report on Form 10Q. We believe that this raises substantial doubt about our ability to continue as a going concern. See “—Going Concern and Operating Outlook.”

Current wording

As of June 30, 2026, and December 31, 2025, we had cash and cash equivalents of $7.7 million and $17.1 million, respectively, and current obligations consisting primarily of $0.7 million and $1.1 million of accounts payable, respectively, and $6.6 million and $7.0 million of accrued liabilities, respectively. For the six months ended June 30, 2026, net losses were $13.7 million. For the six months ended June 30, 2025, net losses were $11.7 million. For the six months ended June 30, 2026 and June 30, 2025, net cash used in operating activities was $9.4 million, and $11.9 million, respectively. We do not believe our existing cash and cash equivalents will be sufficient to fund operations for at least the next twelve months from the issuance date of the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. We believe that this raises substantial doubt about our ability to continue as a going concern. See “—Going Concern and Operating Outlook.”

Previous wording

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”), (b) 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 (c) 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 additional 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 (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 $0.0001). Entities affiliated with Perceptive Advisors LLC, an affiliate of ours, purchased Pre-Funded Warrants and Milestone Warrants for an aggregate purchase price of $4,250,000.

Current wording

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, or pre-funded warrants (the “2025 PIPE Pre-Funded Warrants”) to purchase shares of our common stock in lieu thereof, and (ii) accompanying (a) Tranche A Warrants to purchase an aggregate of 6,012,943 shares of our common stock (or pre-funded warrants in lieu thereof) (the “Tranche A Warrants”), (b) Tranche B Warrants to purchase an aggregate of 6,012,943 shares of our common stock (or pre-funded warrants in lieu thereof) (the “Tranche B Warrants”) and (c) Tranche C Warrants to purchase an aggregate of 6,012,943 shares of our 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 additional 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 2025 PIPE 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 (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 2025 PIPE Pre-Funded Warrant and accompanying Milestone Warrant is $1.9402 (equal to the combined purchase price per Share and accompanying Milestone Warrants, minus $0.0001). Entities affiliated with Perceptive Advisors LLC, an affiliate of ours, purchased 2025 PIPE Pre-Funded Warrants and Milestone Warrants for an aggregate purchase price of $4,250,000.

Previous wording

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 wording

Each Milestone Warrant is exercisable for one share of our common stock at an exercise price of $1.71 per share. The Tranche A Warrants expired unexcised in May 2026. The Tranche B and Tranche C Warrants will expire upon the earlier of (i) five years from the date of issuance or (ii) (a) for the Tranche B Warrants, the date that is thirty (30) days following our announcement of FDA approval of our vCLAS Cryoablation System, and (b) 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 2025 PIPE Pre-Funded Warrants are exercisable for one share of our common stock at an exercise price of $0.0001 per share. The 2025 PIPE Pre-Funded Warrants are immediately exercisable and may be exercised at any time until all of the 2025 PIPE Pre-Funded Warrants are exercised in full.

Previous wording

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 wording

A holder (together with its affiliates) of the 2025 PIPE Pre-Funded Warrants or Milestone Warrants, as the case may be, may not exercise any portion of the 2025 PIPE 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 2025 PIPE 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 our 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 our common stock underlying the Milestone Warrants or if the prospectus contained in such registration statement is not available for the resale of shares of our common stock underlying the Milestone Warrants by the Milestone Warrant holder.

Previous wording

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 wording

In lieu of making the cash payment otherwise contemplated to be made to us upon exercise of a 2025 PIPE 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 our common stock determined according to a formula set forth in the 2025 PIPE Pre-Funded Warrants.

Previous wording

Refer toNote 9 – Warrants in our consolidated financial statements for additional details.

Current wording

Refer toNote 9 - Warrants in our condensed consolidated financial statements for additional details.

Previous wording

We believe that our existing cash and cash equivalents will enable us to fund our ongoing development and submission activities to support FDA evaluation of our first and next generation ULTA 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 research and development plans, we expect to have sufficient resources to fund our planned operations into the third quarter of 2026.

Current wording

We believe that our existing cash and cash equivalents will enable us to fund our ongoing development and submission activities to support FDA evaluation of our first generation ULTA products. We will require additional capital to fund continued clinical activities for our next-generation product, to fund our manufacturing activities, to fund commercial 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 research and development plans, we expect to have sufficient resources to fund our planned operations into the fourth quarter of 2026.

Previous wording

Comparison for the three months ended March 31, 2026 to the three months ended March 31, 2025

Current wording

Comparison for the six months ended June 30, 2026 to the six months ended June 30, 2025

Previous wording

Net cash used in operating activities for the three months ended March 31, 2026 was $4.1 million, consisting primarily of a net loss of $7.0 million, adjusted by non-cash items of $1.8 million and net changes in operating assets and liabilities of $1.1 million. Non-cash items primarily consisted of $0.2 million in depreciation and amortization, $0.4 million in stock-based compensation, $1.1 million from the change in fair value of convertible notes payable, and $0.1 million from the change in fair value of warrant liabilities. Changes in operating assets and liabilities included a $0.8 million increase in other accrued liabilities, a $0.1 million increase in accrued liabilities, and a $0.1 million increase in accounts payable.

Current wording

Net cash used in operating activities for the six months ended June 30, 2026 was $9.4 million, consisting primarily of a net loss of $13.7 million, adjusted by non-cash items of $3.4 million and net changes in operating assets and liabilities of $0.9 million. Non-cash items primarily consisted of $0.4 million in depreciation and amortization, $0.9 million in stock-based compensation, $2.2 million from the change in fair value of convertible notes payable, and $50 thousand from the change in fair value of warrant liabilities. Changes in operating assets and liabilities included a $1.6 million increase in other accrued liabilities and a $0.3 million decrease in prepaid expenses and other current assets, partially offset by a $0.3 million increase in inventory, a $0.4 million decrease in accrued liabilities, and a $0.4 million decrease in accounts payable.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2025 was $7.2 million, consisting primarily of a net loss of $7.7 million, adjusted by non-cash items of $0.2 million and net changes in operating assets and liabilities of $0.2 million. Non-cash items primarily consisted of $0.3 million in depreciation and amortization, $0.2 million in stock-based compensation, and a $0.2 million net gain from the change in fair value of convertible notes payable. Changes in operating assets and liabilities included a $0.3 million increase in inventory and a $0.6 million decrease in accrued liabilities, partially offset by a $0.7 million increase in other accrued liabilities.

Current wording

Net cash used in operating activities for the six months ended June 30, 2025 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 $0.3 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 wording

Net cash used in investing activities for the three months ended March 31, 2026 and the three months ended March 31, 2025 was $2 thousand and $0.3 million, respectively. The decrease in cash used in investing activities was due to the decrease in purchases of property.

Current wording

Net cash used in investing activities for the six months ended June 30, 2026 and the six months ended June 30, 2025 was $8 thousand and $0.3 million, respectively. The decrease in cash used in investing activities was due to the decrease in purchases of property and equipment.

Previous wording

Net cash provided by (used in) financing activities for the three months ended March 31, 2026 and 2025 was nil.

Current wording

Net cash provided by (used in) financing activities for the six months ended June 30, 2026 and 2025 was nil.

Previous wording

During the three months ended March 31, 2026, there have been no material changes to our critical accounting policies from those disclosed in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the 2025 Annual Report.

Current wording

During the six months ended June 30, 2026, there have been no material changes to our critical accounting policies from those disclosed in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the 2025 Annual Report.