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SeaStar Medical Holding CorpHealth Care · Surgical & Medical Instruments & Apparatus · CIK 1831868 · FY ends Dec 31
$3.27
-0.07 (-2.10%)
USD · as of 2026-08-19 · marketstack

ICU · 10-K · period ended 2025-12-31

← all ICU documents
filed 2026-03-25 · EDGAR original ↗

Our rendering of the filing — original pagination and typography are not reproduced, and tables are reduced to their short label cells (the figures live on FA). Nothing is summarized: every line below is the filing's own text.

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Objective

The following discussion and analysis are intended to help you understand our business, financial condition, results of operations, liquidity, and capital resources. You should read this discussion in conjunction with our consolidated financial statements and related notes included elsewhere in this Annual Report. In addition to historical financial analysis, this discussion and analysis contains forward-looking statements based upon current expectations that involve risks, uncertainties, and assumptions, as described under the heading “Cautionary Note Regarding Forward-Looking Statements.” Actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of various factors, risks and uncertainties, including those set forth under “Risk Factors” included elsewhere (or incorporated by reference) in this Annual Report.

Unless the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” to “SeaStar Medical”, “we”, “us”, and “our”, are intended to mean the business and operations of SeaStar Medical Holding Corporation and its consolidated subsidiaries (the “Company”, “We”, “SeaStar Medical” or “Us”) following the October 28, 2022, merger between LMF Acquisition Opportunities Inc. (“LMF”), and SeaStar Medical, Inc. (the “Predecessor”) (the transaction herein defined as the “Business Combination” or “Merger”). In connection with the Business Combination, the Predecessor was determined to be the accounting acquirer.

Overview

On October 28, 2022, LMAO consummated a series of transactions that resulted in the combination of LMF Merger Sub, Inc. and the Predecessor pursuant to an Agreement and Plan of Merger. Immediately upon consummation of the Business Combination, LMAO was renamed SeaStar Medical Holding Corporation (as defined above).

We are a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. Our Selective Cytopheretic Device (“SCD”) is designed as a disease-modifying device that neutralizes over active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. It has broad potential applications for patients suffering from both acute and chronic kidney diseases as well as cardiovascular and other serious inflammatory diseases.

We received Food and Drug Administration (“FDA”) approval on February 21, 2024, under a Humanitarian Device Exemption (“HDE”) for our pediatric SCD therapy. It is the only FDA-approved product for use in pediatric patients with acute kidney injury (“AKI”) due to sepsis or a septic condition requiring continuous renal replacement therapy ("CRRT"). We shipped our first commercial pediatric SCD (“QUELIMMUNE”) in July 2024. In addition, we are currently conducting a pivotal clinical trial (“NEUTRALIZE-AKI”) to assess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring CRRT.

Our SCD therapy has been awarded Breakthrough Device Designation (“BDD”) for six therapeutic indications by the FDA, including the use of the SCD therapy for adult patients with AKI, patients with cardiorenal syndrome awaiting left ventricular assist device (“LVAD”) implantation, patients with hepatorenal syndrome, patients with end stage renal disease (“ESRD”) and adult and pediatric patients undergoing cardiac surgery. The BDD enables the potential for a speedier pathway to approval and the ability to have more frequent and flexible meetings with the FDA.

The inflammatory response is essential to the healing process of critical organs; however, the overactivation of inflammatory cells, which can be triggered by many different bodily insults such as trauma, surgery or infection, can send the body into shock and cause severe damage to a variety of critical organs such as the heart, lungs and kidney. Central to inflammation are the cells within blood and lymph circulatory systems, called white blood cells (primarily neutrophils and monocytes). In a normal inflammatory response, neutrophils are the first immune cells to arrive at the site and are key to the entire immune response that kills pathogens and promotes tissue repair. These inflammatory cells release chemicals (cytokines) that trigger the immune system to eliminate foreign pathogens or damaged tissue, enhancing the immune response.

If the inflammatory response becomes excessive and dysregulated (referred to as proinflammatory), the inflammatory cells will continue to produce cytokines and other damaging molecules, further enhancing the dysregulated immune response, and altering feedback mechanisms that regulate the immune system. This results in damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute chronic solid organ dysfunction or failure, including the heart, lung, kidney, liver, and even death. This hyperinflammatory response is also known as the “cytokine storm,” referring to the body’s reaction to the category of small-secreted proteins released by hyperinflammatory cells that affect communication between cells. Currently, there are no therapeutic options that specifically neutralize the white blood cells that are primarily responsible for the destructive hyperinflammatory response.

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Currently, few therapeutics are available to clinicians to address hyperinflammation and for those options that do exist, such options are either immunosuppressive or only target one cytokine. We believe our technology has the potential to overcome limitations in existing anti-inflammatory treatments and address the challenge of selectively targeting activated neutrophils and monocytes.

We are leveraging our patent protected and scalable SCD technology platform to develop proprietary therapies that are organ agnostic and target both acute and chronic indications. Preclinically, our SCD was tested in various animal models, which include acute myocardial infarction, intracranial hemorrhage, chronic heart failure, sepsis, and acute respiratory distress syndrome. The animal models demonstrated the inflammatory response and how it was modified by our SCD. We will continue to explore the application of our SCD technology across a broad range of markets and indications where proinflammatory activated neutrophils and monocytes may contribute to disease progression or severity in both acute and chronic indications.

We are using our SCD initially to clinically validate several acute organ injury indications, including kidneys and lungs. Our investigational SCD for adults is an extracorporeal synthetic membrane device that is currently being evaluated in a pivotal clinical trial in the U.S. for premarket clearance by the FDA. The SCD for adults is designed to be easily integrated into existing CRRT systems that are commonly installed in hospitals, including in ICUs throughout the United States. Similar to QUELIMMUNE, once approved and commercialized, our adult SCD is expected to initially target acute kidney injury in adults on CRRT. In addition, we are developing our SCD to address inflammation associated with liver disease, acute respiratory distress syndrome, chronic dialysis and chronic heart failure in adult populations. See Part I, Item 1A “Risk Factors” for additional information.

We have incurred net losses in each year since our inception in 2007. As of December 31, 2025 and 2024, we had an accumulated deficit of approximately $151.7 million and $139.6 million, respectively. Our net losses were $12.2 million and $24.8 million for the years ended December 31, 2025 and 2024, respectively. The majority of our net losses for the years-ended December 31, 2025 and 2024, respectively, resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. The remaining net losses primarily resulted from non-cash, non-operating changes in fair value of our financial instruments recognized in our statement of operations for the same two fiscal years. For the year ended December 31, 2025, these non-cash, non-operating losses related to change in fair value of convertible notes, change in fair value of liability classified warrants, and interest expense, which were partially offset by interest income.

As of December 31, 2025, we had cash of approximately $12.0 million. The Company does not hold any cash equivalents

The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial costs and regulatory approval expenses, and the amount of cash reserve are factors that raise substantial doubt about our ability to continue as a going concern for the twelve-month period following the issuance date for the consolidated financial statements for the year ended December 31, 2025. See Note 1 to our audited consolidated financial statements for the year ended December 31, 2025, included elsewhere in this Annual Report for additional information on our assessment.

Our accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and liabilities in the normal course of business. Our consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern.

Our need for additional capital will depend in part on the scope and costs of our development activities. To date, we have not generated significant revenue from the sale of commercialized products. Our ability to generate significant product revenue will depend on the successful development of our adult SCD and eventual ongoing commercialization of QUELIMMUNE. Until such time, if ever, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, 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 Part I, Item 1A “Risk Factors” for additional information.

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Key Components of Results of Operations

Revenue

Our pediatric SCD therapy, QUELIMMUNE, received HDE approval from the FDA in February 2024. Since that time, we have been building out our commercial operations, developing our customer base and growing commercial sales of QUELIMMUNE. We shipped our first commercial QUELIMMUNE units in July 2024. We recognized $1.2 million and $0.1 million of revenue from the sale of QUELIMMUNE for the years ended December 31, 2025 and 2024, respectively. Historically, prior to 2024, revenue has been primarily derived from government and other grants. We will continue to focus our efforts on generating revenue in the future based on product sales of QUELIMMUNE, as well as potential future payments from license or collaboration agreements and government and other grants.

We expect that any revenue we generate will fluctuate from quarter to quarter as we continue to advance our sales of QUELIMMUNE to pediatric hospital customers. We also continue to develop our adult SCD for which we are currently enrolling patients in a pivotal study to support FDA approval. If we fail to complete the development of, or fail to obtain regulatory approval to commercialize our adult SCD in a timely manner, our ability to generate additional future revenue, and our results of operations and financial position, could be materially adversely affected.

Research and Development Expenses

Since inception, we have focused our resources on research and development activities, including conducting preclinical studies and clinical trials, and developing our process and activities related to regulatory filings for our products. Subject to the availability of additional funding, we plan to further increase our research and development expenses for the foreseeable future as we continue the development of our SCD as well as a next generation SCD. Research and Development expenses also include salaries and related costs for employees in clinical and medical affairs roles, which include stock-based compensation expenses and benefits for such employees.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related costs for employees in executive and finance roles, which also include stock-based compensation expenses and benefits for such employees.

Other significant general and administrative expenses include facilities costs, professional fees for accounting and legal services, sales and marketing expenses, and expenses associated with obtaining and maintaining patents and obtaining financing, and expenses related to SEC reporting and compliance. As we continue to expand and grow our operations, we expect that our general and administrative expenses will increase, including additional expenses relating to new hires, travel, an enterprise resource planning platform, and branding.

Loss from Operations and Operating Margin

Loss from operations consists of our gross profit less our operating expenses. Operating margin is loss from the operations as a percentage of our net sales.

Other Income (Expense), Net

Total other income (expense), net primarily consists of (i) interest expense relating to interest incurred on notes payable, (ii) a one-time charge for a financing fee related to our standby equity purchase agreement, (iii) changes in the fair value of liability classified warrants, and (iv) interest income derived from cash balances maintained at a commercial financial institution.

Net Loss

Net loss consists of our loss from operations, offset by other income, net and taxes.

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Factors Affecting Our Operating Results

We believe that our performance and future success depend on several factors that present significant opportunities for us but also pose risks and challenges. Please see the factors discussed elsewhere in this Annual Report, including those discussed in Part I, Item 1A, “Risk Factors,” for additional information.

Results of Operations

Comparison of Year Ended December 31, 2025 to Year Ended December 31, 2024

The following table sets forth a summary of our results of operations. This information should be read together with our consolidated financial statements and related Notes included elsewhere in this Annual Report.

Year Ended

December 31, Change

Cost of goods sold 53 $ — 53 *

Operating expenses

Income tax provision 3 3 — —

(*) - revenue or expenses which were new to the year ended December 31, 2025, compared to the year ended December 31, 2024.

Revenue

Net revenue increased $1.1 million to $1.2 million for the year-ended December 31, 2025, compared to $0.1 million net revenue for the year-ended December 31, 2024. The increase is primarily attributable to (i) increased adoption of QUELIMMUNE, resulting in ten customers as of December 31, 2025, an increase from three as of December 31, 2024, and (ii) a full year of sales activity during the 2025 fiscal year compared to only six months of sales activity during the 2024 fiscal year, as sales did not commence until July 1, 2024.

Research and Development Expenses

The following table discloses the breakdown of research and development expenses:

Year Ended

December 31, Change

Other research and development expenses 317 276 41 15 %

Research and development expenses for the years ended December 31, 2025 and 2024 were approximately $7.5 million and $9.1 million, respectively. The decrease in research and development expenses of $1.6 million was primarily driven by (i) a $1.0 million decline in consulting expenses as the Company both made a concerted effort to reduce usage of consultants and hiring key employees to bring certain critical skillsets in-house, (ii) a $0.6 million decline in pre-clinical expenses as we started the NEUTRALIZE-AKI study in 2024, resulting in limited pre-clinical activities in 2025, (iii) a $0.5 million decline in compensation and benefits as a result of certain voluntary recissions of accrued bonuses accrued, (iv) a $0.4 million reduction in outside services as we switched clinical research organizations, and (v) $0.4 million in contra-expenses were recognized in 2025 as we agreed to provide clinical research organization services to a third-party, for which the Company will be able to utilize the results of this study.

These decreases described above were partially offset by (i) a $1.0 million increase in clinical trial costs, mostly driven by the increased activity relating to the NEUTRALIZE-AKI study, (ii) a $0.2 million increase in the adult SCD related supply costs due to both the NEUTRLAIZE-AKI study and device development efforts, and (iii) a $0.1 million increase in medical affairs.

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General and Administrative Expenses

General and administrative expenses for the years ended December 31, 2025 and 2024 were $5.8 million and $8.9 million, respectively. The decrease of $3.1 million in general and administrative expenses is due primarily to (i) a $1.0 million decline in accounting and legal related activities, primarily driven by the 2024 restatement of previously filed financial statements, with no such expense in the 2025 fiscal year, (ii) a $0.6 million decline in Board compensation due to the voluntary recission of accrued director fees, (iii) a decrease of $0.5 million in compensation and benefits primarily due to the voluntary recission of accrued bonuses, (iv) a $0.5 million decline in other professional fees, and (v) a $0.3 million reduction in costs as we had a one-time settlement in 2024 with a former distributor , and (vi) a $0.2 million decline in travel and conference activity.

These decreases were partially offset by the increase of $0.1 million due to due diligence fees paid to a third-party financial institution for a standby equity purchase agreement that we entered into during the fiscal year ended December 31, 2025.

Other Income (Expense)

Other income (expense) for the years ended December 31, 2025 and 2024 was other income, net of $28 thousand and other expense, net of $7.0 million, respectively. The change was the result of (i) interest income increasing $0.2 million as a result of our increased cash during the 2025 fiscal year compared to the 2024 fiscal year, (ii) $0.2 million decline in interest expense due to the reduction in our outstanding notes and convertible notes, (iii) a $6.1 million loss on the change in fair value of convertible notes in the fiscal year ended December 31, 2024, with no such charge during the year ended December 31, 2025, and (iv) we recognized a $32 thousand gain on the change in fair value of liability classified warrants for the year ended December 31, 2025, compared to a loss of $0.7 million for the year ended December 31, 2024.

This was offset by a $0.3 million financing charge related to the standby equity purchase agreement that we entered into during the year ended December 31, 2025.

Income Tax Provision (Benefit)

We recorded a provision for income taxes of $3 thousand for each of the years ended December 31, 2025, and 2024, respectively.



Under Accounting Standards Codification (“ASC”) 740-10-30-5, Income Taxes, deferred tax assets should be reduced by a valuation allowance if, based on the weight of available evidence, it is more-likely-than-not (i.e., a likelihood of more than 50%) that some portion or all of the deferred tax assets will not be realized. We consider all positive and negative evidence available in determining the potential realization of deferred tax assets including, primarily, the recent history of taxable earnings or losses. Based on operating losses reported during 2025 and 2024, we concluded there was not sufficient positive evidence to overcome this recent operating history. As a result, we believe that a valuation allowance continues to be necessary based on the more-likely-than-not threshold noted above. A valuation allowance of $32.0 million and $28.5 million was recorded as of and for the years ended December 31, 2025 and 2024, respectively.

Net Loss

During the year ended December 31, 2025, we had a net loss of $12.2 million compared to a net loss of $24.8 million for the year ended December 31, 2024. The decline in net loss of $12.7 million primarily resulted from (i) a $1.0 million increase in revenue in 2025 compared to 2024, (ii) $4.6 million decrease in operating expenses in 2025 compared to 2024, and (iii) $7.0 million favorable change in other income or expense in 2025 compared to 2024.

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Liquidity and Capital Resources

To date, we have financed our operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows. As of December 31, 2025 and 2024, we had an accumulated deficit of $151.7 million and $139.6 million, respectively.

As of December 31, 2025, we had cash of $12.0 million. We expect that our existing cash will be insufficient to fund our operations for the twelve months from the filing date of this Annual Report for the year ended December 31, 2025, including clinical trial expenses and capital expenditure requirements. We believe that this raises substantial doubt about our ability to continue as a going concern. To finance our operations beyond that point, we would need to raise additional capital, and there is no guarantee that we will be able to secure additional funding on favorable terms, or at all. We have concluded that these circumstances raise substantial doubt about our ability to continue as a going concern within one year after the issuance date of this Annual Report. See Note 1 to our audited consolidated financial statements for the year ended December 31, 2025.

Cash Flows

The following table shows a summary of our cash flows for each of the periods shown below:

Year Ended

December 31,

Statement of cash flow data:

Total cash (used in)/provided by:

Investing activities — —

Cash Flow from Operating Activities

Net cash used in operating activities for the fiscal year ended December 31, 2025 was $13.6 million compared to $16.0 million for the fiscal year ended December 31, 2024. The decrease in cash used for operating activities of $2.4 million is primarily due to the decline in consulting, legal and accounting related activities (see Results of Operations above).

Cash Flow from Financing Activities

Net cash provided by financing activities for the fiscal year ended December 31, 2025, was $23.8 million, primarily related to proceeds from the issuance of common stock from certain registered direct offerings and ATM issuances, and proceeds from the issuance of pre-funded warrants.

Net cash provided by financing activity for the fiscal year ended December 31, 2024, was $17.7 million, primarily related to proceeds from the issuance of common stock from certain registered direct offerings and ATM issuances, proceeds from the issuance of convertible notes, and proceeds from the issuance of certain pre-funded warrants.

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Capital Resources

Sources of Liquidity

We finance our operations from a combination of sales of common stock and warrants, through registered direct or public offerings, our at-the-market program, and our standby equity purchase agreement. We finance certain insurance needs through a short-term note payable.

Shelf Registration

On December 8, 2023, we filed a shelf registration statement on Form S-3 (File No. 333-275968), which was declared effective by the SEC on December 22, 2023. This shelf registration statement covered the offering, issuance and sale of up to an aggregate of $100.0 million of our common stock, preferred stock, debt securities, warrants, rights and units (the “2023 Shelf”).

Since the date of effectiveness and through December 31, 2025, we have raised approximately $44.1 million under the 2023 Shelf and have approximately $55.9 million remaining for future offerings. However, actual availability for primary offerings is limited by the “baby shelf” restrictions applicable to our use of Form S‐3.

At-The-Market Offering

On August 20, 2024, we entered into an At-The-Market Offering Agreement (the “ATM Agreement”) with Wainwright as sales agent, to sell shares of Common Stock, from time to time, through an “at the market offering” program under which Wainwright will act as sales agent. As of December 31, 2025, approximately $1.2 million remained available for issuance under our ATM program as a result of baby shelf limitations, which is a component of the 2023 Shelf.

Standby Equity Purchase Agreement

On April 25, 2025, we entered into a standby equity purchase agreement (“SEPA”) with Lincoln Park Capital, LLC (“Lincoln Park”) pursuant to which we have the right to sell to Lincoln Park shares of Common Stock, subject to certain limitations, from time to time over the 36-month period commencing on the Commencement Date. As of December 31, 2025, approximately $15.0 million in aggregate capacity remained available under the SEPA.

2025 Offering Activity

During the year ended December 31, 2025, we raised under the 2023 Shelf: (i) approximately $14.4 million through three registered direct offerings and concurrent private placements of Common Stock, pre-funded warrants, warrants and placement agent warrants, and (ii) approximately $6.1 million through our ATM Agreement. We also raised outside the 2023 Shelf: (i) approximately $4.0 million through a best-efforts public offering of Common Stock, pre-funded warrants, warrants and placement agent warrants, and (ii) approximately $40 thousand from the SEPA.

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Future Funding Requirements

We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue clinical development of our SCD product for approval by the FDA, and (ii) if regulatory approval is obtained, to launch and commercialize our products in the U.S. markets. We will need additional funding in connection with these activities. Our future funding requirements, both short-term and long-term, will depend on many factors, including:

• conditions in the capital markets;

Until such time, if ever, as we are able to successfully develop and fully commercialize our products, we expect to continue financing our operations through the sale of equity, issuance of debt, borrowings under credit facilities or through potential collaborations with other companies, other strategic transactions or government or other grants. Adequate capital may not be available when needed or on acceptable terms.

Based on our results of operations and liquidity as of December 31, 2025, we believe our cash is not sufficient to meet our operations, working capital and capital expenditure requirements for a period of at least twelve months from the date of our audited consolidated financial statements for the fiscal year ended December 31, 2025. In addition, we do not expect to receive significant cash proceeds from the exercise of warrants in the near term, because the trading price of our common stock is currently below the exercise price of the majority of the warrants. We will require additional cash to fund our growth through future debt or equity financing transactions; however, there can be no assurance that we will be able to obtain additional capital on terms acceptable to us, if at all, or that we will generate sufficient future revenues and cash flows to fund our operations. Our estimates of our results of operations, working capital and capital expenditure requirements may be different than our actual needs, and those estimates may need to be revised if, for example, our actual revenue is lower, and our net operating losses are higher than we project and our cash position is reduced faster than anticipated.

We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures. Debt financing would also result in fixed payment obligations. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required 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 titled “Risk Factors” for additional risks associated with our substantial capital requirements.

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Critical Accounting Policies and Estimates

The preparation of the consolidated financial statements and related disclosures in conformity with U.S. GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and income and expenses during the periods reported. Although actual results could materially differ from those estimates, such estimates are developed based on the best information available to management and management’s best judgments at the time.

Significant estimates include the valuation of the (i) incurred-but-not-billed clinical trial site costs, (ii) liability classified warrants, and (iii) stock-based compensation expense.

While our significant accounting policies are described in Note 2 - Summary of Significant Accounting Policies to the notes to our audited consolidated financial statements included elsewhere in the Annual Report on Form 10-K, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our annual consolidated financial statements.

Incurred-But-Not-Billed Clinical Trial Site Costs. Our NEUTRALIZE-AKI clinical trial is being conducted at multiple qualified healthcare facilities as of December 31, 2025. We are responsible to cover the costs of these clinical trial efforts, including the cost of patient care relating to the adult SCD. It is common practice that the costs incurred by the clinical trial sites are incurred, but not billed until months after the event giving rise to the unbilled activity. Accordingly, we estimate the value of these “incurred-but-not-billed” activities at the end of each reporting period. Any impact to the consolidated statement of operations is recognized as a component of research and development expense and included as a component of accrued expenses on the consolidated balance sheet.

Liability Classified Warrants. We have entered into or assumed various financial instruments in the form of warrant agreements that require classification as liabilities. This classification requires us to measure the warrants at fair value at inception and then remeasure the fair value of the warrants at each reporting period. The liability classified warrants consist of the following (see Note 8 for more information):

We use a Black-Scholes option pricing model to fair value liability classified warrants, using standard option pricing inputs such as the strike price of each warrant tranche, estimated volatility, time to maturity, and the risk-free interest rate. The risk-free interest rate is the U.S. Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance. The change in fair value of liability classified warrants each reporting period is recorded to the change in fair value of warrants liability in the consolidated statement of operations.

Stock-Based Compensation Expense. We estimate the grant date fair value of all grants of equity-based awards (which has historically consisted of either stock options or restricted stock units). We use a Black-Scholes option pricing model to fair value of stock options, and use the price of our stock on the grant date for restricted stock units.

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Emerging Growth Company Status

We are an emerging growth company (“EGC”), as defined in the JOBS Act. The JOBS Act permits companies with EGC status to take advantage of an extended transition period to comply with new or revised accounting standards, delaying the adoption of these accounting standards until they apply to private companies. We have elected to use this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an EGC or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our consolidated financial statements may not be comparable to companies that comply with the new or revised accounting standards as of public company effective dates.

In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Since we intend to rely on such exemptions, we are not required to, among other things: (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act; (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act; (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the consolidated financial statements (auditor discussion and analysis); and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation.

We will remain an EGC under the JOBS Act until the earliest of (i) the last day of our first fiscal year following the fifth anniversary of the closing of the Business Combination, (ii) the last date of our fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the date on which we are deemed to be a “large-accelerated filer” under the rules of the SEC with at least $700.0 million of outstanding securities held by non-affiliates, or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three years.

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Contractual Obligations and Commitments

The following table summarizes our contractual obligations as of December 31, 2025:

($ in thousands) Total Less than 1 year 1-3 years 3-5 years More than 5 years

Contractual Obligations:

Insurance Financing 525 525 — — —

Total contractual obligations $ 525 $ 525 $ — $ — $ —

Insurance Financing

In October 2025, we entered into a financing arrangement with a lender to finance a portion of the annual premium of an insurance policy in the amount of $0.7 million. It is to be paid down in 10 monthly installments through August 2026. This financing arrangement is recorded as a note payable on our consolidated balance sheet.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

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Item 8. Financial Statements and Supplementary Data

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm (PCAOB ID: 100) 74

Consolidated Balance Sheets as of December 31, 2025 and 2024 75

Notes to Consolidated Financial Statements 79

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of

SeaStar Medical Holding Corporation:

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of SeaStar Medical Holding Corporation (the “Company”) as of December 31, 2025 and 2024, and the related consolidated statements of operations, changes in stockholders’ equity (deficit), and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.

Substantial Doubt About the Company’s Ability to Continue as a Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered recurring operating losses and negative cash flows from operating activities since inception and expects to continue incurring operating losses and negative cash flows in the future. These matters raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ WithumSmith+Brown, PC

We have served as the Company’s auditor since 2023.

East Brunswick, New Jersey

March 25, 2026

PCAOB ID No. 100

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Consolidated Balance Sheets

(in thousands, except for share and per-share amounts)

ASSETS

Current assets

Inventory 66 —

LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT)

Current liabilities

Notes payable, net of deferred financing costs 525 574

Liability classified warrants 1 33

Commitments and contingencies (Note 11)

Stockholders’ equity/(deficit)

Total stockholders’ equity/(deficit) 10,416 (2,183 )

Total liabilities and stockholders’ equity/(deficit) $ 14,158 $ 4,658

The accompanying notes are an integral part of these consolidated financial statements.

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Consolidated Statements of Operations

(in thousands, except for share and per-share amounts)

Year Ended December 31,

Cost of goods sold 53 —

Operating expenses

Other income (expense)

Interest expense (31 ) (244 )

Other financing costs (298 ) —

Change in fair value of convertible notes — (6,145 )

Change in fair value of warrants liability 32 (697 )

Total other income (expense), net 28 (6,985 )

Loss before provision for income taxes (12,147 ) (24,827 )

Provision for income taxes 3 3

Net loss per share of common stock, basic and diluted $ (5.86 ) $ (66.33 )

Weighted-average shares outstanding, basic and diluted 2,073,087 374,356

The accompanying notes are an integral part of these consolidated financial statements.

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Consolidated Statements of Changes in Stockholders’ Equity/(Deficit)

(in thousands, except for share and per-share amounts)

Common Shares

Issuance of shares - conversion of convertible notes 60,077 — 10,215 — 10,215

Issuance of shares - vesting of RSUs 1,314 — — — —

Issuance of shares - stock issued for employee bonuses 1,033 — 73 — 73

Stock-based compensation — — 814 — 814

Issuance of shares - standby equity purchase agreement issuances 8,000 — 42 — 42

Issuance of shares - vesting of restricted stock units 8,005 — — — —

Stock-based compensation — — 624 — 624

The accompanying notes are an integral part of these consolidated financial statements.

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Consolidated Statements of Cash Flows

(in thousands, except for shares and per-share amounts)

Year Ended December 31,

Cash flows from operating activities

Adjustments to reconcile net loss to net cash used in operating activities

Amortization of deferred financing costs 18 102

Shares issued for the standby equity purchase agreement commitment fee 298 —

Stock-based compensation 624 887

Change in operating assets and liabilities

Accounts receivables, net (125 ) (112 )

Inventory (66 ) —

Other liabilities — (100 )

Net cash used in operating activities (13,599 ) (16,007 )

Cash flows from financing activities

Proceeds from issuance of convertible notes — 979

Payment of convertible notes — (700 )

Proceeds from issuance of shares, net of offering costs 16,126 17,441

Proceeds from exercise of warrants 1,815 853

Proceeds from pre-funded warrants 5,886 3,766

Proceeds from issuance of notes payable 767 713

Payment of notes payable (834 ) (5,402 )

Net cash provided by financing activities 23,760 17,650

Supplemental disclosure of cash flow information

Cash paid for interest $ — $ 553

Cash paid for income taxes $ 3 $ 3

Exercise of liability classified warrants $ — $ 3,106

Shares issued from conversion of convertible notes $ — $ 10,210

Offering cost incurred but not paid $ — $ 45

Board compensation settled in shares of common stock in lieu of cash $ — $ 210

Issuance of convertible note warrants $ — $ 586

The accompanying notes are an integral part of these consolidated financial statements.

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Notes to the Consolidated Financial Statements

Note 1. Description of Business

Organization and description of business

SeaStar Medical Holding Corporation, a Delaware corporation, and its wholly owned subsidiary, SeaStar Medical, Inc. (the “Predecessor”), are collectively referred to as the “Company”. The Predecessor was incorporated as a Delaware corporation in June 2007, and it is headquartered in Denver, Colorado. The Company is a commercial stage business and also focused on product development. The Company is principally engaged in the research, development, and commercialization of a platform medical device technology designed to modulate inflammation in various patient populations. The initial target of this technology is for the treatment of acute kidney injuries in pediatric patients.

On October 28, 2022, LMF Merger Sub, Inc., a wholly owned subsidiary of LMF Acquisition Opportunities, Inc. (“LMF”), merged with and into the Predecessor (the “Business Combination”), with the Predecessor surviving the Business Combination as a wholly owned subsidiary of LMF. Following the consummation of the Business Combination, LMF was renamed to “SeaStar Medical Holding Corporation”.

Basis of Presentation

The Company’s consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”).

On June 7, 2024, the Company effected a 1-for-25 reverse-stock split (the “2024 Reverse Stock Split”) of its issued and outstanding shares of common stock, par value $0.0001 (the “common stock”). Following the effect of the 2024 Reverse Stock Split, each 25 shares of the Company’s common stock that were issued and outstanding automatically converted into one outstanding share of common stock.

On January 5, 2026, the Company elected a 1-for-10 reverse-stock split (the “2026 Reverse Stock Split,” together with the 2024 Reverse Stock Split, the “Reverse Stock Splits”) of its issued and outstanding shares of common stock, par value $0.0001 (the “common stock”). Following the effect of the 2026 Reverse Stock Split, each 10 shares of the Company’s common stock that were issued and outstanding automatically converted into one outstanding share of common stock.

Combined, this had the effect of a 1-for-250 reverse stock split. All stock options and warrants of the Company outstanding immediately prior to each of the Reverse Stock Splits were proportionally adjusted except for the Listed Warrants and the private placement warrants that were issued as part of the SPAC transaction that closed on October 28, 2022, which total 16,788,000 outstanding warrants in the aggregate (the “Unadjusted Warrants”). The Unadjusted Warrants each retained an $11.50 exercise price and require the exercise of 250 warrants to purchase one share of common stock. Unless otherwise indicated, all other share and per share amounts in this annual report reflect the effect of the Reverse Stock Splits. The par value of the Company’s common stock remained unchanged at $0.0001 per share and the number of authorized shares of common stock remained the same after each of the Reverse Stock Splits.

Liquidity and going concern

As of December 31, 2025, the Company has an accumulated deficit of approximately $151.7 million and cash of approximately $12.0 million. The Company does not believe that its cash on hand will be sufficient to enable it to fund its operations, including clinical trial expenses and capital expenditure requirements for at least 12 months from the issuance of these consolidated financial statements. The Company believes that these conditions raise substantial doubt about its ability to continue as a going concern.

The Company’s need for additional capital will depend in part on the scope and costs of its development activities. To date, the Company has generated approximately $1.2 million in revenue from the sales of QUELIMMUNE. Its ability to generate meaningful product revenue will depend on the successful launch of QUELIMMUNE and development and eventual commercialization of the adult SCD. Until such time, if ever, it expects to finance its operations through the sale of equity or debt securities, borrowing under credit facilities, or through potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to the Company when needed or on acceptable terms.

If the Company is unable to raise capital, it could be forced to delay, reduce, suspend, or cease its research and development programs or any future commercialization efforts, which would have a negative impact on its business, prospects, operating results and financial condition. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

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Notes to the Consolidated Financial Statements

Risks and uncertainties

The Company is subject to risks common to early-stage companies in the medical technology industry including, but not limited to, new medical and technological innovations, dependence on key personnel, protection of proprietary technology, and product liability. There can be no assurance that the Company’s products or services will be accepted in the marketplace, nor can there be any assurance that any future products or services can be developed or deployed at an acceptable cost and with appropriate performance characteristics, or that such products or services will be successfully marketed, if at all. These factors could have a materially adverse effect on the Company’s future financial results, financial position and cash flows.

Note 2. Summary of Significant Accounting Policies

Use of Estimates

The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the period. Significant estimates for the year ended December 31, 2025, include the (i) valuation of the liability classified warrants, (ii) unbilled clinical trial costs, and (iii) stock-based compensation expense. Although actual results could differ from those estimates, such estimates are developed based on the best information available to management and management’s best judgments at the time.

Cash and cash equivalents

The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. The Company did not have any cash equivalents as of December 31, 2025 and 2024.

Concentrations of credit risk

Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash. Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.

Accounts Receivable

The Company recognizes accounts receivables from sales to customers at the time revenue is recognized and a customer invoice is created. The need for a credit loss allowance is evaluated each reporting period based on the Company’s assessment of the credit worthiness of its customers or any other potential circumstances that could result in a credit loss. The Company initially estimates credit losses based on a portfolio-wide method using an aging schedule at the end of each reporting period. Any customer specific collections subsequent to the reporting period are then adjusted accordingly. As of December 31, 2025 and 2024, the Company had a current expected credit loss reserve of $3 thousand and $0, respectively.

Income taxes

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the consolidated financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates expected to apply to taxable income in the periods in which such differences are expected to reverse. A valuation allowance is provided when the realization of net deferred tax assets is not deemed more likely than not.

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Notes to the Consolidated Financial Statements

The Company complies with the provisions of Accounting Standards Codification (“ASC”) 740,Income Taxes, which provides a comprehensive model for the recognition, measurement, and disclosure in consolidated financial statements of uncertain income tax positions that a company has taken or expects to take on a tax return. Under this guidance, a company can recognize the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position; otherwise, no benefit can be recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. Additionally, the Company accrues interest and related penalties, if applicable, on all tax exposures for which reserves have been established consistent with jurisdictional tax laws. Interest and penalties are classified as income tax expense in the consolidated financial statements.

Use of Derivative Instruments

The Company’s derivative instruments historically have consisted of financial instruments that arose as part of the Company’s ongoing efforts to raise capital to fund the Company’s operations. It is likely that ongoing efforts to raise capital in the future will result in additional derivative instruments to be issued as part of those efforts. The Company has not nor does it intend to utilize derivative instruments for risk management (i.e. hedging) or investing activities.

These derivative instruments have taken the form of warrants, convertible debt, and other financing arrangements such as a prepaid forward purchase option. The classification of these financial instruments as either a component of liabilities or equity is specific to the terms within each financial instrument agreement. and the application of U.S. GAAP. For those that are liability classified, the Company recognized changes in the fair value of each financial instruments as a “non-operating income / (expense)” component of the consolidated statement of operations and an adjustment to operating cash flows within the consolidated statement of cash flows each reporting period.

The issuance of each derivative instrument is reported as a proceed in the financing section to the consolidated statement of cash flows, while the ultimate settlement of each derivative instrument could be reported either as an adjustment to operating cash flows, paydown within financing cash flows, or a non-cash transaction depending on the settlement.

Fair value option of accounting

Generally, when financial instruments are first acquired that are not required to be recorded at fair value per U.S. GAAP, ASC 825,Financial Instruments allows an entity to elect the fair value option (“FVO”). The FVO may be elected on an instrument-by-instrument basis only at the time of acquisition and once elected is irrevocable. The FVO allows an entity to account for the entire financial instrument at fair value with subsequent changes in fair value recognized in earnings through the consolidated statements of operations at each reporting date. A financial instrument is generally eligible for the FVO if, amongst other factors, no part of the financial instrument is classified in stockholders’ equity.

Based on the eligibility assessment discussed above, the Company historically concluded that its previously held convertible notes were eligible for the FVO and accordingly elected the FVO for those debt instruments. This election was made because of operational efficiencies in valuing and reporting for these debt instruments at fair value in their entirety at each reporting date. The convertible notes contained certain embedded derivatives that otherwise would require bifurcation and separate accounting at fair value.

The convertible notes, inclusive of their respective accrued interest at the stated interest rates (collectively referred to as the “FVO debt instruments”) were initially recorded at fair value as liabilities on the consolidated balance sheets and subsequently re-measured at fair value at the end of each reporting period presented within the consolidated financial statements until they were settled in 2024. The changes in fair value of the FVO debt instruments are recorded in changes in fair value of convertible notes, included as a component of other income (expense), net, in the consolidated statements of operations.

The Company did not have any convertible notes outstanding during the year ended December 31, 2025.

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Notes to the Consolidated Financial Statements

Fair value of financial instruments

The following provides a summary of those assets or liabilities for which the Company is required to measure at fair value either on a recurring basis, the valuation techniques and summary of inputs used to arrive at the measure of fair value. Changes in fair value of these assets or liabilities are recognized as a component of net income in the consolidated statements of operations. Changes in fair value of these assets or liabilities are considered unrealized gains or losses and therefore are classified as non-cash adjustments to reconcile net income to operating cash flows. Significant increases (decreases) in unobservable inputs used in fair value measurements could, in isolation, potentially result in a significantly lower or higher valuation for those assets or liabilities requiring recurring fair value measurements at each reporting date.

Liability Classified Warrants. The Company has entered into or assumed various financial instruments, in the form of warrant agreements, that require classification as liabilities. This classification requires that the Company measure the warrants at each fair value at the end of each quarterly and annual reporting period.

The Company uses a Black-Scholes option pricing model to fair value the warrants, using standard option pricing inputs such as the strike price of each warrant tranche, estimated volatility, time to maturity, and the risk-free interest rate. The risk-free interest rate is the U.S. Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance, which is five years. The change in fair value of the liability classified warrants each reporting period is recorded to the change in fair value of warrants liability in the consolidated statements of operations.

Operating Current Assets and Current Liabilities. The estimated fair value of cash, accounts receivables, prepaid expenses, accounts payable and accrued expenses approximate their fair value because of the short-term nature of these instruments.

Classification of Derivative Gains and Losses on the Consolidated Statement of Cash Flows. Changes in fair value related to the Company’s derivative financial instruments consisting of (i) liability classified warrants and (ii) convertible notes are classified in operating cash flows as adjustments to net income. During the year ended December 31, 2025, the only activity related to liability classified warrants, as the Company fully settled all outstanding convertible notes during the year ended December 31, 2024.

Revenue Recognition

Overall

Under ASC Topic 606, the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company evaluates the following criteria: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) performance obligations are satisfied.

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Notes to the Consolidated Financial Statements

At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct combined performance obligation is identified. The Company then allocates the transaction price to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. The estimate of the transaction price for each contract includes all variable consideration to which the Company expects to be entitled, subject to the constraint on variable consideration. The Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized at the contract level is not significant.

The Company records any payments received from customers prior to the Company fulfilling its performance obligation(s) as contract obligations. Amounts expected to be recognized as revenue within the one year following the consolidated balance sheet date are classified as current contract obligations. Amounts not expected to be recognized as revenue within the one year following the consolidated balance sheet date are classified as contract obligations, net of current portion. See Note 3 – Revenues and Contract Obligations for further details.

Product Sales Revenue

The Company has sold and intends to continue to sell its products either through a combination of distributor(s) and/or directly to end-user qualified customers through the Company’s own internal commercial/sales resources. The acting distributor during the year ended December 31, 2024 subsequently resold and was to continue to resell the products to present and future customers, until such time the Company terminated its agreement with the distributor (see Note 3).

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Notes to the Consolidated Financial Statements

The Company will continue to monitor all of the above as the Company continues to commercialize and increase its customer base, which could result with each distributor or end-user customer agreement resulting in its own unique terms and conditions, that will potentially impact the timing and amount of revenue recognition pursuant to U.S. GAAP.

Cost of Goods Sold

Prior to July 2024, the Company manufactured/assembled QUELIMMUNE and adult SCDs only for research oriented and/or clinical trial related activities. Inventory purchased prior to July 2024 was expensed as a period expense at the time of purchase as a research and development expense. Accordingly, all QUELIMMUNE units sold prior to the three months ended June 30, 2025, had no recognized inventory value. During the year ended December 31, 2025, the Company recognized approximately $53 thousand for cost of goods sold.

The Company purchases supplies for the production of QUELIMMUNE and adult SCDs, some of which is used in the production of both. The Company's policy for the accounting for these three categories of inventory as follows:

Stock-based compensation

In accordance with ASC Topic 718,Compensation – Stock Compensation, the Company recognizes compensation expense for all stock-based awards issued to employees based on the estimated grant-date fair value, which is recognized as expense on a graded vesting approach over the requisite service period. The Company has elected to recognize forfeitures as they occur. The fair value of stock options is determined using the Black-Scholes option-pricing model. The determination of fair value for stock options on the date of grant using an option-pricing model requires management to make certain assumptions including implied volatility, expected term, risk-free interest rate and expected dividends ($nil) in addition to the Company’s common stock valuation. The determination of fair value of restricted stock units is valued based on the value of the Company’s common stock on the grant date.

Research and development expenses

Expenditures made for research and development are charged to expense as incurred. External costs consist primarily of payments for laboratory supplies purchased in connection with the Company’s discovery and preclinical activities, and process development and clinical development activities. Internal costs consist primarily of employee-related costs, consultants fees and costs related to compliance with regulatory requirements.

The Company records expenses related to external research and development services based on services received and efforts expended pursuant to invoices and contracts with consultants that supply, conduct, and manage preclinical studies and clinical trials on its behalf.

Funded Research & Development Expense

During the year ended December 31, 2025, the Company entered into an agreement to provide contract research services to an outside party, which involves a study of the Company's selective cytopheretic device relating to patients with severe, chronic heart failure. The Company is able to bill the outside party for a certain portion of the costs incurred to provide these services. The Company will own and is able to benefit from the knowledge gained from the results of this study. Accordingly, the Company will account for any funds paid by the outside party to the Company as a reimbursed expense, in accordance with ASC 730-20 as a funded research and development arrangement. Accordingly, any amounts incurred and billed will offset the Company's operating expenses categorized as research and development expense on the Company’s condensed consolidated statement of operations for the year ended December 31, 2025. The reimbursed expenses for the year ended December 31, 2025, totaled approximately $0.4 million. No funded research and development agreement existed in 2024.

Emerging growth company status

The Company is an “emerging growth company”, as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Under the JOBS Act, emerging growth companies can take advantage of an extended transition period for complying with new or revised accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (1) no longer an emerging growth company or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.

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Notes to the Consolidated Financial Statements

Net loss per share attributable to common stockholders

The Company’s basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period. The diluted net loss per share attributable to common stockholders is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. The dilutive effect of these potential common shares is reflected in diluted earnings per share by application of the treasury stock method. See Note 14 for disclosures on exclusion of certain instruments which would be anti-dilutive in circumstances where the Company is reporting a net loss for that earnings period. Basic and diluted net loss per share attributable to common stockholders is presented in conformity with the two-class method required for participating securities as certain outstanding warrants are considered participating securities. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders. As the Company has reported a net loss for the periods presented, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders for these periods. The significant increase in common stock outstanding is expected to impact the year-over-year comparability of the Company’s net loss per share calculations.

Recently adopted accounting standards

Accounting Standards Update 2023-09—In December 2023, the FASB issued ASU 2023-09Income Taxes (Topic 740) Improvements to Income Tax Disclosures. ASU 2023-09 enhances the transparency and decision usefulness of income tax disclosures. The amendments in this update are effective for public business entities for annual periods beginning after December 15, 2024. Early adoption was permitted, but the Company elected not to early adopt and adopted for the year ended December 31, 2025. ASU 2023-09 requires the Company to consistently categorize and provide greater disaggregation of information in the rate reconciliation it must further disaggregate income taxes paid. However, as the Company is currently generating net operating losses, pays no federal and limited state taxes and does not operate in foreign jurisdictions, this does not have a significant impact to the Company's income tax disclosures (see Note 13).

Recently issued accounting standards not yet adopted

Accounting Standards Update 2024-03—In November 2024, the FASB issued ASU 2024-03 - Income Statement - Reporting Comprehensive Income – Expense Disaggregation (Subtopic 220-40): Disaggregation of Income Statement Expenses. ASU 2024-03 requires the disclosure of additional information related to certain costs and expenses, including amounts of inventory purchases, employee compensation, and depreciation and amortization included in each income statement line item. The ASU is effective for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of adopting this guidance on its consolidated financial statements and disclosures.

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Notes to the Consolidated Financial Statements

Note 3. Revenues and Contract Obligations

In December 2022, the Company entered into a License and Distribution Agreement (the “Distribution Agreement”) with Nuwellis, Inc. (“Nuwellis”) granting exclusive distribution rights of the Company’s pediatric SCD within the United States of America. Under the terms of the Distribution Agreement, Nuwellis would pay the Company consideration comprising both (i) a per unit sales price for each unit shipped and (ii) a royalty for all units sold to customers.

In addition, Nuwellis also agreed to pay (i) a $100 thousand upfront payment at contract inception (the “Up-front Payment”), and (ii) two contingent milestones payments consisting of (a) $450 thousand payment upon meeting the regulatory milestone of receiving HDE approval from the FDA (the “Regulatory Milestone Payment”), and (b) $300 thousand payment upon meeting a sales-based milestone (the “Sales Based Milestone Payment”).

The Company had the following performance obligations within the Distribution Agreement: (i) a material right to Nuwellis consisting of an exclusive option for Nuwellis to purchase additional pediatric SCDs during the term of the Distribution Agreement for a discounted price, (ii) to provide training to Nuwellis personnel and medical professionals at end-user customers of Nuwellis and (iii) upon each receipt of a valid Nuwellis purchase order, delivery of pediatric SCDs. The transaction price for the Nuwellis material right and training is comprised of the Upfront Payment, the Regulatory Milestone Payment and the Sales Based Milestone Payment. The transaction price for each pediatric SCD device sold was the actual price for each device and the estimated royalties to be received.

Prior to the Company’s termination of the Distribution Agreement discussed below, the Company received full consideration for the Up-front Payment and the Regulatory Milestone Payment for a total of $550 thousand, which had been recorded as contract liabilities and was to be recognized over the remaining term of the Distribution Agreement. However, the Company and Nuwellis entered into a confidential settlement agreement on October 20, 2024 (the “Settlement Agreement”), in connection with the Company’s termination of the Distribution Agreement on August 18, 2024. Under the Settlement Agreement the Company agreed to refund Nuwellis the entire $550 thousand comprising of the Upfront Payment and Regulatory Milestone plus an additional $350 thousand for a total of $900 thousand, of which the $350 thousand was charged to general and administrative expense. The amounts were paid to Nuwellis in three installments during the quarter ended December 31, 2024.

As a result, the Company (i) was precluded from recognizing revenue of approximately $0.1 million for product shipments to Nuwellis during the year ended December 31, 2024, (ii) was precluded from recognizing any revenues related to contract liabilities arising the Upfront Payment and Regulatory Milestone through December 31, 2024, (see below), and (iii) does not anticipate there will be any future shipments of pediatric SCDs to Nuwellis going forward. Due to the termination of the Distribution Agreement and related Settlement Agreement, the Company did not recognize any revenue from the Up-Front Payment or the Regulatory Milestone Payment as it refunded the payments to Nuwellis as part of the Settlement Agreement.

Since the termination of the Distribution Agreement, the Company developed its own commercial operations and sold approximately $1.2 million and $0.1 million to end-user customers during the years ended December 31, 2025 and 2024, respectively.

The following table summarizes the changes in the Company’s contract liability balance for the years ended December 31, 2025 and 2024:

Year Ended December 31,

Contract liabilities, beginning of period $ — $ 100

Consideration received — 450

Consideration refunded — (550 )

Contract liabilities, end of period $ — $ —

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Notes to the Consolidated Financial Statements

The Company had no contract assets at the beginning or end of the fiscal years ended December 31, 2025 and 2024. The accounting policies used to measure the profit and loss of the segment are the same as those described in the summary of significant accounting policies.

Note 4. Trade Accounts Receivable

The table below presents the opening and closing balances of accounts receivable, on a gross and net basis, with the total change in expected credit losses:

Changes in accounts receivable 128 (3 ) 125

Note 5. Accrued Expenses

Accrued expenses consisted of the following amounts as of December 31, 2025 and 2024:

Accrued research and development $ 1,525 $ 1,023

Accrued director compensation 70 391

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Notes to the Consolidated Financial Statements

Note 6. Notes Payable

Notes payable consisted of the following as of December 31, 2025 and 2024, respectively:

Insurance financing $ 525 $ 574

Less current portion (525 ) (574 )

Non-current portion $ — $ —

Insurance Financing

In October 2025,  the Company entered into a financing arrangement with a lender to finance a portion of the annual premium of an insurance policy in the amount of $0.7 million. Interest on the financing agreement was 7.940% per annum. The October 2025 financing agreement is to be paid in 10 monthly installments, with the final installment set for August 2026.

In October 2024, the Company entered into a financing arrangement with a lender to finance a portion of the annual premium of an insurance policy in the amount of $0.7 million. Interest on the financing agreement was 8.440% per annum. The October 2024 financing agreement was to be paid in 10 monthly installments, but was paid in full in June 2025.

Note 7. Equity Transactions

August 2025 Offering

On August 1, 2025, the Company closed on a registered direct offering with certain institutional investors (the “August 2025 Offering”), pursuant to which the Company sold and issued to the Purchasers, (i) 496,055 shares of the Company’s common stock par value $0.0001 per share and (ii) in a concurrent private placement, warrants to purchase up to an aggregate of 496,055 shares of Common Stock (the “August 2025 Common Warrants”) at an exercise price of $7.62 per share. The combined offering price for each share of common stock and accompanying August 2025 Common Warrant was $8.87. The August 2025 Common Warrants are exercisable upon issuance and will expire on August 12, 2030.

The Company received aggregate gross proceeds from the August 2025 Offering of approximately $4.4 million before deducting fees of approximately $0.5 million in offering costs comprised of a cash fee of 7.00%, a management fee of 1.00%, legal fees and other fees. Also in connection with the August 2025 Offering, the Company agreed to issue to the placement agent or its designees warrants (the “August 2025 Placement Agent Warrants”) to purchase up to an aggregate of 34,724 shares of common stock. The August 2025 Placement Agent Warrants have an exercise price of $11.08 per share (which represents 125% of the offering price per share of common stock and accompanying August 2025 Common Warrant), are exercisable upon issuance and will expire on July 31, 2030.

The August 2025 Common Warrants and August 2025 Placement Agent Warrants collectively herein are referred to as the “August 2025 Warrants”. No August 2025 Warrants have been exercised and all August 2025 Warrants remain outstanding as of December 31, 2025.

In accordance with ASC 815-40,Derivatives and Hedging-Contracts in Entity’s own Equity, the Company determined that all of the August 2025 Warrants issued in connection with the August 2025 Offering met the conditions for equity classification and were included as a component of stockholders’ equity/(deficit).

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Notes to the Consolidated Financial Statements

July 2025 Offering

On July 11, 2025, the Company closed on a registered direct offering with certain institutional investors (the “July 2025 Offering”), pursuant to which the Company sold and issued to the Purchasers, (i) 484,124 shares of the Company’s common stock par value $0.0001 per share and pre-funded warrants to purchase up to 40,124 shares of common stock (the “July 2025 Pre-Funded Warrants”) at an exercise price of $0.01 per share (the July 2025 Pre-Funded Warrants were fully exercised concurrent with the July 2025 Offering), and (ii) in a concurrent private placement, warrants to purchase up to an aggregate of 524,247 shares of common stock (the “July 2025 Common Warrants”) at an exercise price of $6.378 per share. The combined offering price for each share of common stock and accompanying July 2025 Common Warrant was $7.63. The July 2025 Common Warrants are exercisable upon issuance and will expire on August 12, 2030.

The Company received aggregate gross proceeds from the July 2025 Offering of approximately $4.0 million before deducting fees paid of $0.4 million in offering costs comprised of a cash fee of 7.00%, a management fee of 1.00%, legal fees and other fees. Also in connection with the July 2025 Offering, the Company agreed to issue to the placement agent or its designees warrants (the “July 2025 Placement Agent Warrants”) to purchase up to an aggregate of 36,698 shares of common stock. The July 2025 Placement Agent Warrants have an exercise price of $9.538 per share (which represents 125% of the offering price per share of common stock and accompanying July 2025 Common Warrant), are exercisable upon issuance and will expire on July 10, 2030.

The July 2025 Common Warrants and July 2025 Placement Agent Warrants collectively herein are referred to as the “July 2025 Warrants”. No July 2025 Warrants have been exercised and all July 2025 Warrants remain outstanding as of December 31, 2025.

In accordance with ASC 815-40,Derivatives and Hedging-Contracts in Entity’s own Equity, the Company determined that all of the warrants issued in connection with the July 2025 Offering met the conditions for equity classification and were included as a component of stockholders’ equity/(deficit)

June 2025 Offering

In June 2025, the Company did a best efforts public offering (the “June 2025 Offering”) pursuant to which the Company issued an aggregate of (i) 493,539 shares of the Company's common stock, (ii) 121,847 pre-funded warrants to purchase up to 121,847 shares of common stock (the “June 2025 Pre-Funded Warrants”) with an exercise price of $0.001, (iii) 615,385 Series A warrants to purchase up to 615,385 shares of common stock with an exercise price of $6.50 (the “June 20205 Series A Warrants”), and (iv) 615,385 Series B warrants to purchase up to 615,385 shares of common stock at an exercise price of $6.50 (the “June 2025 Series B Warrants”). All 121,847 June 2025 Pre-Funded Warrants were exercised as of December 31, 2025.

The Company received aggregate gross proceeds from the June 2025 Offering of approximately $4.0 million, before deducting approximately $0.5 million in offering costs comprised of cash fee of 7.00%, a management fee of 1.00%, legal fees and other fees. Also in connection with the June 2025 Offering, the Company agreed to issue to the placement agent or its designees warrants (the “June 2025 Placement Agent Warrants”) to purchase up to an aggregate of 43,077 shares of common stock. The June 2025 Placement Agent Warrants have an exercise price of $8.13 per share (which represents 125% of the offering price per share of common stock and accompanying June 2025 Series A and Series B Warrants), are exercisable upon issuance and will expire on June 20, 2030. No June 2025 Placement Warrants have been exercised and all June 2025 Placement Warrants remain outstanding as of December 31, 2025.

The June 2025 Series A Warrants and June 2025 Series B Warrants were immediately exercisable with the June 2025 Series A warrants expiring on June 23, 2030 and the June 2025 Series B Warrants expiring on December 23, 2026. During the year ended December 31, 2025, 40,770 and 238,462 Series A June 2025 Warrants and Series B June 2025 Warrants have been exercised, respectively and 574,616 and 376,924 Series A June 2025 Warrants and Series B June 2025 Warrants remain outstanding, respectively, as of December 31, 2025.

In accordance with ASC 815-40,Derivatives and Hedging-Contracts in Entity’s own Equity, the Company determined that all the different warrants issued or amended in connection with the June 2025 Offering met the conditions for equity classification and were included as a component of stockholders’ equity/(deficit).

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Notes to the Consolidated Financial Statements

February 2025 Offering

In January 2025, the Company entered into a Securities Purchase Agreement with an institutional investor, pursuant to which the Company issued on February 3, 2025, to the investor, (i) in a registered direct offering, 71,300 shares of the Company’s common stock, and pre-funded warrants to purchase 281,642 shares of common stock (the “February 2025 Pre-Funded Warrants”) with an exercise price of $0.001 per share, and (ii) in a concurrent private placement, warrants (the "February 2025 Common Warrants") to purchase 352,942 shares of common stock with an exercise price of $17.00 (the “February 2025 Offering”).

The Company received aggregate gross proceeds from the February 2025 Offering of approximately $6.0 million, before deducting approximately $0.5 million of fees and other estimated offering expenses payable by the Company. The February 2025 Pre-Funded Warrants did not have a set expiration and were exercisable upon issuance and at any time until all of the February 2025 Pre-Funded Warrants were exercised in full. During the year ended December 31, 2025, a total of 281,642 February 2025 Pre-Funded Warrants were exercised, and no February 2025 Pre-Funded Warrants remain outstanding.

The February 2025 Common Warrants became exercisable on March 28, 2025, the effective date of stockholder approval for the issuance of the shares of common stock issuable upon exercise of the warrants and expire on March 28, 2030.

Prior to their exercise, the February 2025 Pre-Funded Warrants had dividend participation rights, and any unexercised pre-funded warrants are included in the Company's weighted-average shares outstanding for calculation of the Company's net loss per share.

In connection with the February 2025 Offering, the Company amended the exercise price of the January 2024 Series A and January 2024 Series B Common Warrants (collectively the “January 2024 Warrants”), issued in a previous financing transaction with the same institutional investor in January 2024, to $17.00 from the original exercise price of $207.60. Furthermore, the expiration date of all 65,046 January 2024 Warrants was extended to January 30, 2029, upon stockholder approval on March 28, 2025. No January 2024 Warrants have been exercised and all January 2024 Warrants remain outstanding as of December 31, 2025.

The Company issued 24,706 warrants to its placement agent (the "February 2025 PA Warrants") to purchase shares of the Company's common stock at an exercise price of $21.25. The February 2025 PA Warrants were exercisable upon issuance and expire on January 30, 2029. The February 2025 PA Warrants and February 2025 Common Warrants are herein defined as the "February 2025 Warrants". No February 2025 Warrants have been exercised and all February 2025 Warrants remain outstanding as of December 31, 2025.

In accordance with ASC 815-40,Derivatives and Hedging-Contracts in Entity’s own Equity, the Company determined that all the different warrants issued or amended in connection with the February 2025 Offering met the conditions for equity classification and were included as a component of stockholders’ equity/(deficit).

At-The-Market Offering

On August 20, 2024, the Company entered into an At-The-Market Offering Agreement (the “ATM Agreement”) with Wainwright as sales agent, to sell shares of its common stock, from time to time, through an “at the market offering” program under which Wainwright will act as sales agent. The sales, if any, of the Company’s Common Stock made under the ATM Agreement will be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on or through the Nasdaq Capital Market or on any other existing trading market for the Company’s common stock (the “ATM”).

Through December 31, 2025, the Company has raised approximately $10.4 million, net of offering costs of $0.4 million utilizing the ATM since inception in August 2024, issuing approximately 1.1 million shares of the Company’s Common Stock. During the year ended December 31, 2025, the Company raised approximately $5.9 million, net of offering costs of $0.2 million, issuing approximately 0.9 million shares of the Company's common stock.

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Notes to the Consolidated Financial Statements

Standby Equity Purchase Agreement

On April 25, 2025, the Company entered into a standby equity purchase agreement (“Common Stock Purchase Agreement”) and related registration rights agreement (the “Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), collectively the “SEPA”. Pursuant to the Common Stock Purchase Agreement, the Company has the right, but not the obligation, to direct Lincoln Park to purchase up to $15.0 million in aggregate gross purchase price of newly issued shares of Common Stock, subject to certain limitations and conditions as described below (the “SEPA Program”) at a purchase price equal to 97% of the lesser of (i) the lowest sale price of the common stock on the purchase date or (ii) average of the three lowest closing sale prices of the common stock over the last ten business days prior to the purchase date.

The Company controls the timing and amount of any sales to Lincoln Park, which depend on a variety of factors including, among other things, market conditions, the trading price of the Company’s common stock, and determinations by the Company as to appropriate sources of funding for its business and operations. However, Lincoln Park’s obligation to purchase shares is subject to certain conditions, including the daily trading volume of the Company’s stock. In all instances, the Company may not sell shares of Common Stock under the Purchase Agreement if it would result in Lincoln Park and its affiliate beneficially owning more than 9.99% of outstanding voting power or shares of the Common Stock at any one point in time.

As part of the SEPA, the Company agreed to pay Lincoln Park 23,641 shares of the Company’s common stock, valued at approximately $0.3 million on the date of issuance, April 25, 2025 (the “Commitment Fee”).

The Company evaluated the contract that includes the right to require Lincoln Park to purchase shares of common stock in the future (“put right”) considering the guidance in ASC 815-40,Derivatives and Hedging — Contracts on an Entity’s Own Equity and concluded that it is an equity-linked contract that does not qualify for equity classification, and therefore requires fair value accounting. The Company analyzed the terms of the freestanding put right and concluded that it has an immaterial value at the issuance date of April 25, 2025, and as of December 31, 2025.

Through December 31, 2025, the Company raised approximately $40 thousand and issued 8,000 shares of the Company's common stock.

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Notes to the Consolidated Financial Statements

Note 8. Warrants

The Company has the following warrants outstanding at December 31, 2025 and 2024:

Liability Classified Warrants

Equity Classified Warrants

The following tables provides the weighted average strike price and time to maturity for each warrant tranche as of December 31, 2025 and 2024:

Liability Classified Warrants

Equity Classified Warrants

Liability Classified Warrants

Equity Classified Warrants

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Notes to the Consolidated Financial Statements

Below is the warrant activity for the year ended December 31, 2025, for those warrants with activity during the year ended December 31, 2025.

Outstanding as of December 31, 2024 — — — — 196

Forfeited / cancelled — — — — (46 )

During the year ended December 31, 2025, the Company recognized an unrealized gain of $32 thousand from the change in fair value of all remaining liability classified warrants.

Note 9. Common Stock and Preferred Stock

As of December 31, 2025, the Company is authorized to issue 460,000,000 shares, consisting of (a) 450,000,000 shares of common stock and (b) 10,000,000 shares of preferred stock (the “Preferred Stock”). On December 18, 2025, the Company’s shareholders voted at a Special Meeting to reduce the authorized shares of common stock to 425,000,000. The change became effective on January 5, 2026.

Common stock

The charter of the Company (the “Charter”) provides the following with respect to the rights, powers, preferences, and privileges of the common stock.

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Notes to the Consolidated Financial Statements

Voting power

Except as otherwise required by law or as otherwise provided in any certificate of designation for any series of preferred stock, the holders of common stock possess all voting power for the election of the Company’s directors and all other matters requiring stockholder action. Holders of common stock are entitled to one voter per share on matters to be voted on by stockholders. The Charter does not provide for cumulative voting rights.

Dividends

Subject to the rights, if any, of the holders of any outstanding shares of preferred stock, under the Charter, holders of common stock will be entitled to receive such dividends, if any, as may be declared from time to time by the Board of Directors in its discretion out of funds legally available therefor.

Liquidation, dissolution and winding-up

In the event of the Company’s voluntary or involuntary liquidation, dissolution, distribution of assets or winding-up, the holders of the common stock will be entitled to receive an equal amount per share of all of the Company’s assets of whatever kind available for distribution to stockholders after the rights of the holders of the Preferred Stock have been satisfied and after payment or provision for payment of the Company’s debts.

Preemptive or other rights

There are no preemptive rights or sinking fund provisions applicable to the shares of the Company’s common stock.

Preferred stock

The Charter provides that shares of preferred stock may be issued from time to time in one or more series. The Board of Directors is authorized to fix the voting rights, if any, designations, powers, preferences, the relative, participating, optional, or other special rights and any qualifications, limitations, and restrictions thereof, applicable to the shares of each series. The Company has no preferred stock outstanding at December 31, 2025 or 2024.

Note 10. Stock-Based Compensation Awards

The following table sets forth the total stock-based compensation cost included in the Company’s consolidated statements of operations for the years ended December 31, 2025 and 2024:

Year Ended December 31,

Research and development $ 91 $ 157

General and administrative 533 730

Total stock-based compensation $ 624 $ 887

Equity incentive plan - summary

2022 Omnibus Incentive Plan

The Company’s Board of Directors adopted, and the shareholders approved the 2022 Omnibus Incentive Plan to provide long-term incentive for its employees and non-employee service providers. The vesting of stock options is stated in each individual grant agreement, which is generally either one or four years. Options granted expire 10 years after the date of grant.

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Notes to the Consolidated Financial Statements

2019 Stock Incentive Plan

The Company’s Board of Directors adopted the 2019 Stock Incentive Plan on February 25, 2019, to provide long-term incentive for its employees and non-employee service providers. The Stock Incentive Plan was terminated on October 28, 2022, and no further awards were granted under such plan.

Stock Options

Option activity for the year ended December 31, 2025, is as follows:

2022 Omnibus Incentive Plan - Options

Exercised —

Issued —

Forfeited / cancelled (192 )

2019 Stock Incentive Plan - Options

Exercised —

Issued —

Forfeited / cancelled (196 )

Restricted Stock Units

A summary of the Company’s restricted stock unit (“RSU”) activity for the year ended December 31, 2025, is as follows:

2022 Omnibus Incentive Plan - RSUs

Number of RSU Weighted-Average Grant Date Fair Value (per share)

Forfeited / cancelled (1,000 )

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Notes to the Consolidated Financial Statements

2019 Stock Incentive Plan - RSUs

Number of RSU Weighted-Average Grant Date Fair Value (per share)

Granted —

Vested (75 )

Forfeited / cancelled —

Outstanding at December 31, 2025 — $ —

Note 11. Commitments and Contingencies

Lease agreements

The Company is part of a membership agreement for shared office space and can cancel at any time, consisting of office space and dedicated space for warehousing and assembly of SCDs. Rent expense was approximately $75 thousand and $43 thousand for the years ended December 31, 2025 and 2024, respectively.

Litigation

On July 5, 2024, Forrest A K Wells, a purported stockholder of ours, filed a putative class action complaint in the United States District Court for the District of Colorado, captioned Wells v. SeaStar Medical Holding Corporation, et al., Case No.1:24-cv-0187 (the “Class Action”). The Class Action alleges that the Company, our Chief Executive Officer, and former Chief Financial Officer made or caused to be made material misstatements or omissions regarding: (a) the projected timing for obtaining FDA approval of our SCD; and (b) our recognition of certain financial instruments, allegedly culminating in our restatement of our consolidated financial statements, disclosed in a Form 8-K and filed on March 27, 2024. The Class Action asserts claims pursuant to the Securities Exchange Act of 1934, including Section 10(b), Rule 10b-5 promulgated thereunder, and Section 20(a). The Class Action seeks to recover, among other remedies, compensatory damages. On March 4, 2025, the Plaintiff filed an amended complaint. The Defendants moved to dismiss the complaint. The Defendants’ motion to dismiss the complaint was referred to United States District Court Magistrate Judge Timothy P. O’Hara. On February 27, 2026, Magistrate Judge O’Hara issued a written report and recommendation to United States District Judge Regina M. Rodriguez that the complaint be dismissed with leave to amend (“R&R”). Lead Plaintiff filed an objection to the R&R on March 13, 2026, and Defendants are expected to respond on March 27, 2026. The Company cannot predict whether the Magistrate Judge’s R&R will be adopted, modified or rejected by the District Court, or whether the Lead Plaintiff will amend the complaint.

On December 13, 2024, Jose Lazo, a purported stockholder of ours, filed a putative stockholder derivative action complaint captioned Lazo v. Schlorff et. al., C.A. No.1:24-cv-3444 in the United States District Court for the District of Colorado (the “Derivative Action”). The factual allegations of the Derivative Action are substantially similar to the Class Action. On January 30, 2025, upon joint motion of the parties, the Court stayed the Derivative Action pending the Court’s resolution of an anticipated motion to dismiss to be filed in the Class Action.

The Derivative Action alleges, among other things, that the Company's Chief Executive Officer, former Chief Financial Officer, and certain of the Company's current and former directors violated Section 14(a) of the Exchange Act, breached fiduciary duties and were unjustly enriched by making or allowing to be made purportedly false and misleading statements regarding the Company's prospects for success in obtaining FDA approval for its SCD. The Derivative Action further alleges that there were purported deficiencies in the Company's internal financial controls and procedures and improper accounting for classification of certain financial instruments leading to the restatement of its previously issued financial statements. The Derivative Action also asserts claims under Section 10(b) and 21D of the Exchange Act against the Company's Chief Executive Officer and former Chief Financial Officer. Among other remedies, the Derivative Action seeks to recover damages and restitution on behalf of the Company and certain injunctive relief concerning the Company's corporate governance and internal controls. Additional stockholders may file substantially similar complaints in the future. The Company will not make separate disclosure of such complaints unless they are materially different than the Derivative Action.

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Notes to the Consolidated Financial Statements

Note 12. Fair Value Measurements

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). Inputs used to measure fair value are classified into the following hierarchy:

Level 1 – quoted prices in active markets for identical assets and liabilities.

Level 2 – other significant observable inputs (including quoted prices for similar assets and liabilities, quoted prices for identical assets in inactive markets, interest rate, credit risk, etc.).

Level 3 – significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities).

The fair value of the forward option on prepaid forward contracts, convertible notes, and the warrants liability is classified as Level 3 in the fair value hierarchy.

Fair Value Measurement Hierarchy

The following table presents the Company’s financial assets and/or liabilities that were accounted for at fair value on a recurring basis as of December 31, 2025 and 2024, by level withing the fair value hierarchy. There were no non-recurring fair value measurements, as the Company does not have any long-lived assets, including fixed assets, intangible assets or goodwill which can require non-recurring measurements for impairment.

Fair Value Measurements at December 31, 2025

(Level 1) (Level 2) (Level 3) Total

Liabilities:

Liability classified warrants $ — $ — $ 1 $ 1

$ — $ — $ 1 $ 1

Fair Value Measurements at December 31, 2024

(Level 1) (Level 2) (Level 3) Total

Liabilities:

Liability classified warrants $ — $ — $ 33 $ 33

Total $ — $ — $ 33 $ 33

Summary of Level 3 Input Changes

The following table presents the changes in the liability classified warrants for the years ended December 31, 2025 (in thousands):

Level 3 Roll Forward Liability Classified Warrants

Additions —

Cash paid to settle —

Shares issued upon conversion or exercise —

Changes in fair value (32 )

Level 3 Inputs

For assets or liabilities for which the Company is required to remeasure the fair value on a recurring basis at each reporting date, generally the Company is required to disclose certain quantitative data related to the inputs used at the most recent reporting period date. However, for those assets or liabilities for which the Company has elected to take the fair value option in accordance with ASC 825, Financial Instruments, then such quantitative disclosures are not required. As of December 31, 2025, there were no assets or liabilities for which the Company elected to take the fair value option.

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Notes to the Consolidated Financial Statements

Liability Classified Warrants

Significant assumptions used in valuing warrants which require liability classification were as follows as of December 31, 2025 and 2024:

December 31, December 31,

The only liability classified warrants that were outstanding as of December 31, 2025 and 2024, were the Private and PIPE warrants. These warrants are valued using the same inputs into a Black-Scholes standard option pricing model and therefore, there is no range of inputs.

Note 13. Income Taxes

The Company recorded approximately $3 thousand and $3 of current income tax expense for the years ended December 31, 2025 and 2024, respectively. The Company paid approximately $2 thousand to California, and less than $1 thousand each to North Carolina and New Jersey during the year ended December 31, 2025, comprised of statutory minimum taxes.

The table before provides the updated requirements of ASU 2023-09 for 2025 (see Note 2. Summary of Significant Accounting Policies – Recent accounting pronouncements for additional details on the adoption of ASU 2023-09.

The effective income tax rate of the Company’s provision for income taxes for the year ended December 31, 2025, differed from the federal statutory rate as follows (in thousands and percentages):

Amount Percent

Federal tax at statutory rate $ (2,551 ) $ 21.00 %

State Tax net of federal benefits 4 -0.03 %

Nontaxable or nondeductible items (3 ) 0.01 %

Change in Valuation Allowance 2,740 -22.44 %

Other Adjustments 88 -0.85 %

Tax Expense $ 3 $ -0.03 %

As previously disclosed for the years ended December 31, 2024, prior to the adoption of ASU 2023-09, the effective income tax rate differs from the statutory federal income rate as follows:

Amount Percentages

Federal tax at statutory rate $ (5,214 ) $ 21.00 %

Stock compensation expense 18 -0.07 %

Unrealized gains and losses, net, for liability classified warrants 146 -0.59 %

Unrealized gains and losses, net, for convertible debt 1,291 -5.20 %

Adjustment to prior period federal deferred tax assets 95 -0.38 %

Non-deductible expenses 6 -0.03 %

Change in valuation allowance 2,910 -11.72 %

Total effective income tax rate $ 3 $ 0.00 %

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Notes to the Consolidated Financial Statements

Significant components of deferred tax assets for federal and state income taxes were as follows:

December 31, December 31,

Deferred tax assets:

Finance charges and origination fees — 133

Stock-based compensation 87 47

Section 174 research and development capitalization 2,099 2,771

Section 59(e) research and development capitalization 1,292 —

Capitalized start-up fees 197 209

Net deferred tax assets $ — $ —

In accordance with U.S. GAAP, a valuation allowance should be provided if it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The Company’s ability to realize the benefit of its deferred tax assets will depend on the generation of future taxable income. Due to the uncertainty of future profitable operations and taxable income, the Company has recorded a full valuation allowance against its net deferred tax assets. For the years ended December 31, 2025 and 2024, the net increase in the valuation allowance was approximately $3.5 million and $2.8 million, respectively.

As of December 31, 2025 and 2024, the Company had federal net operating loss carryforwards of approximately $117.9 million and $108.4 million, respectively, of which approximately $65.0 million of federal net operating loss carryforwards post 2017 will be carried forward indefinitely. The remaining $52.8 million of federal net operating loss carryforwards begin expiring in 2027. The Company has also generated approximately $11.4 million of net operating loss carryforwards in California carryforward for 20 years, first expiring in 2039, $4.0 million of Florida net operating losses that carryforward indefinitely; $7.1 million of Illinois net operating loss carryforwards that carryforward for 20 years, first expiring in 2044 and $1.7 million of net operating loss carryforwards in Virginia that carryforward indefinitely. The Company has not used any net operating loss carryforwards to date.

The Company has not claimed any federal or state Research Credit carryforwards pre-2022. The Company believes that the Company has qualified research activities and qualified research expenses, but missed claiming the R&D credits in prior years. The tax provision reports no pre-2022 R&D credit carryforwards, consistent with the tax return filings through 2021. The Company will record R&D credit deferred tax assets (and the related valuation allowance) if/when the Company amends prior year tax filings to claim R&D credits.

The Company had federal energy credit carryforwards of approximately $0.6 million as of December 31, 2025 and 2024, which will expire starting in 2027 if not utilized. The Company has federal research and development credit carryforwards of approximately $0.7 million and $0.5 million as of December 31, 2025 and 2024, respectively, which will expire starting in 2042 if not utilized.

Pursuant to Internal Revenue Code (“IRC”) Sections 382 and 383, the Company’s ability to use net operating losses (“NOL”) and research tax credit carryforwards to offset future taxable income may be limited if the Company experiences a cumulative change in ownership of more than 50% within a three-year testing period. The Company has not completed an ownership change analysis pursuant to IRC Section 382. If ownership changes within the meaning of IRC Section 382 are identified as having occurred, the amount of NOL and research tax credit carryforwards available to offset future taxable income and income tax liabilities in future years may be significantly restricted or eliminated. Further, deferred tax assets associated with such NOLs, and research tax credits could be significantly reduced upon realization of an ownership change within the meaning of IRC Section 382.

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Notes to the Consolidated Financial Statements

Source: SEC EDGAR (public domain) · 10-K for the period ended 2025-12-31, filed 2026-03-25 · accession 0001437749-26-009797

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