SeaStar Medical Holding Corp

Note1. Description of Business

Organization and Description of Business

SeaStar Medical Holding Corporation, a Delaware corporation (“SeaStar”) and its wholly owned subsidiary, SeaStar Medical, Inc., are collectively referred to as the “Company”. SeaStar Medical, Inc. was incorporated as a Delaware corporation in* June 2007,and it is headquartered in Denver, Colorado. 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 Company received FDA approval for QUELIMMUNE, its commercial pediatric Selective Cytopheretic Device ("SCD") therapy on February 21, 2024,*under a Humanitarian Device Exemption (“HDE”). 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 kidney replacement therapy. In addition, the Company is currently conducting a pivotal clinical trial to assess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring continuous renal replacement therapy (“CRRT”).

The initial target indications for this technology have been for the treatment of patients with AKI, but through additional Breakthrough Device Designation (“BDD”) from the Food and Drug Administration (“FDA”), the Company has expanded development of the SCD therapy into treatments for patients with cardiorenal syndrome awaiting left ventricular assist device implantation, patients with hepatorenal syndrome, patients with end stage renal disease 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.

Basis of Presentation and Consolidation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules and regulations, certain notes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal, recurring adjustments that are necessary to present fairly the Company’s results for the interim periods presented. The results from operations for thethree months ended* March 31, 2026*, arenot necessarily indicative of the results to be expected for the year ending* December 31, 2026*, or for any future annual or interim period.

The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with the annual consolidated financial statements and the related notes for the year ended* December 31, 2025*. There have beenno material changes in our significant accounting policies as described in our Annual Report on Form10-K for the year ended* December 31, 2025*.

The interim unaudited condensed consolidated financial statements include the consolidated accounts of the Company’s wholly owned subsidiary, SeaStar Medical, Inc. All significant intercompany transactions have been eliminated in consolidation.

On* June 7, 2024,the Company effected a1*-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 the2024 Reverse Stock Split, each 25 shares of the Company’s common stock that were issued and outstanding automatically converted intoone outstanding share of common stock.

On* January 5, 2026,the Company elected a1*-for-10 reverse-stock split (the*“2026* Reverse Stock Split,” together with the2024 Reverse Stock Split, the “Reverse Stock Splits”) of its issued and outstanding shares of common stock, par value $0.0001. Following the effect of the2026 Reverse Stock Split, each 10 shares of the Company’s common stock that were issued and outstanding automatically converted intoone outstanding share of common stock.

Combined, this had the effect of a1-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 Special Purpose Acquisition Corporation 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 purchaseone* share of common stock. Unless otherwise indicated, all other share and per share amounts in this quarterly 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.

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Segment Information

The Company is comprised of asingle reportable segment, its Device Segment. This organizational structure aligns with how our Chief Operating Decision Maker (“CODM”), the Chief Executive Officer, manages the Company’s business, including resource allocation and performance assessment. The Company is focused entirely on the development, regulatory approval and commercialization of the Company’s adult and pediatric SCDs. The Company had a total of 17 employees at both* March 31, 2026* and* December 31, 2025,and total assets of $11.3 million and $14.2 million, as of March 31, 2026*, and* December 31, 2025*, respectively.

For segment reporting purposes, the CODM uses operating profit/(loss) to evaluate segment performance and allocate resources. As a Company that only recently began limited commercial sales of QUELIMMUNE, the CODM is primarily focused on evaluating the overall spending for research and development activities needed to fund further development of the SCDs, and general and administrative activities incurred to support the research and development activities of the Company. Accounting policies associated with the Company’s sole segment are the same as those described in Note2. See Note14 for Segment Reporting information.

All of the Company’s sales are located within the United States. As of the date of this report, the Company has obtained regulatory approval for commercial sales in the U.S. of QUELIMMUNE from the FDA. The Company doesnot have any inter-entity sales or transfers.

Liquidity and Going Concern

The Company incurred losses of $3.5 million for thethree months ended* March 31, 2026*. As of* March 31, 2026*, the Company has an accumulated deficit of $155.2 million and cash of $9.3 million. The Company doesnot 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 least12 months from the issuance of these unaudited condensed 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 $1.9 million revenue from the sales of its commercialized product, QUELIMMUNE to fund its operations. Its ability to generate meaningful product revenue will depend on the progress of the commercial launch of QUELIMMUNE and successful development and eventual commercialization of the adult SCD. Until such time, if ever, the Company 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 unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and donot 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.

Risks and Uncertainties

The Company is subject to risks common to early-stage companies in the medical technology industry including, butnot limited to, new medical and technological innovations, dependence on key personnel, protection of proprietary technology, and product liability. There can beno 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.

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Note2. Summary of Significant Accounting Policies

Use of Estimates

The preparation of the unaudited condensed 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 unaudited condensed consolidated financial statements and reported amounts of revenues and expenses during thethree months ended* March 31, 2026.*Significant estimates include (i) accrued unbilled clinical trial costs, and (ii) 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.

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.

Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity ofthree months or less to be cash equivalents. The Company didnot have any cash equivalents as of* March 31, 2026and December 31, 2025.*

Accounts Receivable, net

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. As of* March 31, 2026and December 31,*2025, the Company had a current expected credit loss reserve of $1 thousand and $3 thousand, respectively.

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 isfive 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 Condensed Statement of Cash Flows.Changes in fair value related to the Company’s *derivative financial instruments consisting of liability classified warrants are recognized as a component of other income/(expense).

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Revenue Recognition

Overall

Under ASC606, Revenues from Contracts with Customers("Topic606") 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 Topic606, 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.

At contract inception, once the contract is determined to be within the scope of Topic606, 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 determinednot 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 isnot constrained if the potential reversal of cumulative revenue recognized at the contract level isnot significant.

The Company currently doesnot receive customer deposits or prepayments prior to the Company fulfilling its performance obligation(s) under each contract obligation(s).

Product Sales Revenue

The Company sells its products directly to end-user qualified customers using the Company’s own internal commercial/sales resources.

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The Company will continue to monitor all of the above as the Company continues to commercialize and increase its customer base, which could result in each distributor or end-user customer agreement having 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 2024was expensed as a period expense at the time of purchase as a research and development expense. Accordingly, all QUELIMMUNE units sold prior to thethree* months ended* June 30, 2025,hadno* recognized inventory value. During thethree months ended* March 31, 2026* , the Company recognized approximately $46 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 thesethree categories of inventory is as follows:

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 ASC730*-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 statements of operations for thethree* months ended* March 31, 2026and2025.* The reimbursed expenses for thethree months ended* March 31, 2026and2025* totaled approximately $39 thousand and $0, respectively.

Emerging Growth Company Status

The Company is an “emerging growth company”, as defined in the Jumpstart Our Business Startups Act of2012 (“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 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.

Recently issued Accounting Standards

Accounting Standards Update2024*-03 — In November 2024,the FASB issued ASU2024*-03 -Income Statement - Reporting Comprehensive Income–* Expense Disaggregation (Subtopic220-40): Disaggregation of Income Statement Expenses*. ASU2024-03 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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Note3. Revenues and Contract Obligations

The Company recognized $0.5 million and $0.3 million in revenues for thethree months ended* March 31, 2026and2025,* respectively. The Company’s sales are entirely in the United States, as it doesnot have any regulatory approval to sell elsewhere as of* March 31, 2026*.

Contract Assets and Liabilities

There are and wereno contract assets or liabilities as of and at any time during thethree months ended* March 31, 2026and2025,* respectively. This is because the Company's current contracts with customers donot contain features, terms or conditions that would give rise to such contract assets or liabilities.

Note4. Accounts Receivable, net

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.

Note5. Accrued Expenses

Accrued expenses consisted of the following amounts as of* March 31, 2026*, and* December 31, 2025*:

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Note6. Notes Payable

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, to be paid overten* months, with the final payment in* August 2026.As of March 31, 2026*, the Company owed approximately $0.3 million under this arrangement.

Note7. Equity Transactions

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, butnot* 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 thethree lowest closing sale prices of the Common Stock over the lastten 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 anyone point in time.

As part of the SEPA, the Company agreed to issue to 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 ASC815-40, Derivatives and Hedging —Contracts on an Entity’s Own Equity and concluded that it is an equity-linked contract that doesnot 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 March 31, 2026and December 31, 2025.*

Through* March 31, 2026,the Company raised approximately $0.3 million, net of offering costs of approximately $18 thousand, issuing approximately 138,184 million shares of the Company's Common Stock. During thethree* months ended* March 31, 2026,*the Company raised $0.3 million, net of offering costs of approximately $16 thousand, issuing 130,184 million shares of the Company's Common Stock.

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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 Rule415* promulgated under the Securities Act of1933, 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* March 31, 2026*, the Company has raised approximately $10.4 million, net of offering costs of approximately $0.4 million, utilizing the ATM since inception in* August 2024,issuing approximately 1,081,207 shares of the Company’s Common Stock. During thethree* months ended* March 31, 2026*, the Company raised approximately $0.1 million, net of offering costs of approximately $2 thousand, issuing approximately 18,880 shares of the Company's Common Stock.

Note8. Warrants

The Company issued warrants in connection with various financing transactions. The Company had the following warrants outstanding at* March 31, 2026*, and* December 31, 2025*:

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The following tables provide the weighted-average strike price and time to maturity for each warrant share equivalent outstanding for each warrant tranche as of* March 31, 2026* and* December 31, 2025*:

There wereno new warrants issued, or existing warrants exercised or expired during thethree months ended* March 31, 2026.*

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Note9. Stock-Based Compensation Awards

The following table sets forth the total stock-based compensation cost included in the Company’s unaudited condensed consolidated statements of operations for the periods indicated:

Equity Incentive Plan - Summary

2022 Omnibus Incentive Plan

The Company’s Board of Directors adopted, and the stockholders approved the2022 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 generallyone tofour years. Options granted expire 10 years after the date of grant.

2019 Stock Incentive Plan

The Company’s Board of Directors adopted the2019 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,andno* further awards were granted under such plan.

Stock Options

Option activity for thethree months ended* March 31, 2026*, is as follows:

2022 Omnibus Incentive Plan - Stock Options

2019 Omnibus Incentive Plan - Options

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Restricted Stock Units

There areno outstanding restricted stock units outstanding under the2019 Stock Incentive Plan. A summary of the Company’s restricted stock unit (“RSU”) activity is as follows:

2022 Omnibus Incentive Plan - RSUs

Note10. Commitments and Contingencies

Lease Agreements

The Company is part of a membership agreement for shared office space for two suites at the same location. The first suite is on a month-to-month basis and the Company can cancel any time, while the second suite has an annual renewal option. Rent expense was approximately $19 thousand and $21 thousand for thethree months ended* March 31, 2026and2025,* respectively.

Litigation

Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. From time to time, the Company* may*become involved in legal proceedings arising in the ordinary course of business.

Shareholder Claims

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, CaseNo.* 1:24-cv-0187 (D. Colorado) (the “Class Action”). The Class Action alleges that we, our Chief Executive Officer and former Chief Financial Officer made or caused to be made material misstatements or omissions regarding our business and operations, allegedly culminating in our restatement of our consolidated financial statements, disclosed in a Form8-K and filed on* March 27, 2024.The Class Action asserts claims pursuant to the Securities Exchange Act of1934,* including Section10(b), Rule10b-5 promulgated thereunder and Section20(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”). On March 30, 2026,Judge Rodriguez adopted the Magistrate Judge’s R&R and dismissed the complaint with leave to amend. On April 21, 2026the parties filed a Stipulation and Proposed Order of Dismissal with Prejudice (“Stipulation”). On April 27, 2026*the Court ordered that the case is dismissed with prejudice.

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 the then-anticipated motion to dismiss to be filed in the Class Action.

The Derivative Action alleges, among other things, that our Chief Executive Officer, former Chief Financial Officer, and certain of the Company's current and former directors violated Section14(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 our prospects for success in obtaining FDA approval for our 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 our restatement of previously issued financial statements. The Derivative Action also asserts claims under Section10(b) and21D of the Exchange Act against our Chief Executive Officer and former Chief Financial Officer. Among other remedies, the Derivative Action seeks to recover damages and restitution on behalf of us and certain injunctive relief concerning our corporate governance and internal controls. Additional stockholders* mayfile substantially similar complaints in the future. The Company willnot* make separate disclosure of such complaints unless they are materially different than the Derivative Action.

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Note11. 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:

Level1 – quoted prices in active markets for identical assets and liabilities.

Level2 – other significant observable inputs (including quoted prices for similar assets and liabilities, interest rate, credit risk, etc.).

Level3 – significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities).

The fair value of the warrants liability is classified as Level3 in the fair value hierarchy.

Fair Value Measurement Hierarchy

The following tables present the Company’s financial assets and/or liabilities that were accounted for at fair value on a recurring basis as of* March 31, 2026* and* December 31, 2025*, by level within the fair value hierarchy. There wereno non-recurring fair value measurements, as the Company doesnot have any long-lived assets, including fixed assets, intangible assets, or goodwill which can require non-recurring measurements for impairment.

Summary of Level3 Input Changes**

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The following table presents the changes in the fair value of the liability classified warrants for thethree months ended* March 31, 2026* (in thousands):

Level3* 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 ASC825, Financial Instruments, then such quantitative disclosures arenot required.

Liability Classified Warrants

The liability classified warrants as of* March 31, 2026* and* December 31, 2025*, includetwo classes of warrants with the exact same terms, and therefore, the range of assumptions are the same, and disclosed below. Significant assumptions used in valuing warrants which require liability classification were as follows as of* March 31, 2026* and* December 31, 2025*.

Note12. Income Taxes

In accordance with U.S. GAAP, a valuation allowance should be provided if it is more likely thannot that some or all of the Company’s deferred tax assets willnot be realized. The Company’s ability to realize the benefit of its deferred tax assets will depend on the generation of future taxable income. Except as noted below, 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. The Company has recognized an insignificant provision for certain minimum state taxes of approximately $3 thousand as of* March 31, 2026*.

The Company believes its tax filing position and deductions related to tax periods subject to examination will be sustained under audit and, therefore, hasno reserve for uncertain tax positions.

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Note13. Net Loss Per Share

The following table presents the calculation of basic and diluted net loss per share (in thousands except share and per share information):

The following outstanding potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive:

Note14. Segment Reporting

The Company is comprised of asingle reportable segment, its Device Segment. This organizational structure aligns with how our CODM, the Chief Executive Officer, manages the Company’s business, including resource allocation and performance assessment. The Company is focused entirely on the development, regulatory approval and commercialization of the Company’s adult and pediatric Selective Cytopheretic Devices (SCDs). The Company had total assets of $11.3 million and $14.2 million, as of* March 31, 2026* and* December 31, 2025*, respectively.

For segment reporting purposes, the CODM uses operating profit/(loss) to evaluate segment performance and allocate resources. As a Company that only recently began limited commercial sales of QUELIMMUNE, the CODM is primarily focused on evaluating the overall spending for research and development activities needed to fund further development of the SCDs, and general and administrative activities incurred to support the research and development activities of the Company. Accounting policies associated with the Company’s sole segment are the same as those described in Note2.

All of the Company’s sales are located within the United States. As of the date of this report, the Company has obtained regulatory approval for commercial sales in the U.S. of QUELIMMUNE from the FDA. The Company doesnot have any inter-entity sales or transfers.

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The following table represents the Company’s sole segment’s operating results for thethree months ended* March 31, 2026and2025*, respectively(*).

(*) The above table excludes other segment items consisting of interest expense, interest income, and gains and losses from changes in the fair value of liability classified financial instruments.

Note15. Subsequent Events

Except for certain legal matters as disclosed in Note10 –* Commitments and Contingencies, there have beenno* other material subsequent events requiring disclosure.

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