SeaStar Medical Holding Corp

This Annual Report on Form 10-K (this “Annual Report”) contains statements that are forward-looking and as such are not historical facts. These statements are based on the beliefs and assumptions of management. Although the Company believes that its plans, intentions, and expectations reflected in or suggested by these forward-looking statements are reasonable, the Company cannot assure you that it will achieve or realize these plans, intentions, or expectations. Forward-looking statements are inherently subject to risks, uncertainties, and assumptions. Generally, statements that are not historical facts, including statements concerning the Company’s possible or assumed future actions, business strategies, events, or results of operations, are forward-looking statements. In some instances, these statements may be preceded by, followed by or include the words “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “will,” “should,” “seeks,” “plans,” “scheduled,” “anticipates” or “intends” or the negatives of these terms or variations of them or similar terminology.

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our plans to conduct further clinical trials and anticipated enrollment, clinical sites, completion, results, and timing thereof;

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our plans and expected timeline related to our products, including timing of commercial launch, or developing new products, to address additional indications or to obtain regulatory approvals or clearances or otherwise;

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the expected use of our products by clinicians, including market awareness, acceptance and adoption of our products, and anticipated utilization of our products;

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our expectations regarding the number of procedures that will be performed with our products, the number of clinicians we expect to train, and the number of our sales territories;

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our ability to obtain, maintain, and expand regulatory clearances for our current products and any new products we create;

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our expectations regarding government and third-party payer coverage and reimbursement;

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our ability to obtain an adequate supply of materials and components for our products from our third-party suppliers, most of whom are single-source suppliers;

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our ability to manufacture sufficient quantities of our products with sufficient quality and the sufficiency of our current manufacturing capabilities;

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our ability to obtain and maintain intellectual property protection for our products and our business;

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our ability to expand our business into new geographic markets and the anticipated timing thereof;

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our compliance with extensive Nasdaq and SEC requirements and government laws, rules and regulations both in the United States and internationally;

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our expectations regarding operating trends, future financial performance and expense management and our estimates of our future expenses, ongoing losses, future revenue, capital requirements and our need for, or ability to obtain, additional financing;

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our ability to identify and develop new and planned products and/or acquire new products;

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our experience with inflationary and price pressures and increased labor costs and labor and staffing shortages as a result of general macroeconomic factors;

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developments and projections relating to our market opportunity and penetration, competitors, or our industry; and

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our intended use of net proceeds from our public offerings.

You should understand that the following important factors, among others, could affect the Company’s future results and could cause those results or other outcomes to differ materially from those expressed or implied in the Company’s forward-looking statements:

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the Company’s future capital requirements and sources and uses of cash;

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the Company’s ability to obtain funding or raise capital for its operations and future growth;

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any delays or challenges in obtaining FDA approval of the Company’s SCD product candidates;

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economic downturns and the possibility of rapid change in the highly competitive industry in which the Company operates;

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the ability to develop and commercialize its products or services following regulatory approval of the Company’s product candidates;

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the failure of third-party suppliers and manufacturers to fully and timely meet their obligations;

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product liability or regulatory lawsuits or proceedings relating to the Company’s products and services;

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inability to secure or protect its intellectual property;

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dispute or deterioration of relationship with the Company’s major partners and collaborators;

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the ability to maintain the listing of its Common Stock on Nasdaq;

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the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, and the ability of the Company to grow and manage growth profitably; and

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other risks and uncertainties indicated in this Annual Report, including those under “Risk Factors” herein, and other filings that have been made or will be made with the SEC.

These and other factors that could cause actual results to differ from those implied by the forward-looking statements in this Annual Report are more fully described in the “Risk Factors” section. The risks described in “Risk Factors” are not exhaustive. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can the Company assess the impact of all such risk factors on its business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. The Company undertakes no obligations to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

EXPLANATORY NOTE

Restatement of Consolidated Financial Results for the fiscal year-ended December 31, 2022, and interim periods for the fiscal year-ended December 31, 2023.

As previously disclosed in the Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission on March 27, 2024, certain of the Company’s previously filed interim unaudited and annual audited consolidated financial statements should no longer be relied upon and a restatement is required for these previously issued consolidated financial statements. The Company has restated herein its consolidated financial statements as of and for the year ended December 31, 2022 (see Notes 3 and 19). In addition, the Company has restated its unaudited quarterly financial data for the first three quarters of the year ended December 31, 2023 as presented in Note 19, Restatement of Unaudited Quarterly Results.

Part I