SeaStar Medical Holding Corp 10-Q for FY2025 Q1
SeaStar Medical Holding Corp (ICU)
About this 10-Q
SeaStar Medical Holding Corp filed this 10-Q on May 14, 2025, covering the quarter ended March 31, 2025 (FY2025 Q1).
Headline figures
Quarter ended March 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $293K
- compared with $0 a year earlier
- Net loss
- $3.77M
- compared with a net loss of $12.7M a year earlier
- Diluted EPS
- -$0.44
- compared with -$4.73 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO |
Commission File Number
(Exact name of Registrant as specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act ). Yes ☐ No
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐
As of May 12, 2025, the registrant had
SeaStar Medical Holding Corporation
March 31, 2025
Table of Contents
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PART I. |
1 |
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Item 1. |
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Condensed Consolidated Balance Sheets (March 31, 2025 Unaudited) |
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2 |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity/(Deficit) (Unaudited) |
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Notes to Condensed Consolidated Financial Statements (Unaudited) |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
20 |
Item 3. |
27 |
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Item 4. |
27 |
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PART II. |
29 |
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Item 1. |
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Item 1A. |
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Item 2. |
29 |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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i
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
SeaStar Medical Holding Corporation
Condensed Consolidated Balance Sheets
(in thousands, except for share and per-share amounts)
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March 31, |
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December 31, |
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(unaudited) |
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ASSETS |
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Current assets |
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Cash |
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$ |
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$ |
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Accounts receivable, net |
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Inventory |
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Prepaid expenses |
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Total current assets |
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Other assets |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) |
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Current liabilities |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Notes payable, net of deferred financing costs |
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Liability classified warrants |
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Total current liabilities |
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Total liabilities |
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Stockholders’ equity/(deficit) |
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Preferred stock - $ |
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Common stock - $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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Total stockholders’ equity/(deficit) |
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Total liabilities and stockholders’ equity/(deficit) |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
SeaStar Medical Holding Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except for share and per-share amounts)
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Three Months Ended March 31, |
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2025 |
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2024 |
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Net revenue |
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$ |
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$ |
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Cost of goods sold |
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Gross profit |
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Operating expenses |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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Other income (expense) |
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Interest expense |
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( |
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( |
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Interest income |
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Change in fair value of convertible notes |
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( |
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Change in fair value of liability classified warrants |
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( |
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Total other income (expense), net |
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( |
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Loss before provision for income taxes |
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Provision for income taxes |
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Net loss |
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$ |
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$ |
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Net loss per share of common stock, basic and diluted |
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$ |
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$ |
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Weighted-average shares outstanding, basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
SeaStar Medical Holding Corporation
Condensed Consolidated Statements of Changes in Stockholders’ Equity /(Deficit)
(unaudited)
(in thousands, except for share and per-share amounts)
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For the three months ended March 31, 2025 and 2024 |
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Common Shares |
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Shares |
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Amount |
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Additional Paid-In Capital |
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Accumulated Deficit |
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Total Stockholders’ Deficit |
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Balance, December 31, 2023 |
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$ |
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$ |
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$ |
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Issuance of shares - conversion of convertible notes |
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— |
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— |
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Issuance of shares - exercise of warrants |
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— |
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— |
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Issuance of shares - equity offering (including pre-funded warrants), net of issuance costs |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
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( |
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Balance, March 31, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Balance, December 31, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
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Issuance of shares - exercise of warrants |
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— |
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— |
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Issuance of shares - equity offering (including pre-funded warrants), net of issuance costs |
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— |
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— |
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Issuance of shares - vesting of restricted stock units |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
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( |
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Balance, March 31, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
3
SeaStar Medical Holding Corporation
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands, except for shares and per-share amounts)
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Three Months Ended March 31, |
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2025 |
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2024 |
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Cash flows from operating activities |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities |
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Amortization of deferred financing costs |
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Change in fair value of convertible notes (issued, converted and outstanding) |
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Change in fair value of liability classified warrants (exercised and outstanding) |
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( |
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Stock-based compensation |
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Change in operating assets and liabilities |
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Accounts receivables, net |
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Inventory |
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( |
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Prepaid expenses |
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Other assets |
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Accounts payable |
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( |
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Accrued expenses |
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Net cash used in operating activities |
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( |
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( |
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Cash flows from financing activities |
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Proceeds from issuance of convertible notes |
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Proceeds from issuance of shares, net of issuance costs |
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Proceeds from sale of pre-funded warrants |
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Proceeds from exercise of warrants |
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Payment of notes payable |
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( |
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Net cash provided by financing activities |
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Net increase in cash |
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Cash, beginning of period |
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Cash, end of period |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Supplemental disclosure of cash flow information |
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Exercise of pre-funded warrants |
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$ |
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$ |
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Shares issued as payment of convertible notes |
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$ |
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$ |
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Issuance of convertible note warrants |
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$ |
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$ |
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4
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
Note 1. 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 initial target of this technology is for the treatment of patients with acute kidney injuries ("AKI"), but through additional Breakthrough Design Designation (“BDD”) from the Food and Drug Administration (“FDA”), has expanded into treatments of 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.
The Company received 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 AKI due to sepsis or a septic condition requiring kidney replacement therapy. We shipped our first commercial pediatric SCD (“QUELIMMUNE”) in July 2024. In addition, we are 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”).
On October 28, 2022, LMF Merger Sub, Inc., a wholly owned subsidiary of LMF Acquisition Opportunities, Inc., (“LMAO”) merged with and into SeaStar Medical, Inc. (the “Business Combination”), with SeaStar Medical, Inc. surviving the Business Combination as a wholly owned subsidiary of LMAO. Following the consummation of the Business Combination, LMAO was renamed “SeaStar Medical Holding Corporation.”
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 the three months ended March 31, 2025, are not necessarily indicative of the results to be expected for the year ending December 31, 2025, 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, 2024. There have been no material changes in our significant accounting policies as described in our Annual Report on Form 10-K for the year ended December 31, 2024.
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.
5
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
prior to the Reverse Stock Split 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
Segment Information
The Company is comprised of a reportable segment, its Device Segment. This organizational structure aligns with how our Chief Operating Decision Maker (“CODM”), the , 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 a total of
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 does not have any inter-entity sales or transfers.
Liquidity and Going Concern
The Company incurred losses of $
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 very little revenue from the sales of its commercialized product, 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, 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 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.
Risks and Uncertainties
The Company is subject to risks common to early-stage companies in the medical technology industry including,
6
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
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 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 the period. Significant estimates include the (i) valuation of the liability classified warrants, (ii) provision for income taxes, (iii) convertible debt measured at fair value, (iv) unbilled clinical trial costs, and (v) 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.
Accounts Receivable, net
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 uses an aging schedule method for estimating expected credit losses. As the Company just commenced commercial operations since July 1, 2024, with a limited customer base, the Company’s estimates are based on customer specific facts, until such time that the Company has developed sufficient collection history data in which to apply a portfolio-wide expected credit loss estimate based on an aging schedule (see Note 4).
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.
The Company uses a Black-Scholes option pricing model to estimate the fair value of 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, which is an interpolated value based on the remaining term of each individual instrument. The change in fair value of the liability classified warrants
7
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
in each reporting period is recorded to the change in fair value of liability classified warrants in the consolidated statements of operations.
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.
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 balance sheet date are classified as current contract obligations. Amounts not expected to be recognized as revenue within the one year following the balance sheet date are classified as contract obligations, net of current portion. See Note 3 – Revenue and Contract Obligations for further details.
Product Sales Revenue
The Company sells its products directly to end-user qualified customers using the Company’s own internal commercial/sales resources.
8
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
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 2024 was expensed as a period expense at the time of purchase as a research and development expense. Accordingly, all QUELIMMUNE units sold during the three months ended March 31, 2025 had no assigned value and the Company recognized
As the Company procures inventory in the future, the Company will recognize the cost of materials to inventory. Use of inventory for QUELIMMUNE will be charged to cost of goods sold while inventory used for adult SCDs will be charged to research and development upon shipment.
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.
Recently issued accounting standards
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.
Accounting Standards Update 2023-09 — In December 2023, the FASB issued ASU 2023-09 Income 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 is permitted. The Company is currently assessing the impact of this guidance on its consolidated financial statements and disclosures, however the impact from the adoption of this guidance, if any, will not be reflected until the Company's Annual Report to Form 10-K for the year-ended December 31, 2025, due to the Company's net loss position and 100% valuation allowance for all deferred tax assets.
Note 3. Revenues and Contract Obligations
9
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
The Company currently only sells a single product, QUELIMMUNE, which has been approved under a Humanitarian Device Exemption (“HDE”) by the FDA for use with pediatric patients for treatments allowed under approved therapeutic indications. The Company can only sell QUELIMMUNE kits directly to qualified healthcare facilities (the “Customers”) that have qualified as capable of receiving and utilizing QUELIMMUNE in accordance with the terms of the HDE.
Each sale to a customer is independent from any past or future sales to that customer. Revenue is recognized at the point in time that control of the product transfers to the customer, which typically aligns with the shipping terms defined by each individual purchase order. Most sales are shipped “free-on-board” destination.
There are no up-front payments, material post-sale performance obligations, license agreements or other arrangements that could require the Company to defer a portion of the transaction price and recognize on a basis that is different from that of the physical transfer of QUELIMMUNE to the customer. See Note 2 for the Company's accounting policy relating to revenue recognition under ASC 606 - Revenue from Contracts with Customers.
The Company had no contract assets for the periods ended March 31, 2025 and December 31, 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.
Revenue by Geographic Location
The Company’s sales are entirely in the United States of America, as it does not have any regulatory approval to sell elsewhere as of March 31, 2025.
Note 4. 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.
($ in thousands) |
|
Accounts Receivable, Gross |
|
Expected Credit Losses |
|
Accounts Receivable, Net |
|
|||
December 31, 2024 |
|
$ |
|
$ |
— |
|
$ |
|
||
Change in accounts receivable, net |
|
|
|
|
( |
) |
|
( |
) |
|
March 31, 2025 |
|
$ |
|
$ |
( |
) |
$ |
|
||
Note 5. Accrued Expenses
Accrued expenses consisted of the following amounts as of March 31, 2025, and December 31, 2024:
($ in thousands) |
March 31, |
|
|
December 31, |
|
||
Accrued bonus |
$ |
|
|
$ |
|
||
Accrued director compensation |
|
|
|
|
|
||
Accrued research and development |
|
|
|
|
|
||
Other |
|
|
|
|
|
||
Total accrued expenses |
$ |
|
|
$ |
|
||
10
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
Note 6. Notes Payable
Insurance Financing
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 $
Note 7. Equity Transactions
February 2025 Offering
In January 2025, the Company entered into a Securities Purchase Agreement with an institutional investor (the "Q1 2025 SPA"), pursuant to which the Company issued on February 3, 2025, to the investor, (i) in a registered direct offering,
The Company received aggregate gross proceeds from the February 2025 Offering of approximately $
In connection with the February 2025 Offering, the Company amended the exercise price of the warrants issued in conjunction with the January 2024 Offering, (the “Series A and Series B common warrants” (collectively “January 2024 Warrants”), issued in a financing transaction with the institutional investor in January 2024, to $
The Company paid approximately $
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).
August 2024 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”).
11
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
Through March 31, 2025, the Company has raised approximately $
Note 8. Warrants
The Company issued warrants in connection with various financing transactions.
|
|
March 31, |
|
|
December 31, |
|
||
Liability Classified Warrants |
|
|
|
|
|
|
||
Private Placement Warrants |
|
|
|
|
|
|
||
PIPE Investor Warrants |
|
|
|
|
|
|
||
Subtotal |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Equity Classified Warrants |
|
|
|
|
|
|
||
February 2025 Warrants |
|
|
|
|
|
|
||
February 2025 Pre-Funded Warrants |
|
|
|
|
|
|
||
July 2024 Warrants |
|
|
|
|
|
|
||
January 2024 Warrants |
|
|
|
|
|
|
||
Public Stockholders’ Warrants |
|
|
|
|
|
|
||
Legacy Warrants |
|
|
|
|
|
|
||
Subtotal |
|
|
|
|
|
|
||
Grand Total |
|
|
|
|
|
|
||
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, 2025 and December 31, 2024:
March 31, 2025 |
|
Warrant Share Equivalents |
|
|
Weighted-Average Strike Price |
|
|
Weighted-Average Time to Maturity |
|
|||
Liability Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
Private Placement Warrants |
|
|
|
|
$ |
|
|
|
|
|||
PIPE Investor Warrants |
|
|
|
|
$ |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Equity Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
February 2025 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
February 2025 Pre-Funded Warrants |
|
|
|
|
$ |
|
|
(*) |
|
|||
July 2024 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
January 2024 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Public Stockholders’ Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Legacy SeaStar Inc. Warrants |
|
|
|
|
$ |
|
|
|
|
|||
(*) - the February 2025 Pre-Funded Warrants have a strike price of $
12
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
December 31, 2024 |
|
Warrant Share Equivalents |
|
|
Weighted-Average Strike Price |
|
|
Weighted-Average Time to Maturity |
|
|||
Liability Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
Private Placement Warrants |
|
|
|
|
$ |
|
|
|
|
|||
PIPE Investor Warrants |
|
|
|
|
$ |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Equity Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
July 2024 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
January 2024 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Public Stockholders’ Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Legacy SeaStar Inc. Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Below is the warrant activity for the three months ended March 31, 2025, for those warrants with activity during the three months ended March 31, 2025:
|
|
February 2025 Warrants |
|
|
February 2025 Pre-Funded Warrants |
|
|
||
Outstanding as of December 31, 2024 |
|
|
|
|
|
|
|
||
Issuance |
|
|
|
|
|
|
|
||
Exercised |
|
|
|
|
|
( |
) |
|
|
Forfeited / cancelled |
|
|
|
|
|
|
|
||
Outstanding as of March 31, 2025 |
|
|
|
|
|
|
|
||
During the three months ended March 31, 2025, the Company incurred a gain of approximately $
Note 9. 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:
|
|
|
|
Three Months Ended March 31, |
|
|||||||
($ in thousands) |
|
|
|
|
|
2025 |
|
|
2024 |
|
||
Research and development |
|
|
|
|
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
|
|
|
|
||
Total stock-based compensation |
|
|
|
|
|
$ |
|
|
$ |
|
||
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 to
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.
13
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
Stock Options
Option activity for the period ended March 31, 2025, is as follows:
2022 Omnibus Incentive Plan - Stock Options
|
|
|
|
Options |
|
|
Weighted-Average Exercise Price |
|
|
Total Intrinsic Value |
|
|
Weighted-Average Remaining Contractual Life (Years) |
|
||||
Outstanding at December 31, 2024 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Forfeited / cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Outstanding at March 31, 2025 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Vested and exercisable at March 31, 2025 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
2019 Omnibus Incentive Plan - Options
|
|
|
|
Options |
|
|
Weighted-Average Exercise Price |
|
|
Total Intrinsic Value |
|
|
Weighted-Average Remaining Contractual Life (Years) |
|
||||
Outstanding at December 31, 2024 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Forfeited / cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Outstanding at March 31, 2025 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Vested and exercisable at March 31, 2025 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Restricted Stock Units
A summary of the Company’s restricted stock unit (“RSU”) activity is as follows:
2022 Omnibus Incentive Plan - RSUs
|
|
|
|
Number of RSU |
|
|
Weighted-Average Grant Date Fair Value (per share) |
|
||
Outstanding at December 31, 2024 |
|
|
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
|
|
||
Vested |
|
|
|
|
( |
) |
|
|
|
|
Forfeited / cancelled |
|
|
|
|
|
|
|
|
||
Outstanding at March 31, 2025 |
|
|
|
|
|
|
$ |
|
||
14
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
2019 Stock Incentive Plan - RSUs
|
|
|
|
Number of RSU |
|
|
Weighted-Average Grant Date Fair Value (per share) |
|
||
Outstanding at December 31, 2024 |
|
|
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
|
|
||
Vested |
|
|
|
|
( |
) |
|
|
|
|
Forfeited / cancelled |
|
|
|
|
|
|
|
|
||
Outstanding at March 31, 2025 |
|
|
|
|
|
|
$ |
|
||
Note 10. Commitments and Contingencies
Lease Agreements
The Company is part of a membership agreement for shared office space and can cancel at any time. Rent expense was approximately $
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.
2024 Securities Class Action Lawsuit
On July 5, 2024, Forrest A K Wells (the “Plaintiff”), a purported stockholder of the Company, filed a putative class action complaint in the United States District Court for the State of Colorado, captioned Wells v. SeaStar Medical Holding Corporation et al, Case No. 1:24-cv-0187 (D. Colorado) (the “Class Action”). The Class Action alleges that the Company, its Chief Executive Officer and former Chief Financial Officer made or caused to be made material misstatements or omissions regarding the Company’s business and operations, allegedly culminating in the Company’s restatement of its 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. The Company intends to vigorously defend the action.
The Company has not recognized a contingent liability for this Class Action event as it does not qualify for the recognition criteria under ASC 450 - Contingencies.
Note 11. 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, interest rate, credit risk, etc.).
15
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
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 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 March 31, 2025 and December 31, 2024, by level within 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.
Summary of Level 3 Input Changes
|
|
Fair Value Measurements at March 31, 2025 |
|
|||||||||||||
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liability classified warrants |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Fair Value Measurements at December 31, 2024 |
|
|||||||||||||
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liability classified warrants |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table presents the changes in the forward option-prepaid forward contracts, convertible notes measured at fair value, warrants liability, and the notes derivative liability for the period ended March 31, 2025 (in thousands):
Level 3 Roll Forward |
|
|
|
Liability Classified Warrants |
|
|
Balance December 31, 2024 |
|
|
|
$ |
|
|
Additions |
|
|
|
|
|
|
Cash paid to settle |
|
|
|
|
|
|
Shares issued upon conversion or exercise |
|
|
|
|
|
|
Changes in fair value |
|
|
|
|
( |
) |
Balance March 31, 2025 |
|
|
|
$ |
|
|
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 FVO in accordance with ASC 825, Financial Instruments, then such quantitative disclosures are not required.
Liability Classified Warrants
The liability classified warrants as of March 31, 2025 and December 31, 2024, include three classes of warrants, and therefore, the range of assumptions used has been provided. Significant assumptions used in valuing warrants which require liability classification were as follows as of March 31, 2025 and December 31, 2024.
16
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
|
|
March 31, |
|
|
|
December 31, |
|
||
|
|
2025 |
|
|
|
2024 |
|
||
Expected volatility |
|
|
% |
|
|
|
% |
||
Equivalent term |
|
|
|
|
|
|
|
||
Risk-free rate |
|
|
% |
|
|
|
% |
||
Dividend yield |
|
|
% |
|
|
|
% |
||
Stock price |
$ |
|
|
|
$ |
|
|
||
Strike price |
$ |
|
|
|
$ |
|
|
||
Note 12. Income Taxes
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. 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 $
The Company believes its tax filing position and deductions related to tax periods subject to examination will be sustained under audit and, therefore, has no reserve for uncertain tax positions.
Note 13. 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):
|
|
|
Three Months Ended March 31, |
|
||||||
|
|
|
|
2025 |
|
|
2024 |
|
||
Net loss |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average shares outstanding - basic and diluted |
|
|
|
|
|
|
|
|
||
Basic and diluted net loss per share |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
The following weighted-average outstanding shares of 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:
|
|
|
|
As of March 31, |
|
|||||||
|
|
|
|
|
|
2025 |
|
|
2024 |
|
||
February 2025 warrants |
|
|
|
|
|
|
|
|
|
|
||
July 2024 warrants |
|
|
|
|
|
|
|
|
|
|
||
January 2024 warrants |
|
|
|
|
|
|
|
|
|
|
||
Investor D warrants |
|
|
|
|
|
|
|
|
|
|
||
Public Stockholders’ warrants |
|
|
|
|
|
|
|
|
|
|
||
Private Placement warrants |
|
|
|
|
|
|
|
|
|
|
||
PIPE Investor warrants |
|
|
|
|
|
|
|
|
|
|
||
Legacy warrants |
|
|
|
|
|
|
|
|
|
|
||
Employee based options to purchase common stock |
|
|
|
|
|
|
|
|
|
|
||
Unvested employee based restricted stock units |
|
|
|
|
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
|
|
|
|
||
17
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
Note 14. Segment Reporting
The Company is comprised of a reportable segment, its Device Segment. This organizational structure aligns with how our Chief Operating Decision Maker (“CODM”), the , 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 $
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 does not have any inter-entity sales or transfers.
The following table represents the Company’s sole segment’s operating results for the three months ended March 31, 2025 and 2024, respectively.
|
|
|
Three Months Ended March 31 |
|
||||||
|
|
|
2025 |
|
|
|
2024 |
|
||
|
|
|
|
|
|
|
|
|
||
Net Revenue |
|
$ |
|
|
|
$ |
|
|
||
Cost of goods sold |
|
|
|
|
|
|
|
|
||
Gross profit |
|
$ |
|
|
|
$ |
|
|
||
Operating expenses |
|
|
|
|
|
|
|
|
||
Research and development |
|
|
|
|
|
|
|
|
||
General and administrative |
|
|
|
|
|
|
|
|
||
Total operating expenses |
|
$ |
|
|
|
$ |
|
|
||
Loss from operations |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
(*) - Non-operating expenses consist of interest expense, interest income, and gains and losses from changes in the fair value of liability classified financial instruments such as warrants and convertible debt.
Note 15. Subsequent Events
At-the-Market Offering
From April 2, 2025 through May 12, 2025, the Company raised approximately $
Exercise of February 2025 Pre-Funded Warrants
On April 8, 2025, an investor exercised
Equity Line of Credit Purchase Agreement
As disclosed on a Form 8-K on April 25, 2025, the Company entered into a purchase agreement (the “Purchase
18
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
March 31, 2025
Agreement”) and a registration rights agreement (the “Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) pursuant to which Lincoln Park committed to purchase up to $
Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $
After the Commencement Date, on any business day, the Company may direct Lincoln Park to purchase up to
Sales of shares of the Company's common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of our common stock and our determination as to the appropriate sources of funding for our operations. The Company expects that any proceeds it receives from such sales will be used for working capital and general corporate purposes.
In addition, under applicable Nasdaq rules, the Company may not issue or sell to Lincoln Park under the Purchase Agreement more than
Lincoln Park has no right to require the Company to sell any shares of its common stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to the conditions and limitations in the Purchase Agreement including beneficial ownership limitations.
In connection with entering into the Purchase Agreement, on April 25, 2025, the Company issued
19
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
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 condensed consolidated financial statements and related notes included elsewhere in this Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024 (filed March 27, 2025) and Form 10-K/A for the year ended December 31, 2024 (filed April 23, 2025).
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 Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024. 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”, “our,” and “the Company” are intended to mean the business and operations of SeaStar Medical Holding Corporation and its consolidated subsidiaries following the Business Combination.
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 Holdings Corporation (as defined above).
We are a commercial-stage healthcare company focused on transforming 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 disease 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 kidney replacement therapy. We shipped our first commercial pediatric SCD (“QUELIMMUNE”) in July 2024. In addition, we are 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”).
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
20
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.
Clinicians typically address hyperinflammation with therapies that are either immunosuppressive or that target one cytokine, both of which are generally suboptimal in the treatment of hyperinflammation. 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. Clinical and preclinical studies conducted over the last 15 years have demonstrated that our SCD therapy can modulate the degree of activity of proinflammatory cells to help reduce tissue damage and speed the repair and recovery of organ function. Data from our trials demonstrated that the use of our SCD therapy to reverse the cytokine storm in more than 150 pediatric and adult patients with acute kidney injury on CRRT reduced mortality rates by 50%, and of those patients who survived 60 days, none have required dialysis. We believe our SCD therapy has the potential to transform the treatment of acute organ failure in the intensive care unit (“ICU”) and to improve organ function in patients with chronic kidney disease, certain cardiovascular diseases, and other serious inflammatory diseases.
Preclinically, we evaluated our SCD therapy in various animal models representing multiple hyperinflammatory indications, including 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 therapy. We will continue to explore the application of our SCD therapy across a broad range of indications where proinflammatory activated neutrophils and monocytes contribute to disease progression or severity in both acute and chronic indications.
We are leveraging our patent protected and scalable SCD therapy platform to develop proprietary treatments that are organ agnostic and target both acute and chronic indications. The SCD therapy is delivered via an extracorporeal synthetic membrane device that easily integrates into existing CRRT systems that are commonly employed for patients with acute organ injury in hospitals, including in ICUs throughout the United States. It also has the potential to be integrated into kidney dialysis systems for chronic kidney disease patients receiving renal replacement therapy at centers throughout the United States. We believe that the ease of use and broad applicability of the therapy across multiple disease states should enable us to capture a sizable market for our SCD therapy with increasingly favorable economics.
Our senior management team and Board have an average of over 19 years of experience in the healthcare industry, including expertise in regulatory and medical affairs, commercialization and distribution in our initial therapeutic priority areas. We also have assembled a team of well-respected scientific advisors who are experts in the development of our technology and products.
There is a substantial clinical need for safe and effective control of hyperinflammation and we believe that our first-in-class SCD therapy can address the large potential market of over one million patients each year that face life-threatening hyperinflammatory conditions, including organ failure and potential loss of life.
We have incurred net losses in each year since our inception in 2007. As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of $143.3 million and $139.6 million, respectively. Our net losses were $3.8 million and $12.7 million for the three months ended March 31, 2025, and 2024, respectively. For the three months ended March 31, 2025, substantially all our net losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. For the three months ended March 31, 2024, our net losses results from a combination of operating costs which comprised (i) research and development, and (ii) general and administrative, coupled with non-operating gains and losses due to changes in the fair value of certain liability classified financial instruments.
As of March 31, 2025, and December 31, 2024, we had cash of $5.3 million and $1.8 million, respectively.
Our accompanying unaudited condensed 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 unaudited condensed 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.
The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial 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 from the date the unaudited condensed consolidated financial statements are made available. See Note 1 to our unaudited condensed consolidated financial
21
statements for the three months ended March 31, 2025, included elsewhere in this Form 10-Q for additional information on our assessment.
Our need for additional capital will depend in part on the scope and costs of our development activities. To date, we have generated revenue of approximately $0.5 million from the sale of commercialized pediatric SCD products. Our ability to generate product revenue in the future will depend on the successful roll-out of our QUELIMMUNE pediatric SCD to hospitals and the development and eventual successful commercialization of our adult SCD. Until such time we are able to generate significant revenue from product sales, 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 and 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.
Key Components of Results of Operations
Revenue
Our QUELIMMUNE received HDE approval from the FDA in February 2024. Since that time, we have begun to build out our commercial operations, develop our customer base and initiate commercial sales of QUELIMMUNE. We shipped our first commercial QUELIMMUNE units in July 2024. Through March 31, 2025, we have recognized approximately $0.4 million of revenue from the sale of QUELIMMUNE. Historically, prior period 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 introduce QUELIMMUNE to pediatric hospital customers. We also continue to develop our adult SCD for which we are enrolling patients in a pivotal trial to support a FDA approval. If we fail to complete the development of, or fail to obtain regulatory approval for commercialization of our adult SCD in a timely manner, our ability to generate 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, sales and commercial and finance roles, which also include stock-based compensation expenses and benefits for such employees.
Other significant general and administrative expenses include facilities costs, insurance, professional fees for accounting and legal services and expenses associated with obtaining and maintaining patents obtaining financing. 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 interest expense relating to interest incurred on our notes, interest incurred on our convertible notes, change in the fair value of warrants liability, change in fair value of
22
convertible notes, gain on issuance of convertible notes, change in fair value of forward-option forward contracts, and gain on sale of recycled shares.
Net Loss
Net loss consists of the loss from operations, less other expenses.
Factors Affecting Operating Results
We believe that our performance and future success depend on a number of factors that present significant opportunities for us but also pose risks and challenges. Please see the factors discussed elsewhere in this Form 10-Q, including those discussed in Part II, Item 1A, “Risk Factors,” for additional information.
Results of Operations
Comparison of the Three Months Ended March 31, 2025 to the Three Months Ended March 31, 2024
The following table sets forth a summary of our results of operations. This information should be read together with our unaudited condensed consolidated financial statements and related Notes included elsewhere in this Form 10-Q.
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
||||||||
|
|
|
March 31, |
|
|
|
Change |
|
|||||||||||
($ in thousands) |
|
|
2025 |
|
|
|
2024 |
|
|
|
$ |
|
|
% |
|
||||
Revenue |
|
|
$ |
293 |
|
|
|
$ |
— |
|
|
|
$ |
293 |
|
|
* |
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
2,431 |
|
|
|
|
1,697 |
|
|
|
|
734 |
|
|
|
43 |
% |
General and administrative |
|
|
|
1,684 |
|
|
|
|
2,253 |
|
|
|
|
(569 |
) |
|
|
(25 |
)% |
Total operating expenses |
|
|
|
4,115 |
|
|
|
|
3,950 |
|
|
|
|
165 |
|
|
|
4 |
% |
Loss from operations |
|
|
|
(3,822 |
) |
|
|
|
(3,950 |
) |
|
|
|
128 |
|
|
|
(3 |
)% |
Total other income (expense) |
|
|
|
53 |
|
|
|
|
(8,747 |
) |
|
|
|
8,800 |
|
|
|
(101 |
)% |
Loss before income tax provision |
|
|
|
(3,769 |
) |
|
|
|
(12,697 |
) |
|
|
|
8,928 |
|
|
|
(70 |
)% |
Income tax provision (benefit) |
|
|
|
3 |
|
|
|
|
— |
|
|
|
|
3 |
|
|
* |
|
|
Net loss |
|
|
$ |
(3,772 |
) |
|
|
$ |
(12,697 |
) |
|
|
$ |
8,925 |
|
|
|
(70 |
)% |
(*) - there was no activity for the three months ended March 31, 2024.
Revenue
Revenue increased $0.3 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024, as we commenced commercial sales in July 2024. This was made possible because we obtained an HDE for QUELIMMUNE in February 2024, and final regulatory clearance to sell commercially from the FDA under this HDE in July 2024. The Company has five customer sites for QUELIMMUNE as of March 31, 2025.
Research and Development Expenses
The following table discloses the breakdown of research and development expenses:
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
||||||||
|
|
|
March 31, |
|
|
|
Change |
|
|||||||||||
($ in thousands) |
|
|
2025 |
|
|
|
2024 |
|
|
|
$ |
|
|
% |
|
||||
Clinical trials |
|
$ |
|
1,268 |
|
|
$ |
|
613 |
|
|
$ |
|
655 |
|
|
|
107 |
% |
External services |
|
|
|
102 |
|
|
|
|
345 |
|
|
|
|
(243 |
) |
|
|
(70 |
)% |
Payroll and personnel expenses |
|
|
|
925 |
|
|
|
|
690 |
|
|
|
|
235 |
|
|
|
34 |
% |
Other research and development expenses |
|
|
|
136 |
|
|
|
|
49 |
|
|
|
|
87 |
|
|
|
178 |
% |
|
|
$ |
|
2,431 |
|
|
$ |
|
1,697 |
|
|
$ |
|
734 |
|
|
|
43 |
% |
23
Research and development expenses for the three months ended March 31, 2025 and 2024 were $2.4 million and $1.7 million, respectively. The increase in research and development expenses of approximately $0.7 million, or 43%, was primarily driven by (i) a $0.7 million increase in clinical trial costs due the Company's NEUTRALIZE-AKI pivotal trial, which increased from five (5) clinical trial sites as of March 31, 2024, to sixteen (16) clinical trial sites as of March 31, 2025, (ii) a $0.2 million increase in personnel costs related to increased headcount during the three months ended March 31, 2025 compared to this same period ended March 31, 2024, (iii) $0.1 million increase in other costs, mostly due to an increase in medical affairs activities.
This was offset by a $0.2 million decline in external services, due to (i) pre-clinical activities declined during the three months ended March 31, 2025 compared to the same period ended March 31, 2024, as the NEUTRALIZE-AKI pivotal trial was in its formative stage during the three months ended March 31, 2024, while, as of March 31, 2025, the Company had already enrolled 94 patients, and (ii) a $0.1 million decline in device component expenses, as the Company did not commence commercial operations until July 2024, and the cost of components used to manufacture the Company's SCDs were expensed to research and development expense in Q1 2024, while components purchased in Q1 2025 are recognized as inventory.
General and Administrative Expenses
General and administrative expenses for the three months ended March 31, 2025 and 2024 were approximately $1.7 million and $2.3 million, respectively. The $0.6 million decrease in general and administrative expenses of approximately was the result of (i) $0.2 million decline in accounting related costs, as the Company during the three months ended March 31, 2024, incurred additional costs due to certain financial statement restatements that were not incurred during the three months ended March 31, 2025, (ii) $0.2 million decline in legal related expenses, (iii) $0.2 million decline in consulting expenses. This was offset by a $0.1 million increase in SEC-related expenses due to the Company's need for a special meeting of the shareholders during the three months ended March 31, 2025, and other non-routine filing demands.
Other Income (Expense)
Other expenses (net) decreased approximately $8.8 million, or near a decline of 100% for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The key drivers for this decrease were as follows: (i) the Company recognized a loss of $5.8 million for changes in the fair value of convertible notes during the three months ended March 31, 2024, however, the Company did not have any convertible notes outstanding during the three months ended March 31, 2025, (ii) the Company recognized a gain of $16 thousand for its liability classified warrants for the three months ended March 31, 2024, while incurring a loss of approximately $2.8 million for the three months ended March 31, 2023, largely driven by the value of the Company's stock, (iii) the Company recognized interest income, net of expenses of $37 thousand, compared to interest expense of $143 thousand during the three months ended March 31, 2024. This was because the Company reduced its outstanding debt obligations from approximately $4.2 million at March 31, 2024, to $0.4 million as of March 31, 2025, and implemented an overnight sweep program with its main commercial banking financial institution beginning in the second quarter of 2024.
Income Tax Provision (Benefit)
We recorded a provision for income taxes of $3 thousand for the three months ended March 31, 2025, and no provision for income taxes for the three months ended March 31, 2024.
Net Loss
During the three months ended March 31, 2025, we had a net loss of approximately $3.8 million compared to a net loss of approximately $12.7 million for the three months ended March 31, 2024. The decreased net loss of approximately $8.9 million has been disclosed in the above discussion.
Liquidity and Capital Resources
Sources of Liquidity
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
24
significant operating losses and negative cash flows. As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of approximately $143.3 million and $139.6 million, respectively.
As of March 31, 2025 and December 31, 2024, we had cash of $5.3 million and $1.8 million, respectively. Based on our results of operations and liquidity as of March 31, 2025, we believe our cash and cash equivalents, including the cash we obtained from the registered direct financing in the first quarter of 2025 and the registered direct offering in July 2024, are not sufficient to meet our working capital and capital expenditure requirements for a period of at least twelve months from the date of our unaudited condensed consolidated financial statements for the three months ended March 31, 2025, are made available. We believe that this raises substantial doubt about our ability to continue as a going concern.
To finance our operations, we will need to raise additional capital. As described below, we do not expect to receive any 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 such warrants. We are seeking 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. We do not currently have any committed external source of funds. We have concluded that these circumstances raise doubt about our ability to continue as a going concern within one year after the issuance date of this Form 10-Q. See Note 1 to our unaudited condensed consolidated financial statements for the period ended March 31, 2025.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of existing 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.
We would receive the proceeds from any exercise of warrants that are exercised for cash pursuant to their terms. To the extent any warrants are exercised on a “cashless basis,” the amount of cash we would receive from the exercise of the warrants will decrease. We would expect to use any such proceeds received from warrants that are exercised for cash in the future for general corporate and working capital purposes, which would increase our liquidity. However, we will only receive such proceeds if and when the warrant holders exercise the warrants. The exercise of the warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our common stock and the spread between the exercise price of the warrant and the price of our common stock at the time of exercise. There is no assurance that the warrant holders will elect to exercise for cash any or all of such warrants, and we believe that any such exercise currently is unlikely to occur. The likelihood that warrant holders will exercise the warrants, and therefore the amount of cash proceeds that we would receive from such exercise, is dependent upon the trading price of our common stock. If the trading price for our common stock remains less than the respective exercise price of our outstanding warrants, we believe our warrant holders will be unlikely to exercise their warrants. There is no guarantee that the warrants will be in the money following the time they become exercisable and prior to their expiration, and as such, the warrants may expire worthless, and we may not receive any proceeds from the exercise of the warrants. To the extent that any of the warrants are exercised on a “cashless basis,” the amount of cash we would receive from the exercise of the warrants will decrease.
As of the date of this Quarterly Report, we have neither included nor intend to include any potential cash proceeds from the exercise of our warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability of warrant exercise over the life of our warrants and the merit of including potential cash proceeds from the exercise in our liquidity projections.
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 adult SCD for approval by the FDA, invest in our commercialization of our pediatric SCD, and (ii) if regulatory approval is obtained, to launch and commercialize our adult SCD in the U.S. market,
25
including potential subsequent launches in key international 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:
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 and cash equivalents position is reduced faster than anticipated. Until such time, if ever, as we are able to generate significant revenue from the commercialization of our products, we expect to continue financing our operations through the sale of equity, 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 to us when needed or on acceptable terms.
Contractual Obligations and Commitments
Insurance Financing
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. The Company will pay the remaining five monthly installments of principal and interest totaling approximately $0.4 million with the last payment being made in August 2025.
Cash Flows
The following table shows a summary of our cash flows for each of the periods shown below:
|
|
Three Months Ended |
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|||||
|
|
March 31, |
|
|||||
($ in thousands) |
|
2025 |
|
|
2024 |
|
||
Statement of cash flow data: |
|
|
|
|
|
|
||
Total cash (used in)/provided by: |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(2,654 |
) |
|
$ |
(3,488 |
) |
Investing activities |
|
|
— |
|
|
|
— |
|
Financing activities |
|
|
6,131 |
|
|
|
8,331 |
|
Net increase in cash |
|
$ |
3,477 |
|
|
$ |
4,843 |
|
Net cash used in operating activities for the three months ended March 31, 2025 was $2.7 million compared to $3.5 million for the three months ended March 31, 2024. The decrease in cash used for operating activities of $0.8 million is primarily due to the $0.8 million due to the timing of certain (i) payments from customers or to vendors to reduce our cash outflows for operating activities.
Net cash provided by financing activities for the three months ended March 31, 2025 was $6.1 million, was primarily related to (i) $1.6 million received from the issuance of new shares of common stock, and (ii) $4.8 million in proceeds from issuance of pre-funded warrants. This was offset by (i) $0.2 million paid to settle outstanding notes payable.
26
Critical Accounting Policies and Estimates
The preparation of the unaudited 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.
There has been no material change from the policies or methods disclosed in our Annual Report to Form 10-K filed March 27, 2025, and as amended by Form 10-K/A filed April 23, 2025, for the year-ended December 31, 2024.
Emerging Growth Company Status
We are an emerging growth company (“EGC”), as defined in the Jumpstart Our Business Startups (“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 emerging growth company 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
Item 3. 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.
Item 4. Controls and Procedures.
We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required financial disclosures.
During the fiscal period covered by this report, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act). Based on
27
such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of March 31, 2025, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act are recorded, processed, summarized and reported within the required time periods and are designed to ensure that information required to be disclosed in our reports is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) during the three months ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
28
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
Shareholder Derivative 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 State of Colorado, captioned Wells v. SeaStar Medical Holding Corporation et al, Case No. 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 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. We intend to vigorously defend the action.
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 our Chief Executive Officer, former Chief Financial Officer, and certain of our 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 our prospects for success in obtaining FDA approval for our SCD. The Derivative Action further alleges that there were purported deficiencies in our 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 Section 10(b) and 21D 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 may file substantially similar complaints in the future. We will not make separate disclosure of such complaints unless they are materially different than the Derivative Action.
Item 1A. Risk Factors.
In addition to the other information set forth in this report, you should carefully consider the factors discussed in the “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and our other public filings, which could materially affect our business, financial condition or future results. No additional risk factors have arisen not already disclosed in our Annual Report on Form 10-K for the year-ended December 31, 2024, filed March 27, 2025
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
During the three months ended March 31, 2025, we did not have sales of unregistered securities not previously included in a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities.
N/A
Item 4. Mine Safety Disclosures.
N/A
Item 5. Other Information.
During the three months ended March 31, 2025, no director or officer of the Company
29
Item 6. Exhibits
Exhibit Index
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Exhibit |
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Description |
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4.1 |
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4.2 |
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4.3 |
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10.1 |
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10.2 |
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31.1** |
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31.2** |
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32.1** |
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32.2** |
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101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
** Filed herewith
30
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
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SeaStar Medical Holding Corporation |
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|
Date: May 14, 2025 |
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By: |
/s/ Eric Schlorff |
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|
Eric Schlorff |
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Chief Executive Officer (Principal Executive Officer) |
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|
|
Date: May 14, 2025 |
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By: |
/s/ David Green |
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David Green |
|
|
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
31
EXHIBIT 31.1
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Eric Schlorff, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of SeaStar Medical Holding Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 14, 2025
|
|
|
/s/ Eric Schlorff |
||
Eric Schlorff |
||
Chief Executive Officer |
||
EXHIBIT 31.2
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, David Green, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of SeaStar Medical Holding Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 14, 2025
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/s/ David Green |
||
David |
||
Chief Financial Officer |
||
EXHIBIT 32.1
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
I, Eric Schlorff, Chief Executive Officer of SeaStar Medical Holding Corporation (the “Company”), certify that:
1. the Quarterly Report on Form 10-Q of the Company for the three months ended March 31, 2025, as filed with the Securities and Exchange Commission (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 14, 2025
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/s/ Eric Schlorff |
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Eric Schlorff |
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Chief Executive Officer |
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EXHIBIT 32.2
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
I, David Green, Chief Financial Officer of SeaStar Medical Holding Corporation (the “Company”), certify that:
1. the Quarterly Report on Form 10-Q of the Company for the three months ended March 31, 2025, as filed with the Securities and Exchange Commission (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 14, 2025
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/s/ David Green |
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David Green |
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Chief Financial Officer |
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