SeaStar Medical Holding Corp
For the period ended Mar 31, 2025. Filed May 14, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 14, 2025
ICU$1.88-2.1%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0000950170-24-126498
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresOther InformationCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0000950170-25-071583
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresOther InformationThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 45 previous paragraphs and 10 current paragraphs.
7 unchanged; 3 reworded; 0 added; 35 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Removed paragraphs (35)
Previous report
Our Common Stock may be delisted from Nasdaq if we do not maintain compliance with Nasdaq’s continued listing requirements. If our Common Stock is delisted, it could negatively impact the Company.
Previous report
Continued listing of a security on Nasdaq is conditioned upon compliance with various continued listing standards. There can be no assurance that we will be able to comply with the applicable listing standards.
Previous report
On June 14, 2023, we received a letter from the Nasdaq Staff notifying us that the MVLS of our Common Stock had been below the minimum $35,000,000 MVLS Requirement (the “MVLS Requirement”).
Previous report
The letter also stated that we would be provided 180 calendar days, or until December 11, 2023, to regain compliance with the MVLS Requirement. On December 13, 2023, we received a notification from the Listing Qualification Department of Nasdaq that we had not regained compliance with the MVLS Requirement and that our Common Stock would be subject to delisting unless we timely requested a hearing before a panel (the “Panel”). On December 19, 2023, we submitted a hearing request to the Panel to appeal the delisting determination. On the same date, we received a notice from Nasdaq stating that its delisting action had been stayed pending a final written decision by the Panel and that a hearing would be held on March 12, 2024. On February 6, 2024, we received notification from Nasdaq that we had regained compliance with the MVLS Requirement.
Previous report
On June 26, 2023, we received a letter from the Listing Qualifications Department of Nasdaq notifying us that the Company was not in compliance with the $1.00 per share minimum Bid Price Requirement for continued inclusion on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2).
Previous report
This letter had no immediate effect on the listing of the Company’s Common Stock on Nasdaq and the Company had 180 calendar days from the date of the notice, or until December 26, 2023, to regain compliance with the Bid Price Requirement. On December 27, 2023, we received notification from Nasdaq that the Company had not regained compliance with the Bid Price Requirement and that the Panel would consider this matter in rendering a determination regarding the Company’s continued listing on Nasdaq. Pursuant to Listing Rule 5810(d), the Company should present its views with respect to this deficiency at its Panel hearing to be held on March 12, 2024. If we failed to address the aforementioned issue, the Panel would consider the record as presented at the hearing and would make its determination based upon that information.
Previous report
On February 21, 2024, the Company made a pre-hearing submission to Nasdaq, outlining its plan to gain compliance with the minimum Bid Price Requirement. On March 6, 2024, we received a letter from the Nasdaq Staff granting the Company a temporary exception until June 24, 2024, subject to certain milestones, to regain compliance with the Bid Price Requirement by evidencing a closing bid price of $1.00 or more per share for a minimum of ten consecutive trading sessions. On June 7, 2024, the Company effected a reverse stock split to regain compliance with the Bid Price Requirement. On June 27, 2024, we received a letter from the Nasdaq Staff indicating the Company regained compliance with the minimum Bid Price Requirement for listing on Nasdaq.
Previous report
On June 24, 2024, we received a letter from the Nasdaq Staff indicating the Company was no longer in compliance with the MVLS of $35 million required for listing on Nasdaq. The Company has 180 days, or until December 23, 2024, to regain compliance with the MVLS Requirement.
Previous report
On July 3, 2024, the Company provided notice to the Listing Qualifications Department of Nasdaq regarding the Company’s possible violation of Nasdaq Listing Rule 5635(d)(2). The notification to Nasdaq related to the issuance of shares of the Company’s Common Stock upon conversion of certain convertible notes and upon exercise of certain warrants issued to an institutional investor in connection with a March 15, 2023 securities purchase agreement that may have required additional shareholder approval prior to the issuance of such securities.
Previous report
The Company believed at the time of these issuances and adjustments that the entire transaction had been approved by shareholders. The Company requested that Nasdaq determine whether the issuance of and adjustment to the conversion price of certain of the convertible notes to a price that was lower than the floor price initially agreed to in the subject securities purchase agreement, and the issuance of certain warrants (the "Additional Transactions") did not violate Nasdaq Listing Rule 5635(d)(2).
Previous report
The notification to Nasdaq was made in accordance with Nasdaq Listing Rule 5625. Pursuant to the notice, the Company committed to fully comply with all Nasdaq shareholder approval requirements, to involve certain advisers and to notify Nasdaq prior to the issuance of any securities for one year following the date of notice.
Previous report
While the Additional Transactions may have violated Nasdaq Listing Rule 5635(d)(2), Nasdaq has agreed to not issue a delisting letter if the Company obtains shareholder ratification of the Additional Transactions by the end of 2024. In order to obtain such approval and ratification of the Additional Transactions, the Company will hold a special meeting of its shareholders on November 26, 2024. The Company has filed with the Securities and Exchange Commission (“SEC” ) a proxy statement on Schedule 14A that contains more information on the special meeting and the voting rights of the Company's shareholders. If shareholder approval and ratification is not obtained, the Company’s Common Stock may be delisted from Nasdaq.
Previous report
If the Company’s Common Stock ultimately were to be delisted for any reason, it could negatively impact the Company by (i) reducing the liquidity and market price of the Company’s Common Stock; (ii) reducing the number of investors willing to hold or acquire the Company’s Common Stock, which could negatively impact the Company’s ability to raise equity financing; (iii) limiting the Company’s ability to use a registration statement to offer and sell freely tradable securities, thereby preventing the Company from accessing the public capital markets; and (iv) impairing the Company’s ability to provide equity incentives to its employees.
Previous report
If the Company fails to obtain additional financing, it would be forced to delay, reduce or eliminate its product development program, which may result in the cessation of its operations.
Previous report
Developing medical device products, including conducting preclinical studies and clinical trials, is expensive. The Company expects its research and development expenses to substantially increase in connection with its ongoing activities, particularly as it advances its clinical programs. As of September 30, 2024 and December 31, 2023, SeaStar Medical had negative working capital of $3.0 million and $10.7 million, respectively. The Company currently does not have sufficient capital to support its operations and complete its planned regulatory approval process. The Company will need to secure additional capital to continue its operation, and such funding may not be available on acceptable terms, or at all.
Previous report
Even if the Company receives sufficient capital in the future, the Company will be required to raise additional funds to support its own operations and complete its planned regulatory approval process, and such funding may not be available in sufficient amounts or on acceptable terms to the Company, or at all. If it is unable to raise additional capital when required or on acceptable terms, the Company may be required to:
Previous report
significantly delay, scale back or discontinue the development or commercialization of its product candidates;
Previous report
seek corporate partners on terms that are less favorable than might otherwise be available;
Previous report
relinquish or license on unfavorable terms, its rights to technologies or product candidates that it otherwise would seek to develop or commercialize itself;
Previous report
If we are unable to raise additional capital in sufficient amounts or on acceptable terms, the Company will be prevented from pursuing development and commercialization efforts, including completing the clinical trials and regulatory approval process for its SCD product candidates, which would have a material adverse impact on its business, results of operations and financial condition.
Previous report
Supply interruptions affecting the availability of components used in the Company’s SCD Clinical Kits could have an adverse effect upon its clinical trials and revenue prospects.
Previous report
The Company currently outsources the manufacturing of all components used with its SCD which are then assembled (kitted) and shipped by the Company. Manufacturing of the Company’s SCD cartridge is an involved process and is currently limited to one approved supplier. Manufacturing of the Company’s SCD blood tubing set is straight-forward but is also currently limited to one approved supplier. Certain other SCD kit components are readily available from multiple sources.
Previous report
To support its current clinical trial needs and its commercial sales, the Company complies with, and intends to continue to comply with, current Good Manufacturing Practice (“cGMP”) for the outsourced manufacturing and in-house kitting of its products where applicable. The Company’s ability to adequately procure the outsourced components and supply its SCD in a timely matter is dependent on the uninterrupted and efficient operation of its third-party suppliers and manufacturers, and those of the parties producing raw materials and supplies upon which it relies for the manufacturing of its products. Availability of the Company’s products may be impacted by:
Previous report
the availability of specified components, particularly those for which it has no other currently approved supplier;
Previous report
the ability of the Company to assemble and fulfill orders for pediatric and adult SCDs;
Previous report
maintenance of its quality management system and facility qualifications;
Previous report
continued compliance with regulatory requirements and cGMP;
Previous report
facility environmental contamination or catastrophic loss or damage;
Previous report
If efficient manufacture and supply of its SCD is interrupted, the Company may experience delayed shipments or supply constraints. If it is unable to provide an uninterrupted supply of its products, the Company’s ongoing clinical trials may be delayed, and/or commercial sales can be impaired, which could materially and adversely affect its business, results of operations, and financial condition.
Previous report
The Company recently terminated its exclusive distribution agreement with a third-party distribution partner.
Previous report
In August 2024, the Company terminated its Distribution Agreement with Nuwellis, which was the Company’s exclusive distribution agreement with a third-party distribution partner. The Company has currently elected to commercialize its FDA approved SCD-PED (SCD-pediatric, tradename ‘QUELIMMUNE’), using its own commercial resources. The Company does not have experience with selling and distributing QUELIMMUNE and its results may fall short of investors’ expectations. If the Company is unable to develop effective sales and distribution capabilities internally, we may not be able to successfully generate sales of our products, including QUELIMMUNE, and our business and results of operations may be adversely affected.
Reworded paragraphs (3)
Previous wording
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, 2023 and our other public filings, which could materially affect our business, financial condition or future results. Except as set forth below, there has been no material changes from risk factors previously disclosed in “Risk Factors” in our Form 10-K for the year ended December 31, 2023 and our other public filings:
Current wording
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
Previous wording
During the three- and nine- months ended September 30, 2024, we did not have sales of unregistered securities not previously included in a Current Report on Form 8-K.
Current wording
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.
Previous wording
During the three- and nine- months ended September 30, 2024, no director or officer of the Company adopted orterminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
Current wording
During the three months ended March 31, 2025, no director or officer of the Company adopted orterminated a“Rule 10b5-1 trading arrangement” or“non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.