SeaStar Medical Holding Corp
For the period ended Sep 30, 2024. Filed Nov 13, 2024.
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.
Sep 30, 2024 · Filed Nov 13, 2024
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 2024-06-30; filed 2024-08-13.
0000950170-24-096356
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresOther InformationCurrent 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 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 28 previous paragraphs and 45 current paragraphs.
16 unchanged; 7 reworded; 21 added; 5 removed; 0 previous and 1 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.
Added paragraphs (21)
Current 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.
Current 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.
Current 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.
Current 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:
Current report
significantly delay, scale back or discontinue the development or commercialization of its product candidates;
Current report
seek corporate partners on terms that are less favorable than might otherwise be available;
Current report
relinquish or license on unfavorable terms, its rights to technologies or product candidates that it otherwise would seek to develop or commercialize itself;
Current 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.
Current 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.
Current 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.
Current 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:
Current report
the availability of specified components, particularly those for which it has no other currently approved supplier;
Current report
the ability of the Company to assemble and fulfill orders for pediatric and adult SCDs;
Current report
maintenance of its quality management system and facility qualifications;
Current report
continued compliance with regulatory requirements and cGMP;
Current report
facility environmental contamination or catastrophic loss or damage;
Current 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.
Current report
The Company recently terminated its exclusive distribution agreement with a third-party distribution partner.
Current 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.
Removed paragraphs (5)
Previous report
We may become a defendant in one or more stockholder derivative, class-action, and other litigation, and any such lawsuits may adversely affect our business, financial condition, results of operations and cash flows.
Previous report
We may in the future become defendants in one or more stockholder derivative actions or other class-action lawsuits. For example, certain former directors of the Company have threatened litigation for purported harm to the Company in connection with certain allegations made by the former directors against other members of our Board of Directors and management of the Company. The former directors have also made demands in connection with certain alleged contractual rights and purported agreements with the Company. The Company and the Board of Directors dispute these allegations and believe they are unfounded.
Previous report
In addition, 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 (the “Class Action”), alleging that the Company and its management members made material misstatements or omissions regarding the Company’s business and operations, including disclosures relating to FDA approval of product candidates of the Company, allegedly culminating in the restatement of the Company’s consolidated financial statements as disclosed in the Form 8-K filed on March 27, 2024. The Class Action asserts claims under Section 10(b) of the Exchange Act against the Company, its Chief Executive Officer and former Chief Financial Officer (collectively, the Defendants”), as well as claims under Section 20(a) of the Exchange Act against the Defendants. Among other remedies, the Class Action seeks to recover compensatory and other damages. The Company intends to vigorously defend the action.
Previous report
Any such lawsuit could divert our management’s attention and resources from our ordinary business operations, and we would likely incur significant expenses associated with their defense (including, without limitation, substantial attorneys’ fees and other fees of professional advisors and potential obligations to indemnify current and former officers and directors who are or may become parties to such actions). In connection with these lawsuits, we may be required to pay material damages, consent to injunctions on future conduct and/or suffer other penalties, remedies or sanctions, or issue additional shares upon the exercise of certain warrants, which may cause additional dilution. In addition, any such future lawsuits could adversely impact our reputation and/or ability to launch and commercialize our products, thereby harming our ability to generate revenue. Accordingly, the ultimate resolution of these matters and any future matters could have a material adverse effect on our business, financial condition, results of operation and cash flow and, consequently, could negatively impact the trading price of our common stock.
Reworded paragraphs (7)
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:
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, 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:
Previous wording
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.
Current wording
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 wording
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 request 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.
Current wording
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 wording
On June 24, 2024, we received a letter from the Nasdaq Staff indicating the Company was no longer in compliance with the MLVS of $35 million required for listing on Nasdaq. The Company has 180 days, or until December 23, 2024, to regain compliance with the MVLS.
Current wording
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 wording
The Company believed at the time of these issuances and adjustments that the entire transaction had been approved by shareholders. The Company is requesting 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 did not violate Nasdaq Listing Rule 5635(d)(2).
Current wording
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 wording
During the three months ended June 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- 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.
Previous wording
During the three and six months ended June 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
Current 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Risks Related to our Business Operations