SeaStar Medical Holding Corporation

On May 9, 2023, SeaStar disclosed that it had received a letter from the Center for Biologics Evaluation and Research (“CBER”) of the U.S. Food and Drug Administration (“FDA”), rejecting the Company’s Humanitarian Device Exemption (“HDE”) application for its pediatric Selective Cytopheretic Device (“SCD”) because “the application [wa]s not approvable in its current form[.]” The Company also stated that it had engaged in “a series of [purported] collaborative meetings and correspondence over the past 10 months” with the FDA, had made repeated responses “to the Agency’s recommendations,” and that there were “current deficiencies cited by the Agency in their letter[.]”

On this news, SeaStar’s stock price fell $0.77, or $39.7%, to close at $1.17 per share on May 10, 2023, thereby injuring investors.

Then, on March 27, 2024, SeaStar announced that it had “determined that certain complex financial instruments required accounting treatment that differed from [its] previous judgment,” and that, due to the reporting of non-cash accounting items, the Company would need to restate financial statements for the fiscal year 2022 and the first three quarters of fiscal year 2023.

On this news, SeaStar’s stock price fell $0.04, or 4.8%, to close at $0.71 per share on March 27, 2024, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) SeaStar and/or Legacy SeaStar had deficient compliance controls and procedures related to the HDE Application; (2) accordingly, there were deficiencies with the HDE Application, the FDA was unlikely to approve the HDE Application in its present form, and the SCD’s regulatory prospects were overstated; (3) the Company had downplayed the true scope and severity of deficiencies in its financial controls and procedures, while overstating Defendants’ efforts to remediate the same; (4) accordingly, SeaStar had failed to properly account for the classification of certain outstanding warrants and the Prepaid Forward Agreement; (5) as a result, SeaStar was likely to restate one or more of its previously issued financial statements; (6) accordingly, SeaStar’s post-Merger business and financial prospects were overstated; and (7) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.