SeaStar Medical Holding Corp said the FDA determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry fulfilled post-approval study requirements under the therapy’s original Humanitarian Device Exemption approval. SeaStar Medical said hospitals can now use the therapy without the research infrastructure required by the registry and that it will continue voluntary enrollment at participating centers.
Registry results presented at ASN Kidney Week 2026 reported 90-day survival of 65.1% among 43 QUELIMMUNE patients, versus 47.5% among 196 patients in clinically aligned Kids’ Inpatient Database cohorts (P = 0.043); the presentation also reported no device-related adverse events. QUELIMMUNE’s HDE approval was based on safety and probable benefit, and its effectiveness for this use has not been demonstrated.
SeaStar Medical Holding Corporation is registering up to 1,767,784 shares of common stock for resale by selling stockholders. The shares comprise up to 854,002 shares issuable under each of the Series A and Series B warrants, plus 59,780 shares under placement agent warrants.
The Series A and Series B warrants have $3.616 per-share exercise prices; the placement agent warrants have a $4.8325 exercise price. All are immediately exercisable. Series A and placement agent warrants expire five years after the resale registration statement becomes effective, and Series B warrants expire after 18 months. SeaStar receives no proceeds from resales but could receive approximately $6.5 million if all warrants are exercised for cash; it intends to use any proceeds for general corporate purposes. The audit report on the 2025 and 2024 financial statements includes an explanatory paragraph citing substantial doubt about the company’s ability to continue as a going concern.
SeaStar Medical Holding Corp reported a Rule 506(b) exempt offering with $3,301,572 sold and $0 remaining to be sold. The first sale was reported on October 5, 2026. Securities listed include options, warrants or other rights to acquire another security, and securities to be acquired upon exercise.
The issuer paid approximately $355,075 in placement agent fees and clearing expenses and issued the placement agent warrants to purchase up to 59,780 shares of common stock as offering compensation. H.C. Wainwright & Co., LLC is named under Sales Compensation.
SeaStar Medical Holding Corporation (ICU) completed the cash exercise of warrants covering 854,002 common shares at a reduced exercise price of $3.866 per share, generating approximately $3.3 million in gross proceeds before placement-agent fees and offering expenses. The closing occurred October 5, 2026. SeaStar intends to use net proceeds for general corporate purposes, which may include working capital and capital expenditures.
In connection with the exercise, holders received unregistered, immediately exercisable Series A and Series B warrants, each covering up to 854,002 shares at $3.616 per share. Series A warrants have a five-year term and Series B warrants an 18-month term, each measured from the effective date of the resale registration statement. SeaStar also issued its placement agent warrants for 59,780 shares at $4.8325 per share. The company agreed to file the resale registration statement within 30 calendar days after October 2, 2026, and to use commercially reasonable efforts to have it declared effective within 60 calendar days, or 90 calendar days in the case of an SEC full review.
SeaStar Medical Holding Corp (ICU) reported that Chief Financial Officer Michael Messinger purchased 750 shares of Common Stock on August 18, 2026 in an open market or private transaction at $3.27 per share. Following this purchase, he directly owns 2,500 shares of SeaStar Medical common stock.
SeaStar Medical Holding Corporation reported continued early commercial progress but significant losses for the three and six months ended June 30, 2026. Net revenue was $615,000 in the quarter and $1.11 million year-to-date, up from $338,000 and $631,000 a year earlier, driven by increased adoption of its FDA-approved pediatric QUELIMMUNE therapy for acute kidney injury.
The company remains deeply loss-making. It recorded a net loss of $3.7 million for the quarter and $7.3 million for the first half of 2026, with operating expenses of $4.4 million in the quarter largely from research and development on its adult SCD program and general and administrative costs. Cash declined to $7.0 million at June 30, 2026, down from $12.0 million at year-end, and operating activities used $5.8 million of cash in the first half.
Management states that existing cash will not fund operations, including clinical trials, for 12 months and that this raises substantial doubt about the company’s ability to continue as a going concern. SeaStar is relying on equity financing facilities, including an at-the-market program and a standby equity purchase agreement, and has raised modest additional capital, while advancing pivotal adult AKI and other clinical studies on its SCD platform.
SeaStar Medical Holding Corporation reported second quarter 2026 results with strong revenue growth but widening losses. Net revenue for the three months ended June 30, 2026 was $0.615 million, up from $0.338 million in 2025, an 82% increase driven by growing adoption of QUELIMMUNE pediatric AKI therapy. Gross margin remained high at 91% on cost of goods sold of $54 thousand.
Operating expenses rose significantly as the company invested in its pipeline and commercialization. Research and development expense increased to $2.52 million from $1.04 million, primarily from higher clinical trial and personnel costs, while general and administrative expense rose to $1.83 million from $1.03 million. Net loss for the quarter widened to $3.73 million, or $0.91 per share, compared with a net loss of $2.00 million, or $1.77 per share, with weighted-average shares rising to 4.08 million.
Cash was $6.96 million as of June 30, 2026, down from $11.98 million at December 31, 2025, after using $5.76 million in operating cash during the first half of 2026. The company highlighted business progress including adding three top-rated children’s hospitals to the QUELIMMUNE customer base, advancing enrollment in the 339-patient NEUTRALIZE-AKI pivotal adult AKI trial, and obtaining ICD-10-PCS codes to support standardized inpatient billing for its SCD therapies.
Schlorff Eric reported acquisition or exercise transactions in this Form 4 filing.
SeaStar Medical Holding Corp Chief Executive Officer Eric Schlorff received an equity grant in the form of restricted stock units. The award covers 10,288 shares of common stock at a stated price of $0.00 per share, reflecting a compensation-related grant rather than an open-market purchase.
According to the filing, the restricted stock units will vest in three equal installments on July 1, 2026, November 1, 2026, and March 1, 2027. After this grant, Schlorff holds 50,140 shares of SeaStar Medical common stock directly.
Chung Kevin reported acquisition or exercise transactions in this Form 4 filing.
SeaStar Medical Holding Corp reported that Chief Medical Officer Kevin Chung received a grant of 7,202 shares of common stock in the form of restricted stock units. These RSUs were awarded at no cash cost to him as part of his compensation.
The award will vest in three equal installments on July 1, 2026, November 1, 2026, and March 1, 2027. After this grant, Chung directly holds 28,021 shares of SeaStar Medical common stock, showing his equity-based alignment with the company’s long-term performance.
Vincent Bernadette N reported acquisition or exercise transactions in this Form 4 filing.
SeaStar Medical Holding Corp director Bernadette N. Vincent reported an equity compensation grant on a Form 4. She received 4,000 shares in the form of restricted stock units that will vest in full on July 1, 2027. These units were awarded at a stated price of $0.00 per share, reflecting a compensation grant rather than a market purchase. After this award, her directly held common stock position increased to 8,200 shares, indicating a relatively small but notable addition to her ownership stake through long-term incentive compensation.