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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 

 
FORM 8-K
 

 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): August 12, 2026
 

 
SeaStar Medical Holding Corporation
 
(Exact name of Registrant as Specified in Its Charter)
 

 
Delaware
001-39927
85-3681132
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
     
3513 Brighton Blvd,
Suite 410
 
Denver, Colorado
 
80216
(Address of Principal Executive Offices)
 
(Zip Code)
 
Registrants Telephone Number, Including Area Code: 844 427-8100
 
(Former Name or Former Address, if Changed Since Last Report)
 

 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
 
Trading
Symbol(s)
 
Name of each exchange on which registered
Common Stock par value $0.0001 per share
 
ICU
 
The Nasdaq Stock Market LLC
Warrants, each whole warrant exercisable for one share of Common Stock for $11.50 per share                   
 
ICUCW
 
The Nasdaq Stock Market LLC
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
 
Emerging growth company
 
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.
 
 
 

 
 
Item 2.02 Results of Operations and Financial Condition.
 
On August 12, 2026, the Company issued a press release announcing its financial condition and results of operations for the three and six months ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1.
 
The information in this Current Report on Form 8-K, including the information contained in the press release furnished as Exhibit 99.1, is deemed to be “furnished” and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is not otherwise subject to the liabilities of that Section, and shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
 
 
Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits
 
 
Exhibit
No.
  
Description
   
 99.1
  
   
 104
  
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
     
SeaStar Medical Holding Corporation
 
   
By:
/s/ Eric Schlorff
Date:
August 12, 2026
Name:
Eric Schlorff
   
Title:
Chief Executive Officer
 
 
EX-99.1 2 ex_973548.htm EXHIBIT 99.1 - Q1 2026 EARNINGS RELEASE ex_973548.htm
 

 

Exhibit 99.1

 

 seastarlogo2.jpg

SeaStar Medical Reports Second Quarter 2026 Financial Results and
Provides Business Updates

 

Added 3 top-rated childrens hospitals to QUELIMMUNE® pediatric acute kidney injury (AKI) customer base, increasing net revenue 82% versus second quarter 2025

 

Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI

 

Obtained ICD-10-PCS codes to enable standardized inpatient hospital billing for its
selective cytopheretic device (SCD) therapy, including QUELIMMUNE

 

Webcast today at 4:30 pm Eastern Time

 

DENVER, CO (August 12, 2025) – SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today financial results for the three months ended June 30, 2026, and provided business updates on key initiatives. 

 

“The enthusiasm for the use of our QUELIMMUNE therapy is resonating broadly throughout the pediatric critical care community,” said Eric Schlorff, CEO of SeaStar Medical. “We believe our continued QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market that is 50 times larger than the current pediatric market in the U.S.”

 

Mr. Schlorff continued, “We are keenly focused on achieving our enrollment target of 339 adult AKI patients in the NEUTRALIZE-AKI trial, and we are working with the FDA on our modular Premarket Approval (PMA) application for our SCD therapy as an organ-sparing and life-saving treatment for the adult patient population. With strong gross margins for QUELIMMUNE and universal ICD-10-PCS codes already established for our SCD therapies, we believe this first-in-class therapy for the treatment of adult patients with AKI has clear potential to both save lives and create significant shareholder value, should we obtain FDA approval.” 

 

Key Business Highlights

 

SeaStar Medical’s achievements since the beginning of the second quarter of 2026 include the following: 

 

 

Expanded the use of QUELIMMUNE (SCD-PED) therapy for ultra-rare pediatric AKI, adding 3 new customers from top-rated children’s hospitals, bringing the total customer base to 20 and building increased depth in customer orders. This led to second quarter 2026 net revenue of $0.6 million for QUELIMMUNE product sales, an increase of 82% versus the second quarter of 2025.   

 

 

Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial evaluating the SCD therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy. The trial has enrolled 223 of 339 patients to date. Completion of enrollment is anticipated around year end or into the first quarter of 2027, which would enable a PMA application to the FDA near the end of 2027, pending a positive outcome of the trial.

 

 

Received from the Centers for Medicare & Medicaid Services (CMS) dedicated International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) codes. These codes enable administrative, billing, and statistical reporting for the use of SeaStar Medical’s SCD therapy in patients with AKI requiring renal replacement therapy in the inpatient hospital setting. The new ICD-10-PCS codes are expected to take effect on October 1, 2026.

 

 

Sponsored and participated in the KidneyBee Summit 2026. The Summit, which occurs annually, is a highly specialized, interdisciplinary conference that brings together nurses, advanced practice providers, and physicians from across the country. Its core importance stems from tackling the exact systemic failures that leave pediatric kidney failure under-recognized.  

 

 

Assembled leading experts in the treatment of pediatric AKI to speak at the SeaStar Medical educational webinar, “Rethinking Pediatric Sepsis-Associated AKI,” that brought together practicing pediatric nephrologists, critical care physicians, advanced practice providers, nurses, and critical care teams to learn more about pediatric sepsis-associated AKI and the use of the QUELIMMUNE therapy.   

 

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Financial Results for the Second Quarter 2026

 

Net revenue for the three months ended June 30, 2026, was approximately $0.6 million reflecting increased demand for the QUELIMMUNE therapy. This compared to net revenue of approximately $0.3 million for the three months ended June 30, 2025.

 

Cost of goods sold for the three months ended June 30, 2026, and 2025, was $54 thousand and $27 thousand reflecting gross margins of 91% and 92% for the three months ended June 30, 2026, and 2025, respectively.

 

Research and development expenses for the three months ended June 30, 2026, and 2025, were $2.5 million and $1.0 million, respectively. The increase in research and development expenses was primarily driven by increased clinical trial expenses and personnel costs. 

 

General and administrative expenses for the three months ended June 30, 2026, and 2025, were approximately $1.8 million and $1.0 million, respectively. The increase in general and administrative expenses was the result of an increase in compensation costs, legal and professional fees, and certain Securities and Exchange Commission (SEC) related expenses.

 

Other income (net) was $0.1 million for the three months ended June 30, 2026, compared to other expense (net) of $0.2 million for the three months ended June 30, 2025. The change was primarily related to a reduction in financing fees and increased interest income.

 

Net loss for the three months ended June 30, 2026, was approximately $3.7 million, or $0.91 per share on approximately 4.1 million weighted-average shares outstanding. This compares with a net loss of approximately $2.0 million, or $1.77 per share, on approximately 1.1 million weighted-average shares outstanding for the three months ended June 30, 2025.  

 

Cash at June 30, 2026, was $7.0 million, compared to $12.0 million at December 31, 2025.

 

SeaStar Medical Second Quarter Financial Results Conference Call

 

Date/Time:                  Wednesday, August 12, 2026, at 4:30 p.m. ET / 2:30 p.m. MT

 

Webcast:                     The live webcast and replay can be found here.

 

Register for the call:     Preregistration is required to attend the live call and can be accessed here. A pin code and dial in number will be provided with registration.

 

A replay of the call will be available after 7:30 p.m. ET and can be accessed here.

 

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About QUELIMMUNE

 

The QUELIMMUNE® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application.

 

Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device.  In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine.

 

The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life. 

 

About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy

 

The SCD therapy 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. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease.  Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous RRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future continuous RRT, including dialysis, and prevent loss of life.  

 

About NEUTRALIZE-AKI Pivotal Trial

 

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to continuous RRT as the standard of care, compared with the control group receiving only continuous RRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. 

 

About Acute Kidney Injury (AKI) and Hyperinflammation 

 

AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

 

About SeaStar Medical

 

SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.

 

For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

 

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Forward-Looking Statements

 

This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect our future potential opportunity in the adult AKI market; the size of the adult AKI market compared to the pediatric market; commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; ; the anticipated timing of regulatory submissions; the ability to meet our enrollment targets; the ability to create shareholder value;  the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. 

Contact:  

 

IR@SEASTARMED.COM

 

 

 

 

— Financial Tables to Follow —

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SeaStar Medical Holding Corporation

Condensed Consolidated Balance Sheets

(in thousands, except for share and per-share amounts)

 

 

   

June 30,

2026

   

December 31,

2025

 
   

(unaudited)

         

ASSETS

 

Current assets

               

Cash

  $ 6,959     $ 11,980  

Accounts receivable, net of allowance for credit losses of $2 and $3, respectively

    208       237  

Inventory

    77       66  

Prepaid expenses

    984       1,297  

Total current assets

    8,228       13,580  

Other assets

    421       578  

Total assets

  $ 8,649     $ 14,158  
                 

LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT)

 

Current liabilities

               

Accounts payable

  $ 750       948  

Accrued expenses

    3,468       2,268  

Notes payable, net of deferred financing costs

    134       525  

Liability classified warrants

    1       1  

Total current liabilities

    4,353       3,742  

Total liabilities

    4,353       3,742  
                 

Commitments and contingencies (Note 10)

               
                 

Stockholders’ equity

               

Preferred stock - $0.0001 par value, 10,000,000 shares authorized at June 30, 2026 and December 31, 2025; no shares issued and outstanding at June 30, 2026 and December 31, 2025

           

Common stock - $0.0001 par value per share; 425,000,000 and 450,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively; 4,259,842 and 3,844,613 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively

    4       4  

Additional paid-in capital

    163,257       162,126  

Accumulated deficit

    (158,965 )     (151,714 )

Total stockholders’ equity

    4,296       10,416  

Total liabilities and stockholders’ equity

  $ 8,649     $ 14,158  

 

 

 

 

 

5

 

 

 

 

SeaStar Medical Holding Corporation

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except for share and per-share amounts)

 

 

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 
   

2026

   

2025

   

2026

   

2025

 
                                 

Net revenue

  $ 615     $ 338     $ 1,110     $ 631  

Cost of goods sold

    54       27       100       27  

Gross profit

    561       311       1,010       604  

Operating expenses

                               

Research and development

    2,520       1,037       4,864       3,468  

General and administrative

    1,832       1,030       3,540       2,716  

Total operating expenses

    4,352       2,067       8,404       6,184  

Loss from operations

    (3,791 )     (1,756 )     (7,394 )     (5,580 )

Other income (expense)

                               

Interest income

    69       45       160       93  

Interest expense

    (8 )     (9 )     (14 )     (18 )

Other financing costs

          (298 )           (298 )

Change in fair value of warrants liability

          16             32  

Total other income (expense), net

    61       (246 )     146       (191 )

Loss before provision for income taxes

    (3,730 )     (2,002 )     (7,248 )     (5,771 )

Provision for income taxes

                3       3  

Net loss

  $ (3,730 )   $ (2,002 )   $ (7,251 )   $ (5,774 )

Net loss per share of common stock, basic and diluted

  $ (0.91 )   $ (1.77 )   $ (1.81 )   $ (5.78 )

Weighted-average shares outstanding, basic and diluted

    4,084,283       1,132,952       4,001,770       998,122  

 

 

 

 

6

 

 

 

 

SeaStar Medical Holding Corporation

Condensed Consolidated Statements of Cash Flows

(unaudited)

(in thousands)

 

 

 

   

Six Months Ended June 30,

 
   

2026

   

2025

 
                 

Cash flows from operating activities

               

Net loss

  $ (7,251 )   $ (5,774 )

Adjustments to reconcile net loss to net cash used in operating activities

               

Amortization of deferred financing costs

    14       18  

Change in fair value of liability classified warrants

          (32 )

Shares issued for the standby equity purchase agreement commitment fee

          298  

Stock-based compensation

    (8 )     264  

Change in operating assets and liabilities

               

Accounts receivables

    29       (105 )

Inventory

    (11 )     (77 )

Prepaid expenses

    313       784  

Other assets

    157       156  

Accounts payable

    (198 )     112  

Accrued expenses

    1,200       (1,305 )

Net cash used in operating activities

    (5,755 )     (5,661 )
                 

Cash flows from financing activities

               

Proceeds from issuance of shares, net of offering costs

    1,139       5,154  

Proceeds from exercise warrants

          2  

Proceeds of pre-funded warrants

          5,580  

Payment of notes payable

    (405 )     (592 )

Net cash provided by financing activities

    734       10,144  

Net increase (decrease) in cash

    (5,021 )     4,483  

Cash, beginning of period

    11,980       1,819  

Cash, end of period

  $ 6,959     $ 6,302  
                 
                 

 

QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.

 

# # #

 

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