ICU 10-K & 10-Q changes, risk factors and insider trading
SeaStar Medical Holding Corp (also ICUCW) · Nasdaq · Surgical & Medical Instruments & Apparatus · CIK 1831868 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “There is substantial doubt about our ability to continue as a going concern, and we will need additional financing to execute our business plan, to fund our operations and to continue as a going concern, and if we are unable to obtain additional financing, we may be required to pursue a restructuring of our operations or reorganization proceedings under applicable U.S. bankruptcy or insolvency laws.”
New heading “In the event we pursue a restructuring or reorganization under applicable law, we will be subject to the risks and uncertainties associated with such proceedings.”
New heading “Conflicts, military actions, terrorist attacks, political events, public health crises, changes in regulatory regimes and general instability, could adversely affect our business.”
New heading “The sale of our Common Stock in at-the-market offerings, our standby equity purchase agreement or through any similar arrangements may cause substantial dilution to our existing stockholders, and such sales, or the anticipation of such sales, may cause the price of our Common Stock to decline.”
Removed heading “If we fail to obtain additional financing, we would be forced to delay, reduce or eliminate our product development program, which may result in the cessation of our operations.”
Removed heading “We have limited experience in identifying and working with large-scale contracts with medical device manufacturers.”
Removed heading “We outsource many of our operational and development activities for which we may not have full control.”
Removed heading “Our business is subject to risks arising from future pandemics.”
Removed heading “New technology may lead to our competitors developing superior products which would reduce demand for our products regardless of any patent protection we may have.”
Largest changes
“There is substantial doubt about our ability to continue as a going concern, and we will need additional financing to execute our business plan, to fund our operations and to continue as a going concern, and if we are unable to obtain additional financing, we may be required to pursue a restructuring of our operations or reorganization proceedings under applicable U.S. bankruptcy or insolvency laws.”see in full comparison
“In the event we seek to pursue a restructuring, or if we file for relief under the United States Bankruptcy Code, either Chapter 7, Chapter 11 or other proceedings, our operations, our ability to develop and execute our business plan and our continuation as a going concern will be subject to the risks and uncertainties associated with bankruptcy proceedings, including, among others: our ability to execute, confirm and consummate a plan of reorganization; the high costs of bankruptcy proceedings and related fees; …”see in full comparison
“Furthermore, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. These fluctuations often have been unrelated or disproportionate to the operating performance of those companies. These broad market and industry fluctuations, as well as general economic, political, and market conditions such as recessions, interest rate changes or international currency fluctuations, may negatively impact the market price of shares of our Common Stock. …”see in full comparison
see in full comparisonAnySuchsuch lawsuitlawsuits 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, theThe ultimate resolution of these matters and any future matters could have a material adverse effect on our business, financial condition, results of operations and cash flow and, consequently, could negatively impact the trading price of our common stock.
“The trading price of our Common Stock has been and is expected to remain volatile because it is influenced by many factors beyond our control. These include overall market conditions, economic trends, interest rate changes, investor sentiment, and industry-specific developments. Company-specific events such as earnings announcements, changes in management, strategic decisions, or unexpected news can also cause sharp price fluctuations. …”see in full comparison
“In the event we pursue a restructuring or reorganization under applicable law, we will be subject to the risks and uncertainties associated with such proceedings.”see in full comparison
Full comparison: every changed paragraph (256)
We have not generated revenue sufficient for positive operating cash flows, have incurred significant losses since our inception and may continue to incur significant losses for the foreseeable future.
If we fail to obtain additional financing, we would be forced to delay, reduce or eliminate our product development program.
We have a limited operating history.
We may not be able to use our net operating losses to offset future taxable income.
We may suffer from a lack of availability of future funds.
We may become a defendant in one or more stockholder derivative, class-action, and other litigation.
We may face challenges in obtaining additional FDA approvals to market our product.
The United States could change tariff, trade, or tax provisions related to the manufacturing and sales of our products in ways that we currently cannot predict.
We may not be able to manage our growth effectively.
Changing priorities within the U.S. government resulting in the loss of government grant funding could adversely impact our future growth plans.
We will initially depend on revenue generated from a single product.
We may fail to comply with extensive regulations of United States and foreign regulatory agencies.
Delays in successfully completing our planned clinical trials could jeopardize our ability to obtain regulatory approval.
Delays, interruptions, or the cessation of production by our third-party suppliers of important materials or delays in qualifying new materials, may prevent or delay our ability to manufacture or process our SCD device.
We have limited experience in identifying and working with large-scale contracts with medical device manufacturers.
Difficulties in manufacturing our SCD could have an adverse effect upon our revenue and expenses.
We face intense competition in the medical device industry and our SCD technology may become obsolete.
If our products, or the malfunction of our products, cause or contribute to a death or a serious injury, we will be subject to medical device reporting regulations.
We outsource many of our operational and development activities for which we may not have full control.
A lack of third-party coverage and reimbursement for our devices could delay or limit their adoption.
Adverse changes in reimbursement policies and procedures by payors may impact our ability to market and sell our products.
We may be subject to enforcement action if we engage in improper marketing or promotion of our products.
We are and will be exposed to product liability risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon us should we be sued.
United States legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained.
We are subject to stringent and changing privacy laws, regulations and standards Our business operations will be adversely affected if our security measures, or those maintained on our behalf, are compromised, limited or fails.
We depend on key personnel and our inability to attract and retain qualified personnel could impede our ability to achieve our business objectives.
Our products may in the future be subject to product recalls.
Our estimates of market opportunity, industry projections and forecasts of operating and financial results and market growth may prove to be inaccurate.
We rely upon exclusively licensed patent rights from third parties which are subject to termination or expiration.
If we are unable to obtain and maintain sufficient patent protection for our products, our ability to commercialize such products successfully may be adversely affected.
We may not be able to obtain protection under the Hatch-Waxman Act and similar non-United States legislation for extending the term of patents covering our products.
Issued patents covering one or more of our products could be found invalid or unenforceable if challenged in patent office proceedings, or in court.
If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be adversely and materially affected, and our business could be harmed.
Competitors may develop superior products based on new technologies.
The United States government may exercise certain rights with regard to our inventions, or licensors’ inventions, developed using federal government funding.
Changes to the patent law in the United States and other jurisdictions could diminish the value of our patents in general, thereby impairing our ability to protect our products.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies.
We may obtain only limited geographical protection with respect to certain patent rights, We do not have long-term experience operating as a United States public company.
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 us.
We may redeem your unexpired warrants prior to their exercise at a time that is disadvantageous to you, thereby making your warrants worthless.
The trading price of our Common Stock has been volatile and is likely to be volatile in the future.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
Future sales, or the possibility of future sales, of a substantial number of shares of our Common Stock could adversely affect the price of the shares and dilute stockholders.
We have devoted most of our financial resources to research and development, including clinical trials and non-clinical development activities, and obtaining regulatory approval of our SCD product candidates. Since the completion of the Business Combination, we relied primarily on the sales of securities to fund our operations and are limited as we need to meet certain conditions before such funding becomes available. The size of our future net losses will depend, in part, on the rate of future expenditures and our ability to generate revenues. If our product candidates are not successfully developed or commercialized, or if revenues are insufficient following marketing approval, itwe will not achieve profitability and our business may fail. Even if we successfully obtain regulatory approval to market our product candidates in the United States, our revenues are also dependent upon the size of the markets outside of the United States, regulatory approval outside of the United States, and our ability to obtain market approval and achieve commercial success.
We expect to continue to incur substantial and increased expenses as we expand research and development activities and advancesadvance clinical programs through the regulatory approval process. We also expect an increase in our expenses associated with commercialization of our products and creating additional infrastructure to support operations as a public company. As a result of the foregoing, we expect to continue to incur significant and increasing losses and negative cash flows for the foreseeable future.
We have not generated any significantsubstantial revenue to date and we may never be profitable.
Our ability to generate meaningful future revenue from product sales depends heavily on our success with the following items:
Our ability to generate sustainable revenue and achieve profitability depends on our ability, alone or with collaborators, to successfully commercialize our approved pediatric SCD and complete the development, obtain the necessary regulatory approvals of and commercialize our adult SCD. We do not anticipate generating substantial revenue for the foreseeable future. Our ability to generate meaningful future revenue from product sales depends heavily on our success with the following items:
commercializing our pediatric SCD, including securing adoption and increasing awareness;
completing the clinical development of our adult SCD;
obtaining regulatory approval for our adult SCD, including the PMA from the FDA;
scaling our commercial operations, including building a hospital-directed sales force and collaborating with third parties;
obtaining third-party reimbursement status from government agencies and insurance carriers; and entering into collaboration agreements and partnerships to commercialize our products.
Because of the numerous risks and uncertainties associated with medical device commercialization and product development, we are unable to predict the timing or amount of increasedexpenses, expenses,or when, or if, we will be able to achieve or maintain profitability. In addition, our expenses could increase beyond expectations if itwe isare required by the FDA to perform additional, unanticipated studies.
Even if our product candidates are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. In the case of our SCD product candidatetherapy for the treatment of pediatric AKI, we will be limited in our ability to sell and distribute our SCD unitsQUELIMMUNE due to certain restrictions under the HDE requirements that limit the number of units that can be sold on an annual basis, which will further limit the amount of revenue that could be generated by us. Even if we successfully expand sales of our products, we may not become profitable and may need to obtain additional funding to continue operations.
We expect to have ongoing needs for working capital in order to fund operations, continue to expand our operations and recruit experienced personnel. To that end, we will be requiredneed to raise additional funds through equity orand debt financing.financings. However, there can be no assurance that we will be successful in securing additional capital on favorable terms, if at all. If we are successful, whether the terms are favorable or unfavorable, there is a potential that we will fail to comply with the terms of such financing, which could result in severe liability for us. If we are unsuccessful, we may need to (a) initiate cost reductions; (b) forego business development opportunities; (c) seek extensions of time to fund liabilities, or (d) seek protection from creditors. In addition, any future sale of our equity securities would diluteFurther, the ownership and control of your shares and could be at prices substantially below prices at which our shares currently trade. Our inability to raise capital could require us to significantly curtail or terminate our operations altogether. We may seek to increase our cash reserves through the sale of additional equity or debt securities. The sale of convertible debt securities or additional equity securities could result in additional and potentially substantial dilution to our shareholders. The incurrence of indebtedness would result in increasedadditional debt service obligations and could result in operating and financing covenants that would restrict our operations and liquidity. In addition, our ability to obtain additional capital on acceptable terms is subject to a variety of uncertainties.
In addition, if we are unable to generate adequate cash from operations, and if we are unable to find sources of funding, it may be necessary for us to sell all or a portion of our assets, enter into a business combination, or reduce or eliminate operations. These possibilities, to the extent available, may be on terms that result in significant dilution to our shareholders or that result in our shareholders losing all of their investment in us.
If we fail to obtain additional financing, we would be forced to delay, reduce or eliminate our product development program, which may result in the cessation of our operations.
Developing medical device products, including conducting preclinical studies and clinical trials, is expensive. We expect our research and development expenses to substantially increase in connection with our ongoing activities, particularly as we advance our clinical programs. As of December 31, 2024 and December 31, 2023, we had negative working capital of $3.0 million and $4.2 million, respectively. We currently do not have sufficient capital to support our operations and complete our planned regulatory approval process. We will need to secure additional capital to continue our operations, and such funding may not be available on acceptable terms, or at all.
Management's Discussion & Analysis (MD&A)
New heading “At-The-Market Offering”
New heading “Standby Equity Purchase Agreement”
New heading “2025 Offering Activity”
Largest changes
“General and administrative expenses for the years ended December 31, 2024 and 2023 were $8.9 million and $8.2 million, respectively. …”see in full comparison
“General and administrative expenses for the years ended December 31, 2025 and 2024 were $5.8 million and $8.9 million, respectively. …”see in full comparison
“As of December 31, 2025, we had cash of approximately $12.0 million. The Company does not hold any cash equivalents The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial costs and regulatory approval expenses, and the amount of cash reserve are factors that raise substantial doubt about our ability to continue as a going concern for the twelve-month period following the issuance date for the consolidated financial statements for the year ended December 31, 2025. …”see in full comparison
“The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial costs and regulatory approval expenses, and the amount of cash reserve are factors that raise substantial doubt about our ability to continue as a going concern for the twelve-month period following the issuance date for the consolidated financial statements for the year ended December 31, 2024. …”see in full comparison
Full comparison: every changed paragraph (66)
The following discussion and analysis are intended to help you understand our business, financial condition, results of operations, liquidity, and capital resources. You should read this discussion in conjunction with our consolidated financial statements and related notes included elsewhere in this Annual Report. In addition to historical financial analysis, this discussion and analysis contains forward-looking statements based upon current expectations that involve risks, uncertainties, and assumptions, as described under the heading “Cautionary Note Regarding Forward LookingForward-Looking Statements.” Actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of various factors, risks and uncertainties, including those set forth under “Risk Factors” included elsewhere (or incorporated by reference) in this Annual Report.
On October 28, 2022, LMFLMAO consummated a series of transactions that resulted in the combination of LMF Merger Sub, Inc. and the Predecessor pursuant to an Agreement and Plan of Merger. Immediately upon consummation of the Business Combination, LMFLMAO was renamed SeaStar Medical HoldingsHolding Corporation (as defined above).
We are a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. Our Selective Cytopheretic Device (“SCD”) 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. It has broad potential applications for patients suffering from both acute and chronic kidney diseases as well as cardiovascular and other serious inflammatory diseases.
We received Food and Drug Administration (“FDA”) approval on February 21, 2024, under a Humanitarian Device Exemption (“HDE”) for our pediatric SCD therapy. It is the only FDA-approved product for use in pediatric patients with acute kidney injury (“AKI”) due to sepsis or a septic condition requiring continuous renal replacement therapy ("CRRT"). We shipped our first commercial pediatric SCD (“QUELIMMUNE”) in July 2024. In addition, we are currently conducting a pivotal clinical trial (“NEUTRALIZE-AKI”) to assess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring CRRT.
Our SCD therapy has been awarded Breakthrough Device Designation (“BDD”) for six therapeutic indications by the FDA, including the use of the SCD therapy for adult patients with AKI, patients with cardiorenal syndrome awaiting left ventricular assist device (“LVAD”) implantation, patients with hepatorenal syndrome, patients with end stage renal disease (“ESRD”) and adult and pediatric patients undergoing cardiac surgery. The BDD enables the potential for a speedier pathway to approval and the ability to have more frequent and flexible meetings with the FDA.
We are a commercial stage medical technology company developing a proprietary platform therapy, our SCD to reduce the consequences of hyperinflammation on vital organs. We received FDA approval for our pediatric SCD (“QUELIMMUNE”) on February 21, 2024, under a HDE, and shipped our first commercial pediatric SCD in July 2024. A pivotal clinical trial for the SCD in adult patients with AKI is underway with 94 patients enrolled as of March 25, 2025.
The inflammatory response is criticalessential to fendthe offhealing infectionsprocess of critical organs; however, the overactivation of inflammatory cells, which can be triggered by many different bodily insults such as trauma, surgery or infection, can send the body into shock and repaircause damagedsevere tissuedamage into a variety of critical organs such as the body.heart, lungs and kidney. Central to inflammation are the cells within blood and lymph circulatory systems, called white blood cells (primarily neutrophils and monocytes), also referred to commonly as “pus” cells.. In a normal inflammatory response, neutrophils are the first immune cells to arrive at the site and are key to the entire immune response that kills pathogens and promotes tissue repair. These inflammatory cells release chemicals (cytokines) that trigger the immune system to eliminate foreign pathogens or damaged tissue, enhancing the immune response.
If the inflammatory response becomes excessive and dysregulated,dysregulated normal(referred neutrophilto dieas offproinflammatory), maythe beinflammatory delayed,cells will continue to produce cytokines and other damaging molecules, further enhancing the dysregulated immune response, and altering feedback mechanisms that regulate the immune system. This results ofin damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute chronic solid organ dysfunction or failure, including the heart, lung, kidneykidney, liver, and livereven diseases.death. This hyperinflammatory response is also known as the “cytokine storm,” referring to the body’s reaction to the category of small-secreted proteins released by hyperinflammatory cells that affect communication between cells. TheCurrently, cytokinethere storm,are whenno lefttherapeutic uncontrolled,options canthat leadspecifically toneutralize organthe damagewhite andblood evencells death.that are primarily responsible for the destructive hyperinflammatory response.
We are using our SCD initially to clinically validate several acute organ injury indications, including kidneys and lungs. Our investigational SCD for adults is an extracorporeal synthetic membrane device that is currently being evaluated in a pivotal clinical trial in the U.S. for premarket clearance by the FDA. The SCD for adults is designed to be easily integrated into existing CRRT systems that are commonly installed in hospitals, including in ICUs throughout the United States. Similar to our pediatric SCD (QUELIMMUNE),QUELIMMUNE, once approved and commercialized, our adult SCD is expected to initially target acute kidney injury in adults on CRRT. In addition, we are developing our SCD to address inflammation associated with liver disease, acute respiratory distress syndrome, chronic dialysis and chronic heart failure in adult populations. See Part I, Item 1A “Risk Factors” for additional information.
We have incurred net losses in each year since our inception in 2007. As of December 31, 20242025 and 2023,2024, we had an accumulated deficit of approximately $139.6$151.7 million and $114.7$139.6 million, respectively. Our net losses were $24.8$12.2 million and $26.2$24.8 million for the years ended December 31, 20242025 and 2023,2024, respectively. ApproximatelyThe 72% and 54%majority of our net losses for the years-ended December 31, 20242025 and 2023,2024, respectively, resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. The remaining net losses primarily resulted from non-cash, non-operating changes in fair value of our financial instruments recognized in our statement of operations for the same two fiscal years. For the year ended December 31, 2024,2025, these non-cash, non-operating losses related to change in fair value of convertible notes, change in fair value of liability classified warrants, and interest expense, which were partially offset by interest income.
As of December 31, 2025, we had cash of approximately $12.0 million. The Company does not hold any cash equivalents The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial costs and regulatory approval expenses, and the amount of cash reserve are factors that raise substantial doubt about our ability to continue as a going concern for the twelve-month period following the issuance date for the consolidated financial statements for the year ended December 31, 2025. See Note 1 to our audited consolidated financial statements for the year ended December 31, 2025, included elsewhere in this Annual Report for additional information on our assessment.
As of December 31, 2024 and 2023, we had cash and cash equivalents of approximately $1.8 million and $0.2 million, respectively.
The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial costs and regulatory approval expenses, and the amount of cash reserve are factors that raise substantial doubt about our ability to continue as a going concern for the twelve-month period following the issuance date for the consolidated financial statements for the year ended December 31, 2024. See Note 1 to our audited consolidated financial statements for the year ended December 31, 2024, included elsewhere in this Annual Report for additional information on our assessment.
Our need for additional capital will depend in part on the scope and costs of our development activities. To date, we have not generated significant revenue from the sale of commercialized products. Our ability to generate significant product revenue will depend on the successful development of our adult SCD and eventual ongoing commercialization of QUELIMMUNE. Until such time, if ever, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. See Part I, Item 1A “Risk Factors” for additional information.
Our pediatric SCD therapy, QUELIMMUNE, received HDE approval from the FDA in February 2024. Since that time, we have begunbeen to buildbuilding out our commercial operations, developdeveloping our customer base and initiategrowing commercial sales of QUELIMMUNE. We shipped our first commercial QUELIMMUNE units in July 2024. Through December 31, 2024, we haveWe recognized approximately$1.2 million and $0.1 million of revenue from the sale of QUELIMMUNE.QUELIMMUNE for the years ended December 31, 2025 and 2024, respectively. Historically, prior periodto 2024, revenue has been primarily derived from government and other grants. We will continue to focus our efforts on generating revenue in the future based on product sales of QUELIMMUNE, as well as potential future payments from license or collaboration agreements and government and other grants.
We expect that any revenue we generate will fluctuate from quarter to quarter as we introducecontinue to advance our sales of QUELIMMUNE to pediatric hospital customers. We also continue to develop our adult SCD for which we are currently enrolling patients in a pivotal study to support FDA approval. If we fail to complete the development of, or fail to obtain regulatory approval to commercialize our adult SCD in a timely manner, our ability to generate additional future revenue, and our results of operations and financial position, could be materially adversely affected.
Total other income (expense), net primarily consists of (i) interest expense relating to interest incurred on ournotes notes,payable, (ii) a one-time charge for a financing feesfee related to our convertiblestandby notes,equity gainpurchase onagreement, issuance(iii) of convertible notes, changechanges in the fair value of convertible notes, change in fair value of warrants liability, termination of forward purchase agreement, gains from early extinguishments of convertible notes, changes in fair value of the derivative liability relatedclassified to the conversion option of convertible notes,warrants, and (iv) interest income derived from cash balances maintained at a commercial financial institution.
Net loss consists of our loss from operations, lessoffset by other expenses,income, net.net and taxes.
Net revenue increased $0.1$1.1 million to $0.1$1.2 million for the year-ended December 31, 2024,2025, compared to no$0.1 million net revenue for the year-ended December 31, 2023.2024. The increase is primarily attributable to the(i) commencementincreased adoption of QUELIMMUNE, resulting in ten customers as of December 31, 2025, an increase from three as of December 31, 2024, and (ii) a full year of sales afteractivity receiving approval fromduring the FDA2025 fiscal year compared to commerciallyonly sellsix ourmonths pediatricof selectivesales cytophereticactivity device,during QUELIMMUNE,the on2024 Februaryfiscal 21,year, 2024.as Salessales did not occurcommence until after July 1, 2024.
Research and development expenses for the years ended December 31, 2025 and 2024 were approximately $7.5 million and $9.1 million, respectively. The decrease in research and development expenses of $1.6 million was primarily driven by (i) a $1.0 million decline in consulting expenses as the Company both made a concerted effort to reduce usage of consultants and hiring key employees to bring certain critical skillsets in-house, (ii) a $0.6 million decline in pre-clinical expenses as we started the NEUTRALIZE-AKI study in 2024, resulting in limited pre-clinical activities in 2025, (iii) a $0.5 million decline in compensation and benefits as a result of certain voluntary recissions of accrued bonuses accrued, (iv) a $0.4 million reduction in outside services as we switched clinical research organizations, and (v) $0.4 million in contra-expenses were recognized in 2025 as we agreed to provide clinical research organization services to a third-party, for which the Company will be able to utilize the results of this study.
These decreases described above were partially offset by (i) a $1.0 million increase in clinical trial costs, mostly driven by the increased activity relating to the NEUTRALIZE-AKI study, (ii) a $0.2 million increase in the adult SCD related supply costs due to both the NEUTRLAIZE-AKI study and device development efforts, and (iii) a $0.1 million increase in medical affairs.
Research and development expenses for the years ended December 31, 2024 and 2023 were approximately $9.1 million and $6.0 million, respectively. The increase in research and development expenses of $3.1 million, or 52.4%, was primarily driven by increases in clinical trial expenses of $1.8 million and external services of $0.1 million due to the Neutralize-AKI Adult SCD study, in which we ended the year 2024 with 14 clinical trial sites enrolled, an increase in payroll and personnel expenses of $1.0 million due to increased head count and equity grants, and an increase in other costs of approximately $0.1 million, due to increased travel and other costs relating to increasing clinical trial site enrollees.
General and administrative expenses for the years ended December 31, 2025 and 2024 were $5.8 million and $8.9 million, respectively. The decrease of $3.1 million in general and administrative expenses is due primarily to (i) a $1.0 million decline in accounting and legal related activities, primarily driven by the 2024 restatement of previously filed financial statements, with no such expense in the 2025 fiscal year, (ii) a $0.6 million decline in Board compensation due to the voluntary recission of accrued director fees, (iii) a decrease of $0.5 million in compensation and benefits primarily due to the voluntary recission of accrued bonuses, (iv) a $0.5 million decline in other professional fees, and (v) a $0.3 million reduction in costs as we had a one-time settlement in 2024 with a former distributor , and (vi) a $0.2 million decline in travel and conference activity.
These decreases were partially offset by the increase of $0.1 million due to due diligence fees paid to a third-party financial institution for a standby equity purchase agreement that we entered into during the fiscal year ended December 31, 2025.
General and administrative expenses for the years ended December 31, 2024 and 2023 were $8.9 million and $8.2 million, respectively. The increase in general and administrative expenses 7.7% is due primarily to (i) an increase in payroll and related expenses of $0.6 million, due to increased head count as we invested in our finance and commercial functions, (ii) a $0.6 million increase in accounting related costs due to the restatement of certain financial statements for the 2023 and 2022 Forms 10-K and for interim period financial statements on Forms 10-Q, (iii) a $0.1 million increase in legal expense, and (iv) a $0.2 million increase in consulting expenses for various strategic and commercial endeavors, offset by (i) a $0.6 million reduction in SEC related expenses as we transitioned from outside parties to internal resources for SEC related filings and compliance activities, and (ii) a $0.3 million decline in other activities such as public relations, investor relations and certain marketing activities.
Other income (expense) for the years ended December 31, 2025 and 2024 was other income, net of $28 thousand and other expense, net of $7.0 million, respectively. The change was the result of (i) interest income increasing $0.2 million as a result of our increased cash during the 2025 fiscal year compared to the 2024 fiscal year, (ii) $0.2 million decline in interest expense due to the reduction in our outstanding notes and convertible notes, (iii) a $6.1 million loss on the change in fair value of convertible notes in the fiscal year ended December 31, 2024, with no such charge during the year ended December 31, 2025, and (iv) we recognized a $32 thousand gain on the change in fair value of liability classified warrants for the year ended December 31, 2025, compared to a loss of $0.7 million for the year ended December 31, 2024.
This was offset by a $0.3 million financing charge related to the standby equity purchase agreement that we entered into during the year ended December 31, 2025.
Other income (expense) for the years ended December 31, 2024 and 2023 was expense of $7.0 million and $12.0 million, respectively. The decrease of approximately $5.0 million primarily resulted from (i) $4.2 million decline in the loss from the change in fair value on extinguishments of convertible notes, (ii) a decrease in interest expense of $0.8 million due to the reduction in our outstanding notes and convertible notes, (iii) interest income of $0.1 million during 2024 compared to $0.0 million for 2023, and (iv) we did not recognize a loss from the change in the fair value of forward purchase agreement derivative liabilities for 2024 as the instrument did not exist during 2024, while incurring a loss on the change in fair value of forward purchase agreement derivative liabilities of $1.3 million in 2023.
This was primarily offset by an approximately $1.2 million unfavorable impact due to the change in the fair value of liability classified warrants in 2024 compared to 2023.
We recorded a provision for income taxes of $3 thousand for each of the yearyears ended December 31, 2024,2025, and did2024, not record a provision for income taxes for the year ended December 31, 2023.respectively.
During the year ended December 31, 2024,2025, we had a net loss of $24.8$12.2 million compared to a net loss of $26.2$24.8 million for the year ended December 31, 2023.2024. The decline in net loss of $1.4$12.7 million primarily resulted from (i) a decline$1.0 million increase in revenue in 2025 compared to 2024, (ii) $4.6 million decrease in operating expenses in 2025 compared to 2024, and (iii) $7.0 million favorable change in other income or expense of $5.0 million (as discussed above in “Other2025 Incomecompared (Expense)”to offset by increases in general and administrative expenses of $0.6 million, and increases in research and development expenses of $3.1 million.2024.
To date, we have financed our operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows. As of December 31, 20242025 and December 31, 2023,2024, we had an accumulated deficit of $139.6$151.7 million and $114.7$139.6 million, respectively.
As of December 31, 2024 and December 31, 2023,2025, we had cash of $1.8$12.0 million and $0.2 million, respectively.million. We expect that our existing cash will be insufficient to fund our operations for the twelve months from the filing date of ourthis FormAnnual 10-KReport for the year ended December 31, 2024,2025, including clinical trial expenses and capital expenditure requirements. We believe that this raises substantial doubt about our ability to continue as a going concern. To finance our operations beyond that point, we would need to raise additional capital, and there is no guarantee that we will be able to secure additional funding on favorable terms, or at all. We have concluded that these circumstances raise substantial doubt about our ability to continue as a going concern within one year after the issuance date of this Annual Report. See Note 1 to our audited consolidated financial statements for the year ended December 31, 2024.2025.
Net cash used in operating activities for the fiscal year ended December 31, 20242025 was $16.0$13.6 million compared to $10.3$16.0 million for the fiscal year ended December 31, 2023.2024. The increasedecrease in cash used for operating activities of $5.7$2.4 million is primarily due to the increaseddecline activityin consulting, legal and accounting related to clinical trial activities for(see theResults Neutralize-AKIof clinicalOperations trial, and certain general and administrative costs.above).
Net cash provided by financing activities for the fiscal year ended December 31, 2024,2025, was $17.7$23.8 million, primarily related to proceeds from the issuance of new shares of common stock from the combination of certain registered direct offerings and at-the-marketATM issuances, proceeds from convertible notes, and proceeds from the issuance of pre-funded warrants.
CashNet cash provided by financing activity for the fiscal year ended December 31, 2023,2024, was $10.4$17.7 million, primarily related to proceeds from the issuance of new shares of common stock,stock from certain registered direct offerings and ATM issuances, proceeds from the issuance of convertible notes, and proceeds from the saleissuance of recycledcertain shares,pre-funded partially offset by payments of notes payable, and payment of convertible noteswarrants.
We finance our operations from a combination of sales of common stock and warrants, through registered direct or public offerings, our at-the-market program, and our standby equity purchase agreement. We finance certain insurance needs through a short-term note payable.
Shelf RegistrationsRegistration
Shelf Registration 333-275968 - On December 8, 2023, we filed a shelf registration statement on Form S-3.S-3 (File No. 333-275968), which was declared effective by the SEC on December 22, 2023. This shelf registration statement covered the offering, issuance and sale by us of up to an aggregate of $100.0 million of itsour common stock, preferred stock, debt securities, warrants, rights and units (the “2023 Shelf”). Since the date of effectiveness, we have raised approximately $23.5 million as of December 31, 2024, through the combination of registered direct offerings and “At-the-Market” offerings. As of December 31, 2024, we have approximately $76.5 million remaining to for future offerings, of which, $20.5 million is currently restricted to capital raised from the “At-the-Market” offering.
Since the date of effectiveness and through December 31, 2025, we have raised approximately $44.1 million under the 2023 Shelf and have approximately $55.9 million remaining for future offerings. However, actual availability for primary offerings is limited by the “baby shelf” restrictions applicable to our use of Form S‑3.
At-The-Market Offering
On August 20, 2024, we entered into an At-The-Market Offering Agreement (the “ATM Agreement”) with Wainwright as sales agent, to sell shares of Common Stock, from time to time, through an “at the market offering” program under which Wainwright will act as sales agent. As of December 31, 2025, approximately $1.2 million remained available for issuance under our ATM program as a result of baby shelf limitations, which is a component of the 2023 Shelf.
Standby Equity Purchase Agreement
On April 25, 2025, we entered into a standby equity purchase agreement (“SEPA”) with Lincoln Park Capital, LLC (“Lincoln Park”) pursuant to which we have the right to sell to Lincoln Park shares of Common Stock, subject to certain limitations, from time to time over the 36-month period commencing on the Commencement Date. As of December 31, 2025, approximately $15.0 million in aggregate capacity remained available under the SEPA.
2025 Offering Activity
During the year ended December 31, 2025, we raised under the 2023 Shelf: (i) approximately $14.4 million through three registered direct offerings and concurrent private placements of Common Stock, pre-funded warrants, warrants and placement agent warrants, and (ii) approximately $6.1 million through our ATM Agreement. We also raised outside the 2023 Shelf: (i) approximately $4.0 million through a best-efforts public offering of Common Stock, pre-funded warrants, warrants and placement agent warrants, and (ii) approximately $40 thousand from the SEPA.
We have raised $0.9 million from our “At-the-Market” program since January 1, 2025. On February 3, 2025, we raised approximately $6.0 million through an offering of our common stock.
conditions in the capital markets;
our ability to receive cash proceeds from our existing funding instruments, including a potential equity line of credit;
the progress and results of our clinical trials and interpretation of those results by the FDA and other regulatory authorities;
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and the costs of operating as a public company, including hiring additional personnel as well as increased director and officer insurance premiums, audit and legal fees, investor relations fees and expenses related to compliance with public company reporting requirements under the Securities Exchange Act of 1934, as amended, and rules implemented by the SEC and Nasdaq.
Until such time, if ever, as we are able to successfully develop and fully commercialize our products, we expect to continue financing our operations through the sale of equity, issuance of debt, borrowings under credit facilities or through potential collaborations with other companies, other strategic transactions or government or other grants. Adequate capital may not be available when needed or on acceptable terms.
Based on our results of operations and liquidity as of December 31, 2024,2025, we believe our cash and cash equivalents areis not sufficient to meet our operations, working capital and capital expenditure requirements for a period of at least twelve months from the date of our audited consolidated financial statements for the fiscal year ended December 31, 2024.2025. In addition, we do not expect to receive significant cash proceeds from the exercise of warrants in the near term, because the trading price of our common stock is currently below the exercise price of the majority of the warrants. We arewill seekingrequire additional cash to fund our growth through future debt or equity financing transactions; however, there can be no assurance that we will be able to obtain additional capital on terms acceptable to us, if at all, or that we will generate sufficient future revenues and cash flows to fund our operations. Our estimates of our results of operations, working capital and capital expenditure requirements may be different than our actual needs, and those estimates may need to be revised if, for example, our actual revenue is lower, and our net operating losses are higher,higher than we project and our cash and cash equivalents position is reduced faster than anticipated.
Significant estimates include the valuation of the (i) incurred-but-not-billed clinical trial site costs, (ii) prepaid forward purchase agreement derivative liability, (iii) convertible notes (iv) liability classified warrants, and (viii) share-basedstock-based compensation expense.
Incurred-But-Not-Billed Clinical Trial Site Costs. Our Neutralize-AKINEUTRALIZE-AKI clinical trial studyis isbeing conducted at 14multiple qualified healthcare facilities as of December 31, 2024.2025. We are responsible to cover the costs of these clinical trial efforts, including the cost of patient care relating to the adult SCD,SCD. It is common practice that the costs incurred by the clinical trial sites are incurred, but not billed until months after the event giving rise to the unbilled activity. Accordingly, we estimate the value of these “incurred-but-not-billed ” activities at the end of each reporting period. Any impact to the Statementconsolidated statement of Operationsoperations is recognized as a component of research and development expense and included as a component of accrued expenses on the Balanceconsolidated Sheet.balance sheet.
Prepaid Forward Purchase Agreement Derivative Liability. The prepaid forward purchase agreement derivative liability (the “FPA Derivative Liability”) is required to be recognized as a liability as the financial instrument fails the “Indexation Guidance” of ASC 815-10 in addition having certain settlement features that could or will require settlement in cash or shares, depending on the feature. The FPA Derivative Liability was initially recorded at $5.2 million on October 28, 2022 (see Note 5). The FPA Derivative Liability was remeasured each reporting period using a Monte-Carlo Simulation in a risk-neutral framework (a special case of the Income Approach). Specifically, the future stock price is simulated assuming a Geometric Brownian Motion. For each simulated path, the forward purchase value was calculated based on the contractual terms and then discounted at the term-matched risk-free rate. Finally, the value of the forward was calculated as the average present value over all simulated paths. Changes in the fair value of the FPA Derivative Liability are recorded each reporting period to the change in the fair value of the forward purchase agreement derivative liability in the consolidated statement of operations. This instrument no longer existed as of December 31, 2024.
Investor D Convertible Notes. The convertible notes are recorded as liabilities and are recorded at fair value based on Level 3 measurements. The estimated fair values of the convertible notes are each determined based on the aggregated, probability-weighted average of the outcomes of certain possible scenarios. The combined value of the probability-weighted average of those outcomes is then discounted back to each reporting period in which the convertible notes are outstanding, in each case, based on a risk-adjusted discount rate estimated based on the implied interest rate using the changes in observed interest rates of corporate rate debt that we believe is appropriate for those probability-adjusted cash flows. The change in fair value of the Investor D Convertible Notes each reporting period is recorded to the Change in fair value of convertible notes in the consolidated statement of operations. These notes no longer existed at December 31, 2024.
Liability Classified Warrants. We have entered into or assumed various financial instruments in the form of warrant agreements that require classification as liabilities. This classification requires us to measure the warrants at fair value at inception,inception and thethen remeasure the warrants.fair value of the warrants at each reporting period. The liability classified warrants consist of the following: (see Note 108 for more information):
Private Placement Warrants. We assumed 229,520 Private Placement warrants as part of the Business Combination.
What changed in the latest 10-Q
Risk Factors
Removed heading “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 us.”
Largest changes
“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 us.”see in full comparison
“If our Common Stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market price of our Common Stock; (ii) reducing the number of investors willing to hold or acquire our Common Stock, which could negatively impact our ability to raise equity financing; (iii) limiting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees.”see in full comparison
“Pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we are subject to a Mandatory Panel Monitor until July 1, 2026. …”see in full comparison
“There can be no assurance that we will successfully maintain with the Minimum Stockholder's Equity Requirement or maintain compliance with other Nasdaq listing requirements. If we fail to regain compliance with Nasdaq’s continued listing standards during any period granted by the Panel, the Securities could be subject to delisting from Nasdaq, unless another exception is granted by Nasdaq.”see in full comparison
“On July 31, 2025, we received a letter from Nasdaq notifying us that we were 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), (the "Minimum Bid Price Rule"). This letter had no immediate effect on the listing of the Company’s Common Stock on Nasdaq and we had 180 calendar days from the date of the notice, or until January 27, 2026, to regain compliance with the Bid Price Requirement.”see in full comparison
“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. We have in the past received notifications of noncompliance with Nasdaq’s continued listing standards and there is no guarantee that we will not receive such notifications in the future.”see in full comparison
Full comparison: every changed paragraph (8)
Developing medical device products, including conducting preclinical studies and clinical trials, is expensive. We expect our research and development expenses to increase in connection with our ongoing activities, particularly as we advance our clinical programs. While the Company has positive working capital of $6.8$3.9 million as of MarchJune 31,30, 2026, we currently do not have sufficient capital to support our operations and complete our planned regulatory approval process. We will need to secure additional capital to continue our operations, and such funding may not be available on acceptable terms, or at all.
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 us.
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. We have in the past received notifications of noncompliance with Nasdaq’s continued listing standards and there is no guarantee that we will not receive such notifications in the future.
Pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we are subject to a Mandatory Panel Monitor until July 1, 2026. If, within that one-year monitoring period, the Nasdaq Listing Qualifications staff (the “Staff”) finds us again out of compliance with the Minimum Stockholders’ Equity Requirement, notwithstanding Nasdaq Listing Rule 5810(c)(2), we would not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and the Staff would not be permitted to grant additional time for us to regain compliance with respect to that deficiency, nor would we be afforded an applicable cure or compliance period pursuant to Nasdaq Listing Rule 5810(c)(3). Instead, the Staff would issue a “Delist Determination Letter” and we would have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable.
On July 31, 2025, we received a letter from Nasdaq notifying us that we were 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), (the "Minimum Bid Price Rule"). This letter had no immediate effect on the listing of the Company’s Common Stock on Nasdaq and we had 180 calendar days from the date of the notice, or until January 27, 2026, to regain compliance with the Bid Price Requirement.
On January 20, 2026, the Company received a letter from Nasdaq confirming that the Company has regained compliance with the minimum bid price requirement of the Minimum Bid Price Rule.
There can be no assurance that we will successfully maintain with the Minimum Stockholder's Equity Requirement or maintain compliance with other Nasdaq listing requirements. If we fail to regain compliance with Nasdaq’s continued listing standards during any period granted by the Panel, the Securities could be subject to delisting from Nasdaq, unless another exception is granted by Nasdaq.
If our Common Stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market price of our Common Stock; (ii) reducing the number of investors willing to hold or acquire our Common Stock, which could negatively impact our ability to raise equity financing; (iii) limiting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees.
Management's Discussion & Analysis (MD&A)
New heading “Results of Operations”
New heading “Comparison of the Six Months Ended June 30, 2026 to the Six Months Ended June 30, 2025”
New heading “Revenue, Cost of Goods Sold and Gross Profit”
New heading “Research and Development Expenses”
New heading “General and Administrative Expenses”
New heading “Other Income (Expense)”
New heading “Income Tax Provision (Benefit)”
Largest changes
“Comparison of the Six Months Ended June 30, 2026 to the Six Months Ended June 30, 2025”see in full comparison
General and administrative expenses for the three months endedsee in full comparisonMarchJune31,30, 2026 and 2025 were approximately$1.7$1.8 million and$1.7$1.0 million,respectively,respectively.with a slightThe increaseofin$24generalthousand.andThisadministrative was the result of (i) $0.5 million increase in Director fees primarily as a result of the Directors having approved the rescission of any earned-but-unpaid director fees as of June 30, 2025, (ii) legal expenses increased approximately $0.4 million due to litigation related matters, (iii) $0.1 million increase inlegalaudit and SEC relatedfees due to litigation related expenses, (ii) a $0.1 million increase in accounting related expenses due to timing ofactivities,and (iii) a $0.1 million in marketing related expenses as the Company continues to commercialize QUELIMMUNE. This wasoffset by (i)a$0.2 million decline in compensationcosts due to reduced headcount, and (ii) a $0.1 million decline in SECrelated expenses primarily driven by the reversal of previously recognized stock compensation due to thefactunderlyingthatgrantsthebeingCompany held a special meeting of the Stockholders during the three months ended March 31, 2025.forfeited.
“General and administrative expenses for the six months ended June 30, 2026 and 2025 were approximately $3.5 million and $2.7 million, respectively. …”see in full comparison
Full comparison: every changed paragraph (42)
The following discussion and analysis are intended to help you understand our business, financial condition, results of operations, liquidity, and capital resources. You should read this discussion in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 20252025, (filed on March 25, 2026).2026.
In addition to historical financial analysis, this discussion and analysis contains forward-looking statements based upon current expectations that involve risks, uncertainties, and assumptions, as described under the heading “Cautionary Note Regarding Forward Looking Statements.” Actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of various factors, risks and uncertainties, including those set forth under “Risk Factors” included elsewhere (or incorporated by reference) in this Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2025. Unless the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” to “SeaStar Medical”, “we”, “us”, “our,” and “the Company” are intended to mean the business and operations of SeaStar Medical Holding Corporation and its consolidated subsidiaries following the Business Combination.subsidiaries.
We have pursued patent protection for our SCD therapy as well as other technologies. Our patent portfolio consists of 46 patents and 1 pending patent application in the U.S. and certain foreign jurisdictions. Of these patents and patent applications, 21 patents and 1 patent applications are owned exclusively by us, and 25 patents are co-owned with the University of Michigan (“UOM”). The UOM has granted us an exclusive worldwide, royalty-bearing license to the UOM’s interest in all of the co-owned patents and applications. This license permits us to commercialize our SCD therapy in all human therapeutic indications. For more information, see “Intellectual Property” below.
We have incurred net losses in each year since our inception in 2007. As of MarchJune 31,30, 2026 and December 31, 2025, we had an accumulated deficit of $155.2$159.0 million and $151.7 million, respectively. Our net losses were $3.5$7.3 million and $3.8$5.8 million for the threesix months ended MarchJune 31,30, 2026,2026 and 2025, respectively. For the threesix months ended MarchJune 31,30, 2026, substantially all our net losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
As of MarchJune 31,30, 2026,2026 and December 31, 2025, we had cash of $9.3$7.0 million and $12.0 million, respectively.
The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial and regulatory approval expenses, and the amount of cash reserve are factors that raise substantial doubt about our ability to continue as a going concern for the twelve-month period from the date the unaudited condensed consolidated financial statements are made available. See Note 1 to our unaudited condensed consolidated financial statements for the three and six months ended MarchJune 31,30, 2026, included elsewhere in this Form 10-Q for additional information on our assessment.
Our need for additional capital will depend in part on the scope and costs of our development activities. To date, we have generated revenue of approximately $1.9$2.5 million from the sale of commercialized pediatric SCD products. Our ability to generate product revenue in the future will depend on the successful roll-out of our QUELIMMUNE pediatric SCD to hospitals and the development and eventual successful commercialization of our adult SCD. Until such time we are able to generate significant revenue from product sales, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs and any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. See Part I, Item 1A “Risk Factors” to our Annual Report on Form 10-K for the year ended December 31, 2025, for additional information.
Our QUELIMMUNE therapy received HDE approval from the FDA in February 2024. Since that time, we have begun to build out our commercial operations, develop our customer base and initiate commercial sales of QUELIMMUNE. We shipped our first commercial QUELIMMUNE units in July 2024. We recognized $0.5$0.6 million and $1.1 million in revenue for the three and six months ended June 30, 2026, and $0.3 ofmillion revenueand $0.6 million for the three and six months ended MarchJune 31,30, 2026 and 2025, respectively.2025. Through MarchJune 31,30, 2026, we have recognized approximately $1.9$2.5 million of revenue from the sale of QUELIMMUNE.QUELIMMUNE Historically,since priorour periodfirst revenuesale hasin beenJuly primarily derived from government and other grants.2024. We will continue to focus our efforts on generating revenue in the future based on product sales of QUELIMMUNE, as well as potential future payments from license or collaboration agreements and government and other grants.
Other significant general and administrative expenses include facilities costs, insurance, professional fees for accounting and legal services and expenses associated with obtaining and maintaining patents and obtaining financing. To the extent we expand and grow our operations, we expect that our general and administrative expenses will increase, including additional expenses relating to new hires, travel, an enterprise resource planning platform, and branding. However, the Company is also in the process, as evidenced by the results of the three months ended March 31, 2026, of reducing overall general and administrative spend, and identifying efficiencies.
Total other income, net primarily consists of interest income due to overnight sweep activity with the Company's main commercial financial institution and interest expense relating to interest incurred on our note for the three and six months ended MarchJune 31,30, 2026.
Comparison of the Three Months Ended MarchJune 31,30, 2026 to the Three Months Ended MarchJune 31,30, 2025
(*) – there was no activity for the three months ended MarchJune 31,30, 2026 and June 30, 2025.
Net revenue increased $0.2$0.3 million to $0.5$0.6 million for the three months ended MarchJune 31,30, 2026, compared to $0.3 million net revenue for the three months ended MarchJune 31,30, 2025. The increase is primarily attributable to both increased customer adoption of QUELIMMUNE and increase in existing customer demand during Marchthe 31,three 2026months ended June 30, 2026, compared to Marchthe 31,same period ended June 30, 2025. Cost of goods sold increased $27 thousand, commensurate with the increased sales of QUELIMMUNE.
The following table discloses the breakdown of research and development expenseexpenses for the three months ended MarchJune 31,30, 2026 compared to the same period ending MarchJune 31,30, 2025:
Research and development expenses for the three months ended MarchJune 31,30, 2026 and 2025 were $2.3$2.5 million and $2.4$1.0 million, respectively. The decreaseincrease in research and development expenses of approximately $0.1$1.5 million, or 4%,143%, was primarily driven by (i) $0.3$0.8 million declineincrease in payroll costs primarily driven by a $0.5 million favorable reduction in bonus expense during Q2 2025, due to the agreement by certain employees involved in research and development to rescind unpaid 2023 and 2024 performance bonuses owed to them, (ii) $0.6 million increase in clinical trial expenses,costs dueas towe (a)continue our NEUTRALIZE-AKI study efforts, including a $0.1$0.3 million reduction in preclinicalour consultingfunded research and development expense offset from services provided to a third-party for certain clinical research services (see Note 2), and (b) by $0.2 million decrease in clinical trial site costs related to the Neutralize-AKI study; offset by (iiii) $0.1 million increase in compensationexternal costs,services andprimarily (ii)due $0.1 million increase into device development costs.
General and administrative expenses for the three months ended MarchJune 31,30, 2026 and 2025 were approximately $1.7$1.8 million and $1.7$1.0 million, respectively,respectively. with a slightThe increase ofin $24general thousand.and Thisadministrative was the result of (i) $0.5 million increase in Director fees primarily as a result of the Directors having approved the rescission of any earned-but-unpaid director fees as of June 30, 2025, (ii) legal expenses increased approximately $0.4 million due to litigation related matters, (iii) $0.1 million increase in legalaudit and SEC related fees due to litigation related expenses, (ii) a $0.1 million increase in accounting related expenses due to timing of activities, and (iii) a $0.1 million in marketing related expenses as the Company continues to commercialize QUELIMMUNE. This was offset by (i) a $0.2 million decline in compensation costs due to reduced headcount, and (ii) a $0.1 million decline in SEC related expenses primarily driven by the reversal of previously recognized stock compensation due to the factunderlying thatgrants thebeing Company held a special meeting of the Stockholders during the three months ended March 31, 2025.forfeited.
OtherWe recognized other income, net increasedof $32approximately thousand$0.1 million for the three months Marchended 31,June 202630, 2026, compared to other expense, net of approximately $0.2 million for the same period endingended MarchJune 31,30, 2025. The increasechange is driven primarily by an(i) increasea one-time $0.3 million financing charge related to our standby equity purchase agreement incurred in Q2 2025, while no such charge was incurred in Q2 2026, and (ii) increased interest income as a result of our increased cash during the threesix months ended MarchJune 31,30, 2026 compared to the same period ending MarchJune 31,30, 2025.
We recorded ano provision for income taxes of $3 thousand and $3 thousand for the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025.2025 respectively.,respectively.
During the three months ended MarchJune 31,30, 2026, we had a net loss of approximately $3.5$3.7 million compared to a net loss of approximately $3.8$2.0 million for the three months ended MarchJune 31,30, 2025. The reason for the decreasedincrease in net loss of approximately $0.3$1.7 million has been disclosed in the above discussion.
Results of Operations
Comparison of the Six Months Ended June 30, 2026 to the Six Months Ended June 30, 2025
The following table sets forth a summary of our results of operations. This information should be read together with our unaudited condensed consolidated financial statements and related Notes included elsewhere in this Form 10-Q.
Revenue, Cost of Goods Sold and Gross Profit
Net revenue increased $0.5 million to $1.1 million for the six months ended June 30, 2026, compared to $0.6 million net revenue for the six months ended June 30, 2025. The increase is attributable to both increased customer adoption of QUELIMMUNE and increased in existing customer demand during the six months ended June 30, 2026, compared to the same period ended June 30, 2025.
Research and Development Expenses
The following table discloses the breakdown of research and development expense for the six months ended June 30, 2026 compared to the same period ending June 30, 2025:
Research and development expenses for the six months ended June 30, 2026 and 2025 were $4.9 million and $3.5 million, respectively. The increase in research and development expenses of approximately $1.4 million, or 40%, was primarily driven by (i) $0.8 million increase in compensation expense due primarily to a favorable reduction in bonus expense during Q2 2025, due to the agreement by certain employees involved in research and development to rescind unpaid 2023 and 2024 performance bonuses owed to them, while we reinstated a 2026 incentive bonus plan for 2026, (ii) $0.3 million increase in clinical trial costs as we continue our NEUTRALIZE-AKI study efforts, (iii) $0.2 million reduction in our funded research and development expense offset from services provided to a third-party for certain clinical research services (see Note 2), (iv) $0.1 million increase in travel related costs, offset by a $0.1 million decline in external clinical resource organization service costs.
General and Administrative Expenses
General and administrative expenses for the six months ended June 30, 2026 and 2025 were approximately $3.5 million and $2.7 million, respectively. This increase was primarily the result of (i) $0.6 million increase in legal costs due to litigation and related matters, (ii) $0.5 million increase in Director fees as a result of the Directors having approved the rescission of any earned-but-unpaid director fees as of June 30, 2025, (iii) $0.1 million increase in audit and SEC related activities, offset by (i) $0.5 million decline in compensation related expenses primarily driven by the reversal of previously recognized stock compensation due to the underlying grants being forfeited, coupled with a decline in payroll costs.
Other Income (Expense)
We recognized other income, net of approximately $0.1 for the six months ended June 30, 2026, compared to other expense, net of approximately $0.2 million for the same period ended June 30, 2025. The change is driven by (i) a one-time $0.3 million financing charge related to our standby equity purchase agreement, and (ii) increased interest income as a result of our increased cash during the six months ended June 30, 2026 compared to the same period ending June 30, 2025.
Income Tax Provision (Benefit)
We recorded a provision for income taxes of $3 thousand and $3 thousand for the six months ended June 30, 2026 and June 30, 2025. respectively.
Net Loss
During the six months ended June 30, 2026, we had a net loss of approximately $7.3 million compared to a net loss of approximately $5.8 million for the six months ended June 30, 2025. The reason for the increase in net loss of approximately $1.4 million has been disclosed in the above discussion.
Since the date of effectiveness and through MarchJune 31,30, 2026, we have raised approximately $44.1 million under the 2023 Shelf and have approximately $55.9 million remaining for future offerings. However, actual availability for primary offerings is limited by the “baby shelf” restrictions applicable to our use of Form S‑3.
On August 20, 2024, we entered into an At-The-Market Offering Agreement (the “ATM Agreement”) with Wainwright as sales agent, to sell shares of Commoncommon Stock,stock, from time to time, through an “at the market offering” program under which Wainwright will act as sales agent. As of MarchJune 31,30, 2026, we are currently restricted from raising capital on the ATM Agreement due to the baby shelf limitations, which is a component of the 2023 Shelf.
On April 25, 2025, we entered into a standby equity purchase agreement (“SEPA”) with Lincoln Park Capital, LLC (“Lincoln Park”) pursuant to which we have the right to sell to Lincoln Park shares of Commoncommon Stock,stock, subject to certain limitations, from time to time over the 36-month period commencing on the Commencementcommencement Date.date, May 14, 2025. As of MarchJune 31,30, 2026, approximately $14.7$13.8 million in aggregate capacity remained available under the SEPA.
To finance our operations, we will need to raise additional capital. As described below, we cannot expect to receive any cash proceeds from the exercise of warrants in the near term, because the exercise of warrants is not in our control. We are seeking additional cash to fund our growth through future debt or equity financing transactions; however, there can be no assurance that we will be able to obtain additional capital on terms acceptable to us, if at all, or that we will generate sufficient future revenues and cash flows to fund our operations. We do not currently have any committed external source of funds. We have concluded that these circumstances raise doubt about our ability to continue as a going concern within one year after the issuance date of this Form 10-Q. See Note 1 to our unaudited condensed consolidated financial statements for the period ended MarchJune 31,30, 2026.
The following table summarizes our contractual obligations as of MarchJune 31,30, 2026:
Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was $2.8$5.8 million compared to $2.7$5.7 million for the threesix months ended MarchJune 31,30, 2025This2025. This is primarily due to the timing of certain payments to vendors.vendors as well as increased expenses as discussed in the above "Results of Operations".
Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026 was $0.1$0.7 million, was primarily related to (i) $0.3$1.1 million received from the issuance of new shares of common stock, net of offering costs, which was partially offset by (ii) approximately $0.2$0.4 million paid to settlereduce outstanding notes payable. Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2025 was $6.1$10.1 million, was primarily related to (i) $1.6$5.2 million received from the issuance of new shares of common stock, and (ii) $4.8$5.6 million in proceeds from issuance of pre-funded warrants. This was partially offset by $0.2approximately $0.6 million paid to settlereduce outstanding notes payable.
ICU insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 1 Form 4 filing (1 insider, 1 trade date, 750 shares, about $2.5K) and open-market sales in 0 filings. Net open-market shares: 750 (purchases minus sales); net value about $2.5K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-08-18 | Messinger Michael |
Open-market purchase | 750 | $3.27 | $2.5K |
| 2026-07-01 | Schlorff Eric |
Grant/award | 10,288 | — | — |
| 2026-07-01 | Chung Kevin |
Grant/award | 7,202 | — | — |
| 2026-07-01 | Vincent Bernadette N |
Grant/award | 4,000 | — | — |
| 2026-07-01 | Neuman John |
Grant/award | 4,000 | — | — |
| 2026-07-01 | Van Heel Kenneth |
Grant/award | 4,000 | — | — |
| 2026-07-01 | Baird Jennifer A |
Grant/award | 4,000 | — | — |
Well-known investors holding ICU (13F)
None of the 59 investors we track reported a position in their latest 13F.