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What changed in SeaStar Medical Holding Corp's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of SeaStar Medical Holding Corp's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+428 added−484 removedSource: 10-K (2026-03-25) vs 10-K (2025-03-27)

Top changes in SeaStar Medical Holding Corp's 2025 10-K

428 paragraphs added · 484 removed · 354 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

150 edited+15 added−14 removed146 unchanged
Biggest changeUpon completion of the HDE review, FDA may: (i) issue an Approval Order, which authorizes commercial distribution in accordance with any prescribed conditions of approval; (ii) issue an Approvable Letter that indicates FDA’s belief that the HDE is approvable and states what additional information FDA requires (generally resolution of minor deficiencies or completion of an FDA inspection); (iii) issue a Major Deficiency Letter to inform the applicant that the HDE application lacks significant information necessary for FDA to complete the review and that the application must be amended to provide the necessary information (e.g., additional clinical experience, additional non-clinical data, scientific rationale for data already provided, or new validation data and analyses); (iv) issue a Not Approvable Letter which indicates that FDA does not believe that the application can be approved ‘as-is’ because of significant deficiencies.
Biggest changeOverall, an HDE must be reviewed and a final determination made by FDA within 75 days from the date of the application being filed; however, the review of the application may occur over a significantly longer period of time due to hold periods during which the submitting sponsor (the company) gathers information to address FDA requests for additional information. 24 Table of Contents Upon completion of the HDE review, FDA may: (i) issue an Approval Order, which authorizes commercial distribution in accordance with any prescribed conditions of approval; (ii) issue an Approvable Letter that indicates FDA’s belief that the HDE is approvable and states what additional information FDA requires (generally resolution of minor deficiencies or completion of an FDA inspection); (iii) issue a Major Deficiency Letter to inform the applicant that the HDE application lacks significant information necessary for FDA to complete the review and that the application must be amended to provide the necessary information (e.g., additional clinical experience, additional non-clinical data, scientific rationale for data already provided, or new validation data and analyses); (iv) issue a Not Approvable Letter which indicates that FDA does not believe that the application can be approved ‘as-is’ because of significant deficiencies.
The UOM has granted to 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.
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.
CRRT is the newest of AKI dialysis modality in the market, first becoming available in 1997, and according to Fortune Business Insights, it is estimated that it has grown to a $986 million global market ($354 million market in the U.S.) as of 2019.
CRRT is the newest AKI dialysis modality in the market, first becoming available in 1997, and according to Fortune Business Insights, it is estimated that it has grown to a $986 million global market ($354 million market in the U.S.) as of 2019.
A similar study known as SCD-PED-02 was undertaken in pediatric patients weighing between 10 and 20 kg. The study enrolled 6 patients (proposed maximum of up to 10 patients). 5/6 (83%) patients survived to ICU discharge and all surviving patients were dialysis-independent by Day 60.
A similar study known as SCD-PED-02 was undertaken in pediatric patients weighing between 10 and 20 kg. The study enrolled 6 patients (proposed maximum of up to 10 patients). 5 of the 6 (83%) patients survived to ICU discharge and all surviving patients were dialysis-independent by Day 60.
We strive to protect the proprietary technologies that we believe are important to our business. We have and will continue to seek patent protection for our SCD product and related technologies, as well for any future products.
We strive to protect the proprietary technologies that we believe are important to our business. We have and will continue to seek patent protection for our SCD product and related technologies, as well as for any future products.
Premarket Approval Pathway A premarket approval application must be submitted to the FDA for Class III devices for which the FDA has required a PMA. The premarket approval application process is more extensive than the 510(k) premarket notification and de novo request processes.
Premarket Approval Pathway A PMA application must be submitted to the FDA for Class III devices for which the FDA has required a PMA. The PMA application process is more extensive than the 510(k) premarket notification and de novo request processes.
Healthcare providers that use medical devices generally rely on third-party payors to pay for all or part of the costs and fees associated with the medical procedures being performed or to compensate them for their patient care services.
Healthcare providers that use medical devices generally rely on third-party payors to pay for all or part of the costs and fees associated with the medical procedures being performed or to compensate them for their patient care services.
The patents and applications in Patent Family 4 are as follows: 20 Patent Family 4† Jurisdiction Status Expiration Subject Matter Date United States Granted 2032 Methods for increasing myocardial function in subject with acute decompensated heart failure United States Granted 2032 Methods for increasing myocardial function in subject with chronic heart failure Australia Granted 2032 Methods for increasing myocardial function in a subject with acute chronic heart failure or chronic heart failure Australia Granted 2032 Methods, cartridges, and systems for improving myocardial function and treating inflammation associated with acute decompensated heart failure and chronic heart failure Canada Granted 2032* Devices for use in treating subjects with chronic heart failure and acute decompensated heart failure Europe Pending 2032* Devices for use in treating subjects with chronic heart failure or acute decompensated heart failure * Expiration date if application is granted. † This patent family was developed with U.S. federal government funding and is subject to obligations under the Bayh-Dole Act.
The patents and applications in Patent Family 4 are as follows: Patent Family 4 † Jurisdiction Status Expiration Subject Matter Date United States Granted 2032 Methods for increasing myocardial function in subject with acute decompensated heart failure United States Granted 2032 Methods for increasing myocardial function in subject with chronic heart failure Australia Granted 2032 Methods for increasing myocardial function in a subject with acute chronic heart failure or chronic heart failure Australia Granted 2032 Methods, cartridges, and systems for improving myocardial function and treating inflammation associated with acute decompensated heart failure and chronic heart failure Canada Granted 2032 Devices for use in treating subjects with chronic heart failure and acute decompensated heart failure Europe Pending 2032* Devices for use in treating subjects with chronic heart failure or acute decompensated heart failure * Expiration date if application is granted. † This patent family was developed with U.S. federal government funding and is subject to obligations under the Bayh-Dole Act.
This complex highly coordinated process is critical for host defense and tissue repair but needs to be tightly regulated by the body’s inflammatory signaling and cellular apoptosis. If it is not tightly regulated and begins to spiral out of control, further tissue destruction may occur when uncontrolled hyperinflammation leads to degradative reparative processes with worsening tissue or organ function.
This complex highly coordinated process is critical for host defense and tissue repair but needs to be tightly regulated by the body’s inflammatory signaling and cellular apoptosis. If it is not tightly regulated and begins to spiral out of control, further tissue destruction may occur when uncontrolled hyperinflammation leads to degradative processes with worsening tissue or organ function.
Such relationships enable us to expand and refine the design and execution of our clinical plans with a more targeted outcome and objectives. On February 21, 2024, we received the FDA HDE Approval Order, which allows sales to qualified healthcare facilities. In February 2023, we received FDA IDE approval for the adult AKI indication.
Such relationships enable us to expand and refine the design and execution of our clinical plans with a more targeted outcome and objectives. On February 21, 2024, we received the FDA HDE Approval Order, which allows sales of QUELIMMUNE to qualified healthcare facilities. In February 2023, we received FDA IDE approval for the adult AKI indication.
Data from our trials demonstrated that the use of our SCD therapy to reverse the cytokine storm in more than 150 3 pediatric and adult patients with acute kidney injury on CRRT reduced mortality rates by 50%, and of those patients who survived 60 days, none have required dialysis.
Data from our trials demonstrated that the use of our SCD therapy to reverse the cytokine storm in more than 150 pediatric and adult patients with acute kidney injury on CRRT reduced mortality rates by 50%, and of those patients who survived 60 days, none have required dialysis.
Our SCD therapy is an extracorporeal synthetic membrane device designed to bind activated leukocytes (neutrophils and monocytes) when integrated into an existing CRRT circuit in conjunction with the use of regional citrate anticoagulation (“RCA”). The SCD is simply added to the standard CRRT circuit that uses regional citrate anticoagulation and is placed immediately following the standard hemofilter cartridge.
Our SCD therapy is an extracorporeal synthetic membrane device designed to bind activated leukocytes (neutrophils and monocytes) when integrated into an existing CRRT circuit in conjunction with the use of regional citrate anticoagulation (“RCA”). The SCD is simply added to the standard CRRT circuit that uses RCA and is placed immediately following the standard hemofilter cartridge.
Globally consistent criteria for diagnosing AKI have recently emerged with Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease, an international consensus classification for AKI staging and diagnosing guidelines introduced in 2004, the Acute Kidney Injury Network staging system in 2007, and finally the Kidney Disease: Improving Global Outcomes, AKI Staging and Diagnosing Guidelines published in 2012.
Globally consistent criteria for diagnosing AKI have recently emerged with the RIFLE classification (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease), an international consensus classification for AKI staging and diagnosing guidelines introduced in 2004, the Acute Kidney Injury Network staging system in 2007, and finally the Kidney Disease: Improving Global Outcomes, AKI Staging and Diagnosing Guidelines published in 2012.
The most frequent categories of SAEs were infections and infestations as well as cardiac, respiratory, thoracic and mediastinal disorders. Furthermore, none of the SAEs were considered “definitely” related to the SCD device per the principal investigator. Overall adverse events did not differ between the treatment and control groups in the intent to treat analysis.
The most frequent categories of SAEs were infections and infestations as well as cardiac, respiratory, thoracic and mediastinal disorders. None of the SAEs were considered “definitely” related to the SCD device per the principal investigator. Overall adverse events did not differ between the treatment and control groups in the intent to treat analysis.
The FDA and/or the IRB at each site at which a clinical trial is being performed may withdraw approval of a clinical trial at any time for 25 various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply with FDA or IRB requirements.
The FDA and/or the IRB at each site at which a clinical trial is being performed may withdraw approval of a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply with FDA or IRB requirements.
In addition to seeking patent protection, we also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider 17 appropriate for, patent protection. We also rely on know-how, confidentiality agreements, license agreements and other agreements to establish and protect our proprietary rights.
In addition to seeking patent protection, we also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. We also rely on know-how, confidentiality agreements, license agreements and other agreements to establish and protect our proprietary rights.
Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or approval of our products under development. 26 Healthcare Regulation In addition to the FDA’s restrictions on marketing of pharmaceutical products and medical devices, the United States healthcare laws and regulations that may affect our ability to operate include: the federal fraud and abuse laws, including the federal anti-kickback and false claims laws, federal data privacy and security laws, and federal transparency laws related to payments and/or other transfers of value made to physicians and other healthcare professionals and teaching hospitals.
Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or approval of our products under development. 26 Table of Contents Healthcare Regulation In addition to the FDA’s restrictions on marketing of pharmaceutical products and medical devices, the United States healthcare laws and regulations that may affect our ability to operate include: the federal fraud and abuse laws, including the federal anti-kickback and false claims laws, federal data privacy and security laws, and federal transparency laws related to payments and/or other transfers of value made to physicians and other healthcare professionals and teaching hospitals.
For this trial, the control group received standard CRRT with regional citrate 13 anticoagulation (“RCA”) and the SCD-treated group received up to seven days of SCD therapy. The study was sponsored by the Predecessor with the support of a third-party contract research organization.
For this trial, the control group received standard CRRT with regional citrate anticoagulation (“RCA”) and the SCD-treated group received up to seven days of SCD therapy. The study was sponsored by the Predecessor with the support of a third-party contract research organization.
Nuwellis disputed the validity of the termination and on October 20, 2024, we entered into the Settlement Agreement with Nuwellis, pursuant to which we agreed to pay Nuwellis an aggregate of $900,000 payable in three installments through December 31, 2024.
Nuwellis disputed the validity of the termination and, on October 20, 2024, we entered into the Settlement Agreement with Nuwellis, pursuant to which we agreed to pay Nuwellis an aggregate of $900,000 payable in three installments through December 31, 2025.
However, lack of third-party coverage and reimbursement for our devices could delay or limit their adoption, and as such harm our competitive advantage in the market. Sales and Marketing We use a direct model for marketing and selling QUELIMMUNE.
However, lack of third-party coverage and reimbursement for our devices could delay or limit their adoption, and as such harm our competitive advantage in the market. Sales and Marketing We use a direct model for marketing and sales of QUELIMMUNE.
This results in damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute chronic solid organ dysfunction or failure, including the heart, lung, kidney, liver, and even death.
This results in damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute and potentially chronic solid organ dysfunction or failure, including the heart, lung, kidney, liver, and even death.
The primary objective of the study was to evaluate the safety of up to seven consecutive 24-hour treatments of our SCD. The secondary objective was to evaluate the efficacy of up to seven consecutive 24-hour SCD treatments on all-cause mortality and dialysis 14 dependency at Day 28 and Day 60.
The primary objective of the study was to evaluate the safety of up to seven consecutive 24-hour treatments of our SCD. The secondary objective was to evaluate the efficacy of up to seven consecutive 24-hour SCD treatments on all-cause mortality and dialysis dependency at Day 28 and Day 60.
A PMA application must be supported by extensive data, including but not limited to technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s satisfaction reasonable evidence of safety and effectiveness of the device.
A PMA application must be supported by extensive data, including but not limited to technical, preclinical, clinical, manufacturing and labeling to demonstrate to the FDA’s satisfaction reasonable evidence of safety and effectiveness of the device.
The patents and the application in Patent Family 2 are as follows: Patent Family 2† Jurisdiction Status Expiration Subject Matter Date United States Granted 2032 Cartridge for treating leukocytes or platelets United States Granted 2032 Methods for processing leukocytes or platelets and for treating a subject with an inflammatory condition United States Pending 2031* Methods for processing leukocytes or platelets and for treating a subject with an inflammatory condition Australia Granted 2031 Cartridge for treating leukocytes or platelets and methods for treating a subject with an inflammatory condition France, Germany, Italy, Spain and the United Kingdom Granted 2031 Cartridge for sequestering leukocytes or platelets Canada Granted 2031* Cartridge for processing leukocytes or platelets Japan Granted 2031 Cartridge for treating leukocytes or platelets Japan Granted 2031 Cartridge for treating leukocytes or platelets * Expiration date if application is granted. † This patent family was developed with U.S. federal government funding and is subject to obligations under the Bayh-Dole Act.
The patents and the application in Patent Family 2 are as follows: Patent Family 2 † Jurisdiction Status Expiration Subject Matter Date United States Granted 2032 Cartridge for treating leukocytes or platelets United States Granted 2032 Methods for processing leukocytes or platelets and for treating a subject with an inflammatory condition United States Granted 2031 Methods for processing leukocytes or platelets and for treating a subject with an inflammatory condition Australia Granted 2031 Cartridge for treating leukocytes or platelets and methods for treating a subject with an inflammatory condition France, Germany, Italy, Spain and the United Kingdom Granted 2031 Cartridge for sequestering leukocytes or platelets Canada Granted 2031 Cartridge for processing leukocytes or platelets Japan Granted 2031 Cartridge for treating leukocytes or platelets Japan Granted 2031 Cartridge for treating leukocytes or platelets † This patent family was developed with U.S. federal government funding and is subject to obligations under the Bayh-Dole Act.
We have agreed to indemnify FUSA against certain third-party claims. 16 In December 2024, we entered into the Second Amendment to the initial Supply Agreement, which extended the Supply Agreement through December 31, 2027, updated a part number as well as clarified that FMCNA has 90 days to provide notice to us in the event that FUSA intends to switch the fibers within the SCD as well as the first right of refusal to be the exclusive distributor of the SCD in the United States.
We have agreed to indemnify FUSA against certain third-party claims. 16 Table of Contents In December 2024, we entered into the Second Amendment to the initial Supply Agreement, which extended the Supply Agreement through December 31, 2027, updated a part number as well as clarified that FMCNA has 90 days to provide notice to us in the event that FUSA intends to switch the fibers within the SCD as well as the first right of refusal to be the exclusive distributor of the SCD in the United States.
SCD Therapy for Adult Patients We are currently conducting a pivotal trial, NEUTRALIZE-AKI, to evaluate the safety and efficacy of our SCD therapy in 200 adults with AKI in the ICU receiving CRRT.
SCD Therapy for Adult Patients We are currently conducting a pivotal trial, NEUTRALIZE-AKI, to evaluate the safety and efficacy of our SCD therapy in adults with AKI in the ICU receiving CRRT.
These sources have helped clinicians to improve recognition, staging, 9 diagnosing and subsequent documentation of less obvious cases of AKI secondary diagnoses. While our initial market is focused on AKI patients on CRRT, future indications will likely benefit from improved characterization and diagnosis of patients. As a result, demand for ICU renal replacement therapy is growing.
These sources have helped clinicians to improve recognition, staging, diagnosing and subsequent documentation of less obvious cases of AKI secondary diagnoses. While our initial market is focused on AKI patients on CRRT, future indications will likely benefit from improved characterization and diagnosis of patients. 9 Table of Contents As a result, demand for ICU renal replacement therapy is growing.
Our plans are focused on developing an optimal infrastructure for an effective U.S. commercial launch inclusive of commercial staff requirements, marketing, sales and reimbursement strategies and refinement of the target account universe. 22 Government Regulation Our SCD product is subject to regulation by various regulatory bodies, primarily the FDA and comparable international regulatory agencies, as applicable.
Our plans are focused on developing an optimal infrastructure for an effective U.S. commercial launch inclusive of commercial staff requirements, marketing, sales and reimbursement strategies and refinement of the target account universe. 22 Table of Contents Government Regulation Our SCD product is subject to regulation by various regulatory bodies, primarily the FDA and comparable international regulatory agencies, as applicable.
Information contained on, or that may be accessed through our website is not part of, and is not incorporated into this Annual Report. In addition, the SEC maintains a website that contains reports, proxy statements, and other information about issuers, such as us, who file electronically within the SEC. The address of the website is www.sec.gov. 28
Information contained on, or that may be accessed through our website, is not part of, and is not incorporated into this Annual Report. In addition, the SEC maintains a website that contains reports, proxy statements, and other information about issuers, such as us, who file electronically within the SEC. The address of the website is www.sec.gov. 28 Table of Contents
Additionally, with historical mortality rates approximately 50%, treating AKI is increasingly of interest to clinicians, hospitals, and product manufacturers alike. The AKI patient population is growing on average 6.9% per year according to the Healthcare Cost and Utilization Project commissioned by the Agency for Healthcare Research and Quality, a U.S. federal agency.
Additionally, with historical mortality rates of approximately 50%, treating AKI is of increasing interest to clinicians, hospitals, and product manufacturers alike. The AKI patient population is growing on average 6.9% per year according to the Healthcare Cost and Utilization Project commissioned by the Agency for Healthcare Research and Quality, a U.S. federal agency.
In consideration for such exclusive license, during the term of the UOM License Agreement, we agreed to pay the UOM a royalty fee equal to 1% of net sales as well as a one-time milestone payment of $0.1 million upon FDA approval of the first licensed product under the license, and to reimburse patent costs.
In consideration for such exclusive license, during the term of the UOM License Agreement, we agreed to pay the UOM a royalty fee equal to 1% of net sales as well as a one-time milestone payment of $0.1 million upon FDA approval of the first licensed product under the license (paid in 2024), and to reimburse patent costs.
The inflammatory response is essential to the healing process 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 cause severe damage to a variety of critical organs such as the heart, lungs and kidney.
The inflammatory response is essential to the healing process 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 cause severe damage to a variety of critical organs such as the heart, lungs and kidneys.
On December 27, 2022, we entered into a license and distribution agreement with Nuwellis. We appointed Nuwellis as our exclusive distributor for the sale and distribution of SCD product throughout the United States once we receive written authorization from the FDA to market our SCD for pediatric use pursuant to our HDE application.
On December 27, 2022, we entered into a license and distribution agreement with Nuwellis. We appointed Nuwellis as our exclusive distributor for the sale and distribution of SCD product throughout the United States once we received written authorization from the FDA to market our SCD for pediatric use pursuant to our HDE application.
Therapies that present a cost-neutral to cost-beneficial impact to the health economic system are generally viewed as more favorable from a reimbursement perspective. To this end, we conducted health economic outcomes research (HEOR) to estimate the economic impact of the SCD-PED (QUELIMMUNE) within the pediatric AKI-CKRT patient population.
Therapies that present a cost-neutral to cost-beneficial impact to the health economic system are generally viewed as more favorable from a reimbursement perspective. To this end, we conducted health economic outcomes research (HEOR) to estimate the economic impact of the QUELIMMUNE within the pediatric AKI-CKRT patient population.
These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling, marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting of medical devices. The SCD cartridge interacts with and deactivates the patient’s hyperinflammatory cells prior to their return to the patient.
These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling, marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting of medical devices. The SCD therapy interacts with and deactivates the patient’s hyperinflammatory cells prior to their return to the patient.
Also, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. 23 Although the FDA is not bound by the advisory panel decision, the panel’s recommendations are important to the FDA’s overall decision-making process.
Also, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. 23 Table of Contents Although the FDA is not bound by the advisory panel decision, the panel’s recommendations are important to the FDA’s overall decision-making process.
For example, if the typical course of treatment using an HDE device, in accordance with its intended use, requires the use of seven devices per patient per year, then the ADN for that HDE device would be 56,000 (i.e., 7 x 8000).
For example, if the typical course of treatment using an HDE device, in accordance with its intended use, requires the use of seven devices per patient per year, then the ADN for that HDE device would be 56,000 (i.e., 7 x 8,000).
The subjects who received >96 hours of SCD treatment, per protocol, had a further reduction in mortality to 31% (5/16) ( P Crit Care Explor . 2022;4(5):e0694). SCD-003: Additional Details SCD-003 was a controlled, randomized, and multicenter clinical trial that was initiated in September 2011 and terminated in September 2013 under an FDA approved IDE.
The subjects who received >96 hours of SCD treatment, per protocol, had a further reduction in mortality to 31% (5/16) ( P Crit Care Explor . 2022;4(5):e0694). 13 Table of Contents SCD-003: Additional Details SCD-003 was a controlled, randomized, and multicenter clinical trial that was initiated in September 2011 and terminated in September 2013 under an FDA-approved IDE.
Flow cytometry confirmed that they were the most activated neutrophils and monocytes (see Figure 1 below). Above image: Activated leukoctyes adherence to the membranes. Light micrograph stained with Hematoxylin and Eosin (H&E). Panel A: Low-power micrograph showing adherent cells around each fiber (160x). Panel B and C: Higher-power micrographs showing the clustering of bound leukocytes (400x).
Flow cytometry confirmed that they were the most activated neutrophils and monocytes (see below) Above image: Activated leukocytes adherence to the membranes. Light micrograph stained with Hematoxylin and Eosin (H&E). Panel A: Low-power micrograph showing adherent cells around each fiber (160x). Panel B and Panel C: Higher-power micrographs showing the clustering of bound leukocytes (400x).
(the “Predecessor”) prior to the consummation of the Business Combination. Overview We are a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life.
(the “Predecessor”) prior to the consummation of the Business Combination. Overview We are a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life.
We believe our partners will benefit from insight in other SCD trials around the world as well as data generation that is being conducted by our trials. We believe that our SCD therapy has the potential to apply to multiple indications.
We believe our partners will benefit from insight into other SCD trials around the world as well as data generation that is being conducted by our trials. We believe that our SCD therapy has the potential to apply to multiple indications.
Distribution The Supply Agreement contains a provision granting FUSA a right of first refusal for the first three years after regulatory approval of our SCD product candidate to distribute QUELIMMUNE and adult SCD products in the United States.
Distribution The Supply Agreement contains a provision granting FUSA a right of first refusal for the first three years after regulatory approval of our SCD product candidate to distribute the adult SCD products in the United States.
Our Approach - The SCD Therapeutic Device Our 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. In many serious acute illnesses, a hyperinflammatory response occurs as a well-defined coordinated sequential response.
Our Approach - The SCD Therapeutic Device Our SCD therapy is designed as a disease-modifying device that neutralizes overactive 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. In many serious acute illnesses, a hyperinflammatory response occurs as a well-defined coordinated sequential response.
In addition, we may also explore strategic relationships with partners who can provide sources of raw materials while collaborating with us on the marketing and distribution of our product candidates. Our Commercial Stage Product The following disclosure summarizes the key clinical studies in which our SCD product candidates (QUELIMMUNE for pediatrics) have been evaluated.
In addition, we may also explore strategic relationships with partners who can provide sources of raw materials while collaborating with us on the marketing and distribution of our product candidates. Our Clinical Development of the SCD Product Candidates The following disclosure summarizes the key clinical studies in which our SCD product candidates (QUELIMMUNE for pediatrics) have been evaluated.
Clinicians typically address hyperinflammation with therapies that are either immunosuppressive or that target one cytokine, both of which are generally suboptimal in the treatment of hyperinflammation. We believe our technology has the potential to overcome limitations in existing anti-inflammatory treatments and address the challenge of selectively targeting activated neutrophils and monocytes.
Clinicians typically address hyperinflammation with therapies that are either immunosuppressive or that target a specific cytokine, both of which are generally suboptimal in the treatment of hyperinflammation. We believe our technology has the potential to overcome limitations in existing anti-inflammatory treatments and address the challenge of selectively targeting activated neutrophils and monocytes.
Our Growth Strategies Key elements of our growth strategy include innovating and expand our applications through clinical trials; differentiation through medical education; business development and out-licensing activities and scaling production with manufacturing partners.
Our Growth Strategies Key elements of our growth strategy include innovating and expanding our applications through clinical trials; differentiation through medical education; business development and out-licensing activities, and scaling production with manufacturing partners.
In this group, the 60-day mortality rate was 16% in the SCD-treated group compared to 41% in the control group. Furthermore, the composite endpoint of mortality and/or dialysis dependency at day 60 was lower in the PP SCD-treated group compared to the control group (16% vs. 58%, respectively, p = 0.01) (Tumlin JA, et al. PLoS One . 2015;10(8):e0132482).
Furthermore, the composite endpoint of mortality and/or dialysis dependency at day 60 was lower in the PP SCD-treated group compared to the control group (16% vs. 58%, respectively, p = 0.01) (Tumlin JA, et al. PLOS One . 2015;10(8):e0132482).
This study was sponsored by the Predecessor with the support of a third-party contract research organization. Sixteen patients (eight male and eight female) were enrolled in the study at four United States pediatric medical centers, which ran from December 2016 through February 2020.
This study was sponsored by the Predecessor with the support of a third-party contract research organization. 14 Table of Contents Sixteen patients (eight male and eight female) were enrolled in the study at four United States pediatric medical centers, which ran from December 2016 through February 2020.
We may also terminate the agreement by giving the UOM 90-day advance notice provided certain conditions are met. 19 In addition to the co-owned patents and patent applications in Family 1, we also solely own three additional patent families (Families 2-4) directed to the SCD Technology.
We may also terminate the agreement by giving the UOM 90-day advance notice provided certain conditions are met. 19 Table of Contents In addition to the co-owned patents and patent applications in Family 1, we also solely own three additional patent families (Families 2-4) directed to the SCD technology.
We believe that our SCD approach, which targets activated cells, is a potentially transformative, if not disruptive, therapeutic approach to a range of acute and chronic inflammatory disorders.
We believe that our SCD approach, which targets only highly activated cells, is a potentially transformative, if not disruptive, therapeutic approach to a range of acute and chronic inflammatory disorders.
As of December 31, 2024, we fulfilled all of our obligations to Nuwellis and have hired sales and marketing employees focused on the commercialization of QUELIMMUNE into the U.S. market.
As of December 31, 2025, we fulfilled all of our obligations to Nuwellis and have hired sales and marketing employees focused on the commercialization of QUELIMMUNE into the U.S. market.
FDA’s Pre-market Clearance and Approval Requirements Each medical device we seek to commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, a de novo request or a PMA or HDE approval from the FDA.
FDA ’ s Pre-market Clearance and Approval Requirements Each medical device we seek to commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, a de novo request or a PMA or HDE approval from the FDA.
We received our first BDD in 2022, two additional BDDs in 2023, and a fourth BDD in 2024. • On April 29, 2022, we received a BDD for the use of our SCD in the treatment of immunomodulatory dysregulation in adult patients (18 and older) with AKI, which is expected to accelerate the regulatory approval process for our ongoing pivotal trial. • On September 28, 2023, we received BDD for our SCD for use in patients in the hospital ICU with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device. • On October 18, 2023, we received BDD designation for our SCD for use with patients in the hospital ICU with AKI and acute on chronic liver failure. • On November 6, 2024, we received BDD for our SCD to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis, also known as chronic dialysis.
We received our first BDD awards in 2022 with the following additional BDDs in adult patient indications thereafter: • On April 29, 2022, we received a BDD for the use of our SCD in the treatment of immunomodulatory dysregulation in adult patients (18 and older) with AKI, which is expected to accelerate the regulatory approval process for our ongoing pivotal trial. • On September 28, 2023, we received BDD for our SCD for use in patients in the hospital ICU with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device. • On October 18, 2023, we received BDD designation for our SCD for use with patients in the hospital ICU with AKI and acute on chronic liver failure. • On November 6, 2024, we received BDD for our SCD to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis, also known as chronic dialysis.
Cardiorenal Syndrome Cardiorenal syndrome (“CRS”) is a clinical disorder in which therapy to relieve the congestive symptoms of chronic heart failure is limited by a decline in renal function.
Study in Cardiorenal Syndrome Patients Cardiorenal syndrome (“CRS”) is a clinical disorder in which therapy to relieve the congestive symptoms of chronic heart failure is limited by a decline in renal function.
We have issued patents that have terms expiring from 2025 through 2034, although terminal disclaimers, patent term extension or patent term adjustment can shorten or lengthen the patent term. The following table summarizes the number of our patents and patent applications as of December 31, 2024: U.S. Patents Foreign Patents U.S.
We have issued patents that have terms expiring from 2025 through 2032, although terminal disclaimers, patent term extension or patent term adjustment can shorten or lengthen the patent term. The following table summarizes the number of our patents and patent applications as of December 31, 2025: U.S. Patents Foreign Patents U.S.
If the FDA determines that an HDE holder is eligible to sell the device for profit, the FDA will determine the ADN and notify the HDE holder. The ADN is calculated by taking the number of devices reasonably necessary to treat or diagnose an individual per year and multiplying it by 8000.
If the FDA determines that an HDE holder is eligible to sell the device for profit, the FDA will determine the ADN and notify the HDE holder. The ADN is calculated by taking the number of devices reasonably necessary to treat or diagnose an individual per year and multiplying it by 8,000.
We call the SCD mechanistic process of binding these cells, deactivating them, and releasing them back into circulation as “catch-and-release” system. 7 Histological evaluation of our SCD Microscopy of our SCD after being used for patient treatment demonstrated the binding of leukocytes on the outer surface of the hollow fiber membranes of the cartridge along the blood flow path within the extracorporeal circuit.
We call the SCD mechanistic process of binding these cells, deactivating them, and releasing them back into circulation, a “catch-and-release” system. 7 Table of Contents Histological evaluation of our SCD Microscopy of our SCD after being used for patient treatment demonstrated the binding of leukocytes on the outer surface of the hollow fiber membranes of the cartridge along the blood flow path within the extracorporeal circuit.
The FDA has 180 days of FDA review time to review a filed premarket approval application, although the review of an application generally occurs over a significantly longer period of time due to hold periods during which the submitting sponsor (the Company) gathers information to address FDA requests for additional information.
The FDA has 180 days of FDA review time to review a filed PMA application, although the review of an application generally occurs over a significantly longer period of time due to hold periods during which the submitting sponsor (the Company) gathers information to address FDA requests for additional information.
By pursuing and establishing business relationships with partners who may have strong capabilities beyond AKI, such as the markets for respiratory distress syndrome, we may be able to expand our solutions to the chronic disease setting. • Scaling production with manufacturing partners: As we progress through our planned clinical trials and the commercial launch of our SCD in pediatrics (QUELIMMUNE) as well as additional adult product candidates if FDA approval is received, we are focused on identifying and securing various suppliers and manufacturing partners to scale production in response to the expected demand for our solutions.
By pursuing and establishing business relationships with partners who may have strong capabilities beyond AKI, such as the markets for ESRD and respiratory distress syndrome, we may be able to expand our solutions to the chronic disease setting. • Scaling production with manufacturing partners: As we progress through our planned clinical trials and the commercial launch of our QUELIMMUNE in pediatrics as well as potential additional adult indications for our SCD therapy if FDA approval is received, we are focused on identifying and securing various suppliers and manufacturing partners to scale production in response to the expected demand for our solutions.
Our success depends in large part on our ability to protect our proprietary technology, including our SCD technologies, and to operate without infringing the proprietary rights of third parties. The term of individual patents depends on the legal term of the patents in the countries in which they are obtained.
Our success depends in large part on our ability to protect our proprietary technology, including our SCD technologies, and to operate without infringing the proprietary rights of third parties. 17 Table of Contents The term of individual patents depends on the legal term of the patents in the countries in which they are obtained.
If this excessive systemic inflammation is severe and prolonged, multi-organ failure, including cardiovascular, respiratory, kidney, liver and neurologic dysfunction may occur, resulting in poor clinical outcomes. Prior therapeutic approaches to block soluble mediator targets, such as cytokines or free radicals have not proven successful.
If this excessive systemic inflammation is severe and prolonged, multi-organ failure, including cardiovascular, respiratory, renal, hepatic and neurologic dysfunction may occur, resulting in poor clinical outcomes. Prior therapeutic approaches to block soluble mediator targets, such as cytokines or free radicals have not proven successful.
Among the per-protocol (PP) cohort of patients who achieved the recommended iCal range, the composite of death or dialysis dependency at 60 days was observed in 16% of SCD-treated subjects versus 58% of control subjects. The incidence of serious adverse events did not differ between the treated and control groups.
Among the per-protocol (PP) cohort of patients who achieved the recommended iCal range, the composite of death or dialysis dependency at 60 days was observed in 16% (03/19) of SCD-treated subjects versus 58% (18/31) of control subjects. The incidence of serious adverse events did not differ between the treated and control groups.
Our BDD awards by the FDA in four therapeutic areas are expected to expedite the clinical development 4 and regulatory review of the SCD therapy for use in the designated patient populations and are the primary focus of our future clinical development decisions.
Our BDD awards by the FDA in multiple therapeutic areas are expected to expedite the clinical development and regulatory review of the SCD therapy for use in the designated patient populations and are the primary focus of our future clinical development decisions.
Clinical Trials Clinical trials are almost always required to support premarket approval and are sometimes required for 510(k) clearance. In the U.S., for significant risk devices, these trials require submission of an application for an IDE to the FDA.
Clinical Trials Clinical trials are almost always required to support PMA and are sometimes required for 510(k) clearance. In the U.S., for significant risk devices, these trials require submission of an application for an IDE to the FDA.
We intend to focus our marketing strategies not only on the therapeutic capabilities of our technology, but also the economic consequences of hyper-inflammation in the current standard of care and treatment infrastructure and highlight the differentiating factors of our SCD product candidates that can provide a cost-effective solution. • Business development and out-licensing activities: We intend to explore and pursue business development opportunities with major medical and pharmaceutical companies to establish partnerships, including outbound licensing arrangements.
We intend to focus our marketing strategies not only on the therapeutic capabilities of our technology, but also the economic consequences of hyper-inflammation in the current standard of care and treatment infrastructure and highlight the differentiating factors of our SCD therapy that can provide a cost-effective solution. 10 Table of Contents • Business development and out-licensing activities: We intend to explore and pursue business development opportunities with major medical and pharmaceutical companies to establish partnerships, including outbound licensing arrangements.
We are also conducting exploratory clinical research with the University of Michigan to define the patient population for potential treatment with SCD product candidates, and any future studies will be based upon initial clinical data collected in these studies. Other Clinical Studies The table below lists the major studies conducted in AKI to date with our SCD.
We have also conducted exploratory clinical research with the University of Michigan to define the patient population for potential treatment with SCD product candidates, and any future studies will be based upon initial clinical data collected in these studies. 12 Table of Contents Other Clinical Studies in AKI The table below lists the major studies conducted in AKI to date with our SCD.
A recent study in the Journal of the American Medical Association in 2020 demonstrated that while the use of regional citrate anticoagulation has the same mortality profile as heparin, regional citrate anticoagulation has been shown to be more effective in preserving filter life and is used to create the low calcium environment for our SCD therapy, which impacts the white cells interaction with the SCD membrane leading to the reduction in inflammation.
A study in the Journal of the American Medical Association in 2020 demonstrated that while the use of RCA has the same mortality profile as heparin, RCA has been shown to be more effective in preserving filter life and is used to create the low calcium environment for our SCD therapy, which impacts the white blood cells interaction with the SCD membrane leading to the reduction in inflammation.
This led to the FDA granting the SCD a BDD for HRS in October 2023. Myocardial Ischemia in End-Stage Renal Disease Patients on Chronic Hemodialysis A major cause of death in patients on chronic dialysis is due to cardiovascular disease.
This led to the FDA granting the SCD a BDD for HRS in October 2023. Pilot Safety Trial of SCD Therapy in Myocardial Ischemia in End-Stage Renal Disease Patients on Chronic Hemodialysis A major cause of death in patients on chronic dialysis is due to cardiovascular disease.
After a premarket approval application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive review and thus whether the FDA will file the application for review.
After a PMA application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive review and thus whether the FDA will file the application for review.
Silver and Glenn M Chertow titled “The Economic Consequences of Acute Kidney Injury” stated hospital costs associated with AKI in the U.S. are between $5.4 billion and $20 billion per year. The kidneys are a silent killer within medical triage.
In fact, a 2017 study by Samuel A. Silver and Glenn M. Chertow titled “The Economic Consequences of Acute Kidney Injury” stated hospital costs associated with AKI in the U.S. are between $5.4 billion and $20 billion per year. The kidneys are a silent killer within medical triage.
In addition, we are currently conducting a pivotal clinical trial to assess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring continuous renal replacement therapy (“CRRT”).
In addition, we are currently conducting a pivotal clinical trial, also referred to as "NEUTRALIZE-AKI" to assess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring continuous renal replacement therapy (“CRRT”).
In conjunction with terminating the Distribution Agreement, we have hired internal sales and marketing employees focused on the initial launch into the U.S. Pediatric Market. Our traction with QUELIMMUNE in pediatric hospitals continues to increase as we add new commercial accounts and work through the IRB process in target accounts.
We have hired internal sales and marketing employees focused on the initial launch of QUELIMMUNE into the U.S. Pediatric Market. Our traction with QUELIMMUNE in pediatric hospitals continues to increase as we add new commercial accounts and work through the IRB process in target accounts.
We commenced our first product shipment of QUELIMMUNE in July 2024 and are now targeting top-tier pediatric medical facilities for adoption of the QUELIMMUNE therapy. As a condition of the approval, the FDA stipulated that we would need to institute a post approval patient surveillance registry to track certain safety and performance metrics.
We commenced our first product shipment of QUELIMMUNE in July 2024 and continue to target top-tier pediatric medical facilities for adoption of the QUELIMMUNE therapy. As a condition of the approval, the FDA stipulated that we would need to institute a post approval patient surveillance registry to track certain safety and performance metrics (the "SAVE Surveillance Registry").
SCD-PED-02 To assess the safety of SCD in children with AKI weighing ≥10 kg and ≤20 kg Safety AKI N=6 None 5/6 (83%) patients survived to ICU discharge and all surviving patients were dialysis-independent by day 60 (Goldstein SL, et al. Kidney Medicine. 2024, doi: https://doi.org/10.1016/j.xkme.2024.100). See additional details below on the SCD-PED studies.
SCD-PED-02 To assess the safety of SCD in children with AKI weighing ≥10 kg and ≤20 kg Safety AKI N=6 None 5/6 (83%) patients survived to ICU discharge and all surviving patients were dialysis-independent by day 60 (Goldstein SL, et al. Kidney Medicine. 2024). See additional details below on the SCD-PED studies.
The two largest operators in the CRRT market by revenue are Fresenius Medical Care Holdings, Inc. and Baxter International, which represent over 80% of the market today in the U.S.
The two largest operators in the CRRT market by revenue are Fresenius Medical Care Holdings, Inc. and Vantive, Inc. (formerly a business of Baxter International), which represent over 80% of the market today in the U.S.
Our senior management team and Board have an average of over 19 years of experience in the healthcare industry, including expertise in regulatory and medical affairs, commercialization and distribution in our initial therapeutic priority areas. We also have assembled a team of well-respected scientific advisors who are experts in the development of our technology and products.
Our senior management team and Board have extensive experience in the healthcare industry, including expertise in regulatory and medical affairs, commercialization and distribution in our initial therapeutic priority areas. We also have assembled a team of well-respected scientific advisors who are experts in the development of our technology and products.
On June 19, 2019, we amended our corporate name to SeaStar Medical, Inc., herein the Predecessor as defined above. On October 28, 2022, LMF Acquisition Opportunities, Inc.
On August 3, 2007, we amended our corporate name to CytoPherx, Inc. On June 19, 2019, we amended our corporate name to SeaStar Medical, Inc., herein the Predecessor as defined above. On October 28, 2022, LMF Acquisition Opportunities, Inc.
We have been granted four Breakthrough Device Designations from the FDA for the SCD device, each of which is expected to expedite the clinical development and regulatory review of the SCD for use in the designated patient population. • Differentiation through medical education: We intend to dedicate resources to educate physicians, hospital clinicians and other decision makers in the medical communities on the role of neutrophils and monocytes in both 10 acute and chronic indications, and therapeutic benefit of controlling and modulating excessive inflammatory response.
We have been granted six BDDs by the FDA for the SCD device, each of which is expected to expedite the clinical development and regulatory review of the SCD therapy for use in the designated patient population. • Differentiation through medical education: We intend to dedicate resources to educate physicians, hospital clinicians and other decision makers in the medical communities on the role of neutrophils and monocytes in both acute and chronic indications, and the therapeutic benefit of controlling and modulating excessive inflammatory response.
QUELIMMUNE therapy was projected to be cost-beneficial by lowering mortality as well as reducing hospital LOS by 3 days in pediatric AKI patients requiring CKRT, with estimated savings of ~$70,000 per hospitalization.
QUELIMMUNE therapy was projected to be cost-beneficial by lowering mortality as well as reducing hospital LOS by 3 days in pediatric AKI patients requiring CKRT, with estimated savings of ~$40,000 per hospitalization after six days of QUELIMMUNE use.
On September 28, 2023, we received Breakthrough Device Designation for our patented and cell-directed SCD for use with patients in the hospital ICU with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device.
On September 28, 2023, we received BDD for our SCD therapy for use with patients in the hospital ICU with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

136 edited+30 added−91 removed184 unchanged
Biggest changeRisk Factor Summary • 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. 29 • 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.
Biggest changeRisk Factor Summary • We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. • We have not generated substantial revenue to date and we may never be profitable. • We may suffer from lack of availability of additional funds. • There is substantial doubt about our ability to continue as a going concern. • 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. • We have a limited operating history, which makes it difficult to forecast our future results of operations. • Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations. • 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. • Difficulties in manufacturing our SCD could have an adverse effect upon our revenue and expenses. • Our SCD technology may become obsolete. • We face intense competition in the medical device industry. • 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 litigation be pursued. • 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. 29 Table of Contents • 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 forecasted operating and financial results rely upon assumptions and analyses development by us and actual results could be significantly below forecasts. • Our estimates of market opportunity, industry projections and forecasts of operating and financial results and market growth may prove to be inaccurate. • Conflicts, military actions, terrorist attacks, political events, public health crises, changes in regulatory regimes and general instability, could adversely affect our business. • 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. • We could become involved in intellectual property litigation that could be costly, require us to pay damages, prevent us from selling commercially available products at all or reduce margins we may realize from 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. • 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 licensors terminate the licenses or fail to maintain or enforce the underlying patents, our competitive position could be materially harmed. We rely in part upon exclusively licensed patent rights for the development of our SCD technology. For example, we co-own with, and exclusively licenses from, the UOM patents related to the SCD technology.
If licensors terminate the licenses or fail to maintain or enforce the underlying patents, our competitive position could be materially harmed. We rely in part upon exclusively licensed patent rights for the development of our SCD technology. For example, we co-own with, and exclusively licensed from, the UOM patents related to the SCD technology.
We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we intend to continue to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved, and exemptions from any rules that the Public Company Accounting Oversight Board may adopt requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.
We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we intend to continue to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved, and exemptions from any rules that the Public Company Accounting Oversight Board may adopt requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.
Even if we receive regulatory approval to market and sell our 32 other SCD product candidates, our revenue growth could slow in the future, or our revenue could decline or fluctuate for a number of reasons, including slowing demand for our products, increasing competition, changing demand in the markets, new scientific or technological developments, a decrease in the growth of our overall market, our failure to attract more customers, the inability to obtain reimbursement for our products by government agencies and insurers, or our failure, for any reason, to continue to take advantage of growth opportunities.
Even if we receive regulatory approval to market and sell our other SCD product candidates, our revenue growth could slow in the future, or our revenue could decline or fluctuate for a number of reasons, including slowing demand for our products, increasing competition, changing demand in the markets, new scientific or technological developments, a decrease in the growth of our overall market, our failure to attract more customers, the inability to obtain reimbursement for our products by government agencies and insurers, or our failure, for any reason, to continue to take advantage of growth opportunities.
The following examples are illustrative: • others may be able to make products that are the same as or similar to our products but that are not covered by the claims of patents that we own or have rights to; • we or our licensors or any current or future strategic partners might not have been the first to conceive or reduce to practice the inventions covered by our patents or pending patent applications; • we or our licensors or any future strategic partners might not have been the first to file patent applications covering the inventions in our patents or applications; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • our pending patent rights may not lead to issued patents, or the patents, if granted, may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors; • our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • third parties manufacturing or testing our products or technologies could use the intellectual property of others without obtaining proper licenses; • we may not develop additional technologies that are patentable; and • third parties may allege that our development and commercialization of our products infringes their intellectual property rights, and the outcome of any related litigation may have an adverse effect on our business, results of operations and financial condition.
The following examples are illustrative: • others may be able to make products that are the same as or similar to our products but that are not covered by the claims of patents that we own or have rights to; • we or our licensors or any current or future strategic partners might not have been the first to conceive or reduce to practice the inventions covered by our patents or pending patent applications; • we or our licensors or any future strategic partners might not have been the first to file patent applications covering the inventions in our patents or applications; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • our pending patent rights may not lead to issued patents, or the patents, if granted, may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors; • our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • third parties manufacturing or testing our products or technologies could use the intellectual property of others without obtaining proper licenses; • we may not develop additional technologies that are patentable; and • third parties may allege that our development and commercialization of our products infringe their intellectual property rights, and the outcome of any related litigation may have an adverse effect on our business, results of operations and financial condition.
If we fail, or it is perceived we have failed, to address or comply with such obligations, it could: • increase our compliance and operational costs; • expose us to regulatory scrutiny, actions, fines and penalties; • result in reputational harm; interrupt or stop our clinical trials; • result in litigation and liability; result in an inability to process personal data or to operate in certain jurisdictions; or • harm our business operations or financial results or otherwise result in a material harm to our business.
If we fail, or it is perceived we have failed, to address or comply with such obligations, it could: • increase our compliance and operational costs; • expose us to regulatory scrutiny, actions, fines and penalties; • result in reputational harm; interrupt or stop our clinical trials; • result in litigation and liability; result in an inability to process personal data or to operate in certain jurisdictions; or • harm our business operations or financial results or otherwise result in material harm to our business.
Thus, we cannot be certain that our European patents and patent applications will avoid falling under the jurisdiction of the UPC. This 50 could enable third parties to seek revocation of our European patents in a single proceeding at the UPC rather than through multiple proceedings in each of the jurisdictions in which the European patent is validated.
Thus, we cannot be certain that our European patents and patent applications will avoid falling under the jurisdiction of the UPC. This could enable third parties to seek revocation of our European patents in a single proceeding at the UPC rather than through multiple proceedings in each of the jurisdictions in which the European patent is validated.
For example, we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in post-grant review procedures such as oppositions, derivations, reexaminations, inter parties review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of third parties.
For example, we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in post-grant review procedures such as oppositions, derivations, reexaminations, inter partes review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of third parties.
Our commercial opportunities will be reduced or eliminated if our competitors develop and market products for any of the diseases we target that: • are more effective; • have fewer or less severe adverse side effects; • are better tolerated; • are easier to administer; or • are less expensive than our products or our product candidates.
Our commercial opportunities will be reduced or eliminated if our competitors develop and market more effective products for any of the diseases we target; have fewer or less severe adverse side effects; are better tolerated; are easier to administer; or are less expensive than our products or our product candidates.
The Class Action asserts claims under Section 10(b) of the Exchange Act against us, our Chief Executive Officer and former Chief Financial Officer (collectively, the “Defendants”), as well as claims under Section 20(a) of the Exchange Act against the 33 Defendants. Among other remedies, the Class Action seeks to recover compensatory and other damages.
The Class Action asserts claims under Section 10(b) of the Exchange Act against us, our Chief Executive Officer and former Chief Financial Officer (collectively, the “Defendants”), as well as claims under Section 20(a) of the Exchange Act against the Defendants. Among other remedies, the Class Action seeks to recover compensatory and other damages.
If our assumptions regarding these risks and uncertainties and our future revenue growth are incorrect or change, or if we do not address these risks successfully or forecast its results accurately, our operating and financial results could differ materially from our expectations, and our business could suffer.
If our assumptions regarding these risks and uncertainties and our future revenue growth are incorrect or change, or if we do not address these risks successfully or forecast our results accurately, our operating and financial results could differ materially from our expectations, and our business could suffer.
Accordingly, the 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 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.
We are building experience operating as a United States public company, of which, our executive officers have limited experience in managing a United States public company, which makes their ability to comply with applicable laws, rules, and regulations uncertain.
We are building experience operating as a United States public company and our executive officers have limited experience in managing a United States public company, which makes their ability to comply with applicable laws, rules, and regulations uncertain.
As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing similar or identical products. 48 Depending upon the timing, duration and requirements of FDA marketing approval of our product candidates, our United States patents, if issued, may be eligible for a limited patent term extension under the Hatch-Waxman Act, or under similar legislation in other countries.
As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing similar or identical products. 48 Table of Contents Depending upon the timing, duration and requirements of FDA marketing approval of our product candidates, our United States patents, if issued, may be eligible for a limited patent term extension under the Hatch-Waxman Act, or under similar legislation in other countries.
If we or our licensors fail to maintain the patents and patent applications covering our products, our competitive position would be adversely affected. 53 We may obtain only limited geographical protection with respect to certain patent rights, which may diminish the value of our intellectual property rights in those jurisdictions and prevent us from enforcing our intellectual property rights throughout the world.
If we or our licensors fail to maintain the patents and patent applications covering our products, our competitive position would be adversely affected. 53 Table of Contents We may obtain only limited geographical protection with respect to certain patent rights, which may diminish the value of our intellectual property rights in those jurisdictions and prevent us from enforcing our intellectual property rights throughout the world.
If we are unable to hire the additional accounting and 56 finance staff necessary to comply with these requirements, we may need to retain additional outside consultants.
If we are unable to hire the additional accounting and finance staff necessary to comply with these requirements, we may need to retain additional outside consultants.
Although we are responsible for the disclosure provided in this Annual Report and believes such third-party information is reliable, we have not independently verified any such third-party information. In addition, projections, assumptions and estimates of the future performance of the industry in which we operate are subject to uncertainty and risk due to a variety of factors.
Although we are responsible for the disclosure provided in this Annual Report and believe such third-party information is reliable, we have not independently verified any such third-party information. In addition, projections, assumptions and estimates of the future performance of the industry in which we operate are subject to uncertainty and risk due to a variety of factors.
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.
Our ability to generate meaningful future revenue from product sales depends heavily on our success with the following items: • commercializing QUELIMMUNE, 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 potentially 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.
In addition, we may not have sufficient resources to litigate, enforce or defend our intellectual property rights. 49 Issued patents covering one or more of our products could be found invalid or unenforceable if challenged in patent office proceedings, or in court. Competitors may infringe our patents, trademarks, or other intellectual property.
In addition, we may not have sufficient resources to litigate, enforce or defend our intellectual property rights. 49 Table of Contents Issued patents covering one or more of our products could be found invalid or unenforceable if challenged in patent office proceedings, or in court. Competitors may infringe our patents, trademarks, or other intellectual property.
Item 1A. Risk Factors. Investing in our securities involves risks. Before you make a decision to buy our securities, in addition to the risks and uncertainties discussed above under “Cautionary Note Regarding Forward-Looking Statements,” you should carefully consider the specific risks set forth herein.
Item 1A. Risk Factors. Investing in our securities involves risks. Before you make a decision to buy our securities, in addition to the risks and uncertainties discussed above under “ Cautionary Note Regarding Forward-Looking Statements, ” you should carefully consider the specific risks set forth herein.
In the ordinary course of our business, we handle and processes proprietary, confidential and sensitive information, including personal data, intellectual property, trade secrets, and proprietary business information owned or controlled by us or other third parties, or collectively. We may use and share such sensitive information with service providers and other third parties.
In the ordinary course of our business, we handle and process proprietary, confidential and sensitive information, including personal data, intellectual property, trade secrets, and proprietary business information owned or controlled by us or other third parties, or collectively. We may use and share such sensitive information with service providers and other third parties.
In addition, if any intellectual property owned or licensed by us becomes subject to any of the rights or remedies available to the U.S. government or third parties pursuant to the Bayh-Dole Act, this could impair the value of our intellectual property and could adversely affect ourbusiness.
In addition, if any intellectual property owned or licensed by us becomes subject to any of the rights or remedies available to the U.S. government or third parties pursuant to the Bayh-Dole Act, this could impair the value of our intellectual property and could adversely affect our business.
Any such lawsuit could divert our management’s attention and resources from our ordinary business operations, and we would likely incur significant expenses associated with their defense (including, without limitation, substantial attorneys’ fees and other fees of professional advisors and potential obligations to indemnify current and former officers and directors who are or may become parties to such actions).
Such lawsuits 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).
While we expect the BDD to expedite the clinical development and regulatory review of the SCD program for use in this patient population, there is no guarantee that we will be able to expedite the clinical development or obtain regulatory approval.
While we expect the BDD to expedite the clinical development and regulatory review of the SCD therapy for use in this patient population, there is no guarantee that we will be able to expedite the clinical development or obtain regulatory approval.
Cyberattacks, malicious internet-based activity and online and offline fraud are prevalent and continue to increase, including the possibility that the ongoing conflict between Russia and Ukraine could result in cyberattacks or cybersecurity incidents that may have a direct or indirect impact on our operations.
Cyberattacks, malicious internet-based activity and online and offline fraud are prevalent and continue to increase, including the possibility that the ongoing conflict between Russia and Ukraine or other regional conflicts, could result in cyberattacks or cybersecurity incidents that may have a direct or indirect impact on our operations.
If we are at any time unable to provide an uninterrupted supply of our SCD, our ongoing clinical trials and commercialization of QUELIMMUNE may be delayed, which could materially and adversely affect our business, results of operations and financial condition. Our SCD technology may become obsolete.
If we are at any time unable to provide an uninterrupted supply of our SCD, our ongoing clinical trials and commercialization of QUELIMMUNE may be delayed, which could materially and adversely affect our business, results of operations and financial condition. 38 Table of Contents Our SCD technology may become obsolete.
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. Our business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing, and marketing of medical devices.
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 litigation be pursued. Our business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing, and marketing of medical devices.
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.
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 forego business development opportunities, sell all or a portion of our assets, enter into a business combination, or reduce or eliminate operations.
We are also subject to numerous other risks relating to the regulatory approval process, which include but are not limited to: • an inability to secure and obtain support and references from collaborators and suppliers required by the FDA; • a disagreement with the FDA regarding the design of the trial, including the number of clinical study subjects and other data, which may require us to conduct additional testing or increase the size and complexity of our pivotal study; • a failure to obtain a sufficient supply of cartridges to conduct our trial; • an inability to enroll a sufficient number of subjects; • a shortage of necessary raw materials, such as calcium; and • delays and failures to train qualified personnel to operate the SCD therapy. 34 Even if we obtain approval, the FDA or other regulatory authorities may require expensive or burdensome post-market testing or controls.
We are also subject to numerous other risks relating to the regulatory approval process, which include but are not limited to: • an inability to secure and obtain support and references from collaborators and suppliers required by the FDA; • a disagreement with the FDA regarding the design of the trial, including the number of clinical study subjects and other data, which may require us to conduct additional testing or increase the size and complexity of our pivotal study; • a failure to obtain a sufficient supplies to conduct our trial; • an inability to enroll a sufficient number of subjects; • a shortage of necessary raw materials, such as calcium or IV fluids; and • delays and failures to train qualified personnel to operate the SCD therapy. 34 Table of Contents Even if we obtain approval, the FDA or other regulatory authorities may require expensive or burdensome post-market testing or controls.
Our management and other personnel will need to devote a substantial amount of time to compliance initiatives applicable to public companies, including compliance with Section 404 and the evaluation of the effectiveness of our internal controls over financial reporting within the prescribed timeframe.
Our management and other personnel will need to devote a substantial amount of time to compliance initiatives applicable to public companies, including compliance with Section 404 of the Sarbanes-Oxley Act and the evaluation of the effectiveness of our internal controls over financial reporting within the prescribed timeframe.
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 increased expenses, when, or if, we will be able to achieve or maintain profitability. In addition, our expenses could increase beyond expectations if it is required by the FDA to perform additional, unanticipated studies.
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 expenses, or when, or if, we will be able to achieve profitability. In addition, our expenses could increase beyond expectations if we are required by the FDA to perform additional, unanticipated studies.
We have incurred significant net losses since our inception and had an accumulated deficit of $139.6 million and $114.7 million as of December 31, 2024 and 2023, respectively. 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.
We have incurred significant net losses since our inception and had an accumulated deficit of $151.7 million and $139.6 million as of December 31, 2025 and 2024, respectively. 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.
As a result, we have a limited commercial operating history, making it difficult to accurately forecast future results of our operations and subject to a number of uncertainties and risks, including our ability to plan for and model future growth.
As a result, we have a limited commercial operating history, making it difficult to accurately forecast future results of our operations and subjecting us to a number of uncertainties and risks, including our ability to plan for and model future growth.
The manufacturing of our products may be impacted by: • the availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other supplier; • our ability to comply with new regulatory requirements and cGMP; • potential facility contamination by microorganisms or viruses; • updating of our manufacturing specifications; • product quality success rates and yields; and • global viruses and pandemics.
The manufacturing of our products may be impacted by: • the availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other supplier; • our ability to comply with new regulatory requirements and cGMP; • potential facility contamination by microorganisms or viruses; • updating of our manufacturing specifications; • product quality success rates and yields; and • disruptions outside of our control, such as global viruses and pandemics.
We could become involved in intellectual property litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, prevent us from selling our commercially available products and/or reduce the margins we may realize from our products.
We could become involved in intellectual property litigation that could be costly, result in the diversion of management ’ s time and efforts, require us to pay damages, prevent us from selling our commercially available products and/or reduce the margins we may realize from our products.
For example, the SCD relies on the existing footprint of CRRT pump systems in ICUs, as well as the growing use and adoption of regional citrate as an anticoagulant. Further developments in these areas could require us to reconfigure our SCD product candidates, which may not be commercially feasible, or cause them to become obsolete.
For example, the SCD relies on the existing footprint of CRRT pump systems in ICUs, as well as the growing use and adoption of RCA. Further developments in these areas could require us to reconfigure our SCD product candidates, which may not be commercially feasible, or cause them to become obsolete.
We have received approval for our pediatric SCD, but the product has not received regulatory approval from the FDA, or any foreign regulatory agencies, for use with adult patients.
We have received FDA approval for our pediatric SCD under the HDE (QUELIMMUNE), but the SCD product has not received regulatory approval from the FDA, or any foreign regulatory agencies, for use with adult patients.
Although there may be other suppliers that have equivalent materials that would be available to us, FDA review of any alternate suppliers, if required, could take several months or more to obtain, if it is able to be obtained at all.
Although there may be other suppliers that have equivalent materials that would be available to us, FDA review of any alternate suppliers, if required, could take several months or more to obtain, if they are able to be obtained at all.
Manufacturers may, under their own initiative, recall a product if any material deficiency in a device is found. The FDA requires that certain classifications of recalls be reported to the FDA within ten working days after the recall is initiated.
Manufacturers may recall a product if any material deficiency in a device is found. The FDA requires that certain classifications of recalls be reported to the FDA within ten working days after the recall is initiated.
If approved for use in the United States, we expect that any products that we develop, including the SCD, will be purchased primarily by medical institutions through their operations budget. Payors may include the CMS, which administers the Medicare program and works in partnership with state governments to administer Medicaid, other government programs and private insurance plans.
We expect that any products that we develop, including the SCD, will be purchased primarily by medical institutions through their operations budget. Payors may include the CMS, which administers the Medicare program and works in partnership with state governments to administer Medicaid, other government programs and private insurance plans.
Whether actual operating and financial results and business developments will be consistent with our expectations and assumptions as reflected in our forecast depends on a number of factors, many of which are outside our control, including, but not limited to: • whether we can obtain sufficient capital to develop and commercialize our SCD product candidate and grow our business; • whether we can manage relationships with key suppliers; • the ability to obtain necessary regulatory approvals; • demand for our products; 45 • the timing and costs of new and existing marketing and promotional efforts; • competition, including from established and future competitors; • our ability to retain existing key management, to integrate recent hires and to attract, retain and motivate qualified personnel; • the overall strength and stability of the economies in the markets in which it operates or intends to operate in the future; and • regulatory, legislative and political changes.
Whether actual operating and financial results and business developments will be consistent with our expectations and assumptions as reflected in our forecast depends on a number of factors, many of which are outside our control, including, but not limited to: • whether we can obtain sufficient capital to develop and commercialize our SCD product candidates and grow our business; • whether we can manage relationships with key suppliers or contract research organizations; • the ability to obtain necessary regulatory approvals; • demand for our products; • the timing and cost of new and existing marketing and promotional efforts; • competition, including from established and future competitors; • our ability to retain existing key management, to integrate recent hires and to attract, retain and motivate qualified personnel; • the overall strength and stability of the economies in the markets in which we operate or intend to operate in the future; and • regulatory, legislative and political changes.
If any such parties are successful in opposing its foreign patent applications, we may not gain the protection afforded by those patent applications in particular jurisdictions and may face additional proceedings with respect to similar patents in other jurisdictions, as well as related patents.
Other parties may challenge certain of our foreign patent applications. If any such parties are successful in opposing our foreign patent applications, we may not gain the protection afforded by those patent applications in particular jurisdictions and may face additional proceedings with respect to similar patents in other jurisdictions, as well as related patents.
Product liability claims are expensive to defend and could divert the attention of our management, result in substantial damage awards against us, and harm our reputation. 41 We intend to outsource and rely on third parties for the clinical development and manufacture, sales and marketing of our SCD or any future product candidates that we may develop, and our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties.
Product liability claims are expensive to defend and could divert the attention of our management, result in substantial damage awards against us, and harm our reputation. 41 Table of Contents We intend to outsource and rely on third parties in part for the clinical development and manufacture, sales and marketing of our SCD or any future product candidates that we may develop, and our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties, for which we will not have full control.
While we recently obtained approval from the FDA to conduct the AKI adult pivotal trial for SCD, there is no guarantee that we will be able to complete such trial in a timely manner, or at all, nor will there be any assurance that positive data will be generated from such trials.
While we have obtained approval from the FDA to conduct the pivotal trial for SCD therapy in the adult AKI patient population, there is no guarantee that we will be able to complete such trial in a timely manner, or at all, nor can there be any assurance that positive data will be generated from such trials.
We do not have the required financial and human resources to carry out on our own all the pre-clinical and clinical development for our SCD product candidate or any other or future product candidates that we may develop, and do not have the capability and resources to manufacture, market or sell our SCD product candidate or any future product candidates that we may develop.
We do not have the required financial and human resources to carry out on our own all the pre-clinical and clinical development for our SCD product candidate or any other or future product candidates that we may develop, and do not have the full capability and resources to manufacture, market or sell our SCD product candidate or any future product candidates that we may develop without the potential reliance on third parties.
Any of these outcomes could result in SEC enforcement actions, monetary fines, or other penalties, as well as damage to our reputation, business, financial condition, operating results and share price. 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.
Any of these outcomes could result in SEC enforcement actions, monetary fines, or other penalties, as well as damage to our reputation, business, financial condition, operating results and share price. Our Common Stock may be delisted from Nasdaq if we do not maintain compliance with Nasdaq ’ s continued listing requirements.
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.
We currently do not have sufficient capital to support our operations and complete our planned regulatory approval process for the adult AKI patient indications. We will need to secure additional capital to continue our operations, and such funding may not be available on acceptable terms, or at all.
Delays in successfully completing our planned clinical trials could jeopardize our ability to obtain regulatory approval. Our business prospects will depend on our ability to complete studies, clinical trials, including our planned pivotal trials of our SCD for adult AKI indication, obtain satisfactory results, obtain required regulatory approvals and successfully commercialize our SCD product candidate.
Our business prospects will depend on our ability to complete studies, clinical trials, including our planned pivotal trials of our SCD for adult AKI indication, obtain satisfactory results, obtain required regulatory approvals and successfully commercialize our SCD product candidate.
Legislation could be adopted in the future that limits payments for our products from governmental payors. Furthermore, commercial payors such as insurance companies, could adopt similar policies that limit reimbursement for medical device manufacturers’ products. Therefore, it is possible that our products or the procedures or patient care performed using our products will not be reimbursed at a cost-effective level.
Furthermore, commercial payors such as insurance companies, could adopt similar policies that limit reimbursement for medical device manufacturers’ products. Therefore, it is possible that our products or the procedures or patient care performed using our products will not be reimbursed at a cost-effective level.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage. The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage.
In addition, we sometimes engages individuals or entities to conduct research relevant to our business. The ability of these individuals or entities to publish or otherwise publicly disclose data and other information generated during the course of their research is subject to certain contractual limitations. But these contractual provisions may be insufficient or inadequate to protect our confidential information.
The ability of these individuals or entities to publish or otherwise publicly disclose data and other information generated during the course of their research is subject to certain contractual limitations. But these contractual provisions may be insufficient or inadequate to protect our confidential information.
If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such third party, or those to whom the third party communicates such technology or information, from using that technology or information to compete with us.
If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such third party, or those to whom the third party communicates such technology or information, from using that technology or information to compete with us, and our business, results of operations and financial condition could be adversely affected.
Further, disputes may arise regarding the ownership or inventorship of our patents. While we have entered into assignment of intellectual property agreements with our employees, consultants, and collaborators and believe that we own our patents and applications, the assignment and other ownership agreements that we rely on could be challenged.
While we have entered into assignment of intellectual property agreements with our employees, consultants, and collaborators and believe that we own our patents and applications, the assignment and other ownership agreements that we rely on could be challenged.
Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations. As of December 31, 2024, we had net operating loss (“NOL”) carryforwards for federal and state income tax purposes of $108.2 million and $36.3 million, respectively, which may be available to offset taxable income in the future.
Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations. As of December 31, 2025, we had net operating loss (“NOL”) carryforwards for federal and state income tax purposes of $117.9 million and $52.5 million, respectively, which may be available to offset taxable income in the future.
If we are unable to raise additional capital as and when we need it, our business, results of operations, financial condition and cash flows, and prospects may be materially and adversely affected. 59 Item 1B. Unresolved Staff Comments. None.
If we are unable to raise additional capital as and when we need it, our business, results of operations, financial condition and cash flows, and prospects may be materially and adversely affected. 59 Table of Contents
Our forecasted operating and financial results rely in large part upon assumptions and analyses developed by us. If these assumptions and analyses prove to be incorrect, our actual operating and financial results may be significantly below our forecasts. We have previously provided projected financial and operating information that reflected our estimates of future performance.
If these assumptions and analyses prove to be incorrect, our actual operating and financial results may be significantly below our forecasts. We have previously provided projected financial and operating information that reflected our estimates of future performance.
In the case of our SCD product candidate for the treatment of pediatric AKI, we will be limited in our ability to sell and distribute our SCD units 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.
In the case of our SCD therapy for the treatment of pediatric AKI, we will be limited in our ability to sell and distribute QUELIMMUNE 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. 31 Table of Contents We may suffer from lack of availability of additional funds.
We may also be the subject of phishing attacks, viruses, malware installation, server malfunction, software or hardware failures, loss of data 43 or other computer assets, or other similar issues any of which could have a material and adverse effect on our business, results of operations and financial condition.
We may also be the subject of phishing attacks, viruses, malware installation, server malfunction, software or hardware failures, loss of data or other computer assets, or other similar issues any of which could have a material and adverse effect on our business, results of operations and financial condition. 43 Table of Contents We depend on key personnel and our inability to attract and retain qualified personnel could impede our ability to achieve our business objectives.
An inability to receive government funding could adversely impact our future growth plans. We will initially depend on revenue generated from a single product and in the foreseeable future will be significantly dependent on a limited number of products.
An inability to receive government funding could adversely impact our future growth plans. We currently depend on revenue generated from a single product and in the foreseeable future will be significantly dependent on a limited number of products. We currently depend on revenue generated from QUELIMMUNE and, if approved, our SCD product candidate for adult patients with AKI.
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.
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.
Redemption of the outstanding Public Warrants could force Public Warrant holders (i) to exercise the Public Warrants and pay the exercise price therefore at a time when it may be disadvantageous for Public Warrant holders to do so, (ii) to sell the Public Warrants at the then-current market price when the Public Warrant holders might otherwise wish to hold the Public Warrants or (iii) to accept the nominal redemption price which, at the time the outstanding Public Warrants are called for redemption, is likely to be substantially less than the market value of the Public Warrants.
Redemption of the outstanding Public Warrants could force Public Warrant holders (i) to exercise the Public Warrants and pay the exercise price therefore at a time when it may be disadvantageous for Public Warrant holders to do so, (ii) to sell the Public Warrants at the then-current market price when the Public Warrant holders might otherwise wish to hold the Public Warrants or (iii) to accept the nominal redemption price which, at the time the outstanding Public Warrants are called for redemption, is likely to be substantially less than the market value of the Public Warrants. 57 Table of Contents 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.
Lastly, our ability to achieve significant and sustained growth in our key target markets will depend upon our success in hospital penetration, utilization, publication, our SCD’s reimbursement status and medical education. Our products may not remain competitive with products based on new technologies.
Lastly, our ability to achieve significant and sustained growth in our key target markets will depend upon our success in hospital penetration, utilization, publication, our SCD’s reimbursement status and medical education.
In some cases, litigation may be threatened or brought by a patent holding company or other adverse patent owner who has no relevant product revenues and against whom our patents may provide little or no deterrence.
In some cases, litigation may be threatened or brought by a patent holding company or other adverse patent owner who has no relevant product revenues and against whom our patents may provide little or no deterrence. If we are found to infringe any patents, we could be required to pay substantial damages.
If we were to file a claim against a third party to enforce a patent covering one of our products, the defendant could counterclaim that our patent rights are invalid and/or unenforceable (a common practice in the United States).
If we were to file a claim against a third party to enforce a patent covering one of our products, the defendant could counterclaim that our patent rights are invalid and/or unenforceable (a common practice in the United States). Grounds for a validity challenge could be an alleged failure to meet one or more statutory requirements for patentability.
We rely on third-party consultants, vendors and distributors to manage and implement much of the day-to-day responsibilities of conducting clinical trials and manufacturing and distribution of our current products and product candidates. Accordingly, we are and will continue to be dependent on the timeliness and effectiveness of the efforts of these third parties.
We rely on third-party consultants, vendors and distributors to manage and implement much of the day-to-day responsibilities of conducting clinical trials and manufacturing and distribution of our current products and product candidates.
Depending on future actions by Congress, the United States courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in ways that would weaken our ability to obtain new patents or to enforce our existing and future patents.
Depending on future actions by Congress, the United States courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in ways that would weaken our ability to obtain new patents or to enforce our existing and future patents. 52 Table of Contents Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over financial reporting, we have expended, and anticipate that we will continue to expend, significant resources, including accounting-related costs, and significant management oversight.
However, as an emerging growth company, an attestation of an independent registered public accounting firm will initially not be required. In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over financial reporting, we have expended, and anticipate that we will continue to expend, significant resources, including accounting-related costs, and significant management oversight.
Consequently, patents may not be issued from any applications that are currently pending or that are filed in the future. As such, we do not know the 47 degree of future protection that we will have for our technology. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain.
Consequently, patents may not be issued from any applications that are currently pending or that are filed in the future. As such, we do not know the degree of future protection that we will have for our technology.
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 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 liability for us. Further, the sale of convertible debt securities or additional equity securities could result in additional and potentially substantial dilution to our shareholders.
If medical personnel or their patients suffer injury as a result of any failure of our products to function as designed, or our products are designed inappropriately, we may be subject to lawsuits seeking significant compensatory and punitive damages.
If medical personnel or their patients suffer injury as a result of any failure of our products to function as designed, we may be subject to lawsuits seeking significant compensatory and punitive damages. We have obtained general clinical trial liability insurance coverage; however, our insurance coverage may not be adequate or available.
Although we believe that certain of our patents and applications, if they are granted, will help protect the proprietary nature of our SCD technology, this protection may not be sufficient to protect us during the development of that technology.
Although we believe that certain of our patents and applications, if they are granted, will help protect the proprietary nature of our SCD technology, this protection may not be sufficient to protect us during the development of that technology. Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.
We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 and we intend to continue to take advantage of reduced disclosure and governance requirements applicable to emerging growth companies, which could result in our Common Stock being less attractive to investors and adversely affect the market price of our Common Stock or make it more difficult to raise capital as and when we need it.
If we do not pay dividends, our Common Stock may be less valuable because a return on your investment will only occur if our stock price appreciates. 58 Table of Contents We are an “ emerging growth company ” as that term is used in the Jumpstart Our Business Startups Act of 2012 and we intend to continue to take advantage of reduced disclosure and governance requirements applicable to emerging growth companies, which could result in our Common Stock being less attractive to investors and adversely affect the market price of our Common Stock or make it more difficult to raise capital as and when we need it.
We cannot assure that analysts will continue to cover us or provide favorable coverage. If one or more of the analysts who cover us downgrade our stock or change their opinions of our stock, our share price would likely decline.
If one or more of the analysts who cover us downgrade our stock or change their opinions of our stock, our share price would likely decline.
Although we are developing and implementing governance, compliance, risk management and control framework and culture required for a public company, we may not be able to meet the requisite standards expected by the SEC and/or our investors.
Although we are developing and implementing governance, compliance, risk management and control framework and culture required for a public company, we may not be able to meet the requisite standards expected by the SEC and/or our investors. 54 Table of Contents As a United States public reporting company, we incur significant costs for legal, accounting, insurance, compliance, and other expenses.
To support our current clinical trial needs, we comply with and intend to continue to comply with current Good Manufacturing Practice (“cGMP”) for outsourced manufacturing and in-house assembly of our products.
We outsource the manufacturing of component parts of our SCD and complete final assembly of our SCD kits in-house. The outsourced manufacturing of SCD cartridges is complex and specialized. To support our current clinical trial needs, we comply with and intend to continue to comply with current Good Manufacturing Practice (“cGMP”) for outsourced manufacturing and in-house assembly of our products.
We compete with numerous United States and foreign companies in the medical device industry, and many of our competitors have greater financial, personnel, operational and research and development resources than us. We believe that multiple competitors are or will be developing competing technologies to address cytokine storms.
We compete with numerous United States and foreign companies in the medical device industry, and many of our competitors have greater financial, personnel, operational and research and development resources than us.
If our stockholders sell substantial amounts of Common Stock in the public market, or the market perceives that such sales may occur, the market price of our Common Stock and our ability to raise capital through an issue of equity securities in the future could be adversely affected. 58 In addition, in the future, we may issue additional shares of Common Stock or other equity or debt securities convertible into Common Stock in connection with financing, acquisition, litigation settlement, employee arrangements or otherwise.
If our stockholders sell substantial amounts of Common Stock in the public market, or the market perceives that such sales may occur, the market price of our Common Stock and our ability to raise capital through an issue of equity securities in the future could be adversely affected.
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.
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. 55 Table of Contents If we are unable to develop and maintain an effective system of internal controls over financial reporting, we may not be able to accurately report our financial results in a timely manner, which may materially and adversely affect our business, results of operations and financial condition.
If we do not apply for patent protection prior to such publication, or if we cannot otherwise maintain the confidentiality of our proprietary technology and other confidential information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized.
If we do not apply for patent protection prior to such publication, or if we cannot otherwise maintain the confidentiality of our proprietary technology and other confidential information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized. 51 Table of Contents The United States government may exercise certain rights with regard to our inventions, or licensors ’ inventions, developed using federal government funding.
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. The trading market for our Common Stock is impacted by the research and reports that securities or industry analysts publish about us or our business. We do not have any control over these analysts.
The trading market for our Common Stock is impacted by the research and reports that securities or industry analysts publish about us or our business. We do not have any control over these analysts. We cannot assure that analysts will continue to cover us or provide favorable coverage.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Item 1C. Cybersecurity . We have an information security program designed to identify, protect, detect and respond to and manage reasonably foreseeable cybersecurity risks and threats. To protect our information systems from cybersecurity threats, we use various security tools that help prevent, identify, escalate, investigate, resolve and recover from identified vulnerabilities and security incidents in a timely manner.
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Item 1C. Cybersecurity 60 Item 2. Properties 60 Item 3. Legal Proceedings 60 Item 4. Mine Safety Disclosures 60 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 61 Item 6. [Reserved] 61 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 62 Item 7A.
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These include, but are not limited to, internal reporting, monitoring and detection tools. We regularly assess risks from cybersecurity and technology threats and monitor our information systems for potential vulnerabilities. We utilize third-party information technology services help identify , measure, and prioritize cybersecurity and technology risks, as well as to develop related security controls and safeguards.
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Quantitative and Qualitative Disclosures About Market Risk 72 Item 8. Financial Statements and Supplementary Data 73
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While we have not, as of the date of this Form 10-K, experienced a cybersecurity threat or incident that resulted in a material adverse impact to our business or operations, there can be no guarantee that we will not experience such an incident in the future.
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Such incidents, whether or not successful, could result in our incurring significant costs related to, for example, rebuilding our internal systems, implementing additional threat protection measures, defending against litigation, responding to regulatory inquiries or actions, paying damages, providing customers with incentives to maintain a business relationship with us, or taking other remedial steps with respect to third parties, as well as incurring significant reputational harm.
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In addition, these threats are constantly evolving, thereby increasing the difficulty of successfully defending against them or implementing adequate preventative measures.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties. We lease our headquarters in addition to our final assembly, warehousing and fulfillment facilities at 3513 Brighton Boulevard, Denver, Colorado 80216 pursuant to a lease agreement on a month-to-month basis. We believe this property is adequate to operate our business.
Biggest changeItem 2. Properties. We lease our headquarters on a month-to-month basis and our facility for final assembly, warehousing and fulfillment pursuant to an annual lease agreement at 3513 Brighton Boulevard, Denver, Colorado 80216. We believe this property is adequate to operate our business.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeAmong other remedies, the Derivative Action seeks to recover damages and restitution on behalf of us and certain injunctive relief concerning our corporate governance and internal controls. Additional stockholders may file substantially similar complaints in the future. We will not make separate disclosure of such complaints unless they are materially different than the Derivative Action. Item 4. Mine Safety Disclosures.
Biggest changeAdditional stockholders may file substantially similar complaints in the future. The Company will not make separate disclosure of such complaints unless they are materially different than the Derivative Action.
Item 3. Legal Proceedings. Shareholder Derivative Claims On July 5, 2024, Forrest A K Wells, a purported stockholder of ours, filed a putative class action complaint in the United States District Court for the State of Colorado, captioned Wells v. SeaStar Medical Holding Corporation et al, Case No. 1:24-cv-0187 (D. Colorado) (the “Class Action”).
Item 3. Legal Proceedings. Shareholder Derivative Claims On July 5, 2024, Forrest A K Wells, a purported stockholder of ours, filed a putative class action complaint in the United States District Court for the District of Colorado, captioned Wells v. SeaStar Medical Holding Corporation et al, Case No. 1:24-cv-0187 (D. Colorado) (the “Class Action”).
The Derivative Action alleges, among other things, that the our Chief Executive Officer, former Chief Financial Officer, and certain of our current and former directors violated Section 14(a) of the Exchange Act, breached fiduciary 60 duties and were unjustly enriched by making or allowing to be made purportedly false and misleading statements regarding our prospects for success in obtaining FDA approval for our SCD.
The Derivative Action alleges, among other things, that our Chief Executive Officer, former Chief Financial Officer, and certain of the Company's current and former directors violated Section 14(a) of the Exchange Act, breached fiduciary duties and were unjustly enriched by making or allowing to be made purportedly false and misleading statements regarding our prospects for success in obtaining FDA approval for our SCD.
The Class Action asserts claims pursuant to the Securities Exchange Act of 1934, including Section 10(b), Rule 10b-5 promulgated thereunder and Section 20(a). The Class Action seeks to recover, among other remedies, compensatory damages. On March 4, 2025, the Plaintiff filed an amended complaint. We intend to vigorously defend the action.
The Class Action asserts claims pursuant to the Securities Exchange Act of 1934, including Section 10(b), Rule 10b-5 promulgated thereunder and Section 20(a). The Class Action seeks to recover, among other remedies, compensatory damages. On March 4, 2025, the Plaintiff filed an amended complaint. The Defendants moved to dismiss the complaint.
The Derivative Action further alleges that there were purported deficiencies in our internal financial controls and procedures and improper accounting for classification of certain financial instruments leading to our restatement of previously issued financial statements. The Derivative Action also asserts claims under Section 10(b) and 21D of the Exchange Act against our Chief Executive Officer and former Chief Financial Officer.
The Derivative Action further alleges that there were purported deficiencies in the Company's internal financial controls and procedures and improper accounting for classification of certain financial instruments leading to our restatement of previously issued financial statements.
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The Defendants’ motion to dismiss the complaint was referred to United States District Court Magistrate Judge Timothy P. O’Hara. On February 27, 2026, Magistrate Judge O’Hara issued a written report and recommendation to United States District Judge Regina M. Rodriguez that the complaint be dismissed with leave to amend (“R&R”).
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Lead Plaintiff filed an objection to the R&R on March 13, 2026, and Defendants are expected to respond on March 27, 2026. We cannot predict whether the Magistrate Judge’s R&R will be adopted, modified or rejected by the District Court, or whether the Lead Plaintiff will amend the complaint.
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The Derivative Action also asserts claims under Section 10(b) and 21D of the Exchange Act against our Chief Executive Officer and former Chief Financial Officer. Among other remedies, the Derivative Action seeks to recover damages and restitution on behalf of us and certain injunctive relief concerning our corporate governance and internal controls.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our Common Stock trades on The Nasdaq Capital Market under the symbol “ICU” Holders As of February 24, 2025, there were 81 stockholders of record of our Common Stock.
Biggest changeItem 5. Market for Registrant ’ s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our Common Stock trades on The Nasdaq Capital Market under the symbol “ICU.” Holders As of March 1, 2026, there were 86 stockholders of record of our Common Stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThe 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.
Biggest changeThe 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.
Our future funding requirements, both short-term and long-term, will depend on many factors, including: • 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.
Our future funding requirements, both short-term and long-term, will depend on many factors, including: • conditions in the capital markets; • our ability to receive cash proceeds from our existing funding instruments, including our 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.
If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, 69 which would have a negative impact on our business, prospects, operating results and financial condition.
If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required 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.
Until such time, if ever, as we are able to successfully develop and 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.
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.
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, than we project and our cash and cash equivalents position is reduced faster than anticipated.
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 than we project and our cash position is reduced faster than anticipated.
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 future revenue, and our results of operations and financial position, could be materially adversely affected.
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.
Preclinically, our SCD was tested in various 63 animal models, which include acute myocardial infarction, intracranial hemorrhage, chronic heart failure, sepsis, and acute respiratory distress syndrome. The animal models demonstrated the inflammatory response and how it was modified by our SCD.
Preclinically, our SCD was tested in various animal models, which include acute myocardial infarction, intracranial hemorrhage, chronic heart failure, sepsis, and acute respiratory distress syndrome. The animal models demonstrated the inflammatory response and how it was modified by our SCD.
We consider all positive and negative evidence available in determining the potential realization of deferred tax assets including, primarily, the recent history of taxable earnings or losses. Based on operating losses reported during 2024 and 2023, we concluded there was not sufficient positive evidence to overcome this recent operating history.
We consider all positive and negative evidence available in determining the potential realization of deferred tax assets including, primarily, the recent history of taxable earnings or losses. Based on operating losses reported during 2025 and 2024, we concluded there was not sufficient positive evidence to overcome this recent operating history.
Please see the factors discussed elsewhere in this Annual Report, including those discussed in Part I, Item 1A, “Risk Factors,” for additional information. Results of Operations Comparison of Year Ended December 31, 2024 to Year Ended December 31, 2023 The following table sets forth a summary of our results of operations.
Please see the factors discussed elsewhere in this Annual Report, including those discussed in Part I, Item 1A, “Risk Factors,” for additional information. Results of Operations Comparison of Year Ended December 31, 2025 to Year Ended December 31, 2024 The following table sets forth a summary of our results of operations.
We will remain an EGC under the JOBS Act until the earliest of (i) the last day of our first fiscal year following the fifth anniversary of the closing of the Business Combination, (ii) the last date of our fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the date on which we are deemed to be a “large-accelerated filer” under the rules of the SEC with at least $700.0 million of outstanding securities held by non-affiliates, or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three-years. 71 Contractual Obligations and Commitments The following table summarizes our contractual obligations as of December 31, 2024: ($ in thousands) Total Less than 1 year 1-3 years 3-5 years More than 5 years Contractual Obligations: Note Payable (Insurance Financing) $ 574 $ 574 $ — $ — $ — Total contractual obligations $ 574 $ 574 $ — $ — $ — Insurance Financing In October 2024, we entered into a financing arrangement with a lender to finance a portion of the annual premium of an insurance policy in the amount of $0.7 million.
We will remain an EGC under the JOBS Act until the earliest of (i) the last day of our first fiscal year following the fifth anniversary of the closing of the Business Combination, (ii) the last date of our fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the date on which we are deemed to be a “large-accelerated filer” under the rules of the SEC with at least $700.0 million of outstanding securities held by non-affiliates, or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three years. 71 Table of Contents Contractual Obligations and Commitments The following table summarizes our contractual obligations as of December 31, 2025: ($ in thousands) Total Less than 1 year 1-3 years 3-5 years More than 5 years Contractual Obligations: Insurance Financing 525 525 — — — Total contractual obligations $ 525 $ 525 $ — $ — $ — Insurance Financing In October 2025, we entered into a financing arrangement with a lender to finance a portion of the annual premium of an insurance policy in the amount of $0.7 million.
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 Annual Report. See Note 1 to our audited consolidated financial statements for the year ended December 31, 2024.
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, 2025.
Overview On October 28, 2022, LMF 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, LMF was renamed SeaStar Medical Holdings Corporation (as defined above).
Overview On October 28, 2022, LMAO 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, LMAO was renamed SeaStar Medical Holding Corporation (as defined above).
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 will require 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 have elected to use this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.
We have elected to use this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an EGC or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.
See the section titled “Risk Factors” for additional risks associated with our substantial capital requirements. Critical Accounting Policies and Estimates The preparation of the consolidated financial statements and related disclosures in conformity with U.S.
See the section titled “Risk Factors” for additional risks associated with our substantial capital requirements. 69 Table of Contents Critical Accounting Policies and Estimates The preparation of the consolidated financial statements and related disclosures in conformity with U.S.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. Objective 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.
Item 7. Management ’ s Discussion and Analysis of Financial Condition and Results of Operations. Objective 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.
Based on our results of operations and liquidity as of December 31, 2024, we believe our cash and cash equivalents are 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.
Based on our results of operations and liquidity as of December 31, 2025, we believe our cash is 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, 2025.
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.
Central to inflammation are the cells within blood and lymph circulatory systems, called white blood cells (primarily neutrophils and monocytes). 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.
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.
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.
As a result, we believe that a valuation allowance continues to be necessary based on the more-likely-than-not threshold noted above. A valuation allowance of $28.5 million and $25.6 million was recorded as of and for the years ended December 31, 2024 and 2023, respectively.
As a result, we believe that a valuation allowance continues to be necessary based on the more-likely-than-not threshold noted above. A valuation allowance of $32.0 million and $28.5 million was recorded as of and for the years ended December 31, 2025 and 2024, respectively.
This shelf registration statement covered the offering, issuance and sale by us of up to an aggregate of $100.0 million of its common stock, preferred stock, debt securities, warrants, 68 rights and units (the “2023 Shelf”).
This shelf registration statement covered the offering, issuance and sale of up to an aggregate of $100.0 million of our common stock, preferred stock, debt securities, warrants, rights and units (the “2023 Shelf”).
We expect that our existing cash will be insufficient to fund our operations for the twelve months from filing date of our Form 10-K for the year ended December 31, 2024, including clinical trial expenses and capital expenditure requirements. We believe that this raises doubt about our ability to continue as a going concern.
We expect that our existing cash will be insufficient to fund our operations for the twelve months from the filing date of this Annual Report for the year ended December 31, 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.
Net Loss During the year ended December 31, 2024, we had a net loss of $24.8 million compared to a net loss of $26.2 million for the year ended December 31, 2023.
Net Loss During the year ended December 31, 2025, we had a net loss of $12.2 million compared to a net loss of $24.8 million for the year ended December 31, 2024.
For the year ended December 31, 2024, 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, 2024 and 2023, we had cash and cash equivalents of approximately $1.8 million and $0.2 million, respectively.
For the year ended December 31, 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 $12.0 million.
Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition.
If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition.
Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance. The change in fair value of liability classified warrants each reporting period is recorded to the change in fair value of warrants liability in the consolidated statement of operations. Share Based Compensation Expense.
The risk-free interest rate is the U.S. Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance. The change in fair value of liability classified warrants each reporting period is recorded to the change in fair value of warrants liability in the consolidated statement of operations.
Cash Flows The following table shows a summary of our cash flows for each of the periods shown below: Year Ended December 31, ($ in thousands) 2024 2023 Statement of cash flow data: Total cash (used in)/provided by: Operating activities $ (16,007 ) $ (10,285 ) Investing activities — — Financing activities 17,650 10,414 $ 1,643 $ 129 Cash Flow from Operating Activities Net cash used in operating activities for the fiscal year ended December 31, 2024 was $16.0 million compared to $10.3 million for the fiscal year ended December 31, 2023.
Cash Flows The following table shows a summary of our cash flows for each of the periods shown below: Year Ended December 31, ($ in thousands) 2025 2024 Statement of cash flow data: Total cash (used in)/provided by: Operating activities $ (13,599 ) $ (16,007 ) Investing activities — — Financing activities 23,760 17,650 Net increase in cash $ 10,161 $ 1,643 Cash Flow from Operating Activities Net cash used in operating activities for the fiscal year ended December 31, 2025 was $13.6 million compared to $16.0 million for the fiscal year ended December 31, 2024.
Although actual results could materially differ from those estimates, such estimates are developed based on the best information available to management and management’s best judgments at the time. Significant estimates include the valuation of the (i) incurred-but-not-billed clinical trial costs, (ii) prepaid forward purchase agreement derivative liability, (iii) convertible notes (iv) liability classified warrants, (v) share-based compensation expense.
Although actual results could materially differ from those estimates, such estimates are developed based on the best information available to management and management’s best judgments at the time. Significant estimates include the valuation of the (i) incurred-but-not-billed clinical trial site costs, (ii) liability classified warrants, and (iii) stock-based compensation expense.
Similar to our pediatric SCD (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.
Similar to 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.
Net Loss Net loss consists of our loss from operations, less other expenses, net. Factors Affecting Our Operating Results 65 We believe that our performance and future success depend on several factors that present significant opportunities for us but also pose risks and challenges.
Net Loss Net loss consists of our loss from operations, offset by other income, net and taxes. 64 Table of Contents Factors Affecting Our Operating Results We believe that our performance and future success depend on several factors that present significant opportunities for us but also pose risks and challenges.
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 introduce QUELIMMUNE to pediatric hospital customers.
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.
See Part I, Item 1A “Risk Factors” for additional information. Key Components of Results of Operations Revenue 64 Our pediatric SCD 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.
See Part I, Item 1A “Risk Factors” for additional information. 63 Table of Contents Key Components of Results of Operations Revenue Our pediatric SCD therapy, QUELIMMUNE, received HDE approval from the FDA in February 2024. Since that time, we have been building out our commercial operations, developing our customer base and growing commercial sales of QUELIMMUNE.
Other Income (Expense) Other income (expense) for the years ended December 31, 2024 and 2023 was expense of $7.0 million and $12.0 million, respectively.
Other Income (Expense) 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.
We shipped our first commercial QUELIMMUNE units in July 2024. Through December 31, 2024, we have recognized approximately $0.1 million of revenue from the sale of QUELIMMUNE. Historically, prior period revenue has been primarily derived from government and other grants.
We shipped our first commercial QUELIMMUNE units in July 2024. We recognized $1.2 million and $0.1 million of revenue from the sale of QUELIMMUNE for the years ended December 31, 2025 and 2024, respectively. Historically, prior to 2024, revenue has been primarily derived from government and other grants.
We use a Black-Scholes option pricing model to fair value liability classified warrants, using standard option pricing inputs such as the strike price of each warrant tranche, estimated volatility, time to maturity, and the risk-free interest rate. The risk-free interest rate is the U.S.
We issued PIPE Warrants concurrent with the Business Combination, and the PIPE Warrants include features similar to the Private Placement Warrants. We use a Black-Scholes option pricing model to fair value liability classified warrants, using standard option pricing inputs such as the strike price of each warrant tranche, estimated volatility, time to maturity, and the risk-free interest rate.
Our consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern.
Our consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern. Our need for additional capital will depend in part on the scope and costs of our development activities.
Cash Flow from Financing Activities Net cash provided by financing activities for the fiscal year ended December 31, 2024, was $17.7 million, primarily related to the issuance of new shares of common stock from the combination of certain registered direct offerings and at-the-market issuances, proceeds from convertible notes, and proceeds from the issuance of pre-funded warrants.
Cash Flow from Financing Activities Net cash provided by financing activities for the fiscal year ended December 31, 2025, was $23.8 million, primarily related to proceeds from the issuance of common stock from certain registered direct offerings and ATM issuances, and proceeds from the issuance of pre-funded warrants.
Our net losses were $24.8 million and $26.2 million for the years ended December 31, 2024 and 2023, respectively. Approximately 72% and 54% of our net losses for the years-ended December 31, 2024 and 2023, respectively, resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
The majority of our net losses for the years-ended December 31, 2025 and 2024, respectively, resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
We estimate the grant date fair value of all grants of equity-based awards (which has historically consisted of either stock options or restricted stock units). Emerging Growth Company Status We are an emerging growth company (“EGC”), as defined in the JOBS Act.
Stock-Based Compensation Expense. We estimate the grant date fair value of all grants of equity-based awards (which has historically consisted of either stock options or restricted stock units).
Other Income (Expense), Net Total other income (expense), net primarily consists of interest expense relating to interest incurred on our notes, financing fees related to our convertible notes, gain on issuance of convertible notes, change in 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 related to the conversion option of convertible notes, and interest income derived from cash balances maintained at a commercial financial institution.
Other Income (Expense), Net Total other income (expense), net primarily consists of (i) interest expense relating to interest incurred on notes payable, (ii) a one-time charge for a financing fee related to our standby equity purchase agreement, (iii) changes in the fair value of liability classified warrants, and (iv) interest income derived from cash balances maintained at a commercial financial institution.
We are responsible to cover the costs of these clinical trial efforts, including the cost of patient care relating to the adult 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.
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.
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, 2024 and 2023, we had an accumulated deficit of approximately $139.6 million and $114.7 million, respectively.
We have incurred net losses in each year since our inception in 2007. As of December 31, 2025 and 2024, we had an accumulated deficit of approximately $151.7 million and $139.6 million, respectively. Our net losses were $12.2 million and $24.8 million for the years ended December 31, 2025 and 2024, respectively.
Research and Development Expenses The following table discloses the breakdown of research and development expenses: Year Ended December 31, Change ($ in thousands) 2024 2023 $ % Clinical trials $ 4,391 $ 2,546 $ 1,845 72.5 % External services 1,254 1,111 143 12.9 % Payroll and personnel expenses 3,184 2,164 1,020 47.1 % Other research and development expenses 276 152 124 81.6 % $ 9,105 $ 5,973 $ 3,132 52.4 % Research and development expenses for the years ended December 31, 2024 and 2023 were approximately $9.1 million and $6.0 million, respectively.
Research and Development Expenses The following table discloses the breakdown of research and development expenses: Year Ended December 31, Change ($ in thousands) 2025 2024 $ % Clinical trials $ 3,904 $ 4,391 $ (487 ) (11 )% External services 602 1,254 (652 ) (52 )% Payroll and personnel expenses 2,695 3,184 (489 ) (15 )% Other research and development expenses 317 276 41 15 % $ 7,518 $ 9,105 $ (1,587 ) (17 )% Research and development expenses for the years ended December 31, 2025 and 2024 were approximately $7.5 million and $9.1 million, respectively.
Our accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and liabilities in the normal course of business.
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. Our accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and liabilities in the normal course of business.
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, normal neutrophil die off may be delayed, altering feedback mechanisms that regulate the immune system.
These inflammatory cells release chemicals (cytokines) that trigger the immune system to eliminate foreign pathogens or damaged tissue, enhancing the immune response.
Future Funding Requirements We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue clinical development of our SCD product for approval by the FDA, and (ii) if regulatory approval is obtained, to launch and commercialize our products in the U.S. markets. We will need additional funding in connection with these activities.
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 $40 thousand from the SEPA. 68 Table of Contents Future Funding Requirements We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue clinical development of our SCD product for approval by the FDA, and (ii) if regulatory approval is obtained, to launch and commercialize our products in the U.S. markets.
Our ability to generate product revenue will depend on the successful development of our adult SCD and eventual ongoing commercialization of QUELIMMUNE. Until such time, if ever, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, potential collaborations, other strategic transactions or government and other grants.
Until such time, if ever, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms.
We also continue to develop our adult SCD for which we are enrolling patients in a pivotal study to support FDA approval.
We expect that any revenue we generate will fluctuate from quarter to quarter as we continue to advance our sales of QUELIMMUNE to pediatric hospital customers. We also continue to develop our adult SCD for which we are currently enrolling patients in a pivotal study to support FDA approval.
Year Ended December 31, Change ($ in thousands) 2024 2023 $ % Net Revenue $ 135 $ — $ 135 (*) Operating expenses Research and development 9,105 5,973 3,132 52.4 % General and administrative 8,872 8,237 635 7.7 % Total operating expenses 17,977 14,210 3,767 26.5 % Loss from operations (17,842 ) (14,210 ) (3,632 ) 25.6 % Total other income (expense) (6,985 ) (12,022 ) 5,037 -41.9 % Loss before income tax provision (24,827 ) (26,232 ) 1,405 -5.4 % Income tax provision (benefit) 3 — 3 (*) Net loss $ (24,830 ) $ (26,232 ) $ 1,402 -5.3 % (*) - revenue or expenses which were new to the year ended December 31, 2024 compared to the year ended December 31, 2023.
Year Ended December 31, Change ($ in thousands) 2025 2024 $ % Revenue $ 1,234 $ 135 $ 1,099 814 % Cost of goods sold 53 $ — 53 * Gross profit 1,181 135 1,046 775 % Operating expenses Research and development 7,518 9,105 (1,587 ) (17 )% General and administrative 5,838 8,872 (3,034 ) (34 )% Total operating expenses 13,356 17,977 (4,621 ) (26 )% Loss from operations (12,175 ) (17,842 ) 5,667 (32 )% Total other income (expense) 28 (6,985 ) 7,013 (100 )% Loss before income tax provision (12,147 ) (24,827 ) 12,680 (51 )% Income tax provision 3 3 — — Net loss $ (12,150 ) $ (24,830 ) $ 12,680 (51 )% (*) - revenue or expenses which were new to the year ended December 31, 2025, compared to the year ended December 31, 2024.
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 70 fair value at inception, and the remeasure the warrants. The liability classified warrants consist of the following: (see Note 10 for more information): • Private Placement Warrants.
This classification requires us to measure the warrants at fair value at inception and then remeasure the fair value of the warrants at each reporting period. The liability classified warrants consist of the following (see Note 8 for more information): • Private Placement Warrants. We assumed 22,952 Private Placement warrants as part of the Business Combination. • PIPE Warrants.
This results of damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute chronic solid organ dysfunction or failure, including heart, lung, kidney and liver diseases. 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.
This results in damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute chronic solid organ dysfunction or failure, including the heart, lung, kidney, liver, and even death.
As of December 31, 2024 and December 31, 2023, we had an accumulated deficit of $139.6 million and $114.7 million, respectively. As of December 31, 2024 and December 31, 2023, we had cash of $1.8 million and $0.2 million, respectively.
Since our inception, we have incurred significant operating losses and negative cash flows. As of December 31, 2025 and 2024, we had an accumulated deficit of $151.7 million and $139.6 million, respectively. As of December 31, 2025, we had cash of $12.0 million.
Incurred-But-Not-Billed Clinical Trial Site Costs. Our Neutralize-AKI clinical trial study is conducted at 14 qualified healthcare facilities as of December 31, 2024.
Incurred-But-Not-Billed Clinical Trial Site Costs. Our NEUTRALIZE-AKI clinical trial is being conducted at multiple qualified healthcare facilities as of December 31, 2025. We are responsible to cover the costs of these clinical trial efforts, including the cost of patient care relating to the adult SCD.
The cytokine storm, when left uncontrolled, can lead to organ damage and even death. Currently, few therapeutics are available to clinicians to address hyperinflammation and for those options that do exist, such options are either immunosuppressive or only target one cytokine.
Currently, there are no therapeutic options that specifically neutralize the white blood cells that are primarily responsible for the destructive hyperinflammatory response. 62 Table of Contents Currently, few therapeutics are available to clinicians to address hyperinflammation and for those options that do exist, such options are either immunosuppressive or only target one cytokine.
It is to be paid down in 10 monthly installments through August 2025.
It is to be paid down in 10 monthly installments through August 2026. This financing arrangement is recorded as a note payable on our consolidated balance sheet.
Liquidity and Capital Resources 67 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.
The decline in net loss of $12.7 million primarily resulted from (i) a $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 in 2025 compared to 2024. 66 Table of Contents Liquidity and Capital Resources 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.
Income Tax Provision (Benefit) We recorded a provision for income taxes of $3 thousand for the year ended December 31, 2024, and did not record a provision for income taxes for the year ended December 31, 2023.
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. Income Tax Provision (Benefit) We recorded a provision for income taxes of $3 thousand for each of the years ended December 31, 2025, and 2024, respectively.
The increase in cash used for operating activities of $5.7 million is primarily due to the increased activity related to clinical trial activities for the Neutralize-AKI clinical trial, and certain general and administrative costs.
The decrease in cash used for operating activities of $2.4 million is primarily due to the decline in consulting, legal and accounting related activities (see Results of Operations above).
Accordingly, we estimate the value of these “ incurred-but-not-billed ” activities at the end of each reporting period. Any impact to the Statement of Operations is recognized as a component of research and development expense and included as a component of accrued expenses on the Balance Sheet. Prepaid Forward Purchase Agreement Derivative Liability.
Any impact to the consolidated statement of operations is recognized as a component of research and development expense and included as a component of accrued expenses on the consolidated balance sheet. Liability Classified Warrants. We have entered into or assumed various financial instruments in the form of warrant agreements that require classification as liabilities.
Revenue Net revenue increased $0.1 million to $0.1 million for the year-ended December 31, 2024, compared to no net revenue for the year-ended December 31, 2023. The increase is attributable to the commencement of sales after receiving approval from the FDA to commercially sell our pediatric selective cytopheretic device, QUELIMMUNE, on February 21, 2024.
Revenue Net revenue increased $1.1 million to $1.2 million for the year-ended December 31, 2025, compared to $0.1 million net revenue for the year-ended December 31, 2024.
Cash provided by financing activity for the fiscal year ended December 31, 2023, was $10.4 million, primarily related to the issuance of new shares of common stock, proceeds from convertible notes, and the sale of recycled shares, partially offset by payments of notes payable, and payment of convertible notes Capital Resources Sources of Liquidity Shelf Registrations Shelf Registration 333-275968 - On December 8, 2023, we filed a shelf registration on Form S-3. which was declared effective by the SEC on December 22, 2023.
Net cash provided by financing activity for the fiscal year ended December 31, 2024, was $17.7 million, primarily related to proceeds from the issuance of common stock from certain registered direct offerings and ATM issuances, proceeds from the issuance of convertible notes, and proceeds from the issuance of certain pre-funded warrants. 67 Table of Contents Capital Resources Sources of Liquidity 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.
Removed
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.
Added
We are a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life.
Removed
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 critical to fend off infections and repair damaged tissue in the body.
Added
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.
Removed
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.
Added
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.
Removed
Sales did not occur until after July 1, 2024.
Added
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.
Removed
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 66 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.
Added
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.
Removed
General and Administrative Expenses General and administrative expenses for the years ended December 31, 2024 and 2023 were $8.9 million and $8.2 million, respectively.
Added
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.
Removed
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.
Added
The BDD enables the potential for a speedier pathway to approval and the ability to have more frequent and flexible meetings with the FDA.
Removed
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.
Added
The inflammatory response is essential to the healing process 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 cause severe damage to a variety of critical organs such as the heart, lungs and kidney.
Removed
The decline in net loss of $1.4 million primarily resulted from a decline in other expense of $5.0 million (as discussed above in “ Other Income (Expense) ” offset by increases in general and administrative expenses of $0.6 million, and increases in research and development expenses of $3.1 million.
Added
If the inflammatory response becomes excessive and dysregulated (referred to as proinflammatory), the inflammatory 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.
Removed
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.

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