Financial Performance - Net losses for the years ended December 31, 2024, and 2023 were $24.8 million and $26.2 million, respectively, with a decrease of 5.3% in net loss year-over-year [362][378]. - The net loss decreased to $24.8 million in 2024 from $26.2 million in 2023, attributed to a $5.0 million reduction in other expenses [388]. - The company had an accumulated deficit of approximately $139.6 million as of December 31, 2024 [362]. - As of December 31, 2024, the accumulated deficit reached $139.6 million, up from $114.7 million in 2023 [390]. - Other income (expense) improved to an expense of $7.0 million in 2024 from $12.0 million in 2023, mainly due to a $4.2 million decline in losses from convertible notes [384]. Revenue and Sales - The pediatric SCD, QUELIMMUNE, received FDA approval on February 21, 2024, and the first commercial units were shipped in July 2024, generating approximately $0.1 million in revenue by December 31, 2024 [368][380]. - The company expects revenue to fluctuate as QUELIMMUNE is introduced to pediatric hospital customers and is focused on generating future revenue from product sales and potential collaborations [368][369]. Expenses - Research and development expenses increased by $3.1 million, or 52.4%, from $6.0 million in 2023 to $9.1 million in 2024, primarily due to clinical trial costs and increased personnel expenses [370][381]. - Total operating expenses rose by $3.8 million, or 26.5%, from $14.2 million in 2023 to $18.0 million in 2024 [378]. - General and administrative expenses increased by 7.7% to $8.9 million in 2024 from $8.2 million in 2023, primarily due to increased payroll and accounting costs [383]. Cash Flow and Financing - Cash and cash equivalents were approximately $1.8 million as of December 31, 2024, compared to $0.2 million in 2023 [363]. - Cash used in operating activities rose to $16.0 million in 2024 from $10.3 million in 2023, driven by increased clinical trial activities [393]. - Cash provided by financing activities increased to $17.7 million in 2024 from $10.4 million in 2023, primarily from the issuance of new shares and convertible notes [394]. - The company raised approximately $23.5 million through registered direct offerings and "At-the-Market" offerings since the effectiveness of its shelf registration on December 22, 2023 [396]. - The company had cash of $1.8 million as of December 31, 2024, compared to $0.2 million in 2023, indicating a need for additional funding [391]. Clinical Trials - The pivotal clinical trial for the adult SCD is currently underway with 94 patients enrolled as of March 25, 2025 [355]. - The increase in clinical trial expenses was driven by the Neutralize-AKI Adult SCD study, which had 14 clinical trial sites enrolled by the end of 2024 [381]. Future Outlook and Concerns - The company has incurred net losses since its inception in 2007, raising concerns about its ability to continue as a going concern [364][365]. - Future funding requirements will depend on the progress of clinical trials and the ability to secure additional capital, with no committed external sources currently available [400]. Regulatory and Compliance - The company is classified as an emerging growth company (EGC) under the JOBS Act, allowing it to delay compliance with new accounting standards until it no longer qualifies as an EGC or opts out of the transition period [413]. - The company will remain an EGC until it has total annual gross revenue of at least $1.235 billion or meets other specified criteria [415]. - The company is not required to provide an auditor's attestation report on internal controls due to its EGC status [414]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [419]. Obligations and Arrangements - The company has total contractual obligations of $574,000, all of which are due within one year [417]. - In October 2024, the company entered into a financing arrangement for an insurance policy premium amounting to $0.7 million, to be paid in 10 monthly installments through August 2025 [418]. - The company entered into various convertible credit agreements with an institutional investor, which included detachable warrants [416]. - The company assumed 229,520 Private Placement warrants as part of the Business Combination [416].

SeaStar Medical Holding (ICU) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants Jackie Kosman - Investor Relations AdvisorEric Schlorff - CEOTim Varacek - SVP - Commercial & Business OperationsKevin Chung - Chief Medical OfficerDavid Green - CFO Operator Good afternoon, and thank you for standing by. My name is Calvin, and I will be your conference operator today. At this time, I would like to welcome everyone to the Seastar Star Medical Year End twenty twenty four Financial Results Conf ...

Financial Performance - Net revenue for the year ended December 31, 2024, was $0.1 million, compared to no net revenue for the year ended December 31, 2023, due to the initiation of QUELIMMUNE therapy sales[5] - Net revenue for the year ended December 31, 2024, was $135,000, compared to $0 in 2023, indicating a significant increase[26] - Net loss for the year ended December 31, 2024, was $24.8 million, an improvement from a net loss of $26.2 million in 2023, with net loss per share decreasing from $30.26 to $6.63[11] - The net loss for the year ended December 31, 2024, was $24.830 million, a slight improvement from a net loss of $26.232 million in 2023[26] - The company reported a loss from operations of $17.842 million for the year ended December 31, 2024, compared to a loss of $14.210 million in 2023[26] Expenses - Research and development expenses increased to approximately $9.1 million in 2024 from $6.0 million in 2023, driven by clinical trial expenses and increased personnel costs[6] - Research and development expenses rose to $9.105 million in 2024, up from $5.973 million in 2023, reflecting a 52.3% increase[26] - General and administrative expenses rose to $8.9 million in 2024 from $8.2 million in 2023, primarily due to increased headcount and legal expenses[7] Clinical Trials and Approvals - The NEUTRALIZE AKI pivotal trial has enrolled 94 patients to date, with a target of 200 patients, and includes prestigious clinical sites such as Stanford Medical Center and Cleveland Clinic[8] - QUELIMMUNE therapy was approved by the FDA for pediatric patients with acute kidney injury, impacting approximately 4,000 patients annually[4] - SeaStar Medical was awarded a $3.6 million grant from the National Institutes of Health for a clinical trial evaluating SCD therapy in patients with chronic heart failure[8] Capital and Assets - The company secured approximately $31 million in capital during fiscal 2024, improving its balance sheet and reducing debt[8] - Total assets increased to $4.658 billion as of December 31, 2024, compared to $3.513 billion in 2023, representing a growth of 32.5%[24] - Total liabilities decreased to $6.841 billion in 2024 from $17.383 billion in 2023, a reduction of 60.7%[24] Cash Flow and Share Issuance - Cash at the end of the period increased to $1.819 million from $176,000 in 2023, marking a substantial rise[27] - Cash flows from operating activities resulted in a net cash used of $16.007 million in 2024, compared to $10.285 million in 2023[28] - The company raised $17.441 million from the issuance of shares, net of offering costs, in 2024, compared to $4.742 million in 2023[28] - The weighted-average shares outstanding increased to 4,920,156 in 2024 from 1,532,418 in 2023, indicating a significant increase in share issuance[26] Customer and Recognition - The company has added five commercial customers for QUELIMMUNE therapy and is expanding its customer pipeline[4] - SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to pediatric AKI treatment[8]

Core Insights - SeaStar Medical Holding Corporation reported significant progress in 2024, including the approval and commercial launch of QUELIMMUNE therapy, and the expansion of clinical trials for its Selective Cytopheretic Device (SCD) therapy [2][3] Financial Performance - Net revenue for the year ended December 31, 2024, was $0.1 million, a notable increase from no revenue in 2023, attributed to the launch of QUELIMMUNE therapy [3][4] - The net loss for the year ended December 31, 2024, was $24.8 million, an improvement from a net loss of $26.2 million in 2023, with net loss per share decreasing from $30.26 to $6.63 [8][21] - Cash, cash equivalents, and short-term investments at December 31, 2024, were $1.8 million, excluding proceeds from a $6 million financing completed in February 2025 [8][22] Business Developments - The company received its first product approval for QUELIMMUNE therapy, specifically for pediatric patients with acute kidney injury (AKI) due to sepsis, impacting approximately 4,000 children annually [3][15] - SeaStar Medical added 14 new clinical sites for the NEUTRALIZE AKI pivotal trial, with 94 out of the anticipated 200 patients enrolled [2][3] - The company was awarded its fourth Breakthrough Device Designation for SCD therapy, which is expected to expedite the review and approval processes [2][3] Research and Development - Research and development expenses increased to approximately $9.1 million in 2024 from $6.0 million in 2023, driven by clinical trial expenses and increased personnel costs [5][6] - The National Institutes of Health awarded a $3.6 million grant for a clinical trial evaluating SCD therapy as a bridging strategy for patients with chronic heart failure [3][5] Awards and Recognition - SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to improving the lives of pediatric patients with AKI [3][9]

Core Insights - SeaStar Medical Holding Corporation has made significant progress in 2024, including the approval and commercial launch of its QUELIMMUNE therapy, and is positioned for a transformational year in 2025 [2][3] Business Highlights - The FDA granted approval for QUELIMMUNE therapy for pediatric patients with acute kidney injury (AKI) due to sepsis, impacting approximately 4,000 pediatric patients annually [3] - QUELIMMUNE therapy has been adopted by five customers, with a growing pipeline of prospective customers [3] - The NEUTRALIZE AKI pivotal trial has enrolled 94 out of the anticipated 200 patients, with participation from prestigious medical centers [3][12] - SeaStar Medical received its fourth Breakthrough Device Designation for the Selective Cytopheretic Device (SCD) therapy, aimed at treating chronic systemic inflammation in end-stage renal disease patients [3] - The National Institutes of Health awarded a $3.6 million grant for a clinical trial evaluating SCD therapy as a bridging strategy for patients with chronic heart failure [3] - The company was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric patients with AKI [3] Financial Performance - For the year ended December 31, 2024, net revenue was $0.1 million, a significant increase from no revenue in 2023, attributed to the initiation of QUELIMMUNE sales [5] - Research and development expenses rose to approximately $9.1 million in 2024 from $6.0 million in 2023, driven by clinical trial expenses and increased personnel costs [6] - General and administrative expenses increased to $8.9 million in 2024 from $8.2 million in 2023, primarily due to higher headcount and legal expenses [7] - The net loss for the year was $24.8 million, an improvement from a net loss of $26.2 million in 2023, with a net loss per share of $6.63 compared to $30.26 in the previous year [9][23] Balance Sheet Improvements - The company improved its balance sheet by adding approximately $31 million in capital and reducing debt and liabilities [4] - Cash and cash equivalents at December 31, 2024, were $1.8 million, reflecting a significant increase from $176,000 at the end of 2023 [20]

Core Insights - SeaStar Medical Holding Corporation is set to report its fourth quarter and year-end 2024 financial results on March 27, 2025, after market close [1] - The company focuses on transforming treatments for critically ill patients facing organ failure, with its first commercial product, QUELIMMUNE, approved by the FDA in 2024 [2] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to critically ill patients with organ failure and potential loss of life [2] - QUELIMMUNE (SCD-PED) is the only FDA-approved product for life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [2] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for four therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [2] - The company is conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a condition affecting over 200,000 adults in the U.S. annually [2]

Company Overview - SeaStar Medical has been awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric acute kidney injury (AKI) treatment [1][4] - The company's QUELIMMUNE Selective Cytopheretic Device for Pediatrics (SCD-PED) is the first and only FDA-approved therapeutic device for treating pediatric AKI due to sepsis [2][9] - SeaStar Medical focuses on transforming treatments for critically ill patients facing organ failure, with its first commercial product approved in 2024 [9] Industry Context - Approximately 4,000 children in the U.S. with AKI, primarily due to sepsis, require continuous kidney replacement therapy (KRT) annually, with a mortality rate of around 50% [3] - The standard of care for AKI has not changed significantly over the past decades, leading to stagnant patient outcomes [3] - AKI can lead to severe complications, including chronic kidney disease and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [6] Recognition and Impact - The Corporate Innovator Award recognizes companies that address unmet medical needs in nephrology, with past recipients including major pharmaceutical companies [4] - SeaStar Medical's QUELIMMUNE device has been noted for its role in saving children's lives and preventing long-term dialysis [4] - The National Kidney Foundation emphasizes the importance of innovation in improving patient outcomes in kidney care [11]

Core Viewpoint - SeaStar Medical Holding Corporation has successfully closed a registered direct offering, raising approximately $6 million through the issuance of 3,529,412 shares of common stock and accompanying warrants [1][3]. Offering Details - The combined offering price for each share of common stock and accompanying warrants was set at $1.70, with pre-funded warrants priced at $1.699 [2]. - The pre-funded warrants have an exercise price of $0.001 per share and are exercisable immediately upon issuance, while the warrants have an exercise price of $1.70 per share and require shareholder approval for exercise [2]. Use of Proceeds - The net proceeds from the offering are intended for general corporate purposes, which may include working capital and capital expenditures [3]. Regulatory Compliance - The securities were offered under a shelf registration statement on Form S-3, which was filed with the SEC on December 8, 2023, and declared effective on December 22, 2023 [4]. - The warrants issued in the concurrent private placement were offered under Section 4(a)(2) of the Securities Act of 1933 and have not been registered under the Act or applicable state securities laws [5]. Company Overview - SeaStar Medical is a commercial-stage therapeutic medical technology company focused on developing extracorporeal therapies aimed at reducing excessive inflammation in vital organs [7]. - The company is innovating solutions for critically ill patients by targeting effector cells that drive systemic inflammation [7].

Core Viewpoint - SeaStar Medical Holding Corporation has entered into a securities purchase agreement for the issuance and sale of 3,529,412 shares of common stock and accompanying warrants, aiming to raise approximately $6 million for general corporate purposes [1][2]. Group 1: Offering Details - The offering includes a registered direct offering and a concurrent private placement, with a combined offering price of $1.70 per share and accompanying warrants [1]. - The pre-funded warrants will have an exercise price of $0.001 per share and will be exercisable immediately upon issuance [1]. - The warrants will have an exercise price of $1.70 per share, exercisable upon shareholder approval, and will expire five years after the approval date [1][2]. Group 2: Financial Advisor and Closing Conditions - H.C. Wainwright & Co. is acting as the exclusive financial advisor for SeaStar Medical in connection with this offering [2]. - The closing of the offering is expected around February 3, 2025, subject to customary closing conditions [2]. Group 3: Regulatory Compliance - The shares and warrants are being offered under a shelf registration statement previously filed with the SEC, which became effective on December 22, 2023 [3]. - The securities offered in the registered direct offering will be available through a prospectus filed with the SEC [3]. Group 4: Company Overview - SeaStar Medical is a commercial-stage therapeutic medical technology company focused on developing extracorporeal therapies to mitigate excessive inflammation in critically ill patients [5]. - The company aims to provide innovative solutions targeting effector cells that drive systemic inflammation, which can cause direct tissue damage [5].

Core Insights - SeaStar Medical Holding Corporation has successfully shipped its Selective Cytopheretic Device (SCD), QUELIMMUNE, to a leading pediatric medical center in California, increasing its commercial customer base to five [1][2] - The company aims to expand the use of QUELIMMUNE to over 20 hospitals within the year, with ongoing efforts to secure additional hospital clearances and institutional review board (IRB) approvals [2][3] Company Overview - SeaStar Medical is a commercial-stage therapeutic medical device company focused on developing solutions to mitigate hyperinflammation effects on vital organs [1][6] - The company’s QUELIMMUNE device is specifically designed for critically ill children suffering from acute kidney injury (AKI) and sepsis, approved by the FDA under a Humanitarian Device Exemption (HDE) [3][6] Product Details - QUELIMMUNE targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT), aiming to reduce hyperinflammation and promote organ recovery [5][6] - The device has received FDA Breakthrough Device Designation for four indications, highlighting its potential in treating severe conditions [6][7] Market Context - Acute Kidney Injury (AKI) can lead to severe complications, including multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [4] - The innovative approach of QUELIMMUNE may provide a unique solution in a market with limited treatment options for critically ill pediatric patients [3][4]