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SeaStar Medical Reports Positive Early Results for QUELIMMUNE Therapy in Pediatric Acute Kidney Injury (AKI) at the 5th International Symposium on Acute Kidney Injury in Children
Globenewswire· 2025-09-29 12:36
Core Insights - SeaStar Medical Holding Corporation announced positive preliminary results from the SAVE Surveillance Registry, highlighting the effectiveness of QUELIMMUNE therapy for critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2] Group 1: Clinical Results - The first 21 pediatric patients treated with QUELIMMUNE therapy showed zero device-related adverse events or infections, with a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 [2][3] - Among patients treated with QUELIMMUNE and requiring extracorporeal membrane oxygenation (ECMO), a 60% survival rate was observed at Day 90 [3] - For pediatric survivors without a history of end-stage renal disease (ESRD) or recent kidney transplant, 75% were dialysis-free at Day 28, and 82% at Day 90 [3] Group 2: Therapy Overview - QUELIMMUNE therapy is designed for children with AKI and sepsis, weighing 10 kilograms or more, and is administered in conjunction with Renal Replacement Therapy (RRT) [8] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize overactive immune cells and mitigate destructive hyperinflammation, which can lead to organ failure [11] - QUELIMMUNE therapy was approved under a Humanitarian Device Exemption in February 2024, requiring participation in the SAVE Surveillance Registry for data collection [8] Group 3: Future Implications - The SAVE Surveillance Registry aims to confirm the safety and efficacy of QUELIMMUNE therapy, with plans to collect data from up to 300 patients [4] - Initial results from the registry are expected to support broader adoption of QUELIMMUNE therapy and inform payer discussions [4] - SeaStar Medical is also conducting a pivotal clinical trial (NEUTRALIZE-AKI) for adult patients with AKI requiring continuous renal replacement therapy [12]
Market Downturn Hits Various Industries Hard
Financial Modeling Prep· 2025-09-25 22:00
Market Overview - Several companies have experienced significant losses during the recent market downturn, including SeaStar Medical Holding Corporation, Li Bang International Corporation Inc., Ambipar Emergency Response, Cemtrex, Inc., and BT Brands, Inc., reflecting the broader market's susceptibility to fluctuations [1][7] SeaStar Medical Holding Corporation (ICU) - The company's stock price plummeted over 55% to $0.55, a drastic decline from its year-high of $4.55, despite ongoing clinical trials for adult acute kidney injury [2][7] - The independent Data Safety Monitoring Board reported no device-related safety issues, supporting the potential clinical benefits of the NEUTRALIZE-AKI trial [2] Li Bang International Corporation Inc. (LBGJ) - The company experienced a nearly 45% drop in stock price to $0.74, despite reporting a revenue of approximately $4.7 million for the six months ending December 31, 2024, marking a 27% increase from the previous year's $3.7 million [3][7] Ambipar Emergency Response (AMBI) - The stock price decreased by 43% to $1.93, and the company recently filed its annual report on Form 20-F for the fiscal year ending December 31, 2024, with the U.S. Securities and Exchange Commission [4][7] Cemtrex, Inc. (CETX) - The company's stock price fell over 35% to $0.40, but it has signed letters of intent for two strategic acquisitions in the robotics and aerospace sectors, which are expected to boost total annual revenues to $100 million [5][7] BT Brands, Inc. (BTBDW) - The company experienced a 33% drop in stock price to $0.17, facing significant market challenges despite its long-standing presence in the quick-service restaurant industry since 1987 [6][7]
SeaStar Medical Reports DSMB Recommendation to Continue the NEUTRALIZE-AKI Pivotal Trial in Adult Acute Kidney Injury
Globenewswire· 2025-09-24 20:22
Core Insights - The independent Data Safety Monitoring Review Board (DSMB) has recommended the continuation of the NEUTRALIZE-AKI pivotal trial for the Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury (AKI) [2][3] - The trial's sample size has been re-estimated from 200 to 339 patients to strengthen statistical power, with 137 patients currently enrolled [3][4] - The SCD therapy has shown no device-related safety issues and a potential clinical benefit, as indicated by preliminary results from the QUELIMMUNE SAVE pediatric registry [5][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on treatments for critically ill patients facing organ failure [10] - The QUELIMMUNE therapy, based on the SCD technology, is the only FDA-approved product for life-threatening AKI due to sepsis in critically ill pediatric patients [10] - The company aims to drive shareholder value through successful execution of commercial efforts and completion of the NEUTRALIZE-AKI trial [4][10] Clinical Trial Details - The NEUTRALIZE-AKI trial's primary endpoint is a composite of 90-day mortality or dialysis dependency in patients treated with SCD therapy alongside standard care [3][10] - Secondary endpoints include mortality at 28 days, ICU-free days, major adverse kidney events at Day 90, and dialysis dependency at one year [3] - The trial will also explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome [3] Safety and Efficacy - The SCD therapy has been associated with zero device-related adverse events, consistent with its previously published safety profile [6] - Preliminary data from the SAVE Surveillance Registry indicates a potential reduction in loss of life by over 50% compared to historical data [7][5] - The therapy aims to neutralize over-active immune cells and mitigate destructive hyperinflammation, potentially leading to long-term organ recovery [9]
SeaStar Medical to Present Early SAVE Registry Data of QUELIMMUNE in Pediatric Acute Kidney Injury at the 5th International Symposium on Acute Kidney Injury in Children
Globenewswire· 2025-09-23 12:23
Core Insights - SeaStar Medical Holding Corporation announced preliminary results from the SAVE Surveillance Registry, focusing on QUELIMMUNE therapy for critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2] - The SAVE Registry aims to confirm the safety and efficacy of QUELIMMUNE therapy, with data collection for the first 300 patients treated [2] - QUELIMMUNE therapy is designed for children weighing 10 kilograms or more, approved under a Humanitarian Device Exemption [4][10] Group 1: SAVE Surveillance Registry - The SAVE Surveillance Registry is a Real-World Evidence program to validate QUELIMMUNE therapy's safety and efficacy [2] - Specific outcomes measured will include 90-day survival rates and dialysis dependency, with comparisons to a control group [2] - Initial results are expected to support broader adoption of QUELIMMUNE therapy and inform payer discussions [2] Group 2: Acute Kidney Injury (AKI) - AKI is characterized by a sudden loss of kidney function, often caused by conditions like sepsis and severe trauma [3] - Destructive hyperinflammation in AKI can lead to multi-organ dysfunction and increased mortality risk [3] - Patients recovering from AKI may face complications such as chronic kidney disease or end-stage renal disease [3] Group 3: QUELIMMUNE Therapy - QUELIMMUNE therapy has shown a 77% survival rate compared to standard care, indicating a 50% reduction in mortality [5] - Among survivors, 87.5% had normal kidney function by Day 60 post-ICU discharge [5] - The therapy is integrated with existing CRRT systems to target pro-inflammatory cells and promote organ recovery [9] Group 4: Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure [10] - QUELIMMUNE is the only FDA-approved product for life-threatening AKI in critically ill pediatric patients [10] - The company is conducting a pivotal trial for its SCD therapy in adult patients with AKI, addressing a significant unmet medical need [10]
SeaStar Medical Holding (ICU) FY Conference Transcript
2025-09-05 12:00
SeaStar Medical Holding (ICU) FY Conference Summary Company Overview - **Company Name**: SeaStar Medical Holding - **Ticker Symbol**: ICU (NASDAQ) - **Focus**: Development of QUELIMMUNE Selective Cytopheretic Device for immune-related renal injuries, particularly in critically ill patients facing organ failure [1][2] Core Points and Arguments - **Technology and Approval**: QUELIMMUNE is FDA approved for treating acute kidney injury with sepsis in children under a humanitarian device exemption in 2024 [2][3] - **Market Potential**: - Pediatric AKI market is valued at approximately $100 million with around 4,000 patients in the U.S. - Adult AKI market is significantly larger, with over 200,000 patients annually, representing a market potential of around $4.5 billion [5][18] - **Clinical Studies**: - Pivotal study (NEUTRALIZE-AKI) is currently 60% enrolled, targeting multiple adult indications under breakthrough device designation [4][3] - Clinical data shows a 77% survival rate in pediatric patients treated with QUELIMMUNE, with no patients requiring dialysis after 60 days [12][11] - **Mechanism of Action**: The device targets activated neutrophils and monocytes to quell hyperinflammation without immunosuppression, effectively reducing cytokine storms [8][9][10] Pipeline and Future Indications - **Current Pipeline**: Focus on both pediatric and adult indications, including end-stage renal disease, chronic dialysis, and cardiorenal conditions [4][3] - **Future Studies**: A pivotal randomized controlled study is ongoing for adults, with a primary endpoint of all-cause mortality and dialysis dependency [19][22] Economic Impact and Health Economics - **Cost Savings**: The use of QUELIMMUNE in pediatric patients resulted in a median hospital stay reduction of about 3 days, leading to cost savings for hospitals [16] - **Reimbursement**: The trial has CMS reimbursement, indicating support for the economic viability of the treatment [20] Strategic Focus - **Target Hospitals**: Strategy to focus on the top 50 children's hospitals in the U.S., where 50% of acute kidney injury patients are treated [14] - **Sales and Distribution**: Control over sales and distribution to enhance customer experience and reduce costs [16] Financial Overview - **Market Capitalization**: As of August 12, the stock price was $0.73 with approximately 28 million shares outstanding [23] - **Recent Capital Raise**: Raised around $8.6 million in July 2025 to support ongoing initiatives [24] Conclusion - **Investment Opportunity**: SeaStar Medical presents a best-in-class technology with significant market potential in both pediatric and adult AKI, backed by promising clinical results and a clear strategic focus on commercialization and expansion [25]
SeaStar Medical to Participate in the HC Wainwright 27th Annual Global Investment Conference
GlobeNewswire News Room· 2025-09-04 22:13
Company Overview - SeaStar Medical Holding Corporation is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [3] - The company's first commercial product, QUELIMMUNE, is based on its patented Selective Cytopheretic Device (SCD) technology and was approved by the FDA in 2024 [3] - QUELIMMUNE is the only FDA-approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [3] Product and Technology - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications from the FDA, which may facilitate a faster approval process and better reimbursement dynamics [3] - SeaStar Medical is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a condition affecting over 200,000 adults in the US annually [3] Upcoming Events - SeaStar Medical will participate in the HC Wainwright 27th Annual Global Investment Conference, with a presentation scheduled for September 5, 2025, at 7:00 am Eastern Time [1][2]
SeaStar Medical Announces Newly Published QUELIMMUNE Health Economic Study Projecting Significantly Reduced Health Care Costs in the Treatment of Pediatric AKI due to Estimated Shorter Hospital Stays and Increased Survival
Globenewswire· 2025-09-02 12:22
Core Insights - SeaStar Medical Holding Corporation has published a health economic analysis indicating that the QUELIMMUNE therapy can save approximately $69,146 per hospitalization for pediatric patients with Acute Kidney Injury (AKI) in the ICU compared to standard continuous renal replacement therapy (CRRT) [1][4] - The QUELIMMUNE therapy has shown a 77% survival rate in treated patients, representing a potential ~50% reduction in loss of life compared to historical data [3][8] - The therapy is currently being adopted by leading children's medical centers, which may enhance its broader acceptance in the healthcare market [2] Economic Impact - The analysis estimates that the QUELIMMUNE therapy could offset its own costs, potentially leading to no out-of-pocket expenses for institutions for a median treatment duration of 6 days [1][4] - Modeled hospitalization costs for pediatric patients treated with QUELIMMUNE are estimated at $320,304, significantly lower than $457,092 and $389,451 for patients in the KID and ppCRRT cohorts respectively [4] Clinical Efficacy - QUELIMMUNE therapy has received FDA approval under a Humanitarian Device Exemption for pediatric patients with AKI due to sepsis, showing no dialysis required for survivors at Day 60 post-treatment [3][7] - A pivotal trial, NEUTRALIZE-AKI, is underway to evaluate the safety and efficacy of the SCD therapy in adults with AKI, which has received FDA Breakthrough Device Designation [4][10] Technology Overview - The QUELIMMUNE therapy utilizes patented Selective Cytopheretic Device (SCD) technology aimed at modulating the immune response to prevent destructive hyperinflammation in critically ill patients [11][14] - This therapy is the only FDA-approved option for treating life-threatening AKI due to sepsis in critically ill pediatric patients, addressing a significant unmet medical need [14]
FDA Identifies ICU Medical's Plum Duo Recall as Serious Type
ZACKS· 2025-09-01 14:56
Core Insights - ICU Medical (ICUI) is facing a recall notice from the FDA for its Plum Duo Infusion System due to software issues, but the recall does not require the device to be removed from use [1][5][8] FDA Recall Details - The FDA has classified the recall as the most serious type, warning that the affected Plum Duo Infusion System with software version 1.1.3 or earlier may cause the pump to stop responding, potentially leading to serious injury or death if not corrected [2][8] - The affected devices are identified by Unique Device Identifier 400020401 and Model M335400021, with the software version of 1.13 or earlier [6][9] Device Usage and Impact - The Plum Duo Infusion System is designed for delivering parenteral fluids and medications through intravenous, intra-arterial, and subcutaneous routes in various patient populations [3] - ICU Medical has advised users to quarantine the affected pumps until a software patch is available, emphasizing that if removing the device could harm patient care, users should monitor the 'CONFIRM STOP' message to prevent unintended interruptions [10][9] Company Response and Market Performance - ICU Medical is actively working on software corrections and has issued an Urgent Medical Device Correction notice to all affected users [4] - Despite the recall, ICU Medical's shares have remained steady, with a year-to-date decline of 17.7%, compared to a 7.7% gain in the industry and a 10.1% increase in the S&P 500 Index [5]
SeaStar Medical(ICU) - 2025 Q2 - Earnings Call Transcript
2025-08-13 21:30
Financial Data and Key Metrics Changes - The company recorded its highest quarterly revenue to date, achieving a 15% increase in sequential quarter revenue through sales of Quellimmune therapy, with revenue for Q2 2025 at $338,000 compared to approximately $293,000 in Q1 2025 and $0 in Q2 2024 [27] - Year-to-date revenue reached $631,000, attributed to existing customers expanding their usage of Quellimmune and the addition of new hospital customers [27] - The net loss for Q2 2025 declined to $2,000,000 compared to a loss of $3,200,000 in Q2 2024 [28] Business Line Data and Key Metrics Changes - Quellimmune net revenue for Q2 increased 15% sequentially, with a nearly 370% increase in revenue in the first six months of launch compared to the previous year [6][11] - The company added three new customers for Quellimmune since the beginning of Q2, indicating strong enthusiasm for the therapy [10] Market Data and Key Metrics Changes - The total U.S. market opportunity for the adult SCD therapy is estimated to be over $4 billion annually, with a potential patient population of approximately 200,000 facing organ failure [12] - The company has received FDA breakthrough device designation for five additional indications, indicating a significant market potential for adult indications [13] Company Strategy and Development Direction - The company aims to complete the neutralized AKI pivotal trial for adults and prepare to file a PMA following the trial's completion [30] - The broader strategy includes expanding the use of FCD therapy across a range of hyper-inflammatory conditions beyond AKI, targeting both pediatric and adult populations [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future prospects for SeaStar Medical, particularly regarding the adult AKI market and the potential for significant revenue generation [31] - The company is focused on enrolling the right type of patients in clinical trials to demonstrate therapeutic effects effectively [19] Other Important Information - The company raised $12.4 million in new equity capital through public offerings and registered direct offerings [26] - The gross profit margin for Q2 was approximately 92%, reflecting the transition to recognizing COGS as the company moves into commercial operations [28] Q&A Session Summary Question: What are the expectations for the adult AKI pivotal trial? - Management expects to reach full enrollment by the end of the year and plans to file a PMA in 2026 if the data supports it [22][32] Question: How is the company addressing the enrollment pace in clinical trials? - The company is actively adding new sites and expanding screening into additional ICUs to optimize enrollment rates [21][22]
SeaStar Medical(ICU) - 2025 Q2 - Quarterly Report
2025-08-13 20:45
```markdown PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents SeaStar Medical Holding Corporation's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, and financial activities for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased from **$4.66 million** to **$8.38 million**, with stockholders' equity improving from a **$2.18 million deficit** to **$3.34 million positive** due to decreased liabilities **Condensed Consolidated Balance Sheets (in thousands)** | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :--------------------------------- | :------------------------ | :---------------- | | Cash | $6,302 | $1,819 | | Total current assets | $7,647 | $3,766 | | Total assets | $8,383 | $4,658 | | Total current liabilities | $5,042 | $6,841 | | Total liabilities | $5,042 | $6,841 | | Total stockholders' equity/(deficit) | $3,341 | $(2,183) | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the six months ended June 30, 2025, net revenue was **$631 thousand** and gross profit **$604 thousand**, with net loss significantly decreasing to **$5.77 million** from **$15.93 million** due to reduced operating and other expenses **Condensed Consolidated Statements of Operations (in thousands)** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net revenue | $338 | $0 | $631 | $0 | | Gross profit | $311 | $0 | $604 | $0 | | Research and development | $1,037 | $2,334 | $3,468 | $4,031 | | General and administrative | $1,030 | $2,335 | $2,716 | $4,588 | | Total operating expenses | $2,067 | $4,669 | $6,184 | $8,619 | | Loss from operations | $(1,756) | $(4,669) | $(5,580) | $(8,619) | | Total other income (expense), net | $(246) | $1,436 | $(191) | $(7,311) | | Net loss | $(2,002) | $(3,236) | $(5,774) | $(15,933) | | Net loss per share (basic and diluted) | $(0.18) | $(1.03) | $(0.58) | $(5.36) | [Condensed Consolidated Statements of Changes in Stockholders' Equity/(Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%2F%28Deficit%29) Total stockholders' equity improved from a **$2.18 million deficit** to a **$3.34 million positive** by June 30, 2025, primarily driven by over **$10 million** in capital raises from equity offerings and warrant exercises **Changes in Stockholders' Equity/(Deficit) (in thousands)** | Metric | December 31, 2024 | June 30, 2025 | | :--------------------------------- | :---------------- | :---------------- | | Balance, Stockholders' Equity/(Deficit) | $(2,183) | $3,341 | | Issuance of shares - exercise of warrants | $0 | $2 | | Issuance of shares - equity offering (net) | $0 | $10,734 | | Issuance of shares - SEPA commitment fee | $0 | $298 | | Stock-based compensation | $0 | $264 | | Net loss | $(3,772) (Q1 2025) | $(2,002) (Q2 2025) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities decreased to **$5.66 million**, while financing activities provided **$10.14 million**, leading to a **$4.48 million** net cash increase and a **$6.30 million** ending cash balance **Condensed Consolidated Statements of Cash Flows (in thousands)** | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(5,661) | $(6,312) | | Net cash provided by financing activities | $10,144 | $7,315 | | Net increase in cash | $4,483 | $1,003 | | Cash, beginning of period | $1,819 | $176 | | Cash, end of period | $6,302 | $1,179 | [Notes to Condensed Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) These notes detail **SeaStar Medical's** business, accounting policies, financial instruments, equity, and contingencies, covering **QUELIMMUNE's** commercial launch, financing, legal proceedings, and **going concern** status [Note 1. Description of Business](index=7&type=section&id=Note%201.%20Description%20of%20Business) The company develops and commercializes the **Selective Cytopheretic Device (SCD)** for inflammation, with its pediatric version, **QUELIMMUNE**, receiving **FDA approval** and commercial launch in 2024, despite an **accumulated deficit of $145.3 million** and **going concern** doubts - **SeaStar Medical** is engaged in the research, development, and commercialization of a platform medical device technology (**Selective Cytopheretic Device, SCD**) designed to modulate inflammation[19](index=19&type=chunk) - The company received **FDA HDE approval** for its pediatric **SCD therapy (QUELIMMUNE)** on February 21, 2024, and shipped its first commercial **units** in July 2024[20](index=20&type=chunk) - The company has an **accumulated deficit of $145.3 million** as of June 30, 2025, and **cash of $6.3 million**, leading to **substantial doubt** about its ability to continue as a **going concern** for at least 12 months[29](index=29&type=chunk) - The company effected a **1-for-25 reverse stock split** on June 7, 2024, which proportionally adjusted most stock **options** and **warrants**, except for certain "**Unadjusted Warrants**" that retained an **$11.50 exercise price** and require **25 warrants per share**[24](index=24&type=chunk)[26](index=26&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=9&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) The company recognizes revenue based on **FOB Destination** for **QUELIMMUNE** sales, expenses pre-July 2024 inventory as **R&D**, accounts for **contract research services** as **reimbursed expense**, and uses the **extended transition period** as an **emerging growth company** - The company recognizes revenue when a customer obtains control of promised goods or services, primarily based on a **freight-on-board destination ("FOB Destination")** requirement for **QUELIMMUNE** sales[41](index=41&type=chunk)[44](index=44&type=chunk) - Inventory purchased prior to July 2024 for research/clinical trials was expensed as **R&D**; **units** sold after this period now recognize **cost of goods sold**[46](index=46&type=chunk)[47](index=47&type=chunk) - The company accounts for funds received from an agreement to provide **contract research services** as a **reimbursed expense**, offsetting **research and development expense**[48](index=48&type=chunk) - As an "**emerging growth company**," **SeaStar Medical** has elected to use the **extended transition period** for complying with new or revised accounting standards[49](index=49&type=chunk) [Note 3. Revenues and Contract Obligations](index=12&type=section&id=Note%203.%20Revenues%20and%20Contract%20Obligations) The company's sales are exclusively within the **United States**, with **contract liabilities** at **$0** for the six months ended June 30, 2025 **Revenues and Contract Liabilities (in thousands)** | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Contract liabilities, beginning of period | $0 | $100 | | Consideration received | $0 | $450 | | Consideration refunded | $0 | $(550) | | Revenue | $0 | $0 | | Contract liabilities, end of period | $0 | $0 | - All of the Company's sales are located within the **United States**[54](index=54&type=chunk) [Note 4. Accounts Receivable, net](index=12&type=section&id=Note%204.%20Accounts%20Receivable%2C%20net) **Accounts Receivable, Net** increased to **$217 thousand** by June 30, 2025, after accounting for **$8 thousand** in **expected credit losses** **Accounts Receivable, net (in thousands)** | Metric | December 31, 2024 | June 30, 2025 | | :--------------------------------- | :---------------- | :---------------- | | Accounts Receivable, Gross | $112 | $225 | | Expected Credit Losses | $0 | $(8) | | Accounts Receivable, Net | $112 | $217 | [Note 5. Accrued Expenses](index=12&type=section&id=Note%205.%20Accrued%20Expenses) **Total accrued expenses** decreased to **$1.883 million** by June 30, 2025, from **$3.188 million** at December 31, 2024, driven by reductions in **accrued bonus** and **director compensation** **Accrued Expenses (in thousands)** | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :---------------- | :---------------- | | Accrued bonus | $625 | $1,391 | | Accrued director compensation | $146 | $391 | | Accrued research and development | $871 | $1,023 | | Other | $241 | $383 | | Total accrued expenses | $1,883 | $3,188 | [Note 6. Notes Payable](index=13&type=section&id=Note%206.%20Notes%20Payable) The company fully paid its **$0.7 million insurance financing arrangement** by June 30, 2025 - The Company paid the entire balance of its **$0.7 million insurance financing arrangement** by June 30, 2025[59](index=59&type=chunk) [Note 7. Equity Transactions](index=13&type=section&id=Note%207.%20Equity%20Transactions) The company raised approximately **$4.0 million** in gross proceeds from a **public offering** in June 2025, entered a **SEPA** for up to **$15.0 million** in common stock, and raised **$6.0 million** from a **registered direct offering** in February 2025 - In June 2025, the Company completed a **public offering**, issuing common stock and various **warrants**, raising approximately **$4.0 million** in gross proceeds[60](index=60&type=chunk)[61](index=61&type=chunk) - On April 25, 2025, the Company entered into a **Standby Equity Purchase Agreement (SEPA)** with **Lincoln Park Capital Fund, LLC**, allowing it to sell up to **$15.0 million** in common stock, with a commitment fee of **236,406 shares**. No capital has been raised from the **SEPA** yet[65](index=65&type=chunk)[69](index=69&type=chunk)[71](index=71&type=chunk) - In February 2025, the Company completed a **registered direct offering** and concurrent **private placement**, issuing common stock and **warrants**, raising approximately **$6.0 million** in gross proceeds[72](index=72&type=chunk)[73](index=73&type=chunk) - Through June 30, 2025, the Company raised approximately **$6.8 million** since inception of the **ATM** in August 2024, with **$2.1 million** net raised during the six months ended June 30, 2025[79](index=79&type=chunk)[80](index=80&type=chunk) [Note 8. Warrants](index=15&type=section&id=Note%208.%20Warrants) **Equity classified warrants** significantly increased to **18,624,781** by June 30, 2025, and the company recognized a **$32 thousand gain** from **mark-to-market adjustment** for **liability classified warrants** for the six months ended June 30, 2025 **Warrants Outstanding** | Type | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :---------------- | :---------------- | | Liability Classified Warrants | 249,520 | 249,520 | | Equity Classified Warrants | 18,624,781 | 2,110,305 | | Grand Total | 18,874,301 | 2,359,825 | **Warrant Activity (Six Months Ended June 30, 2025)** | Warrant Type | Issuance | Exercised | Outstanding as of June 30, 2025 | | :--------------------------------- | :---------------- | :---------------- | :-------------------------------- | | June 2025 Warrants | 12,738,463 | 0 | 12,738,463 | | June 2025 Pre-Funded Warrants | 1,218,462 | (1,218,462) | 0 | | February 2025 Warrants | 3,776,471 | 0 | 3,776,471 | | February 2025 Pre-Funded Warrants | 2,816,412 | (2,816,412) | 0 | - The Company incurred a gain of approximately **$16 thousand** and **$32 thousand** from the **mark-to-market adjustment** for all remaining **liability classified warrants** for the three and six months ended June 30, 2025, respectively[85](index=85&type=chunk) [Note 9. Stock-Based Compensation Awards](index=16&type=section&id=Note%209.%20Stock-Based%20Compensation%20Awards) **Total stock-based compensation** was **$264 thousand** for the six months ended June 30, 2025, with **320,205 RSUs** and **11,198 options** outstanding under the **2022 Omnibus Incentive Plan** **Total Stock-Based Compensation Cost (in thousands)** | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $23 | $(7) | $46 | $112 | | General and administrative | $74 | $48 | $218 | $363 | | Total stock-based compensation | $97 | $41 | $264 | $475 | **Stock Options and RSUs Outstanding (June 30, 2025)** | Plan | Options Outstanding | RSUs Outstanding | | :--------------------------------- | :------------------ | :----------------- | | 2022 Omnibus Incentive Plan | 11,198 | 320,205 | | 2019 Stock Incentive Plan | 7,837 | 0 | [Note 10. Commitments and Contingencies](index=20&type=section&id=Note%2010.%20Commitments%20and%20Contingencies) The company is a defendant in a **2024 Securities Class Action Lawsuit** and a **Shareholder Derivative Action**, both alleging **material misstatements**, but has not recognized a **contingent liability** for the Class Action under **ASC 450, Contingencies** - The Company is a defendant in a **putative class action lawsuit** (**Wells v. SeaStar Medical Holding Corporation et al.**, filed July 5, 2024) alleging **material misstatements** regarding **FDA approval timing** and **financial instrument recognition**[98](index=98&type=chunk)[100](index=100&type=chunk)[200](index=200&type=chunk)[201](index=201&type=chunk) - The Company has not recognized a **contingent liability** for the **Class Action** as it does not qualify for recognition criteria under **ASC 450, Contingencies**[100](index=100&type=chunk) [Note 11. Fair Value Measurements](index=21&type=section&id=Note%2011.%20Fair%20Value%20Measurements) The **fair value of liability classified warrants** is categorized as **Level 3**, decreasing from **$33 thousand** at December 31, 2024, to **$1 thousand** at June 30, 2025, due to a **$32 thousand change in fair value** - The **fair value of liability classified warrants** is classified as **Level 3** in the **fair value hierarchy**, using significant unobservable inputs[102](index=102&type=chunk) **Fair Value Measurements of Liability Classified Warrants (in thousands)** | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :---------------- | :---------------- | | Liability classified warrants | $1 | $33 | **Level 3 Roll Forward - Liability Classified Warrants (in thousands)** | Metric | Amount | | :--------------------------------- | :---------------- | | Balance December 31, 2024 | $33 | | Changes in fair value | $(32) | | Balance June 30, 2025 | $1 | [Note 12. Income Taxes](index=22&type=section&id=Note%2012.%20Income%20Taxes) The company has a full **valuation allowance** against its **net deferred tax assets** due to uncertain future profitability, recognizing only a **$3 thousand provision** for **minimum state taxes** - The Company has recorded a full **valuation allowance** against its **net deferred tax assets** due to the uncertainty of future profitable operations[110](index=110&type=chunk) - An insignificant provision for certain **minimum state taxes** of approximately **$3 thousand** was recognized as of June 30, 2025[110](index=110&type=chunk) [Note 13. Net Loss Per Share](index=22&type=section&id=Note%2013.%20Net%20Loss%20Per%20Share) For the six months ended June 30, 2025, **net loss per share** was **$(0.58)** on **9,981,215 weighted-average shares outstanding**, with **19,213,446 potentially dilutive securities** excluded from diluted EPS **Net Loss Per Share (in thousands, except per share amounts)** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(2,002) | $(3,236) | $(5,774) | $(15,933) | | Weighted-average shares outstanding | 11,329,517 | 3,154,782 | 9,981,215 | 2,975,248 | | Basic and diluted net loss per share | $(0.18) | $(1.03) | $(0.58) | $(5.36) | **Potentially Dilutive Securities Excluded from Diluted EPS (as of June 30)** | Security Type | 2025 | 2024 | | :--------------------------------- | :---------------- | :---------------- | | Liability classified warrants | 249,520 | 249,520 | | Equity classified warrants | 18,624,781 | 1,096,085 | | Employee based options | 18,940 | 22,653 | | Unvested restricted stock units | 320,205 | 40,068 | | Total | 19,213,446 | 1,408,326 | [Note 14. Segment Reporting](index=23&type=section&id=Note%2014.%20Segment%20Reporting) The company operates as a **single reportable segment**, the **Device Segment**, focused on **SCDs**, with all sales located within the **United States**, reporting **$631 thousand** in **net revenue** for the six months ended June 30, 2025 - The Company operates as a **single reportable segment**, the **Device Segment**, focused on **SCDs**[115](index=115&type=chunk) - All of the Company's sales are located within the **United States**[117](index=117&type=chunk) **Segment Operating Results (in thousands)** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Revenue | $338 | $0 | $631 | $0 | | Cost of goods sold | $27 | $0 | $27 | $0 | | Gross profit | $311 | $0 | $604 | $0 | | Research and development | $1,037 | $2,334 | $3,468 | $4,031 | | General and administrative | $1,030 | $2,335 | $2,716 | $4,588 | | Total operating expenses | $2,067 | $4,669 | $6,184 | $8,619 | | Loss from operations | $(1,756) | $(4,669) | $(5,580) | $(8,619) | [Note 15. Subsequent Events](index=24&type=section&id=Note%2015.%20Subsequent%20Events) Subsequent events include **public offerings** of common stock and warrants in July 2025, an increase in authorized shares for the **2022 Omnibus Equity Incentive Plan**, and a **Nasdaq notice of non-compliance** with the **$1.00 minimum bid price requirement** - On July 10, 2025, the Company entered into a **Securities Purchase Agreement** for a **public offering** of common stock and **warrants**[120](index=120&type=chunk) - On July 31, 2025, the Company entered into a **Securities Purchase Agreement** for a **registered direct offering** of common stock and **warrants**, which closed August 1, 2025[127](index=127&type=chunk) - On July 3, 2025, shareholders approved an amendment to the **2022 Omnibus Equity Incentive Plan**, increasing authorized **shares** from **570,457** to **2,070,457**[129](index=129&type=chunk) - On July 31, 2025, the Company received a **Nasdaq notice of non-compliance** with the **$1.00 minimum bid price requirement**, with **180 calendar days** to regain compliance[130](index=130&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on **SeaStar Medical's** financial condition and operational results, highlighting the company's strategic focus on its **SCD technology**, recent commercialization efforts, and ongoing financial challenges, including **substantial doubt** about its ability to continue as a **going concern** [Overview](index=26&type=section&id=Overview) **SeaStar Medical** is a **commercial-stage healthcare company** focused on its **Selective Cytopheretic Device (SCD)** to modulate inflammation in critically ill patients, with **QUELIMMUNE** receiving **FDA HDE approval** and commencing commercial shipments in July 2024, despite an **accumulated deficit of $145.3 million** and **going concern** doubts - **SeaStar Medical** is a **commercial-stage healthcare company** focused on its **Selective Cytopheretic Device (SCD)** to modulate inflammation in critically ill patients[135](index=135&type=chunk) - The pediatric **SCD (QUELIMMUNE)** received **FDA HDE approval** in February 2024 and commenced commercial shipments in July 2024[136](index=136&type=chunk) - The company has incurred **net losses** since inception, with an **accumulated deficit of $145.3 million** as of June 30, 2025, and **cash of $6.3 million**, indicating **substantial doubt** about its **going concern** ability[146](index=146&type=chunk)[147](index=147&type=chunk)[149](index=149&type=chunk) [Key Components of Results of Operations](index=28&type=section&id=Key%20Components%20of%20Results%20of%20Operations) This section outlines the drivers of **SeaStar Medical's** financial performance, including **revenue generation** from **QUELIMMUNE**, expected increases in **research and development expenses**, reductions in **general and administrative expenses**, and the impact of **other income (expense)** from financial instruments - **Revenue generation** commenced in July 2024 with the commercial launch of **QUELIMMUNE**, and future revenue is expected to fluctuate[152](index=152&type=chunk)[153](index=153&type=chunk) - **Research and development expenses** are expected to increase as the company continues clinical trials and develops next-generation **SCDs**[154](index=154&type=chunk) - **General and administrative expenses** are being reduced through efficiency measures, including declines in audit/accounting fees, director compensation, and personnel costs[157](index=157&type=chunk) - **Other income (expense), net**, includes interest income/expense and changes in the **fair value of warrants liability** and **convertible notes**[159](index=159&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) [Comparison of the Three Months Ended June 30, 2025 to the Three Months Ended June 30, 2024](index=29&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20to%20the%20Three%20Months%20Ended%20June%2030%2C%202024) For the three months ended June 30, 2025, **net revenue** was **$338 thousand**, **loss from operations** improved by **$2.940 million** (**63%**), and **net loss** decreased by **$1.261 million** (**39%**), primarily due to reduced **R&D** and **G&A expenses** **Three Months Ended June 30 (in thousands)** | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--------------------------------- | :----- | :----- | :--------- | :--------- | | Revenue | $338 | $0 | $338 | * | | Gross profit | $311 | $0 | $311 | * | | Research and development | $1,037 | $2,334 | $(1,297) | (56)% | | General and administrative | $1,030 | $2,335 | $(1,305) | (56)% | | Total operating expenses | $2,067 | $4,669 | $(2,602) | (56)% | | Loss from operations | $(1,756) | $(4,669) | $2,940 | (63)% | | Total other income (expense) | $(246) | $1,436 | $(1,682) | (117)% | | Net loss | $(2,002) | $(3,236) | $1,261 | (39)% | - The decline in **R&D expenses** was primarily due to a **$0.7 million** decline in clinical trial expenses (partially offset by third-party services), a **$0.3 million** decline in external services, and a **$0.3 million** net reduction in personnel costs[165](index=165&type=chunk) - The decrease in **G&A expenses** was driven by a **$0.3 million** decline in audit/accounting fees, a **$0.5 million** decline in Directors' compensation, a **$0.1 million** reduction in SEC fees, a **$0.2 million** decrease in personnel costs, and a **$0.2 million** reduction in consultant expenditures[166](index=166&type=chunk) - **Other income (net)** reversed from a **$1.4 million gain** in 2024 to a **$0.3 million loss** in 2025, mainly due to a smaller favorable gain from **liability classified warrants** and the absence of **convertible notes** activity in 2025[167](index=167&type=chunk) [Comparison of the Six Months Ended June 30, 2025 to the Six Months Ended June 30, 2024](index=31&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20to%20the%20Six%20Months%20Ended%20June%2030%2C%202024) For the six months ended June 30, 2025, **net revenue** was **$631 thousand**, **loss from operations** improved by **$3.066 million** (**36%**), and **net loss** decreased by **$10.186 million** (**64%**), driven by reduced operating and other expenses **Six Months Ended June 30 (in thousands)** | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--------------------------------- | :----- | :----- | :--------- | :--------- | | Revenue | $631 | $0 | $631 | * | | Gross profit | $604 | $0 | $604 | * | | Research and development | $3,468 | $4,031 | $(563) | (14)% | | General and administrative | $2,716 | $4,588 | $(1,872) | (41)% | | Total operating expenses | $6,184 | $8,619 | $(2,435) | (28)% | | Loss from operations | $(5,580) | $(8,619) | $3,066 | (36)% | | Total other expense | $(191) | $(7,311) | $7,120 | (97)% | | Net loss | $(5,774) | $(15,933) | $10,186 | (64)% | - The decline in **R&D expenses** was primarily due to a **$0.1 million** net reduction in personnel costs, a **$0.3 million** decline in consulting services, and a **$0.4 million** decline in pre-clinical related services, partially offset by a **$0.3 million** increase in clinical trial site costs[172](index=172&type=chunk) - The decrease in **G&A expenses** was driven by a **$0.2 million** decline in personnel costs, a **$0.5 million** decline in accounting fees, a **$0.3 million** decline in legal fees, and a **$0.5 million** decline in Directors' compensation[174](index=174&type=chunk) - **Other expenses (net)** decreased by **$7.1 million (97%)** due to the absence of a **$6.1 million loss** from changes in **fair value of convertible notes** in 2025, a gain on **liability classified warrants** in 2025 versus a loss in 2024, and reduced interest expense from lower debt obligations[175](index=175&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company has financed operations primarily through **equity and convertible debt**, incurring **significant operating losses** and **negative cash flows** since inception, leading to **substantial doubt** about its **going concern** ability without further financing - The Company has financed operations primarily through **equity and convertible debt**, incurring **significant operating losses** and **negative cash flows** since inception[178](index=178&type=chunk) **Liquidity Metrics (in thousands)** | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :---------------- | :---------------- | | Shareholders' equity | $3,300 | $(2,183) | | Accumulated deficit | $(145,300) | $(139,600) | | Cash | $6,300 | $1,800 | - **Cash on hand** is insufficient to fund operations for at least **12 months**, raising **substantial doubt** about the company's ability to continue as a **going concern**[179](index=179&type=chunk) - The company relies on **future equity or debt financing**, **collaborations**, or **grants**, but there is no assurance of obtaining additional capital on acceptable terms[180](index=180&type=chunk)[181](index=181&type=chunk) - Proceeds from **warrant exercises** are not included in short-term or long-term liquidity projections due to their dependency on the common stock's trading price and the uncertainty of exercise[182](index=182&type=chunk)[183](index=183&type=chunk) [Critical Accounting Policies and Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights **SeaStar Medical's** critical accounting policies and estimates, including those for **unbilled clinical trial costs** and **stock-based compensation expense**, noting no material changes from prior annual reports - Significant estimates include **unbilled clinical trial costs** and **stock-based compensation expense**[35](index=35&type=chunk) - No **material changes** from the policies or methods disclosed in the **Annual Report to Form 10-K** filed March 27, 2025, and as amended by **Form 10-K/A** filed April 23, 2025, for the year-ended December 31, 2025[190](index=190&type=chunk) [Emerging Growth Company Status](index=35&type=section&id=Emerging%20Growth%20Company%20Status) As an **Emerging Growth Company (EGC)**, **SeaStar Medical** utilizes an **extended transition period** for new accounting standards and benefits from **reduced reporting requirements**, including exemptions from **auditor attestation** on internal controls and certain **executive compensation disclosures** - As an "**emerging growth company**" (**EGC**), **SeaStar Medical** has elected to use the **extended transition period** for complying with new or revised accounting standards[192](index=192&type=chunk) - **EGC status** allows for **reduced reporting requirements**, including exemption from **auditor attestation** on internal controls (**Section 404(b) of Sarbanes-Oxley Act**) and certain **executive compensation disclosures**[193](index=193&type=chunk) - The company will remain an **EGC** until the earliest of (i) the last day of its first fiscal year following the fifth anniversary of the Business Combination, (ii) reaching **$1.235 billion** in annual gross revenue, (iii) becoming a "**large-accelerated filer**," or (iv) issuing over **$1.0 billion** in **non-convertible debt**[194](index=194&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a **smaller reporting company**, **SeaStar Medical** is not required to provide **quantitative and qualitative disclosures about market risk** - As a **smaller reporting company**, **SeaStar Medical** is not required to provide **quantitative and qualitative disclosures about market risk**[195](index=195&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2025, **disclosure controls and procedures** were effective, with no **material changes** in **internal control over financial reporting** during the three months ended June 30, 2025 - As of June 30, 2025, the company's **disclosure controls and procedures** were effective[197](index=197&type=chunk) - There were no **material changes** in **internal control over financial reporting** during the three months ended June 30, 2025[198](index=198&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) **SeaStar Medical** is involved in a **putative class action lawsuit** and a **shareholder derivative action**, both alleging **material misstatements** regarding **FDA approval timing** and **financial instrument recognition**, seeking **compensatory damages** and **injunctive relief**, with the derivative action currently stayed - The Company is a defendant in a **putative class action lawsuit** (**Wells v. SeaStar Medical Holding Corporation et al.**, filed July 5, 2024) alleging **material misstatements** regarding **FDA approval timing** and **financial instrument recognition**[200](index=200&type=chunk) - The Company is also a defendant in a **putative shareholder derivative action** (**Lazo v. Schlorff, et. al.**, filed December 13, 2024) with factual allegations substantially similar to the **class action**, asserting claims against officers and directors for **breach of fiduciary duty** and seeking **damages** and **injunctive relief**[201](index=201&type=chunk) - The **derivative action** is stayed pending the court's resolution of the **motion to dismiss** filed in the **class action**[201](index=201&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company reiterates **substantial doubt** about its ability to continue as a **going concern** due to recurring **operating losses** and **negative cash flows**, requiring **additional financing** that may not be available, and highlights risks from **proposed U.S. tax legislation** and **Nasdaq delisting** threats due to **non-compliance** with listing requirements - There is **substantial doubt** about the company's ability to continue as a **going concern**, requiring **additional financing** that may not be available on acceptable terms[203](index=203&type=chunk)[204](index=204&type=chunk) - Inability to raise **additional capital** could force delays, reductions, or cessation of **development and commercialization efforts**, potentially leading to a **restructuring or reorganization under bankruptcy laws**[206](index=206&type=chunk)[207](index=207&type=chunk) - **Proposed U.S. tax legislation**, including new **Section 899 to the Code**, may adversely impact the company and the value of its securities, particularly for **non-U.S. investors**[208](index=208&type=chunk)[210](index=210&type=chunk) - The company faces risks of **delisting from Nasdaq** due to **non-compliance** with listing requirements, including the **$1.00 per share minimum bid price requirement** (notified July 31, 2025) and previous issues with the **Minimum Stockholders' Equity Requirement**[211](index=211&type=chunk)[214](index=214&type=chunk)[217](index=217&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No **unregistered sales of equity securities** not previously included in a **Current Report on Form 8-K** occurred during the three months ended June 30, 2025 - No **unregistered sales of equity securities** not previously included in a **Current Report on Form 8-K** occurred during the three months ended June 30, 2025[221](index=221&type=chunk) [Item 3. Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable - Not applicable[222](index=222&type=chunk) [Item 4. Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[222](index=222&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a "**Rule 10b5-1 trading arrangement**" or "**non-Rule 10b5-1 trading arrangement**" during the three months ended June 30, 2025 - No director or officer adopted or terminated a "**Rule 10b5-1 trading arrangement**" or "**non-Rule 10b5-1 trading arrangement**" during the three months ended June 30, 2025[222](index=222&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the **Form 10-Q**, including forms of various **warrants**, **securities purchase agreements**, **engagement agreements**, the amended **2022 Omnibus Incentive Plan**, and **certifications** from executive officers - The **exhibit index** includes forms of various **warrants** (Pre-Funded, Series A, Series B, Placement Agent), **Securities Purchase Agreements**, **Engagement Agreements**, the **Amended and Restated 2022 Omnibus Incentive Plan**, and **certifications** from the **Principal Executive Officer** and **Principal Financial Officer**[225](index=225&type=chunk) [Signatures](index=41&type=section&id=Signatures) The report was signed by **Eric Schlorff**, **Chief Executive Officer**, and **David Green**, **Chief Financial Officer**, on August 13, 2025 - The report was signed by **Eric Schlorff**, **Chief Executive Officer**, and **David Green**, **Chief Financial Officer**, on August 13, 2025[228](index=228&type=chunk) ```