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SeaStar Medical Holding (ICU)
NASDAQ:ICU
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SeaStar Medical Holding
(NASDAQ:ICU)
Rating:33Underperform
Price Target:―
Positive Factors
Regulatory Approvals
The FDA granted two new Breakthrough Device Designations for ICU's Selective Cytopheretic Device (SCD) therapy.
Revenue Growth
ICU's 336% sequential revenue growth was driven by its success in adding new pediatric hospital customers and generating strong reorder rates.
Negative Factors
Financial Performance
ICU reported lower revenue and higher operational expenses than expected, indicating potential financial challenges.
SeaStar Medical Holding (ICU) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$15.74M
Dividend YieldN/A
Average Volume (3M)13.03M
Price to Earnings (P/E)―
Beta (1Y)-0.04
Revenue GrowthN/A
EPS Growth75.26%
CountryUS
Employees19
SectorHealthcare
Sector Strength40
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.44
Shares Outstanding22,184,502
10 Day Avg. Volume4,692,940
30 Day Avg. Volume13,029,180
Financial Highlights & Ratios
PEG Ratio>-0.01
Price to Book (P/B)9.15
Price to Sales (P/S)0.00
P/FCF Ratio-0.64
Enterprise Value/Market Cap0.26
Enterprise Value/Revenue6.45
Enterprise Value/Gross Profit9.52
Enterprise Value/Ebitda-0.04
Forecast
1Y Price Target
$7.00Price Target Upside885.92% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering1
SeaStar Medical Holding Business Overview & Revenue Model
Company DescriptionSeaStar Medical Holding Corporation, a medical device company, focuses on providing novel solutions and services to treat hyperinflammation and cytokine storm in critically ill patients. The company is developing and commercializing extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. It is developing products in various therapeutic areas, including pediatric and adult acute kidney injury on CRRT; cardiorenal syndrome in congestive heart failure with and without LVAD; myocardial stunning in end stage renal disease; and hepatorenal syndrome. The company is based in Denver, Colorado.
How the Company Makes MoneySeaStar Medical Holding makes money through the sale and licensing of its Selective Cytopheretic Device (SCD) to hospitals, healthcare providers, and potentially through partnerships with other medical technology companies. Revenue is primarily generated from the commercialization of its patented therapies targeting acute kidney injury and other inflammatory conditions. The company may also derive income from ongoing research and development collaborations and potential future expansions into additional therapeutic areas.
SeaStar Medical Holding Earnings Call Summary
Earnings Call Date:May 14, 2025
(Q1-2025)
| % Change Since: -42.28%|
Next Earnings Date:Aug 19, 2025
Earnings Call Sentiment Positive
The call highlighted significant revenue growth and progress in clinical trials and regulatory approvals, indicating strong future potential. However, challenges in trial enrollment and regulatory processes were noted as hurdles.Q1-2025 Updates
Positive Updates
Revenue Growth
Achieved a fourfold increase in first quarter revenue compared to the fourth quarter of 2024. This was driven by increased adoption of QUELIMMUNE therapy.
FDA Breakthrough Device Designations
Granted two new breakthrough device designations by the FDA for addressing hyperinflammation in adult and pediatric cardiac surgery, expanding the pipeline.
Enrollment Progress in NEUTRALIZE-AKI Trial
Reached 50% enrollment in the NEUTRALIZE-AKI trial for adult patients with AKI and CRRT, triggering a prespecified interim analysis.
Expansion of Customer Base
Added a nationally recognized Children's Hospital as a new QUELIMMUNE customer and are in talks with several others.
Commercial Strategy and Market Opportunity
Outlined a strategy to focus on top 50 pediatric sites in the U.S. and a $4.5 billion total annual market opportunity in the adult AKI market.
Cost Management
Managed resources effectively, resulting in lower sequential operating expenses and a strengthened balance sheet with new capital.
Negative Updates
Slow Enrollment in NEUTRALIZE-AKI Trial
Enrollment for the NEUTRALIZE-AKI trial has been slow at times, affecting the timeline for reaching the 200-patient goal.
Regulatory Process Challenges
Lengthy IRB approval process required for QUELIMMUNE therapy adoption, which can take up to eight months, slowing down customer activation.
Dependency on Continued Success
Future success hinges on completing the NEUTRALIZE-AKI trial and obtaining FDA approval, with a significant market opportunity at risk.
Company Guidance
During the SeaStar Medical first quarter 2025 financial results conference call, several key metrics and updates were discussed. The company experienced a fourfold increase in revenue, reaching $293,000 compared to $68,000 in the previous quarter, driven by increased adoption of QUELIMMUNE therapy. QUELIMMUNE has been adopted by six pediatric hospitals, with more in the IRB process, targeting a $100 million annual market based on 4,000 pediatric AKI patients. SeaStar Medical also achieved 50% enrollment in their NEUTRALIZE-AKI trial, which targets the adult AKI market, estimated at 200,000 patients and a $4.5 billion market potential. The company has secured two new FDA breakthrough device designations, expanding their pipeline. Financially, SeaStar reported a net loss of $3.7 million for the quarter, a significant reduction from $12.7 million a year earlier, and ended the quarter with $5.3 million in cash. The focus remains on expanding QUELIMMUNE adoption, completing the NEUTRALIZE-AKI trial, and preparing for a PMA filing in 2026.SeaStar Medical Holding Financial Statement Overview
Summary
SeaStar Medical Holding is in a precarious financial position with negative equity and ongoing operational struggles. Despite some revenue growth, the company faces significant profitability challenges and relies heavily on external financing, highlighting potential liquidity risks.Income Statement
The income statement reveals significant challenges. The company reported its first revenue in 2024, but the gross profit margin is low, and the net profit margin is negative due to substantial losses. EBIT and EBITDA margins are also negative, indicating ongoing operational struggles. Although there is a revenue introduction, past years show no revenue, and the trajectory needs monitoring.30
Negative
Balance Sheet
The balance sheet shows financial instability with negative stockholders' equity, indicating potential solvency issues. The debt-to-equity ratio cannot be calculated due to negative equity, which is a significant concern. Total liabilities exceed total assets, and the equity ratio is negative, suggesting poor financial health and high financial risk.20
Very Negative
Cash Flow
Cash flow analysis indicates strained liquidity with no free cash flow and operating cash flow issues. The operating cash flow to net income ratio is negligible, reflecting difficulty in converting revenue to cash. Financing cash flow is positive, indicating reliance on external financing to sustain operations, which is risky if not managed well.25
Negative
| Breakdown | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 135.00K | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 135.00K | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -24.58M | -11.14M | -11.61M | -4.36M | -6.37M |
| Net Income | -24.83M | -26.23M | -23.01M | -4.60M | -3.28M |
Balance Sheet | |||||
| Total Assets | 4.66M | 3.51M | 4.77M | 603.00K | 2.91M |
| Cash, Cash Equivalents and Short-Term Investments | 1.82M | 176.00K | 47.00K | 510.00K | 2.81M |
| Total Debt | 574.00K | 9.08M | 8.83M | 2.62M | 83.00K |
| Total Liabilities | 6.84M | 17.38M | 13.00M | 76.77M | 74.49M |
| Stockholders Equity | -2.18M | -13.87M | -8.23M | -76.17M | -71.58M |
Cash Flow | |||||
| Free Cash Flow | -16.01M | -10.29M | -7.79M | -5.11M | -5.57M |
| Operating Cash Flow | -16.01M | -10.29M | -7.79M | -5.11M | -5.57M |
| Investing Cash Flow | 0.00 | 0.00 | 0.00 | -105.57M | 0.00 |
| Financing Cash Flow | 17.65M | 10.41M | 7.33M | 2.82M | 4.89M |
SeaStar Medical Holding Technical Analysis
Neutral
0.71
Price Trends
0.94
Negative
1.27
Negative
1.90
Negative
Market Momentum
-0.08
Negative
49.53
Neutral
38.83
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ICU, the sentiment is Neutral. The current price of 0.71 is above the 20-day moving average (MA) of 0.53, below the 50-day MA of 0.94, and below the 200-day MA of 1.90, indicating a neutral trend. The MACD of -0.08 indicates Negative momentum. The RSI at 49.53 is Neutral, neither overbought nor oversold. The STOCH value of 38.83 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for ICU.
SeaStar Medical Holding Risk Analysis
SeaStar Medical Holding disclosed 57 risk factors in its most recent earnings report. SeaStar Medical Holding reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
SeaStar Medical Holding Peers Comparison
Overall Rating
UnderperformOutperform
Sector (52)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
52 Neutral | $7.34B | -0.07 | -63.86% | 2.34% | 16.17% | 0.23% | |
46 Neutral | $13.78M | 0.65 | -162.42% | ― | -82.24% | ― | |
40 Underperform | $9.88M | ― | -64.18% | ― | ― | 1.00% | |
39 Underperform | $22.47M | ― | 249.03% | ― | -14.43% | 16.04% | |
34 Underperform | $19.25M | ― | -616.17% | ― | ― | 71.39% | |
33 Underperform | $15.74M | ― | 1475.93% | ― | ― | 75.26% | |
| ― | $14.58M | ― | -2264.31% | ― | ― | ― |
* Healthcare Sector Average
Performance Comparison
ICU
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0.71
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GOVX
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0.76
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ADXN
Addex Therapeutics
7.54
-0.52
-6.45%
SNSE
Sensei Biotherapeutics
7.84
-5.54
-41.41%
SeaStar Medical Holding Corporate Events
Private Placements and FinancingBusiness Operations and Strategy
SeaStar Medical Secures $6M Through Equity Agreements
Neutral
Feb 3, 2025
On January 31, 2025, SeaStar Medical Holdings entered a Securities Purchase Agreement with an institutional investor, issuing shares and warrants in both a registered direct offering and a concurrent private placement, expecting gross proceeds of approximately $6 million. The funds are intended for general corporate purposes, potentially impacting its operational capabilities and market strategy by enhancing working capital and capital expenditures.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.