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SeaStar Medical Reports First Quarter 2023 Financial Results and Provides a Business Update DENVER (

Key Takeaway: SeaStar Medical has reported its first quarter 2023 financial results, with an increased net loss compared to the previous year. The company has activated the first clinical site for its pivotal NEUTRALIZE-AKI trial, and enrollment of patients is expected to begin soon. Although facing regulatory challenges, SeaStar aims to obtain a Humanitarian Device Exemption for its Selective Cytopheretic Device (SCD) to treat acute kidney injury in pediatric patients by late 2023. The SCD has shown promising results in reducing mortality rates among critically ill patients.

Market Sentiment Analysis

POSITIVE FACTORS

  • Enrollment of the first patient in the NEUTRALIZE-AKI trial is underway.
  • The SCD has shown favorable clinical results, reducing mortality rates in patients with AKI.
  • The company is actively pursuing a Humanitarian Device Exemption for pediatric AKI treatment.

CONCERNS & RISKS

  • The company received a non-approvable letter from the FDA.
  • There was a significant increase in net losses from $1 million to $5.3 million year-over-year.
  • General and administrative expenses notably spiked due to increased professional fees and marketing costs.

Full Press Release Details

SeaStar Medical Reports First Quarter 2023 Financial Results and Provides a Business Update
DENVER (May 15, 2023) SeaStar Medical Holding Corporation (Nasdaq: ICU) ( SeaStar Medical or the Company ), a medical
device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three months ended March 31, 2023 and provides a business update.
Enrollment of the first patient in our pivotal NEUTRALIZE-AKI trial and activation of additional clinical
trial sites are expected in the coming weeks. This trial is evaluating the safety and efficacy of our patented, first-in-class, cell-directed Selective Cytopheretic
Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT), said Eric Schlorff, SeaStar Medical CEO. Following the recent receipt of a non-approvable letter, we are working with the FDA to secure a Humanitarian Device Exemption (HDE) for use of the SCD to treat critically ill children with AKI, and are now targeting approval in late 2023.
SeaStar Medical provides the following updates on its clinical programs with its patented, first-in-class SCD, a cell-directed extracorporeal therapy for hospitalized patients with AKI requiring CKRT:
Adult Acute Kidney Injury
The first clinical site has
been activated in our pivotal NEUTRALIZE-AKI (NEUTRophil and Monocyte DeActivation via SeLective CytopheretIc Device - a RandomiZEd
Clinical Trial in Acute Kidney Injury) clinical trial to evaluate the safety and effectiveness of the SCD in critically ill adults with AKI in the intensive care unit (ICU) receiving CKRT. Approximately six
million cases of adult AKI are diagnosed annually in the U.S., of which approximately 200,000 require CKRT.
Pediatric Acute Kidney Injury
We anticipate our first U.S. regulatory approval for the SCD will be for pediatric patients with AKI being treated in the ICU with CKRT. About one-half of children in the ICU with AKI who require CKRT survive, with those surviving at risk of long-term life-threatening conditions such as chronic kidney disease.
SeaStar Medical will continue to explore the application of our SCD technology across a broad range of indications where proinflammatory activated neutrophils
and monocytes may contribute to disease progression or severity, in both acute and chronic indications.
First Quarter Financial Results
Research and development (R&D) expenses for the first quarter of 2023 were $1.8 million, compared with $0.4 million for the first quarter of
2022, with the increase primarily driven by an increase in clinical trial expenses of $0.6 million, an increase in the use of external services of $0.3 million and an increase in payroll and personnel expenses of $0.5 million.
General and administrative (G&A) expenses for the first quarter of 2023 were $3.0 million, compared with $0.5 million for the first quarter of
2022, with the increase primarily attributable to an increase in professional fees related to SEC reporting of $0.6 million, an increase in payroll-related expenses of $0.7 million, an increase in insurance expense of $0.4 million,
expenses related to financial instruments of $0.3 million, cost of SEC reporting of $0.2 million, a legal settlement of $0.2 million and an increase in marketing expenses of $0.1 million.
Other expense for the first quarter of 2023 was $0.5 million, compared with other expense of $0.2 million for the first quarter of 2022. The
increase primarily resulted from the change in fair value of forward option-prepaid forward contracts and tranche rights, and loss on issuance of convertible notes, partially offset by the change in fair value of convertible notes and a gain on
sales of recycled shares.
The net loss for the first quarter of 2023 was $5.3 million, or $0.40 per share, compared with a net
loss of $1.0 million, or $0.14 per share, for the first quarter of 2022.
The Company reported cash of $725,000 as of March 31, 2023, compared
with $47,000 as of December 31, 2022. At the closing of the merger agreement in October 2022, the Company entered into forward purchase agreements of shares and warrants with the potential to generate up to $10 million in proceeds,
depending on the market price of shares. The Company also entered into a $100 million equity line of credit. In March 2023 the Company closed a $3.3 million first tranche of a $9.8 million private placement convertible debt offering,
and in recently closed on the second tranche of $2.2 million.
About Hyperinflammation and the Selective Cytopheretic Device (SCD)
SeaStar Medical has identified a clear, urgent, unmet clinical need for technology that addresses hyperinflammation, the overproduction or overactivity of
inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is
known as the cytokine storm. Current treatment options have shown limited efficacy in managing a cytokine storm with many simply treating symptoms instead of stopping the inflammatory effector cells that cause the cytokine storm.
The Selective Cytopheretic Device, or SCD, is a first-in-class, cell-directed
extracorporeal therapy. Unlike pathogen removal and other blood-purification tools, the SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. The Company has observed that these most highly activated immune
cells are turned off in a low calcium environment. The SCD is integrated into existing hemodialysis equipment that is widely available in ICUs across the U.S. It requires less than 15 minutes for physicians or hospital staff to attach. The SCD
therapy mimics nature by creating a unique micro-environment, attracting these highly activated effector cells and neutralizing them in a low calcium setting, with these cells then returned into the body through the blood, and the body is signaled
Clinical Results with the SCD in AKI
SCD therapy has produced favorable clinical results in critically ill adults and children with AKI in the ICU being treated with CKRT, today s standard of
care. The SCD has reduced mortality rates by up to 50% in four non-COVID clinical trials in which adult and pediatric AKI patients had on average three organ failures and with a significant number of patients
also being septic. A similar reduction in mortality was observed in a study of 22 COVID-19 patients with AKI and/or acute respiratory distress syndrome.
About SeaStar Medical
SeaStar Medical is a
medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical s novel technologies rely on science and innovation to provide life-saving
solutions to critically ill patients. The Company is developing and commercializing cell-directed 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. For more information visit www.seastarmedical.com or visit us on LinkedIn or Twitter.
Forward-Looking Statements
This press release contains
certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements
include, without limitation, the FDA letter and SeaStar s intent to pursue appeal options and other actions in response to such letter; the ability of SeaStar to address deficiencies raised
by the FDA; the ability of SCD to treat pediatric patients with AKI, and the potential benefits of SCD to treat other diseases. Words such as believe, project, expect, anticipate, estimate,
intend, strategy, future, opportunity, plan, may, should, will, would, will be, will continue, will likely
result, and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions
and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical s control and are difficult to predict.
Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar may not be able to obtain regulatory approval of its SCD product candidates; (ii) the
risk that SeaStar may not be able to raise sufficient capital to fund its operations, including clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize
its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain
profitability; (v) the risk that SeaStar Medical may not be able to access funding under existing agreements, including the equity line of credit and forward purchase agreements; (vi) the risk that third-parties suppliers and manufacturers
are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical s products and services, (xiii) the risk that SeaStar Medical is unable to
secure or protect its intellectual property, and (xi) other risks and uncertainties indicated from time to time in SeaStar Medical s Annual Report on Form 10-K, including those under the Risk
Factors section therein and in SeaStar Medical s other filings with the SEC. (iii) The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and SeaStar Medical assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
LHA Investor Relations
Financial Tables to Follow
SeaStar Medical Holding Corporation
Consolidated Balance Sheets
(in thousands, except for share and per-share amounts)
March 31, 2023 December 31, 2022
ASSETS
Current assets
Cash $ 725 $ 47
Other receivables 12
Prepaid expenses 2,659 2,977
Total current assets 3,384 3,036
Forward option-prepaid forward contracts, net 1,729
Other assets 2 2
Total assets $ 3,386 $ 4,767
LIABILITIES AND STOCKHOLDERS DEFICIT
Current liabilities
Accounts payable $ 3,022 $ 1,927
Accrued expenses 1,531 2,245
Contingent upfront payment for license agreement 100
Notes payable 493 1,178
Convertible note 2,390
Warrants liability 500
Total current liabilities 8,036 5,350
Forward option-prepaid forward contracts, net 489
Notes payable, net of deferred financing costs 5,745 7,652
Total liabilities 14,270 13,002
Commitments and contingencies
Stockholders deficit (1)
Common stock - $0.0001 par value per share; 100,000,000 shares authorized; 13,296,516 and 12,699,668 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively 1 1
Additional paid-in capital 93,702 91,089
Accumulated deficit (104,587 ) (99,325 )
Total stockholders deficit (10,884 ) (8,235 )
Total liabilities and stockholders deficit $ 3,386 $ 4,767
SeaStar Medical Holding Corporation
Consolidated Statements of Operations
(in thousands, except for share and per-share amounts)
Three Months Ended March 31,
2023 2022
Operating expenses
Research and development $ 1,784 $ 355
General and administrative 2,957 457
Total operating expenses 4,741 812
Loss from operations (4,741 ) (812 )
Other income (expense), net
Interest expense (273 ) (169 )
Change in fair value of convertible note 100
Change in fair value of notes payable (23 )
Change in fair value of forward option-prepaid forward contracts (1,654 )
Gain on sale of recycled shares 1,306
Total other expense, net (521 ) (192 )
Loss before income tax provision (benefit) (5,262 ) (1,004 )
Income tax provision (benefit)
Net loss $ (5,262 ) $ (1,004 )
Net loss per share of common stock, basic and diluted $ (0.40 ) $ (0.14 )
Weighted-average shares outstanding, basic and diluted (1) 13,025,852 7,238,767

Frequently Asked Questions

What is the NEUTRALIZE-AKI trial about?

The NEUTRALIZE-AKI trial evaluates the safety and efficacy of the SCD in adults with acute kidney injury.

What is SeaStar Medical's primary focus?

SeaStar Medical develops solutions to reduce hyperinflammation's effects on vital organs.

What financial results did SeaStar report for Q1 2023?

SeaStar reported a net loss of $5.3 million for the first quarter of 2023.

What is the Selective Cytopheretic Device (SCD)?

The SCD is a first-in-class therapy that targets activated proinflammatory immune cells.

What progress has SeaStar made in pediatric trials?

SeaStar aims for regulatory approval of SCD for pediatric patients with AKI in late 2023.

Last updated: May 15, 2023