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 and nine months ended September 30, 2023 and provides a
business update.
“Recent clinical and regulatory successes have
significantly improved and strengthened our company’s prospects,”
said Eric Schlorff, SeaStar Medical CEO. “We are addressing the
remaining administrative steps outlined by the U.S. Food and Drug
Administration (FDA) for approval of the Selective Cytopheretic
Device Pediatric (SCD-PED) for children with acute kidney injury
(AKI) and sepsis or septic condition requiring continuous kidney
replacement therapy (CKRT). Preparations with our distribution
partner Nuwellis are underway for commercial launch, which we
expect to occur during the first quarter of 2024 following the
receipt of the formal Approval Order from the FDA expected between
December 2023 and January 2024. It is highly gratifying to be on
the cusp of approval to bring the lifesaving benefits of our device
to critically ill children.
“In our pivotal trial in adults with AKI, we
have activated five clinical sites and enrolled seven patients to
date. We are working diligently to qualify additional medical
centers to join this trial and our goal is to enroll one patient
per site per month,” he added. “The addressable adult AKI
population approximates 210,000 patients per year, which is about
50-times larger than the addressable pediatric AKI patient
population.
“We are encouraged by the recent grant of
Breakthrough Device Designation for the SCD in two additional
indications – cardiorenal syndrome and hepatorenal syndrome. We
view these grants as the FDA’s further validation of the potential
for dysregulating immune response in saving lives and improving
outcomes,” Mr. Schlorff concluded.
SeaStar Medical provides the following updates
on its clinical programs with its patented, first-in-class SCD, a
cell-directed extracorporeal therapy:
Adult Acute Kidney Injury
SeaStar Medical is conducting the 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-ADULT in adults with AKI in the intensive
care unit (ICU) receiving CKRT.
- In 2022 the SCD-ADULT received FDA
Breakthrough Device Designation for adult AKI . This designation is
awarded to a therapy to treat a serious or life-threatening
condition with preliminary clinical evidence indicating it may
demonstrate substantial improvement over available therapies on
clinically significant endpoints.
- The NEUTRALIZE-AKI trial is
expected to enroll up to 200 patients at up to 30 U.S. medical
centers. The trial’s primary endpoint is a composite of 90-day
mortality or dialysis dependency of patients treated with SCD-ADULT
in addition to CKRT as the standard of care, compared with the
control group receiving only CKRT standard of care. Secondary
endpoints include mortality at 28 days, ICU-free days in the first
28 days, major adverse kidney events at Day 90 and dialysis
dependency at one year. The study will also include subgroup
analyses to explore the effectiveness of SCD-ADULT therapy in AKI
patients with sepsis and acute respiratory distress syndrome. A
more complete description of the NEUTRALIZE-AKI trial design can be
found in the journal Nephron.
- SeaStar Medical expects regulatory
approval for the SCD-ADULT in the first half of 2025 and commercial
launch in the second half of 2025.
Pediatric Acute Kidney
Injury
SeaStar Medical anticipates its first U.S.
regulatory approval for the SCD-PED will be for pediatric patients
with AKI and sepsis or septic condition weighing 10 kilograms or
more who are being treated in the ICU with CKRT. Only 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.
- In June 2022 the Company submitted
a humanitarian device exemption (HDE) application to the FDA,
having met the criteria with clinical results showing safety and
probable clinical benefit to critically ill children with AKI who
have few treatment options. The U.S. addressable population of
about 4,000 pediatric patients falls within the 8,000-patient HDE
criteria.
- In August 2023 a case series of
three critically ill children with Shiga-toxin-associated hemolytic
uremic syndrome (STEC-HUS), a cause of AKI, treated with the SCD in
two different hospitals was published in the peer-reviewed journal
Blood Purification. Each child showed gradual improvement following
treatment and normalization or near normalization of kidney
function at 60-day follow up.
- In October 2023 the Company
received an Approvable Letter from CBER for use of the SCD-PED in
children weighing 10 kilograms or more with AKI and sepsis or a
septic condition requiring CKRT in the hospital ICU. The Company
expects to complete the administrative action items outlined in the
Approvable Letter in the coming weeks and to receive the formal
approval letter between December 2023 and January 2024, with
commercialization expected in the first quarter of 2024.
- With the license and distribution
agreement in place with Nuwellis for the pediatric AKI indication,
both teams are preparing for commercialization with an initial
focus on the top 50 U.S. hospitals that treat pediatric AKI
patients. Nuwellis’ salesforce has established relationships with
nephrologists and intensive care physicians who are trained in
pediatric extracorporeal therapy.
Additional SCD Indications
SeaStar Medical will continue to explore the
application of its SCD technology across a broad range of
indications involving dysregulated immune processes where
proinflammatory activated neutrophils and monocytes may contribute
to disease progression or severity, in both acute and chronic
indications.
- In September 2023 the Company
received Breakthrough Device Designation for the SCD for use in
cardiorenal syndrome. This was only the ninth Breakthrough Device
Designation granted by CBER since the program’s inception in 2015.
The Company plans to work in partnership with the University of
Michigan to conduct additional clinical studies to gather further
evidence to support a Premarket Approval (PMA) application.
- In October 2023 the Company
received Breakthrough Device Designation for the SCD for use in
hepatorenal syndrome. An ongoing pilot study in this indication at
the University of Michigan is expected to provide valuable insight
in the design and execution of a pivotal study.
Third Quarter Financial
Results
Research and development (R&D) expenses for
the third quarter of 2023 were $1.1 million, compared with $0.7
million for the third quarter of 2022, with the increase primarily
resulting from higher clinical trial expenses and an increase in
payroll and personnel expenses, partially offset by a decrease in
external services.
General and administrative (G&A) expenses
for the third quarter of 2023 were $1.8 million, compared with $1.0
million for the third quarter of 2022, with the increase primarily
due to increases in insurance expense, higher costs associated with
SEC reporting, increases in payroll-related expenses and higher
account and tax expenses.
Other expense for the three months ended
September 30, 2023 was $4.5 million, compared with other expense of
$0.1 million for the three months ended September 30, 2022. The
increase primarily resulted from a change in interest expense,
change in fair value of convertible notes and loss on
extinguishment of convertible notes, partially offset by the change
in fair value of warrants liability and other income.
The net loss for the three months ended
September 30, 2023 was $7.4 million, or $0.37 per share, compared
with a net loss of $1.9 million, or $0.26 per share, for the three
months ended September 30, 2022.
Nine Month Financial
Results
R&D expenses for the first nine months of
2023 were $4.9 million, compared with $1.7 million for the first
nine months of 2022. G&A expenses for the first nine months of
2023 were $6.4 million, versus $2.2 million for the first nine
months of 2022.
Other expense for the nine months ended
September 30, 2023 was $5.1 million, compared with other income of
$0.1 million for the nine months ended September 30, 2022. The
difference primarily resulted from an increase in interest expense,
the change in fair value of convertible notes, the change in fair
value of forward option-prepaid forward contracts and the loss on
extinguishment of convertible notes, partially offset by the change
in fair value of warrants liability, a gain on sales of recycled
shares, the change in fair value of notes payable derivative
liability and other income.
The net loss for the nine months ended September
30, 2023 was $16.4 million, or $1.02 per share, compared with a net
loss of $3.8 million, or $0.52 per share, for the nine months ended
September 30, 2022.
The Company reported cash of $73,000 as of
September 30, 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 May 2023 closed
on the second tranche of $2.2 million. The Company issued two
convertible notes each for $0.5 million in August 2023 and a third
convertible note for $0.5 million in September 2023.
About Hyperinflammation and the
Selective Cytopheretic Device
Hyperinflammation is 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 or damaging to vital
organs, and can result in multi-organ failure and even death. This
is known as the cytokine storm.
The Selective Cytopheretic Device (SCD) is a
medical device that employs immunomodulating technology to
selectively target pro-inflammatory neutrophils and monocytes
during CKRT and disrupt the cytokine storm that causes
inflammation, organ failure and possibly death in critically ill
patients. Unlike pathogen removal and other blood-purification
tools, the device works with hemofiltration systems to enable
precise fluid and solute balance control to selectively target and
transition pro-inflammatory monocytes to reparative and promote
activated neutrophils to be less inflammatory. SCD selectively
targets the most highly activated pro-inflammatory neutrophils and
monocytes. These cells are then returned back into the body through
the blood, and the body is signaled to focus on repair. This unique
immunomodulation approach may reverse injury and eliminate the need
for CKRT going forward.
Clinical Results with the SCD in
AKI
The SCD is a patented, cell-directed,
extracorporeal device intended to be used as an adjunct therapy
that selectively targets and transitions pro-inflammatory monocytes
to promote reparative processes and reduce the acute inflammatory
and damaging effects of activated neutrophils. Pooled analysis from
two non-controlled clinical studies, SCD-PED-01 (funded by the FDA
Office of Orphan Products Development) and SCD-PED-02,
showed that pediatric patients ≥10kg with AKI
requiring CKRT who were treated with the SCD had no device-related
serious adverse events or infections, a 77% reduction in mortality
rate and no dialysis dependency at Day 60. The SCD-PED-01 (weight
range ≥15 kg) and PED-02 (weight range ≥10 kg) studies demonstrated
75% and 83% reductions in mortality, respectively.
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,
SeaStar Medical’s expectations with respect to the ability of SCD
to treat patients with AKI and other diseases; the expected
regulatory approval process and timeline for commercialization; and
the ability of SeaStar Medical to meet the expected timeline. .
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
Medical may not be able to obtain regulatory approval of its SCD
product candidates; (ii) the risk that SeaStar Medical 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, (viii) the risk that SeaStar
Medical is unable to secure or protect its intellectual property,
and (ix) 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. 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.
Contact:LHA Investor
RelationsJody Cain(310) 691-7100Jcain@lhai.com
SeaStar Medical Holding
CorporationCondensed Consolidated Balance
Sheets(in thousands, except for share and
per-share amounts)
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
ASSETS |
Current assets |
|
|
|
|
|
|
|
|
Cash |
|
$ |
73 |
|
|
$ |
47 |
|
Other receivables |
|
|
— |
|
|
|
12 |
|
Prepaid expenses |
|
|
2,172 |
|
|
|
2,977 |
|
Total current assets |
|
|
2,245 |
|
|
|
3,036 |
|
Forward option-prepaid forward
contracts, net |
|
|
— |
|
|
|
1,729 |
|
Other assets |
|
|
2 |
|
|
|
2 |
|
Total assets |
|
$ |
2,247 |
|
|
$ |
4,767 |
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
5,042 |
|
|
$ |
1,927 |
|
Accrued expenses |
|
|
1,481 |
|
|
|
2,245 |
|
Contingent upfront payment for license agreement |
|
|
100 |
|
|
|
— |
|
Notes payable, net of deferred financing costs |
|
|
— |
|
|
|
1,178 |
|
Convertible notes |
|
|
4,405 |
|
|
|
— |
|
Warrants liability |
|
|
1,400 |
|
|
|
— |
|
Total current liabilities |
|
|
12,428 |
|
|
|
5,350 |
|
Notes payable, net of deferred
financing costs |
|
|
5,722 |
|
|
|
7,652 |
|
Total liabilities |
|
|
18,150 |
|
|
|
13,002 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders' deficit (1) |
|
|
|
|
|
|
|
|
Common stock - $0.0001 par value per share; 500,000,000 and
100,000,000 shares authorized at September 30, 2023 and December
31, 2022, respectively; 27,201,087 and 12,699,668 shares
issued and outstanding at September 30, 2023 and December 31,
2022, respectively |
|
|
3 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
99,776 |
|
|
|
91,089 |
|
Accumulated deficit |
|
|
(115,682 |
) |
|
|
(99,325 |
) |
Total stockholders' deficit |
|
|
(15,903 |
) |
|
|
(8,235 |
) |
Total liabilities and stockholders' deficit |
|
$ |
2,247 |
|
|
$ |
4,767 |
|
(1) Retroactively restated to present effect of the reverse
recapitalization
SeaStar Medical Holding
CorporationCondensed Consolidated Statements of
Operations(in thousands, except for share and
per-share amounts)
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,107 |
|
|
$ |
727 |
|
|
$ |
4,898 |
|
|
$ |
1,678 |
|
General and
administrative |
|
|
1,829 |
|
|
|
1,042 |
|
|
|
6,369 |
|
|
|
2,215 |
|
Total operating expenses |
|
|
2,936 |
|
|
|
1,769 |
|
|
|
11,267 |
|
|
|
3,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(2,936 |
) |
|
|
(1,769 |
) |
|
|
(11,267 |
) |
|
|
(3,893 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense),
net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(224 |
) |
|
|
(123 |
) |
|
|
(882 |
) |
|
|
(483 |
) |
Change in fair value of
convertible notes |
|
|
(291 |
) |
|
|
— |
|
|
|
(291 |
) |
|
|
— |
|
Change in fair value of
warrants liability |
|
|
825 |
|
|
|
— |
|
|
|
1,305 |
|
|
|
— |
|
Change in fair value of notes
payable derivative liability |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
578 |
|
Change in fair value of
forward option-prepaid forward contracts |
|
|
— |
|
|
|
— |
|
|
|
(1,723 |
) |
|
|
— |
|
Loss on extinguishment of
convertible notes |
|
|
(4,949 |
) |
|
|
— |
|
|
|
(4,949 |
) |
|
|
— |
|
Gain on sale of recycled
shares |
|
|
— |
|
|
|
— |
|
|
|
1,306 |
|
|
|
— |
|
Other income |
|
|
149 |
|
|
|
1 |
|
|
|
149 |
|
|
|
1 |
|
Total other income (expense), net |
|
|
(4,490 |
) |
|
|
(122 |
) |
|
|
(5,085 |
) |
|
|
96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision for
income taxes |
|
|
(7,426 |
) |
|
|
(1,891 |
) |
|
|
(16,352 |
) |
|
|
(3,797 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes |
|
|
— |
|
|
|
1 |
|
|
|
5 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,426 |
) |
|
$ |
(1,892 |
) |
|
$ |
(16,357 |
) |
|
$ |
(3,798 |
) |
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.26 |
) |
|
$ |
(1.02 |
) |
|
$ |
(0.52 |
) |
Weighted-average shares
outstanding, basic and diluted, retrospectively restated to present
effect of the reverse recapitalization |
|
|
20,048,473 |
|
|
|
7,238,767 |
|
|
|
16,028,118 |
|
|
|
7,238,767 |
|
# # #
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