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.
- In 2022 the SCD received FDA
Breakthrough Device Designation for adult use. 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 on clinically significant
endpoints over available therapies. Breakthrough therapies receive
many benefits, including a commitment by the FDA to expedite
development and review.
- 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 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 therapy in AKI patients with sepsis and
acute respiratory distress syndrome.
- The trial is expected to require 18
months to complete and report topline results. Based on this
timeline, we expect to file a Premarket Approval application in the
third quarter of 2024, with anticipated approval in the first half
of 2025 and commercial launch in the second half of 2025.
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.
- In June 2022 we submitted an 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. A
non-controlled pivotal study funded by the FDA Office of Orphan
Products Development showed that those treated with the SCD had no
reported adverse events, a 50% reduction in mortality rate and no
dialysis required at Day 60. The U.S. addressable population of
about 4,000 pediatric patients is within the 8,000-patient HDE
criteria.
- In May 2023 we
received a letter from the FDA indicating that the application is
not approvable in its current form and outlining specific guidance
as to how the application may be amended and resubmitted. We
believe that each defficiency cited in the letter is readily
addressable and have put in place a plan with the goal of achieving
pediatric HDE approval. In parallel we have initiated the
administrative review and have a further option to appeal. We
anticipate that this process could take between 90 and 120
days.
- With the license and distribution
agreement with Nuwellis for the pediatric AKI indication in place,
both team’s have been preparing for the initial commercial 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. This agreement allows us to focus
on additional clinical applications with the SCD without the
expense of hiring and training a commercial team.
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 to focus on repair.
Clinical Results with
the SCD in AKISCD
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 MedicalSeaStar
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 StatementsThis
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.
Contacts:MediaPSC
ConsultingPatty Caballero(973)
348-5055patty@pscconsulting.net
InvestorsLHA Investor RelationsJody Cain(310)
691-7100Jcain@lhai.com
Financial Tables to Follow
SeaStar Medical Holding
CorporationConsolidated Balance
SheetsAs of December 31, 2022 and
2021(in thousands, except for share and per-share
amounts)Unaudited
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
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 |
|
(1) Retrospectively restated to give effect to the reverse
recapitalization
SeaStar Medical Holding
CorporationConsolidated
Statements of OperationsFor the Years
Ended December 31, 2022 and 2021(in thousands,
except for share and per-share
amounts)Unaudited
|
|
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 |
|
(1) Retroactively restated to give effect to the reverse
recapitalization
# # #
SeaStar Medical (NASDAQ:ICU)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
SeaStar Medical (NASDAQ:ICU)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024