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 six months ended June 30, 2023 and provides a
business update.
“With the recent activation of a second clinical
site, we now have two medical centers open for enrolling patients
in our pivotal trial 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. “We are
working diligently to qualify additional medical centers to join
this trial and expect the activation of several more sites in the
coming weeks. We plan to provide periodic updates on site
activation and patient enrollment as this important trial
progresses.
“There are considerable differences between our
adult and our pediatric AKI programs,” he added. “Among them are
the FDA pathways for approval and the proprietary characteristics
between the pediatric SCD-PED and the adult SCD-ADULT devices. The
two devices are completely different products and meant for
different patient populations, although their mechanism of action
is the same. The regulatory pathway, regulatory events and
decisions between these two devices are independent of each other.
Additionally, the addressable adult AKI patient population
approximates 200,000 per year, which is about 50-times greater than
the addressable pediatric population, which we estimate at around
4,000 patients annually. While the SCD-PED addresses a smaller
commercial opportunity, we are deeply committed to bringing the
potentially lifesaving benefits of this therapy to critically ill
children.
“Most pharmaceutical development programs begin
in adult populations with plans for pediatric studies once safety
and efficacy have been established. We elected to lead with the
Humanitarian Device Exemption (HDE) regulatory pathway for the
pediatric population based on the highly promising data from our
SCD-PED study showing a 50% reduction in mortality and no dialysis
required at Day 60,” said Mr. Schlorff. “Despite a challenging
pediatric approval pathway, we are working collaboratively with the
FDA. To our knowledge the SCD-PED would be among the first
pediatric medical devices to be approved by the
FDA’s Center for Biologics Evaluation and Research (CBER) through
the HDE pathway, presenting a unique regulatory review situation.
We believe the FDA has appropriately set a very high bar in its
evaluation of the SCD-PED given the vulnerability of these
critically ill children in the ICU. That said, we are confident
that the SCD-PED device will meet or even exceed the high standards
set by the FDA.”
During the August 22 business update conference
call, SeaStar Medical management will discuss progress with the
adult AKI trial and review ongoing discussions with the FDA on the
SCD-PED. Management will also review the Company’s value
proposition, including the commercial opportunity. See below for
details about participating in the conference call.
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
Two clinical sites have been activated in 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 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-ADULT 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 over available therapies on
clinically significant endpoints. 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-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. The
study design for NEUTRALIZE-AKI was recently accepted in the
journal Nephron and a more complete description of the study can be
found in the online version of the accepted manuscript here.
- SeaStar Medical anticipates
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 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
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-PED 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 the Company 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.
- The Company continues to work
diligently with FDA toward a resolution of this review process. The
pediatric device SCD-PED is a smaller device than the SCD-ADULT
with unique features, albeit the mechanism of action is still the
same. The regulatory pathway, regulatory events and decisions
between these two devices are independent of each other. With the
license and distribution agreement with Nuwellis for the pediatric
AKI indication in place, both teams have been 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.
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.
Second Quarter
Financial Results
Research and development (R&D) expenses for
the second quarter of 2023 were $2.0 million, compared with $0.6
million for the second quarter of 2022, with the increase primarily
resulting from higher clinical trial and external services costs,
and increases in payroll and personnel expenses.
General and administrative (G&A) expenses
for the second quarter of 2023 were $1.7 million, compared with
$0.7 million for the second quarter of 2022, with the increase
primarily due to increases in insurance expense, higher costs
associated with SEC reporting, and increases in payroll, marketing
and travel expenses.
The net loss for the second quarter of 2023 was
$3.7 million, or $0.25 per share, compared with a net loss of $0.9
million, or $0.12 per share, for the second quarter of 2022. The
increased net loss primarily resulted from higher operating
expenses, and changes in fair value of forward option-prepaid
forward contracts and in fair value of convertible notes, partially
offset by the change in fair value of notes payable during the 2022
quarter, and the gain on issuance of convertible notes and the
change in fair value of warrants liability during the 2023
quarter.
Six Month Financial Results
R&D expenses for the first six months of
2023 were $3.8 million, compared with $1.0 million for the first
six months of 2022. G&A expenses for the first half of 2023
were $4.5 million, versus $1.2 million for the first half of
2022.
The net loss for the first half of 2023 was $8.9
million, or $0.64 per share, compared with a net loss of $1.9
million, or $0.26 per share, for the first half of 2022. The higher
net loss primarily resulted from increases in operating and
interest expenses, change in fair value of convertible notes, and a
change in fair value of forward option-prepaid forward contracts,
partially offset by the change in fair value of notes payable
during the 2022 period, and the gain on issuance of convertible
notes, change in fair value of warrants liability, and a gain on
sale of recycled shares during the 2023 period.
The Company reported cash of $13,000 as of June
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. In August 2023 the Company
issued a convertible note for $543,000.
Business Update Conference
Call
SeaStar Medical management will host a business
update conference call on Tuesday, August 22, 2023 beginning at
4:00 p.m. Eastern time (1:00 p.m. Pacific time) to provide a
business update and answer questions. Participants can pre-register
for the conference call here. Callers who pre-register will be
given a conference passcode and unique PIN to gain immediate access
to the call and bypass the live operator. Participants may
pre-register at any time, including up to and after the call start
time.
Stockholders and other interested parties may
also participate in the conference call by dialing 866-777-2509
from within the U.S. or 412-317-5413 from outside the U.S., and
requesting the SeaStar Medical call.
A live webcast of the call will be available
here and will be archived for 90 days. A replay of the call will be
available beginning two hours after the call ends through August
24, 2023 by dialing 877-344-7529 from within the U.S., 855-669-9658
from Canada or 412-317-0088 from outside the U.S. and Canada, and
entering the conference identification number 8122409.
About Hyperinflammation
and the Selective Cytopheretic Device
(SCD)
SeaStar Medical has identified a clear, urgent,
unmet clinical need for technology that addresses dysregulated
immune responses, including hyperinflammation, which 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 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 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
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.
Contact:LHA Investor
RelationsJody Cain(310) 691-7100Jcain@lhai.com
Financial Tables to Follow
SeaStar Medical holding
Corporartion |
Condensed Consolidated Balance Sheets |
(Unaudited) |
|
|
June 30, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
ASSETS |
Current assets |
|
|
|
|
Cash |
|
$ |
13 |
|
|
$ |
47 |
|
Other receivables |
|
|
— |
|
|
|
12 |
|
Prepaid expenses |
|
|
2,319 |
|
|
|
2,977 |
|
Total current assets |
|
|
2,332 |
|
|
|
3,036 |
|
Forward option-prepaid forward
contracts, net |
|
|
- |
|
|
|
1,729 |
|
Other assets |
|
|
2 |
|
|
|
2 |
|
Total assets |
|
$ |
2,334 |
|
|
$ |
4,767 |
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
4,355 |
|
|
$ |
1,927 |
|
Accrued expenses |
|
|
1,095 |
|
|
|
2,245 |
|
Contingent upfront payment for license agreement |
|
|
100 |
|
|
|
— |
|
Notes payable, net of deferred financing costs |
|
|
5,907 |
|
|
|
1,178 |
|
Convertible notes |
|
|
2,230 |
|
|
|
— |
|
Warrants liability |
|
|
95 |
|
|
|
— |
|
Total current liabilities |
|
|
13,782 |
|
|
|
5,350 |
|
Notes payable, net of deferred
financing costs |
|
|
- |
|
|
|
7,652 |
|
Total liabilities |
|
|
13,782 |
|
|
|
13,002 |
|
Commitments and contingencies
(see Note 10) |
|
|
|
|
Stockholders' deficit (1) |
|
|
|
|
Common stock - $0.0001 par value per share; 100,000,000 shares
authorized; 18,121,238 and 12,699,668 shares issued and outstanding
at June 30, 2023 and December 31, 2022, respectively |
|
|
2 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
96,806 |
|
|
|
91,089 |
|
Accumulated deficit |
|
|
(108,256 |
) |
|
|
(99,325 |
) |
Total stockholders' deficit |
|
|
(11,448 |
) |
|
|
(8,235 |
) |
Total liabilities and stockholders' deficit |
|
$ |
2,334 |
|
|
$ |
4,767 |
|
SeaStar Medical Holding
Corporation |
Condensed Consolidated Statements of
Operations |
(Unaudited) |
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,007 |
|
|
$ |
596 |
|
|
$ |
3,791 |
|
|
$ |
951 |
|
General and administrative |
|
|
1,743 |
|
|
|
716 |
|
|
|
4,540 |
|
|
|
1,173 |
|
Total operating expenses |
|
|
3,750 |
|
|
|
1,312 |
|
|
|
8,331 |
|
|
|
2,124 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,750 |
) |
|
|
(1,312 |
) |
|
|
(8,331 |
) |
|
|
(2,124 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense),
net |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(225 |
) |
|
|
(191 |
) |
|
|
(658 |
) |
|
|
(360 |
) |
Change in fair value of convertible notes |
|
|
(100 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Change in fair value of warrants liability |
|
|
480 |
|
|
|
— |
|
|
|
480 |
|
|
|
— |
|
Change in fair value of notes payable derivative liability |
|
|
— |
|
|
|
601 |
|
|
|
— |
|
|
|
578 |
|
Change in fair value of forward option-prepaid forward
contracts |
|
(69 |
) |
|
|
— |
|
|
|
(1,723 |
) |
|
|
— |
|
Gain on sale of recycled shares |
|
|
— |
|
|
|
— |
|
|
|
1,306 |
|
|
|
— |
|
Total other income (expense), net |
|
|
86 |
|
|
|
410 |
|
|
|
(595 |
) |
|
|
218 |
|
|
|
|
|
|
|
|
|
|
Loss before provision for
income taxes |
|
|
(3,664 |
) |
|
|
(902 |
) |
|
|
(8,926 |
) |
|
|
(1,906 |
) |
|
|
|
|
|
|
|
|
|
Provision for income
taxes |
|
|
5 |
|
|
|
— |
|
|
|
5 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,669 |
) |
|
$ |
(902 |
) |
|
$ |
(8,931 |
) |
|
$ |
(1,906 |
) |
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.25 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.64 |
) |
|
$ |
(0.26 |
) |
Weighted-average shares
outstanding, basic and diluted (1) |
|
|
14,932,866 |
|
|
|
7,238,767 |
|
|
|
13,984,625 |
|
|
|
7,238,767 |
|
(1) Retroactively restated to give effect to
the reverse recapitalization
# # #
SeaStar Medical (NASDAQ:ICU)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
SeaStar Medical (NASDAQ:ICU)
Gráfica de Acción Histórica
De May 2023 a May 2024