04/17/2024 | Press release | Distributed by Public on 04/17/2024 14:02
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In February 2024 SeaStar Medical received its first U.S. regulatory approval for the SCD Pediatric (SCD-PED) device for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with KRT. The SCD-PED is the first product approval in the Company's newly branded Quelimmune product family. Quelimmune was approved under a humanitarian device exemption (HDE) application, having met the applicable 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.
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The Company is working to commercialize Quelimmune with its distribution partner Nuwellis, which has deep relationships with nephrologists and intensive care physicians trained in pediatric extracorporeal
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therapy. Pediatric patients undergoing treatment with Quelimmune are expected to require on average seven Quelimmune units, with the disposable device being changed once every 24 hours.
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In March 2024 the Company sponsored an industry symposium titled "New Therapies in Pediatric Acute Kidney Injury" at the AKI & CRRT 2024 conference. The symposium featured key opinion leaders in nephrology and AKI, who are members of the Company's Scientific Advisory Board.
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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.
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The Company expects to receive regulatory approval for the SCD-ADULT in the second half of 2025 and to launch the product in the first half of 2026.
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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 the FDA's Center for Biologics Evaluation and Research (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 FDA approval.
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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.
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In February 2024 the manuscript "New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation" Pitt, B., Iyer, S.P.N. and Humes, H.D. discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the SCD was published in the peer-reviewed European Journal of Heart Failure.
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In January 2024 the Company appointed healthcare industry veteran David A. Green as Chief Financial Officer. Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
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In January 2024 the Company announced a $9.0 million registered direct offering priced at-the-market.
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In January 2024 a U.S. patent was granted with broad claims directed to methods of using the SCD to treat subjects with inflammatory conditions and to process activated leukocytes and platelets.
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In February 2024 the Canadian Intellectual Property Office issued a patent with broad claims covering the SCD technology.
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2023
|
2022
|
|||||||||
(As Restated)
|
||||||||||
ASSETS
|
||||||||||
Current assets
|
||||||||||
Cash
|
$
|
176
|
$
|
47
|
||||||
Other receivables
|
-
|
12
|
||||||||
Prepaid expenses
|
2,132
|
1,460
|
||||||||
Total current assets
|
2,308
|
1,519
|
||||||||
Other assets
|
1,205
|
1,519
|
||||||||
Total assets
|
$
|
3,513
|
$
|
3,038
|
||||||
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
||||||||||
Current liabilities
|
||||||||||
Accounts payable
|
$
|
4,372
|
$
|
1,927
|
||||||
Accrued expenses
|
1,523
|
2,245
|
||||||||
Contingent upfront payment for license agreement
|
100
|
-
|
||||||||
Notes payable, net of deferred financing costs
|
565
|
1,178
|
||||||||
Convertible notes, current portion
|
4,179
|
-
|
||||||||
Forward purchase agreement derivative liability
|
-
|
10,211
|
||||||||
Liability classified warrants
|
2,307
|
587
|
||||||||
Total current liabilities
|
13,046
|
16,148
|
||||||||
Notes payable, net of deferred financing costs
|
4,143
|
7,652
|
||||||||
Convertible notes, net of current portion
|
194
|
-
|
||||||||
Total liabilities
|
17,383
|
23,800
|
||||||||
Commitments and contingencies
|
||||||||||
Stockholders' deficit
|
||||||||||
Preferred stock - $0.0001 par value, 10,000,000 and 10,000,000 shares authorized at December 31, 2023 and 2022, respectively; no shares issued and outstanding at December 31, 2023 and 2022, respectively.
|
-
|
-
|
||||||||
Common stock - $0.0001 par value per share;
500,000,000 and 100,000,000 shares authorized at December 31, 2023 and 2022, respectively; 47,615,285 and 12,699,668 shares issued and outstanding at December 31, 2023 and 2022, respectively |
5
|
1
|
||||||||
Additional paid-in capital
|
100,859
|
67,739
|
||||||||
Accumulated deficit
|
(114,734
|
)
|
(88,502
|
)
|
||||||
Total stockholders' deficit
|
(13,870
|
)
|
(20,762
|
)
|
||||||
Total liabilities and stockholders' deficit
|
$
|
3,513
|
$
|
3,038
|
2023
|
2022
|
|||||||||
(As Restated)
|
||||||||||
Operating expenses
|
||||||||||
Research and development
|
$
|
5,973
|
$
|
2,503
|
||||||
General and administrative
|
8,237
|
6,916
|
||||||||
Origination cost of prepaid forward contracts
|
-
|
2,190
|
||||||||
Total operating expenses
|
14,210
|
11,609
|
||||||||
Loss from operations
|
(14,210
|
)
|
(11,609
|
)
|
||||||
Other income (expense)
|
||||||||||
Interest expense
|
(1,081
|
)
|
(630
|
)
|
||||||
Change in fair value of convertible notes
|
(5,380
|
)
|
-
|
|||||||
Change in fair value of warrants liability
|
545
|
10,863
|
||||||||
Change in fair value of notes payable derivative liability
|
-
|
(602
|
)
|
|||||||
Change in the fair value of the forward purchase agreement derivative liability
|
(1,308
|
)
|
(10,211
|
)
|
||||||
Loss on extinguishment of convertible notes
|
(4,949
|
)
|
-
|
|||||||
Other income
|
151
|
-
|
||||||||
Total other income (expense), net
|
(12,022
|
)
|
(580
|
)
|
||||||
Loss before provision for income taxes
|
(26,232
|
)
|
(12,189
|
)
|
||||||
Provision for income taxes
|
-
|
1
|
||||||||
Net loss
|
(26,232
|
)
|
$
|
(12,190
|
)
|
|||||
Net loss per share of common stock, basic and diluted
|
$
|
(1.21
|
)
|
$
|
(1.48
|
)
|
||||
Weighted-average shares outstanding, basic and diluted (1)
|
21,670,330
|
8,211,256
|
2023
|
2022
|
|||||
(As Restated)
|
||||||
Cash flows from operating activities
|
||||||
Net loss
|
$
|
(26,232)
|
$
|
(12,190)
|
||
Adjustments to reconcile net loss to net cash used in operating activities
|
||||||
Amortization of discount on notes payable
|
-
|
242
|
||||
Amortization of deferred financing costs
|
48
|
-
|
||||
Non-cash accrued interest related to convertible notes
|
-
|
341
|
||||
Change in fair value of notes payable derivative liability
|
-
|
602
|
||||
Change in fair value of convertible notes
|
5,380
|
-
|
||||
Change in fair value of forward purchase agreement derivative liability
|
1,308
|
10,211
|
||||
Change in fair value of liability classified warrants
|
(545)
|
(10,863)
|
||||
Loss on extinguishment of convertible notes
|
4,949
|
-
|
||||
Stock-based compensation
|
1,930
|
1,311
|
||||
Changes in operating assets and liabilities
|
||||||
Other receivables
|
12
|
4
|
||||
Prepaid expenses
|
(97)
|
(1,073)
|
||||
Accounts payable
|
2,445
|
1,548
|
||||
Accrued expenses
|
517
|
2,073
|
||||
Net cash used in operating activities
|
(10,285)
|
(7,794)
|
||||
Cash flows from financing activities
|
||||||
Proceeds from issuance of convertible notes
|
8,000
|
1,681
|
||||
Proceeds from recapitalization
|
-
|
9,961
|
||||
Payment of recapitalization transaction costs
|
-
|
(1,211)
|
||||
Proceeds from PIPE Investors
|
-
|
7,000
|
||||
Payment for forward contracts
|
-
|
(11,940)
|
||||
Payment of convertible notes
|
(400)
|
-
|
||||
Proceeds from issuance of shares
|
4,742
|
-
|
||||
Proceeds from exercise of convertible note warrants
|
592
|
-
|
||||
Additional warrants
|
180
|
-
|
||||
Payment of commitment fee - equity line of credit
|
(500)
|
-
|
||||
Proceeds from sale of recycled shares
|
1,870
|
40
|
||||
Proceeds from notes payable
|
800
|
1,878
|
||||
Payment of notes payable
|
(4,870)
|
(15)
|
||||
Payment of Government loans
|
-
|
(63)
|
||||
Net cash provided by financing activities
|
10,414
|
7,331
|
||||
Net increase (decrease) in cash
|
129
|
(463)
|
||||
Cash, beginning of period
|
47
|
510
|
||||
Cash, end of period
|
$
|
176
|
$
|
47
|