Whalatane
1月前
Unfortunately the math doesnt math IMHO
Net loss for the three months ended March 31, 2026, was approximately $3.5 million, or $0.90 per share on approximately 3.9 million weighted-average shares outstanding.
This compared with a net loss of approximately $3.8 million, or $4.38 per share, on approximately 0.9 million weighted-average shares outstanding for the three months ended March 31, 2025.
The Company reported cash of $9.3 million as of March 31, 2026, compared to $12.0 million as of December 31, 2025.
Co still has to enroll another 140 patients in its adult trial ( from date of this report ) and its losing over $3m a qt
So another capital raise before EOY is inevitable IMHO .
Was just checking in to see if there was any comments on Kyle Busch's unfortunate death due to sepsis . Wondering if the ICU filter may have helped .
Kiwi
ErnieBilco
2月前
SeaStar Medical Reports First Quarter Financial Results and Provides Updates
Added 7 top-rated children’s hospitals to QUELIMMUNE® pediatric acute kidney injury (AKI) customer base, increasing first quarter revenue 69% versus first quarter 2025 revenue
Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI
Initiated efforts for the submission of a modular post-marketing application (PMA)
Webcast today at 4:30 pm Eastern Time
DENVER, May 13, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today financial results for the three months ended March 31, 2026, and provided business updates on key initiatives.
“Our QUELIMMUNE customer base continues to grow with a groundswell of enthusiasm among key experts that is driving our penetration into new accounts,” said Eric Schlorff, CEO of SeaStar Medical. “We saw a significant jump in revenue of 69% this quarter versus the first quarter of last year. The trajectory is very encouraging as we consider the next opportunity in the adult market, which is approximately 50 times larger than the pediatric AKI market.”
Mr. Schlorff continued, “We are working diligently to enroll adult patients with AKI in the NEUTRALIZE-AKI pivotal trial. We have activated multiple new clinical sites in the last six months and believe that a successful outcome of this trial would position us to file a PMA with the FDA for the adult AKI indication in 2027. Our success in building the QUELIMMUNE market now will provide critical support for this potential future opportunity.”
Key Business Highlights
SeaStar Medical’s achievements since the beginning of 2026 include the following:
Expanded the use of QUELIMMUNE (SCD-PED) therapy for ultra-rare pediatric AKI, adding 7 new customers from top-rated children’s hospitals, bringing the total customer base to 17 and building increased depth in customer orders. This led to first quarter 2026 net revenue of $0.5 million for QUELIMMUNE product sales, an increase of 69% versus the first quarter of 2025.
Advanced enrollment in the NEUTRALIZE-AKI pivotal trial that is evaluating the Selective Cytopheretic Device (SCD) therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy (RRT). The trial has enrolled 198 of 339 patients to date.
Completed the required enrollment in the SAVE Registry, a post-approval surveillance registry evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening AKI and sepsis or a septic condition. The registry has successfully enrolled 50 patients, and the company will be reporting the 28-day safety results from the SAVE Registry to the FDA upon completion of its analysis of the data.
Announced the publication of early post-approval, real-world experience from the use of the QUELIMMUNE therapy in the prestigious, peer-reviewed journal Pediatric Nephrology. The publication, co-authored by leading experts in pediatric critical care management, highlights early experience from the first 21 pediatric patients in the SAVE Registry. The published data from the commercial use of the QUELIMMUNE therapy showed no device related safety events with the QUELIMMUNE therapy with 76% of patients surviving through 60 days and 71% surviving through 90 days. These results are on track to validate a nearly 50% reduction in loss of life compared to historical data, as reported previously in Kidney Medicine.
Presented new data at the 31st International Conference on Advances in Critical Care Nephrology, also known as AKI & CRRT 2026, highlighting patient experience from the first 32 pediatric patients in the SAVE Registry. The clinical experience from the updated cohort demonstrated trends consistent with those previously reported from the initial cohort of 21 patients and the QUELIMMUNE registrational studies, and continue to support the QUELIMMUNE therapy safety and potential benefit in this critically-ill patient population.
Assembled leading experts in the treatment of pediatric AKI to speak at the SeaStar Medical educational symposium at the AKI & CRRT 2026 meeting to discuss the complex pathophysiology of pediatric AKI with sepsis, the SAVE Registry, the immunomodulatory effects of the QUELIMMUNE therapy which may ameliorate dysregulated hyperinflammatory disease states, and other topics of interest to the nephrology community.
Initiated efforts for the submission of a modular PMA to potentially speed the FDA review and approval process for the SCD therapy as a potential treatment for adult patients with AKI in the ICU receiving continuous RRT. SeaStar Medical has also been granted Breakthrough Device Designation by the FDA for this indication, which may expedite the PMA approval process for novel devices that will save lives and treat debilitating diseases.
Anticipated 2026 Milestones
Broaden QUELIMMUNE adoption to include 15 additional top-ranked children’s medical centers, more than doubling the total number of sites from the beginning of the year and building increased depth in customer orders. SeaStar Medical also anticipates achieving approximately $2 million in net product revenue in 2026.
Advance the SCD therapy for the adult AKI indication through completion of enrollment in the NEUTRALIZE-AKI pivotal trial around the end of 2026 and begin submission of relevant PMA modules to the FDA to facilitate the PMA review and approval process.
Evaluate broader applicability of the SCD therapy through the conduct of a clinical trial of the SCD therapy in patients with chronic heart failure with cardiorenal syndrome awaiting left ventricular assist device implantation. SeaStar Medical has also been granted Breakthrough Device Designation by the FDA for this indication given the severity of the disease and lack of current effective treatments.
Explore rapid regulatory pathways to commercialization of the SCD therapy as a first-in-class therapy, designed to save lives and spare organ function in numerous destructive hyperinflammatory conditions. SeaStar Medical will seek additional Humanitarian Use and Breakthrough Device Designations to potentially provide lifesaving support to these patients as rapidly as possible.
Financial Results for the First Quarter 2026
For the three months ended March 31, 2026, net revenue was approximately $0.5 million, reflecting sales of the QUELIMMUNE pediatric SCD therapy. This compared to net revenue of approximately $0.3 million for the three months ended March 31, 2025.
Research and development expenses for the three months ended March 31, 2026, and 2025, were $2.3 million and $2.4 million, respectively. The decrease in research and development expenses was primarily driven by a decrease in clinical trial costs related to the NEUTRALIZE-AKI pivotal trial, offset by increases in personnel costs and costs for external services.
General and administrative expenses for the three months ended March 31, 2026, and 2025, were approximately $1.7 million and $1.7 million, respectively. General and administrative expenses for the three months ended March 31, 2026, reflected an increase in legal and accounting related expenses, offset by declines in personnel costs and SEC related costs.
Other income (net) increased approximately $30 thousand for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. The increase was primarily driven by increased interest income.
Net loss for the three months ended March 31, 2026, was approximately $3.5 million, or $0.90 per share on approximately 3.9 million weighted-average shares outstanding. This compared with a net loss of approximately $3.8 million, or $4.38 per share, on approximately 0.9 million weighted-average shares outstanding for the three months ended March 31, 2025.
The Company reported cash of $9.3 million as of March 31, 2026, compared to $12.0 million as of December 31, 2025.
SeaStar Medical First Quarter Financial Results Conference Call
Date/Time: Wednesday, May 13, 2026, at 4:30 p.m. ET / 2:30 p.m. MT
Webcast: The live webcast and replay can be found here.
Register for the call: Preregistration is required to attend the live call and can be accessed here. A pin code and dial in number will be provided with registration.
A replay of the call will be available after 7:30 p.m. ET and can be accessed here.
ErnieBilco
3月前
Standby Equity Purchase Agreement
On April 25, 2025, we entered into a standby equity purchase agreement (“SEPA”) with Lincoln Park Capital, LLC (“Lincoln Park”) pursuant to which we have the right to sell to Lincoln Park shares of Common Stock, subject to certain limitations, from time to time over the 36-month period commencing on the Commencement Date. As of December 31, 2025, approximately $15.0 million in aggregate capacity remained available under the SEPA.
2025 Offering Activity
During the year ended December 31, 2025, we raised under the 2023 Shelf: (i) approximately $14.4 million through three registered direct offerings and concurrent private placements of Common Stock, pre-funded warrants, warrants and placement agent warrants, and (ii) approximately $6.1 million through our ATM Agreement. We also raised outside the 2023 Shelf: (i) approximately $4.0 million through a best-efforts public offering of Common Stock, pre-funded warrants, warrants and placement agent warrants, and (ii) approximately $40 thousand from the SEPA.
Hot Features
プレミアム
登録してリアルタイムのアラート、カスタムポートフォリオ、市場の動きを入手してください。
glenn1919
3月前
TrendTrade2016
6月前
メールアドレスで登録
