SeaStar Medical Holding Corporation

Good day and thank you for standing by. Welcome to the C-Star Medical's Q4 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. I would now like to hand the conference over to your speaker today, Jackie Kosman.

Thank you, Josh. Good afternoon, and thank you for joining the Seastar Medical fourth quarter and year-end 2025 Financial Results Conference Call. I'm Jackie Kosman with Wheelhouse Life Science Advisors. Joining me from Seastar Medical today are Eric Schlarf, Chief Executive Officer, Dr. Kevin Chung, Chief Medical Officer, Tim Veracek, Senior Vice President of Commercial and Business Operations, and Mike Messinger, Chief Financial Officer. I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results. For a list and description of these risks and uncertainties, please review Seastar Medical's filings with the Securities and Exchange Commission. Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, March 25, 2026. Seastar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law. And now, I'd like to turn the call over to Eric. Eric?

Yeah, thank you, Jackie, and thank you all for joining us today. We are excited to share with you our achievements over the past year and our future plans and passion for what we are doing here at Seastar Medical. In 2025 and into the first quarter of this year, we expanded the use of equal immune therapy for ultra-rare pediatric AJI. We added 13 new customers from top-rated children's hospitals, bringing the total customer base to 16 and building increased depth in customer orders. We reported net revenue of over 1 million from Quell Immune sales in 2025, with pharmaceutical-like gross profit margins above 90%. In addition, we advanced the development of the SCD therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy. achieving over 50% enrollment in the trial, with 181 of the 339 patients enrolled to date in the neutralized AKI pivotal trial. We also initiated a modular premarket application, or PMA, submission process for the SCD therapy and a potential treatment for the adult AKI indication. We have already been granted breakthrough device designation by the FDA for this indication, so we are hoping to potentially speed the PMA approval process through this modular PMA submission. And importantly, we maintain good cost controls and improve the company's balance sheet substantially through the addition of approximately 24 million of capital during 2025, as well as a reduction of over 3 million in operating liabilities. Now, turning to 2026, we have laid out four key milestones to drive stakeholder value and position us solidly for 2027 and beyond. Our primary goal this year and a major driver of our future potential revenue is to advance the SCD therapy for the adult AKI indication. We plan to complete enrollment in the neutralized AKI pivotal trial around the end of 2026. A successful trial would position us to finalize our PMA submission next year. With a market opportunity that is 50 times that of the pediatric AKI market, we are very excited about this future opportunity. With respect to Quellabium, we look to further expand our customer base in 2026. We have strong momentum in the pediatric market with the publication of our SAVE registry data in pediatric nephrology and strong testimonials from existing customers. We plan to add 15 new top-ranked children's medical centers this year with a goal of achieving 2 million in net product revenue from Quell Immune sales in 2026, a significant increase over 2025. We will also evaluate the broader applicability of the SCD therapy in a new indication where we have been awarded the breakthrough device designation approval pathway through the FDA. We announced in late 2025 the initiation of a clinical trial of the SCD therapy in patients with acute congestive heart failure with cardiorenal syndrome awaiting left ventricular assist device implantation. This trial is investigator led and being funded by the NIH. It is in the area of critical need, and we are hoping that we can provide a solution to these patients with little hope of survival because they are too compromised due to hyperinflammation to undergo the surgery required to improve their condition. Finally, we will work with the FDA for expedited approval of our pipeline indications. The humanitarian use and breakthrough device designations would enable us to potentially provide earlier access to patients with destructive hyperinflammatory conditions that face permanent organ failure or loss of life. In short, we have an exciting year ahead and look forward to reporting our progress to you. I now, I will turn it over to Tim to discuss our commercial achievements and market opportunities. Tim?