SeaStar Medical Holding Corporation

Good afternoon and thank you for standing by. My name is Calvin and I will be your conference operator today. At this time, I would like to welcome everyone to the C-Star Medical Year-End 2024 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, please press star one again. Thank you. I would now like to turn the call over to Jackie Kosman. Please go ahead.

Thank you, Calvin. Good afternoon, and thank you for joining the Seastar Medical Year-End 2024 Financial Results Conference Call. I'm Jackie Kosman with Wheelhouse Life Science Advisors. Joining me from Seastar Medical today are Eric Schlorf, Chief Executive Officer, David Green, Chief Financial Officer, Dr. Kevin Chung, Chief Medical Officer, and Tim Veracek, Senior Vice President of Commercial and Business Operations. 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 our list and descriptions of risks and uncertainties, please review Seastar Medical's filings with the Securities and Exchange Commission at sec.gov. Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, March 27, 2025. 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 more importantly, our future plans and our passion for what we are doing here at Seastar Medical. With the launch of Quell Immune, which Tim will talk about shortly, we have witnessed truly amazing patient outcomes about how our SCD therapy has saved lives. One example was recently sent for publication by investigators at the University of Michigan, where the patient had a 95% predicted mortality, and after SCD therapy, they have normal kidney function, resumed chemotherapy, and are at home. We have also witnessed stopping almost certain critical organ damage and children being discharged out of ICU or intensive care units without the need for lifelong renal replacement therapy. For us, these truly amazing clinical cases speak loudly of the opportunity for our SCD therapy as a potential treatment for the approximate 1 million patients that each year face the consequence of destructive hyperinflammation that can damage critical organs and take lives. In our estimation, the longer-term opportunity to treat other serious inflammatory conditions such as cardiorenal syndrome, hepatorenal syndrome, and chronic dialysis expands our opportunity well beyond the initial market that we have identified for the SCD therapy. In short, we are very excited about our opportunities and look to 2025 as a year of growth and momentum with new top-tier pediatric medical centers adopting Quell Immune and the achievement of our clinical development efforts with institutions like Stanford, Cleveland Clinic, and Mayo Clinic joining the Neutralize AKI Adult Pivotal Study. to bring our second therapeutic product to a market that is 50 times larger than the important yet smaller market for pediatric patients with AKI. Our strong momentum coming into 2025 has been fueled by our significant accomplishments in 2024. We not only received our first product approval for Quell Immune, but we advanced our neutralized AKI clinical development program and also ease the cost of the trial by obtaining CMS coverage to pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the trial. We were also awarded our fourth breakthrough device designation for chronic dialysis, and we expanded the medical community's understanding of our SCD therapy through manuscript publications in key journals and presentations at medical conferences. In addition, We further secured our first-in-class proprietary technology through the award of key patents in the United States and Canada. We also appointed David Green, a healthcare industry veteran, as our chief financial officer in January of 2024. Dave has been working diligently to manage our capital structure, secure additional capital, and strengthen our control environment during this time of transition to a commercial stage company. 2025 has started off with success. In just three months, we added two new customers, commercial customers, after transitioning the sales and distribution model in 2024. We activated two additional sites in our neutralized AKI pivotal clinical study, and the FDA approved a feasibility study for our SCD therapy as a treatment for cardiorenal syndrome as a bridge to left ventricular assist device implantation. Just last week, The National Kidney Foundation, a prominent kidney disease advocacy group, announced that Seastar Medical has been awarded its 2025 Corporate Innovator Award. The award was established to recognize industry leaders that advance the field of nephrology by addressing an unmet clinical need or improving upon existing practice, therapeutic or technology. We were honored with the award this year based on our significant contribution to improve the lives of pediatric patients with AKI based on the approval and introduction of our Quell Immune Therapy. Previous winners have included Merck, Johnson & Johnson, and UnitedHealthcare. This is a huge honor and recognition to our team at Seastar Medical who continues to focus on improving clinical outcomes. Now, before I turn it over to the call to Tim, I'd like to talk about our expectations for Quell Immune as a commercial product. We are in the launch phase of commercialization of our first product into a small market of what we estimate to be about 4,000 pediatric patients annually in the United States. As with any launch, there is a level of unpredictability and the time to conversion of accounts can vary widely. This dynamic is further compounded with Quell Immune especially because our adoption process requires that we work with investigational review boards, or IRBs, to implement the patient registry that is part of our commitment to the FDA under the human device exemption approval. As I said earlier, we are thrilled with the feedback to date from our first commercial customers, and we now have a growing pipeline of customers working through the adoption process. Our 2024 sales have reflected the timelines required to bring customers on board and get them up to speed with incorporating Quell Immune into their workflow protocols. As this process becomes more routine for them, we expect customers to expand their use of Quell Immune to more patients that meet the criteria for use of the therapy. That is to say that our sales will be lumpy as we work through the launch of Quell Immune and expand its use at new sites In this early period, the more important metric to follow will be the number of institutions going through the adoption process, which ultimately will lead to product sales and growing revenue. We intend to provide updates on the number of customers working through the IRB adoption process to provide a more meaningful metric on launch. We are not providing guidance due to uncertainties that are inherent in launching a product, But we will say that we are pleased with our progress and believe we are on track to meet our internal revenue targets for 2025. With that, I'd like to turn the call over to Tim.