SeaStar Medical Holding Corporation

Good day and thank you for standing by. Welcome to the C-Star Medical Third Quarter Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please advise that today's conference is being recorded. I'd like to hand the conference over to your first speaker today, Jackie Cosman. Please go ahead.

Thank you, Marvin. Good afternoon, and thank you for joining the Seastar Medical Third Quarter 2025 Financial Results Conference Call. I'm Jackie Cosman with Wheelhouse Life Science Advisors. Joining me from Seastar Medical today are Eric Schlorf, Chief Executive Officer, Dr. Kevin Chung, Chief Medical Officer, Tim Veracek, Senior Vice President of Commercial and Business Operations, and Brad Town, our controller. I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of 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 C-STAR 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, November 13, 2025. C-STAR 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?

Thank you, Jackie. And thank you all for joining us today. Since the beginning of the third quarter, we advanced our business on several fronts that we believe position us well for our future growth. We added three top-ranked children's medical centers to our growing customer base and also reported very impressive survival results for the use of the Quell Immune Therapy in the treatment of 21 pediatric patients in a commercial setting. These remarkable data, which Kevin will cover, came from the SAVE surveillance registry, that was presented at the 5th International Symposium on Acute Kidney Injury in Children in the last week of September 2025. While the requirement for this registry has hampered our ability to add sites quickly, the data in hand continues to demonstrate the value of the therapy and has been very useful in helping our target customers see the benefits of the Quell Immune Therapy in the commercial setting. With respect to our Quell Immune revenue, In the third quarter, we reported net revenue of 183,000. Importantly, as we've mentioned, our sales continue to be a bit variable from quarter to quarter. If we look at the six months ended September 30 versus six months ended March 30, our revenue is up 45%. And we believe with new sites and new data on Quell Immune use in the commercial market, we are gaining traction. In fact, in the first half of the fourth quarter, Quell Immune orders are already exceeding the entire third quarter. In short, we were anticipating full year revenue for the 2025 will be over a million dollars. This provides a strong foundation for growth into 2026. And Tim will describe some additional measures we have taken on the sales front. In the third quarter, we also reported our first full quarter of cost of goods for product sales with a gross profit margin of 92%. which is similar to a branded pharmaceutical product, along with a clear value proposition for hospital systems to save money using Quell Immune. We believe this affords us an opportunity to generate future cash, reducing the amount of cash we need to raise to fund operations. Now, turning our efforts on the neutralized AKI trial, we completed the interim analysis, enabling us to understand early safety data and trends toward efficacy for our neutralized AKI pivotal trial of the selective cytopheretic device or SCD therapy. We also continue to add clinical sites to ensure we meet our new enrollment targets for the trial. In addition, we also announced today that we have opened the first site for the neutralized CRS clinical trial of the SCD therapy to treat patients with acute chronic systolic heart failure with cardiorenal syndrome or CRS. awaiting left ventricular assist device, or LVAD, implantation. This is a small but very important market opportunity, as it would potentially demonstrate the value of the SCD therapy in an indication outside of AKI, supporting its broad applications in many destructive hyperinflammation conditions. Finally, we continued our disciplined effort to reduce costs while achieving strong operational results. and we raised over $12 million to strengthen our balance sheet and extend our financial runway. Now, before I turn the call over to Tim, I'd like to emphasize one last point. That is, the data we see and the stories we hear about how Quell Immune Therapy has saved the lives of critically ill pediatric patients, who in most cases have little hope of survival, are what drives our efforts to expand the use of this therapy to more children and to adults with similar conditions caused by destructive hyperinflammation. These market opportunities are significant, and we are working diligently to bring our life-saving therapy to the patients whose chances of survival due to hyperinflammation are otherwise limited. And now, I will turn the call over to Tim to discuss our commercial achievements and market opportunities.