SeaStar Medical Holding Corporation

Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Seastar Medical first quarter financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, Simply press star, followed by the number one on your telephone keypad. If you'd like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Jackie Kosman. Please go ahead.

Thank you, Tiffany. Good afternoon, and thank you for joining the C-STAR Medical First Quarter 2025 Financial Results Conference Call. I'm Jackie Kosman with Wheelhouse Life Science Advisors. Joining me today from C-STAR Medical, are Eric Schlarf, 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 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 call contains information that is accurate only as of the date of a live broadcast, May 14, 2025. DSTAR 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. We have made great progress on several fronts. Just last week, we added another prestigious nationally recognized children's hospital to our list of Quell Immune customers and achieved 50% enrollment in our neutralized AKI trial. We were granted two new breakthrough device designations by the FDA, expanding our pipeline indications to address the destructive hyperinflammation that can occur during adult and pediatric cardiac surgery. We are especially pleased to see the increased adoption of our Quell Immune Therapy in our existing customer sites. This drove a four-fold increase in our first quarter revenue compared to the fourth quarter of 2024. Tim will discuss our Quell Immune commercialization strategy shortly, but let me just reiterate that our primary goal this year is to grow our customer base. We are clearly seeing that once adopted, customers are experiencing organ sparing and life-saving outcomes from using the Quell Immune therapy in their pediatric AKI patients. As we grow our customer base, we believe we can drive meaningful revenue from this small but important market of about 4,000 patients annually in the United States. Now, turning to what we believe is the significant upside opportunity for Seastar Medical, I'd like to talk about the adult AKI market, as well as the other opportunities for the SCD therapy. Our clinical development is now focused on penetrating the adult markets. It's important to note that our SCD therapy is designed as a disease-modifying therapy that neutralizes overactive immune cells. and stops the destructive hyperinflammation that shuts down critical organ function and takes lives. An extreme example of this was COVID-19, but every year, millions of patients experience surgery, trauma, or infection where their body's immune system overreacts and the cytokine storm yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient's body. Our first opportunity in the adult patient population is for the treatment of hyperinflammation in patients with acute kidney injury, or AKI, requiring continuous renal replacement therapy, or CRRT. This is a similar condition to pediatric AKI that is life-threatening with no effective treatment options. But it is a far larger market opportunity with over 200,000 adults, or 50 times the number of pediatric patients with this condition. Based on our current estimates, this translates to about a $4.5 billion total annual market opportunity in the United States. Our neutralized AKI pivotal trial for adult patients with AKI and CRT is well underway, and if all goes to plan, we intend to file a PMA for this indication in 2026. We announced yesterday that our ongoing neutralized AKI trial has reached a 50% enrollment target. This enrollment milestone also triggered the pre-specified interim analysis by the trial's independent data safety monitoring board, or DSMB. I'll let Kevin describe the details, but the interim analysis is designed to evaluate the safety and powering assumptions for the trial. We anticipate that the DSMB will report its findings to the company in the third quarter of 2025. I would like to emphasize here that in order to maintain the integrity of the trial, Specific data from the interim analysis cannot be shared. We will, however, issue a press release to provide the DSMB's final recommendation. Completing the neutralized AKI trial and potentially obtaining approval are key near-term milestones for us. We are very excited about this market opportunity and are already engaging with physicians and healthcare providers on the medical affairs side to educate them about the SCD therapy. and data that support its use as a potential treatment for patients with AKI and CRT. Beyond the AKI market, the SCD therapy has been granted breakthrough device designations for five other indications. Tim will describe the potential commercial opportunities that we hope to derive from our rich pipeline of indications. And with that as an overview, I'll turn the call over to Tim to discuss our commercial achievements and market opportunities.