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.

Thanks, Eric, and thanks, everyone, for joining us on the Seastar Medical Call. We're thrilled to report the solid increase in revenue in this first quarter, and what's most important to us are the metrics underlying the increase. We continue to see repeat orders at our existing sites as physicians gain more confidence treating pediatric patients based on their treatment experience with Qualimmune Therapy. In addition to the two new customers that we announced earlier this year, we reported today that we have shipped Qualimmune Therapy to another new customer that is a nationally recognized children's medical facility. Our pipeline of potential customers is expanding, and we anticipate bringing on new multiple sites by year end. Qualimmune is the only FDA-approved product for the condition of life-threatening acute kidney injuries due to sepsis or septic-like conditions. in critically ill pediatric patients. The data show that these young patients have a 50% chance of survival, and in many cases that we've seen, it's less than that. If they survive, a significant portion also experience lifelong organ damage and require outpatient renal replacement therapy two to three times per week. This is also known as dialysis. Our qualimmune clinical trials show significant improvement in these outcomes. We believe that over time, we can capture a healthy portion of what we estimate to be about $100 million total annual US market opportunity based on a pediatric AKI population of approximately 4,000 patients. Now, with respect to our overall commercial strategy and current plans, our primary goal is site adoptions. Our specific focus today is on select children's medical facilities that typically treat a higher volume of these pediatric AKI patients. And to put this into perspective, this is a very concentrated market, and our objective is to focus on the top 50 pediatric sites in the U.S. that have the resources to support this registry. As we've said previously, the process of adoption at these medical centers can be lengthy for any new device. And for Qualimmune, the FDA approval requires a post-approval surveillance registry. that has an additional step and requires an additional IRB approval of this registry. That typically takes more time, and that boils down to time to activation, which can vary from several months to approximately eight months. The good news is that we're engaged with most of the top pediatric medical centers in the U.S., and they are truly interested in bringing Quell Immune into their facilities. We see a strong commitment in terms of championing this effort by the pediatric nephrology and ICU teams as we go through the adoption process with them. Our internal tracking today indicates that seven out of every 10 pediatric hospitals we approach to gauge interest ultimately commit to quality and therapy adoption. And we still anticipate that sales will be lumpy until more pediatric hospitals are activated and we can gain a further understanding of the cadence of patient presentation within these hospitals. But the excitement for the outcomes that Quell Immune Therapy can deliver is growing in the pediatric community, and word of mouth is the best validation for expanding Quell Immune adoption. So with that framework of our Quell Immune launch efforts, I'll now discuss our commercial opportunity for the SCD therapy platform. With our neutralized AKI trial well underway, We have begun our pre-commercialization efforts to support a potential launch of the SED therapy as a treatment for adult patients with AKI requiring CRRT. Our current anticipated launch timeline in adult AKI is Q4 of 2026, and this assumes positive clinical trial results and FDA approval. The total market opportunity in the U.S. is approximately 50 times the size of the pediatric population or about 200,000 patients annually that face organ failure and potentially loss of life with no FDA-approved treatment options beyond the current standard of care, which is CRRT and antibiotics. At our current projected revenue per patient, this translates to a total market opportunity of about $4.5 billion. Even a modest market penetration would deliver significant revenue for Seastar Medical. For this near-term potential market, we are also modeling a more favorable time to adoption than Qualimmune based on factors such as increased clinical need due to the size of this population, as well as our ability to leverage pediatric customer experiences with Qualimmune. Kevin and the medical affairs team are already in the process of educational efforts in the peer-to-peer setting, and we are excited about the prospects of adding this potential life-saving therapy for adult patients with AKI and CRRT. And now, turning to the broader market, the adult AKI indication is just the beginning of a long line of indications that could follow. When looking at just the indications, in which we have received FDA breakthrough device designation. We estimate in the U.S. market alone, the total annual market size is hundreds of thousands of patients that currently have no approved therapies to address conditions where destructive hyperinflammation creates critical care issues, organ failure, and death. At Seastar Medical, we are committed to bringing our first and only SED therapy to patients who today face lifelong organ damage and loss of life. And with that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

Thanks, Tim, and thanks to our listeners for joining us today. I am pleased to report that our neutralized AKI trial has not crossed the halfway point towards our enrollment goal of 200 patients. We currently stand at 100 patients enrolled as of Tuesday. Neutralized AKI, as many of you know, is our randomized control pivotal trial designed to determine whether up to 10 sequential 24-hour treatments with STD therapy will improve 90-day survival or recovery from kidney failure in patients with AKI requiring CRRT when compared to CRRT alone. Our goal is to enroll a total of 200 patients with a primary endpoint identified as the composite of mortality or dialysis dependency at 90 days. Us reaching the 100th patient milestone triggers an interim analysis that will be conducted by the DSMB. This analysis will commence once our 100th patient has reached the 90-day primary endpoint. With some additional time for data and review, We anticipate the DSMB will submit their recommendation to the company in the third quarter of 2025. To give you a sense of how the analysis will proceed, the pooled data will be analyzed based on the differences and outcomes between the treated patients versus controls. The DSMB will provide a recommendation to Seastar Medical and the neutralized AKI investigators as to how to proceed with the trial. While we can't be certain of the recommendation from the independent DSMB, we designed the interim analysis to ensure we powered the trial properly. As Eric indicated, we must preserve the integrity of the trial. To set expectations properly, we will only convey the summary decision of the DSMB, and no other clinical results will be shared. The possible DSMB recommendations are as follows. Continue the trial as planned to a total of 200, which is what we anticipate. Increase the total sample size to ensure adequate power if the effect size appears to be smaller than anticipated. Stop the trial for overwhelming efficacy. Or lastly, stop the trial for futility. We expect a completely objective and unbiased recommendation by the DSMB based on what the interim data shows. Now that we've reached the halfway point, We plan on redoubling our efforts towards getting to our goal of 200 as fast as humanly possible. As such, we plan to activate additional sites to ensure we're screening as many patients as needed. I have to emphasize that per trial design, we're focusing the enrollment of the right type of patient through a process called enrichment. There are certain groups of patients, for example, that have absolutely no modifiable disease. In other words, they would live or die regardless of the intervention based on their underlying problem. Countless pivotal studies in the past have failed, falling victim to having too many of these types of patients. This will not be us. While the enrollment rate for this trial has been agonizingly slow at times, like this past month, I want to assure all of you that our team is 100% focused on completing enrollment by the end of this year. Additionally, I am certain that we are enrolling the right type of patients into our trial and appropriately excluding those who have no modifiable disease whatsoever. I know we have optimized our chances of a positive trial. Now, looking beyond the interim analysis, once we have completed the trial and achieved 100% data loss, We intend to rapidly analyze and report our data to the international medical community. Provided we meet our primary endpoint, we plan to complete our PMA filing and submit it to the FDA. The breakthrough device designation, which we hold for adult AKI, should help facilitate speedy communication between us and the FDA during the review and approval process. And as such, we would hope to have product available to patients sometime in the fourth quarter of 2026. The neutralized AKI trial is clearly our focus today. However, our strategic goal as a company is to widen the addressable market rapidly to target other critical unmet medical needs for the treatment of destructive hyperinflammation through additional clinical trials. The only adult AKI indication, we have been awarded breakthrough device designation for five others, including the treatment of patients with cardiorenal syndrome, patients with hepatorenal syndrome, patients with end-stage renal disease, and both adult and pediatric patients undergoing cardiac surgery. Given the organ and disease agnostic characteristic of our therapy, there are several more indications to come. We believe that AKI is just the beginning of our opportunity to spare organs and save lives in these patient populations. With that as our summary of our clinical developmental efforts and goals, I turn the call over to our CFO, David Green.

Thank you, Kevin, and thank you all for joining us today. I'll describe our first quarter financial results and conclude with some of our expectations for the remainder of 2025. First, for some housekeeping, please note that our Form 10Q will be filed with the SEC within the next 24 hours. You can find it at cstarmedical.com or sec.gov. Before I turn to our financial results for the quarter, let me also say that our progress to date in 2025 has included a number of key milestones for the company. As I indicated on our year-end call, our accomplishments in 2024 and now into 2025 A position C star to build on the 1st, 2 quarters of commercial revenue for quality and push forward the neutralize pivotal trial. Since then, we've made good progress at our priorities as reported in our press release today. The highlight 3 Q1 accomplishments. We achieved greater adoption of quality and from existing customers, which drove increased revenue in the 1st quarter. We pushed forward our neutralized AKI pivotal trial for adult AKI patients reaching the 50% enrollment milestone, and we managed resources during the quarter that resulted in lower sequential operating expenses. We also strengthened our balance sheet with the addition of new capital and maintained our practice of careful attention to spending. And with that, I'll turn to our first quarter 2025 financial results. We recorded our highest quarterly revenue to date by achieving a fourfold increase in net revenue through sales of Quell Immune Therapy. Revenants for the first quarter of 2025 was $293,000 compared to approximately $68,000 in the fourth quarter of 2024. and $0 in the year-ago first quarter. As we indicated last quarter, we anticipate the sales will be lumpy in the initial phase of the launch, but we expect to see an overall trend of increases in revenue as existing customers expand their usage of Quell Immune, and we add to the total number of hospitals purchasing Quell Immune therapy. To provide some texture to the Q1 revenue report, We are pleased that all existing customers purchased Quell Immune during the quarter. And as Tim indicated, we are quite optimistic about new hospitals coming on as customers in 2025, which will give more children access to our life-saving therapy. Moving to cost of goods sold, the Q1 financial statements reflect no cost of goods sold. This is consistent with GAAP and due to sales of quell immune units that have been previously recognized as research and development expense. As we build and then sell new inventory as a commercial enterprise, we will record cost of goods sold matching sales from inventory. On a related note, you may have noticed that we recognized an inventory balance for the first time on our 331 balance sheet. We anticipate Q2 to be a transition quarter as we begin to recognize COGS. Operating expenses increased modestly to $4.1 million in the first quarter of 2025 compared to $3.9 million in Q1 of 2024. The change was primarily due to increased spending for our commercial launch and growing enrollment in the neutralized AKI trial. This was partially offset by reduced GMA expenses resulting from a decline in accounting-related costs and reductions in legal and consulting expenses. And finally, our net loss for the quarter of, first quarter of 2025 declined to $3.7 million compared to a loss of $12.7 million in Q1 of 2024. We ended the quarter with approximately $5.3 million in cash. Looking forward, we'll focus our resources on our top three objectives. Number one, new customer acquisition for Qualibune. Number two, completing the neutralized AKI pivotal trial. And number three, preparing to file a PMA following the completion of the adult AKI pivotal trial. In wrapping up, as we drive our strategic objectives forward, we expect forward momentum to continue as we bring our lifesaving SCD therapy to more patients and clinicians, and as more investors become aware of the significant market opportunity developing for our SCD therapy. And with that, I'll hand the call back to Eric.

Yeah, thanks, Dave. Our goal today for our first quarter financial results conference call was to provide you with a summary of our progress as well as a clear picture of why we believe the future opportunities of Seastar Medical are significant. We plan to continue these calls on a quarterly basis. We are also reaching out to a broader investor base through various media outlets and plan to host fireside chats when we have educational information to share about Seastar Medical. We are passionate about our ability to provide a lifesaving therapy to critically ill patients who today have no alternative treatment for calming the cytokine storm caused by an overactive immune system. As we complete the neutralized AKI pivotal trial enrollment, we look forward to reporting the results. Provided the data are supportive, we plan to file a PMA in 2026. If approved, we believe a significant opportunity to capture a sizable portion of the adult AKI market exists. In short, we believe we are continuing to create strong value for our investors and stakeholders, and we'll be looking to close out what we see as a substantial gap in our current market cap and the outlook that we have for our company. With that, I'll ask the operator to open the call for questions. Operator?

At this time, I would like to remind everyone, in order to ask a question, press star then be number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Your first question comes from Nick Sherwood with Maximum Group. Please go ahead.

Good evening. Can you tell me how many sites are currently activated for the adult clinical trial?

Yes. Hey, thanks, Nick. Kevin, why don't you take that one?

Yes. We currently have 15 activated. and probably another five that we plan to activate over the next three months.

Okay. And then what's the total number of pediatric hospitals that you have as customers currently?

Yeah. Tim, you want to take that?

Sure. We have six sites that are commercially active and multiple others that are moving through the IRV process.

Okay. And yeah, kind of talking about that IRB process and the pipeline, what sort of pipeline growth have you seen in the first quarter compared to the fourth quarter? Do you think that, you know, I mean, revenues were up a ton sequentially in this quarter. Is there a lot of word of mouth that where you're seeing that that pipeline really starting to accelerate in this first quarter?

Yeah, it's a combination. Thanks for the question, by the way. It's a combination of things. It is experience that existing sites have. You know, we have a way that these sites are able to communicate with each other and share their experiences. And they're, you know, they're noticing a difference when they use quality immune therapy. So that's One aspect of it is definitely word of mouth, but we actively engage these hospitals as well. And we approach them and talk with them. And quite often, they're very interested in adopting ultimately Quell Immune Therapy. And then it just becomes an operational exercise. And based on the type of hospital it is and the resources they have, that kind of tells you what the timeline is going to be. So sometimes it's easy and it's fairly quick, and other times it takes a little bit longer. But there's no shortage of interest in these institutions about well-immune therapy and what the potential of this therapy represents to these patients suffering with pediatric AKI.

Yeah, that all makes a ton of sense, and I appreciate the detail. Kind of shifting gears, talking about the new breakthrough designations, can you talk about kind of how important these two additional breakthrough designations are and how you're prioritizing the various regulatory processes? Because so many designations, you kind of have to – you don't want to spread your resources too thin, I imagine.

Yeah. Kevin, why don't you address kind of the clinical unmet need that's there in the cardiac surgeries, and then I'll take the second part of that question.

Yeah, thank you, Nick, for that question. So cardiac surgery is one of the largest costs for hospitals in the country, and there was a Newsweek article that came out today that really emphasized that. And part of the reason for that is a relatively high proportion of those patients have a complication that results in AKI. And as a result, both in adults and pediatrics, we believe that this is a massive target of opportunity where we can make a big difference in these outcomes. What's the point of undergoing a cardiac surgery that's very intense and associated with many hospital days if you're not able to survive and you have a complication that commit you to hemodialysis. We intend on preventing that. So in order to look at this, we're going to need to do additional clinical trials. We're hoping that with the adult launch, some of these trials will be funded via grant funding and non-diluted funding. And, you know, a lot of these centers are very interested in applying the FCD in their patient population. And so we also anticipate investigator initiative studies as well. So a combination of things that will help drive our pursuit to get this device approved for that specific patient population. Now, I have to say that with an approval for AKI alone, there will be adoption in those types of patients. So we will be seeing data trickle in already, even with just the AKI indication alone.

Yeah, and just to add on to that, what Kevin has said is that, you know, the commercial and medical affairs teams are working, you know, diligently to assess kind of the market need penetration dynamics of the five additional indications where we have these breakthrough device designations. You know, given that the STD therapy is agnostic to these disease states, and this is that our first adult product will be in the critical care market, it's logical that we could easily add indications in this space and sell products the same customers in those same ICU units. So, you know, we're really excited about the opportunity to rapidly expand our product offering, as we've said in kind of the prepared remarks.

Okay, I appreciate all that detail. So, it sounds like once you get this first adult approval that the subsequent ones are going to be able to move a lot more quickly just because they'll be getting a lot of real world data and you've been through the process before.

Absolutely. Each one of these. Yeah. Yeah, go ahead. Yeah, absolutely. I mean, one of the things that we're looking at with the AKI pivotal trial is safety. And so when the safety issue has been addressed and we're getting, you know, data for the specific other populations, we believe that it'll get easier and easier, and the floodgates will open.

Okay, awesome. Well, thank you for answering all my questions, and I will return to the queue.

Thanks, Nick.

Again, if you would like to ask a question, press star and the number one on your telephone keypad. There are no further questions at this time. I will turn the call back over to Jackie Kostman.

Thank you, Tiffany, and thank you all for joining us today for the Seastar Medical First Quarter Financial Results Conference Call. If you have questions, please contact us at ir.seastarmed.com or visit our website to see our latest news, product, pipeline, and company information. Thank you and goodbye.

Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.