SeaStar Medical Holding Corp (ICU) 2025 Q3 法說會逐字稿

Good day and thank you for standing by. Welcome to the SeaStar Medical third quarter Final results conference call. At this time, (Operator Instructions) Please be advised that today's conference is being recorded.

I'll 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 Cossmon with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, Chief Executive Officer, Dr. Kevin Chung, Chief Medical Officer, Tim Varacek, 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 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, November 13, 2025. Seasar 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.

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 top three ranked children's medical centers to our growing customer base and also reported very impressive survival results for the use of the immune therapy in the treatment of 21 paediatric 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 immune therapy in the commercial setting.

With respect to our QUELIMMUNE 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 30th versus six months ended March 30th, our revenue is up 45%. And we believe with new sites and new data on immune use in the commercial market, we are gaining traction. In fact, in the first half of the fourth quarter, QUELIMMUNE orders are already exceeding the entire third quarter. In short, we are 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 QUELIMMUNE. 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 neutralize 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 enrolment 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 STD therapy to treat patients with acute chronic systolic heart failure with cardio renal syndrome or CRS awaiting left ventricular assist device or LVAD implant plantation. This is a small but very important market opportunity as it would potentially demonstrate the value of the STD 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 paediatric 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.

Thanks, Eric, and thanks everyone for joining us today on the SeaStar Medical third quarter call. Our goal for the QUELIMMUNE launch this year has been to activate up to 20 new pediatric hospitals to drive product revenue, and as the number of centers increase to provide a predictable stream of revenue as we move into 2026 and beyond. We currently have 10 active commercial pediatric hospitals that have completed all IRB approvals and have ordered product, adding 4 new customers since the beginning of the third quarter. We're working diligently to increase that number and expect additional new sites to be added by the end of this year.

As Eric indicated, our fourth quarter product sales in the 1st 6 weeks already position us for revenue exceeding the third quarter net revenue. And it's important to note that we've seen an uptick in patients receiving qua immune therapy. Our focus for the remainder of the year and into 2026 is to ensure all clinically appropriate patients receive qua immune therapy.

Accounts and continue to move sites through immune, the Aqua immune adoption process as quickly as possible. Specifically, we continue to leverage best practices learned throughout the launch of QUELIMMUNE to implement tactics related to brand awareness, clinical performance, and patient identification, such as supplemental clinical training, development of a speaker's bureau, and development of a patient care team forums to share ideas and overcome operational challenges typical to new product adopt adoption within hospital systems.

We've been able to leverage clinical and economic data as well through recent publications such as the cost savings model published in the Journal of Medical Economics and real-world data presentation. From our patient registry illustrating the survival benefit of qua immune therapy when added to CRRT in pediatric AKI. Importantly, we believe that the patient population for this therapy is far broader than it's used today.

Beyond expanding use in our active accounts, we are working to remove hurdles to the adoption process for new target accounts. While the high-level process to qua immune adoption is the same for all hospital systems, how these sites work through the process can vary and how they are structured from a clinical care and administrative perspective.

We continue to refine the operational process of QUELIMMUNE adoption and attempt to simplify this process for the customer, for example, Before we have our first meeting with the new system interested in Qual immune, we diligently work to identify and include key staff such as nephrology, critical care, nursing, procurement, research, and many more. This may sound obvious, but in many cases, the primary investigator and advocate sponsoring QUELIMMUNE for their system.

Isn't fully aware of these staff members. Getting these people in a conference with us all at the same time ultimately shortens the adoption curve as we are able to identify point people, share cross-functional requirements, and allocate specific tasks to be completed in parallel. It is a symphony at work with many role players, and the good news is that we are beginning to see an impact of these efforts, and we recently were able to add a leading pediatric institution in a six month time frame. While still not the norm, it's great progress, and everything we learn in this launch will benefit SeaStar Medical and future commercial launches as well.

And finally, with our early registry data in hand, we have approached the FDA to request relief from the mandatory registry. We are very hopeful that the FDA will agree to this request and believe they will be aligned with accelerating adoption of QUELIMMUNE to potentially save more lives.

Now turning to the market, we have great expectations for 2026 to help patients by delivering QUELIMMUNE therapy to more pediatric hospital systems. We are relentlessly focused on adding new sites as quickly as possible, and the more sites we add, the more we de-risk our revenue variability and ultimately generate a predictable and reliable revenue stream for our investors and Seastar Medical. That's our goal.

We believe that we will capture a sizable portion of this small but important market, and our estimates put the total US market at about $100 million and capturing even a small double-digit percent of this market creates significant value for our stockholders and delivers important revenue for Seasar Medical.

And with that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin.

Thanks, Tim, and thank you to everyone joining us today. I'm pleased to report continued momentum in our neutralized AKI pivotal trial. Since the start of Q3, we've onboarded three additional clinical sites and enrolled 21 more patients, bringing a total enrolment to 146 of our new targets of 339 patients. For those less familiar, neutralized AKI is a randomized controlled trial designed to assess whether up to 10 sequential 24-hour STD treatments can improve 90-day survival or renal recovery in critically ill patients with acute kidney injury requiring CRRT.

The primary endpoint is a composite of mortality or dialysis dependence at 90 days. As planned, we conducted a pre-specified interim analysis at the 100-patient milestone to assess safety and confirm our statistical powering assumptions. I am pleased to share that the Independent Data Safety Monitoring Board or DSMB determined the STD therapy to be safe with no device-related adverse events observed in the treatment arm. This finding is particularly important in the ICU setting, where patients are often critically ill, immune compromised, and subject to multiple organ support modalities.

In this fragile population, even minor safety concerns can have serious clinical consequences, and they often become gating factors for regulatory review and clinical adoption. That is why demonstrating a clean safety profile is not just a trial milestone, but a critical foundation for physician confidence, FDA interaction, and future uptake in real world care. We're encouraged that STD continues to show this level of safety in such high risk environments.

As we have previously disclosed, the interim analysis revealed that the assumed effect size of 20% was not observed at this point. While there was a clear signal of clinical benefit, it was not large enough to achieve statistical significance with the originally planned sample size of 200. Based on this, in accordance with the trial's statistical analysis plan, the DSMB recommended increasing the total enrolment to 339 patients to ensure adequate power to detect meaningful efficacy.

Let me be clear, the DSMB observed a clear and encouraging signal of benefit. The recommendation to expand enrolment is a positive step forward, grounded in data and consistent with our commitment to rigorous clinical science. By increasing the sample size, we are enhancing the statistical power of the study and positioning ourselves to generate results that are more robust, more credible, and more likely to drive regulatory and clinical acceptance.

This is a strategic recalibration and one that strengthens our confidence in the ultimate success of the trial. We have already acted on the DSMB's recommendation. In addition to our 17 active sites, we have begun activating 8 more centers to help us meet our new target. Our team, along with our academic and clinical partners is working with urgency and precision. We understand what's at stake. And we are committed to completing enrolment by the end of 2026.

Let me now turn to our Save surveillance registry, which tracks commercial use of QUELIMMUNE therapy in critically ill children. At the recent 5th International Symposium on acute kidney injury in Children, we presented encouraging early results from 21 pediatric patients treated under real-world conditions for life threatening AI and sepsis. Among these high-risk patients, many treated as a last resort, 76% survived through 60 days and 71% through 90 days.

As a critical care physician, I find these outcomes remarkable. These were children on the brink of death. While the numbers are still small, the signal is undeniable. QUELIMMUNE is giving these patients a fighting chance. These clinical data, coupled with our previous clinical study data we originally submitted to the FDA now totals 43 children with over 75% survival, clearly demonstrating the value of the therapy.

I would also like to share a unique aspect of how we are learning from the real world use of Qune. Every month we host a Qualmmune user's call. A forum attended by both current and prospective clinical users. During these sessions, we have discussed nearly every patient treated under the same, surveillance registry. The story shared of our device stabilizing a critically ill child, in many cases reversing acute decompensation, are not only clinically powerful but deeply meaningful to all of us at SeaStar Medical.

These discussions are not just anecdotal. They provide critical insights that complement our registry data and inform best practices. At the same time, we're continuing to share pooled outcomes with the broader pediatric nephrology and critical care communities. These real world results are more than encouraging. They reinforce both the life saving potential of our therapy and the mission that drives our entire organization.

Lastly, I'd like to highlight the launch of our neutralized CRS trial. Which evaluates STD in patients with chronic systolic heart failure complicated by cardio renal syndrome, who are not candidates for heart transplant or even LVAD or left ventricular assist device.

The single arm feasibility study will enrol 20 patients in the ICU setting with the goal of demonstrating improvement in renal and cardiac function prior to any mechanical support intervention. One of the main differences in this treatment is the length of STD treatment versus the neutralized AKI study. These patients are treated intermittently for up to 6 hours daily for up to 6 days.

In the neutralized AKI study, the patients are treated continuously for 24 hours daily for up to 10 days. This is important because this could demonstrate the feasibility of intermittent therapy bridging to more outpatient settings. And a broad range of chronic hyperinflammatory diseases.

If successful, neutralized CRS could pave the way for a separate marketing application to the FDA. Opening the door to a new acute therapeutic intervention with a different dosing regimen while setting the foundation towards entry into chronic conditions in outpatient-based therapy.

As Eric noted earlier, this trial is part of our broad strategy to bring STD therapy to multiple indications, whether in AKI, CRS, or beyond. We believe our platform has the potential to transform outcomes in all patients impacted by hyperinflammation.

With that, I'll hand it over to our controller Brad Town.

Thank you, Kevin, and thank you all for joining us today. I'll provide a brief overview of our financial results for the third quarter. Please note that a Form 10 will be filed with the SEC in the next 24 hours and we'll include a more lengthy discussion of the company's financial results for the 3 and 9 months ended September 30, 2025.

You can find the 10-Q at seastarmedical.com or at SEC.gov. We recorded net revenue from uilimmune sales of approximately $183,000 for the third quarter of 2025 compared to $68,000 in the third quarter of 2024. As Eric mentioned, we are already seeing a nice uptick in sales for the 1st 6 weeks of the fourth quarter.

Turning to gross profit The Q3 financial statements reflect a gross profit margin of approximately 92% and as Eric indicated, represents the first full quarter of matching cost of goods sold against culling in unit sales. We did not recognize cost of goods sold for the three months ended September 30th, 2024, as QUELIMMUNE units sold were originally expensed to research and development upon acquisition, which is prior to our commercialization of QUELIMMUNE and consistent with US GAAP.

Operating expenses declined to $3.7 million in the third quarter of 2025 compared to $4.5 million in the third quarter of 2024. The decline was primarily due to decreased consulting expenses and personnel costs, partially offset by increased clinical research and development expenses and increased audit fees. And finally, Net loss for the third quarter was approximately $3.5 million, or $0.13 per share on approximately $26.4 million weighted average shares outstanding. This compares with a net loss of approximately $4.5 million or $1.10 per share on approximately $4.1 million weighted average shares outstanding for the third quarter of 2024.

Cash at September 30, 2025, was 13.8 million compared to 1.8 million at December 31, 2024. During the three months ended September 30, 2025, the company raised $12.4 million from equity offerings and from the exercise of 2.8 million warrants.

With that, I'll turn the call back to Eric.

Thanks, Brad. Our goal today for our third 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 for SeaStar Medical are significant. We are passionate about our ability to provide a life saving therapy to critically ill patients who today have no alternative treatment for calming the cytokine storm caused by an overactive immune system. Our goal over the coming months is to ensure that investors understand the value of the company and the future opportunities.

To that end, we'll be attending a number of upcoming conferences and also meeting with investors during the week of the JPMorgan conference in San Francisco from January 12th to the 15th. We hope to see some of you there. We believe that the opportunities that lie ahead for CSTA are significant, and we look forward to reporting our future progress. With that,

I'll ask the operator to open the call for questions. Operator.

(Operator Instructions) Anthony Vendetti, Maximum Group - Analyst

Thank you. Yeah, so I just wanted to. Get an update. I may have missed it if you gave it out, so as of.

September 24th. 137 of the now required I guess they right the data 50 monitoring board review board recommended 339 up from 200 back in September so. 137 were enrolled as of then. How many? What's the number as of today? And then it was 16 of the 22 to 25 sites. Had been activated. What's that number as of today? And do you feel things are tracking, as you expected, since the September change in the Enrollment number?

Hey Anthony, this is Eric. Go ahead, Eric.

Hey Kevin.

Yeah, hi, Anthony. Thanks, Eric. So, thanks for that question. We are currently at 146, patients enrolled. We, have 17 sites activated. And as I just recently covered, we are moving forward with the activation of at least 8 additional sites, so that'll get us to about 25 sites. And we're hoping to look for more sites, and the selection criteria are pretty stringent. I'm looking for champions who are going to take ownership of the trial within their site. Screening is not easy. Selecting patients and getting patients enrolled is not easy, so we need the right site with the right investigators with the right teams in order to have success.

In terms of our projections, we are projecting that with the additional 8 sites we are going to be able to meet the goal of 339 by December of 2026. Now we are making a number of different moves in order to make this happen. We are extending into, for example, within the sites that we have. Into, other ICUs and so we're training other ICUs, for example, surgical ICUs, in order to, increase, the number of patients that we are able to screen in order to be able to capture more patients. And so, that's just one example, but there are several others, that, several other tweaks that we are making to increase our enrollment rate. Greater than what we have seen over the last few months, and so, based on, the historical enrollment rate, that we have seen with the addition of additional sites, we are confident that we can hit that number, that new number of 339 by December of 2026. Does that answer your question?

Yeah, no, Kevin, that was great. That was the color I was looking for, so that, that's awesome. It sounds like. You, you've already identified, like you said, 8 more sites which would get you up to 25, but you'll move beyond that if all those criteria that you're looking for to be a site are met, and if you move beyond that 25, it, it'll give you further confidence that. You can get to the 339 by the end of December and maybe, if you're able to activate even more sites, maybe you achieve it before December of 26. Is that fair?

Yes, as I stated, we know what's at stake. We know time is of the essence, and, we want to get this study done and therefore, we're tracking this week by week, month to month, and, if we're not meeting the trajectory that we expect. Additional sites will be needed, and so right now, based on, my projections, based on the historical data of the number of patients we've enrolled to date per site per month, we are fairly confident that, the addition of 8 sites will get us there.

Now if it looks like it won't, then we'll make additional adjustments. We're not going to be just sitting idle, hoping that we're going to hit 339. We are approved, as for up to 30 sites, so we'll be, moving in that direction if needed, but right now 25 sites is looking like, the number that we need to hit in order to reach our goal.

Okay, that's great. And when, Eric mentioned about the new cardio renal trial, it's 20 patients, single arm, is that. Is that just literally beginning today and it's, or it's just been announced today, but that's very early stage and anymore, any more color on that. How long that'll take and. I know that's a new whole new category for you, so. Maybe just any color on that would be great. Thanks.

Right, thank you, Anthony. We expect to enroll at, 5, at least 5 sites, for this trial. This is a very special population, who are not, these patients are not candidates for mechanical ventricular assist because of their AKI. And a variety of other reasons. And so we believe that we're going to be able to give these patients a chance to be able to bridge them to, be able to be candidates for mechanical, ventricular assist. In terms of timing, I, it, it's unclear how quickly we're going to be able to enrol. We're hoping to get enrol over the next year and finish in a year's time. But we won't know until we, really get into it and learn about the pace of screening and, the enrolment, over the number of patients screened, for example, at each site, all the institutions that we're working with for neutralized CRS are also neutralized AKI sites.

The patients don't compete, so we're looking for different patients for this particular trial. But we are projecting that, we should be done with, the enrolment of 20 patients, within a year. This is, subject to revision if, for example, site, activation is slowed. We have been screening for a couple of weeks and we've had a couple of, solid candidates, but they just were not enrolled. However, Once we activate the 5 sites, which, we'll be announcing one by one, we should be able to get there within the year, 5 sites, and that's not a lot of patients per site as you can tell.

Sure, no, that's helpful. And then the last question, for Eric, I thought I heard you mention on the call at the beginning of the call, obviously we know revenue at this stage can be a little bit, volatile, a little bit lumpy, but. Did you say, on target to do about a million or north of a million for the full year 25? Let me just clarify, thank you.

Yes, yeah. So thanks, Anthony. Yes, that's what we said is that we were on target to do, a million plus this year.

Okay, great. All right, thanks so much. Appreciate it. I'll hop back to you too.

Thank you. I'm showing no further questions at this time. I would like to turn it back to Jackie Kosman for closing remarks.

Thank you, Marvin, and thank you all for joining us today for the SeaSar Medical 3rd quarter Financial Results conference call. If you have questions, please contact us at ir@cstarmed.com or visit our website at www.Castarmedical.com. Thank you and goodbye.

Thank you for your participation in today's conference. Since that conclude the program, you may now disconnect.