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Date

Nov. 13, 2025 at 4:30 p.m. ET

Call participants

  • Chief Executive Officer — Eric Schlorff
  • Chief Commercial Officer — Tim Varacek
  • Chief Medical Officer — Kevin Chung
  • Controller — Brad Town
  • Investor Relations — Jackie Cossmon

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Takeaways

  • Net revenue -- $183,000 from Quellimmune therapy sales for the fiscal third quarter of 2025; revenue for the six months ended Sept. 30 was up 45% compared to the prior six months.
  • Gross margin -- 92% gross profit margin for the first full quarter of cost of goods sold reporting on Quellimmune sales, characteristic of branded pharmaceutical economics.
  • Operating expenses -- $3.7 million in the fiscal third quarter of 2025, down from $4.5 million in the fiscal third quarter of 2024, due to lower consulting and personnel expenses, partially offset by higher R&D and audit costs.
  • Net loss -- $3.5 million, or $0.13 per share on 26.4 million weighted average shares outstanding, improved from a $4.5 million loss, or $1.10 per share, on 4.1 million shares in the prior-year quarter.
  • Cash position -- $13.8 million at quarter-end, up from $1.8 million at prior year-end, after raising $12.4 million through equity offerings and warrant exercises in the quarter.
  • Hospital adoption -- 10 active commercial pediatric hospital customers for Quellimmune, with four hospitals added since the start of the quarter and additional site launches anticipated by year-end.
  • Volume growth -- Orders for Quellimmune in the first six weeks of the fiscal fourth quarter have already surpassed fiscal third quarter totals.
  • Full-year revenue outlook -- CEO Schlorff said, "we are anticipating full-year revenue for 2025 will be over a million dollars."
  • Clinical data -- SAVE registry results presented for 21 pediatric patients with life-threatening AKI and sepsis reported 76% survival at 60 days and 71% at 90 days; combined real-world and trial data includes 43 patients with over 75% survival at 90 days.
  • AKI trial enrollment -- 146 patients enrolled of a new 339-patient target, up from 137 in September, with 17 active and 8 additional sites being activated to support recruitment through December 2026.
  • Interim DSMB analysis — AKI trial -- Chief Medical Officer Chung stated, "the independent data safety monitoring board (DSMB) determined the SCD therapy to be safe, with no device-related adverse events observed in the treatment arm," and recommended a sample size increase to 339 after effect size was below 20% at interim analysis.
  • CRS trial launch -- New neutralized CRS trial of SCD therapy began enrollment, targeting 20 patients across five sites, aimed at heart failure patients with cardiorenal syndrome who are not transplant or LVAD candidates, with expected enrollment completion within one year if activation pace is maintained.
  • Regulatory efforts -- The company has approached the FDA seeking relief from the mandatory Quellimmune registry to accelerate product adoption.

Summary

SeaStar Medical Holding Corporation (ICU 7.85%) reported accelerating Quellimmune sales, highlighted by strong early fiscal fourth-quarter orders newly exceeding fiscal third quarter results and a projection for full-year 2025 revenue to exceed $1 million. Management detailed a robust hospital expansion strategy, citing 10 active pediatric sites—four of which joined this quarter—and outlined ongoing initiatives to streamline adoption. The company showcased clinically significant survival outcomes from its SAVE registry, with 76% survival at 60 days and 71% at 90 days for high-risk pediatric patients, supporting Quellimmune's impact. Expansion of the pivotal neutralized AKI trial followed a DSMB-recommended sample size increase to 339, reflecting interim data showing safety but effect size below 20%, with 146 patients now enrolled across 17 sites and eight more activations in progress. Initiation of a new CRS pilot study diversified the trial pipeline, targeting previously untreatable heart failure patients and broadening clinical reach.

  • Chief Medical Officer Chung emphasized that safe SCD therapy in critically ill patients represents a key milestone for physician confidence and regulatory engagement, noting, "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."
  • The 92% gross profit margin on Quellimmune sales establishes a favorable economics profile as the company moves to scale commercialization.
  • Controller Brad Town confirmed a strengthened balance sheet with $13.8 million in cash at quarter-end, a result of new capital raised that extends the financial runway.
  • Chief Commercial Officer Varacek highlighted ongoing discussions with the FDA to relax registry requirements, further enabling rapid site adoption and potential market expansion for Quellimmune.

Industry glossary

  • CRRT: Continuous Renal Replacement Therapy, a modality for providing renal support to critically ill patients with acute kidney failure.
  • SCD therapy: Selective Cytopheretic Device therapy, SeaStar Medical's extracorporeal device aiming to modulate immune responses in hyperinflammatory conditions.
  • DSMB: Data Safety Monitoring Board, an independent group monitoring patient safety and treatment efficacy data during clinical trials.
  • AKI: Acute Kidney Injury, a sudden episode of kidney failure or kidney damage that happens within a few hours or days.
  • LVAD: Left Ventricular Assist Device, a mechanical pump used in patients with advanced heart failure.
  • CRS: Cardiorenal Syndrome, a condition in which heart and kidney dysfunctions coexist and worsen one another.
  • SAVE registry: SeaStar Medical’s surveillance database tracking real-world outcomes of Quellimmune therapy in pediatric commercial use.

Full Conference Call Transcript

Eric Schlorff: 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 Fifth 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 Quellimmune 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 Quellimmune use in the commercial market, we are gaining traction. In fact, in the first half of the fourth quarter, Quellimmune orders are already exceeding the entire third quarter. In short, we are anticipating full-year revenue for 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 Quellimmune. 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 cytophoretic device or SCD therapy.

We also continue to add clinical sites to ensure we meet our new enrollment target 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.

Tim Varacek: Thanks, Eric, and thanks, everyone, for joining us today on the SeaStar Medical Third Quarter Call. Our goal for the 20 new pediatric hospitals is to drive product revenue, and as the number of centers increases, 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 products, adding four new customers since the beginning of the third quarter. We are 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 first six 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 Quell immune therapy. Our focus for the remainder of the year and into 2026 is to ensure all clinically appropriate patients receive Quellimmune therapy accounts and continue to move sites through the Quellimmune adoption process as quickly as possible.

Specifically, we continue to leverage best practices learned throughout the launch of Quellimmune to implement tactics related to brand awareness, clinical performance, and patient identification, such as supplemental clinical training, development of a speakers bureau, and development of patient care team forums to share ideas and overcome operational challenges typical to new product 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 Quellimmune therapy when added to CRRT in pediatric AKI.

Importantly, we believe that the patient population for this therapy is far broader than its use 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 Quellimmune 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 Quellimmune adoption and attempt to simplify this process for the customer.

For example, before we have our first meeting with the new system interested in Quellimmune, 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 advocates sponsoring Quellimmune for their system aren'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 points 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 in 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 Quellimmune to potentially save more lives. Now turning to the market.

We have great expectations for 2026, to help patients by delivering Quellimmune 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 derisk 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 SeaStar Medical.

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

Kevin Chung: 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 enrollment to 146 of our new target of 339 patients. For those less familiar, neutralized AKI is a randomized controlled trial designed to assess whether up to 10 sequential 24-hour SCD 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 prespecified 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 (DSMB) determined the SCD 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 SCD 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 enrollment 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 enrollment 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 eight 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 enrollment by 2026. Let me now turn to our SAVE surveillance registry, which tracks commercial use of our Quell immune therapy in critically ill children. At the recent Fifth 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 AKI 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. Quellimmune 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 Quellimmune.

Every month, we host a Quellimmune users call, a forum attended by both current and prospective clinical users. During these sessions, we have discussed nearly every patient treated under the SAVE surveillance registry. The stories 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 new neutralized CRS trial, which evaluates SCD in patients with chronic systolic heart failure complicated by cardiorenal syndrome, who are not candidates for heart transplant or even LVAD or left ventricular assist device. The single-arm feasibility study will enroll 20 patients in the 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 SCD treatment versus the neutralized AKI study.

These patients are treated intermittently for up to six hours daily for up to six days. In the neutralized AKI study, the patients are treated continuously for 24 hours daily for up to ten days. This is important because this could demonstrate the feasibility of intermittent therapy bridging to more outpatient settings in 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 SCD 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.

Brad Town: Thank you, Kevin. Thank you all for joining us today. I'll provide a brief overview of our financial results for the third quarter. Please note that our Form 10-Q will be filed with the SEC in the next 24 hours and will include a more lengthy discussion of the company's financial results for the three and nine months ended 09/30/2025. You can find the 10-Q at seastarmedical.com, or at sec.gov. We recorded net revenue from Quellimmune sales of approximately $183,000 for 2025, compared to $68,000 in 2024. As Eric mentioned, we are already seeing a nice uptick in sales for the first six 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 Quellimmune unit sales. We did not recognize cost of goods sold for the three months ended 09/30/2024, as Quellimmune units sold were originally expensed to research and development upon acquisition, which is prior to our commercialization of Quellimmune, and consistent with US GAAP. Operating expenses declined to $3.7 million in the third quarter of 2025, compared to $4.5 million in 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 09/30/2025 was $13.8 million, compared to $1.8 million at December 2024. During the three months ended 09/30/2025, 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.

Eric Schlorff: 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 12 through the fifteenth. We hope to see some of you there. We believe that the opportunities that lie ahead for SeaStar 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: Thank you. At this time, we'll conduct a question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. And our first question comes from the line of Anthony Vendetti of Maxim Group. Your line is now open.

Anthony Vendetti: Thank you. Yes. So I just wanted to get an update. I may have missed it if you gave it out. So as of 09/24, as of September 24, 137 of the now required, I guess, the data safety monitoring board or review board recommended 339 up from 200. Back in September. So 137 were enrolled as of then. 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, you know, the September change in the enrollment number?

Eric Schlorff: Hey. Thanks, Anthony. This is Eric. Go ahead, Kevin.

Kevin Chung: 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 eight additional sites. So that'll get us to about 25 sites. And we're hoping to look for more sites. And, you know, 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 eight sites, we are going to be able to meet the goal of 339 by December 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 2026. Does that answer your question?

Anthony Vendetti: Yeah. No, Kevin. That was great. That was the color I was looking for, so that's awesome. It sounds like you've already identified, like you said, eight more sites which would get you up to 25. But you'll, you know, 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'll give you further confidence that you can get to these 339 by December, and maybe, you know, if you're able to activate even more sites, maybe you achieve it before December of 2026. Is that fair?

Kevin Chung: Yes. As I stated, you know, 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 eight 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 gonna hit 339.

We are approved, as you know, for up to 30 sites. So we'll be moving 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.

Anthony Vendetti: Okay. That's great. And when Eric mentioned about the new cardiorenal trials, 20 patients, single arm. Is that just literally beginning today, and it's just been announced today, but that's very early stage. And any more color on that? How long that'll take? And I know that's a whole new category for you. So maybe just any color on that would be great. Thanks.

Kevin Chung: Right. Thank you, Anthony. We expect to enroll at least five sites for this trial. This is a very, very special population. 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 candidates for mechanical ventricular assist. In terms of timing, you know, it's unclear how quickly we're gonna be able to enroll. We're hoping to enroll 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 enrollment.

You know, 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 enrollment of 20 patients within a year. This is, you know, 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 five sites, which we'll be announcing one by one, we should be able to get there within the year. Five sites, and that's not a lot of patients per site, as you can tell.

Anthony Vendetti: Sure. No. That's helpful. And then 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.

Eric Schlorff: Thank you. Yes. So thanks, Anthony. Yes. That's what we said is that we were on target to do a million plus this year.

Anthony Vendetti: Okay. Great. Thanks so much. Appreciate it. I'll hop back in the queue.

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

Jackie Cossmon: Thank you, Marvin. And thank you all for joining us today for the SeaStar Medical Third Quarter Financial Results Conference Call. If you have questions, please contact us at ircstarmed.com or visit our website at www.seastarmedical.com. Thank you, and goodbye.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.