SeaStar Medical Q4 2025 Earnings Call - Pivotal adult AKI trial passes midpoint as company pushes for modular PMA

Operator: I would now like to hand the conference over to your speaker today, Jackie Cossmon.

Jackie Kosman, Moderator, Wheelhouse Life Science Advisors: Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical fourth quarter and year-end 2025 financial results conference call. I’m Jackie Kosman 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 Michael Messinger, Chief Financial Officer. 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 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, March 25, 2026. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law. Now I’d like to turn the call over to Eric. Eric?

Eric Schlorff, Chief Executive Officer, SeaStar Medical: Yeah. Thank you, Jackie. Thank you all for joining us today. We are excited to share with you our achievements over the past year and our future plans and passion for what we are doing here at SeaStar Medical. In 2025 and into the first quarter of this year, we expanded the use of QUELIMMUNE therapy for ultra-rare pediatric AKI. We added 13 new customers from top-rated children’s hospitals, bringing the total customer base to 16 and building increased depth in customer orders. We reported net revenue of over $1 million from QUELIMMUNE sales in 2025, with pharma-like gross profit margins above 90%.

In addition, we advanced the development of the SCD therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy, achieving over 50% enrollment in the trial, with 181 of the 339 patients enrolled to date in the NEUTRALIZE-AKI pivotal trial. We also initiate a modular pre-market application or PMA submission process for the SCD therapy as a potential treatment for the adult AKI indication. We have already been granted Breakthrough Device Designation by the FDA for this indication, so we are hoping to potentially speed the PMA approval process through this modular PMA submission. Importantly, we maintain good cost controls and improve the company’s balance sheet substantially through the addition of approximately $24 million of capital during 2025, as well as a reduction of over $3 million in operating liabilities.

Now, turning to 2026. We have laid out four key milestones to drive stakeholder value and position us solidly for 2027 and beyond. Our primary goal this year and a major driver of our future potential revenue is to advance the SCD therapy for the adult AKI indication. We plan to complete enrollment in the NEUTRALIZE-AKI pivotal trial around the end of 2026. A successful trial would position us to finalize our PMA submission next year. With a market opportunity that is 50 times that of the pediatric AKI market, we are very excited about this future opportunity. With respect to QUELIMMUNE, we look to further expand our customer base in 2026. We have strong momentum in the pediatric market with the publication of our SAVE registry data in Pediatric Nephrology and strong testimonials from existing customers.

We plan to add 15 new top-ranked children’s medical centers this year with a goal of achieving $2 million product revenue from QUELIMMUNE sales in 2026, a significant increase over 2025. We will also evaluate the broader applicability of the SCD therapy in a new indication where we have been awarded the Breakthrough Device Designation approval pathway through the FDA. We announced in late 2025 the initiation of a clinical trial of the SCD therapy in patients with acute congestive heart failure with cardiorenal syndrome awaiting left ventricular assist device implantation. This trial is investigator-led and being funded by the NIH.

It is in the area of critical need, and we are hoping that we can provide a solution to these patients with little hope of survival because they are too compromised due to hyperinflammation to undergo the surgery required to improve their condition. Finally, we will work with the FDA for expedited approval of our pipeline indications. The Humanitarian Use and Breakthrough Device designations would enable us to potentially provide earlier access to patients with destructive hyperinflammatory conditions that face permanent organ failure or loss of life. In short, we have an exciting year ahead and look forward to reporting our progress to you. I will turn it over to Tim to discuss our commercial achievements and market opportunities. Tim?

Tim Varacek, Senior Vice President of Commercial and Business Operations, SeaStar Medical: Thanks, Eric, and thanks everyone for joining us today. I’m pleased to report that we ended the year with strong momentum, and that momentum continues into the first quarter of this year. We added six additional customers since the beginning of the fourth quarter, and importantly, we’re seeing a substantial uptick in orders from many of our customers. Our QUELIMMUNE net revenue in the fourth quarter was $315,000, and the first quarter net revenue has already exceeded that number. Now, to put that in perspective, we have indicated all along that this is an ultra-rare market. It’s a market that is important to us, not only because we believe we are saving lives, but because it also provides great validation of our SCD technology, and importantly, it paves the way for future potential opportunities in the adult market.

With the growing adoption of the QUELIMMUNE therapy, key opinion leaders in the field are now publishing and reporting on the use of QUELIMMUNE. We reported in February that nine pediatric AKI experts co-authored the publication of the SAVE Registry data in the peer-reviewed journal, Pediatric Nephrology. In addition, later this month, we will sponsor and host an educational symposium at the AKI & CRRT meeting in San Diego. I’ve previously discussed plans to build the QUELIMMUNE brand in pediatric AKI, and this symposium is an example of a new resource we are developing, an advanced practice provider advisory board. This group of patient care level and operational experts will participate in a panel discussion aimed directly at the QUELIMMUNE adoption process to provide aspiring institutions with best practices and enable them to shorten the overall timeline to QUELIMMUNE activation.

This event already has a large list of attendees and will feature discussions on the use of QUELIMMUNE by a number of prominent key opinion leaders who have been early adopters of the QUELIMMUNE therapy. Also, an abstract by Dr. James Odom at the University of Alabama at Birmingham Children’s of Alabama has been accepted for presentation. It will report findings on the anti-inflammatory properties of our SCD therapy. In short, we’re seeing strong growth in QUELIMMUNE orders, with the pediatric AKI field now viewing it as a key therapy for renal replacement therapy patients in the ICU. One highly regarded institution has formally adopted QUELIMMUNE as its standard of care. Now turning to 2026. We have great expectations 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 stream for our investors and SeaStar Medical. That’s always our goal. The pediatric AKI market is small but important, and we believe it represents a total market of about $100 million. We’ve refined our target market population to pediatric patients in the top 50 children’s hospitals in the U.S. We believe we can capture a relevant share of this market and create significant value for our stockholders while delivering important revenue for SeaStar Medical. We believe this is only the beginning of the commercial opportunities for our SCD therapy. With that, I’ll turn the presentation over to our Chief Medical Officer, Kevin Chung, who will discuss our NEUTRALIZE-AKI progress to date. Kevin?

Dr. Kevin Chung, Chief Medical Officer, SeaStar Medical: Thanks, Tim, and thank you to everyone joining us today. We are working diligently to complete enrollment in our NEUTRALIZE-AKI pivotal trial. Since the start of the fourth quarter, we’ve onboarded four additional clinical sites and enrolled 55 more patients, bringing total enrollment to 181 of our target of 339 patients. For those less familiar, NEUTRALIZE-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 continuous renal replacement therapy or CRRT. The primary endpoint is a composite of mortality or dialysis dependence at 90 days. We are targeting completion of enrollment around year-end, which positions us to potentially report top-line results in mid-2027.

We are aggressively expanding our clinical footprint, including the addition of high-volume sites over the next quarter to drive enrollment momentum. In parallel, we are proactively preparing components of the pre-market approval that are not dependent on clinical outcomes in alignment with FDA guidance to help streamline the review process. Upon completion and review of the NEUTRALIZE-AKI clinical trial and contingent on positive efficacy and safety outcomes, we intend to move quickly to submit the remaining PMA components under our breakthrough device designation, positioning us for potentially accelerated FDA review. Our pediatric AKI indication was approved under a humanitarian device exemption pathway, a pathway that requires site-level IRB approvals prior to use, and in our case, included the mandatory SAVE Registry to track post-market safety of QUELIMMUNE.

By contrast, an approval of SCD therapy for adult AKI would enable commercialization as a therapeutic device without these IRB-related barriers, significantly simplifying hospital adoption and supporting more rapid commercial expansion. Let me now turn to our SAVE registry, which tracks the commercial use of our QUELIMMUNE therapy in critically ill children. We reported earlier this month that we have completed the enrollment of 50 patients in the SAVE registry. This was the FDA’s new enrollment requirement, down from their original request of 300 patients following its review of the data from the first 21 patients in the registry. We are awaiting the 28-day safety data from our last patients enrolled in the registry and will soon submit a report of the top-line safety data to the FDA.

I’d like to briefly highlight a recent publication in Pediatric Nephrology, which reports early post-approval experience with QUELIMMUNE from the first 21 patients enrolled in the SAVE registry. This work was co-authored by leading experts, and we were pleased to see it published in a highly respected peer-reviewed journal. In this initial cohort of pediatric patients with AKI and sepsis requiring renal replacement therapy, there were no device-related adverse events, no infections, and no evidence of immune suppression. Survival rates were encouraging, with 76% at days 28 and 60 and 71% at day 90, tracking toward an approximate 50% reduction in mortality compared to historical controls, consistent with our prior registration study. These early real-world data reinforce the safety profile of QUELIMMUNE and its potential to meaningfully improve outcomes in a highly vulnerable pediatric population.

Ultimately, this is about giving critically ill children who would otherwise have no other options a real chance of survival. Finally, expanding the pipeline of SCD indications remains a key priority for us this year. We initiated the NEUTRALIZE-CRS clinical trial in 2025 and are actively enrolling patients with chronic heart failure and cardiorenal syndrome. This ICU-based study is expected to enroll approximately 20 patients who are not candidates for LVAD or heart transplantation. Importantly, this trial introduces a differentiated treatment paradigm. Unlike the continuous therapy used in NEUTRALIZE-AKI, patients in NEUTRALIZE-CRS are treated intermittently up to six hours daily for up to six days. This approach is designed to demonstrate the feasibility of intermittent SCD therapy with the potential to extend into outpatient settings and address a broader range of chronic hyperinflammatory conditions.

More broadly, this trial reflects our strategy to expand SCD therapy across multiple indications. Whether in AKI, CRS, or beyond, we believe our platform has the potential to meaningfully improve outcomes in patients impacted by hyperinflammation. With that, I’ll hand it over to our CFO, Michael Messinger. Mike?

Michael Messinger, Chief Financial Officer, SeaStar Medical: Thank you, Kevin, and I’m glad everyone could join us on this call today. I’ll provide a brief overview of our financial results for the fourth quarter and year ended December 31, 2025. Please note that our Form 10-K will be filed with the SEC within the next 24 hours and will include a lengthier discussion of the company’s financial results for the 3 and 12 months ended December 31, 2025. You can find the Form 10-K at sec.gov or at seastarmedical.com. We recorded net revenue from QUELIMMUNE sales of approximately $315,000 for the fourth quarter of 2025, compared to $67,000 in the fourth quarter of 2024. As Tim mentioned, we have already exceeded our fourth quarter sales in the first quarter of 2026.

We also recognized $105,000 of net revenue this quarter from the sale of the SCD to the AREVA Research Institute. This represents the first of two orders from the institute. If you’ll recall, we announced this relationship back in June 2025. The funding for the AREVA Research Institute’s program is through a Department of Defense grant to support their cutting-edge research for extracorporeal immunomodulation to reduce inflammation after severe burns, inhalation injury, and septicemia. The DoD grant covers the purchase of the SCD from SeaStar Medical for use by AREVA in its research. We anticipate a second order up to an additional $100,000. The timing of the order is uncertain, but we will report the revenue as earned in subsequent quarters.

For the full year ended December 31, 2025, QUELIMMUNE net revenue was $1.1 million, compared to $135,000 of QUELIMMUNE net revenue in 2024. This increase reflects our first full year of product sales compared to only half a year in 2024. More importantly, our expanding customer base of the top children’s hospitals in the country is what drove the increase. Turning to gross profit, our fourth quarter and full year statement of operations reflects a gross profit margin of greater than 90%. As a reminder, we did not recognize cost of goods sold prior to 2025, as the QUELIMMUNE units sold were originally expensed to R&D prior to approval and commercialization, which is consistent with U.S. GAAP.

Our operating expenses declined to $3.4 million in the fourth quarter of 2025, compared to $4.8 million in the fourth quarter of 2024. For the full year, we reduced our operating expenses to $13.4 million compared to $18 million in the prior year. These reductions have been intentional and represent our continued discipline and our ability to leverage our team’s broad experience, talent, and enthusiasm to work across the organization to ensure our company’s success. Net loss for the fourth quarter of 2025 was approximately $2.9 million, or $0.80 per share, based on weighted average shares outstanding of approximately 3.6 million shares.

This compares with a net loss of approximately $4.4 million, or $8.98 per share in the fourth quarter of 2024, based on approximately 492,000 weighted average shares outstanding. For the full year 2025 and 2024, net loss was $12.2 million and $24.8 million, respectively, again reflecting both the expanded adoption of QUELIMMUNE and our strong discipline in managing our expenses and reducing those expenses. Turning to our financial position, we continued to substantially improve the company’s balance sheet through the addition of approximately $23.9 million in capital during 2025 and a reduction of $3.1 million in operating liabilities. We have no long-term debt.

We have approximately $12 million of cash on our balance sheet as of December 31, 2025, compared to $1.8 million at December 31, 2024. With that, I’ll turn it back to you, Eric.

Eric Schlorff, Chief Executive Officer, SeaStar Medical: Thanks, Mike. The progress we shared with you today will propel the achievement of our milestones in 2026. We plan to further expand QUELIMMUNE adoption, advance enrollment in our NEUTRALIZE-AKI pivotal trial, and broaden our indications and expedite potential approvals for our SCD therapy indications. 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. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for questions. Our first question comes from David Bautz with Zacks Small Cap Research. You may proceed.

David Bautz, Analyst, Zacks Small Cap Research: Hey, good afternoon, everyone. Appreciate the update today. First question is about the QUELIMMUNE adoption in additional centers. You say you’re targeting about 15 additional pediatric centers that you wanna get the QUELIMMUNE into. What gives you confidence that you’ll be able to hit that number this year?

Eric Schlorff, Chief Executive Officer, SeaStar Medical: Hey. Yeah, thanks, David. This is Eric. Thanks for joining us today. Tim, why don’t you tackle that?

Tim Varacek, Senior Vice President of Commercial and Business Operations, SeaStar Medical: Sure. Well, thank you for the question, and I think we’re starting out pretty quickly. We’ve already added six sites towards that goal in the first quarter. You know, this adding sites is not. It’s a continual progress process, and it takes time. We have a very organized list of hospitals within this top 50. We’ve been working with many of them, and we take them through the adoption process, which, you know, it takes some time, but at this point, we’re able to forecast as we move forward when we approximately think those sites will be able to become activated and become QUELIMMUNE customers.

In addition to that, you know, we’re coming to this point around the SAVE registry where we believe we’ve met the requirements of that registry. We’re gonna work with the FDA to review the data out of that registry. The goal here is for us to make this registry optional versus mandatory going forward. If that happens, then we’ll be able to move sites theoretically quicker through the process, because a big piece of this timeline has been related to getting that registry set up and running. We feel good about the addition of new sites. We feel good about the forecast. We feel good in general about the momentum that we’re creating with QUELIMMUNE within the pediatric community.

David Bautz, Analyst, Zacks Small Cap Research: Okay. Great. Appreciate that. I was wondering if you could comment a little bit about the manufacturing capacity for the SCD. I don’t know if it’s, you know, something you need to worry about right now with the pediatric indication, but as you think ahead to the adult indication and getting approval for that, is there any type of investment that’s gonna be needed in order to meet the potential commercial demand there?

Eric Schlorff, Chief Executive Officer, SeaStar Medical: Yeah. Hey, David. Thanks again. Great question. You know, we are actually very confident in the supply chain of kind of the SCD, both for pediatrics as well as adults. As we have disclosed to the market, you know, our contract manufacturer is Fresenius Medical, who obviously has a deep skill and capacity to be able to produce enough SCDs for both pediatrics as well as for adults.

David Bautz, Analyst, Zacks Small Cap Research: All right. Sounds good. Quickly on the CRS study, I don’t know if you have any type of feel for timelines for that study as far as enrollment goes. Maybe more importantly, if the study is positive, what are next steps for that indication?

Eric Schlorff, Chief Executive Officer, SeaStar Medical: Yeah, let me tackle that one. So, you know, we haven’t really given any guidance as to when that study would be completed. You know, what we did announce this last year is that we did initiate. One site is now activated. We’re gonna continue to activate up to five sites in total. I know that the teams are actively screening for patients as well, and so we’ll just kind of update the market as the year kind of progresses along.

At the, you know, end of the day with a successful study, you know, we believe that, because of the orphan nature of the small patient population for this CRS bridging to LVAD patient population, that it actually would be eligible for a humanitarian device exemption, which is the same designation that we have for the pediatric, which really does allow us to, get the therapy to, much, you know, these much needed patients that just really don’t have any solution. But it really doesn’t then require us to do a large clinical study as we’re doing for the adult AKI indication.

David Bautz, Analyst, Zacks Small Cap Research: Yeah. Okay. Sounds good. Last one, financial question here. I guess it’s for Mike. How should we think about spending for this year? Do you think it’s gonna be more in line with this past year, 2025 or more like 2024?

Eric Schlorff, Chief Executive Officer, SeaStar Medical: Yeah. Go ahead, Mike.

Michael Messinger, Chief Financial Officer, SeaStar Medical: Sure. Thanks for joining, David. Really appreciate it. We see spending really more in line with 2025 and sort of more in line with, you know, the last quarter or so. The good thing is we have the team in place to execute this plan both commercially as well as clinically. You can put that into how you see the run rate going.

David Bautz, Analyst, Zacks Small Cap Research: All right. Sounds good. Appreciate you guys taking the questions.

Eric Schlorff, Chief Executive Officer, SeaStar Medical: Thank you.

Operator: Thank you. As a reminder, to ask a question, please press star one one on your telephone. Our next question comes from Anthony Vendetti with Maxim Group. You may proceed.

Anthony Vendetti, Analyst, Maxim Group: Thank you. Just wondering, you’ve treated. I think, Kevin, you said treated, 181 or enrolled 181 of the 339 target patients. How many of those 181 have gone through treatment at this point, if not all of them? What have you learned so far from those? Anything that you could share at this point or do you have to wait until, you know, the trial is fully enrolled at 339 and then wait for those top line results mid-2027?

Eric Schlorff, Chief Executive Officer, SeaStar Medical: Thanks, Anthony. Hey, Kevin, go ahead and answer the question for Anthony.

Dr. Kevin Chung, Chief Medical Officer, SeaStar Medical: Yeah. Thanks, Anthony, for that question. You know, I think clinically, I’m not really able to share any lessons learned with regards to the 181 patients. What I can tell you is that of those, about half were randomized to treatment, which is in line with a randomized controlled trial. We have had a recent in-person investigators meeting, which was very well attended despite real storms across the country at that time, you know. I was very surprised to have even 70% in-person attendance and then another 25-30 people online.

We were able to share best practices in terms of how we identify these patients, specific tactical targets of opportunity, ways to go about you know approaching and really how to talk to the family members to optimize the enrollment rate. Those kinds of best practices really it was very invaluable for us to share across all the sites because not all the sites are equal in terms of their experience with research, and it was very valuable to us. It generated a ton of enthusiasm and also led to introduction to a variety of different other sites that we were referred to by our own investigators, PIs.

We’re again. I think we spoke and Eric said and we all said that we’re targeting around the year-end for our enrollment. What I can say is that we’re 100% committed to that and very enthusiastic about the new sites that we’ve identified that will be on clinicaltrials.gov shortly, once we activate them over the next quarter or so. Very excited about these sites and what’s to come in the next year.

Anthony Vendetti, Analyst, Maxim Group: Okay. Thanks for that, Kevin. That was helpful. Just in terms of maybe on the pediatric AKI side, you know, you completed that SAVE trial. What about anything you’ve learned on the pediatric side in terms of QUELIMMUNE and then in terms of being able to include another 15 top-ranked children’s medical centers, are you targeting you know a certain number of sales reps you need to add this year or do you have the sales reps you need at this point? Maybe how we should think about that metric going forward.

Eric Schlorff, Chief Executive Officer, SeaStar Medical: Okay. Great. Thanks, Anthony. Kevin, why don’t you talk a little bit about, maybe some of the data that we’ve seen from a clinical standpoint, and then Tim can answer the question around the 15 patients, the adoption.

Dr. Kevin Chung, Chief Medical Officer, SeaStar Medical: Right. Thank you, Anthony, for that question. I mean, the paper speaks for itself. What is not completely obvious to folks that are not in the community of taking care of pediatric nephrology and critical care patients is that all these patients were essentially you know at death’s door and were out of options.

The fact that we were able to have over 70% of them alive at 90 days is to me a mini miracle. To be able to replicate the data that were submitted to the FDA is strong. For me, this was surprising given the fact that this was a sicker population. Once we are able to report all 50, you will see how sick these patients really are compared to even prior to commercialization. You know, one thing that is interesting is that whenever life-saving technology is introduced to the market, you know, I have personal experience initiating a CRRT capability initially 20 years ago and then ECMO.

Those technologies are usually given and provided and offered only to the sickest of the sick as a last resort. Oftentimes, outcomes are not as good as what you would think because you’re applying them to dying patients. What we’re seeing and what we’ve seen is something that is very miraculous, at least personally from a professional and personal standpoint. I’m very, very pleased with this outcome. It shows that, you know, it was worthwhile to enter the pediatric market first and we’re saving lives, and that’s what we’re all about.

Anthony Vendetti, Analyst, Maxim Group: Yeah, no, the results are obviously very compelling. Okay, Tim, on the sales front.

Tim Varacek, Senior Vice President of Commercial and Business Operations, SeaStar Medical: Sure. Sure, Anthony. The short answer to your question is no, we’re not adding additional sales people to the effort. You know, as mentioned, we’re exclusively focused on the top 50 pediatric hospitals and, you know, that is the highest volume for us patient-wise. We’re expecting to, you know, add an additional 15. We have six already through the first quarter, and we have others moving through process. What we do expect to do is increase our overall, our clinical representation within those hospitals. Having on-site clinical representation to really expand the, you know, the footprint within these institutions. You know, one thing, this is a continual learning process for us, obviously.

What we’re learning is, you know, we have great momentum, and we need to continue to enhance that by getting to these educational opportunities within these institutions so that there’s more general knowledge about QUELIMMUNE within the institutions that we work with, that more folks and staff, that patient care teams and physicians that work in these institutions understand what QUELIMMUNE is, understand the type of patient to use it for, how to profile that patient, and ultimately the best way to use it to be successful. The other thing we’re doing too is we have a great relationship with this community. You know, one result of that is the advanced practice provider advisory board that we’ve put together.

As I mentioned, they’re going to be active at the symposium at AKI & CRRT later this week. The momentum there is significant as well. In essence, we have evangelists that are within the customer base that really believe in this product the same way we do, and we’re gonna enhance that by working with them as closely as possible as well.

Anthony Vendetti, Analyst, Maxim Group: Okay, great. Thank you very much. I’ll hop back in the queue.

Tim Varacek, Senior Vice President of Commercial and Business Operations, SeaStar Medical: My pleasure.

Operator: Thank you. I would now like to turn the call back over to Jackie Cossmon for any closing remarks.

Jackie Kosman, Moderator, Wheelhouse Life Science Advisors: Thank you, Josh, and thank you all for joining us today for the SeaStar Medical fourth quarter and year-end financial results conference call. If you have questions, please contact us at IR@SeaStarMed.com or visit our website at www.seastarmedical.com. Thank you and goodbye.

Operator: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.