ICU

Hello, and welcome to the SeaStar Medical first quarter 2026 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask the question during the session, you will need to press star one one on your telephone. You would then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. I would now like to hand the conference over to Jackie Cossmon. You may begin.

Thank you, Talonda. Good afternoon, and thank you for joining the SeaStar Medical first quarter 2026 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 & Business Operations; and Mike 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 Federal Securities Laws. These forward-looking statements involve risks and uncertainties and 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 the conference call contains information that is accurate only as of the date of the live broadcast, May 13th, 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?

Thank you. Thank you, Jackie. Thank you all for joining us today. We are making good progress towards achieving our 2026 goals and also maintaining a disciplined use of our financial resources. The increase in our QUELIMMUNE customer base has helped propel our first quarter QUELIMMUNE net revenue with a nearly 70% increase from the first quarter of 2025, with seven new hospitals adopting the QUELIMMUNE therapy in the first quarter of 2026. Our goal this year is 15 new customers, and we are well on our way to achieving that. With our growing presence and the continued adoption of QUELIMMUNE in the pediatric AKI market, we believe we are on track to meet our net revenue goal of approximately $2 million for the year.

More importantly, we are setting the stage for our next and potentially far larger market opportunity in the adult AKI market. To that end, we continue to enroll patients in the NEUTRALIZE-AKI pivotal trial with 198 patients enrolled of our planned total 339 patients. Last year, we determined that we would add new clinical sites to expand our enrollment efforts to reach completion of enrollment around the end of 2026. Kevin and his team are working diligently to make this happen. It has been extremely rewarding to see the highest caliber medical institutions participate in our trial, with UCLA as an example of one of the latest hospitals to join in and more on the way. In addition, we continue to work closely with the FDA on several fronts.

First, we are discussing the elements of a modular PMA submission for the adult AKI indication, which we believe could speed the approval process. Second, we are working with the FDA to obtain agreement on a rapid approval pathways for our SCD therapy. The SCD therapy is a potential life-saving therapy for indications where there are no treatments today, and we believe patients with hyperinflammation should have more immediate access to therapies that could reduce or avoid severe organ damage and potential loss of life. Finally, and before I turn the call over to Tim, we have maintained a strong financial discipline. Mike will share our efforts on this front shortly. Now I will turn the call over to Tim to discuss not only our commercial achievements, but how we are building a strong presence in the pediatric AKI community.

Thanks, Eric. Thanks everyone for joining us today. I'm pleased to report that we ended the first quarter with strong momentum, and it's continuing into the second quarter of this year. As Eric noted, we added seven additional customers in the first quarter, and importantly, we are seeing an uptick in orders from many of our customers. Our QUELIMMUNE net revenue in the first quarter was $495,000, a solid increase of 69% from the first quarter of last year. As Eric indicated, this is a small but important market to us, not only because we believe QUELIMMUNE is saving lives and sparing organ function for young kids, but it also provides great validation of our SCD technology, and importantly, it paves the way for future potential opportunities in the adult market. We're seeing great enthusiasm by the pediatric healthcare community for QUELIMMUNE therapy.

Recently, for example, we sponsored and hosted an educational symposium at the AKI & CRRT meeting in San Diego. Our presence at the meeting and a number of other activities are designed to increase awareness, knowledge, and implementation of QUELIMMUNE therapy to continue to build our brand in pediatric AKI and also position SeaStar Medical in a leadership role to help educate the pediatric medical community about this serious unmet need.

The symposium provided an opportunity for the pediatric community to get answers to key operational questions, gain exposure to the rich content from cutting-edge scientific and clinical data, and utilize the learnings to establish QUELIMMUNE therapy at the hospitals in which they practice. The broadening impact of QUELIMMUNE therapy and the desire by the pediatric healthcare community to learn more about QUELIMMUNE reinforces a key focus for SeaStar Medical to deepen the educational effort on QUELIMMUNE therapy and how to implement it in the treatment of pediatric AKI. Now, turning to our commercial efforts for QUELIMMUNE in 2026. We have great expectations to help patients by delivering QUELIMMUNE therapy to more pediatric hospitals.

We continue to focus on adding new sites as quickly as possible and once a site adopts QUELIMMUNE, ensure pull-through by educating the patient care teams so they are focused on pediatric AKI and the option of QUELIMMUNE therapy for appropriate patients. 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. Kevin?

Thanks, Tim. Thank you to everyone for listening to our call. I want to echo Tim's enthusiasm about our presence at the AKI & CRRT meeting in late March. As a critical care physician, I was struck by just how embedded QUELIMMUNE has become in the conversation. The interest wasn't limited to our own events or data presentations. It showed up organically in plenary and breakout sessions, where clinicians and researchers were referencing QUELIMMUNE unprompted. That kind of grassroots visibility in a specialty community is a meaningful signal. Adding to that momentum, the American Society of Nephrology's Kidney News, widely regarded as the newsroom of the nephrology world, dedicated not one, but two articles to the SCD therapy in its most recent issue.

The first, a feature on the evolution of extracorporeal therapy, identified the SCD therapy as one of the most exciting frontiers in the shift from passive blood filtration to active immune modulation. The second was devoted entirely to the SCD therapy, its mechanism, clinical evidence, and future potential. When the premier nephrology society's publication gives a therapy of this kind, this kind of editorial attention, it is a meaningful signal that the SCD therapy is entering mainstream clinical consciousness. This recognition from conferences and publication is most welcome, the most compelling recognition comes from the bedside. Every month, we convene a virtual clinical users call with current and prospective pediatric nephrology and critical care teams from across the country to review every QUELIMMUNE case together.

The stories we hear on these calls are truly remarkable, and they continue to validate and reinforce why getting this therapy to a broader patient population is so important. The SCD's unique immunomodulatory mechanism positions us to potentially reshape treatment paradigms across a range of serious conditions, not only for AKI, but cardiorenal syndrome, cardiac surgery, end-stage renal disease, and other states of pathologic immune activation where dysregulated cytokine release drives organ failure and death. To that end, we are working diligently to complete enrollment in our NEUTRALIZE-AKI pivotal trial. As a brief overview, 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 adult patients with acute kidney injury requiring continuous renal replacement therapy. The primary endpoint is a composite of mortality or dialysis dependence at 90 days.

We continue to onboard additional clinical sites and now have enrolled 198 of our target of 339 patients. We are targeting completion of enrollment around year-end, which positions us to potentially report top-line results in mid-2027. We are already working with the FDA on our plans to submit a modular PMA, enabling us to complete most of the submission with the exception of pivotal data, then submit pivotal data as the last element of the submission. This is designed to allow FDA early review of the modules that don't relate to the clinical trial data. It often speeds the overall review of the applications.

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 a potentially accelerated FDA review. A PMA approval of SCD therapy for adult AKI would enable commercialization as a therapeutic device without the IRB-related barriers that exist with QUELIMMUNE. This would significantly simplify hospital adoption, and we believe it will support more rapid commercial expansion. Now let me turn to our SAVE Registry, which tracks the commercial use of QUELIMMUNE in critically ill children. In March, we announced completion of enrollment at 50 patients, a meaningful milestone. We are currently completing the 28-day safety analysis on our final enrolled patients and expect to submit top-line safety data to the FDA shortly.

Alongside that submission, we will formally request that the SAVE Registry transition from its current mandatory status to a voluntary post-marketing study. If the FDA agrees, this would meaningfully reduce the administrative burden on children's hospitals, accelerating adoption and expanding access to QUELIMMUNE across more pediatric centers. A clear win for patients, providers, and the healthcare system. With that, I'll hand it over to our CFO, Mike Messinger. Mike?

Thank you, Kevin. It's great to be a part of this, Thank you all for being part of our call today. I'll provide a brief overview of our financial results for the first quarter of 2026. Please note that our Form 10-Q will be filed with the SEC within the next 24 hours, That will include a lengthier discussion of the company's financial results for the three months ended March 31st, 2026. You can find the 10-Q at sec.gov or through our website at seastarmedical.com. We recorded net revenue from QUELIMMUNE sales of approximately $495,000 for the first quarter of 2026, compared to $293,000 in the first quarter of 2025.

As Tim mentioned, we continue to see strong adoption of QUELIMMUNE sales here in the second quarter of 2026. Turning to gross profit, our first quarter statement of operations reflects a gross profit margin of over 90%, consistent with the prior three quarters. As a reminder, we didn't recognize cost of goods sold in the first quarter of 2025, as the QUELIMMUNE units sold were originally expensed to Research and Development prior to approval and commercialization, consistent with U.S. GAAP. Operating expenses were unchanged at approximately $4.1 million in the first quarter of 2026 compared to the first quarter of 2025. This represents our continued discipline and leverage of our team's ability to take on multiple tasks within our organization due to our broad experiences, talents, and enthusiasm to ensure the company's success.

For the remainder of the year, we anticipate meeting our enrollment goals. We expect our Research and Development expenses to increase modestly, around 5% each quarter, as we continue to drive enrollment and support more clinical sites. However, we continue to expect our general and administrative spend to remain pretty consistent from quarter-to-quarter for the remainder of 2026. Net loss for the first quarter of 2026 was approximately $3.5 million or $0.90 per share based on weighted average shares outstanding of approximately 3.9 million shares. This compares with the net loss of approximately $3.8 million or $4.38 per share in the first quarter of 2025 based on approximately 862,000 weighted average shares outstanding.

We have over $9.3 million of cash on our balance sheet as of March 31st, 2026, compared to $5.2 million at March 31st, 2025. Now I'll turn it back to Eric.

Thanks, Mike. Our goal today was to share with you our recent achievements, but also express how keenly focused we are on the key value drivers for our stakeholders, in particular, patients, the medical community, and investors. With a small but passionate team, we believe we are reshaping the possibilities for kids that often face organ failure or death without new therapies to modulate the cytokine storm in AKI. By bringing together the pediatric care community to broaden the understanding of critical care in this setting, we believe we are helping to set a higher standard for all kids that face the trauma of acute kidney injury. In addition, we have established relationships with many of the top nephrologists in the country through the participation in our NEUTRALIZE-AKI pivotal trial. These relationships will serve us well as we look to potentially launch our SCD therapy in the adult indication.

We are actively engaged with our stakeholders to continue to communicate our value proposition and long-term vision for SeaStar Medical. 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?

Thank you. Ladies and gentlemen, as a reminder to ask a question, please press star one one on your telephone, then wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of David Bautz with Zacks Small-Cap Research. Your line is open.

Hey, good afternoon, everyone. Appreciate the update today. First question is, have you begun seeing repeat orders from any of these existing pediatric centers? Kind of if you have, how quickly are those repeat orders happening from the first time that they come online?

Yeah. Hey, David, this is Eric. Hey, thanks for joining. Great question. Hey, Tim, do you wanna take that?

Sure. Happy to do it. Thank you for the question. To answer the first part of your question, we absolutely see repeat orders from our customer base. In terms of the speed at which that happens, it, you know, it is really driven by the presentation of the patient when the patient arrives. In some cases, you know, it could be Some time between patients and in other times, you know, they may finish a therapy on one patient and several more will appear in the ICU that are appropriate patients for QUELIMMUNE. It's fairly unpredictable that way, but it is definitely safe to say that from overall customer base, once they use the product, they gain experience with it, we definitely have repeat orders.

Okay, great. You mentioned earlier about the SAVE Registry and of course, how encouraging all the data is from that. At what point do you talk about if that's gonna influence treatment guidelines or like standard of care discussions?

Yeah, that's a great question. Kevin, do you wanna tackle that?

Yeah. You know, standard of care and implementation into guidelines takes a long time. However, if you look at the pediatric ADQI consensus document that was published a little over a year ago, extracorporeal immune modulation is mentioned. I believe that if we continue down this path and we have a positive NEUTRALIZE-AKI study, that pediatric ADQI and consensus statement will bring forward the SCD as a therapy that's recommended. For these clinical practice guidelines, it takes typically multiple randomized controlled trials and wide adoption for recommendations to surface. We're already mentioned there, that's a good thing.

I have no doubt that with continued use of the therapy as clinical teams see the results, this will become something that everybody's talking about.

Okay, great. Then, lastly, of course, you mentioned the write-ups in the ASN Kidney News. One of the things that they mentioned in there was that, you know, integrating the SCD into the ICU workflow is, I think they used the term non-trivial, but I mean, how non-trivial is it or how easy is it for the unit to be integrated into the protocols at a hospital?

Yeah. Thank you for that question.

Go ahead, Kevin.

Yeah. Thank you for that question. Clinically, the addition of the SCD cartridge, connecting it serially to an already existing CRRT circuit, any CRRT technician, dialysis technician, or CRRT ICU nurse can do that. It takes minutes to connect, and it is as simple as can be. The other thing that a lot of centers around the country have experience with is citrate anticoagulation. We're fortunate that that's the case because that is a critical component of our therapy.

You know, with regards to whether or not it's difficult, if you already have a citrate protocol and you're used to doing CRRT, which 99% of all ICUs in the country, that's a true statement, that the implementation of SCD is not going to be difficult.

All right. Thanks for taking the questions.

Yep.

Our next question comes from the line of Anthony Vendetti with Maxim Group. Your line is open.

Thank you. Yeah, I just wanted to talk about the hospitals that are currently using the product. You know, do you have like a particular ordering pattern? Anything, any other color you can give there? I know you said the reorder frequency, you don't have that exact number, but how many patients total have been treated? Do you currently have like a, if not, a reordering pattern for the hospitals, an average revenue per center? Or is it really just patient-dependent and can vary widely?

Yeah. Thanks. Thanks, Anthony. Great question. Thanks for joining us today. You know, I'll tackle some of this, and then I'll have Tim also come in. You know, one of the things is, you know, how many patients have we treated. We did disclose a couple months back that we had reached the 50 patients for the SAVE Registry. Kinda gives you a general sense of, you know, how many have been treated. Maybe, Tim, you could give a little bit more color on some of Anthony's other questions.

Sure. you know, I think, one way to think about this, Anthony, and thank you for the question, is as it is with many products in the hospital, hospitals, once they understand their utilization patterns, will set a par value. That is basically an inventory level that they want to keep on hand all at all times based on their utilization. To be sure, there are par values that have been set with many of the customers that we have. Others that are, you know, we're scaling, we're still scaling our business here, right? We have 17 customers. At this time last year, you know, We had three or four customers. It's still new.

Many of these new customers, they order product, they use the product, and then they're seeing what the cadence is of patients that come through the system that helps them establish the par value. You know, in addition to that too, the more they use this, the more they think about pediatric AKI.

You heard me talk about the educational efforts that we are really engaging in with a lot of these sites to make sure that, you know, there really is a ripple effect of QUELIMMUNE across these institutions so that many people know about it and they're actively looking for patients. When you're actively looking for patients, you're gonna tend to find more of those. That's basically how it works. We don't single things out in terms of revenue per hospital. At this point, you know, this is an ultra-rare indication and condition. It really is driven by the presentation of a patient within the hospital system itself.

Okay. You know, as you're looking to kind of drive the patient volume, and like you said, it's heavily dependent on the patients needing the treatment. Is there any additional education that's going on at the hospitals that you're in and at the new hospitals that you're trying to sign up, that, you know, maybe accelerates the adoption at other centers?

Yeah.

That's a great question.

Sorry. Sorry, Eric.

Actually, No, that's okay. I actually would, Kevin, maybe you could talk about the monthly users, call that we have.

Yeah.

Who's on those calls, what gets discussed, et cetera.

Sure. Thank you, Anthony, for that question. I mean, you know, this is a very tight community, the nephrology, the pediatric nephrology and critical care community. They all talk to each other. They all share experiences. We sort of leverage that spirit and have been having monthly clinical users calls that we talked about in the update. That is attended by, you know, when we invite about 135 or 50 individuals, most often we have about 60 callers that dial in. They get to hear from the previous months' cases that have occurred at each of the sites that are active.

We go into detail about the cases, how sick they were, you know, why they decided, the reason and rationale for therapy, and what happened to them. Now, you know, we can't save everybody, but for many of these patients, actually, for all these patients, they're very, you know, initiating the SCD at a very, very dire situation, where the patient is very, very sick. Virtually all the patients I don't think would have lived without this option. What we're doing is giving them a chance. These cases are discussed where the patients are sick, sick. They start QUELIMMUNE. Next thing you know, the inflammatory indices start coming down, and they talk about patients doing well.

You know, when the participants who don't have QUELIMMUNE at their institution hear these stories, of course, they're gonna want to get their hands on them because they want to give their children a chance. That's how we spread the message with regards to the potential benefits of QUELIMMUNE. Additionally, we have presented at the premier conferences where all of the pediatric intensivists and nephrologists gather. PNRC, which is the Pediatric Nephrology Research Consortium, we presented at it in Miami. Pretty much 50 or so children's hospitals were represented. Society of Critical Care Medicine, AKI & CRRT. Even the European meeting that I just returned from, there were several pediatric centers represented there from the United States.

You know, the conversation is always centered around how well these patients respond initially to QUELIMMUNE. Even when you have a death, they see the inflammatory indices come down and the patients initially improve. Sometimes, because of the comorbidities, they may not survive, but they see the benefit. Really, it's amplified word of mouth is how I would like to describe it. It's quite effective. There are many centers that contact us, although they haven't even begun the process sometimes, because they have a child that needs it. We do what we can.

That's great. Tim,

Yeah.

Yeah. Maybe, Tim, you could also, just kinda share the newly formed group, this advanced practice group that you've put together.

Happy to do that, Eric. In addition to what Kevin was talking about, you know, we are coming at this from a variety of different ways to educate the community. One of the things we've done is we formed a advanced provider ad board. These are folks that are, you know, really at the patient care level. They are very operational. They're the ones that kinda get a lot of the work done within these institutions to set up a variety of different orders and protocols. They set up training. These folks are, in many cases, the champions within these institutions taking QUELIMMUNE through that hospital system. We're working with them.

We had a symposium at the recent AKI and CRRT meeting. We have several other planned events over the rest of this year. In addition to that, we also have some field-level clinical support at these systems too. Especially, you know, the systems that have adopted QUELIMMUNE, making sure that, again, more people know about it. There are a lot of people that work within a specific hospital. There are a lot of shift changes. There are a lot of people that need to be exposed to this information. You know, I think we have a good handle on what needs to be done, and now we're executing on that.

Okay, great. That was very helpful. Thanks. I'll hop back in the queue. Appreciate it.

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to Jackie for closing remarks.

Thank you, Talonda. 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 [email protected] or visit our website at www.seastarmedical.com. Thank you and goodbye.

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.

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

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 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 Mike 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 25th, 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?

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?

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?

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, Mike Messinger. Mike?

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 31st, 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 three and 12 months ended December 31st, 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 31st, 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 31st, 2025, compared to $1.8 million at December 31st, 2024. With that, I'll turn it back to you, Eric.

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?

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.

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?

Hey. Yeah, thanks, David. This is Eric. Thanks for joining us today. Tim, why don't you tackle that?

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 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.

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?

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.

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?

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.

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?

Yeah. Go ahead, Mike.

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.

All right. Sounds good. Appreciate you guys taking the questions.

Thank you.

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.

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?

Thanks, Anthony. Hey, Kevin, go ahead and answer the question for Anthony.

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.

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.

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.

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.

Yeah, no, the results are obviously very compelling. Okay, Tim, on the sales front.

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.

Okay, great. Thank you very much. I'll hop back in the queue.

My pleasure.

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

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 [email protected] or visit our website at www.seastarmedical.com. Thank you and goodbye.

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