SeaStar Medical (ICU) Q1 2026 Earnings Transcript

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DATE

Wednesday, May 13, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Eric Schlorff
• Chief Commercial Officer — Tim Varacek
• Chief Medical Officer — Colonel Kevin Chung FACP
• Chief Financial Officer — Michael Messinger
• Vice President, Clinical — Tom Mullen
• Head of Investor Relations — Jackie Cossmon

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TAKEAWAYS

• Quellimmune Net Revenue -- $495,000, reflecting a 69% increase year over year and supported by 7 new hospital customers for the quarter.
• Customer Growth -- 7 new hospitals adopted Quellimmune, bringing total customer sites to 17, advancing toward the yearly goal of 15 new customers.
• Gross Profit Margin -- Exceeded 90%, consistent with the past three quarters according to financial statements.
• Operating Expenses -- Unchanged at approximately $4.1 million, demonstrating ongoing cost discipline.
• Cash Balance -- Over $9.3 million as of March 31, up from $5.2 million a year prior.
• Net Loss -- $3.5 million, or $0.90 per share, compared with $3.8 million, or $4.38 per share, in the prior year period.
• NEUTRALIZE-AKI Pivotal Trial Enrollment -- 198 of 339 targeted adult patients enrolled, with completion expected around year-end and top-line results anticipated for mid-2027.
• SAVE Registry Milestone -- Enrollment completed at 50 pediatric patients, with 28-day safety analysis nearing FDA submission and an anticipated request to transition the registry to a voluntary study.
• FDA Regulatory Strategy -- Active discussions on a modular PMA for adult AKI indication and pursuit of a rapid approval pathway for SCD therapy.
• SCD Therapy Clinical Recognition -- Featured in two American Society of Nephrology Kidney News articles highlighting its potential shift in care for extracorporeal therapy and immune modulation.

SUMMARY

SeaStar Medical Holding Corporation (NASDAQ:ICU) is expanding its footprint in the pediatric acute kidney injury (AKI) market through continued Quellimmune adoption and education efforts. The company is advancing toward adult AKI opportunities, with ongoing NEUTRALIZE-AKI trial enrollment through added clinical sites and regulatory interactions structured for expedited review. Progress with the SAVE registry and related FDA processes could accelerate broader pediatric access to Quellimmune if administrative barriers are reduced.

• Management outlined expectations for a modest 5% quarterly rise in research and development expenses to support trial enrollment and new site activations.
• An advanced provider advisory board has been established to enhance operational integration and education within adopting hospitals for Quellimmune.
• Regular virtual users' calls and educational symposia are catalyzing knowledge transfer and word-of-mouth advocacy for Quellimmune within the pediatric nephrology and critical care community.

INDUSTRY GLOSSARY

• Quellimmune: SeaStar Medical's branded immune modulation therapy for pediatric acute kidney injury.
• SCD Therapy: SeaStar's Selective Cytopheretic Device therapy designed for extracorporeal immune modulation in critical illness.
• NEUTRALIZE-AKI: The company's pivotal, randomized controlled trial evaluating SCD therapy in adult AKI patients requiring continuous renal replacement therapy.
• SAVE Registry: Post-marketing registry tracking real-world Quellimmune use and outcomes in pediatric patients under mandatory FDA oversight.
• PMA (Pre-Market Approval): FDA's regulatory pathway for the approval of high-risk medical devices based on efficacy and safety data.
• CRRT (Continuous Renal Replacement Therapy): A dialysis therapy for critically ill patients with acute kidney injury, allowing continuous removal of waste and fluid.

Full Conference Call Transcript

Eric Schlorff: Thank you. Thank you, Jackie, and 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 Quellimmune customer base has helped propel our first quarter Quellimmune net revenue with a nearly 70% increase from 2025. With 7 new hospitals adopting the Quellimmune therapy in 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 Quellimmune 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 of 339 patients. Last year, we determined that we would add new clinical sites to expand our enrollment efforts to reach completion of enrollment around year-end 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 1 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 hyperinflation 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. And 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.

Tim Varacek: Thanks, Eric, and thanks, everyone, for joining us today. I am pleased to report that we ended the first quarter with strong momentum, and it is continuing into the second quarter of this year. As Eric noted, we added 7 additional customers in the first quarter, and importantly, we are seeing an uptick in orders for many of our customers. Our Quellimune net revenue in the first quarter was $495 thousand 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 Quellimmune 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 are seeing great enthusiasm by the pediatric health care community for Quellimmune therapy. Recently, for example, we sponsored and hosted an educational symposium at the AKI and 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 Quellimmune 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 Quellimmune therapy at the hospitals in which they practice.

The broadening impact of Quellimmune therapy and the desire by the pediatric health care community to learn more about Quellimmune reinforces a key focus for SeaStar Medical. To deepen the educational effort on quality of immune therapy, and how to implement it in the treatment of pediatric AKI. Now turning to our commercial efforts for Quellimmune in 2026. We have great expectations to help patients by delivering Quellimmune therapy to more pediatric hospitals. We continue to focus on adding new sites as quickly as possible and once a site adopts Quellimmune, ensure pull through by educating the patient care teams so they are focused on pediatric AKI and the option of Quellimmune therapy for appropriate patients.

We believe this is only the beginning of the commercial opportunities for our SCD therapy. And with that, I will turn the presentation over to our chief medical officer, Kevin Chung. Kevin?

Colonel Kevin Chung FACP: Thanks, Tim. And thank you to everyone for listening to our call. I want to echo Tim's enthusiasm about our presence at the AKI and CRRT meeting in late March. As a critical care physician, I was struck by just how embedded Quellimmune has become in the conversation. The interest was not limited to our own events or data presentations. It showed up organically in plenary and breakout sessions. Where clinicians and researchers were referencing Quellimmune 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 1 but 2 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 1 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 of editorial attention, it is a meaningful signal that the SCD therapy is entering mainstream clinical consciousness.

This recognition from conferences and publications is most welcome. But 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 Quellimmune 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 do not relate to the clinical trial data. It often speeds the overall review of the application.

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 Quellimmune. This would significantly simplify hospital adoption, and we believe it will support more rapid commercial expansion. Now let me turn to our SAVE registry.

Tom Mullen: Which tracks the commercial use of Quellimmune in critically ill children. In March, we announced completion of enrollment at 50 patients, a meaningful milestone. We currently 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 Quellimmune across more pediatric centers. A clear win for patients, providers, and the health care system.

With that, I will hand it over to our CFO, Michael Messinger. Mike?

Michael Messinger: Thank you, Kevin. it is great to be a part of this, and thank you all for being part of our call today. I will provide a brief overview of our financial results for 2026. Please note that our Form 10 Q will be filed with the SEC within the next 24 hours, and that will include a lengthier discussion of the company's financial results. For the 3 months ended March 31, 2026. You can find the 10-Q at sec.gov, or through our website at seastarmedical.com. Recorded net revenue from Quellimmune sales of approximately $495 thousand for 2026, compared to $293 thousand in 2025. And as Tim mentioned, we continue to see strong adoption of Quellimmune sales, here in 2026.

Turning to gross profit. Our first quarter statement of operations reflects a gross profit margin of over 90% consistent with the prior 3 quarters. As a reminder, we did not recognize cost of goods sold in the first quarter of 2025, as the Quellimmune units sold were originally expensed to research and development prior to approval and commercialization, consistent with US GAAP. Operating expenses were unchanged at approximately $4.1 million in 2026, compared to 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 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 a net loss of approximately $3.8 million or $4.38 per share in 2025. Based on approximately 862 thousand weighted average shares outstanding.

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

Eric Schlorff: 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. Also, 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. And finally, 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 Medical are significant. And we look forward to reporting our future progress. With that, I will ask the operator to open the call for questions. Operator?

Operator: Thank you. Ladies and gentlemen, as a reminder to ask a question, please press *11 on your telephone, then wait for your name to be announced. To withdraw your questions, please press *11 again. First question comes from the line of David with SAC Small Capital Research. Your line is open.

Analyst (David): Hi. Good afternoon, everyone. I appreciate the update today. So first question is, have you begun seeing repeat orders from any of these existing pediatric centers and kind of if you have, how quickly are those repeat orders having or happening from the first time that they come online?

Eric Schlorff: Yeah. Hey, David. This is Eric. Thanks for joining. Great question. Tim, do you want to take that?

Tim Varacek: Sure. Happy to do it. Thank you for the question. So 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 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 therapy on 1 patient, and several more will appear in the ICU that are appropriate patients for Quellimmune. So it is fairly unpredictable that way, but it is definitely safe to say that, from our overall customer base, once they use the product, they gain experience with it.

We definitely have repeat orders. Okay.

Analyst (David): Great. And then you mentioned earlier about the save registry and, of course, how encouraging all the data is from that. So at what point do you talk about if that is going to influence treatment guidelines or, like, standard of care discussions. Yeah.

Eric Schlorff: that is a great question. So Kevin, do you want to tackle that?

Colonel Kevin Chung FACP: Yeah. So, you know, standard of care and implementation into guidelines takes a long time. However, if you look at the pediatric AKI consensus document, that was published a little over a year ago. Immune modulation extracorporeal immune modulation is mentioned. So I believe that if we continue down this path, and, we have a positive neutralized API study, That pediatric AKI and consensus statement will bring forward the SCD as a therapy that is recommended. And so for these clinical practice guidelines, it takes typically multiple randomized controlled trials and wide adoption for recommendations to surface. But we are already mentioned there, so that is a good thing.

And 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.

Analyst (David): Okay. Great. And then, last, of course, you mentioned the write ups in the ASN Kidney News. 1 of the things that they mentioned in there was that integrating the SCD into the ICU workflow is I think they use the term nontrivial, but I mean, how nontrivial is it, or how easy is it for the unit to be integrated into the protocols at a hospital?

Eric Schlorff: Yeah. Thank you for that question. Go ahead, Kevin.

Colonel Kevin Chung FACP: Yeah. Thank you for that question. So, 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. And we are fortunate that is the case. Because that is a critical component of our therapy.

And so you know, with regards to whether or not it is difficult, if you already have a citrate protocol, and you are used to doing CRT, which 99% of all ICUs in the country that is that is a true statement, that the implementation of SCD is not going to be difficult. Alright.

Analyst (David): Thanks for taking the questions. Yep.

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

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

Eric Schlorff: Yeah. Thanks. Anthony. Great question. Thanks for joining today. I will tackle some of this, and then I will have, Tim also come in. Know, 1 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. So it gives you a general sense of, you know, how many have been had been treated. Maybe Tim, you could give a little bit more color on some of Anthony's other questions. Sure.

Tim Varacek: You know, I think, 1 way to think about this, Anthony, and thank you for the question, is as it is with many products in a hospital, hospitals once they understand their utilization patterns, will set a par value. So that is basically an inventory level that they want to keep on hand all at all times based on their utilization. And 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 are scaling we are still scaling our business here. Right? So we have 17 customers. At this time last year, you know, we I do not even we had 3 or 4 customers.

So, it is still new. And so many of these new customers, they order product, they use the product, and then they are they are seeing what the cadence is of patients that come through the system. That helps them establish the par value. Know, in addition to that too, the more they use this, the more they think about pediatric AKI And 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 Quellimmune across these institutions so that many people know about it. And they are they are actively looking for patients.

And when you are actively looking for patients, you are gonna tend to find more of those. So that is, basically how it works. We do not single things out in terms of revenue per hospital at this point. You know, this is an ultra rare indication and condition And so it really is driven by the presentation of a patient within the hospital system itself.

Anthony Vendetti: Okay. So, you know, as you are looking to kind of drive the patient volume, and like you said, it is heavily dependent on the patients needing the treatment. But is there any additional education that is going on at hospitals that you are in and at the new hospitals that you are trying to sign up. That, you know, maybe accelerates the adoption at other centers?

Eric Schlorff: Yeah. that is a great question. Sorry, Eric. Actually, no. it is okay. I actually would Kevin, maybe you could talk about the monthly users. Call that we have with them. Yeah. who is on those calls. But gets discussed, etcetera.

Colonel Kevin Chung FACP: 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. And 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 I talked about. The update. And that is attended by you know, when we invite about 135 or 150 individuals, Most often, we have about 60 callers that dial in. And they get to hear from the previous, months cases, that have occurred at each of the sites that are active. And, 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. And now you know, we are we cannot save everybody. But for many of these patients, actually, for all these patients, the they are they are very they are, you know, initiating the SCD at a very, very dire situation-- during a dire situation where the patient is very, very sick. And virtually all the patients, I do not think would have lived without this option. And what we are doing is giving them a chance and these cases are discussed where these patients are sick, sick, sick, They start Quellimmune.

Next thing you know, the inflammatory indices start coming down. And they talk about patients doing well. And so when the participants who do not have Quellimmune at their institution hear these stories, of course, they are going to want to get their hands on it because they want to give their children a chance. And so that is how we spread sort of the message with regards to the potential benefits of Quellimune. Additionally, we have presented at pretty much the premier conferences where all of the pediatric intensivists and nephrologists gather. PNRC, which is the Pediatric Research Network 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. And, you know, the conversation is always centered around how well these patients respond. Initially to Quellimmune. Even when you have a death, they see the inflammatory indices come down, and the patients initially improve. And sometimes, because of the comorbidities, they may not survive. But they see the benefit. And so, really, it is amplified word-of-mouth is what how I would like to describe it. And it is quite effective.

Eric Schlorff: And there are many centers that contact us Although they have not even begun the process, sometimes because they have a trial that needs it. And we do what we can. I saw it. Tim, yeah. Yeah. Maybe, Tim, you could also just kind of share the newly formed group, this advanced practice group. that you have put together? Yeah. Happy to do that, Eric.

Tim Varacek: So 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 And 1 of the things we have done is we formed an advanced provider-- a practice provider, ad board. So these are folks that are really at the patient care level And they are very operational. They are the ones that kind of get a lot of the work done within these institutions to set up a variety of different, orders and protocols They set up training. And these folks, are really they are, in many cases, the champions within these institutions. And taking Quellimmune through that hospital system.

So we are 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 Quellimmune 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, and so there are a lot of that need to be exposed to this information. So, you know, I think we have a good handle on what needs to be done, and now we are executing on that.

Anthony Vendetti: Okay. Great. That was very helpful. Thanks. I will hop back in the queue. Appreciate it.

Operator: Thank you. Ladies and gentlemen, I am showing no further questions in queue. I would now like to turn the call back over to Jackie for closing remarks. Thank you, Towanda, and thank you all for joining us today for the SeaStar Medical first quarter financial results conference call.

Jackie Cossmon: If you have questions, please contact us at ir@seastarmed.com or visit our website at www.seastarmedical.com. Thank you, and goodbye.

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

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