ICU

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 4:30 p.m. ET Chief Executive Officer - Eric Schlorff Senior Vice President of Commercial and Business Operations - Tim Varacek Chief Medical Officer - Kevin Chung Chief Financial Officer - Michael Messinger Operator: Good day, and thank you for standing by. Welcome to the SeaStar Medical Reports second quarter 26 Financial Results. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speakers' presentation, there will be a question-and-answer session. To ask a question, please press 11 on your telephone, and wait for your name to be announced. To withdraw your question, please press 11 again. I would now like to hand the conference over to your speaker today, Jackie Cossmon. Jackie Cossmon: Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical second quarter 26 financial results conference call. I am Jackie Cossmon with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, chief executive officer Tim Varacek, senior vice president of commercial and business operations doctor Kevin Chung, chief medical officer, 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 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. 08/12/2026. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law. And now I would like to turn the call over to Eric. Eric? Eric Schlorff: Thank you, Jackie. And thank you all for joining us today. We are very pleased with our progress this quarter. Our pediatric AKI market penetration and continued strong QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market, that is 50x larger than the pediatric market in The United States. Successful treatment of pediatric AKI with QUELIMMUNE therapy by patient care teams is driving greater clinical confidence from the tight knit critical care pediatric community, which we believe will only strengthen the future potential launch of this therapy in the adult AKI market. Tim will speak further on our plans for our continued of QUELIMMUNE in the pediatric AKI market, and also discuss how we are strategically planning for a potential launch of this therapy in the adult market. And Kevin will describe our progress in our NEUTRALIZE-AKI pivotal clinical trial and our regulatory strategy for the adult AKI indication Before I turn the call over to Tim, if you are new to SeaStar Medical's story, I would like to clarify that the same foundational therapy in Quellimmune known as the selective cytopheretic device or SCD, is the same therapeutic device that we are evaluating in our pivotal study for the adult AKI indication. The adult version is simply a larger device to accommodate larger blood volumes. Also, like to emphasize that our SCD therapy is first-in-class. It is the only immunomodulatory therapy that targets and neutralizes hyper active leukocytes and monocytes and immune cells the immune cells primarily responsible for causing the cytokine storm. Shuts down organs and takes the lives of far too many patients with AKI requiring renal replacement therapy. Given the unique mechanism of our STD therapy, and the significant value of finding a potential solution to this continuing unmet need, I would note that we anticipate our current pharmacologic, pharmaceutical-like gross margins to continue for QUELIMMUNE and to extend to our adult therapies if approved. Furthermore, we believe that the FDA understands the importance of bringing innovative treatments advancements to critically ill patients with AKI. The FDA approved Quellimmune for pediatric AKI under humanitarian device exemption and also awarded us breakthrough device designation for the SCD for adult patients with AKI on continuous renal replacement therapy which should support a more collaborative and rapid approval process. We also have received breakthrough device designations for our other pipeline indications, including systemic inflammation from cardiac surgery, and chronic inflammation in end-stage renal disease among others. I provide this context today to reiterate our strong belief that our opportunity is significant. We remain keenly focused on achieving our near term goals understand the importance of driving new customer adoption for Quellimmune. Enrolling patients in our NEUTRALIZE-AKI trial. By the same token, we are not losing sight of our long-term opportunities and what SeaStar Medical can achieve for all our stakeholders. With that, I will turn it over to Tim. Tim? Tim Varacek: Thanks, Eric, and thanks, everyone, for joining us today. We are making great progress in our efforts to establish Quellimmune as an important therapy in the critical care of pediatric patients with AKI and sepsis. Currently, 20 of the 50 premier children's hospitals in The US have purchased and used our QUELIMMUNE therapy. Recall that our goal for 2026 is to increase the number of hospitals to 25 by the end of the year from 10 at the beginning. So we have already doubled our customer base this year, and we are well on our way to achieving that goal. And as Eric indicated, the use of QUELIMMUNE therapy is broadly resonating in the pediatric critical care community. Let me describe how. We discussed in our first-quarter call the considerable interest in Quellimmune at the AKI and CRRT meeting in San Diego. Adding to the buzz we observed there, we sponsored and participated in this year's KDP Summit a few weeks ago. The summit occurs annually and brings together a highly specialized interdisciplinary team, including nurses, advanced practice providers, nephrologists, and critical care physicians from across the country. Its core importance stems from tackling the exact systemic failures that leave pediatric kidney failure under-recognized. And just yesterday, we assembled leading experts in the treatment of pediatric AKI to speak at a SEASTAR medical educational webinar. webinar was entitled Rethinking Pediatric Sepsis-Associated AKI: What Clinicians Should Know About QUELIMMUNE? We brought together practicing pediatric nephrologists, critical care physicians, advanced practice providers, and nurses to learn more about pediatric sepsis associated AKI the use of QUELIMMUNE therapy through case reviews, and how to navigate QUELIMMUNE adoption within hospitals. Both events were very well attended and 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, in sepsis associated pediatric AKI, and how to apply that knowledge to employ our QUELIMMUNE therapy the hospitals in which they practice. As previously stated, this is an ultra rare population with a very high unmet need. And as the first and only therapy available to treat children with AKI and sepsis QUELIMMUNE is helping to drive new thinking in the pediatric AKI community. Now turning to our revenue targets and future opportunities in this ultra rare pediatric market. We reported QUELIMMUNE net revenues of $615 thousand in the second quarter. A strong 82% increase over last year's second quarter. And with 6-month net revenue at 1.1 million Momentum remained strong as we advance toward our 2026 net revenue target of $2 million. In short, we are very encouraged by the current rate of QUELIMMUNE adoption and we continue to focus on adding new customers as quickly as possible. We have great expectations, of helping more patients by bringing our QUELIMMUNE therapy to more pediatric hospitals. And as we look to 2027 and beyond, we believe we can expand our overall market opportunity beyond the top 50 pediatric medical centers. We announced in June that the Centers for Medicare and Medicaid Services also known as CMS, assigned ICD 10 PCS codes for our SCD therapy. Allowing hospitals to efficiently bill qualimmune therapy when used in treating sepsis associated pediatric AKI. And we believe all future potential indications for from our SCD therapy will use the same PCS code. The implementation of the new ICD 10 PCS code initiates on October 1 of this year. This is an important administrative development as it removes another potential barrier to QUELIMMUNE adoption. In addition, we have completed the 50 patient SAVE Registry that was required by the FDA to further evaluate the safety of our QUELIMMUNE therapy. Our preliminary report was submitted. And we are now preparing the final report for FDA review. Our results from the first 21 patients were reported in the prestigious peer reviewed journal pediatric nephrology. And that alone has driven continued interest in adopting Quellimmune. So in summary, the future for our QUELIMMUNE therapy looks bright. As we continue to expand into the pediatric market and work in parallel on pre-commercialization efforts focused on the adult AKI population which is estimated to be 50x larger than the sepsis associated pediatric AKI population in The US. Thank you for your attention. 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 growing presence in the pediatric critical care community. It is rewarding to hear how these nephrology and critical care teams are adopting the QUELIMMUNE therapy and understanding that it is truly the first of its kind. These kids have days, if not hours, to live, and we have heard many stories about first-time use of Quellimmune with life saving outcomes. These stories are truly remarkable. And they continue to validate and reinforce why getting this therapy to a broader patient population is so important. And to be clear, we believe that Quellimmune for pediatric AKI indication is just the first of a broad range of indications for SCD therapy. To our knowledge, no other pharmaceutical therapy or medical device on the market today is able to identify, target, and neutralize the specific immune cells that cause hyperinflammation. That means the SCD's unique immunomodulatory mechanism positions us to potentially reshape treatment paradigms across a range of serious inflammatory conditions. Not only for AKI, but cardio renal syndrome, systemic inflammation from cardiac surgery, chronic inflammation in end-stage renal disease, and other states of pathologic immune activation where dysregulated cytokine release drives organ failure and death. Which brings me to the discussion highlighting our efforts to bring our SCD therapy to critically ill adult patients with AKI requiring CRT. We are currently conducting the NEUTRALIZE-AKI trial and have plans to file a modular premarket approval or PMA. With the FDA to potentially speed the overall approval process for this important indication. The modular PMA enables the FDA to review and comment on portions of our application prior to submitting all modules. The last of which would be the submission of the NEUTRALIZE-AKI clinical trial results. I would also note that we have been awarded breakthrough device designation for this indication. Which should support expedited regulatory review. As a reminder, our NEUTRALIZE-AKI pivotal trial is a randomized controlled trial designed to assess the SCD therapy in critically ill adult patients with AKI requiring CRT. The primary endpoint is a composite of mortality, or dialysis dependence at 90 days. We now have enrolled 2 hundred and 23 of our total anticipated 3 hundred and 39 patients in the trial, and have stepped up our site recruitment to accelerate pace of enrollment as we move forward. We recently onboarded 2 additional clinical sites who have already recruited patients. We have 4 additional sites that we anticipate will be screening patients shortly. In at least 8 more sites, that have committed to participating in the trial. Our sites are extremely motivated and are continuously screening patients. When they identify potentially eligible patients, our sites are typically able to successfully consent and enroll those patients into our trial. This reflects highly on the site investigators and incredibly professional research staff who are tactfully approaching family members during a patient's most desperate hour in the ICU. Must emphasize that we continue to be focused on enrolling the right type of patients. This careful selection of patients is essential to demonstrating therapeutic effect and avoiding the limitations that have confounded prior AKI and sepsis trials. 1 of our enrichment criteria is a c reactive protein or CRP level greater than 3.5 mg/dL. Patients who do not have a CRP greater than 3.5 are excluded. Why? CRP is a very sensitive marker of inflammation in those patients with a low CRP are unlikely to benefit from our therapeutic device. In past interventional sepsis or AKI trials directed at inflammation, many of these types of patients were included and those trials ultimately failed. Beyond CRP, we are also we are also applying our carefully considered exclusion criteria to remove patients whose pre-existing conditions could obscure the true treatment effect. Patients who might not survive regardless of whether the SCD works. This is the same disciplined approach we took in our pediatric trials and it is the right way to design a study that can demonstrate therapeutic benefit. It is worth emphasizing that clinical trial populations are by design more narrowly defined than real world practice. We are seeing in the commercial setting physicians who are already applying QUELIMMUNE to a much broader, unlabeled population of pediatric patients than those enrolled in our trials. Including patients with complex comorbidities who would not have met trial eligibility criteria. That broader real world use reflects clinical confidence in the therapy and suggests the addressable patient population is larger than what our trial enrollment numbers alone might imply. We are making meaningful progress in NEUTRALIZE-AKI. And our confidence in the trial design in site execution, has never been higher. As we discussed, enrolling the right patients takes precedence over enrolling quickly. And our sites are delivering on that standard. While we expect to complete enrollment around year end, or in the first quarter of 27, our PMA submission timeline in late 27 remains unchanged. The breakthrough device designation we hold for this indication means that when we submit the FDA is positioned to move quickly. A PMA approval of the SCD therapy for adult patients with AKI on CRT would enable commercialization with ICD 10 PCS codes in place. Significantly simplifying hospital adoption. Also, given the foundation we are establishing, in the pediatric critical care community, with Quellimmune we believe it would support more rapid adoption among nephrology and critical care experts in the adult AKI community. We are passionate about our ability to improve and potentially save lives of these critically ill patients and look forward to reporting our progress. And with that, I will hand it over to our CFO, Michael Messinger. Mike? Michael Messinger: Thank you, Kevin, and thanks everyone for joining our call today. I will provide a brief overview of our financial results for the second quarter of 2026. Please note that our Form 10 Q will be filed with the SEC within the next 24 hours and it will include a lengthier discussion of the company's financial results for the 3 months ended June 30, 2026. You will find the 10 q at sec.gov. Or through our website at seastarmedical.com. We recorded net revenue for the second quarter of $615 thousand reflecting increased demand for QUELIMMUNE. This represents an 82% increase compared to net revenue. Of approximately $338 thousand for the second quarter of 2025. And this is an increase in the rate of growth from the 69% growth we had in the first quarter. And we continue to maintain our gross profit percentage of over 90% in the second quarter of 2026. Consistent with the prior 4 quarters. Turning now to our operating expenses. In the second quarter of 2026, we reported $4.4 million in operating expenses compared to $2.1 million in the second quarter of 2025. Our research and development expenses increased primarily to the additional clinical sites and increased patient enrollment compared to the same period in 2025. Our general and administrative expenses increased compared to the second quarter of 2025 primarily to an increase in compensation costs legal and professional fees, and certain SEC related expenses. As we indicated in our first quarter call, we expected our sequential quarterly research and development costs to increase based on adding additional clinical sites and our focused recruitment efforts. We did see a roughly mid single digit increase over our first quarter, and we continue to expect the same for the rest of 2026, as we anticipate meeting our enrollment goals. Net loss for the second quarter of 2026 was approximately $3.7 million or $0.91 per share based on weighted average shares outstanding of approximately 4.1 million shares. This compares with a net loss of approximately $2 million or $1.77 per share for the second quarter of 25 based on approximately 1.1 million weighted average shares outstanding. We had approximately $7 million of cash on our balance sheet at 06/30/2026 compared to $12 million at December 31, 2025. And with that, I will turn it back to Eric. Eric Schlorff: Thanks, Mike. And our goal today was to share with you our second quarter achievements, but also express how keenly focused we are on the key value drivers both short- and long-term for our stakeholders. We have a small but passionate team at SeaStar Medical, yet we believe we are reshaping the possibility for kids and in the future, potentially adults that often face organ failure or death without new therapies to modulate cytokine storm in acute kidney injury. Our goal is to set a higher standard for the treatment of all patients that face the trauma of AKI. We believe that the opportunities that lie ahead for us 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. As a reminder, to ask a question, please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. 1 moment for questions. Our first question comes from David Bautz with Zacks Small Cap Research. You may proceed. David Bautz: Hey. Good afternoon, everyone. I appreciate you taking the questions. First off, I was wondering if you could comment on what the current monthly enrollment rate is for the NEUTRALIZE-AKI study. And if you are seeing any type of acceleration of enrollment at the newer high volume sites. And then lastly, can you quantify your confidence for hitting that 39 patients either by year end or the first quarter of 2027? Eric Schlorff: Yes. So thanks for the question. So, let me tackle the second 1. What we basically kind of guided the market as is really our time line is around year end or into Q1. Obviously, it is gonna depend on, you know, Kevin and his team bringing on additional sites, etcetera, from an enrollment standpoint. But I am really proud of what Kevin and his team are doing on bringing those on pace. But, you know, if I think about this, David, before, he kind of talks about maybe enrollment, we still believe that we are really on track at the end of the day to have end up 2027 submission for the final PMA module. Which, you know, obviously, really not impacting the timeline. But Kevin, you could talk a little bit about, enrollment of various sites. Colonel Kevin Chung FACP: Right. Thank you, Eric. So on average, over the last few months, we have averaged somewhere around 8 to 10 to 12 patients in each of those months. And that is relatively slower than what I would like. However, I have to emphasize we have to get the right patients. And by right patients, I mean those with modifiable disease. what is the point in getting finished with enrollment if we enroll a bunch of patients out of haste to try to just get our number and we are not enrolling the right patients. That is-- that would be a flawed strategy. For me, the focus is on getting the right patients enrolled so that we optimize our chance for success. that is number 1. Number 2, as, we discussed in the report, in our update, we are very busy right now activating in the process of activating numerous sites. As I said, there are 4 that are so close. To getting activated Just some residual signatures and etcetera, those kinds of things, and we are ready to activate them. And so, we are gonna be very soon be seeing some reinforcements come in with an additional 4 sites ready to go. Already trained. SIB's already performed site initiation So we are ready to go with those sites. There are additional 8 sites half of whom contacted us. Because they wanted in on the trial. And so they have committed. Now whether or not we are gonna be able to activate all 8 sites is still debatable. But we are gonna try. To get as many sites activated as possible because that is gonna get us to 15 to 20 subjects per month, which is more at the pace that I would like. Again, though, focused on the right patients. We have to get the right patients. We have to get that right to have a chance for a positive trial. David Bautz: Okay. Great. So with the enrollment expected by the end of this year, early 2027 and the PMA submission target for the end of 27. Was wondering if you could just walk through what are the major activities for the PMA that need to happen, say, after enrollment or after database lock before you can, you know, fully submit it. Colonel Kevin Chung FACP: Yeah. So your question is what are some of the well, once we once we lock the database, obviously, then we will give out top line results. You know, once it is locked, we can analyze, etcetera. And then, really, it is just submitting the clinical section. it is really essentially because all the other previous sections will have been submitted by that time. And that is really what the goal is so that when the FDA then has their time, you know, they can then focus just merely on the clinical sections and not have to go through things like device and description, etcetera. So that is really what the strategy is. David Bautz: Okay. Sounds good. And then, last 1, talking about the increase in revenue. I was wondering if you could quantify the contribution from existing customers versus the new customers that you added during the quarter. Eric Schlorff: Yes. Thanks. Tim, you want to tackle that 1? Tim Varacek: Sure. Yeah. So it is a combination of new hospital systems as well as existing systems that delivered that revenue, And, you know, we have a very high repurchase rate with the existing sites, and then, obviously, the new sites that come on board they wanna stock the product as soon as they can. So that they are ready to treat patients. So it was a group effort. By all of the customers that were out there. David Bautz: Okay. Great. Appreciate you taking the questions. Eric Schlorff: Thanks, David. Thanks. Operator: Thank you. Our next question comes from Anthony Vendetti with Maxim Group. You may proceed. Anthony Vendetti: Yes. Hi. Thanks. Can you talk about the milestones between completing enrollment and then the final PMA submission? Eric Schlorff: I think you mentioned you submitted the preliminary. Right? Or you submitted We are submitting preliminary reports. So we are submitting no. Well, so you are talking about the PMA, right, for adults? Yeah. Yeah. Yeah. Yeah. Yeah. So, yeah, for that, I mean, obviously, you know, what we are doing right now is a modular PMA. So there is various sections where you talk about the device. You talk about, you know, sterilization. You talk about all sorts of you know, kind of the technical things that go into it. But then you get into, you know, that what the goal really is, Anthony, is to have those sections already submitted to the FDA already have had the discussions with the FDA on those sections. And so really, what you are waiting for at the end is once you have data lock and then you can show top line and, you know, do the analysis, you are really just submitting the clinical section of it. Okay. And you so you have submitted already the certain sections, and No. We are in the process. So yeah. We are in the-- yeah. We are in the process of doing that. Yeah. Got it. Got it. Okay. Tim Varacek: And then you have right now about 20 pediatric hospitals. Right? Correct. So is there is there a process or what do you have to do to make sure they are not just sort of like, okay. They are they are a hospital that uses this, but how do you get them to be a more meaningful recurring customers or are just, hey, you just need the patients to come in and they are they are already on board, and there is nothing really left to do with those particular hospitals. Yeah. Maybe, Tim, you could kind of address it, and then, Kevin, if you would like to add any additional comments on top of it. It is really a multidisciplinary approach that we take to these hospital systems. Okay. Yeah. It absolutely is. Just to give you insight. So let's say a hospital just came into the fold today. They have adopted QUELIMMUNE formally. There was a whole process that took place in terms of IRB approval. Becoming a qualified vendor, all the associated things you have to do to basically be a customer to the hospital system. Then, a patient actually shows up in the emergency room, gets moved to the ICU, and QUELIMMUNE becomes, you know, something that is top of mind. We have, then the clinical team that will come over. They will actually help the setup of that first to ensure everything goes smoothly. Now in terms of what happens after that, there is a lot of work to do. Because these every hospital system is large. They have a lot of different staff. They have different shifts. And so there really needs to be an educational approach to that hospital system that never ends. Because there is turnover like in any other business. And our goal is to continually increase the not just the breadth, but the depth that we get to within all of our customer base and the new ones that we will add so that QUELIMMUNE is something that is top of mind for the patient care teams. Because we believe that while QUELIMMUNE is a super effective therapy, if you do not know about it and a patient comes in and there is not 1 of your advocates there, they may not realize that they could use QUELIMMUNE to treat that patient. So it is a continual effort from a commercial standpoint and from a clinical standpoint to ensure that we really ingrain, the brand into these hospital systems, and they understand the clinical value of it, so that they recognize patients when they come in. And they can choose to use qualimmune therapy as an option when it is when it is there and it is available. Okay. So just to understand. So, obviously, getting into the hospital is just the first step and trying to make sure all the trained health care professionals that could use it, a, know the benefit, know how to use it, and you stay engaged. Because like you said, if there is new doctors, nurses, or so forth that are coming in, you wanna make sure that they are aware of the treatment and of the application of the QUELIMMUNE. Correct? 100%. Yep. Colonel Kevin Chung FACP: Okay. If I may add some color to the clinical perspective, So yesterday, we conducted a webinar that we will make available very soon so that those of you who missed the webinar or had technical difficulties are able to dial in. During that discussion, it became-- it was-- it is-- this has been clear, but it became more clear to me that there is a big difference between new sites that have device and mature sites that have device. New sites anytime there is a new technology, even if it is lifesaving, because of the natural skepticism that is very prevalent within the medical community, they have to see it work. And so, you know, generally, it is used as a rescue therapy. And what I mean by that is it is used for the new sites as a last resort. Oftentimes, with a bunch of other experimental therapies that are not even approved being applied prior to SCD. So that is new sites. that is the approach that they take. And that is been true for almost every site that have been activated because whenever a therapy is new, that is what is gonna happen. And I have to say and have to emphasize that even with those types of patients, that have failed other therapies, we are talking about a 70% survival in that population which I have to emphasize that is remarkable. But yesterday, we are starting to sort of notice the shift, with the mature centers. With the mature sites that have been doing this now for over a year. These sites everybody's already educated. Everybody is already has seen what I call the index case. The moment, the case that converted them and in their mind, made them think, oh my gosh. We need to do this. And this is occurring, and adoption clinical adoption mentally is occurring pretty universally across our mature sites. And so right now, as we speak, those clinicians are scanning their ICU to see who may benefit from the therapy. And so it is no longer now a rescue therapy. They are not waiting until the bitter end. They are starting these patients early, and we are seeing even better outcomes. Which is just, really remarkable. So that was my takeaway from the webinar. Again, we will make this available very soon. And, hopefully, you will be able to watch it and verify my statement. Anthony Vendetti: No, that is helpful, Kevin. Yeah. So I mean, you know, we know the focus as it should be is on you know, the pediatric market and now the adult AKI. You know, with this trial enrollment, and you are at 223 up to 339. And we know it is adult AKI is 50x larger than the pediatric market. But there is other markets that you know, that your, you know, device can of your device can treat. Whether that be acute respiratory distress, hepatorenal syndrome, cardiorenal syndrome, and, of course, sepsis. So I know you want to stay focused as like I said, you should, but you know, behind the scenes, you know, can you give us some insight into what kind of work is being done on these other indications? Eric Schlorff: Yeah. Yeah. So I can tackle that 1. Yeah. So I mean, yeah. So, you know, we do obviously evaluate all the other applications that we believe that, obviously, from our perspective, the there is a pretty long laundry list of things that really would be on our wish list. But obviously, you know, we, as a company, have to be focused on, you know, certain things, and that is really been on Quellimmune for pediatric AKI and adult AKI and neutralized AKI. Obviously, we have got the neutralized CRS study that is actually been funded by NIH. And, you know, we I would say, you know, we have various discussions with various parties looking at, you know, everything from nondilutive to strategic discussions, you know, business development, on all these types of things. To be able to really advance the other indications that we believe we have in our pipeline. But obviously, you know, it will just take time for some of those things to mature and we will just have to see how they pan out. Colonel Kevin Chung FACP: If I may just add really quickly, I should remind everyone that for neutralize AKI, a priority we identify patients with ARDS at the time of enrollment and sepsis at the time of enrollment. And we randomized via this technique called block randomization. What that does is it allows equal distribution of subjects to be assigned in the ARDS bucket in the sepsis bucket, in the combined sepsis and ARDS bucket. We will be able to for sure, make a statement about those specific populations who have concomitant AKI, of course. Anthony Vendetti: No. Yeah. that is that is very that is very helpful. Thank you. Thanks, Eric, Kevin, everyone. Okay. I will hop back in the queue. Thanks. Operator: 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 Second Quarter Financial Results Conference Call. If you have questions, please contact us at seastarmedical.com, 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. 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This article first appeared on GuruFocus. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Qualimmune net revenue grew 82% year-over-year in Q2 2026, with six-month revenue of $1.1 million, tracking toward the $2 million annual target. Customer base doubled to 20 of the top 50 U.S. children's hospitals, with a goal of 25 by year-end, and high repurchase rates from existing sites. CMS assigned ICD-10 PCS codes for SCD therapy, effective October 1, 2026, removing a billing barrier and simplifying future commercialization. Neutralize-AKI trial enrollment reached 223 of 339 patients, with plans to add more sites to accelerate enrollment, and PMA submission timeline remains on track for late 2027. Gross margins remain above 90%, and the company holds breakthrough device designations for multiple indications, supporting expedited regulatory review. Positive real-world outcomes, including a 70% survival rate in rescue-therapy patients and growing adoption at mature sites, validate the therapy's clinical value. Net loss widened to $3.7 million in Q2 2026, up from $2 million in Q2 2025, due to increased R&D and G&A expenses. Cash balance declined to $7 million at June 30, 2026, from $12 million at year-end 2025, raising potential funding concerns. Monthly enrollment in Neutralize-AKI averaged only 8-12 patients, slower than desired, with a risk of missing the year-end/Q1 2027 completion target. Operating expenses more than doubled to $4.4 million in Q2 2026, driven by higher clinical site costs, compensation, and legal fees. The company remains dependent on successful trial outcomes and FDA approval for adult AKI, which is a high-risk regulatory pathway. Pediatric market is ultra-rare, limiting near-term revenue potential, and adult market expansion is still several years away. Warning! GuruFocus has detected 4 Warning Signs with ICU. Is ICU fairly valued? Test your thesis with our free DCF calculator. Q: What is the current monthly enrollment rate for the Neutralize-AKI study, and are you seeing acceleration at newer high-volume sites? Can you quantify your confidence in hitting the 339-patient target by year-end or Q1 2027?A: Dr. Kevin Chung, Chief Medical Officer: Over the last few months, we've averaged around 8 to 12 patients per month. While that's slower than I'd like, our focus is on enrolling the right patientsthose with modifiable diseaseto optimize our chance for success. We are actively activating new sites, with four close to activation and eight more committed, which should bring us to 15 to 20 subjects per month. CEO Eric Schlorf added that the timeline remains on track for year-end or Q1 2027, with the PMA submission in late 2027 unchanged. Q: Can you walk through the major activities between completing enrollment and the final PMA submission?A: Eric Schlorf, CEO: Once we lock the database, we'll release top-line results and analyze the data. The key is that we are using a modular PMA approach, submitting non-clinical sections (device description, sterilization, etc.) to the FDA ahead of time. This means after data lock, we only need to submit the clinical section, allowing the FDA to focus solely on that and expedite the review process. Q: Can you quantify the revenue contribution from existing customers versus new hospitals added during the quarter?A: Tim Varacek, SVP of Commercial and Business Operations: The revenue growth was a combination of both new hospital systems and existing ones. We have a very high repurchase rate among existing sites, and new sites typically stock the product immediately upon onboarding to be ready to treat patients. It was a group effort across all customers. Q: How do you ensure that the 20 pediatric hospitals using Qualimmune become meaningful, recurring customers rather than one-time users?A: Tim Varacek, SVP of Commercial and Business Operations: It's a multidisciplinary, ongoing effort. After a hospital formally adopts Qualimmune, we provide clinical support for the first patient and then maintain a continuous educational approach. Hospital systems have high staff turnover, so we constantly engage with new doctors, nurses, and advanced practice providers to keep Qualimmune top-of-mind. Dr. Kevin Chung added that mature sites (using the therapy for over a year) have shifted from using it as a rescue therapy to proactively scanning their ICUs for eligible patients, leading to even better outcomes. Q: What work is being done behind the scenes on other indications for the SCD therapy, such as ARDS, hepatorenal syndrome, or cardiorenal syndrome?A: Eric Schlorf, CEO: We evaluate all other applications, but as a company, we must stay focused on Qualimmune for pediatric AKI and the Neutralize-AKI trial for adults. We have the NIH-funded Neutralize-CRS study and are in discussions with various parties, including non-dilutive and strategic business development opportunities, to advance other pipeline indications. Dr. Kevin Chung added that the Neutralize-AKI trial uses block randomization to ensure equal distribution of patients with ARDS and sepsis, allowing us to make specific statements about those subpopulations. Q: What are the key milestones between completing enrollment and the final PMA submission?A: Eric Schlorf, CEO: We are in the process of submitting the modular PMA sections. The goal is to have all non-clinical sections (device, sterilization, technical details) already submitted and discussed with the FDA. After data lock, we'll present top-line results and submit the clinical section, which is the final module. This strategy allows the FDA to focus solely on the clinical data, potentially speeding up the approval process. Q: Can you provide more detail on the difference between new and mature sites in terms of clinical adoption?A: Dr. Kevin Chung, Chief Medical Officer: New sites typically use Qualimmune as a rescue therapy due to natural skepticism, often after other experimental therapies have failed. Even in those cases, we see a remarkable 70% survival rate. However, mature sites that have been using the therapy for over a year have experienced an "aha moment" and are now proactively scanning their ICUs for patients who could benefit. They are starting therapy earlier, which is leading to even better outcomes. This shift was a key takeaway from our recent educational webinar. Q: What is the status of the SAVE registry and the ICD-10 PCS codes?A: Tim Varacek, SVP of Commercial and Business Operations: We have completed the 50-patient SAVE registry required by the FDA, submitted the preliminary report, and are preparing the final report for FDA review. Results from the first 21 patients were published in the peer-reviewed journal Pediatric Nephrology. Additionally, CMS assigned ICD-10 PCS codes for our SCD therapy, which will be implemented on October 1st of this year. This removes a significant administrative barrier to adoption and will apply to all future potential indications. Q: What were the key financial results for the second quarter of 2026?A: Mike Messenger, CFO: Net revenue for Q2 2026 was $615,000, an 82% increase from $338,000 in Q2 2025, accelerating from the 69% growth in Q1. Gross profit margin remained above 90%. Operating expenses were $4.4 million, up from $2.1 million, driven by increased R&D costs from additional clinical sites and higher G&A expenses. Net loss was approximately $3.7 million, or $0.91 per share, compared to a net loss of $2 million, or $1.77 per share, in Q2 2025. Cash on hand was approximately $7 million at June 30, 2026, down from $12 million at year-end 2025. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Added 3 top-rated children’s hospitals to QUELIMMUNE® pediatric acute kidney injury (AKI) customer base, increasing net revenue 82% versus second quarter 2025 Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI Obtained ICD-10-PCS codes to enable standardized inpatient hospital billing for its selective cytopheretic device (SCD) therapy, including QUELIMMUNE Webcast today at 4:30 pm Eastern Time DENVER, Aug. 12, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today financial results for the three months ended June 30, 2026, and provided business updates on key initiatives. “The enthusiasm for the use of our QUELIMMUNE therapy is resonating broadly throughout the pediatric critical care community,” said Eric Schlorff, CEO of SeaStar Medical. “We believe our continued QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market that is 50 times larger than the current pediatric market in the U.S.” Mr. Schlorff continued, “We are keenly focused on achieving our enrollment target of 339 adult AKI patients in the NEUTRALIZE-AKI trial, and we are working with the FDA on our modular Premarket Approval (PMA) application for our SCD therapy as an organ-sparing and life-saving treatment for the adult patient population. With strong gross margins for QUELIMMUNE and universal ICD-10-PCS codes already established for our SCD therapies, we believe this first-in-class therapy for the treatment of adult patients with AKI has clear potential to both save lives and create significant shareholder value, should we obtain FDA approval.” Key Business Highlights SeaStar Medical’s achievements since the beginning of the second quarter of 2026 include the following: Expanded the use of QUELIMMUNE (SCD-PED) therapy for ultra-rare pediatric AKI, adding 3 new customers from top-rated children’s hospitals, bringing the total customer base to 20 and building increased depth in customer orders. This led to second quarter 2026 net revenue of $0.6 million for QUELIMMUNE product sales, an increase of 82% versus the second quarter of 2025. Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial evaluating the SCD therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy. The trial has enrolled 223 of 339 patients to date. Completion of enrollment is anticipated around year end or into the first quarter of 2027, which would enable a PMA application to the FDA near the end of 2027, pending a positive outcome of the trial. Received from the Centers for Medicare & Medicaid Services (CMS) dedicated International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) codes. These codes enable administrative, billing, and statistical reporting for the use of SeaStar Medical’s SCD therapy in patients with AKI requiring renal replacement therapy in the inpatient hospital setting. The new ICD-10-PCS codes are expected to take effect on October 1, 2026. Sponsored and participated in the KidneyBee Summit 2026. The Summit, which occurs annually, is a highly specialized, interdisciplinary conference that brings together nurses, advanced practice providers, and physicians from across the country. Its core importance stems from tackling the exact systemic failures that leave pediatric kidney failure under-recognized. Assembled leading experts in the treatment of pediatric AKI to speak at the SeaStar Medical educational webinar, “Rethinking Pediatric Sepsis-Associated AKI,” that brought together practicing pediatric nephrologists, critical care physicians, advanced practice providers, nurses, and critical care teams to learn more about pediatric sepsis-associated AKI and the use of the QUELIMMUNE therapy. Financial Results for the Second Quarter 2026 Net revenue for the three months ended June 30, 2026, was approximately $0.6 million reflecting increased demand for the QUELIMMUNE therapy. This compared to net revenue of approximately $0.3 million for the three months ended June 30, 2025. Cost of goods sold for the three months ended June 30, 2026, and 2025, was $54 thousand and $27 thousand reflecting gross margins of 91% and 92% for the three months ended June 30, 2026, and 2025, respectively. Research and development expenses for the three months ended June 30, 2026, and 2025, were $2.5 million and $1.0 million, respectively. The increase in research and development expenses was primarily driven by increased clinical trial expenses and personnel costs. General and administrative expenses for the three months ended June 30, 2026, and 2025, were approximately $1.8 million and $1.0 million, respectively. The increase in general and administrative expenses was the result of an increase in compensation costs, legal and professional fees, and certain Securities and Exchange Commission (SEC) related expenses. Other income (net) was $0.1 million for the three months ended June 30, 2026, compared to other expense (net) of $0.2 million for the three months ended June 30, 2025. The change was primarily related to a reduction in financing fees and increased interest income. Net loss for the three months ended June 30, 2026, was approximately $3.7 million, or $0.91 per share on approximately 4.1 million weighted-average shares outstanding. This compares with a net loss of approximately $2.0 million, or $1.77 per share, on approximately 1.1 million weighted-average shares outstanding for the three months ended June 30, 2025. Cash at June 30, 2026, was $7.0 million, compared to $12.0 million at December 31, 2025. About QUELIMMUNE The QUELIMMUNE® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine. The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life. About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous RRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future continuous RRT, including dialysis, and prevent loss of life. About NEUTRALIZE-AKI Pivotal Trial The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to continuous RRT as the standard of care, compared with the control group receiving only continuous RRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. About Acute Kidney Injury (AKI) and Hyperinflammation AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. About SeaStar Medical SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually. For more information visit www.seastarmedical.com or visit us on LinkedIn or X. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect our future potential opportunity in the adult AKI market; the size of the adult AKI market compared to the pediatric market; commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; ; the anticipated timing of regulatory submissions; the ability to meet our enrollment targets; the ability to create shareholder value; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact:  [email protected] QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.

Image source: The Motley Fool. Wednesday, May 13, 2026 at 4:30 p.m. ET 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 Need a quote from a Motley Fool analyst? Email [email protected] 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 [email protected] 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. Before you buy stock in SeaStar Medical, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and SeaStar Medical wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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On Wednesday, SeaStar Medical Holding (NASDAQ:ICU) discussed first-quarter financial results during its earnings call. The full transcript is provided below. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. Access the full call at https://edge.media-server.com/mmc/p/d4of9ds2/ SeaStar Medical Holding reported a nearly 70% increase in Quellimmune net revenue for the first quarter of 2026 compared to the same period in 2025, with revenue totaling $495,000. The company is focused on expanding its presence in the pediatric AKI market, adding seven new hospitals in the first quarter and aiming for 15 new customers by year-end. SeaStar Medical Holding continues to progress in its Neutralyze AKI pivotal trial with 198 of the planned 339 patients enrolled, targeting completion by the end of 2026. The company is working with the FDA on a modular PMA submission for adult AKI, designed to expedite the approval process. Management maintains a strong financial discipline, with operating expenses remaining stable at $4.1 million for Q1 2026 and a net loss of $3.5 million, improved from $3.8 million in Q1 2025. OPERATOR 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 11 on your telephone. You will 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 Cosmo. You may begin. Jackie Cosmo Thank you. Good afternoon and thank you for joining The SeaStar Medical First Quarter 2026 Financial Results Conference Call. I'm Jackie Cosman with Wheelhouse Life Science Advisors. Joining me from CISTAR Medical today are Eric Schlarf, Chief Executive Officer, Dr. Kevin Chang, Chief Medical Officer, Senior Vice President of Commercial and Business Operations, and Mike Messenger, 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 CStar 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 13, 2026. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law. And now I'd like to turn the call over to Eric. Eric Schlarf (Chief Executive Officer) Eric, 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 the first quarter of 2025. With seven new hospitals adopting the Quellimmune 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 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 Neutralyze 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 rapid approval pathways for our STD 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 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 Thanks Eric and 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 for many of our customers. Our Quellimmune 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 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're seeing great enthusiasm by the pediatric healthcare 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 CSTAR 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 healthcare community to learn more about Quellimmune reinforces a key focus for CSTAR Medical to deepen the educational effort on Quellimmune therapy and how to implement it in the treatment of pediatric AKI. Now, turning to our commercial efforts for Qualimmune 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'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin Chung Kevin 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 NCRT meeting in late March. As a critical care physician, I was struck by just how embedded qualimmune 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 qualimmune 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, 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 quelloimmune 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, 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 neutralized AKI pivotal trial. As a brief overview, Neutralized AKI is a randomized controlled trial designed to assess whether up to 10 sequential 24-hour SCD treatments can improve 90 day survival or renal recovery in critically ill 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 neutralized 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 Quelimune. 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 qualimmune 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 and accelerating adoption and expanding access to qualimmune 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 Messenger. Mike Messenger (Chief Financial Officer) Mike thank you Kevin. It's great to be a part of this and 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, and that will include a lengthier discussion of the Company's financial results for the three months ended March 31, 2026. You can find the [email protected] or through our [email protected] we recorded net revenue from Quellimmune sales of approximately $495,000 for the first quarter of 2026 compared to $293,000 in the first quarter of 2025. And as Tim mentioned, we continue to see strong adoption of quelamine 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 31, 2026 compared to $5.2 million at March 31, 2025. And now I'll turn it back to Eric. Eric Schlarf (Chief Executive Officer) 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 Neutralyze 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 CSTAR 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. Ladies and gentlemen. As a reminder to ask the question, please press star 11 on your telephone, then wait for your name to be announced. To withdraw your questions, please press star 11 again. Please stand by while we compile the Q and A roster. Our first question comes from the line of David Boats with sacs Small Capital Research. Your line is open. David Boats Hey, good afternoon everyone. 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 happening? From the first time that they come online? Yeah. Hey, David, this is Eric. Thanks for joining. Great question. Hey, Tim, do you want to take that? Tim 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 it could be some time between patients and in other times they may finish therapy on one patient and several more will appear in the ICU that are appropriate patients for Quellimmune. So 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 David Boats okay, 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's going to influence treatment guidelines or like standard of care discussions? Yeah, that's a great question. So, Kevin, do you want to tackle that? Kevin Chung 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 AKI study, that pediatric AKI and consensus statement will bring forward the SCD as a therapy that's recommended. And so for these clinical practice guidelines, it takes typically multiple randomized control trials and wide adoption for recommendations to surface. But we're already mentioned there, so that's 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. David Boats Okay, great. And 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 integrating the SCD into the ICU workflow is. I think they used the term non trivial. But I mean, how non trivial is Kevin Chung 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. 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're fortunate that that's the case because that is a critical component of our therapy. And so, 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. OPERATOR Yep. Our next question comes from the line of Anthony Bandetta with Maxima. Your line is open. Anthony Bandetta Thank you. So, yeah, I just wanted to talk about the hospitals that are currently using the product. You know, is, do you have like a particular ordering pattern? 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 and do you currently have like, if Eric Schlarf (Chief Executive Officer) 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, Anthony. Great question. Thanks for joining 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 registry. So kind of gives you a general sense of, you know, how many have been have been treated. Maybe Tim, you could give a little bit more color on some of Anthony's other questions. Tim 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 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're scaling, we're still scaling our business here. Right. So we have 17 customers at this time last year. You know, we, I don't even. We had three or four customers. So it's still new. And so 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. 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 there really is a ripple effect of quellimmune across these institutions so that many people know about it and they're actively looking for patients. And when you're actively looking for patients, you're going to 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. 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. Okay. Anthony Bandetta So 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. But 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. Eric Schlarf (Chief Executive Officer) Sorry. Sorry, Eric. No, it's okay. I actually would. Kevin, maybe you could talk about the monthly users call that we have with who's on those calls, what gets discussed, et cetera. Sure. Kevin Chung 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 we talked about in the update and that is attended by, you know, we invite about 135 or 50 individuals. Most often we have about 60 callers that dial in and they get to hear from the previous month's cases that have occurred at each of the sites that are active. And we go into detail about the cases, how sick they were, why they decided, the reason and rationale for therapy, and what happened to them. And now we can't save everybody. But for many of these patients, actually for all these patients, they're very, they're, you know, initiating the SCD at a very, very dire situ during a dire situation where the patient is very, very sick. And virtually all the patients I don't think would have lived without this option. And what we're doing is giving them a chance. And these cases are discussed where the 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, you know, when the participants who don't have Quellimmune 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. And so that's how we spread sort of the message with regards to the potential benefits of Quellimmune. 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, akicrt. Even the European meeting that I just returned from, there were several pediatric centers represented there from the United States. And the conversation is always centered around how well these patients respond initially to qualimune. 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's amplified word of mouth is how I would like to describe it. And it's quite effective. And there are many centers that contact us, although they haven't even begun the process sometimes because they have a child that needs it and we do what we can. Eric Schlarf (Chief Executive Officer) That's great, Tim. Yeah, maybe, Tim, you could also just kind of share the newly formed group, this advanced practice group that you've put together. Tim Yeah, happy to do that, Eric. So in addition to what Kevin was talking about, we are coming at this from a variety of different ways to educate the community. And one of the things we've done is we formed an advanced provider, practice provider, ad board. So these are folks that are really at the patient care level and they are very operational. They're 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'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 Quellimmune, making sure that again, more people know about it. There are a lot of people at work within a specific hospital. There are a lot of shift changes and so there are a lot of people 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're executing on that. Anthony Bandetta Okay, great. That was very helpful, thanks. I'll hop back in the queue. Appreciate it. OPERATOR 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, Tawanda. And thank you all for joining us today for the CSTAR Medical first quarter financial results conference call. If you have questions, please contact us at [email protected] or visit our website at www.cstarmedical.com. Thank you and goodbye. Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga: SEASTAR MEDICAL HOLDING (ICU): Free Stock Analysis Report This article Full Transcript: SeaStar Medical Holding Q1 2026 Earnings Call originally appeared on Benzinga.com ﾩ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Added 7 top-rated children’s hospitals to QUELIMMUNE® pediatric acute kidney injury (AKI) customer base, increasing first quarter revenue 69% versus first quarter 2025 revenue Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI Initiated efforts for the submission of a modular post-marketing application (PMA) Webcast today at 4:30 pm Eastern Time DENVER, May 13, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today financial results for the three months ended March 31, 2026, and provided business updates on key initiatives. “Our QUELIMMUNE customer base continues to grow with a groundswell of enthusiasm among key experts that is driving our penetration into new accounts,” said Eric Schlorff, CEO of SeaStar Medical. “We saw a significant jump in revenue of 69% this quarter versus the first quarter of last year. The trajectory is very encouraging as we consider the next opportunity in the adult market, which is approximately 50 times larger than the pediatric AKI market.” Mr. Schlorff continued, “We are working diligently to enroll adult patients with AKI in the NEUTRALIZE-AKI pivotal trial. We have activated multiple new clinical sites in the last six months and believe that a successful outcome of this trial would position us to file a PMA with the FDA for the adult AKI indication in 2027. Our success in building the QUELIMMUNE market now will provide critical support for this potential future opportunity.” Key Business Highlights SeaStar Medical’s achievements since the beginning of 2026 include the following: Expanded the use of QUELIMMUNE (SCD-PED) therapy for ultra-rare pediatric AKI, adding 7 new customers from top-rated children’s hospitals, bringing the total customer base to 17 and building increased depth in customer orders. This led to first quarter 2026 net revenue of $0.5 million for QUELIMMUNE product sales, an increase of 69% versus the first quarter of 2025. Advanced enrollment in the NEUTRALIZE-AKI pivotal trial that is evaluating the Selective Cytopheretic Device (SCD) therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy (RRT). The trial has enrolled 198 of 339 patients to date. Completed the required enrollment in the SAVE Registry, a post-approval surveillance registry evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening AKI and sepsis or a septic condition. The registry has successfully enrolled 50 patients, and the company will be reporting the 28-day safety results from the SAVE Registry to the FDA upon completion of its analysis of the data. Announced the publication of early post-approval, real-world experience from the use of the QUELIMMUNE therapy in the prestigious, peer-reviewed journal Pediatric Nephrology. The publication, co-authored by leading experts in pediatric critical care management, highlights early experience from the first 21 pediatric patients in the SAVE Registry. The published data from the commercial use of the QUELIMMUNE therapy showed no device related safety events with the QUELIMMUNE therapy with 76% of patients surviving through 60 days and 71% surviving through 90 days. These results are on track to validate a nearly 50% reduction in loss of life compared to historical data, as reported previously in Kidney Medicine. Presented new data at the 31st International Conference on Advances in Critical Care Nephrology, also known as AKI & CRRT 2026, highlighting patient experience from the first 32 pediatric patients in the SAVE Registry. The clinical experience from the updated cohort demonstrated trends consistent with those previously reported from the initial cohort of 21 patients and the QUELIMMUNE registrational studies, and continue to support the QUELIMMUNE therapy safety and potential benefit in this critically-ill patient population. Assembled leading experts in the treatment of pediatric AKI to speak at the SeaStar Medical educational symposium at the AKI & CRRT 2026 meeting to discuss the complex pathophysiology of pediatric AKI with sepsis, the SAVE Registry, the immunomodulatory effects of the QUELIMMUNE therapy which may ameliorate dysregulated hyperinflammatory disease states, and other topics of interest to the nephrology community. Initiated efforts for the submission of a modular PMA to potentially speed the FDA review and approval process for the SCD therapy as a potential treatment for adult patients with AKI in the ICU receiving continuous RRT. SeaStar Medical has also been granted Breakthrough Device Designation by the FDA for this indication, which may expedite the PMA approval process for novel devices that will save lives and treat debilitating diseases. Anticipated 2026 Milestones Broaden QUELIMMUNE adoption to include 15 additional top-ranked children’s medical centers, more than doubling the total number of sites from the beginning of the year and building increased depth in customer orders. SeaStar Medical also anticipates achieving approximately $2 million in net product revenue in 2026. Advance the SCD therapy for the adult AKI indication through completion of enrollment in the NEUTRALIZE-AKI pivotal trial around the end of 2026 and begin submission of relevant PMA modules to the FDA to facilitate the PMA review and approval process. Evaluate broader applicability of the SCD therapy through the conduct of a clinical trial of the SCD therapy in patients with chronic heart failure with cardiorenal syndrome awaiting left ventricular assist device implantation. SeaStar Medical has also been granted Breakthrough Device Designation by the FDA for this indication given the severity of the disease and lack of current effective treatments. Explore rapid regulatory pathways to commercialization of the SCD therapy as a first-in-class therapy, designed to save lives and spare organ function in numerous destructive hyperinflammatory conditions. SeaStar Medical will seek additional Humanitarian Use and Breakthrough Device Designations to potentially provide lifesaving support to these patients as rapidly as possible. Financial Results for the First Quarter 2026 For the three months ended March 31, 2026, net revenue was approximately $0.5 million, reflecting sales of the QUELIMMUNE pediatric SCD therapy. This compared to net revenue of approximately $0.3 million for the three months ended March 31, 2025. Research and development expenses for the three months ended March 31, 2026, and 2025, were $2.3 million and $2.4 million, respectively. The decrease in research and development expenses was primarily driven by a decrease in clinical trial costs related to the NEUTRALIZE-AKI pivotal trial, offset by increases in personnel costs and costs for external services. General and administrative expenses for the three months ended March 31, 2026, and 2025, were approximately $1.7 million and $1.7 million, respectively. General and administrative expenses for the three months ended March 31, 2026, reflected an increase in legal and accounting related expenses, offset by declines in personnel costs and SEC related costs. Other income (net) increased approximately $30 thousand for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. The increase was primarily driven by increased interest income. Net loss for the three months ended March 31, 2026, was approximately $3.5 million, or $0.90 per share on approximately 3.9 million weighted-average shares outstanding. This compared with a net loss of approximately $3.8 million, or $4.38 per share, on approximately 0.9 million weighted-average shares outstanding for the three months ended March 31, 2025. The Company reported cash of $9.3 million as of March 31, 2026, compared to $12.0 million as of December 31, 2025. About QUELIMMUNE The QUELIMMUNE® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy. In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine. The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life. About NEUTRALIZE-AKI Pivotal Trial The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to continuous RRT as the standard of care, compared with the control group receiving only continuous RRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. About Acute Kidney Injury (AKI) and Hyperinflammation AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous RRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future continuous RRT, including dialysis, and prevent loss of life. About SeaStar Medical SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually. For more information visit www.seastarmedical.com or visit us on LinkedIn or X. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to product revenue in 2026; anticipated patient enrollment and the expansion of the clinical trial sites; the total addressable market for the SCD applications; the ability of SeaStar Medical to gain market share and generate sales with respect to anticipated revenue in 2026; broadening QUELIMMUNE adoption by the addition of top-ranked children’s medical centers; the amount and timing of future QUELIMMUNE commercial sales; commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact: [email protected] — Financial Tables to Follow — QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. QUELIMMUNE net revenue grew nearly 70% year-over-year, driven by the addition of 7 new hospital customers in the first quarter. Management attributes commercial momentum to deep engagement with the pediatric nephrology community, including educational symposiums and monthly clinical user calls. The NEUTRALIZE-AKI pivotal trial for adult patients has reached 198 of its 339-patient enrollment target, supported by the addition of high-caliber sites like UCLA. Strategic focus is shifting toward the adult AKI market, which management identifies as a significantly larger commercial opportunity than the current pediatric niche. The company is utilizing a modular PMA submission strategy with the FDA to potentially accelerate the approval timeline for the adult indication. Operational discipline maintained consistent operating expenses of $4.1 million, leveraging a lean team to manage multiple clinical and commercial workstreams. Management reaffirmed its 2026 goal of adding 15 new hospital customers and achieving approximately $2 million in annual net revenue. Enrollment for the NEUTRALIZE-AKI trial is targeted for completion by year-end 2026, with top-line results expected in mid-2027. Research and development expenses are projected to increase by approximately 5% per quarter as clinical site support and enrollment activities intensify. The company plans to request a transition of the SAVE Registry from mandatory to voluntary status, which would reduce administrative burdens for hospital adoption. Future expansion plans include exploring SCD therapy for cardiorenal syndrome, cardiac surgery, and other states of pathologic immune activation. Gross profit margin remained above 90%, reflecting the high-margin nature of the SCD technology once commercialized. Cash position increased to $9.3 million as of March 31, 2026, compared to $5.2 million in the prior year period. Breakthrough Device Designation is expected to support an accelerated FDA review process for the adult PMA submission. The transition to a therapeutic device classification for the adult market is expected to remove IRB-related barriers that currently slow pediatric adoption. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed that existing customers are placing repeat orders, though the cadence is unpredictable and driven by specific patient presentations. Hospitals are beginning to establish 'par values' or set inventory levels for QUELIMMUNE as they gain experience with utilization patterns. The SCD cartridge connects serially to existing CRRT circuits in minutes, requiring minimal additional training for dialysis technicians or ICU nurses. Success depends on hospitals having established citrate anticoagulation protocols, which management states are present in 99% of U.S. ICUs. Adoption is being driven by 'amplified word of mouth' where clinicians share successful case studies of inflammatory indices dropping after therapy. Monthly user calls with approximately 60 participants allow prospective customers to hear real-world outcomes from active sites, creating organic demand.

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. SeaStar Medical Holding Corp (NASDAQ:ICU) reported a 69% increase in Quelimmune net revenue for Q1 2026 compared to Q1 2025. The company added seven new hospitals to its Quelimmune customer base in Q1 2026, with a goal of 15 new customers for the year. SeaStar Medical is making significant progress in its NEUTRALIZE-AKI pivotal trial, with 198 out of 339 planned patients enrolled. The company is working closely with the FDA on a modular PMA submission and rapid approval pathways for its SCD therapy. SeaStar Medical maintains a strong financial discipline, with a gross profit margin of over 90% and cash reserves of $9.3 million as of March 31, 2026. The company reported a net loss of approximately $3.5 million for Q1 2026, although this is an improvement from the previous year. Operating expenses remained unchanged at $4.1 million, indicating ongoing high costs. The completion of the NEUTRALIZE-AKI trial enrollment is not expected until the end of 2026, delaying potential market entry. The transition of the SAVE registry from mandatory to voluntary status is pending FDA approval, which could impact adoption rates. Integration of the SCD therapy into ICU workflows is described as 'non-trivial,' suggesting potential challenges in hospital adoption. Warning! GuruFocus has detected 3 Warning Signs with ICU. Is ICU fairly valued? Test your thesis with our free DCF calculator. Q: Have you begun seeing repeat orders from any of these existing pediatric centers? How quickly are those repeat orders happening from the first time they come online? A: Yes, we are seeing repeat orders from our customer base. The speed of repeat orders is driven by patient presentation. It can vary; sometimes there is a gap between patients, while other times, several patients may require therapy consecutively. Once customers use the product and gain experience, repeat orders are common. - Tim, Senior Vice President of Commercial and Business Operations Q: Regarding the SAVE registry, how might the data influence treatment guidelines or standard of care discussions? A: Standard of care and guideline implementation take time. However, extracorporeal immune modulation is already mentioned in the pediatric AKI consensus document. With continued positive results, we expect the SCD therapy to be recommended in future guidelines. - Kevin, Chief Medical Officer Q: How easy is it to integrate the SCD into ICU protocols? A: Integrating the SCD cartridge into an existing CRT circuit is straightforward and can be done by any CRT technician or nurse. It takes minutes to connect. Most centers are familiar with citrate anticoagulation, which is a critical component of our therapy, making implementation relatively easy. - Kevin, Chief Medical Officer Q: Can you provide more details on the ordering patterns and average revenue per center for hospitals using the product? A: Hospitals set a par value based on utilization patterns, which determines their inventory levels. We have 17 customers now, up from three or four last year. The revenue per hospital is not singled out due to the ultra-rare nature of the condition, and it is driven by patient presentation. - Tim, Senior Vice President of Commercial and Business Operations Q: Is there additional education happening at hospitals to accelerate adoption at other centers? A: Yes, we conduct monthly clinical users' calls attended by numerous individuals from the nephrology and critical care community. These calls discuss recent cases and outcomes, spreading awareness and interest in Qualimmune. We also present at major conferences and have formed an advanced practice provider ad board to further educate and support hospital staff. - Kevin, Chief Medical Officer and Tim, Senior Vice President of Commercial and Business Operations For the complete transcript of the earnings call, please refer to the full earnings call transcript.