SeaStar Medical Q2 2026 Earnings Report

SeaStar Medical EPS Results

• Actual EPS: -$0.91
• Consensus EPS: -$0.97
• Beat/Miss: Beat by +$0.06
• One Year Ago EPS: N/A

SeaStar Medical Revenue Results

• Actual Revenue: $0.62 million
• Expected Revenue: $0.49 million
• Beat/Miss: Beat by +$129.00 thousand
• YoY Revenue Growth: N/A

SeaStar Medical Announcement Details

• Quarter: Q2 2026
• Date: 8/12/2026
• Time: After Market Closes
• Conference Call Date: Wednesday, August 12, 2026
• Conference Call Time: 4:30PM ET

SeaStar Medical (NASDAQ:ICU), Inc. (NASDAQ: ICU) is a medical device company focused on the development and commercialization of cerebral embolic protection systems for patients undergoing transcatheter aortic valve replacement (TAVR) procedures. The company’s mission is to reduce the risk of stroke and other neurologic events associated with structural heart interventions by capturing or deflecting embolic debris that can travel to the brain during catheter-based therapies.

The company’s flagship product, TriGUARD® 3, is a next-generation embolic deflection device designed to provide coverage of all three cerebral vessels during TAVR. TriGUARD 3 features an advanced frame and filter design that conforms to varying patient anatomies, enabling physicians to position the device safely and effectively without obstructing critical arterial access routes. SeaStar Medical continues to invest in clinical trials and registry studies to demonstrate the safety and performance of its technology and to support regulatory clearances in North America, Europe and other key markets.

Headquartered in Kansas City, Missouri, SeaStar Medical serves a global customer base through direct sales and distribution partnerships in Europe and parts of Asia Pacific, in addition to its U.S. operations. The company collaborates with interventional cardiologists, cardiac surgeons and research institutions to refine device design and expand indications. Its leadership team brings extensive experience from leading cardiovascular and medical device firms, guiding SeaStar Medical through product development, regulatory interactions and market introduction efforts to address the growing demand for neuroprotection in structural heart care.

SeaStar Medical Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: QUELIMMUNE adoption and revenue accelerated: Second-quarter net revenue rose 82% year over year to $615,000, with gross margins above 90%. The therapy is now used at 20 of the 50 premier U.S. children’s hospitals, versus 10 at the start of 2026, supporting the company’s $2 million full-year revenue target.
• Positive Sentiment: CMS assigned ICD-10-PCS billing codes for QUELIMMUNE, effective October 1, which management believes will remove an administrative barrier to hospital adoption. SeaStar also completed the required 50-patient SAVE registry and is preparing the final report for FDA review.
• Neutral Sentiment: Adult AKI trial enrollment is progressing but remains dependent on site activation and patient selection: NEUTRALIZE-AKI has enrolled 223 of 339 planned patients, with recent enrollment averaging roughly 8–12 patients per month. Management expects enrollment around year-end 2026 or the first quarter of 2027, while maintaining its late-2027 modular PMA submission target.
• Negative Sentiment: Operating expenses more than doubled year over year to $4.4 million as clinical activity and corporate costs increased, producing a $3.7 million quarterly net loss. Cash declined to approximately $7 million at June 30 from $12 million at year-end 2025, highlighting ongoing funding and dilution risk.

Presentation

[Operator]

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

[Jackie Cossmon, Consultant at Wheelhouse Life Science Advisors]

Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical second quarter 2026 financial results conference call. I'm Jackie Cossmon with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, Chief Executive Officer, Tim Varacek, Senior Vice President of Commercial and Business Operations, Dr. 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.

[Jackie Cossmon, Consultant at Wheelhouse Life Science Advisors]

Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, August 12, 2026. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law. Now I'd like to turn the call over to Eric. Eric?

[Eric Schlorff, CEO at SeaStar Medical]

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 50 times larger than the pediatric market in the U.S. 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 adoption 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 AKI market.

[Eric Schlorff, CEO at SeaStar Medical]

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 QUELIMMUNE, 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, I would like to emphasize that our SCD therapy is first in class. It is the only immunomodulatory therapy that targets and neutralizes hyperactive leukocytes and monocytes and the immune cells primarily responsible for causing the cytokine storm that shuts down organs and takes the lives of far too many patients with AKI requiring renal replacement therapy.

[Eric Schlorff, CEO at SeaStar Medical]

Given the unique mechanism of our SCD therapy and the significant value of finding a potential solution to this continuing unmet need, I would note that we anticipate our current 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 treatment advancements to critically ill patients with AKI. The FDA approved QUELIMMUNE for pediatric AKI under Humanitarian Device Exemption and also awarded us Breakthrough Device Designation for the SCD therapy 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.

[Eric Schlorff, CEO at SeaStar Medical]

We remain keenly focused on achieving our near-term goals and understand the importance of driving new customer adoption for QUELIMMUNE and 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, Senior VP of Commercial and Business Operations at SeaStar Medical]

Thanks, Eric, and thanks, everyone, for joining us today. We are making great progress in our efforts to establish QUELIMMUNE 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 U.S. 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. 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 QUELIMMUNE at the AKI and CRRT meeting in San Diego.

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

Adding to the buzz we observed there, we sponsored and participated in this year's KidneyBee 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. Just yesterday, we assembled leading experts in the treatment of pediatric AKI to speak at a SeaStar Medical educational webinar. The 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.

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

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 at 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 $615,000 in the second quarter, a strong 82% increase over last year's second quarter.

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

With six-month net revenue at $1.1 million, momentum remains 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. 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 & Medicaid Services, also known as CMS, assigned ICD-10-PCS codes for our SCD therapy, allowing hospitals to efficiently bill for QUELIMMUNE therapy when used in treating sepsis-associated pediatric AKI. We believe all future potential indications from our SCD therapy will use the same PCS code.

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

The implementation of the new ICD-10-PCS code initiates on October 1st 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.

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

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 QUELIMMUNE. 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 50 times larger than the sepsis-associated pediatric AKI population in the U.S. Thank you for your attention. With that, I will turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

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 QUELIMMUNE 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. To be clear, we believe that QUELIMMUNE for pediatric AKI indication is just the first of a broad range of indications for our SCD therapy.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

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 cardiorenal 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 CRRT. We are currently conducting the NEUTRALIZE-AKI trial and have plans to file a modular pre-market approval, or PMA with the FDA to potentially speed the overall approval process for this important indication.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

The modular PMA enables the FDA to review and potentially 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 control trial designed to assess the SCD therapy in critically ill adult patients with AKI requiring CRRT. The primary endpoint is a composite of mortality or dialysis dependence at 90 days. We now have enrolled 223 of our total anticipated 339 patients in the trial and have stepped up our site recruitment to accelerate the pace of enrollment as we move forward. We recently onboarded two additional clinical sites who have already recruited patients.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

We have four additional sites that we anticipate will be screening patients shortly, and at least eight 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. We 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. One of our enrichment criteria is a C-reactive protein, or CRP level, greater than 3.5 mg/dL.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

Patients who do not have a CRP greater than 3.5 mg/dL are excluded. Why? CRP is a very sensitive marker of inflammation, and 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 applying our carefully considered exclusion criteria to remove patients whose preexisting 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.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

We are seeing in the commercial setting physicians who are already applying QUELIMMUNE to our much broader unlabel 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 and 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 2027, our PMA submission timeline in late 2027 remains unchanged.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

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 CRRT 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 QUELIMMUNE, 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. With that, I'll hand it over to our CFO, Michael Messinger. Mike?

[Michael Messinger, CFO at SeaStar Medical]

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 three 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 $615,000, reflecting increased demand for QUELIMMUNE. This represents an 82% increase compared to net revenue of approximately $338,000 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.

[Michael Messinger, CFO at SeaStar Medical]

We continue to maintain our gross profit percentage of over 90% in the second quarter of 2026, consistent with the prior four 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 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.

[Michael Messinger, CFO at SeaStar Medical]

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 the net loss of approximately $2 million, or $1.77 per share in the second quarter of 2025, based on approximately 1.1 million weighted average shares outstanding. We had approximately $7 million of cash on our balance sheet at June 30, 2026, compared to $12 million at December 31, 2025. With that, I will turn it back to Eric.

[Eric Schlorff, CEO at SeaStar Medical]

Thanks, Mike. 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 the 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 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 star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for questions. Our first question comes from David Bautz with Zacks Small Cap Research. You may proceed.

[David Bautz, Senior Analyst at Zacks Small Cap Research]

Hey, good afternoon, everyone. I appreciate you taking the questions. First one, I was wondering if you could comment on what the current monthly enrollment rate is for the NEUTRALIZE-AKI study and if you're seeing any type of acceleration enrollment at the newer high-volume sites. Lastly, can you quantify your confidence for hitting that 339 patients either by year-end or the first quarter of 2027?

[Eric Schlorff, CEO at SeaStar Medical]

Yeah. Thanks for the question. Let me tackle the second one. What we've basically kind of guided the market as is our, really, our timeline is around year-end or into Q1. Obviously, it's going to depend on Kevin and his team bringing on additional sites, et cetera, from an enrollment standpoint. But I'm really proud of what Kevin and his team are doing on bringing those kind of on pace. But if I think about this, David, before he kind of talks about maybe enrollment, we still believe that we're really on track at the end of the day to have end of 2027 submission for the final PMA module, which obviously really not impacting the timeline. But maybe, Kevin, you could talk a little bit about enrollment of various sites.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

Right. Thank you, Eric. On average, over the last few months, we've averaged somewhere around 8 to 10 to 12 patients in each of those months. And that's 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's 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're not enrolling the right patients? 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's number one. Number two, as we discussed in the report, in our update, we're very busy right now activating, in the process of activating numerous sites.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

As I said, there are four that are so close to getting activated, just some residual signatures and et cetera, those kinds of things, and we are ready to activate them. We are going to be very soon be seeing some reinforcements come in with an additional four sites ready to go. Already trained. SIV's already performed, site initiation visit. We are ready to go with those sites.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

There are an additional eight sites, half of whom contacted us because they wanted in on the trial. They have committed. Now, whether or not we are going to be able to activate all eight sites is still debatable, but we are going to try to get as many sites activated as possible because that is going to get us to 15-20 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, Senior Analyst at Zacks Small Cap Research]

Okay, great. With the enrollment expected by the end of this year, early 2027, and the PMA submission target for the end of 2027, I 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 fully submit it.

[Eric Schlorff, CEO at SeaStar Medical]

Yeah. Your question is, what are some of the Well, once we lock the database, obviously then we will give out top-line results. Once it is locked, we can analyze, et cetera. Then really it is just submitting the clinical section, is really essentially because all the other previous sections will have been submitted by that time. That is really what the goal is, so that when the FDA then has their time, they can then focus just merely on the clinical sections and not have to go through things like device and description, et cetera. That is really what the strategy is.

[David Bautz, Senior Analyst at Zacks Small Cap Research]

Okay, sounds good. Last one, talking about the increase in revenue, I was wondering if you could quantify, say, the contribution from existing customers versus the new hospitals that you added during the quarter.

[Eric Schlorff, CEO at SeaStar Medical]

Yeah. Thanks. Tim, you want to tackle that one?

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

Sure. Yeah, so it's a combination of new hospital systems as well as existing hospital systems that delivered that revenue. We have a very high repurchase rate with the existing sites, and then obviously the new sites that come on board, they want to stock the product as soon as they can so that they're ready to treat patients. So it was a group effort by all of the customers that were out there.

[David Bautz, Senior Analyst at Zacks Small Cap Research]

Okay, great. Appreciate you taking the questions.

[Eric Schlorff, CEO at SeaStar Medical]

Thanks, David.

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

Thanks.

[Operator]

Thank you. Our next question comes from Anthony Vendetti with Maxim Group. You may proceed.

[Anthony Vendetti, Analyst at Maxim Group]

Yes, hi, thanks. Can you talk about the milestones between completing enrollment and then the final PMA submission? I think you mentioned you submitted the preliminary, right?

[Eric Schlorff, CEO at SeaStar Medical]

No, we're submitting preliminary reports.

[Anthony Vendetti, Analyst at Maxim Group]

Yeah.

[Eric Schlorff, CEO at SeaStar Medical]

So we're submitting

[Anthony Vendetti, Analyst at Maxim Group]

No. Well, so you're talking about the PMA, right? For adult

[Eric Schlorff, CEO at SeaStar Medical]

Yeah.

[Anthony Vendetti, Analyst at Maxim Group]

Yeah.

[Eric Schlorff, CEO at SeaStar Medical]

Yeah. For that, obviously, what we're doing right now, it's a modular PMA. There's various sections where you talk about the device, you talk about sterilization, you talk about all sorts of the technical things that go into it. But then you get into 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. So really what you're waiting for at the end is once you have data lock, and then you can show top line and do the analysis, then you're really just submitting the clinical section of it.

[Anthony Vendetti, Analyst at Maxim Group]

Okay. So you've submitted already the certain sections and

[Eric Schlorff, CEO at SeaStar Medical]

No, we are in the process.

[Anthony Vendetti, Analyst at Maxim Group]

Still-

[Eric Schlorff, CEO at SeaStar Medical]

Yeah, we are in the process of doing that. Yeah.

[Anthony Vendetti, Analyst at Maxim Group]

Got it. Okay. You have right now about 20 pediatric hospitals, right?

[Eric Schlorff, CEO at SeaStar Medical]

Correct.

[Anthony Vendetti, Analyst at Maxim Group]

Is there a process or what do you have to do to make sure they are not just sort of like, okay, they are a hospital that uses this, but how do you get them to be more meaningful recurring customers? Or you just need the patients to come in and they are already on board, and there is nothing really left to do with those particular hospitals?

[Eric Schlorff, CEO at SeaStar Medical]

Yeah, maybe, Tim, you could 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.

[Anthony Vendetti, Analyst at Maxim Group]

Okay.

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

Yeah, it absolutely is. Just to give you insight, 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 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 patient to ensure everything goes smoothly. In terms of what happens after that, there is a lot of work to do.

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

Every hospital system is large. They have a lot of different staff, they have different shifts, and 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 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 one of your advocates there, they may not realize that they could use QUELIMMUNE to treat that patient.

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

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 QUELIMMUNE therapy as an option when it is there and it is available.

[Anthony Vendetti, Analyst at Maxim Group]

Okay. Just to understand, so obviously getting into the hospital is just the first step, and trying to make sure all the trained healthcare professionals that could use it, A, know the benefit, know how to use it, and you stay engaged because like you said, if there's new doctors, nurses or so forth that are coming in, you want to make sure that they are aware of the treatment and of the application of the QUELIMMUNE. Correct?

[Tim Varacek, Senior VP of Commercial and Business Operations at SeaStar Medical]

100%. Yep.

[Anthony Vendetti, Analyst at Maxim Group]

Okay.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

If I may add some color to the clinical perspective.

[Anthony Vendetti, Analyst at Maxim Group]

Sure.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

Yesterday we conducted a webinar that we'll 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, this has been clear, but it became more clear to me that there's a big difference between new sites that have device and mature sites that have device. New sites, anytime there's a new technology, even if it's life-saving, because of the natural skepticism that is very prevalent within the medical community, they have to see it work. And so generally, it's used as a rescue therapy. And what I mean by that is it's 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's new sites. That's the approach that they take.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

That has been true for almost every site that has been activated because whenever a therapy is new, that is what is going to happen. I have to say, I 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. Yesterday, we are starting to sort of notice a shift, especially with the mature centers, the mature sites that have been doing this now for over a year. At these sites, everybody is already educated, everybody already has seen what I call the index case, the aha moment, the case that converted them and, in their mind, made them think, "Oh my gosh, we need to do this." This is occurring, and clinical adoption mentally is occurring pretty universally across our mature sites.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

Right now, as we speak, those clinicians are scanning their ICU to see who may benefit from the therapy. 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. Hopefully, you will be able to watch it and verify my statement. Thanks.

[Anthony Vendetti, Analyst at Maxim Group]

No, that is helpful, Kevin. Yeah. We know the focus as it should be is on the pediatric market and now the adult AKI with this trial enrollment, and you are at 223 up to 339 patients, and we know adult AKI is 50 times larger than the pediatric market. There are other markets that your Selective Cytopheretic Device can treat, whether that be acute respiratory distress, hepatorenal syndrome, cardiorenal syndrome and of course, sepsis. I know you want to stay focused, like I said you should, but behind the scenes, can you give us some insight into what kind of work is being done on these other indications?

[Eric Schlorff, CEO at SeaStar Medical]

Yeah.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

Yeah.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

Okay.

[Eric Schlorff, CEO at SeaStar Medical]

I can tackle that one.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

Okay.

[Eric Schlorff, CEO at SeaStar Medical]

Yeah. We do obviously evaluate all the other applications that we believe that, obviously, from our perspective, there's a pretty long laundry list of things that really would be on our wish list. But obviously, we as a company have to be focused on certain things, and that's really been on QUELIMMUNE for pediatric AKI and adult AKI and NEUTRALIZE-AKI. Obviously, we've got the NEUTRALIZE-CRS study that's actually been funded by NIH. And I would say we have various discussions with various parties, looking at everything from non-dilutive to strategic discussions, business development, on all these types of things, to be able to really advance this. The other indications that we believe we have in our pipeline, but obviously, it'll just take time for some of those things to mature, and we'll just have to see how they pan out.

[Kevin Chung, Chief Medical Officer at SeaStar Medical]

If I may just add really quickly. I should remind everyone that for NEUTRALIZE-AKI, a priori, we identify patients with ARDS at the time of enrollment and sepsis at the time of enrollment, and we randomize 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, Analyst at Maxim Group]

No, that's 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.

[Jackie Cossmon, Consultant at Wheelhouse Life Science Advisors]

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 ir@seastarmed.com or visit our website at www.seastarmedical.com. Thank you and goodbye.

[Operator]

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

Participants

Executives

• Eric Schlorff, CEO
• Tim Varacek, Senior VP of Commercial and Business Operations
• Kevin Chung, Chief Medical Officer
• Michael Messinger, CFO

Analysts

• Jackie Cossmon, Consultant at Wheelhouse Life Science Advisors
• David Bautz, Senior Analyst at Zacks Small Cap Research
• Anthony Vendetti, Analyst at Maxim Group