SeaStar Medical Holding Corporation (ICU) Earnings Call Transcript

Good day, and thank you for standing by. Welcome to the SeaStar Medical Report Second Quarter 2026 Financial Results. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Jackie Cossmon.

Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical 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 Business Operations; Dr. Kevin Chung, Chief Medical Officer; and Mike Messinger, Chief Financial Officer. I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws. These forward-looking statements involve risks and uncertainties that 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 this conference call contains information that is accurate only as of the date of the live broadcast, August 12, 2026. The 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?

Thank you, Jackie, and thank you all for joining us today. We are very pleased with our progress this quarter. Our pediatric AKA market penetration and continued strong QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult ACM 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 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. And Kevin will describe our progress in our neutralized 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 story, I'd like to clarify that the same foundational therapy in QUELIMMUNE, known as the selective cytoprinic 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'd 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 immune cells, the immune cells primarily responsible for causing the cytokine storm that shuts down organs and take lives of far too many patients with AKI requiring renal replacement therapy. Given the unique mechanism of our STV therapy and the significant value of finding a potential solution to this continued unmet need, I would note that we anticipate our current pharmacological 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 QUELIMMUNE for pediatric AKI under a 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 designation 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 and understand the importance of driving new customer adoption for QUELIMMUNE and enrolling patients in our neutralized AKI trial. By the same token, we are not losing sight of our long-term opportunities in what SeaStar Medical can achieve for all our stakeholders. With that, I'll turn it over to Tim. Tim?

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. 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 QUELIMMUNE at the AKI and CRT meeting in San Diego. Adding to the buzz we observed there, we sponsored and participated in this year's Kidney B 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. The webinar was entitled Rethinking Pediatric Sepsis Associated AKI, what clinicians should know about QUELIMMUNE. We brought together practicing pediatric nephrologists, critical care physicians, admit 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 at the hospitals in which they practice. As previously stated, this is an ultrarare 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 ultrarare pediatric market. We reported QUELIMMUNE net revenues of $615,000 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 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. 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 build for QUELIMMUNE therapy when used in treating sepsis associated pediatric AKI. And we believe all future potential indications 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 QUELIMMUNE. 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 U.S. Thank you for your attention. And with that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

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 QUELIMMUNE therapy and understanding that it is truly the first of its kind. These kids have days, if not ours 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. And to be clear, we believe that QUELIMMUNE 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 cardiorenal syndrome, systemic inflammation from cardiac surgery, chronic inflammation and end-stage renal disease and other states of pathologic immune activation or 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 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 controlled trial designed to assess the SED 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 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 2 additional clinical sites who have already recruited patients. We have 4 additional sites that we anticipate will be screening patients shortly and 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 an 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 in 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 milligrams per deciliter. 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 in those trials ultimately failed. Beyond CRP, we're 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 on-label 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, insight 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 time line in late 2027 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 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. And with that, I'll hand it over to our CFO, Mike Messinger. Mike?

Thank you, Kevin, and thanks, everyone, for joining our call today. I'll provide a brief overview of our financial results for the second quarter of 2026. The -- 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 $615,000, 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. 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. And 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 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'll turn it back to Eric.

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 base 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'll ask the operator to open the call for questions. Operator?

[Operator Instructions] Our first question comes from David Bautz with Zacks Small Cap Research.

First of all, I was wondering if you could comment on what the current monthly enrollment rate is for the mutualized AK study. And if you're seeing any type of acceleration of enrollment at the new high-volume sites? And then lastly, can you quantify your confidence for hitting that 339 patients either by year-end or the first quarter of '27?

Yes. So thanks for the question. So let me tackle the second one. What we basically kind of guided the market is really our time line is around year-end or into Q1. And 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 is really not impacting the time line. But maybe, Kevin, you could talk a little bit about enrollment of various sites.

Right. Thank you, Eric. So 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 viable 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 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'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. As I said, there are 4 that are so close to getting activated just some residual signatures and et cetera, those kinds of things, and we're ready to activate them. And so we're going to be very soon be seeing some reinforcements come in with an additional 4 sites ready to go, already trained. SIB has already performed site initiation visits. So we're ready to go with those sites. There are additional 8 sites half of whom contacted us because they want it in on the trial. And so they've committed. Now whether or not we're going to be able to activate all 8 sites is still debatable. -- but we're going to try to get as many sites activated as possible because that's going to 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 locations, we have to get that right to have a chance for a positive trial.

Okay. Great. So with the enrollment expected by the end of this year or early 2027 and then the PMA submission target for the end of 2027. I was wondering if you could just walk through one of the major activities for the PMA that need to happen, say, after enrollment or after database lock before you can fully submit it.

Yes. So your question is what are some of the -- well, once we lock the database, obviously, then we'll give out top line results once it's locked and we can analyze, et cetera. And then really, it's just submitting the clinical section. It's really essentially because all their previous sections will have been submitted by that time. And that's 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. So that's really what the strategy is.

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

Yes. Tim, do you want to tackle that one?

Sure. Yes. So it's a combination of new hospital systems as well as existing hospital systems that delivered that revenue -- and 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.

our next question comes from Anthony Vendetti with Maxim Group.