管理層發言
Hello, and welcome to the SeaStar Medical First Quarter 2026 Financial Results Conference Call. Operator provided instructions to participants. I would now like to hand the conference over to Jackie Cossmon. You may begin.
Thank you, Towanda. Good afternoon, and thank you for joining the SeaStar Medical First Quarter 2026 Financial Results Conference Call. I'm Jackie Cossmon with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, Chief Executive Officer; Dr. Kevin Chung, Chief Medical Officer; Tim Varacek, Senior Vice President of Commercial and Business Operations; and Mike Messinger, Chief Financial Officer. I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws. These forward-looking statements involve risks and uncertainties and could cause actual results to differ materially from any anticipated results. For a list and description of these risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission. Furthermore, the content of the conference call contains information that is accurate only as of the date of the live broadcast, May 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?
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 QUELIMMUNE customer base has helped propel our first quarter QUELIMMUNE net revenue with a nearly 70% increase from the first quarter of 2025, with 7 new hospitals adopting the QUELIMMUNE therapy in the first quarter of 2026. Our goal this year is 15 new customers, and we are well on our way to achieving that. With our growing presence and the continued adoption of QUELIMMUNE in the pediatric AKI market, we believe we are on track to meet our net revenue goal of approximately $2 million for the year. More importantly, we are setting the stage for our next and potentially far larger market opportunity in the adult AKI market. To that end, we continue to enroll patients in the NEUTRALIZE-AKI pivotal trial with 198 patients enrolled of our planned total 339 patients.
Last year, we determined that we would add new clinical sites to expand our enrollment efforts to reach completion of enrollment around the end of 2026. Kevin and his team are working diligently to make this happen. It has been extremely rewarding to see the highest caliber medical institutions participate in our trial with UCLA as an example of one of the latest hospitals to join in and more on the way. In addition, we continue to work closely with the FDA on several fronts. First, we are discussing the elements of a modular PMA submission for the adult AKI indication, which we believe could speed the approval process. Second, we are working with the FDA to obtain agreement on a rapid approval pathway for our SCD therapy. The SCD therapy is a potential life-saving therapy for indications where there are no treatments today, and we believe patients with hyperinflammation should have more immediate access to therapies that could reduce or avoid severe organ damage and potential loss of life.
Finally, and before I turn the call over to Tim, we have maintained a strong financial discipline. Mike will share our efforts on this front shortly. 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.
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 7 additional customers in the first quarter, and importantly, we are seeing an uptick in orders from many of our customers. Our QUELIMMUNE net revenue in the first quarter was $495,000, a solid increase of 69% from the first quarter of last year. As Eric indicated, this is a small but important market to us, not only because we believe QUELIMMUNE is saving lives and sparing organ function for young kids, but it also provides great validation of our SCD technology and importantly, it paves the way for future potential opportunities in the adult market. We're seeing great enthusiasm by the pediatric health care community for QUELIMMUNE 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 QUELIMMUNE therapy to continue to build our brand in pediatric AKI and also position SeaStar Medical in a leadership role to help educate the pediatric medical community about this serious unmet need. The symposium provided an opportunity for the pediatric community to get answers to key operational questions, gain exposure to the rich content from cutting-edge scientific and clinical data and utilize the learnings to establish QUELIMMUNE therapy at the hospitals in which they practice. The broadening impact of QUELIMMUNE therapy and the desire by the pediatric health care community to learn more about QUELIMMUNE reinforces a key focus for SeaStar Medical to deepen the educational effort on QUELIMMUNE therapy and how to implement it in the treatment of pediatric AKI.
Now turning to our commercial efforts for QUELIMMUNE in 2026. We have great expectations to help patients by delivering QUELIMMUNE therapy to more pediatric hospitals. We continue to focus on adding new sites as quickly as possible. And once a site adopts QUELIMMUNE, ensure pull-through by educating the patient care teams so they are focused on pediatric AKI and the option of QUELIMMUNE therapy for appropriate patients. We believe this is only the beginning of the commercial opportunities for our SCD therapy. 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 presence at the AKI and CRRT meeting in late March. As a critical care physician, I was struck by just how embedded QUELIMMUNE has become in the conversation. The interest wasn't limited to our own events or data presentations. It showed up organically in plenary and breakout sessions, where clinicians and researchers were referencing QUELIMMUNE unprompted. That kind of grassroots visibility in a specialty community is a meaningful signal. Adding to that momentum, the American Society of Nephrology's Kidney News, widely regarded as the newsroom of the nephrology world, dedicated not one but two articles to the SCD therapy in its most recent issue. The first, a feature on the evolution of extracorporeal therapy, identified the SCD therapy as one of the most exciting frontiers in the shift from passive blood filtration to active immune modulation.
The second was devoted entirely to the SCD therapy, its mechanism, clinical evidence and future potential. When the premier Nephrology Society's publication gives a therapy 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 QUELIMMUNE case together. The stories we hear on these calls are truly remarkable, and they continue to validate and reinforce why getting this therapy to a broader patient population is so important. The SCD's unique immunomodulatory mechanism positions us to potentially reshape treatment paradigms across a range of serious conditions, not only for AKI, but cardiorenal syndrome, cardiac surgery, end-stage renal disease and other states of pathologic immune activation where dysregulated cytokine release drives organ failure and death.
To that end, we are working diligently to complete enrollment in our NEUTRALIZE-AKI pivotal trial. As a brief overview, NEUTRALIZE-AKI is a randomized controlled trial designed to assess whether up to 10 sequential 24-hour SCD treatments can improve 90-day survival or renal recovery in critically ill adult patients with acute kidney injury requiring continuous renal replacement therapy. The primary endpoint is a composite of mortality or dialysis dependence at 90 days. We continue to onboard additional clinical sites and now have enrolled 198 of our target of 339 patients. We are targeting completion of enrollment around year-end, which positions us to potentially report top-line results in mid-2027. We are already working with the FDA on our plans to submit a modular PMA, enabling us to complete most of the submission with the exception of pivotal data, then submit pivotal data as the last element of the submission.
This is designed to allow FDA early review of the modules that don't relate to the clinical trial data. It often speeds the overall review of the applications. Upon completion and review of the NEUTRALIZE-AKI clinical trial and contingent on positive efficacy and safety outcomes, we intend to move quickly to submit the remaining PMA components under our breakthrough device designation, positioning us for a potentially accelerated FDA review. A PMA approval of SCD therapy for adult AKI would enable commercialization as a therapeutic device without the IRB-related barriers that exist with QUELIMMUNE. This would significantly simplify hospital adoption, and we believe it will support more rapid commercial expansion. Now let me turn to our SAVE Registry, which tracks the commercial use of QUELIMMUNE in critically ill children. In March, we announced completion of enrollment at 50 patients, a meaningful milestone.
We are currently completing the 28-day safety analysis on our final enrolled patients and expect to submit top-line safety data to the FDA shortly. Alongside that submission, we will formally request that the SAVE Registry transition from its current mandatory status to a voluntary post-marketing study. If the FDA agrees, this would meaningfully reduce the administrative burden on children's hospitals, accelerating adoption and expanding access to QUELIMMUNE across more pediatric centers, a clear win for patients, providers and the health care system. With that, I'll hand it over to our CFO, Mike Messinger.
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 10-Q at sec.gov or through our website at seastarmedical.com. We recorded net revenue from QUELIMMUNE sales of approximately $495,000 for the first quarter of 2026 compared to $293,000 in the first quarter of 2025. And as Tim mentioned, we continue to see strong adoption of QUELIMMUNE sales here in the second quarter of 2026. Turning to gross profit. Our first quarter statement of operations reflects a gross profit margin of over 90%, consistent with the prior three quarters. As a reminder, we didn't recognize cost of goods sold in the first quarter of 2025 as the QUELIMMUNE units sold were originally expensed to research and development prior to approval and commercialization, consistent with U.S. GAAP.
Operating expenses were unchanged at approximately $4.1 million in the first quarter of 2026 compared to the first quarter of 2025. This represents our continued discipline and leverage of our team's ability to take on multiple tasks within our organization due to our broad experiences, talent 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 a 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.
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 are significant, and we look forward to reporting our future progress. With that, I'll ask the operator to open the call for questions.
分析師問答
Operator provided instructions to participants. Our first question comes from the line of David Bautz with Zacks Small Cap Research.
I appreciate the update today. So first question is, have you begun seeing repeat orders from any of these existing pediatric centers? And if you have, how quickly are those repeat orders happening from the first time that they come online?
Yes. David, this is Eric. Thanks for joining. Great question. Tim, do you want to take that?
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. In other instances, they may finish therapy on one patient and several more will appear in the ICU that are appropriate patients for QUELIMMUNE. So it's fairly unpredictable that way, but it is definitely safe to say that across our overall customer base, once they use the product and gain experience with it, we do see repeat orders.
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 standard-of-care discussions?
Yes, that's a great question. So Kevin, do you want to tackle that?
Yes. So standard of care and implementation into guidelines takes a long time. However, if you look at the pediatric ADQI consensus document that was published a little over a year ago, immune modulation—extracorporeal immune modulation—is mentioned. So I believe that if we continue down this path, and we have a positive NEUTRALIZE-AKI study, that pediatric ADQI and other consensus statements will bring forward the SCD as a therapy that's recommended. For these clinical practice guidelines, it typically takes multiple randomized controlled trials and wide adoption for recommendations to surface. But we're already mentioned there, which is a good thing. I have no doubt that with continued use of the therapy and as clinical teams see the results, this will become something that everyone is talking about.
Okay. Great. And then lastly, of course, you mentioned the write-ups in 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, nontrivial. But how nontrivial is it, or how easy is it for the unit to be integrated into the protocols at a hospital?
Thank you for that question. Clinically, the addition of the SCD cartridge involves connecting it serially to an already existing CRRT circuit. A CRRT technician, dialysis technician or CRRT ICU nurse can do that. It takes minutes to connect, and it is as simple as it can be. The other thing that many centers around the country have experience with is citrate anticoagulation, and we're fortunate that this is the case because that is a critical component of our therapy. So with regards to difficulty, if you already have a citrate protocol and you're used to doing CRRT—which is true for the vast majority of ICUs—the implementation of SCD is not going to be difficult.
Our next question comes from the line of Anthony Vendetti with Maxim.
So yes, I just wanted to talk about the hospitals that are currently using the product. Do you have a particular ordering pattern? Anything else you can share 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, if not a reordering pattern for the hospitals, an average revenue per center? Or is it really just patient dependent and can vary widely?
Yes. Thanks, Anthony. Great question. Thanks for joining today. I'll tackle some of this, and then I'll have Tim also come in. One of the things is how many patients have we treated. We did disclose a couple of months back that we had reached 50 patients for the SAVE Registry. So that gives a general sense of how many have been treated. Tim, could you give a little more color on some of Anthony's other questions?
Sure. I think one way to think about this, Anthony, and thank you for the question, is that as with many products in the hospital, hospitals, once they understand their utilization patterns, will set a par value. That is basically an inventory level they want to keep on hand at all times based on utilization. There are par values that have been set with many of our customers. Others are still scaling their business. We have 17 customers today. At this time last year, we had three or four customers. So it's still new. Many of these new customers order product, use the product, and then determine the cadence of patients that come through that helps them establish the par value. In addition, the more they use this, the more they think about pediatric AKI. As I mentioned, our educational efforts are designed to create a ripple effect of QUELIMMUNE across these institutions so that many people know about it and are actively looking for patients. When you're actively looking, you tend to find more patients. So that's basically how it works. We don't disclose revenue per hospital at this point. This is an ultra-rare indication and condition, and it is driven by the presentation of a patient within the hospital system itself.
Okay. So as you're looking to drive the patient volume, and like you said, it's heavily dependent on the patients needing the treatment, is there any additional education that's going on at the hospitals that you're in and at the new hospitals you're trying to sign up that might accelerate adoption at other centers?
That's a great question. Kevin, maybe you could talk about the monthly users call that we have—who's on those calls and what gets discussed.
Sure. Thank you, Anthony, for that question. This is a very tight community—the nephrology, pediatric nephrology and critical care community—and they all talk to each other and share experiences. We leverage that spirit and have monthly clinical users calls. When we invite about 135 to 150 individuals, most often we have about 60 callers that dial in. They hear from the previous month's cases at each of the active sites. We go into detail about the cases, how sick the patients were, the rationale for therapy and what happened to them. We can't save everyone, but for many of these patients—indeed for many of the cases—the patients are exceptionally ill when therapy is initiated, and virtually all of the patients would have had a very low chance of survival without this option. These cases are discussed in detail: patients are very sick, they start QUELIMMUNE, inflammatory indices begin to come down, and clinicians report patients improving.
When participants who don't have QUELIMMUNE at their institutions hear these stories, they want access to the therapy to give their children a chance. That's how we spread the message regarding QUELIMMUNE's potential benefits. Additionally, we have presented at premier conferences where pediatric intensivists and nephrologists gather—PNRC (Pediatric Research Network Consortium) in Miami, the Society of Critical Care Medicine, AKI and CRRT meetings, and even European meetings. The conversation is always centered around how well these patients initially respond to QUELIMMUNE. Even when there is a death, clinicians often see inflammatory indices decrease and initial clinical improvement. Sometimes patients do not survive due to comorbidities, but clinicians see the benefit. So it's amplified word of mouth, and it's quite effective. There are many centers that contact us, sometimes because they have a child in need, and we do what we can to help.
Yes. Maybe, Tim, you could also share the newly formed advanced practice provider group that you've put together.
Yes, happy to do that. In addition to what Kevin described, we're approaching education from several angles. One of the things we've done is form an advanced practice provider advisory board. These are clinicians who work at the patient-care level and are very operational—they set up orders and protocols, run training, and often act as champions within their institutions to implement QUELIMMUNE. We're working with them closely. We had a symposium at the recent AKI and CRRT meeting and have several other planned events this year. We also provide field-level clinical support at systems that have adopted QUELIMMUNE to ensure that more clinicians know about it. Given shift changes and many staff members in a hospital, a lot of people need exposure to this information. We believe we have a good handle on what needs to be done, and now we're executing on that.
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, Towanda, and thank you all for joining us today for the SeaStar Medical First Quarter Financial Results Conference Call. If you have questions, please contact us at ir@seastarmed.com or visit our website at www.seastarmedical.com. Thank you, and goodbye.
Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.