SeaStar Medical (ICU) Q3 2026 Earnings Call Transcript

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DATE

Wednesday, Nov. 11, 2026

CALL PARTICIPANTS

• Chief Executive Officer - Eric Schlorff
• Senior Vice President of Commercial and Business Operations - Tim Varacek
• Chief Medical Officer - Kevin Chung
• Chief Financial Officer - Mike Messinger

TAKEAWAYS

• Net Revenue -- $635,000, representing 247% year-over-year growth due to increased demand for QUELIMMUNE.
• Gross Profit Margin -- Over 90%, consistent with previous quarters during the fiscal year.
• Nine-Month Net Revenue -- $1.7 million, putting the company in position to exceed its $2 million full-year guidance.
• Operating Expenses -- $5.2 million, compared to $3.7 million in the prior-year period.
• Research and Development Expenses -- Increased primarily due to clinical research activities for the NEUTRALIZE-AKI study and higher personnel costs.
• General and Administrative Expenses -- Decreased due to lower personnel costs and reduced legal, audit, and SEC-related expenses.
• Net Loss -- $4.5 million, or $1.03 per share, compared to a loss of $3.5 million, or $1.30 per share, in the third quarter of 2025.
• Weighted Average Shares Outstanding -- 4.4 million shares, compared to 2.7 million shares in the prior-year period.
• Cash Balance -- $4 million as of Sept. 30, 2026, which excludes $3.3 million in gross proceeds from October warrant exercises.
• NEUTRALIZE-AKI Trial Enrollment -- 251 patients out of a total target of 339, or approximately 75%.
• Trial Completion Guidance -- Midyear 2027, an adjustment from previous timelines due to strict patient eligibility criteria designed for optimized trial outcomes.
• PMA Submission Timeline -- Management anticipates filing the final module of the premarket approval application approximately nine months after completing trial enrollment.
• Customer Adoption -- 20 of the top 50 pediatric medical centers are currently customers, with 10 new customers added so far in 2026.
• SAVE Registry Outcomes -- 65% 90-day survival for QUELIMMUNE-treated patients compared to 47% in a clinically aligned cohort.
• Survival Statistical Significance -- Survival data for QUELIMMUNE-treated patients reached a p-value of 0.043.
• Renal Replacement Therapy Independence -- 83% of treated patients who did not require therapy at baseline remained independent of it at 90 days.
• Breakthrough Device Designations -- Seven total designations received to date, including a recent one for adult patients with sepsis.
• Sepsis Mortality Rate -- Sepsis is involved in 1 in 3 hospital deaths in the United States, representing a significant unmet medical need.
• New Clinical Sites -- The company onboarded four additional clinical sites and plans to activate more by the end of 2026 to accelerate trial enrollment.
• Warrant Proceeds -- $3.3 million in gross proceeds were received from warrant exercises conducted in October.
• Prior Cash Balance -- $12 million as of Dec. 31, 2025, compared to $4 million at the end of the third quarter.
• Prior Net Revenue -- Approximately $183,000 in the third quarter of 2025.
• FDA Review Period -- Management noted the FDA typically has 180 days for review, though modular submissions may shorten the final stage.

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RISKS

• CEO Schlorff indicated disappointment regarding the extension of the enrollment timeline for the NEUTRALIZE-AKI trial, which is now expected to be completed by midyear 2027.

SUMMARY

SeaStar Medical Holding Corporation (NASDAQ:ICU) reported revenue growth driven by increased demand for its QUELIMMUNE therapy and provided updates on its clinical development timelines. Management stated that enrollment for the NEUTRALIZE-AKI pivotal trial is now expected to conclude by midyear 2027, with the company utilizing a modular premarket approval submission process to facilitate FDA review. The company also announced the receipt of a seventh Breakthrough Device Designation for adult sepsis and noted the fulfillment of regulatory requirements for its post-approval registry.

• Chief Medical Officer Chung stated, "The selection of this data as a late breaker reflects the urgent need for better options for children with sepsis-associated AKI."
• Management reported that the FDA confirmed the company has met the requirements of the mandatory post-approval SAVE registry, which previously increased institutional effort for hospital adoption.
• The assignment of ICD-10-PCS codes by CMS allows hospital systems to track and bill for the use of QUELIMMUNE therapy.
• The NEUTRALIZE-AKI trial includes a prespecified analysis to capture the benefit of SCD therapy in patients with sepsis, leveraging data from the current enrollment.
• CEO Schlorff stated, "Our Breakthrough Device Designation for this indication should enable a priority review of the PMA once we submit the final module with the NEUTRALIZE-AKI clinical results."
• Management noted that resolving an infection often fails to halt the dysregulated immune response responsible for organ injury.

INDUSTRY GLOSSARY

• AKI: A sudden episode of kidney failure or kidney damage that happens within a few hours or a few days.
• SCD: A medical device that selectively targets and modulates the immune cells responsible for driving systemic inflammation.
• PMA: The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
• CRRT: A type of blood purification therapy used for patients with acute kidney injury, providing continuous support over 24 hours.
• RRT: Medical treatments such as dialysis or kidney transplantation that replace the normal filtration functions of the kidneys.
• ECMO: A life support machine that provides heart and lung bypass for patients with life-threatening respiratory or cardiac failure.
• ICD-10-PCS: A system of medical classification codes used for reporting hospital inpatient procedures.
• SAVE Registry: A clinical database used to monitor and evaluate the real-world safety and performance of a medical device after it has been approved.
• Breakthrough Device Designation: An FDA program intended to provide patients with more timely access to medical devices that provide more effective treatment for life-threatening conditions.

Full Conference Call Transcript

Operator: Thank you for standing by, and welcome to SeaStar Medical Reports Third Quarter 2026 Financial Results Call. [Operator Instructions] I would now like to hand the call over to Jackie Cossmon. Please go ahead.

Jackie Cossmon: Thank you, Latif. Good afternoon, and thank you for joining the SeaStar Medical Third 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. David (sic) [ 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 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, November 11, 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'll turn the call over to Eric. Eric?

Eric Schlorff: Thank you, Jackie, and thank you all for joining us today. We made good progress on several fronts this quarter. We saw strong QUELIMMUNE demand in the ultra-rare pediatric AKI market, and we continue to build momentum in educating the critical care pediatric health care community. Kevin Chung, our CMO, presented data on QUELIMMUNE at several medical meetings, and we are already sharing with critical care professionals the statistically significant higher survival in QUELIMMUNE-treated patients in our patient registry that was highlighted at the late-breaking presentation at ASN Kidney Week 2026.

And importantly, we believe this growing momentum of interest reinforces the promise of our SCD therapy for our pipeline indications, the first of which is for adult patients with AKI on continuous renal replacement therapy or CRRT. The NEUTRALIZE-AKI pivotal clinical trial for this patient population is well underway and has enrolled about 75% of its intended 339 patients. The results of this trial will be critical for understanding the role of our SCD therapy in preventing lifelong dialysis treatment and saving lives.

As we have said previously, our enrollment in this trial is moderated by strict inclusion and exclusion criteria designed to enroll patients most appropriate for the study, which supports a well-defined trial population and more rigorous evaluation of the SCD's potential benefit in these patients. As a result, we are adjusting our guidance for completion of enrollment in the trial. Based on our current enrollment rate, we would anticipate completing the trial by midyear of 2027. As we continue to add new sites and work with existing sites to ensure they are fully supported in recruiting and enrolling patients, this time line could shorten, but we would like to be cautious in our prediction at this time.

We are clearly disappointed to extend the time line for completion of enrollment, but our highest priority is that the study is conducted to provide our SCD therapy the opportunity for an optimized outcome and ultimately be available to patients. Now turning to the premarket approval or PMA application for adult AKI indication. We are working in parallel to accelerate the path to approval by preparing and submitting modules of the PMA to the FDA in advance of submitting the NEUTRALIZE-AKI clinical results. We have submitted the first module and are preparing additional modules for submission over the coming months.

Also, our Breakthrough Device Designation for this indication should enable a priority review of the PMA once we submit the final module with the NEUTRALIZE-AKI clinical results, provided a positive outcome in the trial. Another important event this quarter was the receipt of the Breakthrough Device Designation from the FDA for our SCD therapy for the treatment of hyperinflammation in adult patients with sepsis or a septic condition.

I've asked Kevin to provide more detail on the importance of this indication, but I'd like to underscore the fact that this is a significant area of unmet need and our existing NEUTRALIZE-AKI trial was designed to include a prespecified analysis to capture the potential benefit of the SCD therapy in patients with sepsis. As such, when we complete the trial, we should have significant data to demonstrate the impact of the SCD therapy as a potential treatment for patients with AKI and sepsis.

And finally, before I turn the call over to Tim to discuss our plans for continued adoption of QUELIMMUNE, I'd like to recognize members of our military services who are being commemorated today, including Kevin, who has served his country as a military combat physician. In fact, Kevin was recently awarded the Combat Nephrology Award that he received at the update in Critical Care Nephrology meeting in Madrid, Spain, where he was also the keynote speaker. The award was established to recognize clinicians, researchers, and military medical officers who have made transformative contributions to renal support in extreme high acuity, trauma and combat casualty environments.

It was awarded by his peers in the field, and I know Kevin was very honored to receive this award. His drive and passion for the care of patients is unparalleled. And through his work at SeaStar, it is clear that he is truly fighting to save each and every life. So congratulations, Kevin, on a well-deserved honor. And with that, I'll turn the call over to Tim.

Tim Varacek: Thanks, Eric, and thanks, everyone, for joining us today. As Eric indicated, we saw strong QUELIMMUNE demand this quarter, and we continue to build momentum educating the pediatric critical care and nephrology community. Our primary goal is to continue to expand the market to ensure every pediatric AKI patient has the opportunity to receive the QUELIMMUNE therapy. Our net revenue for QUELIMMUNE sales jumped significantly to over $630,000 in the quarter, increasing 247% compared to last year's third quarter net revenue. And 9-month net revenue more than doubled to $1.7 million, putting us in a position to exceed our guidance of $2 million in QUELIMMUNE revenue for the year.

So we're very excited to see the growing enthusiasm for our QUELIMMUNE therapy in this ultra-rare condition and expect this to continue in 2027. Additionally, several recent advances paved the way for a potential smoother path to customer adoption in the future. These include FDA's confirmation that we've met the requirements of the mandatory post-approval SAVE registry, which previously added significant institutional time and effort to the QUELIMMUNE adoption process within pediatric hospital systems. And as we recently reported, the assignment of ICD-10-PCS codes by CMS will enable hospitals the ability to track and bill for procedures that use the QUELIMMUNE therapy.

Now with respect to our strategy for 2027 and beyond, given the ultra-rare nature of this condition, we will continue to focus on the top 50 pediatric medical centers as our primary target for QUELIMMUNE adoption. Twenty of these top 50 medical institutions are current customers, and we expect to continue to increase utilization with existing customers. We have added 10 new customers so far in 2026 and plan to continue our push to add new customers throughout this year and beyond.

Based on observed and published outcomes data, we believe our continued focus on QUELIMMUNE education and expansion will potentially save lives in the pediatric patient population and also build the foundation for a potential launch in adult AKI, a much larger and underserved population of patients. So thank you for your attention. And with that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

Kevin Chung: Thanks, Tim, and thank you to everyone for listening to our call. And thank you, Eric, for the kind words. I've spent my entire career caring for the sickest patients in the hospital. First, as an army critical care physician caring for critically ill combat wounded and through the COVID pandemic and beyond. One concept has stuck with me. Patients with multiple organ failure and their families deserve better options. Current standards of care are not good enough. Before I turn to NEUTRALIZE-AKI, I'd like to discuss the SAVE registry results that we presented at the ASN Kidney Week 2026 in late October.

The selection of this data as a late breaker reflects the urgent need for better options for children with sepsis-associated AKI. It is difficult to describe how sick these children are. Many are fighting sepsis and multiple organ failure at the same time, and a substantial number were on extracorporeal membrane oxygenation or ECMO. Nearly all required invasive mechanical ventilation and vasopressor use to treat circulatory shock. ECMO was utilized in about 1/3 of patients. Historically, less than half of these types of patients survive. From a safety assessment perspective, no device-related adverse events were reported across 50 treated patients. This matters because these children are so fragile that a complication from the therapy itself could lead to potential harm.

Turning to survival. We compared QUELIMMUNE-treated patients with a clinically aligned cohort from the Kids' Inpatient Database or KID, the largest publicly available all-payer pediatric inpatient database in the United States. This translated to a 65% 90-day survival for QUELIMMUNE-treated patients compared to 47% in the KID cohort, reaching statistical significance with a p-value of 0.043. 60-day and in-hospital survival were also statistically significant and 83% of the QUELIMMUNE-treated patients who did not require renal replacement therapy or RRT at baseline were independent of RRT at 90 days. As a critical care physician, I find higher observed survival in these children, this sick population very encouraging.

It is why we keep pressing to educate pediatric nephrologists and intensivists about QUELIMMUNE and its role within its approved indication. Now turning to our NEUTRALIZE-AKI pivotal clinical trial. Our randomized controlled 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 have now enrolled 251 of our total anticipated 339 patients and have continued our site recruitment to accelerate the pace of enrollment. We recently onboarded 4 additional clinical sites and have additional sites that are -- that we are working to activate by year-end.

As Eric indicated, we are using our current enrollment run rate to set a time line of midyear 2027 to complete patient enrollment, but we are working hard every day to recruit patients as quickly as possible. As we have mentioned in the past, the relatively steady rate of enrollment is partially governed by our eligibility criteria, which is restricted by design to ensure we are capturing patients with modifiable disease. As Eric mentioned, we are also actively working on the premarket approval or PMA application with the FDA to potentially speed the overall approval process for this important indication. The modular PMA enables the FDA to review and approve portions of our application prior to the trial's completion.

The clinical data module will be submitted after trial completion provided we see positive results from the trial. Finally, I'd like to turn to the recent news related to the FDA's decision to grant us Breakthrough Device Designation for the potential treatment of adult patients with sepsis. Sepsis remains a leading cause of preventable mortality, rehospitalization and long-term functional or cognitive impairment. Sepsis is involved in 1 in 3 hospital deaths in the U.S.

This decision by the FDA underscores a significant unmet need in the treatment of sepsis, which remains one of the most challenging conditions we face in critical care, in large part because merely treating the infection does not necessarily stop the dysregulated immune response that drives organ injury. The SCD therapy is designed to selectively modulate that response without broadly suppressing the immune system. That is why we included in our protocol for the ongoing NEUTRALIZE-AKI pivotal clinical trial, a prespecified statistical analysis of the subset of adult patients with AKI and sepsis. As such, we expect to have important data to present to the FDA for this indication in the near term.

Provided the results are positive, we will move as quickly as possible to submit the relevant data to the FDA and discuss ways forward to help these patients who today have few options for effectively treating sepsis. I would add that this is now the seventh indication for which the SCD therapy has received Breakthrough Device Designation. It reflects the FDA's determination that the applicable criteria have been met, including a reasonable expectation that the technology could provide more effective treatment for life-threatening or irreversibly debilitating conditions.

We believe the breadth of these designations reinforces the disease-agnostic potential of the SCD platform to address this dysregulated inflammation across multiple serious conditions and we are committed to generating the clinical evidence needed to advance these indications. With that, I'll hand it over to our CFO, Mike Messinger. Mike?

Michael Messinger: Thank you, Kevin, and thank you all for joining us today. I'll provide a brief overview of our financial results for the third quarter of 2026. Please note that our Form 10-Q will be filed with the SEC within the next 24 hours and will include a lengthier discussion of the company's financial results for the 3 months ended September 30, 2026. You will find the 10-Q at sec.gov or through our website at seastarmedical.com. We recorded net revenue for the third quarter of approximately $635,000, reflecting increased demand for QUELIMMUNE. This represents a 247% increase compared to net revenue of approximately $183,000 for the third quarter of 2025.

We continue to maintain our gross profit percentage of over 90% in the third quarter of 2026, consistent with the prior quarters this year. Turning now to operating expenses. In the third quarter of 2026, we reported $5.2 million in operating expenses compared to $3.7 million in the third quarter of 2025. Our research and development expenses increased primarily due to increased clinical research activities associated with the NEUTRALIZE-AKI pivotal study, SCD development expenses and personnel costs compared to the same period in 2025. Our general and administrative spend declined compared to the third quarter of 2025 due primarily to lower personnel costs, as well as a decline in legal, audit and SEC-related expenses.

These decreases were partially offset by increased professional services, director fees and franchise taxes. Net loss for the third quarter of 2026 was approximately $4.5 million or $1.03 per share based on weighted average shares outstanding of approximately 4.4 million shares. This compares with a net loss of approximately $3.5 million or $1.30 per share in the third quarter of 2025 based on approximately 2.7 million weighted average shares outstanding. We had approximately $4 million of cash on our balance sheet at September 30, 2026, compared to approximately $12 million at December 31, 2025. Our cash balance as of September 30, 2026, does not include the $3.3 million of gross proceeds from the warrant exercises that occurred in October.

And now I'll turn it back to Eric.

Eric Schlorff: Thanks, Mike. Our goal today for our third quarter financial results conference call was to provide you with a summary of our progress as well as a clear picture of our future opportunities. We are passionate about our ability to provide a life-saving therapy to critically ill patients who today have no alternative treatment for calming the cytokine storm caused by an overactive immune system. 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 the line of David Bautz of Zacks Small-Cap Research.

David Bautz: I appreciate the update today. So first question is, so with the anticipated time line for enrollment being pushed back a little bit, do you have an update on the time line from enrollment completion to top line data and then the final PMA submission?

Eric Schlorff: Yes. Thank you, David, for joining and thank you for the question. I would say, based on kind of the estimated time line for completion of enrollment, we would anticipate filing the final module of the PMA about 9 months after completing enrollment.

David Bautz: Okay. So I want to dive into some QUELIMMUNE numbers, if I can. How many hospitals do you currently have as customers? And then how many are treating patients? And can you share how many patients were treated in either Q3, Q2 or both quarters? And then the sales were relatively flat from like Q2 to Q3. I'm just wondering if you could comment on any reasons for that.

Eric Schlorff: Yes. Thanks for the question. Tim, do you want to tackle that?

Tim Varacek: Sure. Thanks for the question. So we have, as mentioned, 20 customers currently. And they're essentially all using the product. And in terms of when they use it, it really is based on their CRRT census and the patients that come in that are eligible for QUELIMMUNE therapy. The vast majority of the customers we have are repeat customers and use it as they can for their patients. In terms of the flatness of the revenue versus Q2, what I would compare to is where we were Q3 last year, which is what we had done in the discussion earlier. But we have -- what we're seeing is growing momentum and enthusiasm around the product.

The goal here is to continue to add new sites. And then as we add those sites to ensure that we educate those sites appropriately so they can identify patients and treat them. And that is the effort. You have to remember, this is an ultra-orphan population. So there's not a vast majority of patients that constantly crash the hospital. It really is -- it's a unique condition, and there are specialized hospitals that are capable of handling those patients, and those are the hospitals that we're focused on.

David Bautz: Okay. Great. And last one, now with the SAVE registry requirements met, are you seeing any changes in hospital adoption or utilization or the ability to bring new hospital customers online?

Eric Schlorff: Yes. Thanks for the question, again, David. Tim, I think that one is for you as well.

Tim Varacek: Yes, sure. So this is very recent. But yes, what we are getting is a very positive response to the SAVE registry in terms of fulfilling that requirement. I've personally received e-mails from customers who are -- they're in the pipeline now and moving through the process, excited about that. We do think that it will be something that has a positive effect on the overall desire to bring QUELIMMUNE into the hospital because virtually all the customers we talk to, they're very interested in the device and the technology. And sometimes, it's a matter of resources or time lines or the amount of effort they have to commit to it.

So the fact that the registry is not mandatory any longer, that reduces that overall effort level, and it does make it a more attractive option for some of these hospital systems that are waiting for something like this to happen.

Operator: Our next question comes from the line of Anthony Vendetti of Maxim Group.

Anthony Vendetti: First, I wanted to also pass along my congratulations to Kevin. Having met him, I'm not surprised. And on Veterans Day, it's definitely something to take time out and remember. So congrats, Kevin. So the question I have is on the Breakthrough Device Designation. I know it's your seventh one. Using SCD therapy for adult patients with sepsis or a septic condition, right? So can you just elaborate a little bit on what you think the time line would be in terms of getting that through the FDA? What do you have to do right now to sort of expedite that process, if possible?

Or are you in the process of just waiting for them to review it and come up with a plan?

Eric Schlorff: No. Thanks, Anthony, and thanks for joining today. So one of the things that you have to think about. So the Breakthrough Device Designation is designed in such a way that it allows us to have early discussions with the FDA in a much more timely fashion. So as Kevin kind of alluded to, we did proactively actually designing the study to have some prespecified in 2 different populations, subpopulations. One was sepsis, one was for ARDS or acute respiratory distress syndrome. So that was all preplanned.

And so as we continue to finish enrollment, and again, the number or percentage of patients that will have sepsis or a septic condition will likely be probably north of 70% of the total patients here. And so we will, in parallel, kind of have discussions with the FDA about that subpopulation as we complete enrollment and then obviously have discussions as we do the final analysis on the back end after obviously, the last patient has been enrolled and goes through the process of kind of the top line results.

Anthony Vendetti: Okay. Great. All right. So you'll do that in parallel. And then maybe this is more for -- well, this probably is more for Michael. So the guidance for the year for '26, obviously, we just have 1 quarter left was $2 million or so. And I don't see any updated guidance in the report. Is it -- does that mean it just remains the same guidance? Or has there been any change to that?

Eric Schlorff: Mike, go ahead and answer. You got this.

Michael Messinger: Sure. Thanks, Eric. Thanks, Anthony, and it's good to hear from you. So as Tim mentioned, we believe we will exceed our guidance for the year. We're not setting a number at this time. Obviously, it's an incidence-based indication. But we feel very good about our guidance. And obviously, we will be looking to provide 2027 guidance earlier in 2027. So I think we're good where we are if that makes sense to you.

Anthony Vendetti: Okay, sure. And then just, obviously, I think you sort of answered this question, Eric, if you complete the trial by midyear '27, file about 9 months after the completion. So you'd file maybe first quarter '28 and then expect an approval maybe first quarter '29 or first half '29 is how we should look at it?

Eric Schlorff: I mean, what basically the guidance from the FDA is they have 180 days. I mean, obviously, we don't control that, but that's also why we're putting these kind of modular PMA together so that we can potentially shorten any of the final kind of module or the clinical results for that -- for the study.

Anthony Vendetti: Okay. Okay. So it could -- like you said, it could be sooner, but it's -- the midyear '27 for completion is your current guidance.

Operator: [Operator Instructions] As there appear to be no further questions in queue, I would now like to turn the conference back to Jackie Cossmon for closing remarks. Madam?

Jackie Cossmon: Thank you, Latif, and thank you all for joining us today for the SeaStar Medical Third 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: This concludes today's conference call. Thank you for participating. You may now disconnect.

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