SeaStar Medical Holding Corporation Common Stock 2026 Q2 Earnings Call

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

Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical Second Quarter 2026 financial results conference call. I'm Jackie Kosman with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, Chief Executive Officer, Tim Baraczek, 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.

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? 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.

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.

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.

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? 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.

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.

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.

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.

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. 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.