Q2 2026 SeaStar Medical Holding Corp Earnings Call

August 12, 2026

Operator: Good day, and thank you for standing by. Welcome to the SeaStar Medical Q2 2026 financial results. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. I would now like to hand the conference over to your speaker today, Jackie Kostman.

Speaker #1: Good day, and thank you for standing by. Welcome to the SeaStar Medical Report: Second Quarter 2026 Financial Results. At this time, all participants are in a listen-only mode.

Speaker #1: Please be advised that today's conference is being recorded. After this speaker's presentation, there will be a question-and-answer session. To ask a question, please press *11 on your telephone and wait for your name to be announced.

Speaker #1: To withdraw your question, please press star one one again. I would now like to hand the conference over to your speaker today, Jackie Gossman.

Speaker #2: Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical second quarter 2026 financial results conference call. I'm Jackie Gossman with Wheelhouse Life Science Advisors.

Jackie Kostman: Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical Q2 2026 financial results conference call. I am Jackie Kostman 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 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.

Jackie Cossmon: Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical Q2 2026 financial results conference call. I am 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 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.

Speaker #2: Joining me from SeaStar Medical today are Eric Schlorf, Chief Executive Officer; Tim Varicek, Senior Vice President of Commercial and Business Operations; Dr. Kevin Chung, Chief Medical Officer; and Mike Messenger, Chief Financial Officer.

Speaker #2: 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.

Speaker #2: These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results. For our list and description of these risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission.

Speaker #2: 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.

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

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

Speaker #2: And now, I'd like to turn the call over to Eric. Eric?

Speaker #3: 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 Quelamine revenue growth bode well for our future potential opportunity in the adult AKI market, which is 50 times larger than the pediatric market in the United States.

Eric Schlorff: Thank you, Jackie. 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 United States. 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.

Speaker #3: Successful treatment of pediatric AKI with Quelamine therapy by patient care teams is driving greater clinical confidence from a tight-knit critical care pediatric community, which we believe will only strengthen the future potential launch of this therapy in the adult AKI market.

Speaker #3: Tim will speak further on our plans for continued adoption of Quelamine 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.

Speaker #3: 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's story, I'd like to clarify that the same foundational therapy in Quelamine, 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.

Eric Schlorff: 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, 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.

Speaker #3: 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—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.

Speaker #3: Given the unique mechanism of our SCD therapy, and the significant value of finding a potential solution to this continued unmet need, I would note that we anticipate our current pharmacological or pharmaceutical-like gross margins to continue for Quelamine and to extend to our adult therapies, if approved.

Eric Schlorff: 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 pharmacological or 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.

Speaker #3: Furthermore, we believe that the FDA understands the importance of bringing innovative treatment advancements to critically ill patients with AKI. The FDA approved Quelamine 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.

Speaker #3: This should support a more collaborative and rapid approval process. We have also 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.

Speaker #3: 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 Quelamine, and enrolling patients in our Neutralize-AKI trial.

Eric Schlorff: 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?

Speaker #3: 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.

Speaker #3: Tim?

Speaker #4: Thanks, Eric, and thanks, everyone, for joining us today. We are making great progress in our efforts to establish Quelamine as an important therapy in the critical care of pediatric patients with AKI and sepsis.

Tim Varacek: 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 US 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. 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 Q1 call the considerable interest in QUELIMMUNE at the AKI & CRRT Conference in San Diego.

Speaker #4: Currently, 20 of the 50 premier children's hospitals in the U.S. have purchased and used our Quelamine 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.

Speaker #4: 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 Quelamine therapy is broadly resonating in the pediatric critical care community.

Speaker #4: Let me describe how. We discussed in our first quarter call the considerable interest in Quelamine at the AKI and CRRT meeting in San Diego.

Speaker #4: Adding to the buzz, we observed that we sponsored and participated in this year's Kidney Bee 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.

Tim Varacek: Adding to the buzz we observed there, we sponsored and participated in this year's Kidney Week 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.

Speaker #4: 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.

Speaker #4: The webinar was entitled "Rethinking Pediatric Sepsis-Associated AKI: What Clinicians Should Know About Quelamine." We brought together practicing pediatric nephrologists, critical care physicians, advanced practice providers, and nurses to learn more about pediatric sepsis-associated AKI and the use of quelamine therapy through case studies and quelamine adoption within hospitals.

Speaker #4: 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 learn how to apply that knowledge to employ our Quelamine therapy at the hospitals in which they practice.

Tim Varacek: 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. 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.

Speaker #4: 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, Quelamine is helping to drive new thinking in the pediatric AKI community.

Speaker #4: Now, turning to our revenue targets and future opportunities in this ultra-rare pediatric market, we reported Quelamine net revenues of $615,000 in the second quarter.

Speaker #4: A strong 82% increase over last year's second quarter. And with six-month net revenue at $1.1 million, momentum remains strong as we advance toward our 2026 net revenue target of $2 million.

Tim Varacek: 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.

Speaker #4: In short, we are very encouraged by the current rate of Quelamine adoption, and we continue to focus on adding new customers as quickly as possible.

Speaker #4: We have great expectations of helping more patients by bringing our Quelamine 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.

Speaker #4: 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 bill for Quelamine therapy when used in treating sepsis-associated pediatric AKI.

Speaker #4: And we believe all future potential indications for our SCD therapy will use the same PCS code. The implementation of the new ICD-10 PCS code begins on October 1 of this year.

Tim Varacek: The implementation of the new ICD-10-PCS code initiates on 1 October 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 US. Thank you for your attention.

Speaker #4: This is an important administrative development, as it removes another potential barrier to Quelamine adoption. In addition, we have completed the 50-patient SAVE registry that was required by the FDA to further evaluate the safety of our Quelamine therapy.

Speaker #4: 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 Quelamine.

Speaker #4: So, in summary, the future for our Quelamine 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.

Speaker #4: Thank you for your attention, and with that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

Tim Varacek: With that, I will turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

Speaker #1: 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.

Kevin Chung: 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 SCD therapy.

Speaker #1: It is rewarding to hear how these nephrology and critical care teams are adopting the Quelamine therapy and understanding that it is truly the first of its kind.

Speaker #1: These kids have days, if not hours, to live, and we have heard many stories about first-time use of Quelamine 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.

Speaker #1: And to be clear, we believe that CELLMATE for pediatric AKI indication is just the first of a broad range of indications for our SCD therapy.

Speaker #1: 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.

Kevin Chung: 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 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.

Speaker #1: 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 also for cardiorenal syndrome, systemic inflammation from cardiac surgery, chronic inflammation and end-stage renal disease, and other states of pathologic immune activation where dysregulated cytokine release drives organ failure and death.

Speaker #1: 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.

Speaker #1: 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.

Kevin Chung: 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.

Speaker #1: The last of which would be the submission of the neutralized AKI clinical trial results. I would also note that we have been awarded Breakthrough Device Designation for this indication.

Speaker #1: Which should support expedited regulatory review. As a reminder, our neutralized AKI pivotal trial is a randomized controlled trial designed to assess the SCD therapy in critically ill adult patients with AKI requiring CRT.

Speaker #1: The primary endpoint is a composite of mortality or dialysis dependence at 90 days. We have now 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.

Speaker #1: We recently onboarded two additional clinical sites, who have already recruited patients. We have four additional sites that we anticipate will be screening patients shortly.

Kevin Chung: 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 milligrams per deciliter.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: One of our enrichment criteria is a C-reactive protein or 3.5 milligrams per deciliter. Patients who do not have a CRP greater than 3.5 are excluded why?

Kevin Chung: Patients who do not have a CRP greater than 3.5 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.

Speaker #1: 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.

Speaker #1: Beyond CRP, we're also we are 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.

Speaker #1: 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.

Speaker #1: 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 Quelamine to much broader, unlabeled populations of pediatric patients than those enrolled in our trials.

Kevin Chung: We are seeing in the commercial setting physicians who are already applying QUELIMMUNE to a 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. 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 timeline in late 2027 remains unchanged.

Speaker #1: 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.

Speaker #1: We're making meaningful progress in neutralized 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.

Speaker #1: 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.

Speaker #1: 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.

Kevin Chung: 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 will hand it over to our CFO, Michael Messinger. Mike?

Speaker #1: Significantly simplifying hospital adoption. Also, given the foundation we're establishing in the pediatric critical care community with Quelamine, we believe it will support more rapid adoption among nephrology and critical care experts in the adult AKI community.

Speaker #1: We are passionate about our ability to improve and potentially save the lives of these critically ill patients, and look forward to reporting our progress. And with that, I'll hand it over to our CFO.

Speaker #1: Mike Messenger. Mike.

Speaker #2: 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.

Michael Messinger: Thank you, Kevin, and thanks everyone for joining our call today. I will provide a brief overview of our financial results for the Q2 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 30 June 2026. You will find the 10-Q at SEC.gov or through our website at seastarmedical.com. We recorded net revenue for the Q2 of $615,000, reflecting increased demand for QUELIMMUNE. This represents an 82% increase compared to net revenue of approximately $338,000 for the Q2 2025, and this is an increase in the rate of growth from the 69% growth we had in the Q1.

Mike Messinger: Thank you, Kevin, and thanks everyone for joining our call today. I will provide a brief overview of our financial results for the Q2 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 30 June 2026. You will find the 10-Q at SEC.gov or through our website at seastarmedical.com. We recorded net revenue for the Q2 of $615,000, reflecting increased demand for QUELIMMUNE. This represents an 82% increase compared to net revenue of approximately $338,000 for the Q2 2025, and this is an increase in the rate of growth from the 69% growth we had in the Q1.

Speaker #2: 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 30th, 2026.

Speaker #2: You will find the 10-Q at sec.gov or through our website. We recorded net revenue for the second quarter of $615,000, reflecting increased demand for Quelamine.

Speaker #2: 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.

Speaker #2: And 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.

Michael Messinger: We continue to maintain our gross profit percentage of over 90% in the Q2 2026, consistent with the prior four quarters. Turning now to our operating expenses. In the Q2 2026, we reported $4.4 million in operating expenses, compared to $2.1 million in the Q2 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 Q2 2025, primarily to an increase in compensation costs, legal and professional fees, and certain SEC-related expenses. As we indicated in our Q1 call, we expected our sequential quarterly research and development costs to increase based on adding additional clinical sites and our focused recruitment efforts.

Mike Messinger: We continue to maintain our gross profit percentage of over 90% in the Q2 2026, consistent with the prior four quarters. Turning now to our operating expenses. In the Q2 2026, we reported $4.4 million in operating expenses, compared to $2.1 million in the Q2 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 Q2 2025, primarily to an increase in compensation costs, legal and professional fees, and certain SEC-related expenses. As we indicated in our Q1 call, we expected our sequential quarterly research and development costs to increase based on adding additional clinical sites and our focused recruitment efforts.

Speaker #2: 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 due to the additional clinical sites and increased patient enrollment compared to the same period in 2025.

Speaker #2: And our general administrative expenses increased compared to the second quarter of 2025, primarily due to an increase in compensation costs, legal and professional fees, and certain SEC-related expenses.

Speaker #2: 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.

Speaker #2: 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.

Michael Messinger: We did see a roughly mid-single-digit increase over our Q1, and we continue to expect the same for the rest of 2026 as we anticipate meeting our enrollment goals. Net loss for the Q2 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 Q2 2025, based on approximately 1.1 million weighted average shares outstanding. We had approximately $7 million of cash on our balance sheet at 30 June 2026, compared to $12 million at 31 December 2025. With that, I will turn it back to Eric.

Mike Messinger: We did see a roughly mid-single-digit increase over our Q1, and we continue to expect the same for the rest of 2026 as we anticipate meeting our enrollment goals. Net loss for the Q2 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 Q2 2025, based on approximately 1.1 million weighted average shares outstanding. We had approximately $7 million of cash on our balance sheet at 30 June 2026, compared to $12 million at 31 December 2025. With that, I will turn it back to Eric.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: We had approximately $7 million of cash on our balance sheet at June 30, 2026, compared to $12 million at December 31, 2025. And with that, I'll turn it back to Eric.

Speaker #3: Thanks, Mike. Our goal today was to share with you our second-quarter achievements and also express how keenly focused we are on the key value drivers, both short- and long-term, for our stakeholders.

Eric Schlorff: Thanks, Mike. Our goal today was to share with you our Q2 achievements, but also express how keenly focused we are on the key value drivers, both short and long-term, for our stakeholders.

Speaker #3: We have a small but passionate team at SeaStar Medical, yet we believe we are reshaping the possibilities for kids—and in the future, potentially adults—who often face organ failure or death without new therapies to modulate the cytokine storm in acute kidney injury.

Eric Schlorff: 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?

Speaker #3: Our goal is to set a higher standard for the treatment of all patients who 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.

Speaker #3: With that, I'll ask the operator to open the call for questions. Operator?

Speaker #2: 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.

Operator: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. One moment for questions. Our first question comes from David Bautz with Zacks Small Cap Research. You may proceed.

Speaker #2: One moment for questions. Our first question comes from David Bouts with Zack's Small Cap Research. You may proceed.

David Bautz: 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 are seeing any type of acceleration of enrollment at the newer high-volume sites. Then lastly, can you quantify your confidence for hitting that 339 patients either by year-end or the first quarter of 2027?

Speaker #4: Hey, good afternoon, everyone. I appreciate you taking the questions. First of all, I was wondering if you could comment on what the current monthly enrollment rate is for the Neutral-AT AKI study, and if you're seeing any type of acceleration of enrollment at the neuro high-volume sites.

Speaker #4: And then lastly, can you quantify your confidence for hitting that 339 patients seated by year-end or the first quarter of '27?

Speaker #3: Yeah, so thanks for the question. Let me tackle the second one. What we've basically kind of guided the market is really our timeline is around year-end or into Q1.

Eric Schlorff: Yeah. Thanks for the question. Let me tackle the second one. What we have basically guided the market as is really our timeline is around year-end or into Q1. Obviously, it is going to depend on Kevin and his team bringing on additional sites, et cetera, from an enrollment standpoint. But I am really proud of what Kevin and his team are doing on bringing those on pace. But if I think about this, David, before he talks about maybe enrollment, we still believe that we are 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 timeline. But maybe, Kevin, you could talk a little bit about enrollment of various sites.

Speaker #3: 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.

Speaker #3: 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 an end of 2027 submission for the final PMA module, which obviously is really not impacting the timeline.

Speaker #3: But maybe Kevin, you could talk a little bit about enrollment of various sites.

Speaker #4: 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.

Kevin Chung: 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. That's relatively slower than what I would like. However, I have to emphasize, we have to get the right patients. 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 in the process of activating numerous sites.

Speaker #4: And that's relatively slower than what I would like. However, I have to emphasize that we have to get the right patients. And by "right patients," I mean those with modifiable disease.

Speaker #4: What's the point in finishing enrollment if we enroll a bunch of patients out of haste just to hit our number, and we're not enrolling the right patients?

Speaker #4: 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.

Speaker #4: That's number one. Number two, as we discussed in the report—in our update—we're very busy right now with activating, in the process of activating, numerous sites. As I said, there are four that are so close to getting activated, just some residual signatures and et cetera, those kinds of things.

Kevin Chung: 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're ready to activate them. So we're going to very soon be seeing some reinforcements come in with an additional four sites ready to go. Already trained. SIVs already performed, site initiation visits. So we're ready to go with those sites. There are additional eight sites, half of whom contacted us because they wanted in on the trial. So they've committed. Now, whether or not we're going to be able to activate all eight 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.

Speaker #4: And we're ready to activate them. And so we're going to very soon be seeing some reinforcements come in, with an additional four sites ready to go.

Speaker #4: Already trained, SIVs already performed, site initiation visits. So we're ready to go with those sites. There are additional eight sites half of whom contacted us because they wanted in on the trial.

Speaker #4: And so they've committed. Now, whether or not we're going to be able to activate all eight 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.

Speaker #4: 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.

Kevin Chung: We have to get the right patients. We have to get that right to have a chance for a positive trial.

Speaker #4: Okay. Great. So 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?

David Bautz: Okay, great. So 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?

Speaker #3: Yeah. 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, we can analyze, et cetera.

Eric Schlorff: Yeah. Your question is what are some of the. 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. It 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. So that is really what the strategy is.

Speaker #3: And then really it's just submitting the clinical section. It's really essentially because all the other previous sections will have been submitted by that time.

Speaker #3: 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.

Speaker #3: So that's really what the strategy is.

Speaker #4: 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.

David Bautz: Okay. Sounds good. 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?

Speaker #3: Yeah, thanks. Tim, do you want to tackle that one?

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

Speaker #2: 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 want to stock the product as soon as they can.

Tim Varacek: Sure. Yeah. It is 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. Then obviously the new sites that come on board, they want to stock the product as soon as they can so that they are ready to treat patients. So it was a group effort by all of the customers that were out there.

Speaker #2: So that they're ready to treat patients. So it was a group effort by all of the customers that were out there.

Speaker #4: Okay, great. I appreciate you taking the questions.

David Bautz: Okay, great. Appreciate you taking the questions.

Speaker #2: Thanks, David.

Eric Schlorff: Thanks, David.

Speaker #3: Thanks.

David Bautz: Thanks.

Speaker #1: Thank you.

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

Speaker #2: All right. Next question comes from Anthony Vendetti with Maxim Group. You may proceed.

Speaker #5: 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?

Anthony Vendetti: 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?

Kevin Chung: No, we are submitting preliminary reports.

Eric Schlorff: No, we are submitting preliminary reports.

Speaker #3: No, we're submitting preliminary reports. So, we're submitting—no, well—so, you're talking about the PMA, right, for adults?

Anthony Vendetti: Yeah.

Kevin Chung: Well, we are submitting. Well, you are talking about the PMA, right? For adult.

Eric Schlorff: Well, we are submitting. Well, you are talking about the PMA, right? For adult.

Anthony Vendetti: Yeah.

Speaker #5: Yeah. Yeah, yeah, yeah.

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

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

Speaker #3: Yeah. So, yeah, for that—I mean, obviously, what we're doing right now is a modular PMA. So there are various sections where you talk about the device, you talk about sterilization, you talk about all sorts of, kind of, the technical things.

Speaker #3: That go into it. But then you get into what the goal really is, Anthony: to have those sections already submitted to the FDA, and to have already had the discussions with the FDA on those sections.

Speaker #3: And 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.

Speaker #5: Okay. And so you've already submitted certain sections.

Anthony Vendetti: Okay. You have submitted already the certain sections.

Speaker #3: No. We're in the process.

Kevin Chung: No, we are in the process.

Eric Schlorff: No, we are in the process.

Speaker #5: Still working.

Anthony Vendetti: Still working on it.

Speaker #3: So yeah, we're in the—yeah, we're in the process of doing that. Yeah.

Kevin Chung: Yeah, we are in the process of doing that. Yeah.

Eric Schlorff: Yeah, we are in the process of doing that. Yeah.

Speaker #5: Got it. Got it. Okay. And then you have right now about 20 pediatric hospitals, right?

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

Speaker #3: Correct.

Tim Varacek: Correct.

Eric Schlorff: Correct.

Anthony Vendetti: 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 just, hey, 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?

Speaker #5: So is there a process or what do you have to do to make sure they're not just sort of like, okay, they're a hospital that uses this, but how do you get them to be more meaningful recurring customers or just, hey, you just need the patients to come in and they're already on board and there's nothing really left to do with those particular hospitals?

Speaker #3: Yeah. Maybe Tim, you could kind of address it, and then Kevin, if you would like to add any additional comments on top of it.

Eric Schlorff: Yeah, maybe, Tim, you could kind of 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.

Speaker #3: It is really a multidisciplinary approach that we take to these hospital systems.

Speaker #5: Okay.

Anthony Vendetti: Okay.

Speaker #2: Yeah. Absolutely is. Just to give you insight. So let's say a hospital just came into the fold today. They've adopted Qualimune 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.

Tim Varacek: Yeah, it absolutely is. Just to give you insight, let us 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. Now, in terms of what happens after that, there is a lot of work to do. Because every hospital system is large. They have a lot of different staff. They have different shifts.

Speaker #2: Then a patient actually shows up in the emergency room, gets moved to the ICU, and Qualimune becomes something that's top of mind. We have then the clinical team that'll come over.

Speaker #2: They'll actually help with the setup of that first patient to ensure everything goes smoothly. Now, in terms of what happens after that, there's a lot of work to do, because every hospital system is large.

Speaker #2: They have a lot of different staff. They have different shifts. And so there really needs to be an educational approach to that hospital system that never ends because there's turnover like in any other business.

Tim Varacek: There really needs to be an educational approach to that hospital system that never ends, because there is turnover like in any other business. 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.

Speaker #2: 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'll add.

Speaker #2: So that Qualimune is something that's top of mind for the patient care teams because we believe that while Qualimune is a super effective therapy, if you don't know about it and a patient comes in and there's not one of your advocates there, they may not realize that they could use Qualimune to treat that patient.

Speaker #2: So it's 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 Qualimune therapy as an option when it's there and it's available.

Tim Varacek: 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.

Speaker #3: Okay. So 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, of the application of the Qualimune, correct?

Anthony Vendetti: 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 are 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?

Speaker #2: 100%.

Tim Varacek: 100%.

Speaker #3: Yep. Okay.

Anthony Vendetti: Yep. Okay.

Kevin Chung: If I may add some color to the clinical perspective.

Speaker #1: If I may add some color to the clinical perspective, so yesterday we conducted a webinar that will make available very soon so that those of you who missed the webinar or had technical difficulties are able to dial in.

Anthony Vendetti: Sure.

Kevin Chung: Yesterday we conducted a webinar that we will 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 is a big difference between new sites that have device and mature sites that have device. New sites, anytime there is a new technology, even if it is life-saving, because of the natural skepticism that is very prevalent within the medical community, they have to see it work. Generally it is used as a rescue therapy. What I mean by that is it is 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. That is new sites. That is the approach that they take.

Speaker #1: During that discussion, it became it was 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.

Speaker #1: 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 that they have to see it work.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: And that's been true for almost every site that has been activated, because whenever therapy is new, that's what's going to happen. And I have to say, and have to emphasize, that even with those types of patients that have failed other therapies, we're talking about a 70% survival in that population, which I have to emphasize is remarkable.

Kevin Chung: That has been true for almost every site that have been activated, because whenever a therapy is new, that is what is going to happen. I have to say, and 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. But 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.

Speaker #1: But yesterday, we're 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.

Speaker #1: These sites everybody's already educated. Everybody is 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." And this is occurring and adoption clinical adoption mentally is occurring pretty universally across our mature sites.

Speaker #1: And so right now, as we speak, those clinicians are scanning their ICU to see who may benefit from the therapy. And so it's no longer now a rescue therapy.

Kevin Chung: 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. That was my takeaway from the webinar. Again, we will make this available very soon, and hopefully you will be able to watch it and verify my statement. Thanks.

Speaker #1: They're not waiting until the bitter end. They're starting these patients early. And we're seeing even better outcomes, which is just really remarkable. So that was my takeaway from the webinar again, I will we will make this available very soon.

Speaker #1: And hopefully, you'll be able to watch it and verify my statement. Thanks.

Speaker #3: No, that's helpful, Kevin. Yeah, so, I mean, we know the focus—as it should be—is on the pediatric market, and now the adult AKI.

Anthony Vendetti: 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, and we know adult AKI is 50 times larger than the pediatric market. But there are other markets that your Cytopheretic Device can treat, whether that be acute respiratory distress syndrome, hepatorenal syndrome, cardiorenal syndrome, and of course, sepsis. I know you want to stay focused, as 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?

Speaker #3: With this trial and enrollment, you're at 223 of the 339. And we know that adult AKI is 50 times larger than the pediatric market.

Speaker #3: But there's other markets that you're side of fear it's device can treat, whether that be acute respiratory distress, hepatorenal syndrome, cardiorenal syndrome, and of course, sepsis.

Speaker #3: So I know you want to stay focused as 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?

Speaker #2: Yeah. So I can tackle that one.

Kevin Chung: Yeah.

Eric Schlorff: Yeah. I can tackle that one.

Anthony Vendetti: Okay, sure.

Speaker #3: Yeah, so yeah, I mean, yeah. So we do obviously evaluate all the other applications, and we believe that obviously from our perspective, there's a pretty long laundry list of things that really would be on our wish list.

Eric Schlorff: Yeah. We do obviously evaluate all the other applications that we believe that, obviously, from our perspective, there is 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 is really been on QUELIMMUNE for pediatric AKI and adult AKI and NEUTRALIZE-AKI. Obviously, we have the NEUTRALIZE-CRS study that is actually been funded by NIH. 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 the other indications that we believe we have in our pipeline. But obviously, it will just take time for some of those things to mature, and we will just have to see how they pan out.

Speaker #3: But obviously, we as a company have to be focused on certain things. And that's really been on Qualimune for pediatric AKI and adult AKI and neutralized AKI.

Speaker #3: Obviously, we've got the neutralized 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.

Speaker #3: 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: 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.

Speaker #1: If I may just add really quickly, I should remind everyone that for neutralized AKI, a priori, we identify patients with ARDS at the time of enrollment and sepsis at the time of enrollment.

Speaker #1: 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, the sepsis bucket, and the combined sepsis and ARDS bucket.

Speaker #1: We will be able to for sure make a statement about those specific populations who have concomitant AKI, of course.

Speaker #3: No, that's very helpful. Thank you. Thanks, Eric, Kevin, everyone. Okay, I will hop back in the queue. Thanks.

Anthony Vendetti: No, yeah. That is very helpful. Thank you. Thanks, Eric, Kevin, everyone. I will hop back in the queue. Thanks.

Speaker #2: Thank you. I would now like to turn the call back over to Jackie Kossmann for any closing remarks.

Operator: Thank you. I would now like to turn the call back over to Jackie Cossmon for any closing remarks.

Speaker #4: 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.

Jackie Kostman: Thank you, Josh, and thank you all for joining us today for the SeaStar Medical Q2 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.

Jackie Cossmon: Thank you, Josh, and thank you all for joining us today for the SeaStar Medical Q2 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.

Speaker #4: Thank you and goodbye.

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