Q1 2025 SeaStar Medical Holding Corp Earnings Call

Hello, and thank you for standing by my name is Tiffany and I will be your conference operator today at this time I would like to welcome everyone to the C store medical first quarter financial results Conference call. All lines have been placed on mute to prevent any background noise.

Operator: Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press star followed by the number one on your telephone keypad. If you'd like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Jackie Cossmon. Please go ahead.

Speaker Change: After the Speakers' remarks, there will be a question and answer session. If you'd like to ask a question during that time simply press star followed by the number one on your telephone keypad, if you'd like to withdraw your question Press Star. One again. Thank you I would now like to turn the call over to Jacky Kauffman. Please go ahead.

Jacky Kauffman: Thank you Tiffany good afternoon, and thank you for joining the <unk> medical first quarter 'twenty 25 financial results Conference call.

Jackie Cossmon: Thank you, Tiffany. Good afternoon and thank you for joining the SeaStar Medical Q1 2025 Financial Results Conference Call. I'm Jackie Cossmon with Wheelhouse Life Science Advisors. Joining me today from SeaStar Medical are Eric Schlorff, Chief Executive Officer, David Green, Chief Financial Officer, Dr. Kevin Chung, Chief Medical Officer, and Tim Varacek, Senior Vice President of Commercial and Business Operations. I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of the 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 Kaufman: I'm, Jackie Kaufman with Wheelhouse life Science advisors, joining me today from C store medical or Eric.

Speaker Change: Eric Schwartz, Chief Executive Officer, David Green, Chief Financial Officer, Dr. Kevin Chang, Chief Medical Officer, and Tim very check senior Vice President of commercial and business operations.

Speaker Change: I would like to remind listeners that comments made during this call by management will include forward looking statements within the meaning of the securities Federal Securities laws. These forward looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results.

Speaker Change: For a list and description of these risks and uncertainties. Please review C Star Medical's filings with Securities and Exchange Commission.

Jackie Cossmon: Furthermore, the content of this call contains information that is accurate only as of the date of the live broadcast, 14 May 2025. 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?

Speaker Change: Furthermore, the content of this call contains information that is accurate only as of the date of the live broadcast may 14th 2025 days.

Speaker Change: Eastern medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law.

Eric: And now I'd like to turn the call over to Eric Eric.

Eric Schlorff: Thank you, Jackie. Thank you all for joining us today. We have made great progress on several fronts. Just last week, we added another prestigious nationally recognized children's hospital to our list of QUELIMMUNE customers and achieved 50% enrollment in our NEUTRALIZE-AKI trial. We were granted 2 new Breakthrough Device designations by the FDA, expanding our pipeline indications to address the destructive hyperinflammation that can occur during adult and pediatric cardiac surgery. We are especially pleased to see the increased adoption of our QUELIMMUNE therapy in our existing customer sites. This drove a fourfold increase in our Q1 revenue compared to the Q4 of 2024. Tim will discuss our QUELIMMUNE commercialization strategy shortly, let me just reiterate that our primary goal this year is to grow our customer base.

Eric: Thank you Jackie and thank you all for joining US today, we have made great progress on several fronts. Just last week, we added another prestigious nationally recognized children's hospital to our list of quell immune customers and achieve 50% enrollment in our neutralized AK I trial, we were granted two new breakthrough.

Eric: Designations by the FDA, expanding our pipeline indications to address the destructive hyper inflammation that can occur during adult and pediatric cardiac surgery.

Eric: We're especially pleased to see the increased adoption of our quell immune therapy in our existing customer sites.

Eric: This drove a four fold increase in our first quarter revenue compared to the fourth quarter of 2024.

Speaker Change: Ken will discuss our quality and commercialization strategy shortly but let me just reiterate that our primary goal. This year is to grow our customer base.

Eric Schlorff: We are clearly seeing that once adopted, customers are experiencing organ-sparing and life-saving outcomes from using the QUELIMMUNE therapy in their pediatric AKI patients. As we grow our customer base, we believe we can drive meaningful revenue from this small but important market of about 4,000 patients annually in the United States. Turning to what we believe is the significant upside opportunity for SeaStar Medical, I'd like to talk about the adult AKI market as well as the other opportunities for the SCD therapy. Our clinical development is now focused on penetrating the adult markets. It's important to note that our SCD therapy is designed as a disease-modifying therapy that neutralizes overactive immune cells and stops the destructive hyperinflammation that shuts down critical organ function and takes lives.

Speaker Change: We are clearly seeing that once adopted customers are experiencing organ sparing and life saving outcomes from using the quell immune therapy in <unk>.

Speaker Change: There are pediatric Hai patients as we grow our customer base. We believe we can drive meaningful revenue from this small but important market of about 4000 patients annually in the United States.

Speaker Change: Now.

Speaker Change: Turning to what we believe is a significant upside opportunity for <unk> medical I'd like to talk about the adult AK AD market as well as the other opportunities for the S. E T therapy.

Speaker Change: Our clinical development is now focused on penetrating the adult markets. It's important to note that our SCV therapy is designed as a disease modifying therapy that neutralizes overactive immune cells and stops the destructive hyper inflammation, that's shuts down critical organ function and takes lives.

Eric Schlorff: An extreme example of this was COVID-19, but every year, millions of patients experience surgery, trauma, or infection where their body's immune system overreacts, and a cytokine storm yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient's body. Our first opportunity in the adult patient population is for the treatment of hyperinflammation in patients with Acute Kidney Injury or AKI requiring continuous renal replacement therapy or CRRT. This is a similar condition to pediatric AKI that is life-threatening with no effective treatment options, but it is a far larger market opportunity with over 200,000 adults or 50 times the number of pediatric patients with this condition. Based on our current estimates, this translates to about a $4.5 billion total annual market opportunity in the United States.

Speaker Change: An extreme example of this was COVID-19, but every year millions of patients experienced surgery trauma or infection, where their bodies immune system overreacts and the cytokine storm yields destructive hyper inflammation and creates a cascade of events that wreak havoc in the patient's body our first opera.

Speaker Change: <unk> in the adult patient population is for the treatment of hyper inflammation in patients with acute kidney injury or hai requiring continuous renal replacement therapy or <unk> T. This is a similar condition to pediatric AK I that is life threatening with no effective treatment options, but it is.

Speaker Change: A far larger market opportunity with over 200000, adults or 50 times the number of pediatric patients with this condition based on our current estimates this translates to about a four and a half billion dollar total annual market opportunity in the United States.

Speaker Change: Our neutralized AK IDE pivotal trial for adult patients with AK in CRT is well underway and if all goes to plan, we intend to file a PMA for this indication in 2026th we announced yesterday that our ongoing neutralized ATI trial has reached 50% enrollment target this enrollment milestone.

Eric Schlorff: Our NEUTRALIZE-AKI pivotal trial for adult patients with AKI and CRRT is well underway, and if all goes to plan, we intend to file a PMA for this indication in 2026. We announced yesterday that our ongoing NEUTRALIZE-AKI trial has reached the 50% enrollment target. This enrollment milestone also triggered the pre-specified interim analysis by the trial's independent Data Safety Monitoring Board or DSMB. I'll let Kevin describe the details, but the interim analysis is designed to evaluate the safety and powering assumptions for the trial. We anticipate that the DSMB will report its findings to the company in Q3 2025. I would like to emphasize here that in order to maintain the integrity of the trial, specific data from the interim analysis cannot be shared. We will, however, issue a press release to provide the DSMB's final recommendation.

Speaker Change: Also triggered the pre specified interim analysis by the trial's independent data safety monitoring board or D. SMB I'll, let Kevin described the details, but the interim analysis is designed to evaluate the safety and powering assumptions for the trial.

Speaker Change: We anticipate that the D. SMB will report its findings to the company in the third quarter of 2025.

Speaker Change: I would like to emphasize here that in order to maintain the integrity of the trial specific data from the interim analysis cannot be shared we will however issue a press release to provide the D. Smbs final recommendation.

Eric Schlorff: Completing the NEUTRALIZE-AKI trial and potentially obtaining approval are key near-term milestones for us. We are very excited about this market opportunity and are already engaging with physicians and healthcare providers on the medical affairs side to educate them about the SCD therapy and data that support its use as a potential treatment for patients with AKI and CRRT. Beyond the AKI market, the SCD therapy has been granted Breakthrough Device designations for five other indications. Tim will describe the potential commercial opportunities that we hope to derive from our rich pipeline of indications. With that as an overview, I'll turn the call over to Tim to discuss our commercial achievements and market opportunities.

Completing the neutralized Hai trial and potentially obtaining approval our key near term milestones for US. We are very excited about this market opportunity and are already engaging with physicians and health care providers on the medical affairs side to educate them about the SCD therapy and data that support its use as a.

Speaker Change: Potential treatment for patients with Hai and CRT.

Speaker Change: Beyond the Hai market. The SCD therapy has been granted breakthrough device designation for five other indications Tim will describe the potential commercial opportunities that we hope to derive from our rich pipeline of indications.

Speaker Change: And with that as an overview I'll turn the call over to Tim to discuss our commercial achievements and market opportunities.

Tim: Thanks, Eric and thanks, everyone for joining us on the <unk> medical call.

Tim Varacek: Thanks, Eric, and thanks everyone for joining us on the SeaStar Medical call. We're thrilled to report the solid increase in revenue in this Q1, and what's most important to us are the metrics underlying the increase. We continue to see repeat orders at our existing sites as physicians gain more confidence treating pediatric patients based on their treatment experience with QUELIMMUNE therapy. In addition to the 2 new customers that we announced earlier this year, we reported today that we have shipped QUELIMMUNE therapy to another new customer that is a nationally recognized children's medical facility. Our pipeline of potential customers is expanding, and we anticipate bringing on new multiple sites by year-end. QUELIMMUNE is the only FDA-approved product for the condition of life-threatening acute kidney injury due to sepsis or a septic-like condition in critically ill pediatric patients.

Tim: We're thrilled to report the solid increase in revenue in this first quarter and what's the most important to US are the metrics underlying the increase we continue to see repeat orders at our existing sites as physicians gain more confidence treating pediatric patients based on their treatment experience with <unk> therapy.

Tim: In addition to the two new customers that we announced earlier this year. We reported today that we have shipped quality of therapy to another new customer that is a nationally recognized children's medical facility.

Tim: Our pipeline of potential customers is expanding and we anticipate bringing on new multiple sites by year end.

Tim: <unk> is the only FDA approved product for the condition of life threatening acute kidney injury due to sepsis or septic like condition.

Tim: <unk> pediatric patients.

Tim Varacek: The data show that these young patients have a 50% chance of survival, and in many cases that we've seen, it's less than that. If they survive, a significant portion also experience lifelong organ damage and require outpatient renal replacement therapy 2 to 3 times per week. This is also known as dialysis. Our QUELIMMUNE clinical trial shows significant improvement in these outcomes. We believe that over time, we can capture a healthy portion of what we estimate to be about $100 million total annual US market opportunity based on a pediatric AKI population of approximately 4,000 patients. Now, with respect to our overall commercial strategy and current plans, our primary goal is site adoptions. Our specific focus today is on select children's medical facilities that typically treat a higher volume of these pediatric AKI patients.

Tim: The data show that these young patients have a 50% chance of survival and in many cases that we've seen it's less than that.

Tim: If they survive a significant portion also experienced lifelong organ damage and require outpatient real renal replacement therapy two to three times per week. This is also known as dialysis.

Tim: In clinical trials showed significant improvement and these outcomes. So we believe that over time, we can capture a healthy portion of what we estimate to be about $100 million total annual U S market opportunity based on our pediatric ACI population of approximately 4000 patients now.

Tim: Now.

Tim: With respect to our overall commercial strategy and current plans our primary goal is site adoptions.

Our specific focus today is on select children's medical facilities typically treat a higher volume of these pediatric <unk> patients.

Tim Varacek: To put this into perspective, this is a very concentrated market, and our objective is to focus on the top 50 pediatric sites in the US that have the resources to support this registry. As we've said previously, the process of adoption at these medical centers can be lengthy for any new device, and for QUELIMMUNE, the FDA approval requires a post-approval surveillance registry that adds an additional step and requires an additional IRB approval of this registry. That typically takes more time, and that boils down to time to activation, which can vary from several months to approximately 8 months. The good news is that we're engaged with most of the top pediatric medical centers in the US, and they are truly interested in bringing QUELIMMUNE into their facilities.

Tim: Put this into perspective. This is a very concentrated market and our objective is to focus on the top 50 pediatric sites in the U S that have the resources to support this registry.

Tim: As we said previously the process of adoption at these medical centers can be lengthy for any new device and for quality in the FDA approval requires a post approval surveillance registry that adds an additional step and requires an additional IRB approval of this registry.

Tim: That typically takes more time and that boils down to time to activation, which can vary from several months to approximately eight months.

Tim: The good news is that we're engaged with most of the top pediatric medical centers in the U S.

Tim: And they are truly interested in bringing <unk> into their facilities, we see a strong commitment in terms of championing this effort by the pediatric nephrology and ICU teams.

Tim Varacek: We see a strong commitment in terms of championing this effort by the pediatric nephrology and ICU teams as we go through the adoption process with them. Our internal tracking to date indicates that seven out of every 10 pediatric hospitals we approach to gauge interest ultimately commit to QUELIMMUNE therapy adoption. We still anticipate that sales will be lumpy until more pediatric hospitals are activated, and we can gain a further understanding of the cadence of patient presentation within these hospitals. The excitement for the outcomes that QUELIMMUNE therapy can deliver is growing in the pediatric community, and word of mouth is the best validation for expanding QUELIMMUNE adoption. With that framework of our QUELIMMUNE launch efforts, I'll now discuss our commercial opportunity for the SCD therapy platform.

Tim: As we go through the adoption process with that.

Tim: Our internal tracking to date indicates that seven out of every 10 pediatric hospitals, we approach to gauge interest ultimately commit to quality and therapy adoption.

Tim: And we still anticipate that sales will be lumpy until more pediatric hospitals are activated and we can gain a further understanding of the cadence of patient presentation within these hospitals, but the excitement for the outcomes that <unk> therapy can deliver is growing in the pediatric community and word of mouth is the best validation Brooks.

Tim: Standing quality and adoption.

Tim: So with that framework of our quality and launch efforts I'll now discuss our commercial opportunity for the <unk> therapy platform.

Tim Varacek: With our NEUTRALIZE-AKI trial well underway, we have begun our pre-commercialization efforts to support a potential launch of the SCD therapy as a treatment for adult patients with AKI requiring CRRT. Our current anticipated launch timeline in adult AKI is Q4 of 2026, and this assumes positive clinical trial results and FDA approval. The total market opportunity in the US is approximately 50 times the size of the pediatric population or about 200,000 patients annually that face organ failure and potentially loss of life with no FDA-approved treatment options beyond the current standard of care, which is CRRT and antibiotics. At our current projected revenue per patient, this translates to a total market opportunity of about $4.5 billion. Even a modest market penetration would deliver significant revenue for SeaStar Medical.

Tim: With our neutralize ATI trial, well underway, we have begun our pre commercialization efforts to support a potential loss.

Tim: Launch of the SPD therapy as a treatment for adult patients with Hai requiring CRT.

Tim: Our current anticipated launch timeline and adult ATI is Q4 of 2026 and this assumes positive clinical trial results and FDA approval.

Tim: The total market opportunity in the U S is approximately 50 times the size of the pediatric population or about 200000 patients annually.

Tim: The face organ failure and potentially loss of life with no FDA approved treatment options beyond the current standard of care.

Tim: Would you see our RT and antibiotics.

Speaker Change: At our current projected revenue per patient this translates to a total market opportunity of about $4 5 billion.

Speaker Change: Even a modest market penetration would deliver significant revenue for <unk> medical.

Tim Varacek: For this near-term potential market, we are also modeling a more favorable time to adoption than QUELIMMUNE based on factors such as increased clinical need due to the size of this population, as well as our ability to leverage pediatric customer experiences with QUELIMMUNE. Kevin and the medical affairs team are already in the process of educational efforts in the peer-to-peer setting, and we are excited about the prospects of adding this potential life-saving therapy for adult patients with AKI and CRRT. Now turning to the broader market, the adult AKI indication is just the beginning of a long line of indications that could follow.

Speaker Change: For this near term potential market. We are also modeling a more favorable time to adoption in quell immune based on factors such as increased clinical need due to the size of this population as well as our ability to leverage pediatric customer experiences with quality.

Speaker Change: Kevin in the medical Affairs team are already in the process of educational efforts and the peer to peer setting and we're excited about the prospects of adding this potential life saving therapy for adult patients with Hai in CRT and.

Speaker Change: And now turning to the broader market.

Speaker Change: The adult ATI indication is just the beginning of a long line of indications that could follow.

Tim Varacek: When looking at just the indications in which we have received FDA Breakthrough Device designation. We estimate in the US market alone, the total annual market size is hundreds of thousands of patients that currently have no approved therapies to address conditions where destructive hyperinflammation creates critical care issues, organ failure, and death. At SeaStar Medical, we are committed to bringing our first and only SCD therapy to patients who today face lifelong organ damage and loss of life. With that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

Speaker Change: When looking at just the indications in which we have received FDA breakthrough device designation.

Speaker Change: We estimate in the U S market alone. The total annual market size is hundreds of thousands of patients that currently have no approved therapies to address conditions, where destructive hyper inflammation creates critical care issues organ failure and death.

Speaker Change: <unk> medical we are committed to bringing our first and only LCD therapy to patients who today face lifelong organ damage and loss of life.

Speaker Change: And with that I'll turn the presentation over to our Chief Medical Officer, Kevin Chuck Kevin.

Kevin Chung: Thanks, Tim, and thanks to our listeners for joining us today. I am pleased to report that our NEUTRALIZE-AKI trial has now crossed the halfway point towards our enrollment goal of 200 patients. We currently stand at 100 patients enrolled as of Tuesday. NEUTRALIZE-AKI, as many of you know, is our randomized control pivotal trial designed to determine whether up to 10 sequential 24-hour treatments with SCD therapy will improve 90-day survival or recovery from kidney failure in patients with AKI requiring CRRT when compared to CRRT alone. Our goal is to enroll a total of 200 patients, with a primary endpoint identified as the composite of mortality or dialysis dependency at 90 days. Us reaching the 100th patient milestone triggers an interim analysis that will be conducted by the DSMB. This analysis will commence once our 100th patient has reached the 90-day primary endpoint.

Speaker Change: Thanks, Tim and thanks to our listeners for joining us today.

Speaker Change: I am pleased to report that our neutralize Hai trial is not crossed the halfway point towards our enrollment goal of 200 patients. We currently stand at 100 patients enrolled as of Tuesday.

Speaker Change: Neutralize Hai as many of you know is our randomized controlled pivotal trial designed to determine whether up to 10 sequential 24 hour treatment with SPD therapy will improve 90 day survival of recovery from kidney failure in patients with ACI, requiring CRT when compared to CRT alone.

Speaker Change: <unk>.

Speaker Change: Our goal is to enroll a total of 200 patients with a primary endpoint identified as the composite of mortality.

Speaker Change: <unk> dependency at 90 days.

Speaker Change: Reaching a 100 patient milestone triggers an interim analysis that will be conducted by the SNB.

Speaker Change: This analysis will commence once our 100th patient has reached the 90 day primary endpoint.

Kevin Chung: With some additional time for data and review, we anticipate the DSMB will submit their recommendation to the company in Q3 2025. To give you a sense of how the analysis will proceed, the pooled data will be analyzed based on the differences in outcomes between the treated patients versus controls. The DSMB will provide a recommendation to SeaStar Medical and the NEUTRALIZE-AKI investigators as to how to proceed with the trial. While we can't be certain of the recommendation from the independent DSMB, we designed the interim analysis to ensure we powered this trial properly. As Eric indicated, we must preserve the integrity of the trial. To set expectations properly, we will only convey the summary decision of the DSMB and no other clinical results will be shared.

Speaker Change: With some additional time for data and review, we anticipate the SMB will submit their recommendation to the company in the third quarter of 2025.

Speaker Change: To give you a sense of how the analysis will precede the full data will be analyzed based on the differences in outcomes between the treated patients versus controls.

Speaker Change: <unk> will provide a recommendation to CCR medical and neutralize ATI investigators as to how to proceed with the trial.

Speaker Change: While we can't be certain of the recommendation from the independent the SMB. We designed the interim analysis to ensure we powered the trial properly.

Speaker Change: As Eric indicated we must preserve the integrity of the trial.

Speaker Change: Set expectations properly, we will only convey the summary decision of the SMB and no other clinical results will be shared.

Kevin Chung: The possible DSMB recommendations are as follows: Continue the trial as planned to a total of 200, which is what we anticipate. Increase the total sample size to ensure adequate power if the effect size appears to be smaller than anticipated. Stop the trial for overwhelming efficacy. Lastly, stop the trial for futility. We expect a completely objective and unbiased recommendation by the DSMB based on what the interim data shows. Now that we've reached the halfway point, we plan on redoubling our efforts towards getting to our goal of 200 as fast as humanly possible. As such, we plan to activate additional sites to ensure we are screening as many patients as needed. I have to emphasize that per trial design, we're focusing the enrollment of the right type of patient through a process called enrichment.

Speaker Change: The possible DSM be recommendations are as follows.

Speaker Change: Continue the trial as planned to a total 200, which is what we anticipate.

Speaker Change: Increased the total sample size to ensure adequate power if the effect size appears to be smaller than anticipated.

Speaker Change: Stop the trial for overwhelming efficacy or lastly stop the trial for utility.

Speaker Change: We expect a completely objective and unbiased recommendation by the SMB based on what the interim data shows.

Speaker Change: Now that we've reached the halfway point, we plan on redoubling, our efforts towards getting to our goal of 200 as fast as humanly possible.

Speaker Change: As such we plan to activate additional sites to ensure we are screening as many patients that need it.

Speaker Change: I have to emphasize that per trial design, we're focusing the enrollment of the right type of patient through a process called enrichment.

Kevin Chung: There are certain groups of patients, for example, that have absolutely no modifiable disease. In other words, they would live or die regardless of the intervention based on their underlying problem. Countless pivotal studies in the past have failed, falling victim to having too many of these types of patients. This will not be us. While the enrollment rate for this trial has been agonizingly slow at times, like this past month, I want to assure all of you that our team is 100% focused on completing enrollment by the end of this year. Additionally, I am certain that we are enrolling the right type of patients into our trial and appropriately excluding those who have no modifiable disease whatsoever. I know we have optimized our chances of a positive trial.

Speaker Change: There are certain groups of patients for example that have absolutely no modifiable disease.

Speaker Change: In other words, they would live or die regardless of the intervention based on their underlying problem.

Speaker Change: Countless pivotal studies in the past to fail falling victim to having too many of these types of patients.

Speaker Change: This will not be us.

Speaker Change: While the enrollment rate for this trial has been agonizingly slow at times like this past month I want to assure all of you that our team is 100% focused on completing enrollment by the end of this year.

Speaker Change: Additionally, I am certain that we are enrolling the right type of patients into our trial and appropriately excluding those who had no model filed modifiable diseases whatsoever.

Speaker Change: I know, we have optimized our chances of a positive trial.

Kevin Chung: Now, looking beyond the interim analysis, once we have completed the trial and achieved 100% data lock, we intend to rapidly analyze and report our data to the international medical community. Provided we meet our primary endpoint, we plan to complete our PMA filing and submit it to the FDA. The Breakthrough Device designation, which we hold for adult AKI, should help facilitate speedy communication between us and the FDA during the review and approval process, and as such, we would hope to have product available to patients sometime in Q4 2026. The NEUTRALIZE-AKI trial is clearly our focus today. However, our strategic goal as a company is to widen the addressable market rapidly to target other critical unmet medical needs for the treatment of destructive hyperinflammation through additional clinical trials.

Speaker Change: Now looking beyond the interim analysis once we have completed the trial and achieved 100% data lock we.

Speaker Change: We intend to rapidly analyze and report our data to the international medical community.

Speaker Change: Provided we meet our primary endpoint, we plan to complete our PMA filing and submitted to the FDA.

Speaker Change: The breakthrough device designation, which we hold for adult Hai should help facilitate speedy communication between us and the FDA during the review and approval process and as such we would hope to have product available to patients sometime in the fourth quarter of 2026.

Speaker Change: The neutralize ACI trial is clearly our focus today.

Speaker Change: Over our strategic goal as a company is to widen the addressable market rapidly targets other critical unmet medical needs for the treatment of destructive hyper inflammation through additional clinical trials.

Kevin Chung: Beyond the adult AKI indication, we have been awarded Breakthrough Device designation for five others, including the treatment of patients with cardiorenal syndrome, patients with hepatorenal syndrome, patients with end-stage renal disease, and both adult and pediatric patients undergoing cardiac surgery. Given the organ and disease-agnostic characteristic of our therapy, there are several more indications to come. We believe that AKI is just the beginning of our opportunity to spare organs and save lives in these patient populations. With that as our summary of our clinical developmental efforts and goals, I turn the call over to our CFO, David Green.

Speaker Change: Young adult PCI indication, we have been awarded breakthrough device designation for five others, including the treatment of patients with cardio renal syndrome patients with Ocado renal syndrome patients with end stage renal disease, and both adult and pediatric patients undergoing cardiac surgery.

Speaker Change: Given the Oregon and disease agnostic characteristic of our therapy. There are several more indications to come.

Speaker Change: We believe that ACI is just the beginning of our opportunity to spare organs and save lives in these patient populations.

Speaker Change: With that as a summary of our clinical developmental efforts and goals I turn the call over to our CFO David Green.

David Green: Thank you Kevin and thank you all for joining us today.

David Green: Thank you, Kevin. Thank you all for joining us today. I'll describe our Q1 financial results and conclude with some of our expectations for the remainder of 2025. First, for some housekeeping, please note that our Form 10-Q will be filed with the SEC within the next 24 hours. You can find it at seastarmedical.com or sec.gov. Before I turn to our financial results for the quarter, let me also say that our progress to date in 2025 has included a number of key milestones for the company. As I indicated on our year-end call, our accomplishments in 2024, and now into 2025, have positioned SeaStar to build on Q1 and Q2 of commercial revenue for QUELIMMUNE and push forward the NEUTRALIZE-AKI pivotal trial. Since then, we've made good progress on our priorities, as reported in our press release today.

David Green: Describe our first quarter financial results and conclude with some of our expectations for the remainder of 2025.

David Green: First for some housekeeping.

David Green: Please note that our Form 10-Q will be filed with the SEC within the next 24 hours you can find it at <unk> medical Dot com or SEC Dot Gov.

David Green: And before I turn to our financial results for the quarter. Let me also say that our progress to date. In 2025 has included a number of key milestones for the company.

David Green: As I indicated on our year end call.

David Green: Accomplishments in 2024, and now into 2025 and physician see started to build in the first two quarters of commercial revenue for <unk> and push forward the neutralize Hai pivotal trial.

David Green: Since then we've made good progress in our priorities as reported in our press release today. The highlight three Q1 accomplishments, we achieved greater adoption of cloud demand from existing customers, which drove increased revenue in the first quarter.

David Green: To highlight 3 Q1 accomplishments, we achieved greater adoption of QUELIMMUNE from existing customers, which drove increased revenue in Q1. We pushed forward our NEUTRALIZE-AKI pivotal trial for adult AKI patients, reaching the 50% enrollment milestone. We managed resources during Q1 that resulted in lower sequential operating expenses. We also strengthened our balance sheet with the addition of new capital and maintained our practice of careful attention to spending. With that, I'll turn to our Q1 2025 financial results. We recorded our highest quarterly revenue to date by achieving a 4-fold increase in net revenue through sales of QUELIMMUNE therapy. Revenue for Q1 2025 was $293,000, compared to approximately $68,000 in Q4 2024, and $0 in the year-ago Q1.

David Green: We pushed forward or neutralize Hai pivotal trial for adult <unk> patients, reaching the 50% enrollment milestone.

David Green: And we managed resources during the quarter that resulted in lower sequential operating expenses.

David Green: We also strengthened our balance sheet with the addition of new capital and maintained our practice of careful attention to spending.

David Green: And with that I will turn to our first quarter 2025 financial results.

David Green: We recorded our highest quarterly revenue today by achieving a fourfold increase in net revenue for sales of <unk> therapy.

David Green: Revenue for the first quarter of 2025 versus $293000 compared to approximately $68000 in the fourth quarter of 2024 and $0 in the year ago first quarter.

David Green: As we indicated last quarter, we anticipate that sales will be lumpy in the initial phase of the launch. We expect to see an overall trend of increases in revenue as existing customers expand their usage of QUELIMMUNE and we add to the total number of hospitals purchasing QUELIMMUNE therapy. To provide some texture to the Q1 revenue report, we are pleased that all existing customers purchased QUELIMMUNE during the quarter. As Tim indicated, we are quite optimistic about new hospitals coming on as customers in 2025, which will give more children access to our life-saving therapy. Moving to cost of goods sold, the Q1 financial statements reflect no cost of goods sold. This is consistent with GAAP and due to sales of QUELIMMUNE units that have been previously recognized as research and development expense.

David Green: As we indicated last quarter we.

We anticipate that sales will be lumpy in the initial phase of the large but we expect to see an overall trend of increases in revenue as existing customers expand their usage of <unk>.

David Green: And we add to the total number of hospitals purchasing pro immune therapy.

David Green: To provide some texture to the Q1 revenue report.

David Green: We are pleased that all existing customers purchase <unk> during the quarter.

David Green: And as Tim indicated we are quite optimistic about new hospitals coming on as customers in 2025.

David Green: Which we will give more which will give more marshalls or an access to our life saving therapy.

David Green: Moving to cost of goods sold the Q1 financial statements reflect no cost of goods sold.

David Green: This is consistent with GAAP and do the sales and quality being units that had been previously recognized as research and development expense.

David Green: As we build and then sell new inventory as a commercial enterprise, we will record cost of goods sold matching sales from inventory. On a related note, you may have noticed that we recognized an inventory balance for the first time on our 31 March balance sheet. We anticipate Q2 to be a transition quarter as we begin to recognize COGS. Operating expenses increased modestly to $4.1 million in Q1 2025, compared to $3.9 million in Q1 2024. The change was primarily due to increased spending for our commercial launch and growing enrollment in the NEUTRALIZE-AKI trial. This was partially offset by reduced G&A expenses resulting from a decline in accounting-related costs and reductions in legal and consulting expenses. Finally, our net loss for Q1 2025 declined to $3.7 million, compared to a loss of $12.7 million in Q1 2024.

David Green: We built and then sell new inventory as a commercial enterprise, we will record cost of goods sold matching sales from inventory.

David Green: A related note you may have noticed that we recognized an inventory balance for the first time at our $3 31 balance sheet.

David Green: We anticipate Q2 to be a transition quarter as we begin to recognize Cogs.

Operating expenses increased modestly to $4 $1 million in the first quarter of 2025 compared to $3 $9 million in Q1 of 2024.

This change was primarily due to increased spending for our commercial launch and growing enrollment and neutralize Hai trial.

David Green: This was partially offset by reduced G&A expenses, resulting from a decline in account sharing related costs and reductions in legal and consulting expenses.

And finally, our net loss for the quarter of first quarter of 2025 declined to $3 $7 million compared to a loss of $12 $7 million in Q1 of 2024.

David Green: We ended the quarter with approximately $5.3 million in cash. Looking forward, we'll focus our resources on our top three objectives. Number 1, new customer acquisitions for QUELIMMUNE. Number 2, completing the NEUTRALIZE-AKI pivotal trial. Number 3, preparing to file a PMA following the completion of the adult AKI pivotal trial. In wrapping up, as we drive our strategic objectives forward, we expect forward momentum to continue as we bring our life-saving SCD therapy to more patients and clinicians, and as more investors become aware of the significant market opportunity developing for our SCD therapy. With that, I'll hand the call back to Eric.

David Green: We ended the quarter with approximately $5 $3 million in cash.

David Green: Looking forward, we will focus our resources and our team.

David Green: Top three objectives number one new customer acquisition for <unk>.

Number two completing the neutralize Hai pivotal trial and number three preparing to file a PMA following the completion of the adult pivotal trial.

David Green: And wrapping up as we drive our strategic objectives forward, we expect forward momentum to continue as we bring our lifesaving SCD therapy to more patients and clinicians.

David Green: It's more investors become aware of the significant market opportunity developing for our SPD therapy.

Eric: Okay on the call back to Eric.

Eric Schlorff: Thanks, Dave. Our goal today for our Q1 financial results conference call was to provide you with a summary of our progress, as well as a clear picture of why we believe the future opportunities of SeaStar Medical are significant. We plan to continue these calls on a quarterly basis. We are also reaching out to a broader investor base through various media outlets and plan to host fireside chats when we have educational information to share about SeaStar Medical. 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. As we complete the NEUTRALIZE-AKI pivotal trial enrollment, we look forward to reporting the results. Provided the data are supportive, we plan to file a PMA in 2026.

Eric: Yeah. Thanks, Dave our goal today for our first quarter financial results Conference call was to provide you with a summary of our progress as well as a clear picture of why we believe the future opportunities of ceased our medical are significant.

Eric: We plan to continue these calls on a quarterly basis. We are also reaching out to a broader investment investor base through various media outlets and plan to host Fireside chats. When we have educational information to share about CCR medical we are passionate about our ability to provide a life saving therapy to critically ill.

Eric: <unk>, who today have no alternative treatment for calming the cytokine storm caused by an overactive immune system.

Eric: As we complete the neutralized Hai pivotal trial enrollment we look forward to reporting the results provided the data are supportive we plan to file a PMA in 2026, if approved we believe a significant opportunity to capture that a sizable portion of the adult AK market exists in short.

Eric Schlorff: If approved, we believe a significant opportunity to capture a sizable portion of the adult AKI market exists. In short, we believe we are continuing to create strong value for our investors and stakeholders, and we'll be looking to close out what we see as a substantial gap in our current market cap and the outlook that we have for our company. With that, I'll ask the operator to open the call for questions. Operator?

Eric: We believe we are continuing to create strong value for our investors and stakeholders and we will be looking to close out what we see as a substantial gap in our current market cap and the outlook that we have for our company.

Eric: With that I'll ask the operator to open the call for questions operator.

Operator: We'll pause for just a moment to compile the Q&A roster. Your first question comes from Nicholas Sherwood with Maxim Group. Please go ahead.

Eric: At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad.

Eric: Well pause for just a moment to compile the Q&A roster.

Speaker Change: Your first question comes from Nick Sherwood with maximum Maxim Group. Please go ahead.

Nicholas Sherwood: Hey. Good evening. Can you tell me how many sites are currently activated for the adult clinical trial?

Nick Sherwood: Hey, Good evening can you tell me how many sites are currently activated for the adult clinical trial.

Speaker Change: Yes, hey, thanks, Nick.

Eric Schlorff: Yeah. Hey, thanks, Nick. Kevin, why don't you take that one?

Speaker Change: Kevin why don't you take that one.

Kevin Chung: Yes. We currently have 15 activated and probably another five that we plan to activate over the next 3 months.

Kevin Chuck: Yes. So we currently have 15 activated.

And.

Probably another five that we plan to activate over the next three months.

Nicholas Sherwood: Okay. What's the total number of pediatric hospitals that you have as customers currently?

Kevin Chuck: Okay.

Kevin Chuck: And then what's the total number of pediatric hospitals that you have as customers currently.

Speaker Change: Yes, Tim do you want to take that.

Eric Schlorff: Yeah. Tim, you want to take that?

Tim Varacek: Sure. We have 6 sites that are commercially active and multiple others that are moving through the IRB process.

Tim: Sure we have six sites that are commercially active and.

Speaker Change: Multiple others that are moving through the IRB process.

Speaker Change: Okay, and you are kind of talking about that IRB process in the pipeline what sort of pipeline growth have you seen in the first quarter compared to the fourth quarter do you think that.

Nicholas Sherwood: Okay. Yeah, kind of talking about that IRB process and the pipeline, what sort of pipeline growth have you seen in Q1 compared to Q4? Do you think that, revenues were up a ton sequentially in this quarter. Is there a lot of word of mouth that where you're seeing that that pipeline's really starting to accelerate in this Q1?

Speaker Change: You know I mean revenues were.

Speaker Change: Up sequentially in this quarter is there a lot of word of mouth that where youre seeing that pipeline is really starting to accelerate in this first quarter.

Speaker Change: Yes.

Tim Varacek: Yeah. Thanks for the question, by the way. It's a combination of things. It is experience that existing sites have. We have a way that these sites are able to communicate with each other and share their experiences. They're noticing a difference when they use QUELIMMUNE Therapy. That's one aspect of it is definitely word-of-mouth, but we actively engage these hospitals as well. We approach them and talk with them, and quite often, they're very interested in adopting, ultimately, QUELIMMUNE Therapy, and then it just becomes an operational exercise. Based on the type of hospital is and the resources they have, that kind of tells you what the timeline is going to be. Sometimes it's easy and it's fairly quick, and other times it takes a little bit longer.

Speaker Change: Combination. Thanks for the question by the way, it's a combination of things it is.

Speaker Change: Experience that existing sites have we have a way.

Speaker Change: These sites are able to communicate with each other and share their experiences and there.

Speaker Change: They are noticing a difference when they use qual immune therapy. So thats one aspect of it is definitely word of mouth, but we actively engage.

Speaker Change: These hospitals as well and.

We approach them and talk with them and quite often they are very interested in adopting.

Speaker Change: Adopting ultimately quality in therapy, and then it just becomes an operational exercise and based on the type of hospital is in the resources they have it.

Speaker Change: That kind of.

Speaker Change: Tells you what the timeline is going to be so sometimes it's.

Speaker Change: It's easy and it's fairly quick and other times it takes a little bit longer but there is no shortage of interest in these institutions about quality and therapy and what the potential of this therapy represents to these patients suffering with pediatric Hai.

Tim Varacek: There's no shortage of interest in these institutions about QUELIMMUNE therapy and what the potential of this therapy represents to these patients suffering with pediatric AKI.

Nicholas Sherwood: Yeah. That all makes a ton of sense, and I appreciate the detail. Shifting gears, talking about the new Breakthrough designations, can you talk about how important these 2 additional Breakthrough designations are and how you're prioritizing the various regulatory processes? You have so many designations, you don't want to spread your resources too thin, I imagine.

Speaker Change: Mhm yeah.

Speaker Change: Yes that all makes a ton of sense I appreciate the detail and then.

Speaker Change: Kind of shifting gears talking about the new breakthrough designations can you just talk about kind of how.

Speaker Change: These two additional breakthrough designations are and how you're prioritizing.

Speaker Change: Ours regulatory processes.

Speaker Change: Yes.

Speaker Change: Designations, you kind of have to.

Speaker Change: Sure.

Speaker Change: You don't want to spread your resources too thin ice I imagine.

Nick Sherwood: Yes, so Nick.

Eric Schlorff: Yeah. Kevin, why don't you address the clinical unmet need that's there in the cardiac surgeries, and then I'll take the second part of that question.

Speaker Change: Kevin why don't you address kind of the clinical unmet need that's there in the cardiac surgeries and then I'll take the second part of that question.

Kevin Chung: Yeah. Thank you, Nick, for that question. Cardiac surgery is one of the largest costs for hospitals in the country, and there was a Newsweek article that came out today that really emphasized that. Part of the reason for that is a relatively high proportion of those patients have a complication that results in AKI. As a result, both in adults and pediatrics, we believe that this is a massive target of opportunity where we can make a big difference in these outcomes. What's the point of undergoing a cardiac surgery that's very intense and associated with many hospital days if you're not able to survive and you have a complication that commits you to hemodialysis? We intend on preventing that. In order to look at this, we're going to need to do additional clinical trials.

Speaker Change: Yeah. Thank you Nick for that question. So cardiac surgery is one of the.

Speaker Change: Largest.

Speaker Change: Cost for hospitals in the country and there was a Newsweek article that came out today that that really emphasize that.

Speaker Change: And part of the reason for that is.

Speaker Change: A relatively high proportion of those patients have complication that results in an API and.

As a result, both in adults and pediatrics, we believe that this is a <unk>.

Asset target of opportunity, where we can make a big difference in these outcomes.

Speaker Change: What's the point of undergoing a.

Speaker Change: Cardiac surgery that is very intense and associated with many hospital days.

Speaker Change: Youre not able to survive and you have a complication that commit you to hemodialysis, we intend on preventing that.

So in order to look at this we're going to need to do additional clinical trials, we're hoping that with the adult launch.

Kevin Chung: We're hoping that with the adult launch, some of these trials will be funded via grant funding and non-dilutive funding. A lot of these centers are very interested in applying the SCD in their patient population. We also anticipate investigator-initiated studies as well. A combination of things that will help drive our pursuit to get this device approved for that specific patient population. Now, I have to say that with an approval for AKI alone, there will be adoption in those types of patients. We will be seeing data trickle in already, even with just the AKI indication alone.

Speaker Change: Some of these trials.

Speaker Change: Be funded.

Speaker Change: Grant funding and non dilutive funding.

Speaker Change: And a lot of these.

Speaker Change: Centers are very interested in.

Speaker Change: The CD.

Speaker Change: Their patient population and so we also anticipate investigator initiated studies as well so a combination of things that will help drive.

Speaker Change: Our pursuit to.

Speaker Change: Get this device.

Speaker Change: Approved for that specific patient population now I'll have to say that with an approval for ACI alone.

Speaker Change: There will be adoption in those types of patients. So we will be seeing data critical in already even with just the API indication alone.

Eric Schlorff: Yeah. Just to add on to what Kevin has said is that the commercial and medical affairs teams are working diligently to assess the market need penetration dynamics of the 5 additional indications where we have these Breakthrough Device designations. Given that the SCD therapy is agnostic to these disease states, and that our first adult product will be in the critical care market, it's logical that we could easily add indications in the space and sell products to the same customers in those same ICU units. We're really excited about the opportunity to rapidly expand our product offering, as we've said in the prepared remarks.

Speaker Change: Yes, and just to add onto that.

Speaker Change: What Kevin has said is that the commercial and medical affairs teams are working diligently to assess kind of the market need penetration dynamics of the five additional indications where we have these breakthrough device designation give.

Speaker Change: Given that the STB therapy is agnostic to disease disease States. In this is that our first adult product will be in the critical care market. It's logical that we could easily add indications in this space and sell products.

Speaker Change: Same customers in those same ICU units.

Speaker Change: We're really excited about the opportunity to rapidly expand our product offering.

Speaker Change: As we've said in the prepared remarks.

Nicholas Sherwood: Okay. I appreciate all that detail. It sounds like once you get this first adult approval, that the subsequent ones are going to be able to move a lot more quickly just because you'll be getting a lot of real-world data, and you've been through the process before.

Speaker Change: Okay I appreciate all that detail it sounds like once you get this first.

Speaker Change: Adult approval that.

Speaker Change: The subsequent ones are going to be able to move a lot more quickly just because.

Speaker Change: Youre getting a lot of real world data and you've been through the process before.

Speaker Change: Absolutely. Thank each one of these.

Kevin Chung: Absolutely.

Eric Schlorff: Yeah. Yeah. Go ahead.

Yes go ahead.

Kevin Chung: Absolutely. One of the things that we are looking at with the AKI pivotal trial is safety. When the safety issue has been addressed and we are getting data for these specific other populations, we believe that it will get easier and easier, and the floodgates will open.

Speaker Change: Yes, absolutely I mean, one of the things that we're looking at with the Acas pivotal trial is safety and so when the safety issue has been addressed.

Speaker Change: And we're getting.

Speaker Change: Data for the specific other populations.

Speaker Change: We believe that.

Speaker Change: It will get easier and easier and the floodgates are open.

Nicholas Sherwood: Okay, awesome. Well, thank you for answering all my questions. I will return to the queue.

Speaker Change: Okay awesome.

Speaker Change: <unk>.

Speaker Change: Thank you for answering all my questions and I'll return to the queue.

Kevin Chung: Thanks, Nick.

Nick Sherwood: Thanks, Nick.

Operator: Again, if you would like to ask a question, press star, then the number one on your telephone keypad. There are no further questions at this time. I will turn the call back over to Jackie Cossmon.

Speaker Change: Again, if you would like to ask a question Press Star then the number one on your telephone keypad.

Speaker Change: There are no further questions at this time I will turn the call back over to Jacky Kaufman.

Jackie Cossmon: Thank you, Tiffany, and thank you all for joining us today for the SeaStar Medical Q1 financial results conference call. If you have questions, please contact us at IR@SeaStarMed.com, or visit our website to see our latest news, product, pipeline, and company information. Thank you and goodbye.

Speaker Change: Thank you Tiffany and thank you all for joining us today for the <unk> Medical first quarter financial results Conference call. If you have questions. Please contact us at IR at <unk> Dot com.

Or visit our website to see our latest news product pipeline and company information.

You and goodbye.

Operator: Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.

Speaker Change: Ladies and gentlemen, this concludes today's call. Thank you all for joining you may now disconnect.

Speaker Change: [music].

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