SeaStar Medical Holding Corporation (ICU) 2026-08-12 Earnings Call Transcript

Good day, and thank you for standing by. Welcome to the SeaStar Medical Reports second quarter 26 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 speakers' 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. To withdraw your question, please press 11 again. I would now like to hand the conference over to your speaker today, Jackie Cossmon.

Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical second quarter 26 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 doctor Kevin Chung, chief medical officer, and Michael Messinger, chief financial officer. I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results.

Thank you, Jackie. And thank you all for joining us today. We are very pleased with our progress this quarter. Our pediatric AKI market penetration and continued strong QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market, that is 50x 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.

Thanks, Eric, and thanks, everyone, for joining us today. We are making great progress in our efforts to establish Quellimmune 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. 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 QUELIMMUNE therapy is broadly resonating in the pediatric critical care community.

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 Quellimmune 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.

Thank you, Kevin, and thanks everyone for joining our call today. I will provide a brief overview of our financial results for the second quarter of 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 3 months ended June 30, 2026. You will find the 10 q at sec.gov. Or through our website at seastarmedical.com. We recorded net revenue for the second quarter of $615 thousand reflecting increased demand for QUELIMMUNE. This represents an 82% increase compared to net revenue. Of approximately $338 thousand for the second quarter of 2025.

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

Thank you. As a reminder, to ask a question, please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. 1 moment for questions. Our first question comes from David Bautz with Zacks Small Cap Research. You may proceed.

Hey. Good afternoon, everyone. I appreciate you taking the questions. First off, 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. And then lastly, can you quantify your confidence for hitting that 39 patients either by year end or the first quarter of 2027?

Yes. So thanks for the question. So, let me tackle the second 1. What we basically kind of guided the market as is really our time line is around year end or into Q1. Obviously, it is gonna depend on, you know, Kevin and his team bringing on additional sites, etcetera, from an enrollment standpoint. But I am really proud of what Kevin and his team are doing on bringing those on pace. But, you know, if I think about this, David, before, he kind of talks about maybe enrollment, we still believe that we are really on track at the end of the day to have end up 2027 submission for the final PMA module.

Right. Thank you, Eric. So on average, over the last few months, we have averaged somewhere around 8 to 10 to 12 patients in each of those months. And that is relatively slower than what I would like. However, I have to emphasize we have to get the right patients. And by right patients, I mean those with modifiable disease. what is 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 are not enrolling the right patients. That is-- that would be a flawed strategy.

Okay. Great. So with the enrollment expected by the end of this year, early 2027 and the PMA submission target for the end of 27. 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, you know, fully submit it.

Yeah. So your question is what are some of the well, once we once we lock the database, obviously, then we will give out top line results. You know, once it is locked, we can analyze, etcetera. And 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. And that is really what the goal is so that when the FDA then has their time, you know, they can then focus just merely on the clinical sections and not have to go through things like device and description, etcetera. So that is really what the strategy is.

Okay. Sounds good. And then, last 1, talking about the increase in revenue. I was wondering if you could quantify the contribution from existing customers versus the new customers that you added during the quarter.

Yes. Thanks. Tim, you want to tackle that 1?

Sure. Yeah. So it is a combination of new hospital systems as well as existing systems that delivered that revenue, And, you know, we have a very high repurchase rate with the existing sites, and then, obviously, the new sites that come on board they wanna 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.

Okay. Great. Appreciate you taking the questions.

Thanks, David. Thanks.

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

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? Or you submitted We are submitting preliminary reports. So we are submitting no. Well, so you are talking about the PMA, right, for adults? Yeah. Yeah. Yeah. Yeah. Yeah. So, yeah, for that, I mean, obviously, you know, what we are doing right now is a modular PMA. So there is various sections where you talk about the device. You talk about, you know, sterilization. You talk about all sorts of you know, kind of the technical things that go into it.

And then you have right now about 20 pediatric hospitals. Right? Correct. So is there is there a process or what do you have to do to make sure they are not just sort of like, okay. They are they are a hospital that uses this, but how do you get them to be a more meaningful recurring customers or are just, hey, you just need the patients to come in and they are they are already on board, and there is nothing really left to do with those particular hospitals. 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.

Okay. If I may add some color to the clinical perspective, So 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, it became-- it was-- it is-- 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 lifesaving, because of the natural skepticism that is very prevalent within the medical community, they have to see it work.

No, that is helpful, Kevin. Yeah. So I mean, you know, we know the focus as it should be is on you know, the pediatric market and now the adult AKI. You know, with this trial enrollment, and you are at 223 up to 339. And we know it is adult AKI is 50x larger than the pediatric market. But there is other markets that you know, that your, you know, device can of your device can treat. Whether that be acute respiratory distress, hepatorenal syndrome, cardiorenal syndrome, and, of course, sepsis.

Yeah. Yeah. So I can tackle that 1. Yeah. So I mean, yeah. So, you know, we do obviously evaluate all the other applications that we believe that, obviously, from our perspective, the there is a pretty long laundry list of things that really would be on our wish list. But obviously, you know, we, as a company, have to be focused on, you know, certain things, and that is really been on Quellimmune for pediatric AKI and adult AKI and neutralized AKI. Obviously, we have got the neutralized CRS study that is actually been funded by NIH.

If I may just add really quickly, I should remind everyone that for neutralize AKI, a priority we identify patients with ARDS at the time of enrollment and sepsis at the time of enrollment. And we randomized 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.

No. Yeah. that is that is very that is very helpful. Thank you. Thanks, Eric, Kevin, everyone. Okay. I will hop back in the queue. Thanks.

Thank you. I would now like to turn the call back over to Jackie Cossmon for any closing remarks. 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 seastarmedical.com, or visit our website at www.seastarmedical.com. Thank you. And goodbye. Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.