Hello, and welcome to the C-Star Medical First Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to hand the conference over to Jackie Cosma. You may begin.

Thank you, Tawanda. Good afternoon, and thank you for joining the C-Star Medical First Quarter 2026 Financial Results Conference Call. I'm Jackie Kosman with Wheelhouse Life Science Advisors. Joining me from C-Star Medical today are Eric Schlarf, Chief Executive Officer, Dr. Kevin Chang, Chief Medical Officer, Tim Veracek, Senior Vice President of Commercial and Business Operations, 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 and could cause actual results to differ materially from any anticipated results. For a list and description of these risks and uncertainties, please review C-Star Medical's filings with the Securities and Exchange Commission. Furthermore, the content of the conference call contains information that is accurate only as of the date of the live broadcast, May 13, 2026. E-STAR Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law. And now, I'd like to turn the call over to Eric.

Thank you. Thank you, Jackie. And thank you all for joining us today. We are making good progress towards achieving our 2026 goals and also maintaining a disciplined use of our financial resources. The increase in our Quellimmune customer base has helped propel our first quarter Quellimmune net revenue with a nearly 70 percent increase from the first quarter of 2025 with seven new hospitals adopting the Quellimmune therapy in the first quarter of 2026. Our goal this year is 15 new customers and we are well on our way to achieving that. With our growing presence and the continued adoption of QuellImmune in the pediatric AKI market, we believe we are in track to meet our net revenue goal of approximately $2 million for the year. More importantly, we are setting the stage for our next and potentially far larger market opportunity in the adult AKI market. To that end, we continue to enroll patients in the neutralized AKI pivotal trial with 198 patients enrolled of our planned total 339 patients. Last year, we determined that we would add new clinical sites to expand our enrollment efforts to reach completion of enrollment around the end of 2026. Kevin and his team are working diligently to make this happen. It has been extremely rewarding to see the highest caliber medical institutions participate in our trial, with UCLA as an example of one of the latest hospitals to join in, and more on the way. In addition, we continue to work closely with the FDA on several fronts. First, we are discussing the elements of a modular PMA submission for the adult AKI indication, which we believe could speed the approval process. Second, we are working with the FDA to obtain agreement on a rapid approval pathway for our STD therapy. The STD therapy is a potential life-saving therapy for indications where there are no treatments today and we believe patients with hyper inflammation should have more immediate access to therapies that could reduce or avoid severe organ damage and potential loss of life finally and before i turn the call over to tim we have maintained a strong financial discipline mike will share our efforts on this front shortly and now i will turn the call over to tim to discuss not only our commercial achievements but how we are building a strong presence in the pediatric AKI community.

Thanks, Eric, and thanks everyone for joining us today. I'm pleased to report that we ended the first quarter with strong momentum and it's continuing into the second quarter of this year. As Eric noted, we added seven additional customers in the first quarter, and importantly, we are seeing an uptick in orders for many of our customers. Our Quellimmune net revenue in the first quarter was $495,000, a solid increase of 69% from the first quarter of last year. As Eric indicated, this is a small but important market to us, not only because we believe Quellimmune is saving lives and sparing organ function for young kids, but it also provides great validation of our SCD technology and, importantly, it paves the way for future potential opportunities in the adult market. We're seeing great enthusiasm by the pediatric healthcare community for Qualimmune therapy. Recently, for example, we sponsored and hosted an educational symposium at the AKI and CRRT meeting in San Diego. Our presence at the meeting and a number of other activities are designed to increase awareness, knowledge, and implementation of Qualimmune therapy to continue to build our brand in Pediatric AKI, and also positioned C-Star Medical in a leadership role to help educate the pediatric medical community about this serious unmet need. The symposium 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, and utilize the learnings to establish Quell Immune Therapy at the hospitals in which they practice. The broadening impact of Qualimmune therapy and the desire by the pediatric healthcare community to learn more about Qualimmune reinforces a key focus for C-STAR Medical to deepen the educational effort on Qualimmune therapy and how to implement it in the treatment of pediatric AKI. Now, turning to our commercial efforts for Qualimmune in 2026, We have great expectations to help patients by delivering Quellimmune therapy to more pediatric hospitals. We continue to focus on adding new sites as quickly as possible, and once a site adopts Quellimmune, ensure pull-through by educating the patient care teams so they are focused on pediatric AKI and the option of Quellimmune therapy for appropriate patients. We believe this is only the beginning of the commercial opportunities for our SCD therapy. And with that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

Thanks, Tim. And thank you to everyone for listening to our call. I want to echo Tim's enthusiasm about our presence at the AKI and CRT meeting in late As a critical care physician, I was struck by just how embedded Quellamune has become in the conversation. The interest wasn't limited to our own events or data presentations. It showed up organically in plenary and breakout sessions, where clinicians and researchers were referencing Quellamune unprompted. That kind of grassroots visibility in a specialty community is a meaningful signal. Adding to that momentum, the American Society of Nephrology's Kidney News, widely regarded as the newsroom of the nephrology world, dedicated not one but two articles to the SED therapy in its most recent issue. The first, a feature on the evolution of extracorporeal therapy, identified the SED therapy as one of the most exciting frontiers in the shift from passive blood filtration to active immune modulation. The second was devoted entirely to the SED therapy, its mechanism, clinical evidence, and future potential. When the premier nephrology society's publication gives a therapy of this kind, this kind of editorial attention, it is a meaningful signal that the SCD therapy is entering mainstream clinical consciousness. This recognition from conferences and publication is most welcome, but the most compelling recognition comes from the bedside. Every month, we convene a virtual clinical user's call with current and prospective pediatric nephrology and critical care teams from across the country to review every Quilomune case together. The stories we hear on these calls are truly remarkable, and they continue to validate and reinforce why getting this therapy to a broader patient population is so important. The SCD's unique immunomodulatory mechanism positions us to potentially reshape treatment paradigms across a range of serious conditions, not only for AKI, but cardiorenal syndrome, cardiac surgery, end-stage renal disease, and other states of pathologic immune activation where dysregulated cytokine release drives organ failure and death. To that end, we are working diligently to complete enrollment in our Neutralize AKI pivotal trial. As a brief overview, Neutralize AKI is a randomized controlled trial designed to assess whether up to 10 sequential 24-hour STD treatments can improve 90-day survival or renal recovery in critically ill adult patients with acute kidney injury requiring continuous renal replacement therapy. The primary endpoint is a composite of mortality or dialysis dependence at 90 days. We continue to onboard additional clinical sites and now have enrolled 198 of our target of 339 patients. We are targeting completion of enrollment around year-end, which positions us to potentially report top-line results in mid-2027. We are already working with the FDA on our plans to submit a modular PMA, enabling us to complete most of the submission, with the exception of pivotal data, then submit pivotal data as the last element of the submission. This is designed to allow FDA early review of the modules that don't relate to the clinical trial data. It often speeds the overall review of the applications. Upon completion and review of the Neutralize AKI clinical trial and contingent on positive efficacy and safety outcomes, we intend to move quickly to submit the remaining PMA components under our breakthrough device designation, positioning us for a potentially accelerated FDA review. A PMA approval of SCD therapy for adult AKI would enable commercialization as a therapeutic device without the IRB-related barriers that exist with Quellamute. This would significantly simplify hospital adoption, and we believe it will support more rapid commercial expansion. Now, let me turn to our SAVE registry, which tracks the commercial use of Quillimmune in critically ill children. In March, we announced completion of enrollment at 50 patients, a meaningful milestone. We are currently completing the 28-day safety analysis on our final enrolled patients and expect to submit top-line safety data to the FDA shortly. Alongside that submission, we will formally request that the SAVE registry transition from its current mandatory status to a voluntary post-marketing study. If the FDA agrees, this would meaningfully reduce the administrative burden on children's hospitals, accelerating adoption, and expanding access to Qualimmune across more pediatric centers, A clear win for patients, providers, and the healthcare system. With that, I'll hand it over to our CFO, Mike Messinger. Mike?

Thank you, Kevin. It's great to be a part of this, and thank you all for being part of our call today. I'll provide a brief overview of our financial results for the first quarter of 2026. Please note that our Form 10-Q will be filed with the SEC within the next 24 hours, and that will include a lengthier discussion of the company's financial results for the three months ended March 31st, 2026. You can find the 10Q at sec.gov or through our website at cstarmedical.com. We recorded net revenue from Quell Immune sales of approximately $495,000 for the first quarter of 2026, compared to $293,000 in the first quarter of 2025. And as Tim mentioned, we continue to see strong adoption of Quellamine sales here in the second quarter of 2026. Turning to gross profit, our first quarter statement of operations reflects a gross profit margin of over 90 percent, consistent with the prior three quarters. As a reminder, we didn't recognize cost of goods sold in the first quarter of 2025, as the Quellamine units sold were originally expensed to research and development prior to approval and commercialization, consistent with U.S. GAAP. Operating expenses were unchanged at approximately $4.1 million in the first quarter of 2026 compared to the first quarter of 2025. This represents our continued discipline and leverage of our team's ability to take on multiple tasks within our organization due to our broad experiences, talents, and enthusiasm to ensure the company's success. For the remainder of the year, we anticipate meeting our enrollment goals, we expect our research and development expenses to increase modestly around five percent each quarter as we continue to drive enrollment and support more clinical sites. However, we continue to expect our general and administrative spend to remain pretty consistent from quarter to quarter for the remainder of 2026. Net loss for the first quarter of 2026 was approximately $3.5 million or 90 cents per share based on weighted average shares outstanding of approximately 3.9 million shares. This compares with the net loss of approximately $3.8 million, or $4.38 per share in the first quarter of 2025, based on approximately 862,000 weighted average shares outstanding. We have over $9.3 million of cash on our balance sheet as of March 31st, 2026, compared to $5.2 million at March 31st, 2025. And now I'll turn it back to Eric.

Thanks, Mike. Our goal today was to share with you our recent achievements but also express how keenly focused we are on the key value drivers for our stakeholders, in particular patients, the medical community, and investors. With a small but passionate team, we believe we are reshaping the possibilities for kids that often face organ failure or death without new therapies to modulate the cytokine storm in AKI. Also, by bringing together the pediatric care community to broaden the understanding of critical care in this setting, we believe we are helping to set a higher standard for all kids that face the trauma of acute kidney injury. In addition, we have established relationships with many of the top nephrologists in the country through the participation in our neutralized AKI pivotal trial. These relationships will serve us well as we look to potentially launch our scd therapy in the adult indication and finally we are actively engaged with our stakeholders to continue to communicate our value proposition and long-term vision for c star medical we believe that the opportunities that lie ahead for c star are significant and we look forward to reporting our future progress with that i'll ask the operator to open the call for questions. Operator?

Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 11 on your telephone, then wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of David Bowes with SAC Small Capital Research.

Your line is open hey good afternoon everyone appreciate the update today so first question is have you begun seeing a repeat orders from any of these existing pediatric centers and kind of if you have how quickly are those repeat orders having or happening from the first time that they come online yeah hey David this is Eric hey thanks for joining a great question hey Tim do you want to take that?

Sure. Happy to do it. Thank you for the question. So, to answer the first part of your question, we absolutely see repeat orders from our customer base. In terms of the speed at which that happens, it, you know, it is really driven by the presentation of the patient, when the patient arrives. In some cases, you know, it could be some time between patients, And in other times, you know, they may finish a therapy on one patient and several more will appear in the ICU that are appropriate patients for Qualiomene. So it's fairly unpredictable that way, but it is definitely safe to say that from overall customer base, once they use the product, they gain experience with it, we definitely have repeat orders.

Okay, great. And then you mentioned earlier about the SAVE registry and, of course, how encouraging all the data is from that. So at what point do you talk about if that's going to influence treatment guidelines or, like, standard of care discussions?

Yeah, that's a great question. So, Kevin, do you want to tackle that?

Yeah. So, you know, standard of care and implementation into guidelines takes takes a long time. However, if you look at the pediatric ATKI consensus document that was published a little over a year ago, immune modulation, extracorporeal immune modulation is mentioned. mentioned. So, I believe that if we continue down this path and we have a positive neutralized AKI study, that pediatric ADC and consensus statement will bring forward the SED as a therapy that's recommended. And so, for these clinical practice guidelines, it takes typically multiple randomized controlled trials and wide adoption for recommendations to surface. But we're already mentioned there, so that's a good thing. And I have no doubt that with continued use of the therapy as clinical teams see the results, this will become something that everybody's talking about.

Okay, great. And then lastly, of course, you mentioned the write-ups and the ASN kidney news. One of the things that they mentioned in there was that integrating the SCD into the ICU workflow is, I think they use the term non-trivial, but I mean, how non-trivial is it or how easy is it for the unit to be integrated into the protocols at a hospital?

Yeah, thank you for that question.

Go ahead, Kevin.

Yeah, thank you for that question. So clinically, the addition of the SCD cartridge, connecting it serially to an already existing CRT circuit. Any CRT technician, dialysis technician, or CRT ICU nurse can do that. It takes minutes to connect, and it is as simple as can be. The other thing that a lot of centers around the country have experience with is citrate anticoagulation. And we're fortunate that that's the case because that is a critical component of our therapy. And so, you know, with regards to whether or not it's difficult, if you already have a citrate protocol and you're used to doing CRT, which 99% of all ICUs in the country, that's a true statement, that the implementation of SCD is not going to be difficult. All right.

Thanks for taking the questions. Yep.

Our next question comes from the line of Anthony Bendetta with Maxima. Your line is open.

Thank you. So, yeah, I just wanted to talk about the hospitals that are currently using the product. you know, do you have like a particular ordering pattern? Anything, any other color you can give there? I know you said the reorder frequency, you don't have that exact number, but how many patients total have been treated? And do you currently have like a, if not a reordering pattern for the hospitals, an average revenue per center, or is it really just patient-dependent and can vary widely?

Yeah, thanks. Thanks, Anthony. Great question. Thanks for joining us today. You know, I'll tackle some of this, and then I'll have Tim also come in. You know, one of the things is, you know, how many patients have we treated? We did disclose a couple months back that we had reached the 50 patients for the SAVE registry, so it kind of gives you a general sense of, you know, how many have been treated. Maybe, can you give a little bit more color on some of Anthony's other questions?

Sure. You know, I think one way to think about this, Anthony, and thank you for the question, is as it is with many products in a hospital, hospitals, once they understand their utilization patterns, will set a par value. So, that is basically an inventory level that they want to keep on hand at all times based on their utilization. And to be sure, there are par values that have been set with many of the customers that we have. Others that are, you know, we're scaling, we're still scaling our business here, right? So we have 17 customers at this time last year, you know, we, I don't even, we had three or four customers. So it's still new. And so many of these new customers, they order product, they use the product, and then they're seeing what the cadence is of patients that come through the system that helps them establish the par value. You know, in addition to that, too, the more they use this, the more they think about pediatric AKI. And you heard me talk about the educational efforts that we are really engaging in with a lot of these sites to make sure that, you know, there really is a ripple effect of Quellimmune across these institutions so that many people know about it and they're actively looking for patients. And when you're actively looking for patients, you're going to tend to find more of those. So that's basically how it works. We don't single things out in terms of revenue per hospital. At this point, you know, this is an ultra rare indication and condition. And so it really is driven by the presentation of a patient within the hospital system itself. Okay.

So, you know, as you're looking to kind of drive the patient volume, and like you said, it's heavily dependent on the patients needing the treatment, but is there any additional education that's going on at the hospitals that you're in and at the new hospitals that you're trying to sign up that that you know maybe accelerates the adoption at other centers yeah it's a great question sorry sorry actually uh no it's okay I actually would Kevin maybe you could talk about the monthly users call that we that we have with yeah on those calls

but get discussed etc sure thank you Anthony for that question I mean you know this is a very tight community the nephrology the pediatric nephrology and critical care community and they all talk to each other they all share experiences we sort of leverage that spirit and have been having monthly clinical users calls that we talked about in the update, and that is attended by, you know, we invite about 135 or 50 individuals. Most often we have about 60 callers that dial in, and they get to hear from the previous month's cases that have occurred at each of the sites that are active. And we go into detail about the cases, how sick they were, you know, why they decided the reason and rationale for therapy, and what happened to them. And now, you know, we can't save everybody. But for many of these patients, actually, for all these patients, they're very, they're, you know, initiating the SED at a very, very dire situation, during a dire situation where the patient is very, very sick. And virtually all the patients I don't think would have lived without this option. And what we're doing is giving them a chance. And these cases are discussed where the patients are sick, sick, sick. They start Qualimmune. Next thing you know, the inflammatory indices start coming down, and they talk about patients doing well. And so, you know, when the participants who don't have Qualimune at their institution hear these stories, of course, they're going to want to get their hands on them because they want to give their children a chance. And so that's how we spread sort of the message with regards to the potential benefits of Qualimune. Additionally, we have presented at pretty much the premier conferences where all of the pediatric intensivists and nephrologists gather. PNRC, which is the Pediatric Research Network Consortium, we presented at it in Miami. Pretty much 50 or so children's hospitals were represented. Society of Critical Care Medicine, AKICRT. Even the European meeting that I just returned from, there were several pediatric centers represented there from the United States. And, you know, the conversation is always centered around how well these patients respond initially to Qualamune. Even when you have a death, they see the inflammatory indices come down and the patients initially improve. And sometimes because of the comorbidities, they may not survive, but they see the benefit. And so, really, it's amplified word of mouth is how I would like to describe it. And it's quite effective. And there are many centers that contact us, although they haven't even begun the process sometimes because they have a child that needs it. And we do what we can.

That's great. Tim, yeah, maybe, Tim, you could also just kind of share the newly formed group, this advanced practice group that you've put together.

Yeah, happy to do that, Eric. So, in addition to what Kevin was talking about, you know, we are coming at this from a variety of different ways to educate the community. And one of the things we've done is we formed an advanced practice provider ad board. So these are folks that are, you know, really at the patient care level, and they are very operational. They're the ones that kind of get a lot of the work done within these institutions to set up a variety of different orders and protocols. They set up training. And these folks are really they are, in many cases, the champions within these institutions and taking Quellimmune through that hospital system. So we're working with them. We we had a symposium at the recent AKI and CRRT meeting. We have several other planned events over the rest of this year. In addition to that, we also have some field-level clinical support at these systems, too, especially the systems that have adopted Quellimmune, making sure that, again, more people know about it. there are a lot of people that work within a specific hospital. There are a lot of shift changes. And so, there are a lot of people that need to be exposed to this information. So, you know, I think we have a good handle on what needs to be done, and now we're executing on that.

Okay, great. That was very helpful. Thanks. I'll hop back in the queue. Appreciate it.

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to Jackie for closing remarks.

Thank you, Tawanda, and thank you all for joining us today for the C-STAR Medical First Quarter Financial Results Conference Call. If you have questions, please contact us at IR at cstarmed.com or visit our website at www.cstarmedical.com. Thank you and goodbye.

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.