NASDAQ: CTSO
Greg Young: Hello and welcome to the Life Sciences Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we're very pleased you have joined us. The next presentation of the day is from CytoSorbents. Their session will be moderated by Tom Kerr, Senior Equity Analyst with Zacks Small Cap Research. At this point, I'm very pleased to welcome Dr. Phillip Chan, Chief Executive Officer, and Pete Mariani, Chief Financial Officer of CytoSorbents, which trades on the NASDAQ under the symbol CTSO. Welcome, Tom, Phillip, and Pete.
Tom Kerr: Well, thanks, Greg. Let me give a quick 20-second introduction of the company before we turn it over to Dr. Chan. So CytoSorbents is an established medical device company involved in blood purification technology that treats life-threatening conditions in intensive care and cardiac surgery. It is currently in the process of commercializing its EU-approved CytoSorb device in North America, which is called DrugSorb-ATR. This addresses a large and growing unmet need for surgical bleeding solutions related to heart surgery. We believe the FDA approval of DrugSorb-ATR, if approved, could lead to strong, profitable growth over the next three to five years. We have a price target of $5 per share for CTSO stock, and I'm going to turn it over to Dr. Chan for his slide presentation. Thank you.
Dr. Phillip Chan: Thanks very much, Tom, and thanks very much, Greg, for the invitation to be here today and for joining us on this call. As a publicly traded company, please let me remind you of our safe harbor statement for forward-looking statements and our regulatory disclaimer, where CytoSorb is approved in the European Union but is not yet cleared or approved by the FDA or Health Canada, and where DrugSorb-ATR remains an investigational device in the United States but is in the approval process. CytoSorbents is a US-based medical device company based out of Princeton, specializing in blood purification to treat life-threatening conditions in the intensive care unit and cardiac surgery with our proprietary biocompatible porous polymer bead technology. CytoSorb, the first and most studied CE Mark-approved extracorporeal cytokine adsorber in the European Union, is manufactured by us in the United States and distributed in more than 70 countries worldwide, with now more than 300,000 cumulative treatments around the world. To date, it is approved as a cytokine adsorber for cytokine removal and the treatment of cytokine storm. It is also approved for bilirubin and myoglobin removal, as in liver disease and acute trauma, respectively, and also for the removal of blood thinners like ticagrelor and rivaroxaban during cardiothoracic surgery.
DC: In 2025, sales were $37.1 million with 71% product gross margins, with a very high-margin razor blade in someone else's razor business model. We have strategic partnerships with some of the leading players in the world, including Fresenius Medical Care and B. Braun in the space of dialysis and Terumo Cardiovascular in the space of cardiac surgery, and we have been the fortunate recipients of approximately $50 million in grants, contracts, and other non-dilutive funding from the likes of NIH, DARPA, and the DOD. We are currently pursuing US FDA and Health Canada approval of DrugSorb-ATR to reduce perioperative bleeding risk in patients on blood thinners during cardiac surgery, and importantly, we are anticipating operating cash flow breakeven in the second half of 2026. The heart of our technology is a highly porous polymer bead roughly the size of a grain of salt that acts like a tiny sponge to remove harmful substances from blood based on pore capture, surface adsorption, and concentration. Very good at removing things from whole blood and plasma. Its solid-state porous polymer chemistry does not use antibodies, affinity agents, ligands or anything else. All solid-state porous polymer chemistry and it is protected by 20 issued US patents and multiple patents issued and pending worldwide. We're an innovation leader in acute care blood purification with multiple products on the market today, including CytoSorb, which we'll talk about more extensively today, ECOS 300CY for ex vivo organ perfusion to expand the number of organs suitable for organ transplant, VetResQ, which is CytoSorb for animals, PurifY, which is a hemoperfusion first-in-class pump, and HemoSwap, a rapid device interchange system that allows you to change out the device rapidly over time. In addition, we have a deep pipeline. Today we'll talk more about DrugSorb-ATR for blood thinner removal in cardiac surgery, but I'd also like to point out HemoDefend-BGA, which has been developed with $16 million in DOD funding to develop universal blood products that can be given to any patient regardless of their blood type. Currently, we have an FDA pre-IDE feedback scheduled in July, with clinical trials hopefully expected by 2027. The nice thing about our business model is that we are compatible with the existing blood pump infrastructure in hospitals today, for example, those made by our partners Fresenius Medical Care, B. Braun, Terumo Cardiovascular, and many other players in the space.
DC: We can be used in line with dialysis or CRRT, hemoperfusion, ECMO, which is an artificial lung, or cardiopulmonary bypass in cardiac surgery. Now, turning to CytoSorb, which is our core business. CytoSorb is a powerful blood purification CE Mark-approved technology in the EU to reduce cytokines, bilirubin, myoglobin, and blood thinners like Brilinta and Xarelto. It removes many substances that dialysis cannot, and in doing so, is helping to expand the dimension of blood purification. Dialysis, as you know, works like the kidney, removing small molecules, metabolic waste products, and water-soluble drugs. While CytoSorb is designed to work like your other detoxification organ, which is your liver, removing large molecules, fat-soluble substances, important molecules like cytokines, inflammatory mediators, bacterial toxins that can cause disease, proteins and peptides, and fat-soluble drugs. Another thing separating our technology is just the interface through which we interact with blood. Dialysis uses a cartridge that has a semi-permeable membrane that has about three-quarters of a ping-pong table in surface area. While CytoSorb has seven US football fields in a single cartridge, roughly the size of a drinking glass, or for the FIFA fans out there, roughly five European soccer fields or football fields.
DC: There's just massive capacity on which to bind things. Many of you know that acute inflammation is the body's mechanism to fight injury and infection. However, severe inflammation, driven by cytokine storm and other factors, can cause a chain reaction of problems that can end in organ failure and death. And this deadly inflammatory response can cause shock, capillary leak, immune dysfunction, all kinds of organ damage and tissue damage, hypercoagulability, cell-mediated injury, microvascular dysfunction, and many other problems in the body. In fact, severe inflammation is the common thread amongst most critical illnesses and impacts up to 60% of patients in the ICU and is directly correlated with increased severity of illness, organ failure, and mortality. And CytoSorb is specifically designed to address the removal of these inflammatory toxins and other toxins to try to help prevent and treat disease. In critical care, CytoSorb is helping to remove the fuel to the fire of massive uncontrolled inflammation that is often associated with organ failure and death in a lot of different illnesses seen every single day, including sepsis, influenza, COVID, lung injury, trauma, complications of surgery, cytokine release syndrome in CAR T-cell immunotherapy, burn injury, liver failure, and many others.
DC: In cardiothoracic surgery, it is designed to reduce inflammation and blood thinners, targeting the reduction in complications from cardiac surgery like sepsis, bleeding, shock, and others. Now, the nice thing about CytoSorb is that it actually has a much larger opportunity than that seen by other players in the strictly dialysis space, where companies like Fresenius, B. Braun, Baxter, Asahi, and others are really only targeting 10 to 15% of patients in the ICU who have failed kidneys. We, on the other hand, are targeting a much larger market, the 40 to 60% of patients in the intensive care unit who have life-threatening inflammation or toxin overload from a lot of the diseases we already mentioned. CytoSorb is supported by a wealth of clinical data that can be found both on our website and, if you do a quick PubMed search, you'll find it there as well. Now, the key to success is treating the right patient at the right time with the right dose, just like antibiotics. We've found that CytoSorb works most effectively when you treat early, you treat intensively, and you complete the full course of treatment. And if a picture is worth a thousand words, this is our device before treating a patient with severe liver disease, and this is our cartridge after, once you flush out the blood after you treat a patient with chronic liver disease, with acute liver disease. And you can just see visibly how much it is that we're removing, all these toxins that we're removing from this patient.
DC: Now, one of our largest markets is sepsis, and we believe we are leading a new era in sepsis treatment. One in five deaths worldwide is related to sepsis. You may have heard of Kyle Busch, NASCAR legend, who recently died of an undiagnosed pneumonia and then died rapidly of sepsis and septic shock. Or Daveigh Chase, the little girl from The Ring, or the voice from Lilo and Stitch, of Lilo. For more than a decade, CytoSorbents has collaborated with clinicians and scientists around the world to advance the treatment of sepsis and septic shock by complementing traditional antibiotics with the broad-spectrum capability of CytoSorb. Antibiotics treat the infection, while CytoSorb helps to treat the deadly inflammatory response by, again, removing the fuel to the fire that causes a system crash. If you have more interest in learning about the impact that we're having in sepsis and septic shock, you can click on this link to get to a video that was produced last fall during Global Sepsis Awareness Month to find out how CytoSorb is impacting patients with sepsis and septic shock.
DC: Now, turning to the opportunity of DrugSorb-ATR, tens of millions of patients globally are taking blood thinners. Some of these are called direct oral anticoagulants or DOACs like Eliquis and Xarelto, or antiplatelet agents like Brilinta, either chronically or acutely to reduce the risk of heart attack, stroke, and other serious complications. Each year, an estimated 1 to 2% of patients on these blood thinners will require emergent or urgent surgery, often cardiac surgery, because many of these patients, or most of these patients, are actually vasculopaths. Roughly 5 to 10% of emergency cardiac surgeries involve patients on chronic DOAC therapy. And roughly 5 to 10% of heart attack patients on antiplatelet agents are not eligible for a stent and now require urgent or emergent unscheduled CABG surgery, and now run the risk of bleeding due to that blood thinner.
DC: The only way to deal with this today is to delay surgery for multiple days while they're in the throes of critical illness, while they're in the throes of having a heart attack, to reduce the risk, to let the drug wash out of the body and reduce the risk of bleeding. There is a major unmet medical need in patients awaiting urgent cardiothoracic surgery. Patients cannot wait due to the need for emergency surgery, and waiting for drug washout actually may increase the risk of poor patient outcomes, such as sudden cardiac death. DrugSorb-ATR is an FDA Breakthrough Designated Device twice over with the potential to address this pervasive and serious unmet medical need. So here is a typical use case for one of the applications that we're pursuing, which is the use of the super aspirin Brilinta in the case of patients who've had a heart attack. So a patient who has a heart attack knows, first you call 911, and then you take an aspirin, which is a weak antiplatelet agent that's supposed to prevent that clot from getting worse that's in the heart artery. Well, when you go to the emergency room, that patient will get not only aspirin, but a super aspirin like Brilinta. And all these patients will wind up going to the cath lab. 90% will get a stent, but 5 to 10% will not be eligible for a stent and will now need to go to urgent or emergent cardiothoracic surgery. But because of the risk of bleeding from being loaded on a blood thinner just days before.
DC: The American Heart Association and the American College of Cardiology both recommend that these patients who are still having a heart attack should be parked in the hospital, in the ICU at $6,000 to $8,000 a day, in the step-down ICU at $4,000 to $5,000 a day, or in a cardiac-monitored hospital ward at $2,000 to $3,000 a day for three to five days just so that they can go to surgery and have a reduced risk of bleeding. Well, what DrugSorb intends to do is that it is being used right away to be able to avoid these unnecessary delays and allow patients to get the critical surgery that they need while reducing or preventing these bleeding complications. The pivotal STAR-T randomized controlled trial is now available, and you can read it for yourself. This was the pivotal trial for this application of reduction of bleeding risk, specifically for Brilinta. And what they found was that intraoperative DrugSorb-ATR use for ticagrelor or Brilinta removal is safe and can reduce the severity of bleeding after isolated CABG in patients operated on within two days of drug discontinuation.
DC: Again, this trial was led by some of the legends in the field of cardiac surgery and cardiac trials, including Dr. Michael Mack, Dr. Richard Whitlock, and Dr. Michael Gibson, all of whom were co-PIs in the trial. And you can see in this insert here that the relative reduction, that the absolute reduction in risk of perioperative bleeding, when you characterize it either as a universal definition of perioperative bleeding of three or more, which is serious or fatal bleeding, or 24-hour chest tube drainage of more than a liter, which you only have roughly four to five liters of blood, so this represents more than 20% of your blood loss, is that it reduces that risk from 30% to roughly 13.7%. That was statistically significant in CABG patients. And that represented an NNT of six patients treated to avoid one serious bleed. However, the trial was not a pure trial because we did miss the primary endpoint that included not just CABG patients, our main use case, but all cardiac surgery patients, and particularly cardiac surgery patients, for example, undergoing an aortic dissection repair or valve replacement, where they bleed a lot, and they're on the table for a long period of time. Unfortunately, there was an imbalance of these patients in the treatment arm, resulting in us missing our primary endpoint.
DC: But when you look at the CABG subpopulation, we have a statistically significant pre-specified CABG subpopulation. We have a statistically significant benefit. However, there were two important positive outcomes in this decision. The FDA did not identify any safety issues with the device, which is key to the benefit-risk ratio that the FDA uses to judge de novo devices, and based on our understanding, the FDA has agreed to focus the review of a new de novo submission on only the remaining items. Based on additional discussions this year, FDA has requested that additional mechanistic data be included alongside real-world evidence, which will form the basis of demonstrating that the probable benefit outweighs the probable risk, and this data is likely to be generated from an experimental study, not a new clinical trial with clinical endpoints. We now have a pre-submission meeting scheduled with the FDA in August to discuss options to generate these additional mechanistic data, and once the plan is agreed upon, we'll expedite the work to obtain these data and file a new de novo application submission as soon as possible, which is anticipated in late 2026 or early 2027. Following submission, we expect at most a 150-day review, and it could be sooner than that if the FDA can expedite that review as previously noted.
DC: We have a potential second shot on goal with the approval of DrugSorb-ATR for the DOAC class of blood thinners like Xarelto and Eliquis. We have now scheduled a separate pre-submission meeting with the FDA in August to review the data currently available for the DOAC indication and determine what, if any, information may be required to support a parallel de novo submission for DOAC removal. It was always our intent to pursue this approval, but we were planning on doing it after our Brilinta trial. But given the slight delay, we're pursuing this in parallel, and this strategy is consistent with our second FDA Breakthrough Device designation: remove DOACs during cardiac surgery. It should be noted that tens of millions of patients are on chronic or lifelong DOAC therapy for diseases such as atrial fibrillation and other illnesses, with Eliquis being the number seven pharmaceutical in the world and Xarelto being another blockbuster. Meanwhile, real-world evidence using our technology to reduce perioperative bleeding risk in cardiac surgery due to Brilinta and DOACs continues to build. We believe that we have an initial opportunity with just Brilinta alone of $300 million, which could expand to more than $600 million.
DC: When you include the other DOACs and if you can expand that to not just cardiac surgery but other surgeries where blood thinners play a dangerous role, we could expand that to $1 to $2 billion over time. Finally, turning to our financial performance, it's important to know how we actually sell our product into the marketplace. We sell CytoSorb in more than 70 countries worldwide, with more than 300,000 treatments to date. We sell direct in Germany and nine other countries, in about 56%, that accounts for 56% of our revenue, and through distributors and partners in the remaining 44%. We have a history of strong annual sales growth, and here you see a decade's worth of sales, where you see during the pandemic in purple were COVID-specific related sales, whereas blue is our core business. And what you can see here is that we've had, since the pandemic, a steady increase in the growth of our company and trailing 12-month sales of $37.3 million, ending the first quarter of this year. In the first quarter, sales were $8.9 million, up slightly from a year ago, representing 13% growth in direct sales outside Germany.
DC: Germany, which has seen flat growth for several years, has been under restructuring since the beginning of 2025. And they did very well in the first quarter, achieving sales just slightly below last year, but with significantly fewer people. And our distributor sales were flat but would have been higher by roughly half a million dollars due to delayed orders and the ripple effect caused by the unanticipated US-Iran war. Gross margins were 69% versus 71% as we work to reduce production intentionally so that we could work down inventory that was tying up our cash. But this was offset by significant productivity gains, process improvements, and cost reductions, with the goal being to return to double-digit growth. This next slide is very important and something that most of you have not seen before, but this is a graph of our free cash flow by quarter. And what you can see here is that we are making excellent progress in driving improved free cash flow through efficiency development, cash management, and cost reductions. We now expect to be operating cash flow breakeven in the second half of 2026, which is so important to our business model and to maintaining financial sustainability.
DC: We ended the first quarter of 2026 with $6.4 million in cash, cash equivalents, and restricted cash, compared to $7.8 million, with an expectation that our Q2 burn will continue to be lower. We had $1.1 million cash burn in the first quarter, net a small restructuring fee, and again expect that Q2 will be better than that. In summary, we believe that CytoSorbents represents a clear and compelling value that is significantly undervalued, with a sound plan to build and maximize shareholder value. The first thing is to continue growing sales and return to growth. We have an international core business in critical care and cardiac surgery that's already $37.3 million in high-margin product sales on a trailing 12-month basis and an excellent razor business model with expectations for strong future growth. We have significant critical care and cardiac surgery market opportunities with a wealth of clinical data that we're leveraging in the market and active measures to restore overall sales growth to the double digits. Secondly, we are committed to bringing DrugSorb-ATR to the North American market with two planned de novo submissions pending completion of interactive discussions with the FDA. And our goal is to drive cash flow breakeven by the second half of 2026 and turn the corner of profitability potentially in 2027.
DC: With that, let me thank you very much for joining me on this overview of the company. I'd like to now turn it over to Tom to begin our polling for our Q&A. Thank you.
TK: Great, Phil, that was a great presentation. Covered a lot. I just want to reiterate, and you did a good job of this, that you guys are not a startup company. You're an established business with $37 million in revenues, mostly in the EU market. Maybe just a little more color on who the customer is, on the sales channels, and just a minute or two on that, if you don't mind.
DC: Yeah. Roughly two-thirds of our business is focused on critical care. In critical care, we are targeting typically the intensivists, who are specialized medical physicians who are focused specifically on treating critically ill patients in the intensive care unit. But in cardiac surgery, we are also targeting both cardiac surgeons who are operating on patients undergoing very significant surgeries like aortic reconstruction, valve replacement, CABG surgery, etcetera, but also the perfusionists who are running the machine, where CytoSorb is implemented directly into that machine within roughly 10 minutes and does not change the practice of medicine and does not change the flow of that cardiac surgery. Cardiac surgery represents roughly a third to 40% of our business today.
TK: Okay, got it. Moving to the DrugSorb-ATR for a minute. Good description of its benefits, and you've described in the past that it's a win-win-win situation. What are those parties that are winning or benefiting from the DrugSorb-ATR in cardiac surgery?
DC: Well, first it's the patient, right? As I mentioned to you, the only strategy today to reverse the effect of these blood thinners is to sit in the hospital suffering from the heart attack or whatever brought the patient to the hospital, to basically wash out the drug over three to five days. What our therapy enables is for them to get the critical surgery that they need on time, which is so important for trying to help promote good clinical outcomes. The second winner in this is the cardiac surgeon. First of all, they don't like to wait, but they are so fearful of the bleeding that these blood thinners cause that they really don't want to go to surgery and would rather park that patient than operate on them. Because every cardiac surgeon has a horror story of how a patient of theirs, often more than one, has depleted the blood bank. They bled so badly that they depleted the blood bank of that patient's blood type either during surgery, intraoperatively, or after surgery. And so when we talk to cardiac surgeons who know about our technology or have used our technology, they often use the word “no-brainer” because of that.
DC: And then the other win-win is the hospital. They're not wasting valuable hospital resources like $6,000 to $8,000 a day. That's $18,000 to $30,000 just to park a person in the ICU to wash out that drug. Here, with very simple economics and cost savings, they can eliminate all that waiting and get that patient to surgery right away and utilize its resources better. That's the win-win-win.
TK: That's a great unmet need. Real quick on the FDA approval process, for viewers that aren't familiar with the FDA approval process, what is mechanistic data?
DC: Well, what we have already demonstrated in our STAR-T randomized controlled trial in the prospective CABG subgroup, as I mentioned, is that our device can reduce the risk of serious perioperative bleeding. In Europe, where we collect clinical data from real-world usage throughout Europe, we're also seeing the same magnitude of reduction in perioperative bleeding risk. So that's the clinical benefit, reduction in bleeding risk, which is what everybody wants. That's what the patient wants, that's what the surgeon wants, that's ultimately what the hospital wants as well. But mechanistic data is more like pharmacokinetic or pharmacodynamic data in that it demonstrates that there is an underlying mechanism of what it is that we're doing to prevent that clinical bleeding risk. And what we have said all along, and what we provided the FDA with data for, is that we can remove free drug and reduce that perioperative bleeding risk. But the FDA has asked for some more data. We think it's going to be, you know, a small experimental study in either humans or animals. We're waiting for our meeting in August to delineate what that will be, but it is certainly not a large-scale repeat of our randomized controlled trial.
TK: Got it. One quick one for Pete before we go. The old gross margin question. You know, this is a high-gross-margin product, an established business. What can we expect in 2026 and maybe 2027 on the gross margin side?
Pete Mariani: Yeah, thanks, Tom. We've been running mid or low 70s here, 69 to 71% for a while. We have the opportunity with additional volume to move that up into 75% as we continue to drive efficiencies and take advantage of some of the cost reductions that we've been working on here, particularly over the last, call it, six to nine months. Then, as we look to 2027, we get DrugSorb into the mix, certainly driving well into the high 70s, low 80% range is very possible as we drive higher volumes in the business.
TK: Got it. That sounds great. Do you have any final comments?
DC: Well, we know that your program will reach a lot of different investors, and we would welcome an opportunity to speak with them if they had an interest in learning more.
TK: All right, sounds good. Well, thanks for your time today, and we look forward to talking in the future.
DC: Thanks so much, everyone.
PM: Thanks, Tom.
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