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Thursday, Nov. 12, 2026
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Cytosorbents Corporation (NASDAQ:CTSO) achieved its primary financial milestone of positive operating cash flow, excluding restructuring costs, in the third quarter of 2026. Management reported that the company has transitioned from a phase of extensive cost containment to a period of targeted investment in revenue growth, specifically within its German commercial operations. The strategic focus encompasses four distinct value drivers: maintaining financial stability, restoring CytoSorb growth, obtaining U.S. regulatory clearance for DrugSorb-ATR, and monetizing the HemoDefend-BGA asset. The company is advancing two separate regulatory submissions for blood-thinner removal technologies in the U.S. and is exploring strategic partnerships or licensing to unlock the value of its universal blood filtration technology without substantial internal investment.
Operator: Good afternoon, ladies and gentlemen, and welcome to Cytosorbents third quarter earnings conference call. [Operator Instructions] This call is being recorded on Thursday, November 12th, 2026. I would now like to turn the conference over to Peter Mariani, Chief Financial Officer. Please go ahead.
Peter Mariani: Thank you, John, and good afternoon, everyone. Joining me on today's call is Dr. Phillip Chan, our Chief Executive Officer. As we get started this evening, I want to remind everyone that our press release has been filed and is available with the SEC, but in the several delays that many of us have experienced today, apparently there's a delay with the wire service, so hopefully we'll see that cross the wire here very soon. On today's call, we will review our third quarter 2026 operating and financial results, including the key milestone highlighted in today's earnings release, the achievement of our first value driver, operating cash flow breakeven.
We will then provide an update on our remaining value drivers, including our regulatory progress with DrugSorb-ATR, followed by a question-and-answer session. Before we begin, I'd like to remind everyone that statements made during this call that are not historical facts are forward-looking statements, and the company claims protection under the Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
These statements include, among others, statements about our plans, objectives, future targets and outlook, our ability to sustain operating cash flow breakeven, the outcome of our regulatory submissions, our ability to maintain compliance with NASDAQ continued listing requirements, and our ability to finance the company, including the extension, refinancing, or repayment of our existing debt. Actual results may differ materially from those expressed or implied in these statements.
For the discussion of risks and uncertainties that could cause such differences, please refer to the risk factors in our annual report on Form 10-K filed with the SEC on March 30, 2026, as updated by our quarterly reports on Form 10-Q, including the 10-Q we expect to file by Monday, November 16th. We undertake no obligation to update any forward-looking statements, except as required by law. During this call, we will also refer to certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net loss, and adjusted net loss per share.
Reconciliations of these measures to the most directly comparable GAAP measures are included in our earnings press release, which is available on the investor relations section of our website. Also note that our share and per-share amounts reflect the 1-for-20 reverse stock split affected on September 8th, 2026. With that, I'll turn the call over to Phil. Phil?
Phillip Chan: Great. Thank you very much, Pete. Well, thanks, Pete, and good afternoon, everyone. I appreciate you joining us. This was an important quarter for Cytosorbents, not just because of the financial results, but because of what they tell us about the business that we're building. We set a clear objective to reach operating cash flow breakeven in the second half of 2026. I'm pleased to report that we achieved that objective in the third quarter, excluding restructuring-related payments. We generated approximately $43,000 of positive operating cash flow on that basis. Revenue was $9.7 million. Product gross margins reached 75%, up 200 basis points from the prior quarter.
Operating expenses declined 11% year-over-year, and our adjusted EBITDA loss narrowed 86% to approximately $300,000. These results reflect disciplined execution over the past year, better manufacturing and sourcing, tighter cost controls, a leaner organization, and improved working capital management. The significance extends beyond this quarter. Every dollar of operating cash we eliminate reduces our future financing needs and allows more of the value created by future growth to accrue to shareholders. Our strategy centers on four distinct drivers of value creation. The first is achieving sustainable operating cash flow breakeven, and we've now reached that initial milestone. The second is restoring sustainable profitable growth in our core Cytosorb business.
The third is opening the U.S. market through DrugSorb-ATR, and the fourth is unlocking the strategic value of HemoDefend-BGA. Each offers a different opportunity to create value, so our future is not dependent on any single commercial, regulatory, or strategic outcome. Now I will ask Pete to take you through the financial results, the drivers of our cash flow improvement, and then I'll return to discuss the other three opportunities. Pete?
Peter Mariani: Thank you, Phil. I'll focus my comments on the four drivers behind our breakeven: gross margin, operating expenses, operating income, and adjusted EBITDA. First of all, third quarter revenue was $9.7 million, up 3% year-over-year and 1% sequentially, led by an 18% increase in distributor and strategic partner sales. Gross margin. The most significant improvement in our P&L this quarter was gross margin. Product gross margin was 75%, up approximately 2 points from 73% in the second quarter and 5 points from 70% a year ago. It has improved every quarter this year from 69% in the first quarter.
On revenue growth of about $243,000, gross profit rose about $662,000, or 10%, to $7.3 million, and cost of goods sold declined 15% to $2.4 million. These gains are structural. Over the past year, manufacturing and operations teams optimized our production process, improved sourcing of key materials, and drove efficiencies across production while aligning output with demand to keep inventory lean. We believe these improvements are sustainable, and we are targeting product gross margins consistently in the mid-70% range. Operating expenses were $8.5 million, down 11%, or about $1 million from a year ago, and down 12%, or about $1.2 million from the second quarter. Excluding $250,000 of restructuring charges, they were down 13% year-over-year.
SG&A fell 18% to 7.1%, reflecting the full quarter benefit of actions we took over the past year, including the reduction of headcount by approximately 24%, restructuring of our commercial organization, and tightening cost controls across every function. R&D was $1.1 million, up from $900,000 a year ago, reflecting lower grant income in the current year and regulatory work on DrugSorb-ATR, but down 21% from the second quarter. Operating loss and adjusted EBITDA. Higher gross profit and a lower cost base together drove significant improvement in operating performance. Operating loss improved 59%, or about $1.7 million to $1.2 million from $2.9 million a year ago, and improved about $1.5 million from $2.6 million in the second quarter.
Adjusted EBITDA loss, which excludes the impact of non-cash foreign currency changes, non-cash stock compensation, and restructuring charges, improved 86% to approximately $284,000 from $2 million a year ago and $1.6 million in the second quarter, and has improved each quarter this year. Adjusted EBITDA most closely tracks our underlying operating cash generation, and bringing it near break-even was fundamental to our ability to reach operating cash flow break-even this quarter. Net loss improved 42% to $1.8 million, or $0.58 per share, from $3.2 million, or $1.01 per share. Adjusted net loss, which excludes the same items, was $1.5 million, or $0.48 per share, versus $2.6 million, or $0.83 per share in the prior year.
For the nine months ended September, revenue was $28.2 million, up 1%. Gross margin improved to 73% from 71%. Operating expenses fell 9% to $27.4 million, and adjusted EBITDA loss improved 45% to $4 million. Operating loss improved 34%, or $3.5 million to $6.9 million, driven by $800,000 of higher gross profit and lower costs, including $1.1 million in selling, travel, and marketing, $1 million in compensation, $800,000 in financial, legal, and consulting, and $200,000 in R&D, all of which was partially offset by $600,000 of restructuring charges.
Net loss was $11.4 million, or $3.62 per share, versus $2.7 million due to an $11 million swing in non-cash foreign currency, a $1.9 million loss this year against a $9.1 million gain last year. As Phil mentioned, we generated positive operating cash flow of approximately $43,000 in the third quarter, excluding $251,000 of restructuring payments, compared to a burn of $200,000 in the second quarter and $2.7 million a year ago. Including restructuring, total cash burn in the quarter was $200,000, and we ended the quarter with $5.7 million of cash equivalents, and restricted cash.
Inventory fell to $3.2 million from $5.3 million at year-end, and year-to-date cash used in operations was $2 million versus $7.6 million last year, a 73% reduction. With operating cash flow break-even achieved, our focus now shifts to remaining at or near operating cash flow break-even while making targeted investments in growth, including rebuilding our German sales team and advancing DrugSorb-ATR. Break-even will not be a straight line, and we do not expect every quarter to be positive. Results can fluctuate with the timing of orders, collections, and other working capital. Some quarters may show a modest burn and others a modest positive cash flow, and we will report our progress each quarter.
Additionally, we are actively working to satisfy the remaining Nasdaq listing requirement and debt restructuring by the end of this year. With that, I'll turn the call back over to Phil. Phil?
Phillip Chan: Thanks, Pete. This is the natural next phase of our strategy. We've done the difficult work of improving our cost structure. Now we have an opportunity to selectively reinvest in growth, particularly in areas where our commercial reach has been resource constrained. There are encouraging signs across most of our business. Distributor and strategic partner sales increased 18% year-over-year, and direct international sales outside Germany grew 4%. Those two channels accounted for 76% of third quarter sales. Germany, representing the remaining 24%, declined approximately 20%-21% year-over-year, principally because we reduced our sales force and territory coverage during restructuring, not because we believe the market opportunity has disappeared. We're addressing that directly.
We've already added two German sales representatives, expect another one next month, and plan to add two more by early 2027. We also recently welcomed Alex Tiefenbacher as Senior Vice President of Direct Sales. Alex brings extensive acute and critical care medical device leadership experience from C.R. Bard, Becton Dickinson, GE Healthcare, and Baxter. His initial focus will be on rebuilding our German commercial momentum while strengthening execution across our international direct sales organization. At the same time, our right patient at the right time with the right dose approach is gaining traction. Our PuriFi pump platform and HotSwap technology are designed to make treatment delivery simpler and support earlier, more consistent use of Cytosorb.
The clinical evidence base continues to expand as well, with presentations at the European Association for Cardio-Thoracic Surgery Conference covering blood thinner removal, postoperative shock, VA ECMO, and heart transplantation, and our COSMOS critical care registry findings at the European Society of Intensive Care Medicine LIVES 2026 Conference addressing sepsis, liver support, and VV ECMO. We believe renewed growth in Germany, continued international momentum, and stronger clinical support can work together with our more efficient cost structure to drive profitable growth. Importantly, because our product gross margins are healthy, we believe targeted sales investments can produce meaningful operating leverage as revenue builds. Our third value driver is DrugSorb-ATR, our investigational technology for removing blood thinners during urgent cardiac surgery.
The objective is to reduce serious bleeding complications in patients who cannot safely wait for these drugs to clear. Subject to regulatory authorization, we estimate an initial U.S. and Canadian addressable market of approximately $300 million to start, potentially expanding to $1 billion- $2 billion with additional blood thinner and surgical indications. We are pursuing two distinct potential pathways to U.S. commercialization. The first centers on BRILINTA, or generically ticagrelor.
At the European Society of Cardiology Conference in August, an independent patient-matched analysis involving 587 urgent bypass cardiac surgery patients reported a statistically significant 37% relative reduction in severe BARC- 4 bleeding with intraoperative Cytosorb use, and that was 21.8% compared to 34.5% serious bleeding in controls, with a P-value of 0.002. That translates to a number needed to treat of approximately eight patients to prevent one serious bleeding event. The analysis also reported reduced chest tube drainage and red blood cell transfusions with no serious device-related adverse events.
This real-world analysis is especially relevant because FDA previously proposed this analysis during the appeal of our original De Novo submission, and it is expected to be a core component to strengthen the clinical efficacy of DrugSorb-ATR in a new De Novo submission. We expect the new submission will increase fivefold the number of patients treated with our technology to roughly 250 in total, on which to strengthen the probable benefit to probable risk analysis, which is the basis of FDA De Novo marketing approvals. FDA had previously noted no major safety concerns with our therapy for this indication, highlighting the low probable risk.
These data, along with STAR-T results, previously submitted safety data, and additional mechanistic and technical evidence, will form the basis of our new De Novo submission. Following a constructive FDA pre-submission meeting in August, we are working with the agency to finalize an animal study protocol. We currently plan a new BRILINTA De Novo submission in early 2027, subject to the completion of the necessary work and regulatory interactions. Statutorily expect a decision by FDA 150 days later, which could be sooner based upon our Breakthrough Device Designation and priority review status. Separately, we are advancing a potential De Novo pathway for the direct oral anticoagulants Eliquis and Xarelto, for example.
We have discussed the evidence requirements with FDA and expect a separate submission in 2027. These are two distinct regulatory opportunities, each with its own supporting evidence and development strategy. DrugSorb-ATR is not yet cleared or approved in the United States or Canada, and regulatory outcomes remain uncertain, but we believe the expanded evidence package represents meaningful progress. Our fourth value driver is HemoDefend-BGA, an asset with potentially significant strategic value that we believe is not fully captured by the economics of our current commercial business.
HemoDefend-BGA, as we mentioned last time, is a simple gravity-driven filtration technology designed to remove anti-A and anti-B antibodies from plasma and platelet products, potentially enabling universal products that could be transfused to any patient regardless of the recipient's blood type. It does not require electricity, capital equipment, or complex processing, and that could ultimately simplify hospital blood bank inventories and reduce waste and logistical complexity. Longer term, the technology could help make freeze-dried universal plasma available to first responders and military personnel without refrigeration or blood typing, an important potential advance in emergency hemorrhage care, and often called the holy grail of plasma.
Program benefited from approximately $16 million of prior non-dilutive U.S. government funding, and we received constructive FDA feedback on our anticipated clinical development pathway in July. We are now exploring non-dilutive funding, commercial partnerships, licensing, and other strategic alternatives with the objective of unlocking value without requiring substantial investment from our core operations. As we close, I want to return to the broader significance of this quarter. We have made the business more efficient, meaningfully reduced cash consumption, and achieved an important financial milestone. That gives us a stronger operational foundation from which to pursue growth and advance our pipeline.
What makes our position interesting is the combination of these four opportunities: a more sustainable financial model, a core franchise with room to regain momentum, a potential U.S. growth platform in DrugSorb-ATR, and a differentiated strategic asset in HemoDefend-BGA. These are distinct avenues for value creation rather than a single binary bet. To summarize our priorities, first, we achieved operating cash flow breakeven in the third quarter, excluding restructuring payments, and we will work to sustain performance at or near that level. Second, we are selectively rebuilding our commercial capacity to accelerate growth beginning in Germany. Third, we are preparing our expanded ticagrelor BRILINTA evidence package for a planned early 2027 De Novo submission while advancing a separate DOAC pathway.
Fourth, we are pursuing strategic options with HemoDefend-BGA that could unlock value with limited demands on our operating resources. Although we recognize there's more to do and none of these steps are guaranteed, with our improved fundamentals, disciplined capital allocation, and multiple potential catalysts, these all give us reasons for confidence. Our goal is to translate that progress into a stronger, more profitable, and more diversified medical technology company and lasting value for shareholders. Thank you to our employees, clinicians, partners, and investors for your support, and we hope that you have a very happy holiday season. With that, operator, we would now like to take questions.
Operator: [Operator Instructions] We will now take the first question, and this comes from Michael Sarcone from Jefferies.
Michael Sarcone: Phil, can you talk about how you're feeling, your level of confidence in getting over the finish line in the U.S.? You talked about kind of De Novo submission in early 2027, or at least that's what's in the press release. I guess, I would love to hear about your level of confidence, and do you think, to the extent we get approved next year, could we see some decent revenue in 2027 from DrugSorb-ATR in the U.S.?
Phillip Chan: Yeah, it's a great question. What we have seen right now is that the standard for De Novo approval is that the probable benefit has to outweigh the probable risk. As most of our investors know, there was an issue with the original STAR-T trial, where FDA had requested additional patient match data from our European STAR Registry to supplement our STAR-T results to demonstrate the clinical probable benefit of our device. Meanwhile, they have also noted that there are no major safety concerns with our device for this application.
So, we believe that with this additional analysis that has just been made available through a third party, that we have a significant amount of clinical evidence to demonstrate that the probable benefit outweighs the probable risk. One of the only things that is holding us up right now is this additional animal study to obtain additional mechanistic data that we are working actively on and hope to finish before we submit in early 2027. So, let me turn it over to Dr. Makis Deliargyris, our Chief Medical Officer, for his thoughts. Makis?
Makis Deliargyris: Sure. Hi, Michael, and thank you for the question. Attacking your question backwards, you talked about the opportunity in the U.S. market and whether that would be meaningful. So, let me start by saying that I just returned from the TCT conference, where we had a chance to present some of our DOAC data. Over the last couple of years, we've been focused a lot on antithrombotic removal and our STAR-T data, but now we have increasing evidence base around the DOAC removal in cardiac surgery. There was, again, extreme enthusiasm. These are daily issues faced in clinical practice without a solution.
I don't know if you're aware, but less than a year ago, the only available antidote for these DOACs was actually removed from the market by its maker, based on the fact that the FDA concluded a negative benefit-risk analysis on the product. There is tremendous enthusiasm. Once the clearance is provided to enter the U.S. market, irrespective of what the target drug may be on the label, the blood thinner removal opportunity is a real one, and there's a real desire by clinicians, cardiac surgeons, cardiologists, to be able to manage these patients that they see on a daily basis. Having said that, we still have to get over the hump, obviously, with FDA.
Having the two applications now is obviously, we think, a stronger position than where we were before. Each application has its unique aspects since there are differences between these agents in the way that they are pharmacologically built and the profiles that they exhibit once administered in clinical use. We're navigating through the details with a device group over at FDA, which I can tell you, it's also, for them, a little bit of a learning curve to understand some of these intricacies in pharmacology. It's a collaborative effort.
We're making progress, obviously not at the pace that we would have liked, but again, we are dependent to a large extent to our colleagues at FDA on how we advance this. But we are gaining clarity. The more we talk, the more we align, the more we have a path forward, and we're making that progress with the intent of getting both of these applications moving forward with submissions in 2027. Hope that helps.
Michael Sarcone: Thank you, Makis, and thank you, Phil, for the color. I guess just as a follow-up on that, I guess for the animal study where you're looking to collect some additional mechanistic data, I guess what's left to do there? Phil, based on your commentary, it sounded like you've already kicked that off. I guess I'd just be curious of what's left to do, and do you feel confident you could wrap that up by year-end?
Phillip Chan: Yeah, Makis, do you want to take that?
Makis Deliargyris: Sure. First of all, obviously, we don't have internal animal facilities. This is reflective of our collaborative efforts with outside institutions that have the capacity and the capability to execute this study. So once again, it's a collaborative effort between Cytosorbents and our external scientific partners. We're working with them closely. There are some delays associated with institutional review approvals, especially when it comes to potential amendments that the experimental design may require. There's a little bit of a trailblazing going on. These are studies that we're executing right now that there hasn't been any previous similar work done before. But the positive side is that we have identified the right partner to do these studies with.
We have made significant progress into finalizing the experimental design. Once that is in place and our FDA discussions are completed, the actual execution of the study is not a timely endeavor. It's more about getting the design buttoned up, getting the FDA, their review team, with the external experts from the drug side to review, opine, and hopefully approve. Then once that's done, the actual execution of the study, it's not a major delay in the overall process. The majority of time is taking about understanding the intricacies of these experiments, the exact experimental details we want in the protocol, discussing them with FDA, getting that done, and then we're going to execute the study in short order.
Michael Sarcone: Okay, great. That's super helpful. If I could sneak just one more in. Assuming you hit the timeline of getting that new De Novo submission in early 2027, can you help us think about the regulatory or statutory timeline, and kind of milestones we should think about from there?
Phillip Chan: Michael, as I mentioned, the statutory regulatory review cycle is 150 days. We are a Breakthrough Device, and we do qualify for priority review. But also, in our discussions with FDA last year during our appeal, FDA had agreed that they would focus only on the open items in a new De Novo submission, thereby potentially accelerating the review cycle. We'll have to see. We know that FDA has a lot on their plate, but we do believe that as a Breakthrough Device-designated product, there is a great unmet medical need and a desire, I think, to try to get this expeditiously to market.
Operator: Thank you. No further questions that came through at this time. I will now turn the call over back to Phil Chan. Please go ahead, sir.
Phillip Chan: Well, thank you very much, everyone, for taking the time to be on this call. We look forward to the next update. Hopefully, the press release is out, and you will be able to review that tonight. If you have any questions, feel free to reach out to us at ir@cytosorbents.com. Thank you very much, everyone. Have a good night.
Operator: Thank you. This concludes our conference call for today. Thank you all for participating. You may now disconnect.
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