Cytosorbents Corp Q3 FY2021 Earnings Call

Good afternoon. And welcome to the CytoSorbents' Third Quarter 2021 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode. Following formal remarks, we will open the call for your questions. Please be advised that the call will be recorded at the company's request. At this time, I'd like to turn the call over to our moderator, Terri Anne Powers, Vice President of Investor Relations and Corporate Communications. Please go ahead, Ms. Powers.

Thank you, Dave. And good afternoon and evening to everyone that is listening. Welcome to the CytoSorbents' third quarter 2021 financial and operating results call. Joining me today from the company are Dr. Phillip Chan, CytoSorbents' Chief Executive Officer; Vincent Capponi, our President and Chief Operating Officer; Kathleen Bloch, our Chief Financial Officer; Dr. Efthymios Makis Deliargyris, Chief Medical Officer; Dr. Christian Steiner, Executive Vice President of Sales and Marketing and also Managing Director of CytoSorbents Europe; and finally, Christopher Cramer, Vice President of Business Development. Before I turn the call over to Dr. Chan, I'd like to remind listeners that during the call, management's prepared remarks may contain forward-looking statements, which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today. Therefore, the company claims protection under safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today. And therefore, we refer you to a more detailed discussion of these risks and uncertainties in the company's filings with the Securities and Exchange Commission. Any projections as to the company's future performance represented by management include estimates today as of November 4, 2021, and we assume no obligation to update these projections in the future. During today's call, we will also have an overview presentation covering the operating and financial highlights for the third quarter by management. Following that presentation, we will open up the line to your questions with the management team. At this time, it's now my pleasure to turn the call over to Dr. Phillip Chan. Go ahead, Phil.

Thank you very much, Terri Anne. As we have discussed in a number of recent press releases, the past several months have brought us our share of challenges but also opportunities. We'll have more detail in the upcoming slides, but here's a quick overview. As we disclosed earlier last month, total third quarter 2021 revenue was $9.8 million, including product sales of $8.9 million with healthy blended product gross margins of 82%, combining higher direct sale margins with lower distributor margins. We closed the quarter with a solid cash balance of $61 million and no debt. On the operational side, we opened the U.S. STAR-T pivotal trial with the first patient enrolled into the study from the University of Maryland just recently. We also received our second breakthrough device designation, this time for the removal of the direct oral anticoagulants, Eliquis and Xarelto during cardiothoracic surgery and received full FDA approval to initiate the STAR-D pivotal trial for this application in a span of only 3 months. In September, we announced top-line data from our U.S. CytoSorb therapy in COVID-19 or CTC Registry reporting high survival among 52 consecutive patients on CytoSorb in ECMO from 5 major U.S. ECMO centers. Last month, preliminary results from the long-awaited REMOVE endocarditis study evaluating the use of CytoSorb in infective endocarditis were neutral, which showed a favorable adverse event profile. And again validated the ability of CytoSorb to remove cytokines. We are pleased to report that CytoSorb is now distributed in more than 70 countries with the recent expansion to Thailand and Ukraine. Overall, more than 152,000 CytoSorb treatments have been utilized to date, up 38% year-over-year. As we've done since the pandemic began, I would like to now give a quick overview of what we're seeing with COVID-19 since the second quarter earnings call in early August. This is particularly relevant this quarter due to the impact of COVID-19 on our financial results, especially in Germany. In the United States, COVID-19 has migrated from the Southeast, where the Delta variant drove the second worst surge in the country to date, now to the Western U.S. and Alaska. According to the CDC, Delta continues to account for 99% of new U.S. infections. To date, of those eligible 12 years of age or older, 68% of people are fully vaccinated, with 78% with at least one dose. Overall, 58% of the entire population is vaccinated. With the recent FDA approval and CDC recommendation of the lower dose Pfizer vaccine for children aged 5 to 11 years, representing about 8% of the U.S. population, the total vaccinated population is expected to go up significantly. What I'd like to point out on this slide are the lower right-hand figures on new daily COVID-19 cases in red and then how the graphs of hospitalizations and deaths mirror new cases from a relative proportion standpoint. The graphs look very similar. High net cases yields high hospitalizations and deaths. And we'll come back to this as it relates to Germany. That said, in terms of worldwide COVID-19 cases, COVID-19 continues to migrate now impacting countries like the UK and Germany as well as Eastern Europe and Russia. Remarkably, after lagging the U.S. in terms of vaccinations in early August, the percentages of fully vaccinated people in major EU countries has generally surpassed the U.S. as you can see in the lower left corner. And again, in the lower right, you can see the relative proportionality of new cases and deaths. Finally, turning to Germany, I'd like to point out a few things that highlight what happened to us in the third quarter and where we are today. The top chart shows new cases of COVID-19 in Germany and the bottom graph shows deaths in Germany. First, at the purple vertical line, you can see where we were when we provided guidance in early August, where the rates of new COVID-19 cases and deaths were very low. Coupled with an initial lifting of restrictions in Germany and increased sales meetings, we were optimistic for a return to our core non-COVID-19 business in Germany. However, rapidly over the course of weeks, the rates of new cases jumped significantly, prompting hospitals to continue or reinstate restrictions on elective procedures, limit outside visitors, including sales reps, and to reserve ICU resources already stretched thin by staffing shortages for tending critically ill COVID-19 patients. But during Q3, the numbers of critically ill patients expected did not materialize. Looking at these graphs, you can see something very different compared to the U.S. and the major surge in Germany in the fourth quarter of last year; the death rates were proportional to these new cases, as you can see from these two graphs, and as we've seen in the United States as well. However, in the subsequent surge earlier this year in Germany, the number of deaths were disproportionately low. With this last wave, the numbers of deaths reflecting ICU patients and severity of illness was very low despite the third-largest peak in new cases in Germany. In fact, this dissociation of high numbers of new cases with low numbers of deaths is the same trend we observed in other major EU countries, including the UK, France, Italy, and Spain. This is likely partly attributed to increased vaccination rates and the lower severity of illness among those vaccinated as well as the age of those getting sick. So how did this dynamic affect us in Q3? As we have previously discussed, during the pandemic, core sales lost to COVID-19 restrictions were typically replaced by COVID-19 sales in Germany. However, in the third quarter, because of increased restrictions that decreased core non-COVID-19 sales and the low severity of COVID-19 illness, which decreased COVID-19 related sales, all happening in a traditionally seasonal third quarter have led to weakness in Germany. In the past month, there's been a sudden spike in COVID-19 cases in Germany with ICUs starting to fill up with COVID-19 patients and deaths increasing sharply. We're monitoring the situation closely to assess what impact, positive or negative, this may have on our business in Q4. But let me turn it over to Christian to give more color on what happened in Germany in the third quarter and how we're managing around the uncertainty related to COVID-19 this quarter. Christian?

Thank you, Phil. And good afternoon to the U.S. from Berlin, Germany, and good evening to Europe. First slide, please. The third quarter is traditionally a challenging one due to vacation time in Europe. This year, especially due to existing COVID-related restrictions. Despite this, at the time of our second quarter earnings report, we were really confident that we would show good growth within our core business and some additional although declining COVID business. However, the new COVID wave started in August in Europe and particularly in Germany. This led to increased restrictions in hospital and customer access and to another slowdown in or stop of elective surgical programs. As Phil explained earlier, due to less disease severity, the increasing number of infections did not result in more critically ill patients eligible for CytoSorb therapy at that time. Because of this situation, the resulting sales growth in our core business across all geographies was only 3%, and there wasn't enough additional COVID-related business compared to the prior year. Our business in Germany was particularly impacted with a 24% decrease in sales. Markets outside Germany were either not affected or not to the same extent. In the current fourth quarter, the macro environment remains challenging in Germany. As Phil also indicated, currently, we are seeing an increase in COVID-19 cases and rising number of ICU patients. As a result, we are starting to see an increase in CytoSorb usage for those COVID-19 patients. We have a similar situation in many markets, but the impact to CytoSorb has been most relevant in Germany. We expect the environment to get better over time, but the pace of improvement is difficult to predict. Based on what we are currently seeing, we believe that we are on track to meet our fourth quarter product revenue guidance. Several medical conferences have been conducted by different organizers in September and October, although with relatively low attendance. This led to a moderate increase in our marketing efforts and activities. In this context, I want to highlight the CytoSorb users meetings. We have prepared for our customers and potential CytoSorb users; one for our international audience in October and one for our German-speaking users in November. The 8th International CytoSorb Users Meeting was conducted here in Berlin, Germany, 1 week ago. We had a fantastic lineup of more than 20 international opinion and thought leaders in critical care medicine to give their lectures and discuss the benefits of using CytoSorb in different indications. More than 400 doctors and healthcare professionals from around 60 different countries attended our hybrid event. Key opinion leaders stated that based on their experience and the current body of evidence, CytoSorb has a favorable safety profile. In addition, they suggested that benefits and therapeutic effects are reproducible when patient selection, timing, and dosing are appropriate. It was really an exciting and inspiring atmosphere and everyone was focused on how to bring CytoSorb use to the next level. CytoSorbents is tackling the current uncertain environment by applying a dual strategy. One, we are targeting critically ill COVID patients with another promotional campaign which particularly focuses on the right patient selection and appropriate timing and dosing of the treatments. And second, at the same time, we are pursuing the continued development and expansion of our core indications in the fields of critical care, cardiovascular, and liver support therapy. We are also increasing and adjusting our marketing and promotional efforts to address the current additional challenges. We do this by facilitating non-traditional customer meetings to see doctors and CytoSorb users where they are available. This can be, for instance, outside the hospitals after work at scientific seminars, journal clubs, roundtable discussions, and others. We are also holding additional educational meetings and training, both virtually and in person to ensure appropriate attendance. All these efforts are in direct response to the current pandemic situation in which we still must operate. At the same time, we are also continuing to invest in our business to drive medium and long-term growth. We are pursuing initiatives to optimize our sales force, not only in Germany but also in other geographies. We work to increase utilization in existing clinic applications and launch new ones. We also intend to expand our reach into additional direct territories over time. Enthusiasm and interest in CytoSorb remain high. We are absolutely focused on bringing back our German business to our usual growth rates while implementing measures to drive long-term developments.

Thank you, Christian. And good afternoon and good evening to everyone on the call. In the few next minutes, I will be providing an update on the progress of our global clinical programs. As you have seen from our recent press releases, we have made significant progress in our clinical trials in support of FDA marketing approval. The STAR-T study on ticagrelor removal received full FDA approval in July, triggering study start-up activities. Site activations began in September, and we already enrolled the first patient in October. Our primary focus now is to continue bringing up study sites. We currently have 6 sites activated. We plan to provide enrollment updates in future earnings calls. The STAR-D study on apixaban and rivaroxaban removal moved in a very rapid manner from the applications for Breakthrough Designation that was submitted in July and granted by FDA in August. The immediate submission of the IDE application and full FDA approval of the protocol was completed in October. This accelerated timeline is consistent with the efficiencies we expected to observe based on the similarities of the STAR-T and STAR-D studies. The first central IRB approval has already been received. We are now focused on engaging with sites, many of which are already part of STAR-T, with a target of enrolling the first patient in the study early next year. The REFRESH 2-AKI study has resumed enrollment with 15 sites activated. The momentum we saw in enrollment over the summer has slowed significantly in September and October, as surging COVID-19 numbers have led to deferrals of elective cardiac surgeries. As of today, the study has enrolled 178 patients, with 111 of them in the randomized cohort. The timing to interim analysis is entirely dependent on enrollment and as such, may be delayed as a result of the COVID-19 impact. As we have previously disclosed, we continue to view the antithrombotic removal indications as the most expedited and lowest risk paths to FDA approval. We have also made significant progress in our remaining clinical programs listed on this slide. The studies highlighted in green are already active, and we anticipate that the 2 studies in light blue will be active by the end of the first quarter next year. The German process randomized controlled multi-center study in patients with refractory shock is a top priority program evaluating hemodynamic stabilization in patients with severe sepsis. We are happy to report that the trial is now actively recruiting. Next steps include continued site activations and enrollment. The German single-center citation study on ticagrelor removal is also actively recruiting at all 3 German sites and we recently added a fourth site in Luxembourg. Next steps include continued enrollment in the study. The HepOnFire study in patients with liver failure is also a German multi-center study that recently received ethics approval. Next steps include activation of study sites with a target of the first patient enrolled early next year. The next three studies listed on the slide are all registries. First is the U.S. CTC Registry that includes critically ill COVID-19 patients on ECMO treated under the FDA Emergency Use Authorization. Top-line results were presented in August and will be discussed in more detail on my next slide. We expect the data outputs from CTC to continue in 2022. The STAR Registry is an international registry capturing real-world evidence on antithrombotic removal. Currently, the study is active in the United Kingdom and Germany with the first patient already enrolled. We plan to expand the registry in additional EU countries in '22, including, but not limited to, Austria, Belgium, the Netherlands, and Sweden. The final program listed on the slide is the International COSMOS Registry designed to capture real-world evidence with the use of CytoSorb among a broad range of critical care applications. The protocol has been finalized and next, we will be seeking ethics approval in Germany with other EU countries to follow. The target completion dates for these programs are listed on the last column. However, as noted on the bottom of the slide, we continue to experience significant COVID-19-related challenges that add uncertainty to our timetables. What's worth noting is that in addition to the acute effects associated with limited hospital capacity or restricted access to research personnel, we're also seeing evidence that many institutions around the world are also suffering from the long effects of the pandemic. That includes staff fatigue, higher rates of turnovers, and difficulties in hiring new staff. Since our last earnings call, new CytoSorb data were released in COVID-19 and endocarditis. First, in COVID-19, the top-line U.S. multi-center CTC Registry results were presented at the International Symposium of Intensive Care & Emergency Medicine. The data were on 52 consecutive patients treated with CytoSorb while on life support with ECMO at 5 major U.S. centers and showed high 90-day survival rates of 73%. For context, the 90-day survival in the North American cohort of the international ECMO ELSO Registry is 50%, and that is in over 5,000 patients as of October 30 this year. The CTC data have been very well received and are expected to drive CytoSorb usage in COVID-19 plus ECMO worldwide. Future CTC analysis will aim at better defining the optimal use of CytoSorb with ECMO and identify potential additional clinical and economic benefits. Second, two data sets on endocarditis were presented at the European Association of Cardiothoracic Surgery less than a month ago. The results presented at the meeting were mixed. First, the German REMOVE randomized study in 282 all-comer endocarditis patients did not meet the primary endpoint of change in SOFA score with the use of CytoSorb. However, a second observational study from Nuremberg, Germany in 195 patients with left-sided endocarditis showed a reduction in sepsis related mortality with CytoSorb. Importantly, both studies declare that the intraoperative use of the device was safe with the same adverse event rates as a standard of care, meaning the control arm where the device was not used. We intend to work closely with the investigators of both studies to further analyze the data and potentially inform future endocarditis studies. We do believe that the safety data for both studies bode well for the same exact intraoperative device use in our FDA trials. In summary, in the past 12 months, we have scaled up our clinical capability significantly to support the execution of our global clinical plan comprising nine company-sponsored clinical studies. We have made significant progress on our path to U.S. marketing approval that is focused on the antithrombotic removal opportunity with the two FDA-approved randomized, controlled, double-blind STAR-T and STAR-D trials. Outside the U.S., we are focused on generating data in several critical care applications, including sepsis and liver failure, among others. Finally, we expect to have seven of these programs actively recruiting by the end of this year with all nine being active and recruiting by the end of the first quarter of 2022.

Thank you so much, Makis. And greetings to everyone on the call today. Today, I'll be providing a summary of CytoSorbents' third quarter 2021 financial results. I will also reiterate our fourth quarter and full year 2021 guidance. Finally, I will provide an update around our working capital and cash runway. Let's start with product sales for the third quarter, which were approximately $8.9 million, a decrease of 13% compared to $10.2 million last year. This outcome was driven by lower COVID-19-related sales and slower year-over-year growth in our core non-COVID-19 sales of approximately 3%. Product sales in Germany were $3.7 million, down 24% compared to product sales of $4.8 million in Germany last year. This is, of course, a matter upon which Phil and Christian have already provided substantial color. Changes in the euro to dollar exchange rate had little impact on year-over-year product sales. Our income from grants was approximately $859,000, this an increase from prior year grant revenues of $301,000. Our total revenue, which includes both product sales and grant revenue, decreased by 7% to $9.8 million in the third quarter compared to $10.5 million in the third quarter of last year. Our product gross margin remained robust at 82% from Q3 2021 compared to 74% for Q3 2020. Here, we'll have a look at quarterly product sales trends over time. For this analysis, we've broken out our COVID-19 product sales from our core non-COVID-19 product sales. For the third quarter of 2021, our COVID-19 sales were estimated to be approximately $1.1 million, which is in fact, the lowest quarterly COVID-19 sales we reported since the beginning of the pandemic in the first quarter of last year. Our core non-COVID-19 sales were $7.8 million, growing 3% compared to last year's $7.5 million in sales. Turning to our guidance, today we reiterate the guidance we previously provided for the fourth quarter and full year 2021. We expect fourth quarter product revenues to be similar to third quarter 2021 product revenue of $8.9 million. Full year 2021 product revenue is expected to be at least $39.3 million, which is roughly flat compared to 2020 product revenue of $39.5 million. While it is difficult to predict, 2021 core non-COVID product revenue is expected to be approximately $33 million to $34 million for the current year versus $30.1 million in 2020. Based on what we are seeing so far this quarter, we remain confident that these results are achievable. As of September 30, 2021, we have approximately $61 million in cash on hand. During the third quarter of 2021, we continued to invest in mission-critical activities, including a planned increase in spending on our clinical trial as well as activities associated with the build-out of our new manufacturing plant. We are also preparing to invest in the U.S. commercialization build-out, which will be required to support sales and marketing activities once FDA marketing approval is received. We believe we have sufficient liquidity to support these investments, which are expected to drive our growth in the future. Now I'd like to turn the call back to Phil.

Thank you very much, Kathy. Despite the complexities of COVID-19 on our business, we believe we are well-positioned for long-term growth with an outstanding therapy, CytoSorb, that when used on the right patients at the right time with the right dose, works to help save lives. We're boldly trying to solve some of the most complex medical problems in medicine today that claim the lives of millions each year. It's not simple. But with every study, we move closer to unlocking the key. In addition, we believe we have an excellent business model bolstered by strong product gross margins, broad international physician and partner support, a growing body of clinical data, and a solid safety profile with now more than 152,000 treatments utilized across more than 70 countries. We remain confident in our core business both in Germany and internationally and are excited about our pivotal trials in the U.S. that have the potential to open the significant U.S. market and make our therapies available to help even more people. Given the resurgence of the Delta variant, our efforts in the near term will be to increase the international awareness of the positive data using CytoSorb in critically ill COVID-19 patients and drive utilization of CytoSorb for this application. In parallel, we continue to press on our core applications with the goal of returning to growth in our German business and driving our longer-term worldwide growth potential. To this end, we have a strong cash balance that, as you've heard today, we are continuing to direct towards key investments in growth that span clinical studies, sales and marketing infrastructure, and manufacturing capacity expansion. Meanwhile, we're accelerating our U.S. clinical program focused on the removal of antithrombotic blood-thinning medications during cardiac surgery, a potential major future growth catalyst. We want to take the opportunity to thank the entire CytoSorbents community, including all of the healthcare workers on the front lines, our partners for making the therapy available to help patients, our employees for making all of this possible, and our investors who, despite near-term volatility, continue to support the company and share our vision of healthier and longer lives ahead in changing medicine. Thank you again. That ends our formal remarks. Dave, if you would, please open the call for the Q&A session. Thank you.

Certainly. Thank you. Our first question comes from Danielle Antalffy with SVB Leerink. Your line is open.

This is Priya on for Danielle. I've got two questions here. I think first, since pre-announcing, can you talk about some of the trends you've seen in the U.S. and even within the U.S. in the first few weeks of the quarter as it relates to COVID? And appreciate that you can't give guidance, but directionally how are things tracking as we head into 2022?

Yeah. I think that Christian had commented on Europe, in particular Germany, where the rising rates of COVID have translated into increased ICU usage and more ICU patients and beginning of an increase in sales of CytoSorb related to those COVID-19 patients. I think that it depends really on where in the world you're talking about. And where COVID has been increasing, we've been seeing increased CytoSorb sales for COVID-19. In the United States last quarter, just to give you maybe some perspective, when we gave our guidance back in August on the remaining year in terms of COVID-19 sales, we estimated that we would likely do less than $1 million in COVID-19 related sales. In the third quarter, we did $1.1 million in sales already. So we can't really predict exactly what that number will be for the fourth quarter. Although we are seeing COVID-related sales both in the United States as well as in many countries around the world. But again, it's very country-specific.

Great. Thanks. That was helpful. And just another one here for me if that's okay. Congrats on the STAR-D IDE approval and then the first patient for STAR-T. But just curious, you called out a little bit of an impact to REFRESH enrollment. Have you seen any impact thus far to the STAR-T enrollment? And just how are you leveraging those sites that are enrolling now for STAR-T when you do anticipate launch for STAR-D? Thanks.

Thanks, Phil. And thank you, Priya, for the question. So you're correct. The major headwinds relating to enrollment, we're experiencing in REFRESH 2 because it's not getting elective surgeries. Those tend to be postponed and deferred at times when the pandemic is surging. However, as I stated in my prepared remarks, we're also seeing long-term effects among multiple institutions irrespective of the surge in place or not due to the staff being exhausted, sometimes retiring early, and then having difficulty rehiring. So in that regard, we do see that even in the STAR-T and our STAR-D start-up activities. Having said that, we're progressing. We've already activated 6 sites, and we will continue to move forward, activating more and more. So we're uncertain what the exact impact on enrollment will be. We'll have better visibility when we have more active sites and can track the rates of enrollment. As stated in the prepared remarks, we plan to announce trends in enrollment on future earnings calls. To your second point, there's a great overlap between STAR-T and STAR-D at every level, including participating sites. So we do believe that we will be able to deliver the start of the study in the first quarter of next year as we have previously targeted for STAR-D. We do believe we'll get the first patient in early next year.

And our next question comes from Josh Jennings with Cowen. Your line is open.

Hi. This is Bryan for Josh. Thank you for taking my questions. I wanted to start with a clarification question on the COVID conditions in Germany and the guidance. Are you assuming that more normal ICU conditions returned fairly quickly in November in order to achieve the sequentially similar product sales in the fourth quarter? I'm asking because visually, the fourth quarter already looks similar to what you faced in the third quarter in terms of COVID impact. And I assume there could be pressure again in December following what's normally the flu season. So that's my first question, and I have a follow-up if I can.

I'll turn it over to Christian in a moment. But I think the fourth quarter differs from the third quarter in that the third quarter is a traditionally seasonal quarter affected by European vacation schedules where many people leave for vacation in July and August, including healthcare workers. So it's typically a slower quarter, whereas the fourth quarter is typically our strongest quarter. I think that the dynamic of low-severity COVID cases and high restrictions in Q3, in a seasonal quarter, makes Q3 comparisons a little bit more difficult. I think we've said that ICU beds are starting to fill from increased rates of COVID—markedly increased rates of COVID just within the past month. We are starting to generate sales related to COVID-19, which is again different from what we've seen in the third quarter. That being said, I think the overall guidance we provided is that Q4 will be flat with Q3. So we are assuming no benefit and no real changes in the situation necessarily in Germany, but we do expect that this will improve over time. We just can't predict when. Christian, I don't know if you had anything else you wanted to add.

Thank you, Phil. Maybe a few more points just to give you more color on the situation. The fear, obviously, in all markets is that another wave of COVID patients is stressing the healthcare system too much so that the available number of ICU beds is too low and that the patients cannot be treated appropriately. That's why when the wave of COVID infection started in Q3, many ICU beds available were reserved for COVID patients. There is always a lag between infection and hospitalization, followed by another one towards ICU dependency. As I said already before, there are more ICU patients, COVID patients now. You have to see that the pattern of where these patients are has changed over the last year. There are now dedicated COVID centers or sites treating all COVID patients, while other hospitals are on standby. Over the last 12 months, the German health system lost more than 4,500 ICU beds due to staff shortages. This makes the situation difficult in general and also hard to predict how it will progress for COVID and non-COVID patients. Elective surgical programs are down in order to keep stress on the healthcare system lower. Other patients are sometimes not even coming to hospitals because they fear getting infected with COVID. It's a complex situation. I'm not going to provide more guidance than what Phil said; I hope this adds some color.

Thank you. On the U.S. clinical program for antithrombotic removal, STAR-T is a few months ahead of STAR-D. Given the similarities in the trial designs and overlap in the participating sites and investigators, do you plan to make a single FDA submission for both indications? If not, should we expect a roughly 4-month difference in trials' progress to persist into the study's completion and subsequent filings?

That's a good question. Makis, do you want to take that?

Thanks, Bryan. So as you correctly stated, there is a few months difference in the initiation of STAR-T to the expected initiation of STAR-D. However, as I mentioned earlier, it's not yet clear what the exact enrollment trajectory will be for each study. We will have to wait a few months for these studies to be ongoing to see if the speed remains the same. For now, we view them as independent programs. As you know, we have received two independent breakthrough device designations for both. We will see how these trials perform in regard to the sequence of applications with the FDA.

Thanks, Bryan.

There are no further questions. At this time, I would like to turn it back to management for any additional or closing remarks.

Well, thank you everyone for joining today on the earnings conference call. We appreciate your participation. If you have any other questions, please feel free to reach out to Terri Anne Powers at tpowers@cytosorbents.com, and we’ll try to reply to your questions as soon as we can. Thank you.

Thank you. That concludes our conference for today. I'd like to thank everyone for their participation. Have a great evening.