Cytosorbents Corporation

Ladies and gentlemen, good afternoon and welcome to the Cytosorbent Second Quarter 2024 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode. Following the 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, Eric Ribner. Please go ahead, Mr. Ribner.

Thank you and good afternoon. Welcome to Cytosorbance's second quarter 2024 financial and operating results conference call. Joining me today from the company are Dr. Phil Chan, Chief Executive Officer, Vincent Caponi, President and Chief Operating Officer, Kathleen Block, Chief Financial Officer, Dr. Micah DeLeggeris, Chief Medical Officer, Dr. Christian Steiner, Executive Vice President of Sales and Marketing and Managing Director of Cytosorbance Europe, and Christopher Kramer, Senior 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 the 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 SEC. Any projections as to the company's future performance represented by management include estimates today as of August 13, 2024, and we assume no obligation to update these projections in the future as market conditions change. During today's call, we will have an overview presentation covering the operating and financial highlights for the first quarter of 2024 by Dr. Chan, Ms. Block, Mr. Capote, and Dr. DeLeggeris. Following the presentation, we will open the line to your questions during the live Q&A session with the rest of the management team. And now it's my pleasure to turn the call over to Dr. Philip Chan.

Well, thank you very much, Eric, and good afternoon, everyone.

to the Q2 2024 earnings call. First, I'd like to go over our operating highlights for the quarter.

First, more than a quarter million Cytosorb devices have been cumulatively delivered to date, helping to save many lives around the world. Second, in the second quarter, total revenue increased 5% to $9.9 million, while product sales increased by 10% to $8.8 million, and gross product margins for a solid 75%. Importantly, our second quarter operating loss decreased 48% to $3.4 million from $6.6 million a year ago. Following our $10.3 million equity raise in December 2023, we secured an additional $20 million credit facility with Avenue Capital Group, strengthening our balance sheet. And following the quarter, we completed additional cutbacks expected to save an additional annualized $5 million in expenses going forward. Over the past five months, we have decreased our workforce by 17%. Finally, our cash balance at the end of the second quarter was $14.9 million, including $8.5 million in unrestricted cash and $6.5 million in restricted cash.

Today, we are pleased to announce the

the start of our new Chief Financial Officer, Peter J. Mariani, starting tomorrow, and unfortunately, the retirement of our existing CFO, Kathy Block, as of the end of business today.

You'll hear more from both people at the end of this meeting.

We're also on track to send marketing applications in parallel for the Investigational Drug Zerb ATR system to FDA as a de novo application in Health Canada in this third quarter, of this year. You'll hear more about that from both Micah Stelagiris as well as Vince Caponi. In addition, we completed our MD-SAP audit, which is a key requisite to Canadian commercialization. Data from our STAR registry was presented at the EuroPCR 2024 conference, where it was selected as a top five finalist in the Best Scientific Abstract competition. And importantly, we launched a new, redesigned, modern, consolidated corporate and product website. Lastly, we also launched our Cytosorb, our purify, MDR-certified purify hemoperfusion pump, placing, in fact, all 30 pumps from our original order with our OEM and are expecting delivery on the next order from our OEM very shortly. Importantly, the pump itself has received extremely well, good reviews from users, citing it as very easy to use and easy to set up. and easy to implement our therapies. With that, let me turn it over to Cathy Block, our Currency Financial Officer. Cathy.

Thank you, Phil. And hello to everyone on the call. Today, I will discuss our second quarter 2024 financial results, including revenues and gross margins. And additionally, I will provide an update on our working capital and cash runway. Cytosorb product revenue was approximately $8.8 million in the second quarter of 2024 compared to $8.1 million in the second quarter of 2023, an increase of approximately $800,000 or 10%. Second quarter 2024 grant revenue was approximately $1.1 million compared to approximately $1.3 million in 2023, and this decrease was due to the conclusion of several grants, during 2023. Total second quarter 2024 revenue, which includes both product sales and grant revenue, was approximately $9.9 million as compared to $9.4 million in 2023. And product gross margins on devices and device accessories was 75 percent in the second quarter of 2024 compared to product gross margins of 74 percent in 2023. Next slide, please. For the first half of 2024, Cytosur product revenue was approximately $17.8 million compared to approximately $16 million for the first half of 2023, which is an increase of approximately $1.8 million, or 12%. First half 2024 grant revenue was $1.8 million as compared to $2.9 million Again, due to the conclusion of several grants in 2023. And product gross margins on devices and accessories were 74% in the first half of 2024 compared to 71% in the first half of 2023. As we continue to realize more operating efficiencies at our new manufacturing plant in Princeton, New Jersey. Next slide, please. The blue bars on this chart represent our annual product sales for the trailing 12-month periods ending June 30th for each year 2018 to 2024. We know that for the years 2020, 2021, and 2022, sales were very favorably impacted because Cytosorb was used to treat COVID-19 patients. And of course, this usage ceased following the containment of the pandemic in the years ending June 30th, 2023 and 2024. If we take a look at the orange trend arrow, which tracks along core non-COVID-19 revenue, what we see is that the post-COVID-19 12-month periods ended June 30th, 2023 and 2024 continue to show positive growth in our core non-COVID-19 product sales. Our year-over-year trailing 12-month sales for the period ending June 30th, 2024 increased by 9.5% compared to the trailing 12-month sales for the period ended June 30th, 2023. Additionally, excluding the impact of the COVID-19 sales in 2020, 2021, and 2022, our overall CAGR for the six years ended June 30th, 2024 is a respectable 11.2%. I also want to point out for a moment that the green line, which tracks our year-over-year gross margins, indicates a decline in 2022 while we transitioned manufacturing operations to our new facility. Our second quarter 2024 gross margins continue to show improvement at 75%, and these margins are approaching the levels that we had prior to our move to the new facility. With greater volumes, We expect to show further improvements in product gross margins as we continue to realize additional manufacturing efficiencies. Next slide, please. As of June 30, 2024, we have $14.9 million in cash, which includes $6.5 million of restricted cash and $8.5 million in unrestricted cash. We believe that unrestricted cash on hand is sufficient to fund the company's operations through the second quarter of 2025. We have been successful in our efforts to strengthen our balance sheet and reduce operating expenses. On our last call, we indicated that the company was actively pursuing alternative sources of capital. And in June 2024, we entered into a loan and security agreement with the Avenue Group of Funds to provide a total of $20 million in debt financing. $10 million was immediately available under the facility. and $5 million, which is included in our restricted cash, is subject to release by March 31st, 2025, provided that the FDA has accepted the company's application for review with respect to DrugServe ATR and that the company has received a minimum of $3 million in net proceeds from the sale of its equity securities after the closing date. The restricted cash will be released on a dollar-for-dollar basis for equity raised between $3 million and $5 million. And then there's another tranche of $5 million, which may be dispersed at the company's request between July 1st, 2025 and December 31st, 2025, provided that the company receives FDA marketing approval of its drug-absorbed ATR application. Conservation of cash remains a top corporate priority. We have reduced our headcount, adjusted our spending, and taken other measures to reduce our quarterly cash burn in 2024. Cost cuts taken previously have reduced our loss from operations from $6.6 million in the second quarter of 2023 to $3.4 million in the second quarter of 2024, a 48% decrease. In July of 2024, we enacted another round of cost cuts, which are designed to reduce the company's annual cash burn by an additional $5 million. That will conclude my remarks for today. And at this time, I'm delighted to turn the call over to our President and Chief Operating Officer, Vince Caponi.

Go ahead, Vince. Thank you, Kathy. So for the, I'd like to cover the clinical.

Yeah, I think Micas is on the call. Micas, would you like to take the first part of this?

Sure, sure. Thanks, Phil, and thanks, Vince. As you heard, and welcome to everybody on our call this afternoon, as you heard from Phil previously, the regulatory submissions for our investigation of the drug drug ATR system is a top priority for the company. and we are happy to report that we're on track according to previously stated timelines. The start key clinical data we presented earlier this year, the top line results, and the final data analysis has been completed. And in fact, the clinical study report that contains all this information is in the final stages of development and publishing. This will represent the main source for the probable benefit to risk analysis that will be at the crux of our de novo submission to the FDA. We also intend to include in the submission supportive supplementary data with the real-world evidence of Ticagrel removal during CABG that was presented from the STAR registry in a recent European conference. And I'm going to spend the next slide giving you a little bit more visibility on that data. The completion of the technical files is leveraging the electronic eSTAR platform. And as already stated, we're on track for the FDA de novo submission in September with a Health Canada submission leveraging the same platform to follow soon thereafter. Just as a reminder to our listeners, Drugs of ATR is an FDA breakthrough designated device, which means that each submission will be associated with a priority review. A recent analysis suggested that de novo applications of breakthrough-designated devices have an estimated 25% faster review timelines compared to regular applications. And as such, pending the FTA agreement of the de novo pathway submissions and the associated priority review of the breakthrough status of the drug drug ATR device, This means that we could have a potential FDA decision within six to 12 months following submission. Next slide, please. Earlier this year, we had the privilege of being present and presenting at one of the largest cardiovascular conferences in the world, the EuroPCR meeting that is held annually in Paris. During this meeting, with over 12,000 attendees, data from our STAAR registry were selected for an oral presentation. And at the end of the conference, as Phil has already alluded to, the scientific committee awarded the STAAR registry data a top five spot as a finalist in their best scientific abstract competition. So why don't we show within the STAAR registry that we believe is going to be a supportive piece to our regulatory submissions? As you know, removal of ticagrelor during cardiac surgery with cardiopulmonary bypass is an approved indication with Cytosorb since 2020, and is increasingly being used as standard of care in many heart centers in Europe. In the STAAR registry, we're collecting high-fidelity data of this everyday, real-world use of the device for removal of ticagrelor. In the current analysis, we had data from five different countries, 23 investigative sites, totaling 102 isolated CapBuds patients. This is a population that we have discussed previously will be the target intended population for our submissions. These patients were operated very soon since the last dose of ticagrelor, on a mean of 22.8 hours. Just as a reminder, guidelines recommend that these patients should wait for at least 72 hours, but in everyday practice, many times this is not feasible. So these patients were operated in a much shorter window compared to what the guidelines recommend. The device was used for an average of an hour and a half during the CPB run of the operation, which is almost identical to the time that we saw in START-T. Again, very, very comparable population and device use in these two datasets. What we did present in Paris was the fact that in the STAAR registry we observed bleeding rates that were substantially lower than those reported in the European CABG registry among patients on ticagrelor being operated either very early within 24 hours or later on within 24 to 72 hours but always not having completed the recommended washout. You can see the rates presented on the slide. And in fact, among patients who waited for at least a day before being operated, you would see a substantial reduction of severe bleeding to very, very low rates, equivalent to those seen in patients not on Ticagrelor having a CABG operation. Importantly, none of these sites or investigators reported any device-related adverse events. The data from the eCABG registry represent a very good benchmark for us to compare the rates from the STAR registry, and as such, as noted previously, this was very well received at the scientific conference, and we're very pleased to receive the designation in the top five finalists for Best Scientific Abstract. And with that, I would like to turn the call over to Vince to give you a regulatory update.

Thank you, Micah. This is Vince Caponi, and Good day to everybody. As Mike has mentioned, the de novo timeline, we're in the final stages of assembling the technical file that will be submitted through the E-STAR program. At this point, I'm happy to say we're 75% complete with that file. We've concluded most of the engineering documentation and now starting to complete the clinical documentation for that submission. Along with the submission in parallel, we are also working on preparing the Canadian submission, which we hope to have filed shortly after the e-start for FDA. It's very similar, so we believe we can do it in a relatively timely manner. Hopefully also through the Canadian submission, generally speaking, Canadian approvals have generally in the past been a bit faster than U.S. FDA approvals. But, of course, we can't protect that with 100% certainty, but we're hopeful that we will be able to be able to get a quick approval through Canada.

Next slide, please.

Global, from a global regulatory standpoint, as part of the preparation for the Canadian submission, we have completed the MDSAP audit, which is required for a Canadian submission. I'm happy to say that the audit went very well. It's currently under review by DECRA, but we feel very confident that we will be approved for submission to Canada through the MDSAT program. With respect to MDR, which affects obviously our European operations and rest of the world, we are targeting a December 2024 submission to our notified body. and have already requested the MDR audit for June of 2025. We're very confident based on our continual successful audits throughout the product lifecycle of Cytosorb that we will be able to achieve the MDR audit. Again, meeting all the requirements which are more extensive than the MDD, but we are very confident that we'll be able to achieve approval. As Phil mentioned, the purified pump registration was received in June. Working with our partner, Medica, we were able to get that completed and able to receive the first 30 pumps. And we have the second order that will be coming in shortly here. And we are looking forward to, again, expanding that into the market. And as Phil mentioned, it has received very, very good reception in the marketplace. On top of that, we've also received, after over a year and a half worth of effort, a registration in Taiwan, and we're looking forward to now opening up with that market.

With that, I'll turn it back to you, Phil. Great. Well, thanks, Vince.

This year, we have worked diligently to execute upon a broad turnaround strategy that is dependent on attaining a number of key objectives. You've heard today that, one, our guidance – that we continue to expect to submit to our marketing applications to U.S. FDA and Health Canada for drugs or ATR this quarter and have made excellent progress in parallel programs like MD-SAP that are critical to commercialization, for example, in Canada. Secondly, we have strengthened our balance sheet with the addition of a new debt facility from Avenue Capital and believe that if we can hit our milestones, the $20 million in capital will get us to both Health Canada and FDA regulatory decisions. Third, we remain extremely committed to cutting costs to drive efficiency and be self-sustaining. Importantly, you heard that we have made excellent progress in reducing our operating loss and expect to see additional benefit from our most recently completed cost cuts. Fourth, our gross margins continue to be strong and are expected to expand as we grow the markets in Europe and certainly are expected to expand further if we are able to drive U.S. FDA and Health Canada approval where the gross margins for drug-served ATR are expected to be significantly higher than for Cytosorb. And lastly, we have done a lot of work to try to increase our core Cytosorb sales growth beyond the quarter million devices that we've delivered to date. Finally, as you are aware, we have been positioning site assorbance for the next stage of growth, both our existing international franchise, as well as the potential to open the U.S. and Canadian markets. This is why it has taken us so long to find the right CFO candidate to replace our esteemed retiring CFO, Kathy Block. Kathy has gone above and beyond the call of duty, selflessly coming back from retirement last August. to resume her former full-time CFO role, and in the intervening 12 months, helping to secure the future of the company with two key financings and orchestrating our cash conservation strategy. With her retirement announced today, she caps an outstanding CFO career and will continue as a consultant to help manage the smooth transition to our newly appointed CFO, Peter Mariani. On behalf of everyone at Site Assorbance, we thank Kathy for her more than 11 years of dedication and leadership at the company as a trusted colleague and friend with so many contributions that have helped us achieve the success we have today and wish her an enjoyable, relaxing, and well-deserved retirement. With that, I'd like to turn the call over back to Kathy to have some final words. Kathy?

Thank you so much, Phil. I would like to take this opportunity to thank the Board of Directors, my colleagues on the management team, and really all the employees of Sighted Servants for their support and collaboration, which have made my 11-year tenure as CFO so very enjoyable. I especially want to thank the finance and accounting team members who have supported me in the U.S. and in the EU. I would like to thank you for your extraordinary dedication, talent, and contributions to the company. And I wish everyone, including our new CFO, Pete Mariani, the best of success as we head towards the exciting upcoming job of commercialization of drug-served ATR in the United States. So thank you all so much.

Thank you, Kathy.

And with that, I'd like to welcome Pete Mariani to the Cytosorbents team. Pete is a seasoned and accomplished medical device CFO whose many successes at high-growth publicly traded companies such as Axigen, Hanson Medical, and Guiding Corporation speak for themselves. He has consistently demonstrated a disciplined and rigorous approach to financial management, operational excellence, and strategic development both domestically and internationally that aligns perfectly with our next phase of expected rapid growth. Importantly, Cytosorbance today shares many similarities to Axigen when Pete joined as CFO in 2016, including with respect to its size, revenue base, U.S. market opportunity, and high-margin business model. He has proven his ability to fund, scale, and manage impressive growth. As we pursue U.S. and Canadian marketing approval for DrugSorb ATR and drive our OUS business with Cytosorb, we believe Pete will be an outstanding fit where his deep global experience and insight is expected to be vital to our success. We are thrilled to have Pete join Cytosorbence and be a key member of the management team. And in the coming months, we hope to reach out to many of you to introduce you firsthand to Pete. With that, let me have Pete say a few words here as we wind up this call.

Pete.

Thank you, Phil. I appreciate the warm welcome. I appreciate the trust of you and the board. in creating this opportunity for me. It is great to be out with all of you as investors today as well. I am excited to join Cytosorbents at this pivotal time in its history. You know, I've had the great privilege to be part of some of the most significant advancements in medical technology over the years, including advancements in cardiac stents, cardiac rhythm management, medical robotics, laser cataract therapies, and, of course, nerve repair. Cytosorbents blood purification therapy is a natural extension of this, and I am looking forward to partnering to further develop, execute, and scale our long-term growth strategy and bring improved hospitals.

And, of course, I look forward to meeting with many of you in the near future. Thanks again, Phil. Thanks very much, Pete.

That concludes our prepared remarks. Operator, please open the call up for the Q&A session. Just let me remind you, as Pete has not officially started until tomorrow, he will not be participating in the Q&A session. Operator?

Thank you. At this time, if you have a question, please press star 1 on your touchtone phone. If you would like to withdraw your question, press star 1 a second time. please make sure that your mute button is turned off to allow your signal to reach our equipment. And again, it is star one if you would like to ask a question. And your first question comes from the line of Michael Sarkone with Jefferies. Your line is open.

Hey, good afternoon, and thanks for taking the questions. Just to start, congrats to both Kathy and Pete. Kathy, it's been great working with you. I hope you have a great retirement, and Pete, looking forward to working with you again. All right, so I guess the first one for, I guess, for either Phil or Mike is, you know, you're on track for the FDA and Health Canada submission for DrugSorb. Can you just give us an update on how you're feeling about approval? Maybe can you give us an update on any conversations you've had with the regulators, particularly the FDA, more recently?

Thanks very much, Michael. Micah, would you like to take that?

Sure, and thanks, Michael, for the question. As we have discussed previously, we feel that the STAR-T pivotal trial does provide the necessary information to be able to execute the necessary benefit-to-risk analysis. And I think, as we have highlighted in previous calls and stated during our own corporate webinars, is that the STAT-T data has helped us identify more specifically the intended target population, and as we discussed before, we have identified that to be those patients undergoing a coronary artery bypass operation, and also the intended potential benefit associated with the use of the device. So in that regard, we believe that the STAT-T itself can, as a standalone, can support a robust benefit-risk analysis. In addition, as I've shared today on the call, the accumulating real world evidence that is now captured systematically in a high quality registry such as the style registry, we believe will be an important supplement in our conversations with the agency. Having said that, you know, anytime you submit an application, You have to wait, obviously, for the review and the comments from the agency. We have not had any additional discussions with the agency since our last call, so there's no update on that front. But we do believe that the application will provide the necessary information for a very productive and collaborative interaction with the agency and to allow them to proceed with the necessary benefit to risk analysis.

Got it. Thanks, Micah. So then, you know, maybe one or two for Kathy. Just on the gross margins, the press release today mentioned the line of sight to 80%. You know, can you talk about, you know, what gets us to 80%, maybe what level of sales might get you there? And then just kind of the second part of that is more in the near term, how are you thinking about gross margins in the second half of 24th?

Yeah, I think actually Michael... Okay, Kathy, go ahead, please.

Yeah, so Michael, you know, obviously volume is going to... Any amount of volume growth is going to increase our product growth margins, and they should grow up very rapidly. I expect that at 15% to 20% year-over-year growth, we should see approaching 80% or at 80%. So it should be relatively straightforward. Of course, once we get approval in the U.S., the margins will be even higher, and then we would see, like, exceptional growth rates in our overall growth margins.

Got it. Thanks. Sorry, go ahead.

I'm sorry, Michael. You know, one of the people responsible for helping to drive our growth margins higher is Vince Caponi, our President and Chief Operating Officer. Maybe, Vince, you wanted to give a little commentary on how our manufacturing processes have improved and our confidence that we can get to that 80% on a blended basis.

Thanks, Phil.

So we've made a lot of improvements in the last year in the operation. We've actually reduced the labor requirement by almost 30% in part of the operation, the filling processes, to help offset some of the lower volumes that we've had. So with the improvements that we're continually making here, we expect that, you know, we're going to, you know, continue to see improving margins. But as Kathy said, it's really dependent upon the volume as well. I think the other thing we need to keep in mind is that as part of our controlling cost, we're actually lowering our inventories. We're doing that by slowing down the production so that we can conserve the cash as we go through the FDA approval. So to Kathy's point, when we get to the 15% to 20% growth rate, we certainly have a line of sight to that 80-plus percent, plus an approval, obviously, for drugs over ATR with the with much higher ASPs than the current Cytosorb will certainly contribute to that. But it's also based on the mix of the direct sales, the higher, if you will, gross margin direct sales versus distributor, which are lower margins than the direct. So again, there's a lot of factors in that, but what we're doing is we are continuing to improve the operation. And again, it's going, as Kathy mentioned earlier, going to be very dependent upon volume, but we do have a number of cost improvements that we're slowly implementing in the process here to hopefully get us back to that 80% soon.

Great. Very helpful.

Thanks for all the color.

Thanks very much, Mike.

And your next question comes from the line of Yuan Shi with B. Riley. Your line is open.

Congrats on a good quarter, and thank you for taking our questions. Casey, congrats on the retirement, and Paige, welcome on board. Exciting time for you to join here at Central Sorbonne. Maybe Phil, I'll start with you. Can you provide more color? What factors pushed the revenue to grow in the second quarter, and do you see similar trends in 3Q? Any comments on the volume versus the price change will be helpful.

Yeah, I think that in the second quarter, what we saw was strength in the distributor and partner channel. I think that it coincided a little bit with the launch of our purified pump. And as we told you previously, the purified pump is intended to help establish an infrastructure of blood purification capabilities in communities countries where they don't have well-established dialysis infrastructures. And so this typically is found in our distributor territories that are not necessarily in Western Europe, for example, as with Germany and Italy and France and the UK and Spain, for example. So I think that strength in that particular channel was good. And our hope is that, you know, our third quarter, which is typically a seasonal quarter for us because of holidays in Europe, will be a respectable quarter.

Any comments on the volume versus the price change year over year?

You know, as Vince mentioned, the transfer prices to distributors are typically lower than our ASPs for direct sales. But on the other hand, we benefit from having a lower cost of distributor sales because we don't incur those direct costs of a sales force ourselves. That being said, our pricing has been fairly stable across the board, both in transfer pricing as well as in direct sale pricing as well. But what you'll see from Q2 results is that the distributor channel was stronger for this quarter.

Got it. And the following question is, how will the delivery of Purify Palm contribute to the revenue growth in 3Q, either itself or helping the sales of cytotorbing territories without the infrastructure? Can you provide more colors on that?

Yes.

You know, we have a different model for rolling out the purified pump in different parts of the world. And I think, though, the thing to keep in mind is that we're not looking to necessarily make money on the purified pump. This is very much the printer-printer cartridge model where the printer is provided at relatively low cost with the goal of driving disposable revenues of the printer cartridge. This is very similar to our approach to the purified pump. Again, the purified pump is there to establish this infrastructure of blood purification capabilities so that they can use more of our cytosurge devices. And so I think moving forward, you know, the goal is to really drive, set a sort of volume rather than, you know, a typical hardware company trying to drive sales from hardware, if that makes sense.

Yep, got it. That's very helpful. Thank you. Sure.

And your next question comes from the line of Tom Kerr with Zach's Small Cap Research. Your line is open.

Good afternoon, guys, and congratulations, Kathy, and thanks for all your detailed explanations and quick response to questions, so I appreciate it. Can you clarify, I'm unclear on the Canadian submission, because originally I thought it was going to be jointly. Now it's going to happen after the FDA submission, so it's a fourth quarter event. I'm sorry, I don't have the slides in front of me, but can you clarify when that is expected to be submitted to the Canadian authorities?

Yeah, I think that what you heard us say today is that we expect to get both of those submissions in in the third quarter with the prioritization, of course, for the U.S. FDA application. So, you know, I think that we remain on track to try to achieve that, but we certainly will be prioritizing the FDA submission first.

Okay, so it's possible the Canadian submission could roll in the fourth quarter, but that's not your goal, correct?

Yes, that's not the goal, and I think that we're reiterating our guidance of third quarter submission for both.

Okay. All right. Sorry, I misunderstood that. A couple of financial questions on the R&D down to $1.5 million. Is that just the comparison against the STAR-T trials a year ago, or is there anything else in there?

You know, there's been a number of... Go ahead, Kathy, please. Kathy, you may be on mute. Please go ahead.

Oh, thanks, Phil. You know, the largest impact is coming from the START-T trial completion, so we're not incurring those hospital costs and patient costs that are associated with the trial. There have also been, there's also been a strong focus of our R&D efforts on exclusively grant-related activities. where their costs of those personnel are funded through the grant. So we have been prioritizing that, making sure that that is the focus of the team to try to cut down in any non-grant R&D costs. So both of those are contributing, but the highest impact is coming from the SART trial being complete.

the comparisons, right? So is that a good number to use for the second half of the year, $1.5 million per quarter?

I think it is, yes.

Okay. One last big picture question for Phil or anybody. The Taiwan thing seems interesting. Can you talk about that, what the size of that business could be, or could it be the next Germany? Is it that big enough of a market?

Yeah, I think it remains to be seen.

I mean, Taiwan is... as you may have read from the press release, a very large market and a big believer in blood purification. So from an opportunity standpoint, it's very exciting. We're working through a distributor in Taiwan currently, and they, in fact, were helpful in getting the Taiwanese approval and registration. So time will tell to see how this will develop, but we have a lot of hopes for Taiwan, but it's just one of many countries where we're working to drive Cytosurf sales.

Got it. Last financial question for me. You guys did receive a $15 million loan, right? It wasn't a subsequent event at the end of the quarter?

We closed the financing at the last day of the quarter, so it was a Q2 event. And the financing happened in the second quarter.

Yes, that's correct. All right. Thank you. That's all I have for today. Thanks, Thomas.

And as a reminder, it is star one if you would like to ask a question. And your next question comes from the line of Sean Lee with HC Wainwright. Your line is open.

Hey, good afternoon, guys. Congrats to Kathy and hope with you a happy retirement. And welcome, Pete. I look forward to working with you. Most of my key questions have been answered, but I'm just wondering, You were mentioning doing R&D mostly on the grant, so I was wondering what are the major projects that you are working on in terms of the grant-supported ones? I know previously you had worked on HEMO Descent with Pentagon. I was wondering whether that's still going on and whether there are other projects or products that we can look forward to. Thanks.

Sure.

Thanks, Sean. Yes, the programs that R&D programs, preclinical R&D programs that are being funded right now really are focused on hemodefend BGA and the use of hemodefend BGA and in different form factors for either military, civilian, or industrial usage. And I think that we're making excellent progress in that program. We continue to seek additional funding opportunities for that program, and we're getting very close, I believe, to human testing.

So, Vince, would you like to comment about the HEMA-Defend program?

Sure, Phil. Thanks. So, Sean, good to hear from you. We've made quite a bit of progress on the HEMA-Defend BGA, as Phil mentioned. You know, there's a couple different form factors that we're focused on to really get to what we think will be the most accessible markets, which would be the military and then ultimately the civilian. So those programs are, there's two key programs that are funding that right now. We have a couple other grants that are in preparation right now to extend that funding further into commercialization through funding of a clinical trial. and ultimately scaling for commercialization. But as Phil mentioned, there are a number of different form factors, but really the two key form factors that we're pushing forward very aggressively are related to the military application and then also what would be at the point of collection, which, by the way, will feed into potentially the freeze-dried, if you will, plasma and we're working closely with a couple of people in that area as well where we think we can provide some value.

Thanks, Sean.

Thanks, Dave.

Great. Thanks for taking my questions. Thanks, Sean.

And as a reminder, it is star one if you would like to ask a question. And with no further questions at this time, I would like to turn the call back over to Dr. Philip Chan for any additional or closing remarks.

Well, thank you, everyone, for joining the call today. If you do have any other questions, please feel free to reach out to me directly at pchan at cytosorbents.com while we manage this transition, and I'll hopefully be able to reply to your questions where possible. Have a great evening, everyone, and thank you very much. Good night.

And ladies and gentlemen, that concludes our conference for today. We thank you for your participation, and you may now disconnect.