Spectral Medical Inc. (EDT.TO) Earnings Call Transcript & Summary

Greetings. Welcome to Spectral Medical Year-end 2025 Corporate Update End Year Review Call. [Operator Instructions] This conference is being recorded. I will now turn the conference over to Ali Mahdavi, Capital Markets and Investor Relations. Thank you. You may begin.

Thank you, Sherry. Good morning, everyone, and thanks for joining us for today's year-end corporate update call. Joining me this morning are Chris Seto, Chief Executive Officer of Spectral Medical; and Dr. John Kellum, Spectral's Chief Medical Officer. Following remarks from Chris and John, we will open the call for a Q&A session. Before we begin, we are required to provide the following statements regarding forward-looking information, which is made on behalf of Spectral Medical and all of the representatives on this call. Remarks and answers to your questions today may contain forward-looking information about future events or the company's future performance. This information is subject to risks and uncertainties that may cause actual events or results to differ materially. Any information regarding forward-looking statements is made as of today's date and the company does not undertake to provide any forward-looking statements. I'll now turn the call over to Chris.

Thank you, Ali, and good morning, everyone. This morning, Dr. Kellum and I are here to provide our year-end corporate update. Our intention is to give you a clear structured view of where we stand today, the milestones immediately ahead of us and how we are positioning Spectral for a successful 2026. Specifically, we will speak to the upcoming FDA filing in our PMA submission time line, our progress on the Tigris manuscript and expectations for publication, our commercialization readiness activities with Vantive and finally, our funding position. After our prepared remarks, we will open up the floor to the Q&A session. As many of you know, this has been a truly pivotal year for Spectral. Earlier in the year, we achieved full enrollment in the Tigris confirmatory trial with 157 patients in total, yielding 100 treated PMX patients. In the world of sepsis research, that is no small feat. It reflects the sustaining commitment of our clinical site staff, the dedication of our internal team and the willingness of patients and families to participate in the study aimed at addressing one of the most challenging conditions in critical care. We're deeply grateful to all of them. And of course, in August, we released the positive top line results from Tigris. These results demonstrated a clinically meaningful benefit at both 28 and 90 days consistent with the precision medicine approach that underpins PMX and the treatable cohort defined to fighting EUPHRATES. The data reinforced our competence in the therapy and have been very well received by many of our key stakeholders, including clinicians, globally, our distribution partner, our manufacturing partner as well as the capital markets. The top line results not only validated years of scientific work but they also provided that the momentum needed to progress fully into the regulatory phase with clarity and conviction. Those that we said at the time, completing enrollment and releasing the top line results were not the endpoints. They were at the beginning of the next phase with the strength of the Tigris data now well established, our focus shifted immediately toward regulatory execution. From day 1, our priority has been to ensure that our PMA is not only complete but that it is constructed to the highest possible standard, one that anticipates FDA expectations incorporates the most current requirements and fully reflects the quality and significance of the Tigris results. And as our work has progressed, we've continued to receive constructive feedback from the FDA. Much of that feedback has already been incorporated, and the remainder is being integrated now as we finalize the submission package. These updates are strengthening the filing and ensuring that we deliver a PMA that is not -- that is both comprehensive and durable. With that overview, I will now turn the call over to Dr. Kellum, who will walk you through the PMA submission time line and regulatory pathway in more detail. John?

Thank you, Chris. And certainly, good morning to everyone. I'd like to provide some additional clarity on where we stand with the PMA submission and the review pathway that's ahead of us. As Chris has outlined, we have made strong progress on the PMA. Indeed, virtually all the modules are now complete. The clinical, statistical and nonclinical sections have been fully assembled and the remaining work is largely related to required updates that will ensure that the manufacturing quality modules reflect current FDA expectations and standards. Our goal is to submit the full FDA in the first quarter of 2026 as early in the quarter as quarter is possible, and we remain firmly on track to do so. I want to expand briefly on the reason why the shift from our original 2026 -- sorry, October 2025 submission target. As part of our ongoing interactive dialogue with the agency, the FDA has provided additional feedback that arrived later in the process than we had anticipated. The feedback was constructive, but did require that we update certain sections of the PMA, sections that have been previously accepted during our uprate submission in order to meet updated standards. Rather than rushing to meet the October target, we made the deliberative decision to take the time required to incorporate these updates properly and fully. In many ways, the extension has allowed us to further polish and strengthen the submission and ensuring that it is a comprehensive anticipatory and as review ready as possible. It is important to emphasize that none of this affects the Tigris data or the strength of the results. The adjustment simply reflects the reality that address the detailed feedback from FDA and ensuring that PMX is supported by an optimized PMA package. Let me now walk you through the review pathway once the PMA has been submitted. The FDA is up to 15 days in order to formally acknowledge receipt of the submission. Following that, the agency enters into a 45-day initial review -- filing review. The purpose of this stage is to determine whether the PMA is sufficiently complete to proceed with a substantive review. At the end of that period, the FDA will issue either good to file letter or refuse to file a letter. Given the level of rigor and completeness that we are building into the submission process, our expectation is that the FDA will move forward with a substantive review at that time. Assuming acceptance, the PMA then enters into a 180-day substantive review time line. I want to emphasize that this -- that these are 180 FDA days, meaning that the clock pauses for questions, clarifications or additional information requests. During this period, the agency will evaluate the clinical data, the safety findings and the manufacturing and quality system documentation. They will also plan and schedule inspections, including Toray's facilities. And as Chris mentioned earlier, a meaningful part of our strategy is to ensure that Toray's documentation fully inspection-ready well before the FDA arrive on site. I would also like to briefly touch base on where we are with the Tigris manuscript, which includes additional analyses that reinforce the clinical significance of the Tigris findings and further explains the results. We anticipate a publication window sometime in Q1 of 2026. Of course, this is not something in our control. Publication of those results is strategically important. It strengthens the scientific foundation of our program, provides clinicians with confidence in the robustness of the data and supports the reimbursement and health economic modeling. And service is a critical communication tool for early adopter hospitals. As we move into the new year, this manuscript becomes a significant milestone ahead of regulatory review. Finally, it's important to note that additional work on Tigris is still ongoing. We've always promised to provide survival results out to 1 year, and these data should be available before summer. If preliminary results are an indication, we expect that the data will be highly supportive of the primary Tigris manuscript, and we will plan to publish these results in a follow-on paper. In summary, we're very close to the finish line for PMA submission. The final -- sorry, the FDA -- the additional FDA feedback has helped us enhance the submission greatly. We are targeting the earliest possible submission in Q1 of 2026 and once filed, we expect a structured review pathway, which includes the usual 15-day acknowledgment period, a 45-day initial filing review and 180-day substantive review. We believe that our approach positions PMX for a strong and credible regulatory review. And finally, as we move through this process, we remain highly focused on ensuring that our regulatory work is synchronized with our commercialization preparations. The PMA time line, the manuscript publication and substantive market planning are all integrated to ensure that if approved, PMX can be launched with a strong clinical, operational and commercial support from day 1. Thank you, and I'll now turn the call back over to Chris.

Thanks, John. I'm going to steer the conversation now to our ongoing commercialization activities. Once again, I want to emphasize how closely aligned these efforts are with the regulatory work that John has just described. Vantive has been deeply engaged as the build out the go-to-market plan and all of this work remains tightly synchronized with the regulatory time line so that if approved, PMX can enter the U.S. market with a high level of readiness from day 1. Our clinical education framework and early adopter strategies, in particular, are being developed around the same data sets and analyses that underpin the PMA. We anticipate that commercialization will begin in the United States immediately following potential FDA approval. This is where we expect the largest clinical and economic impact and where the earliest adoption curve is likely to occur. Following the U.S. launch, we would anticipate a near-term expansion into Canada, leveraging the existing Health Canada clearance and the strong alignment of ICU practice patterns across both countries. Vantive has brought structure, discipline and real-world commercial experience to every aspect of this preparation. When we look at what is required for a successful launch in the critical care environment, it begins with strong clinical evidence. The top line results we released in August created a solid foundation, and the forthcoming Tigris manuscript would add further strength through peer-reviewed validation. Clinical credibility is the first gatekeeper to the ICU, and we believe PMX is very well positioned on that front. Another essential component is the health economic story. Vantive is conducting an in-depth economic analysis of the Tigris data set informed in part by what we observed in the EUPHRATES trial. In EUPHRATES, we collected detailed information on differences between PMX-treated patients and standard of care patients in areas such as duration of mechanical ventilation, ICU dialysis days, vasopressor requirements and other resource-intensive interventions. Reductions in these measures can serve as important proxies for shorter ICU stays, which in turn could translate into meaningful cost savings for hospital systems. This type of analysis becomes a critical tool for engaging hospital stakeholders including administrators and medical directors, all of whom play central roles and early adoption decisions. Commercial infrastructure is also a key factor. One of our primary considerations in selecting a commercialization partner was their access to the ICU channel. Vantive has the strongest ICU footprint in both the United States and Canada supported by a highly experienced critical care sales force and a dedicated medical education personnel. Their established relationships give PMX the ability to enter the market with credibility, reach and scale from day 1. Manufacturing supply chain alignment is equally important. We're working closely with Toray to ensure that inventory planning, production scheduling and other such activities are synchronized with Vantive's commercial forecast. At the same time, Vantive is building out warehousing distribution and logistics pathways to ensure hospitals can be supplied reliably and efficiently as demand grows. Clinician engagement remains another cornerstone of the launch. Together with Vantive, we are building targeted KOL outreach programs, peer-to-peer education initiatives and early adopter engagement strategies. These efforts should benefit from the experience gained at our Tigris clinical sites, aiding and establishing best practices for PMX use in the ICU setting. And finally, none of this succeeds without a robust clinical education platform. The objective is to ensure that every ICU adopting PMX should feel fully supported clinically, operationally and educationally. These activities represent only a portion of the broader commercialization program underway, but they illustrate the foundation that is being built. All of these efforts, clinical evidence, economic value, commercial infrastructure, manufacturing readiness, clinician engagement and education are moving forward in parallel. All aimed at a single objective being fully prepared on the first day that PMX received potential FDA approval. As we move into 2026, we will continue refining these plans and updating the market as we progress through our regulatory pathway. The final discussion point on our agenda today is our balance sheet. I want to be clear, if you do not have an immediate need for funding at this time. As previously disclosed, a majority of the November 2025 warrants were exercised, Additionally, there is a remaining tranche of Vantive promissory notes that could draw down on FDA acceptance of our PMA submission. Our operating plan is structured to support our PMX regulatory pathway. We're managing our capital carefully and remain disciplined in our expenditures. Earlier this fall, we did file a final base shelf prospectus. This filing was not an indication of financing requirement. It was done purely to provide maximum flexibility to potentially optimize our capital structure. A shelf allows us to act opportunistically should favorable market conditions arise. But to repeat, we have no financing planned and the company does not require capital at this time. Thank you. And with that, we'll now open the line for questions.

[Operator Instructions] Our first question is from Scott McAuley with Paradigm Capital.

Great to hear the updates and definitely big past 12 months since the last update call around this time last year. So congratulations on everything. A few kind of questions just maybe on some of the details. So on the PMA submission in the FDA. Obviously, there's some big changes happening at the agency news releases around staffing and et cetera. So just wanting to kind of hear from you in terms of the people you're dealing with the fact that they're all still there. Their responses continue to be on time, and you haven't noticed any changes based on your interaction with them, given what's happening kind of with the agency overall?

I can take that. Yes, Scott, I have to say I've been pleasantly surprised that in general, things have been pretty much business as usual. I do think some of the feedback that we received rather late in the process with them was interestingly time to opening and closing of federal government. So I'm sure there was some effect in terms of how quickly some of that feedback came to us. But apart from that, we still have the same review team that's -- we've had straight along and I have not received any indication that there are problems related to the restructuring. This portion of the FDA, at least from our perspective, seems to be pretty well intact.

That's great. That's great to hear. And in terms of kind of the process, it was great to hear you kind of lay out the timing and the way things will move once it's been submitted. For my understanding is there's an option for PMA applications if they decide there's kind of a need for an advisory committee meeting. Maybe kind of speak a little about that, if that's something that kind of you're preparing for that you would expect, plus or minuses of it if they decide that that's something that they think they would want and how that would impact the process.

Yes, I can comment on that as well. Scott, I think that there has been times when the FDA has indicated that they want to bring a lot of these things to panels and then the times when they really bring very few. I think it's really sort of an open question. It will potentially impact the time line somewhat because in paneling a review panel and all of that can certainly take a little bit of time. But in general, I think these sorts of things are sort of built into the process. My view is that the FDA has indicated to us that they've always been entrusted in reviewing this with respect to the totality of the evidence, and we feel pretty good about -- about that. We feel like our overall story is quite compelling, bringing in a clinician review panel, I think, if anything, would be -- would work in our favor.

That's great. So if they decided that, that was something they wanted. You don't see that as potentially an issue. If anything, it could strengthen the -- once it is approved, that it was approved with the support of these independent individuals?

Yes. I think that's right.

And I guess in terms of -- there's the process of the 15 days to 45 days, after that 45 days, is there much else in terms of what the market can expect? We -- early in 2026, we get the manuscript, we get the FDA submission, the 15-day, the 45-day acceptance? And then is there kind of anything else from there to the approval, which could be 180-plus FDA days plus days for responses and things like that. Is there anything else that from either the regulatory side or just spectral corporately overall that the market might expect to hear from you guys?

Well, I'm not from FDA process per se. But of course, the manuscript will be published they'll potentially be editorials and other sort of clinician community and academic reaction, so that will be there. We do anticipate, as I mentioned, that will be bringing forth our 1-year follow-up results sometime before summer. And so all of that, I think, will be -- we'll give everyone, I think, some indication as to sort of where things are and what reaction of the community is.

That's great. And any plan -- you talked about the health economic study which obviously is an important part of convincing physicians and hospital systems to adopt the product. Is there any plan to kind of disclose the results of any of those work?

Yes. We haven't figured out what our time line should be for releasing that -- those results. Obviously, the purpose of doing this is to get out into the public space. So they will be published at some point whether or not we announced on the results ahead of time will be a decision that will be reached in conjunction with Vantive, who's really working with us quite closely on that. In fact, to some extent, it's really more of their projects than ours. We're providing the data, but they're really providing the engine for the health economic analysis.

That's great. And I guess on -- just turn to that FDA approval and ideally commercialization day of or very shortly thereafter. I guess, in terms of feedback you're hearing from clinicians from hospitals in terms of either their concerns or things that they think could be a barrier, maybe EAA availability or the things that they're excited about? Like kind of what's the sense you're getting from people on day 1, day 2, people that are going to put their hand up and say, yes, I'm going to use this on my patients.

Well, I think, Scott, it's sort of the usual sort of thing. You have that kind of distribution of early adopters and late adopters and sort of the middle of the back sort of folks. I think people are interested in seeing the results of that are fully flushed out in the Tigris manuscript, which is certainly a lot more information than we've put in any press releases, et cetera, and presentations. So I think there is a bit of that, that people are interested in. In terms of barriers, yes, I mean, I do think that there are a lot of moving parts here, getting the assay installed and validated and put into the work streams for sepsis management is part of it. The intervention itself of course, figuring out who's going to do that, how it's going to be handled? There's a lot of details. And I think individual hospitals all or have their own individual approaches to these things. And so we've been encouraged by the great deal of interest exists within the academic and scientific communities and clinical communities, I think there'll be a lot of interest in adopting this at many of our many hospitals, not just the trial sites, but I think this will be a process. And I think it's too early to sort of indicate any more granularity with respect to how that will play out.

Yes. That's good. And maybe lastly, on -- and I think then it's more of a Vantive thing, but I know one of the outstanding things on their to-do list is getting the Prismax their 510(k) submission and approval for the hemoperfusion mode so that it's kind of easier one to click to you instead of what the trial sites had to do. So I'm assuming that, that process is part of all the ongoing work Chris and John, that you guys were talking about in terms of getting everything aligned so that on day 1 or close to day 1, everything is ready to go.

Yes, that's absolutely right. And I can think at that process, although we're not intimately involved at this point, that process is on track.

Good to hear. Again, congrats on everything over the past 12 months and looking forward to the next 12, and it's been an exciting ride.

Our next question is from Daniel Murphy Private Investor.

So I've been a longtime shareholder to go back to pre-EUPHRATES trial. I just want to ask you is what makes you all the more confident this time with the Tigris trial, this is the EUPHRATES trial because I remember way back then, you were very confident and disappointed with the end result. And also, is it really just all down to efficacy because I know they look at safety, but with PMX having been in use for so long, and is that something that we really don't need to worry about? And lastly, with Vantive in all these hospitals beyond sepsis, is there any potential for some sort of off-label use for other things that Vantive does?

John, do you want to take, I guess, the first portion or address the first?

Yes, sure. And maybe I'll comment on some of the others as we go. These are good questions, and they are important questions. I think the first one, obviously, I mean, if we were having this conversation a year ago, I would have speculated on what confidence is now. We know the results. So that changes everything. We have very clear and convincing evidence of efficacy. So this is a totally different scenario than we were sitting with EUPHRATES, just to remind you, the overall EUPHRATES trial was negative, a subset of patients within that group showed efficacy, but that was not in and of itself sufficient for regulatory approval by the FDA. So we set out to confirm those results with Tigris. We have now done so. And in fact, to a certain extent, we've surpassed the results that we're seeing in the prior subset patients, particularly at 90 days. So yes, I mean, our confidence is built on the actual results now as opposed to what believe it's really sort of what's in front of us. I'll jump to the last one and then maybe Chris can chime in on the others. In terms of the way this gets utilized, I can't speak for Vantive, but Vantive having come out of Baxter. Baxter has always been a fairly conservative company. They're really not going to be sort of marketing this off label, they're really not going to be pursuing beyond the indication. That said, we believe there are 140,000 patients a year in the United States alone and probably another 30,000 or so in Canada who have this condition. And the vast, vast majority of those patients would be appropriate for this therapy. So if you do the math, this is not a small market. This is really quite a large addressable market. And I think we're going to be focused at least for the near future on capturing as much of that market to ensure that everyone who should get this therapy gets this therapy. In terms of broadening the indications out other patients. I think that is a question. And certainly, we get asked a lot about where this company will take its R&D efforts in the future. And I do think looking at adjacencies like as trauma and hard solid organ transplant, particularly liver transplant is very reasonable. But that will happen through the sort of rigorous scientific expansion with additional studies and things like that, not something that's driven by the marketing team, if you will.

John, sorry, if you want to address what part of the question was, is this just what to be measured by efficacy. Once again, this touches on totality of evidence in the way the FDA looks...

Yes, yes, I understand the question. And I think you're right. I think that the safety concerns here are very, very different than if this was sort of a new unknown black box sort of technology. That said, the FDA has a process, right? They have their own standards, they have their own requirements. And they have routinely said things like, wow, just because the manufacturer hasn't got reports related to safety concerns doesn't mean that it passes muster. So we still have to go back and check all the boxes. Some of those boxes, frankly, have changed between the EUPHRATES and now. And so mostly, it's about refiling information as opposed to doing any additional testing. But the FDA could ask us for more information concerning potential risks. I don't think there's any real concerns related to all of this, but that doesn't mean that the FDA won't ask for things that we have to produce. The good news is that -- and this is also sort of part of your question, the fact that it's been around for so long means that there's quite a lot of data to draw on. So it's really not a question so much of well, you have to do something to prove something, it's really more of pulling information out and putting it in front of the FDA. So I think the -- the answer is -- the decision process is going to be almost exclusively related in this particular case to efficacy because safety is really not much of a concern. That said, there are known safety concerns related or adverse event concerns, we'll say, related to any extracorporeal therapy, including hemodialysis, putting in a dialysis catheter has some intrinsic risk putting patients on anticoagulation has some intrinsic risk. The good news is that those risks are well understood by both the FDA and the clinical community. So these are not -- again, they're not sort of black box unknowns that will cause a lot of consternation. They're sort of balancing, okay, there's a small risk related to the procedural events, how do I compare that to relatively well, I would say, a very large signal in terms of mortality for efficacy. And we're really not seeing -- I mean I think we've disclosed this at least at a high level. We're really not seeing any safety concerns related to the Tigris data, and we weren't really seeing any safety concerns related to prior investigations.

Our next question is from Douglas Anderson, Private Investor.

Long-term investor, a long-time investor, having been through a few M&As in my career, I had 3 questions, if you would. I was on the sepsis alliance call, listen to that. I heard the feedback, which was great. Question 1 is, from a commercialization planning standpoint, trying to get an idea, and I'm not trying to put the cart in front of the horse. But is Vantive basically responsible for how this gets commercialized? And are they doing the planning so that assuming a positive FDA approval, the commercialization go-to-market planning is taking place? That would be kind of the question on general area. Two, do you have any time line for -- and what projections if you have them, of what revenue would look like in, say, '27, '28? And third, has the company enlisted any third-party corporate alternative-type bankers?

All right. So with respect to Vantive and their role in overall commercialization, our agreement is fairly simple. When we entered into our distribution agreement with what was Baxter at the time, but now is Vantive back in February of 2020. And that is that they're solely responsible for all commercialization activities. The marketing spend, the branding, distribution, et cetera, et cetera. Spectral's responsibilities are, frankly, to get us to FDA approval. Now of course, Spectral's responsibilities certainly don't just end at that point in time. I think we both -- both parties would like obviously, the most robust adoption possible. And certainly, we have resources that know how this device works and in what settings and we have certainly lots to offer from that perspective to support the overall Vantive commercialization effort. And so we continue to do that, and we will continue to do that. That doesn't mean that we have to build out all sorts of commercial resources to support that. So -- yes. Your second question projections, that's not something we're at liberty to discuss. That's not something that, frankly, at this point in time, we have 100% clarity on and that we're comfortable putting out in the marketplace. I think those are the kinds of discussions and disclosures that come in due course. Certainly, I think our job one right now and our focus certainly is to get this PMA submission in and approved. Your third question, corporate action bankers -- sorry, you're talking about M&A bankers?

Yes. Essentially, yes. I guess the question just being very simple here is seeing what's going on in the world right now. You just hear a whole bunch of projections about what could be happening in next business year. And my question is, and having been involved with a few myself personally, both the acquiree and acquirer and knowing what that drain is to a company. My question is, if people say, hey, this is a great product would fit into ours. I know Vantive obviously or Baxter thought this was complementary to what they do. But I just didn't know if there was potentially anyone else that might come in and say, hey, this is great. We'd like to incorporate this into our portfolio and knowing what it takes to go through that process, which is painstaking I was involved with a CBC related. They were a banker a company that was ultimately acquired by another Canadian company. I just wanted to know at this juncture, essentially, I'm trying to figure out is Vantive basically the players we will be dealing with? Or is there any other interest or potential interest of some other organization coming in and saying, hey, we want this.

Well, yes, I mean, listen, there's all sorts of speculation around this, if you will. Certainly, Vantive would be a logical partner. They've already got the sales force in place, they would internalize our margin. They would have the most insight into what uptake would be and what that pipeline would look like. And certainly, any other potential strategic bidders would not have that certainty of insight, right? That being said, Vantive has greater than 50% market share. So who would this benefit the most? I would say, certainly from a Vantive perspective, they have the most to gain by entering into a transaction or an acquisition of Spectral. Now that being said, there is the ability to create tension in any -- I've spent most of my life as an M&A banker, and I've worked on a gazillion transactions. And there are ways to create competitive attention. Certainly, given that we are an asset-light company. We don't have a whole lot of corporate cost to build out because we have a great partner that is out there selling the product, and we're holding their feet to the fire around that. This is a company, if we were to do nothing else, we would be collecting checks. And so what other players would be interested. There certainly are financial players, royalty players, other private equity firms that would see this cash flow, right? And at least from a very minimum, that's your floor, right? And so that does create and keep any strategic bidder honest at the end of the day. But once again, that's all speculation. I'm not saying that this is the path right now and that there are or are not talks at this point in time. That's not what I'm saying, right?

Our next question is from Tom Xi, private investor.

You've touched on most of my questions. So I'm just going to do a quick fire. There's been a lot of scientific presentations on PMX that the shareholders aren't able to access because they're paywalled or whatnot. Is there any way we can get some of those out sooner because there's been a lot that aren't available?

Yes, I don't know the answer to that. Yes, I don't know the answer to that. I mean they are payroll -- paywalled. The recent we can look into -- since you brought this up, I think one of the things we may be able to do is to license the recording. So there was a presentation at the Toronto meeting, and we can explore that. But I can't make any promises to how easy that is, et cetera. But we can definitely explore that.

Wonderful. And just to clarify on the manuscript, has it been submitted, it's waiting for peer review? Or is it more waiting for the FDA application to be...

It's in the peer review process. Obviously, given the timing for the PMA, some of the same resources that we are utilizing for the PMA. We're also utilizing for the manuscript. So we haven't pushed as hard for all of that as we might have if the PMA was already submitted. But no, it's in the peer review process. We're also looking -- once this is accepted, we're hoping that it will be simultaneously presented at a meeting in the full detail. And so some of that timing and negotiation once it's accepted will also be factored into the time line.

Wonderful, wonderful. The EAA, the doctor in Louisiana wonder doctor that did a presentation recently. He talked about how the cumbersome or time consuming it was to process the EAA. Is there any upgrades in the works to shorten the processing of the EAA?

Yes. I attended that lecture as well. I think it's cumbersome for a clinical coordinator to run, a laboratory technician would have no problem running this. So I don't think the cumbersomeness per se is the issue. I think what's an issue for the assay is that it's really a 20th century assay. Currently, in the clinical laboratory, people expect to have much more of a multichannel analyzer sort of approach where you can add this to an existing platform, one machine, you run a bunch of different things, and there's not a lot of separate machinery or steps involved. Also, the human factors aspects, clinicians -- sorry, technicians, used to run all these tests themselves in the laboratory and now they're all sort of under automation. This test is not an automated test. It's not difficult. It's not time consuming, but it requires a human being to actually handle the tubes. And so that makes it -- and maybe that's what you mean by cumbersome. I think that may well be what Professor Eaton meant during that lecture by cumbersome. But it sort of is what it is, right? So we don't have any plans to replace the EAA in the near future. That said, and Chris may want to comment on this as well. But that said, we have taken steps to try to reduce some of the barriers for clinical adoption in the clinical laboratory. One of them being that the format of the assay a year ago or 2 years ago was -- took a lot of space. There were separate machines that did things we've combined some of that machinery so that's much smaller, really, if you have a the espresso machines in your office, you -- now can kind of imagine what the footprint is. So we're not talking about too much space that's involved, which, of course, is an issue. The manual operation to run the test is still an issue. And although we've been working over the years to try to deal with that, there has been an easy solution. So I think we're going to be with the assay that we have, at least for the near future.

Wonderful, wonderful answer. On that, the recent new analysts that got on board mentioned a patent on EAA which actually had an in-line EAA in the circuit -- the blood circuit that actually was continuously monitoring the endotoxin levels. Is that just 5 years down the road, is that -- what is that? I don't know if you saw it, but...

No, I didn't see. I doubt that it's EAA. Yes, it might be some other way of attempting to measure endotoxin. But court's very tricky. The reason that we have EAA and the reason we have this cumbersome assay is that measuring EAA and blood is actually quite -- measuring endotoxin in blood is quite complicated. And the reason it's complicated is that there's very little free endotoxin that's in the blood. Most of it is bound up in -- by proteins such as LBS binding protein and HDL cholesterol forms micelles around it, complement binds it up. So it's very little free endotoxin. And if you just measure or free endotoxin, it's a very low concentration and it doesn't correlate with the total endotoxin burden that the patient has. So I've not seen the technology that you're -- I'll definitely look for it now that you've commented on it, but it's definitely something that is very difficult to do if it were easy to do, people would have cracked this not a long time ago.

Right. Wonderful answer. It's in the core -- they used to call themselves machy or something, but the new analyst just did a big -- anyway, he mentioned that. Final...

Yes. Thank you for that. I'll take a look at it.

Yes. Final question, it's related to kind of the pharma economic studies that might be coming down the road. Is there any -- after that, will there be any rereview of the PMX pricing model because the pricing model is pretty much from EUPHRATES days, and it's it seems outdated as well that $7,500 per cartridge. And I'm not trying to be -- I want to save lives, but it seems kind of antiquated at the pricing. Is there any plan to rereview the pricing model? And any information you have on that would be great.

Well, I think there's a targeted launch pricing. I wouldn't say that there's any antiquated pricing around this. Certainly, there is the cost benefit analysis. And obviously, that's going to be very important that comes out of a health economic study. This is a premium-priced product still at USD 7,500 cartridge that's USD 15,000 per patient from a therapy perspective. When you look at other ICU therapies, it's not that there are therapies that are extremely higher than our therapy. So this is this is still very well priced. If you're asking, should this be a USD 10,000 per cartridge therapy. Now you start getting into the margins of -- is this just going to cost the hospital too much at the end of the day. I think there's a lot of profit to go around based on the targeted launch price that we're putting out there. And I don't see any point at this time that we would off of this just targeted USD 7,500 per cartridge.

Our next question is from Kevin Ventura, private investor.

Can you hear me okay?

Yes.

Okay. Super. Just a few quick questions. Question number one, John, you had mentioned how you're in consistent discussions with FDA. I'm just wondering, once the PMA gets filed, is it the same group of people that are reviewing that file? Or is it an entirely different team that kind of comes up with [indiscernible] question?

No, it's the same group. You have to remember that there are effectively 3 modules that relate to this. One is really sort of why I would characterize the sort of manufacturing sort of stuff. The other is more of a quality review, it's more of a review of documentation. And then the third is the clinical module. And yes, I would imagine, although the lead reviewer that we've interacted with has been sort of involved in all 3 of those modules. I would imagine there's a separate team that looks at manufacturing stuff, a separate team that looks like quality stuff and a separate team that looks at the clinical side, and I can't imagine that there's not much overlap between those groups other than the lead reviewer who serves as kind of a project manager across those 3 spaces. But we anticipate having the same kind of interaction as we move forward, they'll let us know if they need additional information.

So anything that's kind of big strokes, I would think would be kind of detected even very early in the process, but you're already going through some of those questions. I was presuming is that a fair assumption?

Yes. I would make the same assumption. I think every PMA review process is different because of the details of the technology. So I don't think we can generalize too much. But my sense is similar to yours.

Okay. Next question was around -- you mentioned about Toray being inspection-ready, can you just kind of comment sort of the FDA would have to actually go to Japan to review the facilities or inspect the facilities?

Well, they've done it before, which probably means they're less likely to do it again, that said, it's been some time since they did it. They did it back in EUPHRATES era. So it's not -- it's certainly not unprecedented that they would do an on-site inspection. They have alternatives kind of methodologies where they can inspect documents and things like that without necessarily being on site. But yes, no, it's entirely possible that -- and I think we and Toray need to be prepared for that possibility.

Okay. You commented how next April or May, you'll kind of have the 1-year mortality results. Are you able to comment at this time, how many patients are already at that 1-year threshold? And are the results looking consider...

Yes, not really -- not -- yes, not really. I'm guessing we're probably at 85% or so of the patients haven't met that. But we haven't looked at that data. I think we really won't unpack and analyze that data until it's all locked and clean, and that will be as you say, somewhere around May or so, which means that the earliest will have really credible results would be end of May, beginning of June, something like that.

Okay. One last question for you, John, one question for Chris. So John, my last question is around kind of the phenotyping. There's a lot of papers now looking at this and kind of slicing and dicing and looking at different things with machine learning. Can you kind of comment maybe even at a high level, is this maybe going forward once it does get approved that there might be more kind of analysis done to kind of kind of better target even who gets the PMX?

It's a good question, and it's certainly something we've had our eyes on in terms of -- if you think about what criteria is utilized for selecting patients for this. it's certainly evidence of high amounts of endotoxin in the bloodstream, and that really does require form of measurement. Right now, it's EAA in the foreseeable future, it's going to remain EAA. But the second piece is that it really sort of matters, right? Because there are some patients that can have high levels of endotoxin and they do manage to clear it on their own relatively quickly. If you wait for them to develop organ dysfunction, which is what we currently do to figure out that they're sick enough to go on this therapy then you could argue that we've lost some precious time. And to get ahead of that, and instead of waiting for the organ failure to manifest to use various other techniques to phenotype to patients, as you say, or sub-phenotype to patients, which could include machine learning algorithms, artificial intelligence, additional laboratory testing et cetera, if we can sort of identify these patients as early as possible, that may well drive a better adoption at a time when the efficacy signal could be larger. So we're definitely interested in that. Obviously, none of that is going to be ready for FDA approval. So the FDA will approve it on the basis of those -- of the current clinical phenotyping, which is based on development of working failure and presence of endotoxin. So if we were to promote that or if they can afford to promote that, it would require going back and doing some sort of 510(k) to expand the indications. That said, I do think clinicians, if the data are strong enough clinicians, you have their own ability to select patients in a way that follow the data. I do think we're probably not we could be, but we're probably not talking about expanding the population for this therapy, but we may be talking about better early identification and I think that is important.

Okay. That's great. And just one question for Chris. You talked about how you don't get any capital at this time. Can you comment in terms of like if you were to just have a steady state, the cash you have now, are you good until next June, July? Just give us a kind of rough idea.

Yes. Certainly, we have runway may certainly late into next fall or even close the winter time.

We have reached the end of our question-and-answer session. I would like to turn the floor back over to Chris for closing remarks.

Great. Thanks. I'd like to offer a few closing comments to bring today's update together. As you've heard this morning, the team continues to make strong progress on the PMA, and we remain fully aligned with the FDA on the elements required for a high-quality submission. Our discussions with the agency have been interactive, constructive and focused on ensuring that PMX is supported by the most comprehensive submission package possible. As part of this process, we've been incorporating the FDA's most recent feedback, which we believe will ultimately strengthen the clarity and completeness of the PMA from day 1. Unfortunately, some of the feedback arrived later in the process than originally anticipated. As a result, rather than targeting October 2025 submission as previously communicated, we're now planning for a Q1 2026 PMA submission. While this adjustment is not ideal, we believe it is in the best interest of the program and should support a smoother and more efficient substandard review once the file is formally under review. Importantly, none of these updates have any impact on the strength of the TIGER data or our overall confidence in the clinical profile of PMX. This is simply the reality of a highly detailed PMA and an agency managing significant workload and resourcing demands. We continue to work closely with them and remain fully committed to a robust timely pathway forward. Beyond the PMA, we anticipate publication of our Tigris manuscript in late Q1 2026. We believe this will serve as an important external validation of the results and will be highly valuable for clinicians and hospital decision-makers as we prepare for commercialization. On that front, our commercial efforts with Vantive continue to progress significantly with alignment on launch sequencing, hospital targeting, clinical education pathways and early adopter engagement. As I mentioned before, Vantive brings deep expertise in hospital-based medical technology launches and their partnership continues to materially strengthen PMX's go-to-market readiness. We expect these activities to continue accelerating as we move closer to potential regulatory approval. Finally, I want to reiterate that Spectral does not have any immediate funding requirements. Our operating plan is appropriately resourced to support the PMA submission, the Tigris manuscript activities and our commercialization preparation with Vantive. While we have put a base shelf prospectus in place for strategic flexibility, its purpose is optionality, not execution. Our focus remains firmly on operational delivery. And as an organization, we remain fully committed to bringing PMX to patients who urgently need a targeted therapy for endotoxic septic shock. Thank you, and have a great day and great holidays.

Thank you. This will conclude our conference. You may disconnect your lines at this time, and have a great holiday season. Thank you, everybody.