Greetings. Welcome to Spectral Medical year-end 2025 corporate update and year in review call. At this time, all participants are in listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note 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 its representatives on this call. The 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, 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 and our PMA submission timeline, 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'll open up the floor to a 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 sustained commitment of our clinical site staff, the dedication of our internal team, and the willingness of patients and families to participate in a study aimed at addressing one of the most challenging conditions in critical care. We're deeply grateful to all of them. Of course, in August, we released the positive top line results from Tigris. These results demonstrated clinically meaningful benefit at both 28 and 90 days, consistent with the precision medicine approach that underpins PMX and the treatable cohort defined in EUPHRATES. The data reinforced our confidence 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 the momentum needed to progress fully into the regulatory phase with clarity and conviction. As we said at the time, completing enrollment and releasing the top-line results were not the endpoints. They were 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 one, 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. As our work has progressed, we have continued to receive constructive feedback from the FDA.
Much of that feedback has already been incorporated. 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 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 timeline 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 non-clinical 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 possible, and we remain firmly on track to do so. I want to expand briefly on the reason why the shift from our original 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 it did require that we update certain sections of the PMA, sections that had been previously accepted during our EUPHRATES 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 as 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 addressing 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 has 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 an either good to file letter or a refuse to file letter. Given the level of rigor and completeness that we're 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 timeline.
I want to emphasize 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. As Chris mentioned earlier, a meaningful part of our strategy is to ensure that Toray's documentation is fully inspection-ready well before the FDA arrives 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 these 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 serves as 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 one year, and these data should be available before summer. If preliminary results are any 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 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. 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 timeline, the manuscript publication, and Vantive's go-to-market planning are all integrated to ensure that if approved, PMX can be launched with a strong clinical, operational, and commercial support from day one. Thank you. 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 they build out the go-to-market plan, and all of this work remains tightly synchronized with our regulatory timeline so that if approved, PMX can enter the U.S. market with a high level of readiness from day one. 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 should add further strength through peer-reviewed validation. Clinical credibility is the first gatekeeper into 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 in 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 one. Manufacturing and 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 forecasts. 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 in establishing best practices for PMX use in the ICU setting. 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 receives 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, we 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's a remaining tranche of Vantive promissory notes that can be drawn 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 a 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. To repeat, we have no financing plan, and the company does not require capital at this time. Thank you. With that, we'll now open the line for questions.
Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For a participant using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we poll for questions. Our first question is from Scott McAuley with Paradigm Capital. Please proceed.
Hi, Chris. Hi, Dr. Kellum. Great to hear the updates and definitely, a big past 12 months since the last update call around this time last year. Congratulations on everything. A few questions just maybe on some of the details. On the PMA submission and the FDA, obviously there's some big changes happening at the agency, news releases around staffing and et cetera. Just wanting to 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 at the agency overall?
I can take that. 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 timed to opening and closing of the federal government, so I'm sure there was some effect in terms of how quickly some of that feedback came to us. Apart from that, we still have the same review team that 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 to hear. In terms of the process, it was great to hear you lay out the timing and the way things will move once it's been submitted. My understanding is there's an option for PMA applications if they decide there's a need for an advisory committee meeting. Maybe speak a little about that, if that's something that you're preparing for, that you would expect, plus or minuses if they decide that that's something that they think they would want and how that would impact the process.
Yeah, 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 timeline somewhat because im paneling, a review panel and all of that can certainly take a little bit of time. 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 interested in reviewing this with respect to the totality of the evidence. We feel pretty good about that. We feel like our overall story is quite compelling. Bringing in a clinician review panel, I think, if anything, would work in our favor.
That's great. 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.
Yeah, I think that's right.
I guess in terms of, there's the process of the 15 days, the 45 days. After that 45 days, is there much else in terms of what the market can expect? Early in 2026, we get the manuscript, we get the FDA submission, the 15-day, the 45-day acceptance, and then is there anything else from there to the approval, which could be 180+ 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?
Yeah, I mean, not from FDA process per se, but of course, the manuscript will be published. There'll potentially be editorials and other sort of clinician community and academic reactions. That'll be there. We do anticipate, as I mentioned, that we'll be bringing forth our one-year follow-up results sometime before summer. All of that, I think. We'll give everyone, I think, some indication as to sort of where things are and what the reaction of the community is.
That's great. 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 disclose the results of any of those work?
Yeah, we haven't figured out what our timeline should be for releasing those results. Obviously, the purpose of doing this is to get it out into the public space. It will be published at some point. Whether or not we announce 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 their project than ours. We're providing the data, but they're really providing the engine for the health economic analysis.
Yeah. No, that's great. I guess on just turning to that FDA's 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. What's the sense you're getting from people on day one, day two, people that are going to put their hand up and say, Yeah, fine, I'm going to use this on my patients.
Yeah, 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 pack sort of folks. I think people are interested in seeing the results that are fully fleshed out in the Tigris manuscript, which is certainly a lot more information than we've put in any press releases, et cetera, and presentations. I think there is a bit of that that people are interested in. In terms of barriers, yeah, 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 have their own individual approaches to these things. We've been encouraged by the great deal of interest that exists within the academic and scientific communities and clinical communities. I think there'll be a lot of interest in adopting this at many hospitals, not just the trial sites. 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.
Yeah. That's great. Maybe lastly on, I think this is 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 click to use instead of what the trial sites had to do. I'm assuming 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 one or as close to day one, everything's ready to go.
Yeah, that's absolutely right. I can say that that process, although we're not intimately involved at this point, that process is on track.
Great to hear. Congrats on everything over the past 12 months, and looking forward to the next 12. It's been an exciting ride. Congrats again. Cheers.
Thanks.
Yeah. Thanks, Scott.
Our next question is from Daniel Murphy, private investor. Please proceed.
Hi, gentlemen. How are you?
Hi. Good.
Hello.
Yeah. I've been a longtime shareholder, 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 versus the EUPHRATES trial? I remember way back then you were very confident and disappointed with the end result. Also, is it really just all down to efficacy? I know they look at safety, but with PMX having been in use for so long, is that something that we really don't need to worry about? 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.
Yeah, sure. Maybe I'll comment on some of the others as we go. These are good questions. They're important questions. I think the first one, obviously, if we were having this conversation a year ago, I would have speculated on what our confidence is. Now we know the results, so that changes everything. We have very clear and convincing evidence of efficacy. 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. 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 were seen in the prior subset of patients, particularly at 90 days.
Yeah, our confidence is built on the actual results now as opposed to what we 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 going 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. The vast majority of those patients would be appropriate for this therapy. If you do the math, this is not a small market.
This is really quite a large addressable market. 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 to other patients, I think that is a question. Certainly, we get asked a lot about where this company will take its R&D efforts in the future. I do think looking at adjacencies such as trauma and heart, solid organ transplant, particularly liver transplant, is very reasonable. 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 one part of the question was, is this just going to be measured by efficacy? Once again, this touches on totality of evidence and the way the FDA looks.
Yeah. I understand the question, and I think you're right. I think that the safety concerns here are 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. They have routinely said things like, well, just because the manufacturer hasn't got reports related to safety concerns doesn't mean that it passes muster. We still have to go back and check all the boxes. Some of those boxes, frankly, have changed between the EUPHRATES and now. Mostly it's about refiling information as opposed to doing any additional testing. 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. 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. I think 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 a patient on anticoagulation has some intrinsic risk. The good news is that those risks are well understood by both the FDA and the clinical community. 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 these procedural events. How do I compare that to a relatively, well, I would say, a very large signal in terms of mortality for efficacy? We're really not seeing 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.
Okay, great. I really appreciate the thorough answers.
Sure.
Our next question is from Douglas Anderson, private investor. Please proceed.
Okay, thank you very much. Long-term investor, long-time investor, having been through a few M&As in my career, had three questions, if you would. Thank you very much for taking the call. I was on the Sepsis Alliance call, listened to that, heard the feedback, which was great. Question one is from a commercialization planning standpoint, trying to get an idea. I'm not trying to put the cart in front of the horse, is Vantive basically responsible for how this gets commercialized? Are they doing the planning so that assuming a positive FDA approval, the commercialization go-to-market planning is taking place? That'd be kind of the question one general area. Two, do you have any timeline for, what projections, if you have them, of what revenue would look like in, say, 2027, 2028? Third, has the company enlisted any third-party corporate alternative-type bankers?
Thank you very much.
All right. With respect to Vantive and their role in overall commercialization, our agreement is fairly simple. We entered into our distribution agreement with what was Baxter at the time, but now is Vantive, back in February of 2020. That is that they are solely responsible for all commercialization activities, the marketing spend, the branding, distribution, et cetera. Spectral's responsibilities are, frankly, to get us to FDA approval. Of course, Spectral's responsibilities certainly don't just end at that point in time. I think both parties would like, obviously, the most robust adoption possible. 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. 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.
Okay. Thank you.
Yeah. 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. You're talking about M&A bankers.
Yeah. 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. My question is, and having been involved with a few myself personally, both on the acquiree and the 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. 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. Knowing what it takes to go through that process, which is painstaking.
I was involved with a CVC- related, they were a banker at a company that was ultimately acquired by another Canadian, a 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.
And-
Yeah. 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. Certainly, any other potential strategic bidders would not have that certainty of insight. Right?
Right.
That being said, Vantive has greater than 50% market share. Who would this benefit the most? I would say certainly from a Vantive perspective, they would have the most to gain by entering into a transaction or acquisition of Spectral.
Okay.
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. There are ways to create competitive tension. 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. What other players would be interested? There certainly are financial players, royalty players, other private equity firms that would see this cash flow. Right?
Right.
At least from a very minimum, that's your floor. Right. That does create and keep any strategic bidder honest at the end of the day. 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.
Okay. All right. I hope you appreciate the question, and I appreciate your answer.
Thank you.
Our next question is from Tom Xi, private investor. Please proceed.
Good morning, gentlemen. You've touched on most of my questions. 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? There's been a lot that aren't available.
Yeah, I don't know the answer to that. They are paywalled. Since you brought this up, I think one of the things we may be able to do is to license the recording. There was a presentation at the Toronto meeting, and we can explore that. I can't make any promises to how easy that is, et cetera. We can definitely explore that.
Wonderful. Thank you. Just to clarify on the manuscript, has it been submitted and it's waiting for peer review, or is it more waiting for the FDA application to be applied?
No, 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. We haven't pushed as hard for all of that as we might obviously if PMA was already submitted. 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 full detail, and so some of that timing and negotiation once it's accepted will also be factored into the timeline.
Wonderful. The EAA, the doctor in Louisiana, wonderful doctor that did a presentation recently, he talked about how cumbersome or time-consuming it was to process the EAA. Is there any upgrades in the works to shorten the processing of the EAA?
Yeah, 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. 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 multi-channel 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. Maybe that's what you mean by cumbersome. I think that may well be what Professor Eaton meant during that lecture by cumbersome. It sort of is what it is, right? We don't have any plans to replace the EAA in the near future. That said, 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, two years ago, 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 one of those Nespresso machines in your office, you kind of now can imagine what the footprint is. 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. Although we've been working over the years to try to deal with that, there isn't an easy solution. 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 analyst that got on board mentioned a patent on the EAA, which actually had an inline EAA in the circuit, the blood circuit, that actually was continuously monitoring the endotoxin levels. Is that just a five years down the road? What is that? I don't know if you saw it.
No, I didn't see that. I doubt that it's EAA. Yeah, it might be some other way of attempting to measure endotoxin, of course, that's very tricky. The reason that we have EAA, the reason we have this cumbersome assay is that measuring endotoxin in blood is quite complicated. The reason it's complicated is that there's very little free endotoxin that's in the blood. Most of it is bound up by proteins such as LPS binding protein and HDL cholesterol forms micelles around it, complement binds it up. It's very little free endotoxin. If you just measure free endotoxin, it's a very low concentration, it doesn't correlate with the total endotoxin burden that the patient has. I've not seen the technology. I'll definitely look for it now that you've commented on it's definitely something that is very difficult to do.
If it were easy to do, people would've cracked this not a long time ago.
Right. Wonderful answer. They used to call themselves Mackie or something, but the new analyst, he just did a big 30. Anyway, he mentioned patent. My final question.
Yeah, thank you for that. I'll take a look at it. Yeah.
Thank you, John. Final question is related to the kind of the pharmacoeconomic studies that might be coming down the road. After that, will there be any re-review of the PMX pricing model? Because the pricing model is pretty much from EUPHRATES days, and it seems outdated as well, that $7,500 per cartridge. I want to save lives, but it seems kind of antiquated, the pricing. Is there any plan to re-review the pricing model? Any information you have on that would be great.
Well, I think-
Chris.
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 any health economic study. This is a premium price product still at $7,500 a cartridge. That's $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. This is still very well priced. If you're asking, should this be a $10,000 per cartridge therapy, well, 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.
I don't see any point at this time that we would off of this targeted $7,500 per cartridge.
Wonderful. Well, that's it. Keep up the good work, guys. I'll see you next year.
Thanks.
Our next question is from Kevin Ventura, private investor. Please proceed.
Thanks, John and Chris, for the update. Can you hear me okay?
Yeah, I can.
Yeah.
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 kind of different questions.
Yeah. No, it's the same group. You have to remember that there are effectively three modules that relate to this. One is really sort of what I would characterize as sort of manufacturing sort of stuff. The other is more of a quality, a QMS review. It's more of a review of documentation. Then the third is the clinical module. Yeah, I would imagine, although the lead reviewer that we've interacted with has been sort of involved in all three of those modules, I would imagine that there's a separate team that looks at manufacturing stuff, a separate team that looks at quality stuff, and a separate team that looks at the clinical stuff. I mean, I can't imagine that there's that much overlap between those groups other than the lead reviewer who sort of serves as kind of a project manager across those three spaces.
We anticipate having the same kind of interaction as we move forward. They'll let us know if they need additional information.
Anything that's kind of big strokes, I would think would be kind of detected even very early in the process. You're already going through some of those questions, I would presume. Is that a fair assumption?
Yeah, I would make the same assumption. I think every PMA review process is different because of the details of the technology. 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 kind of comment, so that the FDA would have to actually go to Japan to review the facilities or inspect the facilities?
They've done it before, which probably means they're less likely to do it again. It's been some time since they did it. They did it back in the EUPHRATES era. It's certainly not unprecedented that they would do an on-site inspection. They have alternative inspection kind of methodologies where they can inspect documents and things like that without necessarily being on site. Yeah, no, it's entirely possible. 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 one-year mortality results. Are you able to comment at this time how many patients are already at that one-year threshold, and are the results looking consistent with?
Yeah, not really. I'm guessing we're probably at 85% or so of patients having 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'll be, as you say, somewhere around May or so, which means that the earliest we'll 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. John, my last question's 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 better target even who gets the PMX?
It's a good question, and it's certainly something we 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 some form of measurement. Right now, it's the EAA. In the foreseeable future, it's going to remain the EAA. 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.
To get ahead of that, instead of waiting for the organ failure to manifest, to use various other techniques to phenotype the patients, as you say, or subphenotype the 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. We are definitely interested in that. Obviously, none of that is going to be ready for FDA approval. The FDA will approve it on the basis of the current clinical phenotyping, which is based on development of organ failure and presence of endotoxin. If we were to promote that, or if Vantive to promote that, it would require going back and doing some sort of 510(k), to expand the indications.
I do think clinicians, if the data are strong enough, clinicians do have their own ability to select patients in a way that would follow the data. I do think 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. Just one question for Chris. You talked about how you don't need any capital at this time. Can you comment in terms of, if you were just to have the steady state, the cash you have now, are you good till next June, July? Just give us a kind of rough idea.
Certainly we have runway certainly late into next fall or even close to wintertime.
Okay. Thank you very much. Thank you, everybody.
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 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 one. Unfortunately, some of the feedback arrived later in the process than originally anticipated. As a result, rather than targeting an 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 substantive review once the file is formally under review. Importantly, none of these updates have any impact on the strength of the Tigris 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. 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.