Spectral Medical Inc.

Greetings. Welcome to Spectral Medical year-end 2025 corporate update and year-end review call. At this time, all participants are in a 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 Mondavi, 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 Kellen, 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, 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. Kellam 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 Vantiv, 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. And 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. But as we said at the time, completing enrollment and releasing the top line results were not the end points. 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. And as our work has progressed, we have 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 both comprehensive and durable. With that overview, I will now turn the call over to Dr. Kellam, 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 FTA expectations and standards. Our goal is to submit the full FTA 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 update 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 TIGRS 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 refuse-to-file 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 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 Tore's facilities. And as Chris mentioned earlier, a meaningful part of our strategy is to ensure that Tore'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 tigress 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 tigress 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 acknowledgement period, a 45-day initial filing review, and a 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 timeline, the manuscript publication, and Vantiv'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, 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. Manteva 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 US 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. Vantiv 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 TIGRS 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 economics story. Vantiv is conducting an in-depth economic analysis of the TIGRIS dataset, 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. Vantiv 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 adapt to the market with credibility, reach, and scale from day one. Manufacturing a supply chain alignment is equally important. We're working closely with Tori to ensure that inventory planning, production, scheduling, and other such activities are synchronized with Vantiv's commercial forecasts. At the same time, Vantiv 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 Vantiv, we're 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. 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 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 notes of the November 2025 warrants were exercised. Additionally, there is a remaining tranche of advance of 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. 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.

Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we pull for questions. Our first question is from Scott McAldee with Paragram Capital. Please proceed.

Hi, Chris.

Hi, Dr. Callum. Great to hear the updates and definitely, you know, a 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 and 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, you know, based on your interaction with them, given what's happening kind of with the agency overall?

I can take that. Yeah, 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, 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. But apart from that, we still have the same review team that we've had straight along, and I have not received any indication that, you know, 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. you know, for my understanding is there's an option for, you know, 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, you know, plus or minuses of 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, you know, 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, you know, potentially impact the timeline somewhat because in paneling, you know, a review panel and all of that can certainly take a little bit of time. But in general, you know, I think these sorts of things are sort of built into the process. My view is that, you know, the FDA has indicated to us that they've always been interested in reviewing this with respect to the totality of the evidence, and 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. 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, you know, it was approved with the support of these independent individuals.

Yeah, I think that's right.

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

Well, I mean, not from FDA process per se, but of course, you know, the manuscript will be published. There'll potentially be editorials and other sort of clinician community and academic reactions, so 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. And so all of that, I think, will be – will give everyone, I think, some indication as to, you know, sort of where things are and what the reaction of the community is.

That's great. And any plan – you know, you talked about the health economics 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?

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, so 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 the ANTIF, who's, you know, really working with us quite closely on that. In fact, you know, 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.

Oh, that's great. And I guess on, you know, just turning to that FDA approval and, you know, ideally commercialization, you know, 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 you know eaa availability um or the things that they're excited about like kind of what's the the sense you're getting from people on you know day one day two um people that are going to put their hand up and say that's fine i'm going to use this on on my patients yeah i think scott it's sort of the usual uh sort of thing you know you have that kind of uh uh you know distribution of uh early adopters and and late adopters and sort of the uh

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. So I think there is a bit of that that people are interested in. In terms of barriers, yeah, 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 process. 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. You know, we've been encouraged by the great deal of interest that exists within the academic and scientific communities and clinical communities. I think there will be a lot of interest in adopting this at 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, you know, any more granularity with respect to how that will play out. That's great.

And maybe lastly on, and I think 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 510K submission and approval for the hemoperfusion mode so that it's kind of easier, you know, one click to use instead of, you know, 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 one or as close to day one, everything is ready to go.

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

Great 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. So congrats again. Cheers. Thanks, Scott.

Our next question is from Daniel Murphy, private investor. Please proceed.

Hi, gentlemen. How are you?

Hi.

Good. Hello. So I've been a long-time 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? 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, I mean, is that something that we really don't need to worry about? And lastly, with Vantiv in all these hospitals, beyond sepsis, is there any potential for some sort of off-label use for other things that Vantiv does?

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

Yeah, sure. And maybe I'll comment on some of the others as we go. You know, these are good questions. They're important questions. I think the first one, obviously, I mean, if we were having this conversation, you know, a year ago, you know, I would have speculated on what our confidence is. Now we know the results. So that changes everything. You know, 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 were seen in the prior subset of patients, particularly at 90 days. So, yeah, I mean, our confidence is built on the actual results now as opposed to, you know, 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 Vantiff, but Vantiff, 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, you know, 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, You know, 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 to other patients, You know, I think that is a question, and certainly, you know, we get asked a lot about, you know, where this company will take its R&D efforts in the future, and I do think looking at adjacents such as trauma and heart-cell organ transplant, particularly liver transplant, It is very reasonable, but that will happen through the sort of rigorous scientific expansion with additional studies and things like that, you know, not something that's, you know, driven by the marketing team, if you will.

And, John, sorry, if you want to address, you know, one part of the question was, oh, is this just going to be measured by efficacy? You know, once again, this touches on totality of evidence and the way the FDA looks at it.

Yeah, I understand the question, and I think you're right. I think that, you know, the safety concerns here are very, very different than if this was sort of a new unknown black box sort of technology. That said, you know, the FDA has a process, right? They have their own standards. They have their own requirements. And, you know, they have routinely said things like, well, just because the manufacturer hasn't got reports related to safety concerns doesn't mean that, you know, 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, you know, 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, you know, do something to prove something. It's really more of, you know, pulling information out and putting it in front of the FDA. So I think the question, the answer is, you know, 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. You know, 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. So these are not, you know, 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, you know, a relatively, well, I would say a very large risk 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, 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.

Hey, thank you very much. Long-term investor, long-time investor. Having been through a few M&As in my career, had three questions. And thank you very much for taking the call. I was on the Sceptris Alliance call, listened to that, heard the feedback, which was great. Question one 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 Vantiv basically responsible for how this gets commercialized, and are they doing the planning so that, assuming a positive FDA approval, that commercialization go-to-market planning is taking place? That would be kind of the question one general area. Two, do you have any timeline 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? And thank you very much.

All right. So with respect to Vantiv 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 Vantiv back in February of 2020, and that is that they were 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 both parties would like obviously the most robust adoption possible and certainly we have resources that know how this device works in what settings, and we have certainly lots to offer from that perspective to support the overall advance of 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... 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, you know, 100% clarity on and that we're comfortable putting up in the marketplace. I think those are the kinds of discussions and disclosures that come in due course. Certainly, I think, you know, 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.

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. And my question is, and having been involved with a few myself personally, both on the inquiry and the acquirer, and knowing what that drain is to a company, my question is, if people say, hey, this is a great product, it would fit into ours. I know VanEv 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 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, you know, yeah. I mean, listen, there's all sorts of speculation around this, if you will. Certainly Vantive would be a logical partner. You know, they've already got the sales force in place. They wouldn't 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, you know, Vantive has, you know, greater than 50% market share. So who would this benefit the most? You know, I would say certainly from a Vantive perspective, they would have the most to gain by entering into a transaction or acquisition of Spectral. Now, that being said, there is the ability to create tension. 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 tension. Certainly, given that we are an asset-like 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. You know, this is a company, if we were to do nothing else, we would be collecting checks. And so, you know, 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, you know, any strategic bidder honest at the end of the day. But, you know, once again, that's all speculation. I'm not saying that this is the path right now and that, you know, there are or are not talks at this point in time. That's not what I'm saying, right?

Okay. I hope you appreciate the question, and I appreciate your answer.

Thank you.

Our next question is from Tom Z, private investor. Please proceed.

Good morning, gentlemen. You 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 – Any way we can get some of those out sooner because there's been a lot that aren't available?

Yeah, I don't know the answer to that. Yeah, I don't know the answer to that. I mean, you know, they are payrolled. 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 as to how easy that is, et cetera. But we can definitely explore that.

Wonderful. Thank you. 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 applied?

No, it's in the peer review process. Obviously, given the timing for the PMA, you know, some of the same resources that we, you know, are utilizing for the PMA, we're also utilizing for the manuscript. So we haven't pushed as hard for, you know, 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, you know, once this is accepted, we're, you know, hoping that it will be simultaneously presented at a meeting in the full, you know, full detail. And so some of that timing and negotiation, once it's accepted, will also, you know, be factored into the timeline.

Wonderful, wonderful. The EAA – The doctor in Louisiana, a 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. You know, 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 that cumbersomeness per se is the issue. I think what's an issue for the assay is that it's really a 20th century assay. You know, 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 know, you run a bunch of different things, and there's not a lot of separate machinery or steps involved. Also, the human factors aspects, you know, 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, you know, it sort of is what it is, right? So we don't have any plans to replace the EEA in the near future. That said – And Chris may want to comment on this as well, but that said, you know, 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, you know, 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 have can kind of imagine what the footprint is. So we're not talking about too much space that's involved, which of course, you know, 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, you know, deal with that, there isn't 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. Um, on that, uh, the recent new analysts that got on board mentioned a patent on the EAA, um, which actually had an inline EAA in, uh, in the circuit, the blood circuit that actually was continuously monitoring the endotoxin levels. Is that just a five years down the road? Is that, what is that? I don't know if you saw it, but, um,

Now, I didn't see that. I doubt that it's EAA. Yeah, it might be some other way of attempting to measure endotoxin. But, of course, that's very tricky. The reason that we have EAA and the reason we have this cumbersome assay is that measuring EAA in 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 by proteins such as LBS binding protein and HDL cholesterol forms, micelles around it, complement binds it up. So it's a very little free endotoxin. And if you just measure free endotoxin, it's a very low concentration, and it doesn't correlate with the total endotoxin burden that the patient has. I've not seen the technology that you're in. 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, you know, people would have cracked this not a long time ago.

Right. Wonderful answer. It's in the core. They used to call themselves Mackey or something. But the new analyst, he just did a big 30. Anyway, he mentioned that. Yeah.

final question. Yeah, thank you for that.

I'll take a look at it, yeah. Thank you, John. Final question that'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 re-review 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, you know, I want to save lives, but it seems kind of antiquated, the pricing. Is there any plan to re-review 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 gonna be very important that comes out of any health economic study. This is a premium price product still at 7500 US a cartridge. That's 15,000 US 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 still very well priced. If you're asking should this be a 10,000 US per cartridge therapy, you start getting into the margins of is this just gonna cost the hospital too much at the end of the day. You know, 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, you know, this targeted $7,500 per cartridge.

Wonderful, wonderful. Well, that's it. And keep up the good work, guys. I'll see you next year. Thanks.

Our next question is from Kevin Venstra, private investor. Please proceed.

Thanks, John and Chris, for the update. Can you hear me okay? 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 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 why we characterize this sort of manufacturing sort of stuff. The other is more of a quality, you know, a QMS review. It's more of a review of documentation. And then the third is the clinical module. And, 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. But, you know, we anticipate having the same kind of interaction, you know, as we move forward. You know, 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 would presume. Is that a fair assumption? Yes.

Yeah, I would make the same assumption. I think every PMA review process, you know, is different because of the details of, you know, 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. Do you kind of comment, so does 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 the Euphrates era. So, you know, 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. But, yeah, no, it's entirely possible that – and I think we and Tore 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?

Yeah, not really, not – Yeah, not really. I'm guessing we're probably at, you know, 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, you know, as you say, somewhere around May or so, which means that, you know, the earliest we'll have really credible results would be end of May, beginning of June, you know, 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 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, you know, if you think about what criteria is utilized for selecting patients for this, you know, 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 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, you know, 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, you know, various other techniques to phenotype the patients, as you say, or sub-phenotype the patients, which could include machine learning algorithms, artificial intelligence, additional laboratory testing, et cetera. If we can, you know, sort of identify these patients as early as possible, you know, 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's going to be ready for FDA approval. So 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. So, you know, if we were to promote that or if Antif were to promote that, it would require going back and doing some sort of 510K to, you know, expand the indications. That said, You know, I do think clinicians, if the data are strong enough, you know, clinicians do have their own, you know, ability to select patients in a way that would 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 need 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.

Yeah, 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'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 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 in 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 TIGRS 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 Bantam continue to progress significantly with alignment on launch sequencing, hospital targeting, clinical education pathways, and early adopter engagement. As I've mentioned before, VANA 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 Vantiv. While we have put a base shell 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.