Greetings, and welcome to the Spectral Medical Tigris Trial and Corporate Update 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, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Ali Mahdavi, Spectral Medical. Please go ahead. Thank you, operator, and good morning, everyone. Thank you for joining us for the Spectral Medical Tigris Trial and Corporate Update call. Joining us this morning are Chris Seto, Chief Executive Officer, and Dr. John Kellum, Chief Medical Officer of Spectral. I would like to remind you that a replay of this call will be accessible until midnight on May 29, 2025. Following management's remarks, we'll conduct a question-and-answer session. Instructions will be provided at that time for you to join the queue for questions. 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. 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 the date of this call, and the company does not undertake to update any forward-looking statements. Please read the forward-looking statements and risk factors in the MD&A and annual information form as these outline the material factors which could cause or would cause actual results to differ. 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 a corporate update, specifically on our key regulatory milestone activities and timelines and the recently announced financing with Vantive. After our prepared remarks, we will open the floor to a Q&A session. As we entered into Q2 of this year, we closed on two very important milestones, as you're probably aware. The first was full enrollment of the Tigris study in mid-April. This is a monumental achievement in the world of sepsis clinical research. We ultimately enrolled a total of 157 patients to yield 100 patients who received the PMX treatment. It's been a lengthy journey to get here, but I want to thank all our stakeholders, including our clinical site staff, the patients and their families, our Spectral team, as well as our investors. That being said, while full enrollment is a significant milestone, it is not our ultimate endpoint. As such, our team is in full regulatory mode. John will discuss the process shortly. Before we get into that, I'll discuss the other important milestone achieved in this quarter, which was finalizing our financing with Vantive. Last week, we entered into a debt facility with Vantive for up to $10 million U.S. The importance of this financing is that it provides the path to fully fund Spectral to potential PMX clearance and into commercialization and allows the company to focus all of its resources on the PMX program. This financing is what I would characterize as company-friendly. First, it's a facility that provides for the lowest cost of capital. The coupon is a 9% annual interest rate. We are in discussions with multiple parties on financing alternatives going back to last fall, and indicative terms discussed were nowhere near as attractive as the Vantive debt. Second, this is a four-year term and PIK interest. This should result in zero dilution given the four-year term. Should we have a positive regulatory outcome for PMX, I would expect that we are beyond cash flow breakeven by the time this debt matures. Finally, this is a straight debt instrument. No bells or whistles such as warrants or conversion features. With respect to the drawdown of the debt facility, there are four separate tranches. The first tranche was $4 million, which was triggered upon execution of the debt agreement. The second tranche is $3 million, which is triggered on top-line data release and conditional on Tigris showing a 7% absolute mortality benefit at 28 days and a 10% absolute mortality benefit at 90 days. The third tranche is $1 million and is conditional on the amount of Spectral's November 2025 warrants being exercised. If there is less than $1 million exercised, Vantive will advance $1 million. As a reminder, we have approximately $7 million November 2025 warrants with an exercise price of $0.48. The fourth tranche is $2 million and is conditional on the FDA acceptance of our PMA submission. Once again, a very attractive financing. I think more importantly, it highlights the strength of our relationship with Vantive and the alignment of both Vantive and Spectral on our PMX partnership. I'll now hand the call over to Dr. Kellum, who will provide an overview in our regulatory activities and timeline. Thanks, Chris. Today, I'm pleased to report that together with our CRO, we are completing data monitoring for all 157 patients enrolled in the Tigris trial and have started data cleaning in anticipation for data lock by the end of July. Once this is completed, we will then commence analysis and expect to be able to release top-line results by mid-August. What can we expect to see within these results? Just to remind everyone, our primary endpoint is 28-day all-cause mortality, combining data from a subset of our prior trial with our new data. This involves Bayesian statistics, so it's a little bit complicated. However, if you want to see what we are expecting, our methods paper, published back in 2023, which is Tomlinson et al., Critical Care, November 8th issue, includes a number of simulations. The paper is also useful because it shows how we will report these results. Basically, the output of a Bayesian analysis provides a probability of benefit, something we call a posterior probability when we combine the data. It will never be 100%, of course, but we are expecting a probability well above 90%. Our top-line results will include 28-day mortality, both treated and control patients, the absolute and relative differences, both before and after adjusting for baseline severity of illness, all as described in that paper. We will also be reporting the same data on 90 days. The FDA has informed us that they are not just interested in the 28-day results, but also in longer-term outcomes. We will be presenting those as well. These results will be analyzed using the same Bayesian methods, we'll be able to report out a posterior probability of benefit at 90 days, just like for 28 days. Hopefully, we'll have complete data on all patients for 90 days by that July data lock. Following this analysis, we anticipate submitting our results for publication in late August or early September. While we can't control the publication timeline, it's possible that the manuscript will be published by the end of this year, early 2026 at the latest. Meanwhile, we'll be preparing our FDA submission and expect to submit this in October of this year. The FDA has already accepted our non-clinical data, we're already working with them to finalize these modules. The FDA will take a bit longer to review the clinical trial results, but as we have reported previously, we are expecting this process to be concluded in approximately nine months based on historical trends. Of course, delays are always possible, but this is the best information we have at this time. Importantly, regulatory review of products like this that are used in other jurisdictions are generally based on the totality of the evidence. This includes safety and effectiveness data from other sources in addition to our own results. We actually think this is a significant advantage for us because there's already extensive safety history for this product, and especially over the last few years, there's a large body of evidence of effectiveness from retrospective data. These published reports have already been provided to the FDA, and we do so annually, and these data will provide additional support for our application. Back to you, Chris. Thanks, John. One thing we haven't touched on in detail is commercialization activities. The only thing I will say on this front is that the collaboration between Spectral and Vantive continues to be robust. Our partner remains committed and motivated, and I think the recent financing is a good proxy of that commitment. With that, I'll hand the call over to the operator in advance of our Q&A session. Thank you. We'll now be conducting a question-and-answer session. 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 to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please while we call for questions. Again, as a reminder, if you'd like to ask a question, please press star one. Our first question is from Kevin Vinstra, private investor. Yeah. Thanks for the details. It's great. The first question I had was, you talked about one of the milestone payments and how the CAD 7 million that are expiring in November need to be exercised. You said the strike price was CAD 0.48. I'm just curious, how many of those have been exercised already, if any? I don't have the exact number, Kevin. We've had some dribbles of exercise that have come in. It's not close to U.S. $1 million at this point in time. They still have an expiry till the end of November of this year. Okay. That's good. My next question, which I think most of us are thinking here, given that it is an open label trial and we're already past or right around the 28 days since the last patient has been enrolled, can you just give us some flavor in terms of is it regulatory rules that you need to wait till mid-August? I guess my thought process is the longer you wait, the more chances you have of some information leakage, even maybe at the hospital level, the investigators, given that the data's already, or at least some people know of it. Yeah, I can take that, Kevin. There really are sort of several reasons why the data won't be ready for release until August 1st. Although patients are now all past day 28, that doesn't necessarily mean that we've completed all the follow-up on those patients. For example, if a patient's discharged to LTC, that may take a while for us to find them with phone calls for follow-up. All of the data has to be monitored. We do 100% source verification on all the data, and that's a very time-consuming process. Until that's done, none of that data is official. Finally, the day 28 endpoint, as we've said, is based on a Bayesian analysis which combines our prior data with the current data. That analysis simply will not be completed until August. Given the FDA's strong interest in 90-day outcomes, we feel it very important to provide that endpoint as well in our top-line data report, and several patients have not reached day 90 as yet. Okay. That's fair. Just one follow-up question to that. Based on prior papers or even from the EUPHRATES trial, I can't remember exactly, but the 28, 90-day mortality, the gap between treatment and control, relatively constant. In other words, if it is the case that the 28-day mortality is lower for the treatment group, is that gap between treatment and control relatively stable as you go out to 90 days based on historical kind of data? No. I think we can comment on that based on, not this trial, because we haven't seen the data on this trial yet, but in terms of other sepsis trials going back for many years and also looking, as you alluded to, at EUPHRATES. A big problem with day 28 is that it's still a very unstable time, and patients can be alive at day 28 but then die a few days later. There can be changes. This is probably why FDA is interested in not just the 28 days, because it really doesn't necessarily help people that much if you're alive at day 28, but you're still in the hospital, maybe still on a machine to support you, then you die three days later. They're going to be interested in looking at longer-term outcomes. In terms of where that signal starts to get more stable, different trials show different things, but in general, it's really out past 30, 40, even out past 50 days in some trials that the numbers start to look pretty stable. Is that gap, though, generally still quite constant between treatment control group mortality, at least based on data outside of Tigris? Yeah. All we can say is that we're still in kind of an unstable part of the curve until you get out. This, again, is sort of why it's important to show not only that you're achieving an improvement in a gap, as you call it, early on, but that that gap is sustained. Maybe even it's important to think about this in the context of, for example, cancer trials, right? It's one thing to be alive day 60, day 70, get your affairs in order, that sort of thing. You're still alive in the hospital on day 20. Does it really matter whether you're alive at day 20 versus day 30? I think that's why it's appropriate, and we're not shy about providing that data to the FDA as well as to the public, because I think that if we're going to have a meaningful impact on patient survival, that survival signal should be sustained. Okay. Just a couple more questions. One is around the Bayesian, as I think you've alluded to in the past, that it is definitely more complex than traditional methods. Does Spectral have a consultant that you're consulting to do the Bayesian analysis and maybe just to make sure that you run through all the scenarios? I know you have used one in the past. Do you have a couple individuals just to make sure you're double-checking on the kind of results? Yeah, of course. Yeah, I can comment on that. George Tomlinson, who's a professor of biostatistics at University of Toronto, is an international regarded expert in Bayesian analysis, and he's the lead statistician for the paper back in 2023, in fact, the first author, and is certainly our chief consultant on this project. For the FDA, we also have Bayesian experts in statistics at the CRO who will analyze the data. We have the CRO, as is typical of clinical trials. The CRO manages the data. The company's at sort of arm's length from that process. We chose a CRO with a particular expertise in Bayesian analysis because we knew this would be an issue. On top of all of that, we've retained a number of sort of expert Bayesian statisticians who will help us through the regulatory aspects of explaining the analysis to the FDA, and also helping with all sorts of aspects related to the analysis. Okay. That's fair. Last question I have is around, I know Vantive has spent a lot of time and effort on the ground getting this thing up and running, ready to go, conditional on acceptance. I think it was disclosed before that they've chosen not to receive any information about trial success or details around that. Is that still the case? Yeah, that's still the case. They've seen no data. Okay. That's great. Okay. Thank you so much. Our next question is from Tom Z. with Indie. Hi guys. Can you hear me? Yep. Hi, Tom. Congratulations on all your recent successes. I wanted to ask about something Paradigm recently said. They said they'd be very excited if the Tigris mortality benefit was north of 15%. I just wanted to know if that's, you can't say exactly, but is that still a possibility for Tigris to be so successful on the mortality benefit? Yeah, Tom, that's basically asking sort of what the results are at this point in time. Okay, busted. You got me. Okay. On to my last one. The non-dilutive, great job. Is any part of that pulling forward the final milestone payments? No. No. The milestone payment remains intact upon FDA clearance. Oh, okay. All right, one for two. Thanks, guys. Great job. Thanks, Tom. Our next question is from Douglas Anderson, private investor. Well, thank you for the conference call as an eight-plus year investor. Just a real quick question on what you anticipate from market size, addressable market, and just, for the neophyte here, non-medical person, as I understand it, if you look at a pie chart, a healthy percentage of people with sepsis have treatment by, say, antibiotics. Then there's the latter part of the pie, the folks that are just not treatable and they'll have end of life. Do you have any anticipated idea of what the addressable market would be for your solution? Yeah. John, do you want to start with that? Maybe I'll finish on that. Yeah. I can take that. I think the sort of the way to think about it, and we've run a variety of analyses based on data that's out there, and what we provide, I think is a rather conservative estimate, that there's about 140, 150,000 people in the U.S., and if we add another 15,000 or 20,000 people in Canada, we're talking about upwards of 160, 170,000 people a year. Now, as you point out, some of those people who develop sepsis are going to be so advanced in terms of their underlying disease process that this really is sort of an end-of-life event for them. Certainly, we see this with patients. If we say, okay, well, we've got some 20% of those patients are really not addressable, we back out, what is it, at 30,000 patients or so. If you say, well, in addition to that, there could be some patients that are so sick that we just decide not to treat them. They present late or whatever. It's hard to say whether that really is a group that you wouldn't try a therapy like this on, but there may be some. Where does that leave us? That leaves us somewhere around 120,000-130,000 people a year, who would be appropriate for this therapy. I think that's been pretty consistent with our estimates of a market size really since the very beginning. There are some calculations that put that number a good bit higher, but I think on a conservative estimate, it's right around there. Okay. Thank you. Could I ask one more question? In terms of positive outcome, FDA approval, and having a background in sales and marketing myself worldwide, going to market is a challenge for anybody. Given 20-plus employees, supposedly a relationship with Vantive, Baxter, Carlyle involved, can you give some clarity to the uptake and how you're going to have awareness to doctors, hospitals? In other words, given the size of our organization here, your organization, how the heck does the benefit of this Is it word of mouth? Is it Baxter representatives or whoever? Can you give a little idea of what the uptake could be, and how long do you think this would take, given a positive outcome? Yeah. That's it, and thank you very much. Yeah, Douglas. I'll start, and I think John can come in with sort of the clinical adoption side, which will speak to certainly market penetration. First, our relationship with Vantive is really solely as a distribution partner, one that has an expertise with acute therapies. This really is just putting another product in their bag with respect to the gatekeepers that they deal with in these hospitals and ICUs and the administration. You know, we've characterized Vantive as being sort of the perfect commercialization partner. I would just continue to reiterate that. They have the people in place. I think that there's potential that they will scale their sales force higher, but I can't speak for them. I think certainly there's a number of things that will speak to how quickly this gets adopted. I think first of all, it's the data readout and the absolute and relative mortality benefits based on our study. Also some of the other things, such as the health economic valuation for the utilization of a product like ours, such as decrease in ICU days, decrease in mechanical ventilation or vasopressor-free days, et cetera. All of those things are very expensive within the ICU. Certainly, not only is there a mortality signal, but also the ability to actually eke out and significantly reduce healthcare costs at the end of the day. I think those are certainly some key things as driving towards clinical adoption. John, I don't know if you want to speak to some of the things that clinicians might look for as they look to adopt. Yeah, no, I think that adoption in the ICU for novel technologies is really sort of predicated on what the outcome is, right? If we were looking to sort of have an effect that was debatable in terms of its clinical relevance, I think it would be a much harder battle, particularly if the therapy is an expensive therapy, which this one is. When it's survival, particularly if it's sustained survival out past 90 days, that's the kind of thing that is very hard, I think, for hospitals to sort of ignore. I would expect, there have been different estimates of uptake of this and how quickly it would be, and I think the conservative estimates are pretty conservative. I would view this as being a product that will become the sort of de facto standard of care. Apart from the question that was asked earlier about are there some patients that this would not be appropriate for because they have metastatic stage four cancer or something like that. Apart from that group of people, this really is the only available therapy for people with this subset of this particularly malignant subset of septic shock. Given the fact that there's no competing technology out there, and really none that's on the immediate horizon, it's really hard to see how hospitals could see their way around not adopting this particular therapy. I would expect that although it may take a little bit of time to get it into all these hospitals, I would expect that this would become the de facto standard of care. Great. Thank you very much. Thank you. There are no further questions at this time. I'd like to hand the floor back over to Ali Mahdavi for any closing comments. On behalf of the Spectral team, I'd like to thank everyone for participating on today's call. Beyond that, as Chris pointed out, we'd like to thank all of our shareholders who were not able to join us today. It certainly took some time to get to where we are today, and we look forward to sharing developments in the future as outlined by Chris and John and the timetable. With that, we will bring this call to a close and look forward to speaking with you all again. Operator. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.