Hello, welcome to the annual general meeting of shareholders of Spectral Medical Inc. Please note that today's meeting is being recorded. If you participate in today's meeting and disclose personal information, you will be deemed to consent to the recording, transfer, and use of same. If you disclose personal information of another person in today's meeting, you will be deemed to represent and warrant to Computershare and the company that you first obtained all required consents for the disclosure, recording, transfer, and use of such personal information from all the appropriate persons before your disclosure. Following the completion of the meeting, we'll have a question- and- answer session. If you are joining via the live audio webcast online, please follow the audio Q&A instructions on your screen to dial in and access the Q&A phone line. Once you are on the Q&A phone line, to ask a question during the session, you will need to press star one on your telephone. You will then hear an automated message advising your hand is raised. Please mute your computer audio while waiting to ask a question. For those attending the meeting today in person, please raise your hand to ask a question. It is now my pleasure to turn today's meeting over to Paul Walker. Dr. Walker, the floor is yours. Thank you very much. Ladies and gentlemen, welcome to the annual meeting of the shareholders of Spectral Medical Inc. My name is Paul Walker, as the Chairman of the Corporation, I will act as Chair of today's meeting. I extend to all of you a warm welcome. On behalf of the board, I wish to express thanks to those shareholders who have submitted their proxies in advance of today's meeting. As this meeting is being held both in person and via live audio webcast, we think it's necessary to set out a few rules for the orderly conduct of the meeting. If you have joined the meeting by way of live audio webcast, questions in respect of a motion can be submitted by a registered shareholder or duly appointed proxy holder by following the audio Q&A instructions on your screen to dial and access the Q&A phone line. Once you're on the Q&A phone line, to ask a question during the session, you will need to press star one on your telephone. Please mute your computer audio while waiting to ask a question. For those of us here in person, please raise your hand to ask a question. When asking a question, please indicate your name and which entity you represent, and if any, and confirm that you're a registered shareholder or duly appointed proxy. Questions will only be addressed during the question period at the end of the meeting, provided the questions regarding procedural matters are directly related to motions before the meeting may be addressed during the meeting. For those attending via live audio webcast, voting was open online at the beginning of the meeting and will remain open throughout the meeting. This will allow you to choose to vote on each resolution now or wait until the conclusion of the discussion of each resolution prior to casting your vote. Only registered shareholders and duly appointed proxy holders of the corporation are permitted to participate in the online voting. Shortly after the final resolution is proposed and voted on, we will close the online voting. For those attending in person, voting will be conducted by ballot. If you did not sign your ballot at registration with the scrutineer, please raise your hand at the conclusion of the meeting and your ballot will be collected by the scrutineer. We will now proceed with the formal portion of today's meeting. To expedite the formal portion, I will move all motions. Following the formal meeting, Mr. Seto, the CEO of the corporation, will give a small presentation. I now call to order the annual meeting of the corporation's shareholders. With the consent of the meeting, I will appoint Chris Seto, the corporation's Chief Executive Officer, to act as secretary. For the purposes of this meeting, I appoint Computershare Trust Company of Canada through its representatives as scrutineers to compute the votes of any ballots taken at this meeting and to report thereupon to the chairman of the meeting. The scrutineers have advised that the requisite quorum of shareholders are present. A copy of the final report on attendance will be filed with the records of the meeting. Purposes of today's meeting are set out in the management information circular of the company dated April 19th, 2004. Notice of this meeting, the circular, and the form of proxy were mailed to shareholders on or around May 17th, 2024. The annual audited financial statements of the company for the fiscal year ended December 31st, 2023, and related MD&A were previously mailed to shareholders of the company who requested it and are additionally available on the company's profile on SEDAR+ and on the company's website. Our transfer agent appointee has attested to the proper mailing of notice of this meeting. The proof of service of mailing provided by the company's transfer agent has been provided to me. I direct that a copy of this notice of the meeting as well as the affidavit of mailing of the notice of this meeting and accompanying documents to be annexed to the minutes of this meeting. Unless there is an objection, I will dispense with the reading of the notice of the meeting. Copies of the circular and other meeting materials are available under the company's profile on SEDAR website. For the purposes of the meeting today, if attending and live audio webcast. Voting on all matters will be conducted online through the virtual interface. If attending in person, voting on all matters will be conducted by ballot that was provided to you when you arrived today. For those of you attending via live audio webcast, you may choose to register your votes online now, or you may wait until the conclusion of the discussion of each resolution prior to casting your votes online. As noted earlier, shortly after the resolution is proposed and voted on, we will close the online voting. For those of you attending in person, vote by marking X on the appropriate box of the appropriate ballot. Please print your name clearly on the ballot and sign it before returning it to the scrutineer. At the conclusion of the meeting, please raise your hand and your ballot will be collected by the scrutineer. The scrutineer will compile the votes in respect of each business item, and the corporation will release the final results via press release later today. As noted earlier, to further expedite the formal part of the meeting, I will move all motions in accordance with the bylaws of the corporation. No such motion needs to be seconded. I now declare that this meeting is regularly called and properly constituted for the transaction of business. We now move to the formal part of today's agenda. First item of business is the presentation of the corporate's consolidated financial statements for the final financial year ended December 31, 2023, and the auditor's report thereon. Copies of such documents have been mailed to the shareholders who requested such statements. Unless there is objection, I will dispense with the reading of the auditor's report. I will entertain questions with respect to the financial statements of the corporation in the general question period. We now move to the next point on today's agenda. Next matter to be acted upon is the election of seven individuals to the board of directors. As per the management information circular, Jan D'Alvise, Jun Hayakawa, David Feigal, Chris Seto, William Stevens, Paul Walker, and Cristiano Franzi have been nominated as directors for the ensuing year or until their successors are elected or appointed. Each of the persons nominated has confirmed that he or she is prepared to serve as a director. Each of them qualifies as a director under the provisions of the Business Corporations Act of Ontario. The motion to elect seven nominees is now on the floor. The act requires that the board of directors be elected. Proxies have been solicited for each of the seven proposed qualified persons listed in the management circular. The form of proxy for voting on the election of directors sets out each proposed nominee separately and allows shareholders to vote for each director individually. Is there any discussion or questions on this motion? As a reminder, if joined via live audio webcast, to ask a question, you will need to press star one on your telephone. Can the operator please confirm whether there is any discussion or questions? We have not received any discussion or questions. As mentioned at the beginning of this meeting, voting today is being conducted both online and in person by ballot. If you have not already done so, please vote on this resolution using the virtual interface or by marking X on the appropriate box of the appropriate ballot. I will now move to the next item of business. Next item of business is the reappointment of PricewaterhouseCoopers LLP, chartered professional accountants of the auditors of the corporation, to hold office until the earlier of the next annual meeting or their successors are appointed to authorize the directors of the corporation to fix the remuneration of the auditors. I move and second that PricewaterhouseCoopers LLP be appointed auditors of the corporation to hold office until the earlier of the next annual meeting of the shareholders or their successors are appointed, and that the board of directors be authorized to fix their remuneration. This motion is now on the floor. Is there any discussion or questions on the motion? Can the operator please confirm whether there are any discussion or questions on the motion? We have not received any discussion or questions. If you have not already done so, please vote on this resolution using the virtual interface by marking X on the appropriate box of the appropriate ballot. I will now move to the next item of business. As previously mentioned, voting today will be conducted both online and via the virtual interface and in person by ballot. Now that we have proposed and discussed all the resolutions to be put to shareholders, we will now be closing the online voting momentarily, and the scrutineer will be collecting the ballots. Is there any further discussion or questions related to the matter? Can the operator please confirm if there's any further discussion or questions? We have not received any discussion or questions. Okay. We will reconvene in a few minutes once the voting has been closed. Will you repeat the same thing so many times? Good. Pardon? Okay, good. Voting is now closed. Thank you for waiting. The scrutineer will prepare the scrutineer's report following the completion of the meeting, and we will announce the results of the meeting in a press release in accordance with policies TSX have filed a press release on SEDAR. Is there any other formal business to be properly brought before this meeting? Can the operator please confirm whether there are any questions? We have not received any questions. Thank you. If there's no further business to be brought before this meeting, I move and second that the formal portion of today's meeting be concluded. As the formal business of the meeting of shareholders of the corporation now is completed, just before I turn this over to Chris Seto to proceed with his presentations, I want to take this opportunity to thank Mr. Tony Bihl, who has retired after 16 long, hard years working for Spectral, 14 of which he was Chairman. Tony has led us through some good times, a lot of hard times. He showed great leadership, great integrity, he's made this company a better entity than it was. We appreciate very much his contributions. We did recognize that last night. I also welcome Cristiano Franzi as our new board member. Cristiano brings a great deal of expertise in the area that Spectral is moving into. We look forward to his contributions. Thank you. Thank you, Chris. Great. I think, just use this one. Yeah. Thanks, Paul. Thank you. Good morning, everyone. Today, we have a short presentation in which we'll discuss a few key topics. This includes our immediate focus, the Tigris trial, and driving through to full enrollment. We are also going to discuss what the next phase looks like, including the regulatory path to FDA approval and PMX commercialization in North America. Once again, I cannot underscore enough how well our business is positioned on the regulatory front, on the commercial front, as well as the ability to fund these initiatives. That being said, we entered 2023 with a challenge. That challenge was the slow pace of enrollment. It was about 15 months ago that we communicated key initiatives which we had implemented or were in the process of implementing to boost enrollment. Here in the audience, or many in the audience, may have just seen words on a PowerPoint slide at that point in time. The proof of the pudding is the eating. As we sit here today, I can say those initiatives quite simply worked. Those initiatives are why we're in a position where we're staring down the end of the enrollment phase of Tigris. It's why we hit our 90-patient enrollment milestone this past February. It's why Baxter continues to allocate resources to the PMX partnership. It's why we've been able to fund this business on very company-friendly terms. While there is a final push to full enrollment, there is also significant planning and preparation for the regulatory submission phase and ultimately commercialization of PMX. Let's begin. Turning to slide four, which speaks to the challenges that we faced entering 2023, and also speaks to the enrollment initiatives that we took to remove or mitigate the challenges. As you all know, the key challenge was a slower than anticipated enrollment rate. Some of the underlying issues around the enrollment rate were clinical site staffing and workflow issues in the clinical research enterprise facing long recovery as a result of the pandemic. Tigris is a complex trial to execute at clinical sites, and less difficult trials would recover first. Another of the key challenges was public trust and awareness of investigational devices and therapies. This has been an impediment on the informed consent side. To be clear, the above underlying issues still exist, although not to the same extent as we faced during the pandemic and exiting the pandemic. As you recall, we communicated a number of specific steps that we were taking to enhance Tigris enrollment. The first was getting more shots on net, and that was to increase the number of trial sites. The remainder of our initiatives were focused on site productivity. We were in the process of transitioning to a new CRO, Beaufort. Beaufort brings a highly regarded and experienced team assigned to Tigris. We increased our trial resources internally, which were fully dedicated to Tigris throughout 2023 on the back of spinning off Dialco. We hosted a very successful investigator meeting in mid-May, with incredible attendance from all our sites and stakeholders. This was the first in-person investigator meeting since late 2019, and there was tremendous energy and enthusiasm to be part of Tigris and motivation to get Tigris done. Lastly, we embarked on a meaningful public investigator education campaign through Project MESA and the production of a human interest and medical info video through The Balancing Act. While these initiatives in aggregate were a success, we continue to focus on site productivity initiatives and the drive to full enrollment as expeditiously as possible. Turning to slide five, this is a snapshot of where we are today. As of today, we are at 108 patients randomized, which is 72% of the way through Tigris. versus 61 patients or 41% enrolled exactly one year ago today. In terms of number of sites open for enrollment, we have 23 sites versus 16 sites a year ago. While we are approved for up to 25 sites, that was our target that we communicated last year, we believe that the complement of 23 sites is likely to be the peak number of sites. We're happy with the lineup that we have, and we have a number of recently onboarded sites that are in startup phase, and we believe will contribute meaningfully to future enrollments. Turning to slide six. We mentioned that we have seen significant positive impact from these initiatives. Over the last 12 months, we've experienced a surge in enrollment. To put some of these enrollment metrics into perspective, we enrolled 47 patients since our AGM last year. We've enrolled 55 patients since our April 6th communication of our enrollment initiatives. So far in 2024, year to date, we've enrolled 27 patients, with record enrollment months to start the year in January, February, and then another record month in April. Once again, we expect the 2024 onboarded sites to have a further positive impact. Turning to slide seven. What have been the drivers of this or the cause and effect? It is a recipe of drivers, a combination of new sites, increased resources, increased site presence, continuous training, and critical reviews. These all lead to more shots on goal, increased motivation, going the extra mile to find patients, and increased site productivity, which all leads to enrollment. I am going to turn it over to John Kellum to go a bit deeper into some of these causes, as it is hard to appreciate just words on a page versus some compelling examples. John? Thank you, Chris. Maybe I'll let people digest this slide, and then we can turn to slide seven. Having a little difficulty following with the slides lagging. When you see slide seven, it will have a variety of drivers. I think it's really difficult to put into words just how significant these drivers are because they interact with each other. Still waiting for slide seven. I just can't emphasize enough that it's more than just There we go. It's more than just having additional sites, which are additional opportunities to enroll. Those additional sites that have come on have spurned the existing sites to perform better and to increase enrollment across the entire set of sites that we have. New training that goes on at these new sites helps reinforce existing site training and education. As there's turnover at sites, over the course of the trial, all of that learning is very effective and continues to make the trial participants, the clinical researchers, more competent. It's more than just competence alone. It's also enthusiasm. I think by now, most of our sites have actually experienced firsthand that the therapy works, and they're eager to provide that therapy to their patients. This enthusiasm will also be a major driver of adoption. If we can turn to the next slide, sometime today. This reminds me of the days of paper slides when you couldn't get the carousel to advance, and sometimes you had to do a little song and dance up on the podium. What you will see eventually is a slide that shows our revised timeline, and that timeline is sort of based on two scenarios. What I consider to be sort of a worst-case scenario, where we essentially take our 2023 enrollment, which wasn't bad. It was about 0.19 patients per site per month. Our current enrollment, which is actually 0.29 per patient per month, as a best-case scenario. We project both of those enrollment rates, worst case, best case, on our current site profile, which is 23 sites. We effectively show that we could be finished with this trial as early as November or as late as February. It's a safe bet we'll be somewhere in between, which again is where we're sort of projecting the trial to finish sometime in January or December of this year or January of next year. Tigris should be in complete enrollment somewhere around the end of this calendar year. Next slide speaks to the post-enrollment timeline. If you imagine that T zero is the last patient enrolled, we have 28 days before that last patient reaches the 28-day mark. That's the point at which the CRO begins to lock the database in preparation for analysis. That whole process takes us to about day 75. The analysis will take us another 45 days or so we're out at about 120 days post last patient enrolled. The FDA submission will occur promptly thereafter, usually about 60 days after analysis is complete. In addition to preparing the FDA submission, we will also be submitting a manuscript. Preparation and submission of that manuscript will occur in that period of time, with the expectation, based on usual timing, that paper will be published around 240 days after the last patient is enrolled. The FDA regulatory review will take a little bit longer and will push us out to final FDA approval, estimated to be around 450 days or 15 months after the last patient is enrolled, with commercial launch immediately on the heels of FDA approval. Is that rapid? Is that a aggressive timeline? A little bit, but it reflects the fact that we believe the trial is well-positioned. We believe that our relationship with the FDA is well-positioned, including our Breakthrough Device designation. Therefore, this timeline is realistic. With that, if we're caught up on the slides, I'll turn it over to you. Great. Thanks, John. Turning to the next slide, when it does turn. We discussed our partnership with Baxter or Vantive and their commitment to the commercialization of PMX. In February, we hit a major milestone when we hit our 90 patient enrollment mark. As per our distribution agreement, Baxter had the option to retain its exclusive distribution rights by paying Spectral milestone payment within 60 days of notification. If Baxter declined its option, it would be appointed a non-exclusive distributor of PMX. What's the importance here? First, the signal to the market is very positive. Our takeaway is, and this is our interpretation, that Baxter has confidence in the outcome of Tigris. They believe in the PMX product, and they continue to make significant commitments to our partnership. In exercising its option, the potential for future milestone payments on FDA approval is maintained, along with distribution economics such as minimum quantities and pricing thresholds. On a non-exclusive basis, these commitments would have fallen away. On the quantum of the milestone payment, at first glance, the CAD 2 million milestone payment may not look like a significant investment by Baxter. However, there are a couple of things to point out. First, the CAD 2 million represented the remainder of a milestone payment. When we were looking for funding back in 2022, Baxter pulled forward a portion of the milestone payment to participate and act as lead investor in our funding round on company-friendly terms. Second, it's important not to lose sight of the relationship in totality since we entered into this partnership. From a financial support side, Baxter has committed roughly CAD 15 million to Spectral, comprised of CAD 9 million in non-dilutive payments and CAD 6 million in convertible notes. From a commercialization perspective, Baxter continues to allocate significant resources to our partnership. By our estimates, Baxter has allocated well over 20 individuals from various disciplines, from clinical, regulatory, sales and marketing, reimbursement, procurement, et cetera. This number seems to continue to grow every quarter. Additionally, Baxter has put financial and clinical resources behind our collaboration on the PrisMax sub-study to get FDA clearance for their PrisMax device, for HP mode, which allows for a smoother commercialization uptake in the end. Finally, on the Baxter front, we amended the initial term to 10 years post FDA approval. When we executed the original agreement back in February 2020, the initial term was 10 years, ending December 2029. We also thought that the Tigris trial would be fully enrolled in 15 months, so around mid-2022. As you well know, the actual timeline to fully enroll Tigris has significantly differed from our initial assumptions. As such, both Spectral and Baxter mutually agreed to extend the initial term to 10 years post FDA approval, which brings the initial term of the agreement back in line with the initial intent. Once again, how does this benefit Spectral? Once again, I'll reiterate that Baxter is probably the best partner for Spectral. At the end of the day, Baxter has approximately 50% market share of the installed critical care devices that run PMX in ICUs across the U.S. Additionally, they already have the sales infrastructure in place. They have proven to be both a collaborative and supportive partner. As mentioned previously, they have provided financial support as well as bringing to bear their commercialization machinery. The amendment to the term means that Spectral has secured a long-term partner and sets the company up to benefit from a long-term agreement. An agreement that also motivates Baxter to continue to invest and allocate resources to the PMX partnership. Simply put, from a financial perspective, 10 years of cash flow are worth significantly more than five years of cash flow. Turning to the next slide. No. We already got there. We've shown this many times before, once again, this points to the robust financial returns and shareholder value potential for our platform. We are operating in an untapped CAD 2 billion+ annual market with no competitors. We're well positioned to unlock significant shareholder value. Once again, Baxter is the best commercial partner for Spectral. We said it day one, and we continue to say it today. They've shown themselves to be committed and collaborative and continue to allocate invest commercialization resources, once again, for marketing, regulatory, clinical, and reimbursement. Once again, their 50% market share of installed critical care devices. From a Spectral net economic benefit perspective, our platform has incredible shareholder value potential. In the table, we continue to show market penetration rates and what this could mean to Spectral from an EBITDA perspective. You can see it's robust. We're from tens of millions to hundreds of millions USD. If I look at how this might translate into share price potential, I'll just lay down some illustrative math. Comparable medical device companies trade at EBITDA multiples of, call it, 10x - 15x. For the purposes of our math, I'll use 10 x to be conservative. I'll multiply that across the various net EBITDA scenarios and then divide by, call it, 350 million shares outstanding by the time we're all said and done and taking into account note conversion and potential future financings. That results in some pretty attractive share prices. For shareholders that invest today or invested yesterday or invested longer than that, the potential shareholder returns could be spectacular. Let's turn to the next slide. I think there's an issue with the slides. Well, we'll just continue. The next slide, this is just a couple of comparable commercialization case studies. The first is what's called ECMO therapy. It's inexpensive and complicated to implement, and John, if you want to chime in here at any point. The therapy has been around for over 50 years. As you can see or will see when the slides are eventually up, clinical adoption of this expensive therapy continues to grow in the U.S. On the right-hand side, once again, we've discussed this before, Eli Lilly's Xigris drug, which is no longer on the market. This therapy addressing severe sepsis launched hot with approximately CAD 100 million in sales in year one of its FDA approval. The point being is that there is precedent for strong market penetration of similar ICU therapies at the end of the day. Turning the slide, or the next slide, once again, when it gets there. The next slide. We'll talk about our liquidity profile and just a snapshot of that. We just closed an CAD 8.5 million bought deal convertible note financing on, once again, what I consider very favorable terms to the company. It was 9% cash coupon, no warrant coverage, 20% conversion premium with a four-year maturity. Deals in the equity markets for development stage companies are getting done at significant discounts and at minimum full warrant coverage. We continue to search for the lowest cost of capital and with patient capital. Additionally, we've seen some recent warrant and stock option exercises for approximately CAD 900,000 in net proceeds. Combined with our recent raise, we are in a funded position to see this trial through to last patient enrollment and then some. Turning to the next slide, once again, when we get there. This is simply a chart showing Spectral's relative share price performance over the last 12 months. As you will see, Spectral's traded well above its peers, who are down anywhere from 30%-85%. We, once again, continue to well outperform the broader indices. For good measure, although not shown on this chart, I could throw in Outset Medical, which is down 85% during the same period. Certainly, we have benefited from a strong cadence of enrollment. This is also attributable to constant marketing and exposure of our story to new pockets of capital. On slide 15, we've laid out Spectral's upcoming catalysts. Once again, Tigris enrollment and driving to full enrollment. Post-enrollment, the release of top-line results, and then on to FDA submission, FDA approval, and the commencement of PMX commercialization. Before we get to the Q&A session, I would just like to wrap up the presentation portion with some concluding remarks. The initiatives in 2023, and frankly prior to 2023, have positioned Spectral for the final push to enrollment of Tigris. We've built a strong foundation for success. We have de-risked the regulatory side with the design of the Tigris trial. We have de-risked commercialization with our Baxter partnership. We're planning and preparing for the next phase, regulatory submission and commercialization launch. Most importantly, we are positioned to unlock significant shareholder value. PMX economics are robust, with an estimated CAD 2 billion+ market and targeting the most malignant form of septic shock with no other therapeutic solution. At this point in time, we can open up the call for your questions. It's down here. Read that section. I can read it. First of all, I ask all attendees who'd like to ask a question of management to dial in or raise your hand to do so. We'll answer as many questions as time permits. When asking a question, please state your name, the entity you represent, if any, and confirm you are a registered shareholder or a duly appointed proxyholder. Please limit your questions to topics relating to today's subject matter and keep your questions short and to the point. We'll now give attendees a moment to dial in their questions. As a reminder, if joining via the live audio webcast, to ask a question, you will need to press star one on your telephone. Good morning. Scott McDougal, shareholder, private investor. My first question is with regards to speed of adoption post FDA approval, and centers around the idea. Is it a legal matter for doctors and insurance companies? What are the impediments to? To adoption, other than the fact that certain hospitals may not be aware of the or properly trained and that sort of thing. If this becomes a standard of care treatment, are doctors compelled, even from a legal perspective, to adopt the new, say, PMX therapy, again, should it become FDA approved? That relates to the speed of adoption, which I'm trying to, as a shareholder, trying to get a handle on. I'll just start, I've got two doctors up here on the panel with me who have worked in the ICU, so they can talk about how would they look at adoption, especially for something with a mortality signal that we're looking at, frankly, confirming at the end of the day. John? I think that's right. This is a unique situation because we're talking about a therapy that will not get FDA approved unless there's a significant benefit to mortality. We haven't been very clear, I think, with the market about the long-term benefits. If you go back to the prior trial, patients who survived this therapy don't just die at day 29. There's going to be some compelling rationale for physicians to provide this. In terms of a legal matter, it's really torn, right? It's doctors feeling like not only do they want to use this for the patients because they want the patients to survive, hospitals and doctors will feel like they could get sued if they fail to provide that, and that's real. In terms of hospital adoption, I think generally we look at other life-saving therapies that have come around. ECMO was on the slide that you didn't probably get a chance to really study. ECMO had very low rates of utilization for years, usually just young lung transplants. There were studies done toward the end of 2008, 2009, that began to demonstrate that it could be utilized to save the lives of patients who had acute respiratory failure. This was pre-pandemic and led to why the use in the pandemic was so robust. There's a steep increase, not only in sites that had the capacity to provide ECMO were providing it, but new centers were starting to offer the therapy. I think we'll probably see that kind of adoption with this technology. Not every center has the capacity to even provide acute dialysis. If you don't provide acute dialysis, you probably aren't going to be able to provide this therapy, but you'll have to figure out a way to transfer the patient to a place that provides it. You really don't have a scenario where hospitals would say, "Oh, we don't want to spend the money on this because there's an existing alternative that's less expensive." That's really where the major driver is going to come from, is that there's no alternative. Okay, next question is from me. My name is Kevin Veenstra, an Individual Investor. You mentioned about how the PrisMax system's installed in about 50% of the hospitals. My question is, for those hospitals without the system, what system would they use, and would this be an impediment to the adoption of PMX? Yeah, I can take that one. Traditionally, if you go back many years, the first sort of blood purification that's sort of non-dialysis was for drug overdoses, right? Before we had drugs to treat digitalis toxicity, we would dialyze those patients. We would use charcoal, and we use various other things to remove those toxins from the bloodstream. Those cartridges, although never FDA approved for this indication, were utilized on existing dialysis equipment, and about half of our sites are using PMX on existing dialysis equipment. When the product is approved, it will not be approved as a companion device, which means that it's not approved to run on a specific platform. Although a little bit more complicated to run it on a dialysis machine as opposed to a Baxter PrisMax machine, that is a very reasonable, very easy way to apply this therapy. My guess is, although adoption may be slightly faster with sites that already have the PrisMax device, if you've got just a Fresenius dialysis machine, you can do this. We have protocols that we're utilizing in the trial. You could use this therapy. It should not be a significant impediment. Okay. Next question I had was around this golden hour of sepsis. There's tons of papers that are written on this. I'm just wondering, how has your personal kind of understanding or opinion about this golden hour evolved maybe over the last few years? Okay. Well, that's complicated. I could give you an entire lecture on that. The reality is that sepsis occurs because there's an infection. The tipping point between when infection. We saw the same thing with COVID. Many of you in this room, maybe everyone in this room, has had COVID. You survived. Most of you didn't get all that sick, but you know full well there were some people who developed essentially viral sepsis from COVID. When you have an infection, there is a point at which this becomes not just a contained infection in the lung, but it develops a systemic effect. At that point, that's when people start to talk about golden hours, and they start talking about, well, you've got to move quickly. Most of the interventions are by getting you on antibiotics. Most of the interventions are about getting you in an ICU where we can provide supportive care. This particular intervention really involves removing a toxin, which is otherwise not treated by antibiotics or supportive care. We don't have a lot more time to get this underway, which is good that our diagnostic test is very rapid. This test can be used while the patient is still in the emergency department, while the doctors are prescribing the antibiotics, while the transfer orders to the ICU for supportive care are occurring. I think it's not really a question of you're going to wait until the patient has everything else done and then start this therapy. I think this therapy can be built into protocols for managing sepsis. This particular kind of sepsis requires a specific treatment which can be overlay on top of the existing treatment that patients with sepsis are getting today. Okay, basically, you're not seeing getting it done faster is not really an impediment in terms of we need to reduce the amount of time between when they're, let's say, getting antibiotics and getting the PMX. Well. We're really missing out if we're delaying it by an extra hour. No. I do think that's why I think that the fact that we're guided by a diagnostic and not guided by some hard-to-train clinical judgment. Imagine if we didn't have a diagnostic, then you'd be saying, "Oh, okay, well, I've got the antibiotics on board. I've sent the patient to the ICU, and it looks like the patient's still deteriorating." Then the question is, well, are they getting bad? Do we suspect there might be endotoxin floating around their blood? That could take hours to days before there's enough sort of clinical judgment that this is a patient who should be treated with this therapy. The fact that we have a rapid diagnostic to say immediately the patient does or doesn't have the target in their bloodstream, I think will address that issue. I do agree with you, Kevin. I think that waiting three or four days for someone to get this therapy is not going to do them any good, and we will have patients that simply won't respond at that point or be dead already. Rapid is important. We have a diagnostic. This dovetails very nicely, I think, with a lot of sepsis protocols that sites were already using. Our investigator meeting in San Diego, the last one that we had, we had a speaker who actually talked about integrating the diagnostic and the protocol for delivering the therapy with the existing sepsis protocols at her hospital. I think all of that will happen. It'll happen better at some hospitals than it does at others, but I think you're right. Rapid is important, and I think we're poised to do that. Just one more question from me. Is there a lot of crosstalk now between the different sites? I know that you had a couple investigator meetings, and I would imagine there's a lot of knowledge rather than just getting it from you directly, is that as they experience the use of PMX with their patients, are they talking to each other? I'm just curious. Yeah. In addition to the public events that we have that you're referring to, we have regular investigator calls where we do have coaching that goes on. Existing sites that have been in this for a while can help drive enrollment at new sites. There's also a bit of competitiveness, right? Everybody wants to be top gun in terms of enrolling patients, and a lot of that is interaction between the PIs. No, there's a fair amount of interaction. I'll let other people ask a question. Hi there. Scott McAuley from Paradigm Capital. Two quick ones from me. One on the number of trial sites. You're at 23, you approved up to 25. Is there a goal to reach that 25, or do you feel like the sites you have right now are effective and doing what you need to do to hit the recruitment that you want? Secondly, if you could talk a bit about trends on screening rates and/or that conversion rate of screening to enrollment because I know that's been something of a challenge with how challenging the trial is. With the training and all the other things you've been doing, how that conversion has been improving over time. I'll start on the trial sites. 23 is where we think we max out. By the time we bring on and source other new sites, we're so deep into this trial at this point that, one, the interest to join a trial on the tail end may not be there. Two, their effectiveness or whether they're unknown sites could bring risk ultimately to the trial. We're happy with the setup. Certainly, there are sites that are outperforming others. Where we've gotten to today has frankly been on the back of our existing sites. With these new sites that we brought on, and we brought on a considerable number of sites in the new year, we have, I wouldn't say yet to see them contribute, but they're still firing up, and there's a little bit of a lead in before. There are anomalies, like a couple of them where after opening up, there was an enrollment day four, right? There was another site, their first enrollment was day 35. For the most part, it's a four-month or so lead in. Once again, we like the setup, and we like the contribution of the sites that we have today. I can address the screening issue. It largely relates to the fact that in this precision medicine paradigm, we are very much focused on the right patients, right? The patients who not only have sepsis, they also have to have a significant risk. This is for the trial, like application, and people miss this point a lot, including some of our colleagues out there. You design a clinical trial because you have an endpoint that the FDA will accept. The endpoint that the FDA accepts is 28-day mortality. There is no point in enrolling patients in this trial who are either very unlikely to die or so likely to die that you just can't see an effect. We designed this trial based on the fact that we know that patients with a significant amount of organ failure and an EAA between 0.6 and 0.9 is the right population. That's selecting a very specific population for the trial. That's not to say that a patient with a little bit less organ failure couldn't still benefit, and we have data from EUPHRATES demonstrating that you have less shock, you have less use of dialysis, you have shorter time on mechanical ventilation. We have data from Europe and from Japan that support that. That's clinical application in the real world. For the trial, we have to be very, very precise. It's difficult, right? You've got to not only identify a patient with sepsis, you've got to identify the patient with sepsis and organ failure, and then you have to run an EAA, for which you have to get consent for. You've got to find the family, get consent. The EAA has to come back within range. Now it's got to be Monday through Friday before 5:00 P.M., or you're not going to get this patient on the treatment at most sites. We've had some sites that are actually able to do this 24/7, but it's unusual because it's a research application. These guys don't work 24/7. All of that, Scott, is, I think, why the source population of septic shock is much, much larger than the group that we enroll in the clinical trial. Our estimates continue to be that we're looking at about 120,000 - 140,000 people per year in the United States alone who meet these criteria, and it doesn't look like that market size has really changed at all based on what we've seen. Maybe just a quick follow-up on that. You said there's the challenges of consent and finding patients within the range, I know one of the issues was the dilators of, I think it's 24 hours, and these trial-specific things that, as you mentioned, don't necessarily impact on the market. As you've seen that enrollment rate go up and the fantastic effects of the past 12 months, has there been specific things, like of those specific issues of the challenges of getting from screening to enrollment that have really improved, that has helped drive the better enrollment that you've seen in January, February, March, April to hit those numbers? What has been the delta that's really changed relative to 12 months ago, 16 months ago? I think when you start a clinical trial, and Paul may have other ideas as well, but I think when you start a clinical trial, particularly in sepsis, where, let's face it, most things have failed. There are sites that sign on because they want to do the research, but they may not be convinced, right? They may not say, "It's Friday afternoon. I got dinner plans tonight. You got this patient, let's pass on this one," right? Early in the trial. I think a lot of our sites have now sort of passed that. Right? That they believe in this therapy. When you believe in the therapy, then you're much more likely to say, "Yeah, I'm really busy today, but I hear there might be a patient for this trial in one of the ICUs. I'm going to go see that patient. I got dinner plans tonight, and I'm going to call my wife or my husband and say, 'I'm not coming home. I'm going to take care of this patient.'" That doesn't happen because we pay them. That doesn't happen from my charisma, okay? That happens because the sites believe in the therapy. I think what you're seeing at this point, more than anything else, is that we have sites that are now committed because the trial is now 70% through, and the majority of the sites have experienced that it works. Of course, if I could infuse that magic sauce into the trial early on, that would be great. That's something that the sites have to learn, and I think that's just where we are. We've added good sites, and I think some of our enrollment is coming from new sites. I think that's the biggest factor. Toby Beam, Private Investor, sorry. Just over a year ago, the company announced that there was positive results from phase II clinical trial that included about 50 critically ill endotoxic septic shock patients, and it spoke to an estimated 50% estimated relative mortality reduction with the use of PMX. I'm just wondering if you can maybe tell us a little bit more about that and the significance? It did go on to talk that this aligns with the patient population in Tigris. Anyway, that seems rather impressive to me, and I'd just like to know if you can tell us a little more. I think what you're referring to is a presentation we gave about a year ago or something like that, in which one of the things we showed was some data from Eastern Europe, I think it was a study from Poland. What those investigators did was an interventional study, was simply measuring EAA and identifying patients with the clinical syndrome, septic shock, with and without a positive EAA. If you have endotoxic septic shock, meaning you have septic shock with positive endotoxin, your mortality is about twice that of patients who have endotoxin negative septic shock, meaning that your EAA is less than 0.6. I think we described at the time that that's sort of the upper bound of what you could anticipate as an effect size, right? If you could take away, if you could convert someone from endotoxic positive septic shock to endotoxic negative septic shock, you could potentially capture that survival benefit. No one in this room would design a clinical trial to try to achieve a 50%. I mean, there hasn't been anything that has a 50% improvement in survival. Antibiotics don't have a 50% improvement in survival. We're much more realistic about aiming for a 25% to 30% relative risk reduction. That's what the population, that's what we call the prior distribution in the data from EUPHRATES, that group of patients with a MODS score greater than nine and an EAA between 0.6 and 0.9, they achieve a 10% relative risk reduction, which translates to about a 25%, 30% relative risk reduction. That's huge and virtually unprecedented. We feel that that's already a pretty big target to aim at. We've announced to the market multiple times that our results are really quite in keeping with that expectation, and we say that today as well. Thank you very much for that. As far as COVID patients, upon an FDA approval, I understand for the trial, we have to keep things very narrow and very focused, and that's clearly the right thing to do. After FDA approval, I assume COVID would be included in a much broader audience. It will. One of my former fellows, who went back to Thailand to run a department in Bangkok, did a study during the first wave of COVID that basically showed that the patients who really get sick and die, many of those patients have endotoxin leaking out of their gut. We don't see that many of those patients anymore. Better therapy for COVID, newer variants, which are less aggressive, quite frankly. We don't see as many patients who have that kind of aggressive viral sepsis we did during the first wave. Most of the people that I take care of who die of COVID these days die because they have significant underlying disease, not because they're getting massive amounts of endotoxin. Those patients do exist, and my guess is what would happen in those scenarios is you basically have a patient as a clinical gestalt of septic shock. You don't know if it's from a bacteria that was super infection on top of the COVID, or it's the COVID itself. You measure an endotoxin. If it's sky-high, you would say, "I'm going to put that patient on the therapy. Great. Thank you. Roger St-Germain, I'm a personal investor through one of my companies, 121 Canada Inc, and my foundation, Roger St-Germain. I just want to ask, in the communiqué, sometimes you put at the end that PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients. That number is all the time the same for a while. I just wonder if there has been an increase or is it stable around the world? Yeah. I can't quote you today the number, but it has continued to climb. Perhaps we need to refresh that number to reflect the current utilization. We only know that information, frankly, because regulatory agencies around the world require certain information to be reported. We don't know, for example, India's a good example. There's a lot of PMX that's used in India that is pretty much under the radar. It's not reported to any regulatory agencies that I'm aware of, and so no one even knows how many therapies are provided there. You might say the same thing for some Eastern European countries. In Italy and Japan and Spain and Korea, where there's a lot of utilization, many of those numbers are known. We know, although I don't know to the extent Chris may be able to comment, we know from the manufacturer, we have some sense of how much of the devices are utilized. Okay. Another question for you, Chris. I just want to know, you have completed the last financing. For the next 12 months, are you looking for one or two more financings? Well, we'll see. We have a number of avenues to get there. Certainly, there are a number of warrants that are outstanding. I think we have about 12 million warrants outstanding. They expire July 2024. They're a CAD 0.50 strike. Certainly we have a push on to get those exercised. Certainly, the share price has to be in a certain zone for people to want to exercise, that could add CAD 6 million to the treasury net. Right? There's also another six million or so warrants that expire November 2025, those certainly are in the money as well. They're a CAD 0.48 strike. Once again, there are some avenues. We do have, and they're represented in the audience today as well, a large family office that has led our financings and subscribed to three of the convertible note offerings. They've been supportive. Certainly, I would think that they would be interested to continue to lead those investments. There is no guarantees, but this business has been performing the way we said it would over the last 12 or 18 months or so. Frankly, there is no reason to doubt why I wouldn't see participation in the future. Okay. We have received a question from William Lawson. Please ask your question now. I believe this question would be for Dr. Kellum. Post 150 enrollment, please reiterate the timeline you stated earlier leading up to FDA approval. Are we really looking into 2026 before potential approval? Yeah. Thank you for that question. The usual time course from completion of enrollment to approval under a PMA is around 18 months to two years. We think it'll be faster because of the Breakthrough Device designation, and also because we have what's called a Modular PMA, which allows you to submit some of the modules ahead of time before the clinical module comes in. Some of those modules were actually approved previously. Now they've expired, so we have to resubmit them. They have to be refreshed in terms of new guidelines and new standards. It's a much, much easier process than starting over again. There's inspection of the manufacturing site in Japan. That happened already. It's unlikely that the FDA will do that again. There's a lot of things that I think will move the process faster, that's why we've essentially estimated a 15-month rather than an 18- to 24-month timeline. This is also pretty much on track with what Baxter, soon to be Vantive, will do in terms of their commercialization rollout. That's basically what we're looking at in terms of the timeline. One more quick question. After approval is given, how exactly do we monetize the award? Sorry, Will, could you repeat that? Monetize, sorry, what? After approval is given, how exactly do we monetize the award? How do we make money? How do we generate a revenue stream which ultimately could lead us to a higher level exchange? Well, first and foremost that's our partnership with Baxter. That's how we make money. We have a distribution partnership with them. Frankly, it's a revenue-sharing agreement at the end of the day. It really is about commercialization execution at that point in time. That starts basically day one on the heels of FDA approval. Okay. Thank you. Hi, Scott McDougal again. More for Chris, I think. You indicated Baxter is the right partner moving forward, of course, Baxter has indicated a desire to spin off in the form of Vantive. They've also publicly announced that there's a possibility that the division would be sold off to private equity. Should that come to pass, the second option, what does that do to the distribution agreement that exists currently with Baxter? Could there be a negative impact as a result of that? Is the anticipation that the private equity group would have an agreement with Baxter, whereby Baxter would distribute PMX? Can you walk us through some of the possibilities and options there? No, thanks, Scott. The full intention is that regardless of whether it's private equity or it's a public spin-off into a publicly traded company, Spectral's agreement is going with Vantive one way or the other. That's whether Vantive gets bought out by private equity. This will not be retained at the, let's call it the Baxter legacy company at the end of the day. You mean private equity firm? Yeah. If private equity buys Vantive, Spectral's going with that private equity firm. Our agreement. Who distributes the product? Vantive. Okay. Yep. One way or the other, we are going with the spin-off entity, Vantive. Private equity would have a right to. Well, if private equity buys Vantive, they buy lock, stock, and barrel, everything. They take possession of our distribution agreement. Signed, in other words. Yeah. Okay. Thank you. Yeah. There's not going to be some separate carve-out for PMX and our agreement, et cetera. This is going with that entity, one way or the other. Yeah, sorry, just for Scott. Maybe a little more color. We've always dealt with the acute therapies business. The Vantive spinoff is three business lines. It's two dialysis business, so the PD, HD, then acute therapies business. We will be retained by the acute therapies business, which is in the Vantive business. This might not apply directly, but I'm just curious if you've considered the use of machine learning or AI with the data to maybe try to better indicate where the PMX may work better. I know many other healthcare companies are using these advanced tools. May not be relevant, but just curious if you've considered it. My view on that is that the place where it really sort of comes in is really helping hospitals to identify patients with sepsis. Definitely as a potential output of this, not only would the artificial intelligence be able to help doctors identify sepsis more rapidly, but it may also identify patients with a higher risk of having endotoxic septic shock, which would allow a more rapid testing and allocation to the therapy. I do want to emphasize, though, that there's a lot of buzz around artificial intelligence, I think sometimes to the extent of downgrading the application of native intelligence. I think we basically have a diagnostic and a therapeutic, and I think where AI's really going to come in is probably on the front end of that, so better application. Also potentially a whole lot of other areas that have been touched on in meetings like this where people ask questions about, well, what about other patients? There are other reasons for endotoxin to leak out of your gut, and maybe some of the AI applications, for example, could expand the market further from where we have today. Are there any hospitals in your pool that are actually using machine learning? AI in medicine is a bit more like sex in the third grade. Everybody's talking about it, but nobody's really doing it. Okay, thanks so much. Thanks for that final comment, John. I think we've had a fruitful discussion and really on behalf of management, I do want to thank both Chris and John for their very detailed presentations today. I think this has provided very good information for our shareholders. Really, on behalf of the management and the board of directors, employees, I really want to thank those who have supported this company for a long time, and particularly for attending the meeting today. Today, the only other point I would say is that one of our board members has been online, Jan D'Alvise, but we have him in person. I just want to be sure everybody recognizes Dr. David Feigal is here. We have Jun Hayakawa, who is our representative from Toray. Like Baxter, Toray has been an incredible support to Spectral and a wonderful partner for many years, and we want to thank Jun. Thank you. Our new member, Cristiano Franzi, who, as you all know from the biography, has a long history with Baxter and Vantive and brings that kind of information to the board. Finally, Will Stevens, who is the long-suffering Chair of our FAC. Bottom line is that we have a very engaged board, and we have a board that brings a great deal of information, knowledge, experience to the benefit of the company. I'd like to thank all our shareholders for their commitment and continued support, and we look forward to seeing you again next year. Thank you. This concludes the meeting. If you are joining via live audio webcast, you may now disconnect.