Spectral Medical Inc. ($EDT)

Hello, and welcome to the Annual General and Special 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, and use of such personal information from all appropriate persons before your disclosure. [Operator Instructions] 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 and Special Meeting of the Shareholders of Spectral Medical, Inc. My name is Paul Walker, and as the Chairman of the corporation, I will act as Chair of today's meeting. I extend to you all, a warm welcome at this meeting. On behalf of the Board, which is present with us today, 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, I think it's necessary to set out a few rules for the orderly conduct of this meeting. If you've 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 the right side of your screen under the QA option to dial in 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 5 on your phone. Please mute your computer audio while waiting to ask questions. For those who are here in person, please raise your hand to ask a question. When asking a question, please indicate your name, which entity you represent, and if any, and confirm that you are a registered shareholder or a duly appointed proxy holder. Questions will only be addressed during the question period at the end of the meeting, provided the questions regarding procedural matters or directly related to the motions before the meeting may be addressed during the meeting. For those attending via live audio webcast, voting was opened online at the beginning of the meeting and will remain open throughout the meeting. This will allow you to choose to vote each resolution now or wait until the conclusion of the discussion on each resolution prior to casting your votes. 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 do not sign your ballot -- if you did not sign your ballot on 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 part of the meeting, I will move all motions. Following the formal meeting, Mr. Christopher Seto, the CEO of the corporation, will give a short presentation. I now call to order the Annual and Special Meeting of the corporation's shareholders. With the consent of the meeting, I appoint Chris Seto, the Corporation's Chief Executive Officer, as Secretary of the meeting. For the purposes of this meeting, I appoint Computershare Trust Company of Canada through its representatives as scrutineers to compute the shares of any ballots taken at this meeting and to report thereon to the chairperson of the meeting. 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 27, 2026. Notice calling this meeting, the circular and the form of proxy were mailed to shareholders on or around May 15, 2026. The annual audited financial statements of the company for the fiscal year ended December 31, 2025, and related MD&A were previously mailed to shareholders of the company who requested it and are additionally available at the company's profile on SEDAR and on the company's website. Our transfer agent appointee has attested to the proper mailing of the notice of this meeting. Proof of service of mailing provided by the company's transfer agent has been provided to me. I direct that a copy of the notice of the meeting as well as the affidavit of mailing of the notice of this meeting and accompanying documents be annexed to the minutes of this meeting. Unless there is any objection, I will dispense with the readings of the notice of the meeting. Copies of the circular and other meeting materials is available on the company's profile on SEDAR and the website. For the purposes of the meeting today, if attending via 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 conclusion of discussion on each resolution prior to casting your votes online. As noted earlier, shortly after the final resolution is proposed and voted on, we will close the online voting. For those of you attending in person, voting by marking X on the appropriate box of the appropriate ballot. Please print your name clearly on the ballot and sign it before returning 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 then compile the votes in respect of each business item, and the corporation released the final results via press release later today. I noted earlier, to further expedite the formal part of the meeting, I will move all motions. I now declare this meeting is regularly called, 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 corporation's consolidated financial statements for the financial year ended December 31, 2025, and the auditor's report thereon. Copies of such documents have been mailed to the shareholders who requested such statements. Unless there is an objection, I will dispense with the reading of the auditor's report. I will entertain questions with respect to the financial statements in the general question period. We will now move to the next point on today's agenda. Next matter to be acted upon is the election of 7 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 these 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. Motion to elect 7 nominees is now on the floor. The act requires that the Board of Directors be elected. Proxies have been solicited for each of the 7 proposed qualified persons listed in the management information circular. [ Formal ] proxy for voting on the election of directors sets out each proposed nominee separately and allows shareholders to vote for each individual director. Are there any discussions or questions on this motion?

[Operator Instructions]

Can the operator please confirm where there are any discussion or questions on the motion?

We have not received any discussion or questions on the motion.

Thank you. As mentioned at the beginning of the 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 now will move to the next item of business. Next item of business is the reappointment of MNP LLP, Chartered Professional Accountants, as auditors of the corporation to hold office until the earlier of the next annual meeting of the shareholders or their successors are appointed and to authorize the directors of the corporation to fix the remuneration of these auditors. I move MNP LLP to be appointed auditors of the corporation to hold office until the earlier of the next annual meeting of the shareholders or their successors are reappointed and that the Board of Directors be authorized to fix the remuneration. This motion is now on the floor. Is there any discussions or questions on the motion? Can the operator please confirm whether there is any discussion or questions on the motion?

We have not received any discussion or questions on the motion.

Thank you. If you have not already done so, please vote on this resolution using the virtual interface or by marking X on the appropriate box on the appropriate ballot. I will now move to the next item of business. Next item of business is the ordinary resolution approving the readoption of the corporation's omnibus long-term incentive plan in the text of the long-term incentive plan resolution and full copy of the corporation's long-term incentive plan are set forth on Pages 16 to 17 and Schedule A, respectively, of the management information circular of the corporation. As set out in the management information circular, in order for this resolution to be passed, it must be approved by the affirmative vote of not less than a majority of the votes cast in respect thereof of the shareholders of the corporation present at the meeting or represented by proxy. I move the ordinary resolution approving the readoption of the corporation's omnibus long-term incentive plan be approved. This motion is now on the floor. Is there any discussion or questions on the motion? Can the operator please confirm that there's any discussions or questions on the motion?

We have not received any discussion or questions on the motion.

Thank you. 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 the business is the special resolution authorizing an amendment to the corporation's articles to consolidate the issued and outstanding common shares of the corporation based on a consolidation ratio in the range of 1 post-consolidated shares for 5 pre-consolidation shares to 1 post-consolidated shares for 10 pre-consolidation shares as determined by the Board of Directors of the corporation their the sole discretion. The text of the share consolidation resolution is set forth on Page 19 of the management information circular. As set out in the management information circular, in order for this special resolution to be passed, it must be approved by the [ affirmative ] of not less than 2/3 of the votes cast in respect thereof by the shareholders of the corporation present at the meeting in person or represented by proxy. I move that the special resolution approving the share consolidation be approved. Motion is now on the floor. Is there any discussion or questions on this motion? Can I ask the operator to please confirm whether there's any discussion or questions on the motion?

We have not received any discussion or questions on the motion.

Thank you. If you have not already done so, please vote on this resolution using the virtual interface or by marking X on the appropriate box and the appropriate ballot. I will now move to the next item of business. As previously mentioned, voting today was conducted both online via the virtual interface and in person by ballot. Now that we have proposed and discussed all the resolutions to shareholders, we will be now closing the online voting momentarily, and the scrutineer will be collecting ballots. If there are any further discussions or questions related to the matters of this meeting, now is the chance. Can the operator please confirm whether there are any discussions or questions?

We have not received any discussions or questions.

We will reconvene in a few moments once the voting has been closed. I don't see any voting going on here. Okay. Voting is now closed. Please raise your hand, and your ballot will be collected by the scrutineer. Okay. Thank you for waiting. The scrutineer will prepare the scrutineer's report following the completion of the meeting, and we will announce results of the meeting in a press release in accordance with the policies of the TSX and the press release on SEDAR. Is there any formal -- 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. There is no further business to be brought before this meeting. I will move the formal portion of today's meeting be concluded. As the formal business of the meeting of the shareholders of the corporation has now been completed, I'd like to turn over the floor to Mr. Chris Seto, CEO of the corporation, who will now proceed with his presentation.

Thank you, Paul. Good afternoon, everyone. Thank you for joining us. And many of our long-term shareholders who we've seen year after year today, it's great that you can be with us as well. So when we met last year -- at last year's Annual General Meeting, Spectral had just completed enrollment in the Tigris trial. At that point, we are awaiting top line data pairing our PMA submission and continuing to advance our commercialization plans. 12 months later, we find ourselves in a very different position. For the past year, Spectral has achieved a series of milestones that collectively represent not only one of the most important periods in the company's history, but also in the world of sepsis clinical research. We reported positive Tigris top line results. We demonstrated a robust survival benefit at both 28 and 90 days. We published the study in Lancet Respiratory Medicine, the leading clinical care journal. Tigris data was presented in a headline late-breaking session at [ SCCM ]. We completed 12-month follow-up on every patient enrolled in the study and reported positive long-term -- reported positive long-term outcomes. And most importantly, we submitted our PMA application to the FDA just recently. These accomplishments represent years of work by our clinical investigators, patients and their families, our partners, advisers and employees. More importantly, they represent the culmination of a strategy that has guided Spectral throughout the development of PMX. So for those in the -- there's a little bit of delay on the slides here, but online, everybody can see this. The title of this slide, which will appear shortly for those in the room, is disciplined execution. I believe those two words capture what has defined Spectral over the last several years. One lesson I've learned throughout my career is that creating long-term value is rarely about moving the fastest. It's about making the right decisions, even when those decisions require more time, more effort and more patients. In critical care medicine, shortcuts are rarely rewarded. Moreover, in clinical studies, shortcuts are typically the most direct path to failure. Patients we treat are among the sickest in healthcare. The standards expected by physicians, hospitals and regulators are appropriately high. As a result, our objective has never been to pursue the fastest path. Our objective has been to pursue the path that maximizes the probability of long-term success. It is imperative that Tigris is able to withstand the lens of scrutiny. That meant conducting a rigorous confirmatory clinical trial. It meant collecting long-term follow-up data. It meant publishing our results in a leading peer-reviewed journal. It meant maintaining close engagement with the FDA throughout the development. And it meant preparing for commercialization years before approval was ever granted. There's an old saying, measure twice, cut once. That philosophy has guided our approach. While it sometimes requires patience from shareholders, we believe it has resulted in a stronger evidence package, a stronger regulatory submission and ultimately, a stronger company. This slide highlights how much the company has progressed over the past year. 12 months ago, we completed enrollment in Tigris, and we're preparing the PMA submission. Today, we have positive clinical results, peer-reviewed publication, 12-month follow-up data and completed PMA submission. For many years, Spectral was primarily viewed as a development-stage company. The discussion centered around enrollment, clinical trial execution, financing and regulatory planning. Today, the discussion is increasingly centered around clinical evidence, regulatory review and commercial readiness. That evolution is significant. Each milestone shown on this slide represents an important value inflection point for the company. Collectively, they have transformed Spectral into a company entering the next phase of its development. This slide summarizes what I believe is the most important achievement over the last year. The Tigris trial demonstrated a consistent and sustained survival benefit. At 28 days, the study achieved our prespecified primary endpoint and demonstrated a 95.3% probability of benefit. At 90 days, that probability increased to greater than 99%. Importantly, the treatment effect remained evident through 1 year of follow-up. 12 months mortality was 52.8% in PMX-treated patients compared to 66.7% in patients receiving standard of care alone. This represented an absolute risk reduction of 13.9%. Using Tigris data alone without incorporating prior information from EUPHRATES, the analysis demonstrated a 95.9% probability of benefit. What I find most compelling about these results is not any single endpoint, it is the consistency of the story. We observed benefit at 28 days. We observed greater separation at 90 days. We observed that benefit remained evident through 1 year. In Critical care medicine, that is important. It's not uncommon to observe early treatment effects to diminish over time. What we observed in Tigris was the opposite. Survival difference persisted beyond the acute phase of illness and remained evident long after patients had left the ICU. For Spectral, that is what makes the overall body of evidence particularly compelling. It is also worth noting that the 28- and 90-day results have undergone independent peer review and have been published in Lancet Respiratory Medicine, one of the world's leading journals in critical care medicine. Taken together, we believe Tigris has generated the strongest body of clinical evidence in Spectral's history. With the clinical evidence package complete, the company's focus has shifted to the regulatory review process. Spectral has pursued a modular PMA strategy while maintaining a regular interaction with the FDA. That effort culminated on May 28 with the submission of our PMA application to the FDA. This was an important milestone for the company and represented years of clinical research and preparation. We are currently in the FDA's filing review period, which can take up to 45 days. Assuming a successful filing decision, the application will proceed into substantive review around mid-July. As part of the normal PMA process, we also anticipate inspections of both Spectral and our manufacturing partner, Toray. While regulatory decisions ultimately rests with the FDA, we are pleased with the quality and completeness of the submission package that has been assembled. The submission reflects years of preparation and incorporates comprehensive evidence package we have worked diligently to generate. One thing that investors sometimes underestimate is the amount of work required between regulatory approval and commercial adoption. Obtaining approval is a major milestone. However, successful commercialization requires an entirely different set of capabilities. It requires clinician engagement, scientific education, supply chain readiness, distribution infrastructure, clinical support and launch planning. For the past few years, Vantive has been working with Spectral's involvement to build that foundation. We believe -- we continue to believe Vantive is an ideal commercialization partner. It possesses significant experience in critical care. They have an established presence within intensive care units across North America, and they continue to devote resources and expertise towards preparing the potential launch of PMX. Importantly, commercialization planning did not begin with the PMA submission. We used to count the commercialization planning in months. However, at this time, we can say it has been underway for years. As a result, we believe the company is significantly better positioned today than if commercialization planning had only begun after approval. Ultimately, everything we have discussed today points back to the opportunity in front of us. PMX is targeting -- sorry, PMX is targeting one of the most malignant forms of septic shock. Despite decades of research, treatment options remain limited. We continue to believe the addressable market opportunity is substantial. At the same time, shareholders have seen meaningful appreciation in Spectral's share price over the past year as the company achieved a series of important milestones. While share prices naturally fluctuate over time, we believe the market's recognition reflects the progress that has been made in advancing PMX towards commercialization. Most importantly, we believe the opportunity ahead remains significantly larger than the milestones already achieved. On this slide, we've shown this many times before, but this once again points to the robust financial returns and shareholder value potential for our platform. We are operating in an untapped $2 billion-plus annual market with no competitors. 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. And you can see it's robust, anywhere from tens of millions to hundreds of millions U.S. to Spectral. So for a shareholder that invests today or invested yesterday or even longer than that, the potential total shareholder returns could be spectacular. As we look forward, our priorities are clear: successfully navigating the FDA review process; continue preparing for commercialization; advance additional scientific publications and evidence generation initiatives. In terms of further work on the 12-month survival data, in keeping with our [ basin ] framework, we're analyzing 12 months survival using our informative prior, and we'll also report mortality at 6 and 12 months. Additionally, in the future, we will explore cost effectiveness for PMX using 12-month survival data projections based on [ it ]. As discussed, we are positioning the company for the next phase of growth following potential regulatory approval. The work is not finished, but we believe the foundation that has been built over the past several years positions the company well for what's to come next. Before opening the floor to questions, I would like to leave shareholders with 3 thoughts. First, the past year has provided the strongest body of clinical evidence in Spectral's history. Second, the company has built this program deliberately and thoughtfully with a focus on scientific rigor, regulatory discipline and long-term success. And third, while we are proud of what has been accomplished, we believe the most significant opportunities remain ahead. For many years, Spectral was viewed primarily as a development stage company. Today, we are increasingly becoming a regulatory and commercial stage organization. That transition reflects years of disciplined execution, strategic partnership development and commitment from our employees, investigators and shareholders. While important milestones remain ahead, I believe Spectral today is fundamentally different than it was 1 year ago. We've moved beyond asking whether PMX can generate meaningful clinical outcomes. Our focus is now on advancing through regulatory review, preparing to bring PMX to the patients who need it most. Thank you for your continued support, confidence and patience through this journey. We would now pleased to take -- we would now be pleased to take your questions.

I ask that all attendees who would like to ask a question of management to dial in or raise your hand to do so. We will answer as many questions as time permits. When asking your question, please state your name, the entity you represent, if any, and confirm you are a registered shareholder or a duly appointed proxy holder. Please limit your questions to topics relating to today's subject matter. Keep your questions short and to the point. We'll now give attendees a moment to dial in their questions.

[Operator Instructions] All right. We have received a question from Daniel Murphy. Please ask your question now.

Long-term shareholder. I have a two-pronged question. First of all, in light of the horrible tragic death of NASCAR driver, Kyle Busch, who died within 48 hours, would he have been the sort of individual that Tigris would have been targeted to or might benefit from PMX therapy? That's my first question. And secondly, I don't know if it was an executive order that President Trump signed or if it's legislation. Under right to try, is Spectral [ avail ] under right to trial legislation? And what, if anything, is Vantive doing to ensure that hospitals in the United States are aware of this? And can it be used under right to try?

The Kyle Busch situation.

Well, so thank you for that question. Certainly, Kyle Busch's situation is -- reflects a lot of the very severe cases of sepsis that have been presented over the last few decades. Endotoxin wasn't measured, so we can't say for sure whether he died of endotoxic septic shock, but it may well have been the case. And certainly, the kinds of very high mortality striking young people is kind of a characteristic, if you will, for the type of septic shock that we're focused on. I think that we have such strong -- with regard to your second question, I think we have such strong scientific clinical data that there's no real benefit to thinking about this from a political perspective because the political winds change from year-to-year, administration to administration. I think that we are pursuing the standard canonical appropriate scientific pathway, and I think we'll be successful.

And I think I would just add to that, that Vantive is our [ commercializing ] partner. I'd say, just because an executive order on a right to trial basis have been signed doesn't necessarily mean that, that is the best path for commercialization or the best -- or in the best interest of Spectral either. I think a rollout -- a product rollout like this, while it's very technical, it has to be done right. So just because there's an executive order that was executed doesn't mean that Vantive is necessarily ready to commercialize on just that basis.

Okay. Thank you.

[indiscernible]?

So maybe -- so I'm not a statistician or an FDA staffer, but the way this whole process works, to my understanding, is that we run the analysis in agreement with the plan that we filed with the FDA. The FDA repeats that analysis with their own statistical staff. And as long as we agree with each other, that's really sort of the end of it. The FDA doesn't go out and run exploratory analyses on their own. If they want additional analysis, they'll ask us for that. But the -- to give you some idea, Kevin, it's a 13,000 page document that has been submitted to the FDA. So it's hard to imagine that there's additional statistical analysis that they haven't already asked for. So I don't actually anticipate anything -- what we might anticipate is where there are questions around have we considered this variable or that variable? Could we rerun this analysis? Oh, I see that you did the cutoff at 70 years old for this analysis, could you look at it at 60 years? There might be some of that. But that will be a request to us. We'll run those analyses, and we'll feed that back to the FDA. I think that from -- I mean, the submission process has multiple pieces, right? There's the clinical piece, which I think we're obviously most confident in because this was the clinical trial that we designed, we executed, we analyzed, we published. It's gone through peer review. But there are a number of other features to the submission pathway. For example, there's human factors testing, there's thrombolysis testing, there are standards which change over time and then have to be satisfied. So it's entirely possible that the FDA, when scrutinizing all of that information, asks for something more. I think that's really part of the overall process. The good news is that the way the FDA works, and this is partly related to our breakthrough designation, it's an interactive review. So when they have questions, they don't just wait until the very end and then just give us a laundry list of 2 years' worth of questions to answer. They give it to us along the way. And I -- my personal experience so far with them has been that process has really worked quite well. They've already given us back some interactive reviews just in terms of checking to make sure the application was complete. And they had a question that we answered in 24 hours, and the very next day, they gave us the checklist. So I think that's the way the process is supposed to work. I can't guarantee that it always works that way, but at least our experience so far has been very positive.

[indiscernible]?

Yes. I mean, the number of -- we're sort of a little bit in uncharted territory, right? So it's not as though there have been a bunch of positive sepsis trials over the last 2 decades, and the FDA has approved some and not others. The reality is there's been no approvals because there haven't been any positive trials, okay? The last time we had anything was 25 years ago, which was drotrecogin alfa. And the FDA approved that. And if anything, if you look carefully at that whole history, you would actually, I think, come to the conclusion that in many ways, the data that drotrecogin alfa was approved on, considering both the efficacy signal and the safety signal, was weaker than the signal we have. Now it was a larger trial, was involved [ basin ] analysis, but in terms of whole risks and benefits, which is actually how the FDA makes their decision making, we're actually in a better position than they were. Having said that, there's always uncertainty with dealing with the FDA. But in terms of the fundamental aspects of what the FDA looks at and risks and benefits, I think the company is as confident as it can be. Our job was to execute a well-run clinical trial, and we did that.

[indiscernible]?

Yes. So thank you, Kevin. And I know you'll dig through all the details of this later. I know you will, and I think that's great. Yes, obviously, that there were patients included because they were randomized. And if we had our choice, we wouldn't have randomized any patients that didn't actually receive the therapy. But often in device trials, that -- you can't exclude the fact that something happens in between randomization and when you actually deliver the therapy. So yes, you're right. All of our per protocol analysis, which looks specifically at the patients who actually got the treatment compared to patients who didn't all of those are a little bit better. Some cases are dramatically better on a percentage basis than the patients who were in the intent-to-treat cohort, but the primary analysis that the FDA looks at, the primary analysis that we reported a 95-plus [ post-year ] probability is the intent to treat. So yes, you will -- I haven't run it yet. I haven't seen it run, but I expect that the per protocol analysis, which we will report on the final 12-month analysis, will be better than the intent to treat cohort because that's the way it would work. [indiscernible] not collected. So there's very, very -- one of the interesting things about this is that we will actually bring to the table for the very first time, some true long-term follow-up data. Almost all of the research done until point has really been on short-term mortality. In fact, even 90-day mortality is unusual, right? Everything has been based on hospital mortality, or at most, 28-day mortality. There's only a few studies that have really looked beyond that. And we're the first ones really to bring full -- we actually managed to [ CAT ], which is actually quite remarkable itself -- we managed to get a complete follow-up on the entire 157 patients randomized to Tigris. And the majority of patients who are missing a few patients at 12 months for EUPHRATES, but the vast majority of those patients are also included. And so when we sum all that information up, it will actually represent the biggest, most extensive data analysis on long-term survival post endotoxic septic shock with or without PMX so I think we sort of set the standard in that respect.

[indiscernible]?

Correct. And not even analyzed this yet. We're still working on all of that because none of that data was really scrubbed for purposes of running this kind of analysis, even though we obviously headed in the back of our mind that even though all the FDA was asking for was Tigris data and not really [ analog ], just crude data because they just -- mostly because I think we could guess why, right? They were asking to see it because they wanted to make sure that there was a negative signal at 12 months. But only when we started to actually post 90-day data to actually have a plan for running the 12 months did we realize, okay, we're going to want to combine this with EUPHRATES, and so we started working on that data set.

[indiscernible]?

I can't comment, yes.

[indiscernible]?

Well, that's an interesting question. We have a fully diluted market cap of $500 million right now. For a development stage company, that's a pretty handsome valuation. You can see the rerating of our stock throughout time. So there was a chart there, sorry. It didn't really show up on screen. But we've beaten every broader indices over the last 12 months. You go back 24 months, we've beaten it by a country mile. You go back 3 years, it's even more. The last, I think, 3 years or whatever, we're up almost 3x. So you can appreciate that kind of shareholder rerate versus value rerate. I mean, we're not NVIDIA. We're not a semiconductor. We're not the Korean Stock Exchange, right? But we've had meaningful appreciation. The key, I think, value inflection point was August, when we came out with our top line results. The events after that, our great press releases, I think they just reinforce and confirm those results. So until we move towards, I think, FDA approval, I think that's where you are going to see sort of a significant -- in my -- sorry, in my opinion, a significant re-rate of our stock, right? There's still some risk certainly within the eyes of shareholders out there or potential investors. I mean, as John alluded to, we are the first positive septic shock trial in 25 years. And as John alluded to as well, that was, I wouldn't say weak data, but not as strong as ours. And so if you go back 15 years before that, really, it's 40 to 50 years of septic shock trial graveyards, right? And that's a little bit of negative inertia that we have to overcome. Right? Why should a small company out of Toronto with 29 employees conquer such a big devastating condition and a huge burden on hospitals? If you dig a little bit deeper, and which we do point out to the public, it's about picking the right patients, it's about precision medicine. And all we can do from that perspective is continue to take our message out to the market, non-deal road shows. We're engaged with lots of -- and we get lots of inbound solicitation from institutional investors, from investment banks that want to continue to hear our story. So it's an evolution. We're not running to -- it would be great if we were an NVIDIA or semiconductor ETF, that's great. But we continue to build our value methodically. And we've done that. And you can look at the track record, you can look at the history, you can look at the share price evolution. If people don't like those returns, I honestly don't know -- everybody wants more. Everybody wants more.

[indiscernible]?

Yes. Well, no. Listen, we've had to rebuild the story. And I think we've done it in the scientific manner, in a scientifically rigorous manner. And we will continue to take those steps to continue to build the value here. Right? But there's more catalysts to come for this organization. We're not done yet.

Just to follow on to that. I think that one of the reasons that we press released on the manuscript, one of the reasons we celebrate the paper is that it may not be that important to investors. The investors may have taken our word for it last year when we released the top line data, but it is a very important confirmation to the scientific community and the clinical community that needs to be convinced that this is real. And until they saw it in a high-profile rigorous journal and saw the editorials and saw the podcasts, it's everything else that was sort of tied into it. The vast majority have been incredibly positive, I don't think it was real to them. I think people were still kind of, okay, well, let's wait and see. Investors might be a little more willing to accept things quickly because it's a quick gain. But for the scientific community and the clinical community, they really needed that. And that's why I think we were appropriately in terms of press releases and whatnot.

[indiscernible]?

Yes. I mean, again, we're in uncharted water. So we can't talk about sort of how typical therapies in sepsis get adopted because there are no typical therapies in sepsis. One of the places to look at is oncology, right? If you look at the blockbuster miracle drugs in oncology over the last decade, which have really been checkpoint inhibitor therapy for diseases, for cancers, which have been really some of the scourges of -- I mean, cancer is bad enough. But I mean, there are really bad cancers like metastatic melanoma. And the effect size, the absolute reduction in mortality at 1 year is around 15%, right? So here we are, right? So I -- and certainly, oncologists adopt those therapies. There's really no question about that being a good enough signal. And I think that, that's kind of where we are. So by inference, I would say, it'd be very hard for hospitals not to adopt this therapy, be very hard for clinicians not to order it. That said, it's new, and it's not going to be overnight. And that's what -- I think we're fortunate that we have a partner, a commercialization partner which is experienced with getting novel -- I mean [ CRT IC ] dialysis was a novel therapy when I first started in medicine. Now granted that was 30 years ago. But I mean, this company, Vantive, having been Baxter and then before that, [ Gambro ], has a history of really adopting these therapies, getting them out there. And it doesn't happen overnight, but it is something that I think we're very well poised get there. Will it happen quicker than I think or quicker than you think? I don't know. Will it happen slower? I don't know, but it's going to happen.

[indiscernible]?

Sorry, I couldn't hear your entire question. You're talking about the loss carryforwards?

[indiscernible]?

Roger, I'll have to -- sorry, I'll have to follow up with that. I don't have a specific answer for you, other than the loss carryforwards are accumulation of -- obviously, we've been in a net loss for quite a long time. And so I'd expect the loss carryforwards up until near-term commercialization or commercialization will continue to creep up, right?

[indiscernible]?

Yes. Yes, it's our operating losses, right?

[indiscernible]?

To utilize them going forward? Yes. Yes, we can apply them -- yes.

[indiscernible]?

Roger, I'll have to follow up with you on that.

[indiscernible]?

Yes. So the extension of the expiry date is what you're asking about for, I think, a series of options, is that correct? Yes. So those options are held by executive. And I don't think it would be right for executives to either exercise them during what I would consider a quiet period for the organization. We've submitted our PMA, right? And until it's accepted by the FDA, I don't think it would be correct that -- I don't think it would be good for the organization -- sorry, for the employees and executive if they were to be able to trade in the stock during that time, right? And hence, why they've been extended shortly into the future until after PMX -- anticipated PMA acceptance.

[indiscernible]?

Well, our last reported -- Q1, I think, [ Jesse ], was about $2.5 million in cash.

Right.

So we did draw down on the USD 1 million tranche from Vantive on the promissory note. In terms of sort of what runway we have, Roger, I think is what you're asking or how we're going to fill that gap. The gap is quite small with respect to getting to anticipated FDA approval. As in the past, we've always looked at constructive ways to finance this company. We've fortunately had, I would say, some very supportive investors, whether it's been Vantive or Pinnacle Island. And I would expect that we would have a similar kind of structure to fill that gap, but it's not a very large gap to get there. So once again...

[indiscernible]?

Yes, yes. Yes. So to get the anticipated FDA approval.

[indiscernible]?

We will have a solution to get us to that point.

[indiscernible]?

Yes, it's -- that's pretty simple. And we've had this in the past. We've had this on the docket. We've talked about potentially dual listing in the future. There wouldn't be no share consolidation unless we were going down that path. It provides us with an option or an opportunity just like a base shelf perspective gives you the opportunity or the option, should you need it. So that's all. Otherwise, from here to sort of the next AGM, if we had -- if we do decide to go through the process of dual listing, we would have to organize and call another shareholder meeting. So this sort of takes care of that with one fell swoop, if we are in the opportunity -- we have the opportunity to do it at some point in time. Not saying that we are doing it, it just gives us the optionality to do it.

[indiscernible]?

Well, I think -- I won't answer it in that way. I think the way I'll answer it is that our target market is the U.S. I think there are deeper and sophisticated capital pools in the U.S. And if that allows sort of further access and exposure to the company, then that would be sort of the prudent thing to do.

Next question?

[indiscernible]?

Yes. I mean there's a lot of sausage-making behind that, Kevin. And so I'm not going to go in sort of every line item. I mean, it's all the things that we talked about in the presentation, whether it's infrastructure, preparation, around training, product knowledge, KOL engagement, it is really setting the scene for commercialization. So...

[indiscernible]?

From a clinician perspective? I think I'll let John answer that. [indiscernible] from clinicians on the back of our...

Well, clinicians are a funny lot. I can say that because I am one. But I think that the research community has been incredibly positive. I think the clinicians are positive for the results. But I think they're realistic in the sense of, okay, like how do we adopt this, right? Is the hospital going to buy it? And how do I get the hospital to buy it? Can I get the lab directors to run the test? So I think they're already sort of thinking through like how does this all work? And then the added complexity is that I think it's going to work differently in different hospitals. And so I find the clinicians that I speak to are simultaneously excited, but also at the same point of like I'm not sure I'm going to do this. And so -- but I think that's fine. I think that's good. I think that's realistic.

I would just add, I mean, there's now multiple or a multitude of podcasts out there interrogating the trial, the positives around the trial, some of the negatives. But I think if you look at the punch line or listen to the punch line in a lot of these podcasts who are clinicians themselves, the question they always ask is, at the end, if I had the opportunity to use this, would I use it? And the overwhelming response is, yes, I would use it. So I think there is positive engagement from clinicians. There's always issues around new technologies in terms of the technicality of implementation, right? But at a base level, I think people will use it. They want to use it. So...

[indiscernible]?

So I think there's a lot of questions around that, that we -- it could be a long discussion in and of itself. I think that the way hospitals will want to adopt this is very much on label. And they'll want to do that for a few reasons. One is they want to appropriately apply the evidence that was generated to the clinical scenario. I think that's totally appropriate, and no one would ask them to do anything different from that. Where there are exceptions, I think those exceptions will be managed carefully. In other words, there will be situations where the endotoxin level was slightly too low or slightly too high, but there are mitigating considerations, and physicians will want adopt therapy that's maybe outside of the indications. Hospitals will want to make sure that that's managed very, very carefully. So I think that -- for us, we think this is 120,000, 150,000 people just in the United States and proportionally in Canada. For a small biotech company in Canada, I mean, I think this is a very appropriate market. Is there a bigger market out there? Possibly. Will additional research be required in order to sort of convince everyone that, that's an appropriate group? Because remember, 10 years from now, we don't want to be in a position to say, oh, we know it works. If you have an endotoxic septic shock the way Spectral defined it back in the day. But we don't know anything about these other areas. So we just leave it open for physicians to decide whether they're going to -- it'd be much better to generate new evidence. Maybe not clinical trial evidence, but at least generate some evidence to say this is an appropriate group. This is an appropriate group. And that's how I would sort of see it evolving over time.

[indiscernible]?

No, not immediately. And I think that it's going to be we're not going -- this comes back to your question, we're not going to get 120,000 treatments out of the gates, right? It's going to take some time. There are going to be hospital -- sophisticated hospitals that can deliver this therapy tomorrow. And there are hospitals that are going to have to work to figure out how to get all the moving parts in line. I think Vantive is going to spend the next 5 years really trying to move from a small group of early adopters to kind of the average hospital and then the next 5 years to try to say maybe some other hospitals. And that's exactly what happened with CRRT, continuous renal replacement therapy. So dialysis existed in only very specialized centers back in the 1990s. And over the years, it's moved out to community hospitals, and now pretty much any hospital has an ICU can deliver this therapy, but it didn't happen overnight.

Operator, are there any questions online?

Hearing none, I just want to make a couple of comments. I know a lot of individuals have been involved with this for a long time, but this is my 26th Spectral AGM. So I probably have a longer view than much everybody else. And I think that the maturation of this company in the last few years is quite phenomenal. That's gone from a company trying to do something that was extraordinarily difficult to something that's accomplished that. And along the way, the principles of quality I think have permeated every activity and every individual associated with this project. And I can't underestimate how important that is with respect to the clinicians involved, the regulatory bodies, and I hope the investors as well. But what's been assembled -- and I have to thank the Board. Spectral is blessed with a very knowledgeable, very involved and committed Board, and they make many significant contributions to for this project. And secondly, to Chris and John, into the level of sophistication that they brought in the financial world, organizational world and particularly, scientific world. It's truly unique for a company of this size. It's actually truly unique for almost any company. And the kind of individuals that have worked in this company have brought such high quality to the work that's being done on a daily basis is what's been the success. So -- and I can say that. I've got great hair, and I've been here a long time that I can see what has been accomplished. I'm particularly proud that this company is getting where it needs to be. And I have absolute confidence that it's going to get to where it wants to be in the near future. So thank you all for coming, and we look forward to being able to discuss these sort of things a year from now, but I appreciate all the loyal people who've come in. Roger, all the way from Montreal. And our Board from all over that make this an important moment and allow us to encapsulate essentially what the essence is of this company and where it's going. So thank you all very much.

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