Put it in full screen mode? John, can you just put that in full screen mode and then we'll get going. Yeah, sure. Just working on that right now. Marie is not a patient woman. Why is it not letting me do that? Do you have two monitors or just one? Just one. Okay, so you should just be able to go to, like, start presentation or- Where do I find that? Well, on the bottom you could do it also where it has the little Zoom. There's, like, that one icon right there. There's also a shortcut, let me just see where it is. If you press F5, that should do it too. Click F5? Press F5 on your... That should do it. Or go to the top where it says Slide Show. Where at the top it says, like, File, Home, and hit where it says Slide Show. And then, like the... Yeah, right there, and then From Beginning, just go to the one that says- From Beginning ... From Beginning. From Beginning. Okay. That didn't do it. No, it didn't. For the sake of time, since we have people in the room already, you could present this way. It's just gonna show the slides on the side. It's not the end of the world. Okay. All right. Sorry, everyone, for the little technical glitch, but we'll get started now. With us is John Sperzel from T2 Biosystems. John is the CEO. We should have about 30 minutes, and there should be a couple minutes at the end for Q&A. So if you do have a question, you can type it into the Q&A tab at the bottom of your screen. So why don't we get started, John? That sounds great. Can you see the presentation okay? Yes. Okay, awesome. Thank you all for joining us today. I'll just start with our safe harbor statement. It can be found on the investor relations section of our website. Jump to slide 3. We have a patented cutting-edge diagnostic platform, including the only FDA-cleared direct-from-blood sepsis test. We view our target market as greater than $2 billion. Our products are reimbursed in the U.S. under the DRG payment system, and we have a global footprint. We're now selling in approximately 45 countries. Our customers include some of the world's best 250 hospitals and best hospitals in the United States, and we've shown some of them here, including Henry Ford, New York University Langone, University of Louisville, and University of Alabama, Birmingham. We're advancing our mission by pioneering life-saving diagnostic innovations that enable faster targeted antimicrobial therapy, that is, antibiotics and antifungals. We're focused on sepsis, which is the body's overwhelming and often life-threatening response to an infection. It is a global problem, unfortunately, with fatal consequences. If we look at the data in the U.S., sepsis is the number one cause of death in the United States, claiming the lives of about 350,000 Americans each year, 270,000 in hospitals, 80,000 in hospice. Sepsis is the number one cost of U.S. hospitalization, costing our healthcare system about $62 billion annually. And finally, sepsis is the number one cause of 30-day hospital readmission, requiring approximately one in five patients to be readmitted within 30 days, and approximately two in five sepsis survivors to be readmitted to the hospital within 90 days. So by those measures alone, the current standard of care is failing patients, payers, and providers. The challenge of detecting sepsis-causing pathogens is that it's a race against time, as the risk of death increases by up to 8% for each hour of delayed targeted antimicrobial treatment. The standard of care for patients at risk of sepsis currently relies on broad empiric protocols to administer antimicrobial therapy, again, that is antibiotics or antifungals, despite the fact that data shows that these protocols are only optimal, somewhere between 30%-60% of cases, or about half of cases. And then, to further complicate matters, the current standard of care continues to rely on a positive blood culture to identify the presence of a bloodstream infection and target therapy for those patients suspected of sepsis. There are two major deficiencies with blood culture. One, blood culture typically takes 1-5 days to achieve the growth necessary to identify the causative pathogen. You can see that on this slide. Typically, on average, it's between two and three days. That's the dark vertical bar between 48 and 72 hours. Then the second challenge with blood culture is that it has poor sensitivity. A typical set of blood culture bottles has sensitivity of approximately 60%, which can result in false negative results or missed infections. Just to further compound matters in the use of blood culture as a clinical specimen in the guidelines for patients at risk of sepsis in July of 2024, both the FDA and CDC issued health alerts to inform U.S. healthcare providers that Becton Dickinson is unable to supply sufficient quantities of blood culture bottles. And to put that in perspective, the BD automated blood culture system is used in about 50% of U.S. hospitals, and it is a closed system, so you can't substitute competitive blood culture bottles. That creates a real challenge for patients relying on blood culture to identify causative pathogens, but that creates a significant opportunity for T2, because our products do not require a blood culture to identify the pathogen that is causing sepsis or the antibiotic resistance characteristics. So our aim at T2 Biosystems is to change the standard of care by enabling faster, targeted antimicrobial treatment. We have the first and only FDA-cleared diagnostic products able to detect sepsis-causing pathogens directly from whole blood or culture independent, and we can do that in just 3-5 hours. All of the other products on the right-hand side of this slide rely on a positive blood culture as their clinical specimen. So while they may market that their product can provide results in 1-2.5 hours, that is after they wait 1-5 days for a positive blood culture. I can't underscore that enough. No positive blood culture, little to no clinical value of those products shown on the right-hand side of this slide. Whether that is a false negative result due to poor sensitivity or lack of blood culture bottle availability, we don't need blood culture. We can do this direct from blood. When we think about the future of sepsis care, we view this market evolving to, you know, patient getting admitted to the hospital, first, a set of symptoms being pulled together, either with early warning biomarkers or artificial intelligence to flag patients as having a bloodstream infection or being at risk of sepsis. Then we believe direct from blood detection technologies like ours to identify the causative pathogen quickly and to identify antibiotic resistance characteristics quickly in combination with blood culture to identify the pathogens that we don't detect, is the way that sepsis care will evolve going forward. Our comprehensive portfolio of products includes a highly sensitive, fully automated, easy-to-use instrument that's shown on the left-hand side of this slide. As I mentioned, it provides results in three to five hours. No sample preparation is required. It is an ultrasensitive platform that detects pathogens down to one colony-forming unit per mL. Importantly, unlike blood culture, our technology is not inhibited by prior antimicrobial administration. You can see two of our cartridges in front of the instrument on the insert picture, as well as two tubes of blood inserted into those cartridges. So to use our instrument, simply draw a four mL purple-top tube of blood, put that blood onto the cartridge, put the cartridge in the instrument, everything else is fully automated. Seven tests can be run simultaneously. It doesn't matter if they're all bacteria panels or some combination of bacteria, fungal, and resistance. Typically, the orange drawer that you see on that slide is a stat drawer, which would jump ahead of others in process. We have three test panels in our sepsis portfolio. The T2 Candida Panel, which identifies fungal pathogens, it covers approximately 90% of Candida species with those five targets. We do plan to add Candida auris, which I'll talk about later. That will take our coverage to about 95% of Candida species. That test is FDA-cleared and CE-marked with high sensitivity and high specificity. The second test panel is our T2Bacteria Panel. It is also FDA-cleared and CE-marked, high sensitivity and specificity. It identifies six target pathogens. Those six pathogens account for about 75% of bacterial-driven bloodstream infections. The other 25% get easily covered by blood culture. We chose those six targets not only because they account for the majority of bacterial-driven bloodstream infections, but they are also the six that are most likely to escape broad-spectrum or empiric antimicrobial treatment. That's why you can see the acronym ESKAPE there. They escape this broad-spectrum treatment. Then finally, our T2Resistance Panel, which is CE-marked, and we plan to submit that product to the FDA for 510(k) clearance in the fourth quarter of this year. We have already received FDA Breakthrough Device Designation, so that product will get a prioritized review when we make that submission. Just to put in context, we bat a thousand with the Food and Drug Administration when it comes to submissions and clearances. Our last two clearances, one was an expanded T2Bacteria Panel to add Acinetobacter baumannii. It took about 100 calendar days to get FDA clearance. We did not have Breakthrough Device Designation on that product. The second, I'll talk about a little later, was a multi-target bioterrorism panel, the first of its kind by a U.S. company. That also took approximately 100 days from submission to 510(k) clearance. So we expect a positive outcome once we make the T2Resistance submission in the fourth quarter. There is growing independent support for our products. There are dozens of independent real-world clinical studies. I'll show you the results of a meta-analysis, including 14 of them, in a few minutes. The Food and Drug Administration has granted Breakthrough Device Designation for all three products in our pipeline, the U.S. T2Resistance Panel, which I just covered, a Lyme panel, which I'll talk about shortly, and a Candida auris test, which we're going to add to the T2Candida Panel. CMS, which is responsible for setting payment in the U.S., granted the first ever New Technology Add-on Payment for a diagnostic product, and that was granted to our T2Bacteria Panel that covered about 2/3 of the cost. We received about $31 million from the federal government, or BARDA, to develop our T2Resistance Panel and our T2Biothreat Panel, which we just recently got FDA cleared. We have a contract with Vizient, one of the largest group purchasing organizations in the United States, and we have received funding from the U.S. Department of Health and Human Services, and the Steven & Alexandra Cohen Foundation to advance our Lyme diagnostic. I mentioned I would talk about the results of a number of studies around our sepsis products as compared to the blood culture-based workflow. This is a meta-analysis of 14 controlled studies. It was published in a peer-reviewed medical journal, and the outcomes were three major outcomes: faster time to detection, faster time to targeted therapy, and reduced length of stay. I'll point to just a few of these in the interest of time. First, we were able to identify the causative pathogen or species 77 hours faster than with the blood culture-based workflow. Using our products, clinicians were able to get patients on targeted therapy faster. If the patient tested negative on our product, they were able to de-escalate broad-spectrum antimicrobials 7 hours faster. It doesn't subject patients to unnecessary antimicrobials, leading to additional antibiotic resistance. Also, these broad-spectrum empiric antimicrobials are very toxic to patients. And then, more importantly, for tests positive on T2Resistance or T2 panels, patients were able to receive targeted antimicrobial therapy 42 hours faster than the blood culture-based workflow, and were able to get patients out of the hospital and the ICU approximately 5 days faster. Typical cost of an ICU bed across the United States is around $5,000 a day. We have three corporate priorities across the company in 2024: accelerating our sales, enhancing our operations, and advancing our pipeline. I'll cover each of these briefly. Starting with accelerating our sales, our commercial go-to-market strategy is a little bit different in the U.S. than it is in international markets. We have about 200 instruments in our installed base, divided roughly equally between the U.S. and international markets. In international markets, we sell through distributors almost exclusively. We would have a single exclusive distributor in a territory or a country, and in some cases, multiple countries. We have, for example, Werfen, a large multi-billion dollar diagnostic company, covers Spain and Portugal. D.I.D. covers Italy, and we have a company called Biomedica, who covers more than a dozen countries in Eastern Europe. We continue to expand our international footprint through these distribution partners, and we're expanding in Europe, Middle East, Asia-Pacific, and Latin America. In the United States, we have traditionally sold direct with a small sales team, and as I mentioned on our earnings call at the end of July, we are in negotiations with a multi-billion dollar healthcare company to expand aggressively our commercial footprint in the United States through a strategic partnership. Our commercial execution includes four major phases in our sepsis business. There's an education phase, where we create or share the clinical and economic value proposition, similar to what I disclosed earlier on the meta-analysis, and we talk about patient selection criteria and where those patients are most likely to become septic, the ICU, oncology, and transplant. There's an implementation phase, where we install the instrument, we do comprehensive training and validation. There's a launch phase, where we begin testing patients and work through the workflow within microbiology and go live with testing, and then ultimately into routine testing, and they start to see the clinical and economic value, and we begin to expand testing. So, for example, we might start in oncology, where patients are obviously sick, they're undergoing chemotherapy, they're very much or much more at risk for sepsis, and then expand into transplant to the extent the hospital has it, or more broadly, into the intensive care unit or emergency department. There are three pillars to increase our sepsis business overall. One is adding new customers. Think of that as new store sales. If there's faster implementation, the faster we can go from installing an instrument to broad implementation within a hospital, the faster we can start to sell test. And then lastly, where we're spending the majority of our time today, is expanding testing within our current customers. Think about that as same-store sales expansion. This is very much a razor blade business. Once we get the instrument into an account, they begin to buy tests, we expand the testing. The business is very sticky. I talked about the biothreat panel that we've developed. I'll just go into a little bit of detail. We're detecting six biothreat agents that cause anthrax, glanders, melioidosis, tularemia, typhus, and plague. Our T2Biothreat Panel is highly differentiated. It has unparalleled sensitivity and specificity. Five of the six targets have 100% sensitivity, the other is just under 95%, and all six have 100% specificity. We saw zero false positives in our clinical work. It provides results in approximately four hours on these six pathogens. All six of them are considered high priority by ASPR. This panel runs on the FDA-cleared T2Dx Instrument, and is the only multi-target bioterrorism panel developed and manufactured by a U.S. company. We think that's gonna be important in a Buy America first mindset, which we believe either side of the political aisle sits on. I wanna talk a little bit about our second corporate priority, enhancing our operations. A number of these are sort of internal operational goals. Think of these as investments that we're making to scale the business and improve our cost structure. Because we're supplying life-saving diagnostics, achieving on-time delivery targets is critically important. Improving our product gross margins, our cost of product sales were improved about 40% in the second quarter compared to the prior year. Maintaining our ISO recertification, that's important from a manufacturing perspective. We just got that recertified. Reducing our operating costs. We have made significant strides to reduce our operating costs. If we look at our Q2 2024 results compared to prior year, our SG&A was improved by 13%. Our R&D investments were reduced by approximately 13%, and our cost of product sales, as I mentioned, about a 30% improvement. And then we also implemented or are implementing a number of cost savings initiatives that will flow through the back half of this year into 2024 and beyond. We converted approximately 80% of our debt, which was about $40 million, to common stock over the last twelve months. That's gonna reduce our annual interest payments by about $3.2 million. We're further consolidating our facilities, which is gonna drive about $1 million in annualized savings. We just moved to ADP TotalSource as our PEO. That's gonna save close to $500,000 in annual expenses. And we, in the last sort of bottom right corner of this slide, are more broadly implementing our new Oracle ERP system to inventory management, which we believe is gonna drive down costs as well. So we're making significant progress in improving and strengthening the overall operations of the business. And then I'll just shift to our pipeline and then close with some financials, and happy to take a couple of questions if there's time. We have developed a Lyme diagnostic to detect Lyme disease in the early phase, in the first 30 days. The causative bacterial pathogen for Lyme disease is Borrelia burgdorferi. We can detect that with a 4 ml sample of whole blood. Again, independent of blood culture, it is a highly sensitive test. We believe it will be highly differentiated because the other tests that are used broadly and recommended by CDC are based on the presence of antibodies. Antibodies take the body six to eight weeks to develop, which misses the critical window of treatment for patients with Lyme disease. Many of those patients, if not detected early and treated properly, can go on and develop chronic Lyme disease, and, you know, we hope to make an impact on that and improve patient outcomes with our highly sensitive Lyme diagnostics. We're gonna commercialize that through a partnership. We recently signed an agreement with a collaborator, a non-binding agreement. We're working on finalizing that agreement in a binding format, and we'll launch it as a lab-developed test. We are in the final stages of submitting for FDA 510(k) clearance of our T2Resistance Panel, which I mentioned. We believe this will be a significant growth catalyst for the company. Not only will it drive pull-through on the T2Bacteria Panel, 'cause it's an important part of the clinical decision-making, but we also believe it's gonna drive adoption of our platform overall by being able to offer fungal, bacterial, and resistance testing. All three tests can be run simultaneously on the platform in 3-5 hours without having to wait days for a positive blood culture, if it comes at all. And then finally, in our pipeline is the addition of Candida auris to our T2Candida Panel. As I mentioned earlier, that'll take our detection from 90% of Candida species to approximately 95%. That has FDA Breakthrough Device Designation. And then late in 2023, we made a 510(k) submission to the FDA for a pediatric claim for our Candida test, T2Candida Panel. Once we receive that, we expect to make a similar submission for our T2Bacteria Panel. That'll open up more than 200 pediatric hospitals in the United States that we're unable to market to today. And it will also allow clinicians to get pediatric patients on faster targeted treatment and improve outcomes. I'll just close with our financial performance. For the second quarter, we had $2 million in total product revenue. We sold 2 instruments. We finished with a cash balance of $4.2 million. If we look at the highlights of that quarter, we had growth in our sepsis test business in the first quarter - or in the second quarter, compared to prior year of 27%. 25%, if we look at the first half year compared to the prior year period, led by growth in T2Bacteria and T2Resistance, importantly. We reduced our debt and our quarterly interest payments by approximately 80% from the prior year. We signed multiple new distribution agreements in the Middle East and Asia. We raised about $8 million in gross proceeds through a private placement of stock in May of 2024, and we completed additional clinical studies around the commercialization of T2Lyme as a lab-developed test. So I'll stop there. Happy to take any questions in the interest of time. Great. Thanks, John. So first one is, if a patient is readmitted to the hospital for sepsis, who pays? Hospital pays if it's in the first 30 days. So- So the hospital's highly motivated to know ahead of time if this patient has sepsis. They don't want that patient back. Correct. I would tell you that I'm a sepsis survivor. I was readmitted within the first 30 days. Okay. All right. And when you place the instrument, is that profitable? Do you make money on the instrument, or is instrument revenue the profit primarily on the cartridges? The instrument's a vehicle. In the U.S., we place the majority of the instruments. We're selling tests. We're providing results for patients. In the international markets, we do sell the instrument essentially at break even to the distributor, and they generally place them in their customers' hands, again, focusing on the consumable sales. As volumes ramp up, where do you anticipate the margin for the cartridges to be? The underlying contribution margins on the tests are between 70% and 80%. If you look at our income statements today and our, and our P&Ls, you'll see that we have negative product gross margins. That's simply a matter of the fact that we are not fully absorbed as an organization. So as we scale volume, we'll start to see that contribution margin flow through. In the U.S., you said you have direct sales. You know, how big is that group, and is it expanding? It's 6 people today. We don't anticipate expanding our direct team because we expect to get into a partnership with a, you know, multibillion-dollar healthcare company. So we built that team anticipating that we would have a large partner in the United States. Is the system moderately complex? Yes, it is. What level of revenue do you think you need to achieve to get to cash flow break even? We haven't guided the market on that yet, Jim. We would certainly do that in due course. Okay. You talked a little about the pipeline. What is the nearest term cartridge to be approved? We're gonna launch the T2Lyme Panel in the third quarter as a lab-developed test. Mm-hmm. Obviously, that doesn't need FDA clearance. There's going to be FDA oversight. That's gonna come in the future, so there's a certain window here. The next one that we expect to be FDA cleared could either be the expansion of the claim for T2Candida for pediatrics, and then hopefully shortly thereafter would be the T2Resistance Panel. Okay. And now that you've paid off the majority of the debt, where do you expect the interest costs to be for the remainder, you know, for going forward? Should be about $800,000 annual license and interest payments. It was about $4 million. That conversion is gonna save us about $3.2 million annually. I believe you said you had about $4 million in cash on the balance sheet now? That's what we had at the end of the quarter. Was that? Did you do the funding during the quarter, or was the round of funding after the quarter ended? We did that funding in May. May. So, you know, what, what's the runway for that $4 million in cash? How long do you think you have before you have to raise money again? We haven't guided to that. I mean, certainly we're gonna need to raise capital at the appropriate time. We think that we have a couple of significant catalysts around the corner, and we're gonna do that responsibly. And are those catalysts the launch of some of these new cartridges, or can you tell us what they are? The launch of Lyme and the potential, you know, agreement with a multibillion-dollar healthcare company to help us strengthen our commercialization in the U.S. Those are two. So you anticipate some non-dilutive funding to come along with that agreement, it sounds like? I can't say what type of funding, but we'll strengthen our balance sheet. It will. Okay. All right, well, we are out of time. I appreciate the, you know, that you were here today. I'm sorry that we got started a little late, but we hope to hear from you again soon at another conference and, you know, get an update on how that's all going with the potential partner. Thank you for having me, Jim, and thanks to the audience for taking a look at T2. We appreciate it. All right. Thanks, John. Thank you, Jim.