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H.C. Wainwright 26th Annual Global Investment Conference 2024

Sep 9, 2024

Moderator

Hello, everyone. Welcome to the H.C. Wainwright 26th Annual Global Investment Conference. For our next presentation, we have T2 Biosystems, and joining us today for the presentation, we have Chairman and CEO of T2, John Sperzel. John, great having you with us today. Please go ahead.

John Sperzel
Chairman and CEO, T2 Biosystems

Thank you, Thomas, and thank you all for joining us today. On the next slide is our safe harbor statement. A full copy can be found on the investor relations section of our website. On the next slide, we've developed the only FDA-cleared products able to detect sepsis-causing pathogens directly from blood, which we believe can become the standard of care in sepsis management. We view our target market as greater than $2 billion. Our products are reimbursed under the DRG payment system in the United States, and we have a global footprint now selling in over 45 countries. On the next slide, our customers include some of the world's best 250 hospitals and some of the best hospitals in the United States, including Henry Ford Health, New York University Langone, University of Louisville, and University of Alabama at Birmingham.

On the next slide, we're advancing our mission by pioneering life-saving diagnostic innovations that enable faster, targeted antimicrobial therapy. On the next slide, we're focused on sepsis, which is the body's overwhelming and life-threatening response to an infection. It is a growing global concern with fatal consequences. Sepsis causes the death of approximately 11 million people worldwide each year. That's more than all cancers combined, and it equates to 1 in 5 deaths globally. In the United States, sepsis is the number one cause of death in hospitals and claims approximately 350,000 American lives each year. Sepsis is the number one cost of U.S. hospitalization, costing the U.S. healthcare system nearly $62 billion annually. And finally, sepsis is the number one cause of 30-day hospital readmissions, requiring 20% of survivors to be rehospitalized in 30 days and 40% in 90 days.

By those measures alone, the current standard is failing patients, payers, and providers. On the next slide, 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 current standard of care for patients at risk of sepsis relies on broad empiric protocols to administer antimicrobial therapy, that is, antibiotics or antifungals, despite the fact that data shows that those protocols are only optimal in approximately 1/2 of cases. To further complicate matters, the current standard continues to rely on a positive blood culture to identify the presence of a bloodstream infection, followed by culture-dependent molecular diagnostics to target antimicrobial treatment. There are two major deficiencies with blood culture. One, blood culture is slow. It can take one to five days for a positive blood culture.

And two, blood culture is insensitive. It has very poor sensitivity, approximately 60%, which can result in false negative results or missed infections. Additionally, in July 2024, both the Food and Drug Administration and CDC issued health alerts to inform U.S. healthcare providers that Becton Dickinson is unable to supply sufficient quantities of blood culture bottles. Becton Dickinson has approximately 50% market share in U.S. hospitals. On the next slide, our aim at T2 Biosystems is to change the standard of care by enabling faster targeted therapy. As I mentioned earlier, we have the first and only FDA-cleared products able to detect sepsis-causing pathogens directly from whole blood in just three to five hours.

All other products used to identify sepsis-causing pathogens, shown on the right side of this slide, rely on a positive blood culture as their clinical specimen, which again, can take one to five days, plus one to three hours to run on their device. On the next slide, we view the future of sepsis care to achieve faster targeted antibiotic or antifungal treatment or precision medicine as including early warning biomarkers to establish a sepsis risk score in just minutes, T2's species ID and resistance in a few hours, and blood culture for broad species ID and resistance in a few days. On the next slide, our comprehensive portfolio includes a highly sensitive, fully automated, easy-to-use T2Dx instrument, which is FDA-cleared and can run seven tests simultaneously.

Our current test panels for sepsis include the T2Candida, which is FDA-cleared and CE marked, T2Bacteria, which is FDA-cleared and CE marked, and T2Resistance, which is CE marked. We've completed the U.S. clinical trial and plan to submit the T2Resistance panel for FDA 510(k) clearance in the fourth quarter of 2024, and it has already achieved Breakthrough Device Designation from the FDA, so we will get a prioritized review by the agency. On the next slide, there's growing independent support for our technology, including dozens of independent clinical studies demonstrating clinical utility. I'll show some of those on a future slide. The FDA granted Breakthrough Device Designation for the T2Resistance Panel, the T2Lyme Panel, and our Candida auris test, which will provide for a prioritized review.

CMS granted T2Bacteria Panel the first ever diagnostic product to gain a New Technology Add-on Payment, or NTAP, covering 2/3 of the cost above the DRG payment. The U.S. Department of Health and Human Services, or BARDA, provided $31 million to our company between 2019 and 2023 to advance our T2Resistance Panel, which is nearing FDA submission, and the T2Biothreat Panel, which was FDA cleared. We have a contract with Vizient, the largest U.S. group purchasing organization, for our sepsis products. And finally, we've received funding from LymeX, a partnership between the Cohen Foundation and Department of Health and Human Services, to advance our T2Lyme Panel. On the next slide, a meta-analysis was completed, analyzing 14 controlled studies, seven in the U.S. and seven internationally, comparing our products to the blood culture-based workflow.

The findings, which were published in a peer-reviewed medical journal, were consistent with prior studies, including our FDA submission. Faster time to detection. Time to species ID was 77 hours faster with T2 products compared to the blood culture-based workflow. Faster time to targeted therapy or treatment. Time to targeted antimicrobial treatment was 42 hours faster with T2 products compared to blood culture-based workflow. Reduced length of stay. Length of stay in the hospital and ICU was approximately five days shorter with T2 products compared to the blood culture-based workflow. On the next slide, we have countless patient case studies showing the value of our products, including positive patient outcomes. I'll just review a couple in the interest of time. The first case was a 70-year-old male that presented with shortness of breath to the emergency room. He tested positive for E. faecium,

which is not covered by typical broad-spectrum antibiotic treatment and has a mortality rate of up to 50%. The patient received targeted treatment 20 hours faster than blood culture. The second case was a female patient that presented with persistent fever in the oncology unit. She tested positive for multiple Candida species, not covered by broad-spectrum antibiotics, and had a mortality rate of up to 40%. She received targeted treatment and subsequently was successfully discharged from the hospital. On slide 14, we have three corporate priorities in 2024: accelerating our sales, enhancing our operations, and advancing our pipeline. Let's start with advancing our sales on the next slide, and we can jump to the following slide. Our current installed base is nearly 200 instruments, split almost evenly between the U.S. and international markets.

Internationally, we have a distribution network with partners that covers over forty countries, and we continue to expand in Europe, the Middle East, Asia Pacific, and Latin America. We're in negotiations with a multi-billion dollar healthcare company to establish a commercial partnership in the United States, with the goal to significantly strengthen our U.S. commercialization. On the next slide, we follow a four-phase commercial execution process that includes education, including clinical and economic value proposition and patient selection; an implementation phase, where we install the instrument, train the customer, and validate the results; a launch phase, where we work with the customer on workflow and patient reporting; and finally, expansion, where we expand testing into other departments. On the next slide, our commercial focus is sepsis, and we have three objectives: add new customers, accelerate the implementation process, and expand testing within existing customers.

On the next slide, our objective is to create a flywheel, in a sense, where we gain new customers, install and train, launch or go live with T2 tests, have a positive customer experience, capture the data, and develop new case studies, and gain new customers, and accelerate that process each and every time. On the next slide, in addition to sepsis, we're applying our technology to bioterrorism, and we've developed a multi-target bioterrorism test that detects anthrax, glanders, melioidosis, tularemia, typhus, and plague. On the next slide, the T2Biothreat Panel is highly differentiated, providing rapid turnaround and unparalleled accuracy. The six biothreats that we can detect are all listed on the ASPR High Priority Threat List, and this is the only multi-target virus-bioterrorism test developed and manufactured by a U.S.-owned company. On the next slide, we're also applying our technology to Lyme disease.

We've developed a test for the detection of early Lyme disease in the first 30 days. We believe this will be a substantial improvement over the CDC-recommended two-tier antibody test. We intend to launch our Lyme test for the detection of early Lyme disease as a laboratory-developed test, or LDT, in the third quarter of 2024 , through a partnership with ECO Laboratory. On the next slide, moving to our second corporate priority, enhancing our operations. We can jump to the next slide, please. We continue to take important steps to transform our balance sheet and improve our cost structure. Over the past twelve months, we've reduced our debt by approximately 80%, by converting $40 million of our term loan with entities associated with CRG Servicing, LLC, or CRG, to common stock.

This has significantly strengthened our balance sheet and reduced our overall and annual interest payments by approximately $3.2 million. During the second half of 2024, we plan to further consolidate our real estate space by exiting our facility at 4 Hartwell Avenue in Lexington, Massachusetts, and consolidating those operations into our headquarters at 101 Hartwell Avenue in Lexington, Massachusetts. We expect this move to reduce our facilities cost by approximately $1 million annually. On August 1st, 2024, we partnered with ADP TotalSource as our professional employer organization, or PEO, to provide comprehensive and cost-effective HR benefits, including healthcare benefits, workers' compensation, payroll and tax support, and HR guidance. We estimate this change will result in annualized savings of approximately $400,000.

Since early 2023, we've reduced our headcount by approximately 30% to 113 employees, and at the same time, we've reduced employee-related operating expenses, and finally, during the second quarter, we expanded the use of our Oracle ERP system to improve inventory planning and material management. We believe the Oracle ERP system will favorably impact inventory levels, cost of goods sold, and ultimately improve cash flow. On the next slide, moving to our third corporate priority, advancing our pipeline. We're focused on three— On the next slide, w e're focused on three pipeline programs: the U.S. T2Resistance Panel, pediatric claims for our FDA-cleared T2Candida and T2Bacteria Panels, and adding Candida auris to our FDA-cleared T2Candida Panel. On the next slide, our initiatives are addressing rising healthcare concerns of Lyme disease, antimicrobial resistance, and Candida auris.

On the next slide, the T2 Lyme Panel, it will directly detect the causative bacterial pathogen for Lyme disease, which is Borrelia burgdorferi. It will use 4 mL sample of whole blood. We believe that we have developed a highly sensitive diagnostic that can detect Lyme disease in the first 30 days of tick bite. And as I mentioned earlier, we believe this will be substantially differentiated compared to the CDC-recommended two-tiered antibody test. As you know, antibody tests, or antibodies themselves, take weeks to develop to fight the virus. On the next slide, our T2 Resistance Panel is a direct-from-blood, like all of our other sepsis panels, diagnostic tests that can identify 13 antibiotic resistance genes, again, independent of blood culture. We believe this will be the first direct-from-blood antimicrobial resistance diagnostic.

It has already received FDA Breakthrough Device Designation, so will get a prioritized review, and we plan to submit for FDA 510(k) clearance in the fourth quarter of 2024. This is going to be a very important diagnostic in terms of driving adoption of our platform, driving adoption of the T2Bacteria Panel, because it will be paired with T2Bacteria to identify bacterial pathogens and antibiotic resistance genes, and we look forward to launching that product. On the next slide, we are planning to pursue pediatric claims for both our T2Candida Panel, which we have already submitted to the FDA, and our T2Bacteria Panel, which we intend to submit to the FDA. This will open up more than 220 pediatric hospitals, which we're unable to directly market to today.

We are looking forward to the expansion of this unique panel, both Candida, followed by T2Bacteria, into the pediatric market. On the next slide, I wanna provide a financial summary. As of the end of second quarter 2024, our total revenue was $2 million. It was comprised entirely of product revenue, which was also comprised entirely of sepsis product revenue. We sold two instruments during the quarter and had a cash balance of $4.2 million as of June 30th, 2024. I'll just touch on some of the highlights. We achieved second quarter 2024 and second half 2024 sepsis revenue, which were records for the company, representing growth on a quarter-to-quarter basis of 27%, and a half-year to half-year basis of 25%.

They were driven by both T2Bacteria and T2Resistance Panel sales internationally, underscoring the importance of both bacteria and resistance to the company's future. We reduced our total debt and quarterly interest payments to CRG by approximately 80% from the balance as of May 2023. We signed multiple international distribution agreements in the Middle East and Asia, including in Qatar, Hong Kong, Malaysia, Indonesia, and Macau. We raised $8 million in gross proceeds through the sale, or through a private placement stock sale executed in May 2024, and we completed the clinical studies required to commercialize the T2Lyme Panel as a laboratory-developed test. Again, launch planned for the third quarter of 2024. Thank you very much.

Moderator

Thank you very much for the presentation, John. And I also wanna thank everyone in the audience for joining this presentation as well. Hope everyone have a good rest of the conference, and take care.

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