T2 Biosystems Business Update

T2 Biosystems Business Update

Thank you, operator. I would like to remind everyone

that comments made by management today and answers to questions will include forward-looking statements. Those include statements related to T2 Biosystems future financial and operating results and plans for developing and marketing new

Forward-looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual

results to differ materially from those expressed or implied by these statements, including the risks and uncertainties described in T2 Biosystems annual report on Form 10-K filed with the SEC on

April 1, 2024, and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.

With that, I would like to turn the call over to Chairman and CEO, John Sperzel. John?

Thank you for joining our investor call. The purpose of today s call is to discuss a number of recent developments that we believe can be transformative

for T2 Biosystems. In advance of this call, we solicited questions from investors and we have incorporated our responses to those questions in today s script. While I will focus my comments on our core sepsis business, I will also address two

additional business opportunities: bioterrorism and Lyme disease.

LET S START WITH A BRIEF DESCRIPTION OF SEPSIS AND AN OVERVIEW OF OUR SEPSIS

Sepsis is the body s overwhelming and often life-threatening response to infection that can lead to tissue damage, organ

failure, and death. Sepsis is the leading cause of death in U.S. hospitals, claiming the lives of approximately 350,000 Americans annually. Sepsis

T2 Biosystems Business Update

also represents the leading cost of U.S. hospitalization, costing our healthcare system an estimated $62 billion annually. Lastly, sepsis

is the leading cause of 30-day hospital readmission in the U.S., with 19% of sepsis survivors re-hospitalized within 30 days and 40% within 90 days. To address the human

and economic toll associated with sepsis, T2 Biosystems is commercializing the FDA-cleared T2Dx Instrument and three sepsis test panels: the T2Bacteria Panel, the T2Candida Panel, and the T2Resistance Panel.

The T2Bacteria Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing bacterial

species directly-from-blood, in just 3-5 hours. The T2Bacteria Panel simultaneously detects six bacterial species with 90% sensitivity and 98% specificity, including, E. faecium, S.

aureus, K. pneumoniae, A. baumannii, P. aeruginosa, and E. coli. The six species detected by the T2Bacteria Panel account for nearly 75% of all bacterial bloodstream infections in the U.S.

The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing Candida

species directly-from-blood, in just 3-5 hours. The T2Candida Panel detects five Candida species with 91% sensitivity and 99% specificity, including, C. albicans, C.

tropicalis, C. parapsilosis, C. krusei, and C. glabrata. According to the U.S. Centers for Disease Control and Prevention, or CDC, the five species detected by the T2Candida Panel account for up to 95% of all

Candida bloodstream infections in the U.S.

The T2Resistance Panel is a CE-marked

diagnostic test able to detect antibiotic resistance genes directly-from-blood, in just 3-5 hours. The T2Resistance Panel simultaneously detects thirteen antibiotic resistance genes from both Gram-positive and

Gram-negative bacterial pathogens. The T2Resistance Panel is currently marketed and sold in Europe under a CE-mark and has received FDA Breakthrough Device designation which will provide for a

prioritized 510(k) review process. We expect to submit the T2Resistance Panel to the FDA during the fourth quarter of 2024.

T2 Biosystems Business Update

Our competitors claim that their products can detect sepsis-causing pathogens or antimicrobial resistance in

1.5 to 3 hours; however, and this is important, that is after they wait 1-5 days for a positive blood culture. A September 20, 2024, article which appeared in The Lancet, a world-leading medical

journal, titled Changing the Culture of Blood Culture described the weaknesses of blood culture, including poor sensitivity (i.e., missed infections), slow time to result (i.e., typically 2-3

days); vulnerability to contamination; reduced effectiveness in patients who have received antibiotics; and a labor-intensive process requiring skilled technicians.

Accordingly, our ability to detect sepsis-causing pathogens and antibiotic resistance genes direct-from-blood, without first requiring a positive blood

culture, is a significant competitive advantage. We have a broad intellectual property portfolio that protects our proprietary direct-from-blood detection method. In fact, last week, we announced that we had successfully defended against an

opposition filed against a key patent in our direct-from-blood detection method in the European Union. The opposition was filed by two of the world s largest diagnostics companies, one of which was bioMerieux, a leader in blood culture-based

diagnostics. On September 19, 2024, the European Patent Office ruled that T2 Biosystems intellectual property position on direct-from-blood pathogen detection was maintained and we think this is very important in protecting our

competitive advantage in this space.

LET S MOVE TO THE EXCLUSIVE U.S. AGREEMENT WITH CARDINAL HEALTH.

On our last earnings call, I mentioned that we had been exploring a range of strategic alternatives to accelerate the growth of our business, and that we were

in negotiations with a multibillion-dollar healthcare company regarding a potential U.S. commercial partnership. On October 7, 2024, we announced that we had entered into a multi-year exclusive U.S. agreement with Cardinal Health. Under the

agreement, Cardinal Health has exclusive rights to sell the T2Dx Instrument, the T2Bacteria Panel, and the T2Candida Panel in the United States.

T2 Biosystems Business Update

Who is Cardinal Health?

Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance

and data solutions for healthcare facilities. Cardinal Health trades on the New York Stock Exchange under the symbol CAH, has annual revenue of more than $200 billion, has operations in more than 30 countries, and has approximately 48,000

How does an exclusive U.S. agreement with Cardinal Health help T2 Biosystems?

We believe our agreement with Cardinal Health will be transformative, with the objectives of accelerated revenue growth and a faster path to profitability by

expanding our access to the more than 6,000 U.S. hospitals. We expect the exclusive nature of the agreement to align interests and motivate Cardinal s commercial team.

Cardinal Health is one of the largest healthcare companies in the U.S. that sells to 90% of U.S. hospitals through its extensive commercial organization and

holds contracts with a large number of GPOs. We expect this collaboration to greatly expand our access to the U.S. hospital market as Cardinal Health has significant commercial and distribution infrastructure, including capital equipment specialists

who will sell the T2Dx Instrument.

What are the terms of the exclusive U.S. agreement with Cardinal Health?

The terms of the agreement with Cardinal Health are confidential but I able to provide some color on the agreement. The economics and logistics are similar to

the terms we have with our international distributors. For example, T2 Biosystems will sell our FDA-cleared products to Cardinal Health including the T2Dx Instrument, the T2Bacteria Panel, and the

T2Candida Panel and Cardinal Health will sell the products to U.S. hospitals.

What can this exclusive agreement do for Cardinal Health?

The agreement gives Cardinal Health exclusive rights to the only FDA-cleared direct-from-blood pathogen

detection products. In addition to the economic benefits, having access to T2 Biosystems sepsis products strengthens Cardinal Health s product offering to microbiology laboratories.

T2 Biosystems Business Update

LET S MOVE TO THE COLLABORATION WITH PRXCISION, INC.

We believe that Artificial Intelligence, or AI, will have an important and increasing role in healthcare delivery, and specifically in the management of

patients at risk of sepsis. AI can be used to diagnose diseases, develop personalized treatment plans, and assist clinicians with decision-making. We have been searching for an AI-powered decision support

platform to combine with our rapid direct-from-blood pathogen detection products.

On October 8, 2024, we announced a

co-marketing collaboration with Prxcision, Inc. with the goal of pioneering a new frontier in antibiotic stewardship to combat the growing threat of antimicrobial resistance.

Antibiotic resistance is one of the greatest threats facing modern medicine, with millions of lives at risk. Over 1.27 million deaths are reported

annually due to antimicrobial resistance, or AMR, which threatens to render essential antibiotics useless. The stakes are high, and time is critical each hour of delayed targeted treatment can increase the risk of death by up to 8% for sepsis

Prxcision, Inc. is a NY-based private company that is leveraging two decades of expertise in antibiotic development to create a real-time, AI-powered decision support platform. The product,

pRxcision, is integrated with electronic health records (like EPIC and Cerner), and provides clinicians with ranked, evidence-based antibiotic regimens tailored to each patient s needs. This approach can potentially stop antibiotic misuse,

break the cycle of antibiotic resistance, reduce healthcare costs, and ultimately save lives. I encourage you to watch a presentation and demo of the pRxcision platform at www.prxcision.com/demo

How does the pRxcision Platform Work?

platform is designed to leverage data from diagnostics, such as our T2Dx, to provide another level of precision using advanced pharmacokinetic models, pathogen profiles, and real-time patient data to enable clinicians to prescribe the right

drug, dose, and duration as the patient s condition evolves. The platform adapts continuously to changing clinical information, providing ranked, evidence-based treatment regimens that help clinicians optimize care and improve outcomes.

T2 Biosystems Business Update

How does a collaboration with Prxcision, Inc. help T2 Biosystems?

By combining our direct-from-blood diagnostics with the AI-driven pRxcision platform, we believe we can empower

clinicians with the information to stop infections in their tracks, faster than ever before. Beyond improving patient care, this collaboration is intended to drive product adoption and create exciting opportunities for growth in a rapidly evolving

market. With speed and accuracy at its core, we believe the combined solution can provide hospitals with a powerful tool to improve outcomes and reduce costs. By offering real-time insights and targeted treatment information, T2 Biosystems and

Prxcision, Inc. aim to reduce the burden of AMR, helping healthcare systems across the U.S. take a proactive stance against one of the top global public health threats.

LET S MOVE TO THE FDA 510(k) CLEARANCE FOR T2CANDIDA PEDIATRICS.

On September 16, 2024, we announced that we had received clearance from the U.S. Food and Drug Administration to market the

FDA-cleared T2Candida Panel for the detection of sepsis causing fungal pathogens in pediatric patients. This FDA clearance marks another important milestone in our commitment to expand the clinical utility of

our sepsis test panels and allows our commercial team to immediately begin marketing and selling our test to over 200 U.S. children s hospitals, a significant expansion of our total addressable market.

Studies show that the T2Candida Panel detects Candida species significantly faster, and with greater sensitivity, when compared to blood culture-based

diagnostics, and we believe the new pediatric testing claim will allow clinicians to improve outcomes and reduce cost by achieving faster targeted antifungal treatment for their pediatric patients.

According to the Journal of Fungi, a peer-reviewed scientific journal that provides an advanced forum for studies related to pathogenic fungi,

Candida species are a major contributor to morbidity and mortality in hospitalized children. Moreover, children with

T2 Biosystems Business Update

invasive candidiasis present a significant burden to the U.S. healthcare system, with a mean increased hospital length of stay of 21 days and approximately $92,000 in excess hospital costs.

A Journal of Clinical Microbiology (2022) study conducted at the Bambino Ges hospital in Rome, Italy found that pediatric patients

suspected of fungal bloodstream infections that were tested with the T2Candida Panel received species identification results 121.8 hours faster compared to blood culture.

LET S MOVE TO THE PLAN TO COMMERCIALIZE THE T2LYME PANEL

Consistent with the September 9, 2024, update on our new product development pipeline, we maintain our plan to launch the T2Lyme Panel as a Laboratory

Developed Test (LDT), and we anticipate launching our T2Lyme Panel by the start of the 2025 tick season. Rather than pursue a partnership for the LDT launch, the Company has decided to build or buy its own laboratory.

The Company believes this strategy will be in the best long-term interest of its stockholders as it is expected to result in higher profit margins, give the

Company complete control of its Lyme business, and also provide the potential to use the Lyme laboratory for other tests developed by the Company.

According to the CDC, Lyme disease is the leading vector-borne disease in the U.S., with an estimated 3.4 million tests performed each year at a cost of

nearly $500 million. The current diagnostic process is a two-tiered antibody test algorithm that relies on the presence of antibodies, and which is only accurate four to eight weeks after infection.

During those weeks, the bacteria may spread throughout the body and become much harder to eradicate and treat effectively, and may lead to chronic, debilitating disease.