GlobeNewswire Inc | Jan 11, 2022 09:03AM EST

January 11, 2022

LEXINGTON, Mass., Jan. 11, 2022 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced the initation of a U.S. clinical trial evaluating the performance of its T2Biothreat Panel designed to support a submission to the U.S. Food and Drug Administration (FDA).

The T2Biothreat Panel, which runs on T2 Biosystems T2Dx Instrument, is a direct-from-blood test panel that provides results in 3-5 hours and simultaneously detects six biothreat pathogens identified as threats by the U.S. Government, including B. anthracis,F. tularensis,Burkholderiaspp.,Y. pestis,and R. prowazekii.

The Company plans to file the FDA submission for the T2Biothreat Panel in 2022 following completion of the clinical trial, which includes positive samples being prepared and analyzed at a high-containment Biosafety Level 3 laboratory and negative samples being analyzed at a single site, and is estimated to cost T2 Biosystems $400,000 - $500,000.

We are pleased to initiate the clinical trial for our novel T2Biothreat Panel as we continue to advance our product development strategy ahead of schedule, said John Sperzel, Chairman and CEO at T2 Biosystems. We are confident that the results will highlight the versatility of our technology, including our T2Dx Instrument, and its unique ability to help protect our nation in the face of a biothreat incident. We thank BARDA for its continued support and collaboration as we expand our portfolio of blood culture independent rapid diagnostic products.

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. 75A50119C00053.

About T2 BiosystemsT2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems products include the T2Dx Instrument, T2Candida Panel, the T2Bacteria Panel, the T2Resistance Panel, and the T2SARS-CoV-2 Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR) technology. T2 Biosystems has an active pipeline of future products, including the T2Cauris Panel, and T2Lyme Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers, and biothreat pathogens.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the ability of T2 Biosytems products to help protect our nation in the face of a biothreat incident, as well as statements that include the words expect, intend, plan, believe, project, forecast, estimate, may, should, anticipate, and similar statements of a future or forward looking nature. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. "Risk Factors" in the Company's Annual Report on Form 10-K for the year endedDecember 31, 2020, filed with theU.S. Securities and Exchange Commission, orSEC, onMarch 31, 2021, and other filings the Company makes with theSECfrom time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Companys silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

Media Contact:Meagan Dominick, Vault Communicationsmdominick@vaultcommunications.com 773-369-4255

Investor Contact:Philip Trip Taylor, Gilmartin Groupphilip@gilmartinIR.com 415-937-5406