T2 Biosystems Announces BARDA Exercise of Contract Option 2A Valued at $6.4 Million
Advances Development of Diagnostics for Sepsis-Causing Pathogens, Antibiotic Resistance, and Biothreat Pathogens
LEXINGTON, Mass., Oct. 04, 2021 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, has exercised contract Option 2A providing an additional $6.4 million of funding for the multiple year cost share contract between BARDA and T2 Biosystems (total potential BARDA funding if all contract options are exercised is $69.0 million). Following the Company’s successful completion of the Base Period and Option 1, the additional funding will be used to further advance the development of the following products:
- T2Resistance® Panel: a direct-from-blood test panel designed to detect antibiotic resistance genes associated with sepsis-causing pathogens, to be utilized on the FDA cleared T2Dx® Instrument
- T2Biothreat® Panel: a direct-from-blood test panel designed to detect biothreat pathogens such as B. anthracis, F.tularensis, Y. pestis, Burkholderia spp., and R. prowazekii, to be utilized on the FDA cleared T2Dx Instrument
- Comprehensive Sepsis Panel: a direct-from-blood test panel designed to cover up to 99% of all bloodstream infections by means of greater than 36 reported results, including pan-Gram positive and pan-Gram negative results (detecting greater than 250 species), and resistance genes associated with bloodborne antibiotic resistant threats identified by the Centers for Disease Control and Prevention
- Next-Generation Instrument: a fully-automated, random access, high-throughput instrument designed in parallel with the comprehensive sepsis panel, to detect an increased number of pathogens and antibiotic resistance genes from a single whole blood sample
"We believe the continued funding commitment from BARDA is a testament to our technology and its potential to transform the diagnosis and management of patients at risk of sepsis, reduce antimicrobial resistance, and protect our nation from biothreat pathogens,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Sepsis is the leading cost of U.S. hospitalization and the leading cause of death in U.S. hospitals, costing nearly $62 billion annually and claiming the lives of nearly 270,000 Americans each year. Under this option, we plan to initiate U.S. clinical trials for T2Resistance and T2Biothreat Panels, as well as further advance our comprehensive sepsis panel and next-generation instrument.”
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00053.
About T2 Biosystems
T2 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 T2ResistanceTM 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 T2CaurisTM Panel, and T2Lyme TM Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers, and biothreat pathogens.
This 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 full value of the BARDA contract, the development of products under that contract, and the potential benefit of those products with respect to the diagnosis and management of bloodstream infections, antimicrobial resistance, and patient outcomes, 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 ended December 31, 2019, filed with the U.S. Securities and Exchange Commission, or SEC, on March 16, 2020, and other filings the Company makes with the SEC from 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 Company’s 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.
Gina Kent, Vault Communications
Philip Trip Taylor, Gilmartin Group