T2 Biosystems Accelerates Product Development Initiatives Under Existing BARDA Contract

Rhea-AI Summary

T2 Biosystems (NASDAQ:TTOO) announced modifications to its contract with BARDA to speed up the development of key products including T2Biothreat, T2Resistance, and a comprehensive sepsis panel. The multi-year contract could be valued at up to $69.0 million. The changes allow for accelerated development of these vital panels designed to detect various pathogens and antibiotic resistance. The contract is part of a broader effort to enhance diagnostics and manage sepsis, significantly impacting patient outcomes by reducing diagnostic times and improving treatment options.

Positive

• Modifications to the BARDA contract to accelerate product development.
• Potential contract value of up to $69.0 million if all options are exercised.
• Development of innovative products aimed at detecting biothreat pathogens and antibiotic resistance.

Negative

• No significant negative aspects reported.

Speeds Up Development of T2Biothreat, T2Resistance, Comprehensive Sepsis Panel, Next-Generation Instrument

LEXINGTON, Mass., May 06, 2021 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, announced today that the Company has modified the terms of its existing contract with 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, to accelerate the development of multiple products that are being funded under the contract.

The multi-year contract between BARDA and T2 Biosystems is valued at up to $69.0 million if all options are exercised. T2 Biosystems is accelerating product development by modifying the contract to advance future deliverables into the currently funded Option 1 of the contract, which commenced in September 2020 and is planned to conclude in October 2021, for the following products:

• T2Biothreat: a direct-from-blood panel designed to detect biothreat pathogens such as B. anthracis, F.tularensis, Y. pestis, Burkholderia spp., and R. prowazekii, and to run on the FDA-cleared T2Dx Instrument
• T2Resistance: a direct-from-blood panel designed to detect antibiotic resistance genes associated with sepsis causing pathogens, and to run on the FDA-cleared T2Dx Instrument
• A direct-from-blood comprehensive sepsis panel designed to detect up to 99% of bloodstream infections by means of ≥36 reported results, including pan-Gram positive and pan-Gram negative results (detecting approximately250 species), in addition to resistance genes associated with the bloodborne antibiotic resistant threats identified by the Centers for Disease Control and Prevention (CDC), and to run on the next-generation instrument
• A next-generation instrument designed to process panels with broader pathogen detection and resistant genes.

“We continue to make excellent progress under the BARDA contract aimed at developing new products that have the potential to protect our nation from biothreats and transform the diagnosis and management of bloodstream infections that can cause sepsis,” stated John Sperzel, President and Chief Executive Officer at T2 Biosystems. “We are working closely with the team at BARDA to realize our goal of saving lives, reducing antimicrobial resistance, and improving patient and healthcare outcomes.”

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 T2Resistance^TM 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^TM 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.

Forward-Looking Statements
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, 2020, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2021, 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.

Media Contact:
Gina Kent, Vault Communications
gkent@vaultcommunications.com
610-455-2763

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

FAQ

What are the products being developed by T2 Biosystems under the BARDA contract?

T2 Biosystems is developing T2Biothreat, T2Resistance, and a comprehensive sepsis panel under the BARDA contract.

How much is T2 Biosystems' contract with BARDA worth?

The contract with BARDA is valued at up to $69.0 million if all options are exercised.

What is the purpose of the T2Biothreat product?

T2Biothreat is designed to detect biothreat pathogens directly from blood samples.

When did the BARDA contract with T2 Biosystems begin?

The BARDA contract commenced in September 2020 and is planned to conclude in October 2021.