T2 Biosystems Accelerates Product Development Initiatives Under Existing BARDA Contract
May 06 2021 - 4:04PM
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 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 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.
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 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
Communicationsgkent@vaultcommunications.com 610-455-2763
Investor Contact:Philip Trip Taylor, Gilmartin
Groupphilip@gilmartinIR.com415-937-5406
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