T2 Biosystems Unveils T2Lyme Launch Plans and Provides Additional Business Updates
March 20 2024 - 7:30AM
T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the
rapid detection of sepsis-causing pathogens and antibiotic
resistance genes, today announced plans for the T2Lyme Panel
commercial launch and provided recent business updates.
Recent Highlights
- Announced plans to commercialize
the T2Lyme Panel in the third quarter of 2024 as a laboratory
developed test (LDT) without the need to be run on the T2Dx®
Instrument providing throughput improvements and cost of goods
advantages. The Company is currently in discussions with potential
LDT partners and plans to provide early Lyme disease results to
U.S. reference laboratories nationwide.
- Announced a new publication in
Journal of Clinical Microbiology highlighting the clinical benefits
and performance of the T2Resistance Panel, including demonstrating
high accuracy, faster detection times, and the positive impact of
faster test results on clinical interventions.
- Engaged Dr. Robin Robinson as a
strategic advisor to aid in commercialization of the T2Biothreat
Panel. Dr. Robinson is the former Director of the Biomedical
Advanced Research and Development Authority (BARDA) and former
Deputy Assistant Secretary for Preparedness and Response
(ASPR).
- Received extension from the Nasdaq
Hearings Panel to regain compliance with $35 million Market Value
of Listed Securities requirement as set forth in Nasdaq Listing
Rule 5550(b)(2) on or before May 20, 2024.
“Recently, we have made significant progress on
our three corporate priorities that we believe positions us for a
strong future. Specifically, the anticipated launch of the T2Lyme
Panel in the third quarter, new data validating the clinical
benefits of the T2Resistance Panel and increasing commercial
support and U.S. Government engagement on the T2Biothreat Panel
each represent potential material growth catalysts,”
stated John Sperzel, Chairman and CEO of T2 Biosystems.
“We continue to prioritize our Nasdaq listing and advance the
review of strategic alternatives which are both intended to
increase shareholder value.”
Reiterated 2024 Financial
Outlook The Company continues to expect full year 2024
total sepsis and related product revenue of $10.0 million to $11.0
million, representing growth of 49% to 64%, compared to $6.7
million in 2023. The Company’s 2024 revenue guidance consists
entirely of sepsis and related product revenue and does not include
potential sales of the T2Lyme Panel or the T2Biothreat Panel.
Webcast and Conference Call
InformationThe Company’s management team will host a
conference call today, March 20, 2024, beginning at 8:30 am ET.
Investors interested in listening to the call may do so by dialing
888-506-0062 for domestic callers or 973-528-0011 for International
callers and using conference ID 688651 approximately five minutes
prior to the start time. A live and recorded webcast of the call
will be available on the “Investors” section of the Company’s
website at www.t2biosystems.com.
About T2 BiosystemsT2
Biosystems, a leader in the rapid detection of sepsis-causing
pathogens and antibiotic resistance genes, 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, the T2Bacteria®
Panel, the T2Candida® Panel, the T2Resistance® Panel, and the
T2Biothreat™ Panel, and are powered by the proprietary T2 Magnetic
Resonance (T2MR®) technology. T2 Biosystems has an active pipeline
of future products, including the U.S. T2Resistance Panel, the
Candida auris test, and the T2Lyme™ Panel. For more information,
please visit www.t2biosystems.com.
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
likelihood that the T2Lyme Panel will be launched in the third
quarter of 2024, the ability of the Company to provide T2Lyme
results to U.S. reference laboratories nationwide, the likelihood
that the growing dataset for T2Resistance will be a catalyst for
increased adoption in countries where the T2Resistance Panel is
currently available for purchase, and the likelihood that
increasing commercial support and U.S. Government engagement
represents a material future growth catalyst, as well as statements
that include the words “expect,” “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, 2022, filed with the U.S. Securities and
Exchange Commission, or SEC, on March 31, 2023, and other filings
the Company makes with the SEC from time to time, including our
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
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.
Investor Contact:Philip Trip Taylor, Gilmartin
Groupir@T2Biosystems.com 415-937-5406
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