Full Press Release Details
T2 Biosystems Announces Plans to License its Proprietary Technology to Expand its Leadership in
Direct-From-Whole-Blood Detection of Sepsis-Causing Pathogens
Intends to accelerate broad adoption of direct-from-whole-blood
diagnostics, generate non-dilutive capital, and create a new royalty revenue stream
Mass., December 9, 2024 (GLOBE NEWSWIRE) T2 Biosystems, Inc. (NASDAQ: TTOO) (the Company ), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced plans to license
its proprietary technology to expand its leadership in direct-from-whole-blood detection of sepsis-causing pathogens. T2 Biosystems proprietary technology is a key component of its FDA-cleared products,
including the first and only products able to detect sepsis-causing pathogens directly from whole blood.
T2 Biosystems expanded business model is
intended to generate non-dilutive capital through licensing agreements that provide access to the Company s patented direct-from-whole-blood technology, create a new royalty revenue stream, and accelerate
the broad adoption of direct-from-whole-blood diagnostics to detect sepsis-causing pathogens and antibiotic resistance. The Company s FDA-cleared products are powered by its proprietary sample processing
and Magnetic Resonance (T2MR ) detection. Through its research and development efforts, T2 Biosystems has determined that its patented sample processing may be adapted to other detection
methods, including fluorescence, potentially enabling other diagnostic platforms to also detect sepsis-causing pathogens and antibiotic resistance directly-from-whole-blood.
We believe our proprietary technology is a valuable asset and that by licensing our intellectual property to allow other diagnostic firms to integrate
our direct-from-whole-blood capabilities into their commercially available instruments, we can generate non-dilutive capital, create a royalty revenue stream, and enable widespread market access to accelerate
the broad adoption of blood culture-independent diagnostics, stated John Sperzel, Chairman and CEO at T2 Biosystems. This new strategy further leverages our robust patent portfolio and scientific expertise to accelerate our mission to
improve patient outcomes, lower mortality rates, and reduce healthcare cost by enabling clinicians to make faster, targeted antimicrobial decisions.
In September 2024, T2 Biosystems succeeded in defending against the opposition of a key patent that covers the Company s novel sample preparation method,
which is a key part its proprietary direct-from-whole-blood pathogen detection method. The opposition was filed with the European Patent Office (EPO) by bioMerieux and a strawman representing another multibillion-dollar global diagnostics company
against one of T2 Biosystems previously granted European patents, which covers a novel method for amplifying a target nucleic acid characteristic of a pathogen in a whole blood sample.
T2 Biosystems intellectual property was used to develop the T2Dx Instrument, the T2Bacteria Panel, and the T2Candida Panel, which are the first and only FDA-cleared diagnostics able to
detect sepsis-causing bacterial and fungal pathogens directly-from-whole-blood, in just 3-5 hours, without the need to wait days for a positive blood culture. The Company has developed significant clinical
data to support its direct-from-whole-blood value proposition, built an installed base of nearly 200 instruments, established a number of influential key reference accounts, built relationships with key opinion leaders who advocate for our products
and technology, and recently entered into an exclusive U.S. commercial agreement with Cardinal Health (NYSE: CAH). The Company has achieved record sepsis test growth in 2024, and additional revenue streams will allow continued focus on core
priorities of accelerating sepsis test sales on the T2Dx Instrument and reducing operational costs. Accordingly, the Company believes now is the optimal time to license its proprietary technology to accelerate broad adoption of
direct-from-whole-blood detection of sepsis-causing pathogens and antibiotic resistance.
The Company s competitors that market FDA-cleared products to
detect sepsis-causing pathogens and antibiotic resistance are currently dependent on positive blood culture results. When these firms market that their products provide species identification results in 1-3
hours, or antibiotic susceptibility results in 7 hours, it is important to understand that these turnaround times are only after waiting 1-5 days for a positive blood culture. Further, if blood culture
produces false negative results due to poor sensitivity, these blood culture-dependent diagnostics provide little to no value. The potential to add direct-from-whole-blood detection to other diagnostic platforms may provide a more comprehensive
sepsis solution to hospitals and their patients.
T2 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 are powered by the proprietary T2 Magnetic Resonance (T2MR ) technology
and include the T2Dx Instrument, the T2Bacteria Panel, the T2Candida Panel,
the T2Resistance Panel, and the T2Biothreat Panel. T2 Biosystems has an active pipeline of future products, including the U.S.
T2Resistance Panel, the T2Lyme Panel, and the expended T2Candida Panel to add the detection of Candida auris. For more information, please visit www.t2biosystems.com.
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 Company s ability integrate its direct-from-whole-blood capabilities into other companies commercially available instruments; its ability to generate
non-dilutive capital, create a royalty revenue stream, and accelerate the widespread adoption of blood culture-independent diagnostics; and all other 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, 2023, filed with the U.S. Securities and
Exchange Commission, or SEC, on April 1, 2024, 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.
Philip Trip Taylor, Gilmartin Group