Business Update
As previously disclosed, T2 Biosystems, Inc. (the “Company”) is currently developing aSARS-CoV-2 test, (the“T2SARS-CoV-2 Test”), to run on the Company’s proprietary T2Dx Instrument platform and anticipates shipping the first tests to U.S. customers for clinical use as early as the end of June. TheT2SARS-CoV-2 Test is anticipated to be asample-to-answer test of a nasopharyngeal swab specimen, with a turnaround time of less than two hours and a limit of detection of less than 1,000 genomic equivalents per milliliter. Based on significant interest regarding the availability of theT2SARS-CoV-2 Test the Company has received to date, the Company anticipates that there will be demand for the test upon it being made commercially available for clinical use. The Company currently has the resources to manufacture up to 100,000 tests per month and, subject to the success of the Company’s efforts to secure additionalnon-dilutive funding to support expansion of manufacturing capacity, estimates that it could potentially ramp to approximately 1,000,000 tests per month.
Forward-Looking Statements
This Current Report on Form8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form8-K that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the T2SARS-CoV-2 Test, the Company’s ability to manufacture the T2SARS-CoV-2 Test on the expected scale and timeline, anticipated demand for such tests, the Company’s ability to secure funding to support expansion of manufacturing capacity, the impact ofCOVID-19 on the economy and the Company’s business, 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 Form10-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 Current Report on Form8-K. Any such forward-looking statements represent management’s estimates as of the date of this Current Report on Form8-K. 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 Current Report on Form8-K.
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