Item 1.01 Entry into a Material Definitive Agreement.
On
The Loan Agreement, a copy of which (together with amendments thereto) was filed
as Exhibits 10.13, 10.19, 10.26, 10.27, 10.32, 10.38, 10.46, and 10.60 to the
Company's Annual Report on Form 10-K for the year ended
Item 1.02 Termination of a Material Definitive Agreement.
As previously reported, on
On
The Company disagrees with Landlord's allegations and actions and believes that the Landlord is in breach of certain of its materials obligations under the Lease. The Company intends to vigorously defend itself and pursue all legal remedies available under applicable laws.
The Company believes it will continue to meet its current manufacturing needs
with its operations at its
Item 2.02 Results of Operations and Financial Condition
On
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 of this Current Report on Form 8-K is being furnished and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. Furthermore, such information, including Exhibit 99.1 attached hereto, shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly stated by specific reference in such a filing.
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Item 8.01 Other Events
On
• Achieved full year 2022 total revenue of$22.3 million , including product revenue of$11.3 million and research contribution revenue of$11.0 million • Achieved fourth quarter total revenue of$5.5 million , including product revenue of$2.2 million and research contribution revenue of$3.3 million • Achieved record full year 2022 sepsis and related product revenue globally, and record fourth quarter sepsis test revenue in theU.S. • Achieved record full year 2022 sepsis-driven T2Dx® Instruments, totaling 51 contracts, consisting of 27 from theU.S. and 24 from outside theU.S. • AdvancedU.S. clinical trials for the T2Resistance® Panel and T2Biothreat™ Panel • Initiated studies to expand the T2Bacteria® Panel to include detection of Acinetobacter baumannii, the tenth most common pathogen that has a crude ICU mortality rate of 34.0% to 43.4% • Received FDA Breakthrough Device Designation and LymeX Award for the T2Lyme™ Panel, and announced plans to complete the development of, and commercialize, theT2Lyme Panel • Implemented expense reductions and cost of goods improvements during the second quarter of 2022 reducing our workforce and decreasing operating expenses by approximately 20% • Cash, cash equivalents, and restricted cash totaled$11.9 million as ofDecember 31, 2022
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Item 9.01 Financial Statements and Exhibits
(d) Exhibits Exhibit No. Description 99.1 Press Release issuedJanuary 26, 2021 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
Forward-Looking Statements
This Current Report on Form 8-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 Form 8-K that do not relate to matters of
historical fact should be considered forward-looking statements, including,
without limitation, statements regarding the amount of any alleged damages
incurred by the Landlord and to be paid by the Company in connection with the
Lease termination, the likely result of any dispute between the Company and
Landlord, the availability of additional manufacturing space, our revenue
results and cash balance, financial outlook, cost improvement measures, timing
of completion of clinical trials, anticipated strategic priorities, status of
product development pipeline, product demand, commitments or opportunities, and
growth expectations or targets, 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. The preliminary, estimated financial results for the fourth
quarter and fiscal year 2022 contained in this Current Report on Form 8-K
contain forward-looking statements and are subject to the completion of
management's and the audit committee's final reviews and our other financial
closing procedures and are therefore subject to change. You should not place
undue reliance on such preliminary information and estimates because they may
prove to be materially inaccurate. The preliminary information and estimates
have not been compiled or examined by our independent auditors and they are
subject to revision as we prepare our financial statements as of and for the
quarter and fiscal year ended
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
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