Item 2.02. Results of Operations and Financial Condition.
On
The information in this Item 2.02, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
Preliminary Financial Results
As described above, on
These estimated financial results are preliminary and unaudited, represent management's estimates as of the date of this Current Report on Form 8-K and are subject to the completion of the Company's financial closing procedures. The Company's independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, these estimated financial results.
Cash Runway
As a result of SIVEXTRO sales in the fourth quarter of 2021 and improved
operating efficiencies within the business, the Company anticipates that its
cash, cash equivalents and short-term investments as of
Clinical Update
The Company has initiated a Phase I clinical trial of lefamulin for the treatment of cystic fibrosis patients with bacterial infections and expects to enroll the first patient in the trial in the first quarter of 2022.
Forward-Looking Statements
Any statements in this Current Report on Form 8-K about future expectations,
plans and prospects for the Company, including but not limited to statements
about the sufficiency of the Company's existing cash resources, its preliminary
financial results for the fourth quarter of 2021, the timing of patient
enrollment for its Phase I clinical trial and other statements containing the
words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "target," "potential," "likely," "will," "would," "could,"
"should," "continue," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors, including:
the extent of business and other interruptions resulting from the infection
causing the COVID-19 outbreaks or similar public health crises, the sufficiency
of cash resources and need for additional financing and such other important
factors as are set forth in the Company's annual and quarterly reports and other
filings with the
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press Release datedJanuary 10, 2022 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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