Item 2.02.
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Results of Operations and Financial Condition.
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On November 9, 2017, Histogenics Corporation
(Histogenics) issued a press release and is holding a conference call regarding its results of operations and financial condition for the quarter ended September 30, 2017. The press release is furnished as Exhibit 99.1 to this
Current Report on Form
8-K
and is incorporated by reference herein.
Various statements to be made during the
conference call are forward-looking statements under the securities laws. Words such as, but not limited to, anticipate, believe, can, could, expect, estimate,
design, goal, intend, may, might, objective, plan, predict, project, target, likely, should,
will, and would, or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in
Histogenics forward-looking statements include, among others: the timing and success of Histogenics NeoCart Phase 3 clinical trial; possible delays in releasing the
top-line
data for the NeoCart
Phase 3 clinical trial and timing of filing a biologics license application with the U.S. Food and Drug Administration; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved
products; Histogenics ability to secure a development and commercialization partner for NeoCart in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics product candidates; the ability to obtain
and maintain regulatory approval regarding the comparability of critical NeoCart raw materials; the size and growth of the potential markets for Histogenics product candidates and the ability to serve those markets; Histogenics
expectations regarding its expenses and revenue; the sufficiency of Histogenics cash resources and the availability of additional financing on commercially reasonable terms and other factors that are described in the Risk Factors
and Managements Discussion and Analysis of Financial Condition and Results of Operations sections of Histogenics Annual Report on Form
10-K
for the year ended December 31, 2016 and
Quarterly Report on Form
10-Q
for the quarter ended June 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SECs website at www.sec.gov.
Additional factors may be set forth in those sections of Histogenics Quarterly Report on Form
10-Q
for the quarter ended September 30, 2017, to be filed with the SEC in the fourth quarter of 2017.
In addition to the risks described above and in Histogenics annual report on Form
10-K
and quarterly reports on Form
10-Q,
current reports on Form
8-K
and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics results.
There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they
will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by
the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information conveyed on the conference call
will be provided only as of the date of the call, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements made during the call after the date thereof, whether as
a result of new information, future events or otherwise.
The information in Item 2.02 of this Current Report on
Form 8-K
and the Exhibit attached hereto 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.