Item 8.01 - Other Events.
On
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including,
but not limited to, statements regarding the Company's anticipated path forward
for Vicineum for the treatment of BCG-unresponsive NMIBC, the Company's plans to
conduct an additional clinical trial for potential resubmission of its BLA for
Vicineum, and the Company's expectations to hold a Type C meeting with the FDA
in early 2022 to discuss the protocol for the additional clinical trial, which
are based on the Company's current expectations and inherently involve
significant risks and uncertainties. The Company's actual results and the timing
of events could differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, including the risk that
the Company may not resume its plans to pursue regulatory approval for Vicineum
for the treatment of BCG-unresponsive NMIBC in the US, the risk that the FDA may
not approve the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC if
the Company resubmits the BLA at a future time, the risk that clinical trials of
Vicineum for the treatment of BCG-unresponsive NMIBC may fail to demonstrate
safety and efficacy to the satisfaction of the FDA, or otherwise produce
favorable results, and the risk that Vicineum for the treatment of
BCG-unresponsive NMIBC may cause undesirable side effects, serious adverse
events or have other properties that could delay or halt clinical trials, delay
or prevent its regulatory approval by the FDA, or limit the commercial profile
of its labeling, if approved, or result in significant negative consequences
following any marketing approval, among other risks and uncertainties. A further
description of the risks and uncertainties relating to the business of the
Company is contained in the Company's most recent annual report on Form 10-K and
the Company's quarterly reports on Form 10-Q, as well as any amendments thereto
reflected in subsequent filings with the
A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01 - Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release dated December 9 , 2021 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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