Item 7.01 - Regulation FD Disclosure.
On October 12, 2021, Sesen Bio, Inc. (the "Company") issued a press release
announcing the expansion of its chemistry, manufacturing, and control ("CMC")
and clinical development teams with the hiring of Eun Jang as Senior Director,
Analytical Sciences, and Chèrie Kaefring as Director, Clinical Operations. The
addition of these new team members demonstrates Sesen Bio's strong commitment to
and continued focus on the development of Vicineum™ for the treatment of
BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC").
The information furnished in this Item 7.01, including the press release
attached as Exhibit 99.1, shall not be deemed to be "filed" for the purposes of
Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange
Act"), or otherwise subject to the liabilities of such section, nor shall such
information be deemed incorporated by reference into any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except as shall be
expressly set forth by specific reference in such a filing.
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 commitment to and
continued focus on the development of Vicineum for the treatment of
BCG-unresponsive NMIBC, 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 or Europe, 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 the European Medicines Agency ("EMA"), or otherwise
produce favorable results, the risk that the FDA may not approve the Biologics
License Application ("BLA") for Vicineum for the treatment of BCG-unresponsive
NMIBC if the Company resubmits the BLA at a future time, the risk that the EMA
may not approve the Company's marketing authorization application ("MAA") for
Vicineum for the treatment of BCG-unresponsive NMIBC if the Company resubmits
the MAA at a future time, 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 the EMA, 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 Securities and
Exchange Commission. The Company undertakes no duty or obligation to update any
forward-looking statements contained in this report as a result of new
information, future events or changes in its expectations.
Item 9.01 - Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Press Release dated October 12, 2021
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
--------------------------------------------------------------------------------
© Edgar Online, source Glimpses