Item
8.01. Other Events
Update
on the SEC Investigation
As
disclosed previously, on September 7, 2018, the SEC filed a complaint in the U.S. District Court for the Southern District of
New York captioned SEC v. Honig et al., No. 1:18-cv-01875 (S.D.N.Y. 2018) (the “Honig Lawsuit”) alleging that
certain persons, including John Stetson, our former Chief Financial Officer and Chief Investment Officer, Barry Honig, who is
a former officer and director and currently a greater than 5% shareholder of the Company, and Michael Brauser, who is a former
director and currently a greater than 5% shareholder of the Company, manipulated the price of securities of three public companies
(none of which is PolarityTE). This complaint, which was amended on March 8, 2019 (as amended, the “Complaint”), alleges
that the defendants violated the anti-fraud and other provisions of the Securities Act, the Exchange Act and SEC rules promulgated
thereunder by writing, or causing to be written, false or misleading promotional articles, engaging in a variety of other manipulative
trading practices as well as filing false reports of their beneficial ownership or failure to file reports of their beneficial
ownership when required to do so.
As
disclosed previously, on March 1, 2019, following our receipt and response to a request for information and document preservation
from the SEC, we received a subpoena from the SEC requesting documents related to Barry Honig, John Stetson, Michael Brauser,
and others associated with the Company in or around December 2016. The subpoena requests, among other things, (i) communications
and agreements between us and, among others, John Stetson, Barry Honig and Michael Brauser, (ii) information related to the transaction
pursuant to which Majesco Entertainment Company acquired PolarityTE NV and its regenerative medicine business, (iii) information
related to the performance of and communications with regulators regarding SkinTE, our lead product, and (iv) any promotion of
the Company or its securities.
Since
March 2019, the Company has received additional subpoenas seeking documents on these and other topics. The documents and information
requested in the subpoenas include materials concerning (i) the circumstances under which the Company placed Denver Lough, former
Chief Executive Officer, and Naveen Krishnan, former Vice President of Analytics, on paid administrative leave, (ii) termination
and separation agreements with former employees, and (iii) certain commercialization metrics included in Company disclosures.
The Company has provided documents and information to the SEC in response to these requests and expects to make additional productions
in response to the subpoenas. The Company has endeavored to cooperate fully with the SEC in producing documents and information
requested.
Employment
and Retaliation Issues
On
May 31, 2019, the Company placed Denver Lough, the former Chief Executive Officer, on paid administrative leave, which was publicly
reported on June 4, 2019. On August 26, 2019, the Company publicly reported the resignation by Dr. Lough from his positions as
an officer and director of the Company and the terms agreed with the Company pertaining to that resignation. Also in May 2019,
the Company placed Naveen Krishnan, former Vice President of Analytics, on paid administrative leave. In June 2019, the SEC issued
one of the additional subpoenas mentioned above, which included a request for documents and information concerning the circumstances
under which Drs. Lough and Krishnan were placed on paid administrative leave. The Company terminated Dr. Krishnan’s employment
on July 12, 2019.
In
October 2019, the Company received from counsel for Dr. Krishnan a letter (“Krishnan Letter”) claiming that his termination
was unlawful retaliation in violation of the Sarbanes Oxley Act and the Dodd-Frank Wall Street Reform and Consumer Protection
Act of 2010, and that Dr. Krishnan was wrongfully terminated in violation of the public policy of Utah. Specifically, Dr. Krishnan
claims that the Company’s leadership mistreated, marginalized, and suspended Dr. Krishnan after he allegedly raised concerns
about the accuracy of the Company’s representations to the public in May 2019 and before regarding certain commercial metrics
as indicators of performance, including commercial account definitions and numbers, sales cycle timelines and a graphical representation
of wound types and sizes. The Krishnan Letter does not contain any claim that the Company’s financial information reported
to the public is inaccurate. The Company believes the assertions in the Krishnan Letter are without merit and is proceeding in
the same manner it would with respect to any employment related claim by a former employee.
Forward-Looking
Statements
The
Company cautions you that statements included in this Current Report on Form 8-K that are not a description of historical facts
are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,”
“will,” “should,” “expect,” “plan,” “anticipate,” “could,”
“intend,” “target,” “project,” “contemplates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions.
These statements are based on the Company’s current beliefs and expectations. Actual results could differ from those projected
in any forward-looking statements due to numerous factors. Such factors include, among others, the Company’s ability to
satisfy the conditions in the Purchase Agreement to direct Keystone to make purchases of common stock and thereby generate the
net proceeds it intends to use, and the risk and uncertainties associated with uncertainties in the Company’s business,
including those risks described in the Company’s periodic reports it files with the SEC. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation
to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified
in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.