Item 8.01. Other
Events.
On March 4, 2020, the U.S. Securities and Exchange
Commission (the “SEC”) issued an order under Section 36 (Release No. 34-88318) of the Securities Exchange Act of 1934,
as amended (“Exchange Act”), granting exemptions from specified provisions of the Exchange Act and certain rules thereunder.
On March 25, 2020, the order was modified and superseded by a new SEC order (Release No. 34-88465), which provides conditional
relief to public companies that are unable to timely comply with their filing obligations as a result of the novel coronavirus
(“COVID-19”) outbreak (the “SEC Order”). The SEC Order provides that a registrant subject to the reporting
requirements of Exchange Act Section 13(a) or 15(d), and any person required to make any filings with respect to such registrant,
is exempt from any requirement to file or furnish materials with the Commission under Exchange Act Sections 13(a), 13(f), 13(g),
14(a), 14(c), 14(f), 15(d) and Regulations 13A, Regulation 13D-G (except for those provisions mandating the filing of Schedule
13D or amendments to Schedule 13D), 14A, 14C and 15D, and Exchange Act Rules 13f-1, and 14f-1, as applicable, if certain conditions
are satisfied.
Inspyr
Therapeutics, Inc. (the “Company”) will be relying on the SEC Order to delay the filing of its Annual Report on Form
10-K for the year ended December 31, 2019 (the “Report”) due to the circumstances related to COVID-19. In particular,
COVID-19 has caused severe disruptions in transportation and limited access to the Company’s facilities resulting in limited
support from its staff and professional advisors. This has, in turn, delayed the Company’s ability to complete its audit
and prepare the Report. Notwithstanding the foregoing, the Company expects to file the Report no later than May 14, 2020 (which
is 45 days from the Report’s original filing deadline of March 30, 2020).
In light of the current
COVID-19 pandemic, the Company will be including the following Risk Factors in its Report:
A pandemic, epidemic or outbreak of an
infectious disease in the markets in which we operate or that otherwise impacts our facilities or advisors could adversely impact
our business.
If a pandemic, epidemic,
or outbreak of an infectious disease including the recent outbreak of respiratory illness caused by a novel coronavirus (COVID-19)
or other public health crisis were to affect our facilities or those of our suppliers, our business could be adversely affected.
A pandemic typically results in social distancing, travel bans and quarantine, and this may
limit access to our facilities, management, support staff and professional advisors. These factors, in turn, may not only materially
impact our operations and financial condition, but our overall ability to react timely to mitigate the impact of this event. Also,
it may hamper our efforts to comply with our filing obligations with the Securities and Exchange Commission.
Business or
economic disruptions or global health concerns could seriously harm our development efforts and increase our costs and expenses.
Broad-based business
or economic disruptions could adversely affect our ongoing or planned research and development activities. For example, in December
2019 an outbreak of a novel strain of coronavirus originated in Wuhan, China, and has since spread around the world, including
to the United States. To date, this outbreak has already resulted in extended shutdowns of many businesses around the world, including
in the United States. Global health concerns, such as coronavirus, could also result in social, economic, and labor instability
in the countries in which we or the third parties with whom we engage operate. We cannot presently predict the scope, severity
and longevity of any potential business shutdowns or disruptions, but if we or any of the third parties with whom we engage or
plan to engage, including the suppliers, clinical trial sites, regulators and other third parties with whom we conduct business
or plan to conduct business, were to experience shutdowns or other business disruptions, our ability to conduct our business in
the manner and on the timelines presently planned could be materially and negatively impacted. It is also possible that global
health concerns such as this one could disproportionately impact the hospitals and clinical sites in which we conduct or plan to
conduct any of our clinical trials, which could have a material adverse effect on our business and our results of operation and
financial condition.
Cautionary Note Regarding Forward-Looking
Statements
This Current Report on Form 8-K contains statements
that are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking
statements relate to expectations or forecasts for future events, including, without limitation, our future financial or business
performance or strategies, results of operations or financial condition. These statements may be preceded by, followed by or include
the words “may,” “might,” “should,” “estimate,” “plan,” “project,”
“forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,”
“continue,” “target” or similar expressions. These forward-looking statements are based on information
available to us as of the date they were made and involve a number of risks and uncertainties which may cause them to turn out
to be wrong. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date,
and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they
were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities
laws. As a result of a number of known and unknown risks and uncertainties, including the unprecedented impact of COVID-19 pandemic
on our business, customers, employees, subcontractors and supply chain, consultants, service providers, stockholders, investors
and other stakeholders, our actual results or performance may be materially different from those expressed or implied by these
forward-looking statements. Please refer to our Form 10-K to be filed with the SEC as well as any subsequent filings made by us
pursuant to the Exchange Act, each of which is available on the SEC’s website (www.sec.gov), for a full discussion of the
risks and other factors that may impact any forward-looking statements in this presentation.