Item 1A. Risk Factors
ITEM
1A. RISK FACTORS
An
investment in the Company’s common stock involves a number of very significant risks. You should carefully consider the
risk factors included in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December
31, 2019, as filed with the SEC on March 30, 2020, in addition to other information contained in our reports and in this quarterly
report in evaluating the Company and its business before purchasing shares of our common stock. Except as set forth below, there
have been no material changes to our risk factors contained in our Annual Report on Form 10-K for the year ended December 31,
2019. The Company’s business, operating results and financial condition could be adversely affected due to any of those
risks. In addition:
We
will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
As
our business strategies develop, we must add additional managerial, operational, financial and other personnel. Future growth
will impose significant added responsibilities on members of management, including:
●
identifying,
recruiting, integrating, maintaining, and motivating additional personnel;
●
managing
our internal development efforts effectively, while complying with our contractual obligations to contractors and other third
parties; and
●
improving
our operational, financial and management controls, reporting systems, and procedures.
Our
future financial performance will depend, in part, on our ability to effectively manage any future growth, which might be impacted
by the COVID-19 outbreak, and our management may also have to divert a disproportionate amount of its attention away from day-to-day
activities in order to devote a substantial amount of time to managing these growth activities. This lack of long-term experience
working together may adversely impact our senior management team’s ability to effectively manage our business and growth.
We
currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations,
advisors and consultants to provide certain services. There can be no assurance that the services of these independent organizations,
advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements.
In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided
by consultants is compromised for any reason, we may not be able to advance our business. There can be no assurance that we will
be able to manage our existing consultants or find other competent outside contractors and consultants on economically reasonable
terms, if at all. If we are not able to effectively expand our organization by hiring new employees and expanding our groups of
consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop our business
initiatives and, accordingly, may not achieve our research, development, and commercialization goals.
We
face risks related to health epidemics and other outbreaks, which could significantly disrupt our operations.
Our
business and operating results could be adversely impacted by the effects of epidemics, including but not limited to the current
COVID-19 pandemic. We are closely monitoring the impact of the COVID-19 global outbreak, although there remains significant uncertainty
related to the public health situation globally. Our results of operations could be adversely affected to the extent that such
coronavirus or any other epidemic generally harms the global economy.
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