What changed in this filing

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Item 1A. Risk Factors

2021-05-14 compared with 2020-11-16 · 53 added, 37 removed, 5 unchanged (95% of the section changed)

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,

The Company’s business, operating results and financial condition could be adversely affected due to any of those

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, 2020, as filed with

the SEC on March 30, 2021, 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, 2020.

The Company’s business, operating

results and financial condition could be adversely affected due to any of those risks.

will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.

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,

Future growth will impose

significant added responsibilities on members of management, including:

recruiting, integrating, maintaining, and motivating additional personnel;

our internal development efforts effectively, while complying with our contractual obligations

to contractors and other third parties;

our internal development efforts effectively, while complying with our contractual obligations to contractors and other third parties;

our operational, financial and management controls, reporting systems, and procedures.

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.

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.

face risks related to health epidemics and other outbreaks, which could significantly disrupt our operations.

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.

future financial performance will depend, in part, on our ability to effectively manage any future growth, 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.

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.

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.

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.

are subject to securities class action lawsuits, which may require significant management time and attention and significant legal expenses

and may result in an unfavorable outcome, which could have a material adverse effect on our business, financial condition, results of

operations and cash flows.

are subject to securities class action lawsuits, which may require significant management time and attention and significant legal expenses

and may result in an unfavorable outcome, which could have a material adverse effect on our business, financial condition, results of

operations and cash flows.

and certain of our officers have been named as defendants in a securities class action lawsuit that alleges that we and certain executive

officers violated Section 10(b) of the Exchange Act, Rule 10b-5 promulgated thereunder, and Section 20(a) of the Exchange Act by making

false or misleading statements about, and allegedly failed to disclose material adverse facts concerning, the Company’s business,

operations, and prospects.

While we believe that we have substantial legal and factual defenses to the claims in the class actions and

intend to vigorously defend each case, these lawsuits could divert management’s attention from our ordinary business operations,

the outcome of the pending litigation is difficult to predict and quantify, and the defense against the underlying claims could be costly.

The ultimate resolution of this matter could result in payments of monetary damages or other costs, materially and adversely affect our

business, financial condition, results of operations and cash flows, or adversely affect our reputation, and consequently, could negatively

impact the trading price of our common stock.

have insurance policies related to the risks associated with our business, including directors’

and officers’

liability insurance

However, there is no assurance that our insurance coverage will be sufficient or that our insurance carriers will cover all

claims in that litigation.

If we are not successful in our defense of the claims asserted in the putative action and those claims are

not covered by insurance or exceed our insurance coverage, we may have to pay damage awards, indemnify our officers from damage awards

that may be entered against them and pay the costs and expenses incurred in defense of, or in any settlement of, such claims.

addition, there is the potential for additional shareholder litigation, and we could be materially and adversely affected by such matters.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors