−Removed: pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect our business and
−Removed: recent outbreak of COVID-19 originated in Wuhan, China, in December 2019 and has since spread to multiple countries, including
−Removed: the United States and several European countries.
−Removed: On March 11, 2020, the World Health Organization declared the outbreak a pandemic.
−Removed: The COVID-19 pandemic is affecting the United States and global economies and may affect our operations and those of third parties
−Removed: on which we rely.
−Removed: While the potential economic impact brought by, and the duration of the COVID-19 pandemic is difficult to assess
−Removed: or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which
−Removed: could negatively impact our short-term and long-term liquidity.
−Removed: The ultimate impact of the COVID-19 pandemic is highly uncertain
−Removed: and subject to change.
−Removed: We do not yet know the full extent of potential delays or impacts on our business, financing or the global
−Removed: economy as a whole.
−Removed: However, these effects could have a material impact on our liquidity, capital resources, operations and business
−Removed: and those of the third parties on which we rely.
+Added: factors that affect our business and financial results are discussed in Part I, Item 1A “Risk Factors,”
+Added: in our Annual
+Added: Report on Form 10-K, as amended and supplemented by our Quarterly Reports on Form 10-Q (collectively, the “Reports”).
+Added: Other than as set forth below, there have been no material changes in our risk factors from those previously disclosed in our
+Added: You should carefully consider the risks described in our Reports, which could materially affect our business, financial
+Added: condition or future results.
+Added: The risks described in our Reports are not the only risks we face.
+Added: Additional risks and uncertainties
+Added: not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial
+Added: condition, and/or operating results.
+Added: If any of the risks actually occur, our business, financial condition, and/or results of
+Added: operations could be negatively affected.
+Added: stock price has fluctuated in the past, has recently been volatile and may be volatile in the future, and as a result, investors
+Added: in our common stock could incur substantial losses.
+Added: stock price has fluctuated in the past, has recently been volatile and may be volatile in the future.
+Added: By way of example, on February
+Added: 1, 2021, the price of our common stock closed at $0.32 per share while on February 12, 2021, our stock price closed at $0.45 per
+Added: share with no discernable announcements or developments by the company or third parties.
+Added: On February 5, 2021, the intra-day sales
+Added: price of our common stock fluctuated between a reported low sale price of $0.33 and a reported high sales price of $0.45.
+Added: incur rapid and substantial decreases in our stock price in the foreseeable future that are unrelated to our operating performance
+Added: or prospects.
+Added: In addition, the recent outbreak of the novel strain of coronavirus (COVID-19) has caused broad stock market and
+Added: industry fluctuations.
+Added: The stock market in general and the market for companies such as our in particular have experienced extreme
+Added: volatility that has often been unrelated to the operating performance of particular companies.
+Added: As a result of this volatility,
+Added: investors may experience losses on their investment in our common stock.
+Added: The market price for our common stock may be influenced
+Added: by many factors, including the following:
+Added: reaction to our business strategy;
+Added: success of competitive products or technologies;
+Added: continued compliance with the OTCQB listing standards;
+Added: or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our
+Added: taken by regulatory agencies with respect to our products, manufacturing process or sales and marketing terms;
+Added: in our financial results or those of companies that are perceived to be similar to us;
+Added: success of our efforts to acquire or in-license additional products or product candidates;
+Added: concerning our collaborations or partners;
+Added: or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain
+Added: patent protection for our products;
+Added: ability or inability to raise additional capital and the terms on which we raise it;
+Added: in the market prices of stocks generally;
+Added: volume of our common stock;
+Added: of our common stock by us or our stockholders;
+Added: economic, industry and market conditions;
+Added: events or factors, including those resulting from such events, or the prospect of such events, including war, terrorism and
+Added: other international conflicts, public health issues including health epidemics or pandemics, such as the recent outbreak of
+Added: the novel coronavirus (COVID-19), and natural disasters such as fire, hurricanes, earthquakes, tornados or other adverse weather
+Added: and climate conditions, whether occurring in the United States or elsewhere, could disrupt our operations, disrupt the operations
+Added: of our suppliers or result in political or economic instability.
+Added: broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance.
+Added: Further, recent increases are significantly inconsistent with any improvements in actual or expected operating performance, financial
+Added: condition or other indicators of value, including our loss per share of $0.18 and $0.03 for our fiscal year ended September 30,
+Added: 2020 and the three months ended December 31, 2020.
+Added: Since the stock price of our common stock has fluctuated in the past, has been
+Added: recently volatile and may be volatile in the future, investors in our common stock could incur substantial losses.
+Added: following periods of volatility in the market, securities class-action litigation has often been instituted against companies.
+Added: Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and
+Added: resources, which could materially and adversely affect our business, financial condition, results of operations and growth prospects.
+Added: There can be no guarantee that our stock price will remain at current levels or that future sales of our common stock will not
+Added: be at prices lower than those sold to investors.
+Added: Additionally,
+Added: securities of certain companies have recently experienced significant and extreme volatility in stock price due short sellers
+Added: of shares of common stock, known as a “short squeeze.”
+Added: These short squeezes have caused extreme volatility in both
+Added: the stock prices of those companies and in the market, and have led to the price per share of those companies to trade at a significantly
+Added: inflated rate that is disconnected from the underlying value of the company.
+Added: Many investors who have purchased shares in those
+Added: companies at an inflated rate face the risk of losing a significant portion of their original investment, as in many cases the
+Added: price per share has declined steadily as interest in those stocks have abated.
+Added: While we have no reason to believe our shares would
+Added: be the target of a short squeeze, there can be no assurance that we won’t be in the future, and you may lose a significant
+Added: portion or all of your investment if you purchase our shares at a rate that is significantly disconnected from our underlying
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
+Added: the three months ended December 31, 2019, the Company issued 620,000 shares of stock options.
DEFAULTS UPON SENIOR SECURITIES
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