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net losses of $956,992 and $1,610,097 for the years ended December 31, 2020 and 2019.
−Removed: Of these losses $(18,744) and $418,755
−Removed: represent net gains (losses) attributable to the recorded derivative liabilities and extinguishment of debt for the years ended
−Removed: December 31, 2019 and 2018, respectively.
−Removed: Historically, the Company has relied upon investor funds to maintain its operations
−Removed: and develop its business.
−Removed: The Company needs to raise additional capital within the next quarter from investors for working capital
−Removed: as well as business expansion, and there is no assurance that additional investor funds will be available on terms acceptable
−Removed: to the Company, or at all.
−Removed: If the Company is unable to unable to obtain additional financing to meet its working capital requirements,
−Removed: the Company likely would cease operations.
+Added: Historically, the Company has relied
+Added: upon investor funds to maintain its operations and develop its business.
+Added: The Company needs to raise additional capital within
+Added: the next quarter from investors for working capital as well as business expansion, and there is no assurance that additional investor
+Added: funds will be available on terms acceptable to the Company, or at all.
+Added: If the Company is unable to unable to obtain additional
+Added: financing to meet its working capital requirements, the Company likely would cease operations.
Company requires funding of at least $1.8 million per year to maintain current operating activities.
Over the next 24 months,
−Removed: the Company believes it will cost approximately $5.0 million to $10.0 million to fund:
−Removed: (1) the FDA approval process and initial
−Removed: deployment of the brachytherapy products and (2) initiate regulatory approval processes outside of the United States.
−Removed: The continued
−Removed: deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources and personnel.
+Added: the Company believes it will cost approximately $9 million to fund:
+Added: (1) fund the FDA approval process to conduct human clinical
+Added: trials, (2) conduct Phase I, pilot, clinical trials, (3) activate several regional clinics to administer IsoPet ®
+Added: the county, (4) create an independent production center within the current production site to create a template for future international
+Added: manufacturing, and (5) initiate regulatory approval processes outside of the United States.
principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the
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and partnership agreements or additional capital raises.
−Removed: economic events, including the inherent instability in global capital markets, as well as the lack of liquidity in the capital
−Removed: markets, could adversely impact the Company’s ability to obtain financing and its ability to execute its business plan.
+Added: economic events, including the COVID-19 pandemic, the inherent instability in global capital markets, as well as the lack of liquidity
+Added: in the capital markets, could adversely impact the Company’s ability to obtain financing and its ability to execute its
+Added: business plan.
Company has a limited operating history, which may make it difficult to evaluate its business and prospects.
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the Company will be successful in commercializing its products or expanding the number of customers purchasing its products and
−Removed: The Company had $9,500 in operating revenues, net of discounts for the year ended December 31, 2019, and no operating
−Removed: revenues for the year ended December 31, 2018 as they have commenced sales of IsoPet ®
+Added: The Company had $7,000 and $9,500 in operating revenues, net of discounts for the years ended December 31, 2020 and
+Added: 2019, respectively as they have commenced sales of IsoPet ®
of the Company’s competitors have greater resources and experience than the Company has.
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disclosure of such information, and as result the Company’s competitors could gain a competitive advantage.
−Removed: economic conditions in markets in which the Company does business can impact the demand for the Company’s goods and services.
−Removed: Decreased demand for the Company’s products and services could have a negative impact on its financial performance and cash
−Removed: for the Company’s products and services, in part, depends on the general economic conditions affecting the countries and
−Removed: industries in which the Company does business.
−Removed: A downturn in economic conditions in a country or industry that the Company serves
−Removed: may adversely affect the demand for the Company’s products and services, in turn negatively impacting the Company’s
−Removed: operations and financial results.
−Removed: Further, changes in demand for the Company’s products and services can magnify the impact
−Removed: of economic cycles on the Company’s businesses.
−Removed: Unanticipated contract terminations by customers can negatively impact operations,
−Removed: financial results and cash flow.
−Removed: The Company’s earnings, cash flow and financial position are exposed to financial market
−Removed: risks worldwide, including interest rate and currency exchange rate fluctuations and exchange rate controls.
−Removed: Fluctuations in domestic
−Removed: and world financial markets could adversely affect interest rates and impact the Company’s ability to obtain credit or attract
Company is subject to extensive government regulation in jurisdictions around the world in which it does business.
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operations are subject to political instabilities, restrictions on funds transfers, import/export restrictions, and currency fluctuation.
−Removed: in raw material and energy costs, interruption in ordinary sources of supply, and an inability to recover from unanticipated increases
−Removed: in energy and raw material costs could result in lost sales or could increase significantly the cost of doing business.
−Removed: and economic conditions affecting the costs of raw materials, utilities, energy costs, and infrastructure required to provide
−Removed: for the delivery of the Company’s products and services are beyond the Company’s control.
−Removed: Any disruption or halt in
−Removed: supplies, or rapid escalations in costs, could adversely affect the Company’s ability to manufacture products or to competitively
−Removed: price the Company’s products in the marketplace.
−Removed: To date, the ultimate impact of energy costs increases has been mitigated
−Removed: through price increases or offset through improved process efficiencies;
−Removed: however, continuing escalation of energy costs could
−Removed: have a negative impact upon the Company’s business and financial performance.
RELATED TO THE COMPANY’S COMMON STOCK
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their shares of common stock.
−Removed: Company’s average daily volume of shares traded for the years ended December 31, 2019 and 2018 was 681,623 and 1.795.854,
−Removed: respectively.
−Removed: Failure to develop or maintain an active trading market may negatively affect the value of the Company’s common
−Removed: stock, may make some potential investors unwilling to purchase the Company’s common stock or equity securities that are
−Removed: convertible into or exercisable for the Company’s common stock, and may make it difficult or impossible for the Company’s
−Removed: stockholders to sell their shares of common stock and recover any part of their investment.
+Added: Company’s average daily volume of shares traded for the years ended December 31, 2020 and 2019 was 32,815 and 681,623, respectively.
+Added: Failure to develop or maintain an active trading market may negatively affect the value of the Company’s common stock, may
+Added: make some potential investors unwilling to purchase the Company’s common stock or equity securities that are convertible
+Added: into or exercisable for the Company’s common stock, and may make it difficult or impossible for the Company’s stockholders
+Added: to sell their shares of common stock and recover any part of their investment.
Company’s outstanding securities, the stock or other securities that it may become obligated to issue under existing agreements,
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it more difficult to raise additional equity capital.
−Removed: Company had 214,421,364 shares of common stock outstanding on April 24, 2020.
+Added: Company had 297,346,254 shares of common stock outstanding on March 18, 2021.
The Company also had outstanding on that
date dilutive securities consisting of preferred stock, restricted stock units, options, warrants, and convertible notes (collectively,
−Removed: Common Stock Equivalents ”) that if they had been exercised and converted in full on April 24, 2020,
+Added: Common Stock Equivalents ”) that if they had been exercised and converted in full on March 18, 2021,
would have resulted in the issuance of up to 90,093,648 additional shares of common stock.
−Removed: The issuance of shares upon the exercise
−Removed: of the Common Stock Equivalents may result in substantial dilution to each stockholder by reducing that stockholder’s percentage
−Removed: ownership of the Company’s total outstanding shares of common stock.
−Removed: The issuance of some or all those warrants and any
−Removed: exercise of those warrants will have the effect of further diluting the percentage ownership of the Company’s other stockholders.
+Added: The issuance of shares upon
+Added: the exercise of the Common Stock Equivalents may result in substantial dilution to each stockholder by reducing that stockholder’s
+Added: percentage ownership of the Company’s total outstanding shares of common stock.
+Added: The issuance of some or all those warrants
+Added: and any exercise of those warrants will have the effect of further diluting the percentage ownership of the Company’s other
+Added: stockholders.
sales of the Company’s securities, including sales following exercise or conversion of derivative securities, or the perception
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Company’s stock price is likely to be volatile.
−Removed: the year ended December 31, 2019, the reported low closing price for the Company’s common stock was $0.0112 per share, and
−Removed: the reported high closing price was $0.0893 per share.
−Removed: For the year ended December 31, 2018, the reported low closing price for
−Removed: the Company’s common stock was $0.0208 per share, and the reported high closing price was $0.80 per share.
−Removed: There is generally
−Removed: significant volatility in the market prices, as well as limited liquidity, of securities of early stage companies, particularly
−Removed: early stage medical product companies.
+Added: the year ended December 31, 2020, the reported low closing price for the Company’s common stock was $0.0135 per share,
+Added: and the reported high closing price was $0.245 per share.
+Added: For the year ended December 31, 2019, the reported low closing
+Added: price for the Company’s common stock was $0.0112 per share, and the reported high closing price was $0.0893 per share.
+Added: is generally significant volatility in the market prices, as well as limited liquidity, of securities of early stage companies,
+Added: particularly early stage medical product companies.
Contributing to this volatility are various events that can affect the Company’s
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adversely affect our business.
+Added: Volatility in raw material and energy
+Added: costs, interruption in ordinary sources of supply, and an inability to recover from unanticipated increases in energy and raw
+Added: material costs could result in lost sales or could increase significantly the cost of doing business.
+Added: and economic conditions affecting the costs of raw materials, utilities, energy costs, and infrastructure required to provide
+Added: for the delivery of the Company’s products and services are beyond the Company’s control.
+Added: Any disruption or halt in
+Added: supplies, or rapid escalations in costs, could adversely affect the Company’s ability to manufacture products or to competitively
+Added: price the Company’s products in the marketplace.
+Added: To date, the ultimate impact of energy costs increases has been mitigated
+Added: through price increases or offset through improved process efficiencies;
+Added: however, continuing escalation of energy costs could
+Added: have a negative impact upon the Company’s business and financial performance.
+Added: General economic conditions in markets
+Added: in which the Company does business can impact the demand for the Company’s goods and services.
+Added: Decreased demand for the
+Added: Company’s products and services could have a negative impact on its financial performance and cash flow.
+Added: for the Company’s products and services, in part, depends on the general economic conditions affecting the countries and
+Added: industries in which the Company does business.
+Added: A downturn in economic conditions in a country or industry that the Company serves
+Added: may adversely affect the demand for the Company’s products and services, in turn negatively impacting the Company’s
+Added: operations and financial results.
+Added: Further, changes in demand for the Company’s products and services can magnify the impact
+Added: of economic cycles on the Company’s businesses.
+Added: Unanticipated contract terminations by customers can negatively impact operations,
+Added: financial results and cash flow.
+Added: The Company’s earnings, cash flow and financial position are exposed to financial market
+Added: risks worldwide, including interest rate and currency exchange rate fluctuations and exchange rate controls.
+Added: Fluctuations in domestic
+Added: and world financial markets could adversely affect interest rates and impact the Company’s ability to obtain credit or attract
UNRESOLVED STAFF COMMENTS.
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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.