The following discussion and analysis of our financial condition and results of
operations for the years ended December 31, 2022 and 2021 should be read in
conjunction with the financial statements and the notes to those statements that
are included elsewhere in this Annual Report on Form 10-K. Our discussion
includes forward-looking statements based upon current expectations that involve
risks and uncertainties, such as our plans, objectives, expectations and
intentions. Actual results and the timing of events could differ materially from
those anticipated in these forward-looking statements as a result of a number of
factors. We use words such as "anticipate," "estimate," "plan," "project,"
"continuing," "ongoing," "expect," "believe," "intend," "may," "will," "should,"
"could," and similar expressions to identify forward-looking statements.
Liquidity and Capital Resources
We are in our early stages of development and growth, without established
records of sales or earnings. We will be subject to numerous risks inherent in
the business and operations of financially unstable and early stage or emerging
growth companies.
As of December 31, 2022, we had cash and cash equivalents of $47,282, working
capital deficit of $(3,288,515), and an accumulated deficit of $64,125,176. We
estimate our G&A expenses for 2023 to be approximately $3,500,000, which
includes projected audit and accounting costs of $250,000. R&D expenses for 2023
will vary based on drug formulation and clinical trial project activity that the
Company is engaged in, which in turn is determined by available capital. R&D
expenditures in 2023 will depend on available cash flow and the extent of
additional capital funding.
We can provide no assurance that the Company can continue to satisfy its cash
requirements for at least the next twelve months.
We expect to obtain financing through shareholder loans, private placements
and/or registered offerings of our securities. Shareholder loans may be without
stated terms of repayment or interest. In addition, we may consider taking on
long-term or short-term debt from financial institutions in the immediate
future. Shareholders loans may be granted from time to time as required to meet
current working capital needs. We have no formal agreement that ensures that we
will receive such loans. We may exhaust this source of funding at any time.
We are dependent upon certain related parties to provide continued funding and
capital resources. If continued funding and capital resources are unavailable at
reasonable terms, we may not be able to implement our plan of operations. These
loans may include terms that may be highly dilutive to existing shareholders.
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On September 14, 2017, our Registration Statement on Form S-3 was declared
effective by the SEC. We issued 20,977,638 shares common stock pursuant to the
Company's Registration Statement on Form S-3 and S-1 during the year ending
December 31, 2022. We issued 7,494,792 shares common stock pursuant to the
Company's Registration Statement on Form S-3 during the year ending December 31,
2020. No shares were issued in 2021 under the S-3.
On June 22, 2021, our Registration Statement on Form S-1 was declared effective
by the SEC. We issued 1,000,000 shares of Company common stock pursuant to an
equity purchase agreement, dated on May 14, 2021, and the Registration Statement
on Form S-1 during the year ending December 31, 2021. Subsequent to the year
ended December 31, 2022, the Company issued an additional 8,000,000 shares of
its common stock for cash of $130,000 pursuant to the equity purchase agreement,
which shares were also registered pursuant to the S-3 Registration Statement.
During January 2022, the Company issued 612,104 shares for cash of gross
proceeds of $75,000 pursuant to various stock purchase agreements. The cash was
received in the fourth quarter 2021 and first quarter 2022. The Company also
issued warrants to purchase an aggregate of 612,104 shares of common stock at an
average exercise price of $0.315 per share. The warrants are exercisable within
a three-year period from issuance.
Effective February 10, 2022, the Company issued two short term notes, each
having a face amount of $250,000, in exchange for a total of $500,000 in cash
(the "Short Term Promissory Notes"). The Short Term Promissory Notes bear
interest at the rate of 1.5% per annum and were due and payable on or before
March 10, 2022, unless demand for payment is made prior to such date. One of the
two notes was paid in full on February 14, 2022.
Effective February 10, 2022, the Company issued seven convertible notes to a
series of investors having an aggregate face value of $1,325,000 in exchange for
$1,325,000 in cash (the "Convertible Notes"). One of the Convertible Notes, face
value $25,000, was purchased by Blake N. Schroeder who is a director of the
Company.
Each of the Convertible Notes is (i) unsecured; (ii) bears interest at a rate of
3% per annum; (iii) matures on February 10, 2032; and (iv) is convertible, in
whole or in part, at any time by the holder, into restricted shares of the
Company's common stock at a conversion price equal to the lesser of $0.08125 or
70% of the average of the two lowest closing prices of the Company's common
stock in the ten trading days preceding any particular conversion, provided, the
holder is prohibited from converting the convertible note, or portion thereof,
if such conversion would result in beneficial ownership by the holder and its
affiliates of more than 4.99% of Company's issued and outstanding common stock
as of the date of the conversion.
On February 10, 2022, the Company paid in full the remaining balance due on that
certain convertible note issued to GS Capital Partners, LLC, face value
$1,110,000 (as amended, the "GS Note"). In connection with the repayment, the
Company was required to pay accrued interest in the amount of $21,875, by
issuing 173,390 restricted shares of the Company's common stock pursuant to the
formula set forth in the GS Note.
During 2022, the Company issued 14,837,874 of its shares of common stock
pursuant to a stock purchase agreement for cash gross proceeds of $455,000.
In January 2022 the company issued 7,000,000 of its shares in completion of its
agreement with Advanced Tear Diagnostics regarding the purchase of various
patents.
In December 2019, a novel strain of coronavirus ("COVID-19") was reported in
Wuhan, China. The COVID-19 pandemic, as it was declared by the World Health
Organization, has continued to spread and has already caused severe global
disruptions. The extent of COVID-19's effect on our operational and financial
performance will depend on future developments, including the duration, spread
and intensity of the pandemic, all of which are uncertain and difficult to
predict considering the rapidly evolving landscape.
We expect COVID-19, along with the resulting government-imposed restrictions on
businesses, to negatively impact our operations due to decreased consumer demand
as well as potential production and warehouse limitations which results in an
event or condition, before consideration of management's plans, that could
impact our ability to meet future obligations. We believe that our cash and cash
equivalents on hand and these cost reduction measures, as needed, will provide
sufficient liquidity to fund our operations for the next 12 months from the
issuance of the consolidated financial statements.
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Sources of Capital
We expect to sustain our working capital needs through shareholder loans,
private placements and/or registered offerings of our securities. Shareholder
loans may be without stated terms of repayment or interest. We may consider
taking on any long-term or short-term debt from financial institutions in the
immediate future. Shareholders loans may be granted from time to time as
required to meet current working capital needs. We have no formal agreement that
ensures that we will receive such loans. We may exhaust this source of funding
at any time.
During the next twelve months, we anticipate incurring costs related to:
(i) filing Exchange Act reports;
(ii) contractual obligations;
(iii) building inventory of our approved devices;
(iii) clinical trials; and
(iv) continued research and development of our diagnostic tests.
We believe we will be able to meet these costs through use of funds in our
treasury, deferral of fees by certain service providers and additional amounts,
as necessary, to be loaned to or invested in us by our shareholders, management
or other investors. As of the date of the period covered by this report, we have
limited cash. There are no assurances that we will be able to secure any
additional funding as needed. Currently, however our ability to continue as a
going concern is dependent upon our ability to generate future profitable
operations and/or to obtain the necessary financing to meet our obligations and
repay our liabilities arising from normal business operations when they come
due. Management's plan includes obtaining additional funds by equity financing
and/or related party advances; however, there is no assurance of additional
funding being available.
Known Trends or Uncertainties
We have seen some consolidation in the pharmaceutical and biotechnology
industries during economic downturns. These consolidations have not had a
negative effect on us to date; however, should consolidations and downsizing in
the industry continue to occur, those events could adversely impact our
financial results and business operations going forward.
The potential for growth in new markets is uncertain. We will continue to
explore these opportunities until such time as we either generate sales or
determine that resources would be more efficiently used elsewhere.
As discussed in this Annual Report, the world has been affected due to the
COVID-19 pandemic. The pandemic has negatively impacted our business in various
ways over the last two years, including, more recently, as a result of global
supply chain constraints at least partially attributable to the pandemic. Until
the pandemic has passed, there remains uncertainty as to the effect of COVID-19
on our business in both the short and long-term.
Inflation
Inflation has increased during the periods covered by this Annual Report, and is
expected to continue to increase for the near future. Inflationary factors, such
as increases in the cost of our products (and components thereof), interest
rates, overhead costs and transportation costs may adversely affect our
operating results. Although we do not believe that inflation has had a material
impact on our financial position or results of operations to date, we may
experience some effect in the near future (especially if inflation rates
continue to rise) due to supply chain constraints, consequences associated with
COVID-19 and the ongoing conflict between Russia and Ukraine, employee
availability and wage increases, trade tariffs imposed on certain products from
China and increased product pricing due to semiconductor product shortages.
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Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably
likely to have a current or future effect on our financial condition, changes in
financial condition, revenues or expenses, results of operations, liquidity,
capital expenditures or capital resources that is material to investors.
Going Concern
The Company's financial statements have been presented assuming that the Company
will continue as a going concern. As shown in the financial statements, the
Company has negative working capital of $3,288,515, has an accumulated deficit
of $64,125,176 has cash used in continuing operating activities of $2,044,326
and presently does not have the resources to accomplish its objectives during
the next twelve months. These conditions raise substantial doubt about the
ability of the Company to continue as a going concern. The financial statements
do not include any adjustments related to the recoverability of assets and
classification of liabilities that might be necessary should the Company be
unable to continue in operation.
The Company may not be able to meet its contractual obligations to Arizona State
University regarding ongoing research and maintain its staff at current levels
required by various employment agreements.
The Company intends to raise additional capital through private placements
and/or registered offerings of debt and equity securities, but there can be no
assurance that these funds will be available on terms acceptable to the Company
or will be sufficient to enable the Company to fully complete its development
activities or sustain operations. If the Company is unable to raise sufficient
additional funds, it will have to develop and implement a plan to further extend
payables, reduce overhead, or scale back its current business plan until
sufficient additional capital is raised to support further operations. There can
be no assurance that such a plan will be successful.
Results of Operations
Comparison of the year ended December 31, 2022 and 2021.
December 31, December 31, $ %
2022 2021 Change Change
Revenues $ 8,875 $ 60,460 $ (51,585 ) > -85 %
Gross margin percentage - - - -
Operating expenses 4,661,647 14,035,458 (9,373,811 ) > -67 %
Loss from continuing
operations (4,652,772 ) (13,974,998 ) (9,322,226 ) > -67 %
Loss from discontinued
operations (7,996 ) 7,996 -100 %
Other expenses (income) 1,590,177 2,049,311 (459,134 ) -22.4 %
Net loss $ (6,242,949 ) $ (16,032,305 ) $ (9,789,356 ) > -139 %
Revenue
Revenues from continuing operations recognized for twelve months ended December
31, 2022 and 2021 amounted to $8,875 and $60,460, respectively. The decrease in
revenue from continuing operations is due to the termination Co-production
agreement with empowered diagnostics.
Cost of Revenue
Cost of Revenue from continuing operations recognized for twelve months ended
December 31, 2022, and 2021 amounted to $-0- and $-0-, respectively. The lack of
COGS is due to lack of sales of products to customers in 2022 This is due
primarily to discontinued sale activities of Wellness gum in 2021.
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Operating Expenses
Research and Development Expenses
For the twelve months ended December 31, 2022 and 2021 the Company incurred
research and development expenses of $153,697 and $284,869 from continuing
operations, respectively The decrease is primarily due to discontinued research
and clinical activities of Wellness gum and lack of cash resources.
Selling, General and Administrative Expenses
Our Selling, General and Administrative expenses for the years ending in 2022
and 2021 were $4,081,824 and $5,668,240, respectively. The decrease is primarily
due to the write off of the acquisition of Sapphire Biotech on 2021.
Depreciation Expenses
For the year ended December 31, 2022 our depreciation expenses were $31,680 as
compared to $27,779 for the year ended December 31, 2021. The increase is
primarily due to recognizing the property and equipment as a result of the
acquisition of Laboratory equipment for the Eye Care division.
Amortization Expenses
For the year ended December 31, 2022 our amortization expenses were $394,446 as
compared to $2,087,908 for the year ended December 31, 2021. The decrease is
primarily due to recognizing the write off intangible assets as a result of the
acquisition of Sapphire Biotech.
Impairment Loss
For the year ended December 31, 2022 we recorded an impairment loss of $-0- as
compared to $5,966,452 for the year ended December 31, 2021. The company
impaired it IPR&D and goodwill assets created on acquisition of Sapphire
resulting from an FDA decision not to approve our COVID test.
Other Income and Expenses
Our interest expenses for the years ending 2022 and 2021 were $1,697,455 and
$247,792, respectively. Loss on extinguishment of debt for the years ending in
2022 and 2021 were $479,573 and $1,587,027 respectively, variance was result of
debt exchange and true-up adjustment for stock compensation. Amortization of
debt discount was $178,962 and $238,033 respectively. Income grants from
government for the year ending 2022 and 2021 were $-0- and $279,981,
respectively, and the variance was a result of the termination of innovation
research grants from NCI in 2020.
For the Year Ended December 31, 2022 and 2021
Net Cash Provided by/Used in Operating Activities
Net cash used in continuing operating activities and discontinued operating
activities was $2,044,326 and $-0-, respectively, for the twelve months ended
December 31, 2022, as compared to net cash used of $2,478,769 and $7,996 for the
twelve months ended December 31, 2021. The cash used in operating activities is
primarily attributable to our net loss from operations of $6,242,949 and offset
by net changes in the balances of operating assets and liabilities and non-cash
expenses. For the twelve months ended December 31, 2022, stock-based
compensation was $1,107,494 and amortization of debt discount was $178,692. For
the twelve months ended December 31, 2021 these non-cash expenses were
stock-based compensation of $1,143,730 and amortization of $238. For the twelve
months ended December 31, 2022 and 2021 the Company recorded increase to
accounts payable and accrued expenses of $659,400 and $277,507, respectively, of
continuing operating activities. The Company recorded for the twelve months
ended December 31, 2022 and 2021 a loss on extinguishment of debt of $266,111
and $1,587,027, respectively. The Company recorded amortization of prepaid
expenses for the twelve months ended December 31, 2022 and 2021 of $210,094 and
$376,936 respectively. The Company recorded stock issued for services for the
twelve months ended December 31, 2022 and 2021 of $79,500 and $1,888,391
respectively. The Company recorded impairment of intangible assets for the
twelve months ended December 31, 2022 and 2021 of $394,446 and $2,087,908
respectively.
The company recorded common stock issued for settlement of obligation for the
twelve months ended December 31, 2022 and 2021 of $226,172 and $-0-
respectively. The Company recorded non cash interest expense for the twelve
months ended December 31, 2022 and 2021 of $1,316,846 and $-0- respectively. The
Company recorded change in fair value of derivative liabilities for the twelve
months ended December 31, 2022 and 2021 of $765,556 and $-0- respectively. The
Company recorded an increase in deferred revenue for the twelve months ended
December 31, 2022 and 2021 of $333,125 and $-0- respectively. The Company
recorded an increase in prepaid expenses for the twelve months ended December
31, 2022 and 2021 of $103,230 and $284,574 respectively.
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Net Cash provided by Investing Activities
Net cash used in (provided by) investing activities during the period ended
December 31, 2022 was $8,710 compared to $50,495 for the same period in 2021 due
to acquisition of patents $10,000 and purchase of equipment of $40,495 in 2021.
Net Cash Provided by Financing Activities
Net cash provided by financing activities during the twelve months' period ended
December 31, 2022, was $1,647,355, including $0 used in discontinued financing
activities, compared to $2,533,042 for the same period in 2021. The Company has
successfully raised significant capital in exchange for its common stock for the
twelve months ended December 31, 2022. The company recorded proceeds from
convertible note of $1,325,000 in 2022 and $1,010,000 in 2021. The Company
repaid a convertible note at $1,243,200 in 2022.
Critical Accounting Policies
The preparation of financial statements in conformity with U.S. GAAP requires
management to make estimates and assumptions that affect the reported amount of
assets and liabilities, the disclosure of contingent assets and liabilities and
the reported amounts of revenue and expenses during the reported periods. The
more critical accounting estimates include estimates related to revenue
recognition and accounts receivable allowances. We also have other key
accounting policies, which involve the use of estimates, judgments and
assumptions that are significant to understanding our results, which are
described in Note 5 to our consolidated financial statements.
Our management's discussion and analysis of financial condition and results of
operations is based on our consolidated financial statements, which have been
prepared in accordance with accounting principles generally accepted in the
United States, or GAAP. The preparation of these financial statements requires
us to make estimates and judgments that affect the reported amounts of assets,
liabilities and expenses and the disclosure of contingent assets and liabilities
in our consolidated financial statements during the reporting periods. These
items are monitored and analyzed by us for changes in facts and circumstances,
and material changes in these estimates could occur in the future. We base our
estimates on historical experience, known trends and events, and on various
other factors that we believe are reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying value of
assets and liabilities that are not readily apparent from other sources. Changes
in estimates are reflected in reported results for the period in which they
become known. Actual results may differ materially from these estimates under
different assumptions or conditions.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset, or
paid to transfer a liability, in an orderly transaction between market
participants. A fair value hierarchy has been established for valuation inputs
that gives the highest priority to quoted prices in active markets for identical
assets or liabilities and the lowest priority to unobservable inputs.
Research and Development Costs
Research and development costs are expensed as incurred. Research and
development reimbursements and grants are recorded by us as a reduction of
research and development cost.
Share-Based Payments
We estimate the fair value of each stock option award at the grant date by using
the Black-Scholes option pricing model. The fair value determined represents the
cost for the award and is recognized over the vesting period during which an
employee is required to provide service in exchange for the award. We account
for forfeitures of stock options as they occur.
Income Taxes
We use the asset and liability method to calculate deferred taxes. Deferred
taxes are recognized based on the differences between the financial reporting
and income tax bases of assets and liabilities using the enacted tax rates and
laws that will be in effect when the differences are expected to reverse. We
review deferred tax assets for a valuation allowance based upon whether it is
more likely than not that the deferred tax asset will be fully realized. A
valuation allowance, if necessary, is provided against deferred tax assets,
based upon our assessment as to their realization.
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We recognize tax when the positions meet a "more-likely-than-not" recognition
threshold. There were no tax positions for which it is considered reasonably
possible that the total amounts of unrecognized tax benefits will significantly
increase or decrease within the next year. We recognize interest related to
unrecognized tax benefits in interest expense and penalties in operating
expenses.
Recently Issued Accounting Standards
Note 5 to consolidated financial statements appearing elsewhere in this report
includes Recently Issued Accounting Standards.
Foreign Currency Transactions
Foreign exchange gain (loss) in the year ended December 31, 2022, was $0
compared to $(7,324) for the same period in 2021. All foreign currency gains
(loss) were related to discontinued operations.
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