Forward-Looking Statements
This Report on Form 10-Q contains forward-looking statements which involve assumptions and describe our future plans, strategies, and expectations, and are generally identifiable by use of words such as "may" "will" "should," "expect," "anticipate," "estimate," "believe," "intend," or "project," or the negative of these words or other variations on these words or comparable terminology. These statements are expressed in good faith and based upon a reasonable basis when made, but there can be no assurance that these expectations will be achieved or accomplished.
Such forward-looking statements include statements regarding, among other things, (a) the potential markets for our products, our potential profitability, and cash flows, (b) our growth strategies, (c) anticipated trends in the in-vitro diagnostics industry, (d) our future financing plans, and (e) our anticipated needs for working capital. This information may involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from the future results, performance, or achievements expressed or implied by any forward-looking statements. These statements may be found under "Management's Discussion and Analysis of Financial Condition and Results of Operations" as well as in this Form 10-Q generally. Actual events or results may differ materially from those discussed in forward-looking statements as a result of various factors, including, without limitation, the matters described in this Form 10-Q generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur. In addition to the information expressly required to be included in this filing, we will provide such further material information, if any, as may be necessary to make the required statements, in light of the circumstances under which they are made, not misleading.
Although forward-looking statements in this report reflect the good faith
judgment of our management, forward-looking statements are inherently subject to
known and unknown risks, business, economic and other risks and uncertainties
that may cause actual results to be materially different from those discussed in
these forward-looking statements. Readers are urged not to place undue reliance
on these forward-looking statements, which speak only as of the date of this
report. We assume no obligation to update any forward-looking statements in
order to reflect any event or circumstance that may arise after the date of this
report, other than as may be required by applicable law or regulation. Readers
are urged to carefully review and consider the various disclosures made by us in
our filings with the
Except where the context otherwise requires and for purposes of this Form 10-Q
only, "we" "us" "our" "Company" "our Company" and "
Our Business
We sell and develop in-vitro diagnostic products, including rapid diagnostic tests, such as the COVID-19 test, 6-minute rapid whole blood Ebola test, 6-minute whole blood Zika test, 8-minute whole blood rapid TB test and over 75 other tests more than 40 which are FDA approved.
The Company was founded to develop and market in-vitro diagnostic ("IVD") tests
for over-the-counter ("OTC" or consumer), or consumer-use and point-of-care
("POC" or professional) which includes hospitals, physicians' offices and
medical clinics, including those within penal systems throughout the US and
abroad. The Company currently markets a range of diagnostic test kits for
consumer use through OTC sales, and for use by health care professionals,
generally located at medical clinics, physician offices and hospitals known POC,
in
All of the products we sell are manufactured in a
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We sell products internationally which are not FDA approved to sell in the US. These products include an FDA Certificate of Exportability and include tests such as Ebola, ZIKA, Dengue, Malaria, Influenza, Tuberculosis, Corona Viruses, and other vector borne diseases.
As a result of the COVID-19 pandemic, the Company became laser focused on
developing and selling COVID tests beginning in the second half of fiscal 2020.
The Company achieved sales of COVID tests in fiscal 2021 that were sourced from
third parties. In addition, over the course of fiscal 2021, the Company
continued its efforts to develop an RDT, RT-PCR and antigen test. Due to the
relatively quick commoditization of COVID-19 tests, the Company's strategy of
selling third party tests until it could complete a COVID test of its own proved
ill-timed and caused a drop in sales in the latter part of fiscal 2021. As a
result, the Company refocused its attention on marketing its core FDA OTC
approved products which includes tests for pregnancy, ovulation, colorectal,
drugs of abuse, glucose strips and glucose monitors through various platforms,
including Walmart, Amazon and eBay, in addition to the development of a COVID
antigen test being developed under a Memorandum of Understanding ("MOU") dated
The Company's consolidated financial statements are prepared using generally
accepted accounting principles in
The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it becomes profitable. If the Company is unable to obtain adequate capital, it could be forced to cease operations.
As of
Results of Operations
Three and six months ended
Operating Expenses Three Months Ended December 31, Increase / 2021 2020 (Decrease) Operating expenses: Professional fees $ 14,150$ 13,450 $700 Research and development 862,692 65,000 797,692 Selling, general and administrative 408,964 21,397 387,567 Stock compensation 593,600 - 593,600 Total operating expenses$ 1,879,406 $ 99,847 $1,779,559 Six Months Ended December 31, Increase / 2021 2020 (Decrease) Operating expenses: Professional fees $ 71,400$ 47,225 $24,175 Research and development 1,369,697 204,010 1,165,687 Selling, general and administrative 663,262 54,661 608,601 Stock compensation 980,600 - 980,600 Total operating expenses$ 3,084,959 $ 305,896 $2,779,063 19 Professional Fees
Professional fees relate to expenditures incurred primarily for legal and
accounting services. During the six months ended
Research and Product Development
Research and Product Development ("R&D") costs represent costs incurred to
develop our tests and are incurred pursuant to certain internal R&D cost
allocations, when applicable, and agreements with third-party providers, but
primarily with Pan Probe Biotech, owned by Dr.
Selling, General and Administrative
Selling, general and administrative ("SG&A") costs include all expenditures
related to personnel, rent, travel, public company costs, utilities, marketing
and other office related costs. SG&A costs increased by
Stock Compensation
Stock compensation represents the expense associated with the issuance of stock
in exchange for services and is non-cash in nature. Stock compensation is based
on our stock price at the measurement date and fluctuates as our stock price
changes. During the three months ended
Other Income and (Expense)
Other expense includes "interest expense" which relates to the stated interest
and penalties upon default of our outstanding promissory notes, and
"amortization of debt discount" which represents the accretion of the discount
applied to our notes as a result of the issuance of detachable warrants and the
beneficial conversion feature contained certain notes. During the three months
ended
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Liquidity and Capital Resources
As of
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