What changed in this filing

/stocks — the workspaceLOADING

Item 5. Market for Registrant’s Common Equity

2021-03-25 compared with 2020-03-30 · 161 added, 308 removed, 92 unchanged (84% of the section changed)

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER EQUITY SECURITIES

common stock, from July 12, 2017, was quoted on the NASDAQ market under the symbol “CODX”.

The following table sets

forth the high and low prices for our common stock for the periods indicated, as reported by NASDAQ.

First Quarter (through March 15, 2020)

common stock has been quoted on the NASDAQ market under the symbol “CODX”

since July 12, 2017.

The following table

sets forth the high and low prices for our common stock for the periods indicated, as reported by NASDAQ.

Calendar Quarter Ended:

March 31, 2020

June 30, 2020

September 30, 2020

December 31, 2020

Calendar Quarter Ended:

March 31, 2019

June 30, 2019

September 30, 2019

December 31, 2019

of March 18, 2021, the last reported sales price reported on NASDAQ for our common stock was $13.69 per share.

As of the date of

this filing, we had approximately 336 record holders of our common stock.

The number of record holders was determined from the

records of our transfer agent and does not include beneficial owners of common stock whose shares are held in the names of various

security brokers, dealers, and registered clearing agencies.

The transfer agent for our common stock is VStock Transfer LLC located

at 18 Lafayette Pl, Woodmere, New York 11598.

As of March 18,

2021, we had approximately 150 record holders of our common stock.

The number of record holders was determined from the records

of our transfer agent and does not include beneficial owners of common stock whose shares are held in the names of various security

brokers, dealers, and registered clearing agencies.

The transfer agent for our common stock is VStock Transfer LLC located at

18 Lafayette Pl, Woodmere, New York 11598.

have never declared or paid any cash dividends on our capital stock.

5 unchanged sentences

Sales of Unregistered Securities

relied on the exemption from registration under the Securities Act set forth in Section 4(2) thereof for each of these issuances.

issued the unregistered securities below.

For the issuances of unregistered securities, we relied on the exemption from registration

requirements of the Securities Act of 1933, as amended, available under Section 4(a)(2) promulgated thereunder due to the fact

that such issuances did not involve a public offering of securities.

January 20, 2021, we issued an aggregate of 4,290 shares of our common stock for services rendered pursuant to consulting

of Equity Securities by the Issuer and Affiliated Purchasers

28 unchanged sentences

vexing issues of PCR amplification, the exponential growth of primer-dimer pairs (false positives and false negatives) which adversely

interferes with identification of the target DNA.

interferes with identification of the target DNA/RNA.

proprietary molecular diagnostics technology is paving the way for innovation in disease detection and life sciences research

27 unchanged sentences

that the product as designed meets the user needs.

diagnostics systems enable very rapid, low-cost, sophisticated molecular testing for organisms and genetic diseases by greatly

automating historically complex procedures in both the development and administration of tests.

CDI’s newest technical advance

involves a novel approach to PCR test design (cooperative primers) that eliminates one of the key vexing issues of PCR amplification,

the exponential growth of primer-dimer pairs (false positives and false negatives) which adversely interferes with identification

of the target DNA.

its proprietary test design system and proprietary reagents, CDI has designed and obtained regulatory approval to sell PCR diagnostic

tests for COVID-19, tuberculosis, hepatitis B and C, human papilloma virus, Malaria, chikungunya, dengue, and the Zika virus.

tests for COVID-19, a multiplex test for Flu A, Flu B and COVID-19, tuberculosis, hepatitis B and C, human papilloma virus, Malaria,

chikungunya, dengue, and the Zika virus.

addition to testing for infectious disease, the technology lends itself to identifying any section of a DNA strand that describe

5 unchanged sentences

the specific areas known to be breeding the mosquitos that carry deadly viruses.

January 23, 2020, we announced the completion of the principle design work for a PCR screening test for new coronavirus, COVID-19,

intended to address potential need for detection of the virus.

An outbreak of respiratory illness caused by the pneumonia-like

COVID-19 has spread rapidly over past few months, after first being discovered in the Chinese city of Wuhan on December 31, 2019.

China confirmed human-to-human transmission of the virus and the United States announced the first infection in this country,

detected in a traveler returning from Wuhan.

Our COVID-19 test features the Company’s patented CoPrimer™

and was designed using our proprietary software system, following the guidelines published by the World Health Organization and

Centers for Disease Control.

February 20, 2020, we announced that our Logix Smart™

COVID-19 Test technical file had been submitted for registration with

the European Community, and that it was expected to be available late February as an in vitro diagnostic (“IVD”) for

markets that accept a CE marking as valid regulatory approval.

Subsequently, on February 24, 2020, we announced that our test

obtained regulatory clearance to be sold as an in vitro diagnostic for the diagnosis of SARS-CoV-2 (COVID-19) in markets that

accept CE-marking as valid regulatory approval, and became available for purchase from the Company’s Utah-based ISO-13485:2016

certified facility.

The Declaration of Conformity for the Logix Smart COVID-19 test confirms that it meets the Essential Requirements

of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of

the product as an IVD to commence immediately in the European Community.

We shipped samples of the Research Use Only version of

our test to distributors in Italy and Germany, which allows future customers to confirm the quality and sensitivity of the product

prior to the IVD being available, and for us to accelerate the sales efforts of its diagnostic.

Many other global markets also

accept a CE marking as valid regulatory approval following routine local product registration, which allows sales of our COVID-19

IVD into these areas.

with Synbiotics

Company has entered into a joint venture agreement to manufacture diagnostics tests for seven infectious diseases with Synbiotics

Limited, a pharmaceutical manufacturing company in India.

The Company and Synbiotics shall be equal partners in the joint venture.

The agreement provides for the manufacture of the tests named above and the joint sales and marketing of those tests in India.

The Company will license its technology to the joint venture on a royalty-free basis.

The profits from the partnership shall be

divided as follows:

to $1,000,000

$1,000,000-$2,000,000

$2,000,000-$3,000,000

will be reimbursed by the joint venture for some expenses, such as approximately $96,000 in rent for the manufacturing plant and

office space.

If the joint venture needs additional funding, it will be achieved through loans obtained by the joint venture,

or if loans are not available on commercially reasonable terms, from capital contributions.

There is no term to the joint venture

agreement but it can be dissolved by mutual agreement or by one party upon a material breach by the other party.

December 2019, we announced that CoSara Diagnostics Pvt Ltd (“CoSara,”

or the “JV”), our joint venture

for manufacturing, obtained regulatory clearance for five tests to be manufactured and sold as in vitro diagnostics (“IVDs”)

from their facility in Ranoli India.

tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) met the requirements of

the Central Drug Standard Control Organization (“CDSCO”) Medical Device Rules (MDR) 2017, File no.

29/Misc./3/2017-DC

(292), to be manufactured and sold as IVDs.

CDSCO approval was granted following the completion of the CoSara manufacturing facility

and a comprehensive inspection of the location, presentation of the technology, quality system, procedures, product validation

data and performance evaluation by an independent NABL & CAP accredited laboratory.

The licenses and regulatory clearance

allow CoSara for the first time to manufacture and sell the tests for the detection of the respective pathogens and microorganisms.

distributors have begun taking pre-orders for the five IVDs.

The JV has the exclusive manufacturing rights in India for the complete

menu of our infectious disease molecular diagnostics kits, designed by us using our patented CoPrimer™

technology platform.

Additional tests such as our COVID-19 test have been submitted to the CDSCO for approval and others such as consist a drug-resistant

tuberculosis, HIV and more, including a multiplexed panel specifically for blood-bank screening will be submitted in 2020.

the tests will be conducted in India on Indian citizens, no FDA approval or inspection will be required.

is the country with the highest burden of tuberculosis.

According to the World Health Organization (WHO) tuberculosis statistics

for India for 2015 give an estimated incidence figure of 2.2 million cases of tuberculosis for India out of a global incidence

of 9.6 million.

The tuberculosis incidence for India is the number of new cases of active tuberculosis disease in India during

a certain time period (usually a year).

Property Protection

much of our future success and value depends on our proprietary technology, our patent and intellectual property strategy is of

critical importance.

Four of our initial U.S.

patents related to our technology have been granted by the U.S.

Patent and Trademark

Office, or PTO, including the patent for our CoPrimer technology, which we consider our most important patent.

One of our patents

has been issued in Great Britain, but is still pending in the United States.

As of March 15, 2020, we had three additional patents

pending in the U.S.

and foreign counterpart applications.

Two of our issued patents expire in 2034, one in 2036 and one in 2038.

have identified additional applications of the technology, which represent potential patents that further define specific applications

of the processes that are covered by the original patents.

We intend to continue building our intellectual property portfolio

as development continues and resources are available.

have copyrighted our development software that can be used by any lab or developer to develop diagnostic tests based on our technology.

We have allowed one customer access to our development software and intend to sell customized reagents through that customer to

labs serviced by that customer throughout the world.

To date we have not sold any products through that customer.

had no major customers in 2019, but one customer in the first quarter of 2020 comprised approximately 20% of our sales

to date and payment was received in advance of shipment of the tests.

molecular diagnostics industry is extremely competitive.

There are many firms that provide some or all of the products we provide

and provide many diagnostic tests that we have yet to develop.

Many of these competitors are larger than us and have significantly

greater financial resources.

Because we are not established, many of our competitors have a competitive advantage in the diagnostic

testing industry because they also have other lines of business in the pharmaceutical industry from which they derive revenues

and for which they are well known and respected in the medical profession.

We will need to overcome the disadvantage of being

a start up with no history of success and no respect of the medical and testing professionals.

In the diagnostic testing industry,

we compete with such companies as Roche, BioMerieux, Siemans, Qiagen, and Cephied and with such pharmaceutical companies as Abbott

Laboratories, Becton, Dickinson and Johnson and Johnson.

of these competitors already have an established customer base with industry standard technology, which we must overcome to be

currently employ 23 full-time personnel at our executive offices and lab facilities in Salt Lake City, Utah, and two employees

outside of Utah.

We have engaged independent contractors in the US and India to promote the use of our products and develop outlets

for products and employ the services of an independent sales representatives in our mosquito vector sales efforts.

will be regulated by the U.S.

Federal Drug Administration and our products must be approved by the FDA before we will be allowed

to sell our tests in the United States.

Because our lab is ISO certified we are allowed to apply for CE-Marking, which will allow

us to sell in most countries in Europe, South America and Asia.

We currently have CE Marks issued for our COVID-19 test, tuberculosis

test, our zika virus test, and a triplex test that tests for zika, dengue, and chikungunya simultaneously.

Our joint venture in

India is regulated by the CDSCO and has approved the manufacture and sale of five diagnostic tests and has approved the manufacture

and sale of COVID-19 tests on as a Research Use Only test pending approval for full manufacture and sale.

executive offices are located at 2401 S.

Foothill Drive, Salt Lake City, Utah 84109.

We occupy the space at the executive offices

under a month to month lease.

The lease covers approximately 10,273 square feet of lab and office space leased at a rate of $14,831

We have no other properties.

time to time, we may become involved in litigation relating to claims arising out of our operations in the normal course of business.

There is one lawsuit pending in the State of Florida alleging liable, which we believe is groundless and has no relevance to our

products or services and which will be vigorously defended.

To the best of our knowledge, no governmental authority is contemplating

any proceeding to which we are a party or to which any of our properties or businesses are subject, which would reasonably be

likely to have a material adverse effect on the Company.

We have received inquiries relative to the sudden rise in the price of

our stock from FINRA and NASDAQ, to which we have responded.

OF OPERATIONS

of Operations for the Years Ended December 31, 2020 and 2019

Table derived from audited financial statements

For the years ended

Cost of sales

table below provides a comparison of our operating results for the year ended December 31, 2020 as compared to the year ended

December 31, 2019.

Years Ended December 31,

Cost of revenue

Operating expenses

Selling and marketing

Administrative and general

Sales and marketing

General and administrative

Research and development

1 unchanged sentence

Total operating expenses

Total operating loss

Other expense:

Interest expense

Loss on extinguishment of debt

Net gain (loss) from investment in joint venture

Net gain (loss) on disposition of assets

Income (loss) from operations

Other income (expense)

Interest income

Total other expense

Loss before income taxes

Provision for income taxes

$ (6,195,557 )

Interest expense

Gain (loss) on disposition of assets

Gain (loss) on equity method investment in joint venture

Total other income (expense)

Income (loss) before income taxes

Income tax provision

Net income (loss)

$ (6,195,557 )

of products in the twelve months ended December 31, 2019 were $214,974, which consisted of sales of testing equipment of

$128,124, sales from the license of our technology in the agriculture industry of $50,000 and $36,850 which represented the initial

sales of our diagnostic tests, primarily of our mosquito vector products.

For the twelve months ending December 31, 2018, we realized

revenue from the sale of diagnostic equipment of $10,123 and had licensing revenue of $29,088 and test revenue of $700.

the year ended December 31, 2020, we generated $74.5 million of revenue compared to revenue of $0.2 million in the year ended

December 31, 2019.

The increase in revenue of $74.3 million was primarily due to sales of our LogixSmart COVID-19 test throughout

the world, which was developed in response to the current COVID-19 pandemic.

Of the total revenue in 2020, $3.7 million was from

the sale of third party manufactured equipment and supplies that we sourced and sold to customers to facilitate usage of our test.

The majority of our revenue in 2019 was from sales of equipment and tests to mosquito abatement districts and the remainder was

sales of our test reagents and licensing revenue.

of Revenues and Gross Profit

recorded costs of sales for the twelve months ended December 31, 2019 of $112,431 compared to costs of sales of $9,391 for the

twelve months ended December 31, 2018.

The increase in costs of sales of $103,040 was due to the increase in sales.

increased related to the cost of equipment sold, which was $93,171 as equipment has the highest cost of sales.

Costs of sales

of tests increased $9,869 as a result of increased sales.

There were no costs associated with the license revenue.

incurred total operating expenses of $5,996,284 for the year ended December 31, 2019 compared to total operating expenses of $6,148,336

for the year ended December 31, 2018.

The decrease of $152,052 was due to a decrease in general and administrative expense of

$73,513 and a decrease in sales and marketing costs of $103,955, partially offset by an increase of $15,137 in depreciation and

amortization expense and an increase of $10,279 in our research and development expenses.

general and administrative expenses decreased $73,513 from $3,570,786 for the year ended December 31, 2018 to $3,497,273 for the

year ended December 31, 2019.

The decrease was primarily the result of a decrease of $975,417 in consulting fees and a decrease

of $46,249 in attorney fees.

These decreases were partially offset by an increase of $529,602 in other professional services,

an increase in salaries and related benefits of $116,419 and an increase of $121,443 in option and warrant expense reflecting

the issuance of options to our employees and others.

In addition, insurance costs increased $77,757 and travel expenses increased

sales and marketing expenses for the year ended December 31, 2019 were $1,061,676 compared to sales and marketing expenses of

$1,165,631 for the year ended December 31, 2018.

The decrease of $103,955 was due primarily to incurring a marketing expense of

$497,208 related to acquisition of a distributor network in 2018 that was not repeated in 2019.

Other sales and marketing costs

generally increased.

We experience an increase of $192,786 in salaries and related benefits, an increase of $118,026 in travel

and convention related expenses and an increase of $90,573 in consulting expenses, all of which were incurred as we increased

our sales efforts.

research and development expenses increased by $10,279 from $1,361,154 for the year ended December 31, 2018 to $1,371,433 for

of revenues increased by $16.5 million from $0.1 million for the year ended December 31, 2019 to $16.6 million for the year ended

December 31, 2020.

The increase in cost of revenues was due to the significant increase in revenue discussed above.

margin was 77.7% for the year ended December 31, 2020 compared to 47.7% for the year ended December 31, 2019.

in gross margin was due to the mix of products we sold, as the majority of our 2020 revenue came from sales of our test reagents,

which has a higher profit margin than sales of equipment.

In 2019, the majority of the revenue was generated from equipment sales.

incurred total operating expenses of $16.3 million for the year ended December 31, 2020 compared to total operating expenses of

$6.0 million for the year ended December 31, 2019.

The increase in operating expenses was primarily due to the increase in business

activities experienced as a result of our increase in revenue.

and administrative expenses increased $4.8 million from $3.5 million for the year ended December 31, 2019 to $8.3 million for

the year ended December 31, 2020.

The increase was primarily due to an increase of $163,319 in salaries and related benefits as

we increased research and development activities.

The increase was partially offset by a decrease of $76,795 in consulting fees

for research services, a decrease of $72,528 in other professional services and a decrease of $22,528 in other lab services.

and Other Expense

and other expense items increased for the year ended December 31, 2019 by $147,909.

The increase in expenses related primarily

to an increased loss of $194,117 related to our India joint venture and a loss on extinguishment of debt of $78,241, which occurred

when a loan was converted to preferred stock.

The increase in loss was partially offset by a decrease in interest expense of $106,751and

an increase in interest income of $16,848.

had net loss of $6,271,723 for the year ended December 31, 2018 compared to a net loss of $6,195,557 for the year ended December

The decrease in net loss for the year ended December 31, 2019 compared to the year ended December 31, 2018 was $76,166.

Our total operating expenses decreased by $152,052 and our total other expenses increased by $147,909 as explained in more detail

The increase in general and administrative expenses was primarily due to increased activity

to support the growth of our business.

The primary drivers of the increased expenses related to increases in stock-based compensation,

employee related expenses and increased expenses for professional services.

sales and marketing expenses for the year ended December 31, 2020 were $4.7 million compared to $1.1 million for the year ended

December 31, 2019.

The increase of $3.6 million was primarily a result of increased personnel related expenses, including commissions

paid to our sales team and distributors, due to the growth in revenue noted above.

research and development expenses increased by $1.8 million from $1.4 million for the year ended December 31, 2019, to $3.2 million

for the year ended December 31, 2020.

The increase was primarily due to an increase in salaries and related benefits, including

stock-based compensation, as we have added additional employees to our research and development team to increase our product development

Additionally, there has been an increase in professional and lab services utilized to further help us in our research

and product development activities.

Income (Expense)

income was $875,000 for the year ended December 31, 2020 compared to other expense of $302,000 for the year ended December 31,

The increase in other income of $1.2 million was primarily related to recording a gain of $778,000 from our India joint

venture and incurring no interest expense during 2020.

For the year ended December 31, 2019 we had recorded a loss $233,000 from

our India joint venture and incurred interest expense of $106,000.

Income (Loss)

realized net income for the year ended December 31, 2020 of $42.5 million compared with a net loss of $6.2 million for the year

ended December 31, 2019.

The increase in net income of $48.7 million was primarily the result of sales of our LogixSmart COVID-19

test and resulting margins from those sales offset by increased operating expenses as discussed above.

Additionally, we recorded

an income tax expense of $0.1 million during the year ended December 31, 2020 as a result of our net income for 2020.

we released our deferred tax asset valuation allowance and recorded a deferred tax asset since we utilized our net operating losses

from prior years during the year ended December 31, 2020.

AND CAPITAL RESOURCES

is the ability of a company to generate funds to support its current and future operations, satisfy its obligations, and otherwise

operate on an ongoing basis.

Significant factors in the management of liquidity are funds generated by operations, levels of accounts

receivable and accounts payable and capital expenditures.

date we have financed our operations through sales of common stock and the issuance of debt.

December 31, 2019, we had cash and cash equivalents of $893,138, total current assets of $1,584,254, total current liabilities

of $328,070 and total stockholders’

equity of $1,737,256.

At December 31, 2018, we had cash and cash equivalents of $950,237,

total current assets of $1,051,913, total current liabilities of $2,351,983 and total stockholders’

deficit of $1,058,811.

experienced negative cash flow used in operations during the twelve months ended December 31, 2019 of $5,525,091 compared to negative

cash flow used in operations for the twelve months ended December 31, 2018 of $4,080,036.

In addition, we used $592,764 of our

cash in financing transactions and used $322,000 in contributions to our joint venture in India.

The negative cash flow in 2019

was met by cash reserves received from the completion of a registered direct offering in February 2019 pursuant to our S-3 shelf

registration filed in 2018 and declared effective in September 2018.

We received net proceeds of $5,000,000 from that offering.

In addition, in January 2019 we sold preferred stock from which we received net proceeds of approximately $1,000,000 and converted

$2,000,000 of our debt to the preferred stock.

The amount of our operating deficit could decrease or increase significantly depending

on strategic and other operating decisions, thereby affecting our need for additional capital.

We expect our operating losses

will continue until we are able to generate revenue and our operations become profitable.

We will continue to rely on proceeds

received from our public offerings of stock.

We expect additional investment capital to come from (i) additional issuances of

our common stock with existing and new investors and (ii) the private placement of other securities with investors similar to

those that have provided funding in the past.

monthly cash operating expenses, including our technology research and development expenses and interest expense, were approximately

$460,000 per month during the year ended December 31, 2019.

We completed the registered direct offering described above in January

2019 to fund operations through 2019.

The foregoing estimates, expectations and forward-looking statements are subject to change

as we make strategic operating decisions from time to time and as our expenses fluctuate from period to period.

February 28, 2020, the Company entered into securities purchase agreements with certain institutional investors for the sale by

the Company of 470,000 shares of the Company’s common stock, par value $0.001 per share, at a purchase price of $ 9.00 per

share in a registered direct offering.

The aggregate gross proceeds for the sale of the Common Shares were approximately $4.00

prior years, we financed our operations through the issuance of equity and debt.

In 2020, we financed our operations primarily

through profitable operations and secondarily through the issuance of common stock.

December 31, 2020, we had cash and cash equivalents of $43.0 million and marketable investment securities of $4.3 million that

could readily be converted into cash if needed.

Additionally, our total current assets at December 31, 2020, were $68.4 million

compared to total current liabilities of $4.5 million.

cash provided by operating activities during the year ended December 31, 2020 was $28.2 million, compared to cash used in operating

activities of $5.5 million for the year ended December 31, 2019.

The increase in cash from operating activities was primarily

due to our increased revenue offset by increases in accounts receivable and inventory.

used $5.8 million of our cash for investing activities during the year ended December 31, 2020 as compared to $0.4 million during

the year ended December 31, 2019.

The increase in cash used for investing activities is primarily due to purchasing marketable

investment securities, increased purchases of property and equipment needed to support our increased revenue and additional investment

in our India joint venture offset by proceeds received from maturities of marketable investment securities.

cash provided by financing activities was $19.7 million for the year ended December 31, 2020, compared to $5.9 million for the

year ended December 31, 2019.

The increase is primarily due to net proceeds of $18.0 million received from a series of three registered

direct offerings in January and February 2020 pursuant to our shelf registration in addition to receiving $1.7 million from the

exercise of warrants and options for the year ended December 31, 2020.

Net proceeds of $5.9 million was received during the year

ended December 31, 2019 from the sale of common and preferred stock.

commencing sales of our Logix Smart COVID-19 test in March 2020, we have used our cash generated from those sales to fund the

increase in our inventories and receivables and pay our operating expenses.

We have increased our work force primarily in the

area of research and development to complete development of additional tests to enable us to use our distributor network to sell

other products throughout the world and remain profitable in the future.

believe that our existing capital resources and the cash generated from future sales will be sufficient to meet our projected

operating requirements for the next 12 months.

However, our available capital resources

may be consumed more rapidly than currently expected and we may need or want to raise additional financing for strategic opportunities.

If needed, we expect additional investment capital to come from (i) additional issuances of our common stock with existing and

new investors or (ii) the private placement of other securities with investors similar to those that have provided funding in

We may not be able to secure such financing in a timely manner or on favorable terms, if at all.

October 30, 2020, we filed a Registration Statement on Form S-3 (File No:

333-249651) with the Securities and Exchange Commission

(the “SEC”).

The SEC declared the Form S-3 effective on November 5, 2020.

Pursuant to a prospectus supplement to the

Form S-3, we may offer and sell up to $100 million of the following securities separately or together, in one or more series or

classes and in amounts, at prices and on terms described in one or more offerings:

common stock;

preferred stock;

purchase our securities, each of which may be convertible into equity securities;

or units comprised of, or other combinations

of, the foregoing securities through underwriting syndicates managed or co-managed by one or more underwriters or dealers, through

agents or directly to purchasers.

Each time our securities are offered, we will provide a prospectus supplement to the Form S-3

containing more specific information about the particular offering.

To date, we have not filed a prospectus supplement to, or

sold any securities under, this Form S-3.

is a summary of the direct offerings done in 2020:

January 2020, we sold an aggregate of 3,448,278 shares of common stock to institutional investors for $1.45 per share for

gross proceeds of approximately $5.0 million pursuant to a shelf-registration statement on Form S-3 (File No:

declared effective by the SEC on September 7, 2018 (the “Shelf Registration Statement”).

February 10, 2020, the Company entered into securities purchase agreements with certain institutional investors pursuant to

which such investors purchased an aggregate of 3,324,676 shares of common stock at a purchase price of $ 3.08 per share in

a registered direct offering pursuant to the Shelf Registration Statement.

The aggregate gross proceeds for the sale of the

shares were approximately $10.2 million.

The closing of the offering occurred on or about February 13, 2020.

In the same manner as February 10, 2020 offering,

the Common Shares sold in the offering were offered and sold by the Company pursuant to an effective shelf registration statement

on Form S-3, that was originally filed on August 14, 2018 and declared effective by the Securities and Exchange Commission (“SEC”)

on September 7, 2018, and the base prospectus contained therein (File No.

February 10, 2020, the Company entered into securities purchase agreements with certain institutional investors for the sale by

the Company of 3,324,676 shares of the Company’s common stock, par value $0.001 per share, at a purchase price of $ 3.08

per share in a registered direct offering.

The aggregate gross proceeds for the sale of the Common Shares were approximately $10.2

February 28, 2020, the Company entered into securities purchase agreements with certain institutional investors pursuant to

which such investors purchased an aggregate of 470,000 shares of common stock at a purchase price of $9.00 per share in a

registered direct offering pursuant to the Shelf Registration Statement.

The aggregate gross proceeds for the sale of the

shares were approximately $4.0 million.

The closing of the offering occurred on or about February 28, 2020.

In the same manner as January 23, 2020 offering,

the Common Shares sold in the offering were offered and sold by the Company pursuant to an effective shelf registration statement

on Form S-3, that was originally filed on August 14, 2018 and declared effective by the Securities and Exchange Commission (“SEC”)

on September 7, 2018, and the base prospectus contained therein (File No.

January 23, 2020, the Company entered into securities purchase agreements with certain institutional investors for the sale by

the Company of 3,448,278 shares of the Company’s common stock, par value $0.001 per share, at a purchase price of $1.45

per share in a registered direct offering.

The aggregate gross proceeds for the sale of the Common Shares were approximately $5,000,000.

The closing of the offering occurred on or about January 28, 2020.

The Common Shares sold in the offering were offered and sold

by the Company pursuant to an effective shelf registration statement on Form S-3, that was originally filed on August 14, 2018

and declared effective by the Securities and Exchange Commission (“SEC”) on September 7, 2018, and the base prospectus

contained therein (File No.

March 6, 2020, one of our warrant holders exercised its warrants for 25,000 shares of our common stock at $2.00 per share and

paid us $50,000.

In February and March, 2020 an additional 15 warrant holders exercised an aggregate of 759,445

warrants to purchase 694,492 shares of our common stock on a cashless basis.

January 30, 2019, we entered into a securities purchase agreement with investors, whereby the investors purchased from the Company

30,000 shares of Series A Convertible Preferred Stock of the Company for a purchase price of $3,000,000.

The purchase price was

paid by the investors with $1.0 million in cash and the conversion of a $2.0 million note owed by the Company to one of the investors.

The investors may not convert the Series A Preferred Stock to the extent that such conversion would result in beneficial ownership

by the investors and their affiliates of more than 4.99% of the issued and outstanding Common Stock of the Company.

February 4, 2019, we completed the sale of 3,925,716 shares of the Company’s common stock, par value $0.001 per share, at

a purchase price of $1.40 per share in a registered direct offering.

The aggregate gross proceeds for the sale of the Common Shares

was $5,496,002 and we received net proceeds after offering costs of $4,996,322.

amount of our operating deficit could decrease or increase significantly depending on strategic and other operating decisions,

thereby affecting our need for additional capital.

We expect our operating loses will continue until we are able to generate revenue.

Revenue commenced in 2019 and has increased substantially in 2020 and our need for additional investment will depend on the amount

of revenue generated.

At our current level of operating expenditures, we have sufficient cash to fund operations for the next

twelve months.

Absent a significant acquisition or capital expansion, we do not expect to raise additional capital.

long-term liquidity is dependent upon execution of our business model and the commencement of revenue generating activities and

working capital as described above, and upon capital needed for continued commercialization and development of our diagnostic

testing technology.

Commercialization and future development of diagnostic tests utilizing our PCR technology are expected to

require additional capital estimated to be approximately $1,350,000 annually for the foreseeable future.

This estimate will increase

or decrease depending on specific opportunities and available funding.

foregoing estimates, expectations and forward-looking statements are subject to change as we make strategic operating decisions

from time to time and as our revenue and expenses fluctuate from period to period.

Sheet Arrangements

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What changed 10-K

Item 5. Market for Registrant’s Common Equity