What changed in this filing

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Item 1. Business

2022-03-24 compared with 2021-03-25 · 372 added, 398 removed, 54 unchanged (93% of the section changed)

Co-Diagnostics,

Inc., a Utah corporation (the “Company”

or “CDI”), is developing robust and innovative molecular tools

for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications.

We develop, manufacture

and sell reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or

In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab

systems (which we refer to as the “MDx Device”).

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

complex procedures in both the development and administration of tests.

CDI’s technical advance involves a novel approach

to Polymerase Chain Reaction (“PCR”) test design of primer and probe structure (“CoPrimers”) 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/RNA.

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

research through our enhanced detection of genetic material.

Because we own our platform, we believe we will be able to accomplish

this faster and more economically, allowing for significant margins while still positioning the Company to be a low-cost provider

of molecular diagnostics and screening services.

addition, continued development has demonstrated the unique properties of our CoPrimer technology that make it ideally suited

for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single

Nucleotide Polymorphism (“SNP”) detection and enrichment for next gen sequencing.

scientists use the complex mathematics of DNA/RNA test design, to engineer and optimize a DNA/RNA test and to automate algorithms

that rapidly screen millions of possible options to pinpoint the optimum design.

Satterfield, our founder, developed the Company’s

intellectual property consisting of the predictive mathematical algorithms and proprietary reagents used in the testing process,

Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for

diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including robust and innovative

molecular tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications.

In connection

with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab systems (which we refer to

as the “MDx Device”).

We have also developed a unique, groundbreaking portable PCR device (the “CODX YourTest

PCR™ Device”) that has been designed to bring affordable, reliable gold-standard polymerase chain reaction (“PCR”)

to patients in point-of-care and even at-home settings.

diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating historically complex

procedures in both the development and administration of tests.

CODX’s technical advance involves a novel, patented approach

to PCR test design of primer and probe structure (“CoPrimers™”) 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/RNA.

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

through our enhanced detection of genetic material.

For various reasons, including owning our own our platform, we believe we will be

able to accomplish this faster and more economically, allowing for significant margins while still positioning the Company to be a low-cost

provider of molecular diagnostics and screening services.

addition, continued development has demonstrated the unique properties of our CoPrimer technology that we believe makes it ideally suited

for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single Nucleotide

Polymorphism (“SNP”) detection and enrichment for next generation sequencing.

scientists use the complex mathematics of DNA/RNA test design to engineer and optimize DNA/RNA tests and to automate algorithms that

rapidly screen millions of possible options to pinpoint the optimum design.

Brent Satterfield, our founder, developed the Company’s

intellectual property consisting of the predictive mathematical algorithms and patented molecular structure used in the testing process,

which together represent a major advance in PCR testing systems.

CDI technologies are now protected by eight granted or pending

CODX technologies are now protected by more than 20 granted or pending

US and foreign patents, as well as certain trade secrets and copyrights.

Ownership of our proprietary platform permits us the

advantage of avoiding payment of patent royalties required by other PCR test systems, which enables the sale of diagnostic tests

at a lower price than competitors, while enabling us to maintain profit margins.

may either sell or lease the MDx Device to labs and diagnostic centers, through sale or lease agreements, and sell the reagents

that comprise our proprietary tests to those laboratories and testing facilities.

design our tests by identifying the optimal locations on the target gene for amplification and pair the location with the optimized

primer and probe structure to achieve outputs that meet the design input requirements identified from market research.

done by following planned and documented processes, procedures and testing.

In other words, the data resulting from our tests

verify that we succeeded in designing what we intended at the outset.

Verification is a series of testing that concludes that

the product is ready to proceed to validation in an evaluation either in our lab or in an independent laboratory setting using

initial production tests to confirm that the product as designed meets the user needs.

our proprietary test design system and proprietary reagents, we have designed and obtained regulatory approval in the European

Community and in India to sell PCR diagnostic tests for COVID-19, tuberculosis, hepatitis B and C, human papilloma virus, malaria,

chikungunya, dengue, and the zika virus.

In the United States, CDI has obtained Emergency Use Authorization (“EUA”)

for its COVID-19 test from the FDA and sells that test to qualified labs.

In addition, our LogixSmart COVID-19 test has been approved

for sale in Australia and Mexico by the regulatory bodies in those countries and has been registered for sale in many more countries.

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

describe any type of genetic trait, which creates a number of significant applications.

We, in conjunction with our customers,

are active in designing and licensing tests that identify genetic traits in plant and animal genomes.

We also have three multiplexed

tests developed to test mosquitos for the identification of diseases carried by the mosquitos to enable municipalities to concentrate

their efforts in spraying mosquito populations on the specific areas known to be breeding the mosquitos that carry deadly viruses.

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

Ownership of our proprietary platform permits us the advantage

of avoiding payment of patent royalties required by other PCR test systems, which may allow the sale of diagnostic PCR tests at a lower

price than competitors, while enabling us to maintain profit margins.

may either sell or lease the MDx Device to labs and diagnostic centers, through sale or lease agreements, and sell the reagents that

comprise our proprietary tests to those laboratories and testing facilities.

proprietary test design process involves identifying the optimal locations on the target genes for amplification and pair the locations

with the optimized primer and probe structure to achieve outputs that meet the design input requirements identified from market research.

This is done by following planned and documented processes, procedures and testing.

In other words, we use the data resulting from our

tests to verify whether we succeeded in designing what we intended at the outset.

Verification is a series of testing that concludes

that the product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting

using initial production tests to confirm that the product as designed meets the user needs.

our proprietary test design system and proprietary reagents, we have designed and obtained regulatory approval in the European Community

and/or in India to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus,

malaria, chikungunya, dengue, and the zika virus.

In the United States, CODX has obtained Emergency Use Authorization (“EUA”)

for its Logix Smart ™ COVID-19 detection test from the Food and Drug Administration,

or FDA, and sells that test to qualified labs.

In addition, our COVID-19 detection test and certain of our other suite of COVID-19 products

have been approved for sale in countries such as the United Kingdom, Australia and Mexico by the regulatory bodies in those countries

and have been registered for sale in many more countries.

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

any type of genetic trait, which creates a number of significant applications.

We, in conjunction with our customers, are active in designing

and licensing tests that identify genetic traits in plant and animal genomes.

We also have three multiplexed tests developed to test

mosquitos for the identification of diseases carried by the mosquitos to enable municipalities to concentrate their efforts in managing

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

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

intended to address the potential need for detection of the virus.

An outbreak of respiratory illness caused by the pneumonia-like

COVID-19 has spread rapidly throughout the world since 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 (WHO)

and Centers for Disease Control (CDC).

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

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

the European Union, 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 IVD for the diagnosis of 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 in the European

We shipped samples of the Research Use Only version of our test to distributors in various countries, which allowed

future customers to confirm the quality and sensitivity of the product, and for us to accelerate the sales efforts of the COVID-19

commenced sales of the COVID-19 tests in February and March of 2020 to international customers and have since sold approximately

10,000,000 tests in numerous countries around the world through an expanding distributor network.

April 6, 2020, we announced that we had received an Emergency Use Authorization from the FDA allowing us to commence sales of

our Logix Smart COVID-19 test to laboratories certified by the Center for Medicare and Medicaid Services under the Clinical Laboratories

Improvements Act (“CLIA”) to accept human samples for diagnostics testing throughout the United States and have sold

our Logix Smart COVID-19 test to such CLIA labs since that time.

we believe that testing for the COVID-19 virus is going to be a consideration for public health worldwide even after the current

pandemic has subsided, we have initiated a project to facilitate frequent testing in schools, businesses, and the hospitality

We believe this may be accomplished through the development of a low cost, easy to use by non-professionals, testing

device that can provide PCR quality test results in less than an hour.

This project is possible due to the facts that in 2020

we were able to successfully lyophilize our Logix Smart Covid-19 test reagents and additionally developed a saliva-based collection

system that does not require the RNA/DNA extraction.

While the final result is the same as if done through a lab-based IVD process,

it has the advantages of increased speed and ease of handling thanks to lyophilization.

We have engaged the services of a group

of professionals who have the expertise to develop the hardware for such a device using our CoPrimers as the reagent chemistry.

The device will be available to homes, offices, event facilities, and the travel industry at a cost that will allow screening

frequently to prevent spread of the COVID-19 virus in the future.

The device would also be available to test for other pathogens

detectable through saliva samples as we develop those tests and offer them to the marketplace.

This test features the Company’s patented CoPrimer technology,

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

Centers for Disease Control (CDC).

February 24, 2020, we announced that this test had obtained regulatory clearance to be sold as an IVD for the diagnosis of 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 first US-based company to obtain such a marking for a COVID-19 test.

commenced sales of the COVID-19 tests in February and March of 2020 to international customers and to date have since sold over 30,000,000

of this and other COVID tests in numerous countries around the world through an expanding distributor network.

April 6, 2020, we announced that we had received an Emergency Use Authorization from the FDA allowing us to commence sales of our Logix

Smart™ COVID-19 test to laboratories certified by the Center for Medicare and Medicaid Services under the Clinical Laboratories

Improvements Act (“CLIA”) to accept human samples for diagnostics testing throughout the United States and have sold our

Logix Smart™ COVID-19 test to such CLIA labs since that time.

we believe that testing for COVID-19 is going to be a consideration for public health worldwide even after the current pandemic has subsided,

we have initiated the Eikon platform to facilitate frequent testing in homes, schools, businesses, and the hospitality industry.

this may be accomplished through the development of a low-cost testing device, easy to use by non-professionals, that can provide PCR

test results in around 30 minutes.

The initial project built on this platform, an at-home and point-of-care COVID-19 PCR test, was ultimately

facilitated by our development of a saliva or nasal swab-based PCR test that does not require the RNA/DNA extraction.

While the final

result is believed to be approximately equivalent to those processed by a high-complexity clinical laboratory, it has the advantages

of increased speed and ease of handling thanks to lyophilization (or freeze-drying) of our testing reagents to allow for stability at

room temperatures.

February 15, 2021, we engaged the services of a group of professionals at Idaho Molecular, Inc and Advanced Conceptions, Inc (the “Entities,”)

with the expertise to develop the hardware for such a device using our CoPrimers™ as the reagent chemistry.

22, 2021, we announced that we would be acquiring the Entities along with all existing and future assets and intellectual property related

to the platform and device.

It is expected that the device and test will be available to homes, schools, offices, and the travel industry

among other locations at a cost that will allow screening frequently to prevent spread of the COVID-19 virus in the future.

would also be available to test for other pathogens detectable through saliva or other samples as we develop those tests and offer them

to the marketplace.

All such tests will be subject to regulatory approval.

Disease Product Offering

our proprietary test design system and proprietary reagents, we design and sell PCR diagnostic tests for diseases and pathogens

such as COVID-19, tuberculosis, hepatitis B and C, malaria, dengue, human papilloma virus, chikungunya, and Zika virus, all of

which tests have been designed and verified in our laboratory.

Our tuberculosis test and Zika test received a CE Mark in 2018,

and a triplex test for Zika, dengue and chikungunya received a CE Mark in 2019, qualifying the tests to be sold throughout the

European community and in most countries in central and South America.

In December, 2019, our Indian joint venture received a

license to manufacture and sell tuberculosis, hepatitis B, hepatitis C, human papilloma virus 16/18 and malaria tests in India

from the Central Drugs Standard Control Organization (“CDSCO”).

In February 2020, we received a CE Mark for our Logix

Smart COVID-19 test and in April 2020, our COVID-19 test was approved for manufacture and sale in India by the CDSCO and in Mexico

by the INDRE, Mexico’s equivalent to the United States Center for Disease Control.

In August 2020, we received approval

from the Australian Department of Health Therapeutic Goods Division to sell our COVID-19 test in Australia.

explained above, the development of our Logix Smart COVID-19 test was designed, developed, submitted for regulatory approval and

ready to be used both as a Research Use Only (“RUO”) and as an IVD in countries that accept a CE Mark as approval

for use of the test in a period of just over thirty days.

This is a real-world example of how in an evolving epidemic that the

CDI technology can be used to get diagnostics tools in the hands of medical professionals without delay.

It can be similarly used

to design a test for mutations of the virus should they occur and not be detectable using currently available tests.

our proprietary test design system and proprietary reagents, we and CoSara Diagnostics Pvt Ltd (“CoSara”), our joint venture

for manufacturing in India, design and sell PCR diagnostic tests for detection of diseases and pathogens such as COVID-19, tuberculosis,

hepatitis B and C, malaria, dengue, human papillomavirus, chikungunya, and Zika virus, all of which tests have been designed and verified

in our laboratories.

Our tuberculosis test and Zika test received a CE Mark in 2018, and a triplex test for Zika, dengue and chikungunya

received a CE Mark in 2019, qualifying the tests to be sold throughout the European community and in most countries in central and South

In December, 2019, CoSara received a license to manufacture and sell tuberculosis, hepatitis B, hepatitis C, human papillomavirus

16/18 and malaria tests in India from the Central Drugs Standard Control Organization (“CDSCO”).

In February 2020, we received

a CE Mark for our Logix Smart™ COVID-19 test followed by an Emergency Use Authorization by the FDA a few weeks later, and

in April 2020, our COVID-19 test was approved for manufacture and sale in India by the CDSCO and in Mexico by the INDRE, Mexico’s

equivalent to the United States Center for Disease Control.

In August 2020, we received approval from the Australian Department of Health

Therapeutic Goods Division to sell our COVID-19 test in Australia.

Other regulatory approvals and registrations followed those listed

explained above, our Logix Smart™ COVID-19 test was designed, developed, submitted for regulatory approval and ready to be

used as an IVD in countries that accept a CE Mark as approval for use of the test in a period of just over 30 days.

This is a real-world

example of how the CODX technology can be used in an evolving epidemic to get diagnostic tools in the hands of medical professionals

without delay.

It can be similarly used to design a test for mutated strains of the virus should they not be detectable using currently

available tests.

and Central and South America

initial sales were to entities located in South and Central America.

In some of those countries, there are limited regulatory

hurdles so we started offering our tests immediately.

We have applied for registration of our tests in those countries that require

registration and our distributors in those countries have provided us with in country assistance in completing such registrations.

first offered our Zika test in this region because of the demand for such test, followed quickly by tests for tuberculosis, our

triplex test for Zika, chikungunya, and dengue, hepatitis B and C, and dengue.

Sales of those tests have not been material, but

with the granting of a CE mark for our Logix Smart COVID-19, we began significant sales in this region.

Products are manufactured

for sale upon receipt of purchase orders from distributors, labs and hospitals.

In some of those countries, there are limited regulatory hurdles

so we started offering our tests immediately.

We have applied for and received registrations for our tests in many of those countries

that require registration, and our distributors in those countries have provided us with in country assistance in completing such registrations.

first offered our Zika test in this region because of the demand for such a test, followed by tests for tuberculosis, our triplex test

for Zika, chikungunya, and dengue.

Sales of those tests have not been material, but with the granting of a CE mark for our Logix Smart™

COVID-19, we began significant sales in this region.

Products are manufactured for sale upon receipt of purchase orders from distributors,

labs and hospitals.

January 2017, the Company entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical

manufacturing company in India and formed an Indian joint venture organized as CoSara Diagnostics, Pvt (“CoSara”).

The agreement provided for the construction of a manufacturing plant and the manufacture of the tests named above and the joint

sales and marketing of those tests in India.

We have received a license for the plant in Ranoli, India to manufacture approved

tests and has been used for testing and manufacturing for the Indian market.

mentioned above, the CDSCO has given us the approval for manufacture and sale of the nine tests referred above and the Company

has begun manufacture and sale of those tests.

The Company has commenced a reagent rental program in India with thermocyclers

purchased from third-party vendors and which we refer to as our MDx Device.

Each of the reagent rental placements requires the

purchase of a minimum number of tests per month.

The placement of thermocyclers in India has facilitated the sale of the SaraGene

COVID-19 tests in India, which has made CoSara profitable in 2020.

The World Health Organization (“WHO”) 2019 Global

Tuberculosis Report indicates that India is the country with the highest number of cases of tuberculosis in the world.

WHO tuberculosis statistics for India for 2018 give an estimated incidence figure of 2.69 million cases of tuberculosis for India

out of a global incidence of approximately 10.0 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).

We believe that we will be able to sell our tuberculosis

test in India through our sales distribution network that we are building currently.

manufacturing company in India and formed an Indian joint venture organized as CoSara Diagnostics, Pvt Ltd (“CoSara”).

agreement provided for the construction of a manufacturing plant and the manufacture of the tests named above and the joint sales and

marketing of those tests in India.

We have received a license for the plant in Ranoli, India to manufacture approved tests and is being

used for testing and manufacturing of our products for the Indian market.

mentioned above, the CDSCO has given us the approval for manufacture and sale of the nine tests referred above and the Company has begun

manufacture and sale of those tests.

The Company has commenced a reagent rental program in India with thermocyclers purchased from third-party

vendors and which we refer to as our MDx Device.

Each of the reagent rental placements requires the purchase of a minimum number of tests

The placement of thermocyclers in India has facilitated the sale of the SaraGene COVID-19 tests in India.

The World Health

Organization (“WHO”) 2019 Global Tuberculosis Report indicates that India is the country with the highest number of cases

of tuberculosis in the world.

WHO tuberculosis statistics for India for 2018 give an estimated incidence figure of 2.69 million cases

of tuberculosis for India out of a global incidence of approximately 10.0 million.

March 19, 2020, we announced that CoSara received authorization to begin manufacture and sale of COVID-19 tests in India.

tests in India are branded as SaraGene COVID-19 tests and are sold exclusively by CoSara.

Because any commercial activity in India

was severely restricted until May 2020, CoSara was not able to commence the manufacturing and sale of the SaraGene COVID-19 tests

until late in the second quarter, but sales efforts have resulted in CoSara being profitable since the commencement of sales of

the COVID-19 tests.

The Indian government places restrictions on the price that could be charged for COVID-19 tests which has

limited the sales in India more than we have experienced in other parts of the world.

in India are branded as SaraGene COVID-19 tests and are sold exclusively by CoSara.

The Indian government places restrictions on the

price that could be charged for COVID-19 tests which has limited the revenue in India more than we have experienced in other parts of

At the time of this report, CoSara has received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria,

hepatitis B, hepatitis C, human papillomavirus (HPV), two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex test, and

an influenza A/influenza B/COVID-19 (“ABC”) multiplex test.

diagnostics, such as our tests, are governed in Europe by the framework for in vitro diagnostics (IVDs), which encompasses diagnostic

products such as reagents, instruments and systems intended for use in diagnosis of disease.

The regulatory system for IVDs is

built largely on a self-certification procedure, placing heavy responsibility on manufacturers.

Non self-certified products are

subject to the same standards as self-certified products but are subject to audit and review by a notified body prior to receiving

approval to be CE-marked.

A CE-marking is a manufacturer’s declaration that a product meets the requirements of the applicable

European Commission directive.

Examples of current obligations include having in place a qualitative manufacturing process, user

instructions that are clear and fit for purpose, ensuring that the ‘physical’

features of devices and diagnostics

do not pose any danger.

If a product fulfils these and other related control requirements, it may be CE-marked as an indication

that the product is compliant with EU legislation and sold in the European Union.

We have received CE Marks for six of our tests

including COVID-19, COVID-19 (2 gene test), ABC (a triplex test for Flu A, Flu B and COVID-19), tuberculosis, Zika, and our Zika,

dengue, chikungunya triplex tests.

have received ISO 13485 and ISO 9001 certifications relating to the design and manufacture of our medical device products.

ISO certification indicates that we meet the standards required to self-certify certain of our products and affix a CE-marking

for sales of our products in countries accepting the CE marking (not in the United States) with only minimal further governmental

approvals and registrations in most countries.

The regulatory system for some IVDs allows

for a self-certification procedure, placing heavy responsibility on manufacturers.

Non self-certified products are subject to the same

standards as self-certified products but are also subject to audit and review by a notified body prior to receiving approval to be CE-marked.

A CE-marking is a manufacturer’s declaration that a product meets the requirements of the applicable European Commission directive.

Examples of current obligations include having in place a qualitative manufacturing process, user instructions that are clear and fit

for purpose, and ensuring that the ‘physical’ features of devices and diagnostics do not pose any danger.

If a product fulfils

these and other related control requirements, it may be CE-marked as an indication that the product is compliant with EU legislation

and sold in the European Union.

We have received CE Marks for six of our tests including for COVID-19, COVID-19 (2 gene test), ABC (a

triplex test for Flu A, Flu B and COVID-19), a DS (Direct Saliva, extraction-free) COVID-19 test, tuberculosis, Zika, and our Zika, dengue,

chikungunya triplex tests.

are ISO 13485:2016 certified, relating to the design and manufacture of our medical device products.

The ISO certification indicates

that we meet the standards required to self-certify certain of our products and affix a CE-marking for sales of our products in countries

accepting the CE marking (not in the United States) with only minimal further governmental approvals and registrations in most countries.

Food and Drug Administration (FDA) has granted permission for us to export all of our IVD products.

The FDA’s permission

to export was granted under Section 801(e) of the Federal Food, Drug, and Cosmetic Act, as amended (the “FDC Act”).

Section 801(e) of the FDA Act covers certain medical devices that have not yet received an approved Premarket Approval in the

United States by the FDA, such as our products.

The FDA’s permission to

export was granted under Section 801(e) of the Federal Food, Drug, and Cosmetic Act, as amended (the “FDC Act”).

801(e) of the FDA Act covers certain medical devices that have not yet received an approved Premarket Approval in the United States by

the FDA, such as our products.

We have not commenced any Premarket Approval steps with the FDA.

Section 801(e)

of the FDA Act applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s

Good Manufacturing Practices.

Section 801(e) of the FDA Act applies

to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing Practices.

We have received EUA for our COVID-19 test, which allows sales to qualified labs in the United States.

our EUA, we are actively selling our LogixSmart COVID-19 test to CLIA certified laboratories in the United States and the CLIA

labs are able to use our test as it is or further qualify our LogixSmart test as a Laboratory Developed Test (LDT), a diagnostic

test that has been validated for use in the CLIA lab.

These tests may be used by the lab only in that laboratory.

CLIA laboratories

develop the performance characteristics, perform the analytical validation for their LDT’s and obtain licenses to offer

our EUA, we are actively selling our Logix Smart™ COVID-19 test to CLIA certified laboratories in the United States and

the CLIA labs are able to use our test as it is or further validate our COVID-19 or other tests as Laboratory Developed Tests (LDTs),

which refers to a diagnostic test that has been validated for use in the CLIA lab.

LDTs may be used by the lab only in that laboratory.

CLIA laboratories develop the performance characteristics, perform the analytical validation for their LDTs and obtain licenses to offer

them as diagnostic services.

The FDA has publicly announced its intention to regulate certain LDTs in a phased-in approach, but

draft guidance that was published a couple of years ago was withdrawn at the end of the Obama administration and replaced by an

informal non-enforceable discussion paper reflecting some of the feedback that it received on LDT regulation.

We are currently

marketing our Logix Smart COVID-19 test to CLIA laboratories throughout the US.

The FDA has publicly announced its intention to regulate certain LDTs in a phased-in approach, but draft

guidance that was published a couple of years ago was withdrawn at the end of the Obama administration and replaced by an informal non-enforceable

discussion paper reflecting some of the feedback that it received on LDT regulation.

We are currently marketing our Logix Smart™

COVID-19 test to CLIA laboratories throughout the US.

market opportunity for our tests changed radically with the emergence of the COVID-19 pandemic.

Because we were able to respond

rapidly and produce a quality product, we have been able to build a distribution network

that extends to more than 80 countries with over 50 active distributors, most of which have been the sales network that has allowed

us to export products throughout the world.

Approximately 40% of our sales in 2020 came through sales by our distribution

We believe that after the pandemic is brought under control, the network of distributors that we have built in these

extra-ordinary times will serve us well in sales of other diagnostic tests.

Because we were able to respond rapidly

and produce a quality product, we have been able to build a distribution network that extends to

more than 80 countries with over 50 active distributors, most of which have been the sales network that has allowed us to export products

throughout the world.

We believe that after the pandemic is brought under control, the network of distributors that we have built

in these extra-ordinary times will serve us well in sales of other diagnostic tests.

molecular diagnostics market is a fast-growing portion of the in vitro (test tube-based, controlled environment) diagnostics market.

There are several advantages of molecular tests, such as the ones we market and sell, over other forms of diagnostic testing.

These advantages include higher specificity and sensitivity, the ability to perform multiplex tests and the ability to test for

drug resistance or for individual genes.

There are several advantages of PCR tests, such as the ones we market and sell, over other forms of diagnostic testing.

These advantages

include higher specificity and sensitivity, the ability to perform multiplex tests and the ability to test for drug resistance or for

individual genes.

Vector Control Services

response to market demand, we introduced our first diagnostics tests to be used exclusively to test for mosquito borne pathogens

in June 2019.

Municipalities in the US and many other countries in the world are concerned about the diseases carried by mosquitos

and which infect the human population.

To prevent outbreaks of potentially harmful viruses, such as Zika or West Nile, from infecting

the public the municipalities conduct spraying operations to eliminate the mosquito populations carrying the diseases.

it is too expensive and potentially harmful to the environment to spray all mosquito breeding areas, the solution is to identify

which particular area has mosquitos that are carrying the harmful viruses.

To know where the host mosquitos with the harmful viruses

are located, traps are set, mosquitos collected and then tested to find the areas that most needed spraying.

There are over 3,000

mosquito abatement districts throughout the United States and almost all of them conduct testing to help make the spraying more

response to market demand, we introduced our first diagnostics tests to be used exclusively to test for mosquito borne pathogens in June

Municipalities in the US and many other countries in the world are concerned about the diseases carried by mosquitos and which

infect the human population.

To prevent outbreaks of potentially harmful viruses, such as Zika or West Nile, from infecting the public

the municipalities conduct mitigation operations to eliminate the mosquito populations carrying the diseases.

Because it is too expensive

and potentially harmful to the environment to spray all mosquito breeding areas, the solution is to identify which particular area has

mosquitos that are carrying the harmful viruses.

To know where the host mosquitos with the harmful viruses are located, traps are set,

mosquitos collected and then tested to find the areas that most needed spraying.

There are over 3,000 mosquito abatement districts throughout

the United States and almost all of them conduct testing to help make the spraying more effective.

first vector related test was a triplex test that tests for West Nile, western equine and St.

Louis encephalitis.

We began shipping

the tests in June 2019.

We began shipping the

tests in June 2019.

We added a second test that tests mosquitos for Zika, chikungunya and dengue in a triplex test.

in November 2019, we completed a test for West Nile, eastern equine and St.

Louis encephalitis, specifically for use in the eastern

United States.

As a result, mosquito abatement districts can test for three target viruses in one test as compared to performing

three different tests using other market available tests, which saves our customers money.

Additionally, the districts are more

effective because they can get test results in a matter of hours using our product instead of weeks when they have to wait for

a central lab to process the mosquito tests.

have sold our Vector Smart test products and/or related lab equipment to testing districts in different sections of the country

and are marketing our products through trade shows, electronic and regular mail solicitations and have hired additional sales

personnel in the eastern US to more economically and efficiently market to the east coast areas.

Finally, in November

2019, we completed a test for West Nile, eastern equine and St.

Louis encephalitis, specifically for use in the eastern United States.

As a result, mosquito abatement districts can test for three target viruses in one test as compared to performing three different tests

using other market available tests, which saves our customers money.

Additionally, the districts are more effective because they can

get test results in a matter of hours using our product instead of weeks when they might otherwise have to wait for a central lab to

process the mosquito tests.

have sold our Vector Smart test products and/or related lab equipment to testing districts in different sections of the country and are

marketing our products through trade shows, electronic and regular mail solicitations.

Advantages of Co-Diagnostics

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Affordability:

Lower-cost test kits and low-cost MDx-device.

CDI’s tests have been designed to run on many vendors’

DNA/RNA diagnostic testing machines.

are particularly well suited to the new generation of “lab-on-a-chip”

and “point-of-care”

and POC”), highly portable analysis machinery for field, clinic and office applications.

test kits and low-cost MDx-device.

CODX’s tests have been designed to run on many vendors’ DNA/RNA diagnostic testing machines.

are particularly well suited to the new generation of “lab-on-a-chip” and “point-of-care” (“LOC and

POC”), highly portable analysis machinery for field, clinical and office applications.

We believe our rapid assay design system software provides shorter time to product release.

This has been demonstrated

with the conception, design, product manufacture, clinical verification and submission for a CE Mark for our Logix Smart coronavirus

This has been demonstrated with the

conception, design, product manufacture, clinical verification and submission for a CE Mark for our Logix Smart™ coronavirus

disease (COVID-19) test being approximately 30 days.

We believe our tests are more sensitive and specific than competitors’

and can detect more strains of viruses.

Exclusivity :

We own all patents and all intellectual property used in preparation of our tests.

We project that rising health care costs in developed and developing nations will increasingly require that

health care systems be patient specific to eliminate waste, misdiagnoses, and ineffectiveness.

A critical component will be

accurate, more affordable DNA-based diagnostics, which we plan to offer.

We plan to keep our overhead low.

Our platform technology obviates the need to pay patent royalties typically

required of our competitors, which use patented test platforms to design their tests.

With a dynamic technology that encompasses markets worldwide, we anticipate that we can identify the best

target markets, not only in high burden developing countries (HBDC’s) but also in developed nations.

Industry Category :

We believe that DNA testing is the fastest-growing segment of in-vitro diagnostic testing.

We believe our technology allows us to build tests that are highly sensitive and specific, the two benchmarks for accuracy in PCR

We project that rising health care costs in developed and developing nations will increasingly require that health

care systems be patient-specific to eliminate waste, misdiagnoses, and ineffectiveness.

A critical component will be accurate,

more affordable DNA-based diagnostics, especially in at-home and POC settings, which we plan to offer.

Low-cost Provider :

Our platform technology obviates the need to pay patent royalties typically required of our competitors, which use patented test

platforms to design their tests.

Worldwide Footprint :

With a dynamic technology that encompasses markets worldwide, we anticipate that we can identify the best target markets, not

only in high burden developing countries but also in developed nations.

Growth Industry Category :

We believe that DNA/RNA testing is the fastest-growing segment of in-vitro diagnostic testing.

Product Offering :

Our ultra-sensitive tests can be a well-designed match for a new generation of handheld and other

small point-of-care (POC) devices now entering the market.

Used together, these affordable tests and devices may revolutionize

the molecular diagnostics industry in cost, speed of test results and simplification.

Multi-plexing:

Our existing multiplexed tests demonstrate that our CoPrimer designed tests are able to test for multiple targets

in the same sample without the distortion caused by false negatives and false positives that generally occur in multiplexed

Our sensitive tests can be a well-designed match for a new generation of handheld and other small POC devices

now entering the market, including our own MDx and YourTest PCR™ devices.

Used together, these affordable tests and

devices may revolutionize the molecular diagnostics industry in cost, speed of test results and simplification.

Multiplexing:

existing multiplexed tests demonstrate that our CoPrimer-designed tests are able to test for multiple targets in the same sample

without the distortion caused by false negatives and false positives that often occur in multiplexed tests.

Biopsy for Cancer Screening

development of liquid biopsy tests is expected to spur low-cost testing in many countries.

We believe that our liquid biopsy cancer

screening may be ready for testing in the foreseeable future.

Medical applications of our SNP detection technology can determine

the presence of cancer cells or cell-free genetic material in a liquid or tissue biopsy, and to determine the distinct type of

cancer involved.

A real-life example of this includes being able to identify specific mutation(s) in genes linked to breast cancer

in order to determine a patient’s prognosis, initiate the most effective and affordable treatment and to determine whether

chemotherapy is necessary.

After diagnosis the relative cost of our technology would allow for frequent testing to measure the

effectiveness of the treatment and thus could be a companion diagnostic for a range of treatments.

technology has for all practical purposes essentially eliminated, primer-dimers, which opens up some very unique applications

for liquid biopsy for cancer detection.

Our ability to multiplex the reaction in testing for several DNA targets allows technicians

to detect multiple cancers as free-circulating DNA fragments or whole cells in a blood sample at the same time

detection is also used in the agricultural industry to identify variations in crop genomes to achieve improved seed viability

and other desired characteristics, including drought resistance, disease resistance, pest resistance and higher yield.

enhanced specificity of our technology opens up some unique applications for liquid biopsy, demonstrating its ability to detect small

quantities of mutations associated with cancer within an environment of large amounts of normal DNA, as we position the Company to take

part in this historic and challenging development in human health care.

detection is also used in the agricultural industry to identify variations in crop genomes to achieve improved seed viability and other

desired characteristics, including drought resistance, disease resistance, pest resistance and higher yield.

mid-2017, the Company was first approached by a large agribusiness to evaluate our ability to multiplex certain target genomes.

The results of the development project have successfully demonstrated our ability to not only multiplex the target genomes, but

targeted SNP’s as well.

of the development project have successfully demonstrated our ability to not only multiplex the target genomes, but targeted SNP’s

The project was undertaken in conjunction with the manufacturer of our CoPrimer tests.

of the project encouraged the parent of our manufacturer to seek a world-wide licensing arrangement for our CoPrimers in the agricultural

industry, which was completed in October 2018.

Pursuant to the exclusive license for the agronomics industry, the licensee pays

us a royalty for all CoPrimers sold to the licensee’s customers.

In January 2019, the licensee formally introduced the product

at a large agricultural conference and has branded the product under the name “BHQ CoPrimers”.

The results of the project encouraged

the parent of our manufacturer to seek a world-wide licensing arrangement for our CoPrimers™ in the agricultural industry,

which was completed in October 2018.

Pursuant to the exclusive license for the agronomics industry, the licensee pays us a royalty for

all CoPrimers™ sold to the licensee’s customers.

In January 2019, the licensee formally introduced the product at

a large agricultural conference and has branded the product under the name “BHQ CoPrimers™”.

Licensing and Assay Development

addition, the unique properties of our CoPrimer technology make them ideally suited to a variety of applications where sensitivity

is key to optimal results, including multiplexing several targets, enhanced SNP detection and enrichment for next generation sequencing.

Our licensee for our agricultural testing requested an expansion of our license agreement to include test design services for

their customers and potential customers, both in the infectious disease arena as well as for agricultural customers.

was amended in July 2019 and we expect to derive a license fee from our licensee for its design services.

If any of its customers

desire to commercialize the tests designed, they will need to seek a commercial license directly from us.

Because of these unique

characteristics of CoPrimers, research companies and institutions have requested that we design diagnostics to locate and identify

uncommon gene sequences and SNPs and create tests for the target sequences in a multiplexed reaction.

This application of our

technology is in its beginning stages, but we believe that the results from our initial research indicate a significant step forward

in defining the capabilities of our technology, which we believe can be translated to revenue producing licensing arrangements.

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

critical importance.

addition, the unique properties of our CoPrimer technology make them ideally suited to a variety of applications where sensitivity is

key to optimal results, including multiplexing several targets, enhanced SNP detection and enrichment for next generation sequencing.

Our licensee for our agricultural testing requested an expansion of our license agreement to include test design services for their customers

and potential customers, both in the infectious disease arena as well as for agricultural customers.

The license was amended in July

2019 and we expect to derive a license fee from our licensee for its design services.

If any of its customers desire to commercialize

the tests designed, they will need to seek a commercial license directly from us.

Because of these unique characteristics of CoPrimers™,

research companies and institutions have requested that we design diagnostics to locate and identify uncommon gene sequences and

SNPs and create tests for the target sequences in a multiplexed reaction.

This application of our technology is in its beginning stages,

but we believe that the results from our initial research indicate a significant step forward in defining the capabilities of our technology,

which we believe can be translated to revenue producing licensing arrangements.

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

Five of our initial U.S.

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

Patent and Trademark

Office (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 2021, we had two additional patents pending

and foreign counterpart applications.

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

Patent and Trademark Office (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 still pending in the United States, and another has been granted in South Korea.

As of March 2022, we have an issued

patent in Great Britain and India on “Rapid Oligo Probes.” We also have an issued patent in the U.S.

on “Primers for

Nucleic Acid Extension or Amplification Reactions.” We have another issued patent in the U.S.

on “Detection of Primers for

Nucleic Acid Extension or Amplification Reactions.” We have 3 patents issued in the US, as well as patents issued in Australia,

Korea, and Mexico on “Cooperative Primers, Probes, and Applications Thereof.” We have applications pending in Australia,

Canada, Europe, and the U.S.

for “Methods and Compositions for Next Generation Sequencing (NGS) Library Preparation.” We

have applications pending in the U.S.

and internationally as a PCT application for “Allele-Specific Design of Cooperative Primers

for Improved Nucleic Acid Variant Genotyping.” Lastly, we have a provisional application on file in the U.S.

and Compositions Related to Cooperative Primers and Reverse Transcription.

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.

We intend to continue building our intellectual property portfolio as development

continues and resources are available.

have copyrighted our development software that is used by us to develop diagnostic tests based on our technology.

We have allowed

one potential 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 to that customer.

had certain customers which were each responsible for generating 10% or more of our total revenue for the year ended December 31, 2021.

Two customers together accounted for approximately 48% of total revenue for the year ended December 31, 2021.

customers may not account for the same percentage of sales in future periods.

we were to sell nothing to those customers in the future, it would have a material adverse effect on our financial condition unless

we were able to replace those customers with others.

These customers may not

account for the same percentage of sales in future periods.

we were to sell nothing to those customers in the future, it would have a material adverse effect on our financial condition unless we

were able to replace those customers with others.

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 significant respect from the medical and testing professionals, although this is

changing as we continue to market our LogixSmart COVID-19 tests and other tests in the United States to well-known and successful

laboratories.

In the diagnostic testing industry, we compete with such companies as BioMerieux, Siemens, Qiagen, and Cepheid 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

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 are more recently 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 perceived as a start

up with no significant respect from the medical and testing professionals, although this is changing as we continue to market our Logix

Smart™ COVID-19 tests and other tests in the United States to well-known and successful laboratories.

In the diagnostic

testing industry, we compete with such companies as BioMerieux, Siemens, Qiagen, Cue Health, Lumira Dx and Cepheid 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 successful.

is, and will likely continue to be, particularly intense in the market for COVID-19 diagnostic tests.

Numerous companies in the

United States and internationally have announced their intention to offer new products, services and technologies that could be

used in substitution for our LogixSmart COVID-19 tests.

Many of those competitors are significantly larger, and have substantially

greater financial, engineering and other resources, than our company.

Existing and potential competitors in the market for COVID-19

diagnostic tests include developers of both serological and molecular tests.

We also compete with companies from Asia in certain

markets who are willing to sell their tests for much less than we sell our tests, which creates price pressure on us to reduce

the price of tests to compete.

expect competition to continue to increase as other established and emerging companies enter the market, as customer requirements

evolve, and as new products, services and technologies are introduced.

The entrance of new competitors is being encouraged by

governmental authorities, who are offering funding to support development of testing solutions for COVID-19.

Some of our existing

or new competitors may have strong relationships with current and potential customers, including governmental authorities, and,

as a result, may be able to respond more quickly to new or changing regulatory requirements, new or emerging technologies, and

changes in customer requirements.

the United States, we are regulated by the FDA and our products must be approved by the FDA before we will be allowed to sell

our tests in the United States.

However, the FDA granted us an EUA to manufacture and sell our Logix Smart COVID-19 test to CLIA

labs in the United States.

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

any CE Marked test in most countries in Europe, South America and Asia.

We currently have CE Marks issued for our Logix Smart

COVID-19 test, tuberculosis test, our Zika virus test, a triplex test that tests for Zika, dengue, and chikungunya simultaneously

and a triplex test that distinguishes between Flu A, Flu B and Covid-19.

In addition, our Logix Smart COVID-19 has received the

license to manufacture and sell in India from India’s CDSCO and the National Epidemiology Institute in Mexico evaluated

our Logix Smart COVID-19 test and approved it for sale in Mexico.

Numerous companies in the United

States and internationally have announced their intention to offer new products, services and technologies that could be used in substitution

for our Logix Smart™ COVID-19 tests.

Many of those competitors are significantly larger, and have substantially greater

financial, engineering and other resources, than our company.

Existing and potential competitors in the market for COVID-19 diagnostic

tests include developers of serological, antigen and molecular tests.

We also compete with companies from Asia in certain markets who

are willing to sell their tests for much less than we sell our tests, which creates competitive price pressure on us.

expect competition to continue to increase as other established and emerging companies enter the market, as customer requirements evolve,

and as new products, services and technologies are introduced.

The entrance of new competitors is being encouraged by governmental authorities,

who are offering funding to support development of testing solutions for COVID-19.

Some of our existing or new competitors may have strong

relationships with current and potential customers, including governmental authorities, and, as a result, may be able to respond more

quickly to new or changing regulatory requirements, new or emerging technologies, and changes in customer requirements.

the United States, we are regulated by the FDA and our products must be approved, cleared, or authorized by the FDA before we are allowed

to sell our tests in the United States as in vitro diagnostics.

The FDA granted us an EUA to manufacture and sell our Logix Smart™

COVID-19 test to CLIA labs in the United States.

Being ISO certified greatly facilitates our applications for CE-Marking, which allows

us to sell any CE Marked test in most countries in Europe, South America and Asia, depending on the country and following that country’s

registration process.

We currently have CE Markings issued for our Logix Smart™ COVID-19 test, tuberculosis test, our Zika

virus test, a triplex test that tests for Zika, dengue, and chikungunya simultaneously, a triplex “ABC” test that identifies

and distinguishes between Flu A, Flu B and Covid-19, our SARS-CoV-2 2-gene multiplex test, and our DS (Direct Saliva, extraction-free)

COVID-19 test.

In addition, our Logix Smart™ COVID-19 has received the license to manufacture and sell in India from India’s

CDSCO and the National Epidemiology Institute in Mexico evaluated our Logix Smart™ COVID-19 and ABC tests and approved them

for sale in Mexico.

We have also received approval to sell in Australia.

in the process of registering for sale our Logix Smart COVID-19 test in a number of major countries around the world.

of December 31, 2020, we had 37 full-time employees at our executive offices and lab facilities in Salt Lake City, Utah, and two

employees outside of Utah.

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

for products and employ the services of independent sales representatives on an “as needed”

We are in the process of registering for sale our Logix Smart™

COVID-19 and other tests in a number of major countries around the world.

of December 31, 2021, we had 101 full-time and part-time employees at our executive offices and lab facilities in Salt Lake City, Utah.

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

of independent sales representatives on an “as needed” basis.

Organizational

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Our principal executive office is located 2401 S.

Drive, Salt Lake City, Utah 84109.

Foothill Drive,

Salt Lake City, Utah 84109.

Our telephone number is (801) 438-1036.

Our web address is www.codiagnostics.com .

contents of our website are not incorporated by reference in this Annual Report.

The contents of

our website are not incorporated by reference in this Annual Report.

of Being an Emerging Growth Company

are an “emerging growth company,”

as defined in the Jumpstart Our Business Startups Act of 2012.

We will remain an

emerging growth company until the earlier of (i) the last day of the fiscal year following the fifth anniversary of July 12, 2017,

the date of the first sale of our common stock pursuant to an effective registration statement under the Securities Act of 1933,

as amended (the “Securities Act”);

(ii) the last day of the fiscal year in which we have total annual gross revenues

of $1 billion or more;

(iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous

or (iv) the date on which we are deemed to be a large accelerated filer under applicable SEC rules.

We expect that

we will remain an emerging growth company for the foreseeable future, but cannot retain our emerging growth company status indefinitely.

We refer to the Jumpstart Our Business Startups Act of 2012 herein as the “JOBS Act”.

For so long as we remain an

emerging growth company, we are permitted and intend to rely on exemptions from specified disclosure requirements that are applicable

to other public companies that are not emerging growth companies.

are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012.

We will remain an emerging

growth company until the earlier of (i) the last day of the fiscal year following the fifth anniversary of July 12, 2017, the date of

the first sale of our common stock pursuant to an effective registration statement under the Securities Act of 1933, as amended (the

“Securities Act”);

(ii) the last day of the fiscal year in which we have total annual gross revenues of $1 billion or more;

(iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years;

or (iv) the date

on which we are deemed to be a large accelerated filer under applicable SEC rules.

We expect that we will remain an emerging growth company

for the foreseeable future, but cannot retain our emerging growth company status indefinitely.

We refer to the Jumpstart Our Business

Startups Act of 2012 herein as the “JOBS Act”.

For so long as we remain an emerging growth company, we are permitted and

intend to rely on exemptions from specified disclosure requirements that are applicable to other public companies that are not emerging

growth companies.

These exemptions include:

permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial

statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results

of Operations”

permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements,

with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations”

being required to comply with the requirement of auditor attestation of our internal controls over financial reporting;

being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding

mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit

and the financial statements;

being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory

audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial

disclosure obligations regarding executive compensation;

being required to hold a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute

payments not previously approved.

being required to hold a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments

not previously approved.

as long as we continue to be an emerging growth company, we expect that we will take advantage of the reduced disclosure obligations

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Accordingly, the information contained herein may be different than the information

you receive from other public companies in which you hold stock.

emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities

Act for complying with new or revised accounting standards.

This allows an emerging growth company to delay the adoption of certain

accounting standards until those standards would otherwise apply to private companies.

We have irrevocably elected to avail ourselves

of this extended transition period and, as a result, we will not be required to adopt new or revised accounting standards on the

dates on which adoption of such standards is required for other public reporting companies.

are also a “smaller reporting company”

as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended,

or the Exchange Act, and have elected to take advantage of certain of the scaled disclosure available for smaller reporting companies.

received from other public companies.

emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for

complying with new or revised accounting standards.

This allows an emerging growth company to delay the adoption of certain accounting

standards until those standards would otherwise apply to private companies.

We have irrevocably elected to avail ourselves of this extended

transition period and, as a result, we will not be required to adopt new or revised accounting standards on the dates on which adoption

of such standards is required for other public reporting companies.

are also a “smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the

Exchange Act, and have elected to take advantage of certain of the scaled disclosure available for smaller reporting companies.

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.

What changed 10-K

Item 1. Business