As filed with the Securities and Exchange
Commission on August 14, 2018
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
CO-DIAGNOSTICS,
INC.
(Exact
name of registrant as specified in its charter)
Utah
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|
46-2609396
|
(State
or other jurisdiction of incorporation or organization)
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|
(I.R.S.
Employer Identification Number)
|
2401
S. Foothill Drive
Salt
Lake City, Utah 84109
(801)
438-1036
(Address,
including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Co-Diagnostics,
Inc
2401
S. Foothill Drive
Salt
Lake City, Utah 84109
(801)
438-1036
(Name,
address, including zip code, and telephone number, including area code, of agent for service)
Reed
L. Benson, Esq.
4049
S. Highland Drive
Salt
Lake City, Utah 84124
(801)
278-9769
Peter
DiChiara, Esq.
Ross
D. Carmel, Esq.
Carmel,
Milazzo & DiChiara LLP
55
West 39
th
Street, 18
th
Floor
New
York, New York 10018
(212)
658-0458
Approximate
date of commencement of proposed sale to the public: From time to time, after the effective date of this registration statement.
If
the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please
check the following box. [ ]
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check
the following box. [X]
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration statement number of the earlier effective registration statement
for the same offering. [ ]
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
[ ]
If
this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become
effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. [ ]
If
this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following
box. [ ]
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated filer [ ]
|
Accelerated
filer [ ]
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Non-accelerated
filer [ ] (Do not check if smaller reporting company)
|
Smaller
reporting company [X]
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Emerging
growth company [X]
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|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Exchange Act.
[ ]
CALCULATION
OF REGISTRATION FEE
Title of Each Class
of Securities
to be Registered (1)
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|
Amount to be
Registered (2) (3)
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Proposed
Maximum Aggregate
Offering Price
per Security (2) (3)
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|
Proposed
Maximum Aggregate
Offering Price (2) (3)
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Amount of
Registration Fee (4)
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Common Stock, par value $0.0001 per share
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—
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|
—
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|
|
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—
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|
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—
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Preferred Stock, par value $0.0001 per share
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|
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—
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—
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—
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|
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—
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|
Warrants to purchase common stock, Preferred Stock or other securities (5)
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—
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—
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—
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—
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Units (6)
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—
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—
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—
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—
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TOTAL
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—
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—
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$
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25,000,000
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$
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3,112.50
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(1)
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Securities
registered hereunder may be sold separately, together or as units with other securities registered hereunder.
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(2)
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Not
specified as to each class of securities to be registered pursuant to Form S-3 General Instruction II.D.
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(3)
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The
Registrant is registering an indeterminate aggregate principal amount and number of securities of each identified class of
securities up to a proposed aggregate offering price of $25,000,000, which may be offered from time to time in unspecified
numbers and at indeterminate prices, and as may be issuable upon conversion, redemption, repurchase, exchange, or exercise
of any securities registered hereunder, including under any applicable anti-dilution provisions. In addition, pursuant to
Rule 416 under the Securities Act of 1933, as amended, the shares being registered hereunder include such indeterminate number
of shares of common stock and preferred stock as may be issuable with respect to the shares being registered hereunder as
a result of stock splits, stock dividends or similar transactions.
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(4)
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The
registration fee is calculated in accordance with Rule 457(o) under the Securities Act of 1933, as amended.
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(5)
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Warrants may represent rights to purchase common stock, preferred stock or other securities registered hereunder.
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(6)
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Each
Unit consists of any combination of two or more of the securities being registered hereby.
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The
Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until
the Registrant shall file a further amendment that specifically states that this Registration Statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act or until this Registration Statement shall become effective on
such date as the Commission, acting pursuant to said Section 8(a), may determine.
The
information in this prospectus is not complete and may be changed. We may not sell these securities or accept an offer to buy
these securities until the Securities and Exchange Commission declares our registration statement effective. This prospectus is
not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale
is not permitted.
SUBJECT TO COMPLETION, DATED
AUGUST 14, 2018
PROSPECTUS
CO-DIAGNOSTICS,
INC.
$25,000,000
COMMON
STOCK
PREFERRED
STOCK
WARRANTS
UNITS
We may offer and sell
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; warrants to purchase our securities, each of which may be convertible
into equity securities; or units comprised of, or other combinations of, the foregoing securities.
We
may offer securities through underwriting syndicates managed or co-managed by one or more underwriters or dealers, through agents
or directly to purchasers. The prospectus supplement for each offering of securities will describe in detail the plan of distribution
for that offering. For general information about the distribution of securities offered, please see “Plan of Distribution”
in this prospectus. Each time our securities are offered, we will provide a prospectus supplement containing more specific information
about the particular offering and attach it to this prospectus. The prospectus supplements may also add, update or change information
contained in this prospectus.
This prospectus may not be used to offer or sell securities without a prospectus supplement which
includes a description of the method and terms of this offering.
Our common stock is quoted
on the Nasdaq Capital Market under the symbol “CODX.” The last reported sale price of our common stock on The NASDAQ
Capital Market on August 13, 2018 was $3.48 per share. The aggregate market value of our outstanding common stock
held by non-affiliates is $24,381,200 based on 12,348,027 shares of outstanding common stock, of which 7,006,092 shares are
held by non-affiliates, and a per share price of $3.48 which was the closing sale price of our common stock as quoted on
the NASDAQ Capital Market on August 13, 2018. During the 12 calendar month period that ends on, and includes, the date
of this prospectus, we have not offered and sold any of our securities pursuant to General Instruction I.B.6 of Form S-3.
If we decide to seek
a listing of any preferred stock, purchase contracts, warrants, subscriptions rights, depositary shares or units offered by this
prospectus, the related prospectus supplement will disclose the exchange or market on which the securities will be listed, if
any, or where we have made an application for listing, if any.
Investing
in our securities involves certain risks. See “Risk Factors” beginning on page 9 and any risk factors in our
most recent Annual Report on Form 10-K, which is incorporated by reference herein, as well as in any other recently filed quarterly
or current reports and, if any, in the relevant prospectus supplement. We urge you to carefully read this prospectus and the accompanying
prospectus supplement, together with the documents we incorporate by reference, describing the terms of these securities before
investing.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this Prospectus is ___________, 2018.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission, or SEC,
utilizing a “shelf” registration process. Under this shelf registration process, we may offer and sell, either individually
or in combination, in one or more offerings, any of the securities described in this prospectus, for total gross proceeds of up
to $25,000,000. This prospectus provides you with a general description of the securities we may offer. Each time we offer
securities under this prospectus, we will provide a prospectus supplement to this prospectus that will contain more specific information
about the terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain
material information relating to these offerings. The prospectus supplement and any related free writing prospectus that we may
authorize to be provided to you may also add, update or change any of the information contained in this prospectus or in the documents
that we have incorporated by reference into this prospectus.
We
urge you to read carefully this prospectus, any applicable prospectus supplement and any free writing prospectuses we have authorized
for use in connection with a specific offering, together with the information incorporated herein by reference as described under
the heading “Incorporation of Documents by Reference,” before investing in any of the securities being offered. You
should rely only on the information contained in, or incorporated by reference into, this prospectus and any applicable prospectus
supplement, along with the information contained in any free writing prospectuses we have authorized for use in connection with
a specific offering. We have not authorized anyone to provide you with different or additional information. This prospectus is
an offer to sell only the securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to do
so.
The
information appearing in this prospectus, any applicable prospectus supplement or any related free writing prospectus is accurate
only as of the date on the front of the document and any information we have incorporated by reference is accurate only as of
the date of the document incorporated by reference, regardless of the time of delivery of this prospectus, any applicable prospectus
supplement or any related free writing prospectus, or any sale of a security.
This
prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made
to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents.
Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits
to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below
under the section entitled “Where You Can Find Additional Information.”
This
prospectus contains, or incorporates by reference, trademarks, tradenames, service marks and service names of Co-Diagnostics Incorporated.
CAUTIONARY
NOTE REGARDING FORWARD LOOKING STATEMENTS
This
prospectus and any accompanying prospectus supplement and the documents incorporated by reference herein may contain forward looking
statements that involve risks and uncertainties. All statements other than statements of historical fact contained in this prospectus
and any accompanying prospectus supplement and the documents incorporated by reference herein, including statements regarding
future events, our future financial performance, business strategy, and plans and objectives of management for future operations,
are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,”
“believes,” “can,” “continue,” “could,” “estimates,” “expects,”
“intends,” “may,” “plans,” “potential,” “predicts,” “should,”
or “will” or the negative of these terms or other comparable terminology. Although we do not make forward looking
statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are
only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined under “Risk
Factors” or elsewhere in this prospectus and the documents incorporated by reference herein, which may cause our or our
industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking
statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment. New risks emerge from
time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business
or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained
in any forward-looking statements.
We
have based these forward-looking statements largely on our current expectations and projections about future events and financial
trends that we believe may affect our financial condition, results of operations, business strategy, short term and long-term
business operations, and financial needs. These forward-looking statements are subject to certain risks and uncertainties that
could cause our actual results to differ materially from those reflected in the forward-looking statements. Factors that could
cause or contribute to such differences include, but are not limited to, those discussed in this prospectus, and in particular,
the risks discussed below and under the heading “Risk Factors” and those discussed in other documents we file with
the SEC. The following discussion should be read in conjunction with the consolidated financial statements for the fiscal years
ended December 31, 2017 and 2016 and notes incorporated by reference herein. We undertake no obligation to revise or publicly
release the results of any revision to these forward-looking statements, except as required by law. In light of these risks, uncertainties
and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could
differ materially and adversely from those anticipated or implied in the forward-looking statement.
You
should not place undue reliance on any forward-looking statement, each of which applies only as of the date of this prospectus.
Except as required by law, we undertake no obligation to update or revise publicly any of the forward-looking statements after
the date of this prospectus to conform our statements to actual results or changed expectations.
Any
forward-looking statement you read in this prospectus, any prospectus supplement or any document incorporated by reference reflects
our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating
to our operations, operating results, growth strategy and liquidity. You should not place undue reliance on these forward-looking
statements because such statements speak only as to the date when made. We assume no obligation to publicly update or revise these
forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated
in these forward-looking statements, even if new information becomes available in the future, except as otherwise required by
applicable law. You are advised, however, to consult any further disclosures we make on related subjects in our reports on Forms
10-Q, 8-K and 10-K filed with the SEC. You should understand that it is not possible to predict or identify all risk factors.
Consequently, you should not consider any such list to be a complete set of all potential risks or uncertainties.
OUR
BUSINESS
This
summary highlights selected information contained elsewhere in this prospectus. This summary does not contain all the information
that you should consider before investing in our Company. You should carefully read the entire prospectus, including all documents
incorporated by reference herein. In particular, attention should be directed to our “Risk Factors,” “Information
With Respect to the Company,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
and the financial statements and related notes thereto contained herein or otherwise incorporated by reference hereto, before
making an investment decision.
In
this prospectus, “Co-Diagnostics,” “the Company,” “we,” “us,” and “our”
refer to Co-Diagnostics, Inc. and its consolidated subsidiaries.
Business
Overview
Co-Diagnostics
is developing robust and innovative molecular tools for detection of infectious diseases, liquid biopsy for cancer screening,
and agricultural applications.
Our
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 newest technical advance involves a novel
approach to PCR test design (“Co-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.
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 are able to accomplish this faster and more
economically, allowing for wider margins while still positioning Co-Diagnostics to be a low-cost provider of molecular diagnostics
and screening services.
Co-Diagnostics,
Inc. (“Company,” or “CDI,”), a Utah corporation, is a molecular diagnostics company that has developed
and intends to manufacture and sell reagents used for diagnostic tests that function via the detection and/or analysis of nucleic
acid molecules (DNA or RNA). 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”).
In
addition, continued development has demonstrated the unique properties of our Co-Primer technology that make them ideally suited
to 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.
Dr.
Brent Satterfield, our Chief Technology Officer, created the Company’s suite of intellectual properties. Our scientists
were the first to understand the complex mathematics of DNA test design, to “engineer” a DNA test and to automate
algorithms that rapidly screen millions of possible options to pinpoint the optimum design. Dr. Satterfield developed the Company’s
intellectual property consisting of the predictive mathematical algorithms and proprietary reagents used in the testing process,
which together represent a major advance in Polymerase Chain Reaction (“PCR”) testing systems. CDI technologies are
now protected by five granted or pending US 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 grants us
the opportunity of selling diagnostic tests at a lower price than competitors, while generating a profit margin.
We
may either sell or lease our portable labs to existing diagnostic centers, through sale or lease agreements, and sell the reagents
that comprise our proprietary tests to those laboratories and testing facilities.
CDI’s
low-cost system (pictured at right) uses CDI’s tests to diagnose tuberculosis, Zika, hepatitis B and C, Malaria, dengue
and HIV, all of which tests have been designed and verified in CDI’s laboratory as explained below.
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We
designed our tests by identifying the optimal locations on the target gene for amplification and paired the location 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, the data resulting from our
tests verify that we succeeded in designing what we intended to at the outset. Verification is a series of testing that concludes
that the product is ready to proceed to validation in a clinical evaluation setting using initial production tests to confirm
that the product as designed meets the user needs.
Using
its proprietary test design system and proprietary reagents, CDI will design and sell PCR diagnostic tests for diseases and pathogens
starting with tests for tuberculosis, a drug resistant tuberculosis test, hepatitis B and C, Malaria, dengue, HIV and Zika virus,
all of which tests have been designed and verified in CDI’s laboratory. Our tuberculosis test received a CE Mark in July
2018 qualifying our test to be sold throughout the European community and in most countries in central and South America.
Infectious
Disease Product Offering
We
plan to manufacture molecular diagnostic tests for the following diseases in the following regions, to be sold along with the
MDx device:
Timetable
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Region
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Tests
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Current
(revenues in the 2nd quarter in 2018)
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Caribbean
and Central and South America
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Zika,
Tuberculosis, Hepatitis B and C, Dengue
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India
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Tuberculosis,
Hepatitis B and C, Malaria, Dengue and HIV
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2018-2019
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European
Union; Asia
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Tuberculosis,
Hepatitis B and C
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2020-2025
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United
States
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To
be determined based on need and regulatory barriers
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Caribbean
and Central and South America
Our
initial sales will be to entities within the Caribbean Public Health Agency Members States (Anguilla, Antigua and Barbuda, Aruba,
Bahamas, Barbados, Belize, Bermuda, BES Islands, British Virgin Islands, Cayman Islands, Curacao, Dominica, Grenada, Haiti, Guyana,
Jamaica, Montserrat, Saint Kitts and Nevis, Saint Lucia, St Maarten, Saint Vincent and the Grenadines, Suriname, Trinidad and
Tobago, Turks and Caicos Islands).
In
some of these countries, there are no regulatory hurdles and we can start offering our tests immediately. The U.S. Food and Drug
Administration (FDA) has granted permission for us to export many of 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”). 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. We have not commenced any Premarket Approval steps with the FDA. Section 801(e) applies to medical devices
that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing Practices.
We
will first offer our Zika test in this region because of the demand for such test, followed quickly by tests for tuberculosis,
hepatitis B and C, and dengue, then our full range of tests. Products will be manufactured for sale upon receipt of purchase orders
from labs and hospitals.
India
The
Company has entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical manufacturing
company in India. The agreement provides for the manufacture of the tests named above and the joint sales and marketing of those
tests in India. We have commenced with our joint venture partner to construct a plant that will be used for testing and manufacturing
to service the Indian market. We believe that the plant will be completed and manufacturing activities will begin in the third
quarter of 2018.
Since
the tests will be conducted in India on Indian citizens, no FDA approval or inspection will be required. Certain Indian regulatory
approval from the Central Drugs Standard Control Organization (CDSCO) must be acquired. We are engaging the services of an experienced
consultant in India to help get us through this process. Research Use Only (RUO) reagents are able to be sold without requiring
regulatory approval as long as they are labeled and designated as such. Tests for some of the targeted diseases are available
for sale currently in India.
India
is the country with the highest burden of tuberculosis. 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). We currently have a tuberculosis test and tuberculosis test that measures drug resistance to aid in more
effective treatment.
Europe
Molecular
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 received a CE Mark for our tuberculosis test
in July, 2018.
We
have received ISO 13485 and ISO 9001 certifications 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 in each country. We also expect to have our Zika, dengue and malaria tests CE-marked in 2018. We estimate the remaining
costs for CE-marks on the initial tests we will offer to be approximately $100,000.
United
States
We
do not anticipate offering our tests in the United States in the near future. We believe, however, our tests may be able to qualify
as Laboratory Developed Tests (LDT’s), diagnostic tests that are developed and manufactured by CLIA certified laboratories.
These tests are developed by the lab for use only in that laboratory. CLIA laboratories develop the performance characteristics,
perform the analytical validation for their LDT’s 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.
Market
Opportunity
The
molecular diagnostics market is a fast-growing portion of the in vitro (test tube based, controlled environment) diagnostics market.
Using estimates of the incidence of disease by the Centers for Disease Control, the World Health Organization and other international
health agencies and sources, the Company estimates that the global annual demand for diagnostic tests are:
Tuberculosis
|
|
|
10,400,000
|
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HIV
|
|
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36,700,000
|
|
Multi-drug
resistant Tuberculosis
|
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580,000
|
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Malaria
|
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214,000,000
|
|
Zika
|
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324,000,000
|
|
|
Sexually
Transmitted Illnesses
|
|
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357,000,000
|
|
Hepatitis
B
|
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|
240,000,000
|
|
|
Human
papilloma virus
|
|
|
291,000,000
|
|
Hepatitis
C
|
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130,000,000
|
|
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Dengue
|
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|
390,000,000
|
|
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|
|
|
|
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|
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Total
Annual Tests
|
|
|
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1,993,680,000
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|
There
are several advantages of molecular tests, such as the ones we market and sell, over other forms of diagnostic testing, which
include higher sensitivities, the ability to perform multiplex tests and the ability to test for drug resistance or individual
genes.
Competitive
Advantages of Co-Diagnostics
We
believe that we have the following competitive advantages:
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●
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Affordability:
Lower-cost test kits and low-cost MDx-device.
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●
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Flexibility:
CDI’s tests have been designed to run on many vendors’ DNA diagnostic testing machines. These tests 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, clinic and office applications.
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●
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Speed
:
We believe our rapid assay design system software provides shorter time to product release.
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●
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Accuracy
:
We believe our tests are more accurate than competitors’ and can detect more strains of viruses.
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●
|
Exclusivity
:
CDI owns all patents and all intellectual property used in preparation of its tests.
|
|
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●
|
Personalized
Medicine
:
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 CDI plans to offer.
|
|
●
|
Low-cost
Provider
:
We plan to keep the Company’s overhead low. Its platform technology obviates the need to pay patent
royalties typically required of its competitors, which use patented test platforms to design their tests.
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Worldwide
Footprint
:
With a dynamic technology that encompasses markets worldwide, the Company anticipates that it can identify
the best target markets, not only in high burden developing countries (HBDC’s) but also in developed nations.
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Growth
Industry Category
:
We believe that DNA testing is the fastest-growing segment of in-vitro diagnostic testing.
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Combination
Product Offering
:
CDI’s ultra-sensitive tests can be a well-designed match for a new generation of handheld
and other small point-of-care 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.
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Multi-plexing:
Our initial development efforts have demonstrated that our Co-Primer designed tests will be 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
tests.
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Liquid
Biopsy for Cancer Screening
The
development of the liquid biopsy test will spur low cost testing in many developing countries. We believe that our liquid biopsy
cancer screening shall be ready for testing in 2019 if we have sufficient development resources to dedicate to the project. 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.
Our
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
We
are working with the Wang Group at Stanford University on a study to develop more efficient methods to detect multiple genetic
mutations in the EGFR (epidermal growth factor receptor) gene, including the most frequently occurring mutations in lung cancer,
within a single reaction. The investigators have been conducting research into the subject using commercially available primers
for several years, the results of which have previously been published. It is anticipated that the results of the current study
will be compiled and published later in 2018.
Agricultural
Applications
SNP
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.
In
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 has been to successfully demonstrate our ability to not only multiplex the target genomes,
but targeted SNP’s as well. The project was undertaken in conjunction with the manufacturer of our Co-Primer tests. The
results of the project have encouraged the parent of our manufacturer to seek a world-wide licensing arrangement for our Co-Primers
in the agricultural industry. We expect the licensing arrangement to be negotiated and finalized in 2018.
Additional
Licensing and Assay Development
In addition, the unique properties of our Co-Primer 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 gen sequencing. Because of these unique characteristics of Co-Primers, 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.
Organizational
History and Corporate Information
We
were incorporated as Co-Diagnostics, Inc., in Utah on April 18, 2013. Our principal executive office is located 2401 S. Foothill
Drive, Salt Lake City, Utah 84109. Our telephone number is (801) 438-1036. Our web address is http://codiagnostics.com.
Implications
of Being an Emerging Growth Company
We
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:
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being
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” disclosure;
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not
being required to comply with the requirement of auditor attestation of our internal controls over financial reporting;
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not
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;
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reduced
disclosure obligations regarding executive compensation; and
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not
being required to hold a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute
payments not previously approved.
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For
as long as we continue to be an emerging growth company, we expect that we will take advantage of the reduced disclosure obligations
available to us as a result of that classification. Accordingly, the information contained herein may be different than the information
you receive from other public companies in which you hold stock.
An
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.
We
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.
We may offer shares of
our common stock and preferred stock and warrants to purchase any of such securities, either individually or in units, with a
total value of up to $25,000,000 from time to time under this prospectus, together with any applicable prospectus supplement and
related free writing prospectus, at prices and on terms to be determined by market conditions at the time of offering. Each time
we offer securities under this prospectus, we will provide offerees with a prospectus supplement that will describe the specific
amounts, prices and other important terms of the securities being offered, including, to the extent applicable:
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designation
or classification;
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aggregate
principal amount or aggregate offering price;
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maturity,
if applicable;
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original
issue discount, if any;
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rates
and times of payment of interest or dividends, if any;
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redemption,
conversion, exchange or sinking fund terms, if any;
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conversion
or exchange prices or rates, if any, and, if applicable, any provisions for changes to or adjustments in the conversion or
exchange prices or rates and in the securities or other property receivable upon conversion or exchange;
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restrictive
covenants, if any;
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voting
or other rights, if any; and
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important
United States federal income tax considerations.
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Common
Stock
A
prospectus supplement and any related free writing prospectus that we may authorize to be provided to you may also add, update
or change information contained in this prospectus or in documents we have incorporated by reference. However, no prospectus supplement
or free writing prospectus will offer a security that is not registered and described in this prospectus at the time of the effectiveness
of the registration statement of which this prospectus is a part.
We
may sell the securities to or through underwriters, dealers or agents or directly to purchasers. We, as well as any agents acting
on our behalf, reserve the sole right to accept and to reject in whole or in part any proposed purchase of securities. Each prospectus
supplement will set forth the names of any underwriters, dealers or agents involved in the sale of securities described in that
prospectus supplement and any applicable fee, commission or discount arrangements with them, details regarding any over-allotment
option granted to them, and net proceeds to us. The following is a summary of the securities we may offer with this prospectus.
We
currently have authorized 180,000,000 shares of common stock, $.001 par value. We may offer shares of our common stock either
alone or underlying other registered securities convertible into or exercisable for our common stock. Holders of our common stock
are entitled to such dividends as our Board of Directors (the “Board” or “Board of Directors”) may declare
from time to time out of legally available funds, subject to the preferential rights of the holders of any shares of our preferred
stock
that are outstanding or that we may issue in the future. Currently, we do not pay any dividends on our common stock.
Each holder of our common stock is entitled to one vote per share. In this prospectus, we provide a general description of, among
other things, the rights and restrictions that apply to holders of our common stock.
Financing
Transaction
On
August 3, 2018, we entered into a Note Purchase Agreement with an existing shareholder of the Company and prior invest
or
in our convertible debt securities. Pursuant to the Note Purchase Agreement, we issued a Promissory Note, dated August 3, 2018
(the “Note”), in the principal amount of $2,000,000 in exchange for a loan to the Company of equal principal amount.
The Note bears interest at the rate of nine percent (9.0%) per annum, payable quarterly in arrears. The maturity date of the Note
is July 31, 2019. All unpaid principal and accrued interest on the Note will become due and payable on the maturity date. The
Note is unsecured and provides for a default interest rate of eighteen percent (18.0%) per annum. The Note may be prepaid in full
or in part at any time. The Note contains standard default and other terms and conditions. The Note provides that the repayment
of the principal amount ($2,000,000) must be made in Canadian dollars. The Note establishes a floor designated in Canadian dollars
whereby the Company must pay no less than Cdn$2,600,000 in repayment of the principal amount. Therefore, the Company is required
to bear the risk of currency fluctuations between the U.S. and Canadian dollars in the event the principal repayment of $2,000,000
is less than Cdn$2,600,000.
Corporate
Information
We
were incorporated as Co-Diagnostics, Inc., in Utah on April 18, 2013. Our principal executive office is located 2401 S.
Foothill Drive, Suite D, Salt Lake City, Utah 84109. Our telephone number is (801) 438-1036. Our web address is
http://codiagnostics.com. The information included on our website is not, and shall not be interpreted to be, a part of this
prospectus.
USE
OF PROCEEDS
Except
as described in any prospectus supplement and any free writing prospectus in connection with a specific offering, we currently
intend to use the net proceeds from the sale of the securities offered under this prospectus for general corporate purposes and
working capital and capital expenditures. We may also use the net proceeds to invest in or acquire complementary businesses, products
or technologies, although we have no current commitments or agreements with respect to any such investments or acquisitions as
of the date of this prospectus. We have not determined the amount of net proceeds to be used specifically for the foregoing purposes.
As a result, our management will have broad discretion in the allocation of the net proceeds and investors will be relying on
the judgment of our management regarding the application of the proceeds of any sale of the securities. Pending use of the net
proceeds, we may invest the proceeds in short-term, investment-grade, interest-bearing instruments.
RISK
FACTORS
Our
business is subject to many risks and uncertainties, which may affect our future financial performance. If any of the events or
circumstances described below occur, our business and financial performance could be adversely affected, our actual results could
differ materially from our expectations, and the price of our stock could decline. The risks and uncertainties discussed below
are not the only ones we face. There may be additional risks and uncertainties not currently known to us or that we currently
do not believe are material that may adversely affect our business and financial performance. You should carefully consider the
risks described below, together with all other information included in this prospectus including our financial statements and
related notes, before making an investment decision. The statements contained in this prospectus that are not historic facts are
forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from
those set forth in or implied by forward-looking statements. If any of the following risks actually occurs, our business, financial
condition or results of operations could be harmed. In that case, the trading price of our common stock could decline, and investors
in our securities may lose all or part of their investment.
Risks
Related to Our Business and Industry
We
have a limited commercial history upon which to base our prospects, have not generated revenues or profits and do not expect to
generate profits for the foreseeable future
.
We may never achieve or sustain profitability
.
We
began operations in April 2013, and we have a limited operating history. We have not earned significant revenue to date and do
not expect to earn significant revenue in the near future. We had a net loss of $2.7 million for the six months ended
June 30, 2018 and a net loss of $7.0 million and $1.9 million in the years ended December 31, 2017 and December 31,
2016, respectively. Our accumulated deficit was $15.1 million as of June 30, 2018 and $12.4 million and $5.5 million as
of December 31, 2017 and December 31, 2016, respectively. Potential investors should be aware of the difficulties normally encountered
by a new enterprise, many of which are beyond our control, including substantial risks and expenses in the course of developing
new diagnostic tests, establishing or entering new markets, organizing operations and marketing procedures. The likelihood of
our success must be considered in light of these risks, expenses, complications and delays, and the competitive environment in
which we operate. There is, therefore, nothing at this time upon which to base an assumption that our business plan will prove
successful, and we may not be able to generate significant revenue, raise additional capital or operate profitably. We will continue
to encounter risks and difficulties frequently experienced by early commercial stage companies, including scaling up our infrastructure
and headcount, and may encounter unforeseen expenses, difficulties or delays in connection with our growth. In addition, as a
result of the start-up nature of our business, we can be expected to continue to sustain substantial operating expenses without
generating sufficient revenues to cover expenditures. As discussed in Note 1 to the audited condensed financial statements
and elsewhere in this Form S-3, our recurring operating losses from operations and our need for additional sources of capital
to fund our ongoing operations raise substantial doubt about our ability to continue as a going concern. Any investment in
our company is therefore highly speculative and could result in the loss of your entire investment.
We
will need to raise additional capital, which may not be available on favorable terms, if at all, and which may cause dilution
to stockholders, restrict our operations or adversely affect our ability to operate our business
.
As
of June 30, 2018, our consolidated cash balance was $1,528,267 and our working capital surplus was $1,489,207.
We estimate our current rate of expenditures is approximately $322,840 per month and we estimate that our existing capital resources
as of June 30, 2018 will fund our operations for approximately 5 months. On August 3, 2018, we entered into a
Note Purchase Agreement with an existing shareholder of the Company and prior investor in our convertible debt securities. Pursuant
to the Note Purchase Agreement, we issued a Note, dated August 3, 2018, in the principal amount of $2,000,000 in exchange for
a loan to the Company of equal principal amount. With the proceeds from the issuance of this Note, we will able to sustain
our operations and current business strategy for atleast twelve months. We may be unable to obtain future financing
on favorable terms, or at all, and any additional financings could result in additional dilution to our then existing stockholders
or restrict our operations or adversely affect our ability to operate our business. If we are unable to obtain needed financing
on acceptable terms, we may not be able to implement our business plan, which could have a material adverse effect on our business,
financial condition and results of operations. We may not be able to meet our business objectives; our equity value may decrease
and investors may lose some or all of their investment. If we raise funds by issuing equity securities, the percentage ownership
of our stockholders at such time will be reduced. If we raise funds by issuing debt, the ability of our stockholders to receive
earnings or distributions may be adversely affected and we may be subject to additional covenants and restrictions
Our
near-term success is dependent upon our ability to commence sales of our tests
.
Our
success will depend, in part, upon our ability to commence sales of our tests. Attracting new customers and distribution networks
requires substantial time and expense. Any failure to initiate sales of our tests to validate our platform would adversely affect
our operating results. Many factors could affect the market acceptance and commercial success of our diagnostic tests, including:
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our
ability to convince our potential customers of the advantages and economic value of our tests over competing technologies
and diagnostic tests;
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the
breadth of our test menu relative to competitors;
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changes
to policies, procedures or currently accepted best practices in clinical diagnostic testing;
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the
extent and success of our marketing and sales efforts; and
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our
ability to manufacture in quantity our commercial diagnostic tests and meet demand in a timely fashion.
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If
we cannot successfully develop, obtain regulatory approvals for and commercialize new diagnostic tests, our financial results
will be harmed and our ability to compete will be harmed
.
Our
financial performance depends in part upon our ability to successfully develop and market new tests in a rapidly changing technological
and economic environment. If we fail to successfully introduce new diagnostic tests, we could lose customers and market share.
We could also lose market share if our competitors introduce new diagnostic tests or technologies that render our diagnostic tests
less competitive or obsolete. In addition, delays in the introduction of new diagnostic tests due to regulatory, developmental
or other obstacles could negatively impact our revenue and market share, as well as our earnings. Factors that can influence our
ability to introduce new diagnostic tests, the timing associated with new product approvals and commercial success of these diagnostic
tests include:
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the
scope of and progress made in our research and development activities;
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our
ability to successfully initiate and complete clinical trial studies;
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timely
expansion of our menu of tests;
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the
results of clinical trials needed to support any regulatory approvals of our tests;
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our
ability to obtain requisite regulatory clearances or approvals, where required, for our tests under development on a timely
basis;
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demand
for the new diagnostic tests we introduce;
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product
offerings from our competitors; and
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the
functionality of new diagnostic tests that address market requirements and customer demands.
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We
are subject to many laws and governmental regulations and any adverse regulatory action may materially adversely affect our financial
condition and business operations
.
Although
we intend to sell our tests where regulatory approval is not required, our diagnostic tests may be subject to regulation by numerous
government agencies, including the FDA and comparable foreign agencies. To varying degrees, each of these agencies requires us
to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of
our diagnostic tests. In the clinical market, our diagnostic tests, when sold in the United States, will be regulated by the FDA
and comparable agencies of other countries. In particular, certain regulations govern activities such as product development,
product testing, product labeling, product storage, premarket clearance or approval, manufacturing, advertising, promotion, product
sales, reporting of certain product failures and distribution. Our diagnostic tests will require 510(k) clearance from the FDA
prior to marketing in the United States directly to end users. Clinical trials are required to support a 510(k) submission.
Since
2009, the FDA has significantly increased its oversight of companies subject to its regulations, including medical device companies,
by hiring new investigators and stepping up inspections of manufacturing facilities. Further, 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.
Foreign
governmental regulations have become increasingly stringent and more common, and we may become subject to more rigorous regulation
by foreign governmental authorities in the future. Penalties for a company’s non-compliance with foreign governmental regulation
could be severe, including revocation or suspension of a company’s business license and criminal sanctions. Any domestic
or foreign governmental law or regulation imposed in the future may have a material adverse effect on us.
Our
current and potential customers in the United States and elsewhere may also be subject, directly or indirectly, to applicable
anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws
and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative
burdens and diminished profits and future earnings.
The
life sciences industry is highly competitive and subject to rapid technological change. If our competitors and potential competitors
develop superior diagnostic tests and technologies, our competitive position and results of operations would suffer
.
We
face intense competition from a number of companies that offer diagnostic tests in our target markets, many of which have substantially
greater financial resources and larger, more established marketing, sales and service organizations than we do. The life sciences
industry is characterized by rapid and continuous technological innovation. We may need to develop new technologies for our diagnostic
tests to remain competitive. One or more of our current or future competitors could render our present or future diagnostic tests
obsolete or uneconomical by technological advances. We may also encounter other problems in the process of delivering new diagnostic
tests to the marketplace, such as problems related to design, development or manufacturing of such diagnostic tests, and as a
result we may be unsuccessful in selling such diagnostic tests. Our future success depends on our ability to compete effectively
against current technologies, as well as to respond effectively to technological advances by developing and marketing diagnostic
tests that are competitive in the continually changing technological landscape.
If
our diagnostic tests do not perform as expected or the reliability of the technology on which our diagnostic tests are based is
questioned, we could experience delayed or reduced market acceptance of our diagnostic tests, increased costs and damage to our
reputation
.
Our
success depends on the market’s confidence that we can provide reliable, high-quality diagnostic tests. We believe that
customers in our target markets are likely to be particularly sensitive to product defects and errors. Our reputation and the
public image of our diagnostic tests or technologies may be impaired if our diagnostic tests fail to perform as expected or our
diagnostic tests are perceived as difficult to use. Despite quality control testing, defects or errors could occur in our diagnostic
tests or technologies.
In
the future, if our diagnostic tests experience a material defect or error, this could result in loss or delay of revenues, delayed
market acceptance, damaged reputation, diversion of development resources, legal claims, increased insurance costs or increased
service and warranty costs, any of which could harm our business. Such defects or errors could also prompt us to amend certain
warning labels or narrow the scope of the use of our diagnostic tests, either of which could hinder our success in the market.
Even after any underlying concerns or problems are resolved, any widespread concerns regarding our technology or any manufacturing
defects or performance errors in our diagnostic tests could result in lost revenue, delayed market acceptance, damaged reputation,
increased service and warranty costs and claims against us.
If
our international distributor relationships are not successful, our ability to market and sell our diagnostic tests will be harmed
and our financial performance will be adversely affected
.
Outside
of the United States, we depend on relationships with distributors for the marketing and sales of our diagnostic tests in various
geographic regions, and we have a limited ability to influence their efforts. Relying on distributors for our sales and marketing
could harm our business for various reasons, including:
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agreements
with distributors may terminate prematurely due to disagreements or may result in litigation;
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our
distributors may not devote sufficient resources to the sale of diagnostic tests;
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our
distributors may be unsuccessful in marketing our diagnostic tests; and
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we
may not be able to negotiate future distributor agreements on acceptable terms.
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If
we become subject to claims relating to improper handling, storage or disposal of hazardous materials, we could incur significant
cost and time to comply
.
Our
research and development processes involve the controlled storage, use and disposal of hazardous materials, including biological
hazardous materials. We are subject to foreign, federal, state and local regulations governing the use, manufacture, storage,
handling and disposal of materials and waste products. We may incur significant costs complying with both existing and future
environmental laws and regulations. In particular, we are subject to regulation by the Occupational Safety and Health Administration,
or OSHA, and the Environmental Protection Agency, or EPA, and to regulation under the Toxic Substances Control Act and the Resource
Conservation and Recovery Act in the United States. OSHA or the EPA may adopt additional regulations in the future that may affect
our research and development programs. The risk of accidental contamination or injury from hazardous materials cannot be eliminated
completely. In the event of an accident, we could be held liable for any damages that result, and any liability could exceed the
limits or fall outside the coverage of our workers’ compensation insurance. We may not be able to maintain insurance on
acceptable terms, if at all.
Our
diagnostic tests have not been manufactured on a high-volume scale and are subject to unforeseen scale-up risks
.
While
we have developed a process to manufacture diagnostic tests, there can be no assurance that we can manufacture our diagnostic
tests at a scale that is adequate for our future commercial needs. We may face significant or unforeseen difficulties in manufacturing
our diagnostic tests, including but not limited to:
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technical
issues relating to manufacturing components of our diagnostic tests on a high volume commercial scale at reasonable cost,
and in a reasonable time frame;
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difficulty
meeting demand or timing requirements for orders due to excessive costs or lack of capacity for part or all of an operation
or process;
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changes
in government regulations or in quality or other requirements that lead to additional manufacturing costs or an inability
to supply product in a timely manner, if at all; and
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increases
in raw material or component supply cost or an inability to obtain supplies of certain critical supplies needed to complete
our manufacturing processes.
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These
and other difficulties may only become apparent when scaling up to the manufacturing process of our diagnostic tests to a more
substantive commercial scale. In the event our diagnostic tests cannot be manufactured in sufficient commercial quantities or
manufacturing is delayed, our future prospects could be significantly impacted and our financial prospects would be materially
harmed.
We
or our suppliers may experience development or manufacturing problems or delays that could limit the growth of our revenue or
increase our losses
.
We
may encounter unforeseen situations in the manufacturing of our diagnostic tests that could result in delays or shortfalls in
our production. Our suppliers may also face similar delays or shortfalls. In addition, our or our suppliers’ production
processes may have to change to accommodate any significant future expansion of our manufacturing capacity, which may increase
our or our suppliers’ manufacturing costs, delay production of our diagnostic tests, reduce our product gross margin and
adversely impact our business. If we are unable to keep up with demand for our diagnostic tests by successfully manufacturing
and shipping our diagnostic tests in a timely manner, our revenue could be impaired, market acceptance for our diagnostic tests
could be adversely affected and our customers might instead purchase our competitors’ diagnostic tests. In addition, developing
manufacturing procedures for new diagnostic tests may require developing specific production processes for those diagnostic tests.
Developing such processes could be time consuming and any unexpected difficulty in doing so can delay the introduction of a product.
We
expect to rely on third parties to conduct studies of our diagnostic tests that will be required by the FDA or other regulatory
authorities and those third parties may not perform satisfactorily
.
Although
we intend to sell our tests where regulatory approval is not required, we expect to rely on third parties, such as independent
testing laboratories and hospitals, to conduct such studies. Our reliance on these third parties will reduce our control over
these activities. These third-party contractors may not complete activities on schedule or conduct studies in accordance with
regulatory requirements or our study design. We cannot control whether they devote sufficient time, skill and resources to our
studies. Our reliance on third parties that we do not control will not relieve us of any applicable requirement to prepare, and
ensure compliance with, various procedures required under good clinical practices. If these third parties do not successfully
carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced
or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical protocols
or regulatory requirements or for other reasons, our studies may be extended, delayed, suspended or terminated, and we may not
be able to obtain regulatory approval for additional diagnostic tests.
Product
liability claims could adversely impact our financial condition and our earnings and impair our reputation
.
Inadequate
disclosure of product-related risks or product-related information with respect to our diagnostic tests could result in an unsafe
condition, injury to, or death of, a patient. The occurrence of such a problem could result in product liability claims, or safety
alert relating to, one or more of our diagnostic tests. Product liability claims, regardless of their ultimate outcome, could
have a material adverse effect on our business and reputation and on our ability to attract and retain customers for our diagnostic
tests.
Health
care policy changes, including U.S. health care reform legislation signed in 2010, may have a material adverse effect on us
.
In
March 2010, the Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act
of 2010 were signed into law. Elements of this legislation, such as comparative effectiveness research, an independent payment
advisory board, payment system reforms, including shared savings pilots, and other provisions, could meaningfully change the way
health care is developed and delivered, and may materially impact numerous aspects of our business.
Consolidation
in the health care industry could have an adverse effect on our revenues and results of operations
.
Many
health care industry companies, including health care systems, are consolidating to create new companies with greater market power.
As the health care industry consolidates, competition to provide goods and services to industry participants will become more
intense. These industry participants may try to use their market power to negotiate price concessions or reductions for diagnostic
tests. If we are forced to reduce our prices because of consolidation in the health care industry, our projected revenues would
decrease and our earnings, financial condition, and/or cash flows would suffer.
Our
ability to compete depends on our ability to attract and retain talented employees
.
Our
future success depends on our ability to identify, attract, train, integrate and retain highly qualified technical, development,
sales and marketing, managerial and administrative personnel. Competition for highly skilled individuals is extremely intense
and we face difficulty identifying and hiring qualified personnel in many areas of our business. We may not be able to hire and
retain such personnel at compensation levels consistent with our existing compensation and salary structure. Many of the companies
with which we compete for hiring experienced employees have greater resources than we have. If we fail to identify, attract, train,
integrate and retain highly qualified and motivated personnel, our reputation could suffer and our business, financial condition
and results of operations could be adversely affected.
Our
future success also depends on the continued service and performance of our senior management team. The replacement of members
of our senior management team likely would involve significant time and costs, and the loss of any these individuals may delay
or prevent the achievement of our business objectives.
If
we do not achieve, sustain or successfully manage our anticipated growth, our business and prospects will be harmed
.
If
we are unable to obtain or sustain adequate revenue growth, our financial results could suffer. Furthermore, significant growth
will place strains on our management and our operational and financial systems and processes and our operating costs may escalate
even faster than planned. If we cannot effectively manage our expanding operations and our costs, we may not be able to grow effectively
or we may grow at a slower pace. Additionally, if we do not successfully forecast the timing of regulatory authorization for our
additional tests, marketing and subsequent demand for our diagnostic tests or manage our anticipated expenses accordingly, our
operating results will be harmed.
Other
companies or institutions have commercial diagnostic tests or may develop and market novel or improved methods for infectious
disease diagnostic testing, which may make our diagnostic platform less competitive or obsolete
.
The
market for diagnostic testing is large and established, and our competitors may possess significantly greater financial resources
and have larger development and commercialization capabilities than we do. We may be unable to compete effectively against these
competitors either because their diagnostic platforms are superior or because they may have more expertise, experience, financial
resources or stronger business relationships.
New
technologies, techniques or diagnostic tests could emerge that might offer better combinations of price and performance than our
current or future diagnostic tests
.
It
is critical to our success that we anticipate changes in technology and customer requirements and to successfully introduce, on
a timely and cost-effective basis, new, enhanced and competitive technologies that meet the needs of current and prospective customers.
If we do not successfully innovate and introduce new technology into our product lines or manage the transitions to new product
offerings, our revenues, results of operations and business will be adversely impacted. Competitors may be able to respond more
quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements. We anticipate
that we will face increased competition in the future as existing companies and competitors develop new or improved diagnostic
tests and as new companies enter the market with new technologies.
We
are dependent on single source suppliers for some of the components and materials used in our diagnostic tests, and supply chain
interruptions could negatively impact our operations and financial performance
.
Our
diagnostic tests are manufactured by us and we obtain supplies from a limited number of suppliers. In some cases, critical components
required to manufacture our diagnostic tests may only be available from a sole supplier or limited number of suppliers, any of
whom would be difficult to replace. The supply of any of our manufacturing materials may be interrupted because of poor vendor
performance or other events outside our control, which may require us, among other things, to identify alternate vendors and result
in lost sales and increased expenses. Even if the manufacturing materials that we source are available from other parties, the
time and effort involved in validating the new supplies and obtaining any necessary regulatory approvals for substitutes could
impede our ability to replace such components in a timely manner or at all.
Risks
Relating to Our Financial Position and Need for Additional Capita
We
expect that we will need additional funding to expand our commercialization efforts for our new diagnostic tests
.
Molecular
diagnostic test development, which includes research and development, pre-clinical and human clinical trials, is a time-consuming
and expensive process that takes time to complete. We expect that our expenses will increase substantially as we move new diagnostic
tests through human clinical trials, seek regulatory approvals, and pursue development of additional innovations. If we obtain
marketing approval for the diagnostic tests that we develop, license, or acquire, we expect to incur significant commercialization
expenses related to regulatory compliance requirements, sales and marketing, manufacturing and distribution We had a net loss
of $2.7 million for the six months ended June 30, 2018 and a net loss of $7.0 million and $1.9 million
in the years ended December 31, 2017 and December 31, 2016, respectively. Our accumulated deficit was $15.1 million as
of June 30, 2018 and $12.4 million and $5.5 million as of December 31, 2017 and December 31, 2016, respectively. We need
to obtain additional financing to fund our operations and there can be no assurance that additional financing will be available
to us or that such financing, if available, will be available on favorable terms. Even if we achieve profitability in the future,
we may not be able to sustain profitability in subsequent periods.
Our
inability to raise capital on acceptable terms in the future may cause us to delay, diminish, or curtail certain operational activities,
including research and development activities, clinical trials, sales and marketing, and other operations, in order to reduce
costs and sustain the business, and such inability would have a material adverse effect on our business and financial condition
.
We
expect capital outlays and operating expenditures to increase over the next several years as we work to expand our commercial
activities, expand our development activities, conduct clinical trials, expand manufacturing operations and expand our infrastructure.
We may need to raise additional capital to, among other things:
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fund
clinical trials and preclinical trials for our diagnostic tests as requested or required by regulatory agencies;
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sustain
commercialization of our new diagnostic tests;
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expand
and automate our manufacturing capabilities;
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increase
our sales and marketing efforts to drive market adoption and address competitive developments;
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finance
capital expenditures and our general and administrative expenses;
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develop
new diagnostic tests;
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maintain,
expand and protect our intellectual property portfolio;
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add
operational, financial and management information systems; and
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hire
additional research and development, quality control, scientific, and general and administrative personnel.
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Our
present and future funding requirements will depend on many factors, including but not limited to:
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the
progress and timing of our clinical trials;
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the
level of research and development investment required to maintain and improve our technology position;
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cost
of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights, if any;
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our
efforts to acquire or license complementary technologies or acquire complementary businesses;
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changes
in product development plans needed to address any difficulties in commercialization or changing market conditions;
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competing
technological and market developments;
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changes
in regulatory policies or laws that may affect our operations; and
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changes
in physician acceptance or medical society recommendations that may affect commercial efforts.
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Raising
additional capital may cause dilution to our existing stockholders, and restrict our operations or require us to relinquish certain
intellectual property rights
.
We
may seek additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships
and alliances, licensing arrangements and grants. To the extent that we raise additional capital through the sale of equity or
convertible debt securities, the ownership interest of our existing stockholders may be diluted, and the terms may include liquidation
or other preferences that adversely affect the rights of our stockholders. Debt and receivables financings may be coupled with
an equity component, such as warrants to purchase shares, which could also result in dilution of our existing stockholders’
ownership. The incurrence of indebtedness would result in increased fixed payment obligations and could also result in certain
restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license
intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may
have to relinquish valuable rights to our product candidates, or grant licenses on terms that are not favorable to us. A failure
to obtain adequate funds may cause us to curtail certain operational activities, including research and development, regulatory
trials, sales and marketing, and manufacturing operations, in order to reduce costs and sustain the business, and would have a
material adverse effect on our business and financial condition.
We
have broad discretion in the use of the net proceeds from this offering and may not use them effectively.
Our
management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes
described in the section entitled “Use of Proceeds.” Because of the number and variability of factors that will determine
our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. Our
management may not apply our cash from this offering in ways that ultimately increase the value of any investment in our securities
or enhance stockholder value. The failure by our management to apply these funds effectively could harm our business. Pending
their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing securities. These
investments may not yield a favorable return to our stockholders. If we do not invest or apply our cash in ways that enhance stockholder
value, we may fail to achieve expected financial results, which may result in a decline in the price of our shares of common stock,
and, therefore, may negatively impact our ability to raise capital, invest in or expand our business, acquire additional products
or licenses, commercialize our diagnostic tests, or continue our operations.
Market
and economic conditions may negatively impact our business, financial condition and share price
.
Concerns
over inflation, energy costs, geopolitical issues, the U.S. mortgage market and a declining real estate market, unstable global
credit markets and financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished
liquidity and credit availability, declines in consumer confidence and discretionary spending, diminished expectations for the
global economy and expectations of slower global economic growth going forward, increased unemployment rates, and increased credit
defaults in recent years. Our general business strategy may be adversely affected by any such economic downturns, volatile business
environments and continued unstable or unpredictable economic and market conditions. If these conditions continue to deteriorate
or do not improve, it may make any necessary debt or equity financing more difficult to complete, more costly, and more dilutive.
Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our
growth strategy, financial performance, and share price and could require us to delay or abandon development or commercialization
plans. In addition, there is a risk that one or more of our current and future service providers, manufacturers, suppliers, hospitals
and other medical facilities, our third-party payers, and other partners could be negatively affected by these difficult economic
times, which could adversely affect our ability to attain our operating goals on schedule and on budget or meet our business and
financial objectives.
Risks
Related to Intellectual Property
The
extent to which we can protect our diagnostic tests and technologies through intellectual property rights that we own, acquire
or license is uncertain
.
We
employ a variety of proprietary and patented technologies and methods in connection with the diagnostic tests we sell or are developing.
We cannot provide any assurance that the intellectual property rights that we own or license provide effective protection from
competitive threats or that we would prevail in any litigation in which our intellectual property rights are challenged. In addition,
we may not be successful in obtaining new proprietary or patented technologies or methods in the future, whether through acquiring
ownership or through licenses from third parties.
Our
currently pending or future patent applications may not result in issued patents, and we cannot predict how long it may take for
a patent to issue on any of our pending patent applications, assuming a patent does issue
.
Other
parties may challenge patents issued or exclusively licensed to us, or courts or administrative agencies will hold our patents
or the patents we license on an exclusive basis to be valid and enforceable. We may not be successful in defending challenges
made against our patents and other intellectual property rights. Any third-party challenge to any of our patents could result
in the unenforceability or invalidity of some or all of the claims of such patents and could be time consuming and expensive.
The
extent to which the patent rights of life sciences companies effectively protect their diagnostic tests and technologies is often
highly uncertain and involves complex legal and factual questions for which important legal principles remain unresolved
.
No
consistent policy regarding the proper scope of allowable claims of patents held by life sciences companies has emerged to date
in the United States. Various courts, including the U.S. Supreme Court, have rendered decisions that impact the scope of patentability
of certain inventions or discoveries relating to diagnostic tests or genomic diagnostic testing. These decisions generally stand
for the proposition that inventions that recite laws of nature are not themselves patentable unless they have sufficient additional
features that provide practical assurance that the processes are genuine inventive applications of those laws rather than patent
drafting efforts designed to monopolize a law of nature itself. What constitutes a “sufficient” additional feature
for this purpose is uncertain. While we do not generally rely on gene sequence patents, this evolving case law in the United States
may adversely impact our ability to obtain new patents and may facilitate third-party challenges to our existing owned and exclusively
licensed patents.
We
cannot predict the breadth of claims that may be allowed or enforced in patents we own. For example:
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the
inventor(s) named in one or more of our patents or patent applications might not have been the first to have made the relevant
invention;
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the
inventor (or his assignee) might not have been the first to file a patent application for the claimed invention;
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others
may independently develop similar or alternative diagnostic tests and technologies or may successfully replicate our product
and technologies;
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it
is possible that the patents we own or in which have exclusive license rights may not provide us with any competitive advantages
or may be challenged by third parties and found to be invalid or unenforceable;
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any
patents we obtain or exclusively license may expire before, or within a limited time period after, the diagnostic tests and
services relating to such patents are commercialized;
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we
may not develop or acquire additional proprietary diagnostic tests and technologies that are patentable; and
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others
may acquire patents that could be asserted against us in a manner that could have an adverse effect on our business.
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Changes
in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the value
of our intellectual property rights
.
On
September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes
a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted,
redefine prior art, may affect patent litigation and switch the U.S. patent system from a “first-to-invent” system
to a “first-to-file” system. Under a first-to-file system, assuming the other requirements for patentability are met,
the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of whether
another inventor had made the invention earlier. The U.S. Patent and Trademark Office, or USPTO, recently developed new regulations
and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with
the Leahy-Smith Act, including the first-to-file provisions in particular, only became effective on March 16, 2013. Accordingly,
it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith
Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned and licensed patent
applications and the enforcement or defense of issued patents that we own or license, all of which could have a material adverse
effect on our business and financial condition.
Patent
applications in the United States and many foreign jurisdictions are not published until at least eighteen months after filing
and it is possible for a patent application filed in the United States to be maintained in secrecy until a patent issues on the
application. In addition, publications in the scientific literature often lag behind actual discoveries. We therefore cannot be
certain that others have not filed patent applications that cover inventions that are the subject of pending applications that
we own or exclusively license or that we were the first to invent the technology (if filed prior to the Leahy-Smith Act) or first
to file (if filed after the Leahy-Smith Act). Our competitors may have filed, and may in the future file, patent applications
covering technology that is similar to or the same as our technology. Any such patent application may have priority over patent
applications that we own and, if a patent issues on such patent application, we could be required to obtain a license to such
patent in order to carry on our business. If another party has filed a U.S. patent application covering an invention that is similar
to, or the same as, an invention that we own, we may have to participate in an interference or other proceeding in the USPTO or
a court to determine priority of invention in the United States, for applications and patents made prior to the enactment of the
Leahy-Smith Act. For applications and patents made following the enactment of the Leahy-Smith Act, we may have to participate
in a derivation proceeding to resolve disputes relating to inventorship. The costs of these proceedings could be substantial,
and it is possible that such efforts would be unsuccessful, resulting in our inability to obtain or retain any U.S. patent rights
with respect to such invention.
In
addition, the laws of foreign jurisdictions may not protect our rights to the same extent as the laws of the United States. For
example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. law does. Publications
of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States
and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot
be certain that we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications,
or that we or our licensors were the first to file for patent protection of such inventions. Moreover, the USPTO might require
that the term of a patent issuing from a pending patent application be disclaimed and limited to the term of another patent that
is commonly owned or names a common inventor. As a result, the issuance, scope, validity, term, enforceability and commercial
value of our patent rights are highly uncertain.
The
patent prosecution process is expensive and time-consuming, is highly uncertain and involves complex legal and factual questions.
Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications
and the enforcement or defense of our issued patents
.
Our
success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries
with respect to our proprietary technology and product candidates. We seek to protect our proprietary position by filing in the
United States and in certain foreign jurisdictions patent applications related to our novel technologies and product candidates
that are important to our business.
The
patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable
patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects
of our research and development output before it is too late to obtain patent protection. In addition, we may not pursue or obtain
patent protection in all major markets. Moreover, in some circumstances, we may not have the right to control the preparation,
filing or prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties.
In some circumstances, our licensors may have the right to enforce the licensed patents without our involvement or consent, or
to decide not to enforce or to allow us to enforce the licensed patents. Therefore, these patents and patent applications may
not be prosecuted and enforced in a manner consistent with the best interests of our business. If any of our licensors fail to
maintain such patents, or lose rights to those patents, the rights that we have licensed may be reduced or eliminated and our
right to develop and commercialize any of our product candidates that are the subject of such licensed rights could be adversely
affected.
Our
pending and future patent applications may not result in patents being issued which protect our technology or products, in whole
or in part, or which effectively prevent others from commercializing competitive technologies and products. In particular, during
prosecution of any patent application, the issuance of any patents based on the application may depend upon our ability to generate
additional nonclinical or clinical data that support the patentability of our proposed claims. We may not be able to generate
sufficient additional data on a timely basis, or at all. Moreover, changes in either the patent laws or interpretation of the
patent laws in the United States or other countries may diminish the value of our patents or narrow the scope of our patent protection.
Moreover,
we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation,
reexamination,
inter partes
review, post-grant review or interference proceedings or other patent office proceedings or
litigation, in the United States or elsewhere, challenging our patent rights or the patent rights of others. An adverse determination
in any such submission or proceeding could reduce the scope of, or invalidate, our patent rights; allow third parties to commercialize
our technology or products and compete directly with us, without payment to us; or result in our inability to manufacture or commercialize
products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our owned
and licensed patents and patent applications is threatened, it could dissuade companies from collaborating with us to license,
develop or commercialize current or future product candidates.
Obtaining
and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other
requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance
with these requirements
.
The
USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment
and other provisions during the patent prosecution process and following the issuance of a patent. There are situations in which
noncompliance with these requirements can result in abandonment or lapse of a patent or patent application, resulting in partial
or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market
earlier than would otherwise have been the case if our patent were in force.
Our
intellectual property rights may not be sufficient to protect our competitive position and to prevent others from manufacturing,
using or selling competing diagnostic tests
.
The
scope of our owned and exclusively licensed intellectual property rights will not be sufficient to prevent others from manufacturing,
using or selling competing diagnostic tests. Competitors could purchase our product and attempt to replicate some or all of the
competitive advantages we derive from our development efforts, willfully infringe our intellectual property rights, design around
our protected technology or develop their own competitive technologies and thereby avoid infringing our intellectual property
rights. If our intellectual property is not sufficient to effectively prevent our competitors from developing and selling similar
diagnostic tests, our competitive position and our business could be adversely affected.
We
may become involved in disputes relating to our intellectual property rights, and may need to resort to litigation in order to
defend and enforce our intellectual property rights
.
Extensive
litigation regarding patents and other intellectual property rights has been common in the medical diagnostic testing industry.
Litigation may be necessary to assert infringement claims, protect trade secrets or know-how and determine the enforceability,
scope and validity of certain proprietary rights. Litigation may even be necessary to resolve disputes of inventorship or ownership
of proprietary rights. The defense and prosecution of intellectual property lawsuits, USPTO interference or derivation proceedings
and related legal and administrative proceedings (
e.g.
, a re-examination) in the United States and internationally involve
complex legal and factual questions. As a result, such proceedings are costly and time consuming to pursue, and their outcome
is uncertain.
Even
if we prevail in such a proceeding in which we assert our intellectual property rights against third parties, the remedy we obtain
may not be commercially meaningful or adequately compensate us for any damages we may have suffered. If we do not prevail in such
a proceeding, our patents could potentially be declared to be invalid, unenforceable or narrowed in scope, or we could otherwise
lose valuable intellectual property rights. Similar proceedings involving the intellectual property we exclusively license could
also have an impact on our business. Further, if any of our other owned or exclusively licensed patents are declared invalid,
unenforceable or narrowed in scope, our competitive position could be adversely affected.
We
could face claims that our activities or the manufacture, use or sale of our diagnostic tests infringe the intellectual property
rights of others, which could cause us to pay damages or licensing fees and limit our ability to sell some or all of our diagnostic
tests and services
.
Our
research, development and commercialization activities may infringe or be claimed to infringe patents or other intellectual property
rights owned by other parties of which we may be unaware because the relevant patent applications may have been filed but not
yet published. Certain of our competitors and other companies have substantial patent portfolios, and may attempt to use patent
litigation as a means to obtain a competitive advantage or to extract licensing revenue. In addition to patent infringement claims,
we may also be subject to other claims relating to the violation of intellectual property rights, such as claims that we have
misappropriated trade secrets or infringed third party trademarks. The risks of being involved in such litigation may also increase
as we gain greater visibility as a public company and as we gain commercial acceptance of our diagnostic tests and move into new
markets and applications for our diagnostic tests.
Regardless
of merit or outcome, our involvement in any litigation, interference or other administrative proceedings could cause us to incur
substantial expense and could significantly divert the efforts of our technical and management personnel. Any public announcements
related to litigation or interference proceedings initiated or threatened against us could cause our share price to decline. An
adverse determination, or any actions we take or agreements we enter into in order to resolve or avoid disputes, may subject us
to the loss of our proprietary position or to significant liabilities, or require us to seek licenses that may include substantial
cost and ongoing royalties. Licenses may not be available from third parties, or may not be obtainable on satisfactory terms.
An adverse determination or a failure to obtain necessary licenses may restrict or prevent us from manufacturing and selling our
diagnostic tests and offering our services. These outcomes could materially harm our business, financial condition and results
of operations.
We
may not be able to adequately protect our intellectual property outside of the United States
.
The
laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States,
and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions. The
legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other
intellectual property protection, particularly those relating to medical devices, diagnostic testing and biotechnology, which
could make it difficult for us to stop the infringement of our patents and for licensors, if they were to seek to do so, to stop
infringement of patents that are licensed to us. Proceedings to enforce our patent rights in foreign jurisdictions could result
in substantial cost and divert our efforts and attention from other aspects of our business. Additionally, prosecuting and maintaining
intellectual property (particularly patent) rights are very costly endeavors, and for these and other reasons we may not pursue
or obtain patent protection in all major markets. We do not know whether legal and government fees will increase substantially
and therefore are unable to predict whether cost may factor into our global intellectual property strategy.
In
addition to the risks associated with patent rights, the laws in some foreign jurisdictions may not provide protection for our
trade secrets and other intellectual property. If our trade secrets or other intellectual property are misappropriated in foreign
jurisdictions, we may be without adequate remedies to address these issues. Additionally, we also rely on confidentiality and
assignment of invention agreements to protect our intellectual property in foreign jurisdictions. These agreements may provide
for contractual remedies in the event of misappropriation, but we do not know to what extent, if any, these agreements and any
remedies for their breach, will be enforced by a foreign court. In the event our intellectual property is misappropriated or infringed
upon and an adequate remedy is not available, our future prospects will likely diminish. The sale of diagnostic tests that infringe
our intellectual property rights, particularly if such diagnostic tests are offered at a lower cost, could negatively impact our
ability to achieve commercial success and may materially and adversely harm our business.
Our
failure to secure trademark registrations could adversely affect our business and our ability to market our diagnostic tests and
product candidates
.
Our
trademark applications in the United States and any other jurisdictions where we may file may not be allowed for registration,
and our registered trademarks may not be maintained or enforced. During trademark registration proceedings, we may receive rejections.
Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition,
in the USPTO and in corresponding foreign agencies, third parties are given an opportunity to oppose pending trademark applications
and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our applications and/or
registrations, and our applications and/or registrations may not survive such proceedings. Failure to secure such trademark registrations
in the United States and in foreign jurisdictions could adversely affect our business and our ability to market our diagnostic
tests and product candidates.
We
may be unable to adequately prevent disclosure of trade secrets and other proprietary information, or the misappropriation of
the intellectual property we regard as our own
.
We
rely on trade secrets to protect our proprietary know how and technological advances in test design, particularly where we do
not believe patent protection is appropriate or obtainable. Nevertheless, trade secrets are difficult to protect. We rely in part
on confidentiality agreements with our employees, consultants, third party contractors, third party collaborators and other advisors
to protect our trade secrets and other proprietary information. These agreements generally require that the other party to the
agreement keep confidential and not disclose to third parties all confidential information developed by us or made known to the
other party by us during the course of the other party’s relationship with us. These agreements may not effectively prevent
disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential
information. Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such
disclosure are, or will be, adequate. If we were to seek to pursue a claim that a third party had illegally obtained and was using
our trade secrets, it would be expensive and time consuming, and the outcome would be unpredictable. Further, courts outside the
United States may be less willing to protect trade secrets. In addition, others may independently discover our trade secrets and
proprietary information and therefore be free to use such trade secrets and proprietary information. Costly and time consuming
litigation could be necessary to enforce and determine the scope of our proprietary rights. In addition, our trade secrets and
proprietary information may be misappropriated as a result of breaches of our electronic or physical security systems in which
case we may have no legal recourse. Failure to obtain, or maintain, trade secret protection could enable competitors to use our
proprietary information to develop diagnostic tests that compete with our diagnostic tests or cause additional, material adverse
effects upon our competitive business position.
Risks
Related to Owning our Common Stock and Other Securities
The
price of our common stock may fluctuate substantially
.
The
market price of our common stock may be subject to wide fluctuation in response to various factors, some of which are beyond our
control. Some factors that may cause the market price of our common stock to fluctuate, in addition to the other risks mentioned
in this “Risk Factors” section and elsewhere in this prospectus, are:
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sales
of our common stock by our stockholders, executives, and directors;
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our
ability to enter new markets;
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actual
or un-anticipated fluctuations in our annual and quarterly financial results;
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our
ability to obtain financings to continue and expand our commercial activities, expand our manufacturing operations, conduct
research and development activities including, but not limited to, human clinical trials, and other business activities;
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our
ability to secure resources and the necessary personnel to continue and expand our commercial activities, develop additional
diagnostic tests, conduct clinical trials and gain approval for our diagnostic tests on our desired schedule;
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commencement,
enrollment or results of our clinical trials of our diagnostic tests or any future clinical trials we may conduct;
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changes
in the development status of our diagnostic tests;
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any
delays or adverse developments or perceived adverse developments with respect to review by the FDA or other similar foreign
regulatory authorities of our planned clinical trials;
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any
delay in our submission for studies or test approvals or adverse regulatory decisions, including failure to receive regulatory
approval for our diagnostic tests;
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our
announcements or our competitors’ announcements regarding new tests, enhancements, significant contracts, acquisitions
or strategic investments;
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failures
to meet external expectations or management guidance;
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changes
in our capital structure or dividend policy, including as a result of future issuances of securities and sales of large blocks
of common stock by our stockholders;
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announcements
and events surrounding financing efforts, including debt and equity securities;
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competition
from existing technologies and diagnostic tests or new technologies and diagnostic tests that may emerge;
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announcements
of acquisitions, partnerships, collaborations, joint ventures, new diagnostic tests, capital commitments, or other events
by us or our competitors;
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changes
in general economic, political and market conditions in any of the regions in which we conduct our business;
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changes
in industry conditions or perceptions;
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changes
in valuations of similar companies or groups of companies;
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analyst
research reports, recommendations and changes in recommendations, price targets and withdrawals of coverage;
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departures
and additions of key personnel;
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disputes
and litigations related to intellectual properties, proprietary rights and contractual obligations;
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changes
in applicable laws, rules, regulations, or accounting practices and other dynamics;
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actions
taken by our principal stockholders and release or expiry of lockup or other transfer restrictions; and
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other
events or factors, many of which may be out of our control.
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In
addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences
a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial
condition and results of operations. If any of the foregoing occurs, it could cause our stock price to fall and may expose us
to lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management.
You
may experience immediate and substantial dilution in the book value per share of any common stock you receive in this offering
.
The
purchase price per share in this offering is substantially higher than the net tangible book value per share of our common stock,
and, therefore, you will suffer immediate and substantial dilution in the net tangible book value of the common stock you purchase
in this offering.
Future
sales and issuances of our common stock or rights to purchase common stock could result in additional dilution of the percentage
ownership of our stockholders and could cause our share price to fall
.
We
expect that significant additional capital will be needed in the future to continue our planned operations, including expanding
research and development, funding clinical trials, purchasing of capital equipment, hiring new personnel, commercializing our
diagnostic tests, and continuing activities as an operating public company. To the extent we raise additional capital by issuing
equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities or other
equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock,
convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent
sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior
to our existing stockholders.
Future
sales of our common stock in the public market may cause our stock price to decline and impair our ability to raise future capital
through the sale of our equity securities
.
There
are a substantial number of shares of our common stock held by stockholders who owned shares of our capital stock prior to our
initial public offering that may be able to sell in the public market. Sales by such stockholders of a substantial number of shares
could significantly reduce the market price of our common stock.
Shares
issued by us upon exercise of options granted under our equity plan will be eligible for sale in the public market. If any of
these holders cause a large number of securities to be sold in the public market, the sales could reduce the trading price of
our common stock. These sales also could impede our ability to raise capital in the future.
“Penny
stock” rules may make buying or selling our securities difficult, which may make our stock less liquid and make it harder
for investors to buy and sell our securities
.
If
at any time in the future our shares of common stock are not listed for trading by NASDAQ and begin to trade on an over-the-counter
market such as the Over- the-Counter Bulletin Board or any quotation system maintained by OTC Markets, Inc., trading in our securities
will be subject to the SEC’s “penny stock” rules and, if we are not listing for trading by NASDAQ, it is anticipated
that trading in our securities will continue to be subject to the penny stock rules for the foreseeable future. The SEC has adopted
regulations that generally define a penny stock to be any equity security that has a market price of less than $5.00 per share,
subject to certain exceptions. These rules require that any broker-dealer who recommends our securities to persons other than
prior customers and accredited investors must, prior to the sale, make a special written suitability determination for the purchaser
and receive the purchaser’s written agreement to execute the transaction. Unless an exception is available, the regulations
require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market
and the risks associated with trading in the penny stock market. In addition, broker-dealers must disclose commissions payable
to both the broker-dealer and the registered representative and current quotations for the securities they offer. The additional
burdens imposed upon broker-dealers by these requirements may discourage broker-dealers from recommending transactions in our
securities, which could severely limit the liquidity of our securities and consequently adversely affect the market price for
our securities.
NASDAQ
may delist our common stock from its exchange, which could limit investors’ ability to make transactions in our common stock
and subject us to additional trading restrictions
.
Should
we fail to satisfy the continued listing requirements of the NASDAQ Capital Market, such as the corporate governance requirements
or the minimum closing bid price requirement, NASDAQ may take steps to delist our common stock. Such a delisting would likely
have a negative effect on the price of our common stock, and would impair your ability to sell or purchase our common stock when
you wish to do so. In the event of a delisting, we would take actions to restore our compliance with the NASDAQ Capital Market’s
listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become
listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping
below the NASDAQ Capital Market’s minimum bid price requirement or prevent future non-compliance with the NASDAQ Capital
Market’s listing requirements.
If
the NASDAQ Capital Market does not maintain the listing of our securities for trading on its exchange, we could face significant
material adverse consequences, including:
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a
limited availability of market quotations for our securities;
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reduced
liquidity with respect to our securities;
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a
determination that our shares of common stock are “penny stock” which will require brokers trading in our shares
of common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary
trading market for our shares of common stock;
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a
limited amount of news and analyst coverage for our company; and
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decreased
ability to issue additional securities or obtain additional financing in the future.
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Therefore,
it may be difficult for our stockholders to sell any shares if they desire or need to sell them.
We
do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares
.
We
currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not
anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited
to the increase, if any, of our share price.
We
are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable
to emerging growth companies, which could make our common stock less attractive to investors
.
We
are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act,
and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public
companies that are not “emerging growth companies” including not being required to comply with the auditor attestation
requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our
periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive
compensation and stockholder approval of any golden parachute payments not previously approved. Investors may find our common
stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result,
there may be a less active trading market for our common stock and our stock price may be more volatile. We may take advantage
of these reporting exemptions until we are no longer an “emerging growth company.” We will remain an “emerging
growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of
$1 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of our
initial public offering; (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 the rules of the Securities and Exchange
Commission.
We
have elected to use the extended transition periods for complying with new or revised accounting standards
.
We
have elected to use the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new
or revised accounting standards that have different effective dates for public and private companies until the earlier of the
date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transaction
period provided in Section 7(a)(2)(B). As a result, our financial statements may not be comparable to those of companies that
comply with public company effective dates.
Our
management is required to devote substantial time to compliance initiatives
.
As
a public company, we incur significant legal, accounting and other expenses that we did not incur as a newly formed entity. The
Sarbanes-Oxley Act, as well as rules subsequently implemented by the Securities and Exchange Commission, and NASDAQ, have imposed
various new requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial
controls and changes in corporate governance practices. Our management and other personnel devote a substantial amount of time
to these new compliance initiatives. Moreover, these rules and regulations increase our legal and financial compliance costs and
make some activities more time consuming and costly. We expect these rules and regulations to make it more difficult and more
expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain
the same or similar coverage.
THE
SECURITIES WE MAY OFFER
We may offer shares of
common stock, shares of preferred stock or warrants to purchase common stock, preferred stock or any combination of the foregoing,
either individually or as units comprised of one or more of the other securities. We may offer up to $25,000,000 of securities
under this prospectus. If securities are offered as units, we will describe the terms of the units in a prospectus supplement.
DESCRIPTION
OF CAPITAL STOCK
General
Our
authorized capital stock presently consists of 180,000,000 shares of common stock, par value $0.001 per share. As of August
13, 2018, we had 12,348,027 shares of common stock outstanding and 379 holders of our common stock. The following is a summary
of the terms of our capital stock.
Common
Stock
Holders
of common stock are entitled to one vote for each share held on all matters submitted to a vote of the shareholders and do not
have cumulative voting rights. Accordingly, holders of a majority of the shares of common stock entitled to vote in any election
of directors may elect all of the directors standing for election. Holders of common stock are entitled to receive ratably any
dividends, as may be declared by the Board of Directors out of funds legally available therefor, subject to the rights of the
holders of preferred stock. Upon the liquidation, dissolution or winding up of our company, the holders of common stock are entitled
to receive ratably our net assets available after the payment of our debts and other liabilities. Holders of common stock have
no preemptive, subscription, redemption or conversion rights. The outstanding shares of common stock are fully paid and nonassessable.
Listing
Our
common stock is listed on the NASDAQ Capital Market under the symbol “CODX.”
Indemnification
of Officers and Directors and Insurance
Our
amended and restated articles of incorporation provide for limitation of liability of our directors and for indemnification of
our directors and officers to the fullest extent permitted under Utah law. Our directors and officers may be liable for a breach
or failure to perform their duties in accordance with Utah law only if their breach or failure to perform constitutes gross negligence,
willful misconduct or intentional harm on our company or our shareholders. Our directors may not be personally liable for monetary
damages for action taken or failure to take action as a director except in specific instances established by Utah law.
In
accordance with Utah law, we may generally indemnify a director or officer against liability incurred in a proceeding if he or
she acted in good faith, and believed that his or her conduct was in our best interest and that he or she had no reason to believe
his or her conduct was unlawful. We may not indemnify a director or officer if the person was adjudged liable to us or in the
event it is adjudicated that the director or officer received an improper personal benefit.
Under
Utah law, we will indemnify a director or officer who is successful on the merits or otherwise in defense of any proceeding, or
in the defense of any claim, issue or matter in the proceeding, to which he or she was a party because he or she is or was a director
or an officer, as the case may be, against reasonable expenses incurred by him or her in connection with the proceeding or claim
with respect to which he or she has been successful.
We
maintain a directors’ and officers’ liability insurance policy which, subject to the limitations and exclusions stated
therein, covers our directors and officers for certain actions or inactions they may take or omit to take in their capacities
as directors and officers.
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers and controlling
persons pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the SEC such indemnification
is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
The
Company maintains general liability insurance that covers certain liabilities of its directors and officers arising out of claims
based on acts or omissions in their capacities as directors or officers, including liabilities under the Securities Act. Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers, or persons who control
the Company, the Company has been informed that, in the opinion of the Commission, such indemnification is against public policy
as expressed in the Securities Act and is therefore unenforceable.
These
provisions may discourage shareholders from bringing a lawsuit against the Company’s directors for breach of their fiduciary
duty, or may have the practical effect in some cases of eliminating the Company’s shareholders’ ability to collect
monetary damages from its directors and officers. These provisions may also have the effect of reducing the likelihood of derivative
litigation against directors and officers, even though such an action, if successful, might otherwise benefit the Company and
its shareholders. Furthermore, a shareholder’s investment may be adversely affected to the extent the Company pays the costs
of settlement and damage awards against directors and officers pursuant to these indemnification provisions.
Authorized
but Unissued Shares
Our
authorized but unissued shares of common stock and preferred stock will be available for future issuance without your approval.
We may use additional shares for a variety of purposes, including future public offerings to raise additional capital, to fund
acquisitions and as employee compensation. The existence of authorized but unissued shares of common stock and preferred stock
could render more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger
or otherwise.
Transfer
Agent and Registrar
Our
transfer agent and registrar is VStock Transfer Company, Inc. Its telephone number is 1-212-828-8436.
DESCRIPTION
OF WARRANTS
The following description,
together with the additional information we may include in any applicable prospectus supplements and free writing prospectuses,
summarizes the material terms and provisions of the warrants that we may offer under this prospectus, which may consist of warrants
to purchase common stock or preferred stock and may be issued in one or more series. Warrants may be offered independently
or together with common stock or preferred stock offered by any prospectus supplement and may be attached to or separate
from those securities. While the terms we have summarized below will apply generally to any warrants that we may offer under this
prospectus, we will describe the particular terms of any series of warrants that we may offer in more detail in the applicable
prospectus supplement and any applicable free writing prospectus. The terms of any warrants offered under a prospectus supplement
may differ from the terms described below. However, no prospectus supplement will fundamentally change the terms that are set
forth in this prospectus or offer a security that is not registered and described in this prospectus at the time of its effectiveness.
We
will issue the warrants under a warrant agreement that we will enter into with a warrant agent to be selected by us. The warrant
agent will act solely as an agent of ours in connection with the warrants and will not act as an agent for the holders or beneficial
owners of the warrants. We will file as exhibits to the registration statement of which this prospectus is a part or will incorporate
by reference from a current report on Form 8-K that we file with the SEC, the form of warrant agreement, including a form of warrant
certificate, that describes the terms of the particular series of warrants we are offering before the issuance of the related
series of warrants. The following summaries of material provisions of the warrants and the warrant agreements are subject to,
and qualified in their entirety by reference to, all the provisions of the warrant agreement and warrant certificate applicable
to a particular series of warrants. We urge you to read the applicable prospectus supplement and any applicable free writing prospectus
related to the particular series of warrants that we sell under this prospectus, as well as the complete warrant agreements and
warrant certificates that contain the terms of the warrants.
General
We
will describe in the applicable prospectus supplement the terms relating to a series of warrants, including:
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offering price and aggregate number of warrants offered;
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the
currency for which the warrants may be purchased;
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if
applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued
with each such security or each principal amount of such security;
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if
applicable, the date on and after which the warrants and the related securities will be separately transferable;
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in the case of warrants to purchase common stock or preferred stock, the number of shares of common stock
or preferred stock, as the case may be, purchasable upon the exercise of one warrant and the price at which these shares may be
purchased upon such exercise;
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the
effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants;
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the
terms of any rights to redeem or call the warrants;
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any
provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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the
dates on which the right to exercise the warrants will commence and expire;
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the
manner in which the warrant agreements and warrants may be modified;
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United
States federal income tax consequences of holding or exercising the warrants;
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the
terms of the securities issuable upon exercise of the warrants; and
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any
other specific terms, preferences, rights or limitations of or restrictions on the warrants.
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Before exercising their
warrants, holders of warrants will not have any of the rights of holders of the securities purchasable upon such exercise, including,
in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or, payments upon
our liquidation, dissolution or winding up or to exercise voting rights, if any
Exercise
of Warrants
Each
warrant will entitle the holder to purchase the securities that we specify in the applicable prospectus supplement at the exercise
price that we describe in the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement,
holders of the warrants may exercise the warrants at any time up to the specified time on the expiration date that we set forth
in the applicable prospectus supplement. After the close of business on the expiration date, unexercised warrants will become
void.
Holders
of the warrants may exercise the warrants by delivering the warrant certificate representing the warrants to be exercised together
with specified information, and paying the required amount to the warrant agent in immediately available funds, as provided in
the applicable prospectus supplement. We will set forth on the reverse side of the warrant certificate and in the applicable prospectus
supplement the information that the holder of the warrant will be required to deliver to the warrant agent.
Upon
receipt of the required payment and the warrant certificate properly completed and duly executed at the corporate trust office
of the warrant agent or any other office indicated in the applicable prospectus supplement, we will issue and deliver the securities
purchasable upon such exercise. If fewer than all of the warrants represented by the warrant certificate are exercised, then we
will issue a new warrant certificate for the remaining amount of warrants. If we so indicate in the applicable prospectus supplement,
holders of the warrants may surrender securities as all or part of the exercise price for warrants.
Enforceability
of Rights by Holders of Warrants
Each
warrant agent will act solely as our agent under the applicable warrant agreement and will not assume any obligation or relationship
of agency or trust with any holder of any warrant. A single bank or trust company may act as warrant agent for more than one issue
of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement
or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us.
Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate
legal action its right to exercise, and receive the securities purchasable upon exercise of, its warrants.
DESCRIPTION
OF UNITS
The
following description, together with the additional information we may include in any applicable prospectus supplements and free
writing prospectuses, summarizes the material terms and provisions of the units that we may offer under this prospectus.
While
the terms we have summarized below will apply generally to any units that we may offer under this prospectus, we will describe
the particular terms of any series of units in more detail in the applicable prospectus supplement. The terms of any units offered
under a prospectus supplement may differ from the terms described below. However, no prospectus supplement will fundamentally
change the terms that are set forth in this prospectus or offer a security that is not registered and described in this prospectus
at the time of its effectiveness.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from
a current report on Form 8-K that we file with the SEC, the form of unit agreement that describes the terms of the series of units
we are offering, and any supplemental agreements, before the issuance of the related series of units. The following summaries
of material terms and provisions of the units are subject to, and qualified in their entirety by reference to, all the provisions
of the unit agreement and any supplemental agreements applicable to a particular series of units. We urge you to read the applicable
prospectus supplements related to the particular series of units that we sell under this prospectus, as well as the complete unit
agreement and any supplemental agreements that contain the terms of the units.
General
We may issue units comprised
of one or more shares of common stock, shares of preferred stock and warrants in any combination. Each unit will be issued so
that the holder of the unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the
rights and obligations of a holder of each included security. The unit agreement under which a unit is issued may provide that
the securities included in the unit may not be held or transferred separately, at any time or at any time before a specified date.
We
will describe in the applicable prospectus supplement the terms of the series of units, including:
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the
designation and terms of the units and of the securities comprising the units, including whether and under what circumstances
those securities may be held or transferred separately;
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any
provisions of the governing unit agreement that differ from those described below; and
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any
provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units.
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The provisions described
in this section, as well as those described under “Description of Capital Stock,” and “Description of Warrants”
will apply to each unit and to any common stock, preferred stock, debt security or warrant included in each unit, respectively.
Issuance
in Series
We
may issue units in such amounts and in numerous distinct series as we determine.
Enforceability
of Rights by Holders of Units
Each
unit agent will act solely as our agent under the applicable unit agreement and will not assume any obligation or relationship
of agency or trust with any holder of any unit. A single bank or trust company may act as unit agent for more than one series
of units. A unit agent will have no duty or responsibility in case of any default by us under the applicable unit agreement or
unit, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any
holder of a unit may, without the consent of the related unit agent or the holder of any other unit, enforce by appropriate legal
action its rights as holder under any security included in the unit.
We,
the unit agents and any of their agents may treat the registered holder of any unit certificate as an absolute owner of the units
evidenced by that certificate for any purpose and as the person entitled to exercise the rights attaching to the units so requested,
despite any notice to the contrary. See “Legal Ownership of Securities.”
PLAN
OF DISTRIBUTION
The
selling shareholders may, from time to time, sell any or all of their shares of our common stock on any stock exchange, market
or trading facility on which the shares are traded or in private transactions. If the shares of our common stock are sold through
underwriters, the selling shareholders will be responsible for underwriting discounts or commissions or agent’s commissions.
All selling shareholders who are broker-dealers are deemed to be underwriters. Thereafter, these sales may be at fixed prices,
at prevailing market prices at the time of the sale, at varying prices determined at the time of sale or at negotiated prices.
The selling shareholders may use any one or more of the following methods when selling shares:
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any
national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;
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ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchasers;
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block
trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block
as principal to facilitate the transaction;
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purchases
by a broker-dealer as principal and resale by the broker-dealer for its account;
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transactions
other than on these exchanges or systems or in the over-the-counter market;
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through
the writing of options, whether such options are listed on an options exchange or otherwise;
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an
exchange distribution in accordance with the rules of the applicable exchange;
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privately
negotiated transactions;
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short
sales;
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broker-dealers
may agree with the selling shareholders to sell a specified number of such shares at a stipulated price per share;
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●
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a
combination of any such methods of sale; and
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●
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any
other method permitted pursuant to applicable law.
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The
selling shareholders may also sell shares under Rule 144 under the Securities Act, if available, rather than under this prospectus.
Rule 144 under the Securities Act, which generally permits the resale, subject to various terms and conditions, of restricted
securities after they have been held for six months will not immediately apply to our common stock because we were at one time
designated as a “shell company” under SEC regulations. Pursuant to Rule 144(i), securities issued by a current or
former shell company that otherwise meet the holding period and other requirements of Rule 144 nevertheless cannot be sold in
reliance on Rule 144 until one year after the date on which the issuer filed current “Form 10 information” (as defined
in Rule 144(i)) with the SEC reflecting that it ceased being a shell company, and provided that at the time of a proposed sale
pursuant to Rule 144, the issuer has satisfied certain reporting requirements under the Exchange Act.
The
selling shareholders may also engage in short sales against the box, puts and calls and other transactions in our securities or
derivatives of our securities and may sell or deliver shares in connection with these trades.
Broker-dealers
engaged by the selling shareholders may arrange for other broker-dealers to participate in sales. Broker-dealers may receive commissions
or discounts from the selling shareholders (or, if any broker-dealer acts as agent for the purchaser of shares, from the purchaser)
in amounts to be negotiated. The selling shareholders do not expect these commissions and discounts to exceed what is customary
in the types of transactions involved. Any profits on the resale of shares of our common stock by a broker-dealer acting as principal
might be deemed to be underwriting discounts or commissions under the Securities Act. Discounts, concessions, commissions and
similar selling expenses, if any, attributable to the sale of shares will be borne by a selling shareholder. The selling shareholders
may agree to indemnify any agent, dealer or broker-dealer that participates in transactions involving sales of the shares if liabilities
are imposed on that person under the Securities Act.
In
connection with the sale of the shares of our common stock or otherwise, the selling shareholders may enter into hedging transactions
with broker-dealers, which may in turn engage in short sales of the shares of our common stock in the course of hedging in positions
they assume. The selling shareholders may also sell shares of our common stock short and deliver shares of our common stock covered
by this prospectus to close out short positions and to return borrowed shares in connection with such short sales. The selling
shareholders may also loan or pledge shares of our common stock to broker-dealers that in turn may sell such shares.
The
selling shareholders may from time to time pledge or grant a security interest in some or all of the shares of our common stock
owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer
and sell the shares of our common stock from time to time under this prospectus after we have filed an amendment to this prospectus
under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling shareholders to include
the pledgee, transferee or other successors in interest as selling shareholders under this prospectus.
The
selling shareholders also may transfer the shares of our common stock in other circumstances, in which case the transferees, pledgees
or other successors in interest will be the selling beneficial owners for purposes of this prospectus and may sell the shares
of our common stock from time to time under this prospectus after we have filed an amendment to this prospectus under Rule 424(b)(3)
or other applicable provision of the Securities Act amending the list of selling shareholders to include the pledgees, transferees
or other successors in interest as selling shareholders under this prospectus. The selling shareholders also may transfer and
donate the shares of our common stock in other circumstances in which case the transferees, donees, pledgees or other successors
in interest will be the selling beneficial owners for purposes of this prospectus.
The
selling shareholders and any broker-dealers or agents that are involved in selling the shares may be deemed to be “underwriters”
within the meaning of the Securities Act in connection with such sales. In such event, any commissions paid, or any discounts
or concessions allowed to, such broker-dealers or agents and any profit realized on the resale of the shares purchased by them
may be deemed to be underwriting commissions or discounts under the Securities Act. At the time a particular offering of the shares
of our common stock is made, a prospectus supplement, if required, will be distributed which will set forth the aggregate amount
of shares of our common stock being offered and the terms of the offering, including the name or names of any broker-dealers or
agents, any discounts, commissions and other terms constituting compensation from the selling shareholders and any discounts,
commissions or concessions allowed or re-allowed or paid to broker-dealers. Under the securities laws of some states, the shares
of common stock may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states
the shares of our common stock may not be sold unless such shares have been registered or qualified for sale in such state or
an exemption from registration or qualification is available and is complied with. There can be no assurance that any selling
shareholder will sell any or all of the shares of our common stock registered pursuant to the registration statement, of which
this prospectus forms a part.
Each
selling shareholder has informed us that it does not have any agreement or understanding, directly or indirectly, with any person
to distribute our common stock. None of the selling shareholders who are affiliates of broker-dealers, other than the initial
purchasers in private transactions, purchased the shares of common stock outside of the ordinary course of business or, at the
time of the purchase of the common stock, had any agreements, plans or understandings, directly or indirectly, with any person
to distribute the securities.
We
are required to pay all fees and expenses incident to the registration of the shares of common stock. Except as provided for indemnification
of the selling shareholders, we are not obligated to pay any of the expenses of any attorney or other advisor engaged by a selling
shareholder. We have agreed to indemnify the selling shareholders against certain losses, claims, damages and liabilities, including
liabilities under the Securities Act.
If
we are notified by any selling shareholder that any material arrangement has been entered into with a broker-dealer for the sale
of shares of common stock, we will file a post-effective amendment to the registration statement. If the selling shareholders
use this prospectus for any sale of the shares of our common stock, they will be subject to the prospectus delivery requirements
of the Securities Act.
The
anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of our common stock and activities of the selling
shareholders, which may limit the timing of purchases and sales of any of the shares of common stock by the selling shareholders
and any other participating person. Regulation M may also restrict the ability of any person engaged in the distribution of the
shares of common stock to engage in passive market-making activities with respect to the shares of common stock. Passive market
making involves transactions in which a market maker acts as both our underwriter and as a purchaser of our common stock in the
secondary market. All of the foregoing may affect the marketability of the shares of common stock and the ability of any person
or entity to engage in market-making activities with respect to the shares of common stock.
Once
sold under the registration statement, of which this prospectus forms a part, the shares of common stock will be freely tradable
in the hands of persons other than our affiliates.
LEGAL
MATTERS
The
validity of the issuance of the securities offered hereby will be passed upon for us by Carmel, Milazzo & DiChiara LLP located
in New York, New York. Additional legal matters may be passed upon for us or any underwriters, dealers or agents, by counsel that
we will name in the applicable prospectus supplement.
EXPERTS
Haynie
& Company, an independent registered public accounting firm, has audited our consolidated financial statements for the years
ended December 31, 2017 and 2016 as set forth in their report dated March 27, 2018 which is incorporated by reference in
this prospectus. Our financial statements are incorporated by reference herein in reliance on Haynie & Company and its respective
report, given its authority as an expert in accounting and auditing matters.
WHERE
YOU CAN FIND MORE INFORMATION
We
have filed with the SEC a registration statement on Form S-1, together with any amendments and related exhibits, under the Securities
Act, with respect to our shares of common stock offered by this prospectus. The registration statement contains additional information
about us and our shares of common stock that we are offering in this prospectus. We are subject to the informational requirements
of the Exchange Act and file annual, quarterly and current reports and other information with the SEC. You can read our filings
over the Internet at the SEC’s website at www.sec.gov. You may also read and copy any document we file with the SEC at its
public reference facility at 100 F Street, N.E., Washington, D.C., 20549, on official business days during the hours of 10 a.m.
to 3 p.m. You may also obtain copies of the documents at prescribed rates by writing to the Public Reference Section of the SEC
at 100 F Street, N.E., Washington, D.C., 20549. Please call the SEC at 1-800-SEC-0330 for further information on the operation
of the public reference facility. In addition, you can find more information about us on our website at http://codiagnostics.com.
INCORPORATION
OF DOCUMENTS BY REFERENCE
We
have filed a registration statement on Form S-3 with the Securities and Exchange Commission under the Securities Act. This prospectus
is part of the registration statement but the registration statement includes and incorporates by reference additional information
and exhibits. The Securities and Exchange Commission permits us to “incorporate by reference” the information contained
in documents we file with the Securities and Exchange Commission, which means that we can disclose important information to you
by referring you to those documents rather than by including them in this prospectus. Information that is incorporated by reference
is considered to be part of this prospectus and you should read it with the same care that you read this prospectus. Information
that we file later with the Securities and Exchange Commission will automatically update and supersede the information that is
either contained, or incorporated by reference, in this prospectus, and will be considered to be a part of this prospectus from
the date those documents are filed. We have filed with the Securities and Exchange Commission, and incorporate by reference in
this prospectus:
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●
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Annual
Report on Form 10-K for the year ended December 31, 2017 filed on March 28, 2018;
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Quarterly
Report on Form 10-Q for the quarterly period ended March 31, 2018 as filed on May 14, 2018 and Form 10-Q for the quarterly
period ended June 30, 2018 as filed on August 10, 2018; and
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Periodic Report on Form 8-K filed on August 9, 2018.
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We
also incorporate by reference all additional documents that we file with the Securities and Exchange Commission under the terms
of Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act that are made after the date of the initial registration statement but
prior to effectiveness of the registration statement and after the date of this prospectus but prior to the termination of the
offering of the securities covered by this prospectus. We are not, however, incorporating, in each case, any documents or information
that we are deemed to furnish and not file in accordance with Securities and Exchange Commission rules.
You
may request, and we will provide you with, a copy of these filings, at no cost, by calling us at (801) 278-9769 or by writing
to us at the following address:
Co-Diagnostics,
Inc
4049
S. Highland Drive
Salt
Lake City, Utah 84124
Attn:
Dwight H. Egan, President and Chief Executive Officer
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and Distribution.
The
following table sets forth an estimate of the fees and expenses relating to the issuance and distribution of the securities being
registered hereby, other than underwriting discounts and commissions, all of which shall be borne by the Registrant. All of such
fees and expenses, except for the SEC registration fee and the FINRA filing fee, are estimated:
SEC registration fee
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$
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6,225.00
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Transfer
agent’s fees and expenses
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$
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*
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Legal
fees and expenses
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$
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*
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Printing
fees and expenses
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$
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*
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Accounting
fees and expenses
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$
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*
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Miscellaneous
fees and expenses
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$
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*
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Total
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$
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*
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*
These fees and expenses depend on the securities offered and the number of issuances, and accordingly cannot be estimated at this
time and will be reflected in the applicable prospectus supplement.
Item
15. Indemnification of Officers and Directors.
The
Company’s Articles of Incorporation provide that to the fullest extent permitted by the Company’s bylaws (the “Bylaws”)
or the Utah Revised Business Corporation Act (the “Act”), or any other applicable law, as either may be amended, a
director shall have no liability to the Company or its shareholders for monetary damages for conduct, any action taken, or any
failure to take any action as a director. As permitted by the Act, directors will not be personally liable to the Company or the
Company’s shareholders for monetary damages for any action taken or any failure to take action as a director except liability
for (a) the amount of a financial benefit received by a director to which he’s not entitled; (b) an intentional infliction
of harm on the Company or its shareholders; (c) an unlawful distribution in violation of Section 16-10a-842 of the Act; or (d)
an intentional violation of criminal law.
These
limitations of liability do not alter director liability under the federal securities laws and do not affect the availability
of equitable remedies, such as an injunction or rescission.
In
addition, the Bylaws provide that:
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the
Company will indemnify its directors to the fullest extent permitted by the Act, including advancing expenses in connection
with legal proceedings, subject to limited exceptions; and
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●
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the
Company may, to the extent permitted by the Act, by action of its board of directors, agree to indemnify officers, employees
and other agents of the Company and may advance expenses to such persons.
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The
Company has entered into indemnification agreements with each of the Company’s executive officers and directors. These agreements
provide that, subject to limited exceptions and among other things, the Company will indemnify each of its executive officers
and directors to the fullest extent permitted by law and advance expenses to each indemnity in connection with any proceeding
in which a right to indemnification is available.
The
Company maintains general liability insurance that covers certain liabilities of its directors and officers arising out of claims
based on acts or omissions in their capacities as directors or officers, including liabilities under the Securities Act. Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers, or persons who control
the Company, the Company has been informed that, in the opinion of the Commission, such indemnification is against public policy
as expressed in the Securities Act and is therefore unenforceable.
These
provisions may discourage shareholders from bringing a lawsuit against the Company’s directors for breach of their fiduciary
duty, or may have the practical effect in some cases of eliminating the Company’s shareholders’ ability to collect
monetary damages from its directors and officers. These provisions may also have the effect of reducing the likelihood of derivative
litigation against directors and officers, even though such an action, if successful, might otherwise benefit the Company and
its shareholders. Furthermore, a shareholder’s investment may be adversely affected to the extent the Company pays the costs
of settlement and damage awards against directors and officers pursuant to these indemnification provisions.
Item
16. Exhibits.
*
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Filed
herewith.
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**
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To
the extent applicable, to be filed as an exhibit to a document filed under the Securities Exchange Act of 1934, as amended,
and incorporated by reference herein.
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Item
17. Undertakings.
(a)
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The
undersigned registrant hereby undertakes:
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1.
To file, during any period in which offers or sales are being made, a post-effective amendment to this
registration statement:
i.
To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
ii.
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most
recent post- effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the
information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of
securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed
with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change
in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective
registration statement;
iii.
To include any material information with respect to the plan of distribution not previously disclosed in the registration
statement or any material change to such information in the registration statement; and
iv.
To provide to the underwriter at the closing specified in the underwriting agreements certificates in such denominations and
registered in such names as required by the underwriter to permit prompt delivery to each purchaser.
2.
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall
be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
3.
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering.
(b)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers
and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised
that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act of
1933 and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities, other than the
payment by the registrant of expenses incurred and paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding, is asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has
been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Securities Act of 1933 and will be governed by the final
adjudication of such issue.
(c)
Each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than
registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be
part of and included in the registration statement as of the date it is first used after effectiveness; provided, however,
that no statement made in a registration statement or prospectus that is part of the registration statement or made in a
document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify
any statement that was made in the registration statement or prospectus that was part of the registration statement or made
in any such document immediately prior to such date of first use.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant has duly caused this Registration Statement to be signed on
its behalf by the undersigned, thereunto duly authorized in Salt Lake City, Utah, on August 14, 2018.
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CO-DIAGNOSTICS,
INC.
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By:
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/s/
Dwight Egan
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Dwight
Egan
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Chief
Executive Officer, President and Director
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(Principal
Executive Officer and Interim Principal Financial and Accounting Officer)
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Pursuant
to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in
the capacities and on August 14, 2018.
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By:
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/s/
Dwight H. Egan
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Dwight
H. Egan
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Chief
Executive Officer, President and Chairman of the Board
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(Principal
Executive Officer)
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By:
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/s/
Reed L Benson
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Reed
L Benson
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Chief
Financial Officer and Secretary
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(Principal
Financial and Accounting Officer
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By:
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/s/
Brent Satterfield
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Brent
Satterfield
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Chief
Science Officer and Director
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By:
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/s/
Edward J. Borkowski
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Edward
J. Borkowski
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Director
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By:
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/s/
Frank J. Kiesner
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Frank
J. Kiesner
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Director
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By:
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/s/
Richard S. Serbin
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Richard
S. Serbin
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Director
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